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Today’s edition: Hurricane Ian is forcing the evacuation of thousands of people in nursing homes and hospitals. The Food and Drug Administration approved a hotly debated experimental drug for ALS. But first …
The suicide rate is nearly back up to the 2018 all-time high
The nation’s suicide rate in 2021 increased for the first time in two years with the largest spike seen among males ages 15-24.
The provisional data released today shows a 4 percent rise in suicides last year. It comes as the country is still contending with the aftereffects of covid-19 disruptions and amid calls for officials to address a growing mental health crisis.
The Centers for Disease Control and Prevention didn’t speculate on what’s behind the increase, and the causes of suicide are complex, often determined by multiple factors. Those can consist of depression, family history of suicide, physical illness, childhood trauma and more. Experts also pinpointed issues that might aggravate that risk, such as a rise in guns in the home, loss of jobs and loved ones amid the pandemic, last year’s covid-19 spike and the influence of social media on teens, our colleague Lenny Bernstein reports.
The latest numbers could put further pressure on Congress and the administration to take up additional measures to respond to the country’s mental health crisis. The issue has received renewed attention from lawmakers and the White House this year, spurred in part by the pandemic, but advocates are pushing for more.
The trendline: Suicides increased 35 percent from 1999 to 2018, and then declined 5 percent in total through 2020.
The decrease in 2020 surprised some experts, who had originally predicted a rise amid the grief, isolation and fear of the pandemic’s first year. But instead, suicides decreased that year, and then climbed 4 percent in 2021 when the country began returning closer to normal.
An explanation isn’t completely clear. “The tale of this pandemic in terms of mental health is going to be many, many years to process,” Hannah Wesolowski, chief advocacy officer for the National Alliance on Mental Illness, told Lenny.
Last year’s spike nearly erases the recent declines in suicides, bringing the rate close to the all-time high of 48,344 deaths in 2018. Here’s what the CDC reported this morning:
The caveat: The data is not yet final, but isn’t expected to change significantly.
In December, Surgeon General Vivek Murthy sounded the alarm about a crisis in youth mental health. Since then, the White House and Congress have issued proposals aimed at shoring up the mental health workforce, expanding access to telehealth and beefing up youth mental health services.
Yet some of the administration’s proposals need sign-off from Congress. On Capitol Hill, lawmakers enacted the most significant response to gun violence in decades this summer, which included some mental health provisions, such as a nationwide expansion of a key way of funding community behavioral health clinics.
Additional legislation has been in the works since early this year, but it’s unclear what could be sent to President Biden’s desk in a lame-duck Congress after the midterm elections. Some key lawmakers say they’ll be pushing for passage of mental health legislation, with the next opportunity likely in a year-end deal.
Meanwhile … a new, easy-to-use help line shows promise. The 988 suicide hotline prevention number launched in mid-July, and there’s been a 45 percent jump in overall volume this August compared with August 2021. Roughly 88 percent of calls, texts and chats were answered last month, which is 4 percent higher than in July despite an increase in total contacts.
Florida health-care providers scramble to evacuate thousands as Ian hits
Thousands of people were evacuated from more than 40 nursing homes and hospitals across Florida yesterday as Hurricane Ian pummeled its way through the state, bringing with it a deadly surge of water, unrelenting rain and catastrophic winds, the Associated Press reports.
While the extent of the storm’s damage remains unknown, Biden, while speaking at the Federal Emergency Management Agency headquarters, said the hurricane “could be the deadliest” in Florida history.
Here’s a snapshot of the state of play, per the AP:
For instance: The storm hit HCA Florida Fawcett Hospital in Port Charlotte — located just north of Fort Myers — particularly hard. Fierce winds tore part of its fourth floor roof from its intensive care unit, while staff used buckets and towels to soak up the storm-surge flooding that ripped through the lower level emergency room.
Health-care providers across the state prepared for the storm earlier this week, transferring patients, canceling elective procedures and shoring up their facilities. Even still, Mary Mayhew, CEO of the Florida Hospital Association, described the aftermath of the hurricane as the worst-case scenario “that everyone fears,” our colleague Sabrina Malhi reports.
Footage of Fawcett Memorial Hospital, per ABC 11’s Josh Chapin:
FDA approves first ALS drug in five years after pleas from patients
The Food and Drug Administration overcame doubts from agency scientists yesterday and approved a fiercely debated drug for the devastating illness ALS, our colleague Laurie McGinley reports.
The medication — which will be sold under the brand name Relyvrio — is designed to slow the progression of the fatal neurological disease by protecting nerve cells in the brain and spinal cord destroyed by ALS. Information on the price will be coming soon, Amylyx, the biotech company that makes the drug, said.
The reaction: Patients and advocates hailed the decision, which marks the first new treatment option approved for the disease in five years. But the move raised concerns among some experts about whether drugs for dire conditions receive sufficient scrutiny.
In a memo about the approval, the FDA said the drug showed “a statistically significant treatment benefit” and met its clinical-trial goal — a slowing of decline in patients with ALS. It also said the drug provided a survival benefit, and that there were no safety concerns.
But the agency acknowledged “limitations” to the findings that resulted in some uncertainty about the drug’s degree of effectiveness. The agency said that regulatory flexibility was acceptable because of the “serious and life-threatening nature of ALS and the substantial unmet need” for treatments. Previously, just two other drugs were approved for the ailment but have extremely limited effectiveness.
The decision comes after a tumultuous path for the drug. At the first meeting of the FDA’s advisory committee in March, the panel of independent experts recommended against FDA approval. The panel changed its position earlier this month, when the agency held a rare second meeting to consider additional analyses submitted by the company.
(1/5) AMAZING NEWS! If you took the Ice Bucket Challenge, you helped deliver AMX0035, the first newly developed treatment approved for ALS in years! THANK YOU! AMX0035 slows progression of ALS and extends life for people living with ALS. pic.twitter.com/OAg1PWFpos
— The ALS Association (@alsassociation) September 29, 2022
CMS lays out how it plans to negotiate drug prices
The Centers for Medicare and Medicaid Services hammered out details for how it plans to implement sweeping new drug pricing provisions Congress passed this summer, Stat reports.
According to the proposal sent to lawmakers earlier this month, the agency wants to hire 95 full-time employees to help stand up its new Medicare Drug Rebate and Negotiations Group, which will consist of six divisions, such as contract support and manufacturer compliance and oversight.
Next steps: While the first round of negotiated prices won’t go into effect until 2026, penalties for pharmaceutical companies that raise the cost of drugs faster than inflation will kick in next year, and the measurement period starts Saturday. The agency is planning to issue guidance to help drugmakers understand how the program will work so that they can remain in compliance, Stat’s Rachel Cohrs writes.
Our take: Turning legislative text into action isn’t easy. All eyes will be watching to see whether agency officials can execute the rollout of the new division to meet the critical deadlines outlined in the law for implementing the policies — something the head of CMS previously told The Health 202 that her agency pledged to hit.
How McKinsey Got Into the Business of Addiction (By Walt Bogdanich and Michael Forsythe | The New York Times)
Cerebral Treated a 17-Year-Old Without His Parents’ Consent. They Found Out the Day He Died. (By Khadeeja Safdar | Wall Street Journal)
Kids at risk of lead contamination in federal child care, watchdog says (Joe Davidson, columnist l The Washington Post)
Thanks for reading! See y’all Tuesday.