The downside of blockbuster drugs

[Hawkeye]

The downside of blockbuster drugs
www.suntimes.com/lifestyles/health/406028,CST-NWS-drug30.article

May 30, 2007

BY JIM RITTER Health Reporter jritter@suntimes.com
Northwestern University medical school sleuths keep uncovering rare -- and horrible -- side effects from blockbuster drugs.

The blood thinner Plavix can trigger multi-organ failure that's 90 percent fatal without emergency treatment. Procrit, used to treat anemia in cancer patients, can cause life-threatening bone-marrow failure. Zometa, Fosamax and other bone-protection drugs used for cancer and osteoporosis can, paradoxically, cause deterioration of the jawbone that fosters infection and delays healing when teeth are pulled.

Since 1998, Northwestern's sleuthing program has hit 30 big-name drugs with reports detailing side effects that include patients ending up on ventilators, or needing transplants or additional surgery, or even dying.

"These are not skin rashes," said Dr. Charles Bennett, leader of the program, called Research on Adverse Drug events And Reports -- RADAR, for short.

Bennett and colleagues describe their work in the current issue of the journal Archives of Internal Medicine. RADAR generally investigates billion-dollar drugs used to treat cancer and blood disorders.

Adverse drug reactions are among the 10 leading causes of deaths, killing as many as 100,000 patients a year in U.S. hospitals. Before a drug is approved, it must be proven safe in clinical trials. But such studies typically enroll only a few hundred or a few thousand patients. And those participants tend to be healthier than those who wind up using the drug.

As a result, some rare but serious side effects don't show up until after the drug is approved by the federal Food and Drug Administration.

The FDA maintains a computerized database of "adverse events" reported by patients and doctors. When FDA computers spot a problem, the agency typically changes the drug label or sends a warning letter to doctors. In extreme cases, the drug is removed from the market.

Bennett has eight research assistants and a worldwide network of 25 doctors, funded by $12 million in federal grants. RADAR does not accept drug company funding.