Recent developments in gene transfer research: risk and ethics Mon, 10 Jan 2005 An analysis by Dr. Jonathan Kimmelman, in the British Medical Journal provides an illuminating, clearly articulated discussion about the ethical dilemmas that challenge gene transfer experiments – essentially a kind of human genetic engineering involving somatic cells,…
GlaxoSmithKline CEO: “We had to absorb a number of hits” Mon, 16 Feb 2004 Antidepressant drug safety issues are beginning to have a financial impact. Dow Jones reports: “GlaxoSmithKline PLC said its net income fell 6% in the fourth quarter, hurt by previously announced legal costs related to its anti-inflammatory…
FDA Alert: Effexor warnings added for neonatal adverse effects and suicidality risk Tue, 29 Jun 2004 On June 28, the FDA and Wyeth issued a new MedWatch drug Alert to healthcare professionals: “Neonates exposed to Effexor, other SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors), or SSRIs (Selective Serotonin Reuptake Inhibitors), late…
July 26, 2002 2,610 Infants died of preventable hospital-acquired infections – Chicago Tribune FYI President Bush would limit health care liability http://www.nytimes.com/2002/07/26/politics/26BUSH.html . Clearly neither he nor his advisers have considered The Chicago Tribune’s investigative series, Unhealthy Hospitals (excerpt below). This Tribune series should be required reading for members of the various research…
Fewer Kids Prescribed Drugs for Depression – WashPost Wed, 2 Feb 2005 A report by Medco revealing a decline in SSRI prescriptions for children is giving drug industry stakeholders nightmares about the cash flow. The Washington Post reports "medical groups such as the American Psychiatric Association and the American Academy…
Evidence of Antidepressant Harm that the FDA Sought to Suppress from FDA’s Public Advisory Committee Meeting on February 2 Evidence was presented on February 2 at AHRP’s press briefing by the following scientists: David Healy, MD, Director of the North Wales Department of Psychological Medicine and Visiting Professor, University of…
Additional information as of late Wed Oct 19: Although I was assured that attendance for a presentation by Dr. David Healy (at Columbia University School of Public Health on Oct. 20 at 12:30) would be open to the public, a problem seems to have emerged after an AHRP Infomail about…
Lilly duloxetine drug trial–19 Quit after a suicide – Philadelphia Inquirer Fri, 13 Feb 2004 19-year old Teri Johnson’s suicide occurred one week after an FDA advisory committee had urged the FDA to issue warnings about prescribing antidepressant drugs for children under 18 because of an increased risk in suicide….
Senator Jeff Bingaman resolution: Review military vaccine program Thu, 4 Dec 2003 After months of denial, on Nov. 19, the Pentagon acknowledged that multiple vaccines may have caused the death of Army nurse Rachael Lacy, who died in April after receiving shots for anthrax, smallpox and three other diseases. Critics…
Director of OHRP Dr. Greg Koski resigns Date: Wed, 16 Oct 2002 Dr. Greg Koski has tendered his resignation as director of the federal Office of Human Research Protections. We agree, in principle, with Dr. Koski’s assessment: “to preserve public trust in research, the scientific community must go beyond a…
Forbes: Judgment Day for the FDA, Pfizer Wed, 9 Feb 2005 On Feb. 16-18 COX-2 Inhibitor Safety Issues will be the focus of an FDA Advisory Committee and (simultaneously) the European Medicines Agency (EMA). The entire drug industry will be watching with bated breath. Which causal explanation will be offered…
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 Abstract This paper argues that contrary to the claims made by the research stakeholders in industry, academia and government, the…
