Mike Adams, the Health Ranger
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 Michael T Murray [author of the Encyclopedia of Natural Medicine and many other books on naturopathic healing], and I want to ask you about the current situation with vioxx. As you know, the FDA advisory panel has said we have to keep vioxx legal because patients don't have any other alternatives. But patients do have alternatives. I'd like to hear about that.
Dr. Murray: Well, the first question to ask is: Why would somebody want to take vioxx? You don't get arthritis, pain or inflammation because your body is deficient in vioxx, right? |
Mike Adams, the Health Ranger
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 REPPED: Pharmaceutical giant Merck is now under scrutiny by the Justice Department, which has begun a criminal investigation into the firm’s marketing of the painkiller vioxx (withdrawn from the market on September 30, 2004). Since that time, the vioxx scandal has expanded thanks in part to the publication of internal Merck e-mails by the Wall Street Journal. These e-mails showed that Merck was apparently aware of the dangers of vioxx several years ago and yet attempted to construct clinical studies to obscure those dangers in an effort to continue marketing these drugs to the general public. |
Mike Adams, the Health Ranger
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 That bar has certainly been raised high with the number of deaths from vioxx.
Simontacchi: Yes, they're looking at 140,000 adverse events from vioxx and Celebrex.
Mike: Do you see that as being a dangerous precedent by the FDA? What's your take on it?
Simontacchi: Again, you're asking me to talk about my own cynicism. It's based on dollars. I think the bean counters get together, figure out how many people are likely to die or have an averse event, how much that's going to cost them and whether or not it pays off in the long run to keep the drug on the market. |
Mike Adams, the Health Ranger
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 Now it's time to ramp up the vioxx lawsuits all across the country, then hit the drug companies with litigation on other drugs, including over-the-counter drugs. As many as 60,000 Americans may have been killed by vioxx alone, according to figures from the FDA's own drug safety department. Likewise, an astounding 16,500 Americans are killed each year from gastrointestinal bleeding caused by over-the-counter pain medications. |
Mike Adams, the Health Ranger
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 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. |
Mike Adams, the Health Ranger
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| Now they're coming out with even stronger and more powerful medications than vioxx, not because they need to do that, but because they've run the market dry on vioxx and Celebrex, and they're looking for new markets. We just knew it was going to happen. Something needed to be done because now they are connecting almost every disease category with inflammation.
Mike: We've seen news on the C-reactive proteins, and they're saying that heart disease is all inflammation now.
Simontacchi: Yes, you start at the top and go all the way down. |
| Mike: In the past few months, we've seen the FDA advisory panel make some rather precarious decisions on vioxx, and part of the apparent reasoning of the panel was that they need to keep vioxx and other Cox-2 inhibitors legal because people don't have alternatives. What are your thoughts on that?
Simontacchi: You see, that's not true. That really is not true, because there are some excellent anti-inflammatory herbal products, mineral products [and] oil products that have really good research behind them to show that they work just as well as the non-steroidal anti-inflammatory drugs. |
Mike Adams, the Health Ranger
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| You don't get arthritis, pain or inflammation because your body is deficient in vioxx, right? Good medicine involves trying to identify the underlying cause. The most widespread use of vioxx is in the treatment of osteoarthritis, a degenerative condition where the body does not manufacture sufficient quantities of cartilage. Eventually you get bone rubbing on bone. Natural medicine does extremely well in the treatment of osteoarthritis. In double blind, placebo controlled studies, a number of natural products have confirmed documented benefits. |
Mike Adams, the Health Ranger
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| These e-mails showed that Merck was apparently aware of the dangers of vioxx several years ago and yet attempted to construct clinical studies to obscure those dangers in an effort to continue marketing these drugs to the general public.
It's becoming clear now that some people at Merck were aware of the dangers of this drug, and yet they continued to push the drug anyway. vioxx was marketed as a safe drug and was ultimately taken by as many as 20 million Americans before finally being recalled. |
| Since that time, the vioxx scandal has expanded thanks in part to the publication of internal Merck e-mails by the Wall Street Journal. These e-mails showed that Merck was apparently aware of the dangers of vioxx several years ago and yet attempted to construct clinical studies to obscure those dangers in an effort to continue marketing these drugs to the general public.
It's becoming clear now that some people at Merck were aware of the dangers of this drug, and yet they continued to push the drug anyway. |
Carol Simontacchi
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 First, vioxx (rofecoxib) was removed from the market on September 30, 2004, because of increased risk of heart attack and stroke. Then on December 17, USA Today released a report stating that the over-the-counter pain reliever Aleve (naproxen) had been linked to a 50-percent increased risk of heart attack and stroke. This was followed in rapid succession by similar news about Celebrex (celecoxib).
Studies show that long-term users of both vioxx and Celebrex have more than twice the risk of heart attacks than those taking a placebo drug. |
Mike Adams, the Health Ranger
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| Hopefully the Justice Department will send a strong message with the criminal indictment of Merck executives and FDA decision makers who were involved in what increasingly appears to be a conspiracy to conceal the negative side effects of vioxx while the drug was heavily promoted and sold.
In a report filed by FDA researcher David Graham on November 2nd, it was revealed that vioxx may have contributed to almost 28,000 heart attacks and deaths over the past five years. |
Carol Simontacchi
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| Vioxx, removed the drug from the market. According to numerous reports, upwards of 140,000 people may have suffered a heart event as a consequence of taking either vioxx or one of the other COX-2 inhibitors.
It should be noted that no one knows exactly why the new class of NSAIDs appears to increase the risk of heart disease. One theory that has been offered, however, is that these drugs suppress the body's production of prostacyclin, a prostaglandin that dilates the blood vessels and inhibits the formation of blood clots. |
| Studies show that long-term users of both vioxx and Celebrex have more than twice the risk of heart attacks than those taking a placebo drug. As of this writing, Bextra (valdecoxib) is on the ropes, too, and question marks hang over the entire class of COX-2 inhibitors, part of the family of NSAIDs (nonsteroidal anti-inflammatory drugs). What are people in pain supposed to do?
A GROWING PROBLEM
The anti-inflammatory drugs were introduced into the marketplace for a good reason: increased inflammation. |
Mike Adams, the Health Ranger
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| Vioxx patient, and it has awarded the widow $253.4 million in damages. The 10-2 jury vote sends a powerful message to drug companies around the globe: if you continue to manufacture and sell products that kill people, you will eventually pay the price.
A whopping $229 million of that jury award was designated as punitive damages. This shows that members of the jury not only found Merck liable for the direct financial costs of one death, but they also saw Merck's actions as unethical, dishonest and punishable. This award is saying that Merck should pay for being evil. |
Mike Adams, the Health Ranger
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| 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. |
| REPPED: 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 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. |
| 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. |
Carol Simontacchi
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| According to numerous reports, upwards of 140,000 people may have suffered a heart event as a consequence of taking either vioxx or one of the other COX-2 inhibitors.
It should be noted that no one knows exactly why the new class of NSAIDs appears to increase the risk of heart disease. One theory that has been offered, however, is that these drugs suppress the body's production of prostacyclin, a prostaglandin that dilates the blood vessels and inhibits the formation of blood clots. |
Mike Adams, the Health Ranger
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| 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. |
Mike Adams, the Health Ranger
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| Simontacchi: Yes, they're looking at 140,000 adverse events from vioxx and Celebrex.
Mike: Do you see that as being a dangerous precedent by the FDA? What's your take on it?
Simontacchi: Again, you're asking me to talk about my own cynicism. It's based on dollars. I think the bean counters get together, figure out how many people are likely to die or have an averse event, how much that's going to cost them and whether or not it pays off in the long run to keep the drug on the market. |
Carol Simontacchi
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| In fact, the research project that recently illuminated the connection between the use of vioxx and an increased risk of heart disease was seeking to determine just how, and how much, cancer may be causally linked with inflammation.
We hear more and more about rising health-care costs. How much does inflammation contribute to the health-care burden? In a few short years, Medicare will be unable to keep up with the growing costs. Insurance rates are rising faster than the Cost of Living Index, and there is no end in sight to skyrocketing prices. |
Mike Adams, the Health Ranger
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| In a report filed by FDA researcher David Graham on November 2nd, it was revealed that vioxx may have contributed to almost 28,000 heart attacks and deaths over the past five years. In response to all of this, the FDA has humorously announced that it's going to investigate itself and find out if it did anything wrong. It also said it will stop censoring its own scientists.
These statements, coming from an agency that seems sworn to protect the profits of the pharmaceutical industry, seem laughable. |
Mike Adams, the Health Ranger
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| The most widespread use of vioxx is in the treatment of osteoarthritis, a degenerative condition where the body does not manufacture sufficient quantities of cartilage. Eventually you get bone rubbing on bone. Natural medicine does extremely well in the treatment of osteoarthritis. In double blind, placebo controlled studies, a number of natural products have confirmed documented benefits. So there are a number of products that could be used.
Probably the most well documented product is glucosamine sulfate. |
Carol Simontacchi
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| The COX-2 inhibitors were greeted with enthusiasm as first Celebrex (celecoxib), then vioxx (rofecox-ib), and then Bextra (valdecoxib) entered the market. Unlike the traditional NSAIDs, which came in over-the-counter strengths, these were all prescription drugs. Yet despite the fact that they required a prescription and cost far more than the traditional NSAIDs, the COX-2 inhibitors contributed to a dramatic increase in NSAID use. |
Mike Adams, the Health Ranger
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 Horton was outraged and called for FDA reform:
"In the case of vioxx, the FDA was urged to mandate further clinical safety testing after a 2001 analysis suggested a 'clear-cut excess number of myocardial infarctions'. It did not do so. This refusal to engage with an issue of grave clinical concern illustrates the agency’s in-built paralysis, a predicament that has to be addressed through fundamental organizational reform."
But Dr. Horton didn't stop there. He also explained, "...with vioxx, Merck and the FDA acted out of ruthless, short-sighted, and irresponsible self-interest. |
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