When Teresa Woodruff started working for a biotech company fresh out of graduate school, she says her employer revealed that the first studies for a new heart attack and stroke treatment had been performed on 50,000 men.
She said that seemed a little strange. It was the late 1980s.
“So I kinda raised my hand and said, ‘That’s interesting. Where are the women?’” Woodruff said.
After being told not to worry, Woodruff said that a later trial of the drug — called Tissue Plasminogen Activator or tPA — would feature a slightly different cast of participants …
… 50,000 Italian men.
“I’m like, wait a second,” Woodruff said on the latest Nerdette podcast, “Italian men do not equal women.”
Woodruff, who’s now an ovarian biology expert with a laboratory named after her at Northwestern Medicine, has since spent much of her career studying fertility and championing equal representation in clinical trials.
She spoke with Nerdette co-hosts Tricia Bobeda and Greta Johnsen about the importance of drugs being tested on women, the recent advances in federal policy, and some of her other work (including her attempt at creating Schoolhouse Rock! for sexual education). Below are some interview highlights.
The consequences of decades of drug testing only on men
Teresa Woodruff: There’s been an enormous number of adverse events that have occurred. Eight out of 10 drugs — the last eight out of 10 drugs by the FDA that were pulled from market — were because of adverse events in women. If, on average, you’re studying males and not females, how is it not the case that in fact, on average, more often there will be adverse effects in women?
Equality among men and women, but not among their cells
Woodruff: We are just as smart and we are just as fit, it’s just that our cells differ. And so there is no pejorative to say that your cell has a different level of P450 enzymes. It just is that different.
And what that means is that difference causes [the sleeping prescription drug] Ambien to be cleared from our circulation at a slower pace than males. But if the makers of Ambien only study the efficacy of the drug in males, that means that women on average are going to have Ambien in their circulation in the morning when they’re trying to wake up and get their kids to school — and on average are going to drive into more mailboxes than males!
The thing is, again, we are equal. There is nothing better or worse about my liver or your liver. Our livers are equal. But we have to study how they function in a way that values the hormones that they’ve seen, the actual genes that are expressed as a consequence of being in an XX or XY cell, the size differences — and I think those things are parts of the equation that we just haven’t taken into account.
‘A sea change’
Woodruff: On January 25, 2016, we finally got the National Institutes of Health to say that investigators should consider sex as a biological variable. And that’s a huge deal. It doesn’t say that, in fact, everybody has to compare males and females. It simply says that you have to consider it and you have to really report it.
It’s really exciting. It’s a sea change. Twenty years from now we’ll look back and say that on January 25, 2016, there was a before and an after. There was a time that we didn’t report and didn’t study, and a time after, and look at how our health has changed as a consequence.
Watch: A kind of ‘Schoolhouse Rock!’ for sex ed
Woodruff: We did just publish what we call “A New You,” and it’s a way for kids to sing through songs for puberty, for the menstrual cycle, and for anatomy.
Woodruff: If you’re really uncomfortable with your body and you’re uncomfortable with this topic, or you think it’s somehow “other” or “weird,” it becomes “other” or “weird.” We’ve conflated reproductive change in our bodies with a particular individual as a sexual being. And I want to separate that out, and I think if we do that, we’re going to have better education for the kids and they’re going to have a better understanding of their bodies.
This interview has been edited for brevity and clarity. Click the “play” button to listen to the entire conversation, which was produced and adapted for the web by Justin Bull.