The FDA has a full-blown revolt on its hands. And it’s about time.

After a phony and sleazy “equal rights” campaign, the agency is about to betray millions of women by approving a dangerous new sex drug called ADDYI.

It’s been dubbed the “female Viagra.” But they should call it the “little pink problem” instead, because ADDYI’s own studies prove it doesn’t work and could kill you.

Now, with the clock ticking, nearly 200 of the country’s top scientists are demanding that the FDA do its job.

And that means standing up to political correctness — for once — and protecting America’s women from this coming menace.

The little pink problem“The benefits are modest, maybe less than modest, but I think that puts it in company with other approved drugs, unfortunately.”

When Dr. Jeanmarie Perrone said that about Sprout Pharmaceuticals’ ADDYI at an FDA advisory panel meeting in June, the room exploded in laughter.

But when the agency unleashes this drug on America’s women, it’s going to be no laughing matter.

The FDA is expected to formally approve ADDYI this week (it still hadn’t at the time I was writing this). And when it does, it will be a victory for one of the most shameful public relations scams in Big Pharma history.

As I’ve been telling you for months, ADDYI never met a clinical trial it couldn’t fail. It didn’t work as an antidepressant, and even Sprout’s efforts to resurrect the med as some libido-boosting pill for women were repeatedly rejected by the FDA.

When the FDA — which has made it its mission to rubber-stamp useless and dangerous drugs — won’t put its name on something, you know it’s really a dud.

So instead of making ADDYI’s approval about science, Sprout made it about politics.

The company lined up feminist groups for a campaign called “Even the Score” that included phony TV documentaries and carefully planned demonstrations claiming a sex pill for women was about equal rights.

Sure. Right up there with voting and equal pay.

Unfortunately, it worked. The FDA advisory panel that had previously rejected ADDYI signed off on it by a vote of 18-6 a couple months ago, and the FDA is expected to give its full blessing any day.

Now, some top scientists from around the country are making a last-ditch effort to do something the FDA and its advisors should have done — stop this drug in its tracks.

Nearly 200 university researchers, drug experts and non-profit scientists have written the FDA two letters demanding that ADDYI be rejected.

One letter, signed by Dr. Leonore Tiefer from the New York University School of Medicine, along with 133 other scientists and sex therapists, claims the theory used to support ADDYI’s application has been completely debunked.

The second letter, led by Dr. Adriane Fugh-Berman and a who’s who of researchers that includes the editor of the Annual Review of Sex Research, warns that that prescribing the drug to women with heart problems or who are social drinkers would bring about “an epidemic of serious adverse events.”

And that’s no surprise, considering that Sprout’s own research shows that ADDYI can cause fainting, nausea, dangerous drops in blood pressure that could make a heart condition worse, and serious interactions with alcohol.

The push for ADDYI is nothing but “a brilliant marketing strategy that pressures FDA and gets around laws preventing the promotion of drugs prior to regulatory approval,” Dr. Fugh-Berman said.

But that marketing campaign is about to pay off, and millions of women are going to be put at risk thanks to a drug that our own government knows should never see the light of day.

And let’s face it — unlike Viagra or Cialis, ADDYI isn’t designed to fix a physical problem that would prevent you from having sex. The biggest physical issue for women is dryness — and that’s something you can take care of with a tube of K-Y.

This drug isn’t about helping women and it was never about equal rights. It’s about what Big Pharma considers its right to snatch the money right out of your purse and leave you dealing with the consequences.

Sources:

“Women’s sex drug gets political hard sell” Sarah Karlin, August 13, 2015, Politico, politico.com

“‘Female Viagra’ foes denounce PR campaign to win FDA approval” Robert Lowes, August 10, 2015, Medscape, medscape.com

 


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Allan Spreen, M.D.
Dr. Allan Spreen, Chief Medical Advisor

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