AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav March 14, 2002 Whistle-Blower SaysMarketers Broke the Rules to Push a Drug (Neurontin) FYI The New York Times reports that court papers in a civillawsuit "may provide a…
AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav March 8, 2002 FDA and Pharmaceutical Industry inPrivate Deal to Speed Drug Approval Process FYI According to the Washington Post, the FDA hasreached an agreement with the…
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…
AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav February 19, 2002 How a New FDA Policy Led toSeven Deadly Drugs FYI The Seattle Times reports, "Therelationship between the FDA and pharmaceutical industry changed fundamentallyunder former President…
AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav February 18, 2002 FYI The Fred Hutchison Center in Seattle WA has failedthree FDA inspections The Seattle Times reported on Sunday that aleukemia study at the Fred…
2000 Study by Merck Showed Vioxx Risk: Results Not Given to FDA – Star Ledger Sun, 3 Jul 2005 News reports reveal that Merck failed to disclose Vioxx lethal effects to the FDA. Sheldon Krimsky, a science policy expert at Tufts University states: “if there was evidence the drug was…
January 7, 2002 FYI MAD IN AMERICA (Perseus Press), a new book by Robert Whitaker, a prize winning science journalist, is sure to cause a stir. Whitaker holds psychiatry’s feet to the fire by examining the evidence in the professional psychiatric literature, FDA documents, published treatment outcome studies–including the World…
Studies Link Zyprexa to Diabetes & Deaths_Balt Sun Thu, 20 Mar 2003 Eli Lilly’s best selling drug, olanzapine (Zyprexa), originally approved for schizophrenia, then for bi-polar disorder, is prescribed widely. But the drug has been shown to produce early onset diabetes, severe hyperglycemia–and deaths. Adolescents and young adults appear to…
Text of AHRP Amicus Brief filed with the Maryland Court of Appeals in support of the Court’s ruling against Kennedy Krieger Institute for exposing children to lead poison in an experiment. The Court of Appeals Decision Validates AHRP’s Stand Against Using Children in Harmful Research Experiments.
Comments submitted by Vera Hassner Sharav, John H. Noble, Jr., Ph.D and Howard Fishman, MEd, MSW for AHRP
To: Dr. Bernard Schwetz Acting Commissioner Food and Drug Administration, Dockets Management Branch (HFA-305) Food and Drug Administration
Re: COMMENT ON: Docket #00N-0074 April 24, 2001 Interim Rule: "Additional Safeguards for Children in Clinical Investigations of FDA-Regulated Products
Excerpt: The FDA rightly chose not to permit the section 46.408 (c) waiver by IRBs of parental or guardian permission, as it leaves the specific circumstances for such a violation of parental rights to the discretion of local Institutional Review Boards (IRB). Given the stream of revelations of gross ethical and procedural violations at one after another of the nation’s premier research institutions, assumptions that “procedural safeguards are in place,” or that IRBs can be relied upon to make decisions that protect the best interests of human subjects – adults and children – has been debunked.
OHRP suspends Johns Hopkins Research license for Fed funded research July 19, 2001 The death of Ellen Roche, a healthy young woman before she was killed in a fatal hexamethonium inhalation experiment at Johns Hopkins University, has opened Pandora’s box, demonstrating that the safety of human research subjects has had…
Johns Hopkins Admits Fault in Fatal Experiment July 17, 2001 The experiment that killed Ellen Roche, a healthy 24 year old volunteer–who was clearly not informed about the risks she was incurring by breathing hexamethonium–demonstrates that there are no protections that ordinary people can rely on, when they become research…
