The number one estrogen replacement drug in the world is Premarin (spelled with an "e" in Canada) or PMU for short. It is produced by Wyeth-Ayerst Laboratories, a subsidiary of American Home Products company. The drug introduced in 1942 is produced from pregnant mares' urine and has been a source of controversy since the nineties. Its importance has been raised as aging baby boomers approach their 50s and women reach menopause. Estrogen is considered by many doctors important for menopausal women's health in preventing osteoporosis, heart disease, cutting risk for colon cancer and Alzheimer's disease. Currently, more than nine million women use Premarin or its cousins: Prempro, Premphase and Prempac (also produced by Wyeth-Ayerst Laboratories) in a variety of forms including: pills, creams, injections or patches. With a virtual monopoly on the estrogen replacement drug market, there is room for abuse as the demand for estrogen grows. The ethical question involved with Premarin is: Are the horses being treated humanely?
With about $900 million in revenue each year for Wyeth-Ayerst Laboratories, 80% of the market and the number one pharmaceutical drug export for Canada, there are several forces involved in the continued existence of this drug. Ayerst Organics Ltd. of Brandon, Manitoba, Canada, the distributing and production arm of Wyeth-Ayerst Laboratories, produces the Premarin from the urine and according to their 1997 annual report, plan a new processing plant to triple production. The prices paid, number of farms and urine quotas are directly control by Wyeth-Ayerst. Until 1990, PMU was unregulated except for Ontario's PMU Farm Act of 1968-69, Regulation #217/70, which allowed Ontario to link regulations to licenses and permits (IGHA: par.2). PMU farms relocated to Alberta, Manitoba, Saskatchewan and the Dakotas in the United States where the Farm Act did not apply. Only after pressure from animal welfare groups, various government officials and concerned citizens was a Recommended Code of Practice for the Care and Handling of Horses in PMU Operations published in 1990, but it still remains vague and voluntary.
The environment of the horses, though improved from the horrifying pictures shown by animal right groups, can become inhumane because of the sheer numbers of mares in the farms. Many of the PMU farms house more than 200 mares in one barn with tie stalls, usually associated with cows (average 8' x 4' x 5') rather than the conventional box stall (averaging 12' x 10' x 10') used for horses. The mares are given a variety of food, hay, straw, grain, or pellets, but farmers prefer not to overwater the mares, as a way of receiving more estrogen concentration in the urine. (Farmers are contracted to produce certain amounts of urine, but are paid on the amount of hormones is in the urine.) The urine was collected via catheters until 1968 when regulations led to the use of urine collection devices (UCDs). UCDs are soft rubber cups held under the mare's vulva, suspended overhead on pulleys with a rubber tube that sends the urine to a collection tank (Herbert: par. 13, 20). The UCDs could cause sores, rub hair off the surrounding area or cause urine splash, an irritating skin cluster caused by urine when it stays on the horse's skin for long periods. Because of the UCDs, the mares cannot fully lie on their sides and the smallness of the stalls can cause nicks or cuts when the mares rise against the barriers that keep them from moving too far from the UCDs. Farmers have added rubber to protect the mares' legs, but standing for long periods of time can lead to various leg problems. "In severe cases of inactivity, immobility may lead to problems such as founder (laminitis) or navicular disease, due to impaired circulation in the feet"(Thomas: 42). The Code of Practice is vague in suggesting farmers provide as much exercise as necessary for the health and well-being of the horses.
The other by-products of the mares are their foals and their fate has been a great concern. PMU farmers had contended they don't send the foals to slaughter, but one auctioneer, Kevin Moore said, "‘Ten years ago, probably 80% were going to feedlots. Now, it's probably only 15% going to feedlots'" (IGHA: par 21). Feedlots are temporary places where livestock are fattened up before being sent to slaughter. The horse industry has helped in providing registered stallions, making their foals more valuable and more expensive to sell to slaughterhouses or feedlots. The Performance Horse Registry (PHR) affiliated to the Jockey Club, registers half-thoroughbreds and thoroughbreds for equine sports besides racing, worked in conjunction with PMU farmers to provide Thoroughbreds stallions. With these stallions, the foals produced will be eligible for registration and produce highly desirable riding horses.
The greatest impact of PMU foals would be if the economy sinks into a recession or a downturn in demand for horses causes the whole horse industry to go south. During the tax reform of 1986, thousands of owners left the horse business, selling all their animals at pennies on the dollar. The reforms removed the passive-loss deduction that reduced the cost of horse ownership. Thoroughbreds saw average prices fall at the prestigious Saratoga August sale from $170,000 in 1985 to $70,000 in 1994 (Heckerman: 3791). Production of thoroughbred also fell, with new registrations at 50,429 in 1985 and dropped to 34,600 in 1994. Signs of stabilization of thoroughbred production emerged in 1996. It has taken the thoroughbred industry about twelve years to recover from the tax reforms and recession of 1991.Thoroughbreds were not the only breed to show drastic drops in price and new registrations. Arabians, who were selling for millions, had 30,000 registered in 1985, only to fall to less than 13,000 by 1991. Quarter Horses, who are the most populous and perhaps most popular breed, were not immune either. Their numbers fell from 169,675 in 1984 to 101,390 in 1991, only recovering after the recession (Moore: 118). Many of the horses were sold to slaughterhouses as the expense of owning a horse was more than they were worth. The late 80s and early 90s were poor years for horses who could not earn their keep. Horsemeat was still used in pet food, countries like France and Japan desired horsemeat as the price for this delicacy fell along with the horse industry and there were few regulations concerning the welfare of the slaughter bound. If the economy was to experience another recession or further cuts on deductions used by horsemen, a repeat of the late 80s could occur, only there would be an influx of PMU foals in addition of the regular horse population. Prices could hit bottom and the PMU foals would be one of the first to head to slaughter because the median price for these horses is low and any drop in price would make them more valuable as meat than a living animal.
In a 1996 study of 415 PMU farms by the Canadian magazine, Canadian Veterinarian discovered that 67% of the foals died during the first week of life and 45% mortality rate by the second week of their life (IGHA, par. 18). If these figures are the average for PMU farms, there is a huge problem because the mortality rate is much higher than other large breeding farms. A study in the July 1997 issue of Equine Veterinary Journal by the University of Saskatchewan found Thoroughbred live foal rate at around 70% in western Canada (Barakat: 16).
The industry rejected FDA regulations because they claim the farmers have their own regulations: the Recommended Code of Practice, farm inspectors hired by Wyeth-Ayerst who make inspections and by private veterinarians. These self-emposed regulations took several decades to appear and are weak in enforcement of abusive farms. The Code of Practice is still voluntary and inspections by industry inspectors is ripe with conflicts of interest. The independence of the inspectors is suspect compared to other industries like horseracing who have strict rules regarding various segments of the sport to end any conflicts of interest that may be seen as favoritism. The AAEP (American Association of Equine Practitioners) sponsored independent inspection tours with welfare groups and veterinarians beginning in 1995, but they did not include surprise inspections.
Both the American Association of Equine Practitioners and the American Association of Veterinary Medicine released statements in 1997 giving their support to PMU farms. Nat T. Messer, IV, the AAEP Equine Welfare Committee chair wrote "‘AAEP believes the collection of urine from pregnant mares and care of their offsprings as prescribed by the recommended Code of Practice represents responsible management of horses to produce a commodity for the benefit of mankind that should not result in abuse, neglect or inhumane treatment of horses'" (King: 30). However, Joe Silva of the Massachusetts SPCA, who participated in inspection tours with the AAEP had different views. He said he saw a majority of the farms did not have adequate care for the horses, including exercise, grooming or veterinary care.
In the College of Pharmacists of British Columbia's official journal, The Bulletin, stated in 1996 CES, a soy and yam derived estrogen, can be used interchangeably with Premarin. Ontario had declared the same in 1990 and the other providences are considering following suit since CES is about 25 cents cheaper. Wyeth-Ayerst wrote letters to both the college and doctors throughout British Columbia, stating such action was a deep concern to them.
Premarin also had problems of business ethics when it was disclosed Wyeth-Ayerst gave several thousands to the Democratic party and to the head of the FDA. Last May, Duramed Pharmaceuticals had their application for generic Premarin rejected on grounds, its product did not include an obscure hormone. The decision was considered very controversial because the Drug Price Competition and Patent Term Restoration Act of 1984, stated " . . . manufacturers can market generic versions of brand name drugs after patents expire without doing studies for safety and effectiveness if they can show the FDA that the generics contain the same active ingredients--the ingredients that contribute to the drug's safety and effectiveness--in the same composition and potency as the original drug" (Berlou: 21) and the FDA had stated Premarin contained only two active ingredients: Sodium estrone sulfate and sodium equilin sulfate, which were contained in the generic. However, the FDA did an about face in stating it would not approve Duramed's application because the active ingredients could not be accurately defined and needed further study. Congress found the FDA's statement contradictary to its previous comments. Rep. Joe Barton (Texas) stated "‘It appears that the manufacturer pulled out all the stops to keep the generics from being approved'"(Berlou: 20). Suspicions were further compounded by the FDA's Office of Pharmaceutical Science scientists who wrote two days before the decision to recommend it keeps the requirement of the two active ingredients. The scientists also warned that other decisions would cause problems for other generic estrogen applications. The senior vice president of the watch dog group, Citizens Against Government Waste said the decision was clearly political.
The decision of ethics concerning the PMU industry is difficult because of the secretive nature of Wyeth-Ayerst in disclosing all the facts concerning PMU production. The numbers of farms, horses and foals are all estimates from animal welfare organizations and farmers involved in PMU farms. There is however, substantial circumstantial evidence of violations of business ethics in trying to stop the approval of generic estrogen.
Bibliography
Baraket, Christine. "Live Foals By Age of Mare." Equus. November 1997: 16.
Berlau, John. "Contributions Taint FDA Independence: Food and Drug Administration Rejects Applications for Generic forms of Premarin." Insight on the News. September 8, 1997: 20-22.
King, Marcia. "PMU Update." Horse Illustrated. June 1997:30.
Heckerman, David L. "All American Sale." The Blood-Horse. August 19, 1995: 3790-3795.
Herbert, Kimberly. "Use or Abuse?" Online. Internet. May 11, 1998. Available: http://www.thehorse.com/herbert.html.
IGHA/HorseAid. "IGHA/HorseAid's Premarin(e) Q & A's." Online. Internet. May 10, 1998. Available: http://www.igha.org/pmu_link.html.
Moore, Jack. "Past and Present." Equus. November 1997:106-123.
Thomas, Heather Smith. "Managing Stocked-Up Legs." Horse Illustrated. September 1994: 42-47.