On The Site
Home Slaughter Bills Reintroduced
Wild Horse Crisis Take Action Horse Slaughter Pamphlet Cenestin (synthetic Premarin) Premarin (PMU) Industry Carriage Horses PMU Mare Rescue Equine Abuse Rescue Stories Adopting Related Links Recommended Reading Dinner, Anyone? Organization History Donate
Equine Advocates, Inc. Material and images on this site are the property of Equine Advocates, Inc. Permission must be granted to reprint or reproduce - that includes on the Internet!
Promoting The Humane And Responsible Treatment of Horses
The Premarin (PMU) Industry (part 4 of 5)
PREMARIN AND WOMEN'S HEALTH
"Women are not horses," said one of numerous medical practitioners interviewed by Equine Advocates regarding the health issues associated with Premarin, all of whom conclude that the risks may outweigh the benefits of taking this questionable drug.
Here's more of what some of them had to say:
R. M. Kellosalmi, B.Sc., M.D., L.M.C.C., physician and surgeon, Peachtree Medical Centre:
"I prefer to know exactly what I am prescribing," said Dr. Kellosalmi. "Premarin contains a host of unknown ingredients that have not been identified. Any possible effects that could be caused by such ingredients are thus also unknown. The question has been raised as to whether Premarin would even pass if it were applying for FDA approval today, rather than some 56 years ago. In those days, the regulations were far less stringent.
"Estrogen replacement drugs derived from plant-based natural sources are also purer and simpler drugs. Premarin is a complex blend of known and unknown estrogens, most of which are natural for the horse, but not for the human. Some of the plant-based estrogen products contain only the most active human type of estrogen. This is Estradiol, and these simple single entity estrogens have been passed with flying colors by the FDA for the treatment of menopausal symptoms, including hot flashes and osteoporosis. They are fully effective drugs, and certainly do not need to take a back seat to horse urine products.
"'Formulating' or 'Compounding' pharmacies can also produce natural Estriol or Estriol-Estradiol combinations which have been suggested as minimizing the risks of cancers attributed to other estrogens. I feel very strongly that patients have a right to an informed choice, and that includes information which involves ethics, as in the PMU situation."
Allan Warshowsky, M.D., F.A.C.O.G., board-certified obstetrician and gynecologist:
"For many years, Premarin has been the major estrogen for hormone replacement therapy (HRT) in menopause. Most (but not all) of the studies [of HRT] have been based on Premarin. In my view and in the view of many other physicians, Premarin is responsible for a host of women's health problems including such frightening entities as breast and uterine cancer. Premarin has been given with another drug which many consider to be dangerous, medroxyprogesterone (as opposed to natural progesterone), which can add to the adverse health problems.
"There are many natural hormone alternatives made from soy or yam products which can be used instead of Premarin with equally beneficial results, but eliminating the negative effects. I choose to go with the natural hormones whenever possible."
Don Sloan, M.D., F.A.C.O.G., board certified gynecologist
(excerpted from a 1997 letter to fellow gynecologists)
"As a colleague and practitioner in our specialty over the past many years, I urge you to consider the use of medication other than Premarin for your patients in need of hormone/estrogen replacement therapy (HRT/ERT). It is well established and documented in the medical literature that the many synthetic estrogens readily available at the pharmacy will provide them with adequate coverage...Our patients are becoming more and more aware of Premarin's use of equine urine in its production.
The validity of using another species' excretion for human use is being seriously questioned...Many reports from reliable sources both in Canada and the United States have described the deplorable living conditions these horses endure, all designed to create maximum urinary output...Such practices should disturb us as sensitive human beings in a profession devoted to the care and well-being of others."
Virginia Reath, registered Physicians' Assistant in Gynecology:
"I like to prescribe naturally-occurring estrogens, such as Estradiol and Tri-Est, a combination of Estriol, Estradiol, and Estrone derived from natural sources [which can be produced at a formulating or compounding pharmacy]. I tend not to prescribe Premarin to my patients. There are options to Premarin and patients have the right to know what they are. Medical practitioners should be informed and able to offer different options to women. I don't think we compromise anything by not prescribing Premarin."
POLITICS VERSUS SCIENCE
The approval by the Food and Drug Administration (FDA) of a synthetic/generic form of conjugated estrogens would virtually end the cruelty and save money for millions of women. Both Barr Labs of Pomona, New York and Duramed Pharmaceuticals of Cincinnati, Ohio have produced synthetic/generic forms of Premarin, but the FDA has not approved either. According to the Boston Globe, "It is impossible to predict when a generic, vegetable-synthetic copy of Premarin will be approved by the FDA. Wyeth-Ayerst, grossing a billion dollars a year from Premarin, has the financial incentive to block a generic substitute and has the scientific and legal consultants to do the job."
According to the Washington Post, "Wyeth-Ayerst has played Washington hardball, lining up support from women in Congress and women's organizations. The pitch to the FDA has been that the generics don't contain delta 8,9 dehydroestrone sulfate, an ingredient of Premarin that the FDA has repeatedly found to be an impurity and not a required component of any generic...Nevertheless, Wyeth-Ayerst, which holds the patent on delta 8,9, has been saying both in a citizens petition filed with the FDA and in its public relations campaign that it may be a key ingredient and that the FDA should require it to be included in any generic version."
This is only one of Wyeth-Ayerst's attempt to spin up a wall of pseudo-technology to block generics. In 1991, they persuaded the FDA to withdraw its approval of generics because they were absorbed into the blood faster than Premarin and, according to Wyeth-Ayerst, this faster absorption could increase cancer incidence. FDA took this step and called for lengthy studies of the issue even though Wyeth-Ayerst was selling a fast-absorption version of Premarin in Canada.
Meanwhile, Duramed and Barr went ahead and addressed the absorption issue and were, in 1995, given reason by the FDA to expect approval, but pressure on the FDA from members of Congress and several women's organizations, all of which have received significant amounts of money from Wyeth-Ayerst, led to the delta 8,9 debacle. An internal FDA document from May 1997 is the latest to cite this substance as an impurity and names at least 25 more impurities of unknown medical properties found in Premarin.
Something other than science or medicine appears to be keeping the FDA from approving generic alternatives to Premarin.
(click here for a printable version of all this information)
Equine Advocates, Inc. Permission to reprint MUST be requested - that includes for the Internet!