This week, a pharmaceutical company called Sprout Pharmaceuticals may win approval for the first ‘female Viagra’ drug to boost women’s sexual desire. [1]
Sprout, founded by a husband-and-wife team, once ran Slate Pharmaceuticals, which marketed an implantable testosterone pellet to men with low levels of the hormone. Sprout is facing harsh criticisms due to Slate’s misleading and unsupported statements concerning the benefits of testosterone therapy while downplaying the risks, breaking federal rules. Last year, the FDA held a meeting to examine the over-prescribing of testosterone and used Slate’s commercial as an example of inappropriate marketing.
Sprout’s critics are frustrated with the company’s aggressive push to win the new drug’s approval. The medication has already been rejected twice due to a lack of efficacy and because of side effects including nausea, dizziness, and fainting.
Sprout “already has a history of unethical marketing,” said Dr. Adriane Fugh-Berman of Georgetown University. “If approved, I think this drug will be widely prescribed, and we would see an epidemic of adverse effects.”
Supporters of the company lobbied for a year before the drug won a surprising 18-6 recommendation from a panel of FDA advisers in June. The agency is set to make its final decision on Tuesday.
The female sexual desire drug was acquired by Boehringer Ingelheim in 2011, but the German drug maker dropped the product after FDA advisers unanimously voted against its approval in 2010. Sprout’s founders, CEO Cindy Whitehead and her husband, Bob Whitehead, who preceded her as CEO, eventually sold their testosterone business to pay for the drug.
Because both Slate and Sprout have both been privately held, little is known about the companies’ financial information. According to the Whiteheads, their testosterone implant, Testopel, became the second most-prescribed testosterone treatment among urologists, winning favor over competing gels and injections.
But the FDA issued Slate an 11-page warning letter in March 20 highlighting the company’s misleading, inaccurate, and unsupported statements published in brochures, websites and in a video. The agency made the rare move of holding a teleconference with the drug maker to discuss its “serious concerns.” The letter said that the FDA was unaware of any data to support some of Slate’s outrageous claims about Testopel, including that the drug could benefit patients with depression, diabetes, and HIV.
In a video viewed by Fox News, Slate featured Harvard Medical School professor Abraham Morgentaler, claiming that testosterone could boost men’s energy and libido.
“Their strength may improve. Their workouts at the gym may get better. They start chasing their wives around the room a little bit. They just feel like guys again,” Morgentaler said. The FDA said his claims were unproven.
In May 2015, the FDA began requiring all testosterone drug makers to specify that their products were intended only for men with low testosterone caused by illness or injury, not normal aging. Companies were also directed to mention the risks of heart attack and stroke on the testosterone drugs’ labels.
That information was not required when Slate marketed Testopel. The company conveniently omitted the side effects associated with the implant including prostate cancer, swelling, nausea, vomiting, acne, liver problems and headaches.
Cindy Whitehead said Slate immediately discontinued the materials cited by the FDA, and insists that the new drug will be marketed by Sprout carefully.
“We would never want a patient who’s not going to see a benefit to take it and tell everyone it doesn’t work,” she said. At the FDA meeting in June, Sprout offered to hold off on television advertising for up to 18 months after the drug’s initial approval.
Erik Gordon, a business professor at the University of Michigan, told Fox News that he expects Sprout – which has already raised $50 million in venture capital – will easily recoup that money and that a large drug maker will likely purchase the drug.
“I think they’ll sell a lot of it, and the company will probably get acquired by somebody who wants to acquire all of that cash flow,” said Gordon.
Though there are risks associated with hormone injection, each hormone (and especially having balanced hormones) do offer many benefits via hormone therapy for both men and women. It just takes a little research to see if it’s right for you.
Sources:
[1] Fox News
BBC
Featured image courtesy of AP Photo/Allen G. Breed / Fox News