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‘Female Viagra’: Is This The Moral Of The Story Of The Little Pink Pill?

(Allen G. Breed/AP)

(Allen G. Breed/AP)

Remember “the little pink pill”? The great brouhaha last year about the FDA’s approval of “the female Viagra?”

Let us recap: The drug — flibanserin, brand name “addyi” — is aimed at boosting the libido in pre-menopausal women who have “Hypoactive Sexual Desire Disorder.” (In fact, it’s radically different from Viagra, aimed at desire rather than performance and taken daily, not as needed.)

The Food and Drug Administration declined to approve it twice, citing potential harms and marginal benefits. But then, in August — amid head-spinning debate about whether it’s sexist to approve a drug for female desire or sexist not to — the FDA said yes. Addyi went onto the market in October.

Now, a new meta-analysis, just out in JAMA Internal Medicine, sums up the handful of existing studies on the drug’s benefits — a resounding “eh” — and potential harms.

It finds that women who take the daily pill average just one additional “Satisfying Sexual Event” every two months. Compared to placebo, just 10 percent more women who take it report significant improvement in their sex lives.

“I think that what feminism means is getting good drugs that help more than they hurt.”

– Prof. Lisa M. Schwartz

As for harms, 21 percent of women on the drug reported severe drowsiness, compared to 8 percent on placebo. Of greater concern: When combined with alcohol, the drug can apparently lead to dangerously low blood pressure and even fainting.

The analysis confirms findings from before the FDA approval, and it’s not a very sexy picture. That could be why initial sales of Addyi seem to have been lackluster: Bloomberg reports that only a couple of hundred women got prescriptions for Addyi in the weeks after it was released, compared to the half million men who got Viagra in the month after it came onto the market in 1998.

So what’s the moral of this story? Drs. Steven Woloshin and Lisa M. Schwartz of the Dartmouth Institute of Health Policy and Clinical Practice wrote a biting editorial to accompany the meta-analysis, sub-headlined “Even The Score Does Not Add Up.”

“Even The Score” is the advocacy group that reportedly packed the FDA hearing room with women telling powerful stories of how desperately a treatment for loss of libido is needed. Woloshin and Schwartz write that it “conducted an intense promotional campaign directed at journalists, women’s groups, Congress and the FDA.”

The campaign, Schwartz says, “ignored the idea about the science and made it all about these charges of sexism, as opposed to the idea that there were real concerns about science here.”

“To me, as a woman, I think that what feminism means is getting good drugs that help more than they hurt — or non-drugs. I think it’s important to meet the needs of women, but we want to do that based on good science that tells us that we’re helping more than we’re hurting women. Even the Score started to become about something else.”

The moral, Woloshin says, is that while under such political pressure, “FDA approved a marginally effective drug for a non-life-threatening condition in the face of substantial and largely unnecessary uncertainty about its dangers.” Continue reading

Web Preview: Health Care Award Winners Talk About Controlling Costs

By WBUR’s Martha Bebinger
(scheduled to air today on All Things Considered)

The child of Chinese immigrants who is transforming care for the elderly, a man inspired by the death of his brother and a woman whose leadership is described as a mix of acid and whipped cream are among those honored this year by the New England Healthcare Institute.

The awards showcase the work of these five men and women on improved patient care. We asked these health care innovators how what they’ve learned about improving care might translate to controlling health care costs.

Patricia Gabow

Let’s begin with the petite hospital executive who blends acid and whipped cream in running Denver Health, a national model in health care for the uninsured. CEO Patricia Gabow looks to other industry leaders: Fed Ex, the Ritz Carlton and Toyota and adapts their approach to her goal, improving patient care. Using Toyota’s LEAN model to analyze more than 300 procedures at Denver Health, Dr. Gabow says she found that about 60% of what has happening was waste.

“By taking out waste you improve quality and lower costs and make it (health care) more patient friendly,” says Gabow. “Who wants to sit in a waiting room or get a test you didn’t need? But unfortunately, in health care, a lot of what we think is waste is someone else’s income and that’s why it’s very difficult to change this system.”

Gabow says Denver Health is $66 million better off in savings and efficiencies since adopting the Toyota model. Now Gabow says she, like some hospitals in Massachusetts, is ready to test new ways of getting paid for health care. She expects to try global payments, where doctors and hospitals work under a budget for patients instead of getting paid for each office visit, test and procedure — what’s known as fee for service.

“You have to get rid of fee for service if you want to improve value and lower cost” says Gabow. “It doesn’t take a rocket scientist to say, if you pay people for doing more that they’re going to do more, this is human behavior.”
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