Merck continues its attack on Vioxx victims

Merck relentlessly continued its ongoing attack on Vioxx victims. In a series of statements released yesterday by the firm, Merck is treating Vioxx victims as if they are the ones who have done something wrong. Forget about even a word of apology for the deaths and injuries or even a mention of the pain caused to those who consumed its product. On the other hand, the management team of Merck went on an all-out attack against Vioxx lawyers and victims and proclaimed that it was ready to fight anyone who ends up in court with a Vioxx lawsuit.

So when the Merck CEO says, "The only things we haven't changed are our commitments to patient safety, to the highest ethical standards, and to excellence and integrity in our science," it sounds so hollow. We wonder which patient taking Merck medicines would believe this statement when the company continues to treat patients who took Vioxx as criminals. (Related article: Vioxx class action lawsuits against Merck exploding)

Below are excerpts from the statement made by CEO Raymond Gilmartin in presentation to analysts and investors:

"On the afternoon of Sept. 24, Dr. Peter Kim, President of Merck Research Laboratories, called to alert me to information he had received just that morning. The information was from an independent, external board of physicians and scientists monitoring the safety of patients in a major trial on VIOXX. He told me that in the trial we sponsored – known as APPROVe – there was an increased risk of confirmed cardiovascular events beginning after 18 months of continuous daily treatment in patients taking VIOXX compared to those taking placebo.

That call triggered a series of events that led, within four days of that call, to Merck contacting the FDA to tell them that we were going to voluntarily withdraw VIOXX from the market. The decision that we made to withdraw VIOXX was difficult in several ways. VIOXX was the only nonsteroidal anti-inflammatory medicine or NSAID that was demonstrated to provide pain relief similar to high-dose NSAIDs and proven to reduce the risk of developing debilitating gastrointestinal side effects compared to those on NSAIDs. This was an important benefit for many who suffered from the pain of arthritis and other conditions. An estimated 15,000 Americans die each year from gastrointestinal bleeding associated with NSAID use.

Many patients counted on VIOXX to help them when no other medicine would. We believed that it would have been possible for Merck to continue to market VIOXX with labeling that would incorporate the new data. (Related article: Vioxx most dangerous drug in Cox-2 inhibitors drug category)

On another level, however, the decision we made to withdraw VIOXX was easy. Given the availability of alternative therapies and the questions raised by the data, withdrawing VIOXX was consistent with an ethic that has driven Merck actions and decisions for more than one hundred years. Merck puts patients first. (Related article: Why Merck did not recall Vioxx earlier?)

I would like to make three points clear at the outset.

1. First, the Food and Drug Administration approved VIOXX only after Merck had extensively studied the medicine and found it to be safe and effective. Merck continued to extensively study VIOXX after it was approved for marketing to gain more clinical information about the medicine. (Related article: Vioxx approval may have been a mistake by the FDA)
2. Second, since the time Merck submitted a New Drug Application for VIOXX to the FDA, we have promptly disclosed the results of numerous Merck-sponsored studies, including the VIGOR study, to the FDA, physicians, the scientific community and the media and participated in a balanced, scientific discussion of its risks and benefits. (Related article: Merck mounted an attack on all studies that showed that Vioxx was a problem drug)
3. Third, until APPROVe, the combined data from randomized controlled clinical trials showed no difference in confirmed cardiovascular event rates between VIOXX and placebo and VIOXX and NSAIDs other than naproxen. And we only found an increased risk of cardiovascular events in APPROVe because Merck continued to study VIOXX for such a long time period. When data from the APPROVe study became available, Merck acted quickly to voluntarily withdraw the medicine from the market.

We are confident that a careful and complete examination of Merck's conduct shows that, at all times, we acted responsibly and in a manner consistent with Merck's commitment to patient safety and our rigorous adherence to scientific investigation, openness and integrity. Throughout Merck's history, it has been our rigorous adherence to scientific investigation, openness and integrity that has enabled us to bring new medicines to people who need them. I am proud that we followed that same rigorous scientific process at every step of the way with VIOXX."

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