Friday, April 16, 2004

News of FDA censorship at a public hearing

Being the skeptic that I am, I'm actually surprised to find out that the FDA even admitted to doing this heinous deed.
    Top Food and Drug Administration officials admitted yesterday that they barred the agency's top expert from testifying at a public hearing about his conclusion that antidepressants cause children to become suicidal because they viewed his findings as alarmist and premature.
Recall in March this year, the FDA warned anti-depressant use can trigger suicidal behaviors, especially in the first weeks. This was a curious warning, especially since the FDA at the same time disavowed any serious link beween drug use and suicidal behavior. It sounded to me like a cover-your-ass tap dance: we're not at fault even though we could be because we're being very careful with our words and there's no way can you pin us down.

Now we have more information about the FDA warning. They still seem to be doing that tap dance, which is all too familiar now.
    "It would have been entirely inappropriate to present as an F.D.A. conclusion an analysis of data that were not ripe," Dr. Robert Temple, the Food and Drug Administration's associate director of medical policy, said in an interview. "This is a very serious matter. If you get it wrong and over-discourage the use of these medicines, people could die."

    Dr. Temple was seeking to quell a growing controversy into whether the agency's warnings on March 22 that antidepressant therapy could lead patients to become suicidal were sufficient.

    "There is concern that we hid data," said Dr. Temple. "We did not hide data. It was there for all to see."
All right. So they say didn't hide the data. But they hid their analyst.

The FDA denied a strong connection beween suicidality and anti-depressant use. They also thought the analyst's conclusion was too alarmist. Yet the warning was still issued.

Here's the good news. What a wonderful world it is that two Republicans are on to them.
    Senator Charles E. Grassley, a Republican from Iowa and chairman of the Senate Finance Committee, said he was investigating whether the agency inappropriately suppressed crucial findings. Representative Joe L. Barton, a Republican from Texas who is chairman of the House Energy and Commerce Committee, said he was also investigating.

    "It would have been very wrong for the F.D.A. to withhold any information it had about unintended consequences that might result from the use of antidepressants, especially for children and adolescents," Mr. Grassley said.