Crestor Linked To Patient Death - Statin Drugs Safety Questioned

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Astra Zeneca, the maker of cholesterol lowering statin drug Crestor, has confirmed that a patient died of rhabdomyolysis, a potentially fatal muscle wasting disease linked to statin use, but says that the drug "is safe", reports WebMd.

This case fuels the debate on the safety or rather the lack of safety of statin drugs in general. Meanwhile, the Food and Drug Administration is seeking to block an ad touting the safety of the cholesterol drug, calling the claims misleading.

Dr. Mercola comments that ... "because statins are such a huge money-maker -- try $15 BILLION -- Big Pharma will move mountains to keep them on the market, although virtually no one needs to take them." He also says that "optimizing your diet based on your unique metabolic type and reducing or eliminating grains and sugars can normalize your cholesterol about 98 percent of the time."

But like Crestor, other statin drugs such as Lipitor and in fact the whole class of statin lowering drugs, seem to cause depletion of Co-enzyme Q 10, a substance needed for the proper function of muscles, including that hard working muscle that is our heart. They also may not be effective in preventing heart disease. Although statins do lower levels of cholesterol, the connection of cholesterol and heart disease has long been questioned.

Bill Sardi comments that we may be seeing the beginning of the end of conventional medicine. Indeed big pharma relies on heavily advertised "block buster" drugs such as statins and the "new generation" painkillers like recently withdrawn Vioxx, for much of its huge profits.

Vera Hassner Sharav of AHRP - Alliance for Human Research Protection calls for a moratorium on drug advertising, saying that many of the drugs approved by the FDA are essentially in the experimental stage. Their long term use has not been researched and their safety can therefore not be guaranteed. Here is the AHRP message:

Crestor, a highly advertised cholesterol-lowering drug in the statin class - as was Bayer’s drug Baycol, which was withdrawn from market after 30 patients died of rhabdomyolysis (breakdown of skeletal muscle fibers), has been linked to a patient’s death.

"AstraZeneca confirms that a death possibly attributed to rhabdomyolysis associated with Crestor has been reported. The case details are complex, with clinical features more consistent with neuroleptic malignant syndrome, a condition seen with antipsychotic agents." Both of these drug-induced toxic conditions lead to acute renal failure.

The dirty secret is out: new drugs are being approved before their lethal side effects have been revealed at the testing stage because the clinical trials are not designed to detect rare but lethal side effects that surface with extended use of the drugs.  Clinical trials continue to follow the template that was appropriate for testing antibiotics which are taken for short periods, not chronic use.

Thus, one may legitimately classify newly approved drugs as still in the experimental stage, and FDA’s approval can be considered provisional. Therefore, drugs whose safety is still in doubt, should not be advertised, lest many people will be exposed to lethal effects.
The Alliance for Human Research Protection calls, therefore, for a moratorium on drug advertising - at least for 7 years from the date of FDA’s approval.

See also:

AstraZeneca suffers withdrawal symptoms

From Josef Hasslberger website
January 12, 2005

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