A Conversation with John Abramson, MD: Is It Time To Create a 'Fed Board' To Oversee Clinical Research?
A Conversation with John Abramson, MD: Is It Time To Create a 'Fed Board' To Oversee Clinical Research?
MANAGED CARE January 2005. ©MediMedia USA
The physician-author of “Overdosed America” says that health plans have a logical role in actively assessing the medical literature.
In 1991, universities and not-for-profit facilities conducted four-fifths of the clinical research in the United States. Today, most of that research has been moved to for-profit research companies — giving drug and medical device companies far greater control over studies they sponsor. As John Abramson, MD, sees it, this is one of several signs that Adam Smith's invisible hand of the market may be working all too well in American health care.
In his new book, “Overdosed America: The Broken Promise of American Medicine,” Abramson argues that the privatization of medical research, the diminished role of universities as impartial overseers of medical knowledge, and the drug and medical-device industry's growing influence on government have changed the fundamental purpose of medical knowledge in the United States. He calls for the establishment of a federal oversight body that serves some of the same impartial refereeing functions that the Federal Reserve Board does in the banking industry.
Abramson teaches primary care as a member of the clinical faculty at Harvard Medical School. He has practiced family medicine with the Public Health Service in Appalachia and for 20 years in Hamilton, Mass. He has chaired the department of family practice at Lahey Clinic and was a Robert Wood Johnson fellow. He spoke recently with Senior Contributing Editor Patrick Mullen.
MANAGED CARE: You wrote “Overdosed America” to address what you call a loss of trust in medical science and the weakening of the doctor/patient relationship. Explain how your thinking evolved.
ABRAMSON: For 20 years, I practiced family medicine about 45 minutes north of Boston. I read my journals each week and believed that by applying the latest medical information contained in those journals, I was providing my patients with the best possible care. As the 1990s progressed, I noticed a growing commercial influence in the "scientific evidence" that defines the best way to practice.
MC: Where do commercial interests fit in this equation?
ABRAMSON: The real problem with American medicine is that most of the knowledge that defines good medical care for physicians, patients, and health policy makers is now pushed by the drug companies in pursuit of their own corporate interests. Medical knowledge is growing toward profits the same way that plants grow toward the light. I came to understand how difficult it is for practicing docs to see through the fog of complexity and experts' recommendations to understand how they are being deceived. This is what motivated me to write the book.
MC: You advocate creating a federal body akin to the Federal Reserve Board to oversee clinical research. Describe that board's mission.
ABRAMSON: Such a body would have the independence and expertise of the Institute of Medicine. The Fed provides a model of how this new board could be insulated from political and commercial influence, with long and staggered terms for members, no financial ties to industry, and secure funding from Congress. The board would have a threefold mission. First, it would ensure that medical research is designed with the primary purpose of improving health, in accordance with accepted scientific standards. That means including patients similar to those to whom the results will be applied, identifying appropriate outcome measures, designing studies that go on long enough to contribute important information about the way the drugs will be used, and analyzing results in ways that help determine optimal therapy. The complete results of all studies, published or not, would be available to this body to ensure that data were not withheld and analyses were conducted fairly. Most important, this body would be the recognized source of complete and unbiased medical information, readily accessible to the public, doctors, and health policy makers. Second, this body would provide oversight in developing clinical guidelines for preventing, diagnosing, and treating specific medical problems and promoting health through independent analysis of all available evidence. These impartial guidelines would replace industry-influenced guidelines as the standard of care admissible in malpractice cases. Third, it would identify the need for, fund, and oversee research when important scientific evidence was lacking. For example, studies of new drugs could also include the best-known therapies and lifestyle interventions. This might reasonably include funding from the public sector to broaden studies beyond the focus on the sponsor's drug. In the current context, any drug company CEO who tried to institute a policy of not just comparing the company's drug to a placebo or to a competing drug it was trying to beat up on would face some hard questions from that company's board of directors. The board would be obligated to say, "Look, our job is not to be idealists unless it makes business sense."
MC: How would you respond to those who would reject your proposal as just another government bureaucracy?
ABRAMSON: I haven't heard anybody calling for the Federal Reserve Board to be disbanded because of unnecessary bureaucracy. And I doubt that even the most ardent libertarian would consider revoking the government's power to enforce contracts. Similarly, I don't think it's radical to call on government to ensure that the knowledge that guides our health care is accurate. It's important to understand that the problem can't be fixed with just cosmetic changes.
MC: How do health plans fit in either as part of the problem or part of the solution?
ABRAMSON: Since the purpose of managed care is to oversee the health care of a population of people, to optimize their health while minimizing the cost, managed care plans ought to be part of the solution. It's a match made in heaven. Health plans should play a more active role in critically assessing the medical literature and supporting critical assessment by others of the scientific evidence behind treatment options. This would serve their financial self-interest, and more importantly, would lead to better health outcomes in a health care system that has lower costs. The current system is so expensive in large part because of excess medical care that is unnecessary at best and sometimes harmful. Waste on that large a scale is a clear sign that the medical industry has too much power. It's in our national interest to correct that imbalance. If we could ensure that doctors' primary source of medical information came from unbiased evaluation of all scientific evidence, the potential savings would amount to about 10 times more than we need to take care of all uninsured Americans. In the United States, we spend twice as much per person for health care as other industrialized countries. Even corrected for GDP, we're paying 42 percent more than would be predicted by other countries' expenditures. The profound dysfunction in the American health care system comes to light when we realize that Americans' health ranks behind these same countries.
MC: You teach at Harvard Medical School. Do your students share your views on the need to change the way doctors learn and how they think about how they learn?
ABRAMSON: It gets more difficult each year to address these critical issues with medical students. There is a strong presumption that the drugs that they're struggling to learn how to use are effective because the medical literature and the professors who are their role models say so. Students work hard to learn the indications, doses, and side effects, because that's what they'll be graded on. So, even though they want to learn how to provide the best patient care, when you say, "Let's step back and critically examine the evidence that these drugs really are helpful compared with other interventions," it creates dissonance for them. When I was a medical student in the mid-1970s, none of the professors had financial relationships with drug companies. That would have been unheard of. When I was a Robert Wood Johnson Fellow from 1980 to1982, we spent hours dissecting studies: examining the statistics, the confounding factors, the limits of conclusions that could be drawn based on the design, population, intervention, and outcome measure of each study. I do not recall a single article that we said had a problem because of a commercial bias. Not a one. Now, commercial bias is accepted as a routine and expected part of clinical research. Everyone knows it's going on, but acts as if it won't really distort our medical care. These financial relationships are so deeply woven into American medicine that it's hard to be recognized as a national expert without them.
MC: Why isn't the debate about American health care focused more than it is on the amount of waste in the system or the fact that the most advanced care doesn't necessarily lead to the best outcomes?
ABRAMSON: Medical science has a singular mystique in our society. We tend to think that scientific findings are unimpeachably true and that their truth alone means that their implementation will have positive effects. Leon Kass, MD, PhD, makes a wonderful point about the kinds of truths that science can reveal. He's a biomedical ethicist who chairs the President's Council on Bioethics. He points out that the kinds of truths discoverable by the tools of science are different from the kinds of truths we hold as part of our personal and shared values. Scientific research can lead to conclusions about whether one drug is better than another, or whether people should be treated this way or that way. But scientific studies cannot illuminate basic values. Is it a shared value that all Americans should have health care? Is it a shared value that our health care system should function in ways that best improve our health rather than generate the most profit? An analogy to the debate over stem cell research illustrates the point. In Our Posthuman Future: Consequences of the Biotechnology Revolution, Francis Fukuyama, PhD, warns that once stem cell technology becomes subject to the commercial fray, we'll be on such a commercially slippery slope that we'll lose control of how the technology is used — and risk being plunged into ethical dilemmas from which we won't be able to extricate ourselves. He raises valid concerns, though I don't necessarily agree with his conclusions about stem cell research. The point is that we are already way down a slippery slope in terms of what is considered to be the objective science that makes up the current body of medical knowledge. Concern about future ethical problems is important, but concern about current ethical problems demands even more attention. I'm addressing how far down that commercialized slope we've already come. These are not liberal or conservative values. These are values of human decency that most people share but which are not being implemented. The problems with American medicine are not going to get straightened out until there's a public consensus that the primary function of medical care ought to be to improve our health most effectively and efficiently, and that all Americans have a fundamental right to such medical care. Only then will science serve those values.
MC: Thank you.
In an accompanying article David Nash, MD, MBA and others critique and rebut John Abramson, MD’s proposals