This week’s hottest bio-pharmaceutical story was the June 18 FDA advisory committee’s review of a drug to treat hypoactive sexual desire disorder (HSDD). The committee did not recommend approval of the drug, but encouraged the sponsoring company and others to continue working in this area.

What struck me most was the contrast between the seriousness of the advisory committee in deciding whether the treatment was safe and effective in treating a genuine medical disorder and the inability of the American media to report the story objectively or sympathetically.

The New York Times had at least four articles—two news stories and two commentaries. The coverage in three of them gives focus and space to whether HSDD is a disease, whether biopharma companies create diseases, and the legacy of Victorian beliefs about sex. These were not part of the advisory committee meeting or issues raised by FDA.

The New York Times gave credence to the views that HSDD is primarily caused by bad lovers and high expectations and that the primary remedies are talk therapy, ending relationships and lower expectations. In short, they featured “experts” dueling on tangential, almost ideological, issues reflecting their professional self-interests.

Other than speculation on the number of women affected, there was little space devoted to the unmet medical need. Of most concern, there was no apparent attempt to provide a patient’s perspective or interview a patient. Yet, this would seem routine for a news story concerning drugs being reviewed by FDA—especially where the drug treats a condition for which there is no approved therapy.

To find source material on patient perspectives, NY Times writers needed to look no further than a thoughtful NY Times magazine article from November 2009. Need to talk to a patient? Call the article’s author or one of the researchers he mentions.

Fortunately for patients, FDA had long-ago decided the answers to the questions that the media deemed to be hot topics. In May 2000, the Division of Reproductive/Urologic Drug Products (DRUP) issued a draft guidance for industry entitled, Female Sexual Dysfunction: Clinical Development of Drug Products for Treatment. The guidance deals with the difficulties of proving safety and efficacy. It raises no concerns about whether female sexual dysfunction exists nor does it question the value of products being developed to treat the condition.

There is a solid history of FDA playing a critical, but totally unheralded role, in shaping and reshaping our society’s understanding of disease.

For example, homosexuality was long treated as a disease or mental disorder. For at least the last two decades, it would be unthinkable for FDA to consider an “anti-homosexuality pill.” For hundreds of years, obesity has been a symbol of wealth and well-being. Today, it is being redefined as a disease, complete with claims that it is an epidemic. FDA decided obesity was a “disease” years ago and has considered a number of “anti-obesity pills.”

Other diseases reflect new thinking about what constitutes illness. Examples would include post-traumatic stress disorder, attention-deficit hyperactivity disorder and restless leg syndrome. FDA has approved drugs treating each of these.

FDA seems to make these judgments without any fanfare. The question “is this a disease” doesn’t come up every day at the agency. When FDA does make these judgments, it appears a routine part of the process and not a notable event.

Maybe in the future, the media will have a better grasp of why this is so and respect FDA authority and good judgment about such matters. Meantime, for the benefit of women with HSDD, FDA’s role and earlier decisions are a very good thing.

Steven

Disclosure: Since I don’t usually write about specific drugs, it may be useful to state that I am not working on HSDD for any of my clients nor am I doing any work for the company whose drug was reviewed.

The origins of my views are in a November 2009 column, entitled: “FDA: Invisible Arbiter of What Constitutes Disease,” at http://www.fdamatters.com/?p=646. I have re-used some of the examples from that article, which was focused on whether FDA issues would ever approve an “anti-aging” drug.

Here are the four recent New York Times articles:

http://www.nytimes.com/2010/06/17/business/17sexpill.html

http://www.nytimes.com/2010/06/19/business/19sexpill.html

http://www.nytimes.com/2010/06/27/business/27stream.html?fta=y

http://www.nytimes.com/2010/06/27/opinion/27Paglia.html?th&emc=th

Here is the earlier New York Times Magazine article:

http://www.nytimes.com/2009/11/29/magazine/29sex-t.html

Prioritizing patient needs is not just a media issue. I have previously criticized industry for not acknowledging that “Patients Come First.” http://www.fdamatters.com/?p=632

I have also questioned FDA when it went astray in “One Disease + Two Concerns = FDA’s Need to Communicate Better and Modernize Standards.” http://www.fdamatters.com/?p=430

This entry was posted on Sunday, June 27th, 2010 at 3:04 pm and is filed under Drug Approval and Access, Insight on FDA-regulated Industries. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.