I read with interest the articles in the June issue of The Rheumatologist pertaining to high drug costs. Simon Helfgott rheuminated on it, and Susan Bernstein, a medical journalist, wrote a two-page article titled “Concerns About Cost.” Both articles were thoughtful summaries of a complex issue, putting large question marks over both initial prices and…
FDA Committee Recommends Tofacitinib Approval
The FDA Arthritis Advisory Committee voted 10 to 1 to recommend approval of tofacitinib to treat psoriatic arthritis…
Flimsy Evidence Behind Many FDA Approvals
(Reuters Health)—Many drugs granted accelerated approval by the U.S. Food and Drug Administration (FDA) lack clear evidence of safety and effectiveness, and the same is true for most high-risk medical devices, according to two new reports in JAMA, online Aug. 15. The Accelerated Approval pathway makes potentially promising investigational medicines available for use before the…
FDA Approves Duzallo for Hyperuricemia in Patients with Uncontrolled Gout
(Reuters)—Ironwood Pharmaceuticals Inc. said on Monday the U.S. Food and Drug Administration (FDA) approved its oral drug to treat a condition associated with gout. The company’s once-daily drug, Duzallo (lesinurad and allopurinol), was approved to treat hyperuricemia in patients with gout, Ironwood said. Duzallo combines the standard-of-care treatment, allopurinol, with Ironwood’s lesinurad to treat inefficient…
Little Evidence Shows Cannabis Helps Chronic Pain or PTSD
(Reuters Health)—Even though pain and posttraumatic stress disorder (PTSD) are among the most common reasons people use medical marijuana in the U.S., there isn’t much proof cannabis works for either one of these conditions, two research reviews suggest. That’s because there hasn’t been enough high-quality research to produce conclusive evidence of the benefits or harms…
S.C. Sues Purdue, Maker of OxyContin, Over Deceptive Marketing
(Reuters)—On Tuesday, South Carolina sued Purdue Pharma LP, becoming the latest state or local government to accuse the OxyContin maker of deceptive marketing practices that have contributed to a national opioid addiction epidemic. The lawsuit by South Carolina Attorney General Alan Wilson, filed in Richland County Court of Common Pleas in Columbia, accuses the company…
Sirukumab Approval Stalls
Citing safety concerns, the FDA Arthritis Advisory Committee voted against recommending approval of sirukumab for treating adults with RA…
Rheumatology Drug Updates: Opana ER Painkiller Pulled from U.S. Market; Upadacitinib to Treat RA, and More
Opana ER Pulled from U.S. Market Last month, the U.S. Food and Drug Administration (FDA) asked Endo Pharmaceuticals to remove oxymorphone hydrochloride extended release (Opana ER) from the U.S. market due to public health consequences related to abuse. The agency has concerns that the risks presented by the treatment do not outweigh its benefits.1 On…
Glucosamine Supplements Don’t Help Knee or Hip Arthritis Pain
(Reuters Health)—Oral glucosamine has no more effect than placebo on joint pain, according to a new meta-analysis. The analysis of randomized controlled trials from which data have been made public found that at both three-month and 24-month follow-up points, the supplement had no effect on either hip or knee pain from arthritis. Even sub-groups, such…
Trump Declares National Emergency on Opioid Abuse
BEDMINSTER, N.J. (Reuters)—U.S. President Donald Trump on Thursday declared the opioid epidemic a national emergency and said his administration was drafting papers to make it official. “The opioid crisis is an emergency and I’m saying officially right now it is an emergency,” Trump told reporters in New Jersey. “We’re going to draw it up and…
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