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Tuesday, November 30, 2010

An Interesting Take on How You Can Trust the FDA

Most who know me know that I have worked in mental health and psych for many years, albeit, mainly with a keen interest in natural mental health.

I believe nutrition has a very important role in health, physical and mental.  However, with the furor over S510 it does concern me that good, sound nutrition won't be part of the landscape.

And as you can see here in the following three articles, leaving it to the FDA leads us down a very slippery slope.

Looks like more and more no one in Congress or government is doing too much of a good job for the electorate these days.

And outside the issue of risky antidepressant drugs, FDA allows so many more that we have alerted our readers to their dangers for many, many years... 
The antidepressant reboxetine: A headdesk moment in science

Every so often there comes a truly "headdesk" moment in science. A moment where you sit there, stunned by a new finding, and thinking, blankly..."ok, now what?"
For psychiatry and behavioral pharmacology, one of those moments came a few weeks ago with the findings of a meta-analysis published in the British Medical Journal (Eyding et al., 2010). The meta-analysis showed that an antidepressant, reboxetine (marketed by Pfizer in Europe, but not in the US, under the names Edronax, Norebox, Prolift, Solvex, Davedax or Vestra) doesn’t work. Not only does it not work, it REALLY doesn’t work, and it turns out that Pfizer hadn’t published data on the putative antidepressant from 74% of their patients. Some people have reported that the study found that reboxetine was even "possibly harmful," but that’s not quite true. What the study DID find is that reboxetine produced more side effects (noted as "adverse events") than placebo (as might be expected), but with no positive effects at all. While many antidepressants on the market today are not great, most are effective in around 60% of patients, reboxetine turns out to be even worse than that.
SOURCE and complete article
The next two reports come from the Alliance for Human Research Protection news feed,

A letter of complaint by the Project on Government Oversight (POGO) was sent to the director of the National Institutes of Health, documenting $66.8 million in NIH grants over the last five years awarded to a handful of psychiatrists who used ghostwriters for scientific publications. 

The instances in the letter involve ghostwriting by only one company--Scientific Therapeutics Information-- and involve only one drug--GlaxoSmithkline's antidepressant, Paxil.

Duff Wilson of The New York Times reports that previously sealed GlaxoSmithKline documents reveal that a textbook in psychiatry, whose listed authors are  Charles Nemeroff, MD and Alan Schatzberg, MD, was actually ghostwritten by Sally Laden of STI. GSK paid the ghostwriter and the "authors" who penned their names to the book.

The sheer audacity prompted former FDA commissioner, Dr. David Kessler to exclaim: "To ghostwrite an entire textbook is a new level of chutzpah. "I've never heard of that before. It takes your breath away."  Surely that is a
dubious distinction in academic medicine!
On November 23, 2010, Terry Vermillion, Director of FDA's Office of Criminal Investigation announced his  retirement next month amid a brewing scandal involving corrupt practices.

The announcement came after complaints by Republicans in Congress who raised concern about his misdirection of the Office's resources: instead of pursuing drug companies and researchers who commit crimes when seeking FDA approval for drugs, OCI pursued drug-abuse cases--which are the purview of the Drug Enforcement Agency.

The issue came to a head when Senator Chuck Grassley sent a complaint to the Acting Comptroller General of the General Accounting Office (GAO) about a "less than stellar" GAO investigative report which whitewashed misconduct at OCI. 

The investigation and the report were compromised by a GAO mole who tipped off someone at the Office of Criminal Investigations.   

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