Parker Waichman LLP Injury Alerts
EMERGENCY VIOXX UPDATE - The VIOXX Disaster or: Why Should Merck Have Worried About A Few Heart Attacks When There Were Billions of Dollars to be Made?Oct 1, 2004 Between January 2003 and June 2004, Merck & Co. spent almost $123.9 million dollars in DTC (Direct to Consumer) advertising to persuade the public that Vioxx offered safe and effective treatment for acute and chronic pain associated with osteoarthritis, primary dysmenorrhea (moderate to severe menstrual pain), and other problems. Attractive actors and celebrities, like Olympic figure skating champion Dorothy Hammil, pitched the drug in carefully orchestrated commercials set to The Rascals’ 1968 hit “Beautiful Morning.”
Unfortunately, all of this was taking place while Merck, the FDA, and many highly respected medical experts were aware that the drug was considerably more dangerous than the public knew or even suspected. Despite the efforts by public interest groups and research organizations to have the drug pulled from the market or labeled with far more serious warnings, Merck refused to acknowledge the significant (heart-related) danger VIOXX posed. Rather than challenge Merck’s questionable position, the FDA, which had access to all of the incriminating data, continued to approve the drug for wider applications. (In fact, on September 8, 2004, only three weeks before VIOXX was pulled from the market, the FDA approved the use of VIOXX in the treatment of rheumatoid arthritis in children as young as two).
So, how was the public duped (once again) into believing that a very dangerous prescription drug was relatively harmless? Part of the problem was the inadequate testing and premature FDA approval which have become all too familiar in cases involving prescription drugs which have been pulled from the market in the past several years (BAYCOL, REZULIN, LOTRONEX, PROPULSID, RAXAR, DURACT, RAPLON, POSICOR, MANOPLAX, OMNIFLOX, and REDUX for example). As the following clearly shows, however, the VIOXX story is far more troubling.
VIOXX Was Always a Disaster Just Waiting to Happen.
VIOXX was approved for sale by the FDA on May 20, 1999. Almost immediately thereafter evidence began to emerge that the risks associated with the drug were far more serious than Merck had led the FDA to believe. A safety study done in 2000, and published in the New England Journal of Medicine, showed that VIOXX faced a significantly higher risk of heart attacks and strokes than people taking a traditional pain reliever, naproxen. Although the results of this study should have prompted the FDA to take immediate action in the form of additional warnings, ordering further testing, or suspending the sale of the drug, Merck took the position that the study was inconclusive. Merck argued that the study only demonstrated that naproxen probably reduced the risk of heart attack and stroke and not that VIOXX increased that risk. Merck continued to advertise VIOXX in a way that virtually ignored the results of this study (VIGOR).
In April of 2001, Public Citizen (http://www.citizen.org), a well-respected national non-profit public interest organization, advised the public not to use VIOXX because of potential heart-related risks. Despite the results of the study and the warnings from Public Citizen, Merck continued to promote the drug in a way that minimized this risk.
On September 17, 2001 (and, to Merck’s good fortune, lost in the news of the terrorist attacks of 9/11), the FDA issued an 8-page warning letter to Merck concerning its false and misleading promotional campaign. The FDA found:
“You have engaged in a promotional campaign that minimizes the potentially serious cardiovascular findings that were observed in the VIOXX Gastrointestinal Outcomes Research (VIGOR) study, and thus, misrepresents the safety profile for VIOXX. Specifically, your promotional campaign discounts the fact that the VIGOR study patients on VIOXX were observed to have a four to five fold increase in myocardial infarctions (MIs) compared to patients on the comparator nonsteroidal anti-inflammatory drug (NSAID), Naprosyn (naproxen).”
This information was published by Public Citizen in November 2001. At that time, Merck was also aware of increased risks of thrombotic (blood clotting) adverse effects such as strokes and blood clots in the legs, hypertension, and altered kidney function. However, VIOXX was now a blockbuster moneymaker ($1.5 billion in 2000 and $2.5 billion in 2003) and Merck decided to protect its cash cow at all costs; even if it meant withholding critical information from the public.
Marketing Triumphs Over Science.
With 2 million current VIOXX users in 80 countries, 84 million total users since 1999, and sales in the billions of dollars annually, Merck’s judgment succumbed to the power of the bottom line. “Damn the torpedoes, full speed ahead” was Merck’s philosophy when it came to defending every challenge to its claims that VIOXX was a safe drug. This attitude simply ignored the mounting evidence that VIOXX was, indeed, the killer it had always been suspected of being. This is all the more obvious when one considers the following facts:
* Kaiser Permanente, the largest HMO in the United States, found the 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., the third largest health insurer in the United States, announced that VIOXX was the 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 the 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 the American Heart Association, the National Stroke Association, and the 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 the name of its scientist removed from the list of authors on the study.
Thus, no one can seriously argue that Merck had the public’s best interests in mind when it chose to ignore all of the evidence that VIOXX was an extremely dangerous drug and repeatedly refused to conduct further safety tests, issue stronger warnings to the public, or consider removing the drug from the market. The FDA’s foot dragging was no less disturbing. In fact, all that Merck appears to have been interested in was obtaining wider and wider approval for the drug. Unfortunately, the FDA was a willing participant in this dangerous plan. As noted above, on September 8, 2004, the FDA actually approved the use of VIOXX in the 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.
Merck’s Greed Was Its Undoing.
Although Merck is attempting to make the best out of a very bad situation by making it appear as if its voluntary withdrawal of VIOXX was motivated by concern for the public, the evidence does not support that position. There is little doubt that the removal of VIOXX from the market was anything but a purely financial consideration on the part of Merck which stands to lose $700 to $750 million in the fourth quarter of 2004 alone. The lawsuits are piling up and some will be proceeding to trial shortly.
Corporate analysts who have commented on Merck’s action see it as a sound business move under the circumstances. They do not attribute it to any sudden pangs of conscience on the part of Merck’s CEO or Board of Directors. In fact, the evidence shows that Merck is still interested in Merck and not the safety of the public at all. We ask our subscribers to consider the following facts:
* The study (APPROVe trial) which led to Merck’s decision to voluntarily withdraw VIOXX from the market was really aimed at gaining FDA approval for VIOXX as a treatment for preventing the recurrence of colon polyps. (APPROVe stands for Adenomatous Polyp Prevention on VIOXX which clearly shows the study had nothing to do with safety and everything to do with gaining approval from the FDA for even wider use of VIOXX). In Merck’s open letter to “VIOXX Patients,” which has appeared in newspapers across the country, Merck claims that the study was “a clinical trial to better understand the safety profile of VIOXX.” It was no such thing. In fact, had the 3-year study not been halted abruptly on September 24 by the Data Safety Monitoring Board for safety reasons, VIOXX would still be on the 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 the near future. While ARCOXIA is not yet a billion dollar drug and must gain approval in 33 more countries to equal the worldwide market enjoyed by VIOXX, it is clear that VIOXX was well on the way to being replaced when it was pulled from the 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 the 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…” Thus, Merck would still have kept VIOXX on the market had it not met with the FDA on September 28 and been forced to confront the disastrous results of its own study.
Some Interesting Observations by Medical and Business Experts.
Most experts who are familiar with the history of VIOXX from either a medical or business perspective were not surprised by Merck’s sudden withdrawal of the drug from the market. The only surprise any of these experts seem to have is why it took so long for it to happen.
Dr. Sidney Wolfe of Public Citizen was quoted in the San Francisco Chronicle (10/1/04). He stated: “This family of drugs, the COX-2 inhibitors, once referred to as ‘super aspirins,’ are turning out to be more like super disasters.”
Dr. Eric Topol, Chief of Cardiovascular Medicine and Chief Academic Officer of the Cleveland Clinic, was a co-author of the VIGOR Study discussed above. His comment to the Washington Post (10/1/04) was that Merck’s action was “the right decision about three years too late. This is the sort of thing that Merck should have studied earlier, but they were too busy refuting the warning signs.”
The Wall Street Journal (10/1/04, page B1) noted that “Merck also may face more criticism for having strenuously denied for several years suggestions by outside researchers that use of VIOXX led to heart problems. The company even published its own studies suggesting the drug wasn’t causing harm.”
Parker & Waichman Always Recognized the Dangers of VIOXX.
Parker & Waichman has been in the forefront of prescription drug litigation for many years. As a result, a number of our attorneys devote a substantial amount of time to reviewing medical literature and research studies concerning potentially dangerous drugs. They also attend conferences and seminars with respect to specific drugs as well as the pharmaceutical industry in general. We also work closely with highly qualified medical experts and other law firms engaged in this type of litigation to ensure the best possible results for our clients.
VIOXX was one of those drugs which Parker & Waichman always regarded as too dangerous to justify. It was repeatedly found to pose an unacceptably high risk of heart attack and stroke. Moreover, it was never shown to be more effective than older, safer, and less expensive alternatives. We were also extremely concerned with Merck’s refusal to accept the findings and advice of highly regarded medical experts and research institutions. For these reasons, Parker & Waichman has been investigating the VIOXX-heart attack connection for over three yeas. The firm already represents several clients who claim to have been seriously injured by the drug. Our August 2004 Newsletter (dealing with arthritis medications) specifically addressed the significant heart attack and stroke risks posed by VIOXX.
Immediately following the announcement of the recall, Parker & Waichman received well over 100 e-mails and telephone calls from people who were seeking a free case evaluation or other information regarding VIOXX. Jerrold Parker, who is one of the country’s foremost authorities in pharmaceutical litigation was interviewed and quoted by several publications concerning the VIOXX story. His comments can be found on our website at http://www.yourlawyer.com/articles/read/8580 as well as on Forbes.com at http://www.forbes.com/sciencesandmedicine/2004/09/30/cz_rl_0930vioxxlegal.html. He was also quoted in the New York Daily News (10/01/04 at p.2) stating: “Merck’s exposure is huge because of the number of patients that have taken VIOXX over the years…And each of the side effects is so catastrophic that every case is going to have a very large value.” Mr. Parker was also quoted in the New York Post (10/1/04 at p. 14).
If you have any questions regarding VIOXX or whether you or a loved one has a possible case against Merck & Co. for injuries caused by this drug contact Parker & Waichman immediately online http://www.yourlawyer.com or by calling 1-800-YOURLAWYER (1-800-968-7529). You may also obtain information on VIOXX at http://www.vioxx.com, http://www.merck.com, http://www.fda.gov, and 1-888-463-6332 (FDA).