Why did Merck withdraw Vioxx, a drug that made it $2.5 billion per year?
... or why did they wait so long?
Because the FDA told it to do so? Or because they new that they were going to face more lawsuits than the money they could now make selling the drug? Let's think of $2.5 billion reasons why they waited so long.
It is folly for someone to claim that the risks are worth it in the case of a pain killer. This was not a "life saving drug" as some may want to argue. See for example the missive published in The Madison Record.
There, Mr. Herrick write, "Of course, it's easier to count those few people whom statistics suggest may have died in greater numbers than expected, even if only from natural causes, than to count those whose lives might have been extended by access to a drug that has been taken off the market. The latter have no right to sue."
What we are talking about is a failure on the par tof Merck to WARN of the dangers. They not only did not warn, it appears that they covered it up, according to documents now being brought to light in litigation against Merck.
Mr. Herrick writes, "The evidence that Vioxx was dangerous was pretty slim. Over the course of a multi-year study that followed nearly 2,600 people, 45 of the patients taking Vioxx experienced heart attacks or strokes, compared to 25 people taking a placebo. The number of people in each group who actually died was five."
Slim? Are you kidding me?
But consider, this Vioxx recall timeline, and then you tell me if the evidence was "slim".
1998: Vioxx put on the market amid controversy over the safety of Cox-2 drugs.
January 1999: A study of 8,100 rheumatoid arthritis patients begun in January 1999.
February 2001: FDA members expressed concerns about the heart risks of Vioxx and doctors on FDA panel argued that the drug's possible harm to the heart was a real problem. FDA panel felt that more studies should be done.
March 2000: Clinical trial suggested heart risk concerns. In the study, called Vigor, patients were treated with either Vioxx or naproxen, an older pain reliever. While Vioxx reduced the risk of internal bleeding, it also appeared to raise the incidence of heart problems. Five times as many patients taking Vioxx had heart attacks as those taking naproxen.
March 2000: Company executives were told about the preliminary results from the Vigor trials that showed increased cardiovascular risk and were "open to the possibility that Vioxx was at fault."
April 2000: Merck plays down the heart risk findings, with no basis that has ever been defined by Merck as to why it ignored the findings.
Spring 2000: Merck researchers reviewed safety data from a study of Vioxx and was unable to find that Vioxx posed a risk. "But Merck never ran a clinical trial seeking to scientifically establish the heart-protecting properties of naproxen or to quantify how powerful an effect might be. In recent interviews, company officials said they did not believe there was a reason to conduct such tests because the critical issue was not proving naproxen's benefits but determining if Vioxx posed a risk."
May 2000: Merck marketing executives considered whether to directly test Vioxx for heart risk.
May 2000: Marck's policy-making group met to discuss ways to defend Vioxx against competing drug makers' accusations that it posed cardiac risks. A cardiovascular risk study was considered.
May 2000: Merck's marketing executives opposed further cardiac study.
June 2000: Merck executives rejected pursuing a study focused on Vioxx's cardiovascular risks. Study would require as many as 50,000 patients. Merck worried that this study would hurt its marketing. Marketing of Vioxx was the primary concern for Merck. Many scientists (from the academic community, not from Merck) repeatedly asked Merck to perform studies of the cardiovascular risks from Vioxx.
For the following years, Merck took the position that "Vioxx was safe unless proved otherwise." During this time, "researchers fiercely debated how the question should be pursued, and some even now question whether the drug needed to be withdrawn."
2001: "Dr. Deepak L. Bhatt, a cardiologist at the Cleveland Clinic, proposed to Merck a study of Vioxx in patients with severe chest pain. Merck declined, saying the patients proposed for the study did not reflect typical Vioxx users."
September 2001: FDA sent Merck a warning letter stating that Merck's promotional campaign for Vioxx "minimizes the potentially serious cardiovascular findings" in Vigor.
Septmeber 2001: Merck required by the FDA to send letters to physicians across the country "to correct false or misleading impressions and information."
2001: Merck achieves $2.5 billion dollars of sales of Vioxx.
2001: Study critical of Vioxx appears in The Journal of the American Medical Association. Data from several clinical trials of Vioxx showed that Vioxx may increase the risk of heart attack and stroke, and that the danger from Vioxx appeared higher than other Cox-2 drugs.
October 2002: Study by an epidemiologist at Vanderbilt University, found that high doses of Vioxx caused significantly more heart attacks and strokes than similar patients who were not taking high doses.
2002: Elucida Research examined Vioxx and found that Vioxx damaged the lipids and caused an increase in blood clots.
Late 2002: Merck faces initial lawsuits from individuals suffering from strokes and heart attacks
April 2004: Harvard Medical School found that Vioxx raised the risk of heart attacks relative to Celebrex.
June 2004: Researcher showed that Vioxx increased the risk of hypertension.
August 2004: Epidemiological study F.D.A. researcher based on Kaiser Permanente health care system data showed an increase cardiovascular risk for Vioxx. Study showed increased the risk of heart disease 3.7 times
Septmeber 2004: Merck withdraws Vioxx from the market.
October 2004: Thousands of people come forward with claims that their heart attacks and strokes had been caused by Merck's Vioxx.
October 2004: "Dr. David Graham, estimates Vioxx had been associated with more than 27,000 heart attacks or deaths linked to cardiac problems."
November 2004: SEC announces an investigation into Merck's misrepresentations to its investors.
November 2004: Congress announces hearings into Merck's failures and the failures of the FDA to regulate Merck.
November 2004: The Justice Department launches investigations into what Merck knew and whether there was corporate/criminal malfeasance.
I strongly disagree with Mr. Herrick. He says, "The ones who suffer the consequences are the patients, and they should be allowed to decide whether a drug like Vioxx is worth the risk, rather than having the decision made for them by other people's lawyers. What is truly unfortunate is that the only people to benefit from the development of lifesaving drugs removed from the market due to these lawsuits are the trial lawyers."
I say that the only ones standing between pharmaceuticals who make profits off of a public being poisoned by bad drugs are the trial lawyers.
Comments by Michael Monheit, Esquire. http://www.monheit.com
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