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NEWS AND SPECIAL REPORTS |
Senior Director, Pharmacia Corporation Washington, DC, USA marguerite.d.baxter{at}pharmacia.com
HUMAN SUBJECTS PROTECTION
Federal oversight of clinical trials and human subject protections will be an integral part of the agenda of the 107th Congress and the Bush Administration. Further, within the next seven months there will be several commissioned documents analyzing the adequacy of our current human subject protections which promise to play an important role in Congressional and Administrative action on the matter.
Institute of Medicine
In December, the Institute of Medicine (IOM) began a study commissioned by the Department of Health and Human Services to assess the current system for protecting human research subjects. Two reports will be completed by September 2002 under the terms of the contract with the IOM. The first report, anticipated in April 2001, will be an analysis of accreditation standards for human research subject protection. This report will integrate much of the work already undertaken by the organization, Public Responsibility in Medicare and Research, on the issue of human research subject protection. The second report will be completed in late summer or fall of 2002, and it is expected to be a broad evaluation of oversight of human research subject protection.
General Accounting Office
The General Accounting Office (GAO) is expected to issue its findings late this spring or early summer on an investigation requested last year by Senator Bill Frist (R-TN). Senator Frist requested the study in the wake of hearings investigating the death of a patient enrolled in a gene transfer trial at the University of Pennsylvania. GAO investigators have concluded site visits of the following institutions in the preparation of their report: University of North Carolina at Chapel Hill, the University of California at Los Angeles, Yale University, Washington University at St. Louis, and the University of Washington. Included in the review of university systems for human subject protection by the GAO is an analysis of the institutional financial conflict of interest policies and the financial relationships that investigators have at the various academic institutions.
National Bioethics Advisory Commission
On December 19, 2000 the National Bioethics Advisory Commission (NBAC) issued its draft report on ethical and policy issues in the oversight of human research in the U.S. Comments on the recommendations in the report were due by February 17, 2001. The draft report proposes a new oversight system and recommends the necessary resources to implement the proposal. It also makes recommendations regarding the role and content of informed consent, the role and function of institutional review boards (IRB), and the importance of education in human research protections for those engaged in clinical research. A follow-up report related to international research is presently under deliberation by NBAC.
Food and Drug Administration
The Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) has indicated that it plans to increase inspections of phase I and II clinical trials. This action expands upon last year's survey of gene therapy trials evaluating human subject protections and protocol adherence. CBER has decided to expand its efforts beyond gene therapy to other areas of biologic clinical trials. It is expected that the inspections will cover areas such as record-keeping, adverse-event reporting and follow up, and informed consent.
Congressional Oversight
Senators Frist and Kennedy (D-MA) plan to hold hearings on the adequacy of our human research subject protections during the first session of the 107th Congress. It is widely anticipated that the hearing(s) will be held subsequent to the completion of the GAO report. Senator Frist, who chairs the Senate HELP Public Health Subcommittee, held similar hearings in the last Congress. Senator Kennedy's staff is evaluating the human subject protection recommendations made by NBAC in its December draft report.
Congressman Sherrod Brown (D-OH) forwarded a letter February 15 to the House of Representatives Chair and Ranking Members of both the Commerce and International Relations Committees requesting hearings before each Committee on "how best to prevent the exploitation of human subjects participating in clinical trials." In the letter Congressman Brown states that "When clinical trials are supported by U.S. tax dollars, sponsored by U.S. companies, or conducted in pursuit of FDA approval for a drug or biologic, the U.S. has an important stake in promoting sound research and preventing unethical treatment of human research participants." The impetus for the letter was, in part, a five article series in the Washington Post this past December entitled "The Body Hunters," which presented a variety of alleged abuses of human research subjects in clinical trials conducted overseas by U.S. investigators or corporations. No decision has been made regarding this letter of request as of this writing.
PATIENT PROTECTION ACT
Legislators introduced the Bipartisan Patient Protection Act of 2001 in the U.S. Senate and U.S. House of Representatives, on February 7 and 8, respectively. This bi-cameral effort closely resembles the "Norwood-Dingell" legislation debated in the 106th Congress and passed by the House of Representatives. In the Senate, Senators McCain (R-AZ) and Kennedy (D-MA) are the lead sponsors; in the House of Representatives Congressmen Ganske (R-IA) and Dingell (R-MI) are the lead sponsors. Of importance to oncologists, the Bipartisan Patient Protection Act expands the clinical trial provision, a component of several patient's bills of rights in the 106th Congress, to include FDA-approved trials. If enacted, health plans would be required to cover the cost of a clinical trial for all patients with a serious or life-threatening disease. Trials that would be covered by the statute include those approved by the National Institutes of Health (NIH), a cooperative group or center of the NIH, the FDA, Department of Defense, or the Veterans Administration. This legislation would extend to over 165 million Americans a benefit similar to that which is now provided to Medicare beneficiaries as a result of the Clinton Administration's Executive Order, announced last June and effective this past September.
President Bush has announced "principles" for a patient's bill of rights and indicated that he believes that the White House and the Congress will be able to work together this year to achieve a bipartisan agreement on patient protections. The major area of concern between the White House and the authors of the Bipartisan Patient Protection Act of 2000 relates to the scope of the legislation and liability issues, the same concerns which prevented enactment in the 106th Congress.
EFFORTS CONTINUE TO DOUBLE THE NIH BUDGET
Senators Arlen Specter (R-PA) and Tom Harkin (D-IA) introduced the Biomedical Revitalization Resolution of 2001 on February 13. The resolution calls for an increase in the NIH budget for Fiscal Year 2002 of $3.4 billion. If provided by the Congress, this increase would mark the fourth installment in a five-year plan to double the budget of the NIH.
On February 23, well in advance of sending his FY 2002 budget to Congress on February 28, President George W. Bush signaled that he is likely to recommend an increase of $2.8 billion for the NIH. President Bush indicated in his comments that this increase is the largest proposed for the NIH in its history.
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