Letter Submitted to New England Journal of Medicine re ARDS Investigation

The April 3, 2003 New England Journal of Medicine (NEJM) issue contained an array of articles largely in support of a disputed multi-site, clinical trial sponsored by the National Heart, Lung, and Blood Institute (NHLBI), one of the National Institutes of Health (NIH), involving critically-ill, mentally incapacitated human beings with acute respiratory distress syndrome (ARDS) – who did not give their informed consent.

The accompanying editorial, "Controlling Research Trials," by Dr. J.M. Drazen, who serves on the NHLBI advisory committee that had approved the disputed trial, reveals much about the NIH attitude toward the rest of the world.

FDA Warning Letter Re: Fatal Experiment: Hexamethonium Inhalation_Johns Hopkins

FDA Warning Letter Re: Fatal Experiment: Hexamethonium Inhalation_Johns Hopkins Tue, 22 Apr 2003 An FDA Warning Letter was sent to Dr. Alkis Togias of the Johns Hopkins University Asthma & Allergy Center (March 31, 2003). The letter lists specific federal safety requirements and their violation in the hexamethonium inhalation experiment…

Children are Humans: Don’t Sacrifice their Rights, Dignity & Welfare

We are writing about the Pediatric Research Equity Act of 2003 (S 650). We are in full agreement that children should have the same safeguards as adults; that medications used in children be thoroughly tested for safety, effectiveness and appropriate dose. However, S 650 does not do this. Instead, it requires that children be used to test all drugs as a condition of licensure by FDA – unless a waiver is obtained from the Secretary of the department of Health and Human Services under section 505B.

Former President of Amer Heart Assoc Caught in Fraud – BMJ

Former President of Amer Heart Assoc Caught in Fraud – BMJ December 14, 2002 The British Medical Journal reports about the FDA took action against American cardiologist Dr. David Faxon, immediate past president of the American Heart Association for medical ethics violations, such as: falsification of data, false claims about…

Ethics Questioned in Lung Disease Trial–Feds Demand Patient Data – Newhouse News

Ethics Questioned in Lung Disease Trial–Feds Demand Patient Data – Newhouse News December 13, 2002 A news breaking story by Bruce Seeman of Newhouse News (excerpts below) reveals a major systemic breakdown in medical ethics–“there’s something rotten in the state of [biomedical research].” Complaints about a lung disease air ventilation…

Article

THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Tel. 212-595-8974             142 West End Ave Suite 28P                     FAX: 212-595-9086 New York, NY 10023 www.ahrp.org December 5, 2002 Mr. Edward Swindell Acting Associate General Counsel for Ethics Office of General Counsel, Ethics Division Department of Health and Human Services 200 Independence…

Article

THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Tel. 212-595-8974               142 West End Ave Suite 28P               FAX: 212-595-9086 New York, NY 10023 www.ahrp.org December 5, 2002 Mr. Edward Swindell Acting Associate General Counsel for Ethics Office of General Counsel, Ethics Division Department of Health and Human Services 200 Independence Ave. SW…

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.

Do the Ends Justify the Means in Human Research?

Do the Ends Justify the Means in Human Research? Thu, 5 Sep 2002 A moral struggle is taking place in which research stakeholders–including medical institutions that profit from biomedical research, and their emissaries in government oversight agencies–argue that ethics should be breached to further the interest of research. Patients’ rights…

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."