Thursday, August 25, 2005
The FDA, Vioxx, and Crimes Against Humanity
I am both shocked and appalled at the recent decision by the FDA advisory panel to re-approve Vioxx and put the stamp of safety on all Cox-2 inhibitors, including Bextra and Celebrex. This vote came immediately after another vote in which the panel nearly unanimously agreed that all of these Cox-2 inhibitors significantly increased the risk of heart disease and heart attacks in patients. You may ask, "How can a panel that just voted to recognize the greatly increased risk of these drugs turn around and vote to have them classified as safe for human consumption?" The answer is that they claim the benefits are worth the risks.
Now, this is a fascinating bit of logic. Let's take a look at the benefits outweighing the risks in dealing with Vioxx, Bextra, Celebrex or other prescription drugs. What's the real reasoning behind this? First, let's ask who this applies to. Who benefits from the drug, and who takes the risk? It's very clear that patients don't benefit from taking this drug, because patients are being killed in record numbers. The current estimates of the number of people killed outright by Vioxx alone are anywhere from 25,000 to 55,000. In my own estimate based on Dr. David Graham's studies, more than 61,000 people have died — and that's from just one drug. So the patients aren't benefiting. You might say, "Well, the patients, at least the ones who live, are benefiting by having less pain." The fact is, however, they can have less pain in many other ways that don't require the use of dangerous prescription drugs. There are a huge number of nutritional supplements, vitamins, medicinal herbs and natural health therapies that drastically reduce arthritis pain even better than Cox-2 inhibitors without all of these health risks. Who benefits? Drug companiesWho, then, really benefits from keeping Vioxx and Cox-2 inhibitors on the market? Well, the answer is clear: Drug companies. The stock prices of Pfizer and Merck benefit; in fact, they shot up the moment this decision was made by the FDA advisory panel. The real benefit of these drugs is that they generate profits for the pharmaceutical industry, which the FDA seems sworn to protect. The pharmaceutical industry is the one reaping a benefit.
What about the risks of the drugs? Well, it's very clear that the FDA takes no risk in allowing these drugs to be used. The pharmaceutical companies take no risk in allowing them to be used. The only people taking the risks are the patients themselves. The patients are the ones suffering the heart attacks, strokes and the acceleration of heart disease from consuming these drugs. It's the patients who have to pay for all of the medical care associated with the detrimental health effects of these drugs. It's the patients who lose quality of life or have their lives prematurely ended because they've been taking Cox-2 inhibitors. So all of the risks we're talking about fall on the shoulders of the patients, while all of the benefits are enjoyed by the pharmaceutical companies. With that in mind, let's take another look at the quote from the FDA advisory panel, which says that these drugs should stay on the market because "the benefits outweigh the risks." Translated correctly, what this really says is: "The benefits to the pharmaceutical companies outweigh the risks to the patients." That is the statement that should have been admitted by the FDA advisory panel, because this is all about benefits for the drug companies while the risks are carried by patients. The FDA double standardThere's something else seriously wrong in this whole treatment of benefits versus risks. You'll notice that the FDA only applies this standard to prescription drugs; never to nutritional supplements, herbal medicine, Chinese medicine or anything in the world of alternative medicine. The FDA will argue that drugs that are killing tens of thousands of Americans should be kept on the market because they have some benefit, but when it comes to a natural remedy or a medicinal herb, the FDA will bend over backwards to argue the exact opposite.