Saturday, June 04, 2005

FDA Might Be Forced To Do Their Job

Merck is facing an ever deepening crisis over its test result cover ups and its subsequent questionable marketing of the drug Vioxx.

The FDA, having been shown to have been completely derelict in its duty of protecting the US consumers (and the rest of the world whose regulators largly take their cue from the FDA), has been by-passed by the Department of Justice who have launched CRIMINAL INVESTIGATIONS into the companies actions. The SEC has also begun an enquiry.

Merck has acknowledged that the conclusions of the investigation could prove “highly unfavourable” and could find evidence that “could have a material adverse effect on the company’s financial position, liquidity and results of operations”.

Amongst other matters Merck are being investigated for causing federal health programs to pay for the prescription drug when its use was not warranted. That would be fraud on a grand scale.

They are also being investigated under criminal statutes for the charge of knowingly misleading investors, regulators and public health insurance programs about the safety of the drug

Jerry Avorn, a Harvard University medication safety expert, said, "These developments will help define the standards drug companies are expected to meet in addition to the standards the FDA may or may not have." Avorn added that DOJ and SEC "will be in a sense doing FDA's work at a time when the FDA has been asleep at the switch in its regulatory function".

This action could be the tipping point. For decades Big Pharma has indulged in more and more aggressive marketing of drugs that in many classes have caused more and more misery to the recipients. Simultaneously the public (the victims) have become more and more vocal about the dangers of these drugs that they were never informed of. Something had to snap and I believe that something has. The days of public and government trust of Big Pharma are coming to an end.

I expect this case to cause a massive change at the FDA. If Merck loses this case then watch out for the resignations and firings that will happen at the FDA. The cozy Big Pharma funded retirement deals of those senior FDA executives who for decades have obligingly turned a blind eye to the flawed drug trials could be much harder to come by in the future. The FDA could be rebuilt into a genuine regulatory agency INDEPENDENT of the financial muscle of the pharmaceutical companies.

This will spill over into a re-evalutation of all of Big Pharma’s products. It will not be long before PSYCHOTROPIC DRUGS ARE THE SUBJECT OF GENUINE AND HONEST STUDIES WHERE ALL RESULTS ARE PUBLISHED. This will not bode well for Big Pharma and the strange 20th century cult of psychiatry.

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