View attachment 44625 WASHINGTON — At a small luncheon last July in an elegant downtown restaurant, two well-known Washington feminists came to celebrate Cindy Whitehead, a senior executive at a pharmaceutical firm that is developing a pill to revive women’s sex drive.
In some ways, it was an unlikely gathering. The feminists, Susan Scanlan and Audrey Sheppard, had worked on women’s issues for years, including on Capitol Hill and, in Ms. Sheppard’s case, at the Food and Drug Administration. Ms. Whitehead, many years their junior, had managed brands, sales and marketing strategies for pharmaceutical companies.
But they had a common cause — getting the drug approved — a mission they said they believed in, but also one that the feminists were getting paid to promote. The occasion was captured in a splashy photo spread on the website of a Washington lifestyle magazine.
The women, together with a public relations company, Blue Engine Message & Media, are central players in the unusual story of how a female libido pill that had been twice rejected by the F.D.A. achieved a surprise success on June 4, when a panel of experts recommended the agency approve it. The F.D.A. has not yet made a final decision. But by lending their heft to a campaign for the drug, the feminists won the support of much of the nonprofit women’s health community in Washington, galvanizing it with the charge that a refusal to approve the drug would be sexist.
Less noticed were women’s groups that refused to join the campaign, contending that waving the flag of gender bias would undermine what should be an impartial process based on science. Among them were the National Women’s Health Network and Our Bodies Ourselves. Many believed the pill’s risks — fatigue, fainting, dizziness and nausea — outweighed the benefits, which they said were meager. (Women taking the drug had about one more satisfying sexual event per month than women receiving a placebo.)
The campaign divided the normally cohesive women’s health community, which has long fought together for access to birth control and for abortion rights.
“From my perspective, that was a really inappropriate strategy, and I really didn’t like it,” said Susan F. Wood, director of the Jacobs Institute of Women’s Health at George Washington University. She said the company had “made the rounds,” asking for the support of women’s health organizations, including hers. “There are some very important issues around ensuring that women get studied and women’s health needs are addressed,” she said. “This trivializes that work.”
Women hold many senior roles at the F.D.A., including the director of its Center for Drug Evaluation and Research, Dr. Janet Woodcock. Professor Wood herself served as assistant commissioner for women’s health at the F.D.A. but quit in 2005 over delays in approval of Plan B emergency contraception as an over-the-counter medicine.
Advocates who support the libido drug, flibanserin, say they believe it has the potential to improve the lives of millions of American women and strongly reject the charge that they were in any way co-opted by the company. They say passionate supporters are needed to move impassive federal agencies to action, and cite Act Up, which pushed the F.D.A. on AIDS drugs in the 1980s.
“I’ve been accused of bullying the F.D.A., and I say, ‘No, it’s called advocacy,’ ” said Sally Greenberg, the executive director of the National Consumers League, who took part in the campaign for the drug’s approval.
The drug company, Sprout Pharmaceuticals, was formed by Ms. Whitehead and her husband, Robert Whitehead, after the company that previously owned flibanserin gave up on it following the first F.D.A. rejection in 2010. The F.D.A. made its ruling after a panel of outside experts voted unanimously against the drug, saying it was not very effective and had side effects.
Ms. Whitehead said she was inspired by video testimonials from women in the clinical trials who were told that the drug was being abandoned. Barbara Gattuso, 66, with her husband, Gregg, 67, in Boston last week, on vacation from their home in San Diego. “I was the one initiating sex, much to the surprise of my husband,” Ms. Gattuso said at the F.D.A. workshop in October.
“I immediately saw that for the women whose lives and relationship had been meaningfully improved over the course of the trial, this news was devastating,” she said in an email.
Groups involved in the campaign say Ms. Whitehead is very committed to women’s issues. She took over as chief executive of Sprout from her husband in January. Some critics speculate that the company wanted a woman as the face of the brand. Other than Ms. Whitehead, the company’s board of directors is entirely male. The Whiteheads’ previous enterprise, Slate Pharmaceuticals, sold an implantable testosterone pellet for men. In 2010, it received a warning letter from the F.D.A. saying the company was promoting unapproved uses of the treatment, overstating its effectiveness and minimizing its side effects.
Terry O’Neill, president of the National Organization for Women, said she took notice of flibanserin after the F.D.A. refused to approve it a second time in 2013. That rejection struck many of the groups as unfair in light of what they said was the speedy approval of Viagra in the 1990s.
“I honestly think what’s going on here is the cultural context in which we live and the F.D.A. operates is that women’s sexual pleasure is just not that important,” Ms. O’Neill said.
In early 2014, a group of women’s organizations, including Ms. O’Neill’s, met with Dr. Woodcock and other officials at the F.D.A.’s headquarters in Silver Spring, Md. It was not clear what role, if any, the company had in the trip. Ms. Scanlan, who was among the participants, said they “went out there under our own steam.” Ms. Greenberg said her nonprofit group had paid for the bus. Dr. Anita Clayton, a paid consultant for Sprout who helped in the drug’s testing and who is a psychiatrist at the University of Virginia, said she had accompanied the participants as a medical expert.
The groups came away with the impression that their concerns had been dismissed and wrote a letter to Dr. Woodcock to say so. Ms. Scanlan, chairwoman emeritus of the National Council of Women’s Organizations, said they had told the company what happened.
“We said: ‘This is pure inequity. This is outrageous,’ ” Ms. Scanlan said. “And they said, ‘Well, maybe you could do a campaign or something.’ ”
The public relations company, Blue Engine Message & Media, said it had been approached about starting a campaign by Ms. Sheppard — who directed the office of women’s health at the F.D.A. during the Clinton administration and who was a paid consultant for Sprout — together with other advocates. (Ms. Sheppard said that she had not put it together, but that it had evolved from discussion among the women’s groups.)
The resulting nonprofit, Even the Score, set up a Facebook page that featured photographs of prominent feminists, and a Twitter account that provided a stream of zippy commentary. Ms. Scanlan, who had recently retired and was not representing any particular organization, became its chairwoman.
Jaime Horn, an employee of Blue Engine who serves as a spokeswoman for Even the Score, called it an organic effort by advocacy organizations committed to “providing a voice” to the women who experience a lack of sexual desire. She said Even the Score did not disclose individual contributions.
Ms. Scanlan, who has worked for women’s causes since the 1970s, said she spends about 10 hours a month on Even the Score, though in some months she put in 40 or 50 hours. She said she believed in the drug’s potential, and was not doing it for the money, which she described as an “extremely modest stipend.”
“I’m not going to be taking any vacation to the Riviera on it,” she said.
At the same time, Dr. Clayton, the Sprout consultant, wrote opinion pieces in The Huffington Post making the case for low female libido as a medical condition. Daniel Carpenter, a scholar of regulatory policy at Harvard University, called the campaign for the drug’s approval “the most extreme case of companies using social lobbying to get a drug approved in years.”
He disputed the advocates’ analogy to the AIDS movement, saying Act Up was as suspicious of the drug companies as it was of the F.D.A. “How independent are these groups?” he asked. “Would they turn their backs on the company if the price was really high or if there were safety issues? If all they are doing is greasing the wheels to approval, it’s kind of one-sided.”
Ms. Whitehead said it was premature to discuss how much the drug would cost, because it has not been approved. Diana Zuckerman, president of the National Center for Health Research, which opposed the drug’s approval, said the agency and its panels were not immune from public controversy.
“When a panel gets confronted with a lot of passionate voices from people who have been harmed, they very frequently pick what they think is a compromise path,” she said.
Ms. Horn of Even the Score strongly disputes the contention that the campaign put pressure on the agency.
“People who claim that the F.D.A. advisory committee’s decision was based solely on a public-relations campaign are giving us too much credit,” she said in an email. “If the science didn’t support approval, the F.D.A.-appointed advisory committee of doctors, clinicians and other safety experts wouldn’t have approved it.”
Painting the F.D.A. as sexist did not sit well with some potential supporters. Stephen T. Wills, the chief financial officer of Palatin Technologies, which is also developing a drug to increase women’s libido, said the company asked this month that its name be removed from Even the Score’s website.
“We were just not comfortable with that approach,” he said. Mr. Wills said Palatin had declined several requests to contribute to Even the Score, including one for $5,000 or $10,000 to pay for patients to travel to the F.D.A. workshop last October.
As the panel met on June 4, supporters of the drug packed the audience. Many people wanted to testify, the vast majority in favor of the drug. A few women talked about how the loss of libido had made them feel broken and had threatened their marriages. And one woman said that when she tried flibanserin in a clinical trial, it was as if “a light switch had been turned on.”
There was loud applause when some people spoke in favor of the drug, and when the vote was announced at the end. There was less applause for people testifying against approval.
By Sabrina Taverness - The NY Times/June 15, 2015
Photos: 1-NY Times; 2-NY Post
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