Infomail Archive 2003

Infomail Archive 2003 News Stories on Human Research Protection and Commentary by Vera Hassner Sharav Dec 19, 2003: Eli Lilly Prozac UK Fact Sheet: “Not Recommended” for Children – PMDD Withdrawn in UK Dec 19, 2003: Not-So-Public-Relations: Drug Industry & Bioethics – is it casuistry or sophistry? Dec 18, 2003:…

References: Impact of FDA inclusion of children as test subjects

References for THE IMPACT OF THE FDA MODERNIZATION ACT ON THE RECRUITMENT OF CHILDREN FOR RESEARCH Vera Hassner Sharav Published in ETHICAL HUMAN SCIENCES & SERVICES Summer 2003, vol. 5 pp. 83-108 Agency for Health Care Research & Quality. (1999). Treatment of attention-deficit/hyperactivity disorder: Summary, evidence Report / Technology assessment…

MassHealth: Children overwhelmed with Psychiatric Drugs_Globe

MassHealth: Children overwhelmed with Psychiatric Drugs_Globe Sun, 9 Mar 2003 The Boston Globe reports that the top official for health and human services in Massachusetts plans to take action to stem the abusive “haphazard” prescribing of psychiatric drugs for children: “The use of stimulants, antidepressants, and antipsychotics among children has…

18 Deaths Linked to drug – Serzone Removed from European market, not US

18 Deaths Linked to drug – Serzone Removed from European market, not US Fri, 17 Jan 2003 Bloomberg News reported that the antidepressant, Serzone had been linked to 25 cases of liver damage and 18 deaths. On Jan 8, 2003 European authorities removed the drug from the European market. On…

Infomail Archive Pre 2003

Infomail Archive – Pre 2003 News Stories on Human Research Protection and Commentary by Vera Hassner Sharav December 28, 2002: Will 2 to 5 year old Amer. kids be exposed to Smallpox Vaccine? Israeli Intelligence says “No immediate threat” December 24, 2002: Moral turpitude: Herpes experiment surpasses Tuskegee December 20,…

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…

Infomail Archive

July 15, 2002 Short Drug Tests, Fatal Flaws. Thomas J. Moore. Op Ed. Boston Globe. FYI “We need new laws, a national scientific program, and money to assure that every important drug intended for long-term use receives the same long-term testing as was provided for hormone replacement therapy.” An Op-ed…

Harvard research in China: Open Letter to Pres. Summers

Harvard research in China: Open Letter to Pres. Summers Sat, 12 Apr 2003 On May 15, 2002, The Boston Globe reported that Lawrence Summers, the President of Harvard University, “expressed deep regret that a dozen Harvard-run genetic studies in China failed to give test subjects adequate information about potential pitfalls.”…

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…