FDA approves anti-psychotic, clozapine, to treat suicide

FDA approves anti-psychotic, clozapine, to treat suicide December 20, 2002 The first of the so-called atypical antipsychotic drugs, clozapine (Clozaril), has been approved by the FDA as a treatment against suicide in patients with schizophrenia. The drug has been hailed as a miracle for some, but deadly for others. The…

AHRP Comments on Smallpox Vaccine Testing on Children 2 to 5 Years of Age

Recent public and professional debate about smallpox vaccine and its risks provides the framework for evaluating the ethical justification for conducting clinical trials on children. Dryvax is a particularly impure product made of live vaccinia virus harvested from the pustules of calves infected with (it is believed) cowpox. Although the vaccine, which is scratched on the skin, only causes mild infections in most people, in a small but significant number the infection caused serious adverse reactions similar to the complications of the disease they were designed to prevent: painful, disfiguring skin disorders, blindness, neurological impairments and death.

Documents Show Drug Company Promotion of Unproven Drug – NYT

Documents Show Drug Company Promotion of Unproven Drug_NYT Tue, 29 Oct 2002 Internal company documents unsealed in a federal lawsuit reveal how the unholy alliance between doctors and drug companies has corrupted medical practice and defrauded the US taxpayer. Although it is illegal for drug companies to promote a drug…

AHRP Replies to OHRP Response re Surrogate Consent (ARDS Study)

Thank you for your considered response to our July 29 letter to the director of the Office of Human Research Protection.

We are astonished to learn that OHRP found that all 12 major research institutions involved in this multi-site trial had violated Federal protections (45 CFR 46.117):

(a) "in all cases OHRP found that the informed consent documents approved by the institutional review boards (IRBs) for the research failed to describe adequately the reasonably foreseeable risks and discomforts of the research."

Acute Respiratory Distress Syndrome – ARDSNet experiment criticized – OHRP

Acute Respiratory Distress Syndrome – ARDSNet experiment criticized – OHRP Fri, 28 Feb 2003 An Acute Respiratory Distress Syndrome (ARDS) study conducted between 1996 and 1999, on critically ill patients at 20 medical facilities (14 major research centers belonging to the ARDS Network), was published in The New England Journal…

Article

Why did OHRP SHRED informed consent documents? Sat, 25 Oct 2003 China Daily’s premier medical correspondent, XIONG LEI, raises embarrassing questions that should trouble Americans, not just the bioethics and research community. She makes a plea for justice for some 200,000 Chinese farmers who were used in 12 genetic experiments…

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.