FDA TO REQUIRE SUICIDE DATA

The FDA is requiring drug manufacturers to study whether patients become suicidal during a clinical trial. Read the article from the NY Times HERE. 

From the article: The drug agency’s concerns are consistent with a growing body of research confirming that behavior is heavily influenced not only by genes but also by seemingly innocuous changes in body chemistry. Drugs not reaching the brain were once thought to be largely free of mental effects. 

Class, can you think of another "behavior" disorder (think 299.0* diagnosis code) that could be the result of both genetics and "innocuous/innoculated?" changes in body chemistry?

And here's an interesting quote from Dr. Tom Insel of NIMH:

“One lesson from pharmacology is that you can see effects on emotion and cognition without the drug entering the brain if a drug leads to peripheral changes in other chemicals that enter the brain," said Dr. Thomas R. Insel, director of the National Institute of Mental Health.

Could mean that vaccines, which go directly into the bloodstream, could show an effect on emotion and cognition (similar to orally administered drugs) by leading to peripheral changes in other chemicals that enter the brain, Dr. Insel?

Can you imagine the agony of enrolling in a clinical trial in the hope of treating a medical condition and finding yourself suicidal?  Now, can the FDA make the pharmaceutical companies report the data honestly?  See this Age of Autism post to learn how drug companies hide data.

*299.0 is the behavioral diagnosis code for autism.

Comments

[Gatogorra]

For those who don't have a subscription for the NYT online, the Alliance for Human Research Protection has issued a review of Gardiner Harris' Times article, written by a drug safety researcher who has remained anonymous. Within the next few days, this review, with the full text of the Times article included, will appear at: http://ahrp.blogspot.com
If it doesn't immediately appear, keep checking and it will.

The AHRP article on the Times piece is not merely a review but adds further "insider" background information to ways in which the FDA has already fudged and massaged the drug-induced suicidality data it's been privy to for almost twenty years.

For instance, the FDA has known since 1991 that antidepressants caused suicidality and violence in adults and children and were soon made aware-- also through the drug companies' own studies-- that this was true for individuals with no prior history of depression (those being treated with SSRIs for migraines). They knew--and instead of requiring that the public be informed via safety labelling and the publishing of reports and issuing of warnings to doctors, the FDA engaged in stalling tactics and attempted to cover up the signals (an attempt which initially failed, though practice makes perfect). So it's a concern that the clinical trial requirement for suicide data may merely be a meaningless phantom, just so they can say the safety check is in place as red carpet for the preemption ruling which is currently threatening to be lowered upon the judicial system as the be-all and end-all of tort reforms. The FDA can't just pretend to have integrity. They must be *seen* to be pretending to have integrity.

And there's another very interesting problem with the screening tool that the FDA will require those conducting drug trials to use which warrants further investigation. Anyone who's heard of the Orwellian New Freedom Initiative-generated "Teenscreen" test being foisted on schools (by those who stand to profit by the increased rate of children being referred to psychiatrists for psychotropic drug prescriptions: http://tinyurl.com/2xekvg And no, this site has nada to do with Scientology) knows that this suicide assessment test, which has an 84% false positive rate among those children "positively" screened for suicidal tendencies, was generated by Columbia University Children's Psychiatric Center. Could the also-Columbia generated "Columbia Suicide Severity Rating Scale"-- the one slated to be used in drug trials to test suicide potential among test subjects-- be the SAME TEST? It would be an interesting project to acquire copies of both and compare the two tests to see. I'll venture a wild guess that these two tests will be very different, in fact, converse: with the new Suicide Severity Rating Scale containing, say, a possible 84% false *negative* rate of detecting suicidality. Because, so far, if the FDA had a PR tagline to promote itself to industry, it could be "We're the FDA-- We make signals go away".

[Backwards]

From the NY Times -

"The seeds for the new federal effort were planted four years ago with the discovery that antidepressants may cause some children and teenagers to become suicidal."

It is no wonder that the Center for Biologics has been unable to come up with anything regarding the mercury in the vaccines as the FDA seems to be getting everything backwards. They do not seem to concern themselves with the question about why the children and the teenagers are needing the antidepressants in the first place. But let me guess, they are going to be pointing a finger at - hmmm, who do we pick? The CDC? The AAP? This is like you are perpetually chasing your own tail. Its like you need to approve a peanut vaccine for a peanut allergy that was preventable in the first instance.