Premarin claimed to treat menopausal symptoms such as depression, anxiety, and night sweats. But as it rose in popularity, it went one step farther, declaring it could prevent osteoporosis and cardiovascular disease. Did it live up to the hype?
How Premarin Ads Targeted Both Men and Women
The 1960s saw skyrocketing sales of premarin, pushed by a hugely successful campaign called “Keep her on premarin.”
One ad, titled “Husbands, too, like premarin,” states, “The physician who puts a woman on premarin when she is suffering in the menopause usually makes her pleasant to live with once again.”
Pleasant to live with once again? Compare that to premarin’s words: “Honored, yes, loved with a purer flame than any which she inspired in the bloom of youth and beauty.”
Well, times change. The ad continues, “It is no easy thing for a man to take the stings and barbs of business life, then to come home to the turmoil of a woman ‘going through the change of life.’ If she is not on ‘premarin,’ that is.”
But women were targeted directly, too.
This is a transcript from the video series The Skeptic’s Guide to Health, Medicine, and the Media. Watch it now, on The Great Courses Plus.
A book by British gynecologist Robert Wilson, titled Feminine Forever, became a bestseller when it was released in 1966. It helped convince millions of women that estrogen replacement around menopause wasn’t just a helpful way to relieve symptoms, but something that was necessary to protect their very identities as women.
Wilson wrote, “Every woman alive today has the option of remaining feminine forever.” He compared post-menopausal women to castrated men, but said there was hope. By taking estrogen, her “breasts and genital organs will not shrivel.”
It’s no coincidence that Wilson’s text reflected marketing messages. He was receiving payouts from companies making estrogen compounds, both for his book and for speaking tours.
These messages pervaded articles in women’s magazines and the popular press. Sales of hormone replacement prescriptions quadrupled around the time of the book’s release.
There were some studies, though, that showed a downside of these hormone pills. Two studies published in 1975 reported that estrogen therapy dramatically increased the risk of endometrial cancer. These studies were widely publicized, and estrogen prescriptions plummeted.
A few years later, newer studies showed that this increased cancer risk could be mitigated by the addition of a second hormone to the estrogen regimen, progesterone, and sales of both of these medicines headed back up.
Beyond Menopause: Premarin’s Rise to Blockbuster Status
In 1992, premarin became the most frequently prescribed medication in the United States, and it remained in first or second place for the rest of the century. By then, its use was entrenched for the treatment of menopausal symptoms; the prevention of osteoporosis; and, it was thought, the prevention of cardiovascular disease. It was these latter, long-term purported health benefits that had really propelled these medications to blockbuster status.
Premarin had been FDA approved in 1942. At that time the law only required the manufacturer to show that it was safe, not that it was useful or effective for any specific indication.
Later laws compelled the FDA to look at and approve the indications for medications, which could then guide their marketing—that is, drug companies could only market their drugs for reasons approved by the FDA.
In 1972, six years after Wilson’s influential book, the FDA officially announced that premarin was effective for the symptoms of menopause. By then, thanks to marketing, everyone already knew that. But this confirmed that companies could market it for these symptoms.
Still, you can’t make a super-blockbuster drug with only a fairly narrow indication. Menopause affects all women, but the symptoms of menopause only happen for a few years.
In 1986, the FDA announced that premarin and similar drugs were also effective at fighting the bone loss associated with osteoporosis. Suddenly, a drug that many women had been taking for a relatively short time was now a treatment for a long-term, essentially lifetime condition—a condition that was common, and silently affected millions of women, putting them at risk for debilitating fractures and back pain.
There was talk, then, not only in the popular press, but in the medical literature, that literally every postmenopausal woman should take premarin for the rest of her life.
The idea of using these hormones long-term to prevent heart disease and stroke was also compelling. It was known that the risk of these diseases increased in women after menopause, so if menopause could be effectively erased by giving hormones, wouldn’t that reduce the risk?
Though no clinical trial had ever shown this, reduced cardiovascular risks in women taking hormone replacement therapy were seen in observational studies. That’s not rigorous proof, but it certainly helped support premarin sales.
Learn more about how the press praised hormone replacement therapy as a panacea for menopausal symptoms
Another Win for Premarin
Then, in 1991, the FDA withdrew their approval of less-expensive, generic estrogen products. It’s complicated, but their reasoning went like this: Premarin, itself, is a mixture of at least 50 chemically different estrogen compounds.
It was manufactured—and is still manufactured, to this day—by collecting and processing the urine of pregnant mares. In fact, that’s where the name premarin comes from: it’s short for pregnant mare urine.
Other manufacturers of estrogen compounds couldn’t copy Ayerst’s exact production methods, so their drugs didn’t have the same exact mix of natural estrogens. Therefore, according to the FDA, generic manufacturers could not claim that their drugs worked for the same things as premarin.
It took several years for generic makers to be able to reintroduce their products to the market, and only for narrower indications. To this day, there is no truly generic premarin; no other estrogen compound can be substituted for the original.
Learn more about hormone replacement therapy
Studies Cast Doubt on “Miracle Drug”
By 1999, sales of premarin in the United States totaled $1.5 billion a year.
But it was time for the science to catch up with the marketing. The HERS (“Heart and Estrogen/Progestin Replacement Study”) published in 1998 was the first significant, randomized controlled study of hormone replacement study.
It enrolled nearly 3,000 women, and followed them for an average of four years. The study found that treatment with hormone replacement did not reduce the risk of heart disease, but it did increase the risk of blood clots.
The authors recommended that these medicines not be prescribed as a way to prevent heart disease, though they allowed that women already taking the meds might as well continue them.
These results were amplified in 2002 with the release of the first Women’s Health Initiative study. This was a much larger trial whose results showed that long term combination hormone therapy did not improve survival or prevent chronic illnesses in postmenopausal women.
The study was actually halted earlier than expected because the results were so striking. The study also showed that hormone replacement therapy increased the risk of heart attacks, strokes, and breast cancer.
Some benefits were seen—hormone treatment improved the rates of hip fractures and colon cancer—but the risks of hormone therapy far outweighed the benefits.
Headlines screamed that hormone replacement therapy was causing death and cancer in women. The Guardian, in 2002, declared, “HRT study cancelled over cancer and stroke fears.”
NBC’s chief science and health correspondent sounded breast cancer alarms, stating, “Millions of women could have developed and even died from the disease because of excessive use of hormone replacement therapy.”
And sales reflected these fears. At its peak, an estimated 40 percent of women in the United States ages 50 and older were taking hormone replacement therapy. That figure dropped to 5 percent by 2009.