Drugs

Most People Want to Join Precision Medicine Study: NIH

The National Institutes of Health (NIH) says that a recent survey found that many respondents would be willing to participate in the national Precision Medicine Initiative (PMI) Cohort Program, a longitudinal research program that aims to enroll one million or more U.S. residents to improve the ability to prevent and treat disease based on individual differences in lifestyle, environment, and genetics. An NIH news release (contains link to survey findings) says that participants will be invited to contribute a range of data about themselves with questionnaires, electronic health records, and mobile or wearable devices. They also will undergo a baseline physical evaluation and provide blood and urine samples for analysis.

After hearing a short description of the PMI Cohort Program, some 79% of respondents expressed support for the program, and 54% said they would definitely or probably participate if asked. The researchers say that level of support was fairly constant across racial and ethnic groups as well as other demographic categories.

Some subgroups showed a slightly higher or lower level of interest in participation. Thus, higher percentages of younger people, college educated people, and those who identified as lesbian, gay, bisexual, or transgender reported a willingness to take part. Those with fewer years of education and those ages 60 and above were less inclined to join. Researchers said the results were helpful in identifying areas where the program may want to focus outreach efforts beyond the communities that have been historically under-represented in research.

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