Research, Rivalry, and Investing in the Cure

| Sep 13, 2007

Since the 1950s, the National Institutes of Health (NIH) has funded almost all diabetes research worldwide. From its headquarters in Bethesda, Maryland, the NIH oversees a $28 billion annual medical research budget. More than $1 billion of those taxpayer dollars go specifically toward diabetes research. Still, a cure remains frustratingly elusive.

By most standards, a billion dollars is a lot of money. But when it's the bulk of the annual worldwide budget for research into a diabetes epidemic that racks up $132 billion in healthcare costs every year, it's a relative pittance. And the future doesn't look bright. After more than thirty years of consistent growth, the NIH's overall budget began to slide in 2005. The decline didn't affect diabetes research until last year. But estimates suggest that the downward trend will continue, even as demand for money from laboratories across the country and abroad is going up.

Now scientists are beginning to worry about the effects of growing competition for a shrinking pot of gold. Dr. John Buse, associate professor and director of the Diabetes Care Center at the University of North Carolina School of Medicine, says that the paucity of money is causing a decline in fresh new scientists entering diabetes research.

"When there's [little] funding for new grants," says Dr. Buse, who also serves on the American Diabetes Association's board as President-Elect for Medicine and Science, "it's just a very bad outcome. [A scientist's] training lasts more than a decade. There's not enough compensation to pay their loans....It creates a situation where people leave the field of research, and there are not a whole lot of people going into diabetes research to begin with."

Last year, the National Institute of Diabetes and Digestive and Kidney diseases (NIDDK), the NIH branch that funds over half of all diabetes research, made 1,397 awards for diabetes research. But only 96 of those awards went to brand new investigators at labs outside the institute. Judith Fradkin, MD, director of the NIDDK's diabetes division, says that efforts are underway to encourage more scientists to specialize in diabetes. Next year, the number of NIDDK grants to new researchers is expected to grow to 118. But NIH officials say that the budget must also continue to fund experienced researchers who count on government funding for their research.

Where the Money Goes

NIH money is divided among researchers who compete for grants by undergoing a lengthy review process that includes approval by a group of their peers. Some applicants are awarded ongoing grants that automatically renew for a period of years. Clinical trials, one of the most expensive types of research, can also tie up money for many years. And some money is used to cover contracts for services such as disseminating information.

Researchers lucky enough to be awarded NIDDK grants are undeniably passionate and enthusiastic. Dr. Mitchell Lazar, director of the Institute for Diabetes, Obesity and Metabolism at the University of Pennsylvania, is one of them. Last year, his lab received $1.9 million for research on diabetes and metabolism. He also sits on the NIDDK Advisory Council, which reviews competing grant applications.

Dr. Lazar's research investigates how fat cells affect insulin production and how the genetic code is involved in obesity and diabetes. He argues that such basic research is critical to curing type 2 diabetes and is more promising than conservative efforts that emphasize prevention. Nonetheless, much of the government's current research does focus on prevention and weight loss to combat diabetes. The single largest allocation from last year's NIDDK budget for diabetes research - nearly $508 million - went to two clinical studies examining school-based nutrition and exercise programs aimed at shrinking our children's ever-expanding waistlines. The studies are scheduled to end in 2009 and 2012, which could free up that $28 million for other projects, but Dr. Fradkin says that they will probably be extended. "It makes sense to extend after investing so much," she says.

A Long-Term Investment

Over the years, scientific breakthroughs by NIDDK-funded researchers have underpinned many improvements in diabetes care. Chief among them was the landmark Diabetes Control and Complications Trial in the 1990s, which proved that intensive management reduces or eliminates diabetes complications. "I don't want to say a cure is right around the corner, but the care and tools to treat diabetes have improved dramatically…and I think we're working toward a cure," says Dr. Fradkin. "We're doing our best with money we have."

"Science makes very steady progress, sometimes faster and sometimes slower," says Dr. C. Ronald Kahn, an internationally recognized researcher and president and director of the Joslin Diabetes Center in Boston. "It's basically an investment in the future, and the overall pattern should look a lot like investing in a retirement account."

To achieve a balanced portfolio, scientists say, those investments should extend from the conservative and low-risk, like most government-funded research, to the radical and innovative, like the research privately funded by family foundations. Public charities such as the ADA and the Juvenile Diabetes Research Foundation (JDRF) fall somewhere in between.

Dana A. Ball, Executive Director of the private Iacocca Foundation, says, "Private money has the power to be the most instrumental in the funding stream for new ideas and exploration of new paradigms in research." Private research is also more promising than public, says Mr. Ball, because it skips the peer review required by the NIH. "We have experienced firsthand that…peers will fight advances that threaten their research," Mr. Ball says. "Imagine if when Ford was inventing the Mustang, he was required to get GM & Chrysler's approval. This is one of the advantages of private funding: no peer review. We allow researchers to do 'safe science' with the traditional sources to ensure publication. At the same time, they can use our funds to tackle the projects that otherwise would go unfunded." Mr. Ball also says that more collaboration among all entities would maximize funding resources and thereby speed the course of research. "Unfortunately," he says, "Sometimes you can not even buy collaboration. It is ego-driven."

Conservative or not, everyone agrees that the NIDDK would be more effective if its research funding was more in line with the healthcare expense of diabetes, which currently devours one out of every ten healthcare dollars spent in the United States. "The entire NIH budget is [less than] $30 billion, compared with over a trillion in U.S. healthcare costs," Dr. Kahn says. "We've unfortunately gotten so locked into spending a lot on healthcare, but we're not willing to make a priority of investment."

"Most technology companies have a research budget of between five and fifteen percent," Dr. Kahn says. "We have to put in more than a one percent investment. It requires a change in how we view medical research. It should be viewed just like any other investment."

The ADA and the JDRF are pushing for an increase in the NIH and NIDDK budgets. In June, Chairman David Obey (R-WI) told a U.S. House of Representatives budget subcommittee to keep in mind the bleak prospects for diabetes a decade from now, when experts predict more than 56.7 million Americans with diabetes and 147 million with pre-diabetes.

Groups are also pushing for reauthorization of the NIH's Special Diabetes Program for Indians and the Special Statutory Funding Program for Type 1 Diabetes Research. Both programs, which fund research on these populations, require joint Congressional re-authorization this year. They are considered important additional research funding sources, over and above the general NIDDK budget and the diabetes research within other NIH branches.

"More and more people are devastated by diabetes, but there are many other illnesses which get a great deal more [money]" says Dr. Buse. Dr. Kahn suggests, however, that such competitive reasoning might not be a good idea. "Parents of children with type 1 diabetes will say we never have enough money for type 1, but the big breakthrough may not come that way," Dr. Kahn says. "Progress often comes from an unexpected source."

He provides a compelling example: The A1c test, now the gold standard for measuring long-term diabetes control, was discovered by a Egyptian hematologist studying genetic defects in hemoglobin. He discovered a similarity in the hemoglobin of several individuals who all turned out to be diabetic, and the A1c was born.

"There's so much cross-fertilization with research. This needs to be a global investment," Dr. Kahn says.

Researcher Dr. Lazar agrees that the diabetes community would be wise to support all research. "We need to do the high-risk, high reward research, but also the less sexy research that could have the same result, and [we must support] the infrastructure needed to do the research," Dr. Lazar says. "I would love to think at any moment we can have a breakthrough for a cure… At the same time, we have to be willing to be in it for the long haul."

Editor's Note:

I admit, I'm one of the many people who are frustrated, even downright angry, that there's still no cure. A billion dollars strikes me as a lot of money to spend every single year, and I wonder whether it's really going to projects that will actually benefit people with diabetes.

I don't disagree that basic research is the foundation upon which breakthroughs by pharma and device companies are built. And it's all well and good to point out that the wheels of science turn slowly and must be allowed to roll in unexpected directions. But I question whether the NIH has a focused plan to fund research projects that will really make a difference.

The $28 million that's being spent on type 2 diabetes in children, for example: Is it actually going to accomplish something, or will we just end up with a lot of data that leads to nothing? And how about the Look AHEAD project: It's eating $17 million every year for six long years, apparently to determine whether less food and more exercise leads to weight loss. Give me ten bucks and I'll answer that question myself.

I wonder if the NIH's preference for conservative research is really the best way. Perhaps we would be better served by more radical research like that funded by private charities, research that has the potential to really change paradigms. In short, I think we need to get cracking. We've got a billion dollars a year. Let's see some results.

Show Me the Money

Over half of the NIH's almost $1.04 billion budget for diabetes research is awarded through the NIDDK. The next largest amount devoted to diabetes research, nearly $104 million last year, goes to the National Heart, Lung, and Blood Institute.

The following is a breakdown of the 2006 NIDDK budget for diabetes research:

  • Total: $508 million
  • Extramural awards (to outside research entities): 1,397, worth $456.8 million, including 295 competitive grants for new projects and 901 payments to grantees previously awarded multi-year grants.
  • Intramural awards (to researchers within the Bethesda campus): 31, worth $21.3 million.
  • Contracts(for diabetes-related services performed by outside entities): 24, worth $29.3 million.
  • Special funding for type 1 research (in addition to regular NIDDK budget for diabetes research): $113 million

Sources: NIH, NIDDK

Major NIDDK-funded Research in Diabetes in Fiscal Year 2006

Major Clinical Research Studies (conducted on humans in a clinical setting)

Diabetes Prevention Program Outcomes Study (DPPOS): $10,805,198

DPPOS studies the durability of diet and exercise and the diabetes medication metformin in delaying or preventing type 2 diabetes in participants in the Diabetes Prevention Program. In 2008, the NIDDK will decide whether to extend the trial for five more years or to begin a two-year close-out period.
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Epidemiology of Diabetes Interventions and Complications Study (EDIC): $16,939,061

EDIC follows participants in the Diabetes Control and Complications Trial (DCCT) to determine the long-term effects of a finite period of improved glycemic control. Projected funding ends in 2016.
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Look AHEAD (Action for Health in Diabetes) Study: $17,752,077

Look AHEAD examines the health effects of intensive lifestyle intervention (decreased caloric intake and increased physical activity) in achieving and maintaining weight loss in overweight or obese adults with type 2 diabetes. It also studies the impact of these interventions on the incidence of major cardiovascular events. Projected funding ends in 2013.

Stopp-T2D Initiative consists of two major clinical studies: $28,453,074

TEDDY (Environmental Determinants of Diabetes in the Young): $17,500,000

TEDDY identifies infectious agents, dietary factors, and other environmental factors that trigger type 1 diabetes in genetically susceptible individuals. A 2007 award for funding through 2018 is anticipated. An extension through 2025 is possible, to complete follow-up of subjects through age fifteen.

T1DGC (Type 1 Diabetes Genetics Consortium): $12,500,001

T1DGC organizes and implements international efforts to identify genes that determine risk for developing type 1 diabetes. Subject and samples will be gathered in 2008; analysis is to be completed in 2010.

Clinical Islet Transplantation (CIT) Consortium: $9,337,209

CIT tests new approaches to islet transplantation in adults with difficult-to-control type 1 diabetes. It is performing two pivotal (phase III) trials of islet transplantation alone and islet transplantation in association with kidney transplant. Projected funding ends in 2009.

Targeting Inflammation Using Salsalate for Type 2 Diabetes (TINSAL-T2D): $1,500,000

TINSAL-T2D is a multicenter clinical trial to determine whether salicylates represent a new treatment option for managing type 2 diabetes. Projected funding ends in 2010.

Family Investigation of Nephropathy and Diabetes (FIND): $1,224,832

FIND investigates genetic susceptibility to kidney disease and retinopathy, especially in patients with diabetes. Projected funding for gathering subjects and samples ends in 2008. The timeline for analysis is under development.

Major Research Consortia (projects which include research at multiple research centers)

Beta Cell Biology Consortium (BCBC): $21,192,631

BCBC aims to understand the development of endogenous beta cells in the pancreas and to determine mechanisms underlying beta cell regeneration, with the goal of producing new cellular therapies for diabetes. Projected funding ends in 2010.

Diabetes Genome Anatomy Project: $3,417,748

This project identifies the sets of genes and gene products involved in insulin action and the predisposition to type 2 diabetes, as well as secondary changes in gene expression that occur in response to diabetes-related metabolic abnormalities. Projected funding ends in 2008.

Animal Models of Diabetic Complications Consortium (AMDCC): $2,382,595

AMDCC, an interdisciplinary consortium, develops animal models that closely mimic the human complications of diabetes, in order to study disease pathogenesis, prevention, and treatment. Projected funding ends in 2011.

Mouse Metabolic Phenotyping Centers: $3,896,319

These centers provide scientists with standardized, high quality metabolic and physiologic phenotyping services for mouse models of diabetes, diabetic complications, obesity, and related disorders. The MMPC collaborates with the AMDCC to phenotype new mouse models of disease for a range of diabetes complications. Projected funding ends in 2011.

Nuclear Receptor Signaling Atlas (NURSA): $2,934,813

NURSA researches the structure, function, and role in disease of nuclear hormone receptors. It focuses particularly on metabolism and the development of metabolic disorders, including type 2 diabetes. Projected funding ends in 2012.

Translational Research for the Prevention and Control of Diabetes and Obesity: $16,058,486

This effort integrates successful clinical research into medical practice and community settings. It develops effective, sustainable, and cost-effective methods to prevent and treat type 1 and type 2 diabetes and obesity in clinical practice and other real world settings. Many studies focus on minority populations, which are disproportionately burdened by type 2 diabetes and obesity. New individual projects are awarded each year, for up to five years.

Diabetes Research Centers

The Diabetes Endocrinology Research Centers (DERCs) and the Diabetes Research and Training Centers (DRTCs) provide core resources to integrate, coordinate, and foster interdisciplinary cooperation among established investigators who are researching diabetes and related areas of endocrinology and metabolism. The DERC focuses entirely on biomedical research, while the DRTC has an added component of translational research for diabetes prevention and control.

Diabetes Endocrinology Research Centers (DERCs): $15,894,968

Individual awards are made for five years. There is no plan to discontinue funding.

Diabetes Research and Training Centers (DRTCs): $9,653,000

Individual awards are made for five years. There is no plan to discontinue funding.

Source: NIDDK

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