As the first Vioxx-related death case was about to start in Angleton Texas, a few things were already clear:
· This particular case was going to be one of the most difficult of the plaintiffs’ cases to prove since it was being brought under a medical theory that was not the one most experts saw as the weakest spot in Merck’s armor. (The case, Carol A. Ernst v. Merck & Co. Inc., in District Court of Brazoria County, Tex., had been considered a challenge for the plaintiff because Mr. Ernst’s death certificate said he died of an arrhythmia, or irregular heartbeat.)
· Merck would throw its entire arsenal of experts, corporate executives, and financial power against this first claim since a win for the company would serve as a warning to future plaintiffs that they would have to work very hard to win on a case by case basis.
· A win for Merck would give it superior bargaining power in any future settlement negotiations.
· A loss for Merck could signal the beginning of a costly war for the company, its insurers, and shareholders that many experts estimated could run as high as $18 billion or more in verdicts and settlements.
In anticipation of this critical trial, Merck launched a series of advertisements aimed at convincing the public that the company’s main concern was customer safety and making sure that everyone was able to obtain the drugs they needed despite soaring prices.
Unfortunately for Merck, on the other side of the equation was a mountain of evidence that pointed to a willful pattern of deception (at worst) or denial (at best) concerning the heart-related dangers associated with their blockbuster drug, Vioxx.
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 (TYSABRI, BAYCOL, REZULIN, LOTRONEX, PROPULSID, RAXAR, DURACT, RAPLON, POSICOR, MANOPLAX, OMNIFLOX, and REDUX for example). As the following clearly shows, however, the Vioxx story was far more troubling.
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.
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 (besides Merck) could 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.
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 were even getting close to trial.
Corporate analysts who have commented on Merck’s action saw it as a sound business move under the circumstances. They did 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 was still interested in Merck and not the safety of the public at all. 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 appeared in newspapers across the country, Merck claimed 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 was being marketed in 47 countries and for which Merck expected FDA approval in the near future. While ARCOXIA was not yet a billion dollar drug and needed to be approved in 33 more countries to equal the worldwide market enjoyed by Vioxx, it was 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.
Most experts who were 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.”
Thus, the baggage Merck was carrying into this first trial in Texas was far more burdensome than the company would have liked the public to believe.
As the trial progressed, the negative evidence not only contradicted every defense argument, it was also qualitatively superior. In fact, courtroom observers were of the singular opinion that Merck was losing the trial almost from the beginning.
Its attacks on the plaintiff’s witnesses were unavailing and the testimony of Merck’s experts and corporate executives was simply not convincing since it could not hope to explain away the evidence that had mounted up against Vioxx for years before it was pulled from the market.
As is usually the case when a giant is slain, the death blow is delivered by the least likely of opponents. Here, the multi-billion dollar pharmaceutical giant faced a jury of average people living in an average town. The weapons were power and money on one side and inescapable truth on the other.
In a simple verdict, the seven men and five women found Merck negligent in the death of the 59-year-old triathlete. The jury awarded the man’s widow $24 million in actual damages, plus $229 million in “exemplary,” or punitive damages, for a total of around $253 million.
The jury found Merck failed to warn doctors of the Vioxx’s danger, that the drug was improperly designed, and that Merck’s negligence caused Robert Ernst’s death.
While, predictably, Merck’s attorneys stated that the company planned to review the trial and appeal on several grounds, first blood has been drawn and the wound was deep and decisive.
Merck still plans to fight each of the nearly 4,000 cases against it vigorously and one at a time. While that threat was intimidating a few weeks ago, the blow struck against the giant by a tearful widow in Angleton, Texas has made it sound more like the posturing words of a loser than the confident words of a winner.