Government Shutdown: Why the Pipeline Matters

by Suzanne M. Rivera, Ph.D.

Much attention has been paid to the government shutdown that started last week.  Many of us heard heart-tugging stories on public radio about the NIH closing down new subject enrollment at its “House of Hope,” the clinical trial hospital on the NIH main campus.  These stories gave many people the impression that clinical research halted around the country when the federal government failed to approve a Continuing Resolution.

The reality is both less dramatic in the short term and more concerning for the long term.  For the most part, federally-funded projects at university campuses and hospitals are continuing as usual (or, the new “usual,” as reduced by sequestration), because the grants already awarded are like I.O.U.s from the government.  By and large, university researchers will keep spending on their funded grants, with the knowledge that reimbursement will come once the government re-opens for business. The universities and hospitals are, in a sense, acting like banks that loan the government money while waiting for these expenses to be reimbursed.

Also, many clinical trials are funded by the pharmaceutical industry.  So it is not the case that hospitals are closing their doors to research en masse.  But the long-term effects of a shutdown will have lasting and compounding effects on our science pipeline.  The U.S. federal government is the single largest funder of scientific research at American universities.  Each month, thousands of grant proposals are sent to the various federal funding agencies for consideration.  These in turn are filtered and assigned to peer review committees.  The whole process of review, scoring, and funding approval typically takes months, sometimes more than a year.

Under the terms of the shutdown, the staff who normally receive and triage these grant proposals are considered non-essential.  All but one of the federal grant on-line submission portals have been taken off-line.  So thousands of researchers who had been working for months to write grant proposals for funds needed to conduct the next generation of studies are now left wondering when it will be possible to submit for agency review.  Those studies hold the keys to future discoveries that could bring needed cures to the bedside, important products to the marketplace, and new jobs into the economy. Continue reading

More on NSF and NIH Funding

By Scott Burris

Here’s where some in Congress would like us to go:

ScienceInsider reports:

The new chair of the House of Representatives science committee has drafted a bill that, in effect, would replace peer review at the National Science Foundation (NSF) with a set of funding criteria chosen by Congress. For good measure, it would also set in motion a process to determine whether the same criteria should be adopted by every other federal science agency.

Whether or not you think of this as a partisan attack on science, it challenges the idea of science as an independent way of pursuing knowledge. The fact that this is even on the table, and could be taken seriously, shows how effective the attack on science has been.  It seems to reflect a terrible paradox:  on the one hand, social scientists are pissing some people off in a big way, which is a good sign we are doing something right in the inconvenient truth department; but on the other hand, I don’t see a lot of people rising to our defense, which suggest we matter to fewer people than we should.

This bill may or may not go anywhere, but anyone who cares about evidence-informed governance and the ability of the US to solve its problems ought to be concerned.

 

While We Sleep?

By Scott Burris

Nothing threatens a know-nothing more than the prospect of someone knowing something. Hence there has been increasing pressure on and from some in Congress to reduce government funding of social science research.  I hope every reader of this blog is aware that an appropriations rider added by Tom Coburn has drastically restricted NSF funding of political science research. That’s an ugly development, on par with the scandalous cuts to CDC that put paid to its gun research agenda years ago.

But the big funder of social and behavioral research in health is the NIH. In the past two weeks, I have heard via two different insiders that the agency is under pressure to significantly cut back on social and behavioral research, at least research with any important links to public policy. Now it is true that NIH does far too little policy-relevant research as it stands, but many fine researchers do important work related to law and policy with NIH support, and the important influence of law on health means we need more, not fewer, NIH-supported careers.

So I am hoping I am getting false information. What are you hearing?

Birth Control for Men?

We’re not talking vasectomies or condoms.

Medical Daily reports that the NIH has awarded a $4.7 million grant to come up with a “Pill” for men. Most previous attempts to develop such contraceptives used testosterone to reduce the number of sperm men produce. This one takes aim at its mobility instead, using a non-hormonal compound that promises fewer side effects, according to scientists. Clinical testing into its safety and efficacy, assuming the FDA grants permission, would take at least five to ten years before the agency could consider approving the drug for use.

The availability of male birth control would make it possible for men and women to share responsibility for contraception. Today, women alone shoulder the considerable physical and other burdens that come with the Pill. And only women enjoy the security that control of its use affords over the likelihood of unwanted pregnancy. Tomorrow, we could even things out a bit. That’d surely be a development worth embracing. Or would it? Sharing responsibility for contraception means leaving it to men to take the necessary measures to prevent the reproductive consequences that in our society fall far more heavily on women.

We might suppose that some such men, who have less at stake than their female partners, would be less vigilant about birth control and forget to take the pill. There is also evidence to suggest that other men might use greater control over conception for abusive purposes. A 2010 study found that 15% percent of respondents women ages 16-29 who sought care in several Northern California family planning clinics reported that their male partners had damaged condoms or otherwise sabotaged their birth control.*

Would birth control for men be cause for celebration, or concern? Would it revolutionize sexual equality, or change little at all?

*This “pregnancy coercion,” as the researchers call it, differs in respect of the gestation, abortion rights, and sex-differentiated social expectations involved from the reverse-gender cases that Glenn Cohen has analyzed in which courts “have imposed legal parenthood [] on fathers deceived into believing that their partners could not conceive” or under circumstances in which “conception took place without meaningful consent.”

The Future of Biomedical Research Funding

By Patrick O’Leary

As I’ve written about previously on this blog, the consequences for the FDA of budget sequestration under the Budget Control Act of 2011 could be fairly severe (as well as raise some interesting legal questions). In a recent Online First piece for the Journal of the American Medical Association (JAMA), Hamilton Moses and E. Ray Dorsey note that sequestration would also have a serious impact–to the tune of $2.5 billion–on the National Institutes of Health (NIH), the primary source of public funding for biomedical research in the United States.

While Doctors Moses and Dorsey acknowledge that the immediate consequences of such a cut would primarily affect young researchers and new applicants for funding, “exacerbat[ing] tensions between large infrastructure projects . . . and small investigator-initiated grants, which historically have been the primary source of new clinical insights,” they also argue that sequestration presents an opportunity to reevaluate our emphasis on publicly funded biomedical research. In their telling, sequestration would be just the most recent step in a nearly decade-long trend of reducing federal funding, a trend that “presents an opportunity to reshape biomedical research.” Moses and Dorsey call for new private sources of research support, ranging from specialized financial instruments like Biomedical Research Bonds to an increased role for public charities and private foundations. The future of biomedical research, they argue, will be built on the private sector, not the federal government.

The challenges of shifting the burden of funding research to the private sector are many, of course. One particularly challenging question is whether private funds could effectively replace NIH’s significant role in funding “basic” research. Bhaven N. Sampat’s new article “Mission-Oriented Biomedical Research at the NIH” in Research Policy provides some context for the scale of the problem. Citing a 2010 study by Dr. Dorsey himself, Sampat notes that although NIH funding accounts for only about a third of U.S. biomedical research funding, “there is a sharp division of labor, with NIH funding concentrated further upstream, on ‘basic’ research than private sector funding” from private sector pharmaceutical, biotechnology, and medical device firms. Although the role of private foundations has grown in recent years, Sampat notes that NIH funding continues to exceed all such funding “by a factor of six . . . .” Assuming we continue to value basic research, the capacity and willingness of private actors to fund such research thus remains a major question mark.