DTC is used as a promotional tool to expand the market for drugs far beyond their intended purpose. Lipitor is FDA approved for people who already have heart disease or are at great risk of developing heart disease. But as a result of Pfizer's massive marketing campaign, millions of people with only elevated cholesterol levels are taking the drug every day.
But yet, experts say, despite the drastic increase in statin use, the death rate from heart disease has not changed over the last 75 years. If low cholesterol prevents heart disease, they say, by now studies should show a correlation between lower cholesterol and less heart disease, but they don't.
In reality, experts say, the only thing Lipitor does is lower cholesterol. According to Dr John Abramson, MD, clinical instructor of ambulatory care at Harvard Medical School and author of Overdosed America, "The idea that lowering cholesterol always reduces the risk of heart disease has become the conventional wisdom, which drug companies like Pfizer have taken great pains to promote."
"Millions of women and seniors," he said, "are spending huge sums to take Lipitor every day despite a lack of proof that it's doing anything beneficial for them, and may actually be harming the elderly."
A recent study in the August 10, 2006, New England Journal of Medicine, funded by Pfizer, appears to back up these assertions, at least when it comes to stokes.
The study found Lipitor to be not much better, if any, than a placebo at preventing stokes. And in fact, the study showed the drug to be far less effective in preventing the worst kind of strokes than a placebo.
The study involved more than 4,700 people who had recently had a stroke or "mini-stroke." The subjects had no known coronary heart disease, and their level of "bad" cholesterol was higher than optimal.
They were assigned to take either Lipitor or a placebo daily. After an average of nearly five years, 265 of those in the Lipitor group had had another stroke, compared with 311 in the placebo group, or a difference of 16%, but the study found that mortality rate was about the same in both groups.
However, the study showed that the most serious type of stroke, the hemorrhagic stroke, was by far more common in the Lipitor group with 55 cases, verses only 33 cases in the placebo group.
That said, a key factor not highlighted by the authors of the study, is that hemorrhagic stroke is associated with a higher death rate than ischemic stroke, according to the National Heart Foundation.
But then a caveat at the end of the article explains why the interpretation of the study is manipulated with words that favor Lipitor where it says the study was funded by Pfizer, the maker of Lipitor, which also has financial ties to the study's authors.
Pfizer received another surprise of sorts in September last year when Health Care For All, a PAL coalition member, and others, filed a nationwide class action lawsuit in US District Court for the District of Massachusetts against the company on behalf of women who have taken Lipitor and who have no history of heart disease or diabetes; people aged 65 and over who have taken Lipitor and who have no history of heart disease or diabetes; and third-party payers such as insurance companies, union health and welfare funds, self-insured employers and others, who paid for Lipitor for patients in these groups.
The lawsuit alleges that the success of Lipitor is due in large part to a deceptive advertising and promotional campaign to convince doctors and patients alike that Lipitor reduces heart disease and heart attacks for nearly everyone with elevated cholesterol.
The lawsuit claims Pfizer misled consumers into using Lipitor despite the absence of evidence that the drug is of any benefit to large segments of the population and promoted Lipitor by claiming it prevents heart disease in women and the elderly, where no clinical test has established such a benefit. And in fact, according to the complaint, women in a study without heart disease actually suffered 10% more heart attacks while taking Lipitor, than women who received a placebo.
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