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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.

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White supremacists are embracing genetic testing - but they aren't always that keen on the results

Users of far-right site Stormfront are resorting to pseudo science and conspiracy theories when DNA tests show they aren't as "pure" as they hoped.

The field of genomics and genetics have undergone almost exponential growth in recent years. Ventures like the Human Genome Project have enabled t humanity to get a closer look at our building blocks. This has led to an explosion in genetic ancestry testingand as of 6 April 2017 23AndMe, one of the most popular commercial DNA testing websites, has genotyped roughly 2 million customers.

It is perhaps unsurprising that one of the markets for genetic testing can be found among white suprmacists desperate to prove their racial purity. But it turns out that many they may not be getting the results they want. 

Stormfront, the most prominent white nationalist website, has its own definition of those who are allowed to count themselves as white - “non-Jewish people of 100 per cent European ancestry.” But many supremacists who take genetic tests are finding out that rather than bearing "not a drop" of non-white blood, they are - like most of us a conglomerate of various kinds of DNA from all over the world including percentages from places such as sub Saharan Africa and Asia. Few are taking it well.

Dr. Aaron Panofsky and Joan Donovan, of UCLA’s Institute for Society and Genetics and the research institute Data and Society respectively, presented a research study (currently under peer review for publication) at the American Sociological Association a week ago, analysing discussion of GAT on Stormfront forums. Panofsky, Donovan and a team of researchers narrowed down the relevant threads to about 700, with 153 users who had chosen to publish their results online. While Panofsky emphasised that it is not possible to draw many quantitative inferences, the findings of their study offer a glimpse into the white nationalist movement's response to science that doesn't their self perception. 

“The bulk of the discussion was repair talk”, says Panofsky. “Though sometimes folks who posted a problematic result were told to leave Stormfront or “drink cyanide” or whatever else, 'don’t breed', most of the talk was discussion about how to interpret the results to make the bad news go away”.

Overwhelmingly, there were two main categories of reinterpretation. Many responses dismissed GAT as flimsy science – with statements such as a “person with true white nationalist consciousness can 'see race', even if their tests indicate 'impurity'".

Other commentators employed pseudo-scientific arguments. “They often resemble the critiques that professional geneticists, biological anthropologists and social scientists, make of GAT, but through a white nationalist lens", says Panofsky. 

For instance, some commentators would look at percentages of non-European DNA and put it down to the rape of white women by non-white men in the past, or a result of conquests by Vikings of savage lands (what the rest of us might call colonialism). Panofsky likens this to the responses from “many science opponents like climate deniers or anti-vaxxers, who are actually very informed about the science, even if they interpret and critique it in idiosyncratic and motivated ways".

Some white nationalists even looked at the GAT results and suggested that discussion of 100 per cent racial purity and the "one drop" rule might even be outdated – that it might be better to look for specific genetic markets that are “reliably European”, even though geneticists might call them by a different name.

Of course, in another not totally surprising development, many of the Stormfront commentators also insisted that GAT is part of a Jewish conspiracy, “to confuse whites by sprinkling false diversity into test results".

Many of the experts in the field have admitted to queasiness about the test themselves; both how they come to their results and what they imply. There are several technical issues with GAT, such as its use of contemporary populations to make inferences about those who previously lived in different places around the world, and concerns that the diversity of reference samples used to make inferences is not fully representative of the real world. 

There are other specific complications when it comes to the supramacist enthusiasm for GAT. Some already make a tortous argument that white people are the “true people of color" by dint of greater variation in hair and eye color. By breaking up DNA into percentages (e.g. 30 per cent Danish, 20 per cent German), Panofsky says GAT can provide a further opportunity to “appropriate and colonise the discourse of diversity and multiculturalism for their own purposes". There's is also, says Panofsky, the simple issue that “we can’t rely on genetic information to turn white nationalists away from their views."

“While I think it would be nice if the lesson people would take from GAT is that white nationalism is incoherent and wrong. I think white nationalists themselves often take the exact opposite conclusion."