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Study after 40 years of hormone replacement therapy proves

Profits are hazardous to women's health

By Bev Hiestand, R.N.

The Women's Health Initiative has stopped its clinical trial on the risks and benefits of the most widely used hormone replacement therapy (HRT), known as Prempro, for menopausal women. The proposed eight-year study was halted after only five years when statistically significant evidence of the dangers of HRT became evident. The findings are published in the July issue of the Journal of the American Medical Association.

The WHI study of 16,000 participants found significantly serious risks for those who received HRT compared to those who received placebos.

The study revealed that women receiving HRT had 29 percent more heart attacks, 26 percent more cases of breast cancers, 41 percent more strokes and 112 percent more blood clots in the lungs than those assigned the placebo, according to the July 9 National Institutes of Health News Release.

Study directors had told participating women twice before--in 2000 and 2001--that those taking the drugs seemed to face slightly more health risks, but claimed it was not serious enough to stop the research.

However, in May researchers decided that the dangers to women taking these drugs outweighed the benefits of slight reduction in the risk of bone fracture and colorectal cancers. The study reported that 1 out of 1,000 of those who took HRT faced hip fractures as opposed to 1.5 out of 1,000 per year who did not.

Of approximately 50 million postmenopausal women in the United States, about 14 million are taking hormone treatment. (Washington Post, July 10) For years, women have been told that HRT could keep them young, keep their skin youthful, prevent heart disease, prevent brittle bones and maintain their mental acuity.

It has been known for some time that women in their 30s and 40s are less likely to have heart attacks and strokes than men the same age. While this led some to believe that declining estrogen levels during menopause may be a contributing factor, this was never proven. Nor was it proved that HRT would prevent heart attacks.

The findings from the WHI support recent American Heart Association recommendations that postmenopausal women should not take hormone therapy to lower their risk of heart disease. (Reuters Health Information, July 2) Investigators in an earlier trial reported as early as 1998 that there was a higher risk of heart attack and death during the first year of therapy. Later analysis of that study showed there was also increased risk of blood clots that could cause heart attacks and strokes.

In addition to the WHI study, the June 27 Reuters Health reported an Italian study has found a link between HRT and increased gallbladder cancer risk.

Earlier observational studies had indicated that women who took HRT were healthier than those who did not. But in the early 1990s, women's groups--including the National Women's Health Network--pointed out that the problem with observational studies is that women who choose to take hormones may start out healthier than women who choose not to. They also pointed out that since observational trials don't include dead people, they would not have included data about women who died as a result of hormone use.

Women's groups and some physicians became increasingly aware that there were no definitive scientific studies in scientific literature and they pressed to focus more attention on women's health issues. The efforts of these activists led to the Women's Health Initiative study, which enrolled more than 160,000 U.S. women to investigate strategies for preventing diseases associated with aging--including heart disease, cancer and osteoporosis.

One of these studies was the HRT research, which is the only prospective, randomized controlled trial of the effect of hormone replacement on disease incidence in healthy women.

'Vapid cow' theory: A lot of bull!

How did menopause become a "disease" automatically requiring drug treatment, rather than a natural life transition? An article entitled "The Truth About Hormones" in the July 14 Time magazine provides a little medical history on the question.

"About 40 years ago, attention was focused on just one female hormone, estrogen. Its greatest popularizer was a gynecologist named Robert Wilson, who thought the hormone could serve as an all-purpose rejuvenator for women of a certain age.

"In his hugely successful book, 'Feminine Forever,' published in 1966, Wilson wrote of menopause as a 'living decay' in which women descended into a 'vapid cow-like' state. Supplemental estrogen, Wilson insisted, would almost magically transform the dull cow into a supple, younger-looking wife and mother. She would not only feel better but also make those around her feel better--especially, it was implied, her partner in bed."

Over the years, these arguments for HRT were updated. "The vapid cow-like state was gone, and there was very scientific language about bone density and heart disease," explains Cynthia Pearson, executive director of the National Women's Health Network, and a long-time skeptic of HRT.

However, the main message was always sexist and ageist, says Pearson. It had a constant refrain: "Stay young. Stay healthy. Stay sexually vital. Be less of a pain to your husband." (New York Times, July 10)

After Dr. Wilson died in 1981, his son Ronald Wilson revealed that pharmaceutical giant Wyeth-Ayerst had paid all the expenses of writing "Feminine Forever" and financed his father's organization--the Wilson Research Foundation--that had offices on Park Avenue in Manhattan. (New York Times, July 10)

Prempro is made by Wyeth Pharmaceuticals. Wyeth earned about $900 million in sales of this drug last year. (New York Times, July 17)

By 1975, Wyeth's product Premarin had become the fifth-leading prescription drug in the U.S., reports Nadine Marks, an associate professor at the University of Wisconsin at Madison. "Even textbooks for gynecologists and obstetricians in the 1960s would explain how a woman's life could be destroyed if she didn't have estrogen in her body." (New York Times, July 10)

In the 1970s, studies indicated that estrogen replacement by itself promoted uterine cancers. The drug companies found a way around that by combining progestin with estrogen.

In the 1980s, sales soared with the promise that hormone replacement could prevent osteoporosis.

Hormone replacement drugs continue to bring in huge profits for the pharmaceutical companies and these businesses do everything they can to protect those profits.

A survey by Impact Rx to determine how Wyeth and makers of competing products were reacting to the WHI study showed that sales representative visits to doctors tripled in the week of the study result's announcement. Some of its competitors jumped at the opportunity to gain sales of similar products. But while the hormonal products that compete with Prempro contain chemically different forms of estrogen and progestin, there is no evidence yet that they are safer. ( New York Times, July 17)

Merck & Company ran a full-page ad promoting Fosamax, another drug that treats osteoporosis, in the July 14 New York Times. The practice of promoting drugs directly to the consumer is banned throughout the world except in the United States and New Zealand. (www.policyalternatives.ca)

Pearson stresses, "Pharmaceutical companies have used statistical smoke and mirrors to tout unproven benefits, minimize risks and mislead physicians into being an unsuspecting marketing force for a regimen that harms healthy women. There was never one single clinical trial that showed that HRT prevented cardiovascular disease or stroke. This is not a story of science moving sedately forward, carefully adding pieces to a puzzle before making recommendations to patients. This is a story of the corruption of the medical and scientific community. The belief that hormones are good preventive medicine has been a triumph of marketing over science." (www.womenshealthnetwork.org)

The National Women's Health Network's book, "The Truth About Hormone Replacement Therapy," documents how drug companies entice physicians with free cruises and expensive dinners. Pharmaceutical presentations at scientific conferences, articles in eminent medical journals and continuing medical education programs influence doctors.

And, the book notes, "Pharmaceutical companies control what studies get funded, who gets paid for doing them, where (and whether or not) those studies are published, and how the studies are interpreted. Drug companies, who provide beautiful slides along with a prefab perspective, often pay the physicians and researchers invited to give talks at scientific conferences."

On average, pharmaceutical companies spend $10,000 to $15,000 per physician per year on marketing. (Family Therapy Networker, March 2000) A July 12, 2001, report issued by Families USA, a Washington, D.C.-based healthcare consumers' group, says that leading pharmaceutical companies spend more than twice as much on advertising and marketing as they do on research. (www.gayhealth.com)

And it pays off, richly. From 1990 to the year 2000, per capita spending on prescription drugs in the U.S. increased by more than 206 percent. (Family Therapy Networker, March 2000)

Capitalism: Hazardous to health

How can women find objective, truthful, scientific information about drugs?

A survey of some of the following accounts of pharmaceutical company criminal activity in the pursuit of super profits can be found on the Public Citizen Health Research Group website www.citizen.org.

Abbott Laboratories illegally withheld information concerning eight deaths and other adverse effects of the drug Meridia.

Schering-Plough knowingly shipped millions of asthma drug inhalers that did not contain any active ingredients; inactive medication could be fatal to an asthmatic.

Editors of the most prestigious medical journals--such as the New England Journal of Medicine, the Lancet, the Annals of Internal Medicine and the American Medical Association Journal--found a large number of published articles fail to disclose ties to drug companies. The editors have adopted a uniform policy that reserves the right to refuse to publish drug-company-sponsored studies unless the researchers involved are guaranteed scientific independence. The editors acted after recent charges that drug companies tried to withhold negative research results or present them in the most favorable way. (www.mercola.com)

New statistics reveal that 96 percent of studies sponsored by the pharmaceutical industry find the drug under investigation helpful, while only 37 percent of government-funded studies do. (Family Therapy Networker, March 2000).

No wonder polls are finding women scared and angry about the WHI results. Millions of women are left to wonder what can be done to protect them from the unscrupulous practices of the drugs-for-profit industry.

Many of these women have taken hormone replacement therapy because their physicians told them it would prevent heart disease--the biggest killer of women. Now, they are learning that HRT can CAUSE heart disease.

How can any patients trust their doctors when it has been shown that the greatest influence on physicians' prescribing practices is the visit from pharmaceutical reps? (Family Therapy Networker, March 2000)

Cynthia Person concludes, "The lesson we need to learn for the future is that we need unbiased research. We need to remove drug company influence from all medical education. And pharmaceutical interventions should not be inflicted on healthy people until these interventions are proven safe and effective in randomized controlled trials." (www.womenshealthnetwork.org)

There also needs to be a thoroughgoing struggle against sexism in the delivery of medical care--as well as ongoing battles against racism, homophobia and other barriers to treatment, like lack of health insurance and poverty.

"The idea that our bodies fail us at menopause is ludicrous, extremely sexist and just plain wrong," says Vicki Meyer, founder of a cybercommunity called the International Organization to Reclaim Menopause. (Time, July 14)

But ultimately, the answer is to remove health care--and all other forms of capitalist industry--out of the hands of private ownership by a wealthy handful and into the hands of the vast laboring class that built it with their toil. Under a planned economy--even in the poorest countries trying to build socialism, like Cuba--health care is free for everyone.

Removing the capitalist profit motive--the insatiable drive that is so hazardous to health--lays the basis to explore numerous ways that society can support physical, emotional and mental healthy living through the entire life spectrum from infancy to old age.

Hiestand is chief steward of CWA 1168 in Buffalo. She is also a women's rights activist who, during a right-wing mobilization in Buffalo in the 1990s, helped organize coalition defense of women's clinics that performed abortions.

Reprinted from the Aug. 1, 2002, issue of Workers World newspaper

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