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Roundup of flibanserin – ‘female Viagra’ – approval news; ‘game changer’ to some, ‘monumental bamboozlement’ for others

FDA logoFew were surprised that the FDA followed the recommendation of a sub-committee to approve a pill intended to enhance women’s libidos. Industry watchers expect Addyi (the brand name for flibanserin) to be a blockbuster drug. The drug will be marketed by either Sprout Pharmaceuticals or Valeant Pharmaceuticals. After the FDA approved Addyi on Tuesday, August 18, Valeant announced on August 20 that it was making a move to purchase the rights to the drug from Sprout for $1 billion. If the deal goes through, Valeant will be the third owner of a drug that has yet to go on sale.

Drug policy researcher, author and frequent HealthNewsReview.org contributor Alan Cassels has been following the flibanserin story for many years. When he looked at several examples of Tuesday’s media coverage he found some of them wanting. “The big thing missing from most of these stories – even those that are balanced and include the voices of the critics – is a serious questioning of the disease and the pharmaceutical industry’s role in creating and sustaining the idea that HSDD [hypoactive sexual desire disorder] is a legitimate condition,” he says. “Clearly some women are uninterested in sex and that causes them some distress, but to even remotely think that sexual desire is clinically-based rather than relationship-based is a bamboozlement of monumental proportions.”

There’s more information about the drug and the evidence base for its approval at the bottom of the post. Here’s a rundown of some of our media observations on the approval.

BloombergLibido pill’s risks have insurers weighing whether to cover it

Bloomberg spoke with insurance providers over the very important issue of coverage. “Getting coverage from insurers is crucial for Sprout, which has fought to get FDA approval for Addyi after the agency rejected the drug in 2010 and 2013,” accoding to Bloomberg. “Without help from insurance plans, women will have to consider paying as much as $400 a month for the chance to see whether the drug will work for them. Sprout said Addyi should get reimbursed at the same rate as male sexual-dysfunction drugs.” In its interviews with provider representatives Bloomberg learned that if they do cover Addyi, it’s likely they’ll require a higher co-pay than for other drugs.

CBS NewsWomen, doctors say better treatments for sexual dysfunction needed

This story describes the drawbacks of the drug, but ultimately centers on the need for it, and the ability for women to be able to “choose.” It leads with this statement: “Controversy over a drug to boost women’s libido has brought to light the overwhelming need for new ways to treat sexual problems in women.”

The doctor quoted in the story claiming there’s a “huge need” is Holly Thacker of the Cleveland Clinic, whose identical quote can be found in other stories, including this Q&A (The Short Answer: ‘Viagra For Women’) in The Wall Street Journal.

CBS NewsWomen eager to see if new libido drug will work

This story profiles a married woman who wants to take the drug. The patient profiled appears in numerous stories about flibanserin which suggests to us that someone (the drug sponsor or perhaps one of the advocacy groups that the company supports financially) could be pushing her forward as an unofficial spokesperson. The story is rounded out by a quote from a doctor who suggests the drug gained approval because of Sprout’s public relations campaign.

NBC NewsFDA approves controversial ‘little pink pill” but with restrictions

The story starts out with a critique, but ends with a quote from a doctor claiming that the approval is a “game changer.”

Something important is missing in this and other stories, says Cassels. “It talks about the danger of the drug but no one is saying how short the clinical trials were, the main cause of the nearly 10% dropout rate, and the bigger picture: how will this pill ultimately affect relationships? Will it put pressure on women who truly find their partner repulsive into sex that they are not into?”

Like the CBS story above, this one quotes a patient source who appears in numerous flibanserin approval stories.

CNN ‘Female Viagra” gets FDA approval

CNN’s coverage repeated the canard that the drug produces a “37% increase in sexual desire.”  Cassel calls that figure “so thoroughly misleading that to repeat it is to commit a gross act of marketing. Are we sure this wasn’t a 36% increase in sexual desire? As if you could be that precise with a concept so slippery, and so largely unmeasurable that to try to do so is the ultimate in misdirection.”

NPRFDA approves first drug to boost women’s sexual desire

This story is nicely balanced except for the issue of costs. The story assumes that its audience all have health insurance coverage and those prescribed the drug will only be liable for co-pays and not the entire out-of-pocket expense. “This drug is likely to be very expensive and so far no one has given us a good idea what it will ultimately cost you and your insurer, together,” says Cassels.

New York TimesFDA approves Addyi, a a libido pill for women

The Times story very carefully delineates quotes made by groups who were being partially funded by Sprout. This transparency is commendable.

USA TodayFDA approves world’s first pill to boost women’s libido

USA Today balanced its story with a thorough exploration of the reservations held by different groups, individual physicians and a U.S. congress member.

Boston GlobeFDA approves female sex pill, but with safety restrictions

This is an otherwise strong story whose conclusion is marred by comparing the search for a drug for female sexual dysfunction to the search for “the holy grail.”

Cassels considers the drug’s development a different kind of hunt. “For more than a decade we’ve been tracking the industry’s involvement in creating a disease that could be credibly treated with a pill. Getting the FDA to approve this on the basis of ‘desire’ is a triumph of market creation.”

The Washington Post put the whole story into context with a time line of sexual dysfunction drug research from the 1950s to today. Well worth reading.
From 1952-2015: The path to ‘female Viagra’ has been a rocky one 

About the Flibanserin Approval

The prescription drug will be targeted to pre-menopausal women diagnosed with a new medical designation called “hypoactive sexual desire disorder” (HSDD). Unlike Viagra, the drug must be taken every night and will cost around $400 a month when it goes on the market in October, 2015. The benefits from the drug are arguably minimal. “On average, treatment with Addyi increased the number of satisfying sexual events by 0.5 to one additional event per month over placebo,” the FDA said in its news release about the approval. The FDA also warned that doctors will be prohibited from prescribing the drug to women who use alcohol because combining the two causes low blood pressure and fainting. Other common side effects associated with the drug are dizziness, nausea, sleepiness, fatigue, insomnia and dry mouth.

There’s been plenty of controversy surrounding the drug over the last five years. In 2010 an FDA advisory panel unanimously rejected Boehringer Ingelheim’s (the original drug developer) bid for flibanserin saying it performed no better than a placebo. Sprout, which acquired the rights to flibanserin in 2011, resubmitted an application to the FDA in 2013. The FDA again rejected the application, saying the many side effects of the drug didn’t outweigh the benefits. The agency also registered concerns about as-yet unknown long-term effects from the drug. In late 2013 Sprout requested a Formal Dispute Resolution with the director of the FDA’s Office of New Drugs, and in February 2015 the company re-submitted its application with additional data requested by the FDA. Sprout has been accused of bulldozing its way to FDA approval by using the “gender card.” Through “Even the Score,” its campaign front group, Sprout accused the FDA of “persistent gender inequality” because it had approved many types of drugs for men’s sexual performance but none for women. Sprout also packed an FDA hearing room with advocates and “average women” who pleaded for access to the drug. The company’s efforts were aided by several Congress members who encouraged the FDA to approve the drug as a women’s rights advancement.

Additional coverage:

Philadelphia Inquirer – FDA approves drug to boost women’s libido

Wall Street Journal – FDA approves first drug to boost women’s libido

Washington Post – FDA approves controversial drug for women with low sex drives

USA Today — FDA approves world’s first pill to boost women’s libido

Los Angeles Times — As FDA approves ‘pink Viagra’ for women, controversy persists

HealthDay — FDA approves libido pill for women–with restrictions

Fox News — Female libido pill took long, winding road to market

Fox News — Q & A: First pill approved to boost sex drive in women

Reuters — FDA approves ‘female Viagra’ with strong warning

Bloomberg — Approving first sex-drive pill for women outweighs risks for FDA

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Comments (1)

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Nancy Faigen

September 3, 2015 at 3:51 pm

This debate will continue. Meanwhile, there is one good sign here – namely that in its news release the FDA went out of its way to communicate in a concise, quantitative manner the results of the pivotal trials taken from the full prescribing information (www.addyi.com), and certain details were found in news stories. Sprout did not do the same.

The agency stated in its release: “The effectiveness of the 100mg bedtime dose of Addyi was evaluated in three 24-week randomized, double-blind, placebo-controlled trials in about 2,400 premenopausal women with acquired, generalized HSDD. The average age of the trial participants was 36 years, with an average duration of HSDD of approximately five years. In these trials, women counted the number of satisfying sexual events, reported sexual desire over the preceding four weeks (scored on a range of 1.2 to 6.0) and reported distress related to low sexual desire (on a range of 0 to 4). On average, treatment with Addyi increased the number of satisfying sexual events by 0.5 to one additional event per month over placebo, increased the sexual desire score by 0.3 to 0.4 over placebo, and decreased the distress score related to sexual desire by 0.3 to 0.4 over placebo. Additional analyses explored whether the improvements with Addyi were meaningful to patients, taking into account the effects of treatment seen among those patients who reported feeling much improved or very much improved overall. Across the three trials, about 10 percent more Addyi-treated patients than placebo-treated patients reported meaningful improvements in satisfying sexual events, sexual desire or distress”

Unfortunately, the required “Medication Guide” for patients will once again focus on risks and not on how well the drug works.

This brings us to what the communications experts would like to see. As reviewed on this site, Drs Steven Woloshin and Lisa Schwartz, professors at Dartmouth’s Geisel School of Medicine, have for years been pushing the FDA to get useful and readable quantitative data to doctors and patients through a concise “Drug Facts Box”. More information on them, the company they formed, and the Drug Facts Box they prepared for Addyi can be found at http://www.Informulary.com.