Patient vs. Portfolio: ImClone_Salon December 9, 2002 Salon.com looks at how conflicts of interest impact on patients who are recruited to serve as subjects of clinical drug trials. “Patients affected by the ImClone scandal have been lost in the media’s rush to cover the tale of Martha Stewart and other…
Senate Passes Pediatric Research Equity Act Tue, 29 Jul 2003 Congress and the Bush Administration both are eager to test pharmaceutical products on children who cannot refuse to be test subjects. We at AHRP are in full agreement that medications used in children be thoroughly tested for safety, effectiveness and…
Dying for a Cure: Pediatric Cancer Trial Undisclosed facts – NBC, Chicago Thu, 14 Nov 2002 How can parents protect their children from harmful medical experiments if the facts are withheld from them? So far, Congress has enacted no law to protect children from experiments that disregard their life-safety in…
REASONS FOR OPPOSITION:
Researchers would not be required to first try approved treatments, if any exist, before entering the patient into a medical experiment that may be "risky."
Researchers would not be required to consult with an independent medical expert, a non-researcher who would consider the patient’s best medical interests as paramount.
Researchers would not be required to disclose their own professional and financial interests deriving from the experiment.
Researchers would not be required to fully disclose to the patient’s family what happened to other patients who had already participated in the experiment.
Yale engages in fishing expedition in to expand neuroleptic drug market.
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 March 1, 2002 Anti-Depressant Drug Trials are Rigged FYI “When you take any medicine you assume it’s been foundto be effective for your condition.” But a Brown…
"The voluntary consent of the human subject is absolutely essential," reads the Nuremberg Code of 1947, which was drafted in direct response to the sheer barbarity of Nazi-era medical experiments on Jews and other captive groups.
AHRP Alliance for Human Research Protection AHRP Speaks Out Return to Home PageAHRP Speaks Out Press ReleasesOctober 29, 2001 FYI Widely disparate perspectives are presented in an article in the Maryland Daily Record re: The Court of Appeals of Maryland decision (Gimes v Kennedy Krieger Institute, Aug 16, 2001). That…
