Pfizer Plans to Appeal Product Liability Cases Relative to Premarin and Prempro

Now that Wyeth has be acquired by Pfizer, so goes the legal cases too, part of the deal. Anyway, I have done a bit of writing on the blog relating

back to the Women’s Health Initiative and the ghost writing that was used relative to marketing the drug.

Premarin/Prempro Ghostwriting – The Judge Wants to Know And Orders Unsealing of the Documents

See my interview with Dr. Erika Schwartz where we discussed this issue. It would also as a nice side effect to save some horses too while we are at it if in fact the bioidentical drugs are shown to be safer.

Bioidentical Hormone Replacement Therapy– Interview with Dr. Erika Schwartz

“Dr. Schwartz named several FDA-approved drugs that are bio identical to include Estrace, Evamist, Vagifem, Estraderm, and Climara for estrogen and Prochieve, Prometrium, and Crinone for progesterone.”

In the interview, Dr. Erika and I talked about the lack of studies that compare Premarin to Bio identical Hormones. Also I noticed in this article that there was no mention of FDA approved Bio Identical hormone therapy. I know it has been very controversial with personalized compounding, but what about running some numbers comparing Premarin against the names listed above that are Bio Identical and approved by the FDA?

Where’s the numbers? Could Harvard crank out a study for us? Why do we not talk about the Bio Identical Treatments that “are” approved by the FDA is my question.

Here’s a news video from the past about the horses that are used to create the drug. The horses are not getting a good deal here either. BD

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.

Now Ms. Barton, who said in an interview that she used Prempro in part because her doctor told her it could help prevent heart disease and dementia, 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.

The suits also assert, based on recently unsealed court documents, that Wyeth oversold the benefits of menopausal hormones and failed to properly warn of the risks.

Mr. Loder also notes that Pfizer plans to appeal every product-liability case on menopausal drugs it loses, including Ms. Barton’s.

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.

In 1980, researchers at Boston University Medical Center estimated that the use of hormone therapy had caused more than 15,000 cases of endometrial cancer in the United States between 1971 and 1975 alone.

But Dr. Shuster of the Mayo Clinic says the hormones have not been extensively studied for safety and efficacy. And, unlike branded hormone therapy, she says, they have not been approved by the F.D.A.

Women, Dr. Shuster says, should not assume that compounded hormones are safer than F.D.A.-approved menopausal hormone drugs. Nevertheless, with sales of more than two million books, Ms. Somers has become a menopause guru to millions.

“I think I had a lot to do with making the word ‘menopause’ mentionable,” Ms. Somers, 63, said in a phone interview last week. She said the compounded hormones were safe, and she sent some articles from medical journals to back up her point.