AstraZeneca in Major Dispute with U.S. Regulators

Anthony Fauci's Institute -- the National Institute of Allergy and Infectious Diseases (NIAID) -- issued a mind-blowing statement today:

Late Monday, the Data and Safety Monitoring Board (DSMB) notified NIAID, BARDA, and AstraZeneca that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial. The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data. We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.

It is almost (but not quite) inconceivable that AstraZeneca made an innocent error. The DSMB is accusing the firm of essentially "cherry-picking"  the data “most favorable for the study as opposed to the most recent and most complete.” (NY Times, 3/23) The DSMB's letter to the NIH and AstraZeneca stated that the efficacy rate of the firm's COVID-19 vaccine might be between 69% and 74%, rather than the 79% rate touted by AstraZeneca itself. Did AstraZeneca really think they could slip one past the regulators? And at what cost to its reputation? Not to mention at what cost to the worldwide public-health crisis, where mistrust of science and vaccine-skepticism don't need any more encouragement and support. 

From the Times article: “'Decisions like this are what erode public trust in the scientific process,' the board wrote." 

Medicaid Expansion in Texas: The Time is Now

The Legislature is back in session. A bill has been introduced to authorize Texas to accept the federal government's offer to pay for 90% of the cost of expanding Medicaid eligibility to include all Texans under the age of 65 (when Medicare kicks in) and whose income does not exceed 138% of the federal poverty level: HB 1730, introduced by Republican Representative Lyle Larson. Sen. Johnson's own companion bills are SB 118 and SB 119.

The case for expansion is made in a most compelling and entertaining video (10.5 minutes) by Senator Nathan Johnson (D-Dist. 16 (which covers a big chunk of Dallas)). Please watch it. Share it with your family. Send it to your friends. Get involved. We have already waited too long, left billions of federal dollars on the table, and worst of all, we've ignored the health care needs of 1 million Texans who would benefit from expansion. Let's make this happen this year.

And thanks to DFW Hospital Council CEO Stephen Love for passing the video on to me.

CDC's Guidance for "Fully Vaccinated People"

The guidance was issued earlier today, and you can read the whole document here. Meanwhile, here are the highlights:

Key Points

This is the first set of public health recommendations for fully vaccinated people. This guidance will be updated and expanded based on the level of community spread of SARS-CoV-2, the proportion of the population that is fully vaccinated, and the rapidly evolving science on COVID-19 vaccines.

For the purposes of this guidance, people are considered fully vaccinated for COVID-19 ≥2 weeks after they have received the second dose in a 2-dose series (Pfizer-BioNTech or Moderna), or ≥2 weeks after they have received a single-dose vaccine (Johnson and Johnson [J&J]/Janssen ).†

The following recommendations apply to non-healthcare settings.

Fully vaccinated people can:

Visit with other fully vaccinated people indoors without wearing masks or physical distancing

Visit with unvaccinated people from a single household who are at low risk for severe COVID-19 disease indoors without wearing masks or physical distancing

Refrain from quarantine and testing following a known exposure if asymptomatic

For now, fully vaccinated people should continue to:

Take precautions in public like wearing a well-fitted mask and physical distancing

Wear masks, practice physical distancing, and adhere to other prevention measures when visiting with unvaccinated people who are at increased risk for severe COVID-19 disease or who have an unvaccinated household member who is at increased risk for severe COVID-19 disease

Wear masks, maintain physical distance, and practice other prevention measures when visiting with unvaccinated people from multiple households

Avoid medium- and large-sized in-person gatherings

Get tested if experiencing COVID-19 symptoms

Follow guidance issued by individual employers

Follow CDC and health department travel requirements and recommendations

Free Webinar: Pres. Biden's First 100 Days of Health Policy

This looks like a good webinar:

Boston University's Center for Health Law, Ethics & Human Rights faculty discuss the first 100 days of President Biden’s term:

• Executive Orders,
• proposed bills, and
• other steps to tackle COVID, climate, and economic crises affecting health.

What has happened? What comes next? 

Thursday, March 11, 2021
1:00 - 2:30 p.m. EST

SPEAKERS
George Annas
Nicole Huberfeld
Wendy Mariner
Michael Ulrich

JOIN ZOOM MEETING
https://bostonu.zoom.us/j/93372687004?pwd=NXpoNm5wZW1YOEljeENyeWY2V3dVUT09

Meeting ID: 933 7268 7004
Passcode: 331167

"Governor Abbott Lifts Mask Mandate, Opens Texas 100 Percent" [source: Governor's website]

Yes, it's true. Governor Abbott (along with the Governor of Mississippi) has earned the title "Worst Public Health Decision Maker Still Holding Office in the U.S." with this announcement. The full text of Executive Order GA-34 is here.

Gov. Abbott offered remarks on his remarkable EO in Lubbock. Here is an annotated paragraph:

"With the medical advancements of vaccines and antibody therapeutic drugs, Texas now has the tools to protect Texans from the virus,” said Governor Abbott. 

You bet we have the tools. We simply have to use them. 

"Make no mistake, COVID-19 has not disappeared, but it is clear from the recoveries, vaccinations, reduced hospitalizations, and safe practices that Texans are using that state mandates are no longer needed."

Wow, that's a whopper. To borrow a line from Justice Ginsburg's dissent in Shelby County, in which the majority held that the Voting Rights Act's preclearance mechanism was no longer needed: "Throwing out preclearance when it has worked and is continuing to work to stop discriminatory changes is like throwing away your umbrella in a rainstorm because you are not getting wet." [Opinion, p. 33]

"Today's announcement does not abandon safe practices that Texans have mastered over the past year."

Another whopper. Texans haven't mastered safe practices and now we've been given a green light to abandon them altogether. 

"Effective next Wednesday [Mar. 10], all businesses of any type may open to 100% capacity." "This order ends the statewide mask mandate in Texas."

Abbott helpfully notes that anyone who wants to can wear a mask and businesses can self-limit their own capacity. That's the kind of right-thinking Texas policy that gave us ERCOT and the disaster of two weeks ago. We are going our own way and celebrating Texas independence. Wonderful spirit, but lots of people died. And lots of people are going to die of COVID-19 unnecessarily because of today's order. 

Stephen Love, the President/CEO of the Dallas-Fort Worth Hospital Council had this to say: 

"While we respect Governor Greg Abbott and realize he has faced enormous challenges with the COVID-19 pandemic and recent weather issues, we strongly disagree with removing the mandatory mask requirements. This decision will cause the community spread to increase, forcing our exhausted healthcare heroes to diagnose, treat and save the lives of newly infected patients. If the community spread increases, the risk of mutations will also increase, creating a new set of potentially dangerous challenges. If you truly want to honor our healthcare heroes, then continue to wear a mask! We ask Governor Abbott to please reconsider his decision."

Back to the governor: 

"Instead, it is a reminder that each person has a role to play in their own personal safety and the safety of others." 

Agreed. What the Executive Order ignores is that the state has a role to play, as well. And the governor has just abandoned that responsibility.

"With this executive order, we are ensuring that all businesses and families in Texas have the freedom to determine their own destiny."

And the destiny of all others -- family, workers, strangers -- with whom they come into contact. Gulp.