Четверть государственных экспертов по безопасности лекарств получают деньги от продажи этих лекарств
Catching Conflicts at the FDA
Former Commissioner Crawford's guilty plea is only a step in the right direction.
October 19, 2006
A GUILTY PLEA FROM FORMER FDA Commissioner Lester M. Crawford shows that the ethics guardians are making some progress
against conflicts of interest at the Food and Drug Administration. Now they need to delve deeper into ethical lapses at the
agency, which has been suffering a crisis of confidence.
Crawford, who resigned as commissioner a little more than a year ago, pleaded guilty Tuesday to lying to investigators
about stock he owned in companies that were regulated by the FDA. Yet, according to one study, more than a fourth of the
experts who sit on the FDA's advisory panels, which review the safety and effectiveness of drugs, have potential economic
stakes in drugs they consider.
Other independent reports have found that regulators often ignored safety experts and refused to move against drugs that
showed signs of serious side effects. That's one reason Vioxx, despite its heart risks, remained on pharmacy shelves long
after it should have been pulled. Political pressure also has weighed on the agency, which dithered about approving
over-the-counter sales of Plan B, the morning-after contraceptive pill, despite its positive ratings from agency scientists.
Current legislation to make drug evaluators and safety experts work together more closely, and to give the safety side more
autonomy, would take the agency one step forward. But Congress should take the opportunity to impose more comprehensive
reforms next year when it reconsiders the user fees that provide much of the FDA's funding.
Reforms will require striking a sensible balance between the need for expertise and tolerance for conflict. The agency
needs specialists well versed in the substances it regulates, but such people often gain their expertise by working or
consulting for drug companies. One way to mitigate such conflicts of interest is to require disclosure — and recusal when
there is a meaningful conflict.
The FDA also has suffered from both a literal and metaphorical lack of leadership, spending most of the last two years
under acting and interim commissioners. The current acting commissioner, Texas surgeon Andrew C. von Eschenbach, is a solid
replacement for Crawford. He deserves to be confirmed by Congress so that the FDA can turn its full attention to regaining
the public's confidence and protecting its health.