Drugs

Groups Fault Trial Reporting, Want Full Info Published

Four healthcare integrity organizations (Transparency International, TranspariMed, Cochrane, and CRIT) are urging governments worldwide to ensure that patients, doctors, and scientists can access the full results of all clinical trials. The four sponsored a study that they say showed that the results of medical research are often reported partially, incorrectly, or not at all. They report that:

FDA scientists say that nearly half of clinical trials in antidepressants did not have a positive outcome, but academic literature painted 49 out of 52 trials in a positive light;
35% of results from all clinical trials of 15 drugs allowed onto the market remained unpublished and invisible;
a study of 860 clinical trials found that less than 19% had been prospectively registered, despite this being an ethical requirement; with most trials not registered at all;
11% of publications in journals provided a complete and consistent account of all the serious adverse events experienced by trial participants;
Harvard Medical School researchers found that out of 445 completed trials involving children, 96 had never published results anywhere in any form;
researchers fought for four years to get detailed information on a slimming drug through Freedom of Information requests and found that harms had been “systematically understated” in academic papers and in the summarized results submitted to investigators; and
an Oxford University team found that only nine trials out of 67 published in top medical journals had been accurately reported;

The groups say that governments should (1) ensue that publicly funded clinical trials are transparent; (2) enforce existing rules; and (3) strengthen the legal and regulatory frameworks.

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