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News in Brief
FDA Initiates PD Patient Consultant Program
In July, the Food and Drug Administration (FDA) named three Parkinson's patients to serve as special consultants on the development of new Parkinson's disease therapies with the Neurological Products Division in the Center for Drug Evaluation and Research. These individuals join oncology patients as the second disease category to participate in the FDA's patient consultant program. This program, which is managed by the Office of Special Health Issues, represents a growing effort by the FDA to seek out patient perspectives on the development of new therapies.
The new consultants are Katherine Decker, R.N., David Eger, Ph.D. and Marshall Loeb. Ms. Decker, of Chesapeake, Virginia, has been diagnosed for 12 years and is a nurse and state health occupations vocational education administrator. Mr. Eger has been diagnosed for five years and is a psychologist in private practice in White Plains, New York. The final patient consultant, Marshall Loeb, who was diagnosed two-and-a-half years ago, is a columnist for Market Watch from Dow Jones news service, and an analyst for CBS radio with a focus on business and the economy. Mr. Loeb is the former managing editor of Fortune and Money and senior editor of Time for Time, Inc. "Parkinson's is a good candidate to lead other neurological conditions in this pilot effort because of the active community advocating for enhanced scientific research and new therapy development," stated Perry Cohen, Ph.D., who serves as a patient representative at the FDA on the Deep Brain Stimulation Advisory Panel.
60 Minutes Features GDNF Controversy
On Sunday, September 11, the CBS newsmagazine 60 Minutes aired a segment addressing the controversy surrounding the recently-halted clinical trials of glial cell line-derived neurotrophic factor, or GDNF, a growth factor that is believed to have potential in treating Parkinson's. PDF has consistently supported the patients who wished to continue with GDNF treatment and has urged further investigation to gather more scientific data about the long-term effects of GDNF.
CBS reporter Leslie Stahl talked with several of the participants from the GDNF trial, including Robert Suthers, whose family led the movement to reinstate the therapy for trial participants who wish it. Trial participants have taken the matter to court in Kentucky and New York, but judges in both cases ruled against them. The Kentucky case is currently on appeal.
The 60 Minutes broadcast included excerpts from a formal statement by Amgen, Inc., the manufacturer of GDNF, as well as testimony from Arthur Caplan, an ethicist consulted by the company on the GDNF issue. Both statements maintained that the weak evidence of efficacy in the human trials, and the suggestion of brain lesions in one of the animal trials, made it unethical to continue studies or permit compassionate use of GDNF to trial participants.
Many patient advocates, joined by several scientists, argue that had the efficacy trials followed the protocols of the earlier - and promising - safety trials, it might have been shown that the treatment worked. As to the animal trials, the patient advocates contend that the brain lesions found in some monkeys were caused not by GDNF, but by its sudden withdrawal. Advocates continue with their efforts to keep GDNF as a top priority in the Parkinson's community.
Although Amgen has maintained its original position on safety and efficacy, GDNF remains an area of intense interest amongst the scientific community. Researchers at the University of Kentucky have received government funding to continue studying GDNF, including evaluating dosing and administration techniques of the therapy, and several privately-funded studies are examining other delivery mechanisms for the long-term possibilities of GDNF.