Big Pharma Blocks Studies of Long Term ADHD Drug Effects While FDA and EMEA Dither

by Heidi Stevenson

12 March 2010

The Food and Drug Administration (FDA) and European Medicines Agency (EMEA) dither while Big Pharma blocks studies into long term effects of ADHD drugs—unless, of course, they're produced by their own pet (and very highly paid) researchers, such as Joseph Biederman, Timothy Wilens and Thomas Spencer. Hanging in the balance are the health and futures of millions of children.

FDA Findings and Nonaction

On 3 March 2006, the FDA reported on serious concerns about ADHD drugs⁽¹⁾, including documentation that they can induce psychotic behavior in children, as follows:

The most important finding of this review is that signs and symptoms of psychosis or mania, particularly hallucinations, can occur in some patients with no identifiable risk factors, at usual doses of any of the drugs currently used to treat ADHD. Current approved labeling for drug treatments of ADHD does not clearly address the risk of drug-induced signs or symptoms of psychosis or mania (such as hallucinations) in patients without identifiable risk factors, and occurring at usual dosages. In addition, current labeling does not clearly state the importance of stopping drug therapy in any patient who develops hallucinations, or other signs or symptoms of psychosis or mania, during drug treatment of ADHD. We recommend that these issues be addressed.

It has been more than four years since this memo was sent to the Director of the Office of New Drugs, the Director of the Office of Pediatric Therapeutics, the Acting Deputy Director of the Office of Pediatric Drug Development, and the Deputy Director of the Division of Drug Risk Evaluation. At this point, it appears that nothing has come of it.

Several drugs are specified by name, including:

Adderall
Adderall XR
Focalin
Focalin XR
Concerta
Metadate CD
Methylin
Ritalin
Ritalin LA
Ritalin SR
Strattera
Dexedrine
Provigil (Not then on the market, but since approved by the FDA)
Methylphenidate TD (Not then on the market, but since approved by the FDA)

EMEA's Request and Hiding of the Response

On 22 June 2007, the Committee for Human Medical Products (CHMP), an EMEA agency, sent a request to Big Pharma companies that manufacture ADHD drugs containing methylphenidate, the active ingredient in the drugs named above. They were asked to outline how they could produce studies on certain long term effects of these drugs, including adverse cognitive outcomes and adverse psychiatric outcomes.

The result was a response by a Consortium (self-described) of Big Pharma companies, including Novartis, Johnson & Johnson, Shire, Medice, and Laboratorios Rubió on 30 October 2009⁽²⁾. It has become publicly available only by order of a Swedish court.

Big Pharma's Response

The Consortium's response is full of self-serving and highly questionable references to junk science done by Biederman and other Big Pharma shills. It includes obfuscations trying to create the impression that studies into adverse outcomes are not feasible. Biederman, in particular, is cited. This is the man who created the bipolar diagnosis for children as young as 18 months! Can you imagine a child not having mood swings? Not having moments of manic activity? Perfectly normal and wholesome behavior has been psychiatricized by him—just for the purpose of creating a whole new market for Big Pharma poisons.

On the issue of confounding factors (things that might confuse results), the paper states,

Finally, because we are considering effects that are not specific to treatment, it would be nearly impossible to attribute accurately any observed effects to treatment that may have been stopped well over three years previously.

The utter absurdity of this statement is mindboggling! If they are unable to distinguish adverse outcomes because of confounding effects, then how can they possibly claim to have found beneficial results for their poisons drugs?

The Consortium's response amounts to nothing more than stonewalling. It was issued over four months ago and is only now available because it required a court ruling to let the public see it. Why hasn't the EMEA responded? What possible response can they give, other than, "Until your drugs have been demonstrated to be safe, they are banned"?

Can anyone possibly believe that the FDA and EMEA hold the welfare of children as their primary concern? Where is the FDA's action on its own memorandum of the terrible effects of ADHD drugs? Why did the EMEA allow the Consortium of Big Pharma ADHD drug makers to take 2½ years to respond to their request for a plan to study their products' long term effects? Why was the Consortium's response withheld from the public? Why didn't the EMEA immediately tell the Consortium that their response was not acceptable?

Who runs these agencies? They have sold our children out. How many children are on methylphenidate ADHD drugs, and how many will develop psychoses as a result? That's on top of 10½ times more children failing in schools as a result of taking these poisons. These drugs have been linked to later cocaine and methamphetamine abuse, which certainly shouldn't surprise anyone, since they're hooked on the related methylphenidate. How many parents, if they knew about these risks, would allow their children to be put on them?

Instead, their parents are convinced by doctors, who have been convinced by Big Pharma scams, that their children need these drugs. This cycle must be stopped, but it seems to be up to the parents to call a halt. At this point, it doesn't look like the government agencies tasked with protecting us from dangerous pharmaceuticals is even trying to do the job. Doctors appear to have abdicated, simply going along with whatever the latest drug fad seems to be. That leaves parents on their own to stop the poisoning of their children.

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