First Edition: January 3, 2023

AP:
Probe: Alzheimer’s Drug Approval ‘Rife With Irregularities’

The Food and Drug Administration’s contentious approval of a questionable Alzheimer’s drug took another hit Thursday as congressional investigators called the process “rife with irregularities.” (12/29)

Reuters:
Congressional Report: U.S. FDA Broke Own Protocols In Approving Biogen Alzheimer’s Drug

The FDA’s interactions with Biogen were “atypical” and did not follow the agency’s documentation protocol, according to a staff report on the findings of an 18-month investigation conducted by two House of Representatives committees into the drug’s regulatory review, approval, pricing, and marketing. (Aboulenein, 12/30)

Fortune/AP:
Here’s A Brief Look At The New Laws Now Going Into Effect Across The U.S.

California will allow trained nurse practitioners, midwives and physician assistants to provide abortions without supervision from a physician. In New York, a law dealing with multiple facets of health care requires private insurers that cover births to also cover abortion services, without requiring co-payments or co-insurance. (Lieb and Mulvihill, 1/2)

The Washington Post:
New Laws Take Effect In Virginia, Maryland And D.C.

Another new law in the District will require all health insurance plans issued on or after Jan. 1 to cover certain foods required for some medical conditions, such as inflammatory bowel disease and gastroesophageal reflux disease. (Vozzella and Elwood, 12/31)

The Wall Street Journal:
FDA, Concerned About Safety, Explores Regulating CBD In Foods, Supplements

The Food and Drug Administration is studying whether legal cannabis is safe in food or supplements and plans to make recommendations for how to regulate the growing number of cannabis-derived products in the coming months, agency officials said. (Essley Whyte, 12/29)

The New York Times:
Justice Dept. Sues AmerisourceBergen Over Role In Opioid Crisis

The suit, filed by the department’s civil division in conjunction with federal prosecutors in New Jersey, Colorado, Pennsylvania and New York, is part of a growing effort by federal agencies to hold drug companies accountable for their role in the nation’s opioid crisis. It accuses AmerisourceBergen and two of its subsidiaries of “at least hundreds of thousands” of violations of the Controlled Substances Act. (Thrush and Albeck-Ripka, 12/29)

The Wall Street Journal:
Sanctioned Drug-Use Sites Reach A Crossroads As Funding Runs Out

Medical assistant Alsane Mezon placed cotton balls into metal cups, creating “cookers” for heating illicit drugs. Her colleague Rayce Samuelson spoke with a woman struggling to find an unscarred vein to receive the injection of fentanyl she was holding. “Arms, hands, legs, feet—that’s the rotation,” Mr. Samuelson told her. (Wernau, 1/2)

Newsweek:
Trump Warns Of ‘Doom’ For Republicans Over Extreme Abortion Views

Former President Donald Trump advised Republicans that if they want to win elections, they must support three exceptions to abortion bans. According to Trump, Republicans should support abortion in cases of rape, incest or to protect the life of the mother. If they don’t, he said, they were likely to lose their elections. (Skinner, 12/29)

Newsweek:
Anti-Abortion Group Pressures Trump To Embrace Firm Stance

The blaming of the “abortion issue” by former President Donald Trump as the reason Republicans underperformed in the 2022 midterm elections is receiving pushback from at least one conservative anti-abortion group. (Mordowanec, 1/2)

AP:
Court: Abortion Doctors Can’t Be Charged Under Arizona Law

An Arizona court has ruled that abortion doctors cannot be prosecuted under a pre-statehood law that criminalizes nearly all abortions yet was barred from being enforced for decades. (Billeaud, 12/31)

The Hill:
Biden Administration Seeks To Rescind Trump-Era ‘Conscience’ Protections For Health Workers

The Biden administration is proposing to largely undo a Trump-era rule that boosted the rights of medical workers to refuse to perform abortions or other services that conflicted with their religious or moral beliefs. (Weixel, 12/29)

The Hill:
CDC Warns Of Future Surge In Diabetes Among Young Americans

The U.S. Centers for Disease Control and Prevention (CDC) on Thursday warned a surge of diabetes among young Americans is on the horizon, saying diagnoses for the population are expected to soar in the coming decades. The CDC cited a new study published in the journal Diabetes Care, which models a nearly 700 percent increase of Type 2 diabetes diagnoses in Americans under the age of 20 through 2060, if an expected upward trend continues. (Dress, 12/29)

Stat:
Diabetes In Youth Is Set To Skyrocket In Coming Decades

If the recent acceleration of new diagnoses persists, then 220,000 people younger than 20 would have type 2 diabetes in 2060, compared with 28,000 in 2017, the latest year for which data is available, according to projections published this month in Diabetes Care. Even if the rate of new diagnoses stays constant, there would still be a 70{fe463f59fb70c5c01486843be1d66c13e664ed3ae921464fa884afebcc0ffe6c} increase in type 2 cases by 2060. (Chen, 12/30)

Bloomberg:
US Makes Scant Progress Treating Diabetes Despite Tech Advances 

You might think we’ve gotten better at helping people with diabetes keep their blood sugar in check. After all, over the past 30 years there’s been plenty of  technological advances in the way insulin is given. (Swetlitz, 12/28)

Stat:
Covid’s Winter Surge Is Poised To Exceed Summer Peak

The number of people in the United States hospitalized with Covid-19 is about to surpass the figure reached during this summer’s spike, federal data show, as a confluence of factors — from the continued evolution of the coronavirus to holiday gatherings — drives transmission. (Joseph, 1/3)

The Hill:
COVID Variant XBB.1.5 Now Accounts For 40 Percent Of Cases In The US: CDC

The omicron subvariant XBB.1.5 has rapidly spread to become the dominant COVID-19 mutation in the U.S., now accounting for 40.5 percent of all cases. (Choi, 12/30)

Politico:
Once-Favored Covid Drugs Ineffective On Omicron May Be Putting Millions At Risk

The lack of specialized Covid-19 treatments for people with weak immune systems has left millions of Americans with limited options if they get sick as the pandemic heads into an uncertain winter. Once heralded as game-changers for Covid patients considered at risk for getting seriously ill — one was used to treat then-President Donald Trump in 2020 — monoclonal antibodies are now largely ineffective against current Covid variants. (Gardner, 1/1)

Politico:
Health Care Lobbyists Are Bracing For Chair Bernie Sanders

The Vermont independent is set to take over the Senate’s Health, Education, Labor and Pensions Committee next month. Leading the panel gives the Medicare-for-All proponent oversight authority over some of his policy priorities — drug pricing, workers’ rights and income inequality, and student and medical debt. (Wilson, 1/3)

Politico:
‘The Slippery Slope Is Powerful’: Dems Believe Drug Pricing Law Will Pay Dividends

Democrats staring down a divided Congress in 2023 have an answer for those wondering if the window is closing for significant health care wins: watch and wait. The incoming GOP House majority may block their attempts to enact more federal controls on health costs. But this year’s passage of the Inflation Reduction Act will empower Medicare to negotiate drug prices for the first time, paving the way for more government action over the coming years, argued Peter Welch (D-Vt.). (Miranda Ollstein, 12/29)

Reuters:
Exclusive: Drugmakers To Raise Prices On At Least 350 Drugs In U.S. In January

Drugmakers including Pfizer Inc, GlaxoSmithKline PLC, Bristol Myers Squibb (BMY.N), AstraZeneca PLC and Sanofi SA plan to raise prices in the United States on more than 350 unique drugs in early January, according to data analyzed by healthcare research firm 3 Axis Advisors. (Erman and Steenhuysen, 12/30)

Stat:
Priorities Pile Up For HHS, FDA, CMS, NIH

The nation’s health agencies already have a long to-do list for 2023. Top officials have promised reforms in the food, drug, and public health departments as frustrations mount over the federal response to Covid-19 and last year’s widespread baby formula shortages. (Owermohle, 1/3)

Politico:
‘I Know Firsthand They Failed’: Parents Decry Lack Of FDA Action On Infant Formula Safety

When Kelly Knight gave birth to her son, Ryker, she was thrilled — and carrying the memory of the two babies she’d previously lost at nearly full term. “He was perfect,” Knight said. “It was kind of like filling that empty spot.” But when four-week-old Ryker started vomiting at home, Knight, who has three older children, immediately sensed something was wrong. (Bottemiller Evich, 12/31)

The Washington Post:
This Doctor Prescribes Ketamine To Thousands Online. It’s All Legal

In the past two years, Scott Smith has become licensed to practice medicine in almost every U.S. state for a singular purpose: treating depressed patients online and prescribing them ketamine. (Gilbert, 12/30)

AP:
Alfalfa Sprout Recall Tied To Salmonella Outbreak Expanded

A Nebraska company on Friday expanded a recall of alfalfa sprouts after more than a dozen cases of salmonella were linked to the food. SunSprouts Enterprises doubled its recall that was first announced Thursday, Nebraska health officials said. (12/30)

CIDRAP:
WHO’s New Mpox Guidance: All Contacts Should Avoid Sex For 21 Days

For the first time since August, the World Health Organization (WHO) updated its mpox guidance, recommending that known case contacts avoid sexual contact with others for 21 days, whether symptomatic or not, given that transmission may occur before symptom onset. (Soucheray, 12/27)

The New York Times:
Damar Hamlin Of Buffalo Bills In Critical Condition After Collapsing During N.F.L. Game

Damar Hamlin, a 24-year-old safety in his second season with the Buffalo Bills, was in critical condition in a hospital after suffering cardiac arrest during a Monday night game against the Cincinnati Bengals, the Bills said. (Morgan and Belson, 1/2)

The Washington Post:
Bills’ Damar Hamlin May Have Suffered Heart Arrhythmia, Experts Say

The blow to the chest of Buffalo Bills safety Damar Hamlin may have thrown his heart’s pumping mechanism out of rhythm, disrupting blood flow to his brain and causing his on-field collapse, two experts said Monday night. (Bernstein, 1/3)

CNN:
Hydration Linked With Lower Disease Risk, Study Finds

You may know that being adequately hydrated is important for day-to-day bodily functions such as regulating temperature and maintaining skin health. But drinking enough water is also associated with a significantly lower risk of developing chronic diseases, a lower risk of dying early or lower risk of being biologically older than your chronological age, according to a National Institutes of Health study published Monday in the journal eBioMedicine. (Rogers, 1/2)

Fortune:
Study Finds Women Are More Empathetic Than Men Worldwide At Any Age

It was already common knowledge that women are better than men at placing themselves in other people’s shoes, but now science backs up that statement. Empathy—the ability to understand, imagine, or share the emotions others may be feeling—is a critical characteristic to have in pretty much every avenue of life, especially business. (Bove, 12/28)

CIDRAP:
CDC Describes Mpox Challenges In Trans Community

Today in Morbidity and Mortality Weekly Report (MMWR), researchers describe American transgender mpox patients, suggesting that more than 70{fe463f59fb70c5c01486843be1d66c13e664ed3ae921464fa884afebcc0ffe6c} of patients contracted the virus from sexual intercourse with cisgender men. “These men might be in sexual networks experiencing the highest mpox incidence,” the authors explain. (Soucheray, 12/29)

CIDRAP:
COVID Vaccine Messages Led To More Uptake In ED Patients

A cluster-randomized clinical trial finds that educational messaging significantly boosted COVID-19 vaccine acceptance and uptake among 496 unvaccinated patients at US emergency departments (EDs) over 8 months. (Van Beusekom, 12/28)

CIDRAP:
Increased COVID Vaccination In Nursing Home Staff Cut Cases, Deaths

A study of 15,042 US nursing homes found that before the Omicron variant wave, an increase in staff COVID-19 vaccination with the primary series resulted in fewer cases among residents and staff and fewer deaths in residents. Researchers from the University of Chicago detailed their findings today in JAMA Network Open. (Schnirring, 12/29)

Reuters:
Pfizer’s Hemophilia B Gene Therapy Succeeds In Late-Stage Study

U.S. drugmaker Pfizer Inc (PFE.N) said on Thursday its experimental gene therapy for the treatment of hemophilia B, a rare inherited blood disorder, met its main goal in a late-stage study. Data from the study showed that a single dose of the therapy was superior to the current standard of care in helping reduce the bleeding rate in patients with moderately severe to severe forms of hemophilia B. (12/29)

Stat:
3 Trends To Watch In Hospitals And Health Insurance In 2023

For almost three years, hospitals and health insurers have been riding the waves of the Covid-19 pandemic. Even though they can better predict what lies ahead in 2023, there remain several big unknowns. STAT’s business reporters will be paying attention to three trends in particular: the end of the public health emergency, how hospital price hikes will affect people’s paychecks, and Medicare Advantage’s explosive growth. (Herman and Bannow, 1/3)

Fox News:
Employer-Sponsored Health Insurance Is Not Adequately Covering All Health Services For Many: Report

Many Americans, particularly women, are having difficulty paying for their required health care services — especially dental and mental health care needs — despite having health insurance through their employers. That’s according to a recent report published in the Journal of the American Medical Association (JAMA). (Sudhakar, 1/2)

Modern Healthcare:
Group Medicare Advantage Plans Face Challenges Amid Growth

New York City’s struggle to switch more than a quarter-million retired government workers and their dependents from traditional Medicare to private health insurance could set an alarming precedent for employers and insurers banking on the fast-growing group Medicare Advantage program. (Tepper, 1/2)

Stat:
Health Care Sees A Surge In Financing Platforms For Patients

As inflation-weary shoppers try to make ends meet, many are turning to a modern twist on the layaway plan: buy now, pay later. But while platforms like Afterpay and Affirm were originally built to take the sting out of online shopping, these new financing options are beginning to creep into the world of health care. (Palmer, 1/3)

Reuters:
Gilead Buys Out Rights To Cancer Therapy From Jounce For $67 Mln

Gilead Sciences (GILD.O) will buy all the remaining rights for an experimental cancer therapy, GS-1811, from Jounce Therapeutics (JNCE.O) for $67 million, the drugmaker said on Tuesday. The amended licensing deal will bolster Jounce’s cash resources in a challenging market for biotech companies. (12/29)

Reuters:
Novartis To Pay $245 Mln To End Antitrust Cases Over Exforge Drug Generics

Novartis AG (NOVN.S) said on Wednesday it will pay $245 million to end antitrust litigation accusing the Swiss drugmaker of trying to delay the launch in the United States of generic versions of its Exforge hypertension drug. (Stempel, 12/29)

Modern Healthcare:
Resident Physicians To Train In Metro And Rural Areas

Amid an ongoing shortage of physicians in rural America, one health system and its academic medical partner are putting a new spin on two residency programs. (Berryman, 1/2)

AP:
NYC Nurses, Hospitals Resume Contract Talks; Some Reach Pact 

A possible strike by thousands of New York City nurses loomed Monday even as nurses at one hospital reached a tentative agreement hours before their contract was set to expire. The pact affecting 4,000 nurses at NewYork-Presbyterian Hospital awaits ratification. (1/2)

The New York Times:
Legal Use Of Hallucinogenic Mushrooms Begins In Oregon

On Jan. 1, Oregon became the first state in the nation to legalize the adult use of psilocybin, a naturally occurring psychedelic that has shown significant promise for treating severe depression, post-traumatic stress disorder and end-of-life anxiety among the terminally ill, among other mental health conditions. (Jacobs, 1/3)

The Hill/Nexstar Media Wire:
Myths Surrounding MMR Vaccine May Be Contributing To Ohio Measles Outbreak

A health official in Ohio says declining vaccination rates have likely contributed to a measles outbreak within the state. As of Thursday, Ohio has 82 confirmed cases of measles, 32 of which required hospitalization. (Morse, 12/29)

AP:
Hammond Hospital Set To Close ER After Appeals Court Stay

A northwestern Indiana hospital said it will close its emergency room Saturday, a day after an Indiana Court of Appeals judge issued a stay of a lower court ruling that it must operate those services for nine more months. (12/31)

AP:
Amid Surge At UNM Hospital, Feds Send Relief For Staff

The federal government is dispatching a medical team to assist the University of New Mexico Children’s Hospital, which has been overwhelmed with patients. The Albuquerque hospital announced a 14-member disaster response team from the U.S. Department of Health and Human Services will begin seeing children Saturday. (12/30)