Who is the FDA working for?
Dr. Mercola reports on the US Food and Drug Administration’s covering up of evidence that suggests that antidepressant drugs administered to children increase the risks of suicidal behavior. The article in the British Medical Journal (the link is broken on Mercola’s site) is very disturbing.
The published documents confirm earlier news accounts that a government expert with the FDA’s Office of Drug Safety, Dr Andrew Mosholder, found that children taking antidepressants were twice as likely to become suicidal as children taking placebo. He reportedly urged the agency to follow the lead of British health authorities by warning doctors that the risks of the newer antidepressants, except fluoxetine, might outweigh the benefits when used in children.
The leaked documents show his data and conclusions. The FDA has subsequently acknowledged to the BMJ that Dr Mosholder was prevented from presenting his report at an advisory committee meeting on 2 February and was told that if he was asked any questions during the meeting he could respond to queries only by using a prepared script approved by his supervisors.
“Most Americans undoubtedly believe that the FDA demands reasonable evidence that a drug is safe before it is allowed to be used,” said Professor Hoffman. “But this episode suggests that they reject this `precautionary principle’ in favour of the idea that no drug is dangerous unless it is `proven’ to be so.”
“The FDA… attempted to silence Dr Mosholder [but] repeatedly claimed to `support his concern’ for the safety of children,” added Professor Hoffman, “but this apparently didn’t extend to supporting his desire to express that concern publicly. That may be the most dangerous aspect of this entire affair.”
