Based on an article by Barry Meier. November 18, 2004.
"Nearly a year before Merck received results from the clinical trial that prompted the company to withdraw its painkiller Vioxx from the market, the company received preliminary results from a separate study of patient records that also apparently indicated that the drug posed cardiovascular risks."
What is disturbing is that Merck performed this study on the "hush-hush" and never mentioned it. Even when Merck determined that it must recall Vioxx, Merck made no mention. Only when investigative reporters questioned Merck, did they even confirm the study existed.
Merck "did not receive the final study report until 10 days before the company announced it would stop selling Vioxx. Why? Would $2.5 billion in sales per year be enough reason to be slow about getting the "final" details and making the annoucnement?
According to Joan Wainwright, the Merck spokeswoman, the separate study was "inconclusive" since it was only based on patient records. What more evidence does Merck want? Were people supposed to die because Merck did not do this sort of analysis in actual clinical trial? Shouldn't Merck have paid attention to all of the flashing yellow lights, rather than waiting for one red light telling them of the dangers posed by Vioxx?
The study in question consists of patient records from the UnitedHealth Group, one of the nation's biggest plans. This study looked at the "relative rates of heart attack and stroke in people taking Vioxx" and found that there was an increased risk of more than double.
The results indicated, according to an anonymous source, that Vioxx posed an increased risk of cardiovascular problems, compared with the other drugs studied (Celebrex).
According to Meier's article, "Ms. Wainwright said that the study had been submitted for potential publication in a medical journal. She said that she did not know the name of the journal and that there had been no intentional effort to delay disclosing the results."
Even more shocking is the fact that FDA officials participated in this cover up. According to Dr. David Graham, an FDA reviewer, agency higher-ups discounted calls for attention to Vioxx's problems.
Add that to the fact that even Merck researchers debated the possibility of starting a large-scale study to determine specifically the cardiovascular risks of Vioxx more than 4 years ago (in 2000). Company documents show that marketing drove the decisions and the study was never performed. This is a clear case of putting profits before people. In the end, it will be neither profitable, nor will they have protected their customers, an innocent public that took an unsafe drug and suffered many strokes and heart attacks as a result. When the litigation is done, it is likely that Merck will have to repay all of the more than $10,000,000,000 that they have collected in sales from this drug.
Merck only withdrew the drug when they discovered (again, and again) that it was unsafe. The most recent "discovery" came as Merck was trying to get Vioxx approved for even more uses. They asked the FDA to allow it to be sold for children to take it, and then were trying to get it to be sold for cancer prevention. All of this was in the face of having information that the drug was killing people with heart attacks.
According to Meier, "Merck withdrew the drug after results from one of those studies - a test to see whether Vioxx could prevent a recurrence of colon polyps - found higher risks in patients taking the drug for more than 18 months. The debate over Vioxx's safety dates to 2000, when the company published the results of a clinical trial of a test of Vioxx in arthritis patients that found that the drug reduced the number of ulcers and gastrointestinal bleeding associated with its use. But the trial, which was known by the acronym Vigor, also indicated that Vioxx users in the study suffered heart attacks at five times the rate of those patients taking naproxen, the drug to which it was being compared."
To try to weasle out of these result, Merck tried to explain that the other drug held down the rate of heart attacks, even though this was disputed by the researchers. Merck has also tried to discount many other studies, even ones that they financed, whenever they showed that Vioxx was dangerous. Merck, which financed some of the epidemiological reports, had argued that such research was inconclusive because of methodological problems.
Even the final nail in the Vioxx coffin, the study of UnitedHealth Group patient records, was apparentltly financed by Merck.
We are not currently accepting new Vioxx cases. You should consult another attorney for an opinion on your case.
|
 |
Home |
Site Map |
Blogs |
Do I Have A Vioxx Case?