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Capitol Report

Pharmacia Corporation Marguerite.D.Baxter{at}pharmacia.com

NATIONAL CANCER ACT OF 2002 INTRODUCED

Senators Dianne Feinstein (D-CA) and Gordon Smith (R-OR) have introduced the National Cancer Act of 2002, S. 1976. The legislation is based upon key recommendations from the National Cancer Legislation Advisory Committee (NCLAC) report, Conquering Cancer: A National Battle Plan to Eradicate Cancer in Our Lifetime. The legislation calls for attacking the problem of cancer on several fronts including, but not limited to:

• fully funding the National Cancer Institute's research budget;
  
• fully funding the Centers for Disease Control and Prevention programs that increase access to cancer screening and early detection;
  
• mandatory coverage of breast, colon, cervical, and prostate screening by private insurers;
  
• requiring third party payors to cover participation in cancer clinical trials;
  
• comprehensive tobacco control initiatives, including access to drug therapies and tobacco regulation; and
  
• use of the Orphan Drug mechanism to expedite cancer drug development.
  

MEDICAL PRIVACY RULE IS PROPOSED TO BE MODIFIED

On March 21, the Department of Health and Human Services issued a proposed rule aimed at modifying and clarifying key provisions of the Health Insurance Portability and Accountability Act (HIPPA) privacy regulation. There has been great controversy over the past year as to the impact of the HIPPA regulation with regard to its potential to impede or detrimentally impact the conduct of important research activities. The prior rule required health care organizations to obtain patient consent to use and disclose health care information for treatment, payment, and health care operations. Under the new proposal, this patient consent is no longer required, however, patient authorization is required to use and disclose information for purposes other than the aforementioned. Further, the proposal issued on March 21 would require health care organizations to ask that a patient acknowledge receipt of the health care organization's notice of privacy policy. The Bush Administration believes that these changes will address concerns previously viewed as interfering with access to care.

Organizations involved in the conduct of clinical research had sought modifications in the previous rule prior to implementation. Specifically, the proposed rule affects several initiatives including the following: research authorization requirements; post-marketing surveillance and registry activities; and waiver of authorization by an institutional review board (IRB). The new proposal eliminates the privacy regulation's attempt to distinguish between the "types" of research such as that which involves treatments versus that which is limited to chart reviews and retrospective audits. The new proposal calls for a uniform set of requirements applicable to all authorizations, including those for research purposes. In addition, the new proposal will enable the authorization to be included with other written permissions related to the same study, such as the informed consent. The March 21 proposal also broadens the regulation's transition period to enable the continued use or disclosure of data subsequent to the study so long as legal permission or IRB waiver has been obtained. In that regard, the criteria for waiver of an authorization by an IRB were streamlined in the new proposal and are now linked to a minimal risk standard with regard to the privacy of an individuals protected health information (PHI). In addition, the new proposal enables the disclosure of PHI to entities "subject to [FDA jurisdiction] with respect to an FDA-regulated product or activity for which that person has responsibility, for the purpose of activities related to the quality, safety, or effectiveness of such FDA-regulated product or activity."

SENATE HEARINGS OPEN DIALOGUE ON CONTINUED INCREASES IN THE NATIONAL INSTITUTES OF HEALTH BUDGET "POST-DOUBLING"

For fiscal year 2003, the Bush Administration has proposed a $3.7 billion increase in the budget of the National Institutes of Health (NIH) for an overall funding level of $27.3 billion. This represents a 16% increase over the 2003 funding levels for the agency. Cancer-related spending at the NIH would increase 13% to a total of $5.5 billion. This is the last installment on the Congress and Administration's commitment to double the budget of the NIH over a 5-year period.

During a recent Senate hearing on March 21, Members of the Senate Appropriations Committee expressed concern that future budget proposals would cause funding at the agency to plateau once the doubling of the NIH has been completed. Senators Harkin (D-IA) and Specter (R-PA) indicated at the hearing that the plan was not to double the NIH budget and stop providing funding increases to the agency. Instead, the doubling of the budget was intended to escalate resources to take advantage of research opportunities that existed, and then to keep pace with scientific opportunities in the future.

CLONING TAKES CENTER STAGE ONCE AGAIN

The National Academy of Science has issued a report, "The Scientific and Medical Aspects of Human Reproductive Cloning," which calls for a ban on human reproductive cloning. With that said, the report puts the Academy on record in support of somatic cell nuclear transfer to produce stem cells for clinical and research purposes.

On January 24, 2002, the Senate Appropriations Committee held a hearing on human cloning. The Committee lauded the Academy's report and urged Members of the Senate to evaluate the merits of the scientific arguments presented in the report. In fact several members of the Appropriations Committee who are strongly identified with the conduct of research using stem cells have introduced legislation, S. 1893, calling for a ban on human reproductive cloning. The legislation would ban human reproductive cloning and impose substantial criminal and civil penalties on anyone attempting human cloning.

The Senate Judiciary Committee has also held a hearing on the issue of human cloning. Senator Dianne Feinstein, a member of the Judiciary Committee, has introduced legislation, S. 1758. This bill seeks to make reproductive cloning a crime while enabling therapeutic cloning to move forward.

The House has passed HR 2505, a bill which prohibits all cloning. The Senate is expected to take up this legislative proposal shortly. Neither of the other legislation proposals are due to be considered on the Senate floor in the near future.

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