Over the last four years, medical experts have been doing battle when it comes to the dangers of prescription hormones for women. A major study four years ago suggested that taking such hormones, the bulk made by Big Pharma company Wyeth (WYE), could lead to increased risk of breast cancer and heart problems. Now a new study, just out in the Journal of the American Medical Association and similarly replete with controversy, suggests that the risks were overstated.
While the medical experts have been at each other's throats, another battle over hormones for women, this one akin to a high-intensity guerrilla war, is being waged on the Internet and in doctors' offices and small pharmacies around the country. This one pits Wyeth, with nearly $19 billion annual sales, against small pharmacies around the country, and also pits conventional medicine against alternative therapies.
The conflict came out of the shadows last October when Wyeth, the largest single maker of prescription hormones, filed a complaint with the federal Food & Drug Administration asking it to take action against small pharmacies that make what it and doctors refer to as bioidentical hormones from soy and other plant materials. It has expanded into hand-to-hand combat between the competing interests. (For more on the debate over bio-identical hormones, see BusinessWeek, 3/20/06, “Selling the Promise of Youth”)
While Wyeth clearly expected to improve its position in the multibillion-dollar market for women's hormonal products, the episode thus far shows signs of having the opposite effect. The FDA has yet to rule on Wyeth's complaint, but the huge corporation has stirred up a hornet's nest of opposition from women and doctors around the country, who see it as a classic case of Big Pharma throwing its weight around against small businesses and seeking to remove an important element of choice for suffering patients.
While Big Pharma and makers of nutritional supplements and so-called natural products generally co-exist as uneasy competitors in the health-care marketplace, sometimes they do battle, especially when one or the other feels it is suffering financially or sees a potential competitive opening. Not long after Merck (MRK) withdrew arthritis drug Vioxx from the market in 2004 because of concerns it caused heart problems, supplement maker Metagenics began promoting a supplement, Kaprex, as "a safer option: GI friendly joint relief without the heartbreak."
In its October complaint to the FDA, Wyeth sketched a picture of marketplace problems growing out of a major 2002 study by the Women's Health Initiative (WHI) casting doubt on prescription hormones used to counter the effects of menopause. "The study received a huge amount of publicity in the lay press, leaving many women with questions and concerns," Wyeth states. Wyeth doesn't say it, but the "questions and concerns" had to do with possible increases in risk for breast cancer and heart disease growing out of the hormone therapy.
"In the wake of the WHI findings, women with concerns about HT (hormone therapy) have become targets for vendors offering unproven alternatives as a false remedy. In that regard, many pharmacies are manufacturing and marketing "bio-identical" hormone therapies, which they are promoting as risk-free alternatives to FDA-approved HT products.... In reality, though, these products are plant-derived...and further processed to resemble human hormones...."
A big problem, notes Wyeth, is that "the market for [customized] products has grown...in light of media attention and promotion through talk shows and publications such as Suzanne Somers' books, The Sexy Years and Slim and Sexy Forever, as well as advertising in the lay press and on numerous Web sites." In other words, sales of the non-prescription bio-identical hormonal products have soared, while sales of Wyeth's prescription formula declined, from something in excess of $1 billion in 2002, to $850 million by 2004. They recovered a bit to $908 million last year, says a Wyeth spokesperson.
Once Wyeth filed its petition with the FDA, which calls for "seizures, injunctions and/or warning letters" for offenders, the smaller businesses making the customized medications, along with physicians, began fighting back. On a Web page headlined, "Preserve Your Right to Choose Bioidentical Hormones, Women's Health America/Madison Pharmacy Associates, a 35-employee Madison (Wis.) producer of the bioidentical hormones asks, "Why is Wyeth Pharmaceutical taking this kind of action? The issue is supposedly safety, but doctors and pharmacists across the country, including Women's Health America/Madison Pharmacy Associates believe the real issue is profits."
The company urged women to write the FDA with their experiences using the company's products, and their opposition to Wyeth. (The deadline for comments was Apr. 4.) Write the FDA the women did. One of them, Teri, said she has been taking hormone replacement medications customized for her by a pharmacy for four months.
"I can not tell you how wonderful they are," she wrote. "My hot flashes, night sweats, mood problems, weight problems, have all disappeared." She had previously tried Big Pharma prescription hormones, but, "My body did not tolerate them and the side effects were worse than the symptoms I was trying to get rid of." Courtney told a similar tale. She said she has been taking a customized hormone for six months and "it alleviates PMS, dysmenorrhea, and depression."
On and on the comments posted over the last six months to the FDA's Web site go, nearly 2,000 in total, and they nearly all tell a similar story: Women say they are at long last gaining relief from problems of menopause and related difficulties thanks to the plant-based products compounded for them by pharmacies, usually at the recommendation of a physician or other health-care provider.
(To access the letters, click here.) Most of the writers came to the same conclusion as JoAnne: "PLEASE don't take away yet another right to choice in favor of drug companies."
Dr. Chris Foley, an internist based in Vadnais Heights, Minn., and someone who recommends the customized hormones to his patients, calls Wyeth's efforts "a perfect example of Big Pharma pushing real health efforts into the dirt."
He points to a study he oversaw by a graduate pharmaceutical student at the University of Minnesota in 2004 indicating that half of women who receive prescriptions from their doctors for conventional products like Wyeth's don't even have the prescriptions filled for fear of cancer and possible side effects, while 96% of women follow through on getting the bioidentical hormones that are recommended to them.
The FDA, for now, says it's not sure what to do. In a Mar. 31 response to Wyeth, it stated that it "has been unable to reach a decision on your petition because it raises complex issues requiring extensive review and analysis by Agency officials." That suggests a ruling could be many months off -- plenty of time for patients, doctors, and small businesses to throw more mud at Big Pharma.