In "Dangerous Prescription," FRONTLINE^® investigates the integrity of America's drug safety system. Through interviews with current and former FDA officials, critics, a pharmaceutical industry representative, and consumers, the one-hour documentary examines the FDA's handling of several drugs that were approved but later were pulled from the market after causing injuries and even deaths. The program also examines the role that drug companies play in the approval and monitoring of prescription drugs, and questions whether the FDA's current system is adequate for protecting the public.

"I think Americans need to recognize that every time they put a pill in their mouth — especially a new pill that they've never taken before — it's an experiment," says Dr. Raymond Woosley, vice president for Health Sciences at the University of Arizona.

Since 1997, more than a dozen drugs have been taken off the market due to severe side effects or injuries. It's a statistic that may surprise the many U.S. consumers who believe that FDA approval guarantees a drug's safety.

Not so, say scientists and industry observers.

"When a drug goes on the market, only about 3,000 patients have ever been given that drug," says Woosley, who directs a national center that studies drug side effects. "We will never know all the toxicity that can occur, especially the one [patient] in 10,000 or one in 20,000 that could be seriously harmed. Our detection will only happen after the drug is on the market and exposed to a huge number of patients."

At that point, agency officials say, the FDA depends almost completely on a system that relies on individual doctors and clinicians throughout the country to spot serious side effects or injuries and voluntarily report them to the FDA's Office of Drug Safety.

"In the United States, the initiator of the report does so on a voluntary basis," confirms Dr. Paul Seligman, acting director of the FDA's Office of Drug Safety. "It's critical that we get these reports. There's no other way the FDA has for understanding what's going on with a medicine once it's been marketed."

In most cases, doctors will report side effects not to the FDA but to the drug's manufacturer; when this happens, the company is required by law to report the information to the FDA within 15 days of receiving it. This is the FDA's "MedWatch" system, but some observers and industry insiders see a flaw in it.

The documentary also examines the impact of the Prescription Drug User Fee Act — legislation passed by Congress that allows drug companies to pay a fee of more than $500,000 with each drug application so that the FDA can hire more drug reviewers — thereby speeding up the drug approval process. Critics say the law has pushed the FDA too close to the pharmaceutical companies it is charged with regulating.

"This system has created a very unhealthy relationship between the industry and the FDA, where the FDA says, 'We have to be nice to these people because they are paying our bills,'" says Dr. Sidney Wolfe of Public Citizen's Health Research Group. "The culture at the FDA has become 'please the industry, avoid conflict, look upon our role as getting as many drugs approved as possible.'"

It's a charge FDA officials strongly deny. "We don't really feel pressure to please the industry ... we just reject that we're actually influenced by that," says Dr. Steven Galson, acting director of the FDA's drug division. But, admits Galson, "Our system isn't perfect. ... I think the lesson is, there's a lot of room for us to go in terms of making improvements with the system."

[Editor’s Note: The documentary can be watched online by visiting http://www.pbs.org/wgbh/pages/frontline/shows/prescription/view/]

(Source: www.pbs.org)

Return to table of contents