Even though female readership on this blog is only eight percent, on behalf of that eight percent, inquiring minds find themselves pondering a rather unusual question: Is Horse Estrogen For Women A Good Idea?

What brings this question to light of day is the marketing efforts of Wyeth (now owned by Pfizer via a merger this year), to promote hormonal treatments Prempro, a combination of aptly named Premarin, an estrogen drug produced from the urine of pregnant mares, and an additional hormone, progestin.

As one might suspect simply from the sound of it, various complications, problems, and lawsuits have arisen.

With that introduction, please consider the New York Times article Menopause, as Brought to You by Big Pharma.

MILLIONS of American women in the 1990s were told they could help their bodies ward off major illness by taking menopausal hormone drugs. Some medical associations said so. Many gynecologists and physicians said so. Respected medical journals said so, too.

Along the way, television commercials positioned hormone drugs as treatments for more than hot flashes and night sweats — just two of the better-known symptoms of menopause.

One commercial about estrogen loss by the drug maker Wyeth featured a character named Dr. Heartman in a white coat discussing research into connections between menopause and heart disease, Alzheimer’s disease and blindness.

“When considering menopause, consider the entire body of evidence,” Dr. Heartman said. “Speak to your doctor about what you can do to help protect your health during and after menopause.”

Connie Barton, then a medical office assistant in Peoria, Ill., was one woman who responded to such messages. She says she took Prempro, from 1997, when she was 53, until 2002, when she received a diagnosis of breast cancer. As part of her cancer treatment, she had a mastectomy to remove her left breast.

Ms. Barton is one of more than 13,000 people who have sued Wyeth over the last seven years, claiming in courts across the country that its menopause drugs caused breast cancer and other problems.

In October, a jury in a Pennsylvania state court awarded Ms. Barton $75 million in punitive damages from Wyeth on top of compensatory damages of $3.75 million.

Pfizer says that Prempro is a safe, federally approved drug that did not cause Ms. Barton’s breast cancer. Chris Loder, a Pfizer spokesman, says Wyeth acted responsibly by including a clear warning about a breast cancer risk on Prempro labels and by updating the warning as new evidence emerged.

The latest lawsuits have turned the company’s menopausal hormone franchise into the kind of case study dissected at Ivy League business schools. Lawyers have made some documents public in the suits, and The New York Times and the nonprofit Public Library of Science filed successful motions to unseal thousands of documents in July.

The documents that have surfaced in the Wyeth cases offer a rare glimpse inside the file cabinets and hard drives of a major drug company. And the cases demonstrate the importance of litigation in detailing exactly how drug makers operate their businesses, says Dr. Jerome L. Avorn, a professor of medicine at Harvard Medical School who has written about the subject in The Journal of the American Medical Association.

“The information coming out in litigation helps us understand how a belief in a ‘protective benefit’ of estrogens on the heart was able to spread like wildfire through the medical community,” says Dr. Avorn, who is not involved in the Wyeth litigation.

“Thousands of doctors prescribed the drugs for millions of women on that basis,” he says, adding that studies later contradicted the belief. “It will be very interesting to see whether the courts are able to connect the dots and make it clear whether this was a kind of medical ventriloquism on Wyeth’s part.”

Part of the Premarin saga shows how a drug maker successfully and cannily expanded a franchise whose central ingredient is horse estrogens into a billion-dollar panacea for aging women. Yet several hundred pages of court documents also raise questions about another aspect of Premarin’s trajectory: how Wyeth worked over decades to maintain the image and credibility of its hormone drugs even as the products were repeatedly under siege.

Still, the documents offer a snapshot of Wyeth’s efforts. Taken together, they depict a company that over several decades spent tens of millions of dollars on influential physicians, professional medical societies, scientific publications, courses and celebrity ads, inundating doctors and patients with a sea of positive preventive health messages that plaintiffs’ lawyers say deflected users’ attention from cancer concerns.

Even as evidence mounted of an association of the drugs with cancer — first in the 1970s with Premarin and endometrial cancer, then in the 1990s with Prempro and breast cancer — Wyeth tried to contain the concerns, the court documents show. (A note handwritten in 1996 by a Wyeth employee responding to a new report of breast cancer risks associated with hormone therapy said: “Dismiss/distract.”)

In 2002, researchers halted the largest clinical trial ever conducted of women’s health because participants who took certain combined hormones had an increased risk of breast cancer — as well as a higher risk of heart attack, stroke and blood clots in the lungs — compared with those taking a placebo.

Other parts of the same federal study, called the Women’s Health Initiative, later found that hormone drugs increased the risk of dementia in a subset of participants, those age 65 and older.

That was a lengthy snip but it was all from page one of a four page article. There is much more in the article for inquiring women (and men) to read.

Can Big Pharma Be Trusted?

The real question at hand goes far beyond the obvious question about horse urine. The real question is why anyone should believe any big pharma companies when employees are willing to “Dismiss/Distract” and ignore legitimate concerns.

I am not a lawyer, but in my mind we are not talking about civil liabilities here, but rather criminal ones. Tough questions must be asked “What did Wyeth know?; When did Wyeth know it? And most importantly: To what extent (if any) did Wyeth cover it up, knowingly putting women’s lives at risk for the sake of a buck?”

Pfizer should be addressing those questions instead of callously dismissing claims with a preposterous combination of rhetoric … “Prempro is a safe, federally approved drug that did not cause Ms. Barton’s breast cancer” while simultaneously saying “Wyeth acted responsibly by including a clear warning about a breast cancer risk on Prempro labels.”

That combination of Pfizer statements is not only insensitive and disingenuous, it is point blank stupid. Pfizer’s statements suggest it is not interested in the truth, rather Pfizer simply wants the problem to go away. That is a sure guarantee that it won’t.

Addendum:

DH Writes:

Hi Mish
Another great article exposing big pharma. What you might not know is that bio-identical hormones are available through compounding pharmacies at a fraction of the cost. Recent large, long time studies in Europe reveal that bio identical hormones do not pose the health risk of horse estrogen (pemarin), a non bio identical substance. I have no dog in this fight but my hobby is the study of medicine and alternative treatments, so I know more than most about this. What is the surprise that sticking a foreign substance (horse estrogen) into your body will eventually cause some serious imbalances or worse.

Regards,
DH

SJ writes:

Mish,

Thank you for posting that article. This has long been an area of contention for women. What is quite compelling is how safe B-IHRT bio-identical replacement therapy is. Unfortunately, there’s no money in non-patentable substances.

Big pharma’s hold over women’s health is frightening. The fact that they have stood up in front of Congress and tried to get bio-identical hormones made illegal speaks volumes. B-IHRT is the only safe protection for women who face early menopause, IMHO.

Mike “Mish” Shedlock
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