From the Hill – Winter 2004
NIH facing new pressures; proposed roadmap in doubt
The House and Senate committees charged with overseeing the National Institutes of Health (NIH) held a joint hearing in October that highlighted both the management challenges facing the research agency and the political challenges facing members of Congress as they seek to address those issues.
The Senate Health, Education, Labor and Pensions Committee and House Energy and Commerce Committee scheduled the hearing two days after NIH Director Elias Zerhouni unveiled a new roadmap for biomedical research designed to maximize opportunities and bridge gaps unlikely to be addressed under NIH’s current decentralized structure. The plan proposed a series of new initiatives to encourage cross-disciplinary research involving multiple institutes, some of which the agency has already begun to implement. At the hearing, Zerhouni made it clear that some elements of the plan call for strengthening the office of the director by providing greater authority over the agency’s budget and a more centralized planning mechanism.
The hearing was held amid increasing calls for Congress to step up its oversight of the agency after doubling its budget to about $28 billion during the past six years. In addition to providing Zerhouni an opportunity to present his proposals, the hearing served as a warning that his planned roadmap could encounter some rugged terrain on Capitol Hill. Committee members are contemplating the first reauthorization of NIH since 1993, and a plethora of obstacles could get in the way, from partisan politics to contentious ethical issues, to the complex web of patient groups and research institutions with a stake in the outcome.
One such issue, which has recently garnered much attention, is an attempt by conservatives in the House to prevent NIH from funding certain studies that involve behavioral research relevant to drug abuse and HIV/AIDS transmission. Rep. Patrick Toomey (R-Penn.) proposed an amendment to the Labor-Health and Human Services appropriations bill in July that would have blocked funding for four such studies that had already been approved through NIH’s peer review process. The amendment failed by a vote of 212 to 210. Three of its backers raised the issue with Zerhouni at the hearing.
Further controversy ensued when an Energy and Commerce staff member provided NIH with a list of more than 200 grants that had been deemed questionable by the Traditional Values Coalition, a conservative advocacy group. NIH began contacting recipients of these grants, apparently to request information to help defend the research. But this prompted an outcry from scientific organizations, which expressed concern that such an action would undermine the peer review process and could deter researchers from pursuing projects similar to those targeted.
Rep. Mike Rogers (R-Mich.), who opposed the Toomey amendment, said at the hearing that his former career as an FBI agent had convinced him of the usefulness of research on sexual behavior, but he nevertheless cited a need for NIH to be more transparent.
Among the other contentious issues raised at the hearing were stem cell research, an outsourcing initiative that has rankled NIH staff, and allegations by Rep. Henry Waxman (D-Calif.) that the Bush administration has allowed ideology to interfere inappropriately with scientific panels at NIH.
Many members raised additional issues that are less explosive but nonetheless illustrate the complicated task facing lawmakers who will need to balance a wide array of parochial interests and overarching policy concerns as they craft a bill For example, Sen. Hillary Rodham Clinton (D-N.Y.) urged NIH to undertake comparative effectiveness studies of existing drugs; Rep. Stephanie Tubbs Jones (D-Ohio) focused on the need to address health disparities affecting minorities; and Sen. Edward M. Kennedy (D-Mass.) attacked the fiscal 2004 appropriations bill that awards NIH a much smaller increase than in past years.
Although Zerhouni was flanked at the hearing by two prominent scientists who support the roadmap–former NIH Director Harold Varmus, who now heads the Memorial Sloan-Kettering Cancer Center, and Harold Shapiro, who chaired an Institute of Medicine study of NIH’s organizational structure that was released in the summer of 2003–the plan may prove a nonstarter. The 27 individual institutes that comprise NIH face pressure from constituent groups to focus resources on their specific area of concern. This makes it difficult for institute directors to support the centralized research efforts proposed by the roadmap, which is what motivated Zerhouni to ask Congress for greater authority. Members of Congress, however, face pressure from these same groups, many of which argue that the current decentralized structure is working well. It remains to be seen whether Congress will go along with Zerhouni and pave the way for his proposed reforms.
For more information on the NIH roadmap, see www.nihroadmap.nih.gov.
Coordination of federal counterterrorism R&D examined
On September 30, the National Security Subcommittee of the House Government Reform Committee heard testimony from federal agencies and industry leaders regarding a little-known part of the government called the Technical Support Working Group (TSWG). The hearing focused on the history and practices of this interagency group, which invests in prototype technologies for the intelligence community and first responders in order to prevent terrorist attacks and minimize damage to citizens and infrastructure. The event also offered an opportunity to hear how the new kid on the block, the Department of Homeland Security (DHS), fits into the 20-year-old working group.
In his opening remarks, subcommittee chairman Christopher Shays (R-Conn.) noted that in the past, Congress has found a lack of coordination in federal counterterrorism R&D. Even testimony as recent as March 2000 described duplication of effort in the field of bioterrorism by DOD, DOE, and Department of Justice. Shays lamented, “Now, to that already crowded field, add the Department of Homeland Security, which Congress charged to act as both a developer and clearinghouse for innovative technologies.”
TSWG was created in 1986 as per a recommendation by a cabinet-level Task Force on Counterterrorism led by then-Vice President George H. W. Bush. In his testimony before the subcommittee, Michael Jakub, director of technical programs in the Office of the Coordinator for Counterterrorism at the State Department, noted that the Task Force found that U.S. counterterrorism activities were “uncoordinated and unfocused.” Thus, TSWG was established within an existing program chaired by the State Department called the Interdepartmental Group on Terrorism. The pre-TSWG Interdepartmental Group was created by National Security Decision Directive 30 in 1982 and given responsibility for developing overall U.S. policy on counterterrorism.
The goal of the 1986 Task Force was to create a mechanism for coordinating a national R&D program across relevant agencies that would reduce duplication of effort and easily identify gaps in research that needed to be tackled by the federal government. Although R&D funding continues to be primarily sponsored by DOD, TSWG has grown over the years to include active participation in more than 80 federal programs in 11 cabinet-level departments and 8 independent agencies. The State Department continues to chair the TSWG Executive Committee and provides policy oversight, whereas DOD executes and administers the program.
The R&D portfolio of TSWG is relatively small, $180 million in fiscal year 2003 spread among nine program elements: Chemical, Biological, Radiological and Nuclear Countermeasures; Explosives Detection; Improvised Device Defeat; Infrastructure Protection; Investigative Support and Forensics; Personnel Protection; Physical Security; Surveillance, Collection and Operations Support; and Tactical Operations Support. The majority of federal funds go to Chem-Bio Countermeasures (23 percent), Physical Security (16 percent), and Personnel Protection (13 percent).
DHS, recently invited to participate in TSWG, was given $75 million in its fiscal year 2004 appropriations to support research into prototypes of equipment that could be rapidly developed within the Homeland Security Advanced Research Projects Agency (HSARPA). This is a substantial increase from the $30 million initially requested by the administration, reflecting the serious interest that Congress has in this activity. According to David Bolka, the new HSARPA director, the agency expects to use the TSWG process “for the near term.” “As HSARPA matures and the Systems Engineering and Development branch of the S&T Directorate stands up, we will assume the majority of rapid prototyping responsibility and will coordinate it internally,” he added.
It is Bolka’s last statement that worries members of Congress. Shays compared the current TSWG structure to a chair with legs of different sizes. “I thought DHS would be the only agency evaluating proposals,” he said. “Why not just keep TSWG in the Department of Homeland Security?”
Edward McCallum, director of DOD’s Combating Terrorism Technology Support Office, explained that homeland security technology needs cut across many sectors and that the tools that derive from TSWG can benefit this diverse constituency. He cited as an example a robot for retrieving and/or detonating bombs that is used by the Pentagon, the FBI, and local bomb squads. He also emphasized that the current investment of $180 million does not preclude each department or agency from pursuing separate counterterrorism R&D programs.
Rep. John F. Tierney (D-Mass.) stated that first responders in his district are at a loss about where to go for the latest technology. And a clearly frustrated Shays asked, “How do you know proposals are vetted and weighed appropriately?”
McCallum attempted to reassure Shays that TSWG would continue to use its well-established three-step process for evaluating technologies, from concept phase to preparation of a full proposal. The idea is to quickly review and winnow down the large number of ideas that are submitted for developing counterterrorism technologies. According to McCallum, only 0.5 to 1 percent of ideas that are initially submitted by companies at the concept level move to the second stage of the review process. He further noted that “the success rate of proposals submitted [after the first two steps] is quite high: perhaps nine out of ten.”
The majority of industry representatives at the hearing generally viewed the TSWG model in a positive light. According to Bruce deGrazia, chairman of the Homeland Security Industries Association, the TSWG process “produces significant time and cost savings” to companies that submit ideas. However, he stated that only 15 percent of their 400 industry members are even familiar with TSWG, and he recommended that the TSWG Web site be directly linked to the DHS Web site and that DHS organize a series of educational seminars.
For more information on the Technical Support Working Group, go to www.tswg.gov.
Bill promotes use of cord blood stem cells in treating disease
A bipartisan quintet of senators has proposed a bill that would promote the use of stem cells derived from cord blood, or blood collected from the umbilical cord and placenta after childbirth, in treating disease.
At an October 17 press conference, Sens. Orrin Hatch (R-Utah), Chris Dodd (D-Conn.), Sam Brownback (R-Kan.), Arlen Specter (R-Penn.), and Dianne Feinstein (D-Calif.), who hold different views on controversial embryonic stem cell research, hailed what they called “a new commitment to developing a national infrastructure of cord blood stem cell collection and research that could, in time, save the lives of thousands of gravely ill Americans.”
The Cord Blood Stem Cell Act of 2003 (S. 1717) would authorize the Health Resources and Services Administration, an arm of the Department of Health and Human Services responsible for improving access to health care, to establish and maintain a National Cord Blood Stem Cell Bank Network through contracts with existing or new cord blood banks that are certified at the federal and state level. The bill would set as a goal the collection of at least 150,000 units of human cord blood stem cells that are as genetically diverse as possible.
Cord blood contains hematopoietic stem cells that are able to differentiate into a number of specialized types of cells such as bone marrow. Since the early 1990s, a number of physicians have conducted cord blood transplants on children suffering from diseases such as leukemia and sickle cell anemia. In addition, a number of private cord blood banks have been established to meet demand from parents interested in preserving the cord blood of newborn babies as insurance in case of disease.
One problem is that little empirical evidence exists to show that stem cells extracted from a donor’s cord blood can be used to help the donor. The majority of the successful transplants have involved cord blood from siblings. The American Academy of Pediatrics (AAP) said in a statement that there is “no evidence of the safety or effectiveness of autologous (self) cord blood transplantation for the treatment of malignant [tumors].” Based on existing research on five diseases, AAP determined that conventional therapy or transplantation from a related donor is more effective than autologous cord blood transplantation. The statement, however, encourages the “philanthropic donation of cord blood for banking at no cost for allogeneic (related or unrelated) transplantation” and research.
S. 1717, which has been dubbed the Hatch/Brownback bill, would be a big step toward expanding public access to therapeutic applications developed by cord blood banks that conduct research. For example, the act would require that up to 10 percent of cord blood collected be available for peer-reviewed research. Furthermore, it would establish a registry system for identifying the blood units in order that health care professionals may easily search for suitable donor matches. Encouraging a genetically diverse collection of samples would improve the odds for positive donor/patient matches. Finally, a board of directors composed of physicians, research scientists, patients, and industry representatives would be created to oversee the network. The bill would provide $15 million in fiscal 2004 to support its establishment and operation.
Rep. Christopher Smith (R-N.J.) introduced a companion bill (H.R. 2852) in the House in July.
President signs $3.7 billion nanotechnology research bill
President Bush on December 3 signed a bill that would authorize the spending of almost $3.7 billion on nanotechnology R&D in five agencies over four years. The 21st Century Nanotechnology Research and Development Act passed the House and Senate during the week of November 17th.
The new spending will be shared by the National Science Foundation (NSF), Department of Energy (DOE), National Aeronautics and Space Administration, National Institute of Standards and Technology, and the Environmental Protection Agency. NSF and DOE will be the primary R&D sponsors, with spending of $1.73 billion and $1.46 billion, respectively. Funding is not scheduled to begin until fiscal year 2005. Management of the program will be coordinated through the National Science and Technology Council, with technical and administrative support from staff within a newly created National Nanotechnology Coordination Office.
A point of contention between the House and Senate was the composition of an external advisory committee to provide additional oversight and assessment of the progress of the research programs. The bill calls for the president to establish or designate a National Nanotechnology Advisory Panel, but follows the House intent of providing the administration with greater flexibility in its composition. The provision, however, strongly emphasizes that panel members should come primarily from academia and that the president should consider recommendations from the scientific community and state and local governments.
The legislation also resolves differences between House and Senate committees over the management of research into the ethical and societal implications of nanotechnology. The bill allows the creation of an American Nanotechnology Preparedness Center responsible for the “conduct and dissemination of studies on the societal, ethical, environmental, educational, legal, and workforce implications of nanotechnology.” Sen. Ron Wyden (D-Ore.) had pushed for the separate center, whereas House Science Committee Chairman Sherwood Boehlert (R-N.Y.) would have kept such responsibilities as an element of the R&D programs within each of the participating agencies.
The final bill, however, fails to allocate any funds for the new center, which will be established through a merit-based competitive process. Wyden’s original bill authorized $5 million a year, which members of Congress believed was arbitrary.
In a press release issued shortly after House passage, Boehlert said that, “The United States is the leader in nanotechnology and must remain so as this new field starts remaking the marketplace. The nanotechnology program will be a model of government, university, industry cooperation, and of coordination, interdisciplinary research and public involvement.”
More information is available on the Web site of the National Nanotechnology Initiative (www.nano.gov).
House renews effort to protect commercial databases
After a number of false starts during the past few years, the House is making another attempt to enact legislation that would clarify the legal rights of commercial database owners in the age of the Internet. But even the new bill, which is an attempt at a compromise, is proving to be controversial.
On October 8, Rep. Howard Coble (R-N.C.) introduced the Database and Collections of Information Misappropriation Act (H.R. 3261), which would make illegal the unauthorized use of a database or, as the proposed text defines it, “a collection of a large number of discrete items of information.” The bill has five cosponsors, including House Judiciary Committee Chairman F. James Sensenbrenner Jr. (R-Wisc.) and House Energy and Commerce Committee Chairman W. J. “Billy” Tauzin (R-La.).
Proponents say the bill is needed to protect the significant investments of time and money involved in creating databases, as well as to spur economic growth by promoting the creation of new databases. Their concerns derive from the ease with which electronic materials can be pirated from a commercial database and made commercially available.
Opponents, however, argue that the electronic format of these works is already protected under other laws, such as the Computer Fraud and Abuse Act, and that enactment of the bill might endanger public service activities such as price comparison Web sites or lists of political candidates’ voting records.
Past versions of database legislation sought to clarify the amount of information from a particular database that could be legally used outside of the database and what remedies would be available if that amount was surpassed. The new bill attempts a “clarification” of technological terms but is in the eyes of many opponents potentially damaging. For example, the bill describes that the amount of data that can be legally used as “quantitatively substantial,” a term that is not defined within the act and thus subject to a wide range of interpretations.
Many in the research community rely on databases to share scientific information and have long supported the “fair use” principle that allows factual information to be publicly available. For example, research projects on climate change and the human genome have used publicly accessible databases to facilitate large-scale collaborations by far-flung scientists. Hence, the scientific and library communities have expressed concern about any new database protection legislation.
H.R. 3261 includes a provision that would protect nonprofit educational, scientific, or research institutions from litigation should they make available certain portions of a database. However, these exemptions require that a court first hear a claim against a party to determine if the sharing is “reasonable under the circumstances, taking into consideration the customary practices associated with such uses of such database[s] by nonprofit educational, scientific or research institutions and other factors that the court determines relevant.”
Opponents express concern that such ambiguous language could be used to create delays as courts determine whether research projects fall under the exemption. Similarly, they argue that the legislation fails to clarify the fate of government databases that are owned or cocreated with other entities such as universities, and that these works may fall under the government exemption but may ultimately be open to recapture under other sections of the act.
Database protection legislation was first introduced in the 104th Congress, and proposals have been floated in each Congress since. In the 107th, no bills were formally introduced, but much action took place behind the scenes, leading to the current effort. At an October 16 markup, the House Judiciary Committee’s Subcommittee on Courts, the Internet and Intellectual Property approved the bill by a 10 to 4 vote.
Senate passes bill barring genetic discrimination
By a vote of 95 to 0, the Senate on October 14 voted to prohibit employment and health insurance discrimination based on genetic information. The Genetic Information Nondiscrimination Act (S. 1053) would prevent health insurance providers and employers from using an individual’s genetic predisposition to a disease as a basis for denying access to health coverage or a job.
Although the completion of the human genome sequence has raised hopes of a medical revolution, the bill’s supporters said that to take full advantage of this achievement, the public must be assured that genetic information will be used to improve health and not to discriminate unfairly. They argued that many individuals considering genetic tests have decided against it because of discrimination fears.
“Genetic screening is a powerful tool and can impart highly sensitive and very personal information,” said Senate Majority Leader Bill Frist (R-Tenn.), a key supporter of the legislation. “The fear of genetic discrimination has the potential to prevent individuals from participating in research studies, from taking advantage of new genetic technologies, or even from discovering that they are not at high risk for genetically related illnesses.”
Advocates for the health insurance industry, which opposed the bill, said that there is little evidence that genetic discrimination is actually occurring, and that the Health Insurance Portability and Accountability Act already provides sufficient protection.
Although President Bush has announced his support for the bill, it is unclear whether the House will go along. H.R. 1910, a bill authored by Rep. Louise Slaughter (D-N.Y.) and backed by House Administration Committee Chairman Bob Ney (R-Ohio), is similar to the Senate bill but also provides a right to sue for misuse of genetic information. It has collected 228 cosponsors from both sides of the aisle.
“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.