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Linkage between research sponsorship and patented eye-care technology
ABSTRACTS EDITED BY THOMAS J. LIESEGANG, MD
• Teaching of human rights in US medical schools. Sonis J*, Gorenflo DW, Jha P, Williams C. JAMA 1996; 276:1676-1678.
A
CROSS-SECTIONAL SURVEY WAS PERFORMED OF BIO-
ethics course directors and bioethics section directors of 125 US medical schools in order to determine if human rights issues are taught in US medical schools and to identify the characteristics of the medical schools associated with the extent of human rights issues covered. The main outcome measurement was the percentage of 16 human rights issues taught. Medical schools included about half (45%; 95% confidence interval, 41% to 49%) of the 16 human rights issues in required curricula. Domes tic human rights issues, such as discrimination in the provision of health care to minorities, were covered more frequently than were international human rights issues, such as physician participation in tor ture. Public medical schools included substantially fewer human rights issues than private medical schools did. The authors concluded that required courses in medical schools do not adequately address the medical aspects of human rights issues.—Hans E. Grossniklaus 'Department of Family Practice, University of Michigan Medical School,! 1018 Fuller St, Ann Arbor, Ml 48109-0708.
• The pathologist's role in the use of human tissues in research—legal, ethical and other issues. Grizzle WE*, Woodruff KH, Trainer TT. Arch Pathol Lab Med 1996;120:909-912.
B
ECAUSE OF THEIR CENTRAL ROLE IN EXAMINING AND
storing samples of human tissues obtained for diagnosis or therapy of diseases, pathologists fre
VOL.123, No. 3
quently are involved in providing human tissues for a wide range of research. This is an important role for the pathologist that leads to increased understanding of disease, to potential methods of prevention, and to improved therapy. Recent conferences concerning uses of human tissues in research have indicated that there is confusion with respect to legal issues and requirements of pathologists who are involved in research with human tissues. This paper discusses current federal regulations concerning the use of human tissues and medical information in research as specified in Title 45, Part 46 of the Code of Federal Regulations (45 CFR 46), "Protection of Human Subjects." The authors also recommend approaches that pathologists can utilize to ensure that they are meeting all federal regulations with respect to the use of human tissues in research.—Authors' abstract 'University of Alabama at Birmingham, University Station, Birmingham, AL 35294-0007.
• Linkage between research sponsorship and pat ented eye-care technology. Ellwein LB*, Kroll P, Narin F. Inv Ophthalmol Vis Sci 1996; 37:24952503.
T
HE PURPOSE OF THIS STUDY WAS TO EXAMINE THE
linkage between the funding of ophthalmologic research and the development of patented eye-care technology. The authors screened all United States patents granted from 1975 through 1994, using patent office classifications and key words to identify all eye-care-related patents. Each patent's references in the literature to nonpatented work were examined, and those references to scientific papers were reviewed
ABSTRACTS
433
to determine the authors' institutions and acknowl edged funding sources. Results showed that eye tech nology patents grew from 224 in 1975 to 662 in 1994, the total number of nonpatent references grew from 100 in 1975 to 2000 in 1994, and the National Eye Institute (NEI) and NEI combined with the rest of the National Institutes of Health (NIH) provide the leading single institutional support for patent devel opment. The authors conclude that the NIH is of direct and increasing relevance to the growing num ber of US patented eye-care technologies.—Hans E. Grossniklaus *National Eye Institute, 31 Center Dr, MSC 2510, Bethesda, MD 20892-2510.
• How graduate medical education funding affects residency program changes. Tracy E.* JAMA 1996; 276:1536e.
T
HIS ARTICLE DISCUSSES HOW MEDICARE REIMBURSE-
ment payments affect a hospital's resident selec tion process in cases in which a person switches residencies. Graduate medical education (GME) is primarily funded by Medicare, although other sourc es, such as states, municipalities, grants, and dona tions, provide GME funding. Direct GME payments include salaries and benefits for residents, fellows, and faculty members; indirect GME payments are sub stantially larger and compensate teaching hospitals for all other increased costs associated with the presence of a residency program. This amounts to on average $10,000 direct GME funding and $60,000 indirect GME funding to hospitals per resident per year by Medicare. A resident is counted as 1.0 full-time equivalent (1.0 FTE) per year in the initial residency period for up to 5 years. After that, the resident is counted as 0.5 FTE per year. Therefore, if someone does a second residency, the amount of direct GME money a hospital receives from Medicare is cut in half for that resident. There are various combinations of reimbursement that may occur, for instance, if a resident switches residencies in the middle of a program. Even small reductions in Medi
434
care reimbursement payments can influence a hospi tal's selection process.—Hans E. Grossniklaus *No address given.
• Ophthalmic features of the organoid nevus syn drome. Shields JA*, Shields CL, Eagle RC, Arevalo F, De Potter P. Trans Am Ophthalmol Soc 1996;94: 65-87.
T
HE AUTHORS FROM WILLS EYE HOSPITAL REPORTED
the varied manifestations of the organoid nevus (sebaceous nevus of Jadassohn) syndrome in five patients. This congenital syndrome is characterized primarily by a cutaneous sebaceous nevus, seizures, and epibulbar choristomas. Like the closely related phakomatoses, it often occurs as a forme fruste, without the full expression of the syndrome. Four of the patients had a classic sebaceous nevus in the facial and scalp area, and two had seizures and arachnoid cysts. All five patients had an epibulbar tumor, which proved to be a complex choristoma in the one case that was studied histopathologically. Four of the patients demonstrated a flat yellow discoloration of the posterior fundus, of variable size and shape that appeared to correlate with a dense plaque noted on ultrasonography and computed tomography. Histopathologic examination in one case demonstrated intrascleral cartilage.
In reviewing the literature of this rare syndrome, the authors found no sexual, racial, or familial ten dency and normal karyotyping. Three stages of the sebaceous nevus have been identified, depending on the age of the patient. The first stage in infancy is characterized by underdevelopment of adnexal struc tures; the second stage in puberty is characterized by massive overdevelopment of adnexal structures; the third stage in adulthood is marked by development of benign and malignant tumors in the area of the cutaneous lesion. Twenty percent of patients will develop a basal cell carcinoma in the affected area. Seizures and mental retardation appear to be second ary to arachnoidal cysts, leptomeningeal hemangiomas, unusual hamartomas, and cerebral cortical atrophy. A n anomalous development of the neuro-
AMERICAN JOURNAL OF OPHTHALMOLOGY
MARCH 1997
• Teaching of human rights in US medical schools. Sonis J*, Gorenflo DW, Jha P, Williams C. JAMA 1996; 276:1676-1678.
A
CROSS-SECTIONAL SURVEY WAS PERFORMED OF BIO-
ethics course directors and bioethics section directors of 125 US medical schools in order to determine if human rights issues are taught in US medical schools and to identify the characteristics of the medical schools associated with the extent of human rights issues covered. The main outcome measurement was the percentage of 16 human rights issues taught. Medical schools included about half (45%; 95% confidence interval, 41% to 49%) of the 16 human rights issues in required curricula. Domes tic human rights issues, such as discrimination in the provision of health care to minorities, were covered more frequently than were international human rights issues, such as physician participation in tor ture. Public medical schools included substantially fewer human rights issues than private medical schools did. The authors concluded that required courses in medical schools do not adequately address the medical aspects of human rights issues.—Hans E. Grossniklaus 'Department of Family Practice, University of Michigan Medical School,! 1018 Fuller St, Ann Arbor, Ml 48109-0708.
• The pathologist's role in the use of human tissues in research—legal, ethical and other issues. Grizzle WE*, Woodruff KH, Trainer TT. Arch Pathol Lab Med 1996;120:909-912.
B
ECAUSE OF THEIR CENTRAL ROLE IN EXAMINING AND
storing samples of human tissues obtained for diagnosis or therapy of diseases, pathologists fre
VOL.123, No. 3
quently are involved in providing human tissues for a wide range of research. This is an important role for the pathologist that leads to increased understanding of disease, to potential methods of prevention, and to improved therapy. Recent conferences concerning uses of human tissues in research have indicated that there is confusion with respect to legal issues and requirements of pathologists who are involved in research with human tissues. This paper discusses current federal regulations concerning the use of human tissues and medical information in research as specified in Title 45, Part 46 of the Code of Federal Regulations (45 CFR 46), "Protection of Human Subjects." The authors also recommend approaches that pathologists can utilize to ensure that they are meeting all federal regulations with respect to the use of human tissues in research.—Authors' abstract 'University of Alabama at Birmingham, University Station, Birmingham, AL 35294-0007.
• Linkage between research sponsorship and pat ented eye-care technology. Ellwein LB*, Kroll P, Narin F. Inv Ophthalmol Vis Sci 1996; 37:24952503.
T
HE PURPOSE OF THIS STUDY WAS TO EXAMINE THE
linkage between the funding of ophthalmologic research and the development of patented eye-care technology. The authors screened all United States patents granted from 1975 through 1994, using patent office classifications and key words to identify all eye-care-related patents. Each patent's references in the literature to nonpatented work were examined, and those references to scientific papers were reviewed
ABSTRACTS
433
to determine the authors' institutions and acknowl edged funding sources. Results showed that eye tech nology patents grew from 224 in 1975 to 662 in 1994, the total number of nonpatent references grew from 100 in 1975 to 2000 in 1994, and the National Eye Institute (NEI) and NEI combined with the rest of the National Institutes of Health (NIH) provide the leading single institutional support for patent devel opment. The authors conclude that the NIH is of direct and increasing relevance to the growing num ber of US patented eye-care technologies.—Hans E. Grossniklaus *National Eye Institute, 31 Center Dr, MSC 2510, Bethesda, MD 20892-2510.
• How graduate medical education funding affects residency program changes. Tracy E.* JAMA 1996; 276:1536e.
T
HIS ARTICLE DISCUSSES HOW MEDICARE REIMBURSE-
ment payments affect a hospital's resident selec tion process in cases in which a person switches residencies. Graduate medical education (GME) is primarily funded by Medicare, although other sourc es, such as states, municipalities, grants, and dona tions, provide GME funding. Direct GME payments include salaries and benefits for residents, fellows, and faculty members; indirect GME payments are sub stantially larger and compensate teaching hospitals for all other increased costs associated with the presence of a residency program. This amounts to on average $10,000 direct GME funding and $60,000 indirect GME funding to hospitals per resident per year by Medicare. A resident is counted as 1.0 full-time equivalent (1.0 FTE) per year in the initial residency period for up to 5 years. After that, the resident is counted as 0.5 FTE per year. Therefore, if someone does a second residency, the amount of direct GME money a hospital receives from Medicare is cut in half for that resident. There are various combinations of reimbursement that may occur, for instance, if a resident switches residencies in the middle of a program. Even small reductions in Medi
434
care reimbursement payments can influence a hospi tal's selection process.—Hans E. Grossniklaus *No address given.
• Ophthalmic features of the organoid nevus syn drome. Shields JA*, Shields CL, Eagle RC, Arevalo F, De Potter P. Trans Am Ophthalmol Soc 1996;94: 65-87.
T
HE AUTHORS FROM WILLS EYE HOSPITAL REPORTED
the varied manifestations of the organoid nevus (sebaceous nevus of Jadassohn) syndrome in five patients. This congenital syndrome is characterized primarily by a cutaneous sebaceous nevus, seizures, and epibulbar choristomas. Like the closely related phakomatoses, it often occurs as a forme fruste, without the full expression of the syndrome. Four of the patients had a classic sebaceous nevus in the facial and scalp area, and two had seizures and arachnoid cysts. All five patients had an epibulbar tumor, which proved to be a complex choristoma in the one case that was studied histopathologically. Four of the patients demonstrated a flat yellow discoloration of the posterior fundus, of variable size and shape that appeared to correlate with a dense plaque noted on ultrasonography and computed tomography. Histopathologic examination in one case demonstrated intrascleral cartilage.
In reviewing the literature of this rare syndrome, the authors found no sexual, racial, or familial ten dency and normal karyotyping. Three stages of the sebaceous nevus have been identified, depending on the age of the patient. The first stage in infancy is characterized by underdevelopment of adnexal struc tures; the second stage in puberty is characterized by massive overdevelopment of adnexal structures; the third stage in adulthood is marked by development of benign and malignant tumors in the area of the cutaneous lesion. Twenty percent of patients will develop a basal cell carcinoma in the affected area. Seizures and mental retardation appear to be second ary to arachnoidal cysts, leptomeningeal hemangiomas, unusual hamartomas, and cerebral cortical atrophy. A n anomalous development of the neuro-
AMERICAN JOURNAL OF OPHTHALMOLOGY
MARCH 1997