Tag Archives: FDA

Nakedly Corrupt

Here’s a NYT article about the quest to legalize a women’s libido pill. I don’t really care much either way on the issue, other than a general dislike of the FDA, but the view into this fight is a fascinating just how nakedly corrupt the process is.

To summarize some firm has developed flibanserin, a ‘female viagra’, and the “women’s health community” (ie. the people dedicated to sterilizing women and murdering babies) is in a minor civil war over the drug, with the FDA approval process as the battleground. The pro-pill side is arguing SEXISM!, the anti-pill side is arguing SCIENCE!

The drug was rejected once in 2009 because “it was not very effective and had side effects,” which in reality means that “women taking the drug had about one more satisfying sexual event per month than women receiving a placebo” at the cost of “fatigue, fainting, dizziness and nausea”. Is one more sexy time a month worth it, not mine but to, but I will note that these are women, so if they just said yes to their husbands a bit more, they could probably have one more sexy time a month without a pill. But I digress.

After the rejection our main player, Sprout Pharmaceuticals, bought the drug, which was again rejected in 2013. In response, Sprout rallied. They put a women in charge, solely due to merit I’m sure.

Some critics speculate that the company wanted a woman as the face of the brand.

It seems that you can reject affirmative action without being sexist if you are also a feminist.

This is where the fun begins.They then started to rally feminists to to fight for their barely effective pill. Some saw the ploy for the blatant commerical hijacking it is:

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.”

But a bunch of other feminists were more gullible and signed up to fight for this pill.

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.

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.

A “medical expert”. Here’s a nice HuffPo piece by her where she advocates against the FDA’s “discrimination” while neither mentioning neither the drug nor her getting paid as a consultant, although, her HP bio has a nice list of paid consultancies.

To help in their fight Sprout enlisted PR firm Blue Engine Message and Media, which if you check their source-watch is pretty much an independent PR arm of the Democratic Party.

Audrey Sheppard is one of the spearheads of the campaign and the one who approached Blue Engine. She was the director of the FDA Office of Women’s Health appointed by Clinton and has been deeply involved in Democratic politics for decades. She is also a paid advocate for Sprout.

Together they created a campaign called Even the Score. Take a look at the site; it’s all vague pablum about equality for women. Not one specific mention I could find of the drug they are actually campaigning to support, and the only mention of Sprout is on the supporters page, which is itself amusing. It contains a bunch of random medical-sounding organizations nobody has ever heard of such as the International Society for The Study of Women’s Sexual Health (Dr. Anita Clayton is a director), two pharmaceutical companies (Sprout and Trimel, who are creating their own ‘pink viagra’), and, for some reason, Jewish Women International.

Susan Scanlan is chairing Even the Score and is the other leader of the campaign. She’s neck-deep in the Democrat Party and the bureaucracy, as well as having been a lobbyist for the defence industry in the past. Her husband (who I mention primarily because I could not pass up linking to his insane website) has a work history that reads like a typical Cathedral worker.

The Blue Engine spokeperson for Even the Score is Jaime Horne, who’s also worked the Democrat machine, as well as progressive Air America Radio and some progressive non-profits.

So those are a few of the players in this campaign, I have no time or will to go more in-depth, maybe someone paid to can do so, but here’s how the players describe fighting for the pink pill:

“I’ve been accused of bullying the F.D.A., and I say, ‘No, it’s called advocacy,’ ”

They barely conceal that they’re nakedly mau-mauing the flak-catchers. I like that quote though as it sums it up quite clearly: there is no difference between bullying and advocacy other than if the cause if righteous or not.

Continuing on, here’s what Scanlan has to say about her pay:

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.

Maybe it’s just my blue-collar roots but to me the term “modest stipend” conjures up the thought of ‘not quite covering your gas expenses‘, not ‘not quite covering a fancy vacation to France.’ Maybe I have different definitions of modest from the denizens of the iron triangle.

Beyond the luncheon, which took place at the restaurant Ris, Even the Score paid for dozens of people, including patients, to get to a public workshop on female sexual dysfunction at the F.D.A. last fall. It also gave them teal scarves.

At this point I’m surprised, Ris is more expensive than where I usually eat, but is less ritzy than I thought, cheeseburgers are only $13, $20 with a side and entrees cost $25-50. But Even the Score seems to have deep pockets coming from somewhere (Sprout?) to feed, transport, and house that many people.

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.”

Heh. If you want more, here’s a sexologist and a psychiatrist on the claims of Even the Score from last year.

Ms. Horn of Even the Score strongly disputes the contention that the campaign put pressure on the agency.

Yes, there’s absolutely no impropriety here. None at all. But the next quote clinches it:

“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.”

Too much credit.” She doesn’t even dispute the charges of pressuring the FDA, in fact she seems almost flattered by it, she just says that they helped but not as much as you might think.

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.

When even other pharmaceutical companies think you’ve gone too far…

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.

Many people wanted to testify, the vast majority in favor of the drug.

Absolutely nothing untoward here.

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.

That last line just kills me. That has to be intentional dry humour.

So, to summarize the situation, a pharmaceutical company has rallied the Democratic political machine, the feminist community, the women’s sexual health community (which somehow exists), and a Jewish Woman’s organization for some unknown reason, to bully the FDA into approving an ineffective form of female viagra. The separation between these bureaucracy, the lobby groups, the Democratic Party, industry, the feminists, the media, and the women’s health groups is practically non-existent; almost everybody involved has worked for most of them.

The major players pretty much define the iron triangle. It’s almost astounding how openly corrupt of the process is.

How often does this sort of stop go on that the NYT doesn’t write about because it isn’t as sexy as ‘libido pills’?