Opinion: Covid-19 vaccine effectiveness declines rapidly; seniors need to keep up their immunity, and we need a better vaccine

Covid-Net graph, adapted; gray area may have some delayed reporting and does not indicate trends.

Kevin Kavanagh, M.D.

By Kevin Kavanagh for Infection Control Today

I am at high risk for severe Covid-19, being 65 years or older, with additional health problems. I received my bivalent booster as soon as possible and am approaching my 6-month anniversary. I, thus, watched the CDC’s last Advisory Committee on Immunization Practices meeting with great interest regarding their recommendations for when to obtain my next booster.

Reuters reported that the committee concluded, “There is not sufficient evidence to recommend more than 1 Covid-19 booster shot a year for older people and those with weakened immune systems,” but the committee did voice some flexibility. It needs to be stressed that there was an absence or lack of data—rather than a presence of data—indicating the durability of vaccine immunity, justifying annual boosters.

There was no vote regarding the timing of booster doses, but there was nowhere near a unanimous consensus. Michael Hogue of the American Pharmacists Association said, “We want those clinicians to be able to make good decisions for the individual patient based upon their comfort and desire as long as we have safety in mind, and it is clear that we do have a very safe vaccine with our bivalent vaccine. So, I feel that flexibility needs to be put into this some way, with both older adults and people with immunocompromising conditions.”

I did not hear calls for approving a more frequent administration schedule. One committee member said those over 65 should be allowed to discuss off-label use with their physician in order to receive the booster sooner. Almost all the discussion centered on messenger-RNA vaccines, with little mention of Novavax or the urgent need for newer, more durable vaccines.

Vaccine effectiveness is an important point. Although much of the younger population received a get-out-of-hospital free card for the latest variant, senior citizens were in its crosshairs. Since May 2022, those over 75 had a higher rate of hospitalization than in the Delta surge; those 65 to 75 had about the same. Both age groups continue to be at high risk for death and disability.

However, when I saw data on effectiveness of the monovalent vaccines, the two-dose-or-more immunization that preceded the bivalent vaccine, I felt foreboding. The data showed that for those 65 years and older, the effectiveness of two or more monovalent doses at preventing hospitalizations fell to 28% in less than a year.

Among younger people, the monovalent vaccines were only 19% effective. This finding may seem paradoxical, but could be explained by the elderly leading a safer lifestyle and the possibility that immunity produced by previous infections may not have been as durable. Neither explanation bodes well for vaccine effectiveness lasting a year.

For the bivalent booster, effectiveness against hospitalization fell rapidly, from 52% at a median of 32 days to 31% at a median of 74 days (67-85 days) after the last dose. It should be noted that this effectiveness is on top of some residual immunity from the monovalent vaccine, since the monovalent vaccine was used as the reference.

Let’s face it. The results are dismal, with little durability from an immunity boost from a bivalent booster after an individual has had a monovalent vaccine. The benefit from the bivalent booster rapidly diminishes, and its efficacy in preventing hospitalizations two months after receiving the booster is poor and would be expected to be poorer in the elderly.

Is the bivalent booster worth taking? Yes, definitely. However, this differs from the booster or vaccine we need to navigate this pandemic. We need another warp-speed initiative for vaccine development—a vaccine that is more durable and can reduce spread. The risk of continuing to use a vaccine with reduced effectiveness is shown when the vaccine was seemingly less effective in the young. When vaccinated, many view themselves as invincible and can increase risky behavior far beyond the vaccine's benefits.

It is critical for the elderly to keep their immunity as high as possible. Monoclonal antibodies are no longer effective with the new variants, and far too many cannot receive Paxlovid because of drug interactions. Molnupiravir is often not prescribed since it works by creating viral mutations and has been implicated in speeding variant evolution.

At the conclusion of the CDC committee meeting, my primary impression was that we senior citizens might be viewed as expendable. Far too few policymakers are concerned about our well-being and willing to make the hard decisions that must be made to assure our safety during this pandemic. After looking at the data, I will consult my physician about receiving a booster on an accelerated schedule, possibly at six months.

Kevin Kavanagh is a retired physician from Somerset and chairman of Health Watch USA. This is an edited version of his original article, which was first published in Infection Control Today.

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Humana says it will drop commercial employer-sponsored health insurance and hopes to grow through government programs

Humana's headquarters on Main Street in Louisville

Kentucky Health News

Louisivlle-based Humana Inc., which originated as a nursing-home company 60 years ago, then became a hospital company and then a health-insurance company, is planning to transform itself again – into a compaany that offers general health insurance only through government plans: Medicare Advantage, Medicaid and the military plan.

Humana announced Thursday that it would stop providing employer-sponsored commercial coverage, including self-funded and Federal Employee Health Benefit plans, over the next 18 to 24 months. "Humana will still provide insurance through its military service business," reports Tom Murphy of The Associated Press. "It also will still provide employer-sponsored specialty coverage like vision and dental benefits."

Humana covers more than 13 million people, but fewer than 1 million are in employer-sponsored health insurance, not counting the Tricare plan for active-duty service members, families and retirees, which has an enrolment of nearly 6 million.

“This decision enables Humana to focus resources on our greatest opportunities for growth and where we can deliver industry leading value for our members and customers,” President and CEO Bruce Broussard said. “It is in line with the company’s strategy to focus our health plan offerings primarily on government-funded programs . . . ”

Half of Kentuckians on Medicare have Advantage plans, in which the federal government pays the insurer a flat fee per enrollee, creating an incentive for the insurer to limit the cost of claims. Managed-care Medicaid plans, like those Humana and other insurers have in Kentuckym, are funded likewise.

"Employer-sponsored enrollment growth has largely slowed for insurers, including market leaders like UnitedHealthcare," Murphy reports. "Companies have turned more to government-backed coverage like Medicare Advantage or Medicaid for growth. They also have pushed deeper into managing prescription drug plans and providing care in order to control health-care costs."

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With 'low confidence,' Energy Dept. says Covid-19 likely from lab; FBI confidence 'moderate;' intel panel, 4 other agencies disagree

The Wuhan Institute of Virology is located in the city where
the pandemic began. (Photo by Hector Retamal, AFP/Getty)

The Department of Energy has concluded that the Covid-19 pandemic "most likely arose from a laboratory leak, according to a classified intelligence report recently provided to the White House and key members of Congress," The Wall Street Journal's Michael Gordon and Warren Strobel report.

The department "made its judgment with 'low confidence,' according to people who have read the classified report," the Journal reports. The agency thus joins the FBI "in saying the virus likely spread via a mishap at a Chinese laboratory," the Journal notes. "The FBI previously came to the conclusion that the pandemic was likely the result of a lab leak in 2021 with 'moderate confidence' and still holds to this view. . . . While the Energy Department and the FBI each say an unintended lab leak is most likely, they arrived at those conclusions for different reasons."

Four other agencies and a national intelligence panel still judge with "low confidence" that the pandemic "was likely the result of a natural transmission, and two are undecided," the Journal reports. "The Energy Department’s conclusion is the result of new intelligence and is significant because the agency has considerable scientific expertise and oversees a network of U.S. national laboratories, some of which conduct advanced biological research."

The Journal adds, "The National Intelligence Council, which conducts long-term strategic analysis, and four agencies, which officials declined to identify, still assess with 'low confidence' that the virus came about through natural transmission from an infected animal, according to the updated report. The Central Intelligence Agency and another agency that officials wouldn’t name remain undecided between the lab-leak and natural-transmission theories . . . Despite the agencies’ differing analyses, the update reaffirmed an existing consensus between them that Covid-19 wasn’t the result of a Chinese biological-weapons program, the people who have read the classified report said."

Because no animal source for the novel coronavirus has been confiormed, and Wuhan, where the outbreak began, "is the center of China’s extensive coronavirus research, has led some scientists and U.S. officials to argue that a lab leak is the best explanation for the pandemic’s beginning," the Journal reports. "State Department cables written in 2018 and internal Chinese documents show that there were persistent concerns about China’s biosafety procedures, which have been cited by proponents of the lab-leak hypothesis."

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School officials sound the alarm about students getting sick from vaping and the threat of illegal or deadly substances in devices

Kentucky Health News map; Whitley and Knox counties reflect Corbin Independent Schools.

Harlan County school officials have "asked businesses to guard against selling vape pens to minors after students in a nearby county got sick from using vape pens that may have contained an illegal drug," and school officials in other counties have issued similar warnings, report Bill Estep and Valarie Honeycutt Spears of the Lexington Herald-Leader.

The officials' letter urged businesses "to move vaping products behind the counter and to try to make sure employees don’t sell to minors. The letter said that while most businesses that sell vape products follow the law, school officials had heard from an 'alarming number of underage students' that they had bought such products locally, illegally."

“Please help us avoid a tragedy,” said the letter, which came after incidents in nearby Knox County, "in which students suffered concerning symptoms after using vape pens" Feb. 10-16, the Herald-Leader reports. "The symptoms included shortness of breath, increased heart rate and confusion . . . Four students went to the hospital for treatment and four were treated by a school nurse," according to the Appalachian High Intensity Drug Trafficking Area, a federally funded law-enforcement unit.

"Frank Shelton, spokesman for the school district, said the district had only four incidents, not eight," the newspaper
reports. "After three students at Lynn Camp Middle/High School had adverse symptoms on Feb. 15, Knox County Sheriff Mike Smith said in a news release that the vape pens they used were believed to have contained THC, the ingredient in marijuana. AHIDTA said in its bulletin two vape pens involved in the incidents may have been laced with fentanyl."

If testing at the Kentucky State Police lab "confirm any of the vape pens in Knox County were laced with fentanyl, it would be the first time that has been documented in Kentucky, and would be among only a few cases nationwide, according to the AHIDTA bulletin." Knox County school officials told parents in letters that vaping can be risky for youth because they may not know whether electronic cigarettes contain illegal or deadly substances.

"In Harlan County, school officials told businesses that the use of vaping products by young people is a growing problem," the Herald-Leader reports. School Police Matt Chief Cope told the newspaper that students in the district have become sick from vaping, and he and Safe Schools Director Jim Whitaker visited all 20 businesses in the county that sell vape pens to deliver their request in person.

In November, the board of the Corbin Independent School Distrrict, which includes parts of Knox and Whitley counties, published an open letter saying that some students had become ill after using vaping products. "The letter said that during a talk by an expert in the subject, more than half the middle school students in the audience raised their hands when asked if they knew someone their age who vaped regularly and couldn’t stop," the Herald-Leader reports, citing the News Journal, a Corbin newspaper.

The problem isn't just in southeastern Kentucky schools, the Herald-Leader notes: "After Kentucky State Police used dogs to do a surprise search for illegal substances at Edmonson County High School last month, the principal, Jonathan Williams, said local officials were finding that illegal substances were being sold in vaping products. . . . Earlier this month, the sheriff in Lyon County said a 14-year-old girl was facing charges after she was found with a vape device that contained THC, the chemical in marijuana. The case arose after school officials told police about getting a report that students were vaping on a bus, according to WPKY."

Surveys by the state Department of Education show that the share of middle-school students reporting frequent vaping, defined as 20 days out of the last 30 days, rose from 1.4% in 2015 to 2.9% in 2021, "and the number who said they had ever vaped rose from 21.8% to 24.1% in the same period," the Herald-Leader reports. "Among high-school students, the number reporting frequent use rose from 3.2% in 2015 to 8.1% in 2021, and the percentage who said they’d ever used a vaping product increased from 41.7% to 45.1%."

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Covid-19 risk remains low in most counties; only four estimated to have high risk; Kentucky's 7-day infection rate is 16th in the nation

Centers for Disease Control and Prevention maps

By Melissa Patrick
Kentucky Health News

Most of Kentucky's 120 counties continue to have a low risk of coronavirus transmission and only four of them are at high risk, according to the Centers for Disease Control and Prevention's weekly risk map. 

The CDC's map is based on the number of new coronavirus cases and Covid-19 patients in Kentucky hospitals. It shows 82 Kentucky counties are at low risk, shown in green, and 34 at medium risk, shown in yellow. The four high-risk counties, shown in orange, are Morgan, Elliott, Rowan and Menifee. Elliott County was also at high risk last week, along with Greenup County.

Even as the risk of coronavirus transmission decreases, the CDC continues to offer the same recommendations for medium and high-risk counties.

In high-risk counties, the CDC recommends that you wear a well-fitting, high-quality mask in public indoor spaces, and if you are at high risk of getting very sick, consider avoiding non-essential indoor activities in public where you could be exposed.

If you live in a medium or high-risk county, the CDC advises those who are at high risk of getting very sick to wear a well-fitting mask when indoors and in public and to consider getting tested before having social contact with someone at high risk for getting very sick and consider wearing a mask when indoors when you are with them.

The CDC also provides a community transmission level map, largely used by researchers and health-care facilities, that shows the level of virus in each county, at one of four levels. The map shows 26 counties with moderate levels of transmission and the rest with either substantial or high levels, showing that the virus continues to be widespread in those counties. 

As of  Feb. 24, Kentucky's infection rate for the previous seven days ranked 16th in the nation, with a 33% drop in cases in the last two weeks, according to The New York Times. 

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American Heart Month and Black History Month are the same month, and are related; Blacks are likelier have heart disease

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Bill to ban transgender health or mental-health care of minors in Kentucky has a head of steam in the state House

By Melissa Patrick
Kentucky Health News

A far-reaching anti-transgender bill filed Tuesday, Feb. 21, was assigned to a legislative committee the same day it was filed, has received the first of three required readings and already has 20 co-sponsors.

Rep. Jennifer Decker

House Bill 470, sponsored by Rep. Jennifer Decker, R-Waddy (Shelby County), says "The provision of gender transition services to a person under the age of 18 years by a health-care provider or mental-health care provider is unethical and unprofessional conduct that establishes the provider is unfit to perform the duties and discharge the responsibilities of his or her position or occupation."

The bill defines gender transition as "the process in which a person goes from identifying with and living as a gender that corresponds to his or her sex to identifying with and living as a different gender and may involve social, legal, or physical changes." 

Among other things, the bill includes provisions to :  

• Require health care providers and mental health care providers to be investigated if there is any report that a provider has provided gender transition of provision of gender transition services to a person under the age of 18 years; 
• If confirmed, the provider's license is to be revoked and their public funding terminated; 
• Require that providers be jointly and severally liable for all damages and costs sustained for providing gender transition services or aiding and assisting a person under the age of 18 years to consider or to obtain gender transition services; 
• Provide defense to providers refusing to provide services; 
• Makes failure to report a gender transition service to the Vital Statistics Branch within 30 days of providing the service a crime; 
• Provides provisions for when a person's parents or guardian can bring an action because of personal injury before the person turns 18 and by the person within 30 years of the person turning 18, with exceptions under which the time may be longer;
• Includes conditions for actions and damages;
• Prohibits the use of public funds, including Medicaid, for gender transition services; 
• Prohibits a provider employed by a public agency to provide  and include gender transition procedures; 
• Allows the Attorney General to bring action to enforce provisions;
• Prohibits a public health care or mental health care  provider from intervening in a legal proceeding in defense of the provision of gender transition services; 
• Requires a school to notify each parent or guardian if a student under the age of 18 significantly changes his or her gender expression, expresses an inconsistency between his or her sex and his or her perceived gender or perceived sex; or expresses a desire to be referred to by a name, pronoun or other identifier inconsistent with his or her sex, with some exceptions related to parental abuse. 
• Includes updates to a host of laws to comply with the bill's provisions, including ones that will prohibit a court from changing a person under the age of 18's name if it is to assist them with a gender transition and another to prohibit the Department of Juvenile Justice from classifying a detainee by a sex that is inconsistent with his or her sex as defined in the bill. 

The bill, dubbed the "Do No Harm Act," has been assigned to the Judiciary Committee, of which Decker is a vice-chair. The committee meets at noon on Wednesdays; this bill has not yet been placed on the agenda. If passed and signed into law, it would become effective Jan. 1, 2024. 

This is just one of several bills targeting the LGBTQ+ community, Olivia Krauth reports for the Louisville Courier  Journal: "Several 'parents’ rights' bills include provisions either restricting gender transition services, outing students to their parents or allowing teachers to ignore a student’s preferred pronouns or name. One such measure, Senate Bill 150, already cleared the Senate and now waits in the House for consideration," she writes. "Other proposals include forcing students to use the school bathroom tied to their biological sex, even if they don’t identify with it. HB 120 also would prohibit gender transition procedures for youths."

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Regarding obesity as a disease raises questions about cost of drugs for treating it, and wisdom of diagnosing children too early

Illustration by Shoshana Gordon, Axios

By Caitlin Owens
Axios

Doctors and medical experts are leading a rapid cultural shift around obesity, viewing it as a disease rather than a lifestyle choice. That shift is opening new treatments and better care, but also new controversies over who can access those treatments and how best to use them.

"Obesity is a highly prevalent chronic disease characterized by excessive fat accumulation or distribution that presents a risk to health and requires life-long care. Virtually every system in the body is affected by obesity," six obesity advocacy organizations recently wrote in a joint statement."Every person with obesity should have access to evidence-based treatment."

Some diabetes drugs has shown enormous promise for weight loss, offering a ray of hope to the millions of Americans with obesity. The drugs have become all the rage among some wealthy Americans. Billionaire Elon Musk recently responded to a tweet asking him his "secret" by saying "fasting and Wegovy."

But Wegovy, which is approved for weight loss under certain conditions, has a list price of $1,349 for a month's supply, and many insurers, including Medicare, won't cover suhc drugs for weight loss.

Kristine Grow, a spokesperson for America's Health Insurance Plans, recently told Axios that the therapies have limitations and "have not yet been proven to work well for long-term weight management and can have complications and adverse impacts on patients."The same class of drugs also can be misused. Some digital health startups are advertising and prescribing the drugs to people who aren't overweight, The Wall Street Journal reports.

The treatment landscape is changing rapidly for children as well as adults. Guidance released last month by the American Academy of Pediatrics recommends against delaying obesity treatment for children, and argues that doctors should be proactive about approaches like intensive health behavior and lifestyle treatment and, in some cases, prescription drugs or surgery.

But the guidance is already drawing pushback. Eating-disorder specialists, for example, are warning that it could backfire, NPR reports, quoting specialist Kim Dennis: "We run the risk of doing significant harm to kids who are 6 or 8 by telling them that they have a disease . . . simply based on their weight status."

An unusual array of interest groups is already pushing for Medicare to cover the drugs for obesity, Stat reports. More broadly, the existence of an effective treatment raises big questions about how to prevent yet another prescription drug from becoming commonly misused — and how to balance access to obesity treatment against the risks of perpetuating a stigma.

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Opioid panel head says rules Beshear signed are sufficient, and being more specific would aid 'the most powerful and privileged'

Bryan Hubbard (Photo by Melissa Patrick)

By Melissa Patrick
Kentucky Health News

The executive director of the state Opioid Abatement Advisory Commission spent a fair amount of time at its latest meeting assuring attendees, both in person and by Zoom, that there were regulations directing the grant request for the millions from settlements with drug manufacturers and distributers,  despite comments made at a prior subcommittee meeting and by the governor that suggested otherwise. 

Bryan Hubbard, who works for Attorney General Daniel Cameron, was referring to comments made by commission member Van Ingram, director of Gov. Steve Beshear's Office of Drug Control Policy. At a Jan. 10 subcommittee meeting, Ingram and other subcommittee members said they needed written guidelines to make decisions about recommendations for grant awards.  

On Jan. 12, Beshear was asked at his weekly news conference if he shared Ingram's concerns and said, among other things, that "any process where there's an application for government funds, has to have guidelines, has to have scoring criteria." He went on to say such criteria will be needed to explain why some were selected to receive the grant money and others were not. 

At the commission's Feb. 14 meeting, Hubbard, who also chairs the panel, first praised and thanked Ingram for his many years of service fighting the opioid epidemic. "I also want to thank you for the patient and wise counsel you have given me and my role. You are a tremendous servant of this state and a friend and colleague to me, and I am sincerely thankful for you," said Hubbard. "I'm also sorry for the way in which remarks that you made, as part of a very deliberate and thoughtful conversation in a subcommittee meeting, were parlayed to create an illusory construct of division within this commission, where none indeed exists." 

Hubbard walked through the timeline for developing the regulations that govern the commission's practices, which he said were unanimously passed by the commission and signed by Beshear Dec. 18.

"Since that time, there have been some assertions that this commission lacks criteria with which to evaluate the grant applications and to issue reports on the basis of clear standards that will govern our process," he said.  To dispute that, he read a section of the emergency regulation and referred to Beshear.

"One person who expressed concern regarding an alleged lack of criteria is the very person who signed these into law," said Hubbard. "That concern reflects either a failure to read what was signed, a failure to understand what was signed or a calculated decision to make us look bad, so that the articulator can look good."

Beshear, a Democrat, is running for re-election and Cameron is seeking the Republican nomination to oppose him.

Hubbard concluded by saying, "We will not create or utilize a complicated, inflexible scoring system, which by effect, if not design, favors the most powerful and privileged players in this state – players who have made an arc out of mastering such systems for decades. Our goal is to create as much broad-based, grassroots participation in the commission's work as possible, with modest resources being measured against monumental need and demand. Organizations and individuals who are doing the work government cannot or will not perform will be our priority. Our results will not be perfect, but they will be open, transparent and accountable. Kentuckians deserve no less." 

Other commission news

Hubbard noted that since the early December meeting, the commission has held two town-hall meetings, one in Louisville and the other in Lexington, and a public forum in Paducah, to address the impact of the opioid epidemic on African Americans.

"Fentanyl is now the second leading cause of death in African American men in our state," he said. The Operation Fight Fentanyl's website states that opioids were involved in over 70% of of the state's 2,250 overdose deaths in 2021. 

In addition, he said the commission participated in the Harlan County Drug Summit and provided testimony before the state House and Senate health committees, and its subcommittees have started the process of reviewing the grant applications. 

The state is getting $842 million, half of which will be allocated by the commission, with the other half going to cities and counties. Funds are to be disbursed annually, on various schedules, through 2038.

Hubbard also noted that Cameron has created "Operation Fight Fentanyl" to make it a top public-safety issue and will hold forums across the state to address the problem. 

The first forum was held in Kenton County Feb. 1. Others will be held in Pendleton County Feb. 28, Whitley County March 15, Greenup County March 22, Martin County April 10 and Leslie County April 18. Click here for more details. 

Hubbard said the commission is looking to host a statewide opioid conference in the third week of September. He said it has secured a $100,000 sponsor, who will be announced later, to help cover the cost, which is estimated at about $150,000. Hubbard said he is seeking topics that people would like to see addressed as well as suggestions for speakers.

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18,000 Kentuckians have died as a result of Covid-19, state says

N.Y. Times map adapted by Ky. Health News; Robertson County has had 22 deaths, Harlan 231.

By Melissa Patrick
Kentucky Health News

New cases of the coronavirus in Kentucky have dropped for two weeks in a row, but deaths from the virus have increased, bringing the state's pandemic death toll to exactly 18,000 people. 

The state Department for Public Health's latest weekly report shows the department attributed 61 more deaths to Covid-19 last week, up from 49 the week before. Tiny Robertson County has the highest death rate but is tied with Elliott County for the lowest number of deaths, 22.

There were 4,065 new cases of the virus last week, or 580 per day. That's a 28% drop from last week and down 36% from two weeks ago. People 18 and younger made up 22% of last week's new cases. 

The share of Kentuckians testing positive for the coronavirus in the past seven days was 9.92%, which was virtually the same as the week prior when it was 9.93%. These numbers do not reflect at-home testing. 

The weekly new-case rate was 13.99 cases per 100,000 residents, up from 13.04 cases in the prior weekly report. The top 10 counties were Fayette, 39.4 cases per 100,000; Greenup, 33; Owsley, 25.9; Boyd, 25.1; Taylor, 23.8; Clark, 23.6; Lee, 23.2; Perry, 22.7; Powell, 22; and Wolfe, 22.

The New York Times ranks Kentucky's new case rate sixth among the states. The Times says the South is emerging as something of a hotspot, with Alabama, Louisiana and Tennessee in the top five states for the highest per-capita case reports. 

Kentucky hospitals reported 332 Covid-19 patients on Monday, up 46 from the week before; 50 patients in intensive care, up four; and 23 on mechanical ventilation, the same as the last report.

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In 2006, Congress ordered HHS to integrate health-data systems; it still hasn't been done, and that causes problems

Photo by Irwan, Unsplash

"The pandemic highlighted ineffective data infrastructure across the U.S. health system," reports Sam Whitehead of Kaiser Health News. "Coronavirus case reports sent by fax machine. Clunky tech for monitoring vaccine distribution. . . . Supply chain breakdowns that left health-care providers without needed protective equipment. . . . And Congress knew about the potential for these problems long before Covid. Lawmakers mandated the Department of Health and Human Services to better integrate U.S. data management systems to allow stakeholders to better share information years ago, in 2006."

Whitehead starts with a real-life example: "In early 2020, as they tried to fight covid-19 across two rural counties in North Carolina, the staff of Granville Vance Public Health was stymied, relying on outdated technology to track a fast-moving pandemic." They had to use "five data systems. One was decades old and complicated. Another was made of Excel spreadsheets. None worked well together or with systems at other levels of government."

Whitehead gives several reasons the data system wasn't improved: the complexity of the task and inadequate funding; a federal-first approach to health that deprives state and local agencies of resources; unclear ownership of the project in HHS; insufficient enforcement mechanisms to hold federal officials accountable; and little agreement on what data is even needed in an emergency."

Soumi Saha, senior vice president of government affairs at Premier, a health-technology company, told Whitehead, “What keeps me up at night is that we forget about the past two and a half years, and we just move on — that we don’t take the opportunity and time to truly reflect and make needed changes.”

Whitehead reports: "Different hospitals often use different electronic health-record systems, so are frequently unable to share patient data with one another, much less with the federal government. . . . Much of the 2019 bill mandating the data-sharing network’s creation is set to expire in September, and reauthorizing the law could be a challenge in a split Congress where House Republicans have announced their intention to examine the U.S. response to the pandemic."

Dr. Georges Benjamin, executive director of the American Public Health Association, told Whitehead, “Congress has an opportunity now to build the public health system. What are they doing? Undermining public health legal authorities, demonizing public health officials. It’s almost like we didn’t learn anything.”

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Radio reporter describes with personal detail what it's like to go to another state to buy legal cannabis for a medical condition

What is it like for Kentuckians to buy cannabis in another state under Gov. Andy Beshear's executive order? WUKY's Karyn Czar, who has one of the 21 medical conditions specified in the governor's order, a side effect of chemotherapy, got legal cannabis in Illinois, the only adjoining state where Kentuckians can buy it.

Karyn Czar

Czar was diagnosed in August with multiple myeloma, a form of blood cancer. "I began rounds of chemotherapy that left me exhausted, suffering from joint pain and tremors, and with a condition called neuropathy that causes my hands and feet to go numb," she reports. "I was sidelined from two things that I love, reporting in the field and performing on stage with local theater companies."

In the first report of a three-part series, Czar says she went to Illinois not just to find relief, but to "help any of you who, like me, have a condition that might be helped with medical cannabis. This first hurdle for me was getting over the stigma." Here's part of the conversation she had at the dispensary in Mount Vernon, Ill., with an employee identified only as Valerie:

Czar: "I couldn't sleep last night. I feel like I'm doing something that I shouldn't be doing."
Valerie: "Well, I felt like that at first, but then you have to recognize that it is legal in the state of Illinois. It is a benefit for people who do have cancer and other things wrong with them, and we're just going to follow the law and go with that."
Czar: "So, like where I'm losing the feeling somewhat in my hands and feet. So that the tremors and then sleep are my main things.”
Valerie: "Hearing that information I would suggest an indica. Then I would stick with a plain indica. I wouldn't add anything to it until you know what you were looking for. To be able to help the symptoms."

"Valerie takes me to a kiosk and pulls up a pie chart that lists dozens of medical conditions and symptoms," Czar reports. "She matches mine with the products she believes could offer relief."

Czar: "I'm just going to give you carte blanche to pick what you think I should try first."
Valerie: "So you said that gummy, right? You're interested in the gummy?
Czar: “Yes.”
Valerie: “So I would go back with that one and then the indica because of the symptoms. And then I kind of looked at my little wheel here, so I'm going to go with an indica so I can actually narrow myself down on the kiosk to what I need. I would stick with just a basic one."
Czar: "Okay."
Valerie: "Now, there's two different kinds here. I have one that's a live resin. Live resin is a live plant that has been crushed and frozen and everything extracted out of that, stems and all, that is then made into the gummy. Then I have your regular ones. The regular I call are just cured plants. They've taken that and fused it and made a regular gummy out of it."

The Thrive dispensary in Mount Vernon, Ill., has a wide range of products.

"What was most surprising was the array of products," Czar says. "Smokeable cannabis I expected. I also knew about edibles, but there were also drinks, snacks, lozenges, and topical creams. I got 10 gummies and a lotion. As I got ready to make my purchase, what I didn't expect was to be overcome with guilt. The stigma returned. My voice choked. . . . The tears were twofold. Of course, medical marijuana is still illegal here in Kentucky, and I would be transporting it across state lines. But I was also overwhelmed with the thought that this could help me.

"When we got back to the car, I took a fourth of the gummy, which was recommended and legal for me to do in Illinois, and used some of the topical cream on my left leg, which at this point had become completely numb up to my knee, and I was having to use a cane. About an hour later, when we stopped at a gas station, I got out of the car and the numbness had gone away. Now, it did not cure the neuropathy. However, it was back to a level to where I was able to tell when my foot was completely on the ground and I didn't need to use the cane."

Czar gives the legal basics: "Beshear's executive order offers pardons for having and using the drug if you meet certain criteria. You have to have an approved medical condition such as cancer, MS or PTSD, and have a signed note from a medical professional to prove it. Marijuana products must be purchased in a state that allows non-residents to buy it. And keep the receipt. Finally, you can't possess more than 8 ounces." More than that is a felony in Kentucky.

"There are caveats," Czar cautions. "Physicians can't give you advice on treatment or write a prescription. So I had to rely on trial and error until I figured out which doses and products work for me. You will have a positive result if you're asked to take a drug test. In my case, I might need a bone-marrow transplant, so I have to have a negative test if that moves forward."

She concludes, "Kentucky lawmakers are taking up medical marijuana again in the 2023 legislative session, but legalization efforts still face an uphill battle in the Republican-led Senate."

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Bill would require insurers to cover biomarker testing for cancer; expensive screening tool is ‘cutting edge,’ says sponsor

By Sarah Ladd
Kentucky Lantern

A bill filed Tuesday would require health benefit plans in Kentucky to cover biomarker testing for cancer, with the goal of improving the state’s dismal cancer statistics.

State Rep. Kimberly Poore Moser, R-Taylor Mill, said before filing the legislation, “It’s highly important that we pay attention to science.”

Biomarker testing “is a way to look for genes, proteins, and other substances (called biomarkers or tumor markers) that can provide information about cancer. Each person’s cancer has a unique pattern of biomarkers,” according to the National Cancer Institute.

The American Cancer Society says the testing is “an important step for accessing precision medicine.” It can lead to “improved survivorship and better quality of life for cancer patients.”

The ACS estimates that more than 10,000 Kentuckians will die from cancer this year and 30,000 will be diagnosed with the disease. Kentucky is one of the worst states in the nation for cancer mortality, according to the Centers for Disease Control and Prevention.

Leah Phillips says biomarker testing saved her life.

“I think it’s time for Kentucky to do something a little cutting edge,” Moser said.

“A near normal life”

Leah Phillips, a stage 4 lung-cancer survivor from Oldham County, spoke in the Capitol rotunda Tuesday afternoon. Phillips was diagnosed in December 2019. She did not have a smoking background.

She credited biomarker testing with her quality of life.

“If I had not had biomarker testing,” said Phillips, “I would have been treated like a typical cancer patient with lung cancer … and given chemotherapy.”

Biomarker testing showed her cancer was genetically driven, though. She was eligible for a target therapy drug. That treatment provided her “a near normal life,” though it is expensive and not universally accessible.

Dr. Doug Flora is the executive medical director of oncology at St. Elizabeth Healthcare in Northern Kentucky. He said Tuesday, “We’re past the era of chemotherapy for most cancers.” Biomarker testing, added Flora, allows targeting of cancer’s “Achilles heels.”

Barriers to this screening tool mostly impact the “least advantaged people,” he said.

The National Cancer Institute said last year, for example, that Black Americans have higher death rates from many types of cancers than white people.

Additionally, Black women are more likely to die from breast cancer than white women. And colorectal, lung and cervical cancers are more prevalent in Appalachian regions than in urban areas.

From Kentucky Health News: Health insurers and business interests usually oppose additional coverage requirements, saying they raise costs and premiums. We asked Doug Hogan, the ACA's state government-relations director, about that. He replied, "The cost really depends on the test and who is paying for it. Single gene tests will be far less expensive than more comprehensive testing, but could also require multiple biopsies and multiple tests. A recent actuarial analysis found that the average cost to insurers per biomarker test in the private market was $224, and average cost in the Medicaid market was $78.71. However, a patient forced to pay out of pocket for a biomarker test that wasn’t covered would be much more than this."

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Cameron is among 20 Republican attorneys general warning CVS and Walgreens that mail-order abortion pills are unlawful

By Melissa Patrick

Kentucky Health News

Attorney General Daniel Cameron joined a coalition of 20 Republican attorneys general in sending a letter to Walgreens and CVS saying their plans to distribute abortion pills through the mail are unlawful. 

Daniel Cameron

“Having failed to halt the overturning of Roe v. Wade, the Biden Administration is now promoting its abortion priorities by misinterpreting federal laws that clearly prohibit distributing abortion drugs by mail,” Cameron said in a news release. 

The coalition says federal law prohibits anyone from using the mail to send or receive any drug that will "be used or applied for producing abortion," referring to the Comstock Act of 1873.

Last month, the U.S. Department of Justice issued a legal opinion finding that mailing abortion drugs does not violate the Comstock Act and said the Postal Service is legally allowed to deliver prescription abortion pills to people in states that have strict bans on abortions, like Kentucky currently does. 

The opinion said the Comstock Act “does not prohibit the mailing of certain drugs that can be used to perform abortions where the sender lacks the intent that the recipient of the drugs will use them unlawfully.” It added, “Because there are manifold ways in which recipients in every state may lawfully use such drugs, including to produce an abortion, the mere mailing of such drugs to a particular jurisdiction is an insufficient basis for concluding that the sender intends them to be used unlawfully.”

After the legal opinion was issued, CVS and Walgreens announced plans to sell abortion pills through the mail.

In their letter, the attorneys general informed CVS and Walgreens that the Biden Administration has misinterpreted federal law. 

The coalition writes, “Although many people are unfamiliar with this statute because it has not been amended in a few decades, the text could not be clearer: “Every article or thing designed, adapted, or intended for producing abortion … shall not be conveyed in the mails.’”

Further, the attorneys general also warned that sending abortion pills through the mail may violate the laws of many states across the country.

"In Kentucky, the Human Life Protection Act prohibits “procur[ing] for” or “sell[ing] to any pregnant woman any medicine, drug, or other substance with the specific intent” of causing an abortion," says the release. 

The coalition also says “abortion pills are far riskier than surgical abortions,” and according to medical consensus are “5.96 times as likely to result in a complication as first-trimester aspiration abortions.” 

The Guttmacher Institute, a reproductive-health research and policy organization, disagrees, saying on its website: " A safe and effective option at early gestations, medication abortion accounted for more than one-third (39%) of all abortions in the United States in 2017. Medication abortion is as safe as surgical abortion, but is noninvasive and can be completed in a patient’s chosen setting, such as at home." 

The Kaiser Family Foundation says, "The FDA has found that medication abortion is a safe and highly effective method of pregnancy termination. When taken, medication abortion successfully terminates the pregnancy 99.6% of the time, with a 0.4% risk of major complications, and an associated mortality rate of less than 0.001 percent (0.00064%)."

Cameron, who is seeking the Republican npmination for governor, signed the letter with attorneys general from Alabama, Alaska, Arkansas, Florida, Georgia, Indiana, Iowa, Louisiana, Mississippi, Missouri, Montana, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Texas, Utah, and West Virginia.

To read the letter to CVS, click here; to see the letter to Walgreens, click here.

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Alzheimer's drug under study at University of Ky. and other sites has shown it is 'the first crack in the iceberg,' UK researcher says

By Al Cross
Kentucky Health News

A partially approved drug for Alzheimer's disease that slowed memory decline and loss of functional ability in a study is “the first crack in the iceberg for us,” says a Kentucky researcher involved in the study.

Dr. Greg Jicha of the University of Kentucky, one of about 100 study sites, told reporters last week that he expects more progress.  “Hopefully the day will come when Alzheimer’s will be no more,” he said. “This is fundamentally the start of that process.”

Dr. Greg Jicha (UK photo by Mark Cornelison)

Jicha said in a UK news release, “For the first time, having a medication that we understand can fundamentally change the disease process is the first step and it’s a giant step,” said Jicha. “It tells us and teaches us all that we are on the path to the eventual cure for Alzheimer’s that we’re all looking for.”

On Jan. 6, the Food and Drug Administration approved the drug lecanemab for Alzheimer's patients who have mild cognitive impairment or are in the mild dementia stage of the disease.

That's the population in clinical trials, which have found the drug slowed memory decline by 27 percent and the loss of functional ability by 40%. While the drug does not cure the disease, it "could mean two to two and a half more years of functional life," Jicha told reporters. "That is meaningful; an extension of quality of life."

Jicha said several medicines are available for Alzheimer's, but they treat only symptoms of the disease, and the last one was approved 20 years ago.

The drug removes from the brain the amyloid proteins that are believed to cause Alzheimer's. The plaques can show up in people with very mild memory problems, Jicha said; one of three Americans over age 65 have them.

The study continues, to see if the drug can be used to remove plaques earlier and delay onset of teh disease, Jicha said. "Hopefully we’ll have that answer in the next five to seven years."

UK is still recriting participants for the study. It uses a simple blood test for the protein or likelihood of buildup. If there is a high likelihood, imaging of the brain can see the plaques may be performed. If they are found, the person gets into the study. But only half of them get the drug; the others get a placebo, which is standard for clinical trials. They could get the drug if the study is successful, Jicha said.

To learn more about the study, call 1-800-AHEAD-70 or to find a trial site location enrolling near you, visit www.AHEADstudy.org.

The next step in the study could lead to approval for payments by Medicare and private insurance. The drug's manufacturer, the Japanese firm Esai, says it would like to charge $26,000 a year for the treatment, which requires an infusion every two weeks. Jicha said the Institute for Clinical and Economic Review, a nonprofit organization that does clinical and cost-effectiveness analyses of treatments, has suggested an annual price of $21,000.

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Delta-8 THC, mildly less potent than marijuana's delta-9, is legal in Ky. but has risks and new rules; could face further regulation

Delta-8 gummies on sale in Louisville (Courier Journal photo by Jeff Faughender)

Kentucky Health News

"While politicians debate whether to legalize medical marijuana in Kentucky, a lesser-known product that gets people similarly high is flourishing in the state. And it's already legal," reports Morgan Watkins of the Courier Journal.

Delta-8 tetrahydrocannabinol, which is moderately less potent but "almost identical to the delta-9 THC in marijuana that drives the mental high" can be sold to anyone in Kentucky, "theoretically even children, at the seller's discretion," Watkins reports.

That's due to a law passed by Congress, and the unwritten law of unintended consequences.

"The delta-8 business bloomed from an unforeseen loophole thanks to a law federally legalizing hemp, a cannabis plant with very little delta-9 THC," which Senate Republican Leader Mitch McConnell got passed to help farmers raise hemp, Watkins writes. "Delta-8 can be indirectly derived from hemp, and the way the 2018 law was written opened the door for businesses to make and sell it."

The door opened wider last year, after a circuit judge in Boone County "ruled delta-8 is allowed as long as such products don't have a higher concentration of delta-9 than federal law permits," Watkins notes. "Dozens of business owners in the Louisville area gradually have put delta-8 vapes and edibles on their shelves. This upstart market even fueled the opening of new stores."

Into that regulatory gap has jumped Democratic Gov. Andy Beshear. When he issued an executive order for medical marijuana last fall, he issued another requring delta-8 products to "meet certain rules, including packaging and labeling requirements that apply to other hemp-derived materials," Watkins notes.

New legal challenges could arise at the Kentucky General Assembly, which is again debating the issue of medical marijuana. The state Senate banned delta-8 last year, "but the bill died in the House," Watkins notes. "Conversely, the House has passed legislation to permit medical marijuana in recent years that died in the Senate."

Some in the industry told Watkins that delta-8's popularity in states such as Kentucky, Indiana and Tennessee stems from the fact that medical and recreational marijuana aren't legal there. Jim Higdon, co-founder of Kentucky-based cannabidiol brand Cornbread Hemp, told her: "As a product of prohibition, delta-8 THC is the bathtub gin of our generation."

Delta-8 can be produced from cannabidiol, or CBD, Watkins notes: "The resulting oil is then used in products. With minimal-to-no regulations in various states, pretty much anyone can make delta-8."

But the product has risks. Kent Vrana, pharmacology chair at Penn State, told Watkins that delta-8 products may contain heavy metals, chemical solvents and pesticides. "Using delta-8 also involves some of the same risks as using marijuana, Vrana said, including the possibility of developing an addiction. The U.S. Food and Drug Administration hasn't evaluated or authorized delta-8 products "for safe use in any context." Vrana said research into medical marijuana shows it can stimulate the appetite and limit seizures, and there are indications it can help manage pain. He said there’s no question delta-8 has similar potential."

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Second Appalachian Gathering for Recovery Solutions March 9

The second Appalachian Gathering for Recovery Solutions aims to provide opportunities for in-person communication and networking among recovery programs and resources in Eastern Kentucky. It is a free, one-day gathering set for March 9, at the Union College campus in Barbourville.

Scheduled speakers are Tim Robinson, CEO of Addiction Recovery Care; Dr. Al J. Mooney, author of The Recovery Book; Geoff Wilson, president of the Kentucky Association of Addiction Professionals, and other experienced practitioners from Appalachia, who will discuss advances in substance-abuse recovery.

The gathering will use technology to reach a broader audience interested in all aspects of the recovery pipeline. Participants can choose and attend the panels which are of most interest to them. Register here.

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KET panel discusses bill to legalize medical cannabis in Kentucky

Renee Shaw discusses legislation introduced to legalize medical marijuana in Kentucky on KET's Kentucky Tonight with guests (L-R) Jaime Montalvo, founder of Kentuckians for Medicinal Marijuana; Sen. Phillip Wheeler, R-Pikeville; Dr. Danesh Mazloomdoost, an anesthesiologist and degenerative specialist; and Ed Shemelya, coordinator of the National Marijuana Initiative. 

By Melissa Patrick

Kentucky Health News

Proponents and opponents of a bill to legalize medical marijuana in Kentucky were on KET's Jan. 30 edition of "Kentucky Tonight," with proponents saying Kentuckians are calling for legal access to cannabis and opponents saying doctors shouldn't be asked to prescribe or recommend a substance based only on anecdotal evidence that it works. 

"Passage of the medical marijuana law isn't going to just magically bring marijuana to Kentucky. It's already here," Jaime Montalvo, founder of Kentuckians for Medicinal Marijuana, told KET host Renee Shaw. "What we as patients are asking [for] is the regulation of cannabis so that we can go to a safe environment and purchase a product that is clean from people who are regulated by the state, you know, and are not there to sell us other potentially dangerous chemicals." 

Dr. Danesh Mazloomdoost, an anesthesiologist and degenerative specialist, told Shaw that it would be a stretch to define marijuana or cannabis as medicine, because research does not yet support that. 

"It has medicinal properties, but to call it medicine is a little bit of a misnomer because medicine is a product or compound that we know the pharmacology, the pharmacodynamics," he said. "In other words, what impact it has on the body; what conditions . . . it's applicable to; what are some of the contraindications; what are the risks? And we don't really have any of that information. We don't know what dosages are appropriate. We don't know what an overdose or what excessive dosages are. So to call it medicine conveys a false sense of security."  

The Kentucky House of Representatives has passed two medical marijuana bills, most recently in 2022 with a vote of 59-34. Both bills died in the Senate. Because the bills keep getting shut down in the Senate, this year's bill, Senate Bill 47, sponsored by Sen. Stephen West, R-Paris, will start there. 

Gov. Andy Beshear's Medical Cannabis Advisory Committee reported that 98.6% of Kentuckians who offered an opinion on its website supported medical marijuana. A Kentucky Health Issues Poll for the Foundation for a Healthy Kentucky found that 90% of Kentuckians favor medical cannabis.

Shaw asked Sen. Phillip Wheeler, R-Pikeville, a primary co-sponsor of the bill, if he thought the medical marijuana bill would pass this year. 

Wheeler said, "I hesitate to speak for anybody but myself and the various co-sponsors of the bill, but I am optimistic that this may be the year that you see some action on it in the Senate. We have several new members, some of whom seem to be more open to the idea of medical cannabis." 

Earlier in January, Senate President Robert Stivers, who has long said more research is needed before a medical marijuana bill is passed, showed the first sign that he might be willing to compromise on this issue when he told Shaw Jan. 9 that he might be willing to approve medical marijuana in Kentucky on a very limited basis, to relieve patients' pain at the end of their lives. 

Ed Shemelya, national coordinator of the National Marijuana Initiative, said he opposed passing a medical marijuana law and instead said to allow the recent federal Medical Marijuana and Cannabidiol Research Expansion Act to do its job. 

"What that act did is . . . remove most of those barriers so we can conduct legitimate research into not only the beneficial components of this plant, but also the harmful consequences of it," Shemelya said. "Absent that, if we were making a legislative decision to determine the efficacy and safety of a substance that isn't grounded in science and isn't rounded in research, is grounded in anecdotal stories that may or may not be correct."  

Further, he said diversion is occurring in each of the 37 states that medical marijuana is legal, along with increased incidences of impaired driving; people are experiencing THC psychosis from high-potency products; and treating cannabis as medicine will add to young people's misconception that it is safer than alcohol. 

Both sides criticized Beshear's executive order that used his pardon power to allow people with a medical provider's statement saying they have at least one of 21 specified medical conditions to possess up to eight ounces of cannabis for medical purposes in Kentucky, if bought legally in another state. The only adjoining state that currently allows such purchases by Kentuckians is Illinois.

Montalvo, who said he had just gotten a letter of confirmation from his doctor that he has multiple sclerosis, one of the medical conditions included in Beshear's order, told Shaw that he fears the executive order could result in some patients thinking cannabis is legal and that it could lead to an influx of cases in the court system if police officers can't decipher what is legal or not. 

"I fear that the executive order was well intentioned, but has led or will lead to many more problems," he said. 

Wheeler told Shaw that while he shares the governor's compassion for people wanting cannabis to treat afflictions, he was disappointed in Beshear for not recognizing it is the legislature's job to set the policy and the governor's job to execute it. He also said the order creates confusion among law enforcement and that the use of a prospective pardon creates a "slippery slope" in a state where marijuana possession is illegal. But he said he didn't think the governor's order would impact the bill's process.

Beshear said he was prompted by the lack of legislative action. Wheeler said, "Sometimes it takes many sessions to get [a bill] through and that's part of our constitutional democracy. And I don't think it's appropriate for this governor or any governor to circumvent that by things such as the executive order that he signed." 

Wheeler also revealed several components of the 155-page medical marijuana bill. He said it creates a safe marketplace to buy the products; does not include a list of conditions required to make a person eligible to receive it; requires a time-limited supply; allows flexibility for doctors and pharmacists; says cannabis can't be grown independently; allows children to use it with parental consent; allows only doctors and doctors of osteopathic medicine to prescribe it; directs the Medical Licensure Board to handle cases of prescribing abuse; and gives oversight to the Department of Alcoholic Beverage Control, which would be renamed the Department of Alcoholic Beverage and Cannabis Control. He also said cannabis won't be taxed.  

The hour-long show opened with Preston Cantwell, who was diagnosed with epilepsy when he was 4, telling the story of how medical cannabis has stopped his seizures, which several prescribed medications had failed to do. He said CBD, or cannabidiol, worked to reduce his seizures for a couple of years, but it eventually stopped working. He now uses "whole plant cannabis" and hasn't had a seizure since 2019. "It has basically, just entirely cured it," he said. 

Julie Cantwell, his mother and founder of Kentucky Moms for Medical Cannabis, told KET that every few months they drive to Michigan to get their cannabis, which costs thousands of dollars. "We would like to be able to spend that here," she said.

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Risk is lower, but it's NOT time to resume pre-pandemic life, New York doctors write in one of the nation's top medical journals

An editorial in the New England Journal of Medicine by Dr. Wafaa M. El-Sadr, Columbia University; Dr. Ashwin Vasan, New York City Department of Health and Mental Hygiene; and Ayman El-Mohandes, City University of New York

Wafaa El-Sadr, M.D.

We’ve come a long way. From the early, terrifying days of a rapidly spreading deadly infection to the current circumstances in which — despite a recent steep rise in transmission rates — Covid-19 has, for many people, become no more than an occasional inconvenience, involving a few days of symptoms and a short isolation period. It’s clear that for many, if not most, people, SARS-CoV-2 infection no longer carries the same risks of adverse outcomes as it did in the early months of the pandemic. These shifts have led to a widespread assumption, fueled by political and economic priorities, that the pandemic is behind us — that it’s time to let go of caution and resume prepandemic life.

The reality, however, would starkly contradict such a belief. Covid-19 currently results in about 300 to 500 deaths per day in the United States — equivalent to an annual mortality burden higher than that associated with a bad influenza season. In addition, many people continue to face severe short- or long-term Covid-19 illness, including people who lack access to vaccines or treatment and those with underlying conditions that impair their immune response to vaccines or render them especially vulnerable to Covid-associated complications. The ever-looming threat of the evolution of a new variant, one that can evade our vaccines and antivirals, remains very real. These facts support the assumption that SARS-CoV-2 will continue to play a major role in our lives for the foreseeable future. This new reality compels us to navigate a more complex social, economic, political, and clinical terrain and to take to heart the lessons learned from the Covid-19 response thus far — both the successes and the missteps.

To date, monitoring of the effects of Covid-19 has rested on several epidemiologic and clinical measures, which have shaped the recommended or mandated protective actions. Most commonly, these measures have included estimated rates of Covid-19 cases, hospitalizations, and deaths; monitoring has also been conducted of circulating SARS-CoV-2 variants and their susceptibility to available vaccines and treatments.

Yet in the current situation, some of these traditional measures have limited value. For example, the availability of rapid antigen tests that can be conducted at home — the results of which often aren’t captured by public health surveillance systems — challenges the validity of reported case numbers and transmission rates in some jurisdictions. There is therefore a need for unbiased monitoring of transmission and infection rates by means of regular testing of sentinel populations or randomly selected representative samples of the general population. Hospitalization and death rates are certainly more reliable measures than case rates, but these measures are limited by the fact that some hospitalized patients with SARS-CoV-2 infection have been admitted for other reasons and only incidentally tested positive. Furthermore, hospitalization and death are distal outcomes, so their rates have limited value for triggering early action to control the spread of infection and averting the consequences of a surge in cases. Other measures have gained prominence and now play a critical role in defining risk for infection or severe disease. Vaccine and booster coverage and availability and utilization of treatment for Covid-19 are critical variables that affect both the risk of severe illness or death from SARS-CoV-2 and health system capacity and access.

We have gained a deeper appreciation of the breadth of the pandemic’s effects, beyond its obvious health effects. These effects have included loss of employment or housing, disruption of educational systems, and increased rates of food insecurity. Many of these negative social and economic effects were unintended results of mitigation measures, including stay-at-home orders, the shutting down of public venues, and transitions to remote learning. Although these measures were appropriate at the time, their effects weren’t evenly distributed, with some communities facing disproportionate hardship, particularly historically marginalized racial and ethnic groups and communities with limited social and economic reserves. It is thus necessary to take into account the ways in which public health recommendations and policies may differentially affect various subgroups of the population. Government and nongovernmental entities need to create clear pathways for vulnerable populations to obtain access to the resources they need, including masks, vaccines, no-cost treatment, direct economic assistance, supplemental food, rent abatement, and Internet access to support virtual learning and remote access to health services. Such an approach requires that the federal government continue to invest in the Covid-19 response, since private-sector investment will be insufficient to meet all needs.

One of the key challenges that the public-health community faces as the pandemic evolves is the need to move away from universal recommendations, or population-wide prevention policy, toward a more differentiated or tailored approach — one that takes into account the characteristics of various communities and the pathogen. Relevant characteristics may include those that influence virus transmission or clinical outcomes, such as vaccine and booster coverage and risk factors for severe outcomes, including chronic medical conditions, racism and discrimination based on ethnicity, and lack of adequate health insurance. The implementation of tailored guidance for specific populations, however, is complicated by the legacy of glaring health disparities, the threat of stigmatization, and prevailing mistrust of authorities in some communities. Health-equity and antiracist principles and insights from the fields of health communication and behavioral science must therefore be taken into account from the start in the development and dissemination of recommendations and the implementation of programs and policies.

There is much to lament in the politicization of the Covid-19 pandemic, the spread of disinformation and misinformation, the deep divisions within the U.S. population and, globally, in people’s perceptions of the pandemic and willingness to trust guidance and embrace protective measures. These divisions should inspire a re-examination of the reasons that some public-health recommendations fell flat, in addition to an acknowledgment that political expedience played a role in sowing mistrust. As the pandemic evolves, as the measures of its effects become more complex, and as guidance requires greater tailoring to specific populations, effective communication becomes even more important. Providing clear guidance, including explaining the rationale for various recommendations, acknowledging the social and economic trade-offs involved in complying with them, and offering people the resources they will need to effectively manage these trade-offs, would go a long way toward enabling the adoption of those recommendations.

Most important, attention to the engagement of trusted community leaders and spokespeople is required, as is listening authentically to communities from the start. Rather than focusing solely on what is being recommended, it’s equally important for public health leaders to focus on how recommendations are communicated and disseminated. Early engagement of community representatives is critical so that various aspects of anticipated guidance can be discussed in detail, including rationales, trade-offs, and the most appropriate communication channels and formats. Engagement must not only come in the form of an emergency response, but must involve a consistent presence, which can then be leveraged and activated further during times of urgent need.

The current moment in the Covid-19 pandemic is a pivotal one. There is an urgent need to confront a future in which SARS-CoV-2 will remain with us, threatening the health and well-being of millions of people throughout the world. At the same time, it’s important to acknowledge that objectively we are in a better place with regard to the virus than we’ve ever been and that in fact many people believe the pandemic is behind us. This reality compels us to avoid using alarmist language and to offer valid and feasible solutions to bring people along to a new, nonemergency phase of the pandemic. How we craft our policies, programs, and associated messaging in this context and who delivers the messages is as important as ever.

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