Gene therapy investigations proliferate
Article Abstract:
Jesse Gelsinger is the first person to have died from gene therapy, and controversy surrounds the issues of informed consent and documentation and reporting violations in this case. All 7 gene therapy trials initially authorized by the Food and Drug Administration have been suspended until the investigation is complete.
Publication Name: Nature Medicine
Subject: Health
ISSN: 1078-8956
Year: 2000
User Contributions:
Comment about this article or add new information about this topic:
New measures introduced to monitor gene therapy trials
Article Abstract:
The US FDA will closely examine all clinical trial monitoring plans submitted by gene therapy researchers following the death of a patient who received gene therapy. The National Institutes of Health will even visit trial sites to make sure researchers understand the requirements for reporting adverse reactions.
Publication Name: Nature Medicine
Subject: Health
ISSN: 1078-8956
Year: 2000
User Contributions:
Comment about this article or add new information about this topic:
Gene patent revisions to remove some controversies
Article Abstract:
The US Patent and Trademark Office will no longer award patents based on expressed-sequence tags (ESTs). ESTs are cDNA fragments between 200 and 400 bases long and the USPTO claims these fragments are not sufficient to describe the genes they are associated with.
Publication Name: Nature Medicine
Subject: Health
ISSN: 1078-8956
Year: 2000
User Contributions:
Comment about this article or add new information about this topic:
- Abstracts: In the wake of insurance reform: states revamp laws to meet new federal rules. Dueling proposals for kids' health insurance; lawmakers seeking plan everyone can live with
- Abstracts: Methylnaltrexone for Reversal of Constipation Due to Chronic Methadone Use: A Randomized Controlled Trial. Herbal Medicines and Perioperative Care
- Abstracts: The Rapid Test Paradox: When Fewer Cases Detected Lead to More Cases Treated. Medical Care Expenditures for Genital Herpes in the United States
- Abstracts: Managing the confused patient. Mirror, mirror on the wall. How come we're losing if we scored the equaliser?
- Abstracts: Reduction of postoperative pain: a double-blind, randomized clinical trial. The performance of bonded vs. pin-retained complex amalgam restorations: a five-year clinical evaluation