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Testimony before the
Institute of Medicine Committee
on the
NIH Research Priority-Setting
Process  
 
April 3, 1998
National Academy of Sciences Auditorium
Washington, DC 
Report by
Alastair T. Gordon
The Islet Foundation
The National Academy of Sciences
Washington, DC

Table of Contents

Background
The National Institutes of Health - Structure and Directors
The Institute of Medicine Committee on the NIH Research Priority-Setting Process
The Testimony
    Testimony of Alastair T. Gordon, President, The Islet Foundation
    Testimony of Robin A. Harrison, President, Diabetes Cure NOW!
    Testimony of William T. Schmidt, Director of Public affairs, Juvenile Diabetes Foundation International
    Testimony of Mayer B. Davidson, President, American Diabetes Association
Epilogue
We Need Your Help...

The Institute of Medicine has now released its report on NIH funding priorities, and has called for direct involvement in the research funding process of people actually affected by disease. The IOM report entitled Improving Priority Setting and Public Input at the National Institutes of Health (and summarized in the IOM press release) discusses the importance of NIH including healthcare consumers in its selection of research funding.  It is very encouraging to find this level of support from a group having the stature of the Institute of Medicine.

Background

In 1997, the United States Congress took steps to better understand how the National Institutes of Health (NIH) set priorities for funding biomedical research.  An enormous amount of money was being spent, and there was a growing sense that that there were too few outcomes that contributed to the health of Americans. In order to comply with congress, the Institute of Medicine (IOM) was asked by the NIH, in accordance with congressional provision PL105-78, "to conduct a comprehensive study of the policies and processes used by NIH to determine funding allocations for biomedical research". In pursuing its mandate, the IOM called for testimony from a number of people representing various disease groups, seeking their views of NIH funding practices and soliciting suggestions as to how they could be improved.

Diabetes had a respectable profile at the committee sessions on April 3 in Washington, DC, with testimony from:

Following testimony, each representative was questioned by the IOM committee.

By way of background into why congress decided that the NIH was ripe for such a committee, an article in Washington Fax entitled  House appropriators have questions about how the National Institutes of Health allocates funds provides information on the funding of various diseases, versus the actual prevalence and cost of those diseases in the United States.  Of course, ranking a disease solely according to its economic and demographic impact is only one dimension.  It is essential to also consider how likely finding is to create a major breakthrough, the infectiousness of the disease, historical funding share, and the impact of the disease on the lives of its sufferers.

The National Institutes of Health

In order for this whole event to make much sense, it helps to understand what the NIH is, how it is organized, and why it is such a critical component in realizing a cure for diabetes.

The National Institutes of Health is the umbrella agency within which are various institutes, each dedicated to a specific field of biomedical endeavor. The institutes and offices of the NIH represented at the committee hearing were:
 
National Institutes of Health
Dr. Harold Varmus, NIH Director
National Institute of Diabetes, Digestive and Kidney Diseases Phillip Gorden, MD, Director
National Institute of General Medical Sciences Marvin Cassman, PhD, Director
National Institute on Alcohol Abuse and Alcoholism Enoch Gordis, MD, Director
National Institute of Child Health and Human Development Yvonne T. Maddox, PhD, Deputy Director
National Institute on Drug Abuse Richard Millstein, Deputy Director
National Institute of Environmental Health Sciences Kenneth Olden, PhD, Director
Office of Behavioral and Social Research Norman B. Anderson, PhD, Director
Office of Disease Prevention William Harlan, Director
Office of Science Policy Lana Skirboll, PhD, Director
Office of Communications Anne Thomas, Director
Office of AIDS Research Jack Whitescarver, PhD, Director
 

The Institute of Medicine Committee

The Institute of Medicine (IOM) committee, formed under mandate from the United States Congress to study NIH and recommend changes, consisted of specialists in biomedical research, clinical medicine, epidemiology, pharmaceutical industry, economics, ethics, education, and public policy. The IOM committee included:
 
IOM COMMITTEE ON THE
NIH RESEARCH PRIORITY-SETTING PROCESS 
LEON E. ROSENBERG, CHAIR, Professor, Department of Molecular Biology, Woodrow Wilson School of Public and International Affairs, Princeton University 
JOHN ALDERETE, Professor, Department of Microbiology, University of Texas Health Science Center at San Antonio 
KENNETH B. CHANCE, Dean and Professor of Endodontics, Meharry Medical College School of Dentistry 
CARON CHESS, Director, Center for Environmental ( Communication, Rutgers University, Cook 
PURNELL CHOPPIN, President, Howard Hughes Medical Institute 
JAMES W. CURRAN, Dean and Professor of Epidemiology, Rollins School of Public Health, Emory University 
DAVID CUTLER, Professor, Department of Economics, Littauer Center, Harvard University 
SUE DONALDSON, Professor and Dean, School of Nursing, Professor of Physiology, School of Medicine, Johns Hopkins University 
BARUCH FISCHHOFF, Professor of Social and Decision Sciences, Professor of Engineering and Public Policy, Department of Social and Decision Sciences, Carnegie Mellon University 
SID GILMAN, William J. Herdman Professor and Chair, Department of Neurology, University of Michigan 
ROBERT HILL, James B. Duke Professor, Department of Biochemistry, Duke University Medical Center 
RALPH HORWITZ, Chair and Professor, Yale University School of Medicine, Department of Internal Medicine 
TOM KELLY, Boury Professor and Chairman, Department of Molecular Biology and Genetics, Johns Hopkins University 
ANNE PETERSEN, Senior Vice President, Programs, W.K. Kellogg Foundation 
CHARLES A. SANDERS, Retired Chairman and CEO, Glaxo Inc. 
SUSAN C. SCRIMSHAW, Dean, School of Public Health, University of Illinois at Chicago 
ROGER UNGER, Professor of Internal Medicine, University of Texas Southwestern Medical Center  (Former President of JDF)
MYRL WEINBERG, President, National Health Council 
LINDA WILSON, President, Radcliffe College 
ADAM YARMOLINSKY, Regents Professor of Public Policy in the University of Maryland System 
 

The Testimony

The following report will concentrate on the issues that related to diabetes, most of which are the jurisdiction of the National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK) under its director, Dr. Phillip Gorden.  Most of the disease groups had the same concerns, namely that NIH was setting priorities without the input of those most affected by their decisions.  As a result, the testimony provided by Robin and by me was a reinforcement of the lack of accountability which caused the IOM committee to be formed by congress in the first place.  Where we differed strongly from the other presenters, was in the fact that we advocated the involvement of well-informed diabetes representatives both in the setting of broad priorities, as well as in the scientific review of funding proposals. In addition, every other group called for more dollars to fund their area of concern -- we were unique in that we said the existing funding levels were adequate; the real problem lay in how the dollars were being spent.


Testimony of
Alastair T. Gordon
President
The Islet Foundation
before the
IOM Committee on the NIH Research Priority-Setting Process
April 3, 1998
Washington, DC

Dr. Rosenberg, I would like to thank you and the committee for this important opportunity.

Has anybody ever seen an enterprise work in which no one sought any input from the customer? Has any central, state-planned economy, from Soviet Communism to Third World Marxism, ever produced a society that met the needs of its citizens? Yet the managers of these top-down systems claim they exist solely for the well being of these very citizens. Isn't it funny how these systems always end up serving the needs of the state bureaucrats who run them a lot better than the needs of the masses who support them -- and in whose name they operate?

As I read Diabetes Mellitus: Challenges and Opportunities - Final Report and Recommendations (This document is the NIH's multi-year plan for funding diabetes research), I was reminded of the great five year plans of the Soviet Planning Ministry. The Soviets found that planning was much easier, and a lot less messy, when it was all conducted centrally by "experts", without the input of citizens -- citizens who didn't really understand economics anyway.

Why would I compare this NIH report to such historic failures? Imagine you are a well-informed diabetic consumer, and you know about the promising research being done in universities and companies around the world, research showing that it may just be possible to cure diabetes in the very near term. You know about a world class researcher who has reversed diabetes in spontaneously diabetic monkeys for over two years with one simple procedure. You know about another researcher who has created a small implant that mimics the essential characteristics of a healthy pancreas. You know about several former diabetics who have had islet transplants and are now insulin-free and enjoying the spontaneity and health of normal blood sugar control. You know that many of the top researchers in the world are zeroing in on islet xenotransplantation, the use of pig islets (without immunosuppression) to replace the islets killed by diabetes (after all, diabetics have injected pig insulin for 77 years). And you know that all these researchers are starving for the funds that they need to go the final mile.

Now you, this well-informed diabetic consumer, read the NIH strategic plan and you see that millions of dollars are available for such high priority research goals as:

I could go on and on, but I think you get the idea. The funding practices of the NIH have not and will not deliver much of value to diabetics until curing diabetes becomes the overwhelming focus of diabetes research -- in other words, until diabetics have a significant say in the funding process.
 
Here's the biggest surprise of all. We are not asking the US government to spend any more money on diabetes research. Not an additional penny. What we are asking is that the money be spent in areas that are likely to pay off in the near term, and that the real beneficiaries should be people with diabetes, not the diabetes research industry.
 
So what are we asking for? As the so-called sole beneficiaries of NIH-funded diabetes research, we are asking to be a significant part of the funding decision-making process. We do not want some token role, performing diabetic folk dances at NIH forums. We want as much say in the choice of funded research projects as consumers have in the products they buy.
 
For that reason, the diabetic community must be represented in the NIH funding process by people selected directly by the diabetes community. Intermediate organizations and foundations that are likewise guided by the research community present the same conflict of interest that gave rise to the NIH strategic plan.
 
I have to believe that the NIH would love to save the US economy over $100 billion per year -- the cost of diabetes to this nation-- and to end the immeasurable human suffering.
 
We are so close. It's time for the NIH to listen to its customers.
 
Thank you.

 Testimony of
Robin A. Harrison
President
Diabetes Cure NOW!
before the
IOM Committee on the NIH Research Priority-Setting Process
April 3, 1998
Washington, DC
 
I'd like to thank the committee for this opportunity to speak. I identify under the title of my website, Diabetes Cure NOW!, but it is not a formal organization, nor do I engage in any fundraising. All of my activities are conducted in a volunteer support capacity, and as a diabetic myself, I speak for and about the interests of the actual diabetes consumers.

Diabetics manage their disease using a ‘tripod’ of diet, exercise and medication.

Diabetes consumers must be actively included in what decisions are made for and about them at the NIH and NIDDK. The NIH/NIDDK cannot continue to operate in a vacuum and expect to foster a good public image, nor more funding from taxpayers. PROPOSAL  
Thanks for your consideration.

Testimony of
William T. Schmidt
Director of Public affairs
Juvenile Diabetes Foundation International
before the
IOM Committee on the NIH Research Priority-Setting Process
April 3, 1998
Washington, DC

Dr. Rosenberg, Committee members, thank you for inviting JDF to participate in this important undertaking.

I am Bill Schmidt, Director of Public Affairs for the Juvenile Diabetes Foundation International. Dr. Robert Levine, JDF's Chairman of Government Relations and Member of the NIDDK Advisory Council, had hoped to be here this morning, but under a doctor's orders was unable to make it. He has asked me to provide these comments on his behalf.

Founded in 1970 by parents of children with diabetes, the mission of the JDF is to find a cure for diabetes and its complications through the support of research. JDF gives more money to diabetes research than any other not-for-profit, non-governmental health agency in the world. This year, the Foundation will fund over $40 million in diabetes research, three times what we funded in 1991. By the year 2003, we anticipate providing over $80 million per year. A significant portion of our research expenditure is directed to public/private research partnerships that we have established with a number of NIH Institutes, including, NIDDK, NIAID, NHLBI and NEI. At JDF, we recognize that it will take the determined and coordinated efforts of government, not-for-profit organizations and commercial entities to move us from discovery to cure -- to achieve our goal of a world without diabetes.

This Committee's charge is an important one, and it comes at a time of great scientific and political opportunity. In referring to the broad bipartisan support for significant increases in the NIH budget, Dr. Varmus recently noted, "This must be one of the most auspicious ... years in the history of American science," and it is the potential doubling of the NIH budget over the next 5 years that creates the favorable environment necessary to do the hard work of developing a process to better establish our research goals and priorities.

At JDF, we recognize the complexity and significant demands of your charge. Our rapid growth -- and a recognition of the distance that had developed between the management of our portfolio of "the best diabetes research in the world" and the needs and expectations of our volunteers and donors -- forced us, 18 months ago, to convene a special task force to undertake a bottom up assessment of our research investment strategy.

An important insight gained from our process is relevant to this Committee's work. That is: It is not science per se that the people affected by disease and the public care most about, it is the outcome of science that interests us. So, in addition to evaluating the priority setting process, it will be important for this Committee to assess how NIH coordinates its research undertaking to achieve specific clinically relevant goals, and further, how Institutes and the NIH are held accountable for their process and results.

To fully capitalize on the recent explosion of basic science knowledge, NIH will need to devote significantly greater resources to initiatives that help build a bridge from the laboratory bench to the patient's bedside. For pre-clinical endeavors, the NIH should develop methodology to predict the potential to reduce future disease burden as a way to prioritize the allocation of disease-related resources. Maximizing public benefit from a reinvigorated clinical research enterprise will also require the routine use of cost/benefit analysis of planned disease-specific interventions and study designs.

Also, for people to fully benefit from our research investment, NIH may need to play a greater role in implementing initiatives (in concert with other agencies) designed to facilitate closing the gap between clinical knowledge and the day-to-day practice of medicine.

Let me offer an example of how a more priorities-driven, outcomes oriented, coordinated approach might have been taken in a recent, multi-hundred million dollar clinical trial --the Diabetes Control and Complications Trial (DCCT). The DCCT was a landmark clinical trial of "tight control" in diabetes which demonstrated dramatic reductions in long-term complications, including retinopathy and nephropathy. But tight control of diabetes is very difficult to achieve and is accompanied by a significantly increased incidence of severe hypoglycemia. Hypoglycemia, and the fear of hypoglycemia, is the major obstacle to achieving optimal blood glucose control in patients with Type 1 diabetes. And yet little was known about the mechanisms of hypoglycemia, during the DCCT, and little is still known. As the DCCT progressed a more coordinated approach might have included investing in methods for enhancing and restoring defective counter-regulatory responses to hypoglycemia, or even highlighting the need to develop improved methods for measuring blood glucose - as in a hypoglycemia alarm. Further, concurrent with the DCCT, funding opportunities for evidence-based development of model diabetes management programs to enhance compliance with strict regimens, particularly in children, might have been given higher priority. Finally, following publication of the DCCT results in 1993, a major effort to encourage solving the remaining basic and more applied questions related to mechanical or biological replacement of insulin-producing cells could have been immediately pursued.

To be fair, I should say that some of these issues are now being addressed more aggressively, but this is only as a result of last year's significant increase in NIDDK appropriations and the special diabetes research initiative enacted as part of the Balanced Budget Act of 1997. But for persons with diabetes and their loved-ones, this is 5-8 years lost during which progress in these important, high priority areas might have been made.

You have heard a great deal this morning about the problems with the current priority-setting process. I would like to focus my closing comments on potential solutions:

  1. Adopt the principle of, and develop the methodology necessary to use, the potential to reduce future disease burden as an important means to prioritize disease-based research allocations.

  2.  
  3. Recognize the need to assess the cost-effectiveness of clinical trial design and trial outcomes, and the likelihood that results will be broadly applied for the benefit of patients, as part of the review process.

  4.  
  5. Many in the diabetes community legitimately feel disconnected from the NIH decision making process. Accordingly, NIH should actively solicit public input and support for priorities at the earliest inception of ideas, rather than ask for approval late in the process. Individual institutes should be encouraged to examine functioning models from their sister institutions - two such successful models being the processes of the NIAID and NCI.

  6.  
  7. Recognize the immense value of public advocacy groups in carrying out the NIH mission, and take the lead in finding ways to enhance (not dismiss) their views.

  8.  
  9. Communicate more effectively, e.g. produce documentation in a timely fashion explaining what NIH does in terms relevant to consumers, and put the funding information back into the CRISP system.

  10.  
  11. Recognize that Congressional "earmarking" by disease, though not desirable in principle, results from a perception that the views and needs of the public are being ignored in the priority setting process. Lack of communication on the part of NIH on what it does cannot be the only explanation for this perception, some of it may be structural.

  12.  
  13. Continue to promote and facilitate real collaboration and coordination between institutes, and other federal agencies, to improve the likelihood of significant progress, as it would be defined at the bedside, in priority areas.

  14.  
  15. Establish a clinical outcomes based accountability measure for NIH research managers and directors.
On behalf of the 16 million Americans with diabetes and their loved ones, thank you for this opportunity to add input to your important process.

William T. Schmidt
Director of Public Affairs
Juvenile Diabetes Foundation International
1400 I Street, NW, Suite 500
Washington, DC 20005
Phone: (202) 371-9746
Fax: (202) 371-2760
Internet: bschmidt@jdfcure.com

Testimony of
Mayer B. Davidson
President
American Diabetes Association
before the
IOM Committee on the NIH Research Priority-Setting Process
April 3, 1998

I am Mayer Davidson, MD, President of the American Diabetes Association. I appreciate the opportunity to testify today before the Institute of Medicine. We appreciate your leadership on this very important issue of advancing biomedical research for improved health and a better quality of life for our citizens. As Congressman John Porter, a leading congressional advocate of biomedical research, has noted, “The payback to society through health care cost savings is incredible.” As a case in point, reducing the economic burden wrought by diabetes is key to reaching our nation’s long-term potential, and it can only be done by allocating enough federal biomedical research resources to find a cure.

First, let me share with you who we are. The American Diabetes Association is the nation’s leading nonprofit health organization dedicated to the prevention and cure of diabetes.  Our mission is not only to prevent and cure diabetes, but also to improve the lives of all people affected by diabetes.  Founded in 1940, today we are in more than 800 communities who conduct programs in all 50 states and the District of Columbia.

The ADA funds research, publishes scientific findings, and provides information and other services to people with diabetes, their families, health care professionals and the public.  In addition, during the past two years, we have turned our attention to being the strongest possible advocate for people with diabetes.  The moving force behind our work is a network of more than one million volunteers, including a membership of 380,000 diabetes patients and their families, and a professional society of more than 15,000 physicians, scientists, nurses, dietitians, pharmacists, social workers and educators.

This hearing could not come at a better time. For the first time in a generation, our nation is looking at the “dilemma” of what to do with a budget surplus. Many Members of Congress are advocating doubling the NIH budget over five years. Even the President has sent a request for more research spending to the Hill, although it is based on an elusive tobacco settlement nobody has agreed to yet. So a meaningful examination of how the NIH should set its research priorities is very timely, indeed. In my testimony I address each of the four areas requested by the Institute of Medicine (IOM).

I. NIH Factors and Criteria used to make Funding Allocations

We at the ADA have a radical proposal to make: we strongly believe that the NIH should fairly apply its own published criteria in setting federal biomedical research spending priorities!

In 1997, Dr. Harold Varmus, Director of the NIH, appointed a Working Group on Priority Setting to explain how research priorities are set at the NIH in response to congressional inquiries about the process of allocating research funds. Setting Research Priorities at the National Institutes of Health, published last September, (attached and hereafter referred to as Setting Priorities) lays out two major criteria for NIH to use in deciding how and where to distribute NIH’s money each year. They are 1) to make a fresh assessment of the nation’s health needs and 2) to make a renewed evaluation of scientific opportunity.

ASSESSING HEALTH NEEDS

On page eight of Setting Priorities NIH cites six areas to consider when assessing health needs, including:

1. The number of people who have a particular disease.
2. The number of deaths caused by a disease.
3. The degree of disability produced by a disease.
4. The degree to which a disease cuts short a normal, productive, comfortable lifetime.
5. The economic and social costs of a disease.
6. The need to act rapidly to control the spread of a disease.

But then NIH describes a process of using these criteria that looks at each of them individually, which is clearly inappropriate. “Using any one of these criteria to make funding decisions would produce a different result...All of these criteria for weighing health needs are justifiable, yet applying any one of them exclusively would cause the neglect of some classes of diseases altogether...Clearly, it is not easy to determine how to allocate funds according to the impact of various diseases.” (Page 9.)

No reasonable person would suggest that any one of the six areas should exclusively drive the NIH priority setting process. However, these six areas can and should be used to help set research priorities at NIH. Taken in toto, theses six areas provide an excellent assessment of our nation’s health care needs. But at this point in time, these six areas are not being used to set priorities.

Diabetes is a perfect example of how these criteria are virtually ignored by NIH. For example:
 
Health Needs Measures
Diabetes
Other Diseases
The number of people who have diabetes 16 million diagnosed and undiagnosed.  10 million diagnosed, up 700% since 1959 750,000 HIV/AIDS 
4 million Alzheimer’s 
8 million Cancer
The number of deaths caused by diabetes >180,000 annually 50,000 annually 
AIDS: 50,000 annually 
The degree of disability produced by diabetes Sixth highest number of disease based cases of discrimination before the EEOC Heart Impairments rank at 5 
HIV rank at 10 
Cancer ranks at 12
The degree to which the complications of diabetes cuts short a normal, productive, comfortable lifetime Leading cause of adult blindness, 67,000 amputations annually,  the leading cause of kidney failure
The economic and social costs of diabetes $98.2 billion Cancer:  $96.6 billion 
Stroke:    $43.3 billion 
Arthritis: $64.8 billion
Clearly, taken as a whole, diabetes impacts these six areas as much as or more than virtually any other disease. However, this is not reflected in NIH research funding. Based upon the burden of diabetes, it is not immediately clear why in 1998 AIDS received $1.732 billion, cancer received $2.940 billion and heart disease received $1.082 billion, while diabetes received just $376 million in NIH research funding.  For other ways to compare NIH spending by diseases, see attachment 2.

We are not suggesting the funding for these other diseases be reduced to fund diabetes research. Nor is our argument designed to take away from promising research into rare diseases. In fact, it may be appropriate to establish some sort of baseline spending below which research into any specific disease would not drop. Furthermore, the American Diabetes Association recognizes the important role of the NIH in funding basic research and we are not advocating cutting this critical area But in a period of increasing NIH budgets, we believe strongly that the past decade of neglect toward diabetes can and must be rectified.

Based upon the current and inherently unfair inequities in diabetes research funding, we would strongly oppose a doubling of the disease specific areas of research within the context of doubling the overall NIH budget. In relative terms such an approach would leave diabetes twice as far behind. Instead of being $1.4 billion less than AIDS and $2.6 billion cancer, diabetes would be $2.8 and $5.2 billion behind. This would be completely unacceptable because it would not make up for past neglect and leave us further behind.

ASSESSING SCIENTIFIC OPPORTUNITIES

Perhaps the answer to the current systems priorities lies with the fact that diabetes does not hold any promising opportunities. This premise is explored below.

We agree with the NIH that “assessing scientific opportunities is no less complex than evaluating health needs.” (page 10, Setting Priorities) It is probably more so.

Indeed, as Dr. Varmus likes to point out, it is virtually impossible to know which areas of research will provide the greatest returns the soonest. Dr. Varmus repeatedly warns about not knowing where any given avenue of research will lead. Since scientific opportunities arise from many sources, and since often the breakthrough is in an area that appears only remotely related to the area where it will have the greatest impact, it is hard to see how assessing scientific opportunities can be uniformly applied. This assessment of opportunity is, by its very nature, subjective, intuitive and in some ways guesswork.

This raises questions about the value of using this as a criterion for setting priorities. If it is nearly impossible to know where progress will come from, how can NIH set priorities using this criterion. In any case, diabetes research certainly isn’t lacking for scientific opportunity. At an NIH symposium on diabetes last fall, the country’s leading researchers identified more than 60 promising avenues of diabetes research. Despite the identification of promising scientific opportunities in diabetes research and despite the fact that diabetes is a pressing public health issue, Dr. Varmus told Congress in testimony just last week that diabetes research “is quite well supported.”

We strongly beg to differ. The fact is that NIH has failed to uniformly and appropriately apply its own established criteria of assessing the national health needs and scientific opportunities when making decisions about where to spend the taxpayers dollars it receives from Congress. As a result, in constant dollars we spend less today on diabetes research than was spent in 1987.

II. Process by Which Funding Decisions are made

The American Diabetes Association has not been heavily involved with the NIH process by which funding decisions are made. However, we would like to make a couple of points.

In general we believe the peer review process works adequately. However, Setting Priorities explains that for the most part, grants are funded in order of their rating relative to other applications in the same field. (page 11). This seems to us to constrain research into any given area unless it has a very large budget, it is an NIH area of emphasis, or it receives special attention. For example, if NIH funds about 25 percent of its research applications each year based on ratings relative to others in the field, then the higher the appropriation for a given institute,  the greater the number of grants that will be funded.

This approach seems to contradict assertions that scientific opportunities drive the NIH funding. The fact is funding very clearly drives the science. Life as a research scientist is very often a hand-to-mouth existence. Researchers are constantly awaiting their next grant. It is only natural that they would focus attention on areas with the greatest pools of money. Two astute observers of the NIH funding process recently reaffirmed the role of money in the advancement of science.

Congressman Billy Tauzin (R-LA) noted in testimony before the Commerce subcommittee on Health and the Environment (March 26, 1998) that “when we do target funds…toward a disease…we can make it [gains] happen a lot sooner. [I]t's no coincidence that because we targeted funds at AIDS research that there has been a 70 percent drop in AIDS deaths this last year. That’s remarkable and we know that’s possible.”

At another hearing, NIDDK Director Dr. Phillip Gorden, commenting on the recent mild upturn in diabetes research spending acknowledged the value of additional resources. “Our diabetes research agenda has advanced rapidly as new resources have become available,” he recently told House appropriators. Unfortunately for people with diabetes, this area of research has not been a NIH priority for over a decade.

III. Mechanisms for Public Input

The American Diabetes Association responded to questions in the IOM poll about public input largely in the “not sure” category because we have not been heavily involved with the NIH in recent years.

However, whenever any voluntary health agency gets more heavily involved with NIH, it seems to us that NIH would want to solicit their advice and recommendations. Patient groups are among the NIH’s greatest supporters even when, at times when our views diverge, we are also appropriately critical. From our perspective there seems to be a variety of avenues for citizen input at NIH, but it is not clear to us whether it is either adequate or the extent to which citizen advice is considered when it is offered.

Finally, we recognize that it may be unreasonable to assume that Dr. Varmus can meet with every patient advocacy organization. However, we would like to state for the record that the leadership of the American Diabetes Association has sought to introduce themselves to the NIH Director in light of our Association’s renewed interest in diabetes research funding. However, despite a written request and repeated phone calls from our CEO asking to meet with the Director, we have been flatly turned away. We are puzzled by this behavior in light of the Director’s public invitation to patient groups to reach out to him.

IV. Impact of Congressional Statutory Directives

In general, our political system allows for input by advocacy groups into the legislative process. It is appropriate for patient advocacy groups to be involved with the legislative process.

As part of our involvement in this process, the American Diabetes Association does not and has not advocated so-called “earmarking” on the part of legislators. However, Congress is constitutionally responsible for appropriating NIH funds and the NIH is conversely accountable to Congress. Additionally, it is reasonable to expect Congress will be directive in its approach to the NIH – as it is with virtually every other federal agency – when it feels a need to help provide direction to NIH decision-makers.

Furthermore, Congress appropriates the funding for each of the 22 NIH institutes and centers. This is a duty. This is, to a very large extent, determining the direction of NIH research. To say, as some do, that these decisions can only be made by scientists denies the reality that institute funding levels are determined by Congress. As Director Varmus said in testimony last week, “Congress does exercise, at its discretion, manifestly and absolutely when it assigns different dollar values to each of those categorical institutes and centers. So there is some division of the spoils right at the outset.” (Emphasis added).

No one, I repeat, no one I know supports setting one disease against another.  What does this mean, anyway? Has the President set cancer against other diseases by advocating a 65% increase over five years for cancer research while supporting a 50% increase for the rest of NIH? Did anyone accuse the AIDS community of setting itself against other diseases by forcefully advocating for AIDS funding increases in the eighties and nineties? The answer in both cases is no!

The fact is, it is the constitutional duty of Congress to fund a federal program like the NIH. The NIH decides where to allocate the funds, but Congress funds each institute and center individually. It is their right and responsibility to provide direction as to how federal dollars are spent. If the NIH will not apply its own criteria in the face of overwhelming evidence that they have ignored regarding diabetes, then it is time for Congress to make the tough decision and to choose those priorities which NIH has ignored.

As House Labor-HHS Appropriation Subcommittee Chairman John Porter testified last week, “Our job is to choose priorities. Our job is to make the tough choices. And while we all recognize the interest groups and the contributions that they make in the education that they give us [about their area of interest], in the end, we have to make the tough decisions and choose those priorities.”

The American Diabetes Association could not agree more

Epilogue

It is difficult in a written report to convey both the sense of excitement and the sense of frustration felt at these committee hearings.

Excitement and optimism were driven by:

Frustration derived from the list of research projects that form the NIH/NIDDK strategic plan for diabetes.  This list includes: After the testimony, Dr. Leon Rosenberg, Chair of the IOM Committee, asked us if we were claiming that there was a proven cure for diabetes that would rid the world of this scourge if only it would receive support and funding.  I responded that it is not possible to say yet that islet xenotransplantation is "the cure", but given its proven efficacy and safety, and given the fact that no other technology has come close to its results, it would be an inhuman crime of omission not to provide the modest funding needed to prove once and for all if it will work in small clinical trials.

Dr. Roger Unger, Professor of Internal Medicine, University of Texas Southwestern Medical Center, and a former President of JDF, asked us if the Lay Review Committee (LRC) at the JDF was the type of mechanism that we were proposing to include participation by end-users in the NIH funding process.  I indicated that the LRC, if properly constituted, in the proper ratio, and given the will and ability of its members to argue their case with the scientists, would be a good model for what is needed at NIH/NIDDK.

Both Dr. Rosenberg and Dr. Unger were surprised to hear about the level of success of encapsulated pig islets in primate and human trials, but I believe they were very open-minded and excited about the possibility.  Dr. Rosenberg indicated that he would be making some further inquiries regarding islet xenotransplantation, as we had certainly captured the attention of the IOM Committee.

We Need Your Help...

The support of NIH is critical in advancing a cure for diabetes in the near term.  Although the voice of diabetes was heard at this meeting of the IOM Committee, a lot more work needs to be done.  Since the committee was a result of a congressional mandate, and since congress responds to the voice of the people, it is essential that we all write to the IOM Committee. We need to tell the them that diabetes funding must be focused first and foremost on research that has some chance of delivering a cure. And we need to tell them that only when people with diabetes have a strong say in funding decisions will this disease be eradicated. It is obvious from the existing NIH diabetes research funding priorities that the selection process now in place poses no threat to the perpetuation of diabetes.

Robin Harrison has done a great job of directing and delivering these letters.  You can see some of these letters on our Advocacy Letters Page, and can copy-and-paste sections to formulate your own message.  Please stay tuned for the next Action Alert posted by Robin on The Islet Foundation public message forum for news and direction on the letter campaign.  In the meantime, you can email letters to Robin and (if you would like to have them posted on the letters page) to me.

Thanks for your help.

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