Cholesterol Targets Fraudulent
A few days ago, the New York Times told us that "Federal health officials" had "sharply reduced the desired levels of harmful cholesterol for Americans who are at moderate to high risk for heart disease".
But just two days later, we hear from Newsday: Of the nine panelists, six (later data indicate eight) had received grants or consulting or speakers' fees from companies that produce some of the most popular statin medications on the market, according to published material from 2001. Those drugs include Pfizer's Lipitor; Bristol-Myers Squibb's Pravachol, Merck's Lovastatin and AstraZeneca's Crestor.
In a message titled "The Cholesterol
Fraud", F. Batmanghelidj, M.D., President of the National Association
for Honesty in Medicine (www.nafhim.org)
minces no words:
Cholesterol is the building block for all the hormones - Pregnenolone, Dehydroepiandrosterone, Progesterone, Desoxycorticosterone, 11-Desoxycortisol, Testosterone, Corticosterone, Cortisol, 18-Hydroxycorticosterone, Aldosterone, Prostaglandins, Prostacylin and many other hormones, brain cell membranes and the insulating material for all the nerves of the body. It is a precursor to vitamin-D, essential for prevention of osteoporosis. Why would you want to lower its levels without knowing the reasons the body has resorted to making more cholesterol?
The pseudo-scientists who recommend more
and more drugs for lowering cholesterol levels want to make money at
the expense of the ill informed and trusting American public. Unfortunately
the people in the media, knowingly or unknowingly, set the innocent
public up for their sting. It is not as if the drugs pushed on people
to lower their cholesterol are harmless, they do actually kill.
Pharma manufacturers Merck and Schering-Plough are expected to obtain approval later this month of their new combination product Vytorin, which associates two statins, Zetia and Zocor, which apparently complement each other by attacking cholesterol synthesis in the liver (Zocor) and cholesterol absorption in the intestines (Zetia). According to an article in the Delaware News Journal, Vytorin's expected approval coincides with the release of last week's new guidelines that call for people who have had heart attacks or who are at high risk for heart disease to lower their LDL, or bad cholesterol, to 70 instead of 100, as previously recommended.
Analysts expect the guidelines to help increase the market for cholesterol drugs.
There is room for growth - while an estimated 37 million Americans could benefit from the drugs, only around 14 million take them, according to the cholesterol education program.
Yahoo News published this AP article, saying that the Consumer groups Center for Science in the Public Interest and Public Citizen blasted the new cholesterol guidelines as being tainted by the influence of major pharmaceuticals that make blockbusters such as Lipitor and Pravachol. Last year, drug makers earned $26 billion worldwide on cholesterol-lowering medicines, the top-selling class of drugs.
Vera Hassner Sharav of the Alliance for Human Research Protection has some further comments on the ethics of this type of medical research driven by profits rather than human concerns...
Scientific journal editors are scrambling about how to react to bad publicity emanating from public disclosure that the scientific reports they have published are likely to be biased because the authors had financial ties to the companies whose drugs / devices they report on favorably - and that information was withheld from readers.
A newly released survey by the Center for Science for the Public Interest (CSPI) looked at articles that appeared during a 3 month period--between December 2003 and February 2004--in four premier scientific journals--the New England Journal of Medicine, the Journal of the American Medical Association, Environmental Health Perspectives and Toxicology and Applied Pharmacology -- finding that even in these journals, 8% of authors failed to disclose conflicts of interest.
Among the reports cited by CSPI whose authors failed to disclose their financial conflicts: "Frank D. Kolodgie and Renu Virmani, two scientists at the U.S. Armed Forces Institute of Pathology, failed to disclose their consulting relationships with 20 companies in the heart-disease treatment field in a December article in the New England Journal of Medicine about the formation of plaque in coronary arteries." [Ref. 1]
Inasmuch as biased science affects public health policies and misleads treating physicians who may be unwittingly doing harm to patients, is it not the responsibility of science journals to ensure that they provide accurate, full information to readers?
Here are two modest recommendations: Journal editors should make an effort to publish an update, listing articles whose authors failed to disclose their financial ties to drug companies.
Furthermore, it is essential for journals to retract clinical trial reports that were based on only partial--favorable-data. The results are false and misleading, and may be leading physicians to prescribe medications whose risks outweigh any benefits. [References 2]
The same day that CSPI's survey was reported in the press, the journal, Circulation, published a report announcing new federally endorsed recommendations for the treatment of heart disease--more accurately, recommendations for the increased use of cholesterol lowering drugs. The recommendations were made by a panel convened by the National Cholesterol Education Program on the supposition that they will prevent heart disease. The recommendations will dramatically increase the use of statins to control cholesterol levels.
Statins sales for the current 26 million Americans taking them reach $15 billion. The new recommendations will increase the number of users to 36 million and increase sales to $20.8 billion.
The Wall Street Journal reports today, that the FDA is about to approve Vytorin, a drug, "which packs two cholesterol fighters into one pill. It combines Zetia, a cholesterol-blocker from Schering-Plough Corp., with Merck & Co.'s Zocor, the second-most-prescribed brand in the class of powerful drugs known as statins: "Just as heart patients and their doctors are grappling with updated government guidelines for dramatically lowering cholesterol, a new drug is about to be approved that is sure to deepen the confusion over choosing proper treatment." [Ref 3]
Since the NIH recommendations clearly provide statin drug manufacturers with a mega-billion dollar profit enhancement-and the rationale is controversial -- isn't a bit of skepticism in order?
For starters, why has no one questioned the absence of financial disclosure by the panel members that recommend the new guidelines? Have editors of the journal Circulation not heard about disclosure requirements? [Ref. 4]
Why have reporters failed to ask about possible financial conflicts of interest that may have a bearing on these recommendations? [Ref. 5]
Why has no one in the mainstream media seen fit to inform the public that there are scientists around the world who are skeptical about the intensive statin-cholesterol push, calling it "massive hype" by "Rent-A-Quote" Doctors? [Ref. 6]
Doesn't good science depend upon open debate?
The new recommendations were immediately endorsed by the National Heart, Lung and Blood Institute (NHLBI); the American Heart Association (AHA); and the American College of Cardiology (ACC). But these institutions have a checkered record of endorsing expensive treatments that were no better than cheaper ones, and potentially made matters worse.
For example, the ALLHAT study conducted by NHLBI ("antihypertensive and lipid lowering to prevent heart attack trial") tested the effectiveness of both antihypertensive and lipid treatments. It was published in JAMA (2002) and is cited in the journal, Circulation. The ALLHAT study was critically reviewed in the British Medical Journal (2003), noting that in BOTH arms of this government sponsored study neither expensive treatment endorsed by the AHA and ACC demonstrated better results than cheaper treatments which proved safer. [Ref 7]
Indeed, a cheap diuretic proved safer and more effective against heart attack than either expensive calcium channel blockers and ACE inhibitors or lipid lowering statins which "showed no statistically significant reduction in cardiovascular disease event rates or in deaths."
Of special note is that this study tested statins in patients with higher risk of heart disease -- because such patients had generally shown a greater benefit from statins than do lower risk patients -- yet the outcome was negative.
However, the negative ALLHAT study findings were never publicized and the PR firm handling Pfizer's marketing of the expensive drug, of Cardura, didn't challenge the findings because "The reality is no one promotes a diuretic. So you've got one study that says yes, you should [use a diuretic], then starting the day after, you've got a $10bn [sic] industry. . . and 55 promotional events . . . for an ACE inhibitor..." [Ref 7]
Incredibly, none of the journalists in the major media--including Gina Kolata (NYT), Rob Stein (Wash Post), Ron Winslow (WSJ), among others -- saw fit to even mention the serious risks associated with statins. These include: a potential increase in liver enzymes, muscle aches, weakness, immune system suppression, an increase in cancer risk, and a serious degenerative muscle tissue condition called rhabdomyolysis - and the depletion of Q10, the co-enzyme for the production of cellular energy.
What is Q10? Dr. Peter Langsjoen, an expert cardiologist who has done original research into Q10, says this co-enzyme "is responsible for over 80 per cent of energy and if you knock the level of this essential nutrient down, nothing works as well. Those tissues and organs that use a lot of energy are the first to be affected. The heart, for example, uses a huge amount of juice and if you cut it back with the use of a statin, what you start having first and foremost is lack of energy - you start getting sluggish. So the clinical consequences come about gradually and this weakening - fatigue, getting winded when you're walking up the stairs. It's extremely widespread. If you look for it, you'll see it in just about every single new patient who has been on a statin." [Ref. 8]
Science journalists seem to have very short memories about universally recommended preventive treatments that turned out to increase harm-the hormone replacement therapy debacle seems to have taught them nothing.
The 2003 BMJ report uncovered evidence of Pfizer financial largesse - not surprising, the beneficiaries were the endorsers of Pfizer's high priced cholesterol lowering drugs. Even the NHLBI investigators walked away from their negative study findings, insisting: "we know [statins] work." Is this science or faith? The NHLBI scientists went on to raise questions about their own methodology.
But Dr. Marcia Angell noted that questions about study results should be "hypothesis generating" and cannot be assumed as fact until they are tested. She suggested that what's true of the ALLHAT drug study "may be true of an awful lot of drugs. A lot of newer drugs may not only not be better-they may be worse." The problem arises, Dr. Angell said, because "most drug companies don't want a head to head [study]. And the FDA allows trials to run that are rigged where a drug is tested against placebo or a drug of the same class that is inadequately dosed, or they look at the wrong group of people or the wrong endpoints so their drug looks good." [Ref. 7]
Why, then, have healthcare journalists who reported about statin-sales boosting recommendations failed to raise questions about the risks of statins, or to inform readers how much financial support / grants the manufacturers of statins provide to the three institutions that endorsed the recommendations?
Must we always have to wait for the British to publish reports that raise serious questions about healthcare promotions? Must we wait for the BMJ to investigate unacknowledged financial incentives that may have persuaded those who promote the increased use of statins and other expensive new drugs?
3. THE WALL STREET JOURNAL. New Option for Fighting Cholesterol FDA Is Expected to Approve Pill That Mixes Two Drugs; What the Lower Target Means By SCOTT HENSLEY , July 14, 2004; Page D1
5. The New York Times. Experts Set a Lower Low for Cholesterol Levels By GINA KOLATA July 13, 2004, A-1.
WASHINGTON POST. Lower Cholesterol Targets Urged By Rob Stein
THE WALL STREET JOURNAL. New, Lower Goal Is Set for Cholesterol High-Risk Patients Are Urged to Consider Getting Their LDL Below 70 as Opposed to 100 By RON WINSLOW July 13, 2004; Page D1
7. British Medical Journal. Spin doctors doctors soft pedal data on antihypertensives. By Jeanne Lenzer, BMJ 2003;326:170 (18 January)
By Association for Honesty in Medicine Charges