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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

I then explained why the hype had grown so loud:

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

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

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

Hyped claim #5: The Bush “compromise”

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Lots of folks seem to think we have too much regulation of drugs and devices already—among them Paul Howard at the Manhattan Institute and Scott Gottlieb at the American Enterprise Institute—so much so that it is choking innovation to death. But, if that is so, then why are there so many scandals?

One possible answer is that the companies know they have problems but sit on that knowledge. If that’s sometimes (or oftentimes) the case, then we need a regulatory system that can get around that kind of immoral behavior. We don’t have that system.

What we have is a regulatory system that is too skewed toward looking at the earliest stages of research. Moreover, the way it is designed makes recalls almost inevitable. The diabetes drug Avandia is the latest in a long parade of failures of our current post-clinical trial drug approval process.

Avandia went through the usual approval process with the U.S. Food and Drug Administration. The drug was a blockbuster. But sales began to fall after a 2007 study of people taking the drug suggested that Avandia could cause heart attacks and strokes. I first learned about this while serving on a bioethics advisory board for GlaxoSmithKline, the developer of the drug—a panel that was looking at research ethics issues in poor nations. The panel, on which Science Progress Editor-in-chief Jonathan Moreno also served, came to an abrupt halt.

In response, the FDA put a black-box warning on the drug telling doctors of the heart attack risk. GlaxoSmithKline was not happy. There was a lot of back and forth about the safety of the drug. Over the past few months more evidence become public that shed doubt on Avandia’s safety. Worse, it appears the company withheld data about serious side-effects. The FDA appointed an advisory panel this July to consider these allegations, but the panel itself quickly got caught up in charges of conflict of interest among its members. It is likely that more black-box warnings to doctors will follow, should GlaxoSmithKline choose to keep Avandia on the market.

Avandia is not alone. The drug’s problems in the marketplace follow hard on the heels of Prempro, a hormone replacement therapy made by Wyeth Pharmaceuticals, now part of Pfizer Inc., which became caught up in lawsuits alleging it caused breast cancer. More recently, the FDA released a warning about the Afluria flu vaccine, made by CSL Ltd. of Australia, concerning high fever and seizures. Prior to that was Merck & Co.’s widely publicized recall of Vioxx, which came after problems with Astra Zeneca’s Seroquel, Abbott Laboratory’s Meridia, Pfizer’s Rezulin, C.R. Bard Inc.’s G2 filter, Bayer’s Baycoll, Boston Scientific Inc.’s Express Stent, and on and on.

So is there a real phenomenon here or just more PR associated with recalls? And if there are more recalls going on then what is wrong with the oversight of new drugs and devices?  It is not clear from the literature whether there are more recalls taking place in recent years—there is no real database that would show such a trend. There are certainly more stories about recalls and more people studying the objectivity of the marketplace surveillance being done by pharmaceutical, biotech, and device companies.

No one seems to have reliable numbers on recall trends, yet the Institute of Medicine and other groups still warn that the existing system of drug protections after the FDA approval process is complete does not seem adequate to handle the products that are reaching the market. Fortunately, there is a way to fix the system.

The major problem today is that too many lousy or dangerous drugs and devices get to you without adequate safety review because drug and device regulation is heavily weighted in the United States toward early stages of research. Every drug has to be tried in animals to roughly determine safety. Then drugs are introduced into a small number of humans to further check safety—so-called phase one trials. Then dose and mode of administration are checked for safety, biological activity, and signs of effectiveness—phase two. Only after all this safety testing is a drug or device ready to go to phase three clinical trials. In these studies hundreds or sometimes thousands of subjects are recruited to receive the drug or product for periods of time that range in nearly every case from a few months to a year.  Phase three trials are almost always placebo controlled randomized, blinded studies.

So there is a lot of effort to try and make sure that subjects are not hurt in phase three trials. The deaths of subjects in phase one clinical trials, among them Ellen Roche and Jesse Gelsinger in early stage studies over a decade ago seem to have reinforced regulatory anxiety about the risk of deaths in first in-human studies.

Meanwhile, the weakest link is the fourth and final step in the research process—phase four—in which drugs are to be monitored when out in actual use in the world for adverse events and problems. Drug companies sometimes promise to do these trials to get final product approval but don’t. These studies are heavily weighted to support the funders of these studies, Big Pharma, which results in much more rosy reporting then studies done by independent groups.

Reporting of problems in phase four is left to doctors and patients who rarely do so.  And there is no systematic tracking of a subpopulation taking new drugs or other medical products to see what is going on with real patients in real world conditions. Deaths have to mount rapidly and obviously to get regulatory or physician attention before phase four studies are ever seriously undertaken.

But a lack of independent, well designed phase four trials is not the only problem.  Approving drugs based on current standards for phase three testing has its own built-in limits. Testing drugs and devices in randomized, blinded, placebo control trials is great, but it means that approval is given on the basis of highly controlled studies on highly selective populations—often subjects who are not that old, not that sick and are highly compliant. That’s not the real world, where patients take lots of drugs, some legal some not, are poorly compliant, have multiple diseases, and can be very old or very young.

So what looks safe in a phase two or phase three study can prove lethal when given to real people in uncontrolled, unsupervised environments. What’s more, phase three studies are also relatively short. What looks safe after three months exposure or six may not be after three or six years.

The seemingly endless parade of horrors of FDA approved drugs gone bad merits a reexamination of a regulatory system that is not keeping us safe.  The issue is not too much bureaucracy and too much red tape, but a strategy of safety that puts the emphasis in the wrong place—early not late—and then uses techniques that by themselves cannot ensure safety for real people in the long run.

Update August 17 2010: CNN Money reported that the number of drug recalls in the U.S. surged to 1,742 in 2009, up 309 percent from the 2008 level. Recalls so far in 2010 are also on pace greatly exceed previous levels. However, not all of these recent recalls were due to the drugs themselves being unsafe—some were due to problems with the manufacturing process of generic, over-the-counter drugs.

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

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.

Someday we may get drugs that do what steroids do without any real risk of harm to the user. Would we still want them banned?

Admittedly, putting the challenge of dealing with steroids on the same moral plane as battling poverty is a bit of a stretch. Still, a lot of people all over the world are clamoring for those in charge to get steroids out of sports. That is what makes the recent publication of a number of articles and books challenging the idea that performance enhancement if morally wrong so interesting. While it may seem obvious that athletes using steroids to build strength or gain endurance is wrong, could those intuitions be mistaken?

In one sense they cannot. Steroids are dangerous and there is a real need to protect children who admire athletes from taking serious risks with their health in imitating what their idols do. But put the safety issue aside. Someday we may get drugs that do what steroids do without any real risk of harm to the user. Would we still want them banned?

John Harris, a British bioethicist, is a useful example of someone who is not at all sure that a bit of the “juice” is such a bad thing in athletic competition. In his Enhancing Evolution (2007), he argues that performance enhancement is not only ethically acceptable, but that sometimes it may be morally obligatory.

Harris sees a legitimate role for the use of drugs and genetic engineering to improve performance in sport. But sports are not his main target. He sees a future in which parents happily and willingly use genetic and reproductive technologies to design their children with more capacities and abilities than they otherwise would have had. His main argument in the book is that there are no convincing arguments against performance enhancement and plenty that support it.

Can Harris’s positive view of enhancement be used to as an antidote to the wave of anti-steroid mania tearing through the sports and editorial pages? In Harris’s sports world, the genetically engineered, chemically enhanced, and optimally trained ought serve as our heroes. They will give us performances to remember. And that is the point of sport. Or is it?

Harris’s eloquent defense of performance enhancement as entirely ethical stands in stark contrast to the efforts of sports authorities and prosecutors all over the world to vigorously chase down and defrock of honors athletes who have used steroids and other performance enhancing substances. Are the prosecutions really persecutions? Should performance enhancement simply be accepted as a part of sport? Are those who want seconds shaved off of the time it takes to run a mile or who want to see baseball sluggers smash seventy or more home runs in a single season really all that interested in whether these records are achieved by those who use no drugs in achieving these record performances? The international brouhaha over drug use to improve performance gives some evidence that the road to better living through biochemical engineering may be laced with more ethical potholes than are dreamt of in Harris’s philosophy.

Consider first just a tiny bit of the mess that efforts at drug-based performance enhancement have produced in contemporary sports. The world of cycling is just about kaput as a result of drug allegations and revelations. Marion Jones, the dazzling Olympic sprinter who won three gold medals and two bronzes at the games in Sydney, Australia, has confessed in a U.S. Federal courtroom to using steroids and jail awaits. Her tearful admission came after years of angry denials that she had ever gone near performance enhancing drugs.

Baseball’s all-time homerun hitter, Barry Bonds, faces federal charges for lying about steroid use as part of a larger investigation of an illegal steroids lab, the BALCO company of Burlingame, California. The BALCO probe has turned up the names of many high-profile professional athletes from around the world, as BALCO steroids customers include baseball players, track and field stars, football players, cyclists, and boxers. Baseball had never formally banned steroids and no testing was done to find those who had used them. But Bonds realizes that baseball fans would dismiss his achievements as the product of a chemically enhanced body were he to admit what is obvious from changes in his body over the years —that he used steroids and other performance enhancing drugs.

Roger Clemens, perhaps the preeminent pitcher in the history of baseball, a seven-time Cy Young Award winner—a prize given each year to the best pitcher in baseball—spent a dreary four hours in front of the House Oversight Committee jousting with its chair, Henry Waxman. While there he failed to persuade anyone except a few star-struck, fawning conservative representatives that he had not gotten steroid injections from his personal trainer when he played for the New York Yankees.

Afterall didn’t Jones, Bonds, Clemens, and others give us remarkable and memorable performances?

Clemens’s best friends on the team, Andy Pettitte and Chuck Knoblauch, have admitted using. So did Clemens’ wife! She said she had the trainer shoot her up in preparing for a swimsuit photo-shoot. These admissions make it a feat of epistemological legerdemain to believe that Roger knew what those closest to him were doing but that he did not know he was getting steroids injected into his rump when his trainer inserted a needle there.

An additional problem for crediting Clemens denials that he ever used steroids is that his own career performance statistics contradict him. He was at his most productive late in his career at a time in his life when nearly every other pitcher has begun to lose their speed and stamina. Admitting a flow of steroids through his body would make not only a mockery of his denials but also of the virtuous character he seeks to claim for himself in explaining how he could improve his abilities at a time when nearly every other pitcher in the history of baseball was seeing theirs wane.

The list of steroid scandals goes on and on. But, as these examples make clear, using steroids and other drugs to improve athletic performance grates on the perceptions of fans, the media, sports management and many politicians. But why exactly is that so? Afterall didn’t Jones, Bonds, Clemens, and others give us remarkable and memorable performances?

One of the most interesting critics of pharmacologic enhancement in sport is Harvard political scientist Michael Sandel. Sandel has argued in a series of articles and a book, The Case Against Perfection (2007), that the causal role of human agency plays a key role in substantiating our admiration of athletic performance. In commenting on drug use in baseball he observes that,

…as the role of (drug) enhancement increases, our admiration for the new achievement fades—or, rather, our admiration for the achievement shifts from the player to his pharmacist.

Something like this explanation is at the heart of sports’ current struggle with steroids. Sandel is clearly on to something when he argues that chemically produced performance enhancement undermines our willingness to esteem the performance of the winners of the Tour de France, Roger Clemens, Barry Bonds, or Marion Jones.

This is where Harris weighs in. He does not see much merit in Sandel’s caution that chemistry corrodes admiration for athletic effort. He argues that great efforts are not always required to achieve great performance.

Moreover, in sport an athlete still has to train in order to perform well even when using steroids. Using performance enhancing drugs is not a substitute for effort. Rather, Harris argues, the drugs enhance the results of the effort.

Well, Harris is right that you don’t need to make a great effort to accomplish great things. Every once in a while someone wins the lottery or finds an old heirloom worth a lot of money in the attic and no one seems to mind that they have advanced themselves through luck, not exertion. But that is not true in sport. A lucky bounce or a gust of wind can determine the outcome, but athletes get praise for performance linked to effort, not luck. The whole point of sport is to try and reward effort even if luck plays a crucial role in the outcome. Harris’ point that small efforts can produce big rewards does not moot the point that big efforts that produce big rewards get the praise, not just the notice.

Outcomes don’t define sport—the process leading to outcomes does.

And it is true, as Harris says, that no one gets to be a great athlete simply by taking steroids or growth hormone. You get an edge or an advantage over others who are just as naturally gifted and train just as hard as you do. What Harris misses though, is that some performances are explicitly associated, by the nature of the rules governing the activity, with great effort—admittedly as a matter of history or culture—but nonetheless, it is the effort that is valued. If someone takes a pill and lifts a lot of weight it may be amazing. But it is only a weightlifter’s willingness both to train and to show extraordinary effort that makes weightlifting an athletic achievement as opposed to an exhibition.

Sport is only sport if it is measuring human abilities, as varied as those may be. Sport also links the results achieved to training, will, and effort. Outcomes don’t define sport—the process leading to outcomes does. That is why short circuiting your way to success by pills or hormones as Jones, Bonds, and Clemens did undercuts their performance since both process and outcome are required in assessing performance.

“Professional” wrestling has many fans in North America, Mexico, Asia and Europe. Its athletes can do impressive feats involving agility and strength. They are very strong certainly due to steroids. But no one seriously thinks that pro wrestling is a sport—despite having all the external accoutrements. It is a steroid-infused exhibition. Harris might say “well redefine the sport—there is nothing intrinsically sacrosanct about effort leading to performance.” Except that there is. The definition of sport is human effort based on talent and training leading to performance. This is an activity that need not be preserved but if it is to be preserved—and most baseball, track and cycling fans have an exquisite sensitivity to history—then drugs, huge shifts in equipment, and competing in venues that distort the value of effort, e.g., very high altitudes, won’t work.

So at least in sports, if not on Wall Street or in the classroom, it is how the performance is achieved and not just the performance that is valued. That link between human effort and agency and output may be contingent. But it is surely definitive of what sport is.

Sandel has one more volley to offer in defense of steroid-free sports. He argues that it is the very “giftedness” of talent that make drugs unwelcome. We appreciate that some are borne inclined to be great sprinters and others great pitchers, and drugs—not to mention genetic engineering—ruin all that.

I am not sure about this and neither is Harris. The idea that we value a performance because we admire the random luck of the lottery of life that gives some of us genes for singing, others for strength and still others for superb vision seems implausible. Why is randomness to be admired? Looking for value in the natural distribution of talents and skills is like looking for the source of free will and autonomy in the random nature of evolution or the Heisenberg uncertainty principle. Estimable value does not lurk in random luck. We can accept that luck can bring us fortune and enjoy it, but it is hard to see what role the luck of the draw in genetics has in esteeming sports performances.

The battle over performance enhancement is often fought out as if one size fits all—what makes performance enhancement acceptable in one domain, sports, will make it acceptable in all aspects of life. What the fight between Harris and Sandel reveals is that this is not so. There are reasons to believe that steroids don’t belong in sports, even putting safety concerns aside. But this does not mean that performance-enhancing drugs have no appropriate role in any areas of life and achievement. The decision about what role pharmacology and genetics ought to play depends on whether you are trying to travel to another planet, solve a difficult math problem, learn a new language, or hit a home run.

ArthurL. Caplan, PhD is a member of the Science Progress advisory board, Emanuel and Robert Hart Professor of Bioethics; Chair, Department of Medical Ethics; and Director, Center for Bioethics, University of Pennsylvania.

But no one who is in a position to actually try to apply to humans what the Oregon scientists did with monkeys has any interest in using cloning to reproduce or mass produce people. While the Oregon research team did make monkey embryos, they could not get a viable pregnancy from any of them. This means that cloning to create adults is still very hard to do and certainly very dangerous to try.

The real goal of this work is to see if human embryos can be cloned using the Oregon technique—not to implant the cloned embryos into wombs, but to try and then manipulate them in lab dishes to see if they can provide viable sources of embryonic stem cells.

Up until now the fight about the ethics and funding of embryonic stem cell research has presupposed either making human embryos using sperm and egg or using already existing embryos left over, unclaimed and unwanted, at in vitro fertilization clinics. Cloned embryos would be a better source.

Why? Because if you make a cloned embryo by putting DNA from your own skin or other body cell into an egg, then you can make embryos whose stem cells can be used to repair diseases and injuries that may afflict you without fear of them being rejected by your body’s immune system as foreign tissue. This would let people use their own cells as repair kits to make stem cells that could then be used to repair damaged hearts, severed spinal cords, or worn out parts of the brain that result in Parkinsonism.

Some will argue that none of this research should be permitted in humans. Won’t cloning human embryos make it too tempting to use them for reproduction as well as research? And isn’t it murder, some will say, to clone human embryos to then destroy them by harvesting stem cells from them?

With proper legislation—such as that enacted in Britain and a handful of other countries—which prohibits putting cloned human embryos into a woman’s body, then this will be just as effective a prohibition on reproductive cloning as prohibiting the creation of cloned human embryos. While in principle the case against cloning ourselves is less persuasive then many think, it is still far too dangerous to try at present. Without proof that reproductive cloning works safely in monkeys, a ban on reproductive cloning of humans makes good ethical sense.

It is true that the creation of stem cells means destroying a cloned embryo. But a cloned embryo in a lab dish has no ability or potentiality to develop into a person. It is at best a potential, possible person—not an actual one. Since it is already known that nearly all cloned embryos are so miswired that very few are capable of becoming a healthy adult organisms, they are actually the moral entity of choice when it comes to embryonic stem cell research. Those who argue for more research to develop disabled embryos as alternatives to using human embryos could hardly do better than cloned human embryos.