Merck's top management team reportedly remains un-phased by Vioxx litigation woes. In fact, Prudential Equity Group analyst, Timothy Anderson, says Merck's Chief Executive, Richard Clark, specifically told him that "Vioxx does not keep him up at night."
According to Mr Anderson, "the company believes that lower court cases will be overturned on appeal, and it is even considering trying to reintroduce Vioxx."
"A reintroduction might help Merck's legal case," Mr Anderson states, "as long as the FDA or its advisers do not decide that Merck's risks really do outweigh its benefits," he said in a June 21, 2006, article in Forbes.com,"
Critics say, that's not even a remote possibility because the FDA is still under fire for its own part in the Vioxx disaster and it wouldn't dare pull a stunt like that.
When it comes to saving Merck in the Vioxx litigation, the FDA is at odds with some of the most powerful leaders in Congress. Senator Charles Grassley (R-Iowa), chairman of the Senate Finance Committee, is on record as saying the Vioxx debacle has shown that the FDA has gotten too cozy with drug companies to conduct proper oversight.
"The Vioxx example showed that the FDA and Merck were too close for comfort," he said in a speech. "Testimony and documents at our Finance Committee hearing showed that the FDA allowed itself to be manipulated by Merck."
Documents indeed reveal that the FDA knew about the problems with Vioxx very early on. A memo written by Shari Targum, MD, Project Manager for the Division of Anti-inflammatory Drug Products, clearly shows that as of November 18, 1999, the Data and Safety Monitoring Board of the VIGOR study, a committee independent from Merck, was concerned over the deaths from cardiovascular events in the Vioxx group, compared to the group taking another painkiller.
This memo documents a clear date of recognition by the FDA of when cardiovascular events were brought to the attention of Merck.
Admittedly, if it was up to the Bush administration, the FDA would allow Vioxx back on the market today. Bush does everything in his power to protect the profits of Big Pharma, the industry most responsible for his 8-year rent free lease of the White House.
Under Bush, the FDA has in fact become Big Pharma's chief enabler when it comes to getting away with murder. A newly released report on June 26, 2006, titled, "Prescription for Harm: The Decline in FDA Enforcement Activity," says that FDA enforcement actions have declined by 50% since Bush took office.
"The number of warning letters issued by the agency for violations of federal requirements," the report said, "has fallen by over 50%, from 1,154 in 2000 to 535 in 2005, a 15-year low."
"During the same period," it noted, "the number of seizures of mislabeled, defective, and dangerous products has declined by 44%."
Bush has never hesitated to utilize the FDA in the Big Pharma protection racket. For instance, on January 18, 2006, the FDA issued new regulations for labeling prescription drugs, supposedly aimed at providing doctors and patients with clearer information about their risks. But in the preamble to the regulations, the FDA inserted a claim that lawsuits alleging a failure to warn of known or reasonably knowable risks are preempted by federal law.
Also, amicus briefs filed by FDA attorneys appointed by Bush, on behalf of the drug companies, have tried to claim that because private lawsuits threaten to disrupt the nation's system of drug regulation, federal standards preempt requirements established by state judges and lawmakers, and that if a state court finds that a drug is unsafe, it is in direct conflict with the conclusion reached by the FDA.
With Bush using the FDA to do the dirty work, Republicans lawmakers up for reelection this fall, don't have to make a spectacle of themselves fighting for such blatant industry-friendly legislation during an election year.
A partner in the LA based, Baum Hedlund law firm, attorney Karen Barth Menzies, has been litigating claims against drug companies for more than a decade and says "the Vioxx public health debacle has served to highlight deep-seeded problems within the FDA."
