In my view, once it is on The News Hour then it is really news.
Nature published a commentary by NIH Director Francis S. Collins and NIH Office of Research on Women's Health Director Janine A. Clayton which warns us that the NIH will start insisting on the inclusion of more sex-difference comparisons. These are to extend from cells to animal models across many areas of pre-clinical work.
The NIH is now developing policies that require applicants to report their plans for the balance of male and female cells and animals in preclinical studies in all future applications, unless sex-specific inclusion is unwarranted, based on rigorously defined exceptions. These policies will be rolled out in phases beginning in October 2014, with parallel changes in review activities and requirements.
I cannot wait to see what the "rigorously defined exceptions" will be for several types of research in which I have an interest. Every rat self-admin study must now include both males and females? For all treatment conditions or will it be acceptable to just tack the sex-comparison on at the end?
Furthermore, the NIH will monitor compliance of sex and gender inclusion in preclinical research funded by the agency through data-mining techniques that are currently being developed and implemented. Importantly, because the NIH cannot directly control the publication of sex and gender analyses performed in NIH-funded research, we will continue to partner with publishers to promote the publication of such research results.
oooooh. "partner with publishers" eh? Of course this is because Clayton and Collins realize that higher JIF journals are entirely uninterested in things as pedestrian as sex-comparisons, particularly when the outcome of the study is "no difference". Which, btw, is one of the reasons nobody* wants to waste their precious time and grant money doing something as low-return as sex-comparisons. So somehow the NIH is going to lean on publishers to be...friendlier....to such work. I do hope they realize that this is not going to work. The contingencies are not going to change because the NIH asks. Now, if they actually went all in and dismantled GlamourMagScience culture by the judicious use of grant award, grant auditing and rules about the ratio of publications to effort expended... then we might see some progress. That will never happen and thus there will be no change in the publication contingencies that fight against sex-comparison studies.
Dr. Clayton went on The News Hour where Judy Woodruff asked her (and Phyllis Greenberger of Society for Women's Health Research) some pretty obvious questions. Woodruff wanted to know if there were any clear examples in which women were put at risk or their health suffered because of a lack of such research. She also wanted to know what the implications for research might be- would it be more difficult or more expensive. Finally, Woodruff asked if scientists would resist.
From the transcript:
JUDY WOODRUFF: But how hard is that? Does that mean — is it extra work, is it more expensive? What’s involved in making sure there’s a gender balance?
Now Greenberger snuck in a "Both" off camera but then Clayton went on to be ridiculous and fail to answer the question. The answer is indeed "both" and it is a serious one if the NIH expects to get results. It will be more expensive, progress will be slower and it will be "harder" in the sense of teasing out the right experimental designs and variables so that an interpretable result can be reached. It isn't rocket science, exactly, but it is harder.
JUDY WOODRUFF: Phyllis Greenberger, were there — were there actually individuals who were harmed or where help wasn’t delivered because the research was done only on males?
Greenberger totally walked around this one and Woodruff, to her credit, fronted Clayton with the same question a bit later. Clayton referred to heart attack warning symptoms in women that might differ from men...of course this has nothing whatever to do with preclinical research. Gaaah! So frustrating. Greenberger chimed back in with talk of drugs being removed from the market for adverse effects in women....with no indication that these were adverse effects that would have been identified in female-specific PREclinical research. C'mon NIH! If you are going to take a run at this, please prepare your argument!
JUDY WOODRUFF: And is that the reason that it wasn’t done earlier, Dr. Clayton, that there was just pushback in the scientific community?
The answer is illustrative of the problem at the NIH....
DR. JANINE CLAYTON: It’s hard to say. There are probably a lot of factors that are involved.
And what’s really important now is right now we have been able to put the focus on getting this as a priority. As Phyllis mentioned, the Society and other advocacy groups and scientists and others have talked about this in the past. In fact, we are supporting scientists who are doing this research, but it wasn’t enough of a priority. In some way, it was like a blind spot. Scientists weren’t thinking about it.
Yes, there are a lot of factors. They aren't all that complicated either, since they boil down to scientists who want to conduct sex-differences comparisons being able to win funding to do the work.
Clayton is right. The NIH does indeed support investigators doing sex-differences studies.Those scientists do not have a problem of "priority" from the perspective of their own intrinsic motivation.
With respect to whether scientists resist, I enjoin you to go over to PubMed and type in Sex Differences and see what fill-in choices are offered to you. Click on several of these searches and see what you find. You will find funded projects in many of your favorite domains of interest. If you bother to click on the papers and look at the grant attributions, you may even find that many of these investigations were completed under NIH funding!
So when Clayton (and in the Commentary she is joined by Director Collins) claims it isn't a "priority", it seems misplaced to put this on the shoulders of extramural scientists.
If the NIH wants more sex-differences studies then they need to deploy their tastiest carrot to greater effect. Put out some Funding Opportunity Announcements and see what happens! Fund a few Supplements to the people who are already doing sex-comparisons! Pick up a few grants that missed the payline...again, from the people who are already proposing sex-comparisons!
And if you want to lure in new converts that you didn't get with an RFA or a Program Announcement? This is simple. Just put out a policy that any grant application with a credible stab at a sex-comparison component gets an extra 5 percentile points credit towards the payline for funding.
Just you wait and see how many sudden converts you make!
*of the GlamourMag class investigator