With the two seat Democratic victory in Georgia, that party now has majority control of the Senate (with VP Harris as the tie-breaker). But it is unlikely Democrats can get the 60 votes needed to break a filibuster to pass major legislation. Only reconciliation bills (which affect finances) can be passed if all Democrats vote together. Given this narrow margin, the media are recommending several things that could be done with respect to health care; but they have forgotten one important change- adding back a “tax” on the uninsured. That measure would make any Supreme Court decision to invalidate the ACA moot.
About pharma
Early High-Titer Plasma Therapy to Prevent Severe Covid-19 in Older Adults: “Early administration of high-titer convalescent plasma against SARS-CoV-2 to mildly ill infected older adults reduced the progression of Covid-19.” The full article is available from the NEJM.
Trump Signs Bill Allowing FDA Seizure Of Counterfeits: “President Donald Trump on Tuesday signed the Safeguarding Therapeutics Act, a bipartisan bill that would give the U. S. Food and Drug Administration the authority to seize counterfeit medical devices and products, including vaccines…
Under the act, the U. S. Department of Health Human Services will set regulations that allow the manufacturer of an alleged counterfeit product to challenge the decision before the products are destroyed. During this time, the department will store the products at the manufacturer's costs.”
FDA extends immunodeficiency drug's shelf life as pandemic exacerbates shortages: “The FDA has stretched the expiration date of 42 existing lots of Octapharma’s subcutaneous immune deficiency drug cutaquig and granted a 12-month shelf life extension on future lots stored at 36 degrees to 46 degrees Fahrenheit. The drug was previously cleared to last 24 months when refrigerated.”
This article is a reminder that many medications can be kept past the printed expiration date if stored properly.
Walgreens shares rise after its earnings top estimates, fueled by higher drug sales: “Walgreens said its U.S. pharmacy sales picked up in the fiscal first quarter, despite less foot traffic, lower sales of cough, cold and flu medications, and fewer new prescriptions as people skipped the doctor’s office and socially distanced during the Covid pandemic.”
New drug form may help treat osteoporosis, calcium-related disorders: “Purdue University innovators developed a stabilized form of human calcitonin, which is a peptide drug already used for people with osteoporosis. Researchers at Purdue created a prodrug form of the peptide hormone to increase its effectiveness as an osteoporosis treatment.
In humans, calcitonin is the hormone responsible for normal calcium homeostasis. When prescribed to osteoporosis patients, calcitonin inhibits bone resorption, resulting in increased bone mass.
Unfortunately, human calcitonin undergoes fibrillation in aqueous solution, leading to reduced efficacy when used as a therapeutic. As a substitute, osteoporosis patients are prescribed salmon calcitonin…
To decrease the fibrillation propensity and increase the therapeutic benefit of human calcitonin, Purdue researchers phosphorylated specific amino acid residues.”
About the public’s health
U.S. Is Blind to Contagious New Virus Variant, Scientists Warn: “The United States has no large-scale, nationwide system for checking coronavirus genomes for new mutations, including the ones carried by the new variant. About 1.4 million people test positive for the virus each week, but researchers are only doing genome sequencing — a method that can definitively spot the new variant — on fewer than 3,000 of those weekly samples. And that work is done by a patchwork of academic, state and commercial laboratories.
Scientists say that a national surveillance program would be able to determine just how widespread the new variant is and help contain emerging hot spots, extending the crucial window of time in which vulnerable people across the country could get vaccinated. That would cost several hundred million dollars or more.”
CureVac and Bayer join forces on COVID-19 vaccine candidate CVnCoV: “Bayer has signed a collaboration and services agreement with CureVac N.V…., a biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA). Under the terms of the agreement, Bayer will support the further development, supply and key territory operations of CureVac´s COVID-19 vaccine candidate CVnCoV. To this end, Bayer will contribute its expertise and established infrastructure in areas such as clinical operations, regulatory affairs, pharmacovigilance, medical information, supply chain performance as well as support in selected countries.”
HPV Vaccination Campaign for Young Adults and Health Care Providers Launches from HHS’ Office on Women’s Health: The HPV VAX NOW campaign was announced yesterday. Its aim is to increase HPV vaccination rates.
Swansea University developing world’s first COVID-19 ‘smart-patch’ vaccine that will measure effectiveness: “The research, from the Institute for Innovative Materials, Processing and Numerical Technologies (IMPACT), will produce the vaccine through the use of microneedles (MNs) to create a ‘smart-patch’. This device will simultaneously measure a patient’s inflammatory response to the vaccination by monitoring biomarkers in the skin…
Microneedles provide a safe and effective method to deliver vaccines with added attributes of requiring lower vaccine doses, permitting low-cost manufacturing, and enabling simple distribution and administration. A microneedle delivery patch is easy to apply and minimally invasive – combined with the proposed measurement capabilities, this new vaccine system would enable a personalised vaccination approach…
The primary goal of this project is to create a prototype of smart vaccine delivery device that can not only deliver the COVID-19 vaccine transdermally but also monitor biomarkers in the skin compartment in a minimally invasive way, offering real-time information on the efficacy of the vaccination. The new method would change the way in which vaccine efficacy trials are performed from a statistical assessment to a scientific measurement of patient inflammatory response to vaccination.”
Pfizer, BioNTech Make Offer to South Africa to Price COVID-19 Vaccine at $10 Per Dose: “The price is about half of what the U.S. and EU negotiated with the companies, but the South African government is reportedly pressing for an even lower price.”
This article raises the question of wealthy nations subsidizing costs in developing countries.
Kaiser Permanente data key to nation’s COVID-19 vaccine surveillance strategy: “Kaiser Permanente’s Vaccine Study Center…, part of the Kaiser Permanente Northern California Division of Research, was chosen by the Centers for Disease Control and Prevention (CDC) to carry out a Rapid Cycle Analysis (RCA) through CDC’s Vaccine Safety Datalink (VSD) network. Organizations that share data through the network include 5 Kaiser Permanente regions, HealthPartners in Minneapolis, and the Marshfield Clinic in Wisconsin.
The surveillance involves casting a wide net through electronic patient records, searching for specific potential adverse health effects, such as strokes or anaphylaxis (severe allergic reaction). Eight health care institutions that participate in the VSD share weekly data reports on the selected diagnoses and data analysts search for any possible connection with a COVID-19 vaccination.
Kaiser Permanente’s Vaccine Study Center has been evaluating vaccines for more than 30 years and carrying out rapid response studies through the Datalink for more than a decade…”
People without symptoms spread virus in more than half of cases, CDC model finds: “Fifty-nine percent of all transmission came from people without symptoms, under the model’s baseline scenario. That includes 35 percent of new cases from people who infect others before they show symptoms and 24 percent that come from people who never develop symptoms at all.”
About health insurance
Best Health Insurance Companies For 2021: Kaiser tops the national list of ranking by consumers. You can also view rankings by state.
What Is The Value Of A Star When Choosing A Provider For Total Joint Replacement? A Discrete Choice Experiment: “We conducted a discrete choice experiment in an outpatient setting (an academic joint arthroplasty practice) to study trade-offs that patients are willing to make in choosing a provider for a hypothetical total joint arthroplasty. Two hundred consecutive new patients presenting for hip or knee pain in 2018 were included. The average patient was willing to pay $2,607 and $3,152 extra for an additional hospital or physician star, respectively, and an extra $11.45 to not travel an extra mile for arthroplasty care. History of prior surgery and prior experience with rating systems reduced the relative value of an incremental star by $539.25 and $934.50, respectively.”
Comparison of Utilization, Costs, and Quality of Medicaid vs Subsidized Private Health Insurance for Low-Income Adults: “Public coverage through Medicaid was associated with more ED visits and fewer office visits than private Marketplace coverage, which may reflect barriers to outpatient care or lower cost-sharing barriers to ED care in Medicaid. Results suggest that Medicaid coverage was substantially less costly to beneficiaries and society than private coverage, with mixed results on health care quality.”
An ongoing coverage question is whether Medicaid-eligible people should be insured through that program or through subsidized private insurance. This research starts to shed some light on the answer.