Imagine that you are a policy maker seeking state-of-the art guidance for managing high blood pressure, high blood cholesterol and obesity - common health problems affecting many Americans. Who would you turn to for advice?
Choice One: Physician-scientists who have devoted their lives to conducting research to improve treatments for these conditions, who have extensive experience treating these disorders, who are recognized by their professional colleagues as experts, and have served as leaders of professional societies devoted to advancing medical knowledge on these problems.
Choice Two: Individuals whose reputations rest on their use of the media to demonize the physician-scientists described in Choice One. Why? For their having accepted compensation from the medical products industry for helping to develop effective new treatments that reduce high blood pressure and high cholesterol (obesity is less readily treatable with currently available drugs). Consider that some of these demonizers have never treated a patient, never helped to develop any new treatments for the conditions mentioned above.
Before deciding, you should be reminded why you are seeking advice. High blood pressure, high blood cholesterol and obesity have long been recognized as major risk factors behind heart attacks, heart failure, strokes, compromised blood flow to the legs and to other organs. These conditions can cripple or kill, or lead to serious quality of life related complications - such as impotence.
Old line treatments for these common medical problems had unpleasant side effects, so unpleasant that many patients were unwilling to take them. Until you had a stroke, heart attack or another serious consequence of high blood pressure or high cholesterol, the treatments were worse than the latent diseases they were meant to combat. Newer medications can control blood pressure and high cholesterol without most of the adverse effects of earlier products. The life-saving and life-quality preserving effects of these innovative products are now well-appreciated.
As part of the laborious and costly effort to develop such life-saving treatments, the pharmaceutical industry benefited (and continues to benefit) from the expertise of physician consultants. These consultants have helped companies produce the products and, even more importantly, helped educate fellow physicians on when and how to use them effectively. And unremarkably, these experts, exemplified by "Choice One" - have been appropriately compensated for the immense added value to patient health resulting from these relationships.
But are the Choice Two "experts" correct to insinuate that Choice One experts cannot be trusted to give unbiased advice? No, not according to the evidence. In 2006, Public Citizen published research that is directly on point.
This study examined voting patterns on FDA advisory committee meetings based on perceived conflicts of interest (COI) and found that FDA panel voting was not corrupted by industry ties.
Still, the authors of the study could not resist indulging their anti-industry COI agenda, however. They embraced conclusions and offered recommendations unsupported by and at odds with their research findings - a paradigm case of their bias. And it was shameful for the JAMA reviewers to allow editorializing statements that were at odds with the findings of the research. (Of course, there remains a possibility that the medical-scientists studied by Public Citizen were corrupted, but in ways too subtle for their study to find. However, a belief in corruption undetected by a study designed to find it, is not merely a hypothesis for future research. When unshakeable, it becomes a conflict-of-interest-generating bias.)
The Association of Clinical Researchers and Educators (ACRE) have previously published findings that really should alarm the public: empty seats on critical FDA advisory panels. While the public reasonably expects and eagerly awaits timely FDA review of new drugs and devices, their trust in government is frustrated by overly restrictive COI rules that deny the FDA the best professional advice available.
Sound logic, facts and common sense therefore dictate that overwhelmingly you look to Choice One for advice. But sound logic, facts and common sense take a back seat when a prevalent mania that runs under the pejorative code name "conflicts of interest" demonizing physician-industry relationships comes into play and when the media lovingly promotes it.
A manifestation of the mania was a New York Times article last week bemoaning the presence of Choice One participants on government panels establishing guidelines defining population goals for blood pressure, blood cholesterol and lean-body weight. The article made no mention whatsoever of the substantive qualifications of these participants. Rather, it rolled out the sums of money these persons received for their perfectly appropriate and value-promoting industry relationships and uncritically showcased the finger pointing moralizing of representatives from Choice Two, confidently promoting the unproven and almost certainly false assumption that Choice One experts make guideline recommendations to pander to the bottom lines of companies manufacturing products that lower blood pressure and cholesterol.
It also neglects to point out that before the current conflict of interest mania took hold, physician-experts routinely participated on guideline setting panels - and mortality from diseases like heart disease plummeted, in no small part thanks to the increased use of new medications.
The financial "conflicts" of panelists who help develop clinical guidelines are nowadays almost entirely available in the public domain. Most sensible people can and should ignore them. New York Times reporters and Choice Two enthusiasts can choose not to follow the guidelines on ideological grounds - and take their chances with the medical consequences.
Thomas P. Stossel is the American Cancer Society Professor of Medicine, Harvard Medical School Director, Translational Medicine Unit and Center for Medical Innovation Senior Physician at the Hematology Division of Brigham & Women's Hospital.
Lance K. Stell, PhD, is the Thatcher Professor of Philosophy at Davidson College, and Clinical Professor of Medicine, Medical Ethicist, at the Carolinas Medical Center.



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