From the Hill
Clinton again proposes big budget increases for NIH, NSF
President Clinton would boost total spending on federal research and development (R&D) by 3 percent to $85.3 billion in the fiscal year (FY) 2001 budget (see chart). But the budget also includes a $1 billion increase for biomedical research at the National Institutes of Health (NIH), a $675 million or 17 percent increase for the National Science Foundation (NSF) –the largest dollar increase in its history–and major interagency initiatives in information technology (IT) and nanotechnology.
The administration’s R&D budget once again makes IT a priority. It would provide $2.3 billion in IT R&D, a $605 million increase from last year and a billion dollars more than in FY 1999. The IT initiative would focus on fundamental software research, ensuring the privacy and security of data, and continued advances in high-speed computing. Funding would go to seven agencies, including NSF, the Department of Energy (DOE), the Department of Defense (DOD), the National Aeronautics and Space Administration, and the Department of Health and Human Services, which houses NIH.
Congress has indicated that it supports the administration’s emphasis on IT. On February 15, the House by voice vote approved the Networking and Information Technology Research and Development Act, which would authorize $6.9 billion for FY 2000 through FY 2004 for IT-related research in seven civilian agencies. NSF would be the lead agency and the beneficiary of a $3.34-billion allocation for basic research into high-end computing, the creation of terascale computing capabilities, and education and training grants. An alternative bill has been introduced in the Senate.
A new research priority highlighted by the White House is the interagency National Nanotechnology Initiative, designed to promote basic research in the emerging fields of nanoscience and nanoengineering. The initiative involves six agencies at a total cost of $497 million, $227 million of which is new spending. The bulk of the money would go to NSF ($217 million), DOD ($110 million), and DOE ($96 million).
Clinton bars genetic discrimination against federal employees
President Clinton has signed an executive order prohibiting federal employees from being discriminated against on the basis of genetic information and has challenged Congress to pass legislation that would provide similar protection to citizens in the private sector.
The order prohibits all executive branch departments and agencies from discriminating against new applicants or firing existing employees on the basis of genetic information. It states that the federal government cannot require an employee to submit to a genetic test, and if an employee voluntarily takes a test, the information must remain confidential. An exception to the rules is allowed when a medical condition or a potential predisposition would prevent an employee or an applicant from performing his or her job.
Although some states, including California and New York, have passed laws prohibiting insurance discrimination on the basis of genetic tests, there is currently no federal law providing protection. In 1999, Rep. Louise Slaughter (D-N.Y.) introduced a bill that would prohibit health insurance companies from denying coverage and private-sector firms from using genetic information in a discriminatory fashion. Sen. Thomas Daschle (D-S.D.) introduced a similar bill in the Senate. But there has been no movement on either of the bills. Congressional leaders have made medical confidentiality a higher priority in their legislative agenda.
R&D in the FY 2001 Budget by Agency
(budget authority in millions of dollars)
|FY 1999||FY 2000||FY 2001||Change FY 00-01|
|Total R&D (Conduct and Facilities)|
|All Other DOD R&D||31276||30322||31097||775||2.6%|
|Health and Human Services||15797||18063||18998||935||5.2%|
|Nat’l Institutes of Health||15008||17141||18133||992||5.8%|
|Nat’l Science Foundation||2702||2903||3464||561||19.3%|
|Environ. Protection Agency||670||648||679||31||4.8%|
|R&D Facilities and Equipment||2657||2453||2658||205||8.4%|
|21st Century Research Fund||37032||40038||42895||2857||7.1%|
Source: AAAS, based on OMB data for R&D for FY 2001, agency budget justifications, and information from agency budget offices.
NIH, FDA pledge more oversight after death in gene therapy experiment
In the wake of the death of a young man enrolled in a gene therapy experiment, NIH and the Food and Drug Administration (FDA), both of which have authority to oversee gene therapy experiments, have launched two initiatives designed to strengthen safeguards for clinical trials while improving communication within the scientific community.
FDA will now require sponsors of gene therapy trials to routinely submit for agency review their monitoring plans, including a summary of the experience and training of their monitors. The new Gene Therapy Clinical Trial Monitoring Plan will also support the organization of conferences for investigators to discuss monitoring practices with their peers and other professionals in the field. The second initiative is a series of NIH/ FDA-organized Gene Transfer Safety Symposia designed to allow investigators to share and analyze medical and scientific data resulting from gene transfer research.
After 18-year-old Jesse Gelsinger died while undergoing a gene therapy treatment at the University of Pennsylvania, NIH acknowledged that it had failed to track adverse events during gene therapy trials. Members of Congress have strongly criticized NIH’s lapses. In a hearing held by the Senate Health, Education, Labor, and Pensions subcommittee, Senator Bill Frist (R-Tenn.), the subcommittee chair and a heart transplant surgeon, said that there is “a need for vigilant oversight to ensure patient safety. If we expect patients to participate in moving science forward, then we must be assured that gene therapy clinical trials are safe.”
Much of the hearing focused on why researchers had failed to notify NIH of adverse events during gene therapy trials as required by federal guidelines. But there was also extensive discussion of whether scientists are providing patients with enough information to understand the potential risks of participating in a clinical trial.
The most riveting testimony came from the father of Jesse Gelsinger. Paul Gelsinger testified that he wasn’t given information regarding adverse events in prior experiments conducted by the university and in the private sector–information that would probably have influenced their final decision to participate. “Looking back, I can see that I was fairly naive to have been as trusting as I was,” he said. He expressed serious concerns about the influence of the private sector, its ability to hide behind a proprietary curtain, and a “race to be first” in the field that have all contributed to unnecessary risk to patients. Gelsinger recommended that an independent patient advocate be present at informed consent sessions to ensure that patients are protected when risks are explained.
Gene therapy typically involves an infusion of corrective genes into the body via a virus. Use of gene therapy techniques as a potential treatment for disease began in the 1980s. Both NIH and FDA have established oversight procedures for studies. FDA has oversight over all gene therapy trials, public and private, whereas NIH monitors only those experiments that receive NIH funding.
After Jesse Gelsinger’s death, NIH asked investigators involved in gene therapy treatment to report any adverse event, defined as any expected or unexpected event (not necessarily a death) that can be related to the treatment, the disease itself, or an outside factor. Subsequently, NIH received 652 reports of serious events that previously had not been reported, compared to the 39 events that had been. NIH said that 372 clinical trials are currently registered, and more than 4,000 patients have participated in gene therapy experiments.
Amy Patterson, director of NIH’s Office of Biotechnology Activities, said NIH guidelines require individual investigators to report adverse events. Frist called the lack of reporting and inadequate oversight “inexcusable.”
Although the University of Pennsylvania reported Jesse Gelsinger’s death in a timely manner, FDA, in investigating his death, discovered potential safety violations and shut down the university’s gene therapy studies.
Richardson, Congress clash over DOE reorganization
Energy Secretary Bill Richardson and Congress are clashing over his implementation plan for a new semiautonomous agency responsible for weapons-related research within DOE. Members of Congress are particularly unhappy with Richardson’s decision to appoint several DOE officials to serve concurrently at the new agency, contending that this “dual-hats” policy violates the intent of the reorganization law. Richardson disputes this claim and has criticized the law’s limitations of his ability to exercise authority over the new agency.
The new National Nuclear Security Administration (NNSA), created by Congress in 1999 to tighten security at DOE’s nuclear weapons program, officially opened for business on March 1. Richardson has asked President Clinton to nominate Gen. John A. Gordon to be director of NNSA and undersecretary for nuclear security. Gordon is currently deputy director of the Central Intelligence Agency.
According to a report by the House Armed Services Committee’s Special Oversight Panel on Department of Energy Reorganization, Richardson’s implementation plan “overemphasizes DOE control over the NNSA, undermines the semi-autonomy of the NNSA, and would violate key provisions” of the reorganization bill. It says that dual authority “is clearly in violation” of the law and that the plan “explicitly sustains current reporting relationships . . . [that have] generated redundant and confusing lines of authority in the past.”
Testimony at a March 2 hearing by representatives of the General Accounting Office (GAO) and the Congressional Research Service (CRS) bolstered these claims. According to GAO, the implementation plan “does little to address [DOE’s] dysfunctional structure, with unclear chains of command among headquarters, field offices, and contractors.” Further, it said that dual authority is “contrary to the legislative intent behind the creation of NNSA as a separate entity within DOE.” CRS said that the plan’s “apparent disregard of the statutory provisions delineating certain limitations on the secretary’s direct authority over NNSA officers and employees could arguably be characterized as contrary to the letter and intent of the legislation.”
Rep. Duncan Hunter (R-Calif.) argued that forcing the secretary to operate through the NNSA director and keeping NNSA separate from the rest of DOE was the only way to avoid a repeat of the organizational disarray that plagued the investigation of Wen Ho Lee. Lee, a former physicist at Los Alamos National Laboratory, has been indicted on various charges of security breaches. “At the same time that you’re supporting the nomination of Mr. Gordon,” Hunter asked Richardson, “you’re taking all his power away?”
Richardson denied that he was attempting to undermine NNSA’s autonomy or Gen. Gordon’s authority and defended his implementation plan as legal and appropriate. He said his proposed changes to the law were necessary if he is to be held accountable for the new agency, and he emphasized that only 18 out of 2,013 NNSA employees have dual roles, although that includes several key officials, including the security and counterintelligence chiefs. Regarding the NNSA security structure, he said, “I want to make this efficient, and as rapidly as possible.”
After working primarily on security issues for the past year, Richardson wants to shift the focus back to the scientific research taking place at DOE weapons labs. “There is no longer a culture of lax security,” he said. “That has ended.”
“From the Hill” is prepared by the Center for Science, Technology, and Congress at the American Association for the Advancement of Science (www.aaas.org/spp) in Washington, D.C., and is based on articles from the center’s bulletin Science & Technology in Congress.