The Food and Drug Administration's tightening of conflict-of-interest rules will allow them to claim that they are using only conflict-free scientists, but this is in fact not the case.
Bias in one form or another can never be completely eliminated. The FDA is barring scientists with a direct financial conflict, but are they banning scientists who may have some other type of bias? For example, what if a scientist has built a career on the notion that only diet can lower cholesterol -- but then a new and valid study points to an effective drug, which makes all of that scientist's research outdated and wrong? That scientist too will have a bias. It's called careerism.
The new rules only remove one potential type of bias -- a pro-pharma one at that -- and ignore other potential biases. Potential advisory committee members who believe that pharmaceutical products are dangerous and harm the environment will not be subject to the new ruling. Thus, the FDA will be left with a pool of researchers who are skewed toward an anti-pharma bias. However, if the best qualified scientists are often hired by drug companies (to advise within their field of expertise), it follows that the FDA, by avoiding those scientists, is now limiting itself in ways that hurt the agency's ability to understand our increasingly complex pharmacopeia.
This is more of a PR move than a drug-safety move -- a response to activists' misguided fear that "drug safety" (essentially, the risks from side effects) should be our overarching concern, without any corresponding consideration of drug benefits. The new rules may cater to that fear, but they will do nothing to improve drug safety -- they will likely hamper, not enhance, the public's access to safe and effective products.
Jeff Stier is an associate director at the American Council on Scienceand Health (ACSH.org, HealthFactsAndFears.com).
NOTE: Watch for ACSH's upcoming report on controversies surrounding "industry-funded science."
See also: ACSH's report on Weighing Benefits and Risks in Pharmaceutical Use.
