Research, Rivalry, and Investing in the Cure

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Since the 1950s, the National Institutes of Health (NIH) has fundedalmost all diabetes research worldwide. From its headquarters inBethesda, Maryland, the NIH oversees a $28 billion annual medicalresearch budget. More than $1 billion of those taxpayer dollars gospecifically toward diabetes research. Still, a cure remainsfrustratingly elusive.

By most standards, a billion dollars is a lot of money. But whenit's the bulk of the annual worldwide budget for research into adiabetes epidemic that racks up $132 billion in healthcare costsevery year, it's a relative pittance. And the future doesn't lookbright. After more than thirty years of consistent growth, the NIH'soverall budget began to slide in 2005. The decline didn't affectdiabetes research until last year. But estimates suggest that thedownward trend will continue, even as demand for money fromlaboratories across the country and abroad is going up.

Now scientists are beginning to worry about the effects of growingcompetition for a shrinking pot of gold. Dr. John Buse, associateprofessor and director of the Diabetes Care Center at the Universityof North Carolina School of Medicine, says that the paucity of moneyis causing a decline in fresh new scientists entering diabetesresearch.

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

Last year, the National Institute of Diabetes and Digestive andKidney diseases (NIDDK), the NIH branch that funds over half of alldiabetes research, made 1,397 awards for diabetes research. Butonly 96 of those awards went to brand new investigators at labsoutside the institute. Judith Fradkin, MD, director of the NIDDK'sdiabetes division, says that efforts are underway to encourage morescientists to specialize in diabetes. Next year, the number of NIDDKgrants to new researchers is expected to grow to 118. But NIHofficials say that the budget must also continue to fund experiencedresearchers who count on government funding for their research.

Where the Money Goes

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

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

Dr. Lazar's research investigates how fat cells affect insulinproduction and how the genetic code is involved in obesity anddiabetes. He argues that such basic research is critical to curingtype 2 diabetes and is more promising than conservative efforts thatemphasize prevention. Nonetheless, much of the government's currentresearch does focus on prevention and weight loss to combatdiabetes. The single largest allocation from last year's NIDDKbudget for diabetes research – nearly $508 million – went to twoclinical studies examining school-based nutrition and exerciseprograms aimed at shrinking our children's ever-expandingwaistlines. The studies are scheduled to end in 2009 and 2012, whichcould free up that $28 million for other projects, but Dr. Fradkinsays that they will probably be extended. "It makes sense to extendafter investing so much," she says.

A Long-Term Investment

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

"Science makes very steady progress, sometimes faster and sometimesslower," says Dr. C. Ronald Kahn, an internationally recognizedresearcher and president and director of the Joslin Diabetes Centerin Boston. "It's basically an investment in the future, and theoverall pattern should look a lot like investing in a retirementaccount."

To achieve a balanced portfolio, scientists say, thoseinvestments should extend from the conservative and low-risk, likemost government-funded research, to the radical and innovative, likethe research privately funded by family foundations. Publiccharities such as the ADA and the Juvenile Diabetes ResearchFoundation (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 inthe funding stream for new ideas and exploration of new paradigms inresearch." Private research is also more promising than public, saysMr. Ball, because it skips the peer review required by the NIH. "Wehave experienced firsthand that…peers will fight advancesthat threaten their research," Mr. Ball says. "Imagine if when Fordwas inventing the Mustang, he was required to get GM &Chrysler's approval. This is one of the advantages of privatefunding: no peer review. We allow researchers to do 'safe science'with the traditional sources to ensure publication. At the sametime, they can use our funds to tackle the projects that otherwisewould go unfunded." Mr. Ball also says that more collaboration amongall entities would maximize funding resources and thereby speed thecourse of research. "Unfortunately," he says, "Sometimes you can noteven buy collaboration. It is ego-driven."

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

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

The ADA and the JDRF are pushing for an increase in the NIH andNIDDK budgets. In June, Chairman David Obey (R-WI) told a U.S. Houseof Representatives budget subcommittee to keep in mind the bleakprospects for diabetes a decade from now, when experts predict morethan 56.7 million Americans with diabetes and 147 million withpre-diabetes.

Groups are also pushing for reauthorization of the NIH's SpecialDiabetes Program for Indians and the Special Statutory FundingProgram for Type 1 Diabetes Research. Both programs, which fundresearch on these populations, require joint Congressionalre-authorization this year. They are considered importantadditional research funding sources, over and above the generalNIDDK budget and the diabetes research within other NIH branches.

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

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

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

Researcher Dr. Lazar agrees that the diabetes community would bewise to support all research. "We need to do the high-risk, highreward research, but also the less sexy research that could have thesame result, and [we must support] the infrastructure needed to dothe research," Dr. Lazar says. "I would love to think at any momentwe can have a breakthrough for a cure… At the same time, wehave 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, evendownright angry, that there's still no cure. A billion dollarsstrikes me as a lot of money to spend every single year, and Iwonder whether it's really going to projects that will actuallybenefit people with diabetes.

I don't disagree that basic research is the foundation upon whichbreakthroughs by pharma and device companies are built. And it's allwell and good to point out that the wheels of science turn slowlyand must be allowed to roll in unexpected directions. But I questionwhether the NIH has a focused plan to fund research projects thatwill 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 willwe just end up with a lot of data that leads to nothing? And howabout the Look AHEAD project: It's eating $17 million every yearfor six long years, apparently to determine whether less food andmore exercise leads to weight loss. Give me ten bucks and I'llanswer that question myself.

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


Show Me the Money

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

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

  • 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 Year2006

Major Clinical Research Studies (conducted on humans in a clinicalsetting)

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

DPPOS studies the durability of diet and exercise and the diabetesmedication metformin in delaying or preventing type 2 diabetesin participants in the Diabetes Prevention Program. In 2008, theNIDDK will decide whether to extend the trial for five moreyears or to begin a two-year close-out period.
(http://www.niddk.nih.gov/patient/dpp/dppos.htm; and http://diabetes.niddk.nih.gov/dm/pubs/preventionprogram/)

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.
(http://www.niddk.nih.gov/patient/edic/edic-public.htm; and diabetes.niddk.nih.gov/dm/pubs/control/)

Look AHEAD (Action for Health in Diabetes) Study: $17,752,077

Look AHEAD examines the health effects of intensive lifestyleintervention (decreased caloric intake and increased physicalactivity) in achieving and maintaining weight loss in overweight orobese adults with type 2 diabetes. It also studies the impact ofthese interventions on the incidence of major cardiovascular events.Projected funding ends in 2013.
(http://www.lookaheadtrial.org)

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 ingenetically susceptible individuals. A 2007 award for fundingthrough 2018 is anticipated. An extension through 2025 is possible,to complete follow-up of subjects through age fifteen.
(http://www.teddystudy.org)

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

T1DGC organizes and implements international efforts to identify genesthat determine risk for developing type 1 diabetes. Subject andsamples will be gathered in 2008; analysis is to be completed in2010.
(http://www.T1DGC.org)

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

CIT tests new approaches to islet transplantation in adults withdifficult-to-control type 1 diabetes. It is performing two pivotal(phase III) trials of islet transplantation alone and islettransplantation in association with kidney transplant. Projectedfunding ends in 2009.
(http://www.citisletstudy.org/)

Targeting Inflammation Using Salsalate for Type 2 Diabetes(TINSAL-T2D): $
,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.
(http://www.tinsal-t2d.org)

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

FIND investigates genetic susceptibility to kidney disease andretinopathy, especially in patients with diabetes. Projected fundingfor gathering subjects and samples ends in 2008. The timeline foranalysis is under development.
(http://genepi.cwru.edu/FIND/)

Major Research Consortia (projects which include research atmultiple research centers)

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

BCBC aims tounderstand the development of endogenous beta cells in the pancreasand to determine mechanisms underlying beta cell regeneration, withthe goal of producing new cellular therapies for diabetes. Projectedfunding ends in 2010.
(http://www.betacell.org/)

Diabetes Genome Anatomy Project: $3,417,748

This project identifiesthe sets of genes and gene products involved in insulin action andthe predisposition to type 2 diabetes, as well as secondary changesin gene expression that occur in response to diabetes-relatedmetabolic abnormalities. Projected funding ends in 2008.
(http://www.diabetesgenome.org/)

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

AMDCC, an interdisciplinary consortium, develops animalmodels that closely mimic the human complications of diabetes, inorder to study disease pathogenesis, prevention, and treatment.Projected funding ends in 2011.
(http://www.amdcc.org/)

Mouse Metabolic Phenotyping Centers: $3,896,319

These centersprovide scientists with standardized, high quality metabolic andphysiologic phenotyping services for mouse models of diabetes,diabetic complications, obesity, and related disorders. The MMPCcollaborates with the AMDCC to phenotype new mouse models of diseasefor a range of diabetes complications. Projected funding ends in2011.
(http://www.mmpc.org/)

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

NURSAresearches the structure, function, and role in disease of nuclearhormone receptors. It focuses particularly on metabolism and thedevelopment of metabolic disorders, including type 2 diabetes.Projected funding ends in 2012.
(http://www.nursa.org)

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

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

Diabetes Research Centers

The Diabetes Endocrinology Research Centers (DERCs) and theDiabetes Research and Training Centers (DRTCs) provide coreresources to integrate, coordinate, and foster interdisciplinarycooperation among established investigators who are researchingdiabetes and related areas of endocrinology and metabolism. The DERCfocuses entirely on biomedical research, while the DRTC has an addedcomponent of translational research for diabetes prevention andcontrol.

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

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

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

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

Source: NIDDK

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