Vogel's "FDA Moves against Penn Scientist" 2000

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Revision as of 14:45, 2 March 2010 (edit) 149.166.133.176 (Talk) (Created page with '===Abstract=== *Just put an asterisk as the first character to make a bullet point. **Put two asterices to make a sub point. *Put three single quote marks around text you want to…') ← Older edit		Revision as of 15:26, 2 March 2010 (edit) (undo) 149.166.133.176 (Talk) Newer edit →
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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 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 the same institution, 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.

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Revision as of 15:26, 2 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 the same institution, 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.