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Have a Placebo

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This week there are a couple of related articles, one in bmj showing that half of doctors prescribe their patients placebos, and the other in Journal of Empirical Legal Studies showing that 23% of patients on statins were women without heart disease for whom there is no evidence of benefit.

The article in bmj described how 62% of doctors think is it OK to give placebos, and half of doctors do so on a regular basis. While only 2% reported using actual sugar pills, a larger number used over the counter analgesics (41%), vitamins (38%), antibiotics (13%) and sedatives (13%) as placebos. Most commonly they would describe the placebos to their patients as potentially beneficial medicine or treatment not typically used for their condition. Only 5% of doctors explicitly described them as placebos to their patients.


Comment: If doctors want to give placebos, they should use sugar pills, not drugs that could cause more harm than good. As I have written on this site before, vitamins increase the risk of osteoporotic fracture and are associated with an overall increase in mortality and heart disease, overprescription of antibiotics by doctors for conditions like viral infections that don't respond to antibiotics is increasing drug resistant strains of bacteria, and sleeping pills and sedatives increase the risk of driving accidents, falls and confusion in the elderly.

I would like to add to the list of placebos statin drugs for the treatment of women with risk factors for heart disease but without a history of heart disease. As I have previously pointed out women with risk factors for heart disease but without a history of heart disease get no benefit from statin medications like Zocor, Lipitor, Pravachol and Mevacor, only side effects. Now it looks like the chickens are coming home to roost. As reported in bmj news, the makers of Lipitor may be called on the carpet for promotion of Lipitor to women for whom there was no benefit. An article in the Journal of Empirical Legal Studies presents yet another meta-analysis showing that statins are not helpful for women without heart disease, and discusses the ethical and legal implications of promotion of a drug for a group for which there was no benefit, with a 12 billion dollar per year market for Lipitor (atorvastatin) and 9% of women over 70 without a history of heart disease being prescribed statins, and how this case highlights how preemption of state law by the FDA makes no sense. These facts boggle the mind. By combining data from men and women together and providing blanket recommendations for men and women, and ommitting negative evidence for women, Pfizer (the makers of Lipitor) have driven sales in a group for which there is no benefit, and if anything possibly harm. But anyway, the authors write:

If we are correct about omissions from Pfizer's advertising, then neither market forces nor FDA regulation has effectively regulated the mass marketing of Lipitor. The progression from the underlying scientific study of Lipitor, expressly reporting no benefit for women, to Pfizer's advertising of the world's best selling drug while failing to disclose the absence of benefit for women raises grave concern about the FDA's regulation of drugs and drug company candor.

At a minimum, the FDA should use its authority to address massive questionable marketing. In addition, if consumers have not been properly informed about the efficacy of Lipitor or other drugs, reasonable remedies should exist for costs incurred associated with nondisclosure. Our review suggests the need for modified labelling, marketing, and information for physicians.

Not one of the studies that include women with a mixture of risk factors for heart attacks provides statistically significant support for prescribing Lipitor or other statins to protect against our cardiovascular end points. Pfizer's claims of clinical proof that Lipitor reduces risk of heart attack . . . in patients with multiple risk factors for heart disease, including family history, high blood pressure, age, low HDL ('good' cholesterol) or smoking does not appear to be scientifically supported for large segments of the female population.

Pfizer's advertising also does not disclose critical portions of the Lipitor FDA-approved label, which acknowledges the absence of evidence with respect to women.

The growing multibillion dollar statins market significantly contributes to increasing health-care expenses. Our findings indicate that each year reasonably healthy women spend billions of dollars on drugs in the hope of preventing heart attacks but that scientific evidence supporting their hope does not exist.

Here is Pfizer's response (read out loud with the accompaniment of Jacob blowing on his horn):

Statins have been called one of the most notable triumphs in modern medicine. The statin class has extensive data supporting a reduction in CV [cardiovascular] risk burden and Lipitor's ability to reduce cardiovascular morbidity and mortality has been demonstrated in 12 CV outcomes trials.

Cardiovascular disease is a major cause of death in women as well as men and it ultimately kills as many women as men. However, onset of disease is delayed by some 10-15 years in women compared to men; thus the National Institutes for Health (NIH) ATP III guidelines define age as a risk factor in women at age 55, compared to age 45 for men. In addition, the AHA CVD Guidelines for Women were updated in 2007 and recommend that healthcare professionals should focus on women's lifetime heart disease risk, not just short-term risk.

What a convoluted piece of logic. Women have heart disease, expert guidelines written by doctors and associations with financial conflicts of interest state that women without heart disease should be given statins, even in the absence of empirical evidence, only illustrates the fact that something is indeed rotten in the State of Denmark.

OK, now I am going to get out my crystal ball. Here it is...


My crystal ball tells me that soon lawsuits will be sprouting about across the land as states claim that they were fleeced by Pfizer selling useless Lipitor to their Medicare and Medicaid patients. Check back for an update.

Doug Bremner MD is author of Before You Take That Pill: Why the Drug Industry May be Bad For Your Health

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