This report builds on earlier research from Battelle that looked more broadly at the economic impact and return on the federal investment in the Human Genome Project. The study of the HGP found that the public investment of $3.8 billion spread between 1988 and 2003 yielded $796 billion in economic output, and created nearly 4 million years of full-time employment, or job-years, between 1988 and 2010. This farsighted, bipartisan investment in genomics research helped seed new biotech industries, which in 2010 alone added $67 billion to U.S. gross domestic product—the largest measure of growth in our economy—created $20 billion in personal income for American families, and sustained 310,000 public- and private-sector jobs.

This $3.8 billion public investment in basic research yielded a 14,000 percent return for the economy, so it is no wonder that the ACLA is revisiting the investigation into public investment in biomedical research—it pays. The new study focused more narrowly on the economic impact of genetic and genomic clinical tests developed by the biomedical industry. Battelle’s new report brings to light figures about the benefits of genomic science and research that are just as impressive as the HGP results. According to the report:

Built upon U.S. investment in basic science and translational biomedical research, U.S. industry has produced a broad range of high-value biomedical technologies and products that create high-paying jobs and sustain America’s leadership in the modern innovation economy.

Spawned by the Human Genome Project itself, Battelle found that the genetic and genomic testing industry is currently contributing “more than 116,000 U.S. jobs; nearly $6 billion in personal income for U.S. workers; $9.2 billion in value-added activity; and $16.5 billion in national economic output.” The state and federal taxes collected from this young industry have states competing for the high-tech jobs and revenue generated by the highly profitable sector.

Battelle cites the states’ implementation of strategic planning to attract new biotech firms by “creating tax and regulatory environments to support and expand growing companies” and “supplying capital for facilities funding.” This 2008 report goes on to discuss the close working relationship states are developing with the firms to “develop and create a skilled workforce.” Now here is a jobs plan in action.

But looking beyond the numbers, the genetic testing industry is helping usher in a new era of biotechnology, personalized medicine, and forensics. According to the study, the genetic testing industry is already leading to positive outcomes in diverse fields such as:

Predicting risk of disease, screening newborns, directing clinical management, identifying carriers, and establishing prenatal or clinical diagnoses or prognoses in individuals, families, or population, as well as use for forensic and identity purposes.

The growth of this industry is paving the way for precision diagnoses and targeted therapies that improve health care outcomes. Oak Ridge National Laboratory says using genetic testing can give medical professionals a host of new tools to “clarify diagnoses” and make treatment more effective. One case in point: One study of genetic versus conventional diagnosis for retinoblastoma, a form of eye cancer, found the ability to act on “predictive” genetic tests “can help to save the vision and avoid unnecessary (and invasive) eye examinations for [patients] and their close relatives.” In conclusion the study found genetic diagnosis to be “cheaper” than conventional methods.

Treatments for diabetes, heart disease, Alzheimer’s, and cancer—all diseases thought to have hereditary indicators—comprise 75 percent of U.S. health care costs, according to the Centers for Disease Control. So the ability to detect these diseases through genetic testing long before the symptoms set in may reduce costs associated with costly emergency treatments, and improve the lives of many, though such knowledge comes with its own set of ethical questions, particularly in the case of Alzheimer’s.

But the promise of genetic testing and personalized medicine can only be attained if we continue to invest in publicly funded research, and if we are willing to make some tricky ethical choices, whether they mean choosing to know what’s in our genes, or allowing our genetic information to be used in large longitudinal data sets.

Even Craig Venter, a renowned NIH researcher and biotech CEO who famously competed with the federal government to help unravel the human genome, advocated for the need for federal investment in a hearing before the House Commerce Committee in 2003. “To enjoy the promise of personalized and preventative genomic medicine, we must compare the genomes of tens of thousands of people to better understand the genetic causes of complex diseases,” he said. “Going forward, it is critical that both the NIH and DOE continue to support innovative projects that constantly encourage technological innovation and drive down the costs of sequencing.”

The sequencing of the entire human has decreased “100 fold” since the first human genetic tests became available. The U.S. National Library of Medicine has found “The cost of genetic testing can range from under $100 to more than $2,000, depending on the nature and complexity of the test.” As of 2011, it cost just under $10,000 to sequence a person’s entire genome. That cost reflects a significant “outpacing of Moore’s Law” considering that the first genomes cost nearly $100 million to sequence. (see graphic)

The cost decrease of whole genome sequencing to $1,000 has long been the point at which it is considered cost effective enough to have as a standard medical test. According to the Presidential Commission for the Study of Bioethical Issues, 2012 is likely to be “the year that the cost of whole genome sequencing will reach approximately $1,000.” And beyond the economics, the commission is also helping to sort through some of the ethics and privacy questions to genomic research, such as how whole-person genomic information is collected and stored, and what constitutes informed consent.

From the medical march toward increasing efficiency and accuracy in health care services, to the need to drive down costs, public investment in genetic medicine has provided new avenues for lawmakers and medical professionals to achieve their goals. The fact that such investment creates new industries and jobs is a silver lining that should make for easy legislative budgeting. As the debate rages on over whether or not government spending can create jobs or not, we need to continue to distinguish between spending and smart investments with positive economic and public health returns. As Battelle has once again demonstrated, federal funding for science, research, and development are some of the smartest investments we can make in our long-term economic future.

Jason Thomas is a Science Progress intern at the Center for American Progress.

In the new book, Legally Poisoned: How the Law Puts Us at Risk from Toxicants, Carl F. Cranor brings together decades of legal and academic experience on regulation of industrial, agricultural, and pharmaceutical chemicals and outlines what we need to do better to protect the environment and public health.

In our podcast, Dr. Cranor walks us through the history of regulation and testing of commercial chemicals, from bisphenol A, or BPA, to lead, mercury, pesticides, drugs, and other chemicals. Because many industrial chemicals are designed to be persistent, they bioaccumulate, or build up in our bodies and in the bodies of other organisms, and can even be transmitted to fetuses in utero.

Recent science has shown that these chemicals rarely stay in the products they were designed for. More than 200 industrial chemicals can be found in the body of an average American today. Because they are transmitted to fetuses, even newborn babies have these chemicals in their bodies. Though the effects of many of these chemicals on human health is unknown, studies are showing that more and more chemicals previously thought harmless may have significant negative effects on the expression of genes and early development of babies, or cause disorders, chronic disease and premature death in adults.

We should assume that any molecule we put into the environment will get into our bodies, cross the placenta, and get into the breast milk.

 Though the ways in which industrial chemicals come to reside in our bodies is increasingly well understood, our nation’s testing and regulatory system has not evolved to keep pace. Though the FDA maintains strong testing requirements for new drugs–substances we put into our bodies intentionally–a corresponding process to test the hundreds of industrial chemicals that enter our bodies accidentally does not yet exist.

Because no pre-market testing is required of new industrial chemicals as it is for pharmaceuticals, companies have no incentive to ensure their products are safe for human use. Dr. Cranor argues persuasively, through rigorous scientific and legal research, that moving our industrial chemical safety laws toward a pre-market testing approach can help create incentives for companies to invest in safety and improve human health.

Carl F. Cranor is author of Legally Poisoned: How the Law Puts Us at Risk from Toxicants, and a distinguished professor of Philosophy at the University of California, Riverside. Sean Pool is Managing Editor of Science Progress.

Questions like these are bound to arise more often as scientific discovery and technological development proceed inexorably. “I worry about how this develops,” said California Sen. Diane Feinstein in an interview with the Washington Post. “I’m worried because of what increased technology will make it capable of doing.”

“Each step in the laboratory toward understanding what makes a pathogen tick… ratchets up the dual-use dilemma.” The knowledge can be used for protection, or aggression.

Feinstein was not talking about H5N1 experiments—about mutations created in a biosafety laboratory that allow the deadly virus to infect through the air—but about what the newspaper headlined as “an emerging global apparatus for drone killing.” Remotely piloted drones are quietly but surely changing the face of warfare. Advances in electronics, physics, optics, materials, and other fields represent the “increased technology” Sen. Feinstein alludes to, technology that is certain to evolve because it goes to the heart of national security. Thus funding will be plentiful.

Defense agency funding has flowed generously into biology for two decades and massively since 9/11 and the anthrax attacks that followed. One of the predictable consequences of the federal largess has been the rise of a national biodefense industry with its hub in Arlington, Virginia. Bioprotection against bioterror attacks is offered as the justification for the buildup. Of course, bioprotection is also advanced by microbiologists, virologists, public health agencies, and drug and vaccine manufacturers as justification for experimenting with dangerous microbes.

The problem is that each step in the laboratory toward understanding what makes a pathogen tick and what modifications would make it more robust or enable it to go airborne or evade immunity (in the event evolution consents to such modifications outside the lab) ratchets up the dual-use dilemma.  The National Science Advisory Board for Biosecurity (NSABB) defines dual-use research as “biological research with legitimate scientific purpose, the results of which may be misused to pose a biologic threat to public health and/or national security.”  Because the human immune system is our most vital biodefense shield, technology that mimics its function and discloses its vulnerabilities also ratchets up the dual-use dilemma. As we know, technology rarely stays safely at home.

When asked by the New York Times about what information should be shared from his experiments with the H5N1 virus, Dutch scientist Ron Fouchier said three types: information about the fact that the virus can be genetically modified to go airborne between mammals; information necessary to direct surveillance in the field to these mutations; and information necessary to prepare ourselves “by evaluating vaccines and antivirals.”

As we explain in a chapter of our book The Stem Cell Dilemma, technologies for “rapid vaccine assessment” do exist thanks to the Defense Advanced Research Projects Agency. DARPA banks on high risk, high reward projects. The agency that brought us the Internet, stealth technology, and global positioning system, or GPS, satellites routinely excludes from funding consideration “research that primarily results in evolutionary improvements to the existing state of practice.” In 2002, DARPA’s Defense Sciences Office launched an engineered tissue constructs program. The stated goal of the program was “to develop an interactive and functional human immune system” in the laboratory from “a common stem cell source” using tissue-engineering technologies. Such a system would be used to develop and test new vaccines rapidly in a human immune system replica rather than in mice and rats.

The program morphed into “Modular Immune In Vitro Constructs,” or MIMIC, in 2009, one of three prongs of a new DARPA program called “Blue Angel” designed to speed up the development of vaccines in response to the H1N1 pandemic. The MIMIC machine was developed by VaxDesign, Inc., an Orlando, Florida-based company established by former DARPA program manager William Warren. In 2006, Warren and members of his scientific team filed patent applications in the United States, Canada, and Europe for an “Automated artificial immune system” to test vaccines, drugs, and biologics. According to the application, “Functional equivalency to the human immune system is achieved by building engineered tissue constructs (ETCs) housed in a modular, immunobioreactor system.” The MIMIC, which is manufactured by robots, enables researchers to test the immune response to an experimental vaccine or drug developed to fight natural or engineered viruses or other pathogens. Each well in MIMIC’s 96-well plastic plate is said to represent a human immune system complete with B cells, T cells, and dendritic cells, the progeny of blood-forming stem cells.

The success of VaxDesign’s immune system-mimicking technology was borne out when the French multinational firm Sanofi Pasteur, the world’s largest vaccine manufacturer, purchased the company in 2010. VaxDesign and Sanofi scientists have filed patents claiming propriety interest in using additional immunological components, such as lymph node germinal centers, to enhance the performance of the machine. Step by step, the human immune system is being mechanized.

We write in our book: “What would it mean to capture the power of the human immune system, a system that took evolution millennia to create? The drive to disclose the secrets of the stem cell is relentless. Just as war accelerated the harnessing of the power of the atom, the prospects of bird flu as well as bioterror accelerate the application of molecular and stem cell biology for bioprotection.”

As if on cue, just before the second edition of our book was published last fall, DARPA announced a partnership with the National Institutes of Health and the U.S. Food and Drug Administration in launching its Microphysiological Systems program. The five-year $140 million program ($70 million from DARPA and $70 million from NIH) “will develop a platform that uses engineered human tissue to mimic human physiological systems” including the immune system. Human cell types found in different human physiological systems will be arranged in 3D constructs so they can “talk to each other” on a chip. Biochips equipped with embryonic stem cells, induced pluripotent stem cells, progenitor cells, or cells found in specific tissues and organs will be used to predict whether a drug or vaccine is safe and effective.  A candidate vaccine designed to be protective against Fouchier’s airborne H5N1 virus could be tested and, in theory, perfected.

Such knowledge platforms would be of incalculable value to medicine and public health. They would also be an incalculable hazard were they to fall into the wrong hands, hands capable of engineering lethal agents. With the expansion of biological knowledge around the world, these hands are proliferating, too. The complementarity of sword and shield, arrow and armor, bullet and vest, and bomb and shelter is represented today by engineered viruses and engineered immune systems. The click-click cadence of the dual-use ratchet will surely grow louder.

William Hoffman is co-author with Leo Furcht, MD of The Stem Cell Dilemma: The Scientific Breakthroughs, Ethical Concerns, Political Tensions, and Hope Surrounding Stem Cell Research (Arcade Publishing, 2011). Both are in the Department of Laboratory Medicine and Pathology, University of Minnesota.

A good illustration of this truism is the unanimous recommendation by the National Science Advisory Board for Biosecurity (NSABB) that two leading journals not publish certain details about experiments with a version of the H5N1 virus, also known as “bird flu.”

The board’s concern is that the information about the experiments, which involved genetic mutations that made the virus much more virulent than the versions seen in nature, could lead to a bioterror weapon. But the reaction by the editors of the journals Nature and Science to the proposed de facto censorship of research results was, as described by a Washington Post report, “chilly.” An expert not on the NSABB was quoted as saying that that the recommendation was “ridiculous” because the risks the results present to humans are remote.

The board’s recommendation doesn’t go directly to the journal publishers, scientists or their institutions (one is the University of Wisconsin, the other in The Netherlands), but to the Department of Health and Human Services (DHHS), which in turn can only urge the journals to withhold information. One sticking point that gives the U.S. government leverage is that the research in both institutions was apparently done using federal funds. But the U.S. surely doesn’t want to look like it’s trying to keep the data to itself.

Beyond these short-term calculations, the incident reveals a deep philosophical divide about biological research that could threaten national security and public health, one that I have observed for years as an unpaid advisor to several government agencies including the NSABB (but not having to do with the current studies): How risk-averse should the life sciences community be in an era of asymmetric warfare? In the twentieth century nation-states found biological weapons to be pretty useless and unmanageable, but non-state actors and rogue states might still find them of interest.

Unlike physicists, whose modern discipline grew up in an atmosphere of the deepest possible relevance to national security during World War II, the culture of life scientists is not so woven in with security concerns. An interesting exception was scientists’ self-imposed mid-1970s moratorium on recombinant DNA research, but that didn’t last very long and didn’t involve terrorism fears but rather environmental risks. Obviously that has changed somewhat since the October 2011 anthrax attacks, but international treaties have imposed successful prohibitions on novel development of biological weapons (BW) since 1970. The most extensive effort to develop innovative BW was the secret and illegal Soviet program that continued right up to the end of the cold war. Further complicating the picture is the fact that quite a bit of funding for biology has resulted from post-9/11 worries, particularly in the form of secured laboratories for research on potentially dangerous pathogens.

Still, the default position of biologists is usually that more publicity is protective rather than threatening, that in the long run secrecy works against security rather than for it. Published results, it is generally thought, will help the scientific community and responsible authorities prepare for threats that might be posed by new knowledge well in advance of any actual attempts to use them.

Aiming at a compromise, before accepting the NSABB recommendations the two journals have asked for detailed plans from government that would enable “responsible scientists” to have access to the experiments’ details. How such a program would operate, especially in the hotbed of shared information created by the Internet, is not at all clear. What is clear is that the biological science community is very far from adopting anything like a “prudential principle” that would put the burden of proof on those who say there is no risk to a new source of knowledge.

Jonathan D. Moreno is the Editor-In-Chief of Science Progress. This article is cross-posted at the Huffington Post.

Science Progress Editor-In-Chief Jonathan D. Moreno, in a Huffington Post cross-post.

When the politics of biology rears its head all bets are off.

As I argue in my new book The Body Politic: The Battle Over Science in America, we are in the midst of a new biopolitics in which the power of science confounds the usual left-right spectrum of public policy, one that by no means favors one side or the other. Witness Governor Rick Perry’s awkward defense of his executive order on the HPV vaccine and the rush to defend his policy (if not the governor himself), by women’s health advocacy groups.

Now comes the firestorm over Plan B (the so-called “morning after pill”)

These days the left and the right approach politically desirable science policy in somewhat different ways. The right’s approach is to use evidence when it’s available (or if someone can be found who appears to qualify as an “expert”), but quite willing to default to traditional values and to be explicit in doing so. The left’s approach to a desired political outcome when science is involved is to deny that there is a conflict with evidence and engage in a search for facts to support the wanted theory.

The decision to deny over-the-counter-access to Plan B is particularly awkward for an administration that early on pledged to “base our public policies on the soundest science,” and to be “open and honest with the American people about the science behind our decisions.”

Whatever its political wisdom of foolishness, the administration’s Plan B decision qualifies as a theory in search of the facts. For example, in her statement overruling the Food and Drug Administration (a remarkable event in itself), DHHS Secretary Kathleen Sebelius stated that young girls might not understand the consequences of using Plan B. Yet evidence that reached precisely the opposite conclusion was instrumental in the FDA’s approval recommendation.

As to the sort of expert opinion so valued on the left, The American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the Society for Adolescent Health and Medicine all “denounced” the HHS’s decision.

Cynics will ask, why should science be different? As in business, finance, sports, entertainment and all fields of human endeavor there is always politics. In general that is a good thing, since the only alternative to politics as a way to settle our differences is violence.

Nonetheless, one feature of modernity is the intuitive sense that somehow science should be different. The value of evidence and public demonstration through experimentation is a hard-won Enlightenment principle that, seen through the 200,000-year lens of human history, occurred to us just moments ago. Considering the blood, sweat and tears that took us to this point, cynicism about science and politics is cheap and lazy.

In the short run there’s still a political element when policy decisions are being made, but in the long run the scientific method does make science unique. Our task is to defend the science even — and especially — from those who claim to be its friends.

So how is the country doing in biotech investment? A fascinating and richly detailed new industry report from Jones Lang Lasalle allows us to reach two salient conclusions: first, the United States is holding its own as the global leader; and second, since the 2007 downturn, industry clusters in China, India, and Singapore have displaced traditional powers Ireland, Italy, Germany, and Spain in direct pharmaceutical investment.

This result confirms the narrative we hear in so many fields these days about the turn toward Asia, and well justifies the Obama administration’s reassertion of American interests as a Pacific power.

Digging deeper into the U.S. data, what is striking is the opportunities for development in so much of the country, which is currently dominated by a few regions at the top. According to the report’s ranking system, the top three regional biotech “clusters” are Boston, New York/New Jersey, and the Bay Area. But while it’s pretty clear that clusters in the Northeast and California dominate the biotech industry today, at the same time emerging clusters across the South and Midwest–Atlanta to Denver to Indianapolis to Houston–could have tremendous potential with the right policies and investments. As the report notes:

Some clusters, like Chicago and Houston, have very strong intellectual capacities and research institutions, but struggle to translate innovation from bench to marketplace due to lacking fiscal support or programming. While others, like Florida, Minneapolis and Indianapolis, have strong industry representation but remain challenged by fragmented framework, most notably lackluster funding from NIH and VC sources.

So policy frameworks do make a difference in regional success or failure. The online science policy journal I edit for the Center for American Progress, Science Progress, has long advocated for the value of investing in regional economic clusters as way to accelerate innovation and create jobs. Political candidates should take note that emerging clusters abroad are taking advantage of government policies that make them more competitive in high technology, especially India, China, Singapore, and Brazil. So while the last few years have shown U.S. resilience, there’s no time for complacency. In my new book, The Body Politic: The Battle Over Science in America, I argue that biotechnology needs to become part of the American narrative of progress and innovation. Creating incentives and programs to help level the playing field for nascent innovation clusters across the country would make America more competitive in the face of the emerging clusters abroad.

And a candidate who addresses those regional potentials might just strike a responsive chord that translates into votes.

Science Progress Editor-In-Chief, Jonathan Moreno, in a Huffington Post cross-post.

Dr. Jason Karlawish, author of 'Open Wound'

But in the name of charity and goodness, Beaumont ignores the orders and saves the young man’s life. What neither the doctor nor his patient understands—yet—is that even as Beaumont’s care of St. Martin continues for decades, the motives and merits of his attention are far from clear. In fact, for what he does to his patient, Beaumont will eventually stand trial and be judged.

Rooted deeply in historic fact, Dr. Jason Karlawish’s marvelous new book traces the peculiar career of 19th century clinician-turned-scientist Dr. William Beaumont, who became a scientific one-hit-wonder by exploiting the body of the man who’s life he saved.

Open Wound artfully fictionalizes the complex, lifelong relationship between Beaumont and his illiterate French Canadian patient. The young trapper’s injury never completely heals, leaving a hole into his stomach that the curious doctor uses as a window to understand the mysteries of digestion. Eager to rise up from his humble origins and self-conscious that his medical training occurred as an apprentice to a rural physician rather than at an elite university, Beaumont seizes the opportunity to experiment upon his patient’s stomach in order to write a book that he hopes will establish his legitimacy and secure his prosperity.

As Abigail Zuger writes in her review of the book in Tuesday’s New York Times:

Over the next few decades, the two danced around each other in an extraordinary display of mutual dependence, hostility, loyalty, guilt, gratitude and greed. Who owed whom, and how much? Where did the moral right lie? With the doctor, who had saved St. Martin’s life, supported him financially for years, and aimed to benefit all of humanity with his investigations? Or with St. Martin, a hopeless alcoholic but still a free man with the right to walk away, as he repeatedly did?

Ultimately, in perhaps the only such document to link doctor and patient until today’s informed consents for research subjects, a legal contract was drawn up between them, the patient promising to “serve, abide and continue,” and the doctor promising reasonable compensation. It worked, for a little while.

Dr. Karlawish, a physician and medical ethicist at the University of Pennsylvania, is well attuned to the overtones of his compelling story, from the graphic examples of the principles of autonomy and beneficence to the clear parallels between the rough American frontier and the primitive state of medical research. His Beaumont is a true tragic hero, an unpedigreed nobody determined to succeed on his own merits, yet undermined by exactly that determination.

Beaumont, always growing hungrier for more wealth and more prestige, personifies the best and worst aspects of American ambition and power.

The excerpt below takes place at the moment when Dr. Beaumont, a dedicated clinician, first recognizes the value of his patient’s wound to medical science and also to his career. On this day, Doctor Beaumont would begin his transformation from doctor to researcher, to employer, to entrepreneur, while Alexis would suffer his parallel transformation from patient, to subject, to employee, to object.

Excerpt from Open Wound: The Tragic Obsession of Dr. William Beaumont

Part I – The Taker Made Mad

By early October, three months after the shooting, summer was fast vanishing. Days were shorter but the light brighter, as if the sun were burning more intensely in a futile gesture to stall the onset of winter. The agents from the American Fur Company, and the American soldiers and their officers prepared Mackinac Island for the interminable months of frozen isolation. The brigades of voyageurs and Indians dismantled their tent and lean-to village along the lake shore and embarked in their bateaux and canoes and paddled north to Canada or south to the Michigan Territory to take shelter in the pine and hardwood forests of the mainland. The white children returned to school.

Alexis’ days had settled into a routine which began when Beaumont stepped into the infirmary of the ramshackle hospital carrying his basket of medical supplies.

“Good morning Alexis.”

He smiled as he watched Alexis yawn and rub the mount of his palms against his eyes.

“Good evening mon Doctor Beaumont.” Alexis laughed. “Good morning. Morning.” His accented English ran hard on the d’s, swallowed the r’s.

Still sore from his wound, Alexis lay flat upon his back, gathered his nightshirt under his armpits, then folded over the thin blanket to reveal his abdomen swaddled with the bandages Beaumont had applied the previous evening. Beaumont took care to wrap the bandages tightly around Alexis’ torso from his breasts to his navel. To keep them in place, he passed a final wrapping like a Sam Browne belt, across his right shoulder. The bandages themselves revealed the progress of the wound’s healing. It had been at least four weeks since the outer layer showed the ruddy stain of discharge.

As usual, Alexis gazed straight up at the ceiling, waiting patiently, blinking. “Madame Beaumont, she is well?”

“She’s well. Quite well.”

Alexis nodded and smiled. “Little Sarah?”

“Very well, thank you. They wish you well too. Now please Alexis, if you could just lie still as usual.”

Beside Alexis’ cot Beaumont placed the simple brown wicker basket that held bandage rolls, his surgeon’s pocket kit and a bottle of diluted muriatic acid he had gathered from the supply room. He sat on the edge of the bed, just inches from Alexis. The bed frame creaked as it always did.

Beaumont took his surgeon’s kit from the basket, unrolled it on the mattress, took up his jack knife and set to work methodically cutting away the dressings. Someone whistled as he passed close to Alexis’ window, and Beaumont hummed a few bars of that tune. He found himself tapping his foot to the timing of the blacksmith’s hammer.

He folded away the sliced bandages to reveal a wad of carefully packed bandages the size of a tea saucer. The skin around the wound was still inflamed but no longer grossly purple. It blanched under the gentle press of Beaumont’s thumb. He had not bled Alexis in over eight weeks.

He began to peel away the lint packing and with that packing now removed, the pink ruggated puckering of the inner lining of stomach bloomed through the wound like some large rose. Alexis coughed and the bloom expanded, glistening and covered with a limpid fluid, uniformly spreading over its whole surface and trickling to the edges of the wound. Beaumont gazed upon this display for some moments, then he applied three fingers of gentle pressure to the center of the bloom and it slowly depressed into the blackness of the space that was Alexis’ stomach. An amazing sight each time he witnessed it.

Beaumont folded a clean lint bandage into a square, soaked this with muriatic acid and began to wipe the edges of the wound and the track where once Alexis had a fifth rib. In time, Beaumont thought, all in time, this wound will close and I will have a case worthy of the Medical Recorder.

Alexis coughed again. A bit of meat, chewed, but unmistakably meat, popped out from the aperture and onto the bandages and a slow trickle of gastric juice flowed out from the lower margin of the wound.

Beaumont picked up the meat and inspected it. He had instructed Alexis to keep an empty stomach to prevent just such soiling of the wound during morning dressing changes. Now he held in his hand the evidence that Alexis had stolen a meal some time in the early morning hours. He was disobedient to be sure, yet this clandestine meal also was another sign of his slow, but now certain recovery.

Alexis laughed and muttered in French. Beaumont had seen food in just this state before. There was nothing unique about this morning and this piece of meat.

As he held the partly digested bit of meat between his thumb and forefinger and gazed at the wound, two facts came together for him. He felt as he did that morning some ten years past when he first stepped into his assigned hospital tent at the camp in Plattsburgh. Or when taking calls as apprentice to Dr. Chandler. It was the same sense in his guts and rush of blood to his head as when he was a boy jumping from the barn’s rafters into the hay pile.

For weeks he had observed that the hole into Alexis’ stomach gave off no odor or other evidence of putrefaction. Perhaps the cavity did not work as he had been taught, like a barrel to churn and ferment food, but in some other and, it seemed, more elegant manner. The action of the muriatic acid with which he painted the wound to cleanse it and stimulate healing was the same as the action of the stomach upon this piece of salt pork. The action was like a solvent upon the flesh, a solvent that affected a steady dissolution of the tissues. The stomach was perhaps not as he and so many of his colleagues had thought it to be some grinding bag or fermenting vat. It was some manner of chemistry, like an alchemist’s trick that made flesh disappear.

On this morning, an idea kindled not reason’s ordered plans, but desire laid to make the taker mad.

Alexis was his patient, of course, but he could be something else too. Beaumont could not conjure that proper word but whatever the word, on this morning he realized that this man, this wound, was his window to discovery.

Wondrous discoveries. Discoveries of the secrets of digestion and diet that would rival the work of the famous Parisian physicians. There wasn’t another proper doctor within hundreds of miles, a situation not only conducive to a steady and good income but now there was also the discovery of this treasure. It was his and it was simply waiting to be explored and written into a book. It was like the vast western lands that President Jefferson purchased and Captains Lewis and Clark charted and from which the American Fur Company extracted profits. The unknown was waiting to be known, and once known, rewards would follow. Promotion to Surgeon secured, election to medical societies. He would erase the humility of his medical training as an apprentice and the condescension of the medical college graduates. His reputation would be solid and preserved for posthumous time.

He shook his head like a drinker who’d swallowed more than his fill.

I am a doctor, not a scientist, he thought. This was work he had no sense of how to do, where to begin or how to finish before the wound fully healed and sealed its secrets. How would he convince Deborah of the worth of this sacrifice of time and their family’s money? And if it was ever done, whatever it really was, he had no idea how to sell it. The idea was swallowed bait, a folly even.

“God-damn,” he muttered.

Alexis grew concerned.

“What is it? Is there problem? A type of what you call, what you call, pains. Oui?” His smile had vanished.

Beaumont tried to calm his patient. He began to quickly wrap the bandages into a wad.

“Nothing’s wrong, Alexis. Nothing at all. You’re doing well. Truly, yes, all is well.” He reached out and embraced Alexis. He smiled as best he could. “You’re the very model of recovery.”

Alexis wrinkled his brow, then relaxed and returned his doctor’s smile like a moon reflecting the light of its sun but ignorant of the nature of fire that kindled that illuminating light. He spoke in unusually clear English.

“No, my Doctor Beaumont, I am your miracle.”

To learn more, visit www.press.umich.edu/titleDetailDesc.do?id=3849699 and www.jasonkarlawish.com.

Daniel Engber has authored an excellent, three-part expose at Slate that answers these and other questions about the animal research industry.

Part One, “The Mouse Trap,” looks at the realities and dangers of our dependence on cheap, couch-potato mice for medical research.

Part Two, “The Trouble With Black-6,” examines the peculiarities of the world’s largest research mouse supplier’s best-selling mouse, an inbred, alcoholic critter called Black-6.

Part Three, “The Anti-Mouse,”  looks at recent research using a hairless African rodent called the Naked Mole Rat. What makes this rodent worth study? Researchers have found that it seems to be completely immune to cancer, no matter how many carcinogens it is exposed to.

Additionally, Slate put together this excellent slide show, where you can meet the 10 most common lab rodents. An excerpt from part one follows.

The Mouse Trap

The dangers of using one lab animal to study every disease

The government’s top researcher on tuberculosis—still one of the world’s most deadly infections—seems to be running a midsized wildlife park out of his Maryland home. In a modest house on a tree-lined street in Germantown, Clif Barry keeps two kinds of turtles, three veiled chameleons, two Jackson’s chameleons, six species of frogs, half a dozen fish tanks (filled with cichlids, goldfish, and piranhas, kept separately), two dogs (named Jacques and Gillian), and an Australian tree python. “I’m an animal person,” he tells me. “My house would require a zookeeper’s license if Montgomery County knew what I had.”

Each step leads to the next: No drug can be tested in man until it’s been shown to work in mice, and no drug is tested in mice until it’s been shown to have a reasonable effect in the dish. “The bad part of that,” says Barry, “is that no part of it is predictive:” A new compound that succeeds in the dish might flunk out in the mouse, and something that can cure tuberculosis in a mouse could wash out in people…

The fact that nothing gets to humans today without first passing the mouse test, says Barry, “has cost us a new generation of medicines.” … Read the rest of this article at Slate.

Why do we have trouble defining what a “person” is? The answer may lie in human evolutionary antiquity.

Recent efforts by radical pro-life conservatives to establish a definition of personhood that specifically includes the embryo at the moment of conception have failed both in at least three ways. First, they have been rejected by voters in Colorado (twice) and Mississippi. Second, they have failed to win the hearts and minds of most cultural conservatives themselves, with even respected leaders like outgoing Mississippi Haley Barbour withholding an enthusiastic endorsement. Third, moderate voters worried about the implications for contraception and fertility treatments. The Mississippi initiative defined a person as “every human being from the moment of fertilization, cloning, or the functional equivalent thereof.”

The ambiguous language of “humans”, “human beings” and “persons” is too rarely noticed as a key factor in the ways that people talk past each other. Progressives might blanch at the intuitive implications of calling a human embryo a human being, but (as a leading conservative intellectual pointed out to me years ago), it is surely not a non-human being. Conversely, conservatives worry about the arbitrariness of “person” or “personhood” that could result in dehumanizing those with impaired cognition (like Terri Schiavo), or those who don’t measure up based on some racial or other social prejudice, or of course embryos. For them the term might also be too inclusive, as it might apply to our higher primate relatives or perhaps someday to super-intelligent machines with self-awareness.

Is the idea of personhood like pornography? Do we know it when we see it? As the neuroscientists Martha Farah and Andrea Heberlein put it in a 2007 paper, “personhood is a concept that everyone feels they understand but no one can satisfactorily define.”

Farah and Heberlein note that there is evidence our brains are “hard-wired” to distinguish between persons and non-persons. They cite a rare condition called prosopagnosia. People with this disorder cannot recognize a human face, yet some of them can still recognize an animal face. Brain imaging has even given evidence that there is a specific brain region, called the fusiform gyrus, for human face recognition. Other experiments show that the sight of human bodies themselves, even with the faces obscured, is associated with the activation of the fusiform gyrus and another brain region. Another brain area is active when actions are perceived to be intentional and still another when we just think about someone else’s mental state; in other words, when we think about someone else thinking.

So it seems evolution has set us up to see the world as divided between persons and non-persons. But here’s the problem: we evolved in a world in which we rarely encountered ambiguous cases. As Farah and Heberlein wrote in 2007, during 200,000 years of hunting and gathering, “Sonograms did not show us our fetuses; people did not live long enough to develop Alzheimer’s disease, and vegetative states were fatal. ” They continue:

It is interesting that infants and young children may be the one class of ambiguous cases that our ancestors did encounter on a regular basis, and for these cases it would be adaptive to attribute personhood even in the absence of intelligence and self-awareness. Protohumans who accurately judged their offspring to be lacking in the various traits associated with personhood and accordingly treated them as non-persons would not have many surviving descendents!

It seems that the neuroscientific and evolutionary evidence for a hard-wired but increasingly dysfunctional idea of personhood is compelling (and of course one can accept the neuroscience data without accepting the evolutionary explanation).

In The Body Politic I argue that this kind of disconcerting boundary-erasure is one of the reasons that the new biology, including neuroscience, has stimulated a new biopolitical era. The advocacy group Personhood USA is not giving up, with efforts like the failed Colorado and Mississippi ongoing in other states. And presidential candidate Newt Gingrich has reportedly advocated a federal law that would define a person as present at conception. Although Personhood USA blames Planned Parenthood and the radical left for its defeats, the fact is that the vast majority of voters in a culturally conservative Southern state rejected their campaign.

The possibility that people are giving the matter deeper thought than simply following a convenient ideological line is encouraging. The problem of personhood is even deeper than gaining agreement about the beginning of life. The challenge it presents is the beginning of wisdom, one for which evolution has, we may hope, also prepared us.

So what was I doing inside the Vatican walls? Attending a rather unusual conference sponsored by the Pontifical Academy for Culture.

The general theme of the conference was “can religion and science ever get along?” Specifically, can stem cell research proceed with the blessing of religion? The Roman Catholic Church thinks so. That is why the Vatican held this unprecedented three-day meeting of mainly Catholic theologians, a few ethicists, politicians, doctors, patients, and scientists from around the world that wrapped up this past Saturday with an audience with Pope Benedict XVI.

The Vatican will issue a statement in a week or two about the conference. But since I was given the chance to be one of the invited speakers, I can offer a peek into what they will likely say.

The leaders of the Roman Catholic Church have made it clear time and again that they oppose the destruction of embryos as a way to get stem cells. No news there. In fact, the scientific status of embryonic stem cell research never got a spot in the three-day event. The point of this meeting was partly to reemphasize Rome’s implacable moral opposition to any research involving embryo destruction.

The Vatican is throwing its ethical might and even its money into the debate about where to get stem cells and how best to study them.

That stance leaves the Roman Catholic hierarchy in a tough ethical spot. The church wants to find cures for a long list of awful diseases. But the prelates face the prospect of a possible cure coming from embryonic stem cell research now ongoing in many nations and then having to take a position, likely to be negative, on the morality of the desperately ill using such a cure on themselves or their children.

A major point of the meeting was to address these dilemmas and make it clear to the world that the Vatican is aware of the need to find cures. The meeting was designed to illustrate a new possible way forward via what the church believes is promising research using stem cells found in your own body—so-called adult stem cells. They, the Vatican thinks, hold the moral and scientific answer to the challenge of not having to deal with the possible positive results of embryonic stem cell research.

Efforts to transplant naturally occurring adult stem cells or to tweak them and put them back in more powerful states to fix what ails you is, in the view of the Vatican, worthy of enthusiastic support. So much so that at the meeting, high-ranking church leaders explicitly endorsed the efforts of a new startup company, Neostem.

Neostem is an international biopharmaceutical company with aggressively marketed adult stem cell operations in the United States, a network of adult stem cell therapeutic providers in China, as well as a 51 percent ownership interest in a Chinese generic pharmaceutical manufacturing company. The company has had issues in the past with its highly optimistic recruitment of people to bank their own bone marrow or cord blood at significant cost with uncertain benefit. The connections to China, given a history of problems with the integrity of clinical trials there, also are reasons for concern. Still the church chose Neostem as something of a partner.

The Roman Catholic Church, by holding this meeting sponsored at the highest levels of the church, is trying to steer an emerging area of science—stem cell medicine—down a particular path using a particular moral position as a rudder.

By throwing its ethical might and even its money into the debate about where to get stem cells, how best to study them, and praising the work of scientists and companies that follow the church’s position, the church is telling scientists and investors to focus on adult stem cell work anywhere in the world. That message is what the Vatican will offer when a statement about the conference is issued in the coming weeks.

Do men in red caps and clerical collars know best about how scientists should seek to find cures for terminal and disabling diseases? Not yet and not just because of the battle over the value of researching cells obtained from embryos.

At this meeting, the Vatican’s earnest desire to offer hope without compromising a core moral stance led to way too much enthusiasm about the prospects for current research in adult stem cell research. While some top-tier science was presented at the conference, including research involving the use of adult stem cells to repair damaged heart muscle (out in The Lancet this past Monday), there was too much time given to claims of cures that had little to support them. Time and again patient testimonials, studies with very small samples of subjects with no real long-term follow-up, and, to be blunt, some adult stem cell science that has nothing but the backing of a handful of very optimistic scientists looking to attract a grant or an investor were mixed in with the real thing in terms of legitimate, truly promising adult stem cell work.

The church is not yet very good at picking the wheat out of the biomedical chaff. In its enthusiasm to remain a leading voice on how to help the hundreds of millions of people worldwide suffering from chronic and miserable incurable diseases, the Vatican is dangerously susceptible to hyperbolic claims of cures involving nonembryonic stem cells. To give but one such example, one Italian bishop talked about an alliance he had created with a scientist to procure fetal stem cells in Italy obtained from the brains of spontaneously aborted fetuses to pursue treatments for neurological diseases. This is a horrendously bad idea since it is very hard to control the quality of such cells and the chance of their being abnormal or infected with nasty microbes or necrotic material is significant.

Adult stem cell research holds promise for many diseases. But the Vatican needs to realize that it has its own ethical pitfalls including a lack of adequate international regulatory oversight, companies rushing to hype their work to attract investment, the outsourcing of trials to places where protecting human subjects’ interests is iffy, an absence of standardized registries to evaluate short- and long-term claims of cure, and not a few outright shysters looking to make a quick buck off of the desperate. Pushing for adult stem cell research as the right course to take means pushing for it to be ethical in all regards, not just because embryo destruction is not involved.

It remains to be seen how this effort by the Vatican will play out. Many researchers, patient advocacy groups, and companies pursuing embryonic and cloned stem cell research in the United States, Britain, Singapore, China, Korea, and elsewhere will pay no attention to the church’s message about why adult stem cell work is the most promising avenue to pursue. Politicians in the United States and other nations with large groups of Catholic and evangelical Christian voters are likely to press harder for reorienting funding toward only adult stem cell work. Tommy Thompson, the former secretary of the Department of Health and Human Services and likely senatorial candidate from Wisconsin, did exactly that in his talk at the meeting. Catholic medical schools and universities will be encouraged to move forward with adult stem cell research.

As remarkable as this conference was in explicitly seeking to use an ethical view to shape the science and industry of stem cell research, it left much more to be done. When it comes to adult stem cell research, the Vatican still has a ways to go in distinguishing good science from hype and overpromising by scientists. In pushing for adult stem cell work, the Vatican must insist that both high-quality science and a reliable ethical infrastructure to support it constitute the foundation for what the church wishes to promote as good.

Art Caplan is the director of the Center for Bioethics at the University of Pennsylvania in Philadelphia.

Mississippi’s Initiative 26 and other such “personhood” efforts in several states are intended to target abortion services but they could also be interpreted to limit access to contraception (if they are seen as embryo-destructive), in vitro fertilization (which often involves the creation of more embryos than are used), and human embryonic stem cell research (which requires the destruction of a human embryo).

There is other evidence that, unlike the George W. Bush years, the culture wars around the life sciences have moved to the state level, which makes these incidents harder to track than when they are in the high profile of national politics. For example, in my experience hardly any scientists are aware that more than two years ago Gov. Bobby Jindal (R-LA) signed into law a bill that prohibits the creation of “human-animal hybrids” in the state. Similar legislative activity is brewing in other states.

Notably, these efforts have more momentum in states that are not leaders in cutting-edge biology. A personhood initiative has failed twice in Colorado, where the biosciences industry is thriving, though one can be sure that the Mississippi movement will not be the last.
Those of us who oppose these measures tend to interpret them not only as threats to women’s reproductive health and rights but also as attacks on science. As I point out in my new book, The Body Politic, however, the advocacy groups behind these well-organized initiatives also like to claim the mantle of science. The director of Personhood USA has been reported as asserting that “The unborn child in the womb is scientifically proven to be a human being.” The question is not whether single-celled human embryos are human, but whether they are persons–an issue that is elided in this statement.

Nonetheless, one wonders if these groups’ enthusiasm for “scientific proof” will extend to human embryonic stem cell research. Consistency demands nothing less.

Jonathan D. Moreno is the David and Lyn Silfen University Professor at the University of Pennsylvania and a Senior Fellow at the Center for American Progress. His new book, The Body Politic, examines the battle over science in America.

Four factors need to be considered in weighing the real impact of the board’s recommendation: How likely is an attack? How burdensome is the vaccine? If there was an attack, would it make sense to have your kid take an untested vaccine whatever its risks? And would your child even have a chance to get the vaccine if an attack does occur?

American intelligence agencies believe that the possibility of a terrorist group, domestic or foreign, spraying anthrax around a bus, a school, or a train terminal in a town or city is “credible.” But that is as far as they are willing to go.

How worried are you about an anthrax attack on your family? I suspect it is pretty far down on your “things to worry about” list, far behind getting food on the plate, saving for the college fund, and making sure the kids get picked up after sports. Unless the government is willing to scare the living daylights out of parents, few will bring their kids in to act as subjects in what amounts to a safety study.

Even if you are worried, consider this: The current vaccine requires five shots across 18 months. That alone is going to make it somewhere between very unlikely and absolutely hilariously unlikely that any parent or kid is going to make it through a trial. Even if you offered a lot of money to induce parents to bring their sons and daughters down to the test site, it would take a lot of money to make it worth their time to make five separate visits.

The vaccine has problems. It is not safe for pregnant women since it can harm a fetus. The manufacturer has had various run-ins with the FDA about quality control. Still interested in volunteering your child?

Let’s say we don’t test now. We simply wait for the remote possibility that anthrax is used in an attack. Well, at that point, knowing the risk has become real, we would see most parents in affected areas taking the risk of vaccinating their kids even if there were risks.

And the clincher that guarantees this trial will never happen is that even if the vaccine proved safe and effective for kids, could you even get it for them in an attack? As Jonathan Moreno and Tom Daschle recently observed, local health departments have lost 23,000 jobs over the past three years. Among these are the first responders, whom we would all rely on to get us vaccines during a crisis. If many parts of the nation could not get a credible vaccine program going quickly, then what is the point of testing the vaccine now in kids? Shouldn’t that money go to getting kids access to the only vaccine there is if an attack occurs?

The debate about whether to test the anthrax vaccine in kids has drawn a lot of attention. It shouldn’t. The reality is that it is not going to happen.

Arthur Caplan, Ph.D., is the Director of the Center for Bioethics and the Sidney D. Caplan Professor of Bioethics at the University of Pennsylvania.

Jonathan Moreno’s new book,

Ten years ago, a series of anthrax attacks throughout the country followed hard on the heels of 9/11. The deadly powder made its way through the postal system – including several sent to Senate offices — ultimately claiming five victims. The nation was alerted as never before to yet another threat to national security. Suddenly words like biopreparedness and Cipro were on everyone’s lips.

How much have we learned about biodefense in the last decade? Is America more prepared for a biological weapons attack, or even a pandemic, than it was during that frightening October 2001? In the last few weeks, Hollywood has chimed in with a film, “Contagion,” that plays out the worst possible scenario.

The good news is that there are reasons to be reassured about our preparedness. The bad news is that we are in danger of backsliding.

Whether the source of a pandemic disease is natural or political, the first line of defense has to be medical. Our system for developing, storing and disseminating needed medications is inadequate. Not only do we lack a rich supply of antibiotics and vaccines for recognized threats, scientists worry that new biotechnologies designed to save lives could be diverted to the creation of organisms resistant to our current defenses.

In 2004, Congress passed a law called BioShield, intended to encourage private companies to begin developing new medicines that are both safer and more effective to address biological threats. The usual market incentives don’t necessarily apply when government is the only customer. Industry worries about the legal liabilities of large-scale distribution of medications that may have risky side-effects, like the smallpox vaccine.

BioShield was a good concept — but the results have been mixed at best. Some ideas that researchers thought could be promising have been failures. Worried about BioShield’s ability to take promising scientific findings into development, in 2006 Congress created the Biodefense Advanced Research and Development Authority, known as BARDA, and placed it under the control the Department of Health and Human Services. But Congress has been chipping away at the BioShield funds.

For all the importance of new medications, we have over-emphasized the “high tech” side of biopreparedness. Again, because the first response to an event would require public health assets, regardless of whether the sources were natural or man-made terrorism, we need to focus on the capacity of public health departments.

But these state- and county-level agencies are often understaffed and under-resourced. Coordination between agencies is frequently inadequate. Microbes don’t respect state boundaries — so any failure of cooperation and communication could be deadly.

The Trust for America’s Health provides a biennial report card for state biopreparedness. Their 2010 report concludes that, over the past 10 years, most states have improved their readiness to prevent, identify and contain public health threats. However, “Ready or Not” also notes that 33 states and the District of Columbia have cut health funding since 2008, and local health departments have lost 23,000 jobs since then. Among these are the first responders, whom we will rely on during a crisis.

As we’ve been reminded by Hurricane Irene and the earthquake in the Northeast, these are standing resources we always need — however much we hope we never need to call on them. With the growing pressures on state and local budgets we should be worried about a continuing decline.

There’s no mystery about what needs to be done. There are gaps in funding and infrastructure, disease surveillance, workforce, vaccine and drug research and development and manufacturing, surge capacity and community resilience. The only serious question — and one for which there is no algorithm — is whether the public and our leaders are committed to biopreparedness.

Let us hope that another bioterror incident is not required to focus the mind.

Tom Daschle served as Senate majority leader, when his office was targeted by one anthrax letter. He is now a distinguished senior fellow at the Center for American Progress and senior policy adviser at DLA Piper. Jonathan Moreno, a bioethics professor at the University of Pennsylvania and senior fellow at CAP, is the author of, “The Body Politic: The Battle Over Science in America.”

The creation of human-animal combos has people across the political spectrum worried. Over the summer, a survey by the the U.K. Academy of Medical Sciences found “unease about work that could introduce human traits into animals’ brains, reproduction, or appearance,” according to Nature News.

One conclusion of the U.K. scientists’ report: Strictly verboten is putting human brain cells into higher primates that could make them smarter. A committee of the National Academy of Sciences that I co-chaired in 2005 similarly warned against putting neural stem cells from a human source into a primate without due consideration.

Human-animal chimera are a fundamental part of understanding the biology of cellular development and viral disease.

The point is not that the scientists themselves think there’s something to worry about. The likelihood that anything “human” would survive in the consciousness of primates with human brain cells is remote. Rather, the scientific establishment is worried about what in Washington is called “optics”: How “humanized” creatures might cause a backlash against important biology. Another item in the Daily Telegraph listed cross-breeding a human and a chimpanzee as one of a handful of scientifically valuable but ethically unacceptable experiments.

Still, we obviously find the very idea creepily fascinating. A new Science channel series called “Dark Matter” debuts this fall with the true story of a Soviet scientist’s attempt to create a human-chimpanzee hybrid in the 1920s. The Planet of the Apes series has included provocative suggestions of inter-species crushes.

The trouble with all this is that important medical research does involve putting some human cells into animals. These lab models, usually rodents, are called “chimera,” after a creature in Greek mythology. Although these chimera are not the results of cross-breeding, some chimera are hybrids, like the geep, which is a cross of sheep and goats.

Happily, the U.K. survey also found that non-scientists’ attitudes shifted when people understood the justification for chimera-based research. Using chimera, geneticists are learning how a single gene operates in a complex system. Chimera are being used to build a foundation in stem cell regenerative science, the study of the ability of stem cells to hone and replace damaged tissue. For instance, in models of neurological disorders, human-primate and human-rat brain chimera have been used to test the feasibility of future neural stem cell treatment of Parkinson’s disease and stroke. In addition to their role as model organisms, human-animal chimera are a fundamental part of understanding the basic biology of cellular development and viral disease. Human-mouse bone marrow transplants have been performed since the 1980s and have been part of studies of AIDS and leukemia.

The British are actually behind the curve when it comes to worrying over mixing species. In his 2006 State of the Union address, President George W. Bush asked congress “to pass legislation to prohibit the most egregious abuses of medical research,” including “creating human-animal hybrids,” the latter being a special sort of chimera that involves the fusion of genes from two species. Then-Senator Sam Brownback of Kansas had crusaded for years against human-nonhuman organisms. The senator’s latest attempt, the Human-Animal Hybrid Prohibition Act of 2009, would prohibit the creation of a whole range of human-nonhuman organisms. The draft bill included findings that human-nonhuman hybrids are “grossly unethical” because they “blur the line between human and animal, male and female, parent and child, and one individual and another individual.” Brownback also emphasizes that human-nonhuman hybrids are a threat to human dignity and to “the integrity of the human species.”

Although the Brownback bill never got out of committee, at the state level there has been some success on this track. In 2009, Louisiana Governor Bobby Jindal signed into law a bill that was similar to Brownback’s, prohibiting human-nonhuman hybrids.

Violation of the law is a felony. A bill passed by the Ohio senate lists eight kinds of “human-animal hybrids” that would be outlawed. A similar bill is up for consideration in the Arizona state legislature. Perhaps Governor Brownback will put forward a similar bill in Kansas.

As I explain in my new book, The Body Politic: The Battle Over Science in America, simmering worries about chimera and hybrids, along with debates about stem cells and cloning, are part of an emerging era of biopolitics. Unlike traditional biology that mainly observed and categorized, the new experimental biology threatens to undermine species boundaries, calling into question what it means to be human, our place in the natural order.

Geneticists at the Max Planck Institute have pretty much proven that our ancestors mated with Neanderthals about 40,000 years ago. Perhaps our collective anxiety about mixing human cells with other creatures is a bit of highly conserved species memory about some really bad dates.

Some might argue about the example and his choice of comparison (as Hippocrates said, “life is short but the art is long”). Still, there is no doubt that biology is a hard slog, and getting some lab science into the world of medical treatment is harder still. SP readers know we’ve been intensely following work on embryonic stem cells, including the period in late 2007 when the opposition declared there was no longer a need for this source of pluripotent cells because adult cells had been reprogrammed to resemble those from an embryo.

But the fact is that the jury is very much still out on whether those reprogrammed cells are similar enough to embryonic cells to be substitutes in the lab. Determining whether they are similar to embryonic stem cells is precisely the reason that embryonic stem cell lines are still needed as points of comparison. Even more uncertain is whether it will ever be safe to put them into patients. In fairness, there are also grave safety issues with the derivatives of embryonic stem cells. In my new book, The Body Politic: The Battle Over Science in America, I review the desultory stem cell debate in the context of our growing tensions about the politics of biology.

The embryonic stem cell research slog hasn’t been made any easier by the legal and political issues that have come up in the last decade, though it appears that the recent U.S. case challenging NIH grants has been resolved in favor of the feds’ continued funding. On the private industry side, a company called Geron received FDA approval to clinical trial now underway for spinal cord injury, the first known attempt to use a product of human embryonic stem cells to address a disease in a human being. That study is now underway.

The second clinical trial involving human embryonic stem cells addresses a disease of the eye, Stargardt’s Macular Dystrophy. Two patient-subjects have received that treatment in the United States, and last week Advanced Cell Technology, Inc. announced it has received permission from British authorities to conduct the study there, as well.

This grinding progress attests to the fact that, unlike politics, there’s no room for triumphalism in biology; it’s a hard slog. Meanwhile, the stem cell controversy has shown beyond dispute that punditry is easy, especially the type that doesn’t require evidence.

So we may welcome the Brits to the slogging plod of human embryonic stem cell research. They should know. It’s their language.

Jonathan D. Moreno is the David and Lyn Silfen University Professor at the University of Pennsylvania and a Senior Fellow at the Center for American Progress.

The most intensely personal and revealing encounter at the Tea Party/CNN debate this week in Tampa was not about the state of the economy or jobs or immigration. It was about vaccinating girls to prevent cervical cancer. Even in an election cycle that is dominated by the economy, feelings about cultural issues continue to be the most raw, especially where the power of modern medical science seems to conflict with tradition values.

Welcome to the era of biopolitics.

Biopolitics refers to the ways that issues raised by biology enter the political process. The most longstanding of these issues in America is of course abortion. Then in the last ten years evolution re-entered the picture with the advent of “creation science,” a dubious tip-of-the-hat to science if ever there was one. That happened around the same time presidential candidates needed to take a position on embryonic stem cell research. A more recent addition to the biopolitical list is climate change, and more recent sill, vaccination of girls to prevent cervical cancer.

In my new book, The Body Politic: The Battle Over Science in America, I discuss the simmering popular anxiety about the power of science, especially the implications of modern biology. Although many on the left share these concerns, cultural conservatives are especially troubled by the way that the ability to understand and manipulate life threatens traditional values and the social order. Like any political trope, the “pro-science/anti-science” theme should be read as a signal about how deeply certain politicians identify with those who worry about the values being transmitted to future generations. Those values have to do with the ways scientists might be able to control the very nature of humanity. The fundamental cultural divide between those who see science as a boon or as a threat has already appeared several times in the political season.

For example, a few weeks ago a fourth grader asked Texas Gov. Rick Perry how old the Earth is. In response, Perry told the student that “in Texas we teach both evolution and creationism in our public schools, because I figured you’re smart enough to figure out which one is right.” Less widely noted, his mother reportedly asked the governor “why he doesn’t believe in science.” The media frenzy over the exchange then prompted former Utah Gov. John Huntsman, another Republican presidential hopeful, to say “The minute that the Republican Party becomes the party–the anti-science party–we have a huge problem.” Huntsman repeated this line in the debate at the Ronald Reagan Library, though it undoubtedly contributes to the widespread view that he is a relative moderate in this group of candidates.

At the Reagan Library event Gov. Rick Perry was hammered about his executive order that approved a program to vaccinate girls against the virus that can cause cervical cancer, which cultural conservatives fear will entice them to be sexually active. The fact that Perry followed the medical advice of experts on public health provided him no shelter in this debate. Rep. Bachmann followed up by arguing that it’s wrong to impose vaccination on “innocent young girls” and their parents (though like all such regulation Perry’s program had a parental opt-out clause). A few weeks later at the Tea Party/CNN debate Bachmann hammered Perry on the issue, accusing him of “crony capitalism” in order to gain campaign contributions from the drug company, Merck. Underlying the emotions behind the vaccination issue is the fear that a combination of powerful forces — government, the pharmaceutical industry, and the science establishment — are conspiring to undermine traditional values.

At the Tea Party Forum in South Carolina, one of the panelists was Robby George, a popular Princeton University professor who is a leading conservative thinker. George served on President Bush’s bioethics council. George raised the question whether congress can reverse Roe v. Wade based on that part of the 14th amendment of the constitution that is generally known as the “equal protection” clause, which refers to “any person.”

The question whether fetuses or embryos are “persons” reaches into practices well beyond abortion, especially the stem cell controversy. While he was a member of President Bush’s bioethics council George engaged in a debate with another member, Harvard professor Michael Sandel, about embryonic stem cell research. In 2004, while he was a member of President Bush’s bioethics council, Sandel published a widely read piece in the New England Journal of Medicine on “Embryo Ethics.” Does respect for the human embryo rule out using it in research that might provide important medical advances? Sandel argued that it does not, that those who ground respect for the human embryo in the fact that all persons came from embryos commit a logical error. Embryos are not necessarily equivalent to persons any more than acorns are equivalent to oak trees. “Human life develops by degrees,” Sandel argued. In response, George, coauthored a paper in the conservative journal The New Atlantis in which he deprecated Sandel’s analogy. George wrote that Sandel used a false analogy because human beings have an intrinsic value that acorns and oak trees do not have.

Beyond the old and familiar biopolitics of abortion, the new biopolitics results from the potential of experimental biology for remarkable knowledge and control over the nature of human beings. At the same time, Americans face global competition for new products through biotechnology in this “biological century.” As the U.S. economy continues in the doldrums, this potential source of new wealth poses an interesting challenge for politicians who identify themselves as cultural conservatives.

After the economy, biopolitics might just be the item that most challenges the 2012 candidates’ policy prescriptions.

But these criticisms of the threat to global public health, with which I wholly agree, overlook a still larger question about the emerging use of genetic data in criminal investigations, both foreign and domestic.

The CIA story took me back six years to a week I spent in Karachi. I was there to lecture in the inaugural bioethics course at an institute founded by one of my former students. I am proud to say I have several friends and colleagues there who were impeccable hosts.  Among the events held that week was a dinner party where I was treated to a stream of remarkable conspiracy theories, many involving the United States and Israel, of course, but various international powers were represented, real and imagined.

How much of the stories I heard were found credible by the other guests I cannot say, but all were members of the intelligentsia that included physicians, lawyers, and various academics. One conclusion I drew from the experience that is hardly original to me: Pakistan, a wobbly nation with an extraordinary inferiority complex, is the world capital of conspiracy theories.

But in fairness, American society is hardly immune to such notions, including recent claims that autism is caused by preservatives used in the vaccine for whooping cough and other largely vanquished serious threats to children, and theories that the anthrax vaccine delivered to soldiers in the first Gulf War was part of a massive secret experiment. When I was growing up, many in my small upstate New York town were sure that fluoridation was part of a Communist conspiracy.

One of the other conversations I had that week was with several representatives of the World Health Organization. They were there to audit Pakistan’s efforts to stamp out polio. Although on the whole they found the effort successful, the fact is that there are still polio clusters in remote areas that are very worrisome. So WHO still considers Pakistan a place to be monitored for effective polio vaccination. It goes without saying that epidemics don’t respect national boundaries, so these public health campaigns are in everyone’s interest. Unfortunately, there is evidence of declining vaccination rates even in affluent areas. That’s a recipe for trouble, 19th century style, that is no longer in living memory.

Perhaps it can be granted that spiking conspiracy theories with actual operations is not the best long-term policy for cover operations, especially in a field that is already rife with anxiety and so important to protecting public health. Whether covert operations involving the collection of DNA should be part of a security strategy is a distinct issue that deserves to be part of a public debate. Last year Wikileaks cables reviewed by The Washington Post reported that “A senior department official said the requests for DNA, iris scans and other biometric data on foreign government and U.N. diplomats came from American ‘intelligence community managers.’” The report added that virtually all U.S. diplomats ignore the requests. Someday they might not.

Jonathan D. Moreno is the Editor-In-Chief of Science Progress.

Myriad Genetics, Inc., the owner of the patents, brought the case to Federal Court of Appeals, which overturned the lower court’s decision on July 29 in a 2-1 ruling that has, at least for the time being, reaffirmed the patentability of human genes. Notably, the Obama Administrations Justice Department broke with the Patent and Trademark Office, a co-defendant in the case, in filing an amicus brief in support of the plaintiffs claim that the genes should not be patentable.

The Appeals Court also upheld Myriad’s patents on procedures for therapeutic research on BRCA 1 and 2, but agreed with the lower court that Myriad’s processes for “analyzing” and “comparing” the genes are not patentable. Despite this small concession, it does not seem likely that this will make it easier for scientists who are unaffiliated with Myriad to conduct significant research on BRCA 1 and 2.

“[Myriad’s] short sequence claims [on BRCA 1 and 2] will continue to pose problems,” said Arti Rai, the Elvin R. Latty Professor of Law at Duke Law School and an expert in patent law and innovation policy, in an interview with Science Progress. “I’m not sure that the plaintiffs at the end of the day are in a better position,” she said, noting that they will probably run into many of the same patent infringement issues that they have in the past.

Though the full effects of this ruling on the biotechnology industry and the cancer research community remain to be seen, it is by no means the last word on the issue of gene patents. The plaintiffs, a coalition of doctors, patients, breast cancer researchers, research institutions, and medical associations, are expected to ask for an en banc rehearing—in which all of the justices in the court of appeals would sit for the case, instead of a panel of only three—or appeal the case to the Supreme Court. The Supreme Court can let the appeals court decision stand, or take up the case and issue its own ruling.

Why were genes patentable in the first place?

Patents for biological materials have long been a contentious issue, and decades of Supreme Court cases have interpreted U.S. patent law, which was written over 200 years ago, to fit the complexities of property in modern biotechnology. Currently, the United States Patent and Trademark Office, or USPTO, can issue patents for genes, animals, bacteria, and plants—as long as they are, according to the Patent Act of 1790, “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.”

Patents for biological materials must also fit the “product of nature doctrine,” a standard that excludes entities that occur in nature from patent eligibility. The doctrine was first used in ex Parte Latimer (1889) when the U.S. Patent Commissioner rejected a patent application for isolated pine needle fibers. It was further developed in Funk Bros. Seed Company vs. Kalo Inoculant Co. (1948) when the Supreme Court ruled that natural phenomena and processes are “free to all men and reserved exclusively to none,” and rejected a patent application for a novel mixture of bacteria and soil.

Genes, bacteria, and animals seem like they should fall in the “product of nature” category, but later Supreme Court decisions have shown that sufficient modification of a naturally occurring entity can make it enough of a “new manufacture or composition of matter” to be eligible for a patent. In Diamond v. Chakrabarty (1980), the Supreme Court permitted a patent for a genetically engineered bacterium. In 1984, the USPTO granted a patent to the creators of the “oncomouse,” a mouse that was engineered to express cancer genes in every cell in its body.

Thanks to the precedents set by these and other cases, the USPTO has issued over 40,000 gene patents to date. Myriad Genetics justified their own gene patents via the argument that isolated forms of BRCA 1 and 2 do not occur in nature, and that such isolation results in the formation of different chemical bond structures within the molecules.

In 2010, the New York district court invalidated the BRCA 1 and 2 patents on the basis that the genes, even when isolated, have not acquired any changes to the fundamental nature of its DNA sequence or the genetic information they contain. The majority opinions of the recent federal appeals court ruling, on the contrary, agreed with Myriad Genetics’ original justification for the patent. They also noted that isolated BRCA 1 and 2 can be modified in the lab to form cDNAs, which can then be used to develop genetic probes and markers—a process for which BRCA 1 and 2 are only useful if they are isolated. The dissenting opinion by Justice William Bryson, however, held that the BRCA 1 and 2 genes on their own should not be patentable because Myriad did not discover the genes or use any novel techniques to isolate them. However, he held that the cDNAs, since they are modified by researchers, are patentable.

Gene patents and scientific progress

While the technicalities of what constitutes a “product of nature” or a “manufacture” seem to spark disagreement in the case of isolated genes, the stakes are high for a decision on gene patentability.  According to the U.S. Constitution, patents are supposed to “promote the Progress of Science and useful Arts” by giving inventors the exclusive right to exploit their inventions for a limited period of time.

This is true much of the time, as patents encourage innovation and scientific progress by ensuring that inventors can reap the benefits of their work. Plus, a ruling that would invalidate all existing gene patents could potentially have far-reaching negative effects on patent holders and the biotechnology industry in general.

But the plaintiffs in the Myriad case disagree, and argue that gene patents significantly impede, rather than promote, scientific progress. Researchers from Oncormed and the University of Pennsylvania Genetic Diagnostic Laboratory, or GDL, who are plaintiffs in the case, were already conducting research on and offering their own diagnostic genetic testing services for BRCA 1 and 2 when Myriad acquired its patents on the genes and associated research and testing processes. However, these researchers were forced to stop conducting diagnostic testing and therapeutic research in the late 1990s after Myriad sent them cease and desist orders for patent infringement.

Myriad’s vigorous enforcement of their BRCA patents has rendered them the sole provider of genetic testing for BRCA 1 and 2 in the United States. As a result, women who wish to learn of their genetic risk for breast and ovarian cancer cannot turn to other diagnostics providers for confirmatory tests. Nor can patients seek cheaper alternatives to Myriad’s services, whose BRCA tests cost between $250 and $4,000.

In addition to limiting the competition among diagnostic test providers, Myriad’s monopoly on BRCA also allows them to control the progress of BRCA research. Other scientists cannot research potential improvements for BRCA therapeutics or expand scientific understanding of high-risk BRCA gene mutations without infringing Myriad’s patents.

An issue of authority

The federal appeals court opinions acknowledge the question of whether gene patents promote or impede scientific progress, but instead of answering it outright, they defer it to Congress and do not deal with the case beyond the scope of patent law. “If the law is to be changed, and DNA inventions excluded from the broad scope of [patent law] contrary to the settled expectation of the inventing community, the decision must come not from the courts, but from Congress,” wrote Judge Lourie in the court opinion.

While Congress might be in a better position than the judicial system to consider social, economic, and scientific implications of gene patents, they have never been particularly successful in passing legislation concerning patentable subject matter. “These are policy issues to be decided by Congress, but the fact is that Congress is unlikely to act in this area,” said Rai.

If Congress doesn’t speak out on the issue, the Supreme Court has the authority to make its own decision on the patentability of genes. “For better or for worse,” said Rai, “a court decision in this area may end up being the final word.”

As such, the federal appeals court ruling is just another step in what has been, and what will continue to be, a long process of sorting out property in the genome. The final outcome for the genetic research community and gene patent holders remains to be seen.

Michelle Spektor recently completed her internship at Science Progress and will complete her bachelor’s degree at Cornell University this year.

The plaintiff’s assertions were implausible on substance and process. On substance, there is no “zero sum game” for funding stem cell research. Regardless of the source of the cells, each proposal is reviewed by the National Institutes of Health on its merits. On process, executive branch agencies are normally given the benefit of the doubt by the courts in interpreting congressional intent, and three administrations including that of President George W. Bush had accepted the proposition that funding of research on lines derived from embryonic stem cells did not violate a 1996 rule preventing the NIH from funding embryo destruction.

Stepping back from this legal meandering, the larger importance of this incident lies in the fact that only research on biology has been subject to such a challenge. Even at the fever pitch of our culture wars, no advocates have thought to bring suit against the federal government for funding, say, geological studies that confirmed that the earth is more than 6,000 years old. Indeed, from the infamous Scopes “monkey” trial to present-day creationism lawsuits, biology (in particular, the teaching of evolution) has been the wedge into literal readings of the Biblical period of creation. The fact is that modern biology is threatening in ways that the physical sciences are not, a challenge for a country that is both founded on the promise of science and needs science to sustain its leadership role in the 21st century.

This tension between the growing power of biology and the cultural conservative impulse to hang onto what they consider traditional values is one I elaborate in a new book, The Body Politic: The Battle Over Science in America, which will appear this fall. It’s one that has subsided for the moment but which we can be assured will reappear in many forms, in and out of the courtroom.

The case comes on the heels of a scientific discovery last December, when two research teams independently reported that they could reconstruct fetal DNA taken from the mother’s blood. Analyzing this DNA would allow testing for a range of genetic conditions, including one of the most common chromosomal disorders, Down syndrome, earlier in pregnancy than ever before. Additionally, the simple blood draw would evade the risk of miscarriage that comes with current methods of prenatal screening, including amniocentesis (which involves sticking a needle through the abdomen and into the uterus) and chorionic villus sampling (done either by a needle through the abdomen or by prodding a tube through the vagina and cervix). An early, noninvasive test could in theory become an option for all pregnant women, not just those who carry a high risk of genetic disease.

Due to the earlier testing methods, Down syndrome births decreased 11 percent between 1989 and 2006. Currently, over 80 percent of fetuses diagnosed with Down syndrome are aborted in the United States. These figures hit 91 to 93 percent in the United Kingdom and other parts of Europe. Learning a prenatal diagnosis at nine weeks, in contrast to the 10 to 12 weeks typical for chorionic villus sampling and 15 to 20 weeks for amniocentesis, could alleviate some of the physical and emotional burdens that accompany later abortions, causing these numbers to spike even higher.

A scroll through the online comments to the news stories reveals that the reaction in New Zealand was not unique. “Where do we draw the line?” one user asks. “Screen for autism? Screen for ADD? Abort those kids? How about just screen for anyone with an IQ <100? This notion of ‘designer babies’ is just appalling!” Another laments, “Welcome to the world of ‘Gattaca,’ designer babies and a new ‘master race.’” And yet another: “Anybody who aborts a child with a disability will never know what they are missing, and it is truly your loss, and the world’s loss. I weep for all those unborn babies who never will be able to share their gifts … an unspeakable tragedy.”

Hold that thought.

The Internet critics are right to make the point, as Marcy Darnovsky at Science Progress and many others have, that new developments in the laboratory necessitate profound moral reflection outside of it. But how much of these fears are justified? Is this really eugenics by abortion?

Like it or not, we are afforded a lot of liberty when it comes to reproductive decision-making. Parents may choose how to use their reproductive capacities, what kinds of children they want, and how to raise them according to their own standards of what they believe is best, free from government interference “unless the state could show compelling justification for the restriction,” writes bioethicist John Robertson. This freedom has a legal backing too, with the Supreme Court long protecting the rights of people to make their own decisions with regard to marriage, procreation, motherhood, family, and child rearing. If it’s “designer babies” we are worried about, we are already there. Women can now seek egg donors with criteria as specific as ethnicity and minimum height and SAT scores. Preimplantation genetic diagnosis involves screening for genetic blemishes in embryos created through in vitro fertilization and cherry-picking only the healthy ones to implant.

There is also the freedom not to have kids at all. Regardless of one’s personal opinion on the matter, abortion is legally permitted in this country. Moreover, a woman does not have to disclose her reasons for that choice. If we say yes to abortion for no reason at all, it seems illogical to forbid it for a well-defined reason, such as genetic disease.

So what’s the problem? Answering that means figuring out whether prenatal genetic testing is categorically different—or different only in degree—from what is accepted and established.

Bioethicists have spilt a lot of ink doing just that, and many of their arguments have converged on a similar sentiment. We live in a society in which we nobly aim to promote acceptance of diverse groups. Genetic testing undermines that aim, the argument goes, for it sends an intrinsically offensive message that the lives of people with disabilities are less valuable. As bioethicist Adrienne Asch opined, “As with discrimination more generally, with prenatal diagnosis, a single trait stands in for the whole…. The test sends the message that there’s no need to find out about the rest.” More recently, the New Zealand claimants agree: “The screening programme… devalues children with Down syndrome and is offensive to parents.” Allowing or even encouraging selective abortion based on a single “undesirable” trait is discriminatory, and it should be condemned when directed toward a fetus just as it is when targeting those who have already been born.

Genetic counselors have apparently done little to ease this concern. Counselors and the disability community have a “tenuous relationship,” claims one recent article, in which counselors often hold more negative perspectives on disability than those who are directly affected. These attitudes influence how counselors communicate with patients about prenatal decisions, causing disabled people to feel judged in clinical settings. Adding to the shaky trust is the fact that the National Society of Genetic Counselors, which represents the profession in the United States, has publicly connected itself more with abortion service providers than with disease advocacy organizations.

Doctors are not sporting spotless images either. One analysis concluded that written materials about prenatal screening are often insufficient, and the limitations of testing are not adequately explained. The latter shortcoming is especially problematic in genetics, where testing is probabilistic by nature and thus demands a nuanced explanation to be accurate. Unfortunately, a whopping 45 percent of obstetric fellows say their training on how to deliver a prenatal diagnosis is “barely adequate” or “nonexistent.”

Still, the critique of discrimination relies on an assumption: an attitude toward a diagnosis in a fetus, particularly one’s own fetus, represents an attitude toward an existing person. And social science research shows this may not be true. One discerning study surveyed 197 pregnant women about their beliefs on testing for Down syndrome in their own fetuses along with their attitudes toward the Down syndrome community at large. While unfavorable attitudes toward people with Down syndrome did indeed correlate with the women’s intentions to screen, favorable attitudes toward people with Down syndrome could not predict whether screening would be used. That is, many women who expressed positive attitudes toward the Down syndrome community still wanted to test their own prospective children.

The authors explain this result by pointing to previous research showing that people often make clear mental distinctions between people with a disability who are already born and those yet to be born. As a result, it is perfectly compatible to respect those with Down syndrome while hoping to have a baby without it. One sociologist has dubbed this two-fold position “important to test, important to support.”

Which brings up another big flaw in the testing-is-discrimination rebuke: it puts extraordinary pressure on any given person. Who doesn’t want a healthy baby? A parent’s priority is cultivating the best possible life and opportunities for their children. Asking her to forgo valuable disease testing for the sake of expressing a socially appealing message is making a child into a sacrificial lamb. Some take this argument even farther, saying that prenatal disease testing is not just something parents should do, but rather an ethical obligation. It would be negligent not to screen for genetic diseases if the opportunity to do so existed.

A similar case can be made for nonmedical traits. Want to screen for height genes? For whatever reason, studies have shown that taller people in both genders reach more leadership positions and make more money—an extra $1,000 a year or so—even after factoring out experience and education. And who says it has to end there? We could then open ourselves to the really contentious issue of favoring males because of the regrettable realities of a sexist world. The bottom line being: You can hardly fault a parent for wanting to optimize her child’s social lot. Don’t hate the player; hate the game.

But that doesn’t render the original grievance invalid. Live in a world where everyone acts in his own best interest, and the result could be the so-called “tragedy of the commons” situation, where the group as a whole loses. A powerful example is the selective abortion of female fetuses in India and China, which has caused a noticeably skewed gender ratio leading to a surplus of bachelors unable to find brides. In societies that value marriage as a staple of social acceptance, officials fear an increase in crime by the new male “outcast” group, greater use of the sex industry, and even an increase in the kidnapping of women. Extreme cases like this demonstrate that it can’t be on the shoulders of individuals to do the right thing for society at large. It becomes the law’s responsibility to step in and regulate whatever it is that would damage things for all of us.

This clash in priorities, with the competing interests of parental freedom on one hand and our antipathy toward intolerance (with a worst case scenario of dangerous social ills) on the other, is where the debate often comes to a halt. Both are important values, and saying one overrides the other is a matter of personal inclination.

But maybe there’s a way around taking a blanket stance to support either side. It involves acknowledging that that not all traits are created equal—at least not for prenatal testing purposes. Screening is morally acceptable for some but not others. A clever idea for making that distinction comes from Sara Goering, who uses the values of philosopher John Rawls to distinguish between morally acceptable and objectionable forms of genetic engineering (actually manipulating a fetus’s genome to give it preferred traits, rather than simply testing for what is already there). Some traits are inherently good, she says, regardless of environment. Other traits are only deemed valuable because of subjective prejudices that vary based on your time and place in the world. She gives the examples of cystic fibrosis and Tay-Sachs disease as belonging to the first category and race, height, and sexual preference in the second. Using science to our benefit while rejecting discrimination would involve engineering only those qualities in the first group, she argues. Otherwise, we would be exacerbating arbitrary bias, making us complicit in an unjust system.

An obvious interpretation of Goering’s ideas with regard to testing is drawing the line between medical and nonmedical traits. Based on the unfortunate mental and physical confines of disease, good health can be seen as an objective way of having a better life. In contrast, tallness as better is a societal construct. There is no intrinsic benefit of being tall (maybe they can reach higher things; but they also are worse at escaping notice). Rather than yielding to these prejudices, we should be striving to rectify the existing injustices.

Of course, this is not a perfect science. There is bound to be enormous disagreement over objective versus subjective good. Just look at the dispute over deafness. While most people view hearing loss as a disability, there are those in deaf community who see it as a lifestyle that they want to share with their children.

Realistically, much of this theoretical handwringing may prove moot. Are our prejudices so overpowering that we’d pick abortion over a child with the “wrong” height or eye color? Some people would undoubtedly favor testing without even considering abortion, but rather to prepare better for the baby. Others would opt not to know at all. Characterizing these preferences would require further empirical investigations, and there would surely be very different considerations in societies where biases are more engrained. But intuitively, at least in the United States, it is hard to picture large masses of people opting for prenatal testing of traits like eye color as the deciding factor for whether their child should be born.

This is a passionate issue. People have begun to speak out, whether through semianonymous Internet comments or an official complaint to the International Criminal Court. The concerns are legitimate. Detractors do not need “what if?” slippery slope arguments, often accompanied by references to science fiction, to vindicate their objections. They also do not need emotionally charged analogies to heinous past crimes of eugenics to grant them credibility. There are issues in science that have become so entwined with politics—where people split along predictable party lines, and a presumed clash of values automatically demonizes any opposing view—that open discourse is vetoed before it can begin. Making moral headway in prenatal testing requires that it doesn’t join those ranks.

There is something to be said for following our moral intuitions. There is even more to be said for a rational analysis of their validity, for an informed and respectful exchange of ideas.

Ilana Yurkiewicz holds a B.S. from Yale University and was a staff writer at The News & Observer. Currently an intern with the Presidential Commission for the Study of Bioethical Issues, she will matriculate at Harvard Medical School in the fall.

This new development in the application of adult stem cell technologies has quickly garnered international attention, as well as a great deal of excitement. A segment on ABC News described it as a process of “growing new body parts, growing new medical possibilities,” and asserted that “we are really standing of the brink of something brand new.” They also listed a slew of other organs that could one day be constructed synthetically from stem cells. Meanwhile, other media have also referred to the event as a “landmark” and a “milestone.” Even the stock markets have responded favorably: Shares for several research companies that conduct stem cell research jumped since Friday, one as high as 20 percent.

The seeming fulfillment of decades-old prophecies of the glories of stem cell research is certainly something to be excited about, but could this get overhyped?

In a 2008 article Jenny Kitzinger of Cardiff University described the various stages of “hype” that the stem cell research discourse experienced throughout the 2000s. One of the positive stages, referred to in her article as the “breakthrough” stage, is characterized by  the use of “landmark” imagery, the perceived delivery of promises, and hyperbolic representations of the future—elements that all seem to be present in the discussion of the stem cell trachea phenomenon.

In some ways, ABC could be right in describing last week’s successful transplant as “the brink of something brand new,” or at least the next step in improving transplant patient outcomes. Since the synthetic trachea was constructed from Beyene’s own cells, the risk that his body will reject the organ is considered minimal if not nonexistent. The trachea was also created fairly quickly, eliminating his need to sign up for a long organ transplant waiting list. But all the hype about these successes might obscure the fact that it will take a long time for this type of trachea transplantation to become a widespread standard of care—if it ever does. Even more time will pass before these stem cell and tissue engineering technologies will be used to successfully create other, more complex organs.

Stem cell hype appears in other forms as well, especially in the specific context of embryonic stem cell research. In an article published by Science Progress earlier this year, bioethicist Arthur Caplan discussed the “hyped claim” that adult stem cells are just as useful, if not more useful, than embryonic stem cells in the interest of achieving goals in medicine. This type of rhetoric, which has little scientific backing, has been used by the antiembryonic stem cell research lobby, and was even adopted by the Bush administration, in the interest of justifying embryonic stem cell research restrictions.

Although the recent trachea transplant may serve to reinvigorate positive public interest in stem cell therapies and research, it seems that it could also be spun as a testament to the type of rhetoric Caplan described. Embryonic stem cells had no documented role in the creation of the synthetic trachea.  Rather, the organ was constructed from Beyene’s own mesenchymal stem cells, a type of adult stem cell that originates in the bone marrow, as well as lining cells from his nose. As such, those who oppose embryonic stem cell research could, hypothetically, use this recent success to reify the idea that funding for embryonic stem cell research should be limited in the interest of funding other, allegedly more fruitful adult stem cell and tissue engineering research.

While all types of hype will abound, this trachea transplant should not be used to confuse people about the importance of pursuing both adult and embryonic stem cell research in the effort to advance stem cell technologies; success in one application of stem cell science is not an argument for ignoring the other. Nor should it be looked upon as an assured dawn of a new age. Rather, it is a testament to what can be accomplished through innovation and teamwork, and reminds us of the need to stay on the cutting edge of all kinds of stem cell research and other potential life-saving biotechnologies.

Michelle Spektor is an intern with Science Progress, and a rising senior at Cornell University in Ithaca, NY.

When the Gates Foundation initiated the first round of Grand Challenges in Global Health five years ago, the objectives were clear: Revolutionize global health within a few years by flexing the muscle of the Gates’s billions to foster a global health innovation revolution, and solve basic challenges. But all did not go according to plan. Despite billions of dollars in grant funding, we still haven’t solved basic problems like vaccination, malaria, malnutrition, or the spread of HIV in developing countries.

Since that initial round, the foundation has scaled back its originally ambitious agenda by reducing the amount of each grant awarded and tempering proclamations of any imminent revolutions. This past December, a New York Times article highlighted some of the failed projects from the first round of grants. These included a project aimed at developing dried vaccines, and an expensive attempt at a portable lab.

While other projects have had more success, most of them will require more funding and a few more years before they can be widely used where they are most needed. In fact, a majority of the 43 initial projects, some of which were aimed at innovations such as single-dose vaccines, genetically altered mosquitoes, and portable diagnostic machines, will not receive any further funding. Bill Gates seems resigned to a change in approach, acknowledging the initial project was too ambitious.

Even if we accept a change in strategy, examining the reasons for these initial failures can perhaps yield instructive lessons. Research on global health problems is inherently difficult and is hampered by issues that go beyond surface-level financial constraints. In order to conduct global health research that’s efficient and produces results, we need to focus on five key issues: cost, power sources, portability, local needs, and obstacles to training and support.

Cost

The Grand Challenges were aimed at addressing one of the major barriers to innovation and scientific progress on key health problems in the developing world: the lack of research funds. But the issue of cost isn’t simply one of providing research funds. Researchers need to consider the cost of prototypes and end-user costs from the start. The initial projects funded by the Gates Foundation demonstrate why this is such a crucial consideration.

Initially, there were no limits to the size of initial awards. For instance, one project designed to develop portable diagnostic labs received an initial award of $15 million. The problem was that each prototype cost about $1,000 and this cost was never adequately reduced. This grant has not been renewed, with a cheaper alternative having been created by another researcher. Most surprising is that the alternative lab is designed to conduct similar tests using pieces of paper that costs pennies to buy and use—startling, compared to the original $1,000 prototype. Today, the organization Diagnostics for All has developed paper kits for liver function tests, and hopes to have kits that can test anything from malaria to HIV.

Such a stark contrast in costs for similar tests demonstrates why it is so important to factor these costs in project proposals. A $1,000 price tag for a prototype should have been a working sign, especially considering the target recipients. In countries where governments and clinics are poor and patients are even poorer, the affordability of medical technology is essential. Even $1 per day for malaria treatment can be prohibitively expensive when you are living on $1 per day. Technologies with low upfront costs but high lifetime costs, such as special parts or constant replacements, are no improvement upon high-cost prototypes.

Power sources

Power sources are another key problem. In resource-limited settings, power is often spotty, at best. Even in a country like South Africa—with a strong infrastructure and an extensive power grid—power outages are a problem. For instance, a recent power outage in the Mpumalanga district of South Africa was expected to keep the Rob Ferreira Hospital without power for 6 weeks.

Researchers need to anticipate unreliable and inaccessible power sources and think of possible solutions. Can an instrument run on batteries? If an instrument is battery powered, the batteries should be easily accessible, rechargeable, and long lasting. Many health clinics often serve as points of care for widely dispersed populations and, as a result, portable machines should be able to hold charges for long periods. As laptops become more common at global clinics, one possible solution could be the development of tools powered through USB cables, but those laptops will also require adequate power options.

Portability

Related to the issue of power supply is the question of how easily a technology can be used to reach people over a wide coverage area. In rural areas, mobility is one of the biggest concerns. With clinics few and far between, people often delay seeking medical attention until their conditions progress to critical levels. Developing portable devices and medicine that is easy to store and transport allows clinicians in resource-limited settings to provide earlier care to more people. This also creates a mechanism for care when patients are no longer able to make it to the clinic.

But portability isn’t just about size: Clinics need to use portable devices in remote locations. With the increasing use of cell phones even in resource-limited settings, cell-phone-based tools and applications are a great idea. Nonetheless, connectivity issues need to be factored into the development of any such tools. Additionally, instruments also need to be rugged and durable.

Responsiveness to local needs

Another key challenge in global health is that health care barriers often stem from deeper, nonhealth-related issues. Politics, infrastructure, and complex social norms often stand in the way of substantive progress in health outcomes. As a result, global research priorities should be on high-impact, low-disruption solutions. Researchers need to focus on interventions and technologies that can be implemented without requiring extensive structural or operational changes, as these are often impractical and unrealistic.

For example, handheld diagnostic and monitoring tools will probably have a greater immediate impact than larger, more complex technologies. Consequently, focusing on handheld technologies is a more efficient and realistic way to help clinicians in resource-limited settings establish legitimate and practical mobile health care solutions. Clinics, which are often critical points of care, would have their reach expanded to people in remote locations. Such an approach gives providers a fighting chance against opportunistic co-infections that often go undiagnosed simply because people aren’t getting to the clinics. The way to navigate these structural limitations is often through homegrown efforts and direct engagement with, and input from, the target population. How can structural barriers be identified? Ask the locals. What’s the best way to navigate social norms? Engage the affected population.

Training and technical support

Lastly, proposed interventions and tools have to alleviate the dearth of qualified technicians and physicians in most resource-limited settings. For example, when the President’s Emergency Plan for AIDS Relief, or PEPFAR, program made antiretroviral therapy a realistic option in 15 focus countries starting in 2003, clinics went from not having enough medicine for HIV-infected patients to not having enough doctors to prescribe available medicine. Solutions need to be developed to both brain drain and the low number of physicians and technicians in these settings. We need technologies that are easy to use and don’t require extensive training or large amounts of technical support. Smaller, simpler instruments that any can learn to use in a short period are crucial in places where primary health workers may not have a lot of education.

More medical doctors are needed in Africa, but so are medical schools. Then there is the very real problem of brain drain, with the few physicians present vulnerable to leaving for Europe and the United States. These issues cannot be resolved overnight, so solutions need to be developed for the available health workers.

Técnicos: A pragmatic example of success

Several African countries have started to address this personnel issue by focusing on the development of nonphysician clinicians. These clinicians can be trained in a shorter amount of time and can provide wide-ranging support to physicians. In Mozambique, the emphasis is so great that the government has developed specific guidelines for these clinicians, who are called “técnicos.” These guidelines allow técnicos to be able to care for patients and make important decisions such as determining a patient’s HIV stage. While técnicos do not solve the lack of qualified physicians, they provide an important bridge to care for many people. They also relieve pressure on physicians who may each be in charge of a large number of patients. This effort allows health care from qualified clinicians to reach people who might otherwise go without treatment.

The técnicos of Mozambique demonstrate the approach we should take toward the global health challenges in resource-limited settings. Técnicos provide a low-cost solution to an expensive problem and expand the reach of clinics while alleviating heavy training requirements. They also strategically confront the lack of physicians where it’s needed most. Técnicos are a homegrown idea that is locally managed, providing the kind of expertise to address structural barriers. In essence, técnicos are an attempt to solve complicated problems in a straightforward and pragmatic way. This seems to be the best way to deal with complex global health problems.

Global health innovation will only occur with approaches sensitive to the limitations present in resource-limited settings. The Gates Foundation is taking a step toward encouraging this kind of innovation. They now focus on grants for smaller amounts, which foster true ingenuity as project managers have to figure out how to do more with less, much like those they are trying to help.

There’s more they can do, however, to spur the kind of innovation that’s needed in global health. A small step would be to require all research teams to include collaborators from research-limited settings. If a team thinks a dry vaccine will work in a remote village in Zimbabwe, then they should collaborate with health workers and community leaders from that country to come up with strategies and to learn about possible barriers. This approach, already common in the development world, could go a long way to addressing some of these key issues in global health research.

Takunda Matose is a human subjects protection specialist focusing on HIV/AIDS research at Technical Resources International and has a master of bioethics from the University of Pennsylvania.

With the Human Genome Project complete for over a decade, the benefits of genomic data are now trickling into the business and practice of medicine. The passage of the Genetic Information Non-Discrimination Act in 2008 and the Affordable Care Act in 2010 have set the rules of the road, and made the critical investments necessary to lay the ground work for new advances in American genomics research. In the coming years, as the price of whole-genome scans come down and the medical community enters a new era of personalized medicine, we will have a new set of tools with which to study the origin of diseases affecting specific populations.

Genetics can reveal useful information about an individual’s health status, but they can also reveal unexpected information about group identity. The Latino community is both genetically and culturally diverse; and as gene-based medicine advances, Latinos will need to make sure that new medical technologies serve that diversity.

I believe that to capture the necessary genetic diversity to study the drivers of health disparities, America’s research agenda must include a broad swath of the Latino population. The National Institutes of Health (NIH) has so far committed $61 million to observe more than 16,000 Latinos over six years through the Hispanic Community Health Study, the nation’s largest longitudinal study of Latinos. Yet there is still so much more to be gained by incorporating the study of Latino populations into other research projects. But the research process does not end with research funding decisions. Clinical and biomedical research practices must also be more responsive to patients, who should be empowered to tell researchers and doctors what kinds of questions they want research to answer.

Every step of the biomedical research process — from genetic testing to clinical trials — can be made more inclusive, addressing the broad range of genetic and economic diversity in the U.S. The Latino community will need to work together with research institutions and private companies to overcome the barriers that exist with regards to inclusive biomedical research. These barriers range from economic inequalities and provider biases to lack of awareness, distrust, or cultural and linguistic differences.

Doctors can play a major role in making Latino patients more fully aware of clinical trials or genetic studies by communicating the possible risks and benefits. Doctors should also inform patients of the privacy protections afforded by laws like the Genetic Information Nondiscrimination Act and the Health Insurance Portability and Accountability Act in order to build trust and allay fears of discrimination in employment or insurance. This kind of communication will become a necessity in the future as medical research and clinical care become ever more closely intertwined.

The Department of Health and Human Services has already laid out recommendations for more inclusive research practices in a 2009 report. It recommends the building of a more diverse scientific and health care workforce; outreach to trusted community members who can promote the benefits of research; and the building of cultural awareness surrounding diet, work-life balance and access to resources. The report also elaborated on a research model known as “community-based participatory research,” which would involve the Latino community in the design and conduct of the research, creating a sense of community “ownership” over the results and a greater adherence to the outcomes.

These practices have the potential to create actionable, results-oriented research processes that incorporate the histories, lifestyles and values of Latino patients. The last thing we want is for the research establishment to become overly reliant on a single indicator, measurement or classification that does not account for the needs of individuals in the Latino community and other communities. Only by making sure that every community’s voice is heard, can we be sure that personalized genetic medicine will truly be personalized.

This op-ed is reposted from the Huffington Post. Michael Rugnetta is a former research assistant for Science Progress and author of the new report, “Addressing Race and Genetics: Health Disparities in the Era of Personalized Medicine” .

Download the introduction and summary in pdf here, or read on.

The human genome sequence has been fully completed for a decade now and the price of full genome sequencing is dropping precipitously. Many believe that with these developments, a new era of personalized medicine is about to hit full speed. Personalized medicine is essentially “the use of genetic susceptibility or pharmacogenetic testing to tailor an individual’s preventive care or drug therapy,” although some definitions also include the development of patient outcomes research, health information technology, and care delivery models. Put more simply, it means the development of  medicines and therapies tailored to patients’ unique genetic traits and risks.

The field is evolving rapidly but many hurdles still remain. Individually tailored drugs based on a patient’s genetic makeup are far off, and the cost of developing drugs for genetic subpopulations with largely similar genetic traits for one or more diseases hinders developments in this arena. Similarly, the lack of standards surrounding direct-to-consumer genetic tests and the lack of robust, large-scale genomic data for many diseases and conditions are additional hurdles.

Nevertheless, personalized medicine is making its way into the mainstream. Estimates by PricewaterhouseCoopers indicate that the market for personalized medicine, currently a $232 billion  industry, will grow at a rate of 11 percent annually. Personalized medicine is also making serious strides in the pharmaceutical industry with drugs like the colon cancer drug Erbitux, which is most effective in patients with a certain genetic mutation.

Personalized medicine also has the potential to rein in rising health care costs. For instance, physicians can better prevent adverse drug reactions by using genetic information to calibrate the ideal dosage of the blood-thinning drug Warfarin for an individual patient. This alone could prevent 85,000 serious bleeding cases and 17,000 strokes, and save the health care system $1.1 billion annually.

But the health care and scientific communities will still have to answer important questions about who will have access to these new medical advancements as they develop. Health disparities persist between different groups for various reasons including access to care, lifestyle factors, socioeconomic status, and genetics. Studies indicate that minorities have less access to health care and generally receive a lower quality of care. Studies show that African Americans have lower incidence of breast cancer than white women, for example, but suffer greater mortality. Heart disease is widespread among minorities and a leading killer in the African-American community.

Personalized medicine can potentially alleviate these discrepancies since it could allow physicians to prescribe medication that treats the disease more effectively. African- American women suffer from a more aggressive form of breast cancer that tends to be estrogen resistant, for example. Profiling the genes of the tumor and the genes of the patient could allow a doctor to prescribe the most effective drug regimen.

Yet certain issues regarding racial and ethnic health disparities need to be addressed in order for personalized medicine to offer the greatest benefit to all. This paper examines these issues in detail and then offers some ethical guidelines for policymakers to consider, among them:

• There must be a frank discussion of the social and methodological appropriateness of using race or ethnicity as disease proxies.
• Genetic variation research and clinical trials must systematically incorporate such discussions into their individual study designs and the research itself.
• We cannot ignore structural inequalities in access to health care and in fact should seek to reduce them through research that looks at social, environmental, and behavioral contributions to health status as well as research on the outcomes of different care delivery models for different populations.

In the pages of this report we will demonstrate why these proposed ethical guidelines are
essential to the development of personalized medicine in our country.

Read the full report in pdf here.

Since the nation’s founding, progress in the Enlightenment sense has been key to the idea of America. A corollary belief has been an exceptional level of investment in creating a political, legal, and financial environment that encouraged scientific innovation. Jefferson’s patent statute, for example, gives particular latitude to inventors, as the founders (who were themselves remarkably keen on natural philosophy and numbered several world-class thinkers), sought to make the new nation a welcoming home for the brightest and most creative minds. That desideratum stumbled a bit in the first half of the nineteenth century, as southern members of Congress resisted an extensive role for the central government in financing “internal improvements” like canals and bridges; in one telling example, President Lincoln had to wait until secession to create a National Academy of Sciences, itself created partly to advise him on the most promising new armaments.

After the Civil War, public investment in science gradually intensified, as did the promise of scientific knowledge itself. A firm grounding in science, understood mainly in terms of physics, chemistry, and engineering, was thought to be a key feature of the cultivation of civic virtue, including a healthy Christian outlook. Darwinism was mostly influential as a justification for racial improvement (where “race” had a rather different denotation than it came to have in the early twentieth century, as Americanism itself was often thought to be a racial category). Some poorly defined notion of eugenics was famously embraced by just about everyone interested in social improvement, including of course major Progressive Era figures such as Teddy Roosevelt and Margaret Sanger.

The largely benign view of biology began to change after World War II. Eugenics, in particular, had begun to have a bad odor even before the war, but decisively after the revelations of the Nazi crimes. Then during the Cold War-era the stunning and rapid achievements of laboratory biology produced the bioethics movement, itself a measure of an incipient background concern about the direction of science and the power available to scientists. But this was largely an elite and gentile debate for about 40 years. As ideological lines hardened along the wedge of the 1990s culture wars, so the academic issues of bioethics emerged full-blown into the wider political arena.

The timing of Dolly, the first mammalian clone, in 1996 and the isolation of human embryonic stem cells in 1998 could not have been better—or, perhaps, worse—as these esoteric developments coincided with dismay at President Clinton’s dalliance with a White House intern. For social conservatives, the scandal crystallized larger concerns about the moral direction of American society. The new “liberal eugenics” of abortion, in vitro fertilization, and the increasing ease with which basic bioparts like bits of DNA could be manipulated meshed, for conservatives, with a narrative of a polity adrift from its moral moorings.

Still more intriguing, these worries cut across standard ideological lines. For reasons that focus more on social justice than human dignity, many progressives share cultural conservatives’ reservations about the implications of the powerful new biology. Yet in a century in which national power and prosperity will be determined partly by leadership in the life sciences, some reconciliation with the scientific prospects ahead will be required. That reconciliation will of necessity be a political process.

That political process can be undergirded by an alliance of bioprogessives on the left and the right. Their platform should be a shared commitment to the continued growth of knowledge as a basic humanistic value, the desire to use knowledge as a force for innovation, and an appreciation of innovation as a source of new wealth. Progressives have a unique opportunity to lead this process, but they need to be guided by a vision that integrates science as a cornerstone of human flourishing along with respect for the power of the science being unleashed.

Jonathan Moreno, Ph.D., is the Editor-In-Chief of Science Progress and a Senior Fellow at the Center for American Progress. This article was originally published in the Democracy Journal and is republished here at Science Progress.

Induced pluripotent stem cells are artificially derived from adult cells. The adult cell is tricked into expressing specific genes that are present but latent. iPSCs have until recently been generated from adult nonreproductive cells by expressing four different genes called transcription factors.

The creation of iPSCs was first reported in 2006 by a Japanese team led by Shinya Yamanaka. Many groups have since reported the ability to generate these cells using some variations involving the same four transcription factors. These techniques allow adult cells to behave like embryonic cells—cells capable of being turned into nearly any type of cell. Colleagues of mine at the University of Pennsylvania just recently reported a simpler, safer way to achieve much more efficient adult cell transformation into iPSCs.

Conservatives who abhor embryo destruction have been the greatest proponents of iPSC research as an alternative to using cells from human embryos. Conservative columnist Charles Krauthammer has long gushed that iPSCs make the debate over public funding of embryonic stem cell research moot.

Back in 2007, right after the announcement was made that researchers in Japan had discovered how to reprogram adult skin cells to resemble embryonic stem cells, Krauthammer declared that President George W. Bush had been prescient in banning public funds for embryonic stem cell research. (Hey, I thought President Bush and his defenders claimed then and continue to aver now that what they had in mind was a “compromise,” not a ban. But hey, ban, compromise, whatever, I guess). Krauthammer maintained that since there was a way to create “a magical stem cell that can become bone or brain or heart or liver” without using human embryos, any argument for using stem cells derived from any type of human embryo made no scientific sense.

Krauthammer has had a loud chorus echoing his devotion to the magic of iPSCs. Everyone from William Hurlburt, former member of President Bush’s Bioethics Council, to a host of prolife groups and evangelical publications has been espousing the idea that there was no reason to talk any longer about funding research with stem cells obtained by destroying human embryos.

But the case for iPSCs as the alternative to using embryos has now, as I warned it would, come under fire.

A team led by Yang Xu, professor of molecular biology at the University of California, San Diego, has just reported in the journal Nature that iPSCs trigger severe immune reactions when implanted into mice. In some cases the cells were completely destroyed by the animals’ immune systems.

Although the studies were done in rodents, the findings raise doubts over the future use of iPSCs in humans. Xu said at a press conference that “the assumption that cells derived from iPS cells are totally immune-tolerant has to be reevaluated before considering human trials.” In English he is saying that somehow, in turning adult cells into embryonic-like iPSCs, the immune system sees them as foreign tissue and kills them. This is not a good thing if you are using these modified cells to try and cure diseases.

So what is the take-home message from all of this? Well, iPSCs may still have a future but it is likely to prove rocky. So will research involving embryonic stem cells. So will work using cells derived from cloned human embryos. Even adult stem cells are going to have a few bad days. In the early days of research in a new area, no one can say with any certainty what will work or that anything will work. Research is difficult and often fails. Asking today which form of stem cells are likely to have the most benefit in curing humans is akin to asking the Wright brothers whether they thought interplanetary exploration ought be done by humans or robots.

Making research decisions based on pronouncements by those with huge ethical or ideological stakes in the game—in the case of iPSCs, those opposed to the destruction or manipulation of human embryos—makes for very poor science policy. When people with strong faith commitments about the sanctity of human embryos argue that “science” shows that one type of research eliminates the need for another, watch out! When it comes to science, conflicts of interest can come in the form of cash or a prayer book.

Arthur Caplan, Ph.D., is the Director of the Center for Bioethics and the Sidney D. Caplan Professor of Bioethics at the University of Pennsylvania.

The first example is the welcome decision by a three-judge panel last Friday concerning federal funding of human embryonic stem cell research. Now that two of the three judges found that the government was not necessarily in violation of congressional intent by supporting this work (an interpretation that was also held by the Bush administration), the question returns to the original judge.

Nonlawyers like me may not be able to sort through the complicated technical legal questions, but we can understand the notion that executive branch agencies may make reasonable interpretations of the law. That, in essence, is what the case is about. After all, Congress’s ban on support for research that destroys embryos was put in place years before embryonic stem cell research and (as the judges just found) seems to have prohibited paying for that process but not research on the cells derived from it. The importance of the case extends well beyond stem cell research and goes to the question of how involved the law should be in determining “acceptable” government-funded scientific research.

Of course, the people, acting through their legislators, have every right to decide what is paid for with their tax dollars and what is not, but at least Congress may be expected to act explicitly on these arcane matters of science funding. And where they don’t do so, agencies must be expected to exercise their best judgment.

As mere mortals, it is often too much to expect more than reasonable interpretations of difficult questions, both in the law and in morality, as the other recent example demonstrates. Recently, The Washington Post reported that the first patient-subject of a human embryonic stem cell trial believes that it was God’s will that he receive a transplant of cells derived from an embryo.

Twenty-one-year-old Timothy J. Atchison of Chatom, AL, is a nursing student whose spinal cord was severed in a car accident. “It wasn’t just luck or chance,” Atchison told the newspaper. “It’s not life. It’s not like they’re coming from an aborted fetus or anything like that. They were going to be thrown away. … once they explained to me where the stem cells were coming from, once I learned that, I was okay with it.” The local Pentecostal pastor in whom Atchison confided, and indeed his whole congregation, also had to confront the issue in a concrete way. They, too, seem to have concluded that Atchison’s participation in the clinical trial was a reasonable interpretation of God’s will.

Are Atchison, his pastor, and the other members of the church right? For about 1,500 years, the dominant philosophy of the West was Platonism. From Plato, both secular and theological systems insisted in perfect insight. In Plato’s philosophy, only a few have knowledge of the true nature of things, knowledge that could only be obtained through divine inspiration. Infallibility finally lost its chokehold on Western thought through the Enlightenment, which emphasized experiment and demonstration rather than allegedly divine insight. A natural aristocracy was replaced by merit and the hard work required to understand the nature of reality. The same applies to morality, as we have learned that there are few easy choices. In so many ways, we are still learning to rely on our own best angels rather than the fantasy of perfect wisdom.

Two scientists brought this suit to enjoin the National Institutes of Health from funding research using human embryonic stem cells (ESCs) pursuant to the NIH’s 2009 Guidelines. The district court granted their motion for a preliminary injunction, concluding they were likely to succeed in showing the Guidelines violated the Dickey-Wicker Amendment, an appropriations rider that bars federal funding for research in which a human embryo is destroyed. We conclude the plaintiffs are unlikely to prevail because Dickey-Wicker is ambiguous and the NIH seems reasonably to have concluded that, although Dickey-Wicker bars funding for the destructive act of deriving an ESC from an embryo, it does not prohibit funding a research project in which an ESC will be used.

To translate this a little, Lamberth held that all federally-funded ESC funding violates the Dickey-Wicker Amendment, which prohibits the use of federal funds for “research in which a human embryo or embryos are destroyed.” Even though no federal money goes to studies that actually destroy an embryo, Lamberth concluded that such research requires scientists to build upon previous research that involved the destruction of an embryo, and that this is not allowed.

Lamberth’s decision, however, cannot be squared with Supreme Court precedent. Under the Supreme Court’s decision in Chevron v. NRDC, judges are normally supposed to defer to an agency’s reading of a federal law unless the agency’s interpretation is entirely implausible, and the Obama administration quite plausibly read the Dickey-Wicker Amendment to only prohibit federal funding of the actual destruction of an embryo — not federal funding of subsequent ESC research. Accordingly, the court of appeals reversed.

Today’s decision is a very hopeful sign that Lamberth’s questionable understanding of this law will no longer undermine stem cell research. Both of the judges who joined today’s majority opinion are conservative Republican appointees. Judge Douglas Ginsburg is a hardcore tenther who once called for a return to an Depression-era vision of the Constitution that struck down child labor laws and other very basic legal protections. Judge Thomas Griffith was appointed by George W. Bush.

Their decision did leave open a slight possibility that Lamberth could try to suspend stem cell research once again. The appeals court expressly decided not to weigh on two alternative claims by the plaintiffs, including a claim that federal ESC funding is illegal “research in which a human embryo or embryos are . . . knowingly subjected to risk of injury or death,” because these claims were not first considered by the court below. Nevertheless, the appeals court made clear that “the plaintiffs have not identified, nor have we found, any precedent for upholding a preliminary injunction based upon a legal theory not embraced by the district court.”

So it appears very likely, if not entirely certain, that stem cell research will ultimately be upheld against all challenges.

Ian Millhiser is a Policy Analyst and Blogger at American Progress. This is reposted from the Wonk Room.

After all, who transmits such quantities of data? Colossal information shipment is hard to escape notice. “We never found out for sure, but to this day we assume that administrators who monitor Internet traffic somewhere came into work Monday morning, were struck by the amount of data going through the routers, and shut things down,” Flicek said.

Genomics gave new meaning to the phrase “big data.” One person’s genome, for instance, consists of 3 billion base pairs. Spelling out the order of, or sequencing, each pair requires about two bits of computer storage, making the whole genome’s storage size 12 billion bits. This translates to about 1.5 gigabytes of data. A modern machine can sequence more than 500 billion base pairs in a week or just over. That is 167 human genomes and 250 gigabytes—or the equivalent of 63,000 standard song files or 200 movie files. The research bottleneck used to be collecting data. Now, the greatest challenge is making sense of it.

Things weren’t always like this. When genomics first began carving its niche in the scientific world, the path to gene discovery was quite different. Researchers pored through recent literature, honed in on a handful of genes that sounded promising, and then, armed with these candidates, designed experiments to test correlation between them and the traits they were suspected to underlie. Call it a paragon of the traditional scientific method: Ask a question, conduct background reading, formulate a specific hypothesis, test it with an experiment, and draw a conclusion.

Over the past 10 or so years, however, meta-reviews of the literature to trace the success of candidate gene methods have disclosed staggeringly abysmal conclusions. Of hundreds of published papers using this approach, only a tiny fraction of results—6 of 166, to be exact—could be consistently replicated. Gradually, candidate gene techniques waned in favor of tactics that scanned the entire genome without any conjecture about the role of any particular gene.

Flicek’s story involved a massive undertaking called the 1000 Genomes Project, an international effort to catalogue a wide array of human genetic variation by inspecting the full genetic makeup of—you guessed it—1,000 people. What are the scientists looking for? In projects like this, often they won’t know until they find it. What is the hypothesis? In a word: vague. The human genome is laden with diversity, both among and within populations.

This way of tackling a scientific problem marks a significant shift from the time-honored scientific method. Those in the field might call it data-driven research, to be contrasted with standard hypothesis-driven science. Critics are more likely to make charges of fishing expeditions. However couched, the change in approach is this: Instead of designing an experiment to test a defined, preconceived hypothesis, researchers first amass large banks of information and then wade through them with the aid of powerful computers to unearth biologically pertinent findings.

For the maneuver to be mathematically robust, data sets must be big. Accordingly, the emergence of the method was fostered by the coupling of biology and computer science that enabled mammoth data production and storage. The approach plays a central role in disciplines ending with “-omics,” which by definition seek to characterize biology in a big way. (Some familiar examples include genomics, which deals with the complete DNA sequences of organisms; proteomics, or the large-scale study of all the proteins; and metabolomics, which involves all small molecules generated in metabolism).

Drifting research paradigms raise questions of who in the scientific community is adapting, how rapidly, and how they are interacting with their more traditional counterparts. Specifically, are those controlling the purse strings caught up on what is happening at the research bench?

A recent article in Nature lends some unique insight. Author Kendall Powell takes readers behind the scenes inside a funding committee of the American Cancer Society, which has funded 44 Nobel Prize laureates, as committee members deliberate through multiple rounds of scrutiny and elimination. Their discussions and decisions shed light on the cherished criteria that filter the haves of research funding from the have-nots. One proposal was cut for allegedly committing a very telling blunder:

Another outstanding application … runs into trouble because of a lack of scientific details. … [the primary reviewer] can’t see how the applicant will filter the genes that are pulled from the proposed screen. The problem with this particular fishing expedition, says the second reviewer, is that “he didn’t explain how he would sort through all the fish”. This proposal, too, is knocked out of the competitive range.

To understand the reviewers’ reasoning, it helps to take a look at the recent history of research funding and the relevant pressures that have developed. Over the last decade, many government science agencies have faced stagnant budgets that at best have kept up with inflation despite increasing numbers of competitive applications. At the National Institutes of Health, or NIH, the largest public funding source for biomedical research in the United States, just less than 20 percent of grant applications were funded in 2009, compared to 32 percent in 2000.

The result is a notoriously grueling application process. Researchers typically begin writing a grant months before the deadline and the entire pipeline of peer review can take up to a year. Subject to scrutiny are the researcher’s background, equipment and facilities needed, time, and most importantly the projected overall impact of the scientific outcome. Innovative, thought-out work with expected output is a must. In 2002 the National Science Foundation, which funds approximately 20 percent of all federally supported basic science research in universities, announced that proposals must demonstrate broader impacts on society in order to be seriously considered. Committee members become increasingly nitpicky, writes Powell, with reviewers “looking for any excuse not to fund a project.”

A prime choice for such an excuse is the fishing accusation, many researchers gripe. In her blog, one scientist observes that she and her colleagues have all received the fishing remark at some point in their proposal reviews, and it was always intended as derogatory. “This kind of hedge trimming suggests that only the safest, most predictable work should be done,” she writes, “and any exploratory tangents should be lopped off early.” She continued in an email to me, “It’s a problem of overabundance of caution.” Dr. Tim Birkhead, a professor of behavioral ecology at the University of Sheffield, voices similar concerns in an article printed in the Times Higher Education. “The scientific research councils seem to be obsessed by hypothesis testing. Many times I have heard it said by referees rejecting a proposal: ‘But there was no hypothesis.’” The problem with this model, he says, is crippling risk aversion. When scientists “basically have to know what they are going to find before putting in a research application,” research becomes “trivially confirmatory and inherently unlikely to discover anything truly novel.”

Still, reluctance to support fishing is not necessarily an assault on big data. “The success of fishing depends on how good your lure is,” explains Dr. Peter Good, a program director at the National Human Genome Research Institute who manages portfolios of grants involving genomic technology development. To get funded, “you have to lay out your ideas – technology-driven or hypothesis-driven – demonstrate what you’re doing is significant, better than anything else out there, and show reviewers you know what you’re doing.”

Dr. Elizabeth Pisani takes that argument one step further in her article, “Has the internet changed science?” What goes on in the laboratory has never been as neat as what gets written in the scientific paper, she points out. The paper follows a template that frames research as a linear story, aligning with the steps of the classic scientific method. Yet the findings that become published are frequently not the ones that were initially pursued. As information accumulates and trends can be detected, researchers can come up with new, increasingly refined hypotheses. Thus, drawing a sharp distinction between data-driven and hypothesis-driven methods, much less presenting this divide as new, is misleading. The two are not conflicting, but complementary. As Peter Good says, “Data-driven really means hypothesis-generating.” It would be silly for a committee to bias (intentionally) against one or the other side of the same coin.

Here is another way to view it: Hypothesis-driven and data-driven do not represent two opposing and nonoverlapping camps of inquiry but rather a continuum addressing the initial idea’s degree of specificity. Data-driven research then falls on one end of that continuum, with a more flexible starting hypothesis. In genomics lingo, that would mean the difference between “we predict a genetic basis underlying this trait” and “we predict that X specific gene is implicated in this trait.”

Different fields have varied traditions about where they fall on that spectrum. Genomics is one where data-driven methods have now been in play for a while, meaning geneticists who sit on review committees are less likely to take a knee-jerk “But where is the hypothesis?” reaction to grant proposals. But departments are integrating—or ignoring—big data at unequal rates. Things get tricky when a committee comprises researchers from diverse backgrounds who subscribe to distinct conventions of how research ought to be conducted. “Issues can crop up when you send a grant to a study section with no geneticists, and they say, ‘this is a fishing expedition,’” says Dr. Matthew State, an associate professor of genetics at Yale University School of Medicine. “You then say ‘Right!’ and have to explain that empirically, it works here.” Often, however, no side is clearly right or wrong. Chalk it up to a clash of scientific cultures.

The scientific method may not be becoming obsolete but it is evolving to exploit the power of modern information technology. Meanwhile, funding agencies are dealing with changing burdens of their own. Difficult decisions must be made and disagreement is expected. There will likely never be a perfect system that will satisfy everyone. Here’s to the goal that the laboratory and funding worlds evolve in a way that is as synchronized and symbiotic as possible.

Ilana Yurkiewicz holds a B.S. from Yale University and was a staff writer at The News & Observer. Currently a clinical research assistant at Walter Reed Army Medical Center, she will matriculate at Harvard Medical School in the fall.

The technique being developed analyzes fetal DNA that is collected from women’s blood as early as five weeks into a pregnancy. So-called “noninvasive prenatal diagnosis,” or NIPD, may hit the market as a test for Down syndrome later this year. Soon after, refinements are likely that will allow identification of fetal genes at thousands of sites; two different research groups published papers claiming “proof in principle” of this prospect last December.

Because NIPD would be less invasive, less risky, and less expensive than the kinds of fetal gene tests now available, and because it relies on a simple blood draw so early in pregnancy, it is poised to become a prenatal game changer.

The fetal gene tests now offered are far from a walk in the park. For amniocentesis, a long needle is poked through your abdomen and uterus to extract amniotic fluid when you’re about 15-20 weeks pregnant. Chorionic villus sampling takes a snip of placental tissue, acquired by snaking a catheter through your vagina and cervix at 10-12 weeks. Both procedures carry a 0.5 percent to 1 percent risk of miscarriage.

By contrast, for NIPD you’d simply give a little extra blood at the lab at your first prenatal checkup. There would be no risk at all to you or the fetus. And you’d get the results before you were visibly pregnant, before you’d told your mother or your friends.

Of the 5 million or so pregnancies in the United States each year, only a few percent involve amniocentesis or chorionic villus sampling. Another few thousand fetal gene tests are done on embryos created with in vitro fertilization.

These numbers are relatively small. Even so, the practice of selecting fetuses and embryos with particular genes elicits concerns about the implications for people living with the very disabilities that are often “deselected,” about sex selection, and about parental expectations of a “perfect” child. NIPD could send the yearly number of fetal gene tests skyrocketing into the millions, and the level of concern soaring.

Researchers developing NIPD have already established partnerships with biotech companies eager to commercialize it; San Diego-based Sequenom has announced it will make NIPD for Down syndrome available in the fourth quarter of this year. Detecting hundreds or thousands of genetic variations, as opposed to particular chromosomal configurations, will be more difficult (and, at least initially, far more expensive). But researchers working on NIPD are confident that they’ll soon be able to do just that.

In other words, NIPD might soon be able to present you with the kind of genetic information about your five-week-old fetus that you can get today about yourself by sending a couple hundred dollars and a wad of spit to one of the “direct-to-consumer” gene test companies peddling their wares online. In both cases, you’d get a report that claims to predict risk for scores of common diseases and “conditions.”

But what do such reports mean? Predictions based on genetic testing are often highly misleading. You may learn from your own gene test, for example, that your risk of some condition is 50 percent higher than average—but how important is that if the average risk is only 1 percent? You may be told that you have a genetic variation associated with some disease—but that result may be based on one or a couple of small studies that have since been found wanting. The results look impressive and objective but for the most part their meaning is dubious and their usefulness scant. In fact, an increasing number of medical and genetic experts, and an FDA advisory panel, agree that when it comes to predicting common diseases, gene tests are a waste of money. Responsible medical practice, in this view, would limit gene tests to those that are clinically meaningful and useful.

Of course, some gene test results are helpful and important: If you’re planning children, for example, you may want to know if you’re a carrier for a serious single-gene disorder such as Tay-Sachs; if close relatives have had breast cancer, you may want to learn whether you have the mutation that significantly raises your risk of the rare familial form of the cancer.

But even with genetically imposed risks that are well established—for example, the genetic variation linked to early-onset Alzheimer’s—there are often few if any preventive measures to take. Fetal gene testing, however, is different. It presents an option: terminating a previously wanted pregnancy.

If sequencing large swaths of fetal genomes becomes common, that’s a choice millions might face. But how could pregnant women and their partners possibly interpret the results of tests that claim to predict dozens or hundreds of a future child’s traits? How, for example, could they “balance” a 25 percent increase in one risk against a 15 percent decrease in another? What would any of us do with information like this, even—or especially—if we knew it to be dubious and misleading?

And what of the broader social concerns? How many parents would choose to terminate a pregnancy because their child might be born with a disability—even if it was one with which many people are living full and happy lives? Would health insurers encourage such tests, or even require them, in order to avoid the costs of special-needs children?

It could get worse. Would we see parents using prenatal testing to try for a boy who’d play basketball with Dad or a girl eager to go clothes shopping with Mom? Would we begin to see offers—like the one in 2009 by a Los Angeles fertility clinic—to test fetuses for hair color, eye color, and skin tone?

Two close observers of NIPD’s development, UC Hastings legal scholar Jaime King and Stanford bioethicist Henry Greely, predict NIPD will soon force us to face the “brave new world” questions that “we have been able until now to ignore.” In a January Nature article titled “Get Ready for the Flood of Fetal Gene Screening,” Greely described the pending situation in appropriately dramatic terms: The “spectre of eugenics will loom over the whole discussion,” he noted. And concerns about eugenics “will increase as such testing moves from fatal diseases to less serious medical conditions and then on to nonmedical characteristics.”

Though some will object to NIPD largely because it makes greater numbers of abortions likely, its social and moral implications are not well captured by the abortion debate. Fetal gene testing in ballooned numbers and scope will disquiet reproductive rights advocates, disability rights advocates, and many others. Those of us determined to protect abortion rights will need to find ways to prevent frivolous and medically irrelevant genetic testing that could distort our hard-won reproductive freedoms and carry us into the realm of eugenics.

Marcy Darnovsky, Ph.D., is associate executive director of the Center for Genetics and Society, a public interest organization working for responsible uses and governance of human genetic and reproductive technologies.

I say this because I was a little surprised to recently find myself the object of an Internet tempest for a few days over an interview I did with my friend, conservative political theorist Robert George of Princeton University. Robbie, with whom I disagree about many things but deeply respect for his willingness to engage in honest debate, understood what I had to say and knew I said so prior to this interview. Apparently, other critics of stem cell research had chosen to ignore my caustic comments about some proponents overpromising cures over the years.

In the interview I said many scientists and their supporters favoring public funding of embryonic stem cell research had gone too far in hyping the prospects of rapid cures following right on the heels of generous government funding. They did. My saying so, however, was hardly the news The American Spectator, First Things, and other electronic conservative outlets made it out to be.

Anyone who has followed my advocacy for embryonic stem cell research would know I have long been critical of claims that funding today means people tomorrow will leap from their wheelchairs and walk. This is me in 2006 describing overpromising of embryonic stem cell research in Wired: “There’s big expectations, a lot of hype.” And saying the same thing at greater length two years ago: “There has been hype and overpromising. … I don’t know if stem cell research will work, I think it’s very interesting, I support doing it, but I think you have to be honest and say there’s a small chance nothing will work.”

I then explained why the hype had grown so loud:

There was such a bitter battle over funding, so one side was screaming that you can’t kill embryos to try and save people and in response, the defenders of stem cell research began to say, ‘look, if you would let us do this research we can save lives. … it was in the heat of that political battle to score points that they [proponents] overstated the case.”

Having lived during the 1990s when the hype machine was spinning full throttle about the curative powers of gene therapy, the clinical wonders that would quickly follow from mapping the human genome, and the frothy promise that genetically engineering plants would quickly cash out in the form of fortified foods such as golden rice that would rapidly solve the nutritional deficiencies of the world’s poor, I am keenly sensitive to the kind of overpromising that occurs when a novel form of science is in search of public funding. The fact that the fight over public funding of embryonic stem cell research had the critics screaming “murder” regarding the destruction of human embryos evoked even more overwrought language from proponents about the speedy cures lying right around the corner.

Since everyone for some reason now seems very interested in coming clean about hype in the embryonic stem cell debate, I thought I might take a quick tour of five of the most outrageous, overhyped claims by critics that have characterized what has passed for debate during the years since George W. Bush addressed the nation from the Rose Garden in 2001 to offer his “compromise” position over public funding of embryonic stem cell research.

Hyped claim #5: The Bush “compromise”

The president tried to offer a “compromise” about government funding of embryonic stem cell research. Government funds could be spent on stem cell lines made from human embryos prior to August 9, 2001, but nothing else. The president said there were cell lines available from 64 embryos for which consent had been obtained to use them in research.

Except there were not. Some of the cell lines were owned by non-U.S. companies who would not share them. Some of the cell lines did not grow well. Some of the cell lines had been generated without informed consent from anyone. What was touted as a brilliant “solution” by many conservatives and not a few middle-of-the-road commentators was nothing more than a ban dressed up as a compromise.

Hyped claim #4: Adult stem cells can do it all

The number of antiembryonic stem cell researchers offering up this bit of hype are legion. The argument goes that since adult stem cells have been used to cure many people while embryonic stem cells have not, there is no need to pursue embryonic stem cell research. Father Thad Pacholczyk, often quoted in right-wing circles, who is a staunch critic of embryonic stem cell research, offered one of a zillion such examples in 2006 of why there is no need to pursue embryonic stem cell research, because there are “dozens of diseases currently treatable using these [adult] stem cells, including sickle-cell anemia, leukemia, spinal cord injury, and heart disease.”

I am not sure what he was talking about regarding spinal cord injuries, which as far as I know remain completely incurable, but it is true that bone marrow transplants have cured a lot of children and adults. And bone marrow is a type of adult stem cell. That is where the truth of this claim ends and the hype begins.

The research behind bone marrow transplantation began in the 1950s. It received generous government grant support for the next 50 years. It still does. Embryonic stem cells were first discovered in 1998. Research involving those cells has received minimal funding from any source since then. As Robert George forthrightly said in our discussion, it is just dishonest not to concede that you are giving up a key line of research if you don’t fund embryonic stem cell work by pretending you know that it can be completely replaced by adult stem cell research.

Hyped claim #3: If embryonic stem cell research is so promising, then why isn’t private research behind it?

A typical example of this absurd claim appeared in The Wall Street Journal where Richard Miniter opined in 2001:

Of the 15 US biotech companies solely devoted to developing cures using stem cells, only two focus on embryos. Embryo stem cell research is at the drawing-board stage – not for lack of funds but for lack of promising research to finance. Venture capitalists have no agenda beyond making money; if they see embryo projects that are likely to bear fruit over the next five to seven years – the usual VC time horizon – they will fund them. That the market is speaking so loudly against embryo stem cell research probably explains why embryo researchers are so eager to reverse the ban on government funding.

It has been echoed in the conservative right-wing blogsphere ever since.

This is hype in a very pure form. No venture capitalist or firm is going to back research in a big way that (a) is just starting out, (b) does not yet understand the basic science involved, and (c) has elicited huge opposition from the then-president of the United States and his supporters in Congress. Governments fund basic, early-stage research. The U.S. government has long been the 100-pound gorilla of such funding. It is only later, as commercial possibilities emerge, that the private sector gets really interested. Keep the NIH out of funding basic stem cell research and few private dollars will flow no matter how promising that line of research might be.

Hyped claim #2: IPS cells are the magical solution to the embryonic stem cell quandary

Conservative columnist Charles Krauthammer led the hype machine on this subject. Back in 2007 an announcement was made that researchers in Japan had discovered how to reprogram adult skin cells to resemble embryonic stem cells. Krauthammer immediately declared Bush had been right to ban public funds for embryonic stem cell research (I thought that had been a “compromise”) since there was now a way to create “a magical stem cell that can become bone or brain or heart or liver” without using human embryos. Magical—really? Could there be any claim more fraught with hype then declaring that any biomedical discovery is ready to go right out of the lab to your doctor’s office?

Making adult cells into embryo-like cells remains the current darling of critics of research involving embryos. But the technique is barely understood and its safety is a huge concern to those working in the area. Not only was it hype to declare in 2007 that the game was over for embryonic stem cells or even to continue to say in 2011 that there is no need to pursue embryonic stem cell research (note, by the way, no cures from IPS—five years and counting) is nothing less than unadulterated hype driven by an agenda utterly disconnected from the nascent state of the science.

Hyped claim #1: Frozen embryos should be put up for adoption rather than used as sources of stem cell lines

The meshugana lawsuit that Dr. James Sherley, a biological engineer at Boston Biomedical Research Institute who works on adult stem cells, has brought is currently holding up NIH funding of expanded embryonic stem cell research. Sherley implausibly argues that permitting more funding for research on stem cells derived from human embryos would harm his work by increasing competition for federal funding.

What has been forgotten about this suit is that it was originally joined by an adoption agency called Nightlight Christian Adoptions, which argued that expanding funding for research on embryos obtained from fertility clinics reduces the number available for use in adoption.

Now the Nightlight folks got the axe from a federal judge and were kicked out of the lawsuit. What needs to be remembered, though, is that far too many critics of embryonic stem cell research, including President Bush, advance adoption and continue to do so as if it were an alternative to either the destruction of embryos at fertility clinics or the use of abandoned frozen ones in research.

This is Bush in 2005: “There’s an alternative to the destruction of life, with little babies being born as a result of the embryos that had been frozen.”

Now I am very sensitive on the matter of unwanted embryos left behind at fertility clinics. In 1999 I published a paper with George Annas and Sherman Elias, “Stem Cell Politics, Ethics and Medical Progress,” in which we first outlined the ethical case for using unwanted frozen embryos at infertility clinics as the true compromise position about where to obtain embryos for stem cell research. It was a good idea then and remains so now.

There have been about 50 reported adoptions of frozen embryos from infertility clinics in the past five years. Few will have any interest in using embryos from couples having infertility problems to try and have a child. And the whole point of using infertility treatment in the first place is to create a genetic tie between the child and one or both parents. Knowing there are hundreds of thousands of unwanted frozen embryos in clinics today means pointing to adoption as an “alternative” to their use in research is utter hype.

While I am on this particular bit of hype, I should add that those who do not favor the use of unwanted and certain-to-be-destroyed frozen embryos languishing in clinics worldwide never ever say what they propose be done with them. Conservatives say destruction is unthinkable, however, since it is inevitable then what are they talking about? ( I suppose this constitutes hypocrisy and not hype.)

There is plenty more hype to be had from what has passed as debate over the past decade or so since human embryonic stem cells were first isolated. I don’t mean to suggest that most of the hype has come from critics rather than proponents. I do mean to suggest, however, that those who live in very fragile houses often constructed of hype ought not be quick to cast stones.

Arthur Caplan, PhD, is the Director of the Center for Bioethics and the Sidney D. Caplan Professor of Bioethics at the University of Pennsylvania.

In the last year, scientists all over the world have been closely examining the DNA of many different preparations of human pluripotent stem cells, and they all have come to a similar conclusion: they have mistakes in their DNA sequences (publications are listed below). This is not surprising, because every time a cell divides, there’s a chance that the DNA sequence doesn’t get copied perfectly. This happens every day in our own bodies as our cells renew themselves; our cells can tolerate a lot of little changes without causing problems. DNA mistakes are a normal part of life.

However, not all errors in DNA are benign. Cancers involve changes in the DNA that make cells grow wildly out of control, but these changes are unusual—such as the breaking of chromosomes, inactivating genes that suppress tumor formation or hyper-activating genes that enhance growth. Even these changes don’t usually cause problems because our immune systems recognize these grossly abnormal cells and wipe them out.

Why do pluripotent stem cells have errors in their DNA? The techniques we use require that the cells be expanded from a single cell to a million cells before we can examine their DNA. This means that they have to double at least 20 times, which makes 20 chances for mistakes to be made in copying the DNA sequence. Some errors give the cells a growth advantage—think of evolution and survival of the fittest. If a cell grows just a little faster than its neighbors, eventually, over many cell doublings, it will become the dominant cell type in the culture. This dominant cell type is the one that we detect by sophisticated DNA analysis methods.

So, there are errors in DNA in cancers and there are errors in both human embryonic stem cells, which are derived from embryos, and induced pluripotent stem cells, which are derived from adult tissue. Should we be worried? I think we should be careful, but there are several reasons why we shouldn’t be worried, yet.

First, by far the greatest uses of pluripotent stem cells will not involve transplanting them to humans. Cultures of these cells will be valuable for understanding human disease. They will be very helpful for drug development, where they can be used to improve the testing of drugs in culture dishes before they are tested in people. DNA abnormalities are not important in cultured cells, unless they affect some critical function that is necessary for the assays and experiments that researchers use.

Second, the recent reports of DNA abnormalities in these cells will encourage other scientists in both basic and clinical research to look more closely at the DNA of the cells they are using. This is an important step forward that will improve the quality of stem cell research everywhere.

Last, these new reports strongly argue that when cells are destined to be transplanted to people, they must be checked for abnormalities that are related to cancer. We have not yet determined whether any of the aberrations we have seen in stem cells actually increase the chances that they become cancerous. Small mistakes in DNA are normal, as pointed out earlier. They do not harm us. We are working to identify what, if any, DNA changes reported in the recent scientific papers are dangerous. After we do this, we will know what to worry about.

Jeanne F. Loring is Professor and Director Center for Regenerative Medicine in the Department of Chemical Physiology at The Scripps Research Institute.

References

Gore, A., Li, Z., Fung, H.L., Young, J.E., Agarwal, S., Antosiewicz-Bourget, J., Canto, I., Giorgetti, A., Israel, M.A., Kiskinis, E., Lee, J.H., Loh, Y.H., Manos, P.D., Montserrat, N., Panopoulos, A.D., Ruiz, S., Wilbert, M.L., Yu, J., Kirkness, E.F., Izpisua Belmonte, J.C., Rossi, D.J., Thomson, J.A., Eggan, K., Daley, G.Q., Goldstein, L.S., Zhang, K., 2011. Somatic coding mutations in human induced pluripotent stem cells. Nature 471, 63-67.

Hussein, S.M., Batada, N.N., Vuoristo, S., Ching, R.W., Autio, R., Narva, E., Ng, S., Sourour, M., Hamalainen, R., Olsson, C., Lundin, K., Mikkola, M., Trokovic, R., Peitz, M., Brustle, O., Bazett-Jones, D.P., Alitalo, K., Lahesmaa, R., Nagy, A., Otonkoski, T., 2011. Copy number variation and selection during reprogramming to pluripotency. Nature 471, 58-62.

Laurent, L.C., Ulitsky, I., Slavin, I., Tran, H., Schork, A., Morey, R., Lynch, C., Harness, J.V., Lee, S., Barrero, M.J., Ku, S., Martynova, M., Semechkin, R., Galat, V., Gottesfeld, J., Izpisua Belmonte, J.C., Murry, C., Keirstead, H.S., Park, H.S., Schmidt, U., Laslett, A.L., Muller, F.J., Nievergelt, C.M., Shamir, R., Loring, J.F., 2011. Dynamic changes in the copy number of pluripotency and cell proliferation genes in human ESCs and iPSCs during reprogramming and time in culture. Cell Stem Cell 8, 106-118.

Historically, neuroscientists have had a range of tools to manipulate and observe neural circuits in the brain. These techniques, however, have often lacked the ability to isolate the contribution of specific neurons or types of neurons to the overall network. With optogenetics, researchers can now discretely control neuronal activity by using pulses of light to activate or inactivate specific populations of neurons. These tools are giving neuroscientists the potential to unlock many of the remaining mysteries of how individual groups of cells in the brain control perception and behavior.

The term optogenetics was first coined by one of its pioneers, Karl Deisseroth at Stanford. The technique, which recently won the 2010 Nature Methods method of the year award, makes use of a group of ion channels and other proteins discovered in bacteria and algae called “opsins.” These proteins are light sensitive and can therefore be activated by pulses of light of an appropriate wavelength. Depending on the opsin expressed, this will either excite or inhibit the neurons. The expression of opsins in mammalian neurons is achieved by inserting the encoding DNA into the target cells, which then produce the opsin proteins. The process of DNA addition is called transfection, and is typically accomplished by using a specially selected virus as a carrier to deliver the new DNA. Variants in the viral delivery and DNA coding sequence allow for specific subtypes of neurons to be targeted. Once opsins are expressed in the neurons, the firing rate can then be controlled in vivo by light from an implanted fiber-optic cable or through a small window in the skull.

This technique gives researchers enormous flexibility and control of the behavior of specific cell types in a given brain region. Spatial resolution comes from the location of the injection and the neural cell-type specificity of the viral vector. Temporal control is produced by the frequency of the delivered light pulses, which via the opsins drives the cells to fire at the same frequency as the pulses of light, or alternatively prevents them from firing at specific times.

For example, a group of neurons in a specific area of the brain could be transfected with an opsin that excites the cells, and then is activated at various frequencies to see how this changes the animal’s perception of a stimulus directed to this area of the brain. It can also be used to completely silence a set of neurons during specific behavioral tasks in order to determine the effect of those neurons on that behavior. With this level of precise control, many systems neuroscience questions that had imprecise answers previously can now be addressed by observing awake, behaving animals.

Some of the recent articles published using this technique have demonstrated new insights into previously vexing problems in neuroscience. For example, there has been a tremendous amount of debate about the mechanism of deep brain stimulation, or DBS, utilized to treat movement disorders resulting from Parkinson’s disease.

This treatment uses electrical stimulation targeted to a region of the brain involved in motor output and control, and its mechanism of action is not well understood. It has previously been difficult to assess whether this intervention affects the neurons nearby the electrode directly, the inputs to those neurons, or the targets of the output from these neurons in this circuit.

Researchers utilized a mouse model of Parkinson’s disease and optogenetics to dissect the circuits of the brain involved in the response to electrical stimulation of the targeted area. Their results suggest that rather than leading to a simple excitation or inhibition of the neurons in the targeted area, DBS is activating connections arising from another area, and that this activation is necessary for the effectiveness of the treatment.

Another recent article demonstrated the importance of a single type of neuron to cocaine addiction in mice, suggesting a target for future clinical interventions. Because this particular type of neuron represents only 1 percent of the cells in the investigated area (the Nucleus accumbens), they have been difficult to study up until now, and their function has been the subject of much debate in scientific literature. The precise genetic targeting of the opsins allowed for just this population of neurons to be manipulated during the experiment.

The implications of this new technology for the field of systems neuroscience are profound. Its potential is being realized as the technique is implemented more broadly and more difficult circuits and systems are teased apart. A better understanding of the circuits underlying psychiatric and neurological disorders will hopefully also lead to improved clinical treatments.

One question for the future is whether or not these new techniques may be directly used to treat some human disorders as well. For example, a future version of DBS might be coupled with optogenetics to provide more specific targeting of cells in the basal ganglia, directly affecting the firing patterns of the cells responsible for disrupted movement in Parkinson’s disease. In addition, research efforts in the past year have successfully demonstrated the feasibility of utilizing optogenetics in nonhuman primates. Use of this technology in humans, however, would combine the ethical dilemmas of gene therapy with those of brain-machine interfaces such as DBS. While the road to safe and efficacious use of this technology for treatment in humans is uncertain, it is already providing great benefits to scientists in understanding circuits and their complex regulation in the brain.

As Congress turns back this week to the continuing resolution to fund the government through the end of fiscal year 2011, it is important that we keep in mind the essential role of federal funding in facilitating scientific advances like optogenetics. The original project in Dr. Deisseroth’s laboratory, the first attempt to integrate the microbial opsins into mammalian cells, was funded by a grant awarded by the National Institutes of Mental Health and National Institutes of Health, as are many of the above-mentioned projects that followed. The first scientists describing the light-sensitive proteins in 1971 could not have predicted that their findings would lead to such a profound change in neuroscientific research. These discoveries are one of the best arguments for continuing to fund basic biological research as well as more translational research: We often don’t know where the breakthroughs are going to come from that will be the basis for the next generation of treatments for disease, or that will allow us to better understand the complex systems that make up our daily habits, thoughts, and decisions.

John A. Wolf, Ph.D., is a neuroscientist at the Center for Brain Injury and Repair in the Department of Neurosurgery at the University of Pennsylvania.

The commission has moved quickly since its inception last July to produce a farsighted report on the opportunities and ethics of synthetic biology and emerging technologies in December. In forming the commission the president asked experts to:

• “Review the developing field of synthetic biology
• “Consider the potential medical, environmental, security, and other benefits as well as potential health, security, or other risks
• “Identify appropriate ethical boundaries to maximize public benefits and minimize risks”

Speakers were Nelson Michael, M.D., Ph.D., a member of the commission and director of the Division of Retrovirology at the Walter Reed Army Institute of Research; and Valerie Bonham, J.D., executive director of the commission.

Because of the still emerging nature of this technology, Dr. Michael said, the commission had the “rare and exceptional opportunity to be forward looking instead of reactive,” to “take a deep breath and have a public dialogue.” In other words, it is better to begin to identify where future opportunities and threats may lie as new industries develop rather than to try to address them once entrenched interests have taken root.

Synthetic biology is the application of engineering principles to organisms and biological systems. The president’s formation of the commission was in response to last year’s announcement that Craig C. Venter had rebooted a single celled organism with an entirely synthetic genome. Dr. Michael pointed out that this process cost roughly $40 million and occupied a whole research team, but the feat caught the world by surprise and triggered a national debate.

There is a debate about whether Venter’s achievement specifically—and synthetic biology more broadly—are revolutionary in science, or merely an evolutionary extension of molecular biology and genetic engineering. According to Dr. Michael, “molecular biology was intended to ask questions and interrogate biological systems, whereas synthetic biology takes a different approach…While [it] sits on the shoulders of those that came before,” what is unique about synthetic biology, he continued, is that “synthetic biology seeks to make useful things.”

What kinds of useful things? Some of most promising near-term applications of the technology include more effective and efficient production of vaccines, environmentally friendly biofuels, and improved pharmaceuticals. For example, the chemical Artemisinin is a powerful antimalarial that currently must be extracted laboriously and expensively from the sweet wormwood plant. The hope is that pharmaceutical companies could use synthetic biology to engineer microbes to produce large amounts of this chemical in a form that is easy to refine, leading to a more affordable production technique for the life-saving drug. Similarly, researchers working in energy are hoping to use synthetic biology to engineer fuels from sunlight at the Department of Energy’s energy innovation hub at Lawrence Livermore. Using synthetic biology, researchers are experimenting with the genomes of algae species to produce high quantities of lipids for easy conversion to fuel.

But these possibilities are just the beginning. As with any emerging field of technology, where it will lead is difficult to predict. In one famous example of innovators failing to see the long-term implications of their technologies, Thomas John Watson Sr., the president of IBM Corporation in the 1950s supposedly said he believed there would be a world market for “maybe five computers.” Today there are about a billion computers worldwide. While it is unclear whether Thomas John Watson Sr. ever actually uttered those words, we do know that IBM Corporation suffered for its myopic focus on hardware and for failing to predict the vast and growing market for software that their innovation would create. If there is anything we know about technological innovation, it is that it is unpredictable.

Nonetheless, there are some common questions that we should ask of any new field, even if we do not know what it will look like in five, 10, or 50 years. The commission members and staff at the event on Thursday also noted that the report has implications for assessment of all emerging technologies. The report advocates that for synthetic biology and any emergent field of technology, policy needs to be guided by the principles of public beneficence, responsible stewardship, intellectual freedom and responsibility, democratic deliberation, and justice and fairness.

In investigating these principles for policy on synthetic biology, the commission engaged with leaders from the science, faith-based, legal, and ethics communities to evaluate potential risks, and created 18 principles for maximizing the public good. They also took a number of public comments, according to the commission’s executive director, Valerie H. Bonham, to ensure that they gathered “opinions from broad swath of society, on both technical and scientific issues and ethical concerns.” The results are a sensible balance between the “let science rip” approach—for example, minimal regulation to allow maximum progress, but also maximum risks—and an extremely measured regulatory approach that minimizes risk but also slows progress.

The president’s commission’s active engagement with stakeholders should serve as a model for the assessment of risks and benefits of new technologies.

You can view the event video and summary here, and you can download the commission’s report here.

Jonathan Moreno, Ph.D., is the Editor-In-Chief of Science Progress and a Senior Fellow at the Center for American Progress. Sean Pool is the Assistant Editor of Science Progress.

Biological production of chemicals

Three biologically mediated methods of chemical production are currently under development. The first is “biocatalysis,” or the use of purified enzymes to catalyze, or accelerate, chemical reactions. This approach offers several benefits: enzymes make precise changes to target molecules and yield only biologically active products; they function optimally at body temperature and thus require less energy than standard catalysts; and they are environmentally friendly because they employ renewable starting materials and produce fewer toxic byproducts.  Given these advantages, the chemical and pharmaceutical industries will make greater use of biocatalysis in the coming years. When this technology becomes widespread, however, enzymes called halogenases might be misused to produce highly toxic chemicals containing chlorine or fluorine, including known chemical warfare agents.

A second biologically mediated production method involves inserting clusters of animal or plant genes into bacteria in order to coax them into producing medically useful compounds. This technique, known as “metabolic engineering,” or “synthetic biology,” has the potential to mass-produce molecules that are difficult and costly to extract from their natural sources and are too complex to synthesize chemically on an industrial scale. The antimalarial drug artemisinin, for example, is currently extracted from the sweet wormwood plant. But researchers at the University of California, Berkeley, have used the genes coding for the biosynthesis of a closely related compound to produce artemisinin in bacteria. Synthetic biology is also central to efforts to manufacture ethanol from cellulosic material such as cornstalks and to make diesel fuel from genetically modified algae.  Nevertheless, synthetic biology techniques might be misused to mass-produce highly poisonous natural products such as saxitoxin, which is made by a species of marine algae responsible for the toxic algal blooms called “red tides.” During the 1960s, the CIA sought a supply of saxitoxin to use in suicide pills for captured spies. In order to acquire the deadly poison, the agency secretly spent millions of dollars to harvest tons of clams contaminated by a red tide and process them to extract a few grams of pure saxitoxin. Using synthetic biology techniques, it might be possible to isolate the algal genes responsible for the biosynthesis of saxitoxin and transfer them to bacteria, which would then produce the toxin relatively cheaply. If this scenario were realized, saxitoxin might become a serious chemical warfare threat.

A third biologically mediated process, known as “biopharming,” involves the production of protein-based pharmaceuticals such as vaccines, microbicides, and therapeutic antibodies in transgenic plants and animals. Foreign genes coding for the therapeutic proteins are inserted into crops such as corn and tomatoes, which are then harvested and the desired proteins extracted. Biopharming has a potential dark side, however, because it might be used to mass-produce toxic proteins for hostile purposes.

Chemical production of biological molecules

In parallel with the use of biological processes to manufacture drugs and other chemicals, companies are using chemical methods to synthesize biological molecules such as DNA and proteins from scratch. The invention of advanced DNA synthesizers, for example, has made it possible to construct genes and even entire microbial genomes by stringing together the four chemical units of DNA in any desired sequence. Over the past decade, scientists have recreated several pathogenic viruses by chemical means, including poliovirus, a SARS-like virus, and the formerly extinct “Spanish” strain of influenza, which was responsible for a global pandemic in 1918-19 that killed as many as 50 million people worldwide.

The size and accuracy of the DNA molecules that be created with automated chemical synthesis is increasing and the cost is declining. Moreover, commercial suppliers around the world now produce custom DNA sequences to order. A customer simply enters the desired sequence on an Internet web site, provides a credit card number, and a few weeks later receives a vial in the mail containing the requested DNA molecules in a biologically usable form. The synthesized sequence can then be copied and used for various scientific or industrial purposes. In October 2010, the U.S. government, fearing that outlaw states or sophisticated terrorists might order DNA coding for dangerous viruses and protein toxins of bioterrorism concern, issued voluntary guidelines for the gene-synthesis industry that call for the screening of customers and DNA sequence orders.

Chemical methods are also being applied to produce biological molecules called  peptides: short protein chains made up of 20 possible amino-acid building blocks. Worldwide, pharmaceutical companies are marketing about 40 peptide-based drugs, including the anti-HIV therapeutic Fuzeon and the potent painkiller Prialt, and hundreds more are under development. The human body also produces myriad biologically active peptides called “bioregulators” that control temperature, blood pressure, sleep, immunity, and other vital physiological functions. Although at low concentrations bioregulators are essential for life, they can be toxic at higher levels or if their molecular structure is modified. For example, a bioactive peptide called Substance P, consisting of a chain of 11 amino acids, serves as a messenger chemical in the central and peripheral nervous systems. In 1999, scientists at the Swedish Defense Research Establishment administered low doses of Substance P to guinea pigs the form of an aerosol, an airborne suspension of microscopic particles that can be absorbed in the deep region of the lungs. Under these circumstances, the peptide was acutely toxic, leading the Swedish researchers to warn that Substance P was “a possible future warfare agent.”

Once a toxic peptide has been identified, it could be manufactured in large quantities by chemical means. Peptide synthesis is now a thriving commercial business involving some 80 companies worldwide. These firms produce peptides to order according to customer specifications and in quantities ranging from a few milligrams for research use to thousands of kilograms for the pharmaceutical industry. Although natural peptides are generally unstable in aerosol form and are rapidly broken down in the body, limiting their potential utility as lethal or incapacitating warfare agents, structural variants of these molecules might be developed that resist rapid degradation and can enter the brain from the bloodstream. In addition, engineered nanoparticles might be used to facilitate the delivery of bioactive peptides in aerosol form or to target specific body tissues or organs.

Gaps in the disarmament regime

In 1925, the League of Nations (the forerunner to the United Nations) negotiated the Geneva Protocol prohibiting the use in war of toxic chemicals and bacteriological agents, but not restricting their production and stockpiling. In 1971, seeking to extend the ban to cover development and production, the UN disarmament conference in Geneva agreed to separate biological from chemical weapons because the former had been used only rarely in warfare and were assessed to have little military utility, while the latter had been employed extensively in World War I and other conflicts. The culmination of this negotiating strategy was two separate treaties: the 1972 Biological and Toxin Weapons Convention (BWC) and, two decades later, the 1993 Chemical Weapons Convention (CWC).

Although the two accords each prohibit the development, production, and possession of an entire category of arms, they have distinct provisions and sets of member states. The CWC, for example, has extensive verification measures, whereas the BWC has none. Because both treaties ban the acquisition for hostile purposes of toxic chemicals of biological origin, such as natural toxins and bioregulators, one would expect that the controls in this area would be particularly effective. In practice, however, the overlap has allowed the members of each treaty to deemphasize this category of agents, in the expectation that the other treaty will cover them. As a result, as the British analyst Julian Perry Robinson has pointed out, the overlap between the BWC and the CWC with respect to toxins and bioregulators “risks becoming a gulf into which things disappear.”

Today convergence is creating three gaps in the biological and chemical disarmament regime. The first concerns the biological production of toxic chemicals. At present, the CWC verification system does not cover facilities that make treaty-relevant chemicals by biologically mediated processes, such as biocatalysis or synthetic biology. Although the use of such methods for the large-scale production of chemical warfare agents is not economically viable, that situation could well change as the techniques become cheaper and more widespread.

The second gap in the arms control regime concerns the chemical synthesis of pathogenic viruses from scratch. Although the BWC prohibits the production of viruses for hostile purposes, the treaty does not have any formal mechanisms to verify compliance. Conversely, the CWC has extensive verification measures but does not ban the chemical synthesis of viruses because they do not cause harm through “toxic effects on living systems.” As a result, there is no verification in this area.

The third gap in the regime concerns the synthesis of bioactive peptides like Substance P. Such production is not subject to routine verification under the CWC because no peptides are listed in the treaty’s Schedules of Chemicals, which determine which production facilities must be declared and opened for inspection. At the same time, bioactive peptides are manufactured in quantities too small to be covered by a second CWC verification mechanism covering “other chemical production facilities” (OCPFs) that do not currently produce scheduled chemicals but have the potential to do so. The OCPF regime is based on quantitative production thresholds rather than on specific chemicals.

If nothing is done to close these three gaps, it may become possible for countries to exploit convergent technologies to break out of the BWC and the CWC without risk of detection. In sum, as biological and chemical production methods continue to converge, the traditional strategy of pursuing biological and chemical arms control on separate tracks has become obsolete, and the two treaties will have to become better integrated.

Policy recommendations

Finding concrete ways to prevent the misuse of convergent biological and chemical technologies for weapons purposes will require innovative thinking and political will on the part of the United States and other like-minded countries. The following three steps would help to address the problem of convergence:

1. The international implementing body for the CWC, the Organization for the Prohibition of Chemical Weapons, or OPCW, in The Hague, should convene a panel of scientific and technical experts to assess the biologically mediated production of chemical warfare agents and their precursors, including its feasibility and likely timeframe, to help policymakers determine the level of attention this issue deserves.
2. The member states of the CWC should add a toxic peptide such as Substance P to the Schedules of Chemicals subject to routine verification, using the technical-change procedure provided in the treaty. At present, the CWC Schedules include only two toxins (ricin and saxitoxin) and no bioregulators. Because of its known toxicity, Substance P would be a good placeholder to represent the entire class of bioactive peptides.
3. To better coordinate the implementation of the two treaties in response to convergence, the member states of the CWC should establish a liaison position in the Verification Division of the OPCW for a representative from the BWC Implementation Support Unit, or ISU, in Geneva. Although the ISU currently has only three full-time staff members, the upcoming five-year review conference of the BWC in December 2011 is expected to expand the size of the unit, in which case it may be possible to send an ISU representative to The Hague.

In conclusion, the growing convergence of biological and chemical production methods is outstripping the ability of the CWC and the BWC to prevent the misuse of these technologies for hostile purposes. Although the risks have not yet fully materialized, the rapid pace of technological progress in the biological and chemical fields and the political hurdles facing efforts to strengthen the two treaties suggest that the time to begin is now.

Jonathan B. Tucker, Ph.D., is a policy analyst specializing in biological and chemical arms control and nonproliferation issues. He is the author of Scourge: The Once and Future Threat of Smallpox and War of Nerves: Chemical Warfare from World War I to Al-Qaeda, and the editor of Toxic Terror: Assessing Terrorist Use of Chemical and Biological Weapons. For a more technical discussion of this issue, see: Jonathan B. Tucker, “The convergence of biology and chemistry: implications for arms control verification,” Bulletin of the Atomic Scientists, vol. 66, no. 6 (November/December 2010), pp. 56-66.



There are approximately 33.3 million people in the world today living with HIV/AIDS. Now, 30 years into the epidemic, we are capable of preventing and treating infection, but until today not a single person has been cured. Neither a sterilizing cure with every particle of HIV eradicated from the body nor even a functional cure with near-complete immune system control of the virus without requiring daily, potentially toxic HIV antiretroviral treatment have been found.

Until now. Timothy Ray Brown, known only as the “Berlin Patient” prior to his interview in the German magazine STERN in December 2010, is a 44-year-old who has been living with HIV since 1995. He may be the first to have outwitted the retrovirus. His disease was well controlled through years of taking antiretroviral drug therapy until 2006 when he developed acute myeloid leukemia, or AML—a potentially fatal cancer of the immune system. Mr. Brown became the first person ever to receive a unique stem cell transplant with cells specifically chosen because they are resistant to the most commonly transmitted form of HIV infection. As part of that treatment he also was subjected to highly toxic chemotherapy, total body irradiation, and immunosuppressive drug treatment, all repeated when his AML relapsed seven months later.

AML is a life-threatening blood cancer where stem cell transplantation and its attendant risk of fatal complications is warranted in certain settings. Hematopoietic stem cells are blood-forming stem cells, which grow and divide to produce red blood cells, white blood cells, and platelets. They are found primarily in the bone marrow but also in the peripheral blood (arteries and veins). Chemotherapy used to treat AML destroys these cells in the process of treating the cancer. Stem cell transplantation is the transfusion of stem cells from the peripheral blood of another person/donor (allogeneic) or one’s self (autologous) in order to replace the eradicated cells and rebuild the damaged blood and immune system. It is a very risky procedure and many patients die while waiting for their blood and immune systems to recover.

Although 75 percent of patients requiring allogeneic stem cell transplant will find at least one appropriate donor, the ideal donor is typically a sister or brother of the patient who has inherited similar markers on the surface of their cells. These molecules alert the immune system to the presence of anything foreign in the body so blood and marrow stem cells from one person will be rejected when transplanted into another person if they don’t closely “match” each other.

HIV infects and destroys the cells of the human immune system. In order to get into these cells it must use an access site, or co-receptor, located on the cell’s surface. The most common type of co-receptor is called CCR-5. But if the access site is blocked, HIV cannot enter and infect the cell and transmission doesn’t occur. Recent research has shown that approximately 3 percent of Northern Europeans have inherited from their parents two defective proteins that make up CCR-5, called the CCR5-delta32 base pair deletion. Because they lack the co-receptors where HIV particles access their cells, these individuals are resistant to transmission of the most common form of HIV infection, though they can still become infected with rarer strains.

So the “Berlin Patient” is the extremely rare patient with coincident HIV and AML, who uniquely received HIV-resistant stem cells through two stem cell transplantations from an unrelated stranger with the CCR5-delta32 base pair deletion. In what appears to be an impossible dream to others with the disease, it has been three and a half years since Mr. Brown took his last HIV medication and yet there has been no sign of the infection in his blood, liver, colon, or brain. Perhaps most importantly his immune system has recovered to that of an uninfected individual and has been replaced by that of his donor.

Has the “Berlin Patient” been “cured” of HIV? It’s impossible to say definitively. Although doctors can’t find HIV anywhere they’ve looked, their tools are not able to measure single cells hiding and waiting to multiply and no one knows what timeframe of negative testing will satisfy “has it been long enough.” But it’s fair to say that for this one highly unusual patient. Brown’s case is exceptionally rare, and the team that developed the treatment expects to find only approximately one person each year in all of Germany who meets all of these criteria who could be eligible for it. But though this is just one very specialized case, it is still a step in the right direction. Stem cell transplantation with rarely found HIV-resistant stem cells may one day lead to the elusive “functional cure,” where antiretroviral drugs and their toxicities are no longer necessary.

Dr. Leslie Serchuck is a pediatric infectious disease HIV/AIDS specialist with a master’s degree in psychology and a master’s degree in bioethics from the University of Pennsylvania.

A key reinforcement for their inquiry was an article in the British Medical Journal, or BMJ. Co-authored by Deborah Cohen, the BMJ features editor, and Philip Carter, a journalist who worked for the Bureau of Investigative Journalism in London, the article claimed to have found secret ties between vaccine manufacturers like Glaxo and advisors to the WHO on pandemic flu. The article stated,

“…our investigation has revealed damaging issues. If these are not addressed, H1N1 may yet claim its biggest victim — the credibility of the WHO and the trust in the global public health system.”

Antivaccine groups gleefully received all this conspiracy theorizing. Websites bubbled over with comments like this one:

“The step is a long-overdue move to public transparency of a ‘Golden Triangle’ of drug corruption between WHO, the pharma industry and academic scientists that has permanently damaged the lives of millions and even caused death.”

And why exactly would the allegedly corrupt experts consulted by the WHO recommend worldwide vaccination against H1N1? Because, to cite one sadly typical antivaccine website,

“They say WHO ‘had no choice’ but to declare a pandemic and recommend vaccines, since vaccines are the only treatment option for influenza. That’s a lie, of course: Vitamin D has been scientifically proven to be five times more effective than vaccines at preventing influenza infections, but WHO never recommended vitamin D to anyone.

The entire focus was on pushing more high-profit vaccines, not recommending the things that would actually help people the most. And now we know why: The more vulnerable people were to the pandemic, the more would be killed by H1N1, thereby ‘proving’ the importance of vaccination programs.”

That’s right—the whole pandemic flu scare was driven by the desire by hired expert stooges to hide the preventive powers of Vitamin D so drug companies could profit. Many had to die in order that Flintstone’s vitamins not live.

By July 2010 the Parliamentary Assembly of the Council of Europe had issued its report. They saw evidence of a lack of transparency in the deliberations leading to the call for widespread vaccination against H1N1 on the part of the WHO. They called for more openness in future in identifying experts and their industry ties and in making public health decisions. They essentially reinforced the crackpot conspiracy views of the antivaccine movement.

On January 5 of this year, the very same journal that gave credence to the idea that H1N1 vaccination efforts were nothing but a pharma business conspiracy, the British Medical Journal took a very different tack about experts. They collectively wrung their editorial hands over the 1998 publication in rival journal, The Lancet, of a paper by then-doctor, now defrocked self-proclaimed autism healer Andrew Wakefield. In that paper Wakefield claimed to have found the cause of autism—the measles, mumps, rubella, or MMR, vaccine.

The editor-in-chief of the BMJ declared Wakefield’s paper to not only have been inaccurate but the product of fraud. In an accompanying article the British investigative journalist Brian Deer, who had been on Wakefield’s case for many years, showed how Wakefield manipulated data in his attempts to prove something that he “knew” before he started his research.

Remarkably no one has wondered why the BMJ was so eager to track down the sins of Andrew Wakefield regarding vaccination but so willing to engage in a highly dubious smear campaign against the WHO on the very same subject.

It is most certainly true, as two just-published important books about the mayhem and death caused by the antivaccination movement by Dr. Paul A. Offit, Deadly Choices, and Seth Mnookin’s The Panic Virus, show, that Wakefield did enormous damage. And that he is a charlatan and a fraud.

Offit and Mnookin rightly condemn the raft of celebrities and media lights including Oprah Winfrey, Ariana Huffington, Larry King, Jenny McCarthy, Bill Maher, and Jim Carey who promoted Wakefield’s vaccines-cause-autism blarney. Various “patient” groups, such as Generation Rescue and Barbara Loe Fisher’s scurrilous National Vaccine Information Center, piled onto the vaccines-autism link and are called to account. Offit points the finger of blame for the promotion of antivaccine nonsense at prominent celebrity doctors including Bernadine Healy, Robert Sears, and Mehmet Oz who chimed in with worry as well.

Giving antivaccine propagandists a bully pulpit has worked. In a study done last year one in four American parents admitted they felt vaccines cause autism. And at least 8,000 cases of whooping cough including 10 infant fatalities occurred this past year thanks to parents heeding the sage scientific advice of Bill Maher, Dr Bob Sears, and Jenny McCarthy. This despite the fact that no one had ever replicated Wakefield’s findings and no other studies had found any link between autism and vaccines.

Both books show how the media has fallen hook, line, and sinker for unfounded antivaccine messages. Sometimes it is because in their search for balance, Jenny McCarthy and Barbara Loe Fisher are squared off and thus equated in terms of credibility with pediatric infectious disease experts like Offit. Sometimes, as Mnookin rightly notes, it has been because our society is eager to embrace anecdote, intuition, and experience as on par with evidence, logic, and reason. We credit moms with stories to tell just as much as peer-reviewed articles because science lacks emotional force. And sometimes the media promotes antivaccine messages because fear abhors an explanatory vacuum. When you don’t know why your child is autistic and so many others are too and science cannot say for certain what the cause is then vaccines are as good a reason as any.

What is understated in both books is calling to account mainstream medicine and government institutions over their role in promoting antivaccine beliefs as occurred in response to the H1N1 pandemic that wasn’t. It is great that the BMJ has shown Wakefield to be not just in error but also fraudulent. But, what about their ominous suggestion that big pharma called all the shots in pushing WHO experts to endorse global vaccination against H1N1 flu? And is the Parliamentary Assembly of the Council of Europe really telling the world that the WHO acted as it did in response to worries in 2009 about a scary flu outbreak in Mexico as a result of being led by the nose by Merck, Glaxo, and Sanofi who sought to line their pockets by hiring and then manipulating scientific experts to freak out the WHO? And why are the CDC and other government agencies so willing to kowtow to vaccine know-nothings like Fisher or to put up with unsubstantiated claims about vitamins and natural remedies instead of speaking up loudly and unequivocally in defense of vaccines?

The media and celebrity doctors alone did not convince so many parents that vaccines are dangerous. Mainstream institutions and medical journals did so too, and still are.

It is just irresponsible to suggest that some sort of conspiracy led WHO to pull the wool over the world’s eyes and have everyone get vaccinated to line the pockets of their pharma puppet-masters. The WHO cannot make anyone do anything. It has no power to enforce any mandate or requirements about vaccines or anything else. It relies completely on persuasion. Without the cooperation of individual world governments, medical societies, and public health agencies the WHO can get nothing done. All these entities, including the Parliamentary Assembly of the Council of Europe, would have to be in the pocket of big pharma to impose a worldwide vaccination plan.

The Council of Europe and the BMJ seem to have forgotten their recent history. When H1N1 first appeared there were plenty of scientists from all sorts of nations with all sorts of affiliations who worried that it might prove extraordinarily lethal. In 2006 The Lancet published a study led by Christopher Murray of Harvard’s School of Public Health, an outfit not known to be under the control of big pharma, that worried that pandemic flu could cause as many as 62 million deaths. True, it did not. But, what would BMJ or the Council of Europe have had the WHO and public health agencies do in the face of such concern—nothing? A large-scale vaccination effort was the only prudent course to take.

Keep in mind that when the call for an inquiry was issued by the Parliamentary Assembly of the Council of Europe, at least 14,711 people worldwide had been killed by the H1N1 pandemic. That is not 62 million but it is a lot of deaths. Since, as of November 2009, over 65 million doses of vaccine had been administered in 16 countries. Who is to say that the death toll might have been far worse but for the vaccination campaign?

And as for profits from launching a worldwide flu shot campaign—you have to be kidding! Flu shot manufacturers make very little from flu shots. If you can make 65 million swine flu doses quickly that is probably 65 million regular flu shots they do not make. If you posit say a three or four dollar profit on every H1N1 flu shot made, a limit of say 250 million flu shots that could quickly be made and ignore the impact of all this on making regular flu the entire vaccine industry stood to share in about $1 billion to  $1.5 billion from going crazy trying to make and ship as much H1N1 vaccine as possible. If the council of Europe or the BMJ thinks the main flu shot manufacturers would go out of their way to manipulate the world’s vaccine experts to make a few hundreds of millions of dollars each then they don’t know what pharma thinks of as profits that really matter.

The Offit and Mnookin books tell important stories of how panic and fear due to an indulgent media and irresponsible fringe voices came to dominate too much of our thinking about vaccines. What they leave out is how mainstream medical publications and governmental institutions have fueled that panic and fear too. When mainstream medical journals and governments foster screwball conspiracy theories about pandemic flu instead of explaining how the world dodged a bullet they are part of the problem not the solution.

Arthur Caplan, PhD, is the Director of the Center for Bioethics and the Sidney D Caplan Professor of Bioethics at the University of Pennsylvania.

“Nothing,” I answered.

He nodded in agreement.

At the time, blood pressure of 180 was the body’s physiologic compensation to assure a steady flow of blood through the old man’s hardened arteries. It was normal aging.

One year later, however, this elevated pressure became a disease called isolated systolic hypertension—and I was prescribing blood pressure medications to patients like him. Within four years, when I was a fellow in geriatric medicine, two-thirds of my patients were on these medicines. What had been a routine part of aging had become a minor pandemic.

What happened?

I began treating isolated systolic hypertension in older adults because a study showed that treatment reduced the chance, or probability, of suffering a stroke or congestive heart failure. This study was the last step in a new approach to discovering disease. First, large longitudinal studies identify factors that predict risk. Next, a clinical trial shows whether changing a factor, such as blood pressure, reduces the risk. As a result, what had been just natural variations in human physiology became diseases.

In the years to follow my residency, I felt like I was becoming a small-time insurance salesman. I was ordering a host of tests, such as bone scans and blood cholesterol levels, to decide whether a patient was at enough risk to warrant still more tests and drugs. I was experiencing the transformation of medicine from the care of the sick patient at the bedside to the management of the at-risk patient at the desktop.

And I was ill-prepared to practice this new kind of medicine. I wrote my notes in longhand in a paper chart. I had no training in probability theory and statistics. My last math class was high school calculus. I had not a clue about the psychology of risk.

For much of the modern era, medicine worked at the bedside. “Go to the bedside” was a senior physician’s command to my colleagues and me, a command indicating where to discover, diagnose, and treat disease. The patient’s chief complaint and the detailed history and physical that followed were the foundation of the medical encounter.

But today, medicine now occupies a new space. Physicians discover diseases and diagnose and treat patients at the “desktop.” In a recent issue of the Journal of the American Medical Association, I presented this new model of medicine.

Desktop medicine describes how risk assessment and information technologies are transforming medicine. The desktop with a networked computer—and that computer with its own virtual desktop as well—are where researchers examine large databases to discover risks and where clinicians and patients meet to assess a patient’s risk factors and decide whether the patient needs treatment.

A key actor in these events is technology. An online search for “health risk calculators” reveals the fruits of this technology. Pages of user-friendly websites where physicians and patients can input information, click “submit,” and receive immediate risk results: your 10-year risks of bone fracture, heart attack, or death from colon cancer to name just a few. In developed nations, desktop diseases such as hypertension, osteoporosis, and dyslipemia are prevalent; occupy a substantial portion of a physician’s practice; and are among the leading causes of morbidity and mortality.

And researches are discovering more of these diseases. Among the headline stories this past summer was the announcement from an international conference that Alzheimer’s disease was being redefined from a bedside disease characterized by disabling declines in cognition to an abnormal biomarker signifying the risk of future cognitive decline.

Desktop medicine relies on the mathematical sciences such as statistics and epidemiology, and psychology’s discoveries about how people perceive risk and discount the future. Behavioral economics, a hybrid of psychology and economics, shows that small and periodic monetary incentives can address one of the most vexing problems in desktop medicine—a lack of adherence to long-term risk reduction, such as taking a daily medication.

Unfortunately, medical training and the health care system have not caught up to desktop medicine. Though much has changed in the 18 years since I sent the elderly men with elevated blood pressure home, we still deliver an education suitable for an aspiring bedside physician circa 1975. Premedical requirements have no expectation of proficiency in the basic sciences of risk such as statistics, psychology, and economics.

The board exams that medical students must pass to enroll in a U.S. residency program scarcely address desktop sciences and practice. Expertise in diagnosing and treating anxiety and worry—the principal symptoms of desktop diseases—is relegated to underpaid mental health counselors and the knee-jerk prescription of antidepressants. Many of the problems in “health care reform” come from trying to jerry-rig a bedside health care system to care for patients with desktop diseases.

The result is that it is still possible to practice medicine with little expertise in how to interpret the complex multivariate models that define disease, how to talk to a patient about risk and its management, and how to set up a clinical practice that wisely uses information technology and incentives to diagnose and treat patients with desktop diseases. Physicians often blindly act upon the results of online risk calculators with little attention to the validity or logic of their results, even if those results compel a potentially wasteful test, or yet another prescription.

Just as doctors practicing bedside medicine need a certified, hospital-based laboratory in order to scientifically diagnose, treat, and discover diseases, doctors practicing desktop medicine need a national electronic medical record that functions as a database to track trends in risks and the successes and failures of interventions, and to identify new risks. The FDA needs to consider the value of public review and approval of the technologies that calculate these risks as many of them are owned by private and for-profit interests.

The bottom line is we need to be training our future physicians in the judicious use of information technology and analysis of risk and redesigning our health care system in order to fulfill the promise of a healthier society offered by desktop medicine. Failing this, we should not be surprised if the numbers of students training in primary care, the field at the frontline of desktop medicine, continue their present nose dive. We should also not be surprised to find ourselves less masters of our own technology than mastered by it and its owners.

Jason Karlawish is an associate professor of medicine and medical ethics at the University of Pennsylvania.

There is a lot to talk about regarding LVADs. As Cheney resumes his active role in GOP politics, is he aware that the only reason he is alive is as a result of taxpayer-supported government research at the National Institutes of Health? He might want to mention that the private sector did not do the basic research that led to the invention of the LVAD—public money played the crucial role.

The left ventricular assist devices are used when a heart is no longer capable of pumping blood on its own and cannot recover. Those who receive them will die with them. Which leads to another topic Cheney should be talking about—how he will die.

LVADs are the direct legacy of the program to build a total artificial heart that was instituted at NIH more than 50 years ago. While a total artificial heart proved difficult to create, partial artificial hearts were designed and actively used in government-financed research trials by the late 1990s. While the newly empowered GOP is saber-rattling about huge cuts in government spending, without federal funding for NIH, Cheney would be very unlikely to be alive to join that chorus.

While Cheney’s LVAD is clearly keeping him alive and active, things will not always be so positive. LVADs have a lot of frequent complications including a high risk of infection, device failure, and blood clots. Any of these can cause mental impairment in addition to a high risk of death.

So it is important that the former vice president and anyone else with an LVAD have a conversation with their doctor about end-of-life planning. While politically it has proven difficult to keep a financial incentive in place in Obamacare to encourage this conversation, it is crucial that those who are dependent upon a last ditch technology like an LVAD talk about their wishes and values with their doctors and their families.

Dick Cheney has spent his life combating the untoward influence of big government on individual freedom and as a critic of many nondefense federal programs. Ironically, it is federal spending that created the machine that allows him to continue to push his point of view. And it is the very program he and the GOP have condemned as “death panels” that provides the best hope that he will enjoy the kind of death he chooses. He and the rest of us must do whatever we can to encourage advance care planning as part of our routine medical care.

Arthur Caplan, PhD, is the Director of the Center for Bioethics and the Sidney D Caplan Professor of Bioethics at the University of Pennsylvania.

In 2002, Dr Joseph Bielitzki, chair of DARPA’s Defense Sciences Office, announced a grand program to improve soldiers, with the slogan “Be all that you can be, and a lot more.” His targets: sleep, fatigue, pain, and blood loss. Other projects studied psychological stress, memory, and learning.  The next year, the Army launched the multibillion dollar Future Combat System to transform the military into a fast and flexible force of networked sensors, combat vehicles, and wired soldiers. The words on everybody’s lips were “human enhancement,” the use of science and technology to upgrade the human body and mind. Advances in the life sciences would make soldiers more than human, while computers, digital sensors, and smart communication systems would replace the rigid military hierarchy. According to military futurists, the then-new War on Terror required a new type of soldier, independent, fast and more lethal than ever before.

But in Iraq and Afghanistan, the military discovered that elite special forces alone could not restore stability to war-torn countries. General Petraeus’s counter-insurgency strategy relies on building relationships with local partners and requires soldiers with diplomatic skills, not combat enhancements.  Approximately $4 billion in annual research funding was shifted away from blue-sky projects to better reconnaissance drones and defenses against roadside bombs, the insurgent’s weapon of choice. And in combat, hard lessons were relearned: War is random, and a super-soldier is just as dead as anyone else if his Humvee rolls over an IED.

Meanwhile, the conservative Bush-era President’s Council on Bioethics, wrote on military human enhancement, “This particular case, in short, is the exception that proves the rule: Even in moments of great crisis, when superior performance is most necessary, we must never lose sight of the human agency that gives superior performance its dignity.”  Outflanked on public relations, and with articles about Frankenstein super-soldiers filtering out into the media and the armed forces, DARPA went into damage control mode, trying to spin their research in less controversial directions. In an interview with Wired Magazine, DARPA director Tony Tether said “There’s probably more hype on [Human Enhancement]. You know the old Army saying, “Be all you can be”? That’s really what we’re doing. We’re making it possible for people to be all that they can be, not making them be better than they can be.” Ordinary soldiers, the intended targets of these new inventions, had no desire to become cyborg supermen. The warrior tradition was based on the superiority of human courage and fitness, and turning the body, the last bastion of individual autonomy in the military, into yet another piece of equipment, was deeply disturbing.

By 2008, the focus at DARPA was no longer human enhancement, it was performance optimization. Metabolic dominance research focused on re-engineering mitochondria, the body’s power plant, became Peak Soldier Performance, an investigation into over-the-counter nutritional supplements.  Augmented cognition/improving warfighter information intake under stress, a helmet and vest that monitored the brains of soldiers and processed that data to help them navigate the battlefield and communicate under fire, performed well in trials, and was quietly shelved. The Future Combat System was canceled by Secretary Gates in 2009 at a cost of millions, although individual projects, like a wearable computer for infantry, continue to be funded under new names. A few projects in the life sciences found success. Techniques for surviving massive blood loss and regrowing damaged lungs have been shown to work in animal trials, and Revolutionizing Prosthetics, a robotic artificial limb that links into the nervous system to behave and feel like a normal limb, is undergoing clinical trials at Johns Hopkins.

The turn against human enhancement can also be seen through the lens of the Army Science Conference. Dr John Parmentola, director for Army Research and Laboratory Management, gave the keynote address at the 26^th ASC in 2008, and at an American Association for the Advancement of Science conference described his work on virtual reality for training and treating PTSD as “human enhancement”. The 27^th Army Science Conference held in Orlando, Florida, at the end of November was packed with presentations on human performance and biomedical technologies, but the words “human enhancement” were nowhere to be found.

It might be tempting to assume from all of this that military human enhancement is dead; in all likelihood, it’s merely sleeping. While the rhetorical shift from enhancement to optimization was accompanied by a drawback in the ambition of this research, there is no clear line between enhancement and optimization, and much of the basic science remained the same. With the military entering a period of cutbacks, there will be an urge to do more with less, to turn to technology to solve human problems. Science is iterative, each result builds on the ones that come before, and the seeds planted by Dr Bielitzki are beginning to yield fruit. Compare with computers: the first generation were specialist military tools for code breaking and plotting ballistic tables, the second generation drove an economic revolution, the third generation is an omnipresent fact of life. Funding for these enhancement technologies in neuroscience, biomedicine, and cybernetics continues, albeit at a reduced level.

Wars are fought and won by human beings, and although soldiers are better trained, equipped, and supported than ever before, they are not all that different from what they were fifty years ago, or one hundred, or one thousand. But this may be true for only a little longer. Now is the time for policymakers to discuss military human enhancement, to ask important questions about how technologies and soldiers should be integrated. What kinds of military human enhancement should we pursue? Are there some we should not? Is human enhancement ethical, especially in the context of military authority over soldiers’ choices? Does it align with our democratic values? Is human enhancement an effective path to ensuring America’s national security? Assuming that we decide military human enhancement is ethical and proper, how will we control the flow of military technology to the civilian world? How can we talk about military human enhancement in a way that avoids both hype and fear-mongering?

These decisions are too important to be left to soldiers, scientists, and defense contractors. Human enhancement has the potential to transform every aspect of society.  A change in phraseology from enhancement to optimization does not imply real change in the results of military research, or its potential consequences for liberty, democracy, and national security. It was precipitous for the military to take the lead on this issue without democratic consent, but we now have an opportunity to consider our values, our desired outcomes, and the means to achieve them as they relate to human enhancement. Let’s not waste it.

According to the report, synthetic biology holds great promise to unlock new possibilities in human health and environmental protection. Scientists and entrepreneurs are already working to devise ways to use cells with synthetic genomes to produce renewable fuels, hydrogen, or even generate electricity directly through artificial photosynthesis. In health care it is hoped that synbio may one day lead to improved production of drugs and vaccines, and to novel treatments.

But, as with any valuable new technology, the pursuit of these benefits comes along with certain risks that must be weighed accordingly. Concerns about intentional misuse of synthetic biology aside, there is also the possibility that synthetically developed microbes could escape domestication and cause damage to ecosystems or human health. The report released today recommends a series of regulatory measures to anticipate those risks.

Bioethics Commission Chair Amy Gutmann stated in connection with the release of the study that “We considered an array of approaches to regulation—from allowing unfettered freedom with minimal oversight and another to prohibiting experiments until they can be ruled completely safe beyond a reasonable doubt. We chose a middle course to maximize public benefits while also safeguarding against risks. … prudent vigilance suggests that federal oversight is needed and can be exercised in a way that is consistent with scientific progress,” Gutmann said.

Among the commission’s recommendations:

• The Executive Office of the President, possibly through the Office of Science and Technology Policy, should coordinate federal agencies that oversee areas related to synthetic biology, including oversight, product licensing and funding.
• Risk assessment activities across the government need to be coordinated and field release permitted only after reasonable risk assessment.
• The Executive Office of the President should remain actively engaged with “do it yourself” groups to communicate and discuss applicable safety and security issues.
• Recognizing that international coordination is essential for safety and security, the Department of State, in concert with the Department of Health and Human Services and the Department of Homeland Security, should collaborate with governments around the world, as well as leading international organizations, such as the World Health Organization to promote ongoing dialogue about emerging technologies like synthetic biology.
• The National Institutes of Health, the Department of Energy and other federal agencies should evaluate research proposals through peer-review in order to make sure that the most promising scientific research is conducted on the public’s behalf.
• Educational classes on the ethical dilemmas raised by synthetic biology should be a mandatory part of training for young researchers, engineers, and others who work in this emerging field.
• Forums should be established to improve the general public’s understanding of this field, including the creation of a biology equivalent to FactCheck.org, in which a private group would track statements about the science and offer an independent view of the truth of such claims.

The complete report is available at bioethics.gov.

For the last three years, I have used a global public health lens to discover the hidden burden of neglected infections of poverty in the United States, which closely resemble the impact of NTDs in the world’s poorest countries. These neglected infections are not rare. They represent some of the most prevalent diseases among the 40 million Americans who live in poverty.

There are a number of powerful social and economic forces preventing millions of people from realizing the American dream. These neglected infections may signify another equally potent poverty trap for our nation’s bottom 40 million.

Indeed, America’s neglected infections of poverty may be the most important diseases you have never heard of—diseases of high prevalence that occur largely among the poorest people, especially people of color, who live in areas of the country that are largely forgotten and seldom visited.

In a 2008 article in the open access online journal Public Library of Science Neglected Tropical Diseases, I provided estimates for the number of mostly African Americans, Hispanics, and Native Americans who live in extreme poverty and suffer from parasitic infections. Cysticercosis, a brain parasitic infection, is now the leading cause of epilepsy among Hispanics in the United States, and as many as 1 million Hispanic Americans suffer from Chagas disease, a major cause of chronic heart defects.

It’s important to point out that this is not a problem resulting from immigration. The root cause is poverty first and foremost, with the chronic issues associated with it, including inadequate sanitation, poor quality housing, malnutrition, and lack of access to health care, especially for pregnant women and children.

Today, up to 3 million African Americans living in poverty in this country have a parasitic worm infection known as toxocariasis, a disease associated with asthma and developmental delays, while 1 million African-American women have another parasitic infection of their genital tract known as trichomoniasis, which has been identified as an important co-factor in the HIV/AIDS epidemic in this country. The rates of these two parasitic infections are similar in the United States and Nigeria. Another neglected disease, congenital cytomegalovirus infection, is a major reason African-American children are born with intellectual and hearing deficits.

If this level of parasitic infections occurred among whites in the suburbs, it would never be tolerated. But because the neglected infections mostly affect people of color living in poverty in places such as the Mississippi Delta, post-Katrina Louisiana, the border with Mexico, and inner cities, they remain forgotten diseases among forgotten people.

Together, with several of my scientific research colleagues, we have taken an interdisciplinary approach to begin chipping away at this burden of disease and neglect in the United States. In our Washington, D.C., research laboratories, where we are developing new vaccines for NTDs, we are now working to develop an easy-to-use diagnostic kit for toxocariasis. In collaboration with the Center for Disease Control and Prevention, this kit may one day be used to determine the role of toxocariasis as a cause of asthma and developmental delays in America’s inner cities. Indeed, there is an urgent need to apply modern biotechnology to all of the neglected infections of poverty.

Second, together with the CDC, we have worked with Georgia Congressman Hank Johnson Jr. to launch a new bill, H.R. 5986, the “Neglected Infections of Impoverished Americans Act of 2010.” Recently passed in the House, the bill would require the U.S. Health and Human Services Secretary Kathleen Sebelius to report to Congress on the current state of these diseases. We urgently need active surveillance for these conditions in order to more accurately estimate the full extent of the neglected infections of poverty, as well as to fully determine how they are transmitted and how they trap our nation’s minority populations in poverty.

This fall, I spoke for the first time on neglected infections of poverty to the Institute of Medicine’s Forum on Microbial Threats. Although best known for its work on emerging threats such as influenza, SARS, and potential bioterrorist attacks, both the Institute of Medicine and I felt it was important that we begin turning our attention to what may represent some of the most important and glaring health disparities in our nation.

Peter Hotez, M.D., Ph.D., is distinguished research professor at The George Washington University and president of Sabin Vaccine Institute in Washington, D.C. This year he serves as president of the American Society of Tropical Medicine and Hygiene.

The survey also confirms that “health care voters” were central to the Republicans’ success in the recent congressional election. Republicans attracted a lot of support by demonizing health reform and promising to make repeal a top priority. One of the key demons that Mitch McConnell, Eric Cantor, Darrell Issa, John Boehner, and other GOP congressional leaders will surely be invoking to “kill the bill” next year are death panels.

All of this GOP concern about death panels is bogus. And supporters of health reform need to say so.

The only political effort to implement death panels since Obama got his health reform bill passed has been in the state of Arizona. There the Republican-controlled legislature with the approval of GOP Governor Jan “there are headless bodies turning up all over our desert” Brewer has told 98 people waiting for transplants that they must die.

Those 98, who are either poor or uninsurable by private insurance due to pre-existing conditions, need bone marrow, lung, heart, and other forms of transplants. They were told by the state’s Medicaid program—Arizona Health Care Cost Containment System, or AHCCCS—that they qualified for coverage. But, this October 1, AHCCCS said it could not in fact pay for their transplants. Facing a billion-dollar-plus budget deficit, the Arizona legislature cut out all state funding for transplantation retroactively!

This means that people who were told they had a chance at life had the rug pulled out from under them without any warning. The Republican legislature not only acted as a death panel; it chose to balance the budget on the backs of the poorest and most desperate of Arizonians by welshing on a promise.

Just to be clear, the legislature and governor did not say there would be no more transplant funding going forward. They said they are telling those to whom coverage has already been promised to drop dead.

Those waiting for transplants who had put their faith in the promise of coverage did not get a chance to try and raise money to pay for a transplant. They could not try to move somewhere else to seek coverage. They had no chance to beg the legislature and the governor not to kill them. They simply woke up on October 1 and found that the most mean-spirited death panel imaginable had taken the most unjust course of action possible and pulled the funding rug out from under them.

A member of the Arizona House has suggested there might be a hearing on all this in January. But those needing transplants do not have the luxury of time. The waiting lists for hearts and lungs are short because those waiting die if they are not lucky enough to obtain an organ.

None of this death panel activity has evoked a word of protest from would be presidential candidates such as Sarah Palin, who first sounded the death panel false alarm about Obamacare; Newt Gingrich; or Mitt Romney. Nor has a single word of condemnation passed the lips of the incoming House GOP leadership.

Advocates of the long overdue effort to reform the ailing American health care system need to be ready to tell the American people that when it comes to their health, Republicans are more than willing to renege on their promises and send the weak and the frail to their graves. If the national GOP is serious about death panels there are 98 people in Arizona who would love to hear from them.

Arthur Caplan, PhD, is the Director of the Center for Bioethics and the Sidney D Caplan Professor of Bioethics at the University of Pennsylvania.

Macbeth, Act 5, Scene 1

Even George W. Bush’s severest critics cannot doubt the seriousness of purpose with which he approached the embryonic stem cell question. A summer of Oval Office meetings with scientists, theologians, and philosophers; sessions with his domestic policy staff; readings on ethics; and a meeting with Pope John Paul II preceded his climactic address in August 2001. That seriousness is further evidenced by the former president’s inclusion of the stem cell debate as one of 14 “decision points” in his new memoir. George W. Bush is a man who has come to admire intellectual curiosity, whether he has it or not.

On the subject of stem cells, and anything that has to do with a certain understanding of human dignity, Bush exhibits the zeal of the convert and the latecomer. The widespread impression that his reflection on problems of human destiny is of recent origin gains unintentional support in the opening paragraphs of chapter four, as he describes a White House lawyer reading to him from British writer Aldous Huxley’s Brave New World (a cozy scene in jammies comes to mind), which was published in 1932. It depicts a future in which fetuses are bred and brought up in hatcheries, each engineered to one of five castes. The novel is frequently cited as a thought-provoking warning about science gone wrong. The 1997 American film “Gattaca” makes a similar point.

As a teacher, I know that such dystopias are brilliant ways to engage eager young minds, including it seems those of U.S. presidents, but science fiction has certain inherent limitations as a guide to 21st century science policy. Science fiction is necessarily about our hopes and fears for the future. It is not about the future, which is where we actually have to live. These two facts are easily confused. Fans of science fiction (of which I am one of 50 years’ standing) tend to notice the occasions when writers seem to have been prescient far more than when they have been dead wrong.

To his credit Bush juxtaposes Huxley’s dark vision with Nancy Reagan’s personal appeal on behalf of continued research. He credits a conversation with Professor Leon Kass, later to be chair of his bioethics council, as the one that led to his insight: If he funded research on stem cell lines that had already been derived then his administration wouldn’t be complicit in the destruction of future ones. He quotes Kass himself as confirming the logic of this position. By Solomonically splitting the difference, he wouldn’t be tacitly approving the destruction of future embryos.

The tacit approval argument in philosophy implies that any wrongfully obtained information has a fateful moral taint. It is an interesting and perfectly respectable argument, one that has been paradigmatically applied to any useful knowledge that might have been gained from the horrid experiments involving Nazi concentration camp inmates. For anyone who came along after the Holocaust, that association gives moral taint arguments their emotional power. In the case of human embryos, though, the argument begs the crucial question: Is the moral status of human embryos (in this case, those left over in fertility clinics) so great as to counter their value in learning about terrible diseases that affect born humans, such that there is a “taint” on the cells derived from them?

Arguments like this have an uncertain reach. How far do stains spread? In letting himself off the hook the president didn’t absolve the moral stain on “approved” lines; after all, they themselves came from destroyed embryos. Wouldn’t any knowledge that came from them be stained, including that paid for by the NIH? Why wouldn’t the origin of the material that permitted the exploitation of that knowledge stain the venerable NIH itself? Mightn’t any success even with the “approved” lines lead to further embryo destruction for more research, as has in fact happened? At least that should have been obvious within the first few months, when the technical limitations of the approved lines became evident. (In fairness, Bush quotes one distinguished stem cell biologist as saying that 10 to 15 lines would be enough but he doesn’t seem to understand that, unlike in politics, science changes in light of evidence.)

As might be expected in a political memoir, much of the chapter is devoted to score-settling: with scientists for failing to understand how he had helped them; with John Kerry for exploiting the issue during the 2004 campaign; with all those who painted him as “anti-science”; etc.

Bush ends on a triumphant note, taking credit for the development of induced pluripotent stem cells from adult tissues that mimic embryonic stem cells, even though this was first done in Japan. He cites sheep cloner Ian Wilmut’s enthusiasm for the new method but he fails to note that the biologists who actually developed this new technology have insisted that embryonic stem cells are still needed as laboratory comparisons to develop the new technique. Nor does he recall that his White House blocked Wilmut’s call for a ban on reproductive cloning as a crime against humanity because they wanted to stop all research cloning as well. Selective quotation is not the stuff of science.

Bush notes that the 1995 Dickey amendment to the NIH budget prohibits using federal funds for research that destroys human embryos. But in light of the ongoing legal dispute about NIH funding for embryonic stem cell research, perhaps the most striking aspect of the chapter is what the former president does not say: He does not say he had any doubt that under the Dickey amendment NIH could support funding on at least some embryonic stem cell lines. One hopes the D.C. Circuit Court borrows a copy of Decision Points as they deliberate or, better yet, just Xeroxes (read: clones) of that chapter.

Podcast: Play in new window | Download

Cody Unser is a normal 23-year old woman. A graduate of the University of Redlands in California, she now pursues her master’s in public health at the George Washington University School of Public Health. In her spare time she loves exploring marine ecosystems as a certified scuba diver. But there is more to Cody than meets the eye: paralyzed from the chest down by a rare auto-immune disorder at the age of 12, she now leads a double life as one of the most effective crusaders for stem cell research funding our nation has seen.

Cody hails from a family with a special status in American life:  Her father is two-time Indianapolis-500 winner Al Unser Jr. and her grandfather, Al Unser Sr., is also a repeat winner of the iconic American race, as is her uncle, Bobby Unser. The Unser’s are a veritable racing dynasty, with a total of 9 Indy-500 titles between them. Coming from a family that is considered American royalty by some has certainly helped Cody to tell convey her message. But Cody knows she cannot rely on her family’s notoriety alone.

“As an advocate, I’m trying to understand more about how to use my personal story and bring it together in a more powerful way,” she says. “I don’t want to just use my story, I want to back it with facts and the truth. And what these [embryonic stem cells] are and what the science is.”

With the help of the First Step Foundation, which she runs with the help of her family, Cody travels the country to raise awareness for spinal injuries, paralysis, and research funding for potentially life-changing therapies such as embryonic stem cells that could one day allow her to regain the use of her legs. She was even asked to testify before the Senate Appropriations Committee in September (you can watch the video here). Last Friday, Science Progress’s Jonathan Moreno had a chance to catch up with Cody to talk to her about biopolitics, her future, and educating congress and the public about the importance of science and technology in medicine and society.

“People who walk don’t necessarily think of their shoes as technology as much as I do my wheelchair. There’s a difference there that is interesting,” says Cody. “I rely on [technology] just to get around, from point A to point B. So I’ve learned so much about how technology influences science and health… there are two different avenues it seems… to think of the body not only as biology but also as engineering.”

Cody’s life is intrinsically connected to technology. “I think for a lot of people with paralysis or spinal cord injury, rehab and maintaining their body is a daily struggle—our bodies are deteriorating at a faster rate than most people.” Besides her wheelchair she uses a mechanical standing frame to help keep her bones strong, special scuba gear to allow her pursue her passion of diving, and special electrodes which stimulate her nervous system, allowing her to help maintain leg muscle by peddling on a special bike. From everyday use of technology that young people in her generation have become accustomed to—like Facebook—to the devices that she relies on to live a normal life and maintain her body, to her activism on behalf of millions whose futures literally depend on the rate of advancement of new technologies, Cody knows that she has a special relationship with science and technology.

“I think science gets at the core of our human vulnerability. Both in a negative and a positive [way]. Science has evolved so fast and it freaks people out because we don’t want to lose what makes us human. Science brings about cures in the medical world, stem cell research one day will be able to treat disease and disability. But I don’t think that we will ever lose what makes us human. Science will never be able to push us back that far.”

Science and health policy have a profound impact on Cody’s life, a fact which she thinks has shaped her decision to pursue a career educating Congress and the public about the importance of science and health policy. As an advocate for paralysis victims, Cody represents a population of as many as 6 million Americans living without the use of some part of their body. Of her testimony before the Senate Appropriations Committee on the promise of human embryonic stem cell research, Cody recalls:

“Basically you are the voice of a population whom science can influence and benefit. I was so humbled to be given the opportunity to speak on behalf of a huge community. I represent the spinal chord injury community, but I don’t know what it’s like to have diabetes, Parkinsons… [other diseases that could be cured by stem cell research]. To try to bring everyone together in the same world [to advocate for human embryonic stem cell research] was really cool. To be able to speak on behalf [of that] was something I’ll never forget.”

Ultimately, Cody is humble about the advantages she has had which enable her to pursue her passion for sound science-based healthcare and research policy, and as an advocate for spinal cord injury victims.

“I didn’t have to fight for my right to work or to enjoy my life like anybody else. To be able to now represent that population and not think about those things and move forward…I think the fight is out there. And the fight is different this time.”

Listening to Cody, it’s clear she’s more than up to the fight.

]]> http://scienceprogress.org/2010/11/interview-with-youth-crusader-for-stem-cell-research/feed/ 0 http://scienceprogress.org/2010/09/one-week-reprieve-for-human-embryonic-stem-cell-research/ http://scienceprogress.org/2010/09/one-week-reprieve-for-human-embryonic-stem-cell-research/#comments Tue, 14 Sep 2010 16:56:55 +0000 Jeanne F. Loring, Ph.D. http://www.scienceprogress.org/?p=6860 The drama surrounding human embryonic stem cell research continues. After federal funding for human embryonic stem cell research was abruptly halted by a judge’s order on August 23, a second court ruling temporarily reversed the ban so that the parties could prepare arguments. But on September 20 the paperwork will be in and the court will consider whether to allow the injunction or to overturn it.

As the countdown to the next decision proceeds, stem cell scientists all over the United States are holding their breath, trying to anticipate whether their research can continue. So are Americans with incurable diseases, who rejoiced when the controversy over human embryonic stem cell (hESC) research seemed to have been resolved.

What can we do during this week-long reprieve? Some talented American scientist may finally decide to take a job in China, where funding for stem cell research is expanding in response to the contraction of funding in the United States. Or a scientist may quit his scientific career and decide to go to law school, or become a banker. No matter what choices are made, Americans with incurable diseases will be the losers.

I want to spend the time explaining. I want to explain to Judge Lamberth that he shouldn’t have believed Dr. James Sherley’s claim that he was being financially harmed by the government funding hESC research. The judge should understand that obtaining funding from the NIH has always been a fiercely competitive process—with only the best research funded, no matter whether it concerns hESC or “adult” stem cells. I want to explain that so-called “adult” stem cell research also encompasses research using cells from aborted fetuses. Human embryonic stem cell research has no link to abortion; adult stem cell research does.

I’d like to invite Judge Lamberth to visit my laboratory; he could come any time of day or night—our scientists work long hours and weekends, not to make more money but because they want to have an impact on treating human disease. We are using hESCs to develop treatments for Alzheimer’s disease and arthritis, to understand what causes autism, Fragile X syndrome, and amyotrophic lateral sclerosis (Lou Gerhig’s disease), and to improve the safety of pharmaceutical drugs.

Judge Lambreth, I invite you to my lab, to meet in person the dedicated scientists who know that hESCs and “adult” stem cells serve different, complementary purposes. We need both to treat human disease.

More than 60 years later, George Annas, the distinguished professor of law, bioethics, and public health, finds himself revisiting a similar defence for torture, spying, and violations of basic American constitutional rights. The need to win the “war on terror” was a key rationale offered by members of the Bush—Cheney administration as they rode roughshod over basic civil and human rights in the grim shadow of the 9/11 slaughter. Annas persuasively argues in Worst Case Bioethics that basing policy on extreme nightmare possibilities leads to a distortion of fundamental ethical principles and legal protections.

Whether fighting declared enemies in war, terrorism, and drug cartels, or fighting such threats as a pandemic or cancer, governments and their leaders cannot let fear and paranoia set the moral tone for such battles. Annas offers two defences of his claim that worst case thinking has distorted military, public health, and clinical ethics. The first is that fundamental human rights cannot be compromised out of worries about remotely possible scenarios of utter destruction and death. The second is that the avoidance of death, and the corresponding need to save lives, does not justify throwing our moral compass out the window.

I find these arguments persuasive but only to a point. It is absolutely true that the USA’s concern with national security has led to pressures upon US medicine and psychology to become involved with torture, cruel prisoner interrogations, and forced feeding practices of incarcerated individuals that violate the fundamental ethical norms of these professions. War, as the Nuremberg judges rightly concluded, does not mean all ethical bets are off. Annas rightly condemns contemporary arguments that permit the cavalier disregard of fundamental values and rights. Yet, despite endless disputation since 9/11, we still do not have a carefully articulated set of moral algorithms to guide medical practice…

You can read the rest of this article at the Lancet.

Arthur Caplan, PhD, is the Director of the Center for Bioethics and the Sidney D Caplan Professor of Bioethics at the University of Pennsylvania.

Dear Jonathan Moreno,

‘Halt to U.S. Stem Cell Funding May Thwart Search for New Cures’ — Bloomberg News

This is one of the most pertinent reasons why stakeholders of the stem cells arena are now moving to Asia to leverage on Asia’s laissez-faire regulations and capitalize on Asia’s growth potential in stem cell research and application.

And I was in fact quoted in that Bloomberg News story as follows:

“This is a catastrophe. “…It’s now possible that the United States is now taken out of embryonic stem cell research.”

To read the rest of this article, please visit the San Jose Mercury. To read more about how Asia will benefit from the recent injunction on U.S. stem cell research, go here. To read about how the US will fall behind, go here.

Scientists are good at overcoming barriers, and the first human embryonic stem cell (or, hESC) lines were made in 1998 in the United States and Australia. Three years later, there were around 20 documented hESC lines in countries around the world, and on August 9, 2001, President George W. Bush decreed that federal funding would be allowed for this small number of existing lines; he recognized that hESCs were key to launching a new era in medicine—regenerative medicine.

Progress since 2001 has been nothing short of astonishing. Research using these 20 hESC lines created a foundation that led to remarkable breakthroughs that are already improving medicine. From this hESC research we learned how to turn skin cells into hESC-like cells, and how we may be able to treat diseases that are currently incurable. Knowledge about hESCs is the basis for all of regenerative medicine, including ideas about how to improve the limited abilities of adult stem cells.

Then, on August 23, 2010, after millions of dollars in NIH investment in hESC research, a pair of disgruntled scientists convinced a U.S. District Court judge to issue a preliminary injunction barring federal funding of work involving hESCs. So, a dozen years after hESC research was launched, and well into the development of therapies using these remarkable cells to improve human health, it is possible that this judgment will send us back right back to the stem cell dark age, 1998.

Why?  It’s about money. These two researchers working on adult stem cells were afraid that if the NIH continued to fund hESC research then it was going to make it harder for them to get money for themselves. This argument is ridiculous to anyone who knows anything about how the NIH works, and we fervently hope that this foolishness is resolved quickly.

But let’s look at the damage that will be done if this injunction holds. The meeting of the International Society for Stem Cell Research, held in San Francisco this June, drew a crowd of more than 3,000 scientists from the United States and many other countries.  The society was formed in 2002 to bring together the ever-growing group of scientists whose work was sparked, directly or indirectly, by Bush’s policy. Among the scientists were the next generation, 20- and 30-somethings, who were going to lead the charge for development of hESC therapies in the future.

What will become of these scientists if the injunction stops their research? The first effect will be that some will almost immediately lose their jobs when their NIH funding is stopped. Many graduate students and postdoctoral researchers are supported by the NIH; those working with hESCs will have to find other jobs. This is terrible for the individuals, but it may be worse for the millions of people who will acquire Type I diabetes, Parkinson’s disease, heart disease, and suffer from strokes in the next 20 years. Without this generation of stem cell scientists, the chances of regenerative therapies for these disorders will be miniscule.

The NIH has invested money, and thousands of scientists have invested years of their lives in order to make hESC-based therapies possible. To stop now will mean that all of those dollars and all of that sacrifice will be wasted. Other countries who continue to fund hESC research will rapidly surpass our nation. China, for example, has invested greatly in hESC research. The end of U.S.-based hESC research will mean that the benefits, both medical and financial, will go elsewhere.

We can’t afford the loss of intellectual power that this injunction will bring. In 2010 it would be a tragedy to set hESC research back to 1998 in the United States while scientists in other countries (and perhaps many now working and living here who will soon alight to Asia) forge ahead.

Jeanne F. Loring is a professor and the director of the Scripps Research Institute Center for Regenerative Medicine in La Jolla, CA.

If your credulity hasn’t already been strained to the breaking point, now imagine that you’re a scientist who went to his or her lab this morning not knowing if you could continue your work on, say, Alzheimer’s disease, Parkinson’s or diabetes, work that was funded by the National Institutes of Health months ago that you were doing just yesterday. These are all plausible inferences that could be drawn from a United States District Court judge’s August 23 decision.

Welcome to the real world.

Judge Royce Lamberth issued a preliminary injunction that stops funding for human embryonic stem cell research because, he said, the plaintiffs are likely to succeed when their complaint has a full hearing and they would be irreparably harmed if the funding were to continue in the meantime. Why did the judge reason that this attempt to stop the research would likely succeed?  Mainly because he agrees that the federal funding violates the 1995 Dickey-Wicker amendment to the National Institutes of Health budget, which prohibits the federal government from paying for research that destroys human embryos.

Yet the Clinton, Bush, and Obama administrations all agreed that federal funds can be used to support research on cells that are laboratory-grown descendents of human embryo cells since that research is on cultured cells, not on embryos, and because the federal funds were not used to conduct research on, much less harm, any embryos themselves. No one during the Bush administration, which was not terribly friendly to embryonic stem cell research, objected to this interpretation of the law.

The Department of Justice has yet to interpret fully the judge’s decision, but one reading of the injunction is that the clock on federal stem cell policy is turned back to 2000. Even research on stem cell lines still in use that were approved for research by the Bush administration would have to stop.

Moreover, Judge Lamberth’s decision reveals a stunning disregard for the precedents he is compelled to follow. Under the Supreme Court’s landmark decision in Chevron v. NRDC, a judge must apply a high degree of deference to an agency’s reading of a statute unless the statute’s words are completely unambiguous. So, in refusing to defer to three administrations’ interpretation of the law, Judge Lamberth effectively concluded that all three of them don’t know how to read.

Simply put, it’s far more likely that a single trial judge misread the law than it is that three ideologically diverse administrations all made the same blatant mistake.

Even the application of the Dickey-Wicker amendment to embryonic stem cell research that the court relies on is forced. When Congress passed Dickey-Wicker in 1995 it could not have been thinking about human embryonic stem cell research, which didn’t start until a breakthrough at the University of Wisconsin in 1998. Rather, the amendment was created out of concern for using whole embryos in research, perhaps even creating them for that purpose. Congress wasn’t thinking one way or another about work on cell lines descended from embryos long ago. But now the judge is telling us that the law applies to a condition that could not have been part of congressional intent and is logically distinct from its object.

And the very legal standing that allowed the complainants to get into the court in the first place makes little sense. The plaintiffs include scientists who do research on adult stem cells. They claim they are harmed by the current funding policy because of unfair competition with embryonic stem cell research. But there is no cap on stem cell funding. The NIH will give grants based on the quality of the proposed work, not on the materials to be used.

In fact, adult stem cell research has received three times as much funding as embryonic. Over the past decade funding for adult stem cells has increased, not declined, and it has done so partly because of the greater understanding of stem cell biology gained from work with embryonic stem cells. Where’s the harm to the scientists who work on the adult cells? If their argument prevails they will have used to the courts to elbow out their scientific competition!

The scientists who in good faith have been working on NIH funding for the embryonic stem cell work are the ones who could suffer irreparable harm. More important, so could the rest of us. What the opposition to this legitimate and globalized field has been unable to do through science and the ballot box they are trying to do through the courts.  Let us hope they have only been able to delude a single poorly informed judge.

Update 8-25-10: NIH director Francis Collins has announced that, in light of the court’s preliminary injunction, 50 new grant applications will be withdrawn from scheduled peer review and 12 grants worth an estimated $15 million to $20 million that have already gone through initial review will be stopped.  Another 22 grants totaling $54 million that already are under way and scheduled for annual review in September will be stopped.

As Dr. Collins told reporters: “This will mean very promising research will not get done, screening for new drugs will stop, and researchers who have been energized will likely grow discouraged and move to other countries or on to other research.”

So much for the plaintiffs’ contribution to American science.

Jonathan D. Moreno, Ph.D., is the David and Lyn Silfen University Professor of Ethics and Professor of Medical Ethics and of the History and Sociology of Science at the University of Pennsylvania, and the Editor-in-Chief of Science Progress.