Cholesterol is a major problem in American society. You see news reports everyday about the epidemic of obesity, usually accompanied by video of people with giant bums walking down the street. But as the billion-dollar diet industry is concerned more with that part of the human anatomy, the far larger and more profitable pharmaceutical industry has concerned themselves with another issue connected to cholesterol, heart attacks and strokes.
Statins were initially approved by the Food and Drug Administration (FDA) for reducing high cholesterol levels in order to prevent repeated heart attacks and strokes in at-risk patients. When used for that purpose, the drugs drive down the risk of another heart attack or stroke by lowering levels of LDL (or “bad”) cholesterol.
But then the attitude of the medical community toward the use of statins changed with a little nudging of pharmaceutical manufacturers in order to increase sales and profits.
Physicians came to believe statins could also reduce the risk of at-risk patient’s first heart attack with such factors as high LDL cholesterol or diabetes. Since the change in perception, now instead of statins being a reactionary drug, most patients are prescribed them for “primary prevention” of heart attacks and strokes, a use that has become controversial.
Now, about 24 million Americans take statin drugs. These include drugs such as Pravachol, Mevacor, Lipitor, Zocor and Crestor. The majority of the patients take them regularly believing that the drugs are going to stave off a heart attack or stroke.
But you see, it’s a slippery slope because, though statins appear to drive down the risk of heart attack or stroke by lowering the levels of fatty deposits circulating in the bloodstream, research suggests that statins dampen the inflammatory processes. This can prompt deposits of plaque to break away from blood vessel walls and cause sudden blockages of arteries leading to the heart or brain.
Experts say that this leads to heart attacks and strokes anyway and that the practice is not only misleading, but may be unethical.
Harvard Medical School’s Dr. John Abramson, who has co-written several critiques of the rise in statin use, including one published in June in theArchives of Internal Medicine, is highly skeptical of the current trends in the use of statins.
“There’s a conspiracy of false hope,” Abramson says. “The public wants an easy way to prevent heart disease, doctors want to reduce their patients’ risk of heart disease and drug companies want to maximize the number of people taking their pills to boost their sales and profits.”
This suggests that the loop of deception may be institutional. The drug manufacturers have always tried to promote off-label uses or benefits that have not been clinically tested or proven in order to sell more pills. The distributor and marketers from individual physicians and marketing to the general public use various methods to perpetuate these misguided and untested off-label uses.
All of these activities are illegal. Drugs are only allowed to be promoted based on the uses approved by the FDA. If a company is found to be engaging in these practices then they usually receive a stern warning letter from the FDA and in some very rare occasions a tiny fine, but usually the damage is already done.
Once the physicians have the perception of benefits then they generally begin prescribing the drug, in this case statins, with little to no actual research backing up the rational behind the treatment. It is only based on belief perpetuated my the drug manufacturer rather than empirical evidence.
The fact that the pills trip from manufacturing to the patient’s mouth is all a misguided campaign of deception makes it an institutional conspiracy just as Dr. Abramson suggests.
He has the research to back up his claims that the pharmaceutical companies don’t.
In the first of three studies published recently in the Archives of Internal Medicine, medical researchers found that, contrary to widely held belief, statins do not drive down death rates among those who take them to prevent a first heart attack.
A second article cast significant doubt on the influential findings of a 2006 study, called JUPITER, that has driven the expansion of statins’ use by healthy people with elevated blood levels of C-reactive protein, a measure of inflammation.
In the third article, it suggests potential ethical, clinical and financial conflicts of interest at work in the execution of the JUPITER study. A roundabout way of saying that those who benefit the most financially from the outcome may have seriously influenced the presentation of the data.
This too is somewhat common in the pharmaceutical industry. They fund research with a predetermined outcome, hide research that they don’t find beneficial and seal findings that may prevent the drug from being approved by the FDA. All of these actions are unethical and, in some cases, illegal.
Statins still have ardent admirers, including cardiologist & famed pharmaceutical skeptic Steven Nissen of the Cleveland Clinic, who notes that even if statins do not reduce heart attack deaths, lives are improved by pushing a heart attack further into the future. You may remember his work from earlier articles on this blog where he broke open the massive risk of heart attacks on the diabetes drug Avandia in the Journal of the American Medical Association.
Harvard’s Abramson, author of Overdosed America, opposed his view saying that the best way to drive down the risk is not pills, but healthy diet, exercise, no smoking and moderate drinking.
Sage advise that should be common sense, but unfortunately is only practiced by a small group of Americans.
If you or your loved one has suffered a heart attack or stroke while taking Crestor, it is very important that you find a skilled attorney that is experienced in defective drug litigation so that you can get the compensation you deserve. Call Phillips Webster for a free consultation.
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