Congressional Affairs (Prepared April 12, 2004)

The President's Proposed FY 2005 Budget

For the National Institutes of Health, the FY 2005 President's budget proposes $28.8 billion, an increase of $729 million, or 2.6 percent. For NIDA, the FY 2005 budget request is $1.02 billion, an increase of $28.27 million over the FY 2004 conference level of $990.79 million comparable for transfers proposed in the President's request for an increase of 2.9 percent.

Hearings of Interest

On March 30, 2004, the House Government Reform Subcommittee on Criminal Justice, Drug Policy and Human Resources (Representative Mark Souder [R-IN], Chairman) held a hearing on measuring the effectiveness of addiction treatment to consider how to make the U.S. treatment system more effective. Federal witnesses included Dr. Nora Volkow, Director, NIDA, and Charles Curie, Administrator, SAMHSA. Dr. Volkow's formal testimony is posted on the NIDA website.

Dr. Volkow told the Subcommittee that scientific advances supported by NIDA are coming at an extraordinary rate and are significantly influencing the way this Nation approaches drug abuse and addiction. She stressed that understanding addiction as a chronic relapsing disease that involves the brain, behavior, the environment in which an individual is raised, along with genetic factors, is critical since it frames how we must ultimately develop strategies to treat this disease. Addiction also is a developmental disorder and NIDA is initiating a number of activities to get pediatricians and other primary care physicians more knowledgeable about drug abuse screening and treatments. She said that research shows addiction is similar to other chronic diseases such as type II diabetes, hypertension, cardiovascular disease, and many forms of cancer with respect to its onset, course, and response to treatment. Like these other chronic diseases, drug addiction can be effectively treated and managed over its course, but this requires treatments to be readily available and adhered to. Addiction treatment has also been shown to be an effective way to prevent the spread of diseases, such as HIV/AIDS and hepatitis. Participation in treatment also presents opportunities for screening, counseling, and referral for additional services, which can all help to reduce the spread of diseases to the general population. Numerous studies have shown that addiction treatments are comparable in effectiveness to treatments for other chronic illnesses.

On April 1, 2004, the Senate Appropriations Subcommittee on Labor, HHS, and Education (Senator Arlen Specter [R-PA], Chairman) held a hearing on the Fiscal Year 2005 NIH budget. Dr. Elias Zerhouni, Director, NIH, provided the NIH Overview, accompanied by the NIH IC Directors. Dr. Volkow's formal statement is posted on the NIDA website.

On April 1, 2004, the House Government Reform Subcommittee on Criminal Justice, Drug Policy and Human Resources (Representative Mark Souder [R-IN], Chairman) held a hearing entitled, "Marijuana and Medicine: The Need for a Science-Based Approach." Dr. Nora Volkow, Director of NIDA, testified. Dr. Volkow's formal statement is posted on the NIDA website.

Key Points from the Testimony:

• While there have been reports of marijuana having medicinal properties, numerous deleterious health consequences are associated with its short and long-term use, including the possibility of becoming addicted. During the period of intoxication, marijuana disrupts short-term memory, attention, judgment, as well as other cognitive functions.
• New research is showing that marijuana can affect almost every organ in the body, from the central nervous system to the cardiovascular, endocrine, respiratory/pulmonary and immune systems. Because it is typically smoked, it has been shown to impact the respiratory system and increases the likelihood of some cancers. Animal studies show that THC can impair the immune system's ability to fight infectious disease, thus increasing the likelihood of adverse health consequences.
• Marijuana is a Schedule I drug, which means it has a high potential for abuse and there is no current accepted medical use in the United States. However, based on early studies that found marijuana to relieve the nausea and vomiting accompanying cancer chemotherapy, the main active ingredient in marijuana, THC, has led to the FDA approval of a synthetic form of oral THC for nausea associated with cancer chemotherapy. In addition, its ability to increase appetite has resulted in oral THC being approved for the treatment of AIDS wasting.
• In 1997, the NIH convened a panel of non-federal experts in fields such as cancer treatment, infectious diseases, neurology and ophthalmology to examine the research on medical uses of marijuana. In 1999, the Institute of Medicine (IOM) published an exhaustive study, "Marijuana and Medicine: Assessing the Science Base." Both efforts found that too few scientific studies have been conducted to determine marijuana's therapeutic utility, but research is justified into the use of marijuana for certain conditions or diseases including pain, neurological and movement disorders, nausea in patients who are undergoing chemotherapy for cancer, and loss of appetite and weight related to AIDS. The reports noted there is greater promise in purifying the active constituents of marijuana, such as THC, and developing alternate delivery systems, such as inhalers, rather than smoked marijuana. The reports also noted that FDA-approved medications already exist for the treatment of the majority of proposed uses of smoked marijuana.
• NIH continues to accept proposals to investigate potential therapeutic uses of marijuana. Since the Reports by IOM and NIH were written, there have been two studies supported by NIH. One looked at the effects of smoked marijuana on HIV levels and appetite and reducing weight loss associated with HIV-related wasting syndrome. Another ongoing study is looking at the effects of THC in individuals who have the HIV infection with unintended weight loss. In addition to studying food intake and body composition, this study examines mood and physical symptoms, psychomotor task performance and sleep to determine the drug effects on food intake in relation to other behaviors.
• The Center for Medicinal Cannabis Research at the University of California in San Diego, a state funded research center, is currently conducting 17 pre-clinical or clinical studies that cover topics including cannabis for spasticity/tremors in multiple sclerosis patients, sleep disorders, CD4 immunity in AIDS and neuropathic pain.
• Marijuana is not a benign drug. It is illegal and its use has significant adverse health and social consequences. While studies are showing the development of useful cannabinoid-based medicines is an important area of investigation that could prove fruitful for a variety of health conditions, the use of smoked marijuana as a medicine is problematic due to its adverse health consequences and the inherent difficulties with respect to accurate dosing and purity of the formulation. Approval of the use of any drug must show substantial evidence of effectiveness and show the product is safe under the conditions of use proposed. Safe, in this context, means that the benefits of the drug appear to outweigh its risks.

On April 29, 2004, the House Appropriations Subcommittee on Labor, HHS, Education (Representative Ralph Regula [R-OH], Chairman) scheduled a theme hearing on "Substance Abuse and Mental Health" and asked that NIAAA, NIDA, and NIMH appear together with other agencies funded by the Subcommittee, to present their FY2005 budgets. Drs. T. K. Li, Director of NIAAA, Nora Volkow, Director of NIDA, and Thomas Insel, Director of NIMH, testified. Charles G. Curie, Administrator of SAMHSA and Deborah A. Price, Director, Office of Safe and Drugfree Schools, Department of Education also testified.

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]

HR 3866, the "Anabolic Steroid Control Act of 2004," was introduced March 1, 2004 by Representative James Sensenbrenner (R-WI). HR 3866 would crack down on steroid-like drugs and performance-enhancing supplements. The bill would expand the federal classification of anabolic steroids to include any supplement that is "chemically and pharmacologically related to testosterone," including products made with any of more than 50 specific substances. It also would double the permitted fine for selling or intending to distribute an anabolic steroid within 1,000 feet of a sports facility. HR 3866 would require the secretary of Health and Human Services and the attorney general to report to Congress on the health risks associated with dietary supplements that are not explicitly covered by the bill but contain similar substances. HR 3866 was approved by the House Judiciary Committee; it was also referred to the House Energy and Commerce Committee. Related bills: S 2195.

HR 3922, the "Drug-Impaired Driving Enforcement Act of 2004," introduced by Representative Sensenbrenner (R-WI). The bill would provide assistance and guidance to states to address the growing problem of drug-impaired driving, including offering model legislation and grants to states to enforce the law. The bill calls on the U.S. Secretary of Transportation to develop a model state drug impaired driving law that would in part call for evaluation, counseling, treatment, and supervision for persons convicted; enhance training of police; fund research to develop field tests to identify drug-impaired drivers. The bill was referred to the House Committee on Transportation and Committee on Judiciary.

S 1780, the "Anabolic Steroid Control Act of 2003," is a bill to amend the Controlled Substances Act to clarify the definition of anabolic steroids and to provide for research and education activities relating to steroids and steroid precursors. It was introduced October 23, 2003, by Senator Joseph Biden (D-DE). The bill was referred to the Senate Judiciary Committee. Related measures, HR 3866 and S 2195.

S 2195, the "Anabolic Steroid Control Act of 2004," introduced by Senator Joseph Biden (D-DE) on March 11, 2004, is a companion bill to HR 3866. It closely resembles HR 3866 but would authorize $15 million in grants annually from fiscal 2005 through 2010 to bolster programs in elementary and secondary schools educating children on harmful effects of anabolic steroids. The Senate adopted a resolution (S Res 335) in April 2004 condemning the used of steroids among baseball players and calling on the major leagues to follow other professional sports and tighten their testing program.