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Originally published July 18 2005

The FDA, Vioxx, and crimes against humanity

by Mike Adams, the Health Ranger, NaturalNews Editor

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 companies

Who, 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 standard

There'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.

It's never about the benefits versus the risks in the case of herbs. The FDA will ban an herb nationwide and take it out of the reach of consumers simply because a handful of consumers may have abused it and suffered detrimental effects from it. There are a few dozen people who have been killed by overdosing on ma huang or Ephedra. The FDA touted that as evidence that the herb was dangerous to everyone, and they decided to ban the herb nationwide, effectively turning vitamin shop owners into criminals if they were to sell Ephedra.

Where was the whole argument of benefits outweighing the risks when the FDA was taking a look at Ephedra? That argument was nowhere to be seen. There are literally millions of people in this country who could benefit from Ephedra as part of a Chinese medicine remedy. In Chinese medicine, Ephedra is never taken alone, and never in high doses. It's only taken as part of a medicinal recipe prescribed to patients on a person-by-person basis, and it has been used for literally thousands of years in China and Asia without harm. But here in the United States, a few individuals took it to an extreme and managed to give themselves a heart attack by overdosing on an isolated herb, so the FDA said, "It's dangerous, and we have to take it out of everyone's reach."

If you were to apply the same argument to Vioxx, then the FDA should say, "Vioxx has killed not just a dozen people, nor 100 people, nor 1,000 people, nor not even 10,000 people, but perhaps as many as 50,000 to 60,000 people. Maybe that should be a drug that we take off the market because it's dangerous." But no! The FDA says that "the benefits outweigh the risks," or, as I have translated here, "the benefits to the pharmaceutical companies outweigh the risks to the patients."

You see, that's why the benefit versus risk argument is never applied to herbal remedies. Herbal remedies don't benefit pharmaceutical companies, so there's no reason for the FDA to go out of its way to keep them on the market. In fact, the availability of herbal remedies competes with prescription drugs. Consequently, the FDA, which is out there to protect Big Pharma, has every reason to outlaw herbal remedies. That alone will boost the sales of prescription drugs.

The only real regulatory action the FDA is taking on Vioxx, Bextra and other Cox-2 inhibitor drugs is the requirement of a black box warning on the drugs. This is supposed to be a big deal, but in fact it means little to nothing. This is just a bigger print size of the same warning that's been found in the small fine print of the drug for years. Doctors routinely ignore this information. Patients almost never see it. So a black box warning doesn't mean much anyway.

FDA speak: equally dangerous = perfectly safe

Even if it did mean something, there are some doctors who are trying to argue that a black box warning isn't needed. Why? They're saying that if Vioxx is shown to have no greater heart disease risk than other Cox-2 inhibitors, the black box warning should be removed. This is some really distorted, twisted logic here. They're saying that if all Cox-2 inhibitor drugs are equally dangerous and are equally responsible for killing tens of thousands of Americans, then none of them should carry a black box warning, because none of them are more dangerous than the other brand on the shelf next to them.

So even though the whole class of drugs is extremely dangerous compared to herbal remedies or even relatively safe painkillers, some doctors want these black box warnings removed on the basis that, within this class of drugs, each one carries the same risk as the next. This is the kind of huge distortion of logic that you see in conventional medicine today. Obviously, these doctors are on the payroll of the drug companies that stand to benefit from the removal of these black box warnings. It doesn't take a genius to figure this out.

Just to give you an example of how silly this notion is, it would be similar to discovering that a certain type of airplane was falling out of the sky at a rate that was 1200 percent higher than other types of airplanes and killing tens of thousands of Americans as a result. Then you discover that there were two or three airplanes of a similar type that also fell out of the sky at the same rate. You argue that nobody should be warned about those planes because they all have pretty much the same risk, even though there are completely different airplanes available that have drastically reduced rates of danger. That's the kind of logic that's being applied here. It is saying, essentially, that these drugs are equally dangerous; therefore, they should all be considered safe.

The FDA as drug racket mob boss

The only place you find that sort of distorted logic is, of course, at the FDA. The bottom line with all of this is that the FDA has once again proven itself to be a highly corrupt regulatory agency that will go out of its way to protect the pharmaceutical industry at the risk of public safety. For a while there, I thought that maybe this would be a turning point where the FDA and the public would realize that prescription drugs have been over-hyped and over-marketed, and that maybe it would be time to rein these in and return to some common sense in terms of treating symptoms of disease with synthetic chemicals. But, no. With this decision, the FDA has proven that it is willing to take this con even further.

The agency has proven that it is willing to put the lives of hundreds of thousands of Americans at risk, and that it is willing to do anything necessary to protect the profits of the pharmaceutical industry. The FDA has demonstrated that there is no level of danger that is unacceptable to the agency. A drug can kill tens of thousands of Americans and yet earn the stamp of safety approval by the FDA.

(And, by the way, it's not all the people at the FDA I'm talking about here, it's just the bureaucrats who are closely aligned with the drug companies. The vast majority of FDA employees -- especially in the drug safety office -- actually agree with most of this and they back the idea of radical FDA reform that would take the bureaucrats out of power.)

There is apparently no limit to the number of people that a drug can kill in order for the FDA to consider it to be dangerous. You have to wonder, with this class of drugs killing more Americans than were killed in the Vietnam war and killing vastly more Americans than have ever been killed by terrorists, at what point does the FDA become more dangerous than terrorism? We're spending billions of dollars fighting the so-called "War on Terror," but what are we doing to fight the war on Americans' health being waged by the FDA? The FDA has proven itself to be dangerous to the health of the American people.

In my opinion, the FDA has proven itself to be the single largest threat to the health of the American public that we've ever seen in the history of this country. It is directly responsible for the deaths of hundreds of thousands of Americans today. The agency has decided to put its stamp of approval on a class of drugs that will undoubtedly kill tens of thousands more people each and every year. This is not just politics or a regulatory snafu. This is a crime against humanity. The FDA is guilty of that crime, and its decision makers should be punished as criminals.


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