JAMA Editor Should Apologize & Resign
JAMA Editor Ignites Firestorm By Calling Critic a ‘Nobody and a Nothing’_WSJ
Drug-induced Risk of Cardiac Death: NYS Advisory_APA Guidance
“Current users of typical and of atypical antipsychotic drugs had higher rates of sudden cardiac death than did nonusers of antipsychotic drugs.” NEJM 2009
Letter of Complaint to FDA Commissioner, 2007
Complaint about a surge of FDA administrative approvals for expanded use of highly toxic antipsychotic drugs for children. Approvals were determined by Dr. Thomas Laughren after secret deliberations–without disclosure of scientific data, without an advisory panel or open public discussion.
A Response to Dr. Richard Friedman’s Defense of TeenScreen
Dr. Karen Effrem refutes Dr Friedman who claims there is "a silent epidemic of mental illness among teenagers."
Role of Litigation in Defining Drug Risks_JAMA / BMJ
Documents uncovered during the course of litigation shed light on real risks of drug-induced harm that would not otherwise be known.
NEJM- Caught Covering Up for National Kidney Foundation–an indudstry front group
Readers of the New England Journal of Medicine should be forewarned: The information in the pages of the NEJM is tainted by industry influence, its professional and scientific integrity are tainted.
IRB Forum Not Inclined to Discuss the Most Serious Issue of All
Unssuccessful effort to engage debate within the community of the authorized clinical research gatekeepers charged with protecting the safety and welfare of the human subjects of research–i.e., members of institutional review boards (IRBs–REBs in Canada).
Hospital IRBs are “On the Take”–Tainted by Conflicts ofInterest_NEJM
A study in The New England Journal of Medicine shatters the last myth about the integrity of the current system of checks and balances in medical research.
Dangerous Deception: Hiding the Evidence of Adverse Drug Effects_NEJM
FDA's slip-shod approval of defective, harmful drugs, accompanied by rubber stampped endorsements by compromised FDA advisory committees may be reaching a boiling point.
Potent Narcotic ‘Lollipop’ Becomes Best Seller_WSJ
Off-label prescribing of drugs for unapproved uses puts consumers at high risk of harm–but it is the single most lucrative marketing strategy.
NIMH Chief Child/Adoles Research Blows Wind out TeenScreen Sails_ Los Angeles Times
"Some politicians, public health officials, mental health activists and pharmaceutical companies have worked to establish mental-health screening programs in schools and the community….Researchers and clinicians, meanwhile, say they are far from having developed accurate predictors of a child developing depression. The younger the child, the murkier the crystal ball."
Ethical Violations and Investigations Today
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…