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The alcohol safety of new “female Viagra” drug was tested mostly on men

An investigation into the libido-enhancing drug’s side effects was carried out on a group of 23 men and two women. Spot the problem? 

Say you've designed a new libido-boosting drug aimed specifically at women, which, as it turns out, reacts badly with alcohol. You need to carry out further testing to investigate the side effects. Do you:

A) run a study with a group of mostly male subjects? 

or

B) run a study with a group of mostly female subjects?

To even the average layperson, the answer seems obvious. But drug company Sprout Pharmaceuticals, creator of new headline-grabbing “female viagra” drug Addyi, decided in its infinite wisdom to go ahead with option A anyway.

Addyi, is according to Sprout, to be used "for the treament of premenopausal woman with acquired generalised hypoactive sexual desire disorder", yet in research designed to investigate the interactions of the drug with alcohol, the company used a study group of 23 men and only two women. 

Let's look the study itself. In the notes on the trial supplied by the FDA, it's described thus: 

“A dedicated alcohol interaction study with Addyi in 23 men and 2 premenopausal women.”

OK, perhaps, for some reason, the researchers wanted to study two women's reaction, with a control group of, er, 23 men. Let's give them the benefit of the doubt, and read on.

The study summary then notes that "four of 23 subjects" who were given the drug plus two glasses of wine displayed hypotension (low blood pressure) or syncope (loss of consciosuness caused by hypotension). "Six of the 24 subjects" given four glasses of wine plus the drug experienced these side effects. 

The problem here is that neither of these conclusions separates the results for gender - it could be that both women fainted after a few glasses of wine, or neither did. This implies that the researchers weren't particularly interested in exploring any gender difference in results, depite the fact that, as DrinkAware notes, men and women metabolise alcohol differently. Presumably, they metabolise a drug aimed at the female libido differently, too. 

In Sprout's defence, the skewed study, first picked up by New York Magazine's Science of Us vertical, was not one of the original clinical trials carried out on Addyi. Instead, it was a Risk Evaluation and Mitigation Strategy (REMS). The FDA, which approves new drugs, can require manufacturers to carry out these REMS studies either before or after a product goes on the market to further understand known side effects. 

This REMS was carried out after 13 of clinical trials on the drug, all of which used test groups of women. This sceenshot from the drug's safety information page gives you an idea: 

Screenshot from Addyi's listing on a pharmacy intelligence site.

So we're not implying that the drug wasn't rigorously tested - in fact, it was rejected twice by the FDA before it was finally approved. But the REMS study is still significant: the drug's manufacturers recommend that users shouldn't drink alcohol at all during treatment, thanks to the fainting and blood pressure side effects (which actually contributed to the FDA's earlier decisions to reject the drug). This further investigation, and the patient advice it fed into, is pretty useless to female users if it was carried out mostly on men.

I asked Sprout Pharmaceuticals why the study had such an unhelpful gender divide, and a spokesperson told me:

The alcohol interaction study, which was designed with FDA guidance, required participants to drink the alcoholic equivalent of a half a bottle of wine within 10 minutes on a nearly empty stomach before taking Addyi. More men than women agreed to enroll in this kind of study... Sprout plans to conduct post-marketing studies to further evaluate the effects of alcohol in women when taken with Addyi.

The answer: they just didn't get enough women signing up. It seems reasonable to expect a bit more of drug companies, especially following a series of articles in Nature journal in 2010 outlining how an over-reliance on men in drug trials, along with other gender inequalities in biochemsitry, are "undermining patient care". Let's hope the "post-marketing studies" on Addyi actually focus on the drug's target audience. 

Barbara Speed is comment editor at the i, and was technology and digital culture writer at the New Statesman, and a staff writer at CityMetric.

Photo: Getty
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The rise of the green mayor – Sadiq Khan and the politics of clean energy

At an event at Tate Modern, Sadiq Khan pledged to clean up London's act.

On Thursday night, deep in the bowls of Tate Modern’s turbine hall, London Mayor Sadiq Khan renewed his promise to make the capital a world leader in clean energy and air. Yet his focus was as much on people as power plants – in particular, the need for local authorities to lead where central governments will not.

Khan was there to introduce the screening of a new documentary, From the Ashes, about the demise of the American coal industry. As he noted, Britain continues to battle against the legacy of fossil fuels: “In London today we burn very little coal but we are facing new air pollution challenges brought about for different reasons." 

At a time when the world's leaders are struggling to keep international agreements on climate change afloat, what can mayors do? Khan has pledged to buy only hybrid and zero-emissions buses from next year, and is working towards London becoming a zero carbon city.

Khan has, of course, also gained heroic status for being a bête noire of climate-change-denier-in-chief Donald Trump. On the US president's withdrawal from the Paris Agreement, Khan quipped: “If only he had withdrawn from Twitter.” He had more favourable things to say about the former mayor of New York and climate change activist Michael Bloomberg, who Khan said hailed from “the second greatest city in the world.”

Yet behind his humour was a serious point. Local authorities are having to pick up where both countries' central governments are leaving a void – in improving our air and supporting renewable technology and jobs. Most concerning of all, perhaps, is the way that interest groups representing business are slashing away at the regulations which protect public health, and claiming it as a virtue.

In the UK, documents leaked to Greenpeace’s energy desk show that a government-backed initiative considered proposals for reducing EU rules on fire-safety on the very day of the Grenfell Tower fire. The director of this Red Tape Initiative, Nick Tyrone, told the Guardian that these proposals were rejected. Yet government attempts to water down other EU regulations, such as the energy efficiency directive, still stand.

In America, this blame-game is even more highly charged. Republicans have sworn to replace what they describe as Obama’s “war on coal” with a war on regulation. “I am taking historic steps to lift the restrictions on American energy, to reverse government intrusion, and to cancel job-killing regulations,” Trump announced in March. While he has vowed “to promote clean air and clear water,” he has almost simultaneously signed an order to unravel the Clean Water Rule.

This rhetoric is hurting the very people it claims to protect: miners. From the Ashes shows the many ways that the industry harms wider public health, from water contamination, to air pollution. It also makes a strong case that the American coal industry is in terminal decline, regardless of possibile interventions from government or carbon capture.

Charities like Bloomberg can only do so much to pick up the pieces. The foundation, which helped fund the film, now not only helps support job training programs in coal communities after the Trump administration pulled their funding, but in recent weeks it also promised $15m to UN efforts to tackle climate change – again to help cover Trump's withdrawal from Paris Agreement. “I'm a bit worried about how many cards we're going to have to keep adding to the end of the film”, joked Antha Williams, a Bloomberg representative at the screening, with gallows humour.

Hope also lies with local governments and mayors. The publication of the mayor’s own environment strategy is coming “soon”. Speaking in panel discussion after the film, his deputy mayor for environment and energy, Shirley Rodrigues, described the move to a cleaner future as "an inevitable transition".

Confronting the troubled legacies of our fossil fuel past will not be easy. "We have our own experiences here of our coal mining communities being devastated by the closure of their mines," said Khan. But clean air begins with clean politics; maintaining old ways at the price of health is not one any government must pay. 

'From The Ashes' will premiere on National Geograhpic in the United Kingdom at 9pm on Tuesday, June 27th.

India Bourke is an environment writer and editorial assistant at the New Statesman.

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