And just when you think things couldn’t get worse…

This news from today’s Washington Post on new procedures for entering the Bethesda Campus. The NIH where I did my postdoc was like the United Nations. We came from all over the globe to improve help humans stay well. In my lab alone, there were individuals from Chile, Spain, Nigeria, Italy, Israel and Australia.  Biomedical research is qualitatively different from defense R&D–Zika and Malaria do not respect political boundaries. Nor does Alzheimer’s. I hope my former colleagues in positions of authority there are listening.

Basic human neuroscience studies should not be treated as clinical trials…

In the last year of my service at NSF, the NIH issued a new policy with regards to a particular kind of neuroscience that has become the bread and butter of psychology departments, especially those that focus on cognitive science. These experiments are the modern versions of 20thcentury social psychology experiments where the experimental subjects would be healthy college students (and definitely not patients). In the modern versions, students receive brain scans using functional magnetic resonance imaging machines (fMRI; completely non-invasive) so that the investigator can actually visualize the functioning of the subject’s brains as they perform some task (or even play a game).

The new NIH policy will consider these studies to be “clinical trials”.

Clinical trials are a special animal from the standpoint of NIH’s regulations. In particular, the entire constellation of medical ethics: from informed consent all the way to how results are analyzed and revealed fall under the jurisdiction of a complex set of compliance requirements. That makes sense for patients because they are sick and on the vulnerable side of a power relationship with their caregivers (clinicians). The question is should this thicket of compliance rules apply to the above type of psychology experiments? I don’t think so. Yes, there should be rules but to my mind they should not rise to the levels seen in the medical trials context. These types of studies are qualitatively different. Let’s not force apples to be oranges. This piece in Science has the latest development in this story: NIH has agreed to postpone for one year putting this new policy in place.

Happy New Year…Science not off the Hook

Happy 2013. The Fiscal Cliff compromise that was passed by Congress last night mainly addressed the tax (revenue) side of the fiscal debate between the Democrats and the GOP. The spending side of that debate was put of for a bit…as things stand science funding still will get axed across the board two months from now. With the tax leverage gone, the remaining hope is that somehow the NIH and NSF will get bundled into the debate over DOD such that they are all protected against across the board, mindless cuts. I’m not optimistic on that one, although historically NIH and NSF have enjoyed bipartisan support.

In the meantime, the notion of the need to prudently invest in science–as well as cut back generally–doesn’t seem to be out there as an argument.

Next up however is the second debt-ceiling debate. The House GOP members say they intend to use the debt limit as leverage to get more cuts. My economist colleagues tell me that is playing with fire.

Last thoughts on the fiscal cliff and science

What I wrote in July still stands:

None of this is good for NIH or NSF. Because the fiscal cliff cuts are across the board, they are mindless (remember, the cliff was supposed to be a deterrent) so the excellent will get thrown out with the merely good.

Even, if by some miracle, Congress manages to get something to the President’s desk in time, my guess is it’ll be some sort of agreement on the revenue side (i.e. taxes) that punts on the spending cuts. And I’m not exactly optimistic about any agreement before new years.

Expect some legislative movement encouraged by the markets early in the new year–it’ll be very telling to see if Speaker Boehner has any difficulty being reelected by his caucus–once again probably on the tax side but probably also dealing with DOD. I’m not expecting much good news for science.

Fiscal Rift

I was up on Capitol Hill today and have to say the mood is utterly pessimistic among staffers. The chasm between the two sides is too wide, especially in the House. I don’t think they think they can get it all done during the short period of time they have during the lame duck session. So off the cliff we go I suppose.

Interestingly, there doesn’t seem to be a lot of push back against DOD cuts. It’s the NIH budget that seems to have some real support on both sides of the aisle–I think there is a real understanding that you just can’t put biomedical research on hold. But even with that understanding, my sense is that staffers seemed resigned to the ultimate failure of their bosses in fixing things.

What’s going to happen to NIH and NSF?

If the “fiscal cliff” scenario happens? My current guess is that if the Cliff does kick in on January 1, it’ll create complete havoc inside the Federal government and then will be quickly resolved (possibly at the cost of a credit downgrade) by a further kicking of the can down the road. This regardless who wins the election–I’m beginning to be convinced that either a re-elected or lame duck Obama administration may see the expiration of Bush tax cuts as a strategically good move no matter the chaos…and the GOP in a lame duck session wont be able to do a thing about it.

None of this is good for NIH or NSF. Because the fiscal cliff cuts are across the board, they are mindless (remember, the cliff was supposed to be a deterrent) so the excellent will get thrown out with the merely good.

The DOD contractors have been lobbying intensely about the Cliff for some time now. The problem though: avoiding the cliff requires something qualitatively different from the political paralysis that has become the norm on the Hill.

If aspects of the Cliff are removed in the new Congress: expect a trade on tax cuts for restoration of DOD funding. I have a hard time seeing NIH and NSF being part of that deal. So worst case: road kill on a bridge to nowhere.

Return to DC

I’m back from the Eastern Shore. Was on on the Bay this morning in a classic cat boat, it was very nearly perfect weather.

In the meantime have received abysmal news from NIH concerning the metrics on investigator initiated RO1 grants. The success rates are at an all time low of 17.4% for the year that ended September 30. That combined with “sunset” provisions for NIH RO1’s after one resubmission are changing the game entirely for biomedical research. There is much to worry about.