Drugs

End ‘Unethical, Reckless’ NIH Sepsis Trial: Public Citizen

Public Citizen says the CLOVERS (Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis trial) being conducted by the National Institutes of Health “is deeply flawed, riddled with serious regulatory and ethical lapses, and must be stopped.” In the experiment, a Public Citizen statement says, seriously ill sepsis patients are given one of two treatments, both of which are risky and neither of which is considered standard treatment. “Because no other group of patients in the trial is receiving the usual treatment for sepsis,” Public Citizen says, “researchers can’t ensure that the experiment isn’t causing increased deaths and organ failure.”

The goal of CLOVERS is to determine whether one of the two highly unusual treatments results in more patient deaths. “The design of this disturbing trial is more akin to an experiment that would be conducted on laboratory animals,” says Public Citizen Health Research Group director Michael Carome. “These human subjects are unwitting guinea pigs in a physiology experiment that will not advance medical care for sepsis and likely will harm many.”

In an 8/28 letter to the HHS Office of Human Research Protections, Public Citizen says the trial “fails to (1) materially comply with key requirements of HHS regulations for the protection of human subjects and (2) satisfy the basic ethical principles upon which those regulations are founded.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome