Vioxx: Months of drug therapy = years of risk?
In the last two Daily Doses, I’ve recapped for you all the low spots I’ve reported in the sordid Vioxx story that has unpeeled like a giant, rotten onion over the last two years. I also briefed you on some new data analysis that calls into question Merck’s steadfast (desperate?) insistence that the medication’s increase of heart attack and stroke risk begins ONLY after 18 months of taking the drug – a contention that stands to protect them from untold billions in liability awards
Basically, should this 18-month “safe” time frame be credibly refuted, it’s conceivable that the more than 11,500 lawsuits pending against Merck for Vioxx’s side effects could bankrupt the company. Already, the debacle has yielded the largest liability settlement ever handed down in a drug case – more than a quarter billion dollars to the family of a Texas man last year. Yes, BILLION. From a single case
So, it’s easy to see that a whole lot of eggs are in the “18 month” basket for Merck. Needless to say, the drug giant would no doubt do everything it possibly could to suppress any information (or discredit any analysis) pointing to the possibility that this year-and-a-half threshold may be inaccurate. Yet despite all Merck’s legal maneuvering and all-but-certain “data-stacking,” such evidence has surfaced. The story, continued:
According to a recent New York Times online expose`, some medical experts critical of Merck’s handling of the Vioxx scandal have claimed that the company’s own recently (and grudgingly, no doubt) released data regarding the incidence of strokes and heart attacks in Vioxx test subjects shows that the risks increase after only around FOUR months of treatment with the drug, not 18.
So how’d Merck’s original peer-reviewed data point to a year and a half of safe use before the risks increased?
Because they only counted strokes and coronary events among test subjects that occurred for a scant two weeks beyond termination of their usage of the drug. In other words, adverse events among subjects who may have dropped out of long-term Vioxx studies because of chest pain or other cardiac symptoms were only counted for 14 days past their last dose. Many of these people may have had Vioxx-related heart attacks or strokes on days 16, 20, 30, or even later
And indeed, according to the data Merck turned over to the FDA earlier this year, an unnatural number of heart attacks and strokes happened among these study dropouts AFTER this two-week monitoring period had elapsed – as many as 4 TIMES MORE than among similar subjects in the placebo group.
Naturally, Merck is standing by its previously released data that purports to show that the drug is as safe as a placebo for 18 months – using the concurring analysis of the peer-reviewed New England Journal of Medicine in March of 2005 as supporting evidence. But the data given to that august publication for analysis was the exact same incomplete and skewed study results Merck “cut” to show its drug as risk-free for 18 months!
Incredible. And not to heap the “worse” onto the “bad,” but there’s more.
Even though Merck clearly thought (or wanted the medical world to believe) that Vioxx posed no risk to patients for any longer than two weeks after cessation of administration, new evidence suggests the risks may in fact last YEARS after folks stop popping the killer pain-killer.
Coupled with the other findings recently uncovered in the data, that means if you took Vioxx for any length of time at all, you may STILL be at some level of increased risk for coronary and stroke events – even if your actual time in therapy with the drug was uneventful.
According to a recent Reuters article, a doctor from the FDA’s own Drug Safety and Risk Management Advisory Committee has publicly suggested that Vioxx may cause permanent damage to the cardiovascular system, accelerated arterial hardening, or a sustained increase in blood pressure
The doctor, a professor at Wake Forest, is basing his statements on a 107-page report released by Merck cataloging the medical experiences of Vioxx patients for a whole year following their therapy with the drug. The report’s data reveals that there were fully 75% MORE heart attacks and strokes within this one-year period among Vioxx-takers than compared to similar episodes among the placebo group.
The data also reveals nine strokes of varying severity within the Vioxx group – but none within the placebo group over the course of the same year. And let’s not forget: Within the original drug trial responsible for Vioxx being yanked from the shelves (the colon polyps study so-named APPROVe by Merck), strokes were four times more likely among Vioxx-takers than among placebo poppers!
Of course, I’ll give you more updates on the drug scandal of the century in future Daily Doses. Until then, stay tuned.
