May 11, 2007

CONGRESSIONAL HEARINGS

 

Senate Appropriations Subcommittee on Labor, HHS, and Education (L/HHS) – Burden of Chronic Diseases
On April 20, 2007, the Senate L/HHS Appropriations Subcommittee [Tom Harkin (D-IA), Chairman] held an NIH budget hearing on the burden of chronic diseases. The following NIH Directors testified: Drs. Richard Hodes, Director, NIA; Stephen Katz, Director, NIAMS; Elizabeth Nabel, Director, NHLBI; and Griffin Rodgers, Director, NIDDK.


L/HHS Chairman Harkin’s Opening Remarks:
Senate L/HHS Appropriations Subcommittee Chairman Tom Harkin (D-IA) opened the hearing by stating that the subcommittee intends to meet with the director of every NIH institute this spring. He stated that he and Senator Specter have pledged to reject the President’s proposed cuts to NIH for Fiscal Year 2008, and believes that these kinds of hearings will help make the case for NIH funding. He also remarked that the hearing offered the first opportunity for witnesses to respond to direct questions about the impact of the President’s budget.


L/HHS Ranking Member Specter’s Opening Remarks:
Senate L/HHS Appropriations Subcommittee Ranking Member Arlen Specter (R-PA) stated that the subcommittee deserved a generous allocation and emphasized the importance of providing political muscle to the issue of biomedical research. He encouraged the NIH directors, as well as those in the research field, to provide the justification necessary to generate support for NIH. He also stated how important it is for researchers to come to Washington D.C. to flex their political muscles and put pressure on Congress to do the right thing with regards to medical research.


The Key Question Asked During the Question and Answer Period:
Research Limitations Due to a Challenging Budget Environment?


Question - In the absence of Senator Specter, who had to leave before the questioning began, Senator Cochran asked each of the directors to “comment about the adequacy of these funding levels and what could be done if we are able to increase those above the President’s level” and how such increases might be used.


Answers - The directors all remarked about the importance of protecting new investigators. However, the directors also commented on many other areas. For example, Dr. Hodes mentioned limitations that current funding might place on research initiatives. He noted that the ability now to fund research across the whole spectrum is certainly limited; it is reflected in numbers such as success rates, the proportion of applications, outstanding applications that NIH is able to actually fund, but also in terms of the studies that cannot be done because NIH cannot fund them. He also mentioned examples of what may fall out of the payline, such as studies to understand basic underlying biology or clinical trials on Alzheimer’s disease, or to prevent frailty, to prevent diabetes, to prevent other age related outcomes.

Dr. Katz agreed with Dr. Hodes’ point with regard to the success rate, and noted that there are many outstanding applications that his Institute does not fund now; thus, the success rate would increase with additional funds. He also mentioned initiatives specific to his Institute, such as in regenerative medicine, which will continue but at a slower pace without adequate increases. In addition, clinical studies with regard to surgery verses non-surgery for low back pain will be slowed. There is a major osteoarthritis initiative with NIA and other institutes as well as with private industry, to identify biomarkers and predictors for progression of disease. This will allow NIH to determine who is at risk, and to conduct studies with shorter endpoints. However, without adequate funding increases, such initiatives will be delayed.


Dr. Nabel said that NHLBI has not been able to fund the small, innovative grants which accelerate into the larger ones. Her Institute has had to scale back on supplements that bring in new talent, including physicists and nanomedicine experts to existing grants, all of which would bring new ideas into the pipeline. In the past, supplements have been provided to awards for new equipment, but that is no longer the case. Like her colleagues, she noted that she has a number of very basic investigations and clinical studies that NHLBI would really like to fund. One example of this would be to study patients with diabetes to determine whether early preemption can forestall, prevent, delay, or reverse some of the morbidity and mortality associated with the disease.


Dr. Rogers commented that the budget situation has affected his Institutes’ ability to invest in training programs. He also stated that small innovative grants are being funded at a lower level than NIDDK would like, and that they have had to cut back on funding supplements to existing grants. He also remarked that he would love to be able to support a study to examine ways to pre-empt people from getting diabetes.


Senate Appropriations Subcommittee on Labor, HHS, and Education (L/HHS) – Frontiers of Science
On May 7, the Senate Appropriations Subcommittee on Labor, HHS, and Education (Senator Tom Harkin [D-IA], Chairman) held its third NIH theme hearing on the frontiers of science. Drs. Francis Collins, Director, NHGRI; Jeremy Berg, Director, NIGMS; Roderic Pettigrew, Director, NIBIB; and Donald Lindberg, Director, NLM, testified.


L/HHS Chairman Harkin’s Remarks:
Chairman Harkin remarked that the purpose of the theme hearings is to learn more about and understand what NIH is doing. This particular hearing, which was the third one for the subcommittee, was scheduled to examine the Institutes that enable science to move forward through their support for cutting edge tools and resources. Senator Harkin also commented that there is a lot of exciting things happening at NIH and he hopes to provide NIH with a significant increase, but much is dependent on the allocation his subcommittee receives.
 

Since he was the only Member of Congress in attendance, Senator Harkin spent considerable time asking about topics that intrigued him or for which he just wanted some data. His questions ranged from basic queries to asking for details about NIH’s
summer program and outreach to students across the county to energize them about science careers.
 

The Senator was interested in many of the new discoveries highlighted by the witnesses, including the most recent discovery of new genes for Type II diabetes, which has the potential, as Dr. Collins stated, to open new doors for prevention and treatment. Dr. Collins also discussed spin offs resulting from sequencing the human genome, such as the HapMap, the cancer genome atlas, and the genes and the environment initiative underway. The Senator expressed concern with the rise in health care costs, some due to research discoveries. Dr. Berg responded that this may not be the case in the future as it is just as likely that some costs will go down when people receive medications targeted for the individual. Costly treatments would no longer be given to individuals who, if determined in advance, would not benefit from the treatment.
 

There was also considerable discussion of the new information about a treatment for macular degeneration. Dr. Collins pointed out that this discovery came out of research on cancer, a drug found to reduce the growth of blood vessels which feed tumors. Mr. Harkin asked about nanotechnology and Dr. Pettigrew discussed several new developments with nanotechnology, including one example of a nanoparticle as a drug delivery mechanism.
 

In addition, Senator Harkin raised the issue of public access when he asked, “If Congress required all NIH funded researchers to submit its articles to an NIH database, would it improve scientists’ ability to conduct research?”
 

Dr. Lindberg responded that it would improve their abilities “quite a bit.” He commented that NLM is currently receiving less than 5% of the articles now (the 5% figure he cited does not include those that are deposited directly into PubMed Central). Dr. Lindberg pointed out that 75% of the articles that are deposited into PubMed Central “get used right away.” He also mentioned that NLM is partnering with Wellcome Trust in order to assure that researchers have access to worldwide databases. Senator Harkin commented that he still was unsure as to what direction the subcommittee would take with regards to this issue.


Senator Harkin closed with the thought that it is important to get young people involved in science and interested in research; he does not want the uncertainty of the budgets to destroy their interest. He said that hopefully he and Senator Specter can fix this with “better budgets.”


Hearing on the Welfare of Animals
On Tuesday, May 8, the House Committee on Agriculture’s Subcommittee on Livestock, Dairy, and Poultry held a hearing to review the welfare of animals in agriculture. Congressman Leonard Boswell (D-IA) and Congressman Robin Hayes (R-NC) are the Chairman and Ranking Member of the Subcommittee. In his opening statement,
Chairman Boswell said ‘mistreated animals do not produce’ and it would be counterintuitive for farmers to treat their animals poorly. Ranking Member Hayes stated that he would ‘stand strong for producers and stand-up to [animal activists]’ and he was ‘please to see the scientific community represented’.
 

Although the Members opening statements and questioning focused on issues related to the prohibition on the sale of horses for slaughter, and a discussions related to the strategies and tactics employed by animal rights organizations, the Subcommittee did have an opportunity to hear from a member of the research community. Steven Leary, DVM, presented testimony on behalf of The National Association for Biomedical Research (NABR). Other panelists included:


Former Congressman Charlie Stenholm
Mr. Wayne Pacelle, President and CEO, The Humane Society of the United States
Dr. Gail C. Golab, PhD, DVM, Associate Director, Animal Welfare Division, AVMA
Mr. Gene Gregory, President, United Egg Producers
Mr. Guillermo Gonzalez, Sonoma Foie Gras, on behalf of Artisan Farmers Alliance
Mr. David Martosko, Director of Research, Center for Consumer Freedom
Mr. Gene Baur, President, Farm Sanctuary
Mr. Paxton Ramsey, Member, National Cattlemen’s Beef Association
Ms. Barbara Determan, National Pork Producers Council
Ms. Leslie Vagneur Lange, National Director, American Quarter Horse Association
Ms. Karen Jordan, DVM, Owner, Large Animal Veterinary Services, on behalf of National Milk Producers Federation


Their written statements can be found online: http://agriculture.house.gov/hearings/statements.html


Dr. Leary made a strong case for the humane use of animals in biomedical research, higher education, and product safety testing. In his description of the voluntary requirements that most institutions follow, Dr. Leary stated, ‘Ninety-nine of the top 100 NIH awardee institutions, all US and many international locations of all PhRMA members, all large and most medium-sized biotech companies, all NIH, DOD and VA intramural research programs, have voluntarily sought accreditation with the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International).’


Dr. Leary quoted Dr. Michael DeBakey, Baylor College of Medicine and Director of the DeBakey Heart Center, to express NABR’s members’ goals of finding ways to cure both human and animal ailments. “These scientists, veterinarians, physicians, surgeons and others who do research in animal labs are as much concerned about the care of the animals as anyone can be. Their respect for the dignity of life and compassion for the sick and disabled, in fact, is what motivated them to search for ways of relieving the pain and suffering caused by diseases.” Dr. Leary received no questions from the panel.

 

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