Saturday, February 11, 2006

Is Vioxx still a Tempest for Merck?

Is Merck the sinister, mega- pharmaceutical company as portrayed in the media, or is the Vioxx story just business as usual in the complex world of the drug research and approval process?

There are still storm clouds gathering for the company, since there may be thousands more pending and potential lawsuits out there relating to Vioxx, and in recent news a former FDA official testified that Merck had plenty of time to warn about Vioxx. On the other hand, they are a giant in the pharmaceutical industry with deep pockets, and probably have new potential block buster drugs in the research pipeline. In all likelihood Merck will remain a power house in the pharmaceutical industry once the near term turmoil has subsided, and it could be that their present, somewhat depressed share price is a value buy assuming it discounts the Vioxx bad news... Full Story

Do we know for sure that Vioxx is linked to the serious cardiovascular health risks it is accused of exacerbating such as heart attack and stroke? The answer to that question may be a statistical research nightmare. Surely there must be other drugs out there in the market that may have potentially devastating side effects, or might be linked to adverse events? There are billions of dollars at stake plus significant health implications, and so the answers to such questions have huge implications to the consumer, and the companies involved. Even with impeccable research protocols and data significant drug side effects may not show up in study results. As well, there have been accusations that pharmaceutical companies will play down or ignore valid study results that suggest adverse drug effects to sanitize their marketing and advertising campaigns because of the huge revenue implications. There is an understanding that the FDA follows fairly stringent guidelines in the drug approval process. In fact, it has been accused of being too stringent in the past (i.e. approving experimental AIDS cocktails). When Merck voluntarily withdrew Vioxx from the market in September, 2004 the FDA issued a detailed question and answer discussion about it to address concerns.

Perhaps our society is simply over medicated, and Physicians need to scrutinize their drug prescribing habits.

"Studies show that many simply don't heed even the sternest warnings issued by the FDA. When patients taking the diabetes drug Rezulin from the former Warner-Lambert Co. (now Pfizer (PFE )) started dying from liver failure in the late 1990s, the FDA repeatedly warned doctors to carefully test patients' liver enzyme levels to spot early signs of trouble. Yet fewer than 5% of patients got the tests, and more people died." - Lessons From The Vioxx Fiasco
It may well be impossible to screen out every possible potential adverse event that a drug might be implicated in no matter how many expensive research studies are funded. In the real world as opposed to the laboratory other variables come into play including interactions with other medications taken, and unfortunately those variables might play around with the next pill you take. So consumers beware, and do your homework when it comes to medications prescribed or otherwise - and be just as wary and diligent when it comes to alternative, or herbal treatments as well.




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