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…
Public Comments Re: Smallpox Vaccine Trial on 2 to 5 Year Old Children I find this study to be unnecessary and wasteful. If the desired outcome is to discover if we can stretch our supply of the vaccine, it seems wise to me to trade some of our $300 toilet…
Jan 22, 1999 SCIENCE Volume 283, Number 5401, 22 Jan 1999, pp. 464 – 465 BIOETHICS NIMH to Screen Studies for Science and Human Risks Eliot Marshall For more than a year, patient activists and ethicists have been calling for a revolution in the way clinical studies in psychiatry are…
FDA Accepts Adverse Drug Reaction Reports from Consumers Sun, 22 Jun 2003 Doctors report only 1% to 10% of adverse drug reactions experienced by their patients to FDA’s MedWatch service. The FDA has extended an invitation to the public to submit adverse drug reaction reports directly to the agency: http://www.fda.gov/medwatch/report/consumer/consumer.htm…
Commonly recommended Treatments found Worthless Wed, 19 Mar 2003 Independent analyses of the clinical studies upon which widely recommended drug treatments have been based, have now been found to be fatally faulty, and the drugs are deemed worthless. An analysis of 83 studies found that drugs used to treat 90,000…
Pfizer Nears Drug Settlement Sun, 16 Mar 2003 A 7-year lawsuit filed by Dr. David Franklin, the former Harvard fellow turned whistle blower, may be reaching a resolution. The suit accuses Warner Lambert (now Pfizer) of illegally promoting the epilepsy drug, Neurontin, for conditions not approved or tested. His lawsuit…
British Government Issues New Warnings Re: Use of antidepressant drugs for children Tue, 23 Sep 2003 related link: U.K. Government Document – New SSRI Warnings for Children In light of evidence from previously unexamined data from controlled clinical trials, the British Committee on Safety of Medicines (CSM), an arm of…
Medscape Cites AHRP Concerns Re: New Law Mandates More Testing of Drugs in Children Wed, 17 Dec 2003 Medscape Medical News reports about passage of the Pediatric Research Equity Act (PREA) which replaces FDA’s Pediatric Rule. The Pediatric Rule was struck down by a Federal court in Oct. 2002 because…
British Psychiatrists Debate: “Clinical trials of antidepressant medications are producing meaningless results” Wed, 27 Aug 2003 “The fact that most people support the psychopharmacological orthodoxy is, in itself, no argument and it is important to examine the evidence before drawing conclusions.” The psychiatric establishment is on trial–its foundation and claimed…
2,000 children to get experimental malaria vaccine_Nature / BBC Tue, 22 Jul 2003 Malaria kills millions of African children yearly. For many decades malaria vaccines have been sought but have been dismal failures. NATURE and BBC report that a vaccine experiment will be conducted in 2,000 children in Mozambique–even though…
Hopkins Study: Medical Consent Forms Confusing Wed, 19 Feb 2003 A Johns Hopkins study reviewed the template of informed consent forms of 114 campuses– nearly all the country’s accredited medical schools. It applied two widely used readability tests and found the consent forms approved by local institutional review boards (IRB)…
Seroxat (known as Paxil in the USA) is the subject of a major BBC-TV documentary (Panorama), to be shown on Sunday, 13 October 2002. Sent Fri Oct 11, 2002 The manufacturer of the worldís best selling antidepressant, GlaxoSmithKline, has been ruled in breach of the pharmaceutical industry ís own code…
