Biologics

Heart Trial Protocol Changed: Public Citizen

Public Citizen says HHS has made substantive changes to the protocol and consent forms for a National Institutes of Health clinical trial that the advocacy group said had potentially serious ethical violations. In an 8/1/17 letter, Public Citizen called for immediate suspension of the Myocardial Ischemia and Transfusion (MINT) trial.

A Public Citizen statement says the trial involves randomly assigning patients suffering heart attacks and anemia to one of two blood transfusion strategies — either a “liberal” strategy in which they are transfused sooner at higher red blood cell levels, or a “restrictive” strategy in which they are transfused only when they hit a significantly lower red blood cell count. “Prior studies already strongly suggest that a restrictive transfusion strategy is more likely to lead further heart attacks and death than a liberal strategy,” Public Citizen says.

In its complaint, the group said the trial lacked adequate protections for human subjects and violated these basic ethical principles: (1) the restrictive strategy may put the subjects’ health and lives at unacceptable risk; (2) the trial protocol fails to provide key information that an institutional review board would need to determine whether the study meets approval criteria; and (3) the sample consent form for subjects failed to adequately describe the study purpose, the trial risks, and whether the transfusion strategies being tested are experimental.

Changes made to the trial protocol and consent form, the group says, include:

revising the protocol to better describe current usual care for transfusing patients having acute heart attacks;
adding to the protocol a requirement that a potential subject may not be enrolled unless the person’s attending doctor, with expertise in cardiovascular care, believes that both transfusion strategies are consistent with good medical care for the subject; and
adding to the participant consent form a more appropriate description of the trial purpose and a description of the possible risks of the restrictive transfusion strategy.

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