2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
FDA Comment Number : EC361
Submitter : Mr. Ernest Ryan Date & Time: 12/09/2005 11:12:24
Organization : Mr. Ernest Ryan
Category : Individual Consumer
Issue Areas/Comments
Dear FDA Officials: I am asking you to start protecting the public by putting the public's safety ahead of pharmaceutical company lobbying especially as it pertains to the advertising and approval of psychiatric drugs such as SSRI antidepressants, ADHD drugs like Ritalin, Strattera and Adderal, and antipsychotics like Zyprexa and Geodon. Since the approval of Prozac around 1988 the FDA has allowed a landslide of psychiatric drugs to be approved and aggressively advertised resulting in millions of millions of people on these drugs.

Even though good evidence existed from 1988 when Prozac was approved that SSRI antidepressants caused suicidal ideation, suicide and violence the FDA allowed nearly every major pharmaceutical company to bring out their own versions of these drugs. In February 1990 Martin Teicher published 'The Emergence of Intense Suicidal Preoccupation During Fluoxetine Treatment' in the American Journal of Psychiatry. This was the seminal study in showing SSRI antidepressants cause suicidal ideation. Thousands of life examples from the massacres at Columbine to those at Red Lake, Minnesota this year have shown that there is something seriously wrong with Prozac and all SSRI's.

The weak Black Box warnings the FDA has put on these drugs means nothing to the public as they have no idea of the meaning of them. The fact that Paxil is still on the market after being connected to birth defects and being extremely addictive and difficult for many to come off of as well as it causing suicidal ideation and violence to say nothing of the dozens of lesser side-effects tells me the public interest is totally being subverted at the FDA by the financial power of the pharmaceutical companies.

Do you have any idea how corrupt and buyable many Americans regard FDA officials to be? It used to be the FDA's bulletins and approvals were a blue ribbon hallmark signifying a product that people could trust.

Many civilized countries like Great Britain are now telling doctors to quit prescribing SSRI antidepressants to under 18's as the risks outweigh the benefits. The FDA is now being lobbied by the American public to do the right thing about these dangerous drugs whereas the FDA should have been in the vanguard of protecting the American public all along but it has considered the pharmaceutical companies to be the public it serves.

The false advertising of psychiatric drugs and many other drugs that are now being found to be dangerous such as Vioxx, Advair, etc. has simply pushed the cost of Medicare, Medicaid and private health care provided by employers to all time highs. The result is that health care is being pushed off to the public and outright canceled by corporations. The greed of pharmaceutical companies and the especially high cost of dangerous, ineffective psychiatric drugs is killing health care.

I hope you will take a serious look at actually doing your jobs at the FDA. Advertising of drugs has to stop and approval of dangerous psychiatric drugs and continuing to allow proven dangerous drugs on the market is criminal.

It will not be much longer before enough people get together and form their own drug safety and approval organization to supercede and replace an ineffective FDA. This could be like Consumers Union does with Consumers Reports only it would be dedicated to testing and rating drugs. This may sound fanciful to you but you really have no idea how low the FDA is regarded. Personally I check Health Canada and MHRA if I want to
know anything long before checking FDA's website. I consider those health professionals to be much less influenced by pharmaceutical company lobbying and incentives.

One more thing: Please do something about the false advertising of psychiatric drugs claiming to restore a chemical imbalance. If anything they cause a chemical imbalance. There is no test to determine a chemical imbalance in a living brain or how to restore one. This is false advertising.