The Senate is currently considering legislation which would prohibit the FDA from including on FDA scientific advisory boards scientists "with industry ties" to drug manufacturers (the House already approved this legislation). Today, FDA's Dr. Scott Gottlieb emphatically opposed this proposed legislation, declaring that it would deprive FDA of advice from the best and brightest scientists in America.
Gottlieb noted "I am particularly worried that the value of these committee meetings could be eroded, as well as our ability to attract the experts we need, if current legislative proposals become law, and FDA is hampered in its ability to put experience and expertise as the paramount criteria when recruiting members to serve on these committees. I am worried by some who want appearance to trump acumen--some who want the lack of private sector work to trump a plethora of scientific experience as a criterion when we are selecting who to put on our committees."
In stating the FDA's position on the proposed legislation, Dr. Gottlieb was not dismissing the possibility that a real conflict of interest may indeed exist in some cases: "When a real conflict exists and the magnitude of the conflict outweighs the agency's need for (the) expertise the committee member will provide, we recuse that individual from the proceedings."
Clearly this balanced, commonsense approach is far preferable than a draconian piece of legislation which uses the vague term "industry ties" to prohibit distinguished and accomplished scientists from advising the FDA. It appears that proponents of the pending legislation are convinced that the FDA would be better advised by less accomplished scientists whose primary credential is not what experience they have--but rather their lack of experience in advising industry or conducting clinical drug trials for pharmaceutical companies. Obviously the FDA---correctly--disagrees with this position. According to Dr. Gottlieb, "...this is not the way you usually think when you're trying to seek out expert advice--let's find the person with the minimal amount of practical experience."
"Conflict of interest" charges recently have become an obsession of self-appointed consumer advocates, journal editors and members of the media---yet the term is ill defined. As it currently is used "conflict of interest" refers to a history of paid consultantships with a corporation--or the receipt of research monies from companies---even if that funding is directed through a university and is not paid directly to the scientist. But where does the charge of "conflict of interest" end? Is it applicable if a scientist--or his/her spouse--owns corporate stock? What if the scientist's parents owned large blocks of stock in a drug company--stock the scientists was eventually to inherit? What if the scientist or a family member owns stock in a supplier of a company whose product the committee is evaluating? If the committee is evaluating an AIDS drug, would the sexual orientation or HIV status of committee members need to be disclosed---and perhaps certain members recused? If a committee is considering approval of a drug for, say, Parkinson's disease, would members need to disclose whether or not they have a family member with the disease--and thus have "a conflict of interest?" Outside the pharmaceutical area, if a committee of a federal agency were recommending guidelines on meat consumption, would members be excluded based on their own dietary preferences?
Again, the FDA's Dr. Gottlieb said it best: "It would be a significant step backwards if our primary criterion for selecting members to our committees becomes their lack of private sector work, if we exclude people for deep experience rather than embrace them for it." What is critically important in today's FDA announcement is that the Agency has taken a firm stance against prohibiting committee participation simply because a member has worked in some way with "industry." That stance is not only good for the Agency--but it serves well the interest of consumers who ultimately will be the beneficiaries of the best scientific counsel currently available.
Elizabeth M. Whelan, Sc.D., MPH, is president of the American Council on Science and Health (ACSH.org, HealthFactsAndFears.com).
