Editing 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 [http://en.wikipedia.org/wiki/Jesse_Gelsinger 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 [[Cystic fibrosis lectures#Jesse_Gelsinger_case| the outcome]].