The United States Congress maintains a closeand generally favorablerelationship with the National Institutes of Health. Members of Congress routinely make non-bindingbut never ignoredrecommendations to the NIH that are attached to the annual appropriations bills, and they also communicate support for programs or grants that would benefit their states or address public health concerns of particular interest to them. Dozens of bills that directly affect NIH operations are introduced in each session of Congress.
Because of this, perhaps no one should have been surprised last July when Rep. Pat Toomey (R-Pa.), during appropriations negotiations in the House of Representatives, offered an amendment (which, unlike some recommendations, is legally binding) to remove funding from five NIH-supported projects that had already passed the NIH peer review and selection processes and were under way at various institutions. But many onlookers were indeed surprised when the amendment was defeated by only two votes. Surprise gave way to concern in October when the House Energy and Commerce Committee, which oversees NIH, asked NIH to justify the funding of an additional list of about 200 grants. As this issue of the Journal went to press, the NIH had not yet provided a response to the inquiry. But the whole affair has left many observers dismayed about the direction this Congress has taken in determining the value of scientific research.
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The projects that Toomey found objectionable addressed various aspects of sexual behavior and its relationship to HIV/AIDS, mental health, and drug abuse. An additional grant, added by Rep. Chris Chocola (R-Ind.), supported a study of interactions between human populations and the environment in China. (See box, p. 170.)
"Who thinks this stuff up? And worse, who decides to actually fund these sorts of things?" Toomey asked during debate on the amendment. He questioned the value of these grants in protecting the publics health and pointed to competing priorities as motivation for his position: "I simply want to make the point that there are so many far more important, very real diseases that are affecting real people, and that is what this kind of money could be used for," he said. Chocola agreed: "The people in my district have juvenile diabetes, they have cancer, they have AIDS, they have horrible diseases like Crohns, and that is what we should be spending NIH money on. We should be eradicating these horrible diseases that ruin families, ruin individual lives, rather than [on] grants that really benefit no one that we can identify."
Members opposing the amendment were unified in their regard for NIHs peer review process and their wariness of political interference in the grant selection process. Rep. Ralph Regula (R-Ohio) urged his colleagues to "resist the temptation" to judge the grants based on incomplete knowledge of what they entailed. "It would set a dangerous precedent and put a chill on medical research if we start to micromanage individual NIH grants," he said. Rep. David Obey (D-Wis.) strongly agreed: "The day we politicize NIH researchthe day we decide which grants are going to be approved on the basis of a 10-minute horseback debate in the House of Representatives with 434 of the 435 members in this place who do not even know what the grant isthat is the day we will ruin science research in this country."
Toomey was applauded by the Council for Citizens Against Government Waste, the lobbying arm of a nonprofit organization that monitors government spending, which maintained that, if the projects are important, then they should be paid for privately rather than by the government. Other organizations, however, were concerned about the implications of the amendment. Robert D. Wells, Ph.D., president of the Federation of American Societies for Experimental Biology (FASEB), said via e-mail that "any short term compromise of the peer review process, through Congressional micromanagement of the grant-making process, is a grave threat to biomedical research, the quality of U.S. science, and the health of our fellow citizens."
Reauthorization Hearing
Although the Toomey amendment was narrowly defeated, the issue was revisited during the October 2 joint hearing of the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor, and Pensionsboth committees considering the reauthorization of NIH.
Rep. Joseph Pitts (R-Pa.) was particularly concerned about the suitability of federal support for one study in which, he related, participants were paid to drink alcohol and watch pornography. "What mechanism do you have in place so that even if the peer review process finds these proposals credible, we have some standard of science or common sense oversight before we write a check out from the taxpayers?" he asked of NIH Director Elias Zerhouni, M.D.
Zerhouni responded, "I can definitely understand how one would be concerned if the research is presented that way and not looked [at in] the total context." He declined to comment specifically on the project, but said he had been assured by directors of the awarding institutes that this study and the others listed in the Toomey amendment were scientifically sound and relevant. He voiced his confidence in the integrity of the method by which NIH selects grants for funding and noted the inclusion of public representatives on NIH advisory boards that review and approve grants prior to funding.
Political ideology factors heavily into the discussion, but members of Congress differ on its role in oversight authority. Rep. Henry Waxman (D-Calif.) told Zerhouni, "I dont want your decisions on research to be based on somebody elses view of political correctness." In an e-mail interview, he explained his view of the line between oversight and interference. "Congress is responsible for setting broad boundaries for research. These include assuring basic human subject protections, supporting a system of assigning grants based on the merit of the research. This responsibility does not extend into meddling inside the system that is established by these rules," Waxman said. "In order for our nations scientific institutions to continue to thrive, scientists must have the freedom to pursue their research without worrying about crossing artificial political boundaries or flunking political litmus tests."
In contrast, Rep. John Shimkus (R-Ill.) said during the hearing that, although he had misgivings about congressional involvement in NIHs decision-making at that level, he voted for the amendment. "In this case I had to let ideology or politicsI had to let that intervene. I had to make a statement." Although he ultimately voted against the amendment, Rep. Michael Rogers (R-Mich.) cautioned that "some would argue this is politics from the right and some would argue that its already seeped in from the left."
Rep. Stephanie Tubbs Jones (D-Ohio) also voted against the amendment, but voiced her desire that NIH be responsive to the guidance of the nations elected representatives. "All politics aint so bad," she said, pointing to the achievements of political activism in elevating the cause of research on health issues affecting minorities. "I dont want you to be swayed by the issues of political life, but also I dont want you to be immune to the importance of the body politic saying to you this is an issue that is important."
The "Hit List"
Following the hearing, the NIH asked for and received from the Energy and Commerce Committee a list of all the grants for which supporting information was sought. Unexpectedly, the list contained about 200 grants, nearly all related in varying degrees to sexual behavior. Two of the grants were funded by the National Cancer Institute. Subsequently, it was widely reported in the press that the longer list had originated from a religious conservative political action group called the Traditional Values Coalition (TVC) and was transmitted to the NIH in error, but the committee never sent a replacement, and the NIH plans to respond about all of the grants.
Waxman, who has been outspoken in his criticism of Bush administration treatment of science and scientists, called it a "hit list." He wrote to the Department of Health and Human Services (HHS) conveying his strong suspicion, based on the inclusion in the list of information that is not generally publicly available, that the list was compiled with help from someone inside the department. HHS has denied this allegation, as does TVC Executive Director Andrea Lafferty, but Waxman reiterated his request for information about any contact between HHS employees and the TVC.
The TVC, for its part, characterizes NIH as a "federal agency which obviously requires more adult supervisiona bureaucracy run amok," and a "federal ATM for grant traffickers." Its Web site urges people to contact their Congressional representatives to complain.
Many scientific organizations, including the American Association for the Advancement of Science, the American Association of Medical Colleges, and FASEB, have spoken out to denounce TVCs efforts and support the NIH peer review system. Jeffrey M. Drazen, M.D., editor in chief of the New England Journal of Medicine wrote an editorial comprehensively defending NIHs grant selection process. "The gem of worldwide biomedical research should not be rubbed in political dirt," he wrote.
Some in the Congress are looking to the NIH for help in explaining the value of the targeted studies and fighting disillusionment among their constituents. "The Toomey amendment ... highlighted some grants that raised questions for many of my constituents who are always struggling to get more overall research money for the NIH," said Shimkus via e-mail. "My vote for the Toomey amendment reflected my support of their concerns as well as my hope that the NIH would give a better explanation as to why these grants deserved funding at a time when resources are so scarce."
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