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Public Comments Re: Smallpox Vaccine Trial on 2 to 5 Year Old Children The Code of Federal Regulations (45 CFR 46.407) requires that any experiment involving children which puts them at greater than minimal risk without a potential benefit to justify the risk, requires the Secretary of Health and Human…
Federal Court (Illinois) Rejects FDA-Daniel Troy Preemption Argument
Federal Court (Illinois) Rejects FDA-Daniel Troy Preemption Argument Fri, 11 Nov 2005 In yet another federal case (Zikis v Pfizer) involving the company’s failure to warn physicians and the public about the increased risk of suicide effects for pediatric patients prescribed Zoloft, the court rejected Pfizer’s argument that it didn’t need to war…
Physician Attacks AHRP for Criticizing EPA CHEERS Pesticide Experiment on Children
Physician Attacks AHRP for Criticizing EPA CHEERS Pesticide Experiment on Children Fri, 16 Sep 2005 AHRP’s opposition to EPA’s proposed rules on human pesticide experiments–in particular rules that would allow children to be subjected to pesticide experiments–was criticized by a physician who accuses those opposed to the infamous CHEERS experiment,…
Prozac Suicide Risk – CNN Posts long concealed Eli Lilly Internal Documents
Prozac Suicide Risk – CNN Posts long concealed Eli Lilly Internal Documents Tue, 4 Jan 2005 An internal company document titled Activation and Sedation in Fluoxetine Clinical Trials dated 11/8/1988, provides insight into how marketing divisions of pharmaceutical companies rationalize lethal adverse drug effects. Of note: the terminology in 1988…
Cong Hearing Re: Disclosure Pediatric SSRI Trials
Cong Hearing Re: Disclosure Pediatric SSRI Trials Wed, 7 Jul 2004 A hearing has been tentatively set for July 20th by the House subcommittee on oversight and investigations, chaired by Congressman James Greenwood. The hearing will address issues of disclosure involving pediatric antidepressant drug trials–or more accurately, non-disclosure of adverse…
FDA Tones Down Warning–Shyra Kallas an SSRI Suicide Victim
FDA Tones Down Warning–Shyra Kallas an SSRI Suicide Victim Fri, 4 Mar 2005 In his recent testimony before the Senate Health, Education, Labor, and Pensions committee, Dr. David Fassler, representing the American Psychiatric Association (APA) and the American Academy of Child and Adolescent Psychiatry (AACAP), misrepresented the scientific facts about…