Monday, January 9, 2023

Pfizer's $1 million leads big corporate givers to state Republican Party's building fund, which has no limits on contributions

The Republican Party plans to expand its headquarters into the vacant lot on Third Street in Frankfort, spokesman Sean Southard told Kentucky Health News. (Photo by Tom Loftus for Kentucky Lantern)
By Tom Loftus, for Kentucky Lantern

FRANKFORT, Ky. – In what may be the largest political contribution ever given to a political party in Kentucky, the drug maker Pfizer Inc. gave $1 million last month to the building fund of the Republican Party of Kentucky.

A report filed by the Republican Party of Kentucky Building Fund last week with the Kentucky Registry of Election Finance listed the $1 million from Pfizer along with five other big corporation contributions in the final quarter of 2022 totalling $1.65 million.

That is an extraordinarily large haul for the fund, which had raised only $6,000 during the first three quarters of 2022. The other large corporate donors to the fund in late 2022 were:
  • Metropolitan Life Insurance Co., New York, $300,000;
  • Altria Client Services LLC, of Richmond, Va., $100,000;
  • Comcast Corp., of Philadelphia; $100,000;
  • AT&T, of St. Louis; $100,000;
  • Delta Air Lines, of Atlanta, $50,000.
State and federal campaign finance laws set limits on how much a person or political action committee can give to the executive committee of a political party. A person can give no more than $15,000 per year, and corporation contributions to a party’s executive committee are prohibited.

But part of a campaign-finance bill passed by the General Assembly in 2017 allowed each party to establish a building fund that can accept contributions of unlimited amounts. It also allowed the building funds to accept contributions from corporations.

The Kentucky Democratic Party’s building fund has not yet filed a report on its contributions and expenses for the last quarter of 2022. The party has started a four-year process of selling its headquarters near the Interstate 64 and Versailles Road interchange in Frankfort.

The Republican Party's headquarters are at Capital Avenue and Third Street in Frankfort, in a building named for U.S. Senate Republican Leader Mitch McConnell.

The election registry website says that money in a party building fund “may be used for expenditures related to the purchase, construction, maintenance, renovation, and repair of the state executive committee’s main headquarters facility.”

In response to questions from Kentucky Lantern, Sean Southard, spokesman for the Republican Party of Kentucky, released a statement Monday that said in part “The Republican Party purchased the lot next door to our Frankfort headquarters and is planning an expansion project. Our current headquarters was acquired in 1974. With the growth of the Republican Party in Kentucky, we have a need for additional space.”

In response to a question about the huge size of the corporate contributions, Southard’s statement said, “As we raise funds into the building fund account, we are following both federal and state law. The funds raised into this account can only be used for certain expenditures related to the building and are not eligible to be spent on candidate or issue advocacy.”

Pfizer has long had a lobbying presence in Kentucky and for years it has retained the lobbying firm headed by John McCarthy to represent its interests in Frankfort.

McCarthy, a former chairman of the Republican Party of Kentucky and still a member of its executive committee, did not immediately return phone messages seeking comment on the Pfizer contribution.

Pfizer is a multinational pharmaceutical and biotech company based in New York; its brands include Viagra, Zoloft and Lipitor and more recently the Pfizer-BioNTech Covid-19 vaccine and the antiviral Paxlovid.

Fueled by sales of its Covid vaccine, Pfizer’s revenue doubled to $81.3 billion from 2020 to 2021. The company ranks 43rd on the Fortune 500 list. For the first three quarters of 2022, Pfizer reported $76 billion in revenues.

Pfizer announced in November that it will triple or even quadruple the price of its Covid vaccine once it goes on the commercial market next year, according to Kaiser Health News.

Pfizer is no stranger to political spending. In 2022, the company spent $11.6 million lobbying the federal government, putting it in the top dozen lobbying spenders, according to Open Secrets. Its affiliates and PAC contribute generously to federal candidates of both parties.

Altria Client Services (a subsidary of a cigarette manufacturer formerly known as Phillip Morris), AT&T, Comcast and Delta also are registered to lobby the Kentucky General Assembly. Metropolitan does not retain a lobbyist in Frankfort, according to records of the Legislative Ethics Commission.

Sunday, January 8, 2023

Flu cases are on the decline in Kentucky, but still too high and the season runs through May; it's not too late to get your flu shot

State graph, adapted by Kentucky Health News
By Melissa Patrick

Kentucky Health News 

Influenza cases in Kentucky declined in each of the last four weeks of 2022, but Gov. Andy Beshear said cases are still too high and it's not too late to get a flu shot. Flu season runs through May.

"At least eight children have passed away from the flu already this season" in Kentucky, Beshear said at his regular Thursday news conference. "Flu vaccination is the best way to prevent serious disease. The main strain of flu that's going around right now, the flu vaccine is very effective against it. . . . Go get that flu shot."

The Centers for Disease Control and Prevention recommends annual flu vaccines for everyone 6 months and older as long as flu activity continues. 

The state's latest flu surveillance report, for the week ended Dec. 31, says the flu level in Kentucky has waned to "regional," new meaning cases have been confirmed in at least two, but fewer than half, of the state's 16 regions.   

The report shows that in the week ended Dec. 31, the state confirmed 1,307 cases of the flu, down from 2,132 the week prior, a drop of 39%. The number of confirmed cases this flu season is 37,825.
 
The report said the flu has killed eight children and 106 adults this flu season, with three of the adult cases due to the flu and Covid-19 coinfection. Most flu cases continue to be in people under 20. 

Counties with the highest number of cases in the week ending Dec. 31 were Barren, with 44 cases; Boone, 67; Campbell, 37; Fayette, 57; Floyd, 39; Jefferson, 269; Kenton, 95; McCracken, 31; Morgan, 34; and Pike, 55. 

FDA OKs Alzheimer's drug, which may not be available soon, and carries some risks; UK testing on patients with marker of disease

Medscape photo
Kentucky Health News

The U.S. Food and Drug Administration has approved a drug that has been found to help people in the early stages of Alzheimer's disease and is being studied at the University of Kentucky.

Lecanemab, to be marketed as Leqembi, has been approved through an accelerated approval process. It is to be used for Alzheimer's patients who have mild cognitive impairment or are in the mild dementia stage of the disease, the population that was studied in clinical trials -- which showed the treatment effectively removed amyloid beta plaque, a key marker of Alzheimer's disease, from the brain. The phase 3 trial, of nearly 1,800 people with early Alzheimer's and evidence of amyloid, found that those who got lecanemab for 18 months had a 27% slower cognitive decline than those who got a placebo.

"Longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer’s disease," the study authors reported in The New England Journal of Medicine, noting some "adverse events." The Columbus Dispatch reports that after the study concluded, two patients who remained on the drug died, both were on blood thinners. Marrwan Sabbagh, a neurologist and Barrow Neurological Institute researcher who analyzed the safety of lecanemab on behalf of its manufacturer, told the Dispatch that the deaths of patients on blood thinners "continue to be explored" and that such patients "might need some further consideration."

The Dispatch also noted that the FDA approval came two days after researchers detailed a death possibly linked to the drug. Despite the risks, the Dispatch reports, "Sharon Cohen, a neurologist and director of the Toronto Memory Program, said patients might be willing to accept the drug's risks for benefits such as recognizing loved ones, staying active, or performing everyday tasks."

UPDATE, Jan. 14: The trial found brain swelling and hemorrhage, respectively, in nearly 13% and 17% of the patients who received lecanemab, and only 2% and 9% of the placebo group, National Geographic reports: "Of the patients who took the drug and experienced brain swelling and hemorrhage, roughly 3% developed symptoms like headache, dizziness, and confusion. The others exhibited no symptoms, despite the swelling and bleeding. Matthew Schrag, a neurologist at Vanderbilt University, told National Geographic that could suggest that taking lecanemab is largely safe, “but we don’t know that.”

The Japanese drug firm Eisai, which developed lecanemab in partnership with Biogen, said in a news release that it will price the treatment at $26,500 per year for bi-weekly doses. The Wall Street Journal reports that lecanemab will be out of reach for most U.S. patients in the coming months because Medicare will only pay for this type of Alzheimer's drug for patients enrolled in a "government-sanctioned clinical trial, and no such studies are ongoing or planned." The Alzheimer's Association patient-advocacy group has asked the Centers for Medicare and Medicaid Services to reconsider its policy. 

UK study

Researchers at the University of Kentucky are researching lecanemab to see how it works on people who have no cognitive symptoms of Alzheimer's disease but have the amyloid protein that forms plaques that disrupt brain function, called "preclinical AD."

UK says the study is the first Alzheimer's disease trial to recruit people as young as 55 who are at risk of developing symptoms of the disease as they get older.

The trial still needs study participants and researchers want to make sure the opportunity is available to a wide range of the population.

“We especially want to reach out to those that have experienced health care discrimination,” said one researcher, Dr. Greg Jicha. “If you live in a rural area or are a person of color, you should know that we value you as much as we do everyone else. An effort this important needs to be available to everyone.”

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. Learn more about enrolling in aging studies at UK's Sanders-Brown Center on Aging here.

UPDATE, Jan. 16: For a Q and A about the drug, click here.

Opinion: Covid-19 is mutating and apparently winning, so we need to take preventive measures well beyond vaccinations

Graphs by the New York Times, adapted by Kentucky Health News
By Kevin Kavanagh


There is no such thing as “herd immunity” for Covid-19. In this context it is a concept as antiquated as “the Earth is flat.”

The theory was based upon the work of William Farr in 1840 who proposed a bell-shaped curve which illustrated the body’s ability to mount a lasting response to an unchanging pathogen. As stated by one “herd immunity” supporter in the comments section of my previous article on this point, “The disease dies out because enough people have been exposed and developed relative immunity or died that the disease has no means of propagating itself on a large scale.”

That concept was formulated before science knew what viruses and mutations were, and that many biological systems are highly dynamic and constantly adapting. This is eloquently described in Steffanie Strathdee and Thomas Patterson’s book The Perfect Predator. It describes the biological dance between viral phages and their bacterial prey, each one adapting and re-engaging in a duel, the outcome of which is uncertain. With the exception of smallpox, no pathogen has ever been eradicated from the earth and with smallpox, eradication was achieved with a highly effective long-lasting vaccine.

With mutating RNA viruses such as SARS-CoV-2 (which causes Covid-19), “herd immunity” is an extinct construct. Unlike the relatively stable DNA virus of smallpox, RNA viruses have a much higher mutation rate.

The U.S. epidemiological curve of SARS-CoV-2 is a colliding roller coaster and nowhere near a bell curve. We have been hit with variant after variant; Delta infections transitioned to Omicron; and now we are struck by a soup of variants, composed of pathogens harboring a plethora of different immune-avoiding mutations, making the concept of “herd immunity” next to useless.

Unfortunately, SARS-CoV-2 appears to be the most adaptive and dynamic foe we have ever faced. Hoping that the antiquated concept of “herd immunity” will save the day, causing SARS-CoV-2 to “miraculously (go) away,” is just pure fantasy.

SARS-CoV-2’s high mutation rate is amplified by its extremely high infectivity. The CDC estimated that the Delta variant was as infectious as chickenpox, which has an R0 of 10 to 12. That means an average person infected with Delta infected 10 to 12 other people. Newer variants have evolved into some of the most infectious pathogens known to man. As the virus spreads it mutates. And as it mutates, it increases its ability to infect, evade our immunity and even attack our immune system.

Evidence is mounting regarding the immune dysfunction caused by SARS-CoV-2. We are seeing a dramatic rise in hospitalizations for the seasonal flu, respiratory syncytial virus (RSV) and even scarlet fever. The increase in RSV hospitalizations has been blamed on immunological weakening during the pandemic due to preventive measures such as masking. However, through November, the United States had correspondingly fewer RSV infections than in 2021, when an RSV surge was also seen. Germany also had a surge in RSV hospitalizations last winter, and now is seeing overwhelming RSV hospitalizations.

Not only does SARS-CoV-2 evade and attack our immunity, but the immunity is fleeting. The virus also resides in a variety of animal hosts where it can mutate and then reinvade the human population. Transmission of a mutated virus from whitetail deer to humans has been documented and there is evidence that Omicron originated in rodents then jumped to humans in South Africa.

The dangers of long Covid, persistent cardiovascular disease, blood clots and a plethora of mental problems caused by Covid-19, are real, and are adversely affecting the health of our workforce and our communities.

Our goal must be to decrease pathogen spread so society can function, with infections decreasing to a level that we can live with the virus. In this regard, it appears the virus is currently winning.

We need to embrace vaccinations, the use of N95 masks in crowded venues, along with home delivery, curbside pickup and outside dining. Indoor air quality must be improved to the point where it is safer indoors than it is outdoors.

If we continue to be a society focused on individualism rather than community or public health, I am afraid we will lose this fight. We need a paradigm shift in the way we strategize to control Covid-19, away from “herd immunity” and towards adapting our lives to live with this highly dynamic and constantly adapting foe.

Kevin Kavanagh is a retired physician from Somerset and chairman of Health Watch USA. This is an edited version of his original article, published in the Courier Journal.

Saturday, January 7, 2023

Kentucky counties and cities get first installment of money from national opioid settlements, now must decide how to spend it

Route Fifty photo
By Melissa Patrick

Kentucky Health News

Kentucky's cities and counties have received their first installment of the state's money from the national opioid settlement, most of which must be used to combat the opioid epidemic.  

Knox County Judge-Executive Mike Mitchell said he is exploring how to get the most from the $365,000 or so that the economically distressed county in southeastern Kentucky got from the settlements in 2022, including partnerships with other organizations or implementing programs that focus on prevention, education, re-entry and rehabilitation.

Mitchell said any decisions about how to spend it will require input from the community and a Fiscal Court vote. "We will be very cautious about what we do," he said. "We want the maximum benefit out of this for the community and to make sure that it's being applied to fill the needs that it is intended for."

The money comes from a $26 billion settlement with drug maker Johnson & Johnson and the nation's three top drug distributors, Cardinal Health, AmerisourceBergen and McKesson Corp. Kentucky's share of the settlement was $478 million, with  half the money going to the state and the other half going to local governments. The state's allotment will be distributed by the Opioid Abatement Advisory Commission, housed in the attorney general's office. 

Mitchell said that while he is pleased to get help to fight the opioid epidemic, no amount of money will fix the damage that's been caused by the drug companies.

"It's unfortunate that Kentucky's eligible to receive this because there's no way to replace the damage that's been done by the pharmaceutical people," he said. "I feel they're totally to blame. That's a big part of our drug problem, in the way this opioid was misrepresented. . . . It's not an exorbitant amount of money, for the damage that they've done. . . . There's no way to go back and re-do the impact that they've had in our community." 

Kentucky has been one of the states hardest hit by the opioid epidemic. In 2021, the state recorded 2,250 overdose deaths, with 73% of the deaths involving fentanyl. 

How much did your city or county get? 

Every Kentucky county received its first allotment of settlement money in December, ranging from $15,994 in Robertson County to $6.7 million in Jefferson County. The Kentucky Association of Counties has posted online the estimated allocations for every county through 2038. 

The Kentucky League of Cities reports that 149 Kentucky cities have received an allocation from the settlement and provides a list of the settlement amounts for each participating city for 2022 and 2023; 28 Kentucky cities have not yet signed on to the settlement participation agreement, but remain eligible. If a city did not qualify for at least $30,000, its allotment was rolled into its county's allotment. 

State law says no less than 85% of the proceeds received by each local government "shall go toward abatement of the opioid epidemic in those communities." Another statute defines acceptable use of the funds and includes a wide range of criteria and guidelines for reimbursement of prior expenses and the funding of new programs related to prevention, treatment and recovery of people with opioid-use disorders and co-occurring substance-use disorder, or mental health issues. 

Each year, local governments must tell the Opioid Abatement Advisory Commission how they are spending the money. That agency "is not responsible for the allocation of opioid settlement funds to Kentucky cities and counties," Krista Buckel, communications director for Attorney General Daniel Cameron, said in an e-mail.

How were the allocations determined? 

The amount for each local government was based on "population adjusted for the proportionate share of the impact of the opioid epidemic," according to a National Opioid Settlement FAQ fact sheet. Impact was  determined by the amount of opioids shipped to the state, the number of opioid-related deaths, the number of people with opioid-use disorder in the state, and each political subdivision's proportionate share of those numbers.

"Adjustments were made to reflect the severity of impact because the oversupply of opioids had more deleterious effects in some locales than in others," the fact sheet says. "Ultimately, the model allocates settlement funds in proportion to where the opioid crisis has caused harm." 

Asked for details on how the money was divided between cities and counties, Jennifer Burnett, director of policy, research and communications for the counties association, said they "were assigned a . . . ranking percentage based on three or four data points," and the money was distributed based on a formula applied by Brown Greer PLC, the settlement administrator. Brown Greer, a Richmond, Va., law firm, did not reply to a request for further explanation. 
 
A stated desire to spend the money wisely

Manchester Mayor Steve Collins was just two days on the job when he told Kentucky Health News that he had already reached out to the attorney general's office to get details on how settlement money could be spent. KLC estimates that Manchester received $15,587 from the settlement in 2022. 

"I think it's urgent that we spend it, but I also think it's very important that we . . .  discuss what would be the best way to spend it," he said. "I think that's the main issue, making sure we put it in the right direction. Just do not hurry and spend it to be spending it, but spend it to be actually the most beneficial to the community." 

Woodford County Judge-Executive James Kay said his county already had an Opioid Task Force and there may be several initiatives in place or in discussion that the money could help. He said combining money with other organizations could heighten its impact, and said he would ask the public how they would like to see it spent. The counties association estimates that Woodford County received $123,595 from the settlement in 2022. 

"We want to make sure that we spend the money wisely, efficiently and effectively," Kay said.

Versailles Mayor Brian Traugott said he would like to see the city's settlement money spent on prevention, particularly in finding ways to keep young people busy and off of drugs. In addition, he said it will be important to consider programs that help with "post-treatment" and second-chance employment. KLC estimates that Versailles received $17,551 in settlement funds in 2022. 

Traugott added that it will be important to get "boots on the ground" people involved with how to spend the money as a way to make sure "that we are utilizing these funds in an effective way." 

Cameron recently announced additional settlement agreements with Walmart, Teva Pharmaceuticals and Allergan for their roles in the opioid epidemic. Money from these settlements will also be divided between the state and local governments, with the same requirements.

Thursday, January 5, 2023

CDC says most of Ky. has medium risk of Covid-19 transmission; flu rates remain high; Beshear urges vaccinations and boosters

Centers for Disease Control and Prevention map
By Melissa Patrick
Kentucky Health News

While the number of Kentucky counties with a high risk of Covid-19 transmission went down by two on the latest federal risk map, the medium-risk category has 42 more counties than last week.

"Covid-19 news is a little mixed and a little uncertain," Gov. Andy Beshear said at his regular Thursday news conference, held before the latest risk map was released. "It does appear that activity is increasing nationwide, but fortunately we are not seeing significant increases in cases or hospitalizations in Kentucky." 

Beshear revealed that the big jump in Kentucky Covid-19 cases reported two weeks ago was due to the inclusion of some Indiana cases. Even so, he said that while the decline in cases is not as high as it appears to be, there has still been a decline. 

The Centers for Disease Control and Prevention risk map, which looks at both cases and hospital numbers to determine transmission risk, shows 13 Kentucky counties at high risk, shown in orange; 64 at medium risk, shown in yellow; and 43 at low risk, down from 61 the week before. Low-risk counties are shown in green. 

Most of the high-risk counties can be found in the eastern part of the state and a large cluster of low-risk counties runs down the middle of the state. 

In high-risk counties, the CDC continues to recommend 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.

Centers for Disease Control and Prevention map
The CDC also has a transmission-level map that shows the level of virus spread in each county, at one of four levels. It shows six small Kentucky counties with a moderate level of transmission and the rest have either substantial or high levels of transmission. This data is largely used by hospitals and researchers. 

State officials have encouraged Kentuckians to use the other CDC map to guide their preventive measures. 

Reviewing all the respiratory diseases hitting Kentucky, Beshear said officials are watching the new coronavirus variant that is quickly becoming dominant in the U.S. It is called XBB.1.5 and is a subvariant of the Omicron variant. 

Beshear said XBB is more contagious than the last Omicron subvariant, but we don't yet know whether it will cause more or less serious disease. The previous dominant variant has been milder than previous ones.

"So, it's important that folks who have not gotten their newest booster to go get it," Beshear said. "This new booster provides protection against Omicron and has provided good protection against all of the Omicron variants. Does it mean that it will shield you from getting Covid? Not always. But it certainly makes, if you get it, any health impacts much, much, much less severe." 

Beshear noted that the CDC reports that fewer than 12% of Kentuckians who are 5 or older and thus eligible for the latest, updated booster.

He added that flu levels in Kentucky remain high and that the flu can be deadly. He stressed that it's not too late to get a flu shot and that locations and appointments to get one can be found on vaccines.gov.  

"At least eight children have passed away from the flu already this season" in Kentucky, he said. "Flu vaccination is the best way to prevent serious disease. The main strain of flu that's going around right now, the flu vaccine is very effective against it. . . . Go get that flu shot." 

Beshear said the respiratory synctital virus, a disease that is most dangerous to children and seniors, "appears to be declining."

S.C. high court is first in U.S. since Roe repeal to find abortion right in state constitution; Idaho says no; Ky. case still pending

By Al Cross
Kentucky Health News

The South Carolina Supreme Court has become the first to find a right to abortion in a state constitution since the U.S. Supreme Court said last June that there is no such right in the U.S. Constitution.

The Kentucky Supreme Court might have been the first, tentatively, but it still has not ruled in a case that it heard Nov. 15. Since then, two justices have retired and two new ones have been elected, and they can rehear the case or just watch and read the arguments, Supreme Court Clerk Kelly Stephens said, adding that she does not expect a decison this month.

Meanwhile, the Idaho Supreme Court declined Thursday to find a right to abortion in that state's constitution. The vote was 3-2, the same as in South Carolina, but with the opposite result.

The South Carolina justices said the state’s ban on abortion afer the sixth week of pregnancy violated the state constitution's explicit guarantee of privacy rights. Kentucky's constitutional privacy rights rely on unspecific language and previous interpretations by the state Supreme Court.

South Carolina’s constitution says “The right of the people to be secure in their persons, houses, papers, and effects against unreasonable searches and seizures and unreasonable invasions of privacy shall not be violated.”

The court's majority opinion said any limit of privacy rights “must be reasonable,” meaning that a woman needs “sufficient time to determine she is pregnant and take reasonable steps to terminate that pregnancy.” The court said that six weeks is “quite simply, not a reasonable period of time for those two things to occur” because “women typically do not realize they are pregnant until around six weeks.”

Kentucky also has six-week ban, but also a stronger ban, allowing abortion only to save the woman's life. The latter was in a "trigger law" that took effect after the U.S. Supreme Court struck down Roe v. Wade.

A Louisville judge issued an injunction that blocked the trigger law, but a state Court of Appeals judge blocked the injunction, allowing the law to take effect. A fractured Supreme Court allowed it to stay in effect while it considered the case. It set the hearing for a week after the Nov. 8 election, in which voters defeated a proposed amendment to the state constitution, saying it does not grant a right to abortion or funding of it.

At least initially, the Supreme Court's ruling will be on the injunction, not on the merits of the lawsuit, but a key piece of injunction law is the likelihood of prevailing on the merits.

Similar challenges to state abortion laws, citing state constitutional proviosions, are pending in Arizona, Georgia, Indiana, Iowa, North Dakota, Ohio, Utah, Wisconsin and Wyoming, according to Politico.

Four of the South Carolina court’s five justices are registered Republicans; Chief Justice Donald Beatty, who voted with the 3-2 majority, is a Democrat. All five were appointed by the Republican-conrolled legislature. Kentucky judges are elected by the people in nonpartisan races.

Wednesday, January 4, 2023

FDA expands availability of abortion-inducing medication

Women who want to use a pill to end their pregnancy in the first 10 weeks will now be able to get it directly from health-care providers and pharmacies. The move by the U.S. Food and Drug Administration expands options for women in Kentucky, where almost all abortions are currently illegal. The state Supreme Court, in a pending case, could change that.

The FDA announced the new rules for the abortion-inducing drug mifepristone Tuesday night. The drug is already used in more than half of the abortions in the United States.

"Prior to this announcement, mifepristone could only be dispensed by some mail-order pharmacies, or in person by specially certified providers," MedPage Today notes. "This week's decision will allow patients to pick up the abortion pill at brick-and-mortar locations, including local drugstores or chain pharmacies like CVS or Walgreens." Those chains said they would sell the drug. Rite Aid said it was reviewing the FDA's action, USA Today reports.

Last year, the FDA allowed the drug to be obtained by mail, but the Kentucky General Assembly banned that in a wide-ranging anti-abortion bill. FDA proposed the changes in December 2021, "six months before the Supreme Court overturned Roe v. Wade and left abortion policy up to individual states," notes Beth Wang of Inside Health Policy. In Kentucky, the decision activated a "trigger law" that bans abortion except to save the woman's life.

The changes announced Tuesday allow pharmacies that go through a certification process, still not specified, to dispense the drug directly to patients who have a prescription from a certified prescriber who has an agreement with the certified pharmacy, Wang reports.

UPDATE, Jan. 5: "Legal scholars slammed FDA’s certification requirements for pharmacies to dispense the abortion pill, mifepristone, saying they’re unnecessary and not based in science, and the experts called on FDA to get rid of the prescribing and dispensing restrictions altogether," Wang reports.

"FDA also has permanently removed the requirement that patients see a health-care provider in person before being prescribed the drug," Wang notes. "That requirement was temporarily removed during the Covid-19 public health emergency." However, Kentucky law bans the use of telemedicine to get a mifepristone prescription.

Tuesday, January 3, 2023

New coronavirus cases went down 60% in Kentucky last week, but new hospitalizations of patients with Covid-19 rose 18.5%

New York Times chart, adapted by Ky. Health News, shows new admissions of patients 70 and older with Covid-19 rose from Dec. 25 to Jan. 1. The latest state report covers admissions as of Jan. 2.
By Melissa Patrick
Kentucky Health News

Kentucky reported 60 percent fewer new coronavirus cases last week, but the positive-test rate rose a bit and hospitalizations jumped more than 18 percent.  

The state Department for Public Health's latest weekly report, released Tuesday because of the New Year's holiday, showed 3,532 new cases of Covid-19, or 504 per day. That's down from 1,274 per day in the prior week, when the state saw a 40% increase in cases over the previous week. 

Only 2% of this week's reported cases were in people 18 and younger, perhaps the lowest number yet reported, and probably reflecting school holidays.

The share of Kentuckians testing positive for the virus in the past seven days increased slightly, to 12.74%, up from 12.23%. The week before that this rate was 9.85%. 

It's important to remember that the actual numbers are likely much higher, since the reported percentage doesn't include at-home tests. And as Gov. Andy Beshear has said, by the time a person gets a Covid-19 test that is analyzed by a laboratory, they are pretty sure they have some sort of infection. 

Hospitalizations kept rising. Kentucky hospitals reported 480 patients with Covid-19, up 18.5% from 405 a week earlier, with 58 in intensive care (up nine) and 24 on mechanical ventilation (up eight). 

The weekly new-case incidence rate was 14.6 cases per 100,000 residents, up just slightly from 14.54 the week before. The top 10 counties were Robertson, 54.2 cases per 100,000; Elliott,43.7; Lee, 38.6; Simpson, 35.4; Monroe, 32.2; Bath, 30.9; Owsley, 29.1; Bell, 28.5; Lyon,27.8; and Leslie, 27.5.

The New York Times continues to note that Kentucky and South Carolina are in the midst of worsening conditions. On Wednesday, the Times ranked Kentucky's incidence rate 42nd in the nation, with a 57% decrease in the last two weeks.

Kentucky attributed 27 more deaths to Covid-19 last week, down from 45 the week prior. The state's pandemic death toll is now 17,697.  

Monday, January 2, 2023

Newly dominant variant more likely to evade Covid-19 antibodies, but so far not seen as more likely to cause serious disease

Antibodies at work on the coronavirus (Illustration
by Russell Keightley, via Science Photo Library Art)
With a new subvariant of the novel coronavirus now dominant in the U.S., vaccinated people may be more likely to develop Covid-19 but still be well protected from serious disease, according to preliminary reports.

The XBB.1.5 subvariant "has raised concerns about another potential wave of Covid cases following the busy holiday travel season" but "There’s no indication it causes more severe illness than any other omicron virus, Dr. Barbara Mahon, director of CDC’s Coronavirus and Other Respiratory Viruses Division, told NBC News. . . . The CDC projected Friday that about 40% of confirmed U.S. Covid cases are caused by the XBB.1.5 strain, up from 20% a week ago."

XBB.1.5 is so new that research on it is very limited, but researchers from Columbia University recently reported in the journal Cell that sublineages of the BQ and XBB subvariants had a “dramatically increased” ability to evade antibody protection, even among those who had received the current bivalent booster. “However, it is important to emphasize that although infections may now be more likely, Covid-19 vaccines have been shown to remain effective at preventing hospitalization and severe disease even against Omicron as well as possibly reducing the risk of post-acute sequelae of Covid-19 (PASC, or long Covid),” the researchers reported.

Former deputy secretary in Ky. is Arkansas human services chief

Kristi Putnam
Kristi Putnam, who was deputy secretary of the state Cabinet for Health and Family Services during the administration of Republican Gov. Matt Bevin, has been named secretary of the Arkansas Department of Human Services by Gov.-elect Sarah Huckabee Sanders.

"Kristi and I share a vision for bold reforms that support our neighbors in need, care for our most vulnerable, protect children in foster care, and ensure Arkansans are not trapped in a lifetime of poverty," said Sanders, who was White House press secretary for Donald Trump and is the daughter of former Gov. Mike Huckabee.

Putnam, 51, said in the same news release, "We will protect our fellow citizens while prioritizing reforms and identifying efficiencies and taxpayer savings, which is what I have done throughout my career." In Kentucky, Putnam "oversaw cross-cabinet reforms in health policy, human-services delivery system design, workforce strategies, and child-welfare improvements while leading an organization with more than 8,000 employees and a budget exceeding $14 billion," the release says.

She was most recently chief personnel officer for AppHarvest, the agritech startup with huge vegetable greenhouses in Kentucky. Before that, "She co-founded Connecting the Dots Policy Solutions, which provided policy guidance for the U.S. Department of Health & Human Services, the Kentucky House of Representatives, the State of Arkansas and several other health plans," the release says.

Sunday, January 1, 2023

Beshear's medical cannabis order takes effect, but access for most isn't easy; prospect of legislative action remains unclear

USA Today map adapted by Kentucky Health News; data from Marijuana.procon.org
By Al Cross
Kentucky Health News

People with a medical provider's statement saying they have at least one of 21 specified medical conditions can now possess up to eight ounces of marijuana for medicinal purposes in Kentucky, if they bought it legally in another state, under an executive order issued by Gov. Andy Beshear that took effect Jan. 1.

But for most Kentuckians, exercising the new right is not convenient, because cannabis is not legal in any form in Indiana and Tennessee, and the medical-cannabis laws of Ohio and West Virginia do not apply to out-of-state residents.

Missouri and Virginia have passed laws to legalize cannabis for recreational use, but the Missouri law is not expected to take effect until at least February, and Virginia is not expected to have cannabis dispensaries until next year, reports Joe Sonka of the Courier Journal. That leaves Illinois.

Asked about that at his year-end press conference, Beshear said, "The executive order isn’t going to make it convenient for anyone . . . What it will ensure is that they’re not a criminal" if they qualify and have eight ounces or less, the amount that is otherwise a misdemeanor in Kentucky. Beshear's order uses his pardon power to prevent prosecution of those who qualify.

"I don't want them to have to drive to Illinois, but that takes an act of the legislature," Beshear said. "I want our people to be able to get it close to home."

It is unclear what the Republican-controlled General Assembly will do in reaction to the Democratic governor, who is on the ballot this year. The state Senate has twice refused to move medical-cannabis bills passed by the House, so there is some feeling that the bill should start in the Senate this time, but Senate Majority Floor Leader Damon Thayer, R-Georgetown, says it should start again in the House.

That does not suit Rep. Jason Nemes, R-Louisville, the sponsor of those two bills. "This is a Senate question; it is no longer a House question,: Nemes said Jan. 1. "There's no reason to go through the House again, becase that would delay the prospect of the bill." The current session is a short one, with only 30 legislative days, unlike the 60 days in even-numbered years.

Beshear said Thursday that Kentucky law-enforcement officers would have by Jan. 1 a palm card instructing them how to handle cases in which they find eight ounces or less of marijuana (any more would be a felony) possessed by someone authorized to possess it under the executive order.

The medical provider's written certification must include their medical license number, a statement of a the provider-patient relationship, their diagnosis of the qualifying medical condition, and their dated signature. It must also have the provider's and patient's names, addresses and phone numbers.

The 21 qualifying conditions are including cancer, HIV or AIDS, multiple scleroisis, muscular dystrophy, epilepsy, intractable seizures, intractable pain, severe and chronic pain, severe arthritis, neuropathy, Parkinson's disease, fibromyalgia, glaucoma, Crohn's disease, sickle-cell anemia, post-traumatic stress disorder, hepatitis C, cachexia (wasting syndrome), Huntington's disease, amytrophic lateral sclerosis (Lou Gehrig's disease) or another terminal illness.