The House begins consideration of HR 6 the 21st Century CURES Act today (Thursday July 9th) This bill has bipartisan support and would establish an $8.75 billion Innovation Fund to provide NIH with an additional $1.75 billion a year and the FDA an additional $110 million for the next five years. The money for this Innovation Fund currently would come from mandatory spending instead of discretionary spending, which can get lost in the annual budget fights. The House Energy and Commerce Committee has already identified money for this fund from profits from selling some oil from the Strategic Petroleum Reserve (see this FAQ for an explanation of the funding) and the Congressional Budget Office has estimated that this bill will reduce the federal deficit by more than $500 million over the next 10 years.
Rep. Dave Brat (R-VA) plans to offer an amendment to make the NIH Innovation Fund come from discretionary funding. Since this would defeat the purpose of the Innovation Fund, please ask your Representative to oppose Amendment #29 to the 21st Century Cures Act.
You can find your Representative’s number here: http://www.house.gov/representatives/
Below is a sample script written by the American Physiological Society’s Science Policy Office:
Congressional offices expect to get phone calls from constituents expressing views for and against pending legislation. Therefore, you can explain the reason for your call to the receptionist.
WHAT TO SAY:
“My name is ___________, and I am a constituent of Rep. ________.”
“I support the 21st Century Cures Act because it will increase funding for life-saving biomedical research at the NIH. The bill is H.R. 6.
“Please ask Rep.______ to oppose Brat amendment #29 because it will undermine the Innovation Fund that is meant to help NIH meet crucial health challenges.”
Further talking points are provided below, but please call TODAY.
MORE REASONS TO SUPPORT THE BILL:
- Provides funding for life saving research and treatment and contributes to the economic engine of research and development
- Identifies funding to “offset” the cost of the Innovation Fund and reduces the federal deficit by more than $500 million over the next 10 years (according to the Congressional Budget Office)
- Maintains the Appropriations Committees as gatekeepers to set funding levels annually for biomedical priorities
For more about the bill, see the House Energy and Commerce committee’s website http://energycommerce.house.gov/cures.)
Now is the time of year that the Appropriations Committees in Congress are starting to draft the budgets for FY 2016. Individual member requests for funding can be influential in setting the final appropriations request, so now is a good time to contact your representatives and voice your support for increased federal science funding. Currently there is a ‘Dear Colleague’ letter circulating in the House requesting an $32B for NIH and $7.72B for NSF. You can use FASEB’s action center to send an email to your House Reps asking them to show their support for increased federal investment in science by signing the Dear Colleague letter. Tomorrow members from the Society for Neuroscience will be on Capitol Hill meeting with legislators to ask for a 10% increase in NIH funding. You can contribute to their effort virtually by sending emails to your legislators through their action center.
Last year I attended the SfN Hill Day, which was an experience I’ll never forget. Many societies organize Hill Days for their members and it is a great way to make sure that your legislators hear about the value of federal science funding. It also gives you a firsthand glimpse into our political process. If you are an early career member of Society for Neuroscience or the American Physiological Society you should check out their policy fellowships.
The continuing resolution currently funding the government expires on December 11th. Draft bills increasing federal science funding have been approved by both the Senate and House Appropriations, but have yet to be considered by the full Congress. Please write to your representatives urging them to pass an omnibus spending bill in the next few weeks.
Link to the FASEB Action Alert Page where you can contact your legislators
As mentioned in the last post, the House passed HR 5056, the Research and Development Efficiency Act. This bill would decrease the regulatory burden on universities and investigators. Contact your senators and ask them to pass this bill before the end of the Congressional session.
Link to the FASEB Action Alert Page where you can contact your senators
This summer you couldn’t miss the videos of friends and celebrities dumping themselves with ice water and challenging others to do the same and/or donate to the ALS Association. Over 300 million people donated $100 million and counting to the ALS Association thanks to the viral ice bucket challenge (as of Aug 29th). Money donated to the ALS Association supports research for a cure for ALS, advocacy efforts, public education and outreach, and community services for those suffering form ALS. You can learn about ALS (Amyotrophic Lateral Sclerosis or Lou Gehrig’s Disease) in one fun cartoon by Dwayne Godwin & Jorge Cham.
While the outpouring of individual charity has been heartening, disease specific foundations don’t have the resources needed to fund research into cures on their own. To date the ALS Association has committed $99 million to support biomedical research on ALS compared to over $229 million invested by the NIH in ALS research in just the past 5 years. The NIH and other federal science funding agencies also have more consistent funding and the ability to strategically spend money on basic science research in addition to large scale clinical trials. As I’ve discussed before, the sequester, biomedical inflation, and flat funding to the NIH and NSF have decreased federal funding for biomedical science by ~20% since 2003.
So, keep supporting your favorite charities, but increase the chances that biomedical researchers find a cure by asking your elected officials to support continued investment in science. Call your representatives and ask them to support Senator Tom Harkin’s Accelerate Biomedical Research Act. This bill would increase NIH funding in 2021 to the level it would have been if funding had kept pace with inflation after 2003 ($46.2B).
Go here for Research!America’s easy contact form and email template supporting the Accelerate Biomedical Research Act. If you prefer to call your representatives you can find contact information here.
Women have been traditionally underrepresented in science not only as scientists, but also as experimental subjects. This lack of representation in both clinical trials (especially before the 1993 NIH Revitalization Act that required the inclusion of women and minorities in clinical trials) and preclinical basic research has had negative consequences for women’s health. There are well appreciated sex differences in the basic physiology and prevalence rates of many diseases. Even though cardiovascular disease is the most common cause of death in women, only 1/3 of the subjects in clinical trials on cardiovascular disease are women and less than 1/3 of those trials report the results by sex, meaning they may miss treatments that are promising for one sex but not the other. Women are more likely to suffer from a chronic pain condition than men and even though there is evidence of multiple sex specific pain pathways, 79% of animal studies in the journal Pain from 1996-2005 only used male animals. Sex differences in metabolism can mean that a dose that is effective in men is harmful in women, likely one of the reasons that women experience more side effects than men and that 8 of 10 drugs recently recalled by the FDA led to more serious adverse reactions in women.
Lately the under-representation of female subjects has been getting more attention. In April of this year, a group of senators requested a Government Accountability Office investigation into whether NIH funded clinical trials included appropriate analyses to determine if there were sex differences in the response to treatment. In March a National Policy Summit on the Future of Women’s Health and accompanying report highlighted both the advances in women’s health research since the 1993 NIH Revitalization Act and the many remaining areas of inequality in clinical research. The NIH recently announced plans to require that preclinical research on animal models and cell lines include subjects of both sexes, unless there is scientific justification for a single sex study (these guidelines will be phased in starting October 2014). The Research For All Act introduced in June by Rep. Jim Cooper and Rep. Cynthia Lummis would require the NIH to have guidelines for the inclusion of both sexes in preclinical research (in all cases except those which the NIH director deems unnecessary). This law would also require expedited clinical trials to include enough participants to test the efficacy and safety of the treatment in both sexes and for the NIH to report demographic information in their biennial report.
The new NIH guidelines attempt to address the huge bias in neuroscience, physiology and pharmacology studies to include only male animals or not to report the sex of the animals at all. A common justification for not including female subjects is a potential increase in variability that is caused by the estrous cycle (which would require monitoring of estrous cycle and subject groups for each stage of estrous). Recent meta-analyses have found similar variability in both sexes in response to a variety of pain tests and behavioral, molecular and physiological tests in neuroscience, suggesting that monitoring estrous cycle is unnecessary and that female mice are ‘now liberated for inclusion in neuroscience and biomedical research‘. There has been push back in the scientific community, though, with some arguing that the new guidelines will lead to a huge increase in research costs and time. Since NIH funding levels have stagnated in recent years, this is a cause for concern. It is unclear what will be considered sufficient justification for only studying one sex and whether additional resources will be available. For health issues where there are known sex differences or ones that disproportionately affect women, it is just good science to include female subjects, though.
Since the Research for All Act would require sex balance in NIH funded research, now would be a good time to express your opinions on these guidelines to your elected officials — and of course to remind them of the importance of federal funding in developing treatments for both men and women (to find your elected officials click here). Personally, I think an increased emphasis on the fact that sex is an important biological variable is a good thing, though I would like to hope that the scientific community could be persuaded to do this without a legal imperative. (Full disclosure: my lab is currently looking at both male and female animals, so I don’t have to change my research program and as a woman I have a vested interest in ensuring that treatments are tested in women)