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.
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Conflicts of Interest Hopkins Study: Researchers Don’t Want to Disclose $$
Two surveys confirm medical researchers' resistance to complying with conflict of interest disclosure requirements.
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Medicine In Conflict:Financial Tentacles in Cardiology_Business Week
Business Week reports: "From 1986 to 2003 the number of nonsurgical cardiac procedures, such as propping open arteries with wire-mesh stents, rose twelve fold, according to the American Heart Association.
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Public Comments Re: Smallpox Vaccine Trial on 2 to 5 Year Old Children, Pg 4
More detailed comments Children should not be tested for the Dryvax vaccine for the following reasons: 1) The original trials for the Dryvax vaccine already show that children respond similarly to adults when administered this substance. Since the effective dosage for adults has already been tested, it would be…
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Sharav / Cassidy – OHRP Testimony, 4/01
Testimony Submitted to the Office of Human Research Protection (OHRP) by Vera Hassner Sharav and Marie M. Cassidy, Ph.D, D.Sc. April, 2001 AHRP recognizes that to include children in clinical trials for any medication presents a dilemma of truly Solomonic proportions. It is a choice between continuing the practice of…
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Psychiatry’s Claims Re: Brain Imaging Have Far Outpaced Science – NYT
Psychiatry’s Claims Re: Brain Imaging Have Far Outpaced Science – NYT Tue, 18 Oct 2005 A front page report in The New York Times Science section pulls the rug out from yet another of psychiatry’s myths. Benedict Carey reports: “Not long ago, scientists predicted that these images, produced by sophisticated…
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Pediatric Drug Tests – CNN / NYT Editorial
October 18, 2002. Pediatric Drug Tests_CNN / NYT Editorial Children are increasingly being exploited for profit by the biomedical industry. Between 1983 and 1997, children had been protected from medical experiments that are not in their best interest. But in 1997 Congress passed the FDA Modernization Act (FDAMA), providing a…
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Suffer the Little Children in the Research for Cures_USA Today
Suffer the Little Children in the Research for Cures_USA Today Thu, 29 May 2003 USA Today focuses on safety issues affecting children who are being sought as human guinea pigs by the thousands. They are being recruited clinical trials to test new drugs– whose safety is unproven. “Was the death…
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AHRP in the News
Alliance for Human Research Protection in the Press Feb 17, 2005: FDA Critics Slam Plan for Safety Reform – Nature “This is smoke and mirrors and musical chairs,” says Vera Sharav, president of the New York-based Alliance for Human Research Protection. “They will be using the very same officials that…
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Children in Clinical Research: A Conflict of Moral Values
April 2003. American Journal of Bioethics. Children in Clinical Research: A Conflict of Moral Values. Vera Hassner Sharav http://mitpress.mit.edu/journals/AJOB/3/1/sharav.pdf ABSTRACT (attached & below) This paper examines the culture, the dynamics and the financial underpinnings that determine how medical research is being conducted on children in the United States. Children have…
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Ethics / Science of ARDS Controversy Continues – J Medical Ethics-BMJ
Ethics / Science of ARDS Controversy Continues – J Medical Ethics-BMJ Thu, 6 Oct 2005 The ethics and science of a controversial clinical trial sponsored by the US government and conducted at multiple sites by the ARDS Network comprising of prestigious academic medical centers is the subject of a continuing…
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Efforts to Expand Emergency Exception from Informed Consent
Efforts to Expand Emergency Exception from Informed Consent Thu, 6 Oct 2005 The following announcement posted to the IRB Forum by Dr. Robert Nelson, a KOL (key opinion leader) within the close-knit IRB community– who serve as gatekeepers of human research –demosntrates that the culture of secrecy is entrenched in…