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Kaiser Permanente, largest HMO in United States, found incidence of sudden cardiac death to be three times greater for VIOXX than Celebrex among its patients.
Cigna Health Care regarded VIOXX as a “non-preferred medication” for its policy holders.
Aetna, Inc., third largest health insurer in United States, announced that VIOXX was subject of an ongoing study and recommended “alternative drugs” be prescribed in its place.
Every study ever conducted with respect to VIOXX between 1999 and 2004 showed an increased risk of heart attack.
Several medical research organizations consider entire COX-2 class of drugs to have an increased cardiac-related risk (although it appears that Celebrex may have a lower risk in this area).
A study done at Vanderbilt University, and published in The Lancet on October 5, 2002, noted that patients taking 50mg. of VIOXX for more than 5 days demonstrated a 70% greater likelihood of developing coronary heart disease (CHD).
Despite requests from American Heart Association, National Stroke Association, and Arthritis Foundation that Merck conduct additional safety studies, Merck claimed that VIOXX was safe and that it did not plan to conduct any such study.
An early 2004 study, which was actually funded by Merck, disclosed that VIOXX posed a risk of heart attack and stroke which was three times greater than that of other COX-2 pain relievers. Shamefully, when this finding was made, Merck had name of its scientist removed from list of authors on study.
Now, back to FDA and how bad an actor Merck really is... On September 8, 2004, FDA actually approved use of VIOXX in treatment of infants as young as 2 with rheumatoid arthritis. To say that this request by Merck was anything less than an unconscionable display of corporate greed is an understatement. Next, Merck’s greed was its own undoing. Although Merck is attempting to make best out of a very bad situation by making it appear as if its voluntary withdrawal of VIOXX was motivated by concern for public, evidence does not support that position. There is little doubt that removal of VIOXX from market was anything but a purely financial consideration on part of Merck which stands to lose $700 to $750 million in fourth quarter of 2004 alone. The lawsuits are piling up and some will be proceeding to trial shortly. And Merck is not acting out of an interest in public safety, but only to protect shareholder value. Consider this before concluding that Merck was thinking about safety and not dollars:
The study (APPROVe trial) which led to Merck’s decision to voluntarily withdraw VIOXX from market was really aimed at gaining FDA approval for VIOXX as a treatment for preventing recurrence of colon polyps. (APPROVe stands for Adenomatous Polyp Prevention on VIOXX which clearly shows study had nothing to do with safety and everything to do with gaining approval from FDA for even wider use of VIOXX). In Merck’s open letter to “VIOXX Patients,” which has appeared in newspapers across country, Merck claims that study was “a clinical trial to better understand safety profile of VIOXX.” It was no such thing. In fact, had 3-year study not been halted abruptly on September 24 by Data Safety Monitoring Board for safety reasons, VIOXX would still be on market.
Merck has already developed a new COX-2 pain reliever called ARCOXIA which is presently being marketed in 47 countries and for which Merck expected FDA approval in near future. While ARCOXIA is not yet a billion dollar drug and must gain approval in 33 more countries to equal worldwide market enjoyed by VIOXX, it is clear that VIOXX was well on way to being replaced when it was pulled from market. Clearly, safety was, at best, a distant second when it came to a reason for Merck’s voluntary withdrawal of VIOXX.
Finally, even though VIOXX was finally exposed for what it was; a dangerous drug, Merck stated in its press release that drug was being withdrawn despite Merck’s belief that “it would have been possible to continue to market VIOXX with labeling that would incorporate these new data…” Bull. Merck would still have kept VIOXX on market had it not met with FDA on September 28 and been forced to confront disastrous results of its own study.
So this is 3+ years ago that Merck had reason to know, let alone reason to explore this issue. They chose not to. Again, you know why I think that they made that choice. And having seen this before, in addition to this clear failure of Merck to study this earlier, adverse reports that Merck received in between will, I believe, spell out more than a simple mistake, but at least inference of an intent to simply make money at expense of patient safety.
Michael Monheit, Esquire is the managing attorney for Monheit Law. The practice is focuses on plaintiff personal injury cases and Vioxx Lawyers info can be found at Vioxx Lawyer - Monheit Law