Dissenting Opinion – Proposed Children’s Workgroup Reinterpretation of Fed Regs 45 CFR 46 sects. 404 & 406

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…

Conflicts of Interest in Clinical Trials

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.

Sharav Presentation before US Army Medical Dept., May 6, 2002

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…

Protecting Human Subjects in Research: Are Current Safeguards Adequate?

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.

Abortion Pill Tested in clinical Trials for Severe Depression – NYT

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’…

InfoMail for April 17, 2002

  AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav April 17, 2002 Scandal: Scientists Take Cash forGhostwritten Papers FYI The pharmaceutical industry has gained unprecedentedcontrol over research data. The published papers ended up being written byghostwriters–company…

InfoMail for April 12, 2002

  AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav April 12, 2002 If Placebo Works Without Risk,Side-Effects or Cost — Why Prescribe Anti-Depressant Drugs? FYI As we reported in yesterday’s Infomail, a major governmentfunded study found…

InfoMail for April 10, 2002

  AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav April 10, 2002 For Relief of ModeratelySevere Depression, Study Shows No Significance Difference Among Placebo, Zoloftand  St. Johns Wort — JAMA  FYI The findings of a major…

InfoMail for April 7, 2002

  AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav April 7, 2002 Lancet: Just How Tainted Has Medicine Become? FYI The prestigious British journal, The Lancet,reports that "Total retail spending on prescription drugs was US $155billion in…

InfoMail for March 1, 2002

  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…

InfoMail for February 26, 2002

  AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav February 26, 2002  FYI Severe Side Effects Reported forClozaril Drug induced inflammation of the heart (myocarditis) isone of several potentially fatal side effects of the so-called ‘atypical’antipsychotic…

InfoMail for February 22, 2002

  AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav February 22, 2002  Alzheimer’s Drug Tests Halted When 12Volunteers Contract Encephalitis FYI The culture that led to the death of 19-year old, NicoleWan, a University of Rochester…