Winter, 2006
This is an edited transcript of a forum presented by the Harvard Medical School Division of Medical Ethics in November 2005.
Allan Brandt, PhD, Moderator, Department of Social Medicine and the Division of Medical Ethics, Harvard Medical School:
As a historian of science, it's not my view that science is ever totally free of politics, values and interests. And, in fact, a generation of historians of science and of medicine and public health over the last decades has created a body of work to demonstrate the relationship of science and medicine to politics and other forms of interest. But that said, I think there is little doubt that we're living in a historical moment of radical change in the relationship of science to politics. And it's my hope that today's panel will be at least one mechanism to begin to explore precisely what's happening at this moment, and what it means for our science, for our politics, for our society and for our culture.
It's impossible today to pick up a newspaper, literally on any day, and not be immediately aware that the traditional, we might call it, demilitarized zone between science and culture, between science and politics, has become an incredibly active area of hand-to-hand, if not mortal, conflict And what does that mean for us? That's really what I hope today's panel will be addressing.
Chris Mooney, journalist and author:1
I will outline the current crisis over the political misuse of science and explain why we have such a disturbing crisis. I call it a political science crisis because it has a political explanation.
Finally, I will show how this political explanation casts light on a number of key politicized medical science issues.
There is a crisis over the role that science should be playing, but is not currently playing - in public policy decision-making. It is a subtle crisis because it is veiled from the public by the complexity of scientific disputation. And it's also veiled by the complexities of the government regulatory process. But nevertheless, we realize what is at stake here when we realize that the political misuse of science can threaten public health, the environment and in some cases, respect for knowledge itself in our society. The deeper conundrum is how do we ensure that science plays a proper role in informing public policy and in defining that proper role? That is a question that goes to the heart of the role of science in a democracy. We do not generally expect our political leaders to be PhD scientists. Rather, what we expect is the existence of strong channels of communication between political leaders and scientific experts so that policy making will be informed. Under the Bush administration we have seen a really disturbing deterioration of these necessary channels of communication between scientists and politicians. That has created a crisis that's bad for science, bad for national competitiveness in key areas and bad for public health and the environment.
A historical approach and political approach may help explain the current fights over politics and science. The modern conservative movement today preeminent in the Republican Party has a number of key constituencies, but for our purposes, most important are religious conservatives and big business, or the Christian right and regulated industry. These two constituencies have very different interests. Industry cares about the bottom line, and religious conservatives care about what they view as the moral decline of our society. But what the groups have in common is that they come into conflict with scientific information in key areas that they care a lot about. Religious conservatives want to undermine the teaching of evolution; some fossil fuel companies want to question either the existence or the severity of global climate change. In both cases, they have run headlong into established, mainstream scientific consensus conclusions.
Next, politicians (Republican politicians in this case) cater to the scientific lobbying of the interest groups that put them in power. I call it scientific lobbying because these interest groups, either religious conservatives or industry, have their own specific take on scientific topics, which they further through lobbying agencies or their elected representatives, in the hope that policy-making will reflect their view of the science, which is often not a mainstream view of the science.
The misuse of science by our government is eroding trust in government, and I think this is an extremely damaging issue for the nation's future. I do not claim that no one else has ever abused science. "Cherry picking," or selective use of favorable scientific information to bolster a particular political perspective, is endemic in the political system and routine among interest groups of all points of view, and that includes left-wing groups and Democrats. But what we have now with the Republican Party is something of a "perfect storm," with two interest groups being catered to across a wide variety of issues. Industry is being catered to on climate change, on mercury pollution and so forth. And the religious conservatives are being catered to on stem cells, evolution, condom effectiveness and abstinence education. So it is a systemic problem.
Religious conservatives are not saying deny science and cite scripture. They are offering their own science, which they assert is right, while prevailing science is wrong. They do not reject science; they misuse and abuse it. This phenomenon is clearest in the case of evolution in which they offer "intelligent design" as a scientific alternative to evolution. Christian conservatives use science to achieve what they want on a moral level. In human embryonic stem cell research, which religious conservatives believe is immoral because it destroys embryos, they also make a scientific argument that this research is not medically necessary because there are alternatives, such as adult stem cell research.
The debate over abortion is another example. They view abortion as immoral, but they also emphasize its unique health risks for women. So they argue that abortion increases the risk of breast cancer and mental illness. These claims are well outside of the mainstream, because leading authorities have debunked them. On sex education, they contend that there's good evidence suggesting that abstinence sex education is effective. But that contention is not backed up by social science data. And within the advocacy for abstinence-only education, there is an attack on the condom that exaggerates its failure rates, which is also misleading from a scientific perspective.
I conclude that the political right and the Christian right have created their own shadow scientific community in some sense and their own armamentarium of scientific arguments that they use to advance their moral objectives.
This development of a strategy of scientific argumentation is a pre-condition for the actual abuse of science by political actors, because politicians cannot empower themselves to challenge mainstream scientific conclusions without their own experts and scientific-sounding arguments to turn to. They now have those arguments, which are a central reason for the crisis over the current political misuse of science.
Susan Wood, PhD, former Director of the Office of Women's Health, US Food and Drug Administration:
I will provide a recent example of decision-making not based on the medical and scientific evidence and, in fact, not promoting the health of women and families. I will discuss women's health and the FDA to show what went wrong and what led me to have to resign after the announcement on August 26, 2005, of what was essentially an indefinite delay of the approval of the emergency contraceptive Plan B as an over-the-counter product.
Let me first state what the role of the FDA is and what it is not. The FDA's job is to regulate products to ensure their safety and efficacy, that they're accurately represented in their label and in the package insert for patients, and that they comply with all the laws and regulations for FDA-regulated products.
Where did Plan B fit in? Plan B contains 0.75 milligrams of levonorgestrel, a progestin-based drug approved in 1999 as a prescription product. The manufacturer asked the FDA to approve it for nonprescription status in 2003. To get over-the-counter status, one is not required to redemonstrate its safety and efficacy because that was demonstrated when it was approved as a prescription product. But one must prove that it does not need a prescriber intermediary. One must show that the label is easy to use and understandable, and that the product can be used correctly based solely on the label and without the help of a health professional. The company provided that data.
It is essential to understand that Plan B prevents unintended pregnancy; it is a contraceptive and not an abortifacient. It does not interrupt an established pregnancy. This important distinction has been muddied in popular accounts, deliberately or not. The confusion among the general public is enormous. Plan B prevents unintended pregnancy; its only connection with abortion is that it has the potential to prevent the need for it. That is a goal toward which we should all work for together regardless of our politics. But clearly that did not turn out to be the case. A key fact is that Plan B must be taken within hours after sexual intercourse to be most effective. That is why it is appropriate for over-the-counter use. It is safe, it needs to be taken quickly without barriers, and it can prevent an unintended pregnancy. But this benefit became a political liability.
Let me give a brief overview of the FDA drug approval process. An application can come into the agency to approve a new product, change the labeling, or approve over-the-counter sales. The application is then evaluated by the appropriate review divisions, which in the case of Plan B, were the Reproductive Health Division and the Over-the-Counter Division. Two teams of scientists had evaluated tens of thousands of pages of data about this product. The FDA has the discretion to convene an outside advisory committee and to pose questions to that advisory committee about whether this product is easily used, is appropriate for over-the-counter availability, is safe, is well labeled and merits approval. The reviewers' recommendations will then go through the FDA chain of command, including multiple levels of review in the center for drugs, and then a fifinal decision, once reached, will be conveyed to the manufacturer of the product.
In the case of Plan B, there was enormous consensus throughout this process. FDA does not have to accept the decisions of its advisory committees, and it holds that prerogative dear. There are a number of cases where FDA has essentially not accepted the recommendations of the advisory committee. Overturning an advisory committee does not fundamentally cause a problem because FDA does it frequently. But in this case there was absolute agreement between the reviews and the advisory committee.
After the reviewers make their recommendations, if there is debate at other professional management levels, revisions might be made. The recommendation then goes to the center director and after that to the commissioner who can reverse the center director's decision. This rarely happens, and certainly not when that overturns every layer below him.
Now what happened in Plan B? The advisory committees as mentioned voted in favor of OTC status; the vote regarding safety was a unanimous. We were expecting a decision in May 2004. But instead of that approval, which had been recommended at every review level above the advisory committee, the center director sent a non-approvable letter calling for a two-tier prescription/ nonprescription status, focusing on very young teens.
The issue with young teens is neither safety nor efficacy. The question raised by the agency was whether or not teens could understand the label and use it correctly. That's the requirement for over-the-counter status. The issue raised by the center director was the only technical way of getting at this problem we need to insure that young teens understand and use the label properly. But, in fact, FDA never asked that question for any other product that is available over the counter. We've never asked it for pain medication, cold medication, antihistamines, something for migraines, something for menstrual cramps, anything that you see over the counter. Nor have we ever asked: Do young teens understand how to use it? We've never done subpopulation analysis or required numbers sufficient to do subpopulation analysis before. Why this drug and why now?
The company did resubmit exactly that proposal keep it prescription-status for young teens, nonprescription status for everyone else. We expected by winter 2005, six months later, to get a decision. Inside the agency everyone thought it was to be approved. It went up the chain again and was ready to be approved. I was in London during that time. When I returned in July 2005, the commissioner's nomination and confirmation as commissioner had been held up by Senators Clinton and Murray over the Plan B delay. They got a commitment from the commissioner and from the Secretary of Health and Human Services that action would be taken by September 1.
In late July, people at the agency told me they had recommended approval, but didn't know what the answer would be. The FDA commissioner announced in August, over the disagreement of the center director and everyone below him, that we would go into this unending black box of rule-making on the very issue we thought was a way to get to a faster yes; this two-tier prescription/ nonprescription status.
The problem was twofold. One was we had never previously required that for any of our two-tier status drugs: lower dose, over the counter; higher dose, prescription; simple diagnostic use, over the counter; complicated diagnostic use, prescription; nicotine patch only available to those over the age of 18. Every time we did that, FDA quite happily approved it with these two different conditions, and it worked fine. It's not FDA's job to regulate pharmacy practice or to regulate the practice of medicine, and both prescribers and pharmacies fifigured out how to handle it without a regulatory process. And the regulatory process proposed in August 2005 is a black box. This is saying no, without saying no. If we go through the regular rule-making process, we are talking several to many years. FDA is not going to make a decision for the very long foreseeable future.
This story goes to the heart of how we're supposed to make our health policy decisions, whether it is emergency contraception or the upcoming human papilloma virus vaccine, which unfortunately is getting ensnared in the same arguments - that if we vaccinate young teens or preteens, it might promote teen sexual promiscuity. The vaccine is going to prevent cancer, and we're going to worry about this? We have to make our decisions based on the evidence and on what will promote health, and unfortunately this decision did neither of those.
Every day that nothing happens, every day that there is silence, FDA is telling us quite clearly that the agency is not independent and can't make decisions, at least in this case, based on science and medical evidence. And if the commissioner does nothing, unfortunately that's what he's saying. The professional staff was so removed from the decision that it had no role at all. We cannot risk FDA's credibility. First, physicians and prescribers depend upon it, patients depend upon it, people buying their over-the-counter products depend upon it, and if its credibility is lost, it will be very difficult to regain. And secondly, we might actually lose the infrastructure inside the agency. Right now there are a lot of good folks inside FDA, who should be allowed to do their work properly. But if FDA keeps losing credibility, it is not going to draw first-rate people into the agency. We cannot risk that credibility both here at home and internationally where we truly are considered a gold standard. But on this issue FDA is not seen as credible at all.
Dan Brock, PhD, Frances Glessner Lee Professor of Medical Ethics at Harvard Medical School, Director of the Division of Medical Ethics:
I will address a different context, namely the National Institutes of Health or NIH. And I'm not a scientist, I'm a philosopher by training, and I do work in ethics. I'm going to talk about problems of academic freedom outside of science, but within a scientific agency of the federal government.
I joined the Department of Clinical Bioethics at NIH in 2001 for a year as a visiting scholar, intending to return to my position at Brown University, but was recruited and decided to remain at
NIH. It was an attractive working environment with a large number of very good colleagues. I then learned that NIH has a clearance process for anything published by its scientists and scholars. That process is supposed to improve the quality of information and to ensure the "accuracy, objectivity, utility, and validity of the information." According to NIH policy, materials are reviewed for "propriety, accuracy, completeness, and quality including objectivity, utility, and integrity." And in a memo that the NIH director, Elias Zerhouni, sent to all employees at NIH, he stated "our policies should never inhibit or suppress honest discussion of scientific issues. I endorse NIH's longstanding policies that support the transparency of the research enterprise and the responsible exercise of our freedom to advance public debate."
There's both a history as well as official documents that endorse NIH's commitment to academic freedom. Nevertheless, before scientists or scholars publish anything, it has to be cleared for publication. That process had been largely pro forma for the ethics department. I sent in a paper for clearance, an earlier version of which (coauthored by Bernard Lo of UCSF and Timothy Quill of Rochester) had been published in JAMA about eight or ten years ago, which I had been asked to bring up to date for a book collection. About a week later I got an e-mail from the deputy director for Intramural Research at NIH saying, "Hold up submitting it for publication, I need to talk to some more people in Building One." He indicated he would be back to me in a week or so. But the delay dragged on. I reminded him several times that I needed an answer, and finally about seven weeks after I had initially sent the paper to him, he and I had a phone conversation. He indicated that he had conferred with others, including the deputy director for Public Policy and Raynard Kington, who is the number two person at NIH, and they had come to agreement about what changes they wanted made in the paper before they would accept its publication.
The fifirst change, which I probably could have accepted, was a change in the title of the paper. It was about end-of-life care, and it had "physician-assisted suicide" in the title. But the more significant change was to the conclusion of the paper. They suggested that because it only involved a few sentences, it was not a big change. On the other hand, it was a substantive change of significance. And I was told that, "We don't want something coming out that's in conflict with Ashcroft's policies." Ashcroft was then challenging the Oregon statute permitting physician-assisted suicide as a violation of the drug administration laws.
I should point out that everything one publishes at NIH, even after its been cleared, always has a disclaimer at the bottom that the paper represents the views of the author and does not represent any policies of NIH, the Public Health Service or HHS. So I thought about it for a couple of days and went back to them and said I want to publish it as is, but I'll publish it under my Brown affiliation, where I hold an emeritus appointment, and with no connection to NIH. However, that solution was not acceptable; they refused to publish without those changes.
I asked the director of Intramural Research whether it had always been like this, because he didn't seem happy with what he was required to do. His response was, "Well, there's always been some of it, but it is much worse now." And one of the insidious features of this, and I think this is probably true of other branches of the government, was that this was, in effect, preemptive censorship. NIH was worried about getting trouble from what they call "downtown," which is HHS; that's where more overtly political people are, and NIH had had numerous conflicts with them. It was preemptive censorship in the sense that they wanted to avoid something coming out that would get them in trouble. It became clear that there would not be a satisfactory resolution of the issue, and so I decided to leave NIH, which is why I am now here at Harvard.
This is another context in which (although this wasn't science but rather ethics) politics ruled the day. I want to quote a relevant e-mail that the number two person at NIH sent to the head of the Clinical Center, who forwarded it to me.
"The bottom line is that it is time for all of us to recognize that working on highly policy relevant scholarship in the Federal Government will never be the same as doing that work in a college or a university. This administration has made it very clear that it will exercise its right to limit the ability of staff to voice policy opinions that differ from the official administration view. I think we need to start over and make it very clear to all the reality of the rules that we are working under and then individuals can and should make their own decisions about what they can live with."
That's the kind of attitude that now unfortunately exists in the leadership of this scientific institution. It is a different context than what Chris and Susan have been talking about because my work is in ethics. But nevertheless NIH is a central scientific institution, one that professes, at least, commitment to academic freedom, but when push even comes to a little bit of a shove, it doesn't stand behind it.
Footnotes
1 Mooney C.The Republican War on Science. New York, NY: Basic Books; 2005.
