The FDA is creating a working group to explore how the US can safely import certain drugs from other countries "in the event of a dramatic price increase" for off-patent drugs manufactured by a single company, the HHS announced Thursday. FDA Commissioner Scott Gottlieb stressed that any drug importation would be temporary, lasting only until new competition enters the market.
Researchers used a cohort of 3,549 patients with type 2 diabetes and found an increased risk for hypoglycemic events when titration with insulin glargine 100 U/mL was added to sulfonylurea in patients with low body mass index or low levels of fasting C-peptide, prior to starting basal insulin. The findings, published in Diabetes, Obesity and Metabolism, showed that "people with greater insulin resistance may benefit from the addition of [glargine 100 U/mL] to an oral regimen consisting of metformin, while avoiding sulfonylurea-based regimens and/or withdrawing sulfonylurea when basal insulin is initiated."
A study in Diabetes Care showed that patients with type 2 diabetes and severe hypoglycemia had similar average A1C levels and had a prior diagnosis of non-severe hypoglycemia, compared with those who did not experience severe hypoglycemia. Researchers analyzed 50,439 patients from the Cleveland Clinic Health System and found an association between an increased risk for severe hypoglycemia and A1C level of less than 6%, insulin, increased number of diabetes medications, sulfonylureas, increased Charlson comorbidity index and black race.
Researchers found that the Ten Questions screening tool yielded 100% sensitivity and 51.2% specificity in identifying serious disability among children who were HIV-positive, compared with 90.2% sensitivity and 63.9% specificity for children who were HIV-negative. The study of children in South Africa was reported in PLOS ONE.
Researchers found an harmful association between higher HDL cholesterol levels and atherosclerosis risk among women at least 10 years into postmenopause and those whose age was greater at menopause. The findings in Arteriosclerosis, Thrombosis, and Vascular Biology, based on data for 1,138 women ages 45 to 84, showed that large HDL particles correlated with an increased risk for cardiovascular disease near menopause, but the good qualities of HDL may return as women move further away from menopause.
Louisiana is one of the most economically challenged states in the US but it could become a model in the future for hepatitis C elimination as state officials are working out a deal with Gilead Sciences to change how it pays for those medications for the benefit of the 34,600 people who are not receiving treatment for HCV. State Health Secretary Rebekah Gee has been in talks with Gilead officials to develop what they describe as a subscription model wherein Louisiana would pay a fixed sum over a period of several years while Gilead would supply the state's medication requirements.
The CMS is working on regulation that experts say could mean it will soon resume Affordable Care Act risk adjustment payments to insurers. The agency sent for review an interim final rule titled "Ratification and Reissuance of the Methodology for the HHS-operated Permanent Risk Adjustment Program under the Patient Protection and Affordable Care Act" to the White House Office of Management and Budget earlier this week.
The percentage of primary care physicians accepting new Medicaid patients didn't significantly increase after the implementation of higher payment rates, while there was only a 1.6 percentage point increase in primary care Medicaid participation following the expansion of Medicaid eligibility, with increases concentrated in expansion states, according to a pair of studies in Health Affairs. Pediatricians had a higher likelihood of accepting new Medicaid patients than general or family practice physicians and internists, according to one of the studies.
Children who underwent CT scans were more likely to develop brain tumors than those in the general population, according to a study in the Journal of the National Cancer Institute. However, the findings, based on data from 168,394 Dutch youths who had at least one CT scan between 1979 and 2012, didn't find a link between pediatric CT exposure and leukemia.
Researchers found an association between cellphone use and lower figural -- or nonverbal -- memory among teens, especially those who pressed their phones against the right side of their heads when using them, according to a study to be published in Environmental Health Perspectives. The research, based on data involving nearly 700 Swiss youths, found cellphone use had no effect on verbal memory, and the study found no significant effects associated with use that did not involve pressing the phone against the head.
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