WASHINGTON — Pain patients tell Congress the CDC’s opioid guidelines are hindering access to vital medications, and an FDA panel recommends approval of esketamine for treatment-resistant depression.
Pain Patients to Congress: CDC’s Opioid Guideline Is Hurting Us
Patients with chronic pain are suffering from ham-handed efforts to curb opioid overdoses, a series of witnesses told the Senate Health, Education, Labor and Pensions (HELP) Committee on Tuesday.
In particular, the CDC’s 2016 guidelines for opioid prescribing came under heavy fire, as even a self-described supporter of its recommendations admitted the evidence base was weak.
Cindy Steinberg, national director of policy and advocacy for the U.S. Pain Foundation, argued that well-intentioned efforts to address the epidemic — particularly strategies to tamp down overprescribing — have stoked a “climate of fear” among doctors.
Thousands of patients with chronic pain have been forcibly tapered off their medications or dropped from care by their physicians, said Steinberg. (Physicians in California, under threat of medical-board sanction if patients die from overdoses, have reported similar reactions.)
Such decisions are “inhumane and morally reprehensible,” she said.
FDA Panel Endorses Esketamine for Depression
By a wide margin — 14 yes votes, 2 no, and 1 abstention — FDA advisory committee members voted Tuesday that the benefits of esketamine nasal spray for treatment-resistant depression outweighed its risks.
They also overwhelmingly supported — again with votes of 14-2-1 — that drugmaker Janssen Pharmaceuticals provided sufficient evidence to support the effectiveness of esketamine nasal spray for treatment-resistant depression, and 15-2 in favor of its safety profile.
“I believe there is compelling evidence that esketamine is an effective treatment for this highly treatment resistant population,” said panel member Walter Dunn, MD, PhD, of the University of California, Los Angeles. “I really commend the FDA for considering [the maintenance trial] to be one of the pivotal trials.”
“From our experience with ketamine off-label use for the last 10-plus years, we know it works and we know it works fast,” Dunn continued. “The question is, will that effect last? And I think the maintenance trial really demonstrated there is potential for a long-term benefit for this patient population.”
House Democrats Decry ‘Junk Plans’
Democrats blasted attempts by the Trump administration to “sabotage” the Affordable Care Act during a House Energy & Commerce Health subcommittee hearing on Wednesday.
“We’re inviting people back into a world with mirrors and trap doors, which was exactly the place we wanted to get away from when we passed the ACA,” said Rep. John Sarbanes (D-Md.), who called on his colleagues to “push back against these junk plans.”
House Democrats introduced four bills to roll back administration efforts to loosen or circumvent the ACA’s insurance requirements. In the very unlikely event that they pass the Republican-controlled Senate and gain the president’s signature, the bills would: require all short-term health plans to include a warning explicitly stating which benefits are included and which aren’t; restore marketing and outreach funding for ACA exchange; rescind a regulation that extended the allowable duration of short-term plans (including renewals) to just under 3 years; and cancel the administration’s new guidance around 1332 waivers, which relaxed certain “guard rails.”
Republicans complained that ACA plans are unaffordable for middle-income Americans who don’t receive subsidies, and argued that the Trump administration’s actions allow those same Americans more options for cheaper health plans.
Panel Recommends How FDA Should Assess Vaginal Mesh Data
Several safety and efficacy factors should be considered when evaluating transvaginal surgical mesh for treating pelvic organ prolapse (POP), an FDA advisory panel recommended on Tuesday.
Following a full day of manufacturer presentations, patient testimonials, and statements from professional societies — including the American College of Obstetricians and Gynecologists, the American Urogynecologic Society, and the Society of Gynecologic Surgeons — the panel deliberated for several hours. Of top concern included how to evaluate safety and efficacy, particularly when comparing these therapy options to native tissue repair, another method of POP treatment.
Most panel members said studies comparing the two types of repair must show superior efficacy of the surgical mesh in order to justify its higher risks, and superiority should be demonstrated at 12 months, 24 months, and 36 months post-op.
HHS Proposes Making EHRs More Portable
Patients would have access to their electronic health records free of charge and would be able to transfer them more easily from one provider to another under rules proposed Monday by the Department of Health and Human Services (HHS).
“These proposed rules strive to bring the nation’s healthcare system one step closer to a point where patients and clinicians have the access they need to all of a patient’s health information, helping them in making better choices about care and treatment,” HHS Secretary Alex Azar said in a statement. “By outlining specific requirements about electronic health information, we will be able to help patients, their caregivers, and providers securely access and share health information. These steps forward for health IT are essential to building a healthcare system that pays for value rather than procedures, especially through empowering patients as consumers.”
The rules were issued jointly by the Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS). “For the first time, CMS is now proposing requirements that Medicaid, the Children’s Health Insurance Program, Medicare Advantage plans and Qualified Health Plans in the federally facilitated exchanges must provide enrollees with immediate electronic access to medical claims and other health information electronically by 2020,” the agency noted.
On Wednesday, The Brookings Institution hosts a discussion of policy solutions to address surprise medical bills.
On Thursday, the American Enterprise Institute will explore e-cigarette regulation.