Merck's Vioxx found to pose additional safety problems, according to JAMA study.

Merck's recalled pain reliever Vioxx has been found to carry an increased risk of kidney and heart arrhythmia problems, and in a further blow to the company, was found to be potentially harmful even when taken for a short period of time. The study, which is to be published in JAMA, Journal of the American Medical Association, comes at a crucial time as the deadline for filing claims against Merck is rapidly approaching and this would appear to indicate that short duration heart attack and stroke cases are back in play as viable claims, if this report is accurate. In the words of one of the researchers, " The data do not point to a safe dose level with rofecoxib, which justifies the decision taken to withdraw the drug from sale."

As Merck has consistently maintained that Vioxx only caused cardiovascular issues after 18 months of use, and had worked to bring cases to trial that fit that strategy, this news can only be seen as a set back in that it could potentially expand the number of cases filed prior to the statute of limitations expiring on filing claims. I would expect the defense industry and Vioxx apologists to both downplay and spin this report in an attempt to discourage filing of cases, and I expect they will be successful given the relatively few number of plaintiff blogs out on the internet relative to the well organized defense interests that actively blog on this topic.

 In a further blow to the Vioxx defense, a second analysis said that in a review of old Vioxx data, it appears that the drug increased the risk of suffering renal problems and heart arrhythmia according to researchers at the Harvard School of Public Health, Boston Brigham and Women's Hospital and Harvard Medical School. Furthermore, the researchers added that the risks were seen ONLY with use of Vioxx, and not with similar products such as Pfizer's Celebrex pain reliever. They further added that if a meta-analysis had been conducted at a sooner date on this data, that the safety issues would have been most likely detected. To quote the researchers, " Another key finding in this meta-analysis is that the adverse renal effects of rofecoxib (Vioxx) were apparent in the body of studies dating back to 2000, if careful safety monitoring of the data had been carried out".

I'll be anxious to read the entire report when it is published on October 4, 2006 edition of the Journal of the American Medical Association to see what other conclusions can be drawn, but I think we can draw one simple conclusion from what we know now. That is that Merck appears to have invested well in their legal defense and PR campaign to limit the number of short duration filed or won, but that the facts are turning against them in those cases as the medical establishment finally gets to review all the data available. The question now will be is this information coming out too late, and will the media fail to make people aware that short duration cases MIGHT be viable given this new evidence.

As I've said before, time is not on the side of Merck in this case and I think they know it. They are attempting a four corners stall prior to the expiration of the filing date, if I might use a basketball analogy, to freeze information on short duration cases with the knowledge that those cases could ultimately be a massive headache if people are aware of the elevated risk that appears to occur even with short usage. Hard ball tactics but when the company is at risk, you certainly can't blame them for trying.



Posted on September 12, 2006 .