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FDA Processes May Affect Evidence for Drug Approvals
While the US Food and Drug Administration’s (FDA) approval processes for new drugs have accelerated, these changes may have led to weaker evidence for novel drugs, according to a recent study in JAMA. Researchers observed that this acceleration was due to regulatory and technological changes. However, these “regulatory innovations have not clearly led to an increase in new drug approvals or to reduced total development times.” Researchers concluded that Congress and other government officials should “consider the implications of less rigorous clinical outcome requirements and whether the current complex array of regulatory programs should be simplified.” An unrelated study published in The Lancet found that less than half of clinical trials comply with reporting results.
>> Read More: FDA Approval and Regulation of Pharmaceuticals, 1983-2018
Changes in EHR Can Lower Opioid Prescriptions
After changing the default settings in an electronic health record (EHR), clinicians prescribed fewer opioid medications, according to a prospective study in JAMA Internal Medicine. The randomized study analyzed 4,320 opioid prescriptions and found that “lower default settings were associated with fewer opioids prescribed and a lower proportion of prescriptions that exceeded the opioid prescribing recommendation of the Centers for Disease Control and Prevention.” Researchers concluded that this “low-cost, easily implementable, [EHR]-based intervention could have far-reaching implications for opioid prescribing and could be used as a tool to help combat the opioid epidemic.”
>> Read More: Association of Default Electronic Medical Record Settings With Health Care Professional Patterns of Opioid Prescribing in Emergency Departments
Price Transparency Lacking or Misleading, Study Finds
A new report in JAMA Oncology exposed a lack of price transparency for radiation therapy between National Cancer Institute-designated locations. Among the publicly available chargemasters at 52 hospitals, researchers discovered a “21.7-fold difference in price … between the least and most expensive hospital.” Furthermore, procedure descriptions for standard radiation treatment for prostate cancer were “inconsistent, and the mean price was 10.1 times the price paid by Medicare.” Researchers concluded the complexity of chargemaster information made the actual cost “unclear” to patients, rendering the “value of the information for patients questionable.”
>> Read More: Analysis of Price Transparency via National Cancer Institute–Designated Cancer Centers’ Chargemasters for Prostate Cancer Radiation Therapy
Study: Dietary Differences Contribute to Mortality
A new study published in JAMA Internal Medicine found that differences within “low-carbohydrate and low-fat diets” may affect mortality. In a cohort study of 37,233 adults ages 20 and older, researchers observed that “quality and food sources of macronutrients” impacted mortality. Furthermore, “overall low-carbohydrate and low-fat diets were not associated with total mortality.” However, lower total morality was observed in diets that included “lower amounts of low-quality carbohydrates and higher amounts of plant protein and unsaturated fat” and “lower amounts of saturated fat and higher amounts of high-quality carbohydrates and plant protein.”
>> Read More: Association of Low-Carbohydrate and Low-Fat Diets With Mortality Among US Adults
Centene Acquires WellCare for $17 Billion
Representatives from Centene confirmed the company acquired WellCare for $17 billion. Under the merger agreement, “WellCare became a wholly owned subsidiary of Centene.” The US Department of Justice reviewed and approved the acquisition at the behest of the American Hospital Association. The deal made “Centene the country’s third-largest publicly traded managed care company and double[d] its Medicare footprint,” Shannon Muchmore reported for Healthcare Dive. Following the deal, Centene “now provides access to high-quality and affordable healthcare to its more than 24 million members across all 50 states.”
>> Read More: Centene Completes Acquisition of WellCare, Creating a Leading Healthcare Enterprise Focused on Government-Sponsored Healthcare Programs
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