Background

There continues to be important debate about how much money ought to be invested in research on the various diseases and disorders that burden people. It would be ideal to invest all the money that is required to support all high quality medical research. This situation actually did prevail in the U.S.A. in the 1950's when 90% of research projects approved by the National Institutes of Health (NIH) were funded. However, as the opportunities for relevant high quality research increased (new ideas; new technology; additional highly skilled scientists), the cost of research also increased; the average government supported medical research project in 1955 was $39,000 a year; in 1999 it is $125,000 a year.

The U.S. government, principally by means of the research programs of the NIH, is the nation's major supporter of basic and clinical biomedical research; industry is the major supporter of applied research (e.g. pharmaceuticals; equipment). The NIH budget in 1996 was $11.9 billion, of which $4.9 billion was disease specific; the remainder crossed many disease lines. However, in 1996 the NIH was able to fund less than 33% of approved research projects. The question being asked is how does NIH allocate its funds? Assuming high quality research of relevance and significance, how does it choose among diseases and disorders? By the number of additional people affected each year (incidence)? By the total number of people who have the disorder (prevalence)? By causes of death (mortality)? By years of remaining life lost? By disability-adjusted life years (loss of years of healthy life)? Each of these measures is important, but each measures a different thing.

Study Results

A consortium of investigators supported by the Robert Wood Johnson Clinical Scholars program has reported the results of a study aimed at determining whether the amount of funding the NIH provided in 1996 to medical research on particular diseases is associated with the "burden of disease".

Twenty-nine diseases were studied from data made available by the NIH. One disease group was "perinatal conditions"; neither "cerebral palsy" nor "disability" was one of the categories available for analysis:

• As measured by mortality, perinatal conditions received 0.5% of total funds awarded; it was ranked 14th in the priority order of the 29 diseases studied. Ischemic heart disease was first, stroke was second; and lung cancer was third.
• As measured by years of life lost, perinatal conditions was seventh in the priority order list on 29. Injuries was first; Ischemic heart disease was second; and lung cancer was third.
• As measured by disability adjusted life years, perinatal conditions was eleventh in priority order list of 29. Ischemic heart disease was first, Injuries was second; and Depression was third.

Of the $11.9 billion available in 1996 to NIH, perinatal conditions received a total of $26.4 million (0.2%). By every index analyzed it was among the major underfunded disorders. Using mortality as an index it was the second highest of the underfunded conditions and should have received $81 million additional dollars; using years of life lost, it was the most underfunded condition and should have received $109 million additional dollars; using disability adjusted life years (loss of one year of healthy life) as an index, it was the most underfunded condition and should have received $97 million additional dollars.

The publication documents that by every measure of burden of illness, the perinatal area was one of three specific research areas significantly underfunded by NIH in 1996; the other two underfunded areas were chronic pulmonary disease and peptic ulcer.

Comment

NIH used several criteria in making decisions about the funding of different research areas. These include: the availability of scientific opportunity for significant new research; as a stimulus to encourage additional research in needed areas; and in response to congressionally directed appropriations for research in specified areas.

Each year, the Congress appropriates a specific budget for each of the 19 NIH Institutes and Centers awarding research grants. Thus, Congress determines specifically how much money is available to the National Cancer Institute for cancer research or to the National Heart, Lung and Blood Institute for research on heart disease. Perinatal research is key program of the National Institute of Child Health and Human Development (NICHD). The responsibility for research on cerebral palsy and other developmental brain disorders is shared by NICHD and the National Institute of Neurological Disorders and Stroke (NINDS).

Within each Institute's specific appropriation, the Congress often directs money for specific disorders (e.g. breast cancer in the National Cancer Institute; AIDS in the National Institute of Allergy and Infectious Diseases; mental retardation on the NICHD; Parkinson's Disease in the NINDS). Thus, the congressional appropriation for research to an Institute either by Congressional dollar assignment ("earmarking") or by Congressional intent language can give emphasis to a specific disease area. Congressional earmarking language has not been given to NIH in many years for research on cerebral palsy or on disability.

Since "perinatal conditions" (and cerebral palsy is a major part of perinatal conditions), has now been identified in this publication as one of the significantly underfunded research areas, we need to monitor what NIH and/or the Congress does about it; this is particularly true since there are large numbers of research projects in this area approved for scientific merit but which are in danger of not being funded. Should perinatal disorders receive at least the same degree of attention by NIH, as do other disorders? Why is it seriously underfunded? Does Congress recognize it is seriously underfunded? Should Congress address this in the appropriation process for NIH?

Should Congress also address this need for additional applied research in the appropriation process for the Centers for Disease Control and Prevention, a part of the US Public Health Service? Another government agency with particular interest in research on developmental disorders and disability is the National Institute of Disability and Rehabilitation Research in the Department of Education. These three government organizations have important and complementary roles in the development and support of research of direct importance to the area of cerebral palsy and the disabilities associated with it. They need to be providing the resources necessary to move forward with the national research agenda for this underfunded area; also the resources need to be designated specifically for this area of research as is being done for other areas of national importance.

United Cerebral Palsy Research and Education Foundation August, 1999