Issues and Updates With Federal Funding allow that if this system could not pro- tes, which he sees as the next big chal- vide enough suitable healthy tissue, then lenge in diabetes research. Diabetes has Ban Lifted, Fetal researchers could use tissue from in- been reversed in animals with drug- duced abortions. induced diabetes using islet transplanta- Tissue Research Will Some researchers believe the tion. Dr. Lafferty intends to work with banks cannot deliver sufficient suitable mice that are genetically susceptible to Continue in Earnest tissue under their current restrictions. diabetes—to not only reverse diabetes, Dr. Delbert Dayton, chief of Develop- but to keep it from recurring, all using Researchers are poised and invigorated mental Biology, Genetics, and Teratology islet transplantation. His latest experi- to reinitiate pursuit of an important line at the National Institute of Child Health ment calls for transplanting human fetal of treatment research for insulin-depen- and Development, who has been in- islet tissue into scid mice (which have no immune system). dent diabetes mellitus (IDDM) in fetal volved in the coordination of the bank, tissue transplantation—now that the ban says the tissue has not been readily avail- Dr. Lafferty notes that there is able because of logistical problems in- on federal funding for such research has little difference between fetal pancreas volved in collecting tissue from women been lifted by President Clinton. Prom- tissue and adult pancreas tissue. In fact, who miscarry or spontaneously abort. what some people see as the advantage of ising results observed in early research The first months of the bank's inception, using fetal tissue—reduced immuno- conducted over the past 5 yr—much of it he says, have served for "developing genecity—does not hold true in the fetal showing that IDDM patients require sig- standards for and characterizing of tis- pancreas. Fetal pancreas tissue is actually nificantly less insulin after transplanta- sue, and for developing logistics," which more immunogenic than adult tissue. tion—have encouraged researchers re- he and others believe will show that re- However, one substantial difference is in garding the tremendous potential fetal lying on the two specified sources will availability. Healthy, suitable adult pan- tissue carries. not provide enough tissue. Many in the creas tissue for transplant research is ex- Basic and clinical research using research community, including Drs. tremely difficult to obtain because adult fetal tissue has continued even during Dayton and Kevin Lafferty, a longtime pancreases are difficult to procure— the ban—albeit on a markedly limited diabetes researcher in transplantation at mainly because high-quality organs go to basis—because of the positive results be- the Barbara Davis Center for Childhood transplant surgery. Fetal tissue, relatively ing observed. The research community Diabetes, believe this will eventually lead speaking, is more easily obtained for continued to work within the framework to President Clinton's lifting of restric- medical and scientific research. that was set up; in this case, it was with- tions on tissue from induced abortions In addition to questions of avail- out the support of the federal govern- just as he has lifted the funding ban. ability, fetal tissue researchers have had ment—a situation that always inhibits Dr. Lafferty says that he did not to juggle sizable financial demands. Dr. private funding and support as well. originally feel that the federal ban would Lafferty notes that an adult pancreas ob- Fetal tissue sourcing continues to impede diabetes research, but his own tained through an organ procurement depend exclusively on the National In- experience convinced him of the impor- agency can cost $25,000—a sum that stitutes of Health (N1H)- based fetal tis- tance of having greater access to fetal might consume the greater portion of an sue bank (which obtains tissue only from tissue: One of his projects involving islet entire research grant. (This was made spontaneous abortions and ectopic preg- transplantation had to be put on hold for particularly difficult by the dearth of pri- nancies), as authorized by former Presi- 6 mo because of a shortage of suitable vate funding that resulted from the fed- dent Bush in May 1992. However, the islets. Some of Dr. Lafferty's current work eral government's hands-off policy. Dr. establishing guidelines for the bank also focuses on controlling recurrent diabe- Lafferty comments candidly that, 668 DIABETES CARE, VOLUME 16, NUMBER 4, APRIL 1993 Issues and updates "Whenever government gets involved in encourage private investment again, and science, it creates a problem.") In con- give a much-needed boost to an impor- trast, notes Dr. Lafferty, an amount of tant area of research and treatment. fetal tissue to do comparable research —SLR might be obtained for around $300. Time also has been a problem for fetal tissue researchers, as Dr. Lafferty noted in his own work. It can take Kelly West Award months to procure a suitable adult organ Recipient Calls through an agency, whereas the turn- around time on fetal tissue should be Attention to much quicker once details on logistics are worked out. Consequences of The debate over the use of fetal tissue for medical and scientific purposes Undiagnosed NIDDM began to take shape in 1988 when a request was made of the Department of Undiagnosed non-insulin-dependent di- Health and Human Services (DHHS) to abetes mellitus (NIDDM) is responsible approve research involving implanting for significant mortality and morbidity in Dr. Maureen Harris. human neural tissue in patients with Par- the U.S., and the problem, says Dr. Mau- kinson's disease. The request was denied reen Harris, recipient of the 1992 Kelly by then Assistant Secretary for Health West Award, lies principally in the lack Robert Windom, MD, who instead formed of sufficient screening. In her lecture Toward this end, Dr. Harris ad- a panel to discuss the ethical, legal, and (this issue, p. 642-52), Dr. Harris points vocates a change in the Clinical Practice scientific issues concerning fetal tissue re- out that the onset of NIDDM can occur Recommendations of the American Dia- search. Although that panel found no ob- up to 12 yr before it is diagnosed and betes Association for diabetes screening. jection to the use of fetal tissue for med- that the numbers of people affected are Currently, those recommendations list ical purposes, the discussion continued. staggering: "Among people >50 yr of age the fasting plasma glucose test as the But, another result of the panel's in the U.S. population, —10% have un- screening test of choice. Dr. Harris findings was the passing of a moratorium diagnosed diabetes. This is a very signif- would like to see that changed to the 2- h on the waiver of fetal research regula- icant proportion to have a disease that postchallenge glucose test. Although the tions. When the moratorium expired on conveys increased morbidity and mortal- reliability of the 2-h test might seem to 5 November 1990, a legislative battle be- ity, yet is totally untreated." make it the obvious choice, Dr. Harris gan. After more than a year of wrangling, Dr. Harris says the only way to says it meets with considerable resistance Congress passed legislation that over- begin to combat the massive public in the physician community—in fact, she turned the ban on funding fetal tissue health crisis posed is through more ef- says, most physicians are opposed to it research; however, in July 1992, Presi- fective and extensive screening pro- for general screening—although the rea- dent Bush vetoed the bill. He had already grams. She would like to see all doctors sons are not clear. authorized the fetal tissue bank in May and clinicians use 2-h postchallenge glu- But, Dr. Harris says, if the medi- 1992. cose assessments rather than the fasting cal community finds the test unaccept- Funding for the fetal tissue bank plasma glucose test because the 2-h val- able for general screening, then she feels was scheduled to expire in March 1993, ues are the most effective screen. The it must at least become essential for at which time President Clinton was to sensitivity of 2-h testing is 97%, its spec- screening individuals who fall into high- review its continuation. Dr. Dayton says ificity is 100%, and its positive predictive risk categories for developing diabetes the bank is not likely to continue as it is value is 100%, compared with only a (being overweight, family history of dia- currently structured—particularly since 31% sensitivity for fasting plasma glu- betes, being black or Hispanic). Dr. Har- legislation has not been enacted to allow cose testing. Dr. Harris suggests that the ris also would like to see high-risk indi- direct use of fetal tissue from induced merit of using 2-h postchallenge glucose viduals checked for impaired glucose abortions in research. For now, research- values as criteria for NIDDM would tolerance, but that, she acknowledges, is ers in many fields of medical and scien- quickly become apparent to clinicians as years away. tific study are excited that the federal they confirmed more (previously uni- The potential benefits to screen- funding ban has been lifted. This will dentified) cases. ing more extensively are clear. In her DIABETES CARE, VOLUME 16, NUMBER 4, APRIL 1993 669 Issues and updates lecture, Dr. Harris highlights studies chemistry from Yale University in 1968 alone, but these disturbances are thought showing that people diagnosed early in and an MPH in epidemiology from Johns to be dose related and can be minimized the progression of N1DDM are much eas- Hopkins University. She also serves as by having patients take the drug with ier to treat.