Science Policy For All

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Science Policy Around the Web – April 25, 2017

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By: Eric Cheng, PhD

Photo source: pixabay.com

FDA

FDA Nominee Gottlieb Tackles Vaccines, Trial Design at Hearing

The President’s nominee to head the FDA, Scott Gottlieb, MD, sat before lawmakers for his confirmation hearing before the Senate’s health committee. Gottlieb, a hospitalist and former FDA official, was questioned on many controversial topics on health.  On the topic of vaccines and autism, Gottlieb said, “I think we need to come to the point where we can accept ‘No’ for an answer, and come to the conclusion that there is no causal link between vaccinations and autism.”

On the topic of double-blind randomized trials as the “gold standard” for medical treatment research, Gottlieb was more cautious. He believed that there are more “opportunities to modernize how we do clinical trials in ways that aren’t going to sacrifice on the gold standard of safety and effectiveness. Perhaps there are ways to think of clinical trial constructs that don’t require the tight randomization that current clinical trials do.” What this suggests is a push towards more adaptive trials that would allow researchers to review results before a study’s endpoint and would allow changes to treatment groups in a study, which is in contrast to traditional randomized controlled trials.

Another less controversial but popular topic in the hearing was on opioid abuse. Gottlieb believed that opioid abuse is “a public health emergency on the order of Ebola and Zika” and that bolder steps will be needed to address this issue.

The committee will vote on whether to move Gottlieb’s nomination to the Senate floor after the Senate returns in late April from a 2-week recess. (Joyce Frieden, MedPage Today)

Healthcare Policy

Trump Administration Still Plans to Undo Parts of the ACA, Tom Price Testifies

Health and Human Services Secretary Tom Price made one thing clear during his testimony to the House appropriations committee: “The administration is still intent on dismantling parts of the Affordable Care Act even if Republicans lack the votes to rewrite it.”

Price discussed how, as the Health and Human Services Secretary, his department could scale back several federal mandates that include “essential benefits” in coverage to make insurance plans cheaper. He did not say if the administration will continue to provide cost-sharing subsidies for insurers, which has been a topic of discussion on items to change in the Affordable Care Act. However, removing subsidies will bring “significant premium increases,” said Michael Adelberg, a health-care principal at FaegreBD Consulting. He predicts that the removal of these subsidies will cause some insurers to drop out while the remaining insurers will seek rate increases to compensate.

Regardless of these discussions, the individual mandate remains in place with Price telling the panel, “So long as the law’s on the books, we at the department are obliged to uphold the law.” (Juliet Eilperin and Mike DeBonis, Washington Post)

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Written by sciencepolicyforall

April 25, 2017 at 9:53 am

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