Biologics

Halt ‘Unethical’ MINT Trial Enrollment: Public Citizen

Public Citizen says the HHS Office for Human Research Protections and the Department of Veterans Affairs should immediately suspend the Myocardia Ischemia and Transfusion (MINT) trial that is expected to involve thousands of heart attack patients in the U.S. and Canada, citing alleged serious ethical violations. In an 8/1 letter, the advocacy group says the trial will randomly assign hospital patients suffering acute heart attacks and significant anemia to one of two blood transfusion strategies (“liberal” and “restrictive”) based on their red blood cell levels.

The letter says that prior studies have strongly suggested that a restrictive transfusion strategy is more likely to lead to further heart attacks and death than a liberal strategy.

Public Citizen says it is concerned that the trial lacks adequate protections for its human subjects and violates basic ethical principles:

the restrictive transfusion strategy may be putting subjects’ health and lives at unacceptable risk;
the trial protocol fails to provide key information, including a description of current usual care blood transfusion practices for patients with heart attacks who are hospitalized at the institutions that are to enroll subjects, that an institutional review board would need to determine whether the study meets approval criteria; and
the sample consent form fails to adequately describe the purpose of the research, the trial risks, and whether the transfusion strategies being tested are experimental.

Public Citizen says the two agencies should suspend trial enrollment immediately and require researchers to conduct detailed surveys and/or studies of current blood transfusion practices for heart attack patients hospitalized at the participating institutions. It says the agencies also should require the researchers to revise the protocol to describe all prior evidence from randomized clinical trials that compared liberal and restrictive blood transfusion strategies, and how the MINT trial will affect the care of the patients at the institutions that are to enroll subjects.

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