FDA APPROVES DRUGS EVEN WHEN EXPERTS ON ITS ADVISORY PANELS RAISE
SAFETY QUESTIONS

EDITOR

After reading the editorial questioning whether the Food and
Drug Administration is approving drugs too fast I was perplexed by the
conclusion"probably not."[ref 1] Apparently the authors failed to read
the transcript of the meeting of the administration's advisory
committee for mibefradil (NDA 20-689), which is on the
administration's website one of three drugs recently recalled by the
administration because of deaths and serious morbidity.

If they had read this transcript they would have been overwhelmed by
the number of disturbing signals from committee members throughout the
document (page numbers refer to the Acrobat version): "I'm afraid that
we are rushing into this" (p 199); "I think it's concerning that the
mortality data look the way they do right now" (p 202); "given the
fact that there are a lot of other effective therapies out there, why
not be safe with the public?" (p 205); "I think it's premature [to
approve the product] (p 209); "aren't we obligated to provide some
assurance that the ECG (electrocardiographic) changes we've seen here
today are not ultimately lethal?" (p 127); "I sure don't feel good
about what I've seen" [referring to electrocardiographic changes] (p
126); "you have 8 deaths in the patients treated with mibefradil and 1
death in the placebo or control populations" (p 135); "are you really
comfortable, with so little mortality data, ... that it's safe?" (p
138), etc.

To conclude, as the editorial does, that serious adverse events are
inevitable and "one more bittersweet fact of medical progress" is too
facile. A more plausible explanation recognises that, for some time,
formidable forces both political and economic have insisted that new
drugs and devices be approved more quickly than ever before by the
administration. This interpretation agrees with the view held by many
healthcare policy academics, patient advocate organisations, and
consumer watchdog groups. They argue that in the past few years the
Food and Drug Administration's role has changed. Rather than
regulating the drug industry to protect the health of consumers of
prescription drugs, the administration has become the industry's
partner, rapidly approving drugs for marketing even when medical
experts on its own advisory panels raise serious safety questions.

Although one may not entirely agree with this outlook, it does provide
an explanation for much of the evidence that Kleinke and Gottlieb seem
to have overlooked.

Laurence Landow, Instructor in anesthesia, Harvard Medical School.
Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA
elmrfudd@erols.com

From 1996 to 1998 Dr Landow was a medical officer and acting team
leader in the Anesthetic and Critical Care Drugs Section of the Center
for Drug Evaluation and Research at the Food and Drug
Administration.

Reference

1.Kleinke JD, Gottlieb S. Is the FDA approving drugs too fast? BMJ
1998; 317: 899. (3 October.)