Bombshell -- Major Premarin Trial Halted because of rise in Breast cancer, Heart attack, Stroke and Blood clots

July 15, 2006

Bombshell -- Major Premarin Trial Halted

One of the largest and best-designed federal studies of hormone replacement therapy was halted because women taking the hormones after menopause had a greater risk of:

Breast cancer, Heart attack, Stroke and Blood clots

than those who did not take the drugs. The trial, which was to last for 8.5 years or until 2003, was halted because of a significant increase in the risk of invasive breast cancer.

More than 6 million women in the US currently take estrogen and progestin (Prempro) combination therapy for a variety of reasons, including relief of hot flashes and other menopausal symptoms.

This has significant implications, however on Premarin was introduced in 1942. It was the most-prescribed drug in America each year from 1992 through 1999 and perhaps the most prescribed drug ever.

Last year Premarin generated more than $2 billion in sales for Wyeth.

Please recognize that the progestin drug used in this study is not the same as human progesterone, but a synthetic derivative of the natural female hormone progesterone. Progestin can actually kill a fetus if taken when the woman is pregnant. The only reason it is used the drug companies have a patent on it and can make more money than the safer natural progesterone.

The confusion about estrogen is that it actually raises levels of HDL (or "good") cholesterol in women, which is often considered one of the reasons that a woman's risk of heart disease is low prior to menopause. For years, HRT was widely believed to reduce the risk of heart disease in postmenopausal women, but recent studies have failed to document any protective effects.

The hope -- and the hype of the drug companies -- has been that estrogen would also confer a reduced risk of heart disease. The study suggests the exact opposite though, in that when women take the drugs for more than about 5 years, the risks of the hormones clearly outweigh the benefits.

The trial involved over 16,000 women aged 50 to 79 who still had their uterus. Such women are given a combination of estrogen and progestin, because estrogen alone can promote cancer in the lining of the uterus. The new findings do not apply to the health effects of estrogen alone, which is being looked at in a separate study by researchers at the NHLBI.

The findings support the recent American Heart Association recommendations that postmenopausal women should not take hormone therapy to lower their risk for heart disease.

Interestingly this study comes right on the heels of another full text article that was published the week earlier in JAMA, which showed the similar negative findings regarding estrogen and heart disease

The original Heart and Estrogen/Progestin Replacement Study (HERS) study found that women taking hormone therapy were up to three times more likely to develop blood clots than those taking a placebo.

Hormone therapy was also associated with a higher risk of gallbladder disease surgery in the study. Together, the findings argue that hormone replacement therapy should not be recommended for postmenopausal women with heart disease.

JAMA July 17, 2002;288:321-333 (Free Full Text Article)

Dr. Mercola's Comment:

Any physician who still believes estrogen reduces a woman's risk for heart disease, should have his license suspended. Evidence to the contrary has been published in some of the most widely circulated, peer-reviewed journals for the last four years.

The study published this week is as critical as that published in NEJM in 1975 showing unopposed estrogen increased the risk of uterine cancer. The drug companies easily got around that issue by adding synthetic progestin to estrogen in an attempt to reduce that risk. They were able to circumvent the marketing dilemma and eventually made Premarin the number one consumer drug for nearly a decade.

I can understand how a physician, and certainly the consumer, would be confused on this issue. Twenty years ago, I was too.

In 1984 I was completing my residency and eventually did an additional year of postgraduate training were I compiled a preventive medicine review which focused on osteoporosis prevention and treatment. Since I was fresh out of medical school, and freshly brain washed with the drug model, I was convinced that estrogen was one of the best things since sliced bread. I developed a lecture series about how beneficial estrogen was for preventing disease. I became a speaker for Wyeth in the mid 80s, and they actually paid me to fly around the country lecturing to physician groups about the benefits of estrogen for osteoporosis and heart disease.

Since then, a large number of studies demonstrating how dangerous estrogen is have been done. However, the drug companies knew this for many years. There was a clear deception foisted upon us by the drug companies so they could sell their hormone replacements. They were quite successful. Premarin has become almost synonymous with hormone replacement therapy (HRT).

Premarin was introduced in 1942, long before synthetic alternatives existed. It was the most prescribed drug in America each year from 1992 through 1999; perhaps the most prescribed drug ever. It generated more than $2 billion in sales for Wyeth last year alone.

Wyeth tried to preserve its market share. I was one of the physicians who received the "Dear Doctor" letters from Wyeth. The letter urged physicians to consider talking to patients about the "critical role" that one of its products, Prempro, has in relieving the symptoms of menopause.

However, the letter couldn't hide the facts. Estrogen increases your risk of breast cancer and heart disease. It makes no sense for any woman not surrering from menopausal hot flashes to be on it. Even with hot flashes, estrogen should only be used as last resort, and even then the lowest dose human forms of estrogen would be far preferred to Premarin.