Preparations begins for Vioxx legal battles

Vioxx victims do not have many friends right now. The battle lines are being drawn for Vioxx related class action lawsuits that are expected to go on trial in early 2005. As Merck CEO prepares for answering questions from plaintiffs' lawyers and Vioxx attorneys build their case for seeking compensations, Merck, along with the FDA and Bush Administration is on the attack. Almost everyone out there is trying to make Vioxx victims feel as if something is wrong with them to ask for compensation from Merck for deaths and injuries. Since the recall of Vioxx in September of this year, Merck has actually mounted an aggressive attack on Vioxx victims rather than apologizing for killing tens of thousands of people worldwide and injuring many others. (Related article: Merck continues its aggressive attack on Vioxx victims)

There is another battle being fought in the medical community and this too is part of Merck's attack campaign on Vioxx victims and critics. It is pretty obvious that Merck is getting ready to mount a strong defense in hundreds of Vioxx related class action lawsuits filed by victims.
Essentially the strategy that Merck and its sympathizers are adopting is to attack and discredit anyone who questions their position. You might recall Dr. David Graham, an expert at FDA, who criticized the FDA for its mishandling of Vioxx recall and pointed out that there were at least four more drugs that are as dangerous as Vioxx. Well, he almost lost his job. Only when the senators intervened and the media pointed out the injustice, did he survive. But it is very likely that he will be treated like a pariah and might leave the agency in disgust. (Related article: Vioxx recall critic Dr David Graham harassed by FDA)

Another important person to mention here is Dr. Eric Topol, the world-famous cardiologist. He was an early critic of Vioxx and had asked that the drug be recalled soon after it was approved. Over the next few years, Merck mounted an aggressive campaign in the medical journals to discredit his work. Merck scientists and paid consultants to Merck continued to write articles and letters in medical journals defending a killer drug rather than withdrawing it or issuing warnings to Vioxx consumers. (Related article: Vioxx approval may have been a mistake)

Now the battle with Dr. Topol has intensified. Merck, the FDA, and magazines friendly to Merck (e.g. Fortune magazine published a misleading article accusing Dr. Topol of baseless conflicts of interests.) are mounting a campaign to discredit Dr. Topol. In the latest issue of New England Journal of Medicine, Merck scientists Peter S. Kim, Ph.D. and Alise S. Reicin, M.D. along with FDA scientists Lourdes Villalba, M.D. and James Witter, M.D., Ph.D. have tried to defend their positions and attack Dr. Topol in very strong language saying that he "shows a lack of understanding of the FDA's regulatory authority" and "Dr. Topol's remarks....are false." Merck scientists conclude by saying, "The record, in short, is one of careful analysis at every stage, a continued commitment to research, and prompt and decisive action in response to clinical-study results." Sounds like a lot of marketing baloney that not many Vioxx victims are likely to buy.

In fact, Dr. Topol sets the record straight by pointing out that a critical study was never published and available solely through a subsequent FDA memorandum, and the data presented also suffered from errors of omission. In his opinion, "...many vital steps were not taken (by Merck) to evaluate the cardiovascular safety of rofecoxib (Vioxx) properly." He further adds that, "It took 14 months after the expert FDA panel convened, from February 2001 to April 2002, to change minimally the cardiovascular safety information for rofecoxib (Vioxx) in the package insert. After their cumulative meta-analysis, Juni et al. (scientists at Department of Social and Preventive Medicine, University of Berne, Berne, Switzerland) correctly stated, "Our findings indicate that rofecoxib (Vioxx) should have been withdrawn several years earlier."

Like Vioxx victims, many doctors in the country do not believe any of the arguments presented by either Merck or FDA. The New York Times is reporting that doctors at the Mayo Clinic, the federal Veterans Affairs Department and the Kaiser Permanente health plan have been sharply limiting their use of Vioxx and Celebrex for years. That is because those three institutions, after undertaking separate reviews of test data available on various painkillers, reached the same conclusion: For most patients, Vioxx, Celebrex and a related drug, Bextra, did not work any better than older pain relievers or provide any safety benefits beyond them. These drugs achieved blockbuster drugs simply because of slick direct-to-consumer advertising by Merck and Pfizer.

Recommended article: Merck leaves no other options than class action lawsuits by Vioxx victims