October 26

Cholesterol Myths Debunked–Bad News for Statin Drug manufacturers

Cholesterol Myths Debunked–Bad News for Statin Drug manufacturers

Fri, 11 Jul 2003

The demise of hormone replacement therapy (HRT) is not the only case of medical fraud perpetrated by the medical establishment whose practitioners’ professional judgment and clinical practice is too often guided by the pharmaceutical industry.

A major scientific review of the cholesterol lowering drug strategy shows that, contrary to all the hype, statins (cholesterol lowering drugs) have NOT BEEN SHOWN TO PROVIDE AN OVERALL HEALTH BENEFIT in primary prevention trials.

A June 2003 report by the Center for Medical Consumers describes a two day conference attended by international medical experts, including researchers, practicing physicians, biochemists, as well as farmers, greemanret activist, cooks, parents and people who had been told their cholesterol is too high. The conference message was: cholesterol is NOT the problem, high cholesterol is NOT the cause of cardiovascular disease. “Fats are extremely important to good health…the right kind of fat, that is.”

Uffe Ravnskov, MD, PhD, a Danish physician and author of numerous critical papers and the paperback, “The Cholesterol Myths” was the first presenter. He refuted the claimed association between high cholesterol and cardiovascular disease.

He said that NONE of the results from all major clinical trials showed that lowering cholesterol in healthy people who are at risk would reduce their death rate from heart disease. The studies failed to prove that lowering cholesterol made any lifesaving difference. “The reduced rates of cardiovascular mortality were small for men and non-existent for women.”

“When you look at the CARE trial [Cholesterol And Recurrent Events], Pravachol did show a small benefit–after five years 5.7% had died from heart disease in the [untreated] control group, compared to only 4.6% in the treatment group, but [this benefit] was not dose related.”

Furthermore, he noted the people taking Pravachol had a few more deaths from other causes. Dr. Ranskov cited published studies that found higher rates of infectious disease among hospitalized people with low cholesterol levels.

Another presenter, Paul Rosch, MD, clinical professor of medicine and psychiatry at New York Medical College, noted that half of all heart attacks occur in people with normal cholesterol. He noted that “stress has more deleterious effects on the heart than cholesterol.” But, he noted “Anyone who questions cholesterol usually finds his funding cut off.”

Dr. Ravnskov noted that the Farmingham Heart Study conducted on healthy people in the 1950s to find out what distinguished those who had heart attacks from those who did not evaluated 240 risk factors of which cholesterol was only one. That study, he said, did NOT show that high cholesterol caused heart attacks: public health officials, cardiologists and those who have promoted a low-fat cholesterol lowering diet and stain drugs to lower cholesterol have confused a statistical association with causation. “It’s as if they saw a house burning and determined that the bigger the fire, the more fireman are present, and then concluded that firemen cause burning houses.”

The generally acknowledged risks associated with statins: muscle pain, weakness, fatigue, peripheral neuropathy, and (in rare cases) rhabdomyolysis, a potentially fatal muscle disease,

However, several studies cited found higher cancer rates in people with low cholesterol levels. For example, it was disclosed that in the CARE trial, “there were 12 cases of breast cancer in the women taking Pravachol, compared with only one case in the untreated group.

Another unacknowledged risk associated with statin drugs: Transient global amnesia (TGA):

Duane Graveline, MD, a retired family doctor and former NASA scientist / astronaut recounted his own experience taking Lipitor for only six weeks. Soon after he went for a walk, Dr. Graveline “was found wandering, confused, and reluctant to enter his own home because he didn’t recognize it or remember his wife’s name.” Six hours later–after being examined by a neurologist and undergoing an MRI–he came to his senses. He had been diagnosed with TGA. But neither he nor his physician suspected Lipitor. Six weeks after he was restarted on the drug, he suffered far greater memory loss–no memory of his college years, medical school, or recent past: “Many decades of my life were obliterated.” Once again, TGA was diagnosed.

The report notes that amnesia is not acknowledged in the package insert. Dr. Graveline said “Thousands of cases of memory dysfunction have been reported to the FDA’s Medwatch program, “but after two years, the agency still hasn’t acted. And most practicing physicians are unaware of the problem.”

Dr. Joel M. Kauffman, research professor of chemistry and biochemistry at the University of the Sciences in Philadelphia explained how pharmaceutical sponsored drug trials avoid disclosing the most serious adverse risks: “In drug trials, the pharmaceutical companies often divide similar adverse effects into six or seven different categories to keep the scarier side effects under 1%.” To illustrate his point, Dr. Kauffman said that amnesia– a drug-induced effect for some patients–could be divided into confusion, memory loss, senility, and cognitive impairment.

In hindsight, Dr. Graveline said he questioned why he took Lipitor in the first place?

The cholesterol case is a stunning reminder that drug therapies are often hyped without scientific supporting evidence and that they can cause more harm than good.

Clearly, this serious challenge to the practice of widely prescribing statins (cholesterol lowering drugs)–Lipitor, Mevacor, Zocor, Lescol, Crestor, Advicor–is not what manufacturers of these blockbuster drugs want the public to know. The conference was held last spring in Arlington, Va. One wonders about the silence of the medical establishment and the press.

Thanks to Nicholas Regush of RedFlagsWeekly for alerting us to this important report.

By Maryann Napoli (June 2003)

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