Vogel's "FDA Moves against Penn Scientist" 2000

The FDA has started proceedings that will end in a ruling as to whether Dr. James Wilson will be able to continue clinical trials of gene therapy.
Wilson lead the University of Pennsylvania's clinical trial on gene therapy in which 18 year old Jesse Gelsinger died after treatment.
The FDA's harshest penalty for a researcher is that of disqualification which bars them from receiving drugs for administration to patients--effectively arresting their ability to perform clinical trials.
The FDA sent letters two Wilson and two collaborators (Raper of Penn and Batshaw of the Children's National Medical Center) that listed the claims being brought against them, which include:
- "repeatedly or deliberately violating regulations governing the proper conduct of clinical trials",
- enrolling ineligible patients in the trial,
- not halting the trial upon evidence of severe side effects,
- not informing participants that a similar drug had severely sickened monkeys.
Wilson has 30 days to respond to the letter from the FDA, at which point they will review his response and make a final decision on his disqualification.
One quoted researcher says this is a drastic step while another says that harsh and critical regulation by the FDA will ultimately strengthen gene therapy research.
In class, we learned about the outcome.