The Greatest Experiment Ever Performed on Women: Exploding the Estrogen Myth
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Introduction I: Smart Doctors, Foolish Forecasts
I have a doctor friend who so believed in the value of synthetic estrogens that when the National Institutes of Health announced a large clinical trial to compare these pills with sugar pills, she dismissed it as a waste of money. "Obviously, the women on the hormones will be living longer," she said. "It's unethical to leave volunteers on the placebos for the full eight and a half years of the trial. At some point they'll have to stop the study and offer hormones to everyone."
Her colleagues concurred, but then the opposite came true. On the morning of July 9, 2002, my friend, along with other physicians and the 30 million U.S. patients taking estrogen products, woke up to discover that the world, after all, was flat. A safety-monitoring board had suddenly halted a part of the study involving 16,608 women because those taking hormones had more breast cancer, heart attacks, strokes, pulmonary embolisms, and blood clots than those taking sugar pills. Yes, the volunteers on Prempro also had fewer bone fractures and less colon cancer. But not enough to balance out the risks.
My friend initially heard the startling results on Good Morning America, where Dr. Tim Johnson described this "somewhat surprising outcome." He predicted that most women then taking hormone pills would stop "after talking to their physicians today," failing to anticipate that many doctors would take their telephones off the hook. My friend switched the channel to CNN, where Paula Zahn repeatedly exclaimed: "I tell you -- women gotta go insane today." Channel surfing, my friend caught up with the "usual suspects," certain doctors familiar to TV viewers whose spin skills had been developed by public-relations coaches at agencies that handle pharmaceutical accounts. It was then that my friend got it. These physicians were appearing on stations where paid ads suggested that if only we took estrogen we could look like Lauren Hutton and sing like Patti LaBelle.
That night my friend called me to apologize for having objected to the title I planned for this book. She had called it "over the top and ridiculous," but now she said she could almost agree.
WHAT IS THE GREATEST EXPERIMENT?
While the Prempro arm of the Women's Health Initiative, which lasted 5.2 years and included 16,608 women, was a major test, it is only a small part of what I consider to be The Greatest Experiment Ever Performed on Women. The experiment began in England in 1938, and it has continued for sixty-five years. A British biochemist, desperate to prevent Nazi Germany from cornering the world market on synthetic sex hormones, published his formula for cheap and powerful oral estrogen. Within months, thousands of doctors and scores of drug companies around the world were working with this formula.
That opened the Greatest Experiment. Products made from chemicals that mimicked the feminizing effects of a woman's natural secretions were marketed fresh out of the lab. They were prescribed and sold for a host of concerns -- to slow and prevent aging, to stop hot flashes, to avoid pregnancy or miscarriage, and as a morning-after contraceptive.
I call the marketing, prescribing, and sale of these drugs an experiment because, for all these years, they have been used, in the main, for what doctors and scientists hope or believe they can do, not for what they know the products can do. Medical policy on estrogens has been to "shoot first and apologize later"-- to prescribe the drugs for a certain health problem and then see if there is a positive result. Over the years, hundreds of millions, possibly billions of women, have been lab animals in this unofficial trial. They were not volunteers. They were given no consent forms. And they were put at serious, often devastating risk.
The risks of these drugs have been known and documented from the start. The British doctor who published his estrogen formula in 1938 spent many years thereafter warning the world that these drugs, although containing great promise, put women at serious peril for endometrial and breast cancer. Since the halting of the Prempro trial in July, despite the ignorance or hypocrisy of many doctors who said "Who knew?," there is nothing surprising in the recent findings. We have known since day one that these drugs posed threats. And since then science has added to, not subtracted from, the list of estrogen's problems.
If doctors and scientists have known these dirty secrets for so long, why is the bad press so recent? That is an essential question right now, and this book seeks to present the answer. Part of the answer lies in the vigorous efforts by drug companies to protect an invaluable market. These efforts have included underwriting studies and subsidizing doctors, participating in medical-school curriculums, advertising heavily in medical journals, and seeing that continuing medical education is directed by doctors on the drug industry's payroll. They have also entailed one of the most elaborate promotion and advertising campaigns in the history of the media not only in America but worldwide.
This is not the first time estrogen sales have felt the cold wind of consumer anger. In 1975, the magnitude of estrogen-related endometrial cancer was established; drug sales sank by half in subsequent years. In that instance, as in every other that has cast suspicion on estrogen, the drug companies managed to revitalize sales through new claims, which is why I say that only through learning how these companies buy and influence medical opinion can women protect themselves from any new spin, any new claim that will inevitably emerge about these drugs and countless others.
Estrogen products won't go away, and they shouldn't. One can only wish, as I do, that they will be used now with caution, based on evidence and facts, not illusion. My aim is to consider whether hormone supplements are necessary and for whom. Specifically, I hope this book will help women navigate the estrogen issue and keep anything similar from happening again. But the larger hope is that we can make informed decisions about other drugs as well.
On the sixty-fifth birthday of the Greatest Experiment, I recall a poem by William Butler Yeats entitled "The Corning of Wisdom with Time":
Though leaves are many, the
root is one;
Through all the lying days of my youth
I swayed my leaves and flowers in the sun
Now I may wither into the truth.
Let us hope.