Senator Says FDA Asked Canada NOT to Suspend Adderall, Drug used for ADHD

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Fri, 11 Feb 2005 22:04:51 -0500

[sSRI-Research] Senator Says FDA Asked Canada NOT to Suspend

Adderall, Drug used for ADHD

 

Senator Says FDA Asked Canada NOT to Suspend Adderall, Drug used for

ADHD - NYT

 

Fri, 11 Feb 2005

 

http://www.ahrp.org/infomail/05/02/11.php

 

The New York Times reports that not only has the FDA failed to act to

protect children and adults from a drug that has been linked to about

20 sudden deaths, but the FDA attempted to stop Health Canada from

withdrawing the drug, Adderall, an amphetamine, from the Canadian market.

 

Canadian officials were guided in their decision to withdraw the drug,

by the evidence (fatalities):

 

" It's very difficult to generate a benefit-to-risk balance when the

risk is sudden and unexpected death. "

 

FDA officials, by contrast, repeatedly demonstrate greater concern for

industry's interests than safety considerations. The NYT quotes Dr.

Robert Temple of the F.D.A. " There is little evidence that the drugs

caused any of the deaths. " Dr. Temple always seems to side against the

cautionary principle of medicine-- " First, do no harm. "

 

FDA officials always seems to find arguments against linking evidence

of deadly events to the drug in question: " There is a tendency to

believe that sudden death doesn't occur in children. That is wrong. "

Dr. Temple added: " Psychiatrists say that these drugs are needed. "

 

The reason " psychiatrists say these drugs are needed " is that

psychiatry has failed to develop non-drug treatment alternative

options. Psychiatrists have become 100% dependent on psychotropic

drugs. This dependency has led to a disturbing symbiotic relationship

between the psychotropic drug manufacturers and the prescribers of

these drugs. Both psychiatry and the drug industry have a primary

stake in promoting the extensive use of drugs - even when the

scientific evidence shows the drugs pose unjustifiable risks of harm.

 

Senator Chuck Grassley, chairman of the Senate Finance Committee, in

the letter Thursday to the F.D.A. wrote that reports given to his

staff suggested that the agency was not acting with scientific integrity.

 

Indeed, that lack of scientific integrity was also demonstrated when

the FDA stilthily changed its recently issued warning (October 15,

2004) on antidepressant drug labels - without any scientific

justification.

 

Dr. Steve Romano, Pfizer vice-president announced during court

proceedings in which the antidepressant Zoloft figures prominently,

that the FDA had rescinded the statement acknowledging: " A causal role

for antidepressants in inducing suicidality has been established in

pediatric patients. "

 

That clear statement of causality reflects a deliberative,

scientifically arrived at conclusion. FDA's recsinding of the agreed

upon language (issued on October 15) blurs the clarity and reduces

the impact of the Black Box warning.

 

Once again, FDA officials demontrate an unconscionable disregard for

safety issues in an effort to accommodate the drug industry sustain

its profit margins - even if children's health and lives are sacrificed.

 

Contact: Vera Hassner Sharav

212-595-8974