About Covid-19
Biden Administration to Again Extend the Covid Public-Health Emergency “The Department of Health and Human Services has repeatedly renewed the emergency since it was originally declared in January 2020, with the most recent extension set to expire July 15. The next extension is expected to take effect Friday, according to a person familiar with the matter who asked not to be identified because the details aren’t public.”
Moderna to advance two Omicron vaccine candidates against newer variants “Moderna Inc said on Monday it was advancing two Omicron vaccine candidates for the fall, one designed against the BA.1 variant and another against the BA.4 and BA.5.”
About health insurance
Optum, Red Ventures partner on consumer healthcare platform “UnitedHealth Group's provider arm, Optum Health, has teamed up with Red Ventures on a new consumer health-focused joint venture, RVO Health, which among other things includes doctor ratings through Healthgrades.
Red Ventures is a portfolio of bands that includes Healthgrades, Healthline Media, Optum Perks and Optum Store, as well as virtual coaching programs. Those will all be folded into the RVO Health venture.
According to a report from Moody's Investors Service, RVO Health will combine 120 million UHG customers and 50 million-plus members with Red Ventures' 95 million unique monthly visitors.”
About hospitals and healthcare systems
HHS clarifies: All US hospitals must provide abortions in emergency cases “HHS issued guidance to hospitals July 11 to clarify that abortion is covered under the federal law requiring Medicare hospitals to provide all patients appropriate emergency care — including abortion care — regardless of state law…
The Emergency Medical Treatment and Labor Act was enacted in 1986 by Congress to require that Medicare hospitals provide all patients an appropriate emergency care — including medical screening, examination, stabilizing treatment and transfer, if necessary — irrespective of any state laws or mandates that apply to specific procedures. If a hospital is in a state that prohibits abortion by law and does not make exceptions for the health or life of a pregnant person, EMTALA preempts that state law.
HHS enforces EMTALA through CMS and a complaint-driven process.”
About pharma
FDA to review first ever over-the-counter birth control pill “Perrigo Company said on Monday its unit HRA Pharma has asked the U.S. Food and Drug Administration (FDA) to approve a daily birth control pill for over-the-counter (OTC) sale, the first such request for this type of contraception…
The contraceptive is currently a prescription drug sold under brand Opill.
HRA Pharma expects the regulator to hold an advisory committee meeting and approve the application in the first half of 2023…”
And in a related article: Oral Contraceptives, Hormone Replacement Therapy, and Stroke Risk “Millions of women worldwide use exogenous hormones as oral contraceptives or hormone replacement therapy. Still, time-dependent and long-term consequences of exogenous hormones on stroke risk remains unclear…
Oral contraceptive use and hormone replacement therapy were associated with an increased risk of stroke, especially during the first year of use, possibly due to immediate changes in hemostatic balance. This study provides new insights on the effects of hormone exposure on stroke risk and provide evidence of not only an overall risk but also a pronounced effects seen in the beginning of treatment.”
Robert Califf Sounds Alarm if User Fees Aren’t Reauthorized Quickly ”Five months into his tenure as FDA commissioner, Robert Califf warned that the agency’s ability to review medical products would be drastically curtailed if Congress doesn’t pass a user fee reauthorization package by August.”
Merck sues HHS to avoid fine over 340B contract pharmacy restrictions “The pharmaceutical giant argues in a federal lawsuit filed Friday in the U.S. District Court for the District of Columbia that favorable rulings in similar cases make a warning letter from the federal government moot. The lawsuit is the latest in a feud between the federal government and drugmakers over the 340B program.”
Economic Evaluation of Cost and Time Required for a Platform Trial vs Conventional Trials “Conventionally, clinical trials have a defined end and only compare pre-specified intervention(s), meaning that therapeutic discoveries made during the trial are evaluated in a new trial. This results in multiple independent trials, requiring new infrastructure for each shorter-term evaluation and more patients randomized to placebo or standard-of-care compared with platform trials.
Platform trials are randomized clinical trials that allow for multiple interventions to be simultaneously compared and new interventions to be added after the trial is initiated. They typically aim to continue for an extended period or in perpetuity with interventions entering and leaving the platform at different times. Many published reviews on platform trials describe the statistical efficiencies of platform trials over conventional trial approaches. There is little guidance, however, on substantive resources to establish and maintain platform trials…
The findings of this study suggest that despite having larger initial setup requirements, consolidating clinical evaluation of multiple interventions into a single platform trial can drastically reduce cost and efforts.”
Also, see: An Economic Perspective on Platform Trials—The Gift and the Curse
About the public’s health
Superbug infections spiked in pandemic's first wave “The first wave of the Covid pandemic created the perfect storm for superbugs in the U.S., with cases and deaths from dangerous drug-resistant bacterial and fungal infections spiking in hospitals in 2020, a report published Tuesday finds.
The spike, the Centers for Disease Control and Prevention report said, wiped out the progress made against the deadly pathogens before the pandemic.”
About healthcare IT
Machine Learning Analysis of Handgun Transactions to Predict Firearm Suicide Risk “In this prognostic study of nearly 2 million individuals with handgun transaction records, among transactions classified in the riskiest 5%, close to 40% were associated with a purchaser who died by firearm suicide within 1 year. Among the small number of transactions with a random forest score of 0.95 and above, more than two-thirds were affiliated with a purchaser who died by firearm suicide within 1 year (24 of 35).”
Fascinating, but the gun lobby will never let this technology achieve widespread acceptance.
Epic's revenue up 13% in 2021, hit $3.8B “Epic reported a 15 percent annual growth rate for the decade leading up to last year and then saw 13 percent revenue growth to $3.8 billion.”
About health technology
Medtronic begins Class I recall of 1 million dialysis catheters at risk of leaking “Medtronic has asked healthcare providers to immediately stop using more than 1 million catheters distributed across the U.S. and around the world after discovering a potential safety risk within the devices.
The alert marks the latest Class I recall for a company that has racked up half a dozen such safety events since the start of the year. The FDA dished out its most serious classification to the catheter recall last week, about a month after Medtronic initiated it in early June.”
Philips scores FDA clearance for faster MRI scanning powered by AI “Philips has secured an FDA clearance for artificial-intelligence-powered software designed to speed up the MRI scanning process while still delivering high-resolution images.
Dubbed SmartScan, Philips said the program can help complete scans up to three times faster with ‘virtually no loss in image quality,’ allowing radiology departments to see more patients with the same hardware in about 97% of cases.
That covers a wide range of clinical protocols including the use of injected contrast agents as well as diffusion weighted imaging and quantitative scans of the brain, liver, heart and musculoskeletal system. It is also compatible with implants and can capture organs in motion or even a restless patient.”
Abbott's personalized brain stimulator earns FDA breakthrough tag for treating depression “Abbott said Tuesday that it has earned the agency’s acknowledgement for an ongoing project to apply its deep brain stimulation system to treatment-resistant depression. The label gives the technology a more expedited pathway toward potential FDA clearance.”
CEO of Dozens of Companies and Entities Charged in Scheme to Traffic an Estimated $1 Billion in Fraudulent and Counterfeit Cisco Networking Equipment “According to the indictment, Onur Aksoy, aka Ron Aksoy, aka Dave Durden, 38, of Miami, allegedly ran at least 19 companies formed in New Jersey and Florida as well as at least 15 Amazon storefronts, at least 10 eBay storefronts, and multiple other entities (collectively, the ‘Pro Network Entities’) that imported tens of thousands of fraudulent and counterfeit Cisco networking devices from China and Hong Kong and resold them to customers in the United States and overseas, falsely representing the products as new and genuine. The operation allegedly generated over $100 million in revenue, and Aksoy received millions of dollars for his personal gain.”