Vogel's "FDA Moves against Penn Scientist" 2000
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*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. | *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. | + | *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'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 | + | *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", | **"repeatedly or deliberately violating regulations governing the proper conduct of clinical trials", | ||
**enrolling ineligible patients in the trial, | **enrolling ineligible patients in the trial, | ||
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*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. | *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. | *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]]. | ||
Current revision as of 19:54, 7 March 2010
- 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.
