Drug companies have made billions of dollars treating erectile dysfunction in men.
Seeing the potential for billions more, they have turned to a condition some doctors don’t see as a medical disorder at all: lack of interest in sex.
A diminishing interest in sex naturally occurs as people age. It is not life-threatening. But the treatments created to date carry substantial physical risk with minimal benefit. And for years regulators have allowed them on the market.
Consider the new drug Addyi and the condition known as female sexual interest/arousal disorder.
Low sexual desire has dubious origins as a medical condition. Some 43% of women were said to suffer from some form of sexual dysfunction, including many who simply lacked interest in sex, according to a 1999 paper. But that study was conducted by researchers with drug-company ties and did not measure what percent were distressed by it.
And Addyi, termed the “female Viagra,” can cause a dramatic and dangerous drop in blood pressure if alcohol is used. The U.S. Food and Drug Administration — which had twice rejected the drug — ordered Sprout Pharmaceuticals to do tests on this point.
Sprout conducted a test of only 25 people.
Of those, 23 were men.
Several passed out or had dangerous blood pressure drops of 22 to 48 points.
The FDA staff member reviewing the drug noted that female nondrinkers may have an even more severe reaction to the drug and said it shouldn’t be approved until a more thorough test was done involving women — “the only gender for whom this drug is indicated.”
The FDA approved Addyi anyway.
“I disagree with that on so many different levels,” said Diana Zuckerman, president of the National Center for Health Research, a nonprofit think tank that analyzes health research.
“You call something a medical condition; you find a solution for it; the solution actually doesn’t work and it has substantial risk,” she said. “The scientists say don’t approve it and the FDA approves it.”
Less than 48 hours after Sprout won approval for Addyi, its owners sold the small company and the rights to the drug to Valeant for $1 billion.
And Addyi, the first drug approved to treat lack of interest in sex among women, soon was being prescribed at $800 per month — a little pink pill for women billed as a counterpoint to the little blue Viagra pill for men. […]
A Journal Sentinel/MedPage Today investigation into how lack of interest in sex among men and women entered mainstream medicine found drug-company influence at every step in the process.
For instance, in 2013 when the FDA rejected Addyi for the second time, it noted the drug’s benefits were modest at best, providing a slight increase in sexually satisfying events (less than one per month) compared with a placebo. Those benefits, regulators determined, did not outweigh the potential risks.
What followed was an extensive political campaign that charged the FDA with sexism for not approving a sexual medication for women despite having approved Viagra, Cialis and a host of testosterone products for men.
Much of the pressure came from the advocacy group “Even the Score,” which — according to an editorial in the April edition of JAMA Internal Medicine — was partially funded by Sprout Pharmaceuticals.
The group persuaded several members of Congress to sign a letter to then-FDA Commissioner Margaret Hamburg that called on her to approve the drug. Even the Score also submitted a petition with tens of thousands of signatures.
Ultimately, Addyi was cleared for use.
As for the small study involving mostly men, a review of FDA documents found the agency accepted Sprout’s contention that it could not find moderate female drinkers to enroll.
In an email response to questions, FDA spokeswoman Sarah Peddicord said the agency recognized the drug’s serious side effects and told the company that markets Addyi to conduct three studies in women to better understand the risk of sudden blood-pressure drops that can occur.
The agency also has required doctors who prescribe Addyi and pharmacies that dispense it to be certified in a program designed to reduce the risks of the drug — though the program amounts to a PowerPoint produced by the drug company and completed on its website.
The drug carries the FDA’s most stringent warning. Women who use it are advised not to drink.
“As with all medications, some patients will obtain more benefit than others,” Peddicord said. “Because (the condition) is symptomatic, patients can gauge whether they have meaningful benefit from Addyi.”
A paper published in April in JAMA Internal Medicine found that Addyi produced just 0.5 additional satisfying sexual events per month for women on the drug compared with a placebo.[…]
Valeant, the company that markets Addyi, said that while women may have a drop in blood pressure or pass out if they use alcohol, the incidence of that is low — though the company’s statement did not cite any numbers. It said the ongoing studies will evaluate the “real world” effects of alcohol in women who use the drug.
“Our goal is to make Addyi affordable and accessible to the millions of women (with the condition),” the statement said. “We believe this product has strong potential and are committed to realizing that potential.”
Valeant has been embroiled in a price-gouging scandal since 2015, for vastly inflating the price of two heart drugs it acquired, and for its connections to Philidor, a mail-order pharmacy that allegedly steered customers to expensive Valeant drugs.
The company has been under investigation by two U.S. attorneys and by the U.S. Securities and Exchange Commission.
Unlike omnipresent ads for erectile dysfunction drugs, Addyi will not be peddled in commercials — at least for the next year or so. In an agreement with the FDA, the company has said it will not embark on TV or radio advertising for 18 months, a period that started with the drug’s approval in August 2015. […]
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