Also in the news, why inventing a vaccine for HIV is more difficult than covid, pressure for FTC scrutiny over two pharma mergers, how Congress may focus on drug company “middlemen” and pricing, heavy metals in baby food, biosimilars, and more.
The Washington Post: FDA To Ease Blood Donation Ban On Gay Men, Allow Monogamous To Give
Gay and bisexual men in monogamous relationships will no longer be forced to abstain from sex to donate blood under federal guidelines to be proposed in coming days, ending a vestige of the earliest days of the AIDS crisis. The planned relaxation of restrictions by the Food and Drug Administration follows years of pressure by blood banks, the American Medical Association and LGBT rights organizations to abandon rules some experts say are outdated, homophobic and ineffective at keeping the nation’s blood supply safe. (McGinley, Amenabar and Nirappil, 1/26)
NPR: Why Inventing A Vaccine For HIV Is Harder Than For COVID
The four-decades long effort to create an HIV vaccine suffered a blow last week with news that Janssen Pharmaceuticals, a division of Johnson & Johnson, was discontinuing the only current late-stage clinical trial of a vaccine. Results showed it to be ineffective. “I was disappointed in the outcome,” says Mitchell Warren, executive director of AVAC, an organization that advocates for HIV prevention to end AIDS. “It was a setback in the search for a vaccine.” (Brink, 1/26)
In other pharmaceutical industry news —
Stat: Warren Urges The FTC To Scrutinize Two Pharma Mergers Over “Anti-Competitive” Practices
In her latest bid to address prescription drug prices, U.S. Sen. Elizabeth Warren (D-Mass.) is urging the U.S. Federal Trade Commission to “closely scrutinize” two pending pharmaceutical company mergers over concerns that “rampant consolidation” will drive up costs for consumers. (Silverman, 1/26)
Roll Call: Drug Company Middlemen Likely To Be A Focus In 118th Congress
Factions of the health care system and members of Congress are turning their fire on an oft-maligned part of the drug pricing system — the middlemen who negotiate discounts with drug companies on behalf of health plans. (Hellmann, 1/26)
Stat: A Bellwether For Biosimilars: Why The New Competition For Humira Matters To Pharma, Payers, And Patients
After months of anticipation, the first biosimilar version of Humira will become available next week — a pivotal moment in the long-running debate about whether cheaper copies of pricey biologics can lower soaring U.S. health care costs. (Silverman, 1/27)
Reuters: FDA Identifies Recall Of Emergent’s Decontamination Kits As Most Serious
The U.S. Food and Drug Administration on Thursday classified the recall of Emergent BioSolutions Inc’s skin decontamination lotion kits as the most serious type. The contract manufacturer began the recall of 3,500 units of the kit in November, after receiving three customer complaints of leakage from the packets. No serious injuries or deaths related to the issue were reported. (1/26)
The New York Times: How Do Heavy Metals Like Lead Get In Baby Food?
The Food and Drug Administration’s new plan to keep high levels of lead out of baby foods like mashed sweet potatoes, apple sauce and dry cereal is part of a larger effort to eliminate heavy metals from the foods the youngest children eat. The push follows years of studies by public health, consumer and government experts revealing concerning levels of arsenic in rice cereal and other items fed to infants, including big-name brands like Gerber and organic staples like Earth’s Best. (Jewett, 1/26)
On dementia —
CIDRAP: Rates Of Antipsychotic Drug Prescribing For Dementia Climbed During The Pandemic
Rates of antipsychotic drug prescribing among people with dementia increased substantially in six high-income countries during the initial months of the pandemic and remained elevated through 2021, researchers reported yesterday in JAMA Psychiatry. (Dall, 1/26)
The Washington Post: New Study Finds 6 Ways To Slow Memory Decline And Lower Dementia Risk
A new study of more than 29,000 older adults has identified six habits — from eating a variety of foods to regularly reading or playing cards — that are linked with a lower risk of dementia and a slower rate of memory decline. Eating a balanced diet, exercising the mind and body regularly, having regular contact with others, and not drinking or smoking — these six “healthy lifestyle factors” were associated with better cognitive outcomes in older adults, in a large Chinese study conducted over a decade and published in the BMJ on Wednesday. (Timsit, 1/26)
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