Keep it inside the locker room: FDA drug safety reviews

Congressional investigators and the New York Times have identified at least five reviewers at the Food and Drug Administration (FDA) who have recently been disciplined for uncovering evidence about the dangers of certain popular drugs. They include: Dr. Rosemary Johann-Liang, for her investigation of the diabetes drug Avandia; Dr. Andrew Mosholder over anti-depressants; Dr. David Ross over the antibiotic Ketek; and Dr. Victoria Hampshire over her review of heartworm medicines with fatal effects on more than 500 dogs.

Dr. Hampshire describes a "feeling of fear" among reviewers at the FDA. The FDA Commissioner, Andrew C. von Eschenbach, has urged the safety officials to keep disagreements "inside the locker room," and said those who discussed findings with outsiders would be "traded from the team." Indeed, Dr. Hampshire’s work in uncovering the dangers of heartworm medicine led to her being disciplined and being made the subject of a criminal investigation.

Secrecy by the FDA blocks patients from empowering themselves. And if the FDA does not adequately guard us from dangerous drugs, we have to be more vigilant.

Advice: If you’re prescribed Ketek or Avandia, ask your doctor about adverse reactions. Ask your vet about adverse drug reactions from your dog’s heartworm medicine.

Read another of our Avandia stories, or read Gardiner Harris’ source story in today’s New York Times, "Potentially Incompatible Goals at FDA."