Thursday, April 13, 2006

Demand the FDA Fulfill Its Obligation To Public Safety

I am sending this request to get your assistance on a very vital action that will only take a few minutes of your time. The issue is ADHD drugs. We have received confirmation that many of you have written your letters and THANK YOU. If you haven't yet done it, please write your letter immediately and email me confirmation that you've done it.

Recently, the FDA held hearings on “ADHD” drugs due to numerous reports of hallucinations and psychosis attributed to them. And while the FDA panel did recommend new warning language for these drugs, the panel refused to issue “black box” warnings – the agency’s most severe warning label.

Why? Consider this: There has been a lot of public outcry about millions of children being prescribed ADHD drugs with increasing reports of the drugs causing suicide, psychosis and hallucinations. A few months ago, a leading cardiologist recommended the FDA issue black box warnings due to reports of heart attack, stroke and sudden death from ADHD drugs. So this latest FDA panel --which included psychiatrists with ties to the pharmaceutical industry – had to take some action – so issued increased warning language about the drugs. But why not the black box? Because the FDA appears to be more interested in protecting psychiatric/pharmaceutical interests, than in the public’s interest. When black box warnings are issued, drug manufacturers have to disclose the risks in all advertising.

This is why many of the experts and medical doctors attending the FDA hearing on ADHD drugs called it a sham and said that the FDA yielded to the profit-driven psychiatric/pharmaceutical industry.

The Deputy Director of the Office of Drug Safety himself has stated, “…. products that carry box warnings also have to carry that in their advertising and quite frequently that makes it quite difficult to explicitly advertise that product in direct-to-consumer advertising."

So the issue is simple. Black box warnings mean drug sales go down. The FDA’s own mission statement says it is responsible for “protecting the public health and ensuring the safety, efficacy and security of human and veterinary drugs.” So CCHR is asking everyone to fax letters to the FDA demanding black box warnings on these drugs – and reminding the FDA that they are there to protect the public’s safety and interests–- not psychiatric pharmaceutical interests.

Emails or letters should be sent to the Acting Commissioner of the FDA at:

Andrew C. von Eschenbach, M.D.,
Acting Commissioner
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857-0001

(please blind copy your emails to CCHR at

We want to send copies of all these emails to Senator Charles Grassley, the member of Congress who has been addressing the need for oversight of the FDA.

Or you can fax him yourself at 202-224-6020

Senator Charles Grassley
135 Hart Senate Bldg.
Washington, D.C., 20510-1501

Your help is needed on this. So thanks in advance for your assistance.

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