Is Your Medicine Making You Sick?

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What the FDA Doesn't Know...

orange and blue pill

Of course, it's not just a flawed side-effect reporting system that's to blame for the surge of prescription drug problems. The current drug pre-market approval and post-market surveillance systems, for which the FDA is responsible, have serious problems, which the agency itself recognizes and is working to change.

New drugs are tested for safety and effectiveness in large clinical trials that involves several thousand volunteers. If side effects crop up, FDA scientists determine whether the medication's benefits outweigh potential risks. If the drug is approved, any side effects are noted on the information that goes to doctors and patients.

But since 1992 some drugs have been approved under a congressionally mandated "priority review" process requiring the FDA to act on certain new drug applications within six months or lose user fees paid by the drug companies. In 2006 the Institute of Biochemical Medicine concluded that the agency's testing system was "impaired." "Too often the pressure to get drugs approved quickly led to some drugs being approved with less information than was needed to ensure patient safety," says Sheila Weiss Smith, Ph.D., an associate professor of pharmaceutical health services at the University of Maryland School of Pharmacy.

"There is growing scientific evidence that this practice has contributed to the release of drugs that are not as safe as they should be," says Dr. Furberg. Drugs that received priority review include Rezulin, a diabetes drug pulled in 2000 for causing liver problems, Vioxx and its competitor Bextra, pulled in 2004 and 2005, respectively, for increasing the risk of heart attack and stroke, and cholesterol-lowering Baycol, removed in 2001 for its link to muscle damage. There are no plans to change this practice, according to Steven Nissen, M.D., chairman of cardiovascular medicine at the Cleveland Clinic.

What's more, the agency lacks the expertise in emerging sciences such as genomics and lipidomics to rigorously evaluate the newer biotech drugs created using these new techniques, according to a 2007 report by the FDA's own Science Board, done at the agency's request. This weakness could possibly allow potentially lethal meds to be approved.

"I was struck by two things: the sincerity and dedication of the FDA staff and how crippled they are by systemic deficiencies within the agency," says Garret A. FitzGerald, M.D., a member of the panel and chair of pharmacology at the University of Pennsylvania School of Medicine. "Here is an agency charged with the safety of the American consumer that uses hand-written reports and has outmoded computer sytems. The infrastructure needs to be brought up to 21st-century standards."

Another problem? Clinical testing doesn't always reveal every side effect a drug has. Relatively rare reactions -- they might hit one in 1,000 users -- may not show up until years after the now approved medication has been taken by millions. That's how scientists found the link between SSRI (selective serotonin reuptake inhibitor) antidepressant such as Prozac and Zoloft and higher risks of suicide or bizarre and violent behavior.

One of the ways the FDA monitors the safety of approved prescription drugs is through its MedWatch program, which relies on drug makers, doctors and consumers to voluntarily report adverse reactions to the agency. These reports may not trigger alarm bells in a timely manner. After Vioxx was approved, in 1999, scientists discovered it carried cardiovascular risks that prompted a labeling change, in 2002. It took another two years of study before the drug was pulled off the market. If the reaction is rare enough, the FDA may never learn about it.

Continued on page 4:  What Doctors Don't Tell You


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