The Institute for Human Gene Therapy (IHGT) at the University of Pennsylvania was notified on Friday, January 21, by the FDA that the agency was suspending eight Investigational New Drug Applications (INDs) previously issued to IHGT and pursuant to which IHGT was conducting five active clinical trials in cystic fibrosis, mesothelioma, melanoma and breast cancer, muscular dystrophy and glioma. In its letter, the FDA said that it took this action in light of its recent inspection related to the OTC clinical trial. IHGT received these findings from the FDA in a Form 483 on Wednesday, January 19. The FDA letter said that the inspection had disclosed "serious deficiencies in the procedures in place for oversight and monitoring of the clinical trials conducted by" IHGT. The FDA publicly released the letter (click here) and the Form 483 on Friday.
In light of this action by the FDA, and the agency's expressed concerns with respect to IHGT's monitoring of clinical trials President Judith Rodin has asked Provost Robert L. Barchi to appoint a committee of scientists without affiliation to the University to review IHGT's oversight and monitoring of clinical trials and any remedial steps already undertaken by IHGT, and to recommend any additional remedial steps that may be necessary. President Rodin has asked Provost Barchi to seek the assistance of distinguished scientists with extensive experience in clinical research.The committee will report directly to President Rodin.
President Rodin has previously appointed a committee of distinguished members of the Penn faculty, chaired by Provost Barchi, to review "carefully and completely" all aspects of Penn's research using human volunteers (Almanac January 18). The unaffiliated scientists reviewing IHGT's supervision of clinical trials will operate independently of the University review of research using human volunteers.
President Rodin said that the University has cooperated fully with all aspects of the FDA's investigation and would continue to do so. She has directed IHGT to respond promptly and completely, both to the Form 483 and last week's letter from the FDA.
The School of Nursing has received a gift funding a newly endowed chair in gerontology to be held, effective January 1, 2000, by internationally-known scholar, Dr. Neville E. Strumpf, director of the Center for Gerontologic Science.
The Edith Clemmer Steinbright Chair in Gerontology was made possible through the generosity of the Arcadia Foundation of Norristown, PA. The Steinbright Chair is the sixth of eight endowed chairs to be filled within the School of Nursing.
"I am personally and professionally pleased to name Dr. Strumpf to this endowed professorship, one of many honors in her distinguished and important career as a nursing scholar," said Dr. Norma Lang, the Margaret Bond Simon Dean of Nursing. "Widely respected for her work with elders, Dr. Strumpf has conducted ground-breaking research that has changed many previously accepted practices in health care. Her important work stands as an expression of her concern that older adults be treated with empathy and respect."
"My scholarly work focuses on quality of care and quality of life for frail older adults, regardless of setting or circumstance. I am proud that much of our research has tested the impact of advanced practice nursing interventions on outcomes of care," said Dr. Strumpf. "In so doing, I think we have changed the lives of many older people."
Dr. Strumpf and her colleague, Dr. Lois Evans, the Viola MacInnes/Independence Professor in Nursing, co-authored the preeminent study which has led to significant reductions in the use of physical restraints in hospitals and nursing homes nationally. For this remarkable achievement, Drs. Strumpf and Evans received the Sigma Theta Tau International Baxter Foundation Episteme Award which recognizes a major breakthrough in nursing care.
Dr. Strumpf and colleagues have just completed a $1.8 million clinical study funded by the National Institute on Aging to examine individualized care approaches for hospitalized nursing home residents. Preliminary findings describe the impact of patient behavior on the use of restraints as well as the long-term consequences of physical restraints.
Currently, Dr. Strumpf is studying palliative or end-of-life care in nursing homes under the auspices of the Robert Wood Johnson Foundation. This $450,000 project focuses on staff training in palliative care and the use of interdisciplinary care teams to treat pain and manage symptoms. The program is also designed to improve advanced care planning, family satisfaction, and better use of clinical resources. This innovative program is a partnership with Genesis ElderCare, the third largest long-term care network in the country.
Dr. Strumpf continues as director of the Center for Gerontologic Nursing Science and the Adult and Gerontological Nurse Practitioner programs at the School of Nursing. Renowned in the gerontology field, Dr. Strumpf was named Gerontological Nurse of the Year by the American Nurses' Association in 1994 and has been recognized with numerous teaching and service awards.
Not only did College Green turn white last week, but as snow fell for the first time this year, some new campus landmarks such as Sansom Common, the Inn at Penn and Steve Murray's Way were part of the winter wonderland as well.
(Above) Facilities Services' plows were prepared to clear Steve Murray's Way.
(Below) Antillean Couple stands stoically as snow blanketed its base and 36th Street.
Almanac, Vol. 46, No. 18, January 25, 2000