OTI Online
Winter 1998

The Bitter Pill
by Leora Tanenbaum


BOMBARDED BY PROPAGANDA ON PREMARIN, WE CAN'T TRUST OUR DOCTOR'S AND WE CAN'T TRUST OURSELVES


Barbara Dworkin, 61, is one of eight million American women taking Premarin, an estrogen replacement that eases menopausal symptoms such as hot flashes and dry skin. Dworkin started on Premarin 15 years ago and plans to take the drug for the rest of her life. Although studies have shown that Premarin may increase the risk of breast cancer by 30 percent, as well as cause fatal blood clots, the drug also offers protection against osteoporosis and decreases the risk of fatal heart disease by 53 percent. Besides, as a 911 operator living on Long Island, NY, she leads stressful days fielding emergency calls and feels thankful for Premarin because it "makes my life much more pleasant and secure."

But Premarin costs between $15 and $25 a month. If there were a generic version, Suffolk County, New York (which covers Dworkin's drug plan) could cut its costs by 30 percent - over $3,000 for her lifetime. If you consider that millions of other women lack health insurance or prescription drug coverage, a generic could save them more than $300 million a year.

But economizing isn't the only reason to push for a generic. Premarin is derived from the urine of pregnant horses, a fact that concerns animal rights supporters - and repulses many users. People for the Ethical Treatment of Animals (PETA) claims that the collection methods on "urine farms" are barbaric: some 80,000 pregnant mares are confined to stalls for six months out of the year so that their urine can be collected; the 65,000 foals born to them are slaughtered as unusable byproducts of these pregnancies. PETA advises women to switch to an alternative hormone treatment that doesn't harm animals.

An alternative, however, will not be forthcoming. The FDA announced in May that it will not approve a recently manufactured, affordable, plant-based generic form of Premarin, even though FDA research has shown the generic to be just as effective as the brand-name drug. Rather than heed the recommendation of its own Office of Pharmaceutical Science, the FDA appears to have bowed to political pressure - at the expense of women. While there are several plant-derived, FDA-approved estrogen regimens such as Estrace and Estraderm, they have not been proven to offer longterm health benefits. Only those who can afford Premarin - or whose insurance will pay - will be able to relieve their menopausal symptoms, ward off heart attacks and avoid bone fractures.

Sales of Premarin could reach $3 billion within five years, with more than one-third of all women in the United States currently over the age of 50, and another 20 million will be entering the menopausal years within the next decade.

It's no surprise that the commercial interests of Premarin's manufacturer, Wyeth-Ayerst, have superseded health considerations, but the tactics involved are particularly outrageous. Wyeth-Ayerst cultivated influential supporters through financial contributions. Then, when the company needed them, it prodded its beneficiaries to take a stand against their competition. The result? Several highly visible politicians and advocacy groups - who knew nothing about the issues involved - testified before the FDA against the generic form of Premarin. In the end, the consumer's ability to get the best drugs for the lowest price was sacrificed. The saddest part of this whole incident? Feminist politicians and women's groups were key players.

"Doctor, I Want My Premarin"

You don't have to be menopausal to recognize the brand-name Premarin. No doubt you've seen the drug's fear-inducing magazine ads, which suggest that midlife women who don't take estrogen will be crippled by osteoporosis - if they don't die from a heart attack first. The ads also intimate that midlife women who don't take estrogen can never hope to achieve the carefree, wrinkle-free look of the models depicted.

Premarin, of course, is merely one of dozens of prescription drugs aggressively advertised in magazines such as Newsweek, Redbook, Mirabella, and The New Yorker. In recent years, drug companies have bypassed physicians and marketed their products directly to consumers. Eli Lilly's multimillion dollar campaign for Prozac, for instance, includes ads in more than 20 magazines. Some magazines, like Good Housekeeping and the Ladies' Home Journal, contain so many drug ads you might be tempted to double-check the cover to make sure you're not reading a professional medical journal. Which is precisely the point: drug manufacturers want consumers to play doctor by asking their physicians to prescribe particular drugs. And 99 percent of physicians do comply with patients' requests, market research confirms. In this era of "managed care," when physicians are pressed to see as many patients as possible in the shortest amount of time, educated patients who know how they want to be treated are a dream come true.

A dream come true, that is, for physicians and drug companies - but not necessarily for the patients. We may believe that by asking our physicians for Premarin or Prozac we are empowering ourselves by becoming more assertive in our relationships with our physicians, because only we really know our bodies and whaf s best for our health. But in reality, the drug companies are taking advantage of our adherence to this Our Bodies, Ourselves credo. We are intermediaries in a loop of influence that originates in magazine ads and culminates in a prescription.

Last year alone, pharmaceutical companies spent nearly $600 million advertising prescription drugs directly to consumers - twice as much as they spent in 1995 and almost 10 times more than they spent in 1991, according to Competitive Media Reporting, a company that tracks ad spending. None of that money, however, seems to be spent on factual research: more than half of the drug ads scrutinized last year by the Consumers' Union advocacy group contained misleading information on risks and benefits and false claims about efficacy.

Politics vs. Science

But as the case of the massively popular Premarin shows, the influence of drug companies goes far beyond false advertising. Wyeth-Ayerst Laboratories is a pharmaceutical Goliath that garners $1 billion a year in revenue from Premarin, the most commonly prescribed drug in America. Owned by American Home Products, Wyeth-Ayerst has maintained a monopoly on Premarin ever since it began manufacturing the estrogen replacement in 1942. Even though the patent expired over 25 years ago, Wyeth has gotten the FDA to change its guidelines in determining bioequivalence in generics, making it difficult for competitors to match Premarin. A lot is at stake: sales could reach $3 billion within five years, with more than one-third of all women in the United States currently over the age of 50, and another 20 million entering the menopausal years within the next decade.

Because of the size of that market, two small generic drug companies have decided to compete with Wyeth. After the FDA concluded in 1991 that an effective generic requires only two active ingredients (estrone and equilin), Duramed Pharmaceuticals Corp. and Barr Laboratories Inc. teamed up to develop a urine-free generic according to FDA guidelines. In response, Wyeth filed a citizens petition requesting that one of Premarin's ingredients (an obscure estrogen called delta 8,9 dehydroestrone sulfate or DHES) be reclassified as a necessary component. Duramed has not been able to replicate an equivalent of DHES and Wyeth holds the patent on the estrogen. Furthermore, in 1995 the FDA found that based on clinical trials, there was no evidence that DHES was anything other than an impurity.

And so Wyeth shrewdly lined up the support of several influential women's and health groups by making donations to Business and Professional Women/USA, the American Medical Women's Association, the National Consumers League, and the National Osteoporosis Foundation, among others. Representatives of these groups testified before the FDA on the drug company's behalf, saying that they opposed the approval of a generic that lacks DHES, despite the FDA's own contention that the estrogen wasn't essential. The president of the Women's Legal Defense Fund also testified, although this group did not accept money from Wyeth. None of these groups had taken a position on DHES prior to being contacted by Wyeth.

The company also developed close ties to the White House and the Senate. John Stafford, chairman and CEO of WyethAyerst's parent company, American Home Products, attended an intimate 17-person White House "coffee klatsch" with President Clinton in November 1995. And in June 1996, according to the Federal Elections Commission, American Home Products made a $50,000 contribution to the Democratic National Committee. Several months later, Democratic senators Barbara Mikulski (Md.) and Patty Murray (Wash.) wrote the FDA for assurance that "it has no intention of approving a generic version of Premarin that lacks the 'same' active ingredient as the innovator." According to her press secretary, Murray became involved in this issue after she "was contacted by women's groups. As a result, our office spoke with the manufacturer, who was in contact with the same women's groups."

Lo and behold, the FDA reversed its stance. Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, announced on May 5 that "based on currently available data, there is at this time no way to assure that synthetic generic forms of Premarin have the same active ingredients as the [urine-based] drug." Or, put another way: "Perhaps everything in this pool of animal waste could have benefits for human females," in the words of Duramed CEO and president E. Thomas Arington.

No matter how you look at it, the FDA flip-flop appears to be the result of Wyeth-Ayerst's considerable lobbying muscle. Of course, just because a decision is politically influenced doesn't mean it's wrong. But an internal FDA memo dated May 3 (two days before the decision was announced) supports the generic, saying that DHES is not a necessary component. Even the vice president of Wyeth-Ayerst's regulatory affairs department admitted to The Wall Street Journal that there's "probably nothing" special about DHES, and that "it's but one of many components in Premarin."

Consumer health is clearly the last thing on the minds of everyone involved in the Premarin debacle. "This decision is pure politics," fumes Cynthia Pearson, M.D., executive director of the National Women's Health Network, the only women's organization that publicly supports the generic. Coincidentally, the network does not accept donations from drug companies. The decision "was not backed up by science," says Pearson. "This never would have happened without political pressure orchestrated by Wyeth-Ayerst."

Duramed has challenged the FDA decision in an administrative appeal; the company intends to file a court appeal if it is turned down. But Wyeth is already a step ahead: it is busily working to ensure that no matter what happens, it will continue to dominate the estrogen replacement market. After all, Wyeth is the sole sponsor of an important "memory study" on Premarin's effectiveness in warding off Alzheimer's disease, a study conducted under the aegis of the government-sponsored Women's Health Initiative. If a correlation is found, physicians and consumers alike will naturally turn to Premarin as a preventative for Alzheimer's.

Commercially Sponsored Medicine

Wyeth is hardly the only drug company to use political leverage to protect its turf. The Journal of the American Medical Association (JAMA) recently published results of a 1990 study on thyroid medications and reported that the maker of Synthroid, one of the drugs under study, had suppressed for years the fact that three other medications were equally effective. Like Premarin, Synthroid has long enjoyed domination in a lucrative market because its manufacturer falsely claims that its product is superior to the competition.

Ten years ago, in order to establish Synthroid as the most effective drug in its class, Flint Laboratories (then the drug's manufacturer) approached researcher Betty Dong of the University of California, San Francisco. Dong signed a contract with Flint to conduct comparative studies of the bioequivalence of Synthroid and three other preparations. When her research was completed in 1990, Dong submitted the results to Boots Pharmaceuticals (which had since taken over Flint). It turned out that all four drugs were bioequivalent, and that consumers who chose the other drugs over Synthroid could save $356 million annually. Boots became alarmed: after all, it is the leader in a $600 million-a-year market.

With so much revenue at stake, Boots did everything it could to publicly discredit Dong's research. It dishonestly claimed that the research was flawed in design and execution, and that Dong had breached research ethics. It then published Dong's results in a "reanalysis" that reached the opposite conclusion. Conveniently, Boots was able to prevent publication of Dong's own account of her research, since the contract she originally signed stipulated that nothing could be published without written consent from the drug company.

In the end, the consumer's ability to get the best drugs for the lowest price was sacrificed. The saddest part of this whole incident? Feminist politicians and women's groups were key players.

Finally, under pressure from the FDA, Boots (now part of Knoll Pharmaceutical) agreed to allow Dong's results to be published - seven years after the study was completed. And in August, Boots/Knoll agreed to pay $98 million in a settlement to consumers who purchased Synthroid between 1990 and 1997. But despite the settlement, Boots/Knoll has had the last laugh. A highly-placed physician who refuses to be identified points out that Boots/Knoll earned over $2 billion during the time that it suppressed the research, and that the settlement represents less than one-twentieth of the extra profits.

A Matter of Trust

The growing power of pharmaceutical companies is troubling on a number of levels. It is frightening how poorly we are informed about the appalling treatment of animals in drug manufacturing. It is wasteful to pay for needlessly expensive medications. Forget about President Clinton's 1992 plea to the drug companies to control their prices. In the last few years, big-name drug companies such as Merck and Hoechst have withdrawn from the generics field because they realized they could make far more money selling brand-name drugs. But the real bottom line is that the drug companies have robbed consumers of the ability to trust anyone in the area of drug research: commercialism has infected everyone involved. We can't trust those companies to which we entrust our health to accurately represent their products. We can't assume that the FDA has weighed all of the scientific research fairly. We can't even take for granted that the scientists who perform drug research are working independently.

Savvy consumers, of course, realize that drug companies are motivated by profit. But what about advocacy groups, including women's and health organizations? Aren't they supposed to be looking out for the public good? It's in this arena that consumers are really misled. "I can't understand how any woman in a position of influence would deliberately deny a high-quality, low-cost alternative [the Premarin generic] to postmenopausal women who need this important drug," says Duramed's Arington. It seems that advocates, in the public or private sphere, will do anything for the right price. Even the American Medical Association, whose own internationally respected journal piously disclosed the Synthroid saga, agreed in August to endorse Sunbeam health products in exchange for royalties until, stung by charges of conflict of interest and commercialism, it decided to abandon the plan.

"All medical organizations receive money from the pharmaceutical companies," rationalizes Debra R. Judelson, M.D., president of the American Medical Women's Association, one of the organizations that accepted money from Wyeth and testified before the FDA on the same issue. "There are no virgins. We've all been lobbied by the Pharmaceuticals on all the issues." The National Women's Health Network, the lone women's advocacy group to support the Premarin generic, must be the only virgin at the orgy.

But perhaps the ever-increasing power and determination of certain drug companies to quash their competition isn't so terrible. Look, if we all just took Prozac, it wouldn't seem so bad.


Leora Tanenbaum is writing a book about teen girls labeled "sluts" by their peers. She has written for Ms., The Nation, Seventeen, Newsday, and The Women's Review of Books.


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