“Nothing is more fundamental to the ethical conduct of clinical trials than the informed consent of research participants. The Nuremberg Code and every subsequent major international statement about ethics and medical research enshrine this role.” In his recent article in Science and Engineering Ethics, Dr. Mark Yarborough, Dean’s Professor of Bioethics at the University of…

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Candida auris is a fungus that presents multiple serious health threats that are especially concerning. It is difficult to identify, treat and contain; and it is especially persistent in that it is both resistant to treatment and to eradication methods. What makes this fungus very hard to eradicate is that it forms spores and a…

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Cluster failure: Why fMRI inferences for spatial extent have inflated false-positive rates, by Swedish neuroscientists Anders Eklund, Tom Nichols, and Hans Knutsson, published in the Proceedings of the National Academy of Sciences (2016) reveals the discovery of a major flaw in the software used by neuroscientists in functional magnetic resonance imaging (fMRI) studies. The software…

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I. Hormone replacement therapy (HRT) For decades the norm in clinical practice was to prescribe hormone replacement therapy, a combination of estrogen plus progestin to menopausal women – despite the lack of scientific evidence of its safety and benefits. Science journalist, Barbara Seaman, founder of the Women’s Health Initiative, had examined the evidence and for decades issued warnings…

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Three new studies–one,, a pharmaco-genetic study, is groundbreaking–confirm that widely prescribed psychotropic drugs that pose serious risks of harm, offer no therapeutic benefit.

 

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News and Analysis for Colleges, Universities and Teaching Hospitals

Big Drop in OHRP Letters, Open Cases Raise Questions of Agency Commitment

In 2010, the Office for Human Research Protections issued and posted 16 determination letters, the lowest number in its 11-year history and less than half the number issued in each of the previous five years. Since  2007, the office has averaged 35 letters a year, down from a peak of 146 in 2002 and another high of 86 in 2006.

The number of determination letters is tied to the number of cases OHRP opens, and during the recent past, that number has also declined, RRC has learned, tumbling to an all-time low of six in 2009. Some tie the decline in activity to the arrival of Jerry Menikoff, whose tenure as OHRP director began in the late fall of 2008.

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New York Times reporter Gina Kolata, broadcasts medical hype on the front page of the paper much the way Judith Miller broadcast hype fed to her by Ahmed Chalabi and the Iraq war lobby.[1]

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The study, reported in The Journal of the American Medical Association, "found no evidence of an association between the serotonin gene and the risk of depression, no matter what people’s life experience was."

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