Congressional Affairs (Prepared May 2, 2007)

Appropriations

FY 2007: On February 15, the President signed into law H. J. Res. 20, the "Revised Continuing Appropriations Resolution, 2007," as P.L. 110-5. For NIH, the resolution appropriated an increase of approximately $620 million over FY 2006. NIDA received a slight budget increase ($584,000) for a final FY 2007 level of $999,422,000.

FY 2008: The President's budget proposes $28.621 billion for NIH, $310 million below the FY 2007 Joint Resolution level. Within this total, NIDA would receive a slight increase of $943,000 over the FY 2007 level, totaling $1,000,365,000.

110th Congress

Followup from 2/07 report: As a result of the November 2006 elections, both the Senate and House of Representatives are now under Democratic Party control. As a result of this shift, there are significant changes to both the leadership and membership of those committees most relevant to NIDA's work. Also, certain committee jurisdictions have changed.

Senate: In the Senate, primary focus is on the

• Committee on Appropriations (Subcommittee on Labor, Health and Human Services, and Education; Financial Services [now with ONDCP jurisdiction] and Commerce, Justice, Science);
• Committee on Health, Education, Labor, and Pensions (HELP);
• Committee on the Judiciary (Subcommittee on Crime and Drugs); and the
• Caucus on International Narcotics Control (this is an officially recognized Caucus, established by law in 1985).

House: In the House, primary focus is on the

• Committee on Appropriations (Subcommittee on Labor, Health and Human Services, Education, and Related Agencies; Financial Services [now with ONDCP jurisdiction], and Commerce, Justice, Science and Related Agencies);
• Committee on Energy and Commerce (Subcommittee on Health); and the
• Committee on Oversight and Government Reform (formerly Government Reform). (Subcommittee on Domestic Policy - formerly Criminal Justice, Drug Policy, and Human Resources).

Subcommittee Rosters - Senate

Appropriations - Labor, Health and Human Services, and Education

Democrats Tom Harkin, IA (Chair) Daniel Inouye, HI Herbert Kohl, WI Patty Murray, WA Mary Landrieu, LA Richard Durbin, IL Jack Reed, RI Frank Lautenberg, NJ

Republicans Arlen Specter, PA (Ranking Member) Thad Cochran, MS Judd Gregg, NH Larry Craig, ID Kay Bailey Hutchison, TX Ted Stevens, AK Richard Shelby, AL

Appropriations - Financial Services

Democrats Richard Durbin, IL (Chair) Patty Murray, WA Mary Landrieu, LA Frank Lautenberg, NJ Ben Nelson, NE

Republicans Sam Brownback, KS (Ranking Member) Christopher Bond, MO Richard Shelby, AL Wayne Allard, CO

Appropriations - Commerce, Justice, Science

Democrats Barbara Mikulski, MD (Chair) Daniel Inouye, HI Patrick Leahy, VT Herbert Kohl, WI Tom Harkin, IA Byron Dorgan, ND Dianne Feinstein, CA Jack Reed, RI Frank Lautenberg, NJ

Republicans Richard Shelby, AL (Ranking Member) Judd Gregg, NH Ted Stevens, AK Pete Domenici, NM Mitch McConnell, KY Kay Bailey Hutchison, TX Sam Brownback, KS Lamar Alexander, TN

Health, Education, Labor, and Pensions (NIH jurisdiction retained by full committee)

Democrats Edward Kennedy, MA (Chair) Christopher Dodd, CT Tom Harkin, IA Barbara A. Mikulski, MD Jeff Bingaman, NM Patty Murray, WA Jack Reed, RI Hillary Rodham Clinton, NY Barack Obama, IL Bernard Sanders, (I), VT Sherrod Brown, OH

Republicans Mike Enzi, WY (Ranking Member) Judd Gregg, NH Lamar Alexander, TN Richard Burr, NC Johnny Isakson, GA Lisa Murkowski, AK Orrin Hatch, UT Pat Roberts, KS Wayne Allard, CO Tom Coburn, OK

Judiciary (Crime and Drugs)

Democrats Joseph Biden, DE (Chair) Edward Kennedy, MA Herbert Kohl, WI Dianne Feinstein, CA Russ Feingold, WI Charles Schumer, NY Richard Durbin, IL

Republicans Lindsey Graham, SC (Ranking Member) Arlen Specter, PA Orrin Hatch, UT Charles Grassley, IA Jeff Sessions, AL John Cornyn, TX

Caucus on International Narcotics Control

Democrats Joseph Biden, DE Diane Feinstein, CA Appointment pending Appointment pending

Republicans Charles Grassley, IA Jeff Sessions, AL Norm Coleman, MN

Subcommittee Rosters - House

Appropriations - Labor, Health and Human Services, Education, and Related Agencies

Democrats David Obey, WI (Chair) Nita Lowey, NY Rosa DeLauro, CT Jesse Jackson, IL Patrick Kennedy, RI Lucille Roybal-Allard, CA Barbara Lee, CA Tom Udall, NM Michael Honda, CA Betty McCollum, MN Tim Ryan, OH

Republicans James Walsh, NY (Ranking Member) Ralph Regula, OH John Peterson, PA Dave Weldon, FL Michael Simpson, ID Dennis Rehberg, MT

Appropriations - Commerce, Justice, Science, and Related Agencies

Democrats Alan Mollohan, WV (Chair) Patrick Kennedy, RI Chaka Fattah, PA C.A "Dutch" Ruppersberger, MD Adam Schiff, CA Michael Honda, CA Rosa DeLauro, CT John Olver, MA

Republicans Rodney Frelinghuysen, NJ John Culberson, TX Harold Rogers, KY Tom Latham, IA Robert Aderholt, AL

Appropriations - Financial Services

Democrats Jose Serrano, NY (Chair) Carolyn Kilpatrick, MI C.A "Dutch" Ruppersberger, MD Debbie Wasserman Schultz, FL Peter Visclosky, IN Robert "Bud" Cramer, Jr., AL Maurice Hinchey, NY Lucille Roybal-Allard, CA

Republicans Ralph Regula, OH Tom Latham, IA Mark Kirk, IL Dennis Rehberg, MT Rodney Alexander, LA

Energy and Commerce - Health

Democrats Frank Pallone, NJ (chair) Henry Waxman, CA Edolphus Towns, NY Bart Gordon, TN Anna Eshoo, CA Gene Green, TX Diana DeGette, CO Lois Capps, CA Tom Allen, ME Tammy Baldwin, WI Eliot Engle, NY Jan Schakowsky, IL Hilda Solis, CA Mike Ross, AK Darlene Hooley, OR Anthony Weiner, NY Jim Matheson, UT

Republicans Nathan Deal, GA (Ranking Member) Ralph Hall, TX Charlie Norwood, GA Barbara Cubin, WY John Shadegg, AZ Steve Buyer, IN Joseph Pitts, PA Mary Bono, CA Mike Ferguson, NJ Mike Rogers, MI Sue Myrick, NC John Sullivan, OK Tim Murphy, PA Michael Burgess, TX

Oversight and Government Reform - Domestic Policy

Democrats Dennis Kucinich, OH (Chair) Tom Lantos, CA Elijah Cummings, MD Diane Watson, CA Christopher Murphy, CT Danny Davis, IL John Tierney, MA Brian Higgins, NY Bruce Braley, IA

Republicans Darrell Issa, CA (Ranking Member) Dan Burton, IN Christopher Shays, CT John Mica, FL Mark Souder, IN Chris Cannon, UT Brian Bilbray, CA

HEARINGS, BRIEFINGS, AND EVENTS OF INTEREST

Friends of NIDA Congressional Briefing - Blending Research and Practice

On February 22, 2007, the Friends of the National Institute on Drug Abuse held its seventh in a series of educational briefings on Capitol Hill. The briefing, titled "Drug Abuse Treatment: The Blending of Research and Practice," drew an audience of over 100, including staff from a total of 50 different House and Senate offices, and was co-sponsored by 18 scientific and professional organizations.

The event focused on the issue of bridging the divide between scientific findings and their implementation and how to quicken the pace of real-world application of science-based research results. In order to accomplish this, the NIDA Research and Practice Blending Initiative has been developed, which is an innovative effort to translate research to practice and to incorporate feedback from multiple stakeholders to make the best treatments available to those who need them. Through the Blending Initiative, NIDA is able to directly address the challenge of connecting the science of drug abuse and addiction to real life practice.

NIDA Deputy Director Dr. Timothy Condon opened the briefing with an overview of the Institute's work in this crucial area. He was followed by Dr. Gregory Brigham, who shared his experiences as a member of a Blending Team, which provides the tools necessary to access and adopt NIDA research protocols. Brigham is the Chief Research Officer at Maryhaven, a Community Treatment Program (CTP) in Columbus, Ohio, and a Research Scientist in the College of Medicine at the University of Cincinnati. Maryhaven joined the NIDA Clinical Trials Network (CTN) in 2000 as a member of the Ohio Valley Node. Finally, Dr. Dennis McCarty, a professor in the Department of Public Health and Preventive Medicine at Oregon Health Sciences University, discussed his work as Principal Investigator for the Oregon Node of the CTN. These presenters did an excellent job in not only describing their own work, but in how the work of NIDA, the CTN research coordinators, and all of the CTPs continue to work together to discover, understand, and implement crucial approaches to successful drug abuse and addiction treatment. For additional details and some photos, go to http://www.thefriendsofnida.org/022207_event.asp.

House Appropriations Hearing for NIDA

On March 1, 2007, NIDA Director Dr. Nora Volkow testified in front of the House Appropriations Subcommittee on Labor, Health and Human Services, and Education. She joined NIH and SAMHSA colleagues in a "theme" hearing focusing on drug abuse and mental health. See full hearing report below.

House Appropriations Hearing for NIH

On March 6, 2007, NIH Director Dr. Elias Zerhouni testified in front of the House Appropriations Subcommittee on Labor, Health and Human Services, and Education. See full hearing report below.

Senate Appropriations Hearing for NIH

On March 19, 2007, NIH Director Dr. Elias Zerhouni testified in front of the Senate Appropriations Subcommittee on Labor, Health, and Human Services, and Education. See full hearing report below.

Senate Appropriations Hearing for NIDA

On March 26, 2007, NIDA Director Dr. Nora Volkow testified in front of the Senate Appropriations Subcommittee on Labor, Health and Human Services, and Education. She joined NIH colleagues in a "theme" hearing focusing on "mind, brain, and behavioral research." See full hearing report below.

BILLS OF INTEREST

[For the full text and additional information about any bill, go to the Library of Congress website at http://thomas.loc.gov]

Potential Institute Name Change -- H.R.1348/S. 101 - On March 6, 2007, Representatives Patrick Kennedy (D-RI) and John Sullivan (R-OK) introduced H.R.1348, to redesignate the National Institute on Drug Abuse as the National Institute on Diseases of Addiction, and to redesignate the National Institute on Alcohol Abuse and Alcoholism as the National Institute on Alcohol Disorders and Health. Similarly, on March 28, 2007, Senators Joseph Biden (D-DE), Edward Kennedy (D-MA) and Michael Enzi (R-WY) introduced S. 1011, the Recognizing Addiction as a Disease Act of 2007, which would make the same changes. In a press release, Senator Biden said the intent of the legislation is to recognize addiction as a preventable and treatable neurobiological disease, and to better identify the roles and missions of our research institutes. "Addiction is a neurobiological disease - not a lifestyle choice - and it's about time we start treating it as such," said Sen. Biden. "We must lead by example and change the names of our Federal research institutes to accurately reflect this reality. By changing the way we talk about addiction, we change the way people think about addiction, both of which are critical steps in getting past the social stigma too often associated with the disease." The House bill was referred to the Health Subcommittee of the Energy and Commerce Committee; the Senate bill was referred to the Health, Education, Labor and Pensions Committee.

Stem Cells -- H.R. 3/S. 5 - On January 5, 2007, Representative Diana DeGette (D-CO) introduced H.R. 3, the Stem Cell Research Enhancement Act of 2007. The Senate companion, S. 5, was introduced on January 4, 2007 by Senate Majority Leader Harry Reid (D-NV). The bills would require the Secretary of HHS to conduct and support research using human embryonic stem cells regardless of the date on which such cells were derived. The House passed its bill on January 11, 2007 and the Senate passed its bill on April 11, 2007. The Senate bill was amended prior to floor consideration. As amended, the bill would also require the Secretary to conduct and support research involving methods of obtaining pluripotent stem cells that do not involve the use of human embryos. The White House has issued Statements of Administrative Policy in opposition to both S. 5 and H.R. 3.

Stem Cells -- S. 30 - On April 11, 2007, the Senate passed S. 30, the Hope Offered Through Principled and Ethical Stem Cell Research Act, by a roll call vote of 70-28. The bill, introduced on March 29, 2007, by Representative Norm Coleman (R-MN) would require the Secretary to support research to develop pluripotent stem cells using methods that do not involve either the creation of, harm to, or destruction of human embryos. The White House issued a Statement of Administrative Policy in support of S. 30.

Genetic Non-discrimination -- H.R. 493/S. 358 - On January 16, 2007, Representative Louise Slaughter (D-NY) introduced H.R. 493, the Genetic Information Nondiscrimination Act of 2007. The Senate companion, S. 358, was introduced by Senator Olympia Snowe (R-ME) on January 22, 2007. These bills, which would prohibit discrimination in health insurance and employment on the basis of predictive genetic information, are identical to legislation passed by the Senate during the 109th Congress. The bills would prohibit health insurers in both the group and individual markets from (1) using genetic information to impose enrollment restrictions or to adjust premium or contribution amounts, (2) requesting genetic testing or results except as necessary for treatment, payment, or health care operations, or (3) requesting or requiring the use of genetic information for the purposes of underwriting. The bills define a genetic test as an analysis of human DNA, RNA, chromosomes, proteins, or metabolites that detects genotypes, mutations, or chromosomal changes. The House passed its bill on April 25, 2007; the Senate Health, Education, Labor and Pensions committee has reported its bill favorably; floor action in the Senate is pending.

Insurance Parity for Mental Health and Substance Abuse -- H.R. 1424/S.558 - On February 12, 2007, Senator Pete Domenici (R-NM) introduced the Mental Health Parity Act of 2007, a bill to provide parity between health insurance coverage of mental health benefits and benefits for medical and surgical services. On March 9, 2007, Representative Patrick Kennedy (D-RI) introduced the Paul Wellston Mental Health and Addiction Equity Act of 2007, to amend section 712 of the Employee Retirement Income Security Act of 1974, section 2705 of the Public Health Service Act, and section 9812 of the Internal Revenue Code of 1986 to require equity in the provision of mental health and substance-related disorder benefits under group health plans. The Senate bill has been reported favorably from committee. The House bill awaits further committee action.

Community Re-entry for Prisoners -- H.R. 1593/S. 1060 - On March 20, 2007, Representative Danny Davis (D-IL) introduced the Second Chance Act of 2007, to reauthorize the grant program for reentry of offenders into the community in the Omnibus Crime Control and Safe Streets Act of 1968, to improve reentry planning and implementation, and for other purposes. The Senate version of this bill was introduced by Senator Joe Biden (D-DE) on March 29, 2007. The bills include a strong focus on drug treatment in the criminal justice system, and consultation with NIDA is required in several bill sections. The House bill has been reported favorably out of committee; the Senate bill awaits action.

Tobacco -- H.R. 1108/S. 625 - On February 15, 2007, Representative Henry Waxman (D-CA) introduced H.R. 1108, the Family Smoking Prevention and Tobacco Control Act - a bill to protect public health by providing the Food and Drug Administration with certain authority to regulate tobacco products. Senator Edward Kennedy (D-MA) introduced an identical bill in the Senate. There have been hearings in the Senate on this bill. Further action is pending in the House and Senate.

H.R. 1170 - On February 16, 2007, Representative Martin Meehan (D-MA) introduced H.R. 1170, the Comprehensive Awareness of Problem Gambling Act of 2007. H.R. 1170 includes a research provision which would require the President to establish a national program of research on problem gambling. The bill would require the President to appoint an advisory commission to coordinate activities of Federal agencies relating to research on problem gambling including the activities of the NIH. H.R. 1170 was referred to the House Committee on Energy and Commerce.

H.R. 1200 - On February 27, 2007, Representative Jim McDermott (D-WA) introduced H.R. 1200, the American Health Security Act of 2007. The purpose of the bill is "to provide for health care for every American and to control the cost and enhance the quality of the health care system." Of interest to NIH is section 722, which would establish the Office of Primary Care and Prevention Research within the Office of the Director; require the establishment of a data system of information regarding primary care and prevention research that is conducted or supported by the ICs; require the establishment of a clearinghouse to provide information on research and prevention activities of the ICs that relate to primary care and prevention research; require a biennial report on primary care and prevention research; and authorize $150 million for FY 2008, $180 million for FY 2009, and $216 million for FY 2010. In addition, the legislation would amend the authorities of the NIH Director to require that sufficient resources are sufficiently allocated for projects on primary care and prevention research. H.R. 1200 was jointly referred to the House Committees on Energy and Commerce; Ways and Means; Oversight and Government Reform; and Armed Services.

H.R. 1309 - On March 14, 2007, the House passed H.R. 1309, the Freedom of Information Act Amendments of 2007. Provisions of interest to NIH would shorten the time limits on which to act on requests, require agencies to establish a system to assign an individualized tracking number for each request for information, establish a telephone line or Internet service regarding the status of a request, institute additional reporting requirements regarding FOIA requests and processing times, and broaden "media status" to those who have "internet publications." The bill has been referred to the Senate.

H.R. 1663 - On March 23, 2007, Representative Pete Stark (D-CA) introduced HR 1663, The Medicare Mental Health Modernization Act of 2007, to amend title XVIII of the Social Security Act to expand and improve coverage of mental health services under the Medicare Program. The bill was referred to the Committee on Ways and Means, and the Committee on Energy and Commerce.

S. 884 - On March 14, 2007, Senator Richard Durbin (D-IL) introduced the Family-Based Meth Treatment Access Act of 2007, to amend the Public Health Service Act regarding residential treatment programs for pregnant and parenting women, a program to reduce substance abuse among nonviolent offenders, and for other purposes. The bill was referred to the Committee on Health, Education, Labor and Pensions.

S. 980 - On March 23, 2007, Senator Dianne Feinstein (D-CA) introduced the Online Pharmacy Consumer Protection Act of 2007, to amend the Controlled Substances Act to address online pharmacies. The bill was referred to the Judiciary Committee.

S. 1082 - On April 10, 2007, Senator Edward Kennedy (D-MA) introduced the Food and Drug Administration Revitalization Act. On April 18, 2007, the Senate Committee on Health, Education, Labor and Pensions reported out an amended version of the bill. The bill would expand the Clinicaltrials.gov registry to include mandatory reporting of certain drug and device clinical trials. The bill would also require that the ClinicalTrials.gov website provide corresponding linkages to peer-reviewed literature and certain publicly available FDA information regarding the results of those trials. S. 1082 also includes provisions to reauthorize the Best Pharmaceuticals for Children Act. Senate floor action is pending.

HEARING REPORTS

House Appropriations Subcommittee on Labor-HHS and Education Holds Hearing on
President's Budget Request for SAMHSA, NIDA, NIAAA and NIMH;
Directors of Each Agency Testify

(Summary provided to NIDA by the Legal Action Center)

On Thursday, March 1, 2007, the House Appropriations Subcommittee responsible for funding programs within the Departments of Labor, Health and Human Services and Education convened a hearing to discuss the FY 2008 budget request for each of the key federal agencies responsible for administering drug and alcohol and mental health prevention, treatment, education and research programs. The witnesses representing each of the agencies were: Terry Cline, Ph.D., Administrator of the Substance Abuse and Mental Health Services Administration; Nora Volkow, M.D., Director of the National Institute on Drug Abuse, T.K. Li, M.D., Director of the National Institute on Alcohol Abuse and Alcoholism; and Thomas Insel, M.D., Director of the National Institute of Mental Health. Chairman of the Full House Appropriations Committee and the Subcommittee on Labor-HHS, Congressman David Obey (D-WI), chaired the hearing. Other Committee members in attendance included Subcommittee Ranking Member Representative James Walsh (R-NY), and Representatives Jesse L. Jackson, Jr. (D-IL), Patrick J. Kennedy (D-RI), Lucille Roybal-Allard (D-CA), Tom Udall (D-NM), Michael Honda (CA), Tim Ryan (D-OH), John E. Peterson (R-PA), and Dennis R. Rehberg (R-MT). Substance Abuse and Mental Health Services Administration.

Dr. Cline began his testimony by stating that despite the President's request to cut the budget of SAMHSA by $159 million from the FY 2007 continuing resolution funding level which would represent a five percent overall reduction for SAMHSA, an aggressive agenda has been set for the upcoming year. According to Dr. Cline's remarks the focus of SAMHSA's budget is on service delivery programs, such as the Mental Health and Substance Abuse Block and Formula Grants; resources will also be invested in program priority areas of children's mental health services, suicide prevention, school violence prevention, prevention and treatment of Post-Traumatic Stress Disorder, the Screening, Brief Intervention, Referral, and Treatment (SBIRT) program, HIV/AIDS and criminal and juvenile justice. In regards to expanding substance abuse treatment capacity, Dr. Cline articulated that the FY 2008 budget enhances accountability and improved performance outcomes by requiring States to report on the Community Mental Health Services (MHBG) and Substance Abuse Prevention and Treatment (SAPT) Block grant funds; States reporting on the SAPT Block Grant National Outcomes (NOMS) could receive an increase to their State allocation if some States do not report.

Dr. Cline testified that SAMHSA continues to expand treatment capacity through the Access to Recovery (ATR) program and provides increases for screening of drug addiction and treatment for those involved with the criminal justice system. Despite a cut of $36.4 million to the Center for Substance Abuse Prevention, Dr. Cline stated that the budget will continue to fully support the prevention activities of SAMHSA, including the Minority HIV/AIDS and Substance Abuse Prevention Grants, the Fetal Alcohol Spectrum Disorder Center for Excellence, and the Strategic Prevention Framework grant program. Citing the progress that has been made in reducing youth drug use in America Dr. Cline also stated that SAMHSA will continue to focus energy and take a leadership role in the prevention of underage drinking; alcohol remains the drug of choice among adolescents and Dr. Cline acknowledged that more progress needs to be made in reducing underage drinking rates.

National Institute on Drug Abuse

Dr. Volkow began her remarks by highlighting the results of NIDA's latest Monitoring the Future survey which show a 23 percent decline over the last five years in any past-month illicit drug use by students in the 8th, 10th and 12th grade combined. Despite progress with rates of youth drug use, Dr. Volkow cited concern with misuse of prescription medications which has produced steep increases in abuse-related emergency room admissions; additionally, use of prescription medications, along with over the counter drugs (cough medicine), account for five of the top six drug abuse categories reported by 12th graders. Prevention was emphasized as critical and Dr. Volkow explained that NIDA continues to focus on adolescence, because that is typically when drug abuse and addiction begin. Since addiction results from a complex interaction of drugs, genes and environmental and developmental factors, NIDA has also made the study of these interactions a priority. NIDA's treatment research identifying the brain circuits that underlie addiction, such as craving, euphoria, and inhibitory control have opened the door to different treatment approaches, including the possibility of using neurofeedback, where patients learn to regulate specific regions in their brains by getting feedback from real-time brain images. Dr. Volkow also cited progress in the development of addiction medications, as well as immunotherapeutic strategies, which are based on the development of vaccines to generate antibodies to the drug that block its entry into the brain and thereby interfere with its effects.

Dr. Volkow emphasized one of NIDA's major objectives of translating research into practice by highlighting its Criminal Justice Drug Abuse Treatment Studies (CJ-DATS) initiative; this initiative is aimed at bringing new treatment models into the criminal justice system to improve outcomes for individuals with drug histories. Dr. Volkow also spoke about the Drug Abuse Treatment Clinical Trials Networks (CTN) which brings evidenced-based treatments to community settings, and the establishment of four Centers of Excellence for Drug Abuse Information, in collaboration with the American Medical Association. Another area of priority, according to Dr. Volkow's testimony, is HIV/AIDS where NIDA is supporting preclinical and clinical studies that examine the interactions between: drugs of abuse and HIV medication, HIV and the plasticity (relative to changes that lead to addiction), and HIV and neurotoxicity (with regard to the adverse drug effects that result in conditions such as dementia and Parkinsonian symptoms); NIDA is also supporting research to make testing more acceptable in communities nationwide.

National Institute on Alcohol Abuse and Alcoholism

Dr Li's testimony began with a reminder about the seriousness of excessive alcohol use which costs the Unites States an estimated $185 billion annually and is ranked by the Centers for Disease Control and Prevention as the third leading cause of preventable death in the United States. Dr. Li articulated NIAAA's strong research and prevention focus on pregnant women, children and adolescents, including the agency's work on the interplay between hormones, brain development, and alcohol use. Dr. Li also spoke about the work of the Interagency Coordinating Committee for the Prevention of Underage Drinking and the forthcoming Surgeon General's Call to Action on underage drinking. In addition to recent research findings that will improve the diagnoses of alcohol dependence, NIAAA is supporting research to improve treatment options, including identifying the next generation of medications, and understanding how individuals change harmful drinking patterns. In particular, Dr. Li emphasized that success can only be achieved if individuals have access to treatment and that coverage of mental health and drug and alcohol addiction services would allow a greater proportion of individuals to receive the care they need.

National Institute of Mental Health

Dr. Insel began his remarks by summarizing how research has transformed the understanding of mental disorders by defining mental disorders as brain disorders that begin early in life; mental disorders along with addictive disorders are the most common chronic illnesses of young people in the United States. NIMH's efforts have focused on predicting who is at risk for developing disease; pre-empting the disease process; personalizing interventions; and ensuring that clinical research involves participation from the diversity of people and settings involved in health care. Dr. Insel indicated that NIMH plans to expand its efforts in treatment development, with an enhanced focus on medications that reverse the cognitive deficits in schizophrenia, additional studies of novel antidepressants, and new efforts in autism, anxiety disorders, and eating disorders. Dr. Insel emphasized NIMH's collaboration with SAMHSA's Center for Mental Health Services (CMHS) on the Mental Health Transformation State Incentive Grant program.

Members' Remarks

Subcommittee Ranking Member Congressman James Walsh (R-NY) began his opening remarks by stating his concern with how the agencies are addressing the mental health issues of active duty troops and veterans. Rep. Walsh also stated that building a foundation for research is good, but only if it translates into practice, and that he would like to hear more about the agencies' efforts to turn research into practice. Chairman Obey (D-WI) began by expressing his frustration with the belief that level funding means that there will not be cuts, when in fact, it does not take into account inflation and population growth; Obey stated "we are headed in the wrong direction" with the Administration's budget request and asked the witnesses to explain the challenges that level funding would create for their agencies. Dr. Cline responded by highlighting the efforts of SAMHSA to develop a comprehensive data strategy, which will help translate data into outcomes to better show results; additionally, he emphasized the continued importance of investing in prevention. Dr. Volkow discussed the difficulty of bringing medications into medical practice, in part due to the lack of involvement of the pharmaceutical industry in this particular area of medication development, and also stated that clinical trials are delayed because of budget shortfalls. Dr. Li articulated that it is a struggle to change the culture of binge drinking in youth and that it remains important to identify those who are at high risk for alcohol dependence, both of which are priority areas of NIAAA.

Congresswoman Roybal-Allard (D-CA) and Congressman John Peterson (R-PA) both remarked that they are concerned about underage drinking. Rep. Peterson asked why there is not more information made available to young people about the damage excessive drinking can cause to the brain while it is in development. Dr. Cline confirmed that alcohol is the number one drug of choice for young people and that SAMHSA is investing resources in its Strategic Prevention Framework to combat underage drinking as well as focusing on the environmental factors such as schools, parents and peers that prevent underage drinking. Congressman Ryan (D-OH) offered his support for after school programs that prevent alcohol and drug use and keep youth involved in activities during that vulnerable time period. Rep. Ryan asked the witnesses about what efforts are being undertaken to study stress and the role it plays as a trigger for alcohol and drug use and mental health conditions. Dr. Volkow responded that stress is one of the most important environmental factors that contribute to drug use and poverty, that many prevention interventions work and that it is critical that such effective interventions are applied in communities.

Congressman Kennedy (D-RI) expressed his disappointment with the cuts proposed in the FY 2008 budget request by stating it is a departure from reality and that it will result in shifting costs to other systems, including the criminal justice system, which is also receiving significant cuts in the FY 2008 budget request. Rep. Kennedy inquired as to how treatment of co-occurring disorders could be best administered in order to eliminate bureaucratic waste of resources and stated his position that the mental health and substance abuse block grants should be integrated. Dr. Cline responded by stating that SAMHSA is working on a number of best practices in the area of co-occurring disorders as well as supporting policy academies for information sharing. Additionally, Dr. Cline highlighted the flexibility that currently exists within SAMSHA to administer programs for co-occurring populations.

For more information on the House Appropriations Committee and the Appropriations process please visit: http://www.appropriations.house.gov/.

NIH Hearing Summary (provided by NIH/OLPA)

Overview of FY 2008 Budget Request for NIH
House Appropriations Subcommittee on Labor, HHS, and Education

March 6, 2007

Members: The hearing was attended by Representatives David Obey (D-WI), Chair; Jesse Jackson, Jr, (D-IL); Lucille Roybal-Allard (D-CA); Barbara Lee (D-CA); Michael Honda (D-CA); Betty McCollum (D-MN); Tim Ryan (D-OH); James Walsh (R-NY), Ranking Minority Member; Ralph Regula (R-OH); John Peterson (R-PA); Dave Weldon (R-FL); Dennis Rehberg (R-MT); and Jerry Lewis (R-CA).

Witnesses: Dr. Elias Zerhouni, Director, NIH, accompanied by Drs. Elizabeth G. Nabel, Director, NHLBI; John E. Niederhuber, Director, NCI; Anthony S. Fauci, Director, NIAID; Duane F. Alexander, Director, NICHD; John Ruffin, Director, NCMHD; Francis Collins, Director, NHGRI; Story Landis, Director, NINDS; Sam Wilson, Deputy Director, NIEHS; Griffin Rodgers, Acting Director, NIDDK; and Barbara Alving, Acting Director, NCRR.

Summary: In summary, the Chairman criticized the FY2008 President's budget, both because it did not take into account the actions of the FY2007 Joint Resolution which provided in excess of a $600 million increase over FY2006 for NIH, and especially absence of funding for the National Children's Study (NCS), which was explicitly funded in the Joint Resolution. The Chairman called the FY2008 request a "step backwards, " took issue with "OMB's plan to use NIH as the Bank of Bethesda when it comes to funding the Global AIDS Initiative," and with regard to the NCS, stated that "we're going to put that money back next year, too, and it will not squeeze other research, because we will expand the institutes' budget, just as we did last year."

There were questions about stem cells from Representative Walsh and also from Representative Ryan, which elicited the response from Dr. Zerhouni that it is important to pursue all lines of research (adult, human embryonic, etc.) and that as we look ahead, "we should find a way of allowing our scientists to have access to more experimental models, including embryonic stem cells, to understand the fundamental issue."

There were a number of questions about health disparities from Representatives Jackson, Roybal-Allard, Lee, and Honda. There was interest in other topics, including new and promising developments that would have an impact on the HIV/ AIDS vaccine; how NIH is progressing in the area of translational research, getting results into the hands of the health care providers; whether the budget could be devised to reflect future paradigm and priorities; genetic discrimination (to be provided for the record); and the third-generation anthrax vaccine research and RFP that was put out recently and then rescinded.

Chairman Obey opened the hearing noting, as he has at the previous hearings, that he had charged all of the appropriation subcommittees to ask, "What will this country look like in 10 years? What will the demographic changes be, what will the traffic needs be, what will the environmental problems be, what are the scientific opportunities that we should be thinking about?" He also noted the increase provided to NIH in the FY2007 Joint Resolution and that "the budget presented by the President this year is actually a decrease from the previous year... the budget that it has presented is inadequate and needs to be augmented."

Mr. Walsh opened his statement with praise for the NIH, noting that NIH discoveries have the potential to change medicine, but also stated his concern with the pace at which those advances reach local doctors and community hospitals. "There are reasons for delays in taking this research to that level, including safety and cost. But I think we need to look for ways to move this research into practice as quickly as possible without sacrificing safety." He also mentioned that he would like to "underscore the need for sound financial management, which I know is something that you and your leadership staff have stressed" and "Congress has, I think, strongly -- over the last eight years or so -- and dramatically, increased National Institutes of Health funding to respond to the needs of the country, and we need to make sure the investment is being placed wisely and where it can do the most good."

The Director of NIH testified about where NIH has been over the past 30 years, where we are today, and what is our vision for the future. Due to the investment of Congress in biomedical research over the past 30 years, he reported that for the second consecutive year, annual cancer deaths in the United States have fallen. Furthermore, there has been a 60 percent drop in mortality for heart disease and stroke. There is a decline in the chronic disability indices that we have measured since the 1980s, and there has been a decrease of 30 percent in disability rates for Americans over the age of 65, a decrease which is actually accelerating. Life expectancy has risen to 78 years, up six years since 1974, or about one year every five years. He emphasized that we were poised to use NIH-supported discoveries to transform the medical treatment paradigm in the 21st Century, from one that responds to symptoms to one that predicts disease, personalizes treatment and preempts disease, striking it before it strikes the patient. He also noted that the new paradigm will require participation, because patients will have to participate, communities will have to participate, individuals will have to take more responsibility for their own care earlier than ever before. "This is the era of what we call precision medicine." He noted recent discoveries which are illustrative of the "four Ps," including remote glucose sensors; biomarkers from saliva; the development of the first anticancer vaccine, the HPV vaccine, the first FDA-approved vaccine against cancer; and the launching of a trial for a new class of HIV/AIDS vaccine. Also, he described the development of a genetic test to determine which patient would have intracranial bleeding from the use of immunoglobulin for treatments of certain diseases. He closed by noting that the scientific challenge before us is the one of biological complexity; that we are really in a race to understand in this century what the life sciences need to do, and to advance that understanding as we did with physical sciences in the 20th century. If we do not understand the biological circuitry, it will be very hard to advance our vision of the new health care system.

The first questions were a series of stem cell questions from Representative Walsh, who was attempting to elicit information on whether other than human embryonic stem cells (HESC) would be able to do all that HESC can do, without destruction of a human embryo. There was discussion about investigators who have reported that they can reprogram adult stem cells to produce pluripotent cells and the Congressman was looking for validation of this. Dr. Zerhouni responded that understanding DNA programming and reprogramming is the largest challenge and that, from the scientific standpoint, and at this point, it is important to pursue both lines of research as vigorously as we can. This topic was visited again by Representative Ryan, who wondered if the United States and its scientists were falling behind in the quest to understand the action of stem cells.

There was extensive discussion of health disparities, beginning with the status of the strategic plans, and whether the coordinating role of the NCMHD is clear to the ICs by Representative Jackson, who stated that he wanted "to make sure that NIH does not overlook or misinterpret the intent of the Minority Health and Health Disparities Research Education Act of 2000." Representative Lee took issue with the positive statistics on cancer and heart disease decline, noting that this did not apply to African Americans and other minorities. Representative Honda was interested in Asian-Pacific Islanders and Representative Roybal-Allard was interested in a recently launched NHLBI longitudinal study, the Hispanic Community Health Study. Who pays for peer review of articles destined for deposition under the Public Access was raised by Representative Honda, and the response will be submitted for the record. The final, major topic was raised by Representative Obey, the National Children's Study. He pressed Dr. Zerhouni about reasons for the agency's unwillingness to fund the study and wanted to hear whether the decision was science or budget driven. Dr. Zerhouni responded that "unless there were additional resources, it wouldn't have been wise to sacrifice the next generation for this study, which is basically a budgetary decision. There's no opposition or scientific reluctance on our part."

NIH Hearing Summary (provided by NIH/OLPA)

Overview of FY 2008 Budget Request for NIH
House Appropriations Subcommittee on Labor, HHS, and Education

March 19, 2007

Members: The hearing was attended by Senators Tom Harkin (D-IA), Chairman, and Arlen Specter (R-PA), Ranking Member.

Witnesses: Panel 1: Dr. Elias Zerhouni, Director, NIH. Panel 2: Joan S. Brugge, Ph.D., Chair, Department of Cell Biology, Harvard Medical School; Brent Iverson, Ph.D., University Distinguished Teaching Professor of Organic Chemistry and Biochemistry, The University of Texas at Austin; Robert Siliciano, M.D., Ph.D., Professor of Medicine and Principal Investigator, Howard Hughes Medical Institute, Johns Hopkins University School of Medicine; Stephen Strittmatter, M.D., Ph.D., Professor of Neurology and Neurobiology, Yale University of Medicine.

Summary: This overview hearing with the NIH Director was held to address the overarching issues affecting NIH, with the promise that this was the first of six hearings on NIH and that the subcommittee looked forward to hearing from every Institute and Center (IC) Director. The major issues addressed were the inadequacy of the FY2008 President's budget, the fact that although the Joint Resolution provided funding to launch the National Children's Study, in the FY08 budget the NCS would be ceased. Senator Harkin said, "I think I can say we will not allow those cuts to take place." He then turned to the topic of stem cells and whether the current policy is restricting science and delaying cures. Dr. Zerhouni responded that embryonic stem cell research should be expanded beyond current restrictions.

There was then a request by Senator Specter for NIH to focus on the issue of cost savings resulting from research; what would it take to cure the many strains of cancer; what would be the impact on NIH if the budget is cut by more than $500 million with an inflationary factor of 2 percent; and what research would be done by way of prevention (what savings would there be if many diseases were prevented). Senator Specter reiterated the need for something concrete to show the importance of health and how much NIH means to promoting health, and how much it means in reducing costs by preventing disease.

Senator Harkin asked what NIH could accomplish with an increase of $1.9 billion; what NIH hopes to accomplish with the Common Fund, examples of the kinds of initiatives that would be funded through the Fund and whether initiatives for particular diseases would be included; and what is the scientific value of public access and why it needs to be mandatory.

On public access, Dr. Zerhouni responded that NIH has tried a voluntary policy with very low rates of deposition of articles from NIH supported research; the publications that are being submitted represent less than 10 to 15 percent of the universe. He said further that he believes that we need to make this deposition of articles a condition of receiving NIH funds and said that "we need you to express the wish of Congress to do that."

Dr. Zerhouni thanked Senators Harkin and Specter for their efforts to provide NIH with an increase in FY2007, and discussed how our country's ability to compete globally will be based on our mastery of the biological world. He said that no country will excel without advances in the life sciences. He also explained how advances in research can make a difference in confronting the challenges of rising U.S. health expenditures, and predicted that advances in science will allow us to preempt diseases before they reach the critical stage. Dr. Zerhouni concluded by explaining that it is vitally important for our political leaders and research advocates to communicate the strategic importance of NIH, especially when the rest of the world is investing heavily in the life sciences.

Panel 2 was comprised of working scientists who gave a common message about the impact of flat budgets on the research enterprise. They participated in the creation of a document, released at a press conference at the conclusion of the hearing, entitled "Within our Grasp or Slipping Away-Assuring a New Era of Scientific and Medical Progress." Dr. Iverson spoke about the many researchers like himself, poised to make a difference with all the tools now in place, but limited by a flat budget. He said flat funding, as we have now, has the effect of making grant funding decisions overly conservative, stifling innovation and encouraging support for worthy, older ideas. Current graduate students are being dissuaded from an academic research career by the difficulty young faculty are having in receiving funding now. Fewer research grants means fewer opportunities for undergraduate researchers and consequently, undergraduate students. Dr. Brugge spoke about the promise of research and described particular opportunities in cancer research.

Dr. Siliciano spoke about the transformation in health care, a the direct result of the nation's investment in health science, and the vital importance of funding basic research. He spoke of his collaborative work with Dr. Anthony Fauci in HIV, in particular how HIV hides in the body and escapes from the drugs that are being used to combat the infection. He echoed earlier testimony about having difficulty taking on new students and beginning new projects, and said that investigators are leaving research altogether and fewer scientists want to tackle high risk problems because they know this kind of research will be difficult to fund. He pointed to the dramatic increase in time spent applying for grants.

Dr. Strittmatter also spoke to the impact of the recently flat NIH budget in stifling creative high-risk research. As a neurologist, he spoke about his research and that of others supported by NIH during the doubling, which today would not likely be funded. As he put it, when researchers and peer review panels are faced with junior investigators not being funded at all or senior investigators losing funding, the shift is towards safe science. Scientists pursue those experiments that have the highest probability of success in the short term, which produces only incremental gains.

NIH Hearing Summary (provided by NIH/OLPA)

Fiscal 2008 Budget for Mind, Brain and Behavioral Research at NIH
Senate Appropriations Subcommittee on Labor, HHS, and Education

March 26, 2007

Members: The hearing was attended by Senators Tom Harkin (D-IA), Chairman, and Arlen Specter (R-PA), Ranking Member.

Witnesses: Drs. Story Landis, Director, NINDS; Tom Insel, Director, NIMH; Nora Volkow, Director, NIDA; T. K. Li, Director, NIAAA; and James Battey, Director, NIDCD.

Summary: This hearing represented the first time in over a decade that this Subcommittee has heard testimony from individual institutes of the NIH. This is the first of 5 hearings expected over the next months where all of the NIH ICs will have the opportunity to sit before this Subcommittee. The witnesses for this hearing were unaccompanied by a Departmental representative and, in a departure from the previous years under the Chairmanship of Senators Specter and Harkin (briefly), the panel did not present all the testimony before the questioning, but rather spoke one at a time. The Chairman indicted that he wanted to have a more conversational interchange by hearing from each witness and then asking questions before moving on to the next witness.

Senator Specter had an opening statement similar to the one he offered at the NIH Overview hearing; he added that he and Senator Harkin had succeeded in attaching an amendment to the Senate Budget Resolution for $2.2 billion. He reiterated his need for quantification of the "best estimates you can make as to what this research means in terms of saving lives...how long it will take to find a cure for a given malady and how much it will save." In addition, he said, "And I know that Senator Harkin will endorse me in this. We will provide the kinds of resources you need to the maximum extent of our capabilities, which is now more limited than it used to be." Senator Harkin echoed this at the close of the hearing, noting that he hoped to have the finances and the budget and the money to encourage younger scientists to know that this is something that they to which they can dedicate their, but cautioned, "It's going to be very tough. It's going to be very tough."

True to his word, Senator Harkin asked his questions based on topics included in the statements of the witnesses. There were questions on the state of the science in areas of personal interest to the Senator such as the regeneration of hair cells to restore hearing; whether post-traumatic stress disorder is more prevalent now than it was in previous wars; where is the U.S. relative to other countries with controlling drug abuse; and what are we learning about the reasons for binge drinking among college students. He asked about new science such as ethogenetics, the discovery of the genes involved in spinal muscular atrophy, and who is supporting the neuroscience blueprint and what have we learned so far.

Senator Specter, who had to leave before he could ask all of the questions he wanted, did ask a few. He asked whether there is any answer from NIDA research to deal with drug addiction that is within the financial reach of what society is prepared to spend on corrections facilities. He also asked about brain injuries incurred by soldiers and what should be the government response, so that these young men and women and their families do not have to bear the cost burden for a war not of their choosing or their making.

QUESTIONS

HARKIN

• (To Insel) So, you are saying that the mental health care piece of all health care costs (which represent 16 percent of the GDP) is about 6.2 percent of the overall health care costs?
• Are we putting too much into drugs development, or should we be looking at some of the underlying causes?
• With regard to eating disorders, are you looking into eating disorders and the underlying mental health problems that either lead to it or exacerbate it?
• What is ethogenetics? Have you done much about that area in the past?
• (To Volkow) If studies of childhood exposure to "stressors" has shown that they are 10 times more likely to become addicted than those that are not, what are some of these stressors? So, a factor of 10 is pretty important, and drug abuse leads a lot of times to mental illness?
• Have you looked at addiction in the United States versus other countries? How about state by state? What's it look like? When we look at addiction in this country, what does it look like compared to other countries?
• You talked about drug abuse being a chronic disease. How do we know it's related to disease?
• (To Li) You mentioned advances in knowledge of molecular medicine; we are developing better and better medications to treat alcohol dependence once it has developed. What medicines?
• Doctor, every institute out there needs to do outreach to the communities around the country. How well are you doing in reaching out to states and local communities to put into practice some of your findings? I'd like to know more about how that's done.
• Young people getting involved in drinking -- I wonder about messages that they receive about drinking -- all the advertising about the glamorizing of drinking alcohol. I just wonder about the impact of these messages and how they're reinforcing young people that it's all right to drink. Are you doing any research in this? Any results?
• What kind of research are you doing on binge drinking, especially among college students? Are you doing research on why they drink to intoxication? What's motivating young people to do this?
• (To Dr. Battey) Let's get into the whole thing of regeneration of hair cells. When I first chaired this committee in 1989, I engaged in questions with the then director about this. Now that's at least 17 years ago, and almost what I hear you saying is what I heard 17 years ago. Are you regenerating hair cells in mammals? How long have you been doing this? Is there more than one locus of this research going on right now? When do you think they'll be ready to go to higher mammals? Where is this research being funded? I'm just wondering how soon they might be ready to take it to a higher order of mammals. And this is a genetic intervention?
• I don't know much about how much regeneration they've had. Has it been a percentage? Is it like 10 percent of the hair cells are restored? Is it 20? Is it 30? Do you have any idea? Why are there differences from guinea pig to guinea pig?
• (To Landis) Are you saying that diabetes is a leading indicator for having a stroke?
• About the debilitating effects of migraine headaches, how prevalent migraine headaches are; I don't know whether I'm just hearing more about it now and finding more people, or is it increasing?
• One disease that you know that I've been interested in is spinal muscular atrophy. Haven't you identified the gene? Tell me about the progress on spinal muscular atrophy, because I keep hearing that this has some lynchpin or some connectivity to other types of diseases.
• You mentioned that deaths have declined due to stroke, but I just wonder about the incidence of stroke. I don't think the incidence of stroke has. I think stroke remains still one of the feared things that can happen to someone, because they're just so unexpected and can happen to anyone at any time. And, it's that early intervention, and if you can get to it right away, that helps, you know, if you get that TPA.
• I'm also interested in Parkinson's disease. In your testimony, you talked about deep brain stimulation for Parkinson's. How much progress is being made in this area? What about a therapy in Greece where scientists had developed something like a helmet they put over a patient's head, but it didn't penetrate the skull (Transcranial magnetic stimulation).
• (To Insel) I've been told that one out of every three Iraqi veterans seeks mental health help sometime during the first year. Whether that's one out of three or one out of four, it's very high. And, that's just those who actively seek it. What about those that don't? How many more are out there that are trying to tough it out? Any thoughts on why it's so prevalent? Why these returning vets are having really mental health problems? Talk to me a little bit more about post-traumatic stress disorder. What is it? Is it more prevalent now than in the past? Is this more prevalent than any war in the past? Your institute is actually actively doing research in post-traumatic stress disorder?
• Your institute's budget for next year is $1.4 billion. What would be the largest sector where that money would go for research? What department or sector?
• Dr. Insel, would you be the proper person that I would ask this question? I'm going to ask about the effect that stress plays in diseases. So are you looking at stress? Is this part of your $1.4 billion, looking at stress and how stress levels affect a person's ability to ward off diseases and illnesses or become more susceptible because they have a higher level of stress? Is that you or is that somebody else? But somewhere in this $1.4 billion you do have research on stress that's ongoing?
• (To Volkow) You were talking about the environmental factors for drug abuse, but you said that 50 percent of the factors are genetic for addiction. I mean, you really hold that's 50 percent?
• Talk to me about what you've done in terms of looking at the role that stress plays in addiction to drugs to relieve stress.
• (To Landis) All the institutes today have been involved in a collaborative effort called the NIH blueprint for neuroscience research. Dr. Landis, what is this effort? What's been achieved? What are you doing and what are the plans for next year and how do you all participate? Who else is involved?

SPECTER