Why did an FDA panel finally agree to okay this terribly risky ‘women’s drug’?

It’s being called the “female Viagra” or even the “little pink pill.”

But ADDYI (flibanserin), a new libido drug, is about to become a red hot mess for millions of American women.

An FDA advisory committee last week voted 18-6 to recommend that the agency approve ADDYI – a move that could come in just a couple short months.

Drug maker Sprout Pharmaceuticals and women’s groups are calling it a win, saying that with male sex drugs like Viagra and Levitra on the market, it’s about time we ladies got our turn.

But this isn’t a victory for science… for common sense… or for women.

Because ADDYI is on the brink of approval thanks to one of the slimiest public relations campaigns in recent history. And the FDA may be ready to greenlight a drug that will fail nine of every 10 women who take it, and may leave a deadly wave of cancer in its wake.

Not so pretty in pink

The only thing ADDYI has ever been successful at is generating headlines. But in terms of safety and performance, it has a failure rate that would rival just about any dud drug ever submitted to the FDA.

The med was first developed by Boehringer Ingelheim several years ago as an antidepressant. But it didn’t work.

So after some experiments with mice, the company decided… with much fanfare… to repackage ADDYI as a libido-boosting drug for women.

Only the drug failed in that department, too. In clinical trials ADDYI only worked for about 10 percent of the women who tried it, but 15 percent had to quit because of side effects like nausea, dizziness, dangerously low blood pressure and fainting.

That’s right – ADDYI was actually proven more likely to cause side effects than give your sex drive a boost.

Worse still, an animal study linked ADDYI to breast tumors – the higher the dose, the more tumors researchers were finding.

ADDYI’s test results were such a train wreck that the FDA initially said there was a “fundamental question” about whether the benefits of the drug outweighed the risks. That’s why the same FDA advisory panel that just approved ADDYI overwhelmingly rejected it in 2010 and again in 2013.

And those rejections sparked a shameful PR campaign that used countless women as drug company pawns.

Boehringer hired Ogilvy Public Relations — one of the most expensive marketing agencies in America – to launch a campaign about how women are discriminated against when it comes to sexual dysfunction. They set about trying to convince America that the FDA – which was run by Dr. Margaret Hamburg at the time – was the modern-day equivalent of some woman-hating boy’s club.

They invented sham women’s groups, hired celebrity spokespeople, and even funded their own television propaganda.

Boehringer paid for and supervised a phony documentary about female sexuality that aired three times on the Discovery Channel in 2010.

And when Boehringer sold the rights to ADDYI to Sprout Pharmaceuticals a few months later, things only got worse. Women were bussed around the country to speak out for equal rights, as part of what one women’s health expert called a “slick pharmaceutical campaign masquerading as a grassroots feminist movement.”

There was a new website called “Your Voice, Your Wish” with videos and petitions. But that website wasn’t a voice for American women – it was a mouthpiece for Sprout, which plans to make billions selling ADDYI to every female consumer it can reach.

Of course, not every women’s group was sold on ADDYI or the ridiculous argument that its approval was some battle of the sexes.

In a recent Washington Post op-ed, Cindy Pearson, executive director of the National Women’s Health Network, couldn’t hide her disgust that the FDA advisory panel finally bowed to political pressure and gave ADDYI the go-ahead. And she points out that the drug’s approval, which could come as early as August, could be a nightmare scenario for women.

Because, of course, all of Boehringer’s and Sprout’s slick marketing hasn’t made the drug any more effective – and it can’t wash away ADDYI’s links to cancer and other debilitating side effects.

“Every woman deserves to have positive sexual experiences without risking her physical health,” Pearson wrote.

Now that’s a women’s rights campaign we could all get behind.

Sources:

“FDA panel backs a ‘female Viagra’” Ed Silverman, June 4, 2015, The Wall Street Journal, wsj.com

“Astroturfers rule the day: FDA’s flibanserin reviewers were “emotionally blackmailed” by a slick lobbying campaign” Alan Cassels, June 5, 2015, Health News Review, healthnewsreview.org