Bioethics


FDA: regulatory protections for children. Comments submitted by Vera Hassner Sharav, John H. Noble, Jr., Ph.D and Howard Fishman, MEd, MSW for AHRP August 6, 2001 To: Dr. Bernard Schwetz Acting Commissioner Food and Drug Administration Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, […]

FDA: Regulatory Protections for Children. Comments by Sharav, Noble, & ...


Bayh-Dole Act: The Law of Unintended Consequences – Fortune Sun, 25 Sep 2005 The author of this Infomail is Dianne N. Irving, M.A., Ph.D. Revisiting the Bayh-Dole Act (1980): Spawned Big Biotech, Now Has Opposite Debilitating Effects Today’s specter of harmful and inordinately priced drugs pressed on legislators and the […]

Bayh-Dole Act: The Law of Unintended Consequences – Fortune




AHRP Campaign to Protect Children from Harm Oct 15: FDA Orders Black Box Warnings on Antidepressants labels and Patient Information Guides to Warn about Suicide risk Oct 3: BBC PANORAMA TONIGHT – Taken on Trust – 13 years-Medical Deception Sep 30: GSK Sales Reps told NOT to Divulge Paxill Data […]

Research Protection for Children


Junk Science Hits Front Page Headlines: Most Americans Will Be Mentally Ill at Some Point – NIMH / Harvard Study Says Tue, 7 Jun 2005 Americans may be astonished to learn that $20 million in taxpayers’ money was spent on a study whose unacknowledged purpose is to increase the use […]

Junk Science Hits Front Page Headlines: Most Americans Will Be ...


October 18, 2002. Pediatric Drug Tests_CNN / NYT Editorial Children are increasingly being exploited for profit by the biomedical industry. Between 1983 and 1997, children had been protected from medical experiments that are not in their best interest. But in 1997 Congress passed the FDA Modernization Act (FDAMA), providing a […]

Pediatric Drug Tests – CNN / NYT Editorial



April 2003. American Journal of Bioethics. Children in Clinical Research: A Conflict of Moral Values. Vera Hassner Sharav http://mitpress.mit.edu/journals/AJOB/3/1/sharav.pdf ABSTRACT (attached & below) This paper examines the culture, the dynamics and the financial underpinnings that determine how medical research is being conducted on children in the United States. Children have […]

Children in Clinical Research: A Conflict of Moral Values


Charitable Choice: Research Grants–Juvenile Diabetes Research Foundation – National Journal Tue, 8 Mar 2005 The Washington Post reports that conservatives have crafted a “bioethics agenda” on cloning and stem cell research. Such an agendaq determines what research the government will and will not fund. http://www.washingtonpost.com/wp-dyn/articles/A15569-2005Mar7.html Below is an excerpt of […]

Charitable Choice: Research Grants–Juvenile Diabetes Research Foundation – National Journal


OHRP Found NHLBI Lung Experiments Violated Informed Consent Mon, 7 Jul 2003 On July 3 the federal Office of Human Research Protections (OHRP) issued a stinging indictment of the research review and approval process at some of the nation’s most prestigious research institutions–including the National Heart Lung and Blood Institute […]

OHRP Found NHLBI Lung Experiments Violated Informed Consent



Ethical Violations / Investigations Today Congressional Investigations Office of Human Research Protections (OHRP) Letters of Determination: http://ohrp.osophs.dhhs.gov/detrm_letrs/lindex.htm Office of Protection from Research Risks* (OPRR) List of Compliance Oversight Investigations Resulting in Restrictions or Actions to federally licensed Institutions between 1990 – 2000. *Reorganized in 2000 as OHRP Mar 30: AHRP […]

Ethical Violations and Investigations Today