The Washington Examiner reports that “President Joe Biden signed the nearly $2 trillion omnibus spending bill into law Thursday night while vacationing in St. Croix.”

The New York Times relates,

The Food and Drug Administration’s process for approving the Alzheimer’s drug Aduhelm, despite great uncertainty about whether it worked, was “rife with irregularities,” according to a congressional investigation released on Thursday. The agency’s actions “raise serious concerns about F.D.A.’s lapses in protocol,” the report concluded.

The 18-month investigation, initiated by two congressional committees after the F.D.A. approved the drug, also strongly criticized Biogen, Aduhelm’s manufacturer. Internal documentsshowed the company set “an unjustifiably high price” of $56,000 a year for Aduhelm because it wanted a history-making “blockbuster” to “establish Aduhelm as one of the top pharmaceutical launches of all time,” even though it knew the high price would burden Medicare and patients, the report found.

STAT News seconds the Times report:

The downfall of Aduhelm, the first new treatment for Alzheimer’s disease in two decades, is largely the story of a drug company choosing to maximize its potential profits at the expense of patients and taxpayers, according to a congressional investigation that cites thousands of pages of internal Biogen documents.

STAT News also presents eight key takeaway‘s from the Congressional report on Aduhelm’s approval and reports

Pfizer said Thursday that its experimental gene therapy for hemophilia B significantly reduced the number of bleeds patients experienced over a year. 

Data from the 45-patient trial could set the stage for a second gene therapy to be approved for patients with the rare and serious bleeding disorder in as many years. In November, UniQure won approval for Hemgenix, the first hemophilia B gene therapy. 

“The results from this long-awaited study are great news for hemophilia B patients that soon may have access to a second durable treatment option,” Luk Vandenberghe, a gene therapy expert at Harvard, said in a text message, after reviewing the results. 

Looking toward next year, STAT News discusses “three things to watch in chronic disease in 2023: obesity drugs, long Covid and health care costs.”

Consider the already-astronomical cost of chronic disease care in the United States: trillions of dollars devoted to diabetes, heart disease, kidney disease, cancer and other conditions, and still so many people unable to access necessary care and treatments. Consider the strain of Covid on the health care system, the decimation of public health staffing, and the scarcity of health care workers — and how all these costs make their way to patients. What bold moves can be made in 2023 to help reduce the cost of care? We’ll see.

Also, from the healthcare cost front, Beckers Hospital Review looks into “Questions about hospitals’ culture, leadership, survival and opportunity come with a trillion-dollar price tag given the importance of hospitals and health systems in the $4.3 trillion U.S. healthcare industry.” 

From the public health front, the Wall Street Journal reports

A measles outbreak among mostly unvaccinated children in Ohio that local health officials feared could take months to control has slowed in the past week, giving hope that what was expected to be a lengthy battle could be cut short.

The total number of cases since the outbreak began in November reached 82 on Thursday, but new cases have fallen off significantly in the last seven days or so, said Mysheika Roberts, Health Commissioner for the city of Columbus.

“It could be much worse,” Dr. Roberts said Thursday. “I’m hoping due to our outreach in the community, and the community’s willingness to roll up their sleeves and get vaccinated, that we might be starting to see the end of this. But obviously, it’ll take several weeks and days before we’ll know if this is actually over.”

From the Rx coverage front, Medscape tells us

Merck & Co Inc’s COVID antiviral molnupiravir speeds up recovery but does not reduce the hospitalisation or death rate in higher-risk vaccinated adults, detailed data from a large study showed on Thursday. * * *

When Merck originally tested molnupiravir, it was found 30% effective in reducing hospitalisations, but that was in unvaccinated patients.

In the latest study, led by University of Oxford researchers, nearly all of the more than 25,000 patients in the study had received at least three vaccine doses.

These results demonstrate that vaccine protection is so strong that there is no obvious benefit from the drug in terms of further reducing hospitalisation and deaths, said study co-author Jonathan Van-Tam from the University of Nottingham.

The drug was, however, effective in reducing viral load and can help hasten patient recovery by roughly four days, researchers estimated based on study data. 

In interesting social news,

• The Wall Street Journal reports

About 2.6 million couples are saying “I do” this year [2022] — roughly 600,000 more than in prepandemic years, according to The Knot, a company that offers wedding-planning tools, a vendor marketplace and a gift-registry platform. 

The wedding boom is the byproduct of two years of the pandemic, when many ceremonies were postponed or pared down, says Lauren Kay, executive editor of The Knot. And ceremonies this year have a whole new vibe. Now, “people feel empowered to personalize, push the envelope—rules are out the window,” Mrs. Kay says. * * *

This year, “weddings are back, and people are excited to celebrate,” Mrs. Kay says. In 2023, weddings in the U.S. will likely return to prepandemic levels at 2.1 million, according to internal research from The Knot.

• The Washington Post looks into “Why do people like being tipsy? Here’s how alcohol affects the brain. The buzz produced by alcohol comes from a cocktail of pharmacology and social ingredients, research shows.” The article also discusses how to enjoy alcoholic beverages responsibly.

Finally, the Department of Health and Human Services announced

a Notice of Proposed Rulemaking (NPRM), entitled Safeguarding the Rights of Conscience as Protected by Federal Statutes, which proposes to restore the longstanding process for the handling of conscience complaints and provide additional safeguards to protect against conscience and religious discrimination. * * *

Public comments on the NPRM are due 60 days after publication of the NPRM in the Federal Register.

The NPRM may be viewed here: https://www.hhs.gov/sites/default/files/conscience-rule-nprm.pdf – PDF