>Dangers of Statins – Time Life Article


So many times, when an article appears in the media or on the internet, discussing the dangers of Statin Drugs, used by the medical profession to control blood lipids (cholesterol), it just as quickly disappears, is taken down.

For this reason I am copying the entire TIME LIFE MAGAZINE article here for you to read and learn from.

I belong to a group on the internet who support patients who have been damaged by these prescription medications, which many doctors out-rightly deny can cause health issues. All I ask of you is to read this article, and learn as much as you can about these drugs.

YES all drugs can have side effects in susceptible people. Statins seem to have a far greater number of known side effects, for a drug which is so frequently prescribed and ‘hailed’ as a heart healthy saviour of mankind!

The Prescription Gender Gap
By Catherine Elton Monday, Mar. 29, 2010

Lynne Newhouse Segal was the picture of robustness. At 59, the slim former lawyer was an avid runner, golfer and yoga practitioner. Segal, who lives in San Francisco, was healthy by nearly every measure–except her cholesterol level, which a routine test four years ago revealed was high. High cholesterol is a key risk factor for heart disease, especially in a patient Segal’s age and with her family history (several close relatives had had heart attacks), so her doctor put her on a cholesterol-lowering statin drug as a preventive measure.

Segal was one of 24 million people taking drugs to lower cholesterol in the U.S. that year. The workhorse of American medicine, statins–first sold in the U.S. in 1987 and marketed under brand names like Lipitor, Zocor and Crestor–are designed to clear away LDL cholesterol, the waxy buildup that can clog arteries and trigger heart attacks and strokes. Doctors say the majority of current statin users are healthy people who don’t have heart disease but who, like Segal, simply have high cholesterol. Use among this group, known as the primary prevention population, has made these drugs one of the world’s best-selling classes.

But Segal’s statin ended up preventing her from living a heart-healthy lifestyle. A month after she started taking the drug, she suffered muscle pain so severe, she had to stop all physical activity and was unable to sleep at night. Although her husband, who was worried about her risk of heart attack, pleaded with her to stay on the drug, she discontinued using it. The muscle pain receded. “My husband was scared for me. Doctors scare you. But I was in so much pain, I told him I would have rather died than stay on them,” says Segal.

That grim situation could have been avoided, researchers say. An estimated 12 million American women are routinely prescribed statins, which carry a risk of serious side effects. Yet there is little evidence that they prevent heart disease in women. In past research, statin therapy has been shown to prolong the lives of people with heart disease. It has also been shown to stave off the onset of heart disease in healthy at-risk adults. But researchers who have broken out and analyzed the data on healthy female patients in these trials found that the lifesaving benefit, which extends to men, does not cross the gender divide. What’s more, there’s evidence that women are more likely than men to suffer some of the drugs’ serious side effects, which can include memory loss, muscle pain and diabetes.

In a smaller group of women–those who already have heart disease–the data suggests that statins can reduce heart-related deaths. But as Dr. Beatrice Golomb, a professor of medicine at the University of California, San Diego, says, they don’t reduce deaths overall. “Any reduction in death from heart disease seen in the data has been completely offset by deaths from other causes,” she says. Which raises the question: If statins do not help prolong women’s lives, why are so many women taking them?

Slicing the Sex Data

“There are millions of women on a drug with no known benefit and risks that are detrimental to their lifestyle–and no one is talking about it. Why?” asks Dr. Rita Redberg, a prominent cardiologist at the University of California, San Francisco.

One reason may be that the field of gender-based medicine, which takes into account the differences between men and women in the diagnosis and treatment of disease, has been slow to catch on, especially in the pharmaceutical industry. Before the 1990s, women were largely excluded from clinical drug trials–an attempt to protect pregnant women from harm and avoid the potentially confounding effects of women’s hormone fluctuations. Since then, as studies have actively recruited women, gender-based research has begun to reveal crucial information about how the development of diseases–such as heart disease, lung cancer and autoimmune disorders–may affect women in markedly different ways from men.

But researchers say the field has not taken the next step: tailoring treatments according to gender-specific data. In many cases, notably with statins, they say the data are missing or have not been properly analyzed.

Even acknowledging the lack of data, however, researchers like Dr. Scott Grundy of the University of Texas Southwestern Medical Center in Dallas have long argued that statins should be prescribed to women at moderately high risk for heart disease. Grundy says the underrepresentation of women in drug trials does not discount statins’ benefit; it results only in a failure to show a statistically significant effect. Grundy was one of the authors of the 2001 national guidelines for lowering cholesterol and the 2004 revisions that greatly expanded the use of statins–and were criticized because of his and other authors’ ties to the drug industry.

The Jupiter Trial

Grundy says he now has the evidence he’s been waiting for. In a paper published in February in the journal Circulation, researchers analyzed data on women who took part in the Jupiter trial, a large, industry-funded study that sought to compare the effectiveness of the statin Crestor (rosuvastatin) with that of a placebo in healthy patients. The study, which ended in 2008, involved nearly 18,000 participants–including 6,801 women, more than in any previous statin trial–who had high levels of C-reactive protein, a risk factor for heart disease, but did not have high cholesterol.

The gender-specific analysis showed that women who took 20 mg of Crestor daily for an average of 1.9 years had a 46% reduction in cardiovascular events–similar to the 42% reduction in men–compared with the placebo group. “I said once we had the large numbers of women, we’d see benefit. Jupiter now provides that evidence,” says Grundy.

Other researchers say that evidence is muddy. The reduction in cardiovascular events sounds impressive until you take a closer look. Men taking Crestor had a lower risk of hard events, including fatal and nonfatal heart attack and stroke. But the only statistically significant benefits for women treated with Crestor involved less extreme end points, like hospitalization for unstable chest pain and arterial revascularization (a category of procedures that includes major surgery). To prevent one event, 36 women would need to take the statin for five years–a modest result, critics say.

Meanwhile, women on Crestor were more likely to develop diabetes compared with those getting a placebo–a result not seen in men. And because the trial lasted only 1.9 years on average, researchers say the full magnitude of the side effects may not have been captured.

Judith Hsia, senior director for clinical development at AstraZeneca, which makes Crestor, says the trial was designed to measure the statin’s effect on all end points together, not individual end points. “The people who had bypass surgery or stenting would not characterize that as a nonevent,” says Hsia. “It’s not death, but it’s still substantial.”

It’s the Risk Profile, Stupid

Why statins fail to show equal benefits for men and women is unclear, but one reason may be that women are simply at lower risk of heart disease than men. You would need a powerful treatment to lower an already low risk. Researchers also don’t know why women are more likely than men to suffer side effects from statins and many other drugs but posit that lower body weight and hormonal fluctuations play a role. Biological explanations aside, the larger point is the same: with any treatment, the benefits should outweigh the risks.

Margaret, 59, who asked that her last name be withheld, says her experience with statin side effects was harrowing. Margaret was in her early 50s and had high cholesterol and diabetes when her doctor put her on statins. Soon after, she says, she forgot how to do basic math and got lost driving to familiar places. But when she described the symptoms, she says, her doctor refused to believe they were related to the drugs. “I felt like I was going crazy,” says Margaret, “but within a week or two of stopping the statins, my brain started to work again.

“Many doctors may be so unfamiliar with the side effects of statins, says Golomb, that they deny their connection to the drugs. That may contribute to the underfiling of adverse-drug-reaction reports with the Food and Drug Administration (FDA).

The FDA seems unperturbed by criticism of the Jupiter trial. In February, on the basis of Jupiter data, the agency expanded the eligible patient population for Crestor to include older healthy at-risk adults. The move could increase the number of women taking statins by many millions, according to calculations by Dr. Jon Keevil of the University of Wisconsin. Researchers will continue to disagree over whether that is heartening news or not.

His and Her Diagnoses

The same disease may express itself differently depending on who has it [This article contains a table. Please see hardcopy of magazine.]

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About JustMEinT Musings

I like writing, reading and expressing my opinions. I prefer natural health and healing to pharmaceutical drugs. Jesus Christ is my Lord and Saviour.
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