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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