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|Vioxx Reapproved by FDA Panel Members With Ties to Drug Companies
|Last review: 08/12/10 Mercola.com
Ten of the 32 Food and Drug Administration (FDA) drug advisers whose total votes favored the controversial painkillers Celebrex, Bextra and Vioxx had financial ties to the industry. According to public records and disclosures in medical journals, the 10 advisors had recently consulted with the drugs’ makers.
Although most (8) of the 10 members said their ties did not influence their votes, had they not voted the advisory committee results would have been as follows:
12 to 8 to withdraw Bextra from the market
14 to 8 to keep Vioxx off the market
However, the advisors with company ties voted 9 to 1 to keep Bextra on the market and 9 to 1 to bring Vioxx back to the market. Their votes did not significantly influence the decision to keep Celebrex on the market.
It’s commonly known that researchers who work with industry serve on FDA advisory panels; the agency says it works to balance expertise with potential conflicts of interest. However, the FDA often keeps such ties secret from the public and experts say studies have shown that money does influence scientific judgments.
The 10 advisors had worked in some capacity for Merck, Voixx’s maker, Pfizer, which makes Celebrex and Bextra, or Novartis, which is applying to sell Prexige, a similar drug.
Three votes were taken for each drug. Out of the 30 votes cast by the 10 advisers in question, 28 voted to continue marketing all three drugs. Comparatively, out of the 66 votes cast by the remaining 22 members of the panel, only 37 voted in favor of the drugs.
The FDA said that the committee members were “screened for conflicts of interest according to the same strict ethics guidelines FDA applies to all its advisory committees.''
Merck, which pulled Vioxx from the market in the biggest drug recall to date, has not determined whether they will reintroduce the drug.
San Francisco Chronicle February 25, 2005
Bloomberg February 26, 2005
Dr. Mercola's Comment:
Last week, in the lead story in the February 23 newsletter I pointed out that there just had to be a massive conflict of interest for Vioxx to be reintroduced to the market after killing 55,000 people. Here is my quote from that article:
At this time I have no details on the physicians who were on this "expert" FDA advisory panel, but I would not be surprised to find out that there is massive conflict of interest involved. Please don't be shocked, but massive conflict of interest is a regular event with the FDA.
It was blatantly obvious that these drugs wouldn’t have been voted for favorably if financial ties weren’t involved. There was no other way that Vioxx could have been approved and be allowed to kill even more people. Makes absolutely no sense unless you factor in corporate greed--pure, unadulterated corporate greed that places money ahead of human life, pain and suffering.
If this doesn't wake you up to just how EVIL the drug companies are then I simply don't know what will. This is one of the biggest stories since I started this newsletter in 1997, yet the media has not given it the attention it truly deserves and before you know it, the story will be buried and away from the consciousness of most Americans. For most Americans the virtually meaningless Academy Awards dwarfs the importance of this story.
Thank God for the New York Times. Without question, they are one of the best, if not the best, investigative papers in the world. They’re the ones who made the request to have the FDA “expert” advisory panel’s industry ties analyzed.
To add insult to injury, the day after the NY Times story the FDA had the audacity to state that they had done their due diligence and screened the members of the "expert" advisory panel for conflict of interest so they would give an unbiased vote in the decision of whether or not Vioxx should be put back on the market.
Well, they did indeed screen EVERY panel member for any potential conflict of interest. That would lead the public to believe they were doing their job. BUT, guess what happened if they found a potential conflict of interest? They gave the doctor a waiver so they could participate in the "expert" panel.
Folks, it just doesn't get any more blatant than this. We have got to put an end to this nonsense and start the process to have responsible leadership at the FDA. If this appaling behavior disgusts you as much as it does me then I encourage you to forward the story to your friends and relatives, especially if they are convinced the FDA is their friend and protects them. Nothing could be further from the truth. The media isn’t doing their job so we need public support to expose the FDA’s crimes.
Fortunately there are some amazing individuals at the FDA. Dr. David Graham is the associate director of the Office of Drug Safety for the FDA. He is a graduate of the John Hopkins University School of Medicine and trained in Internal Medicine at Yale and in adult Neurology at the University of Pennsylvania. Earlier this week I was able to find a link to his entire testimony to Congress in November 2004. This is the testimony in which he blew the whistle on the Vioxx.
This event would be partially mitigated if the drugs in question were absolutely necessary and the only option for this problem, but the fact is there are many natural effective alternatives to these medications.:
Normalize your daily ratio of omega-3 and omega-6 fats by taking a high-quality fish or cod liver oil.
Reduce (with the idea of soon eliminating) grains and sugars from your diet.
Optimize your diet according to your body's unique metabolic type.
Consider herbal alternatives I've outlined in a recent article.
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The author's statements have not been evaluated by the Food and Drug Administration and are not provided to diagnose any disease or to suggest that liquid glucosamine and chondroitin will treat, cure, or prevent any disease.