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Communications Corner

ASA Monitor Today

This section covers all things communications — from current ASA initiatives, to ASA member messaging in the news, and all things in between.


January 26  |  January 24  |  January 17


Sign up to receive the Monitor Editor-in-Chief’s Covid Updates

January 26

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About once every month, 1,500 people receive my “Irregular Covid Update.” I distributed a daily update in the first year of the pandemic, a weekly update in the second year, and a fortnightly update last year. I started modeling the Covid pandemic in March 2020 out of personal interest, using data that are drawn from the usual sources (Hopkins, Oxford, the CDC) and modeling code that I posted to GitHub. Initially, the email list consisted of Stanford faculty who requested my models. The list has continued to expand, and now comprises a global assortment of scientists, physicians, business executives, venture capitalists, journalists, engineers (with SpaceX particularly well represented), and even politicians. These updates are circulated within the FDA and CDC.

Each update starts with the current projections, followed by a summary of the scientific advances from the pages of Nature, Science, Cell, The New England Journal of Medicine, JAMA, The Lancet, The British Medical Journal, and preprint servers. I am still tracking the pandemic daily because it remains a killer: “Today’s graph shows that over the last week, Covid killed more than 4,000 Americans. We may be tired of SARS-CoV-2, but it isn’t tired of us.” If you want to receive my irregular (~monthly) Covid updates, simply add your email address to this Google group. The site also has a searchable index of all of the Covid updates since October 2020. Just click the “Join group” box at the top of the Google webpage, and you’re in.

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Physician Anesthesiologists Week

January 24

Physician Anesthesiology Week 2023 bannerOne week to go until the 9th Annual Physician Anesthesiologists Week, observed on Jan. 29-Feb. 4. This awareness week was developed to highlight the contributions of anesthesiologists during critical moments in health care, whether during a surgical crisis, providing pain management, or protecting safe anesthesia care for Veterans.

The society encourages member participation! Join the conversation on #PhysAnesWk23 for coverage on how anesthesiologists are uniquely qualified to lead patient care. Our members are speaking out via visits with legislators, social media posts, media interviews, in-hospital activities, podcasts, videos, or collaborating with our component societies to secure state proclamations.

Watch (and share!) videos from our members on how physician anesthesiologist training has saved lives in critical situations.

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Why is it so difficult to obtain Paxlovid?

January 17

Man in PPD holding Paxlovid packagingAs noted in this week’s Nature News, Paxlovid (nirmatrelvir / ritonavir) should have been a game changer for Covid-19 (Nature 2023;613:224-225). Paxlovid is highly effective at preventing serious illness, hospitalization, and death. The ascendent BQ and XBB strains of SARS-CoV-2 are making Paxlovid ever more important, as no monoclonal antibodies are effective against these immune evading strains (N Engl J Med 2023; 388:89-91) Paxlovid’s problem isn’t the drug. It’s us.

An opinion piece in JAMA “Getting treated for Covid-19 shouldn’t be this difficult” sums up the Paxlovid dilemma well (JAMA 2023;329:123-4) Quoting the article (and reflecting my own personal experience) on getting Paxlovid for faculty with Covid-19, “Academic rank didn’t matter. From a clinic director to a vice dean to a vice chancellor, all had the same story: it was very hard to get their loved one Paxlovid.”

In December, I reached out to the HHS help line for Covid therapeutics on the topic of why Paxlovid cannot be prescribed for every patient with Covid-19. They promptly replied to tell me that prescribing Paxlovid outside of the existing highly restrictive label “is not permitted”. I wrote back and I what they mean by “is not permitted”. Specifically, I wanted to know whether any law prevented physicians prescribing Paxlovid outside of the very limited indications on the label? What was that law? Who enforces it? What penalties exist? Here is their verbatim response:

Good Afternoon Dr. Shafer,
Thank you for your patience as we worked to formulate a response. An EUA is a specific authority to allow use of certain products during a health emergency, Paxlovid is not an approved drug. Please refer to the LOA for more information (asamonitor.pub/3iEukCT), specifically Section II which includes “The use of Paxlovid covered by this authorization must be in accordance with the authorized Fact Sheets.”
Regards,
HHS - Coordination Operations and Response Element (H-CORE)
Administration for Strategic Preparedness & Response
U.S. Department of Health and Human Services

I invite you to click on the link above. It is the FDA’s letter to Pfizer with the Emergency Use Authorization.

In other words, there is no law. There is no enforcement. There are no penalties for physicians prescribing Paxlovid in a manner consistent with the best care of their patients.

The response shows that FDA has placed the burden of enforcing the EUA label on Pfizer. Last I checked Pfizer does not have a police force. As a practical matter, Pfizer isn’t going to start denying Paxlovid to physicians who prescribe Paxlovid for patients with Covid-19 in a manner not strictly in accordance with the EUA label. Covid-19 is killing > 2000 Americans each week. What pharmaceutical company wants to deny an effective treatment for a fatal disease?

The State of California recently issued to all California physicians a “Reminder to Lower Barriers to Prescribing Covid-19 Therapeutics to Mitigate Impact of Covid-19” (asamonitor.pub/3W1BzlH). Quoting from this reminder issued by the State of California:

We should optimize all of our tools to decrease the hospitalizations, deaths, and long term impacts of Covid-19… There is ample supply of Covid-19 therapeutic agents, but they have been underused – especially among populations disproportionately impacted by Covid-19… Providers should have a low threshold to prescribe Covid-19 therapeutics given the broad range of individuals who are at higher risk for severe Covid-19 and can benefit from Covid-19 treatment.

The reference by the State of California to “Covid-19 treatment” is a reference to Paxlovid. There are only two other drugs that qualify as treatments. Molnupiravir doesn’t work very well, and remdesivir is only available intravenously. If your primary care provider is reluctant to prescribe Paxlovid for Covid-19, send her or him the link to the California page.

Attaining Paxlovid is even more challenging for minorities. An article in JAMA from the CDC noted enormous inequities in Paxlovid prescribing, finding that “Patients from certain racial and ethnic groups who sought outpatient care for Covid-19 were about 20% to 36% less likely to be prescribed Paxlovid (nirmatrelvir-ritonavir)” (JAMA 2022;328:2203-04).

A study in Nature Communications Biology looked at viral evolution over time in patients treated with molnupiravir, Paxlovid, or receiving no treatment at all (Commun Biol 5 2022; 1326). Molnupiravir produced more genetic drift (i.e., mutations) than Paxlovid or no treatment. However, no mutations decreased the efficacy of either drug. Thus, at present there is no evidence that SARS-CoV-2 is developing resistance to Paxlovid.

The bottom line is that Paxlovid is our most effective tool to treat Covid, with nearly 90% effectiveness against hospitalization (asamonitor.pub/3vUNhEl). Yes, the ritonavir that is included in the Paxlovid dose inhibits CYP3A4. Some drugs (e.g., warfarin, anti-epileptics, beta blockers) may need to be reduced when given concurrently with the 5-day course of Paxlovid. However, with Covid-19 still causing 2000 weekly deaths, my hope for 2023 is that physicians will aggressively prescribe the only oral drug that demonstrably prevents hospitalization, serious illness, and death.

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