Tuesday, April 12, 2005

Some FDA History, with "Safety ... at the Back of the Bus."

The Boston Globe provided some historical context for how the US Food and Drug Administration (FDA) got into its current troubles. Here are some salient points:
  • In the late 1980's, the FDA was under pressure from gay activists to speed up its approval process for drugs for HIV infections. "Protesters stood atop buses and stopped traffic. Some broke into the FDA and smashed computers. They hung then-FDA commissioner Frank Young in effigy." Protesters chanted "Hey, hey, FDA, how many people have you killed today."
  • Pharmaceutical companies also wanted to speed up the approval process, and threatened to "move research, development, and clinical studies abroad" if their wishes were denied.
  • In 1992, in response to budget pressure, Congress passed the Prescription Drug User Fee Act, which would speed up the FDA review process in exchange for direct fees paid by the pharmaceutical companies.
  • Since then, total user fees paid to the FDA have climbed from US $87.5 million in 1997 to $382 million this year. The speed of reviews has also increased.
  • However, the need for speed, plus financing coming direct from pharmaceutical companies appeared to change the FDA culture. The article included several charges that FDA personnel were pressured and intimidated to speed drugs along even if they had doubts about their safety. For example, Dr. Jerry Avorn of Harvard alleged "the purposeful supppression of individuals within FDA who are concerned about problems and are told 'Don't make waves. We need to get this drug approved.'" Dr. Erick Turner said that reviewers who tried to delay approvals due to safety concerns were called before "tribunals." The reviewer who tried to delay the approval of Rezulin because he suspected it would cause liver problems was taken off the case after he got in a verbal altercation with an official of Rezulin's manufacturer, Warner-Lambert. Rezulin was taken off the market in 1997.
  • The article ended with a quote from FDA whistle-blower David Graham, "Safety, as I a said before, is at the back of the bus."
A few more global comments.
One can sympathize with the "activists" who applied political pressure via 1960's style street theatre to try to speed up treatment for a then rapidly fatal disease. However, their pressure had broader effects than they intended, and hence unintended consequences.
It seemed reasonable to essentially tax pharmaceutical companies for a rapid review process that would benefit them (as well as the public, it was hoped.) However, sending the tax money direct to the FDA in the form of "user fees" created an institutional conflict of interest.
It is upsetting that so many of the stories we discuss on this blog culminate in the final common pathway of intimidation of well-meaning professionals, physicians, and scientists by overbearing bureaucrats and administrators. All too often the coincidence of self-interest and power leads to censorship and intimidation.

1 comment:

InformaticsMD said...

Make that "overbearing bureaucrats and administrators who oftenlack the educational credentials and seasoned expertise to bemaking such decisions."

-- SS