Vogel's "FDA Moves against Penn Scientist" 2000

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-	===Abstract===	+	*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.
-	*Just put an asterisk as the first character to make a bullet point.	+	*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.
-	**Put two asterices to make a sub point.	+	*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.
-	*Put three single quote marks around text you want to be '''bold''', perhaps for '''new terminology'''.	+	*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:
-	*Put two single quotes around ''things that should be italicized''.	+	**"repeatedly or deliberately violating regulations governing the proper conduct of clinical trials",
-		+	**enrolling ineligible patients in the trial,
-	===Introduction===	+	**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]].

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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.