Health IT

Reddit conversation shows how government shutdown may be fatal for vaccine R&D startup

The government shutdown has some pretty wide-ranging impacts on drug developers and biotechnology researchers, from facing delays on grant applications to screwing up clinical trial recruitment. Even the National Center for Biotechnology Information, which includes PubMed, was impacted. So Reddit, in its best tradition as the virtual water cooler, asked scientists to talk about how […]

The government shutdown has some pretty wide-ranging impacts on drug developers and biotechnology researchers, from facing delays on grant applications to screwing up clinical trial recruitment. Even the National Center for Biotechnology Information, which includes PubMed, was impacted. So Reddit, in its best tradition as the virtual water cooler, asked scientists to talk about how the government shutdown will affect them and their work. Here’s a sample of their responses:

99trumpets

Anybody relying on continuing funds from an ongoing federal grant should be prepared for a SLOW spin-up and a long delay in getting your FY2014 funds, possibly 6-8 months delay even if the actual shutdown is very short…Anybody who has submitted a proposal for a new grant should (IMHO) have a fallback plan in mind for other support for 2014.

The same post also included links to back up resources such as a link to National Science Foundation grant, fellowship and dissertation forms.

A compelling exchange called attention to how startup biotechnology companies are impacted by the shutdown:

Sporkinmyeye

We don’t have any federal grants, but I am a scientist with a small vaccine R&D startup. We were slated to have a meeting with the FDA in the next month to discuss moving forward with an IND application and bringing our first vaccine to clinical trials. Now….it is looking like that meeting won’t happen. It’s a bit terrifying, since our gap funding is about to run out and our next round of funds was dependent upon the meeting with the FDA. I’ll be upset if we close our doors and can’t try to bring our (potentially very useful) vaccine to market because of this.

N0  shunning

What kind of vaccine?

Sporkinmyeye

It’s a live attenuated arbovirus vaccine. I don’t want to say which arbovirus at the moment.

No_shunning

Neat! Sorry to hear about the setbacks due to the stupid government.

reddishpanda

I’ll just assume it has something to do with ticks, based on wikipedia.

On a side note, Happy cake day!

Sporkinmyeye

Thanks! No ticks, Mosquitos. It’s a virus related to West Nile. Hopefully it will keep moving forward!

I_am_a_BalbC

Feel for you. Our NIH Product Development Package has come to a screeching halt for our vaccine. Our vaccine was developed with NIH money and is now licensed to a company. It’s like, “Okay, we’ll invest millions of dollars, now we’re going to delay everything.”

Sporkinmyeye

Doesn’t it suck?? It’s so much fun explaining to your investors “well, I’d really like to bring this to market. Really. Except, our government is run by a bunch of toddlers and they shut down the government so I can’t. Could I have another 100k, please?”.

Bombauer

A new cancer drug I’ve been working on for a few years was going to begin human clinical trials in December. Because of the shutdown the FDA IND process will be disrupted and now it will [be] delayed. Some people will die because every day counts to these patients who have exhausted all other therapies.

Another touched on the ripple effect of reduced staffing at the NIH and thereby PubMed:

someenglishrose

I am in the UK and had no idea this could take down Pubmed. I will be crippled if that happens!

Furthermore, we are funded by the Wellcome Trust, which requires that everything they fund be open access (a policy I totally agree with, by the way). Making our end of project reports, I have papers in the Journal of Immunology, which has its own open access portal, so we thought we were okay for satisfying our funding requirements. Just yesterday, the Wellcome told us everything would need to be on Pubmed Central (not JI’s own portal). Okay, not a problem, I put all the paperwork through today (although I had no idea about this sh*tstorm). Here’s hoping our work makes it onto PMC in time to meet our funding requirements and, if it doesn’t, that the Wellcome is understanding!

Another exchange touched on concerns tied to ongoing research:

wh44

Do you know if there are any NIH employees doing research that needs daily maintenance? A friend of mine is a researcher here in Germany, and he needs to be there or have a colleague there every day, Saturdays, Sundays and holidays, to be sure that his experiments are maintained.

Funk_Soul_Brother

I’m at the NIH. They granted “excepted” status to people with ongoing research that would have to be wasted if no one can work on it. If you have ongoing animal/cell culture experiments, you are allowed to come in. Although PI’s need to justify everyone on excepted status, so far, it appears to be on an honors system. We are still allowed unquestioned access to the facilities.

omi_palone

I work in regulatory testing policy with the federal government, so my work is largely at a standstill. I was hoping to have a call with some CDC and USDA people today, which probably isn’t going to happen in time for good science to influence a meeting on duplicative testing abroad on the 15th of the month. Dangit.

There was also some discussion on the measures being taken to prevent scientists from accessing labs:

EagleFalconn

Part of me is tickled by the idea of the national guard showing up in my office sometime in the next hour to prevent me from going into the lab.

YoohooCthulhu

It also likely varies by institution. Large medical centers and universities that have continuous income streams can make it through a temporary lapse in appropriations without much trouble. At smaller research institutions that are funded almost entirely on soft money (think Scripps, Burnham, Salk, etc) an extended shutdown likely will force them to furlough employees to preserve basic operating funds if there’s an extended delay in obligation of funds.