Lipitor - Vioxx: Discovering The Statin - Painkiller Chain Reaction
The 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 in 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 system responses causes the body to send out cholesterol to repair the weakening wall of the artery. [2]
More of a Band-Aid response rather than a cause. This is why statin drugs that suppress the liver's cholesterol production are prescribed. All the consumer ads for these Statin drugs warn that there is a danger of liver damage. Sound Familiar?
In the process of creating the first statin drug, Merck discovered that an essential enzyme called Co Enzyme Q 10 is reduced in the body if you take a statin drug that suppresses your cholesterol. Cells in your body require Co Enzyme Q 10 as well as cholesterol, but medical researchers pushed on with the concept that high cholesterol is bad for you and ignored the consequences of too little cholesterol or Q 10 in the body. Over the years the manufacturers have convinced physicians that lower and lower values of cholesterol should be the norm. Early on 220 was considered the upper limit of normal. Now, Pfizer has been promoting that 150 is the max.
Profit motives surpass realistic medical guidelines.
In 1990, Merck received a patent for the combination drug of lovastatin and Co Enzyme Q 10. (Patent#‚s 4929437 & 4933165). They have never marketed this combination drug. Today, 14 years later, neither the NIH nor FDA nor any other medical authority has demanded that the way Statins are prescribed and patients are treated has to be changed to include the supplement Co Enzyme Q 10. I would have thought that if they were not going to market this combination of drug, at least they would have told the prescribing physicians that a Q 10 supplement should be taken along with the statin drug. So much for patient concerns and medical ethics. Medical Ethics has been relegated to the rear of the classroom and in many cases has never left academia. How else can you explain the lack of outcry from physicians for being convinced to prescribe a class of drugs that may do harm not only to the liver but also the heart that requires adequate Co Enzyme Q 10 to function properly. [3]
When this 1000-pound Gorilla called Statin comes out of his cage and his rampaging is heard, then maybe the Democrats and the Republicans will learn how to spell the word "Bipartisanship".
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.
Restoring Medical & Business Ethics to the Pharmaceutical Arena would go a long way in improving Healthcare in the US and reducing costs.
President Bush is proposing Selfcare as part of the solution, which is what 45 million Americans practice because they can't afford Healthcare. Congress does not want to act to reduce medical costs because of their dependence on Campaign Contributions from medical sources for 100's of millions of dollars in campaign funds. Their attitude, while 100's of thousands die from avoidable medical events, seems to be. "Let's not stop the medical carpetbaggers; it may be bad for politics."
Copyright,2004 Thomas Braun RPh
1. HHS Semiannual Report to Congress 10/1/03 to 3/31/2004, Top 100
False Claims Act Cases
2. The Inflammation Syndrome, 2003 Jack Challem
3. Peter H. Langsjoen, MD., F.A.C.C. presentation to FDASee also:
Petition calls on World Health Organization to investigate Statin Drug Use
Statin therapies are being prescribed to people around the globe. Evidence has emerged that statins can be hazardous to health. The prime rationale for their use is the notion that raised cholesterol is harmful. However, much evidence suggests that a low serum cholesterol is associated with depression, suicide, muscle damage, memory loss and general ill-health. The petition calls on the World Health Organisation to initiate a full and impartial, global investigation into the damage caused by therapeutic doses of all available statins, for the treatment of all forms of hypercholesterolaemia. There are far too many casualties of statin therapy for them all to be statistically insignificant.August 2005: BIG PHARMA'S PAIN-FOR-PROFIT INDUSTRY BOOMING DESPITE VIOXX VERDICT
Cholesterol is NOT the Cause of Heart Disease
...an article on Dr Mercola's site for more background on cholesterolVitamin/Nutritional Supplements for Heart Attack
Scientist raises estimate of Vioxx ill-effects
Marketing of Vioxx: How Merck Played Game of Catch-Up
"Show me the money," appeared on an internal Merck document near Dr. Altman's name. He said those were neither his words nor his intent. He also said his involvement in the trial did not affect his prescribing. Merck's dinner with Dr. Altman, internal company documents show, was a brief stop in a long-running campaign by Merck to enlist the support of doctors for Vioxx or, at the least, to defuse their support for Celebrex - to "neutralize" them as the documents put it.Arthritis drug 'harmed thousands'
Pfizer takes painkiller Bextra off market, FDA wants warnings on others
Thursday, April 7, 2005 - BY CONNIE CASS - ASSOCIATED PRESS
WASHINGTON - The painkiller Bextra was taken off the market Thursday, and the government wants other drugs in the same class to carry the strongest possible warnings about increased risk of heart attack and stroke among the millions of people who rely on them.HMO Bans Pfizer's Cox-2 Inhibitor Bextra
January 30, 2005 - The largest HMO in the United States has banned the dispensing of the arthritis painkiller Bextra made by Pfizer, because it could possibly up the risk of heart attacks and strokes in some patients. It's the first time Kaiser Permanente has banned the use of a drug approved by the US Food and Drug Administration.Statins: A risk to your baby?
By Rita Rubin, USA TODAY - Some birth-defects specialists say they are concerned about the possibility of a cholesterol-lowering statin drug going over the counter, a move to be considered today and Friday by a Food and Drug Administration advisory committee.Monday, February 21, 2005 - Commentary
With COX-2 decision, no longer any doubt about FDA corruption and U.S. drug racket
Following the death of as many as 60,000 Americans from COX-2 inhibitors (source: British Medical Journal, author Dr. David Graham, FDA drug safety researcher), an FDA advisory panel has now voted to allow the drugs to return to the market with full FDA safety approval. The fact that a single COX-2 drug has reportedly killed more Americans than the entire Vietnam War is apparently not sufficient for the FDA to characterize it as unsafe.Tuesday, February 22, 2005 - Globe and Mail -
Weak law blamed in Vioxx case
Canadian regulators say they lack the power to force drug companies to research specific safety concerns once a medication is on the market, despite the suspicion of heart-attack risk that swirled around Vioxx and other painkillers for years. Mark Bethiaume, director of Health Canada's marketed pharmaceuticals division, said those who feel the department failed to protect the public from the dangers of Vioxx and other cox-2 drugs misunderstand Health Canada's abilities.February 23, 2005 - Globe and Mail
Health Canada too slow to act on drug-safety plan, experts say
Researchers who submitted a plan to Health Canada last year to improve drug-safety monitoring complain that the federal department has been too slow to act on it. Over the past year, as concerns grew around the heart risks of popular cox-2 painkillers, including Vioxx, Health Canada was processing a proposal from university researchers to cull information about drug safety and drug use from the health-care system's databases.
FDA whistle-blower scientist David Graham used similar information from a health management group to reach the conclusion last summer that Vioxx could have caused more than 80,000 heart attacks in the United States.FDA Chooses Drug Industry Health Over Public Health
by Ritt Goldstein - Commondreams.org
The U.S. Food and Drug Administration (FDA) is supposed to ensure the safety and quality of drugs reaching the public, acting on the taxpayers' behalf. As of Friday (February 18), an extraordinary three-day FDA Advisory Committee meeting is finishing, but investigation suggests business interests have superseded public health at the agency.The Statin Scam Marches On
Considering that tens of millions of Americans now take statins to lower cholesterol, the following headline was conspicuously absent from the major media this month: "Statins Found to Turn On Gene that Causes Muscle Damage." It's now a fact of science; a new study shows that taking statins destroys your muscle to a greater or lesser degree. And let's not forget that the heart is a muscle.Place this study juxtaposed to another rather interesting recent finding: the more fit you are the longer you will live – and the two just don't add up. How can you destroy muscle and be more fit? You can't. Sure you can drug your cholesterol number lower, but will you be healthier, fit, and live longer?
The Hidden Truth About Cholesterol-Lowering Drugs
... is yet another weapon fit for your arsenal of intellectual self-defense against the myth that cholesterol causes heart disease and that, to protect your health, you must contribute your fair share to the $26 billion/year empire of cholesterol-lowering statin drugs. The author Shane Ellison possesses a Master's degree in organic chemistry. After first-hand experience in drug design, he abandoned what he calls "synthetic medicine" to become an independent researcher, nutritional consultant, developer of product testing certification, and designer of numerous nutritional supplements. He is also a member of The International Network of Cholesterol Skeptics.BBC News - Thursday, 1 June 2006
Heart attack risk with pain drugs
People taking high daily doses of two common painkillers are at increased risk of heart attack and stroke, say Oxford researchersMedicine Net: Study Shows Pain Drugs Raise Risk of Death for Patients Who Survive Heart Attacks
It's not just Vioxx. Nearly all common painkillers may greatly -- and quickly -- increase the risk of death in heart attack survivors.First comprehensive paper on statins' adverse effects released
"Muscle problems are the best known of statin drugs' adverse side effects," said Golomb. "But cognitive problems and peripheral neuropathy, or pain or numbness in the extremities like fingers and toes, are also widely reported." A spectrum of other problems, ranging from blood glucose elevations to tendon problems, can also occur as side effects from statins.
posted by Sepp Hasslberger on Monday December 6 2004
updated on Tuesday December 7 2010URL of this article:
http://www.newmediaexplorer.org/sepp/2004/12/06/lipitor_vioxx_discovering_the_statin_painkiller_chain_reaction.htm
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March 28, 2005 - Chris Gupta
