Biden zeros in on healthcare competition in executive order: 10 notes: More details about yesterday’s lead story. Here is the White House Fact Sheet. “The Order includes 72 initiatives by more than a dozen federal agencies…” Many of the actions start with the word “encourages,” so not much will change immediately.
About Covid-19
CDC says students vaccinated against the coronavirus can go maskless in fall: “The Centers for Disease Control and Prevention issued new guidelines for schools Friday that give students who have been vaccinated the option of going maskless this fall while their classmates who have not had shots continue to wear face coverings.
The much-awaited easing of pandemic rules for kindergarten through 12th grade follows the opening of vaccine eligibility this spring to anyone 12 and older.”
Pfizer to seek OK for 3rd vaccine dose; shots still protect: “Pfizer is about to seek U.S. authorization for a third dose of its COVID-19 vaccine, saying Thursday that another shot within 12 months could dramatically boost immunity and maybe help ward off the latest worrisome coronavirus mutant…
Hours after Pfizer’s announcement, U.S. health officials issued a statement saying fully vaccinated Americans don’t need a booster yet.”
Mapping the human genetic architecture of COVID-19: From Nature : “We formed a global network of researchers to investigate the role of human genetics in SARS-CoV-2 infection and COVID-19 severity. We describe the results of three genome-wide association meta-analyses comprised of up to 49,562 COVID-19 patients from 46 studies across 19 countries. We reported 13 genome-wide significant loci that are associated with SARS-CoV-2 infection or severe manifestations of COVID-19. Several of these loci correspond to previously documented associations to lung or autoimmune and inflammatory diseases3–7. They also represent potentially actionable mechanisms in response to infection. Mendelian Randomization analyses support a causal role for smoking and body mass index for severe COVID-19 although not for type II diabetes.”
Guidance for Health Care Leaders During the Recovery Stage of the COVID-19 PandemicA Consensus Statement: “The 10 imperatives in the framework are: (1) acknowledge staff and celebrate successes; (2) provide support for staff well-being; (3) develop a clear understanding of the current local and global context, along with informed projections; (4) prepare for future emergencies (personnel, resources, protocols, contingency plans, coalitions, and training); (5) reassess priorities explicitly and regularly and provide purpose, meaning, and direction; (6) maximize team, organizational, and system performance and discuss enhancements; (7) manage the backlog of paused services and consider improvements while avoiding burnout and moral distress; (8) sustain learning, innovations, and collaborations, and imagine future possibilities; (9) provide regular communication and engender trust; and (10) in consultation with public health and fellow leaders, provide safety information and recommendations to government, other organizations, staff, and the community to improve equitable and integrated care and emergency preparedness systemwide.”
BioNTech/Pfizer plan to trial Delta variant vaccine in August: FYI
About pharma
10 US Approval Decisions To Look Out For In Q3: List available with free trial. One novel introduction: “A pharmacokinetic issue and likely a divided advisory panel are the reasons for a delay with the FDA’s decision on approval of Provention Bio, Inc.’s teplizumab beyond its 2 July PDUFA date. If approved, teplizumab would be the first drug for type 1 diabetes prevention.”
House Dems' report slams drugmaker stock buybacks as Pelosi presses to give Medicare negotiating powers: “A new House oversight report found that 14 of the largest drugmakers in the U.S. spent $577 billion on stock buybacks and dividends from 2016 to 2020 as Democratic leadership presses to give Medicare drug negotiation powers.
The report (PDF), released Thursday from the House Oversight Committee, comes as Congress is exploring giving Medicare the power to negotiate for lower drug prices as part of an infrastructure package.”
Sanofi puts $1B-plus on the table for Eureka's multiple myeloma treatment candidate: “The French Big Pharma penned a licensing agreement with Eureka Therapeutics and Memorial Sloan Kettering [MSK] Cancer Center for the non-CAR use of a new, human binding domain that targets G Protein Coupled Receptor Family C Group 5 Member D (GPRC5D).
Eureka discovered the binding domain using its proprietary antibody discovery platform and was developed under a collaboration with MSK.”
Parexel snapped up, again, as Goldman Sachs, EQT spend $8.5B on the CRO: “The suitors and soon-to-be owners are the Swedish investment firm EQT Private Equity and the U.S. giant Goldman Sachs Asset Management, giving Pamplona a healthy return on the $5 billion it spent on the CRO [contract research organization] in 2017.”
FDA head calls for inspector general investigation of agency’s dealings with Biogen, maker of controversial new Alzheimer’s drug: “Woodcock said on Twitter she was requesting the review because of the ‘ongoing interest and questions’ about the approval of the drug, called Aduhelm, on June 7. She said the review would focus on interactions between representatives of Biogen and the FDA during the process that led to the approval.”
AbbVie, Biogen, Pfizer launch public database linking genes and diseases: Called “ Genebass database, for gene-based association summary statistics…” It will be maintained by the Broad Institute of MIT and Harvard.
Contraceptive mini-pill available over-the-counter without prescription for the first time: “Two types of the oral contraceptive pill will now be sold over the counter in the UK without a prescription.
Later this month, the progesterone-only pill (POP), or ‘mini pill’ as it’s also known, will be available from high-street pharmacies.
The specific brands of pill — called Hana and Lovima — will be accessible without the need to visit a GP, but pills with oestrogen will still require a consultation.”
Colorado Caps Insulin Costs for All Diabetics: “Colorado has become the second state — after Minnesota — to pass a law capping the price of insulin for both insured and uninsured diabetic patients, continuing a trend of states passing legislation to rein in the cost of the life-saving medicine — so far, mostly for people with health insurance — in response to what they see as inaction by Congress and the federal government.
Slated to take effect Jan. 1, 2022, the new law creates an insulin affordability program that will give eligible diabetics access to insulin for 12 months at a cost of no more than $50 for a 30-day supply and allow for a once-a-year emergency insulin prescription priced at $35 or less for a 30-day supply.”
Marlboro maker Philip Morris strikes deal for UK inhaler group Vectura: “One of the world’s largest tobacco groups, Philip Morris International, has struck a £1bn deal to buy a UK developer of inhalers, the next step in what the owner of the Marlboro cigarette brand said was its plan to become a ‘healthcare and wellness company’…
PMI has said it is focusing on respiratory drug delivery as part of its plan to generate at least $1bn in annual revenues by 2025 from what it calls Beyond Nicotine products.”
McKesson Corporation Enters Agreement to Sell Certain European Businesses to the PHOENIX Group: “McKesson Corporation… announced that it has entered into an agreement to sell its European businesses in France, Italy, Ireland, Portugal, Belgium, and Slovenia to the PHOENIX group. This transaction also includes McKesson’s German-based AG headquarters in Stuttgart, Recucare GmbH, its German wound-care business, its shared services center in Lithuania, and its 45% ownership stake in Brocacef, the company’s joint venture in the Netherlands. The transaction is expected to close in 2022, subject to customary closing conditions, including receipt of required regulatory approvals.
The remaining European businesses in the UK, Norway, Austria, and Denmark are not included in this transaction and will continue to be operated by McKesson.”
About health insurance
CMS pitches payment rules for 2022: 21 notes for hospital execs: “CMS has released its annual proposed payment updates for inpatient facilities, kidney care facilities, home health, skilled nursing facilities, hospices, inpatient psychiatric facilities and inpatient rehabilitation facilities.”
The article is a good summary of institutional payment rules for 2022.
As With The Medicare Plan Finder, CMS Efforts To Improve Physician Compare Have Not Worked: The author goes through examples of how the site is not working well.
About healthcare IT
Hospitals lack consistent cybersecurity plan for networked medical devices: “Even as hospitals continue to face cyberattacks that risk patient harm, Medicare lacks consistent oversight of networked device cybersecurity in hospitals, according to a report from the Department of Health and Human Services Office of Inspector General…
Large hospital systems could have around 85,000 medical devices connected to its network, which translates into a broad attack surface…”
Patient Experience in Virtual Visits Hinges on Technology and the Patient-Clinician Relationship: A Large Survey Study With Open-ended Questions: Be wary of studies like this one.
”Adults with a virtual visit between June 21, 2017, and July 12, 2017, were invited to complete a survey of 21 Likert-scale items and textboxes for comments following their visit.” First, the data is 4 years old, and relies on technology at least that old. Second, it is a study of those who actually were willing and did use the technology- a biased group.
VA Cerner rollout price tag climbs to $18.5B: The saga continues…
”The price tag of the Department of Veteran Affairs's Cerner EHR rollout could go up another $2.5 billion, according to a July 7 report by the Office of the Inspector General.
The cost was originally budgeted at $10 billion, then got a 60 percent increase to $16 billion. Now it could need a bump of $2.5 billion to account for IT infrastructure updates, the report said.”
About the public’s health
U.S. cancer death rates declining, report shows: “Death rates between 2014 and 2018 fell for 11 of the 19 most common cancers among men, and 14 of the 20 most common among women, according to the report from the American Cancer Society, Centers for Disease Control and Prevention, National Institutes of Health, and the North American Association of Central Cancer Registries.”
The lie of “expired” food and the disastrous truth of America’s food waste problem: “Forty percent of food produced in America heads to the landfill or is otherwise wasted. That adds up. Every year, the average American family throws out somewhere between $1,365 and $2,275…
There are two vital facts to know about date labels on foods in the US: They’re not standardized, and they have almost nothing to do with food safety…”
Read the article for more details.
About healthcare devices
St. Jude Medical, Alere pay combined $65M to settle DOJ claims they knowingly sold defective devices: “The U.S. Department of Justice (DOJ) collected two separate settlements from medical device makers after the government said they continued to sell defective products for years amid receiving reports of injuries and deaths linked to their hardware.
Both settlements were announced July 8: St. Jude Medical agreed to pay $27 million, while Alere shelled out $38.75 million. Despite the hefty fines, neither serves as an admission of guilt.
The federal cases were each brought under the False Claims Act and stem from allegations that, by continuing to sell the potentially harmful products to healthcare facilities, where they were used to treat patients enrolled in federal healthcare programs such as Medicare, both companies played a role in securing government payments for devices they knew were defective.”
Avanos Medical Inc. to Pay $22 Million to Resolve Criminal Charge Related to the Fraudulent Misbranding of Its MicroCool Surgical Gowns: “According to court filings, Avanos falsely labeled the gowns as providing the highest [FDA-designated] level of protection against fluid and virus penetration…
In addition, according to court documents, an employee and an agent of Avanos obstructed a July 2016 FDA for-cause inspection of the company’s surgical gown business by making numerous false entries in four documents requested by FDA investigators.”
FDA Releases Final Guidance on its Unique Device Identification System: “The FDA has released a long-awaited final guidance on the form and content of its Unique Device Identification (UDI) system, which has been available in draft form for almost five years.
The UDI must be presented in two forms on device labels and packages — easily readable plain-text and a scannable automatic identification and data capture (AIDC) format.”
About healthcare quality
What Patients Think About Their Hospitals and Ambulatory Surgery Centers: An Analysis of Patient Experience Surveys: From the Leapfrog Group. Read the entire report for details. The “bottom line” is: “Leapfrog’s assessment of CAHPS survey results across different settings of care suggests that despite some positive responses, significant challenges persist, particularly related to communicating about patient understanding of medication protocols, clarity about treatment following discharge, and overall communication. For pediatric patients in hospitals, there are exceptionally troubling signs with parents’ ability to raise concerns about problems and mistakes regarding the care of their children. Outpatient surgical units and ambulatory surgery centers (ASCs) have positive results generally. Regardless, all facilities show signs of patient safety challenges that hospitals and ASCs should address with urgency.”