Hello GFPs, well you really are a bloody lovely lot aren't you. I love our little...not sure what to call us. Community? Monstrous regiment? Yes maybe that's better. Either way I love the emails you send me, they're so interesting and often so kind. They make doing this newsletter so worthwhile. Keep them coming! In the meantime, here are a few bits and pieces to keep you suitably pissed off 💪

Default Male of the week

So, I have been vaguely aware for years that a while back humans beamed out some kind of message to the universe about our existence. It's a very Planet Earth thing to do. But I never really knew what had actually been said. Until now. Because of one of my GFPs!

He writes: "The Arecibo Message was sent out in 1974 (mostly as a publicity stunt but kinda) to announce the presence of humankind to the universe - you know where this is going don't you. The message was very cleverly coded, a semi-prime, meaning that it can only be divided by two prime numbers, meaning that if you spot this, the signal turns into a picture, with the planets and DNA, and the Sun and some molecules and some basic information about life on Earth."

These basic pieces of information include things like: the numbers one (1) to ten (10); a bunch of info about our DNA; which planet we're from; annnddddd, next to the third planet, a graphic figure of a human.

Yeah this is gonna be good. Here is what Wikipedia has to say about it:

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Yep, average American male just about sums up humanity, you are correct, wikipedia.

Gender data gap of the week

Here's a fun one. Readers of Invisible Women may remember the section where I talk about the whacking great data gap when it comes to medical research and female bodies. Historically, the vast majority of data we have on the body, on how diseases progress, on how drugs interact with bodies and diseases, has been collected in males: male cells, male animals, male humans.

And, as I explained, things have got a bit better in certain areas. For example certain funding bodies require females to be represented in human trials -- although how forcefully they enforce this "requirement" has been brought into question (see IW p.208) and of course there is very little data on this either way because who needs to track whether or not regulations are being enforced amirite?!

Unfortunately, however, for the vast majority of trials, there is no requirement to include females as well as males, nor to sex disaggregate or sex analyse the data. And that includes trials for generic drugs, which account for the majority of clinical drug trials. From Invisible Women p.203-4:

Drugs trials for generic drugs are much less rigorous than original trials, having only to demonstrate equal bioavailability, and they are conducted ‘almost exclusively’ in young adult males. This matters because even with the same active ingredient, different inactive ingredients and different fabrication technology can affect a drug’s potency. And sure enough, in 2002 the FDA’s Center for Drug Evaluation and Research showed ‘statistically significant differences between men and women in bioequivalence for most generic drugs compared with reference drugs’. 

That research was done in 2002. This month, in the year 2020, some more research was done on so-called inactive ingredients, hurrah!

From the paper abstract:

Most drug formulations comprise mainly inactive ingredients known as excipients. Excipients are tested in animal studies and do not display toxicity at allowed concentrations, but their interaction with molecular targets has not been systematically explored.

Wow. Guess we'd better look into that, huh? So they did. Hurrah!

They found that, yep, not all inactive ingredients are actually "inactive":

In cellular models, five excipients had fingerprints predictive of system-level toxicity. Exposures of seven excipients were investigated, and in certain populations, two of these may reach levels of in vitro target potency, including brain and gut exposure of thimerosal and its major metabolite, which had dopamine D3 receptor dissociation constant Kd values of 320 and 210 nM, respectively. Although most excipients deserve their status as inert, many approved excipients may directly modulate physiologically relevant targets

Just one teeny tiny minor issue. Just a small thing. I almost feel silly mentioning it. It's just, you know...THEY DIDN'T SEX DISAGGREGATE THEIR DATA. HURRRAAAARRRRGGGHGHGHGHGHGHHGGHH.

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Just a tiny reminder of the 2007 analysis of animal studies I cited in Invisible Women, where "of the few studies that did involve rats or mice of both sexes, 54% revealed sex-dependent drug effects." And, just because it would be rude not to, a reminder of the years researchers spent puzzling over "the unpredictability of transplanted muscle-derived stem cells (sometimes they regenerated diseased muscle, sometimes they didn’t do anything) until they realised that the cells weren’t unpredictable at all – it’s just that female cells promote regeneration and male cells don’t."

And just once more for those at the back: "in 2002 the FDA’s Center for Drug Evaluation and Research showed ‘statistically significant differences between men and women in bioequivalence for most generic drugs compared with reference drugs’." 

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No, really. I really am fine.[/caption]

Poppy Pic of the Week

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Poppy The Relentless continues her career in pillaging (see last week's newsletter if you missed that OMG HOW DID YOU MISS THAT)[/caption]

That's it! Until next time, my most excellent GFPs xoxoxo