Decisions, Decisions: NIH's Disease-By-Disease Allocations Draw New Fire

'BODY-COUNT BUDGETING'? Rep. Ernest Istook (R-Okla.) is concerned that diseases that cost taxpayers the most money may not be getting a proportionate amount of NIH funds. For the third year in a row, the National Institutes of Health came under fire this month for slighting some diseases and favoring more politically correct ills when it parcels out its research-funding billions. "What this whole thing boils down to," NIH director Harold Varmus recently told a special Institute of Medicine (IOM) committee studying NIH priority-setting, "is whether you think the NIH does a good job in assigning the money it gets." Varmus and other high-level NIH officials clearly think they do quite well indeed in allocating research dollars--$13.6 billion this year, and $14.8 billion under the administration's proposed budget for next year--to fund basic science and support research into, essentially, all human ailments. But not everybody agrees. In particular, many of the patient-advocacy groups that lobby Congress for increased funding don't agree that their diseases are getting their fair share of NIH attention. The escalating battle over how NIH sets spending priorities now is flaring on two fronts--and a third front may not be far behind. On Capitol Hill, as hearings on NIH's budget for next year got serious, several members of the House Appropriations Subcommittee on Labor, Health and Human Services (HHS) and Education pressured Varmus on March 10 to increase funding for diabetes, clinical research, and other research areas. Subcommittee Chairman John Porter (R-Ill.) pledged that the panel will not "earmark" funds for specific diseases, but he accused the administration of indulging in earmarking itself with the "Cancer Initiative" that it proclaimed in January. "While it may be good politics," Porter said, "I think it is very bad policy to earmark any disease as being politically important and take away from science the right to decide where scientific opportunity and progress lie." At IOM, the study committee chaired by former Bristol-Myers Squibb research chief Leon Rosenberg on March 6 began a congressionally ordered study of how NIH sets priorities and assigns research funding to various diseases. Varmus and several NIH institute directors described the process by which they try to direct funds to areas where the "scientific opportunities" are most promising--a largely freewheeling, partly structured series of consultations among institute officials, outside scientists, and patient-advocacy group representatives. National Institute of Allergy and Infectious Diseases director Anthony Fauci said the current process "leads to a synergy among the institutes that's really quite extraordinary." The 20-member IOM panel, officially named the Committee on the NIH Priority-Setting Process and composed mostly of scientists, will hear from advocacy groups on April 3. It's scheduled to report to Congress by midsummer how well NIH's priority-setting works and whether it should be changed. SEEKING OPENNESS: Sen. Bill Frist (R-Tenn.) wants NIH to let advocacy groups have input into the priority-setting process. In the Senate, Sen. Bill Frist (R-Tenn.), who chairs the Senate Labor Committee's Subcommittee on Public Health and Safety, hopes to introduce a new NIH Reauthorization Act to update NIH's basic legislative charter within the next month or so. It has been five years since Congress last enacted such legislation, and requests for special treatment for various diseases have been piling up, Anne Phelps, a Frist staff aide, told the IOM committee. Frist, a heart surgeon/ researcher (and former NIH grant recipient), doesn't want to "micromanage" NIH, Phelps said. But she said members of Congress want NIH's priority-setting to be an open process that considers the burdens of various diseases as well as scientific opportunities, and that gives advocacy groups a chance to have their say. And she made clear that Frist is looking to the IOM committee to come up with a way of doing that. In other words, observed committee member James Curran, dean of the Rollins School of Public Health at Emory University in Atlanta, the IOM panel is being asked to recommend changes in "procedures that are described to us as totally not broken but incredibly complex, and differing from institute to institute." When patient-advocacy groups get their turn, however, they aren't likely to tell the IOM committee that NIH's decision-making process is "totally not broken." Over the past three years, several groups--particularly the American Heart Association, the Parkinson's Action Network, the Juvenile Diabetes Foundation, and the American Diabetes Association--have stepped up complaints that NIH spends too little money researching their diseases compared with research into others, such as AIDS. The advocacy groups say NIH should pay greater attention to "disease burden"--that is, to factors such as how many Americans are afflicted with a particular disease, how many die and at what age, the cost to society in medical expenses and in lost economic potential, and disparities in the way diseases strike different ethnic and economic groups. Porter's subcommittee echoed the disease-burden complaint in its formal report on NIH's appropriations bill last year, and Reps. Henry Bonilla (R-Texas) and Jay Dickey (R-Ark.) reprised it on March 10 in pressing Varmus for higher spending on diabetes research. Funding for diabetes, Bonilla said, "was nonexistent" when he arrived in Congress in 1993 and still is "low-priority." INVESTIGATIVE WORK: An IOM committee chaired by Leon Rosenberg is studying how NIH sets priorities. Varmus argued that, following a workshop organized last year in response to congressional and advocacy-group pressure, diabetes research would increase by 11 percent under the administration's proposed budget. "I do believe that there isn't a stone that people believe should be turned that is not being turned," he said, although he acknowledged that "we are very far from having a perfect treatment for diabetes." Spending more money isn't always the answer, Varmus told both panels. "If you've got an undeveloped scientific area, simply putting extra money into that field, giving it to the investigators who are already there, is not going to have a big impact," he said. Far more effective is to press NIH to sponsor workshops or take other steps to attract new investigators, with new ideas, to the field. "We're only as good as our ideas," Varmus commented. Later in the subcommittee's eight days of NIH hearings, Rep. Ernest Istook (R-Okla.) planned to confront Varmus with an updated array of numbers showing disparities between the cost of illnesses and the research funds NIH devotes to them. For example, according to HHS figures, people with diabetes accounted for 26.5 percent--$45.9 billion--of Medicare spending in 1996. About 19.7 percent of Medicare heart disease patients, 32.1 percent of kidney disease patients, 23.9 percent of liver disease patients, and 26.7 percent of stroke patients also had diabetes. Yet only about 6.4 percent of NIH's disease-specific funding is allocated to diabetes research this year. Istook also planned to restate his concern that AIDS research funding is out of line with funding for other equally serious diseases that affect more Americans, staff aides say. DIABETES DOLLARS: Rep. Henry Bonilla (R-Texas) calls NIH funding for diabetes "low-priority." Varmus originally rejected such unfair-funding charges with more heat. Under aggressive questioning by Istook two years ago, he fired back, "As many of my colleagues, especially Dr. [National Heart, Lung and Blood Institute Director Claude] Lefant have pointed out to me, budgeting by body count is not the right way to go." Now, Varmus takes a milder line. "There will always be discussions of this issue because one of the reasons people care about the NIH is that they believe it's going to benefit their health, and they have a right to want to know where the money's going," he said in an interview earlier this year. "My continual anxiety about this issue is that we not overly politicize it and that we not neglect the [basic] research we can't classify. Because there's a lot of it, and that's our best hope." Advocacy groups have another, more basic complaint: Many feel locked out of the NIH decision-making process, according to Myrl Weinberg, president of the National Health Council, an umbrella organization representing more than 100 advocacy groups. Weinberg--who is a member of the IOM committee--told Frist's subcommittee last year that NIH funding allocations "must be made in collaboration with all interested parties" in "an open, inclusive, thoughtful process that protects the right of patient groups to speak out." She hasn't changed her mind. Varmus insists that he and other NIH officials welcome advocacy-group advice. "I like to think that most of us are pretty open to hearing from the advocacy groups," he told the IOM committee. "Our advocacy groups are our best supporters." And four days later, he told Porter's subcommittee, "Many of our advocacy groups are extremely well informed about diseases, understand the grant portfolios, know investigators, and are very helpful in our decision-making processes." He wasn't being facetious, Varmus said, when he suggested last year that people who don't know how to get their ideas through to NIH can E-mail him (varmus@nih.gov) "and I will direct them to the right place." But, he added, "I just don't know if we need an extra office" to handle that chore. The IOM panel is clearly under pressure to come up with something a bit more formal than that. In last year's appropriations bill for NIH, Congress ordered an IOM study to assess the criteria by which NIH makes disease-funding decisions; the decision-making process itself; mechanisms "for public input"; and "the impact of statutory directives"--that is, earmarks--on research-funding decisions. Varmus elaborated on these themes in a list of questions that he said he would like to see the committee answer. Among these were, "How can we work most effectively with our constituencies? What should we be doing, and are we doing all we can?" He added, "I think we do things reasonably well, but it's not perfect." He didn't add, although he might have, that the process is still under adjustment. In his opening statement to Porter's subcommittee, he observed that in putting together the spending plan for the next fiscal year, "we have sought more advice than usual from many of our professional and advocacy constituencies." Informal consultations, however, may no longer suffice. Both the advocacy groups and lawmakers--many of whom are uncomfortable being lobbied about scientific issues that they lack the background to judge--appear to want a more structured mechanism.* (Dollars in millions) Research/Disease AreaFY1998 EstimateFY1999 Estimate%Chg FY1999/FY1998 Aging **1,039 1,118 8% AIDS *1,607 1,731 8% Minority AIDS300 323 8% Pediatric AIDS174 188 8% Vaccines153 180 18% Alzheimer's Disease349 375 7% Cancer Research **2,942 3,232 10% Breast Cancer **433 458 6% (Breast Cancer Genetic)100 106 6% Lung Cancer151 161 7% Prostate Cancer114 122 7% Cardiovascular Research1,155 1,223 6% Cystic Fibrosis74 79 7% Decade of the Brain (Brain Disorders)2,696 2,902 8% Diabetes ***373 415 11% Emerging Infectious Diseases99 108 9% Epstein-Barr Virus25 27 8% (Chronic Fatigue Syndrome)8 8 0% Gene Mapping915 988 8% Gene Therapy269 288 7% Health & Behavioral Research954 1,027 8% Human Fetal Tissue Research20 21 5% Hypertension175 189 8% Kidney Disease209 225 8% Lupus36 39 8% Nutrition474 507 7% Osteoporosis **121 132 9% Parkinson's98 107 9% Schizophrenia117 126 8% Sexually Trans. Diseases/Herpes128 138 8% Sickle Cell Disease53 57 8% Sleep Disorders88 95 8% Spinal Cord Injury65 70 8% Sudden Infant Death Syndrome47 50 6% Tobacco Research449 486 8% Tropical Diseases122 132 8% Tuberculosis Research69 70 1% Vaccine-Related Research377 418 11% Women's Health Research2,110 2,278 8% *Represents Budget Authority for AIDS. **Reflects effect of Women's Health Initiative transfer in all years. ***Includes transfer of $27m for Type 1 diabetes research for FY98-02 in accordance with the Balanced Budget Act. Does not reflect Breast Cancer funds associated w/FY97 Budget Supplement ($15m) NIH PRIORITIES: National Institute spending plans in selected research areas for this fiscal year and under President Clinton's proposed FY1999 budget. NIH officials note that the calculations may not include research indirectly relevant to particular diseases, and they emphasize that the figures exclude basic research that cannot be assigned to a specific disease. Bruce Agnew is a science writer based in Bethesda, Md.

Decisions, Decisions: NIH's Disease-By-Disease Allocations Draw New Fire

Interested in reading more?

Become a Member of