| BioEdge | Sunday, June 18, 2017 |
The fake news about female libido
by Michael Cook | 17 Jun 2017 |
“Fake news” is not the exclusive preserve of Macedonian teenagers exploiting the anxieties of American voters. Big Pharma also creates fake news. Two years BioEdge reported that a small company, Sprout Pharmaceuticals, had been sold to Valeant for US$1 billion. Sprout’s main product was Addyi (flibanserin), an FDA-approved drug to treat low female libido.
What Valeant really paid for was the approval. Sprout had run a highly professional campaign to pressure the FDA to approve a drug which has proved to be too pricey, too inconvenient, too dangerous and ineffective. And to top it all, Addyi has been a commercial failure.
But, according to PharmedOut, a Georgetown University Medical Center project for evidence-based prescribing, the most important lesson was that the FDA can be suckered into approving a bad drug by clever public relations.
Sprout hired Blue Engine Media to lobby the FDA. It promoted a largely fake disease, Hypoactive Sexual Desire Disorder, and created a fake grassroots feminist movement, “Even the Score”, whose theme was that women deserved their own Viagra. It hired lobbyists, including a former director of the FDA Office of Women’s Health, and recruited dozens of consumer groups to testify in Addyi’s favour.
Immediately after the approval Even the Score evaporated. Its website no longer exists.
“Where are the crowds of women with low libido clamoring for Addyi?” asks members of PharmedOut on The Hastings Center blog. “They never existed, except in a PR firm’s fantasy.” They draw two lessons from this regulatory disgrace:
What Valeant really paid for was the approval. Sprout had run a highly professional campaign to pressure the FDA to approve a drug which has proved to be too pricey, too inconvenient, too dangerous and ineffective. And to top it all, Addyi has been a commercial failure.
But, according to PharmedOut, a Georgetown University Medical Center project for evidence-based prescribing, the most important lesson was that the FDA can be suckered into approving a bad drug by clever public relations.
Sprout hired Blue Engine Media to lobby the FDA. It promoted a largely fake disease, Hypoactive Sexual Desire Disorder, and created a fake grassroots feminist movement, “Even the Score”, whose theme was that women deserved their own Viagra. It hired lobbyists, including a former director of the FDA Office of Women’s Health, and recruited dozens of consumer groups to testify in Addyi’s favour.
Immediately after the approval Even the Score evaporated. Its website no longer exists.
“Where are the crowds of women with low libido clamoring for Addyi?” asks members of PharmedOut on The Hastings Center blog. “They never existed, except in a PR firm’s fantasy.” They draw two lessons from this regulatory disgrace:
First, don’t trust, support, or listen to purported consumer advocacy groups that take money from pharmaceutical companies. Their opinions, or silence, are up for sale, and they don’t truly represent the best interest of the constituencies they claim to stand for ...Second, the media, the FDA, and patients should listen to independent advocacy groups. Only the groups that don’t take industry money truly represent consumers.
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Sunday, June 18, 2017
A Massachusetts woman has been found guilty of involuntary manslaughter in a case which was reported across the United States and could affect the debate about assisted suicide.
In 2014 Michelle Carter, then 17, used phone calls and text messages to bully her boyfriend, Conrad Roy III, 18, into asphyxiating himself in his car.
Their relationship was a bizarre one. Although they lived only an hour away from each other, they met in Florida on family holidays. Thereafter they only met each other a handful of times. But they texted each other incessantly, especially about Roy’s desire to kill himself. Ms Carter encouraged him.
However, when he was sitting in his car and the fumes were building up, he got out, clearly wanting to live. She instructed him to get back in. He did and he died.
There are two schools of thought about Ms Carter’s bullying. Most people would agree with the judge that she had a duty to try to save Roy’s life and acted in a “wanton and reckless” manner.
But others, while acknowledging that her words were reprehensible, point out that Massachusetts has no law against assisted suicide and that words are not bullets. They argue that her incitement was protected free speech.
The American Civil Liberties Union has yet another reason why Ms Carter should have been acquitted: “If allowed to stand, Ms. Carter’s conviction could chill important and worthwhile end-of-life discussions between loved ones.” In other words, this throws sand in the gears of legalising assisted suicide.
What do you think?
Michael Cook
Editor
BioEdge
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