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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/informing-the-genetically-engineered-crop-debate/ http://scienceprogress.org/2010/09/informing-the-genetically-engineered-crop-debate/#comments Wed, 08 Sep 2010 14:58:03 +0000 Paul B. Thompson http://www.scienceprogress.org/?p=6809 Genetically engineered crops now account for 80 percent of cotton, corn, and soybean acreage in the United States. This year’s National Research Council report identifies the consequences of this new technology on the socioeconomic landscape of the American agro-economy. While the debate about genetically engineered, or GE, crops rages on in both the United States and Europe, the new NRC report provides some data and insight that advocates on both sides would do well to note.

Today, science policy analysts often assume a standard narrative about the controversy over genetically engineered crops and animals intended for use in agriculture or food. It goes something like this: GE products were introduced with little notice or public protest in the United States, but Europeans took a more precautionary approach, alleging a host of environmental and food safety risks. European precautionary attitudes launched a global controversy of GE crops that, depending on one’s perspective, is a tempest in a teapot—a great deal of worry over very little actual risk—or is a signal event that has exposed grave weaknesses in the U.S. regulatory approach.

From this starting point, proponents and critics of GE crops and animals commence their mudslinging. More generally, scholars of science and technology cite this narrative as evidence of the need to conduct public consultations in advance of introducing a potentially controversial technology.

Although the standard narrative has a germ of truth, it is in two respects quite mistaken. For one thing, early GE products were subjected to significant debate in the United States, concluding with an unprecedented congressionally imposed moratorium that only expired after the completion of an equally unprecedented study conducted by the executive branch Office of Science and Technology Policy in 1992.[i] For another, the U.S. biotech industry did in fact conduct extensive public consultations between 1988 and 1995. These consultations revealed the potential sensitivity of points that eventually became deeply controversial, but they also convinced mainstream U.S. environmental organizations that issues in agricultural biotechnology were not the most important fish they had to fry.[ii]

There are many lessons that might be inferred from these correctives to the standard narrative, but in the present context the point is simply this: What everyone knows is sometimes wrong.

The first genetically engineered microbe intended for use in agriculture or food production were bacteria that had been modified to produce bovine somatotropin, a hormone secreted naturally by lactating dairy cows. The synthetic version made by GE microbes could be produced at a scale and cost that made it feasible for dairies to administer shots of the hormone in order to increase milk production, particularly in cows nearing the end of a lactation cycle. The second microbe, however, was recombinant rennet, the complex of enzymes (traditionally derived from the entrails of slaughtered calves) used to turn milk into cheese. Although recombinant bovine somatotropin was one of the most controversial technologies ever to move through the U.S. Food and Drug Administration, recombinant rennet elicited not a peep of protest. It was, perhaps, unseemly to suggest that we should keep slaughtering baby calves in order to make cheese.

The silence that accompanied the introduction of recombinant rennet in the mid-1990s led some scientists to think that the hubbub over genetic engineering was already over when the first GE crops were introduced a few years later. Indeed, as implied above, regulatory actions at the FDA, the Environmental Protection Agency, and the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service announcing the first generation of herbicide-tolerant soybeans hardly generated any protest at all from the environmental community. Pest-resistant varieties of cotton and corn that produce a toxin specific to caterpillars (bacillus thuringiensis, colloquially Bt) were also approved at the EPA with little public note.[iii] These GE crops were picked up in record time by the vast majority of U.S. farmers, but when biotechnology companies attempted to introduce them into Europe, they botched the job badly.

Soon the boomerang struck: European resistance was covered in the press and soon, GE crops were controversial everywhere. This is the part of the standard narrative that is correct, and reporter Dan Charles’s book Lords of the Harvest tells the story with aplomb. His book is still recommended reading for science buffs of all kinds.

In a political world where even the announcement of the first organism with an entirely chemically synthesized genome is already so last month, all this would seem like ancient history. Yet biotechnology continues to be a polarizing technology in agricultural and food science, and in rural America, generally. The recent NRC report “Impact of Genetically Engineered Crops on Farm Sustainability in the United States” released in May will not settle the controversy. This report is remarkably thorough in documenting the way that GE crops have affected pesticide use as well as analyzing the economic fate of mainstream American farmers.

For the most part, the report characterizes these impacts in a positive light:

• Herbicide-tolerant or Bt varieties of corn, soybeans, cotton, and sugar beets have led to a reduction in both the amount and toxicity of agricultural chemical use in comparison to conventionally grown non-GE varieties of these crops.
• Use of GE crops is associated with other conservation practices such as reduced tillage, and public or worker health benefits have been observed in connection with the reduction of chemical use.
• Neither the movement of genes to wild or weedy relatives of these crops nor toxicity to nontarget species has occurred in a manner that raises concern.
• Farmers have achieved greater cost efficiencies in the production of GE crops, even after user fees for GE technology are included.
• The contracts and licenses introduced to protect companies’ intellectual property have not had an adverse economic impact on farmers.

But the report does document some negative consequences. Crops tolerant to the relatively benign glyphosate herbicides—Roundup is Monsanto’s version—have resulted in so much reliance on these chemicals that weeds are now becoming resistant. This may precipitate a switch to more environmentally harmful methods of weed control. Scientists have been more successful in forestalling insect resistance to Bt. In fact, Bt crops in particular have been responsible for reducing the unwanted effect of pesticides on species of insects such as bees or other pollinators, that not only do not damage crops, but may be beneficial.

The report is also quite candid in stating that the research needed to determine impacts on social capital and the quality of life in rural America has never been done, despite early warnings that these would be the areas in which biotechnology would pose the greatest threats to the sustainability of U.S. agriculture. Although processes of gene flow or environmental consequences have been studied with respect to impacts on native flora and fauna and with respect to ecosystem processes, they have not been studied with respect to their impact on other farmers who may be trying to grow organic or non-GE crops for the European market.

It is economically unimportant whether the commodity grades of corn and soybeans that are being used domestically are “contaminated” by pollen from neighbors’ fields. But the report notes unsubstantiated reports that farmers targeting “non-GE” markets may suffer economic losses from the effects of pollen drift. The reports are unsubstantiated because scientists at the USDA and in agricultural universities simply have not conducted the research needed to evaluate these claims. In this respect the report testifies to a gap between scientific work that gets done and scientific work that is constantly underfunded and deferred. This gap is arguably itself an “impact of genetically engineered organisms” and one of the main sources of continuing tension in rural America.

This research gap began to have real-world implications when organic growers started experiencing contamination from the GE crops being grown by their neighbors. The conflict between farmers using GE and non-GE organic growers is complex and lies at the heart of the issues that the NRC report identifies as insufficiently understood and under-researched. Organic standards prohibit the use of genetic engineering. This was a choice made by the organic growers themselves, albeit with considerable support from their customers. The big problem with GE pollen or seeds that blow across the fencerow is that they are simply not supposed to be there in an organic crop. Organic rules permit some contamination, so long as the organic certifier states that the GE pollen and seeds were not intentionally introduced, but neither growers nor buyers of organic crops are happy with this situation. The contamination problem is especially serious for those who produce organic seed. Small levels of contamination will be multiplied as the crop is grown out, and the value of an organic seed crop so contaminated can be substantially reduced.

In response to this problem, organic growers in some states lobbied for and in a few cases successfully passed local ordinances banning GE crops, generally on a countywide basis. This was, not surprisingly, resisted by those conventional farmers who wanted to grow GE crops in those counties. It was also seen as a threat by biotechnology companies and by conventional farmers in other areas who felt that their crops were being irresponsibly maligned by people who were campaigning for these ordinances. I’m sure that readers will be shocked, shocked to discover that getting voters to support such ordinances provoked statements on both sides that are not strictly true. In some states such as Michigan, statewide laws were passed to block efforts to enact these local ordinances. These fights caused bitter divisions in many rural areas, and in some cases, pitted university researchers who do work with organic growers against their colleagues who work with biotechnology.

The ante was raised even higher as a result of few legal actions taken by Monsanto, the leading biotechnology company, against farmers who stated that their crops had been contaminated by GE seed. The most celebrated case occurred in Canada, and concerned a farmer named Percy Schmeiser. Monsanto alleged that Schmeiser, who has never purchased Monsanto’s herbicide-tolerant canola seed nor signed Monsanto’s license agreement, was, in fact, growing Monsanto’s patented variety of canola, and sued him for infringement of their patent. Schmeiser claims that his fields were inadvertently contaminated. Canadian courts upheld Monsanto’s claim, holding that Monsanto’s patent was valid and that Schmeiser had intentionally violated it.[iv]

What may be more important than the facts of this case is the way that it has reinforced the view among opponents of GE that pollen drift is actually a conspiracy of the biotechnology industry to damage organic markets or even claim ownership of non-GE crops of all kinds. This view was promulgated among Mexican corn growers following the alleged discovery of transgenic maize (illegal in Mexico) in a sample collected from peasant fields near Oaxaca in 2002.[v] While this generated some controversy and a hearing of the Commission on Environmental Cooperation, a side treaty of NAFTA, the inability of either side to provide concrete evidence ultimately left the dispute unresolved.

The bitterness and distrust that has been sown in rural America over these disputes does not come through in the bland prose from the NRC report:

Anecdotal stories suggest that the crops of U.S. organic growers are being screened in the marketing chain for the presence of GE material and are being rejected if levels exceed market-determined levels. We do not have evidence to judge how widespread such testing is in the United States. This issue deserves more investigation.[vi]

The report is much more profuse (and should be strongly commended) in its presentation of evidence showing that, on balance, the impacts of GE crops have been positive when viewed from an environmental or public health perspective, at least over the short run. This evidence is especially important in light of continued allegations on the part of GE opponents that these crops are unhealthful and environmentally damaging. Schmeiser’s own website at www.percyschmeiser.com contains many links to others who make such allegations.

The report does discuss the complex economic causality that makes calculation of total impact difficult and inherently controversial. If, for example, farmers start using less of a toxic chemical, the makers of that toxic chemical may well lower the price, which may lead farmers to start using more of it. Should biotechnology be given credit for the initial decrease? Should it be blamed for the later increase? Questions like this have given those who would wrangle over “real” impact of biotechnology much fodder to chew on.

The NRC report may not silence those debates once and for all, but it does provide a very detailed analysis that should become the standard for contending parties who want to continue them. More importantly, to claim biotechnology has achieved environmental benefits involves an implicit comparison. Benefit relative to what was being done in mainstream agriculture before biotechnology is, in some respects, a very unambitious comparator. Benefit relative to what might have been accomplished had a significant fraction of the research funding that went into genetic engineering been dedicated to alternative agricultural technologies is so speculative as to be virtually meaningless.

Yet certainly some of the organic farmers who feel that the USDA and land grant universities abandoned them are thinking in just such terms. For them, it is a case of the road not taken, and that has made all the difference.

Paul B. Thompson is the W.K. Kellogg Chair in Agricultural, Food and Community Ethics at Michigan State University.

[ii] Thompson, P. B. 2008. “Nano and Bio: How are they Alike? How are they Different?” in  K. David and P. B. Thompson, eds, What Can Nanotechnology Learn from Biotechnology? Social and Ethical Lessons for Nanoscience from the Debate over Agricultural Biotechnology and GMOs (Burlington, MA: Academic Press, 2008) p. 125–155.

[iii] Frederick H. Buttel, “The Environmental and Post-Environmental Politics of Genetically Modified Crops and Foods.” Environmental Politics 14 (3) (2005): 309–323.

[iv] Bruce Ziff, “Travels with my plant: Monsanto v. Schmeiser revisited.” University of Ottawa Law and Technology Journal 2 (2) (2005): 493–509.

[v] Abby J. Kinchy,  “Genes out of place: Science, activism, and the politics of biotechnology.” Ph. D. thesis, (University of Wisconsin, 2007).

[vi] National Research Council. The Impact of Genetically Engineered Corps on Farm Sustainability in the United States (2010) 3–33.

Additional Reference Materials:

Charles, Dan. 2001. Lords of the Harvest: Biotech, Big Money, and the Future of Food. Cambridge, MA: Perseus Publishing.

Buttel, Frederick H. 2000. “The recombinant BGH controversy in the United States: Toward a new consumption politics of food?” Agriculture and Human Values 17 (1): 5–20.

Those wishing an excruciatingly detailed overview of social and ethical issues associated with agricultural biotechnology might wish to consult:

Thompson, Paul B. 2007. Food Biotechnology in Ethical Perspective. 2^nd ed. Dordrecht, NL: Springer.

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.

Last week the Food and Drug Administration gave its first approval for a clinical trial of an embryonic stem cell treatment. Embryonic stem cells are special because they can grow, or differentiate, into any kind of human tissue. Many believe they hold great promise for treating a wide range of diseases and disorders, from Alzheimer’s to cancer to spinal cord injuries to blindness.

The FDA had put the application from biopharmaceuticals company Geron Corp, which produced the cells, on clinical hold after some mice given the treatment developed tiny spinal cysts. But another animal study found no cysts. The testing will involve patients with recent spinal cord injuries, who will receive infusions of embryonic stem cells that have been differentiated into cells that can produce myelin, the coating that conducts electrical impulses in the spine.

There is no expectation that this cell treatment would magically regenerate spinal cords, though much could be learned from a greater understanding of how new cells integrate into damaged tissue. Rather, the goal is to facilitate some improved potential for movement along with strenuous physical rehabilitation. It is thought that recently injured patients might be more susceptible to improvement.

The company is reported to have spent $150 million to get the trial approved.

The stem cells developed by the company are derived from an embryo that was left over following fertility treatment. It had to be donated with full informed consent by the couple. Geron was able to proceed with the lab work to develop the treatment in spite of the Bush administration policy that severely limited federally funded embryonic stem cell research.  Several years ago the company produced dramatic footage of injured rats that had been treated with the cells and were able to regain movement.

The greatest concern that experts have about the trial is that potent cells injected into the spine might develop into tumors called teratomas. This worry explains the FDA’s cautious approach.  Although there are nonembryonic stem cell treatments for spinal cord injury that have been tried, they have been criticized for inadequate safety data from animals and unclear explanations of surgical procedures. By contrast, owing to the potential harm, novelty, and public controversy, the Geron trial is surely among the most intensively reviewed proposed clinical trials in history.

All this does not guarantee success, of course, nor does it guarantee that no harms will result.  This is biology in the real world, not a computer simulation. But it does establish a reasonable regulatory pathway for human embryonic stem cell treatments for serious diseases that currently have only very inadequate therapies, a milestone that would have been all but political science fiction just a few years ago.

Meanwhile, thanks to the Obama administration’s responsible stem cell policies, dozens of new embryonic stem cell lines are being approved for federally funded research under grants from the National Institutes of Health. This should lead to more academic centers engaging in targeted research with these and other stem cells sources.

While the FDA’s approval of the Geron trial is just a small incremental step forward for potentially lifesaving research, it represents a significant break from past bickering, and raises the inkling of hope that someday we may wonder what all the shouting was about.

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.

Agricultural innovations through modern biotechnology have delivered significant economic, environmental, health and consumer benefits in recent years, but the full potential is even greater. Producers have embraced these innovations wherever they have had access, and consumers have purchased everything produced. The principal obstacle to additional innovations that will extend and expand benefits even further is ill-considered and scientifically unjustified or illogically implemented regulation. While the United States has had a comparative advantage over many other countries with a regulatory regime more closely anchored in science than most, regulations and implementation have not kept pace with scientific advances and accumulated experience.

The United States is the leading exporter of agricultural products in the world with $82 billion worth of goods exported in 2007, the last year for which complete data are available.^[2] Our nation boasts a $12 billion net positive trade balance in agriculture, and is the world’s second-largest agricultural producer (after China) with an estimated market of value of over $200 billion in 2007. The United States is the world’s leading producer of major products such as maize, soybeans, beef and milk. In recent years, productivity has increased and costs constrained through the use of innovative technologies developed through U.S. investment in agricultural research. Seeds improved through modern biotechnology have made a major contribution to U.S. agriculture; the United States leads the way globally in area planted with genetically engineered crops.^[3]

A major reason for this has been the clear delineation of regulatory requirements and authorities, and a system that (usually) delivers predictable decisions in a timely manner. But regulatory requirements and, even more importantly, their implementation, have not kept pace with increased understanding and experience. All domesticated crops have been extensively genetically modified during millennia of plant breeding and improvement, but breeding methods for the introduction of useful traits into crops have been markedly improved in recent years. Agricultural products derived through modern biotechnology—for the purposes of this paper, in vitro recombinant DNA , or rDNA techniques coupled with transformation^[4]—are now a major and increasing part of global commerce.

The techniques of in vitro gene transfer are faster, more precise, more predictable, and better defined than older methods of catalyzing the genetic modification of crops^[5]. By expanding the selection of genes that can be incorporated into new varieties to include genes from essentially all living organisms, recombinant DNA technology allows researchers to introduce new beneficial traits that would be difficult or impossible to create with any other breeding technology. This has allowed for the development and commercialization of crops with innovative improvements in performance. In the United States today, 86 percent of the cotton harvest, 92 percent of soybeans, and more than 80 percent of the corn harvest consist of varieties improved through biotechnology.^[6]

In a world where global agricultural commodity trade is increasingly competitive, improved qualities, value, and production efficiencies provided through biotechnology have preserved jobs here at home, especially in rural areas, by enabling U.S. farmers to remain powerful players in the global market.^[7] While the number of individuals directly involved in farming continues to decline,^[8] other jobs related to agricultural production are on the rise^[9]—with a portion of the increase coming from high paying jobs in biotechnology and related science fields. And the United States continues to retain a leading global role as agricultural exporter despite dramatic increases in production from other countries, including those with much lower labor costs.^[10]

Although the food and agricultural sector appears secure and profitable, both U.S. and global agriculture face a staggering array of challenges. These include factors as varied as shrinking land and water resources, rising energy costs, the effects of global climate change, and competition between food and industrial (biofuel) uses for agricultural products.^[11] Recent events have shattered the illusion that there is a surplus of food in the world, and world food reserves have recently been at an all time low of 53 days.^[12] Over 850 million people are malnourished, most of them in developing countries, and over 1.2 billion live on less than a dollar a day.^[13] Despite years of international efforts by affluent developed countries led by the United States, after decades of decline the number of poor and hungry in the world is again growing in parallel with increasing population^[14].

The upshot: a simultaneously looming humanitarian crisis and a potential source of great political instability—food and water shortages—will drive future global politics. This approaching catastrophe, however, is not preordained, even though the serious challenges posed by food and water shortages are real and growing. The Obama administration can take concrete steps to stimulate more ambitious and widespread innovation that would unfetter the tools needed to address these challenges. The specific measures proposed in this paper would stimulate the process of innovation in seed improvement. Improved crop varieties resulting from these innovations would enable the production of more food, feed, and fiber with lower inputs, reduced environmental impacts, and greater profitability. Such consequences would be economically beneficial to all players in the chain from farm to fork, but perhaps felt most acutely and directly by agricultural producers themselves, boosting the viability of rural communities. As argued in the following pages, several things are needed:

• A realignment of regulations so that oversight is, in fact, anchored in up-to-date scientific understanding and real world experience, and focused on unknowns that may poses risks in need of management, while reducing the burdens on innovations that have been so widely adopted as now to be accepted as conventional
• A more active program of international diplomacy to share information with other countries on the impacts of biotech improvements to agriculture, and the widely shared economic uplift thus enabled
• A more active and coordinated educational outreach program implemented by regulatory agencies and coordinated by diplomats to illuminate the conditions required to enable the widest dissemination of such innovations and their benefits, including strong intellectual property rights and science-based approaches to regulation and risk management.

In the analysis that follows, this report will detail the role of agricultural biotechnology in the United States and around the globe. It will examine issues inhibiting the application of potentially beneficial technologies, including the effects of scientifically unjustifiable and disproportionate regulation and the malign influence of special interest opposition groups. And it will present specific recommendations to improve an enabling environment in which the best of U.S. science and technology can be applied to the national and global challenges that confront us and will define our future.

Global Adoption of Agricultural Biotechnology

The primary biotechnology crops planted in the world today are insect protected and/or herbicide tolerant varieties of corn, soybeans, cotton, and canola. Brookes & Barfoot show net benefits at the farm level of $6.94 billion in 2006 and $33.8 billion over the prior eleven years.^[15] They also show a 286 million kilogram reduction in pesticide applications leading to a 15.4 percent decrease in the environmental impacts associated with their use. Associated greenhouse gas emissions were reduced during 2006 alone by an amount equivalent to removing 6.56 million cars from the road.

Data compiled by noted agricultural biologist Clive James^[16] shows for 2007 a 12 percent year-on-year increase of global biotech crop area (30 million acres/12.3 million hectares), with the total global area devoted to growing biotech improved crops at 282.4 million acres. These crops are grown by 12 million farmers around the world, of whom 11 million are smallholders in developing countries, thus reaffirming the scale-neutrality of the technology. Biotech improved crops are today grown in 23 countries, including 11 industrial and 12 developing nations.

While these data show rapid adoption and market penetration of products derived from plants improved through biotechnology, similar rapid growth has not been equally evident in animal husbandry and livestock improvement. Indeed, the transgenic animal product closest to wide commercial availability today (approved in the European Union, and in phase III clinical trials in the United States) is ATryn,^[17] an animal-derived drug that helps prevent excessive bleeding during surgical procedures.

The animal product perhaps closest to regulatory approval in the United States is a transgenic “advanced hybrid” salmon that reaches market size in half the usual time on 20 percent less food. This has been in the regulatory pipeline for the better part of a decade or more, and is reportedly nearing approval. Numerous other products and applications are in development but the lack of clear understanding on how these products would be regulated has created a perverse incentive that has discouraged investment.^[18]

Regulatory agencies have grappled with these issues for more than a decade, but a lack of attention by the outgoing Bush administration left proposals languishing in bureaucratic limbo for years, a defect partially remedied in recent weeks by publication of draft guidance by the Food and Drug Administration.^[19] Many uncertainties remain, including questions as to how several federal agencies with different or overlapping authorities will coordinate their responsibilities. But concrete decisions emerging from these agencies are the ultimate test and requirement, and a hurdle that remains to be cleared.

Constraints to Adoption

Dramatic as the advances and benefits from agricultural biotechnology have been to date, they represent only a small fraction of what is possible. While many plants improved through biotechnology have been field-tested,^[20]and at least 22 crops have been approved for food and feed use in the United States,^[21] the majority of the global trade in biotech-improved crops to date has involved only four plants: soybeans, cotton, corn (maize) and canola. The improvements delivered through biotechnology thus far have been primarily insect resistance and herbicide tolerance.

Biotechnology is capable of solving many more of the problems and challenges facing agriculture around the world than this short list suggests^[22]. Why are more of these solutions not available today? There are many contributing factors, but there is also wide agreement as to the major obstacle. James has described the impact of overly burdensome regulatory regimes on developing countries, but the critique is no less relevant to industrial nations:

“The most important constraint to biotech crops… is the lack of appropriate cost-effective and responsible regulation systems that incorporate all the lessons of a dozen years of regulation. Current regulatory systems… are usually unnecessarily cumbersome and in many cases it is impossible to implement the system to approve products which can cost up to US$1 million or more to deregulate… With the accumulated knowledge of the last dozen years it is now possible to design appropriate regulatory systems that are responsible, rigorous and yet not onerous, requiring only modest resources… Today, unnecessary and unjustified stringent standards… are denying… countries timely access to products such as golden rice, whilst millions die unnecessarily in the interim. This is a moral dilemma, where the demands of regulatory systems have become “the end and not the means”, overriding common sense, and where “the regulatory surgery may be successful but the patient died.”[23]

The problem, in fact, is larger than this indicates—a dispassionate review of the global experience to date with field testing and commercial growing of transgenic plants and the underlying science suggests that all existing regulatory regimes apply a level of scrutiny and control that is disproportionate to the risks they seek to manage.[24] Science shows that any regulatory review process that is triggered by the fact that an organism has been modified by in vitro rDNA techniques per se is unjustified. Numerous authoritative analyses have concluded that the potential hazards associated with crops improved through biotechnology are the same as those with which we are familiar from conventional crops.[25] Case in point: The European Commission concluded in 2001 that “the use of more precise technology and the greater regulatory scrutiny probably make (biotech derived foods) even safer than conventional plants and foods.”^[26] This conclusion has recently been reinforced by a study from the Joint Research Center of the European Commission.^[27]

These findings from the epicenter of political opposition to biotechnology in agriculture, the EU, have been confirmed in studies and experience around the world.^[28] Indeed, the only findings in the scientific literature which show significantly different levels of hazard between biotech improved crops and other crops favor biotech crops.[29] It is fair to ask, then, how it is possible to justify, other than through bureaucratic inertia and political pressure manufactured by interest groups,[30] a situation wherein the highest regulatory barriers to market entry are placed in the path of products that are better understood and demonstrably more productive, beneficial, and often safer than competing products?

Barriers to Trade

Policies adopted by the EU, for example, have created de facto trade barriers that discourage the development and use of transgenic crops. U.S. farmers have been reluctant to plant some biotech improved crops such as wheat, potato, and rice because these crops have not been approved by the EU regulatory system, and out of concern over potential loss of market share. The United States, Argentina, and Canada brought a World Trade Organization case against the EU, which was decided in their favor in 2005[31]. Yet the EU has so far been intransigent in agreeing to any resolution of the judgment against them.

Moreover, the EU has invested hundreds of millions of euros in various trade distorting measures, promoting fear and misinformation, and advancing their approach to regulation as a model for other countries.[32] EU support has been targeted at a variety of measures attempting to ensure that developing nations adhere to the Cartagena Biosafety Protocol by installing biosafety systems but which, in fact, create barriers to the adoption of transgenic crops. Not only is the EU unwilling to approve transgenic crops in a timely manner, but after approval for use transgenic crops are discriminated against by a mandatory labeling regime that requires segregation of transgenic from “conventional” crops, which adds 10 percent-to-20 percent to the cost of these commodities and foods prepared from them.[33]

What’s more, EU policies and EU civil organizations have focused on keeping biotechnology away from developing countries that most need to improve their agriculture.[34] This politicization of regulation has eroded the role of science and experience, leading to counterproductive policies that add enormous costs to the food and feed system, such as regulatory and compliance costs, the cost of segregation and testing, and numerous opportunity costs.

Bruce Ames and Lois Gold (University of California, Berkeley) have described this phenomenon as: “damage by distraction: regulating low hypothetical risks. Putting huge amounts of money into minuscule hypothetical risks has a negative impact on public health by diverting resources and distracting the public from major risks.”[35] The misplaced focus on GMOs also creates damage by diverting regulatory and consumer attention and resources away from real food safety issues, such as food borne pathogens and mycotoxins, which do real harm.

Barriers Created by Existing U.S. Policy & Regulations

In contrast to the EU, the United States relies on regulatory policy more firmly anchored in reliance on science-based risk assessment, in which regulators are directed to base decisions on data and experience rather than political considerations. Existing U.S. policy was set out in 1986,[36] and is widely known as the Coordinated Framework. The scientific consensus that plants improved through recombinant DNA techniques present no novel or unfamiliar risks by comparison with their conventional counterparts justified the use of existing legislative authority granted to the U.S. Department of Agriculture, the Environmental Protection Agency and the Food and Drug Administration.[37] Experience in the intervening years has produced nothing to cast doubt on this consensus. Each of these agencies has put in place regulations, promulgated policies, and adapted them over time, some repeatedly. Indeed, this system has, for the most part, entailed clear regulatory requirements and decisions taken by regulators have generally produced predictable results in a timely manner—affording the United States a comparative advantage over many other countries.

But the U.S. regulatory oversight system as it presently functions, is imperfect in the extent to which its regulatory burdens track credible risks or significant uncertainty. Vast experience has been accumulated under existing regulations, especially at USDA, but proposed updates to these regulations fall significantly short of changes justifiable on the basis of experience to date.[38] The situation is exacerbated by lawsuits and court decisions which appear to be driving USDA in the direction of repairing procedural vulnerabilities at the expense of regulatory reforms that would more closely align oversight with genuine risks and uncertainties.[39]

While a wholesale overhaul is not required, several updates and course corrections are overdue. The problems created by their absence are best seen by examination of some of the concrete innovations possible with modern agricultural biotechnology, and the disproportionate regulatory obstacles they face.

Improved production and quality of fruits and vegetables. There are a great many “minor” crops for which production is constrained by a disease, an insect pest, or another environmental stress or factor for which biotechnology could readily provide one or more solutions. The markets for these products are generally much smaller than those for major commodity crops, making the prospects for recovery of the costs of regulatory approval[40] through amortization of several years of market growth for new biotech varieties much more tenuous.

Improved production of medicines through plant made pharmaceuticals. Field trials of plants modified to become more productive and economical sources of innovative medicines have been burdened with and impeded by measures to impose isolation and containment out of proportion to any reasonable estimate of potential hazard. A classic example in this regard is the use of rice economically to produce lactoferrin as a medication to treat childhood diarrhea. Lactoferrin is a protein found in mothers’ milk. There is no indication its consumption would present any potential for harm, yet permits for field trials have been burdened with onerous requirements to ensure that pollen does not carry the lactoferrin gene beyond the test plots,[41] and absolutely no commingling of the experimental rice is permitted with other rice.

Reduced environmental impacts in large scale commodity crop production through improved weed control/herbicide tolerance. Many crop plants carry innate tolerances for exposure to different herbicides as a natural consequence of plant physiology and genetic variation in nature. Crops produced through biotechnology carrying similar phenotypes are subjected to intense scrutiny while those produced using older less precise methods can be marketed without any regulatory review. Experience with the newer herbicide tolerant crops has generated so robust an affirmation of safety that the burden of evidence should now be on those arguing for scrutiny greater than that applied to herbicide tolerance derived through mutagenesis and conventional breeding. Detailed and duplicative reviews for all biotech herbicide tolerant crops are beyond what can be justified by any data on hazard or experience in the field. Future regulatory reviews of herbicide tolerant crops, however derived, should focus only on any novel risks.

Improved pest control. Many different agricultural crops possess varying degrees of resistance to different potential pests. Crops enhanced through biotechnology to resist herbivorous insects (“plants with pesticidal properties”) are regulated by EPA under the same laws and with generally comparable methods applied to conventional pest control substances. In a dramatic and unprecedented departure, however, plants containing an insecticidal protein derived (through biotechnology) from Bacillus thuringiensis, or Bt, are required by EPA to be planted under a “resistance management plan.” EPA stipulates setting aside an area (usually 20 percent) for growing non-Bt plants as a means of forestalling the inevitable evolution of insect resistance. Integrated pest and resistance management are clearly valuable, but such “refugia” requirements have not before been imposed on other types of insect protected plants, nor have they been applied to use of Bt as a topical pesticide (e.g., as practiced by organic growers, in the only situation to date where, in fact, resistance has been seen to evolve in the field).

Resistance management is an issue of product longevity more than of environmental protection and it can be argued that issues of product longevity are better left to market forces. EPA should encourage innovation and good stewardship in pest management more effectively with a shift towards performance standards and away from rigid prescriptions. This would accelerate the development of pest protected plants incorporating multiple modes of action and other innovative approaches.

Improved cellulosic biomass production. Cellulosic biomass is widely used for myriad purposes: in the construction industry as structural material; throughout business, education, commerce and life through paper products; increasingly of late for energy, either directly or through production of ethanol or other energy storing compounds to concentrate energy and make it more easily transported. Several novel sources of cellulosic biomass (Miscanthus, switchgrass, Eucalyptus and poplars) are being genetically engineered in order to make them suitable for efficient and economical pulp and/or biofuel production. The greatest obstacles limiting their development and adoption are regulatory barriers that treat all biotech crops as a suspect class subject to heightened regulatory scrutiny. Regulatory agencies continue, for example, to impose significant constraints on biotech crops in R&D field trials to eliminate any potential for gene flow, even in cases where no possible harm to humans or the environment could result. It is difficult, for example, to imagine an unfamiliar risk from a plant modified to resist a well characterized herbicide, yet new crops containing resistance to such herbicides due to biotech manipulations are subject to scrutiny while similar crops produced conventionally are not.

Improved livestock production, Recombinant DNA technology can be used to improve livestock and companion animals in many ways—improved feed conversion and nutritional qualities, shortened time to market, resistance to disease, reduced environmental impacts, improved efficiency as sources of human medicines, and more. Although the emergence of policy guidance and regulations from the FDA has been slow, the principle obstacle here has not (yet) been disproportionate regulatory burdens so much as regulatory uncertainty caused by such delays. The primary cause of the delays appears to have been a failure by the White House Office of Management and Budget’s Office of Information and Regulatory Affairs to allow proposed regulatory guidance documents to be published for public comment.

A promising recent development has been the publication of guidance by the FDA[42] detailing how they would regulate transgenic animals and their products. The Agency has assigned responsibility to the Center for Veterinary Medicine to apply regulations governing new animal drugs. It remains to be seen if the resulting oversight will provide scrutiny at levels proportionate to the level of risk and in a timely manner, but it is clear that to unleash this technology and enable it to proceed at a pace dictated by the rate of scientific advance the remedy is simple: the Obama administration should renew the requirement for transparency, and more specifically proportional reviews and timely decisions. Future adaptations of regulations must be delivered through prompt publication of proposed policy documents and regulatory guidance by responsible agencies, accompanied by timely responses and decisions.

Lost opportunities and opportunity costs. Regulatory barriers, trade barriers, and the dissemination of deliberate misinformation about crops produced using modern biotechnology have had a chilling effect on adoption of existing approved varieties, and they have discouraged researchers and corporations from undertaking development projects that utilize rDNA technology. Nowhere has this had more damaging impact than in developing nations that suffer from recurrent food insecurity and hunger, and which desperately need to improve agricultural productivity and sustainability. The magnitude of these lost opportunities is difficult to calculate, however, if the productivity gains and environmental benefits reported for four major crops^[43] were extrapolated to all crops for which biotech solutions have not been adopted, the lost potential would obviously be enormous. This is setting aside the fact that higher yields and nutritionally enhanced crops such as Golden Rice might have saved millions of lives per year.^[44]

Policy Recommendations to Reignite Innovation in Agricultural Biotechnology

Biotechnology applied to agricultural has, for good reason, been described as Promethean.^[45] It promises to re-shape the relationship between humans and our environment in dramatically greener and more sustainable ways than anything that has gone before. Although the technological challenges remain formidable, the science accessible to us today would enable more rapid innovation than we have seen to date, primarily because of regulatory obstacles for which experience has over the past two decades eroded the scientific justification. There are a number of specific steps that could be taken to reduce or eliminate such obstacles.

Reform the US regulatory system. Regulations must be based in science and should be frequently updated to take into account the lessons gained from experience. Judicial decisions based on perceived procedural deficiencies^[46] should not be allowed to drive regulatory action in directions unsupported by science. The system should not seek zero risk as this is unattainable in the real world. Regulatory review should seek to establish that novel products are as safe as others in the marketplace. In making this evaluation regulators must take into account both the harms caused by present practices as well as opportunity costs, the potential benefits that would be lost by non-adoption. The degree of regulation should be commensurate with real risks and harms. Specifically:

• The trigger for regulatory review should be the novelty of the introduced trait (introduced by whatever method) and not the process used to introduce the trait. The degree of scrutiny should depend on the relative risk associated with the phenotype and the host when it can be shown that the methods used do not add to the risk. The system should have clear guidelines that quantitatively specify timely decision-making.
• Exempt phenotypes from regulatory review if they could be accomplished through classical methods. If a phenotype comparable to that under review could be produced by a variety of production methodologies (classical breeding vs. recombinant DNA modifications, for example) then there should be a strong presumption against any review process that would make it more difficult, for example, to see the rDNA product move into the field for R&D or commercial purposes when there is no scientific justification for such discrimination.
• Recognize that gene flow is a natural phenomenon and is not intrinsically hazardous. The potential for gene movement via pollen flow is a natural phenomenon. Regulatory agencies must stop treating gene flow as intrinsically hazardous, and shift their focus to appropriate risk management/mitigation in the rare cases where genes so disseminated could, in fact, present a genuine hazard.
• Shift to phenotype-based regulatory triggers. Agencies should transition from an event-based regulatory process to a phenotype-based process, as the hazard of a phenotype that is stably inherited has more to do with the distinguishing features of the phenotype than with the precise details of the process through which it was produced.
• Enhance effectiveness, adaptability, and public confidence by accelerating regulatory updates and transparency. To unleash this technology and enable it to proceed at a pace dictated by the rate of scientific advance the remedy is simple: the new administration should insist on transparency and require prompt publication of proposed policy documents and regulatory guidance by responsible agencies, which must then be tasked with timely responses to public comment. This will galvanize innovation not only in the animal biotech sector, which has suffered acutely in this regard, but broadly.

Fund outreach and education here and abroad. A program to counter misinformation and offer developing countries regulatory models that will create an enabling climate for biotechnology is essential. Regulators from USDA, FDA, and EPA should be a much more active and visible presence on the international stage and in multilateral fora, sharing the American experience with agricultural biotechnology and correcting misunderstandings fueled by opponents driven by concerns unanchored in data and experience. The Department of State should play a larger leadership and coordinating role focusing these efforts on countries of key strategic importance and global significance.

Make helping developing countries attain sustainable food security a major priority for U.S. foreign aid, open not only to biotechnology but to all technological innovation. Such a policy would be relatively inexpensive (by comparison with the costs of dealing with consequences of the alternatives, including inaction) and yield beneficial results on numerous fronts, including national security. Reversing the past three decades of decline of support, through USAID, for international agricultural research through the CGIAR^[47] would be a good first step.

Maintain strong intellectual property protection as an essential stimulus to investment. Intellectual property contained in the genetics of self-replicating plants is easily infringed. The administration should advocate for patent law and PTO administrative reforms that reward private investment in valuable agricultural innovations.

Conclusion

In summary, biotechnology applied to agriculture has enormous potential to enhance our ability to develop seeds for improved crops and for enhanced livestock to enable us to meet the food, feed and fiber challenges of a growing world and stressed ecosystems in coming years. Significant impediments are created by unwarranted or outdated regulatory burdens that could easily be removed. The resulting, stronger scientific basis for regulatory oversight will increase the efficiency of regulation designed to prevent or manage risks and uncertainties while enabling more rapid development of innovative, safer products. Benefits to human health, the environment, global political stability and national security would follow.

L. Val Giddings, Ph.D, is President, PrometheusAB, Inc. and Bruce M. Chassy, Ph.D., is Professor of Food Microbiology, Department of Food Science and Human Nutrition at the University of Illinois, Urbana.

Endnotes

^[1] Nina Fedoroff & Nancy Marie Brown. 2004. Mendel in the Kitchen: A Scientist’s View of Genetically Modified Foods. Joseph Henry Press, Washington, DC. 370pp. ISBN 0-309-09205-1.

^[2] http://usinfo.state.gov/products/pubs/economy-in-brief/page3.html

^[3] Clive James, 2008. Global Status of Commercialized Biotech/GM Crops, 2007. ISAAA Brief 37-2007: Executive Summary at http://www.isaaa.org/resources/publications/briefs/37/executivesummary/default.html.

^[4] Combining two or more DNA molecules in the laboratory, and then inserting the resulting DNA into the hereditary material of a plant or animal; also sometimes referred to as “transgenics” or (inaccurately) “GMOs” for Genetically Modified Organisms.

^[5] Chrispeels, Maarten & David E. Sadava. 1994. Plants, Genes & Crop Biotechnology (2^nd Edition). Jones & Bartlett, New York. ISBN-13: 9780763715861. also Fedoroff & Brown, 2004 (note 1 above).

^[6] Economic Research Service, USDA, 2008; see http://www.ers.usda.gov/Data/BiotechCrops/.

^[7] See http://www.ers.usda.gov/Data/FATUS/ .

^[8] See http://www.ers.usda.gov/StateFacts/US.htm.

^[9] See http://www.csrees.usda.gov/newsroom/news/2005news/USDA_05_Report2.pdf.

^[10] See http://web.worldbank.org/WBSITE/EXTERNAL/EXTDEC/EXTDECPROSPECTS/EXTGAT/0,,menuPK:547863~pagePK:64167702~piPK:64167676~theSitePK:547846,00.html and http://www.ers.usda.gov/Briefing/AgTrade/

^[11] See www.fao.org.

^[12] See http://www.discovery.org/a/5601.

^[13] See http://www.unmillenniumproject.org/documents/table_2.gif; and http://www.fao.org/newsroom/en/news/2006/1000433/index.html.

^[14] Evans, L.T. 1998. Feeding the Ten Billion. Cambridge, New York. ISBN 0 521 64685 5.

^[15] Graham Brookes & Peter Barfoot, 2008. Global Impact of Biotech Crops: Socio-Economic and Environmental Effects, 1996-2006. AgBioForum 11(1):21-38 at http://www.pgeconomics.co.uk/pdf/agbioforumpaper2008final.pdf.

^[16] James, 2008.

^[17] Scott Gottlieb & Matthew Wheeler, 2008. Genetically engineered animals and public health: Compelling benefits for health care, nutrition, the environment, and animal welfare. At http://www.bio.org/foodag/animals/ge_animal_benefits.pdf.

^[18] See http://www.bio.org/foodag/animals/ge_animal_benefits.pdf.

^[19] See FDA, 2008 (18 September), “Guidance for Industry 187, Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs” at http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0394-gdl.pdf.

^[20] See USDA APHIS data on field trials at http://www.isb.vt.edu/cfdocs/biocharts1.cfm.

^[21] See the US Regulatory Agencies Unified Biotechnology Website at http://usbiotechreg.nbii.gov/database_pub.asp

[22] See, for example, Leonard P. Gianessi, Cressida S. Silvers, Sujatha Sankula, and Janet E. Carpenter, 2002. Plant Biotechnology: Current and Potential Impact for Improving Pest Management in US Agriculture. National Center for Food & Agricultural Policy, at http://www.ncfap.org/biotechcrops.html, and also Gabrielle J. Persley, 1990. Agricultural Biotechnology: Opportunities for International Development. CAB International. Wallingford, UK, 495pp. ISBN 0-85198-643-9.

^[23] James, 2008.

[24] Kalaitzandonakes K, Alston JM, Bradford KJ (2007) Compliance costs for regulatory approval of new biotech crops Nat Biotech 25: 509 – 511.

^[25] One of the earliest such studies was NAS 1987, Introduction of Recombinant-DNA Engineered Organisms Into the Environment; Key Issues. National Academy Press, Washington. 25pp. A more recent corroboration was Charles Kessler & Ioannis Economidis, 2001. EC-sponsored Research on Safety of Genetically Modified Organisms: A Review of Results. European Commission, Brussels. ISBN 92-894-1527-4. Additional authoritative examples are legion.

[26] European Commission, Press Release of 8 October 2001, announcing the release of 15 year study incl 81 projects/70M euros, 400 teams. See (http://ec.europa.eu/research/fp5/eag-gmo.html and http://ec.europa.eu/research/fp5/pdf/eag-gmo.pdf ).

^[27] See http://ec.europa.eu/dgs/jrc/downloads/jrc_20080910_gmo_study_en.pdf.

^[28] See, for example, http://www.nap.edu/openbook.php?record_id=9889.

^[29] See, for example: Munkvold, G. P., Hellmich, R. L., Showers, W. B. 1997. Reduced fusarium ear rot and symptomless infection in kernels of maize genetically engineered for European corn borer resistance. Phytopathology 87:1071-1077; & Munkvold, G. P., Hellmich, R. L., Rice, L. G. 1999. Comparison of fumonisin concentrations in kernels of transgenic Bt maize hybrids and non-transgenic hybrids. Plant Disease 83:130-138. .

^[30] Pressure groups opposed to agricultural biotechnology, such as Friends of the Earth, Greenpeace, and the Soil Association (UK) and a small handful of sister groups have prosecuted major campaigns in opposition to agricultural biotechnology.

^[31] See http://www.wto.org/english/tratop_e/dispu_e/cases_e/ds291_e.htm.

^[32] See http://www.economist.com/world/europe/displaystory.cfm?story_id=9832900 and http://www.foodnavigator.com/Publications/Food-Beverage-Nutrition/NutraIngredients/Regulation/EU-regulations-attract-global-attention/?c=BsQPsnsxVtbvnOzYL7sWTw==

^[33] See http://www.pgeconomics.co.uk/pdf/Global_GM_Market.pdf and Kalaitzandonakes, N., R. Maltsbarger, & J. Barnes, 2001. The costs of identity preservation in the global food system. Canadian Journal of Agricultural Economics 49:605-615.

^[34] Robert Paarlberg, 2008. Starved for Science: How biotechnology is being kept out of Africa. Harvard University Press, 235pp. ISBN-13: 978-0-674-02973-6; also, 2001. The Politics of Precaution. Johns Hopkins University Press. 181pp. ISBN 0-8018-6668-5; and Jon Entine (ed.), 2006. Let Them Eat Precaution. AEI Press, 203pp. ISBN 0-8447-4200-7.

^[35] Bruce N. Ames & Lois Swirsky Gold, 2000. Paracelsus to parascience: the environmental cancer distraction. Mutation Research 447:3-13.

^[36]See Office of Science & Technology Policy, Coordinated framework for regulation of biotechnology; Announcement of Policy and Notice for public Comment. 51 FR 23,392, 26 June, 1986 also at http://usbiotechreg.nbii.gov/ .

^[37] See OECD 1986: Recombinant DNA Safety Considerations – Safety considerations for industrial, agricultural and environmental applications of organisms derived by recombinant DNA techniques. ISBN 92-64-12857-3; and National Research Council, 1989. Field Testing Genetically Modified Organisms: Framework for Decision. Washington, DC, National Academy Press. ISBN

ISBN-10: 0-309-04076-0 ;

^[38] See, for example, USDA proposals and comments to the APHIS Docket at http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2008-0023.

^[39] See, for example, http://www.ca9.uscourts.gov/ca9/newopinions.nsf/4C054C94994E1DB3882574B80059C7B9/$file/0716458.pdf?openelement.

^[40] http://www.pewtrusts.org/news_room_detail.aspx?id=24758

^[41] See, for example, http://www.epa.gov/EPA-IMPACT/2005/May/Day-13/i9606.htm.

^[42] FDA, 2008.

^[43] Brookes & Barfoot, 2008.

^[44] Ingo Potrykus, 2001, “Golden Rice & Beyond: Emotions are the problem, not rational discourse.” Plant Physiology 125:1157-61 at http://www.plantphysiol.org/cgi/content/full/125/3/1157.

^[45] See http://www.worldbank.org/html/cgiar/publications/prometh/pscont.html; also Gabrielle J. Persley, 1990. Beyond Mendel’s Garden: Biotechnology in the Service of World Agriculture. CABI Press, Wallingford, UK. ISBN 0-85198-682-X; and Gordon Conway, 1997. The Doubly Green Revolution – Food for all in the 21^st Century. Comstock Publishing, New York. ISBN -13- 9780801486104.

^[46] See, e.g., Geertson Seed Farms v. Johanns, No. 06-01075, 2007 WL 518624 (N.D. Cal. Feb. 13, 2007).

^[47] The Consultative Group for International Agricultural Research, see http://www.cgiar.org/.

U.S. agriculture assistance abroad should provide a full spectrum of agricultural choices to increase food production without contributing to water pollution and other environmental harm amid global warming. These choices should favor agricultural techniques such as conventional seed breeding as well as breeding enhanced by our increased understanding of seed genomes, both of which are proven to increase yield. Favoring agricultural genetic engineering instead makes no sense.

That’s a shame because this legislation, introduced by Sen. Richard Lugar (R-IN), generally reflects the growing public recognition of the increasing challenges to produce enough food with limited resources such as fresh water and non-renewable energy. Climate change today, along with increasingly severe weather, will make it harder to grow our food at the same time that rising population will require greater food production. At the center of this overlapping set of crises is the issue of crop yield-producing enough food from available land and resources. How we resolve these crises will determine our success in ensuring that enough food is produced in coming years.

This effort requires emphasizing methods that work best rather than more impressive-sounding technologies like genetic engineering. The agricultural biotechnology industry, which produces genetically engineered crops, has naturally seized upon the threat of inadequate crop yield to promote its vision for agriculture. Genetic engineering involves inserting into the genetic material of a crop one or a few genes from an organism such as a bacterium—that may not be able to share genes with the crop through traditional breeding—using laboratory-based methods.

The industry has a big stake in promoting genetic engineering as an important solution for increasing yield. It has invested billions of dollars in the infrastructure needed to produce genetically engineered crops. And the ability to control the use of genetically engineered seed through U.S. patent law changes in the 1980s makes genetic engineering especially attractive to these companies. In the United States, the biggest market for GE seed, farmers cannot save patented genetically engineered seed as they previously could with traditional seed varieties from most crops, but must buy new seed every year.

From the beginning, proponents of genetic engineering have made bold claims about the revolutionary potential of the technology, from reducing the environmental footprint of agriculture to making foods more nutritious, and from boosting the ability to raise crops under drought conditions to raising crop yields. But it is this last claim—to raise the yield of crops—which is especially important to the debate about producing enough food.

Increased yield has always been a major goal of U.S. agricultural research. Indeed, agricultural scientists have succeeded in producing a six-fold increase in corn yields since 1930 and soybean yields have increased by a third over the past 30 years. Because a large part of the world’s most productive agricultural land is already used to produce food, getting more food out of cultivated land will require continuing increases in yield. Otherwise, even more forests or grasslands will continue to be converted into cropland, with serious negative consequences for climate change and biodiversity.

The amount of land needed to feed a future global population, however, also largely depends on meat and dairy consumption. The reason: These foods use land much less efficiently than when crops are consumed by people. That means even greater crop yields will be necessary to produce enough food for immediate consumption and to feed the livestock we in turn will consume unless we reduce growing meat-consumption trends.

How successful has genetic engineering been at addressing the important question of improving crop productivity? In our recent report, “Failure to Yield,” the Union of Concerned Scientists found that for the two major genetically engineered food and livestock feed crops in the United States, corn and soybeans, engineered genes have not met the promises of their supporters despite 13 years of commercial production and over 20 years of research.

To better understand the performance of these genetically modified crops, we need to distinguish between two types of yield. Intrinsic yield is the maximum yield obtainable under ideal conditions. Operational yield is the amount of the crop obtained after pests and stresses such as drought reduce the intrinsic yield. Only intrinsic yield raises the ceiling of how much food can be obtained. Operational yield, however, is also important, since pests and stresses typically cause significant losses-especially in developing countries that often have fewer means to control pests and mitigate stress.

After a careful review of several dozen of the best studies in the United States—where much of the best peer-reviewed research has been conducted—we found that no genetically engineered crop increases intrinsic yield. The most widely-used traits, which confer herbicide tolerance to soybeans and corn, also provide no overall operational yield benefit. Several traits, called Bt, which are widely used in corn to control several insect pests, do increase operational yield in the presence of pests, but only modestly. Averaged over the whole corn crop, these traits provide only about a 3 percent to 4 percent yield benefit. Bt genes have not been used in soybeans, so no increase in soybean yield has occurred because of these genes.

These results compare unfavorably to ongoing yield gains from other agricultural methods such as traditional crop breeding, or breeding enhanced by our increasing understanding of crop genomes such as marker-assisted selection. These more traditional and improved methods boosted soybean yields by about 16 percent over the past 13 years. Over that same period corn yields have increased about 24 percent to 25 percent due to conventional breeding and other agricultural advancements.

The meager results of genetic engineering so far compared to more traditional agricultural methods are not for lack of effort. The experimental record over the past 20 years shows over 3,000 field tests approved for genes associated with yield. This represents a major investment of effort and funds with little to show.

What about the future? As the technology advances, scientists continue to discover new genes that may raise yields. Many of these new genes, however tend to interact with the plant genetic material in much more complex ways than the few genes such as Bt that have been successful so far. These complex interactions alter the function of many plant genes—often with unpredictable and sometimes harmful effects.

Case in point: a gene that otherwise shows promise for increasing operational yield through drought tolerance was found to also increase the susceptibility to several types of crop diseases. It is unclear whether this problem can be resolved. If not, we may pay for increased drought tolerance with reduced yield when the pathogens are present, or increased pesticide use to control disease losses.

The upshot: it will be challenging to make these genes work as intended without causing unintended harm.

By contrast, ecologically-based methods have been shown by the United Nations to more than double yields in hundreds of farmers’ fields in Africa and elsewhere, at low cost, and with environmental benefits. A joint World Bank-United Nations report that involved hundreds of scientists concluded that genetic engineering should take a back seat to ecologically-based methods such as organic farming, infrastructure development, and farmer-assisted crop breeding in developing countries. These methods are usually ignored by the private sector because they do not provide a way to easily capture profits and are best developed through public research initiatives.

One can only wonder, then, why the Global Food Security Act of 2009 includes a provision in a proposed amendment to foreign food aid law, requiring the inclusion of “genetically modified technology” in research funded by the legislation without mention of any other methods. The increasing need for food demands that we refocus our public resources on proven methods for increasing yields. That means promoting conventional breeding and demoting genetic engineering.

Doug Gurian-Sherman is a Senior Scientist in the Food and Environment Program at the Union of Concerned Scientists.

The benefits consist mainly in improving the productivity of cropping systems used in the developing world. The risks address biodiversity, health, and poor farmers’ economic vulnerability to the viscitudes of climate and world markets. The question of what biotechnology actually is, however, becomes the more contentious issue for those following this path.

The proven successes among transgenic crops are pest-resistant crops that produce their own Bt pesticides and crops resistant to chemical herbicides. The latter are of little use to resource-poor farmers, though they have been widely adopted by commercial soybean farmers in Latin America. The pest-resistant crops protect against only a limited range of caterpillars, but Bt cotton has been taken up by many cotton farmers in India, where it has also been deeply controversial.

Imagined crops include the nutritionally enhanced “Golden Rice,” still in development ten years after the initial hoopla, and so-called “terminator crops” that produce infertile seed, limiting farmers’ ability to save and sow seeds in successive years. Though the terminator technology is proven in principle, biotechnology companies deny having actually released any varieties containing this genetic construct. Anti-biotechnology activists assert that the terminator is in use.

Other disputants note that biotechnology is broader than genetically modified organisms, or “GMOs,” and assert that the most useful applications involve the use of genomics and genetic markers in selective breeding programs, or noncontroversial methods of cell culture or clonal propagation that can be described as laboratory enhanced extensions of the “cuttings” method used by home gardeners. Opponents have not yet taken this bait, except to see these alternatives as a Trojan Horse for GMOs. Thus goes the give and take along this rather well-trodden path.

I submit that dropping back and considering some more general tenets in the philosophies of development and of agricultural science is a more useful way to understand what is at issue. This is the less-traveled path, but perhaps the more useful in this debate. Here, too, however, there are broadly “pro” and “con” perspectives.

Although the lines of thinking here are complex, the “pro-biotech” perspective can be summarized in terms of three main themes. First, developing agriculture is the most effective and least objectionable route to achieving the goals of sustainable development. Second, improving the biological productivity of developing country farmers is critical to agricultural development. Finally, genetic enhancements (by whatever means) have been and remain critical to improvements in biological productivity. Each theme is both complex and potentially controversial in its own right, so succinct characterizations (such as I am giving here) are clearly simplified.

In the 1950s and 1960s the noted agricultural economist Theodore W. Schulz undertook theoretical and empirical studies of economic development in the least developed nations, concluding that the then-dominant strategy of promoting manufacturing and urban infrastructure was mistaken. It was far better, Schulz argued, to start where people already were, which was in rural areas, and to build upon expertise they already had, which was in farming. Relatively small gains in farm income would create room for household savings, even among the poor. This minimal capital could, with investment in skills and education, provide the basis for a bottom-up strategy that would pave the way for gradual expansion of developing economies from the inside out.

Though Schulz won the 1979 Nobel Prize in Economics for this work, it caught on slowly. Today, adaptations of Schulz’s ideas are viewed as responsible for the success of Pacific Rim nations such as Taiwan or South Korea, where investments in agriculture indeed paved the way for a more broadly based national development. What is more, in its focus on improving the capabilities of poor people this approach to development anticipated much of the re-thinking on international development strategy that occurred in the 1980s and 1990s.

Even today it is estimated that 50 percent to 70 percent of the world poverty exists in rural areas where the strategy of improving farm incomes could both lift many from extreme poverty as well as stimulate a more broadly distributed and enduring trend of economic growth. Yet the means for improving farm incomes in the developing world is itself a complicated matter.

It is generally conceded that developed world farm subsidies and negotiated terms of trade place developing farmers at an unfair economic disadvantage. Many agricultural scientists would add that the basic biological productivity of developing country farming systems places them at a disadvantage, too. On this view, the present-day competitiveness of developing country farmers depends on the relatively low return to labor. When compared as biological systems alone, developed country farmers are able to squeeze far more total production of farm commodities out of their soil, water, seed, and other purchased inputs than are farmers in the developing world.

This theme needs careful qualification on a case-by-case basis. It would not apply, for example, to crops that thrive only in tropical climates. Some economists would argue that biological productivity matters little, in any case. Fluctuations in oil prices could also make energy-intensive developed world farming methods less competitive. Yet these complicating factors notwithstanding, improvements in the underlying biological productivity of farming systems have been critical to all technological revolutions that have sparked significant economic growth, both within and beyond the agricultural sector. A powerful and persuasive argument for this claim can be found in A History of World Agriculture from the Neolithic Age to the Current Crisis, by Marcel Mazoyer and Laurence Roudart, published in 2006.

It should be clear in any case that few agricultural specialists, including economists, would dispute the need for new crop varieties, new farming methods and new tools that increase farmers’ net yields, once losses suffered to pests, in harvest or in transport, have been taken into account. Thus, the third tenet, that genetic improvement is critical to improve yields, becomes critical, as well. This tenet has both direct and indirect support. Rice varieties developed by plant breeders at the International Rice Research Institute in the 1960s and 1970s produced a higher output of grain as a result of improved genetics, making them attractive even to farmers who were not using amendments such as chemical fertilizer.

But fertilizers were not useful on traditional varieties, which would simply grow so tall that they fall over or “lodge” during heavy wind or rain. Shorter or “dwarf” varieties needed to be bred in order to make the addition of fertilizer practical. Even mechanical technologies such as harvesters require crops with uniform heights or that ripen at uniform times—traits rarely found in wild-types or traditional varieties grown by small-scale farmers prior to the agricultural revolutions of the 19^th and 20^th centuries.

As such, virtually all technological improvements in agricultural production methods that have occurred over the last 150 years have relied upon genetic improvements in the crops farmers were growing. As such, there is a widespread belief among the agricultural scientists who populate ministries of agriculture and the Food and Agricultural Organization of the United Nations that future breakthroughs in productivity will require the best available tools for genetic improvement. Today, that means biotechnology.

An “anti-biotechnology” view might also track along three broad themes. First, many opponents of biotechnology in the developing world have been strongly influenced by critiques of development theory that were launched in the 1970s and 1980s. They are skeptical of whether so-called development processes truly benefit the poor. This skepticism can be reinforced by the agriculture-specific analysis of the “technology treadmill”—productivity enhancing technologies hurt the poor and lead to concentration in the ownership of land.

Finally, a systems-based view of agricultural science has challenged assumptions of the genetics model in agricultural science. Advocates of the systems view have been critical of the way that mainstream agricultural science has neglected system-level impacts of industrial farming methods at both the farm and ecosystem scale.

I will not provide detailed discussion of the arguments developed by skeptics of development. At the same time that Schultz was doing his work, analysts such as Gunnar Myrdal, Denis Goulet, Paul Streeten, and Samir Amin were showing that so-called development often made victims of the poor. In some respects, at least, Schultz’s agriculture-focused “human capital” approach anticipated these critiques, yet it is clear that Schultz’s affiliation with the University of Chicago meant that he was not viewed sympathetically by those who, in the 1990s, began to attack the free-market orientation of the so-called “Washington Consensus.”

Suffice it to say that liberals and progressives have ample reason to be skeptical of any claim that an economic development program will actually benefit the poor. The intellectual gap between Schultz’s emphasis on agriculture and the progressive critics of neo-classical economics still yawns. David Crocker’s recent book Ethics of Global Development reviews the critics of mainstream development thinking, but he does not discuss Schultz or agriculture.

The technology treadmill is more directly pertinent to agriculture, in any case. Adopters of productivity-enhancing agricultural technology have lower production costs, but because demand for food grows slowly, at best, the market response is usually a drop in the price of agricultural commodities. Farmers are just running harder (producing more) to stay in the same place (have the same income). One can be skeptical about whether productivity increases really benefit farmers at all.

What is more, early adopters reap windfall prices while the market prices still reflect the production costs of older methods, but late adopters go broke. They cannot recover their still-high production costs at the new, adjusted prices they receive for their crops. The windfall of the early adopters gives them ready cash to purchase the land of failing late adopters. Thus, new technologies fuel a process where better-off farmers get bigger, and worse-off farmers must leave the land.

The logic of the technology treadmill is amplified further when new technologies must be purchased as inputs for the farming process. Marxist social theorist Karl Kautsky noticed as early as 1899 that when farmers had to purchase technology, they were effectively sharing the return on agricultural production with the capitalist owners of machinery or chemical companies that supplied these inputs. The treadmill logic ensures that farmers may have little choice about purchasing and adopting these new tools. Failure to adopt the most efficient technology means certain bankruptcy. But the net effect is a loss of farmer autonomy and a deeper and deeper dependence on capital and decision making that resides in the manufacturing sector of the economy.

Combined with a general skepticism of development processes, the technology treadmill has given many advocates of the poor reason to doubt whether new agricultural technologies are the answer for developing country farmers. The final nail in the anti-biotechnology coffin is supplied by critics of the genetics-focused philosophy of agricultural science that has dominated agricultural universities and government research stations for the last century. This critique is also somewhat complex in its details. One line of argument can be found in the work of Sir Albert Howard, a British scientist who worked especially in India. Howard developed and improved a composting method for animal manures, and railed against the effects of synthetic fertilizers on beneficial soil microbes. This work has earned him an epithet as the “father of organic agriculture.”

But Howard also attacked what he regarded as the excessive reductionism that was taking root in mainstream agricultural science during the 1930s and 1940s. In contrast to detailed laboratory work on plant physiology and genetics, Howard argued that agricultural research could not achieve valid results unless it was conducted in the context of a working farm.

Here, he thought, pest problems and declines in soil health that he associated with chemical-intensive methods would be more obvious. Subsequent researchers noticed system-level effects beyond the farm gate. In 1962, environmentalist Rachel Carson’s Silent Spring brought widespread public attention to ecosystem impacts of agricultural pesticides, though Carson’s work would face hostility within agricultural research institutions well into the 1980s.

In fact, much of the science that began to recognize adverse environmental consequences of farming came from outside agricultural research institutions. Advances in organic farming methods were made mostly by farmers themselves, and were shared at organic farming conferences or through the International Federation of Organic Agriculture Movements. With the exception of limited programs of biological pest control, it is only quite recently (and partly as a result of anti-GMO protest) that mainstream agricultural research has begun to utilize ecological research methods and to take the system-level implications of agricultural technology seriously as a research methodology.

Speaking specifically of international agricultural research, such systems-oriented research as existed in the Consultative Group on International Agricultural Research centers had been phased out by the end of the 1980s in favor of genetics-based approaches and biotechnology.

The upshot is that skeptics of mainstream development and mainstream agricultural science have powerful reasons to believe that it is time to look at an alternative approach. They may not have a persuasive vision of the alternative, but the jaundiced view they take on the agricultural technologies of the 20^th century means that they are unlikely to take claims of promised benefits by the boosters of agricultural biotechnology very seriously.

This skepticism has very little to do with the use of genetic engineering, concerns about “playing God” or “yuk factor” responses to GMOs. It does not even rely particularly strongly on risks that biotechnology poses for biodiversity. It is a mindset whose pivots are found in the way that agricultural science has abetted technology-driven processes that lead to more and more concentration of ownership. The fact that biotechnology has become embroiled in controversies over patents only heightens a concern about concentration and control that exists independently of intellectual property conventions or the idea of “owning life.”

So what should progressives think about the prospects for using biotechnology to improve the lot and prospects of poor farmers in the developing world? I believe that there is space for rethinking the putative tensions between Schultz-style agricultural development and contemporary development ethics. Furthermore, we should not dismiss the way that burgeoning processes of development in India, China, and the Pacific Rim had their roots in agriculture—even if these development processes were plagued by unevenness that sometimes victimized the poor.

At the same time, my cautious prepotency does not mean that we should open the door to agricultural biotechnology companies who see the developing world as a playground for developing biofuels and who moralistically portray “ending hunger” as a cloak for making inroads into local seed and supply markets.

It is, in fact, past time for progressives to discard simplistic thinking on agriculture in general, as if were a domain of quaint rusticity and guileless rubes. No blanket endorsement or condemnation of biotechnology makes any sense at all. Each proposal will have to be evaluated case by case. But doing that will require a discourse that is capable of following an argument of some sophistication and complexity. And that, in turn, will require a bit more literacy in the methods, purposes, and history of agriculture and agricultural science.

Biotechnology can help the poor, but whether it will depends on people of good will taking the time to understand and consider the arguments in some detail.

Paul B. Thompson is the W.K. Kellogg Chair in Agricultural, Food and Community Ethics At Michigan State University.

Further Reading

Paul B. Thompson, Food Biotechnology in Ethical Perspective, 2nd Ed. (Dordrecht, NL: Springer, 2007).

Paul B. Thompson, “Shall We Dine? Confronting the Strange and Horrifying Story of GMOs in Our Food,” in Food and Philosophy: Eat, Think and Be Merry, Fritz Allhoff and Dave Mason, Eds. (Oxford: Basil Blackwell, 2007), pp. 208-220.

At the moment, the United States has no existing federal policies on a host of reproductive technologies, including techniques at the center of bioethical debates, from reproductive cloning to preimplantation genetic diagnosis. The latter is a technology that made news last week when a Los Angeles reproductive clinic, Fertility Institutes, announced that it will soon offer services that will allow parents to choose some of an embryo’s physical traits like eye color, hair color, and complexion.

Richard Hayes, of the Center for Genetics and Society, surveyed human biotechnology policies around the world for Science Progress last year, and this map captures his research on regulations in place across the planet:

It suffices to say that the United States has fallen behind the rest of the world in its regulation of reproductive biotechnologies. Many peer nations, including England, France, Japan and Australia, socially prohibit sex selection technologies. However, there are currently no U.S. federal regulations on this controversial technique. In fact, a 2006 survey by the Genetics and Public Policy Center at Johns Hopkins University found that 42 percent of 137 clinics in the United States that offer preimplantation genetic diagnosis also offer a gender-selection service. The United States does not even have any regulation in place governing inheritable genetic modification in humans, a technique used in animal experimentation that determines phenotypic traits passed on to children. Dozens of industrialized countries in Europe and Asia strongly prohibit the technology.

The science behind these biotechnologies is moving fast. It’s time for the policy to catch up.

[Note: The map above displays data available in the Center for Genetics and Society’s BioPolicyWiki as of October 28, 2008.]

As western Pennsylvania’s only investment organization with a pure life sciences focus, PLSG serves as an investor conduit for life sciences companies. Additionally, PLSG promotes the region’s biosciences innovations and achievements through media relations, industry events, and one-on-one relationship building with investors across the United States and around the world. PLSG grew out of a 2001 initiative, led by then-Pennsylvania Gov. Tom Ridge and the Pennsylvania legislature, which took the bold policy step of investing its share of the state’s portion of the $206 billion tobacco settlement money into health-related programs.

As part of this effort, the state took a hard look at where Pennsylvania excelled and where it was falling behind in the biosciences. The state’s strength in research wasn’t translating into funding for start-up companies. Patent creation was on par with or outpaced many competitor regions, yet Pennsylvania’s share of venture capital lagged behind dramatically.

Pennsylvania responded by creating three innovative programs to fuel growth in the life sciences industry: the Life Sciences Greenhouse Initiative for very early stage life sciences start-ups and regional workforce plan development projects; the CURE grants program to help maturing start-ups access the next round of development capital; and the funding of venture capital groups in the state to help finance these start-ups as they begin to register sales and profits. In the pages that follow we will examine each of these programs as they relate to the emergence of the Pittsburgh Life Sciences Greenhouse as an innovation powerhouse in western Pennsylvania.

The Life Sciences Greenhouse Initiative

The Life Sciences Greenhouse Initiative was one of the programs created to successfully commercialize university technologies and was designed to be one of the very few state/university/industry- funded programs focused exclusively on the life sciences. The LSGI created three regional Life Sciences Greenhouses, with each Greenhouse given the mandate to leverage the unique strengths and opportunities in its region. To achieve their mandate, the Greenhouses were empowered from the very beginning with flexibility in creating programs to increase life sciences commercialization through accelerated technology transfer, company formation, and sustainable company growth.

Western Pennsylvania was ripe for accelerated company formation and commercialization of life sciences companies because of the University of Pittsburgh and Carnegie Mellon University, the region’s premier research institutions, which were consistently securing substantial federal research funds. Despite the impressive level of research support and activity, the level of commercialization lagged well behind regions that had established a sustainable life sciences industry.

The ability to commercialize opportunities generated by research at the universities was hampered by the fact that the region attracted only one-tenth of the venture capital expected based on the magnitude of federally funded research. An absence of local venture capital firms focused on the life sciences, and a regional lag in competing for Small Business Innovation Research grants and other non-VC commercialization funds, resulted in a new life sciences company formation rate of only two or three companies per year. The Pittsburgh Life Sciences Greenhouse set out to fix this problem.

PLSG focuses on guiding researchers, entrepreneurs, and emerging companies through the difficult challenges faced in the early stages of company development. By helping them build sustainable business models and secure capital investments, the Greenhouse makes it possible for companies to deliver biomedical innovations to the marketplace more quickly and efficiently than they ever could alone. In addition to nurturing young companies, we fuel the expansion of life sciences companies in the growth and maturity stages by supporting new product and market developments and by introducing them to new investors.

People with deep life sciences commercialization experience are a core attraction of venture capital to the region. Investors want to know that people who have “been there, done that” are managing their investments. In that spirit, PLSG over the years has significantly adapted our existing Executive-in-Residence program, adding new elements on a regular basis. The success of this program is now a foundational component of the new PLSG Executive Program because of two key aspects—economic development know-how and industry-specific know-how. Our economic development skills help mentor companies through the formulaic steps necessary to start a company, preparing companies with the components they will need to obtain outside capital.

Having an executive as an account manager to foster access to economic development programs is clearly helpful and efficient. But equally important is having industry-specific knowledge to accelerate a company’s impact within its business sector. Executives who have “been there, done that” are deeply knowledgeable in the industry’s commercialization strategies and tactics. They bring their “Rolodexes” of industry relationships to the program to accelerate access to industry insiders and forge relationships with future partners and acquirers.

The Focus on Life Sciences

In 2007, the U.S. gross domestic product was $13.8 trillion, spread over hundreds of industry specialties. U.S. health care accounted for $2.3 trillion (16.6 percent) of GDP, and the manufactured products side of health care, called life sciences, was estimated to account for $848 billion or 6.1 percent of GDP. Life sciences products are categorized into five verticals: pharmaceutical, diagnostics, medical devices, biotechnology, and health care information technology.

In short, our executives need to be experienced in 6.1 percent of the economy, whereas at traditional economic development organizations, with their broader charters, executives would need to be experienced in hundreds of verticals to achieve similar results. This is the value of focused incubators such as PLSG. As mistakes are the mother of experience, our executives ensure that companies do not encounter the same stumbling blocks that they experienced.

This model also has been validated independently by the franchise industry. Its value proposition, similar to that of our Executive Program, is that people choose franchising to start a new business because it often requires a smaller investment and less risk than the cost of establishing a new venture. People who develop these models are industry experts. Our Executive Program provides a similar benefit and as it continues to evolve it will help the local life sciences community grow even stronger in the future.

The next step is to find capital for these companies. With federal Small Business Innovation Research grants a company can secure vital capital at its earliest research and development stages. Our innovative SBIR Advance Program teaches a company how to pursue SBIR funds effectively so that it can rapidly achieve its technology commercialization milestones. Developed for researchers and entrepreneurs and launched in 2002, the Pittsburgh Life Sciences Greenhouse SBIR Advance Program is the only western Pennsylvania resource dedicated to the specific needs of life sciences entrepreneurs.

SBIR Advance is designed to enhance researchers’ existing understanding of the SBIR Phase I, Phase II, and Fast-Track proposal processes. Phase I focuses on funding a company’s proof of concept and funding ranges from $60,000 to $200,000. These proposals generally take six to 12 months to complete. Phase II focuses on developing a working prototype product. Phase II grants generally are funded in a range of $500,000 to $1,000,000 and can take up to two years to complete. A Fast-Track proposal combines a Phase I and II request all at once. The advantage to the company is obvious but this proposal is less likely due to its more risky nature.

During a two-day group workshop and the following one-on-one consultations, our industry experts guide companies through the proposal process, with training and scientific and editorial review of federal grant applications. Participants who attend all required sessions receive these extensive consulting services free of charge. The benefits of the PLSG SBIR Advance Program include: expert instruction in the efficient development of SBIR funding applications; a track record of improving applicant success rate; and constant, individualized support throughout the application development, submission, and post-award notification process.

Since inception, the PLSG SBIR Advance Program has assisted nearly 100 companies with their federal grant strategies. To date, these companies have received more than $17 million in federal grant funding. Locally, companies such as ALung Technologies Inc., which received more than $3 million, Separation Design Group ($1.7 million), and COHERA Medical Inc. ($1.8 million) funded 10 percent to 50 percent of their capital to date through these programs.

Workforce Development Program

A prepared workforce will help regional companies keep pace with market demand. To accomplish this goal, PLSG offers direct assistance to our region’s growing businesses and leads initiatives to prepare the western Pennsylvania workforce for emerging career opportunities in the life sciences industry. PLSG’s Workforce Development Program is customized to life sciences workforce challenges—whether recruiting new employees or expanding the skills of existing talent.

The Greenhouse connects life sciences companies to educational partners and funding sources for cost-effective workforce development. Our workforce development program includes administering a first-of-its-kind $2.4 million federal grant from the U.S. Department of Labor to train western Pennsylvania workers for the life sciences industry. PLSG is working in partnership with Community College of Allegheny County, Lyceum Group LLC, and the Pittsburgh Technology Council. To date, the workforce program has trained more than 6,000 workers, far exceeding its original goal of 400.

As part of our efforts to foster economic opportunities in the life sciences, PLSG also is facilitating the implementation of a full-scale Mobile Laboratory Program to serve the region’s Science, Technology, Engineering, and Mathematics, or STEM, educational and workforce development needs. Mobile laboratories are self-contained, traveling laboratories that allow for student participation in laboratory-focused biosciences investigations on board. Mobile laboratories already are successfully serving tens of thousands of students in places such as Arizona, Connecticut, Georgia, Iowa, Massachusetts, Maryland, North Carolina, Texas, Virginia, South Dakota, and portions of Pennsylvania outside western Pennsylvania.

The Incubator

The PLSG Incubator offers cost-effective space to qualified seed and early-stage life science companies, including those relocating to western Pennsylvania. The PLSG Incubator offers far more than preassembled cubicles: Incubator companies have access to amenities that free them from the more tedious tasks of growing a company, and these firms will be instantly placed in the midst of a supportive early stage business community. Offering companies world-class meeting rooms for investor presentations, the Incubator provides computer, communications and Internet infrastructure that present an image of stability and professionalism to investors. Access to the Executive-in-Residence pool offers support and immediate advice to the sometimes-secluded entrepreneur.

Young start-up companies also benefit from the close proximity of neighboring life sciences start-ups and the experts of PLSG, which has two Incubator facilities equaling 20,000 square feet of available space for growing companies. The main Incubator, PLSG East, is adjacent to PLSG’s administrative offices. It is a 13,000-square-foot facility consisting of 40 percent modern wet lab space and 60 percent office space. The second facility, PLSG West, is 7,000 square feet of mostly laboratory space.

The benefits of the PLSG Incubator include wired offices for data and voice communications, basic utilities, and flexible lease terms. All Incubator tenants have access to small and large conference rooms, office furniture, office equipment, and a kitchen, balcony, and ample tenant and visitor parking. Industry-specific neighbors or building tenants include ThermoFisher, the University of Pittsburgh, the McGowan Institute for Regenerative Medicine, Novitas Capital, and UPMC Health System.

The PLSG Incubator has a prime Pittsburgh location within the Pittsburgh Technology Center, which conveniently places it between Oakland’s university cluster and Downtown Pittsburgh’s legal and financial center. It also puts us in the Greater Oakland Keystone Innovation Zone, which offers financial incentives to life sciences companies. The Greater Oakland Keystone Innovation Zone is a partnership of collaborating organizations, including: Allegheny Conference on Community Development and Affiliates, Allegheny County Department of Economic Development, Carnegie Mellon University, Idea Foundry, Innovation Works, MPC Corporation, Pittsburgh Life Sciences Greenhouse, Pittsburgh Gateways Corporation, Pittsburgh Technology Council, The Technology Collaborative, University of Pittsburgh, University of Pittsburgh Medical Center, and Urban Redevelopment Authority of Pittsburgh.

Entrepreneurship often begins with an individual and an innovative idea, but it takes a team effort to create a marketable product and a sustainable business. The Pittsburgh Life Sciences Greenhouse gives western Pennsylvania’s entrepreneurs a reach into the global biotechnology industry. PLSG leads collaborations that support our regional industry’s growth and benefit the individual company. These efforts include access to capital investment networks. The Greenhouse develops and maintains venture capital partnerships to make funding more accessible for our region’s life sciences companies. Firms such as Pittsburgh’s Adams Capital Management, Birchmere Capital, Draper Triangle Ventures, and Novitas Capital, Boston’s Techno Ventures Management, Philadelphia’s Quaker BioVentures, and Silicon Valley’s Longitude Venture Partners LP all have invested in the region.

Other collaborations with global industry life sciences companies are offered via trade missions. PLSG leads and facilitates foreign trade missions in Europe and Asia to identify strategic and cost-effective business development opportunities. Similarly, the Greenhouse hosts regional networking events, working with regional industry groups to create opportunities for peer-to-peer collaboration. And PLSG develops industry-specific promotions. Through international conferences and media relations, we promote western Pennsylvania’s life science innovations and achievements.

Finally, PLSG prepares start-up life sciences companies to spread their business wings in the region and the state. Life sciences companies require highly specialized facilities to adequately house research and development activities, production, and daily operations. Through its contacts with the region’s foremost site selection services, PLSG aids companies in the search for light industrial, manufacturing, or headquarters space.

Both expanding local companies and those looking to relocate to the Pittsburgh region can take full advantage of our site selection services. By arming our site selection partners with our knowledge of a company’s unique business needs, we can ensure that their next location will be the perfect fit for any regional life sciences company.

The Role of CURE Grants

In addition to the Life Sciences Greenhouse Initiative, the state also initiated the Commonwealth Universal Research Enhancement Program, called the CURE Grant Program for short, to support and encourage Life Sciences-related research, recruitment of scientists, and development of laboratories. This program was enacted by the State of Pennsylvania in 2001 to direct the Pennsylvania Department of Health to establish a health research program. Under this program research grants are awarded for clinical, health services, and biomedical research. All funds must be used in a way that is consistent with the research priorities as established by the Department of Health. Approximately $68 million per year has been distributed to universities, colleges, and companies working in collaboration to support these goals.

The majority of the funds are allocated to the universities directly by a formula in proportion to their National Institutes of Health grant funding levels. The remainder of the funding is distributed by a careful and thorough external peer review process (non-formula funding) to projects chosen in research areas selected by a state commission under the Secretary of Health. Projects submitted in response to this RFP are then reviewed by an impartial external review mechanism.

All the money in both the formula and non-formula components is in the form of grants. Follow-up reports and presentation of results for the non-formula funding are required. The program is now in its eighth year and has been very successful in achieving its goals and encouraging collaborative research efforts in the Life Sciences focused area. Examples of funding include Carnegie Mellon University, which received a $710,806 grant to quantify the evaluation of Elder Care Environments, and the Allegheny-Singer Research Institute, which received a $237,838 award to study the impact of cigarette smoking and tobacco use on wound healing.

The Role of State-Based Venture Capital Funding and Co-Funding

The third component of the state’s program entails co-funding three venture capital funds to invest a significant proportion of their funds in Pennsylvania-based life sciences companies. The program is a $60 million fund designed to provide loans to venture capital companies looking to make investments in companies located in historically underserved areas of Pennsylvania. The program also requires a match by the venture capital firm of three dollars of investment into Pennsylania-based companies for every one dollar the state provides, creating to date $240 million in investment capital that has been tapped by, among others, Birchmere Capital, Novitas, and New Spring Capital—the first recipients of these funds.

Three local start-up companies, Renal Solutions Inc., Cellumen Inc., and Red Path, started with early Pittsburgh Life Sciences Greenhouse involvement and advanced their funding to tens of millions of dollars. Most recently, Renal Solutions was sold to Fresenius Medical Care AG & Co. for $190 million—completing the state’s vision of providing support through a company’s entire financial life cycle. It is important to note that Renal Solutions remains in the Pittsburgh region.

Of course, a six-year-old incubator program for life sciences startups such as PLSG will probably need another six years before it knows how many of its young companies will survive and thrive in the competitive life sciences industries. Developing a successful life sciences company from the lab to Wall Street is no easy task, taking well over a decade in most cases. So far, however, PLSG has worked with 280 start-up companies. Currently, 118 companies are active and the PLSG has invested in 56 companies, helping western Pennsylvania’s young life science companies to take a shot at the successful commercialization of their products and services. It’s a model other regions of the country with prominent universities boasting comparative advantages in key science, technology and innovation arenas should actively consider.

James F. Jordan is Distinguished Service Professor and Director, Master of Science in Biotechnology Management, Carnegie Mellon University, H. John Heinz III School of Public Policy and Management, and Vice President and Chief Investment Officer, Pittsburgh Life Sciences Greenhouse. Paul L. Kornblith, MD, is Director of the Pennsylvania Biotechnology Association for Western Pennsylvania.

Throughout, Cohen makes heavy weather of the point that science cannot tell us whether its ends are worthwhile, or its methods within the bounds of moral decency or virtue. In the first chapter, “The Spirit of Modern Science,” he tries to establish that “scientists” deny this rather obvious truth. He first sets up science as opposed to theism, and then suggests theism is the only genuine source of meaning and moral guidance. We are meant to conclude that those who embrace the scientific endeavor are left with scientific enquiry as the only possible source of meaning and moral guidance—thus science has to justify both its aims and means. The purported incompatibility of the modern scientific world-view and theism is dubious. But it is Cohen’s second premise, which entails dismissing scores of secular and deist moral philosophers, some of whom antedate his preferred versions of theism by hundreds of years, that is truly jaw-dropping.

It is also a dangerous book, because it contains reactionary policy recommendations, nestled within pages of highbrow prose carefully structured to mimic fair- and open-mindedness.

There are three values Cohen appeals to at various points, and that he claims we have to be Jewish or Catholic theists to appreciate: love, excellence, and the equal dignity and worth of all human beings. He ignores the fact that the philosophy of Ancient Greece and its descendants place excellence and loving well at the center of the good life. And he fundamentally misrepresents a tradition that places people’s basic moral equality at its center: modern liberalism. Cohen repeatedly describes the liberal project as trying to make people equal. This description skews the liberal belief that justice requires structuring society so that people are free to pursue their own conception of the good—a requirement based on the assumption that all people are equal. Different liberal theorists believe in this basic moral equality for different reasons. Kant and the early Rawls find it in the fact that we are capable of principled self-government. Locke finds it in his deism.

Thus, the entire book is based on a false dilemma. It is also a dangerous book, because it contains reactionary policy recommendations, nestled within pages of highbrow prose carefully structured to mimic fair- and open-mindedness. Cohen is forever attributing humanitarian and just motives to his opponents, and rather than state his opposition outright, he usually leaves off his enquiries with a set of rhetorical or near-rhetorical questions. For example, his opposition to genetics is encapsulated in the following remarks on testing for genetic disease: “In those situations where some therapeutic preemption is possible, like for those who test positive for the breast cancer mutation, the young often face drastic and wrenching decisions: Is the greater chance of longer life worth living with the scars of mastectomy, or living without the possibility of bearing children of one’s own? Is it really better to have the knowledge that makes such a tragic choice necessary, rather than the ignorance that would allow us to live without being so haunted until the disease really comes?” (91).

Cohen is more straightforward when it comes to research using human embryos. He writes, “If I could stop all embryo research before it really gets going I would do so, and if I could put the embryo back inside the [woman’s] body, I would probably do so” (78). But why? He clearly wants to side with the religious right, and so writes admiringly of conservatives who “are for treating seemingly unequal beings (like early stage embryos) more equally” (68). He also says he believes “the only rational view of the embryo that is fully consistent with democratic decency and democratic equality is the welcoming one—to treat the embryo as ‘one of us’” (75).

Yet he also rightly recognizes that human embryos pose a unique challenge to our moral categories. Particularly when created in a lab, they lack all resemblance to the creatures we know as rights bearers; nor do they resemble the creatures we know we owe protection and love. However, many of them would become such creatures, if nourished in a certain way. Also, these embryos are genetically related to us, and we have only just begun to think about the moral significance or insignificance of genetic relatedness. (Cohen appears to think he knows the significance, and it is high—in chapter six, he accuses an egg donor of “abandoning her child.”) In short, it is not easy to know what to say about the right and decent ways to relate to embryos, and kudos to Cohen for not jumping on the human-genetic-code-equals-right-to-life bandwagon. Unfortunately, he instead leaps from the difficulty of the issue to the impossibility of reasoning about it, and then abruptly concludes that we should stop all research that requires destroying embryos, plumping for his preferred answer because the question is too hard.

This is not the only place in the book where Cohen opposes medical research and discovery on the grounds that they pose difficult moral questions. In chapter five, it would be better not to pursue knowledge about genetic disease because it is hard to know what to do with such knowledge. In chapter six, the fact that anti-depressants are morally problematic means it would be better not to have these drugs at all. Although he pretends to acknowledge the value and promise of recent and possible future developments in medical research, he does not seem to realize that refusing to pursue these developments is itself a morally momentous decision—that inaction has consequences too.

Cohen exhorts us to see the “wretchedness” of disability and disease as “a pilgrimage” culminating in salvation in the afterlife. On the individual level, such a view is no doubt of great comfort to many. But as policy, it abandons future persons. As a society, we should do our best to help the diseased and disabled by removing or alleviating their suffering. There is virtue in thoughtfulness and moral caution in our efforts to relieve suffering through science and medicine. There is no virtue in evading hard questions through fatalism.

Adrienne M. Martin is an assistant professor of philosophy at the University of Pennsylvania and a Senior Fellow at the Penn Center for Bioethics.

Americans get the importance of science and technology.

Because the American people are not dense. Despite all the news stories about the last-ditch efforts to keep creationism in our public schools, Americans know which side their bread is buttered on, and that side is science and technology. They can see on television that science and technology are fueling the economies of Europe and Asia. Science and technology will create the good jobs in the United States and will maintain the country’s preeminence in the 21st century. That is why the fact that our kids are falling behind the rest of the world in science literacy is viewed with alarm and a fair degree of nervous joking—Americans get the importance of science and technology.

The public also understands that solutions to some of the major challenges this nation and the entire world face—affordable fuels, global warming, controlling highly infectious diseases, growing sufficient and nutritious food, reducing pollution, cleaning up the oceans and improving transportation, all depend on science and technology. And while the public may not fully appreciate the fact that there have been breathtaking bursts of knowledge in areas such as genomics and neuroscience resulting from heavy taxpayer-supported government funding, they can easily understand that it would be foolish not to make the resources and incentives available to move this new knowledge into practical application in terms of jobs and better health as rapidly as possible.

So in the spirit of three is about as far as you can get (but cheating a little to cover all the areas I am hoping to get on the next administration’s radar) here are six things: three in health and three in science and technology that the next administration ought to argue for vigorously and fund generously during its first term.

Health

Modest but ethically important reform

Most discussions of our strained health care system focus on proposals for single-payer systems, universal health care, and the value of markets and choice. But consider this: the American health care system accounts for about 17 percent of our gross national product, and this inordinate expense is straining industrial productivity and cannot be justified in terms of what we get for our money.

Healthcare expenses affect every level of U.S. industry. For large corporations health care costs mean higher prices on our products along with massive “legacy costs” to insure retired employees. For small business owners healthcare expenses make it impossible both to hire candidates they would otherwise take or to sufficiently incentivize inefficient workers to move on, damaging productivity. Some economists maintain that as many as 42 million U.S. jobs are “susceptible” to offshoring in a future where technology allows the more efficient transfer of jobs and employee health care costs are far less.

As nearly every politician recognizes, something must be done. But the new administration needs to understand that a drastic overhaul of the gargantuan, money gobbling, bloated mess that passes for American health care is not going to fly. There are just so many stakeholders in the hugely inefficient, highly inequitable, but incredibly lucrative broken system that we now have to change it quickly.

The new president should talk boldly but move slowly. Praise the drive toward some day achieving universal coverage, but accelerate change by focusing political momentum on children—the group most likely to command ethical empathy across the political spectrum. The new administration should come up with a proposed basic package, including dental, hearing and eye care, for every American child. Prenatal and post-natal care for every mom ought be there as well.

Of course we need universal coverage for basic health care, but the place to start in practical terms is with those under eighteen years of age. Millions of American children lack health insurance. Not only do they deserve it, but they are the moral key to insuring the rest of us. Show success with kids and the rest will follow.

Stem cell research is great but…

Way, way too much political energy has gone into the embryonic stem cell issue. Working with embryonic stem cells is a very exciting area of biomedical research but it is hardly the only area; nor is it the one that will have guaranteed practical payoffs any time soon. All the new president needs to do is flip the Bush administration restrictions on federal funding, which are inconsistent and wildly unpopular; gin up a new federal panel at the NIH to make sure that oversight of all stem cell research is comprehensive, including all early animal and human trials public and private, transparent, and standardized among the states; put some Federal money into the pot; and get out of the way. The stem cell scientists—adult, fetal, embryonic, induced, and cloned—will take it from there.

America needs much more funding of basic research in genomics, proteomics, and bioinformatics. The “ics” hold the future in terms of mining the little we now know about a whole lot of genes. Without that investment, we will be stuck with half-witted, premature schemes to map our individual genomes—what we can call spitomics—spit-in–a-cup DNA testing. This rapidly growing sector is riding an ill-grounded wave of hype that makes weak, next-to-useless correlations between gene markers and disease states without really having much idea what to tell its customers to do about the risk information that testing companies find.

Fix public health

Our public health system is a wheezing, uncoordinated, underfunded eyesore. It needs to be rebuilt to face the challenges that 21^st century living poses to health, ranging from asthma, to diabetes, to the flu. City and county health departments need federal help across the board. Proactive public health is a key element of our national security. The next administration should demand that Congress pay for it.

So how are we going to fund all this glorious new research? In reality the price tag is not all that big—we hardly spend very much now as a percentage of gross domestic product on basic research in health, technology, and science, especially if you don’t count defense related research. But for those who want a new idea as to funding, here is a bonus suggestion for the next president: It is time to revisit the National Institutes of Health and National Science Foundation budgets and see whether a twist on the Bayh-Dole Act that gives universities incentives to work with industry makes sense.

The NIH budget does not grow in hard times. Congress won’t go there in times of deficit. Private companies wait to see what tax-payer funded basic research looks promising and then develop that, only to sell it back to the taxpayers (you and me) who originally funded the work at high prices. So why not put a 3 percent tax on all products that are generated from NIH, NSF, or other government-sponsored basic research? Keep the core budget there and adjust it to rise in response to inflation, but let American science and the American people really benefit from breakthroughs. In that way the incentives are there to translate basic research into practical products, while at the same time allowing the NIH budget to grow more rapidly without having to whine for more money from Congress every year. Here is a real incentive to universities, think tanks and academic scientists—make real and useful breakthroughs and watch your budget for future research grow!

Science and Technology

A New Push in Agricultural Research

We need safer, healthier food that has far less of a footprint on the environment. Science and technology can help but we need presidential leadership to get us there. To reduce the burden of chemically based farming that depends on fertilizers, herbicides, pesticides and huge amounts of irrigation, we need to apply the genetic revolution to agriculture. Let’s break the link forged by big agribusiness between the “old” chemically based agriculture and genomics and drive forward with a biology-based agriculture that uses genetic knowledge to screen foods and insure their safety; engineers them to make them heartier, more healthful and less oil and chemically-reliant; and creates the next generation of creative farming in cities, estuaries, empty government lands and national forests. And, for those who see creative possibilities in new forms of organic farming and alternative modes of agriculture— working to achieve the “natural” control of pests, better pollination through diversity and using less water through better soil management—give them a bit of money to let them show what they can do as well.

Clean Water

The president needs to understand that clear, drinkable water is going to be a major political issue both in this nation and worldwide very soon. If we have the technology in place to use less, to get more from the oceans, to recapture more from our current industry and farming uses, and ways to identify, track and get rid of microbial pollutants in lakes, rivers, and oceans, we will hold a key foreign policy card. Nanotechnology, micro-sensing technology, better semiconductor technology, and even improved synthetic biology are the tools to get us where we need to go. We just need a president committed to getting us there. If the new president wants to make fast friends in China, the Middle East, India, and Africa he could do worse then by promising to fund and share the science that will lead to more clean water.

Synthetic Biology

The next president and his administration can’t let human hubris about how wonderful our bodies and genes are fool them. We love to think that it is the science of human genetics and human biology that holds the key to our better future. But the fact is, microbes are usually easier to work with than human beings, and are just as useful for making gains in human health, well-being, safety, and security. That means the government should put more money into research in synthetic biology aimed at fighting diseases, making synthetic fuels, eating pollutants, cleaning the oceans and our arteries. As HIV and pandemic flu show, you cannot ever underestimate a microbe. By developing the microbial and synthetic biological science to manipulate these tiny critters, the next president can go a long way toward solving a host of our current headaches.

Keep It Real

In health care and in science and technology, the new administration can make a huge difference by keeping its eye both on what is practical and what is likely to provide the greatest return on investment. These have not always been the watchwords of health and biomedical science policy in the past. There is no need for administrations elected on a promise of “change” to let history repeat itself in the future.

Arthur L. Caplan, PhD is an adviser to Science Progress and the Emanuel and Robert Hart Professor of Bioethics, chair of the Department of Medical Ethics, and director of the Center for Bioethics at the University of Pennsylvania.

Great Britain, which put a blanket ban on all GM crops in 2004, is now beginning to grant new applications for field trials of bioengineered crops, and British scientists are pushing for allowances to conduct even more GM research. A policy shift among European Union member states would be particularly significant, as most of the global food trade is affected, directly or indirectly, by European regulations. An EU move towards acceptance of GM foods would undoubtedly inundate global markets with bioengineered crops, much to the chagrin of the many protesters in both the United States and abroad.

AP

Scientists can engineer seeds that are drought resistant, can withstand harsh chemicals, or that contain extra vitamins.

The debate about the safety of GM foods isn’t going to end any time soon, in Europe or the United States. Here at home, though, debate over the benefits and potential pitfalls of the technology must be framed around the fact that engineered seeds have to pass through the screening procedures of three different agencies, a more rigorous testing procedure than any other food undergoes.

In 1986, the United States established the Coordinated Framework for Regulation of Biotechnology, which describes what safety requirements each agency is accountable for monitoring and the intricate detail in which the agencies must work together. The U.S. Department of Agriculture evaluates the seed’s agricultural safety, while the Environmental Protection Agency assesses hazards the new crop might hold for the environment. The Food and Drug Administration ensures that the crop (with its newly engineered protein falling into the “food additive” category) is safe to eat.

While this battery of evaluations is by no means foolproof, it does ensure that genetically engineered foods that make it to our tables are at least as safe, by any testable standard, as other foods on the market. Critics of genetically modified crops, however, raise other issues. They point out that most of the genetically modified seeds that are sold are engineered to be resistant the high levels of pesticides or herbicides. This use of such technology only furthers the interests of the corporations who produce the seeds and, invariably, the chemicals for which they have resistance. It also encourages farmers to use a heavy hand when applying these toxic chemicals to their fields.

Others worry about the lack of definitive tests to ensure the safety of genetically modified foods. The concern is that the engineered crops could produce surprising toxins, or that the spliced-in DNA might escape the digestion process in our stomachs and fuse with our DNA or the DNA of our gut flora, causing mayhem. The list of concerns goes on, and every blog or news outlet will provide a different spin.

Certainly, there are issues to be addressed by policymakers. Foods containing GMOs are not currently labeled, and it is thought that as much as 70 percent of all processed foods on the shelves in American grocery stores contain GM ingredients. Some groups have suggested that there should be some system requiring labels for these products to enable consumers to make informed choices about their food purchases.

Before that could happen, though, there would need to be a better system for keeping engineered seeds from infiltrating organic crops. One of the biggest contentions farmers have with engineered seeds is their tendency, like any other seed, to drift. Many organic farmers have found high percentages (frequently over 20 percent) of their crops to be contaminated with GM seed. One solution might be to establish GMO-free zones, like those in place in California, to allow organic farmers to raise their crops without worry of contamination from nearby farms.

While U.S. farmers, the media, concerned parents, and all the other interest groups continue to go back and forth on this issue, there is a global dimension to the debate that policymakers must also weigh. In small areas of Africa, farmers have introduced seeds engineered to increase the crop yield and the nutrition of those yields. These crops can be a huge source of relief in parts of the developing world where malnutrition affects over 800 million people, a number that will only continue to increase with the rapidly growing global population and the skyrocketing costs of food.

Plants that are engineered to have higher levels of essential vitamins or nutrients help children develop properly and help adults keep their immune systems healthy. Crops engineered to be drought resistant or have higher yields can help stem the global food shortage while bringing much needed income to poor farmers. The first step in any long-term solution to the food crisis is to increase the self-sufficiency of starving populations. This can be partially accomplished by giving farmers access to improved seeds.

At the heart of the matter, the debate over genetically modified crops is really two separate issues. Much of the genetic engineering done on crops in the United States improves the crops’ ability to withstand powerful chemicals. The genetic engineering that could contribute to the malnourishment problem in the developing world improves crops’ ability to feed people. Thus the debate over GMO foods should be conducted as two debates.

The first: whether chemical companies are using biotechnology to sell more of their product and maintain a stronghold on seed technologies and thus agricultural production. And the second: whether supporting the use of biotechnology is an appropriate means to help solve an urgent humanitarian problem that will continue to grow if the global community doesn’t act aggressively. After all, the majority of processed foods in the United States contain some genetically modified ingredients that over the past two decades have not resulted in any immediate adverse health effects, but malnutrition kills ten million people a year. The seeds of this biotechnology have already been sown; it is now our responsibility to make sure we utilize them for good.

Joined by author Jonah Leher and Science Progress Editor-in-Chief Jonathan Moreno at the Seed Magazine-sponsored briefing, Farah began by explaining that 20th-century advances in neuroscience came primarily in the fields of basic scientific research and medicine. Shifting to real-world applications, she said that 21st-century neuroscience has already brought and will bring more non-medical applications of this research, and these developments have already altered the way we can manage human capabilities. “Neuroscience has rappelled down from the ivory tower and eloped from the hospital ward,” she said, explaining that for any sphere, “in which it is important to understand, assess, predict, control, or improve human behavior, neuroscience can help.”

But the fundamental ethical question at the heart of developing brain enhancement technologies is the role of doctors. Most neuroscience research is tied to biomedical practice and infrastructure, and enhancement changes the nature of this establishment when producing non-medical applications. Farah explained that with advances in the field, the mission of medical groups is up for debate. She said that doctors must ask: “Are we in the business of just healing people and fixing the sick, or are we in the business of enhancing people and improving their lives?”

She identified two major approaches to altering and understanding the brain: drugs and devices, and some of the policy considerations related to each. The tradition of using chemicals to alter mental states or enhance mental performance goes back thousands of years, but some current non-medical applications of psychopharmacology that raise ethical questions include stimulants that improve attention or reduce the need for sleep. Farah cited a research study indicating that up to 25 percent of students on some college campuses use prescription stimulants like Adderall or Ritalin, originally designed to treat attention deficit hyperactivity disorder, for non-medical purposes. With the drugs, students can work or study additional hours without sleeping, potentially leveraging that time as an educational advantage. But she noted, “the students I teach did not wait to read about this study”–rather, the social pressure to succeed and the ready availability of the controlled substances incentivizes using the stimulants to increase their productivity.

Modafinil, marketed as Provigil, is a prescription drug with growing popularity that confers an even more powerful enhancement: it allows people who take it to function for days on end without the need for sleep, and without any short-term side effects. In addition to raising the same ethical questions about advantages in productivity in competitive fields associated with stimulants, Moreno pointed out that the Air Force already prescribes Provigil to pilots in order to allow them to carry out long missions without the need for rest. Both also questioned the impact these technologies have on personal freedom. If higher productivity can come in a harmless pill, Farah wondered if workers might find themselves saying one day, “I want this job, but I don’t want to have to take a drug to get it.” Addressing military applications specifically, Moreno pointed out that citizens in military service were going to have to accept more and more interventions to improve their performance and abilities, but he warned that “we need to think about what these young soldiers are going to tolerate.”

Farah explained several other pharmaceuticals that raise significant ethical and policy questions. Courts, she said, already have the authority to prescribe anti-androgen treatments that inhibit sex drive for sex crime offenders, raising the specter of Clockwork Orange-like state control over the bodies of prisoners. Many drug companies, she said, are working to bring drugs to market that combat the natural memory loss effects of aging. Propranolol, a beta-blocker that can dampen memory formation and retention, is currently used to treat post-traumatic stress disorder in soldiers. Considered through a different lens, the drug could ease the psychological burden of killing enemy soliders in combat. Moreno asked, “Are guilt-free soldiers the kind the United States wants to have?”

The pharmacological applications of neuroscientific research that Farah outlined are all real and commercially available. In shifting her discussion to devices, she was careful to stay with real applications, because the topic, “can easily get into science fiction.” The two primary categories of device applications are machines that stimulate or augment brain function, or machines that image and observe brain function. The former class includes Transcranial Magnetic Stimulation devices, which use magnetic pulses to activate specific areas of the brain and trigger a response. Portable TMS machines have battlefield applications: the direct brain stimulation can heighten awareness and alertness in demanding situations.

Neuromarketing is the burgeoning field of brain imaging applied to the development of effective corporate messaging. “A large number of Fortune 500 companies are paying neuromarketing firms to vet their advertising,” Farah said. For example, a Boston-based ad firm showed test subjects a series of potential images for use in marketing Jack Daniels whiskey, narrowing the most effective photos by observing the brain response of young men in an MRI machine.

Perhaps one of the most sensational fields of imaging research includes experiments that apply fMRI technology for lie detection. Farah explained the process by which researchers train computer algorithms to associate certain brain responses of study subjects with true and false statements, and then attempt to use the machines to determine the truthfulness of subsequent statements. While highly structured experiments have produced positive results, she registered her own skepticism “that this is ever going to transfer from the laboratory to any high-stakes purposes.”

One imaging application with high-stakes applications that could make it out of the lab allows researchers to associate personality characteristics with patterns of brain function. This allows scientists to predict extraversion, unconscious racial attitudes, or educational abilities without the usual pencil-and-paper tests–and without subjects necessarily knowing what researchers are looking for. The technology, already accurate, raises privacy concerns for job screening and discrimination.

Farah closed by pointing out that most neuroscience research is jointly funded by private enterprise and the federal government. Because private companies realize the potential of capitalizing on these technologies, the government should address future concerns about its responsible use by exerting ownership and control while it still maintains significant financial involvement, ensuring that its benefits are not inequitably distributed. “It’s going to happen anyway, and we ought to own it,” she said.

The Seed Vault is a major attempt to preserve existing biodiversity. The underground storage facility will freeze seeds from all over the world, shielding them from blight, climate change, seed bank mismanagement, and war. (The bunker was designed to withstand a nuclear explosion.)

Sequencing the maize genome represents another big step forward in agricultural genetics. Funded by the NSF, the USDA, and the DOE, the genome map can facilitate the production of hardier, higher-yield breeds that carry specific traits university or agribusiness researchers are looking for.

Genetically modified food doesn’t carry the same stigma in the United States as it does in the EU, but Alexis Madrigal, writing at earth2tech, raises the point that in the U.S., farm bill subsidies support corn growing, GM or not. And one possible application of this new genetic knowledge is the ability to manipulate corn genes so the plant might produce oil. Agricultural subsidies for oil-bearing corn would only make it harder to move biofuel conversations past the resource-intensive crop and on to the next generation of biofuels.

And questions about access to genetic resources necessarily raise the issue of intellectual property. Andrew Revkin points to some of the problems raised with the Svalbard approach–and centralized seed banking in general–including the fact that it takes genetic resources out of the hand of farmers, “the world’s original, and ongoing, plant breeders,” in the words of Grain.org. (For more on that, see the New Yorker‘s extensive back story on the vault from last summer.) With respect to the corn genome, the latest work could prompt discussion of gene patenting in industrial agriculture; as the AP points out, agribusiness giant Monsanto helped with the sequencing and will be able to license the fruits of the research for its products.

Now, an experimental vaccine to treat cocaine addiction may well upend the stale strategies that underpin the “war on drugs.” If the vaccine proves effective in clinical trials then “Just Say No” may take on an entirely new meaning: your body will agree even if your mind wants to say yes.

If the vaccine does prove to be efficacious, it is not just the science that should be applauded. So, too, should the public- and private-sector financing model that would have funded the vaccine all the way to the marketplace—something that hardly ever happens with vaccines in the world of drug development. The applause, however, for bridging this financial “valley of death” might just stop there. The reason: profitability is not at all assured even if the last clinical trials prove successful.

Public health officials must then answer the question of “who gets vaccinated,” which in turn will determine just how much money the private investors behind the cocaine vaccine will reap in profits from the more than decade-long effort to bring the it to market. This cocaine vaccine, then, boasts a number of potential lessons for scientific researchers, public and private investors in vaccine development, and public health professionals and policymakers.

A Novel Vaccine Pathway

Researchers at the Baylor College of Medicine in Houston requested permission in December 2007 from the Food and Drug Administration to begin Phase III clinical trials for a vaccine called TA-CD. These late-stage clinical trials will test the efficacy of TA-CD’s ability to blunt or even to prevent cocaine’s effects on users among a group of several hundred humans, which if successful would move the drug very close to commercialization.

Among all these drugs, however, only the TA-CD vaccine stops cocaine from interacting with the brain at all.

Reaching Phase III trials is a monumental achievement, as very few drugs make it that far in the research-and-development and regulatory approval phases of development. And for TA-CD, it’s been a long time coming. The TA-CD vaccine first made headlines in 1996, when Barbara Fox and collaborators published in Nature Medicine that rats could be inoculated against cocaine’s euphoria.[1] The same approach then proved feasible in early stage clinical trials with about 20 humans. By attaching the cocaine molecule to an inactive cholera protein, the TA-CD vaccine stimulates the subject’s immune system to produce antibodies that bind to cocaine and prevent it from passing from the blood into the brain, which means vaccinated users no longer experience the same high from cocaine, and hence, demand it less.

The initial vaccination is usually administered in several shots over weeks or months, which trains the body to associate cocaine with cholera. Results from 2005 suggest a booster shot is necessary every four months to maintain the vaccine’s efficacy, which has been enough time for some people in trials to cut their cocaine use significantly.[2]

TA-CD is not the first vaccine to combat drugs. In 1974, for example, Dr. Charles Schuster (then at the University of Chicago) developed a vaccine that prevented monkeys from getting high on heroin, but he and other researchers opted not to pursue its application to humans because users could easily switch to other opiates. One of those other opiates, methadone, is commonly used to wean heroin addicts from their habit. It is not yet clear if TA-CD will suffer the same drawbacks, or if users could increase their dosage dramatically—and dangerously—to defeat the vaccination. The initial trials, however, have found no users tried either approach to circumvent TA-CD.

The idea of fighting addictions—including cocaine—with vaccines, however, did not end with methadone. The National Institute of Health’s National Institute on Drug Abuse has emphasized that approach since it founded the Medication Development Program in 1990. The federal government today currently lists around 200 NIDA-funded clinical trials that use drugs to change how cocaine and your brain interact.[3]

Most of those drugs approved for actual use in the marketplace were first approved for other uses but also showed some ability to dampen cocaine’s impact by affecting brain function. Modafinil, for example, is sold as Provigil to treat narcolepsy. Disulfiram (better known as Antabuse) makes people crave cocaine less and feel much more paranoid when they take it, similar to how Antabuse makes people ill when they imbibe alcohol. A third drug, baclofen, started as a muscle relaxant.

Yet another drug, buprenorphine—which can be injected during surgery as a painkiller—also counters cocaine when taken orally, though it has been studied more as a tool to fight heroin addiction. Buprenorphine will soon enter a large trial on prison inmates to see if it reduces how much they use heroin and, secondarily, cocaine, after they return to regular life in Baltimore.

Among all these drugs, however, only the TA-CD vaccine stops cocaine from interacting with the brain at all. It arrests the narcotic in the bloodstream, where it can be metabolized into less harmful pieces. That is its physiological revolution.

A Novel Financial Pathway

The financial revolution is that a vaccine that does not target an especially wealthy or wide audience may still make money for its private investors. TA-CD development built a novel bridge over the so called “valley of death” funding gap between basic biomedical research and development and—perhaps—eventual drug commercialization.

Public money supported the initial research on demand-side efforts to counter cocaine addiction, as is almost always the case in experimental efforts to develop drugs for markets limited in size or lucre. But public money then also helped finance the development of the vaccine at later stages of its development alongside private, venture capital investors as the drug passed one test after another.

The leading researcher on the TA-CD vaccine trials, Thomas Kosten, today has $3 million in grants from NIDA to study cocaine treatments, and has spent about five times that much in previous grants since the late 1990s. Kosten ran his earlier trials at a Veteran’s Administration hospital in New Haven, Connecticut. Now that Kosten has moved from Yale to Baylor, he runs the trials from the Michael DeBakey VA Hospital in Houston.[4]

Federal dollars spent over the entire course of the development process, in tandem with lots of additional private sector funding, led to what may well be a marketable vaccine that could well produce a public good.

Celtic Pharma, a Bermuda-based firm that invests in drug development start-up companies around the world, bought Xenova, a British company working on the TA-CD vaccine in August 2005. Kosten received money from Xenova for consulting but has cooperated with many companies as the drug changed hands several times during clinical trials over the previous decade. When Celtic Pharma bought Xenova, the acquired company was concurrently developing a vaccine approach to nicotine with similar success under the name TA-NIC. That drug will likely begin Phase III trials soon, and competitors are working on their own versions.

Previously, in 2001, Xenova had acquired both vaccines from another British company, Cantab Pharmaceuticals. Cantab, in turn, got the drugs when it bought the vaccine program of ImmuLogic Pharmaceutical Corp., operating in Massachusetts with nominal headquarters in Delaware. ImmuLogic also worked on allergy medications and held the patent for the technique common to TA-CD (known as IPC-1010 at the time), and TA-NIC: binding addictive substances to immunogenic compounds, an approach known as hapten-carrier conjugates.

Tens of millions of dollars changed hands in these three deals.[5] But it all started when NIDA awarded ImmuLogic a Small Business Innovation Research grant of $700,000 in 1996 to develop a vaccine for humans.[6] Now, more than a decade later, public and private financing has carried the vaccine to Phase III clinical trials, which are about to commence and are expected to last one to two years.

Celtic Pharma (according to its website)[7] sees these types of drugs as potential blockbuster investments that could “build real value by driving them through the final stages of the approval process” with the intention to “achieve extraordinary returns for its investors by monetizing these important and innovative drugs.” A mix of biotech and hedge fund veterans, Celtic Pharma stands at the end of a long chain of investors, though without NIDA funds driving the research and federal hospitals providing some of the infrastructure through the first phases of clinical trials, the TA-CD vaccine might never have emerged from the Petri dish.

The upshot: Federal dollars spent over the entire course of the development process, in tandem with lots of additional private sector funding, led to what may well be a marketable vaccine that could well produce a public good: fewer people in the thrall of cocaine addiction.

The Public Health Pathway

The story of TA-CD doesn’t end there, however, either scientifically or financially. If the clinical trials are as successful as the developers of the vaccine hope they will be, then policymakers in the United States and abroad will have plenty to consider. Indeed, this potential physiological revolution has already prompted much discussion about the public health implications of vaccinating current or possibly future users.

It may well spark other private-public partnerships in search of other novel techno-chemical methods to tackle the scourge of addictive drugs in our society today.

With TA-CD facing only a few—though still significant—hurdles on its way to the marketplace, questions have been arising about this novel way to tame a social problem with the standard tools of public health. Cocaine addicts would probably benefit from the vaccine, and hypothetically the U.S. government and public health officials in other countries might be able to contain the spread of cocaine contagion by inoculating parts of the general population.

That hypothetical, however, in turn has already raised questions about who might be required or encouraged to try the vaccine and under what circumstances. Should TA-CD be considered in the standard childhood battery of measles, mumps, and rubella shots? Should it be administered to all adolescents? Or should it be limited to more definable “at risk” groups, such as those arrested for drug use who are about to be released from prison?

Less sanguine comparisons have been made to the contraceptive Norplant,[8] which U.S. courts in the early 1990s offered women in the criminal justice system as an alternative to tougher prison sentences. Critics said Norplant was a dubious way of biologically-based social control to shrink the so-called underclass. Norplant was later yanked from U.S. markets because the drug displayed some significant side effects.

The National Academy of Sciences is already considering similar questions, having published in 2004 a book on immunotherapies for addiction entitled New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions. That study essentially recommended thinking long and hard about using immunotherapeutic drugs to treat drugs of abuse, including how to make vaccines more permanent, how to protect people from coerced vaccination, and how to anticipate changes in the drug market or users’ behavior in response to the vaccine.[9]

How public health officials decide to distribute the TA-CD vaccine—providing it clears Phase II clinical trials and is then approved for sale to the general public by the U.S. Food and Drug Administration—will be enormously consequential financially for TA-CD’s investors and society at large. In the end, those decisions may well determine whether this novel approach to researching and financing this public good succeeds for all involved. And if it works well for all, then it may well spark other private-public partnerships in search of other novel techno-chemical methods to tackle the scourge of addictive drugs in our society today.

Mark Meier is a writer and analyst in Virginia.

Notes

[1] Barbara Fox, et al. “Efficacy of a therapeutic cocaine vaccine in rodent models,” Nature Medicine 2 (1996): 1129–32. Available at http://www.nature.com/nm/journal/v2/n10/abs/nm1096-1129.html.

[2] Thomas Kosten and S. Michael Owens, “Immunotherapy for the treatment of drug abuse,” Pharmacology and Therapeutics 108.1 (2005): 76-85. Available at http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6TBG-4GMGW53-1&_user=10&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=659bc0b778788646614ccc7e9788a09b.

[3] The NIH operates the website to track clinical trials in the United States and 150 other countries. See http://clinicaltrials.gov/.

[4] Dr. Kosten’s curriculum vitae, including grant information, can be found at http://www.bcm.edu/psychiatry/?PMID=7342.

[5] Information on the various transactions can be found at http://sec.edgar-online.com/2001/03/20/0000950135-01-000851/Section18.asp; http://sec.edgar-online.com/1997/03/31/00/0000950135-97-001528/Section2.asp; and http://www.secinfo.com/d14SA9.zAc.d.htm.

[6] The NIH lists grant funding at http://grants.nih.gov/grants/funding/sbirsttr96.txt and http://grants.nih.gov/grants/funding/sbirsttr97.txt.

[7] www.celticpharma.com

[8] See, for two examples, Dru Stevenson’s article “Libertarian Paternalism” available at http://www.rutgerspolicyjournal.org/journal/vol3issue1currentIssues/Stevenson_Paternalism.pdf or the Center for Cognitive Liberty and Ethics’ report “Threats to Cognitive Liberty: Pharmacotherapy and the Future of the Drug War” available at http://www.drugpolicy.org/docUploads/Pharmacotherapy2004.pdf.

[9] The text is available from http://books.nap.edu/openbook.php?record_id=10876&page=R1.

Ecologists have produced a global map of human impacts on marine ecosystems. They synthesized 17 data sets of changes from coastal pollution, climate change, sea floor damage, fishing, and other factors, and colored the ocean map according to six levels of impacts. The spectrum ranges from “very low impact” in the polar regions “very high impact” along coastlines in the Northern Hemisphere. The researchers hope the map, presented at the meeting and published today in Science, will aid in the allocation of planning, conservation, and ecosystem management resources. Duke University ecologist Larry Crowder, who was not involved in the study, pointed out that some small, severely threatened ecosystems, such as rare coral reefs, are too small to show up in the new map (via Nature).

Chemists at the University of California, Los Angeles have developed a method for creating a porous material that can store up to 83 times its own volume of carbon dioxide. The extremely porous material, called a zeolitic imidazolate framework, could potentially be useful for capturing carbon dioxide from smokestacks and coal gasification plants. “Now it’s in the hands of industry,” said Omar Yaghi, a lead researcher on the project. He hopes the material could be commercialized in two to three years (via Technology Review).

Harnessing the energy of sea currents, tides, and waves off the coast of Florida could provide a third of the state’s electricity, according to researchers planning to test an underwater turbine in the gulf stream in the coming months. Although the technology is in its infancy, tide and current energy could eventually supply 6.5 percent of the nation’s electricity according to Roger Bedard of the Electric Power Research Institute. The Federal Energy Regulatory Commission has handed out 47 permits for projects studying the potential of ocean, wave, and tidal energy, and research is underway to determine the cost-effectiveness and environmental effects of ocean energy technologies.

The Sunshine Project, an organization that investigated safety at the nation’s biodefense labs, has been forced to close up shop (subscription) due to lack of funding, reports Science. News of the watchdog’s demise, whose accomplishments include uncovering safety violations at Texas A&M’s biodefense labs and helping destroy smallpox stocks, was met with mixed feelings among scientists and university officials. Some who were subjected to constant probing were relieved, while others lauded the efforts to make the “community more careful” about biosafety.

In assessing the possibility of using geoengineering projects to mitigate the effects of global climate change, Dr. Daniel Schrag from Harvard University arrived at a conclusion similar to that articulated by Chris Mooney in a recent Science Progress column: given certain catastrophic warming scenarios, geoengineering would be a complex but possibly necessary solution. But he was careful to say that that, “geoengineering is a band-aid for a wound that keeps getting bigger.” He emphasized the importance and feasibility of “changing our energy infrastructure,” which he noted, “will only cost 1% of our GDP.”

Presenting on research in counter-bioterrorism, Dr. James Baker of the University of Michigan highlighted work measuring and characterizing the physical processes by which viruses and their antidotes bind to cells. He explained that understanding this process could reveal populations that are particuarly susceptible to certain kinds of viruses; from there, researchers could explore how to protect or treat those populations. He also explained that bioterrorism is uniquely difficult to prevent or respond to when compared to conventional terrorism, saying that, “bombs, weapons, and planes can be traced; but with a virus, we don’t know if it is natural or not.” He added that in investigating the West Nile virus and SARS outbreaks, the CDC examined whether or not terrorists had released the pathogens. Noting that “we haven’t had the modeling or characterization we’ve had with nuclear,” he went on to suggest that first responders need to develop more sophisticated methods for handling potential bioterror scenarios.

Dr. Jay Keasling of UC Berkeley and Lawrence Berkeley National Lab, also presented a cautionary warning on the dual-use dangers of the rapidly expanding field of synthetic biology, saying, “biology is so complex, its easier to do harm than good.” He called for “a standard-setting organization like IEEE,” that would both ensure the safety and expand the scale of the synthetic biology industry by implementing the use of prefabricated biological components. Such components would allow different biotech firms to maximize and economize their creativity while remaining within industry-imposed boundaries that will keep their creations safe.

Open-source standards and net neutrality can support and improve global health—especially in developing nations (Global Health Report).

An NIH panel concludes that gene therapy was not the cause of death for a patient receiving experimental treatment for rheumatoid arthritis (The Scientist Blog).

The U.S. Patent Office tests peer review of applications (Cairns Blog).

A McKinsey & Company report concludes that current technology can get the U.S. to the 2030 emissions goals in current proposed legislation, and at manageable costs (Hill Heat).

Google announces it will invest in renewable energy that is cheaper than coal (SciGuy).

“There aren’t good blueprints for how to ‘broaden the impact’ of one’s research and the resources to develop such things are thin.” Excerpts from an interview on science and public discourse with Dr Chris Brodie, associate editor of American Scientist magazine (Terra Sigillata).

What makes iPS cells special is the fact that they were created from somatic cells. Specifically, Yamanaka used facial skin cells and connective tissue cells from joints, Thomson used fetal fibroblast cells, and both used neonate foreskin cells. Both teams then used retroviruses to insert copies of four new genes into these cells, thereby reprogramming them with the ability to differentiate into any of the over 200 cell types found in the human body. This method side-steps the ethical concerns of those who object on moral or religious grounds to harvesting pluripotent embryonic stem cells from human embryos, which destroys the embryos. This approach also allays the ethical concerns of those who fear that women could be exploited for their eggs which would then be used to clone embryos and harvest stem cells.

Moreover, research on iPS cells would be eligible for federal funding, unlike embryonic stem cells. James Battey, vice-chairman of the NIH’s stem cell task force told the Washington Post today,”I see no reason on Earth why this would not be eligible for federal funding.”

Regardless of the ethical concerns, these discoveries represent a major scientific breakthrough, revealing that somatic cells are much more malleable than previously thought. The Washington Post also reports that Yamanaka was able to coax the iPS cells into becoming nerve cells and beating heart cells. Moreover, these new cells are genetic matches to the donor cells, meaning they could replace or repair the donor’s tissue without risk of rejection.

Both teams used retroviruses to introduce the new genes into the skin cell genomes. This method is far simpler than Somatic Cell Nuclear Transfer, which replaces the entire genome of an egg. Dr. Yamanaka tells the Wall Street Journal that, “Any scientist with basic technology in molecular and cell biology can do reprogramming.”

Both teams used dangerous viruses to transplant the genes into the skin cells, but Yamanaka and other scientist are testing other non-harmful viruses and are confident that a safe method of gene transfer is close at hand. The retroviruses could also cause tumors in tissues grown from the cells, so the best reprogramming method might be one that switches on a cell’s existing genes for pluripotency rather than insert new genes. Harvard University’s Douglas Melton tells ScienceNow that, “it is not hard to imagine a time when you could add small molecules that would tickle the same networks as these genes,” which would produce reprogrammed cells without genetic alterations. Robert Lanza of Advanced Cell Technologies in MA tells NewScientist that, “The FDA would never allow us to use these virally modified cells in patients.”

Despite being nearly identical, the iPS cells still differ from real embryonic stem cells (ESCs). Yamanaka states in the Cell article that, “DNA microarray analyses showed that the global gene-expression patters are similar, but not identical between human iPS cells and hES cells.” So embryonic stem cells are still the gold standard against which researchers will have to measure any new cells pluripotent cells. However, in an interview with the LA Times, Yamanaka admits, “‘Even if there are subtle differences…I don’t think they have to be identical’ to embryonic stem cells to be useful in medical applications.”

Thomson explained the SCNT/ESC issue to MSNBC’s Alan Boyle:

Yeah, my feeling is that somatic cell nuclear transfer was an experimental technique, and it could have led to a mechanistic understanding of how reprogramming could occur. But I was skeptical that it could ever enter the clinic because of practical reasons.

This may not be the end of the story. These pluripotent cells may not be perfectly like embryonic stem cells. We don’t know yet. But I do think this is the path that people are going to follow now.

Tackling the bioethical implications of the discoveries, Science Progress advisory board member Art Caplan argues that, “it is a bit too soon to stop working on cloning as a technique to generate stem cells.” He admits that “even though these announcements are momentous, until a reprogrammed panacea cell is used to make stem cells that actually function properly to repair a damaged nerve, spinal cord or heart, all avenues of research must be funded and pursued.”

Yuval Levin notes on the National Review Online that the political controversy should be put aside and credit should be given where it’s due: “It’s the scientists’ extraordinary work—and not the politicians—that really made this possible. This is not a win for one side or the other.”

Thomson told CNNMoney: “I believe that these results, while they don’t eliminate the controversy, are probably the beginning of the end of the controversy.”

Production of the One Laptop Per Child computers began in China this week. The first machines will ship to students in Uruguay, Peru, and Mongolia.

Reward drug development with cash prizes, not patents. A proposal for the federal government to lower drug costs by offering prizes for medical research.

Sixty million Americans live in places where laundry clotheslines are banned, but activists concerned about saving energy by avoiding electric dryers are fighting for their “right to dry” (NPR audio).

Google hit a bump in the road on its quest to acquire online advertising company DoubleClick: the European Commission did not approve the deal on account of antitrust concerns and has ordered a review. In the U.S., the Federal Trade Commission is still reviewing the aquisition.

Nobel Laureate Al Gore is now a partner at Kleiner Perkins Caufield & Byers, one of the largest and most well-known venture capital firms in Silicon Valley, where he will focus on researching investments in alternative energy start-ups.

The deal is set to cover about 47,000 sets of plaintiffs, with the average plaintiff receiving just more than $100,000 before legal fees, which can amount to as much as 30 percent of the actual settlement sum. To receive settlements, plaintiffs will not need to prove that Vioxx caused their heart attacks or strokes. But they will have to provide evidence that they did suffer a heart attack or a stroke, that the heart attack or stroke occurred less than two weeks after they last took Vioxx, and that they had taken Vioxx for at least one month.

The agreement may reflect a new strategy for businesses defending themselves against lawsuits. Instead of agreeing to a quick, early settlement, Merck aggressively defended itself in more than 20 Vioxx civil trials over the past few years, successfully convincing juries of its innocence in the majority of the cases. Playing hardball paid off for the company, with its settlement a mere fraction of what analysts had predicted years earlier.

In a country with an underperforming health system and the average consumer more vulnerable than ever to the whims of insurance companies and financially strapped medical centers, news of corporations like Merck going to bat against the American public and winning is not inspiring news. If we are serious about improving the health of our nation, steps need to be taken to ensure that companies like Merck cannot expect to get away with settlements that do not reflect the irreparable harm caused by its actions.

Biopact.com summarized some of the leading criticisms of the report and JCVI’s approach to the possible hazards of synthetic biology. The ETC group criticized the report’s U.S.-centered approach and argued that it focused too much on the dangers of synthetic organisms being used for bio-terror at the expense of addressing bio-error, i.e.: the unintended mistakes of benign research.

ETC also criticized JCVI’s recommendation that biotech firms vest Institutional Biosafety Committees with the responsibility of evaluating synthetic genomic projects. ETC quotes Edward Hammond, Director of the Sunshine Project, a biotech and bioweapons watchdog, who argues that IBCs, “are a documented disaster… [and] aren’t up to their existing task of overseeing genetic engineering research, much less ready to absorb new synthetic biology and security mandates. ”

On a conceptual level, ETC felt that JCVI did not ask sufficient background questions such as whether synthetic biology is desirable or acceptable, who should control it, what the potential impacts might be, and who has the authority to make those decisions.

ETC released a report in January entitled “Extreme Genetic Engineering” where they call for a broad debate on the social and ethical implications of synthetic biology across all of civil society. They note that bio-terror and bio-safety are not the only issues; synthetic biology policy must also address matters of intellectual property and biodiversity.

In light of these fears, ZDNet offers a perspective-shifting quote from Venter, who spoke at the Web 2.0 summit a few weeks ago: “People get paranoid about bacteria. They are living on the wrong planet. We are in a complete bacterial spectrum.”

Nevertheless, this marks a huge step towards one day developing real cures for diseases like diabetes, Alzheimer’s, and Parkinson’s. According to CNNMoney, this first step concerns a treatment for vision loss diseases being carried out by Advanced Cell Technology. According to Chief Scientific Officer, Robert Lanza, the testing could last a minimum of five years followed by the review of an experimental drug which could last a minimum of six months.

The Geron Corporation has also submitted applications for human testing and plans to develop a treatment for spinal cord injuries that has been successful in rats. Both companies plan to begin the actual testing as soon as next year.

Novocell Inc., a privately-held biotech firm, is developing a treatment for diabetes using ESC, but has not completed studies in mice and are still a few years away from human testing.

Currently, the only stem-cell-based product the FDA has approved is Osteocel, a therapy for repairing bone defects by stimulating growth that is classified as a an implant. Osiris Theraputics produces the treatment.

The San Francisco Gate recently covered biotech startup StemLifeLine Inc., located in San Carlos, California. The company plans to acquire left over embryos from from couples who would like to personally benefit from their own stem cells.

The problems with this enterprise are numerous: First, there is no guarantee that stem cell therapies will arise for the specific diseases for which the donors or their family members might eventually need treatment. Stanford bioethicist David Magnus also comments that stem cell therapy might not be around for 30 to 40 years and that the stem cells saved today might not be usable then due to certain technical protocols which might develop in the interim. Moreover, the stem cells, although genetically related to the donors and their families, would not be identical and could still be rejected if transplanted. Nevertheless, Susan Fisher, an advisory-board member of StemLifeLine and director of UC San Francisco’s stem cell program, maintains that the tissues created from these stem cells would still require less anti-rejection drugs than other transplanted tissues.

There is also the ethically thorny issue of couples creating embryos solely to save them for themselves and their families, as opposed to using leftover embryos that were created while trying to conceive a child. As R. Alta Charo (a Science Progress advisory board member) pointed out in the SF Gate article, the ethical approach to this practice “depends on your view of the moral status of the embryo.”