Lipitor - Vioxx: Discovering The Statin - Painkiller Chain Reaction
CategoriesThe recent withdrawal of Merck's blockbuster painkiller Vioxx may actually afford us a glimpse of a chain of events that is normally well hidden in research papers, at best selectively disclosed to the medical community. Vioxx and other new-generation painkillers such as Bextra and Celebrex have all come under fire for their tendency to cause an increase of heart attacks.
Statin Drugs, such as Lipitor, Zocor, Pravachol, Lesocol and Mevacor which are promoted as lowering the risk of heart disease, have their own side effect profile, which includes liver and kidney damage as well as muscle pains. One statin, Bayer's Baycol, was removed from the market over the prevalence of such side effects.
Cholesterol + Statins = Muscle Pain + Pain Killers = Heart Attacks
Is there an obvious but overlooked connection between statin drugs, their side effects and the new-generation painkillers of the Vioxx class? An intriguing question for anyone interested in drug safety, one would think - except the FDA does not seem overly concerned.
In a recent article published in RedflagsWeekly, insider Thomas A. Braun, a drug marketing executive, stirs the pot by linking Vioxx, which he calls a "300-pound Gorilla" that "has been let out of the cage", with statin drugs, which he calls the next over-sized gorilla ready to hit the streets. Braun also points out one of those interesting time coincidences: Niacin, a cheap and apparently effective way of lowering cholesterol, was "found to cause liver damage" just before the first statin, Merck's Mevacor, hit the market in the early 1980's. Today, Merck's Mevacor is still one of the most popular statin drugs along with Pfizer's Lipitor, while niacin, a vital nutrient, is thoroughly discredited with available dosages soon to be limited to a measly 35 mg. Statins as a class of drugs produce about 20 billion Dollars a year in profit for the pharma giants.
Merck discovered that statin drugs deplete the body of Coenzyme Q-10, a substance needed for proper muscle function, which is found in a particularly high concentration in the heart muscle. The company applied for and received two patents in connection with this discovery (Patent No. 4929437 and Patent No. 4933165) but in an inexplicable turnabout, it never did incorporate Coenzyme Q 10 into any of its statin drugs.
Here is where things get interesting.
Statin drugs cause muscle damage. Soreness and pain are extremely widespread. You can get an idea of just how how widespread this side effect apparently is by seeing the comments on this article and on this other article, previous posts on this site about Lipitor and its side effects. Also check out the comments on this page, which are replies posted to an article by Chris Gupta (Bad News About Statin Drugs). If statin consumption is continued, the consequent degradation of the muscle tissue, called rhabdomyolysis, may lead to kidney damage and eventually death by toxic overload of the kidneys.
Why has Merck not "put on the breaks" and at least added a decent quantity of Coenzyme Q 10 to its statin products to prevent the pain and muscle degeneration associated with the use of statins? Why has the FDA not required that patients be informed to add CoQ10 to their statin prescription? Some say, CoQ10 is expensive, and that may well have been a factor in Merck's decision to not follow up on these patents - but I rather like to explore the "unthinkable" and ask some questions:
Might there have been a calculated decision to leave statins "undisturbed" by any doubts about their safety? Certainly all statins would have suffered from a sudden admission of the muscle pains side effect and what is now a 20-billion-$-a-year market might never have grown to those gigantic proportions.
Might it just be that the calculation (to accept the painful side effect of statins) extended to include the addidional profits expected on the sale of other new and expensive drugs to kill the pain, such as Vioxx, Bextra, Celebrex? These last-generation painkillers have, in their own right, grown into blockbuster sellers netting the pharma producers who make them several billion dollars a year.
Perhaps the pharma manufacturers have discovered their own version of nuclear energy and are by now harnessing the statin-painkiller chain reaction? Certainly there is too much suffering, and certainly there is too much profit.
See here what Thomas Braun has to say about pharma gorillas in his excellent article. A quote to whet the appetite:
US Healthcare ranks 37th in the World and, at almost 15% GDP, costs the majority of the citizens twice what it does in the other countries that deliver better healthcare to their citizens. There are 45 million Americans who can't afford healthcare at all. I can't understand why the physicians of this country don't demand complete and honest medical information and take back their profession from special interests.
Medical & Business Ethics and Gorillas
Thomas A. Braun RPh
In my business career as a pharmaceutical buyer and later as a Drug Marketing executive, I had nothing but the highest respect for Merck. They had an image of impeccable business and medical ethics and they ran their own show. This image was confirmed by trade surveys year after year. Somewhere along the way, they started to lose focus on healthcare and the focus shifted to the bottom line.
When Clinton was running for the presidency, he often showed up in the company of Merck. This week, Arianna Huffington wrote a biting article about Merck's fall from grace titled "You want a Moral Issue? How about drugs that don't kill". The theme is that the Democrats should come together and open the medicine chest and clean up the hidden mess that is inside.
The problem is that the Democratic Party has long shared in the money dole from the pharmaceutical manufacturers. It's somewhere around a 60-40 split, with the Republicans getting the bigger piece of the donation pie. Big Pharma has always hedged their bets and it doesn't matter which party is running this country because they have seduced most of the Congressmen with money and junkets and the like. Phil Crane from Illinois, one of Big Pharma's champions was not re-elected this fall. Abbott Laboratories, in his former district, has paid over 100 million dollars in fines for not following Good Manufacturing Practices. Total fines and judgments have been over one billion dollars in the last five years for Abbott, the Champion fine payer. [1] Another 7 Pharmaceutical manufacturers accounted for an additional one Billion plus dollars in fines and penalties paid for fraudulent business practices over the last five years. The only way you recoup these losses is to raise your prices.
A 300-pound Gorilla has been let out of the cage called Vioxx. There is another Gorilla rocking his cage called Statin. Back in the early 1980's, time-release Niacin (which is a vitamin) was beginning to gain acceptance by physicians as a way to control high cholesterol. It appeared to work in many cases. Was not expensive and if you didn't overdose on it, you were in great shape.
I remember reading a Clinical paper, when it was first published, about a 10 patient study from the St. Louis VA hospital that claimed that Niacin caused liver damage. No one confirmed that the liver of these 10 VA patients was normal before the study began. Mysteriously, this small study got nation wide press and Niacin was discredited.
Within 90 days of the nationwide negative publicity on Niacin, the first prescription statin drug was marketed by none other than Merck. All those who were worried about their cholesterol levels were saved. The drug was called Mevacor. Would anyone suggest that Merck primed the pump for their new drug by discrediting Niacin? This was the first of a long line of cholesterol-lowering drugs called Statins. Today, the most popular ones are Merck's Mevacor and Pfizer's Lipitor. Baycol from Bayer was removed from the market due to its deadly side effects. Class Action law suits continue to this day. Crestor is under attack for its high side effect profile and may be the next drug to be removed from the market. In the meantime, Statin drugs produce about $20 billion dollars in sales for the manufacturers and every day these drugs remain on the market they provide a power house of profit.
It still is an open question today whether high cholesterol causes Heart disease. Is it the cause or an effect? Some medical researchers theorize that inflammation of the artery walls which is caused by unknown pathogens &/or immune
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