INTERNAL DOCUMENTS CONTINUE TO RAISE SERIOUS QUESTIONS CONCERNING MERCK�S AGGRESSIVE MARKETING OF VIOXX IN THE FACE OF MOUNTING EVIDENCE THE DRUG POSED AN INCREASED RISK OF HEART ATTACKS

As more and more of Merck’s internal documents come to light, the more questionable the company’s long-standing defense of VIOXX as a safe drug becomes.

Only last month, documents released at a congressional hearing left little doubt that Merck’s sales representatives were given intensive training with respect to deflecting doctors’ questions and concerns about the safety of the drug. Every aspect of the representatives’ interactions with doctors was carefully orchestrated by Merck to minimize both the scope and the duration of risk-related discussions. Those risks were to be downplayed and even trivialized.

Now, the Associated Press reports it has acquired an additional internal document that was “mistakenly provided by Merck” to attorneys representing the plaintiffs in one of many ongoing VIOXX lawsuits. The “communication between Merck researchers and the company’s patent department stated that the way VIOXX works to reduce pain might also increase cardiovascular problems.”

The document reveals a desire to reformulate VIOXX to combine it with an agent that would lessen the cardiovascular risk of the drug. In suggesting this approach, the document clearly discusses a potential mechanism which may be the cause of the problem.

Thus, while Merck has maintained it was always convinced of the drug’s safety, the company’s “desire to reformulate the drug suggests a level of urgency that goes beyond previously disclosed internal e-mails that discussed safety risks.”

A number of legal experts see this document as evidence that Merck’s defense is questionable. Taken in conjunction with all of the other circumstances surrounding VIOXX and the COX-2 class of painkillers (VIOXX, Bextra, and Celebrex), Merck’s approach seems to have been the ultimate triumph of marketing over science.

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).

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 (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 made a clear business decision to protect this highly profitable asset by whatever means necessary. Many critics now believe that included withholding critical information from the FDA and the public.
      
With 2 million VIOXX users in 80 countries, 84 million total users since 1999, and sales in the billions of dollars annually, Merck’s judgment appears to have succumbed to the power of the bottom line.

When it came to defending every challenge to its claims that VIOXX was a safe drug, Merck simply “stonewalled.”  This attitude simply ignored the mounting evidence that VIOXX was, indeed, the potential killer numerous highly qualified experts had always suspected it 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.
•    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. Shockingly, when this finding was made, Merck had the name of its scientist removed from the list of authors on the study.       

Although Merck attempted 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.  

Most business experts have little doubt that the removal of VIOXX from the market was anything but a purely financial consideration on the part of Merck which stood to lose $700 to $750 million in the fourth quarter of 2004 alone. The lawsuits were piling up and some of the cases were close to trial.

Corporate analysts who 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 showed that Merck was still solely interested in widening the market for COX-2 inhibitors. That evidence included the following:

•    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 actually 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 probably still be on the market.
•    Merck had 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 the billion dollar drug VIOXX was, it is clear that VIOXX was well on the way to being replaced when it was pulled from the market.
•    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 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 seems 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.”  

The ongoing congressional inquiry, FDA scrutiny, and billions of dollars in personal injury litigation have placed Merck’s corporate philosophy, with respect to VIOXX at least, under a microscope.  In the end, Merck’s decision to aggressively market a drug in the face of scientific evidence of its dangers may prove to be a costly mistake indeed.

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