FDA response to AHRP procedural questions From: Cerny, Igor Sent: Wednesday, January 07, 2004 11:52 AM To: Cc: Patel, Anuja; Laughren, Thomas P Subject: RE: FDA Advisory Committee Meeting: Procedural Concerns Follow Up Flag: Follow up Flag Status: Flagged Dear Ms. Sharav: Thank you for your email of December 1,…
April 2003. American Journal of Bioethics. Children in Clinical Research: A Conflict of Moral Values. Vera Hassner Sharav http://mitpress.mit.edu/journals/AJOB/3/1/sharav.pdf ABSTRACT (attached & below) This paper examines the culture, the dynamics and the financial underpinnings that determine how medical research is being conducted on children in the United States. Children have…
Simply put, I am opposed to the vaccine study. These children’s immune systems are not yet fully mature and I feel their systems are already overwhelmed by the numerous vaccines they are given. Why risk a live virus vaccine in our country where no cases exist? I feel the threat…
Smallpox Comments Sent: Saturday, November 30, 2002 11:46 PM “I DO NOT support the smallpox vaccine study, Docket No. 02N-0466.” However, I would consider supporting the study if it involves only the children and grandchildren of the people proposing, advocating and conducting the study. You have no right to use…
Public Comments Re: Smallpox Vaccine Trial on 2 to 5 Year Old Children Personally, I think it’s a bad idea to test the smallpox vaccine on children. Especially because of side effects. I can’t imagine anyone I know who has a child between theses agea allowing their child to be…
Public Comments Re: Smallpox Vaccine Trial on 2 to 5 Year Old Children I find this study to be unnecessary and wasteful. If the desired outcome is to discover if we can stretch our supply of the vaccine, it seems wise to me to trade some of our $300 toilet…
Public Comments Re: Smallpox Vaccine Trial on 2 to 5 Year Old Children I wholeheartedly oppose the use of administering a smallpox vaccine to small children in a randomized study. More controls need to be made to ensure the children’s safety in this situation, and there is too great of…
Public Comments Re: Smallpox Vaccine Trial on 2 to 5 Year Old Children Being proactive is generally a good idea. But in the absence of a definitive outbreak it is difficult to justify exposing pediatric patients to potential risks such as neurologic complications which may not show up for years….
Anne, comments 1, 2, 3 are (more or less) short repeats… the others are more substantive so I separated them vera Sent: Monday, December 02, 2002 6:07 AM Subject: RE: Docket No. 02N–0466 I DO NOT support the smallpox vaccine study, Docket No. 02N–0466. I oppose this study!!! Vaccines are…
More detailed comments Children should not be tested for the Dryvax vaccine for the following reasons: 1) The original trials for the Dryvax vaccine already show that children respond similarly to adults when administered this substance. Since the effective dosage for adults has already been tested, it would be…
Public Comments Re: Smallpox Vaccine Trial on 2 to 5 Year Old Children The Code of Federal Regulations (45 CFR 46.407) requires that any experiment involving children which puts them at greater than minimal risk without a potential benefit to justify the risk, requires the Secretary of Health and Human…
The Children’s Hospital of Philadelphia Department of Anesthesiology and Critical Care Medicine Robert M. Nelson, M.D., Ph.D. 34th Street & Civic Center Boulevard, Rm. 1513 Chair, Committees for the Protection of Human Subjects Philadelphia, Pennsylvania 19104-4399 Associate Professor of Anesthesia and Pediatrics (215) 590-9180 Office (267) 426-5035 Fax November 25,…
