THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) New York, NY 10023 212-595-8974 July 29, 2002 Greg Koski, MD, Ph.D. Office of the Secretary Office of Public Health and Science Office of Human Research Protection The Tower Building 1101 Wooten Parkway, Suite 200 Rockville, MD 20852 RELATED PAGES OHRP Investigation of…
High Mortality Rates in Clinical Trials Mon, 4 Nov 2002 Serious concerns are being raised about the high death rate in clinical trials. According to several articles in the American Journal of Respiratory and Critical Care Medicine, the lives of critically ill patients have been put at increased risk due…
Dr. Meryl Nass
An estimated 500,000 first responders, lab and hospital workers will receive smallpox vaccine, the DHHS announced yesterday.
This is an interesting announcement, because to my knowledge there exist no FDA-licensed smallpox vaccines.
There are three vaccine candidates whose safety and efficacy are uncertain at this time.
The first vaccine made available was Wyeth’s Dryvax, which was pulled out of storage after approximately thirty years.
Dissenting Opinion (NHRPAC Children Workgroup) re: Proposed Reinterpretation of Fed. Regs Protecting Children (45 CFR 46, sections 404 and 406) May 14, 2002 To: Alan Fleischman, MD, Chair, Children’s Workgroup of NARPAC Mary Faith Marshall, Ph.D., Chair, NARPAC From: Vera Hassner Sharav Re: Dissenting Opinion re: Report to NHRPAC, proposing…
Presented by Vera Hassner Sharav
14th Tri-Service Clinical Investigation Symposium
Sponsored by The U.S. Army Medical Department and The Henry M. Jackson Foundation for the Advancment of Military Medicine
The cornerstone of public trust in medical research is the integrity of academic institutions and the expectation that universities, which rely on public funding, have a responsibility to serve the public good. Financial conflicts of interest affect millions of American people – those who are subjects of clinical trials testing new drugs and those who are prescribed drugs after their approval.
CONFLICTS OF INTEREST Presented by Vera Hassner Sharav 14th TRI-SERVICE CLINICAL INVESTIGATION SYMPOSIUM Sponsored By THE U.S. ARMY MEDICAL DEPARTMENT And THE HENRY M. JACKSON FOUNDATION FOR THE ADVANCMENT OF MILITARY MEDICINE May 5-7, 2002 The cornerstone of public trust in medical research is the integrity of academic institutions and…
Current federal regulations set no limits on the level of risk that a competent adult may voluntarily choose to undertake for the sake of science. The regulations require prior approval by a review board (IRB) to ensure the research meets scientific and ethical justification, to ensure that the risks and benefits (if any) are fully disclosed to the subject, and that the subject can exercise the right to give or withhold informed consent.
AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav April 19, 2002 DHHS / FDA flip-flopsecond time re: " pediatric rule" FYI Tommy Thompson, Secretary of The Department of Health andHuman Services has reversed the FDA’s…
Abortion Pill Tested in clinical Trials for Severe Depression_NYT Mon, 28 Oct 2002 The New York Times reported that Corcept Therapeutics is testing the controversial abortion pill, Mifepristone (formerly known as RU-486, brand name, Mifreprex), in clinical trials for the treatment of severe depression. The article uncritically transcribed the sponsors’…
AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav April 9, 2002 Debate on Value of ScreeningTests for Cancer FYI Today’s Science section in The New York Timesprovides the kind of critical reporting that has not…
AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav April 8, 2002Testing Drugs On Children: A Collision ofInterests FYIThe New York Times editorial (below) berates the Bush administration forabandoning (what they call) "a farsighted regulation designed…
AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav March 25, 2002 Federal Agency Does Not Adequately Enforce Federal Standards of Ethics andSafety. FYI The Boston Globe takes a critical look at the federalOffice of Human…
