Health - Gene Therapy

Gene Therapy

Adverse Event Data From Gene Therapy Trials Overseen By The National Institutes of Health (NIH) Suggests NIH's Oversight Has Been Inadequate

History of the Correspondence on Gene Therapy

June 26, 1996
Letter from Representative Waxman, Senator Ron Wyden, Senator David Pryor and Senator Mark Hatfield to Dr. Harold Varmus, now former Director of NIH

January 10, 1999
Letter from Representative Waxman to Dr. Kirschstein regarding December 21, 1999 letter from Dr. Varmus

November 23, 1999
Letter from Representative Waxman to Dr. Varmus regarding deaths in protocols overseen by RAC and FDA

December 21, 1999
Letter from Dr. Varmus to Representative Waxman in response to Waxman´s November 23, 1999 letter

January 31, 2000
Letter from Representative Waxman to Dr. Kirschstein requesting copies of the 652 adverse event reports from NIH

February 1, 2000
Letter from Dr. Kirschstein to Representative Waxman in response to Waxman´s January 10, 2000 letter

February 9, 2000
Letter from Lana Skirboll, PhD, Director of NIH´s Office of Science Policy, Representative Waxman accompanying delivery of adverse event reports from NIH

February 23, 2000
Letter from Representative Waxman to Dr. Ruth Kirschstein, Acting Director of NIH