Wednesday, April 4, 2007

Safety First

For years, drug companies have steadily co-opted the FDA while oversight and enforcement have lagged. Might this year finally see some change?
By Christopher Moraff (from American Prospect Online)

On March 13, Kim Witczak stood before the Senate Committee on Health, Education, Labor, and Pensions and recounted the death of her husband, Tim.

Known to his friends as Woody, Witczak hung himself from the rafters of the couple's Minneapolis garage in 2003 just five weeks after being prescribed Zoloft by his family physician. He was 37 years old. According to his wife, Woody was given the drug for insomnia and had no history of mental illness or depression.
"From the beginning," she testified, "something didn't add up about Woody's death."

In fact, increased risk of suicide had been identified as a possible side effect of anti-depressant drugs like Zoloft as far back as the 1980s, during preliminary trials. But it wasn't until 2004 that drug companies were forced to issue a warning about the side effect, and then only for patients under 18. Thus, the Witczaks were never informed of the risks.

The Senate committee Witczak addressed was gathering testimony as part of an ongoing discussion about how the Food and Drug Administration (FDA) can better ensure the safety of the drugs Americans are taking. A key issue involves the renewal of the Prescription Drug User Fee Act (PDUFA), which allows pharmaceutical companies to fast track the drug approval process by paying the FDA for their time and effort....Read the rest of this article at the Amercian Prospect Online.