FDA Slow to Reform

December 5, 2002

Although there are many promising vaccines for the treatment of cancer, most patients can't get them, critics charge, because the Food and Drug Administration (FDA), concerned that it might give its "seal of approval" to a drug that ultimately is not effective, is too wedded to statistics and to procedures that result in only the sickest cancer patients being offered the vaccines.

Why the wait?

  • Patients who are less ill or who have treatable cancers don't often enroll in the FDA-required trials.
  • Most of the patients receiving the vaccines in the trials are severely ill and their depleted immune systems are hard-pressed to respond.
  • Not surprisingly, trials rarely yield statistically favorable results, and treatments aren't approved.
  • An even larger problem inside the FDA stems from a struggle that pits its statisticians, who favor large placebo trials, against its medical doctors, who are more inclined to overlook the statistical shortcomings of some clinical trials when it comes to deadly diseases and drugs with potentially powerful benefits.

So long as the statisticians remain in charge, a climate where mathematics trumps sound medical judgment will prevail, observers say. Patients who enroll in these cancer trials, seeking one last shot at a cure, will be victims twice over: first to their spreading cancers, then to a regulatory culture that favors statistical rigor over curing sickness, and compels drug companies to test their new treatments on the very patients who are least likely to benefit from them.

Source: Scott Gottlieb, "FDA Rules Hinder Cancer Vaccines," USA Today, December 5, 2002.

For text

http://www.usatoday.com/news/opinion/2002-12-04-forum-two_x.htm

 

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