About the public’s health
White House Blocks New Coronavirus Vaccine Guidelines: This action is the reason many people will not trust the vaccine when it comes out. “Top White House officials are blocking strict new federal guidelines for the emergency release of a coronavirus vaccine, objecting to a provision that would almost certainly guarantee that no vaccine could be authorized before the election on Nov. 3, according to people familiar with the approval process.
Facing a White House blockade, the Food and Drug Administration is seeking other avenues to ensure that vaccines meet the guidelines. That includes sharing the standards — perhaps as soon as this week — with an outside advisory committee of experts that is supposed to meet publicly before any vaccine is authorized for emergency use. The hope is that the committee will enforce the guidelines, regardless of the White House’s reaction.”
Trump health official meets with doctors pushing herd immunity: This article is a great explanation of a strategy to open society to the least vulnerable and let COVID-19 spread in order to achieve “heard immunity.” Do you agree?
WHO: 10% of world’s people may have been infected with virus: “The head of emergencies at the World Health Organization said Monday the agency’s ‘best estimates’ indicate roughly 1 in 10 people worldwide may have been infected by the coronavirus — more than 20 times the number of confirmed cases — and warned of a difficult period ahead.”
BioNTech, Pfizer start rolling EMA approval filing for COVID-19 vaccine:”BioNTech and Pfizer have started a rolling submission of their COVID-19 vaccine BNT162b2 to the European Medicines Agency (EMA). The news comes days after EMA named AstraZeneca's AZD1222 as the first COVID-19 vaccine to start the rolling review process.
The EMA uses rolling reviews to start assessing data on an experimental candidate before all the evidence needed to make a final decision is available, cutting the time it takes to decide whether to approve a prospect once the pivotal clinical trial results are submitted to the agency.”
About pharma
8 drugs Trump has been given for his COVID-19 treatment: A good summary of the science (or lack of it) behind the drugs the President received for his COVID-19 infection.
Lopinavir–ritonavir in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial:“In patients admitted to hospital with COVID-19, lopinavir–ritonavir was not associated with reductions in 28-day mortality, duration of hospital stay, or risk of progressing to invasive mechanical ventilation or death. These findings do not support the use of lopinavir–ritonavir for treatment of patients admitted to hospital with COVID-19.”
Trump’s use of Regeneron’s experimental coronavirus treatment creates ‘very tough situation,’ CEO says: In a related story:
“The president, who announced Friday that he tested positive for the coronavirus, was given an 8 gram dose of Regeneron’s monoclonal antibody treatment, his doctors said.
The company said it provided the drug to the president in response to a ‘compassionate use’ request from Trump’s doctors.
That means that while the president’s doctors were confident enough of the drug’s benefit to administer it to Trump, the treatment remains unavailable to most Americans.”
Compassionate use is usually reserved for patients who have few choices left for their therapies when proven treatments have failed. The medications are in the development or testing phase and show potential promise.
About health insurance
Walmart and Clover Health team up to offer Medicare Advantage plans:”Insurer Clover Health has partnered with Walmart to offer a series of Medicare Advantage plans aimed at low-income, Medicare-eligible beneficiaries in Georgia.
This will be the first foray for Walmart into the health plan space, though the retail giant does have a co-branded Medicare Part D plan with Humana. It has also launched a series of health clinics.”
About hospitals and health systems
New Report Finds Rapid Growth of Catholic Health Systems: Among the study’s findings:
“The 10 largest Catholic health systems have grown and strengthened through mergers and acquisitions, and now own or control 394 short-term acute care hospitals, a 50 percent increase since 2001. The reach of these 10 systems extends beyond traditional acute care hospitals, with over 1,100 total inpatient health care facilities, 864 urgent care centers, 385 ambulatory surgery centers and 274 physician groups.”
About healthcare IT
With ‘nutrition labels’ and an anthropologist’s eye, Duke pioneers a new approach to AI in medicine: “If not for an anthropologist and sociologist, the leaders of a prominent health innovation hub at Duke University would never have known that the clinical AI tool they had been using on hospital patients for two years was making life far more difficult for its nurses…
The researchers are part of a larger team at Duke that is pioneering a uniquely inclusive approach to developing and deploying clinical AI tools. Rather than deploying externally developed AI systems — many of which haven’t been tested in the clinic — Duke creates its own tools, starting by drawing from ideas among staff. After a rigorous review process that loops in engineers, health care workers, and university leadership, social scientists assess the tools’ real-world impacts on patients and workers.”