Friday, August 16, 2019

'Juul-alikes' fill niche left when firm stopped selling some flavors; Drug Free Lexington releases videos aimed at e-cig users

New York Times photo by Brittainy Newman
Pressed by the chief of the Food and Drug Administration last fall, Juul Labs "stopped selling most of its hugely popular flavored nicotine pods in stores last fall," but now other companies are "trumpeting their own fruity and candy-flavored pods as compatible with Juul devices," Sheila Kaplan reports for The New York Times. That illustrates "just how entrenched the youth vaping problem has become, and that voluntary measures are unlikely to solve it."

Chris Bostic, deputy director for policy of Action on Smoking & Health, told Kaplan that the FDA “needs to step in,” but the agency's willingness to do that has been unclear since Scott Gottlieb left the commissioner's office. He had proposed requiring that stores put flavored electronic cigarettes, except menthol, mint and tobacco flavors, "to areas off limits to minors," Kaplan notes. "But the details of the proposal were vague, and with Dr. Gottlieb’s departure, it’s unclear how federal policy might change." Acting Commissioner Norman E. Sharpless has said he is working on the plan.

The company has filed lawsuits and international-trade complaints against other companies’ "Juul-alikes" but "says it still has the legal right, under FDA rules, to bring back dozens of its own sweet flavors that it once sold in very limited release. They include varieties of watermelon, strawberry and melon, which competitors are already selling, as well as specially designed concoctions: Coconut Bourbon, Elderflower Fizz, Mimosa and Thai Tea, and others," Kaplan writes. "In April, Juul told Congress it had no intention of bringing those flavors back in the United States."

A poll last year showed that 27 percent of Kentucky high-school seniors reported using electronic cigarettes, up from 12 percent in 2016.

Meanwhile, Drug Free Lexington has released three "public service announcements" about Juuls. "These fast-paced, fact-based PSAs, designed to target parents, teachers, administrators and other working with youth, are free for all to use," the Foundation for a Healthy Kentucky reports. "These short ads provide insight into the chemicals in Juul and their harmful effects, the rising popularity of Juul, why youth may be more susceptible to e-cigarette use and addiction, and why e-cigarettes are especially damaging for teens including negative health costs and long-term adverse health effects."

Thursday, August 15, 2019

FDA proposes new, graphic warnings for cigarette packs and ads

A Food and Drug Administration photo illustration shows three  of the 13 proposed warnings.
The Food and Drug Administration has again published a proposed rule to "require color graphics depicting the negative health consequences of smoking be added to cigarette packages and in cigarette advertisements," Inside Health Policy's Beth Wang reports.

The warnings would be the first update to cigarette package warnings in more than 30 years. They were authorized by a 2009 law, but a tobacco-company lawsuit blocked FDA's first attempt.

Wang describes the proposed warnings:

“Tobacco smoke can harm your children,” with an image that shows the head and shoulders of a boy 8 to 10 years old, wearing a hospital gown and receiving a nebulizer treatment for chronic asthma.

“Tobacco smoke causes fatal lung disease in nonsmokers,” with an image showing gloved hands holding a pair of diseased lungs containing cancerous lesions.

“Smoking causes head and neck cancer,” with an image showing the head and neck of a woman 50 to 60 years old who has a tumor protruding from the right side of her neck, just below her jawline.

“Smoking causes bladder cancer, which can lead to bloody urine,” with an image of a gloved hand holding a specimen cup with bloody urine.

“Smoking during pregnancy stunts fetal growth,” with an image of an infant on a medical scale with a digital display reading 4 pounds.

“Smoking can cause heart disease and strokes by clogging arteries,” with an image of a 60- to 70-year-old man with a large, recently sutured incision in his chest as he undergoes monitoring.

“Smoking causes COPD, a lung disease that can be fatal.” There are two versions of the COPD warning. One will have an image of gloved hands holding a pair of diseased, darkened lungs removed from a smoker; the other will have an image of the head and neck of a 50- to 60-year-old man who has a nasal canula under his nose supplying oxygen, with the oxygen tank behind him.

“Smoking reduces blood flow, which can cause erectile dysfunction,” with an image of a 50- to 60-year-old man sitting on the edge of a bed and leaning forward with one elbow resting on each knee. The man’s head is tilted down with his forehead pressed into the knuckles of his right hand while his female partner sits behind him on the bed, looking in another direction.

“Smoking reduces blood flow to the limbs, which can require amputation,” with an image of feet with several toes amputated due to damage resulting from peripheral vascular disease caused by smoking.

“Smoking causes type 2 diabetes, which raises blood sugar,” with n image of a personal glucometer device showing a high blood sugar level.

“Smoking causes age-related macular degeneration, which can lead to blindness,” with the image of a senior man getting an injection in his right eye to prevent additional macular degeneration.

“Smoking causes cataracts, which can lead to blindness,” with the image of a man who is at least 65 years old who has a cataract covering his right pupil.

A lawsuit by public-health and anti-smoking advocates prompted FDA to issue the proposal, Wang notes: "The proposed warnings are required by law to be displayed on half the front and rear panels of cigarette packages, and on the top 20% of the area at the top of advertisements.

"This marks the second time FDA has issued a proposed rule to require graphic warnings on cigarette labels and advertisements," Wang notes. "The first rule was blocked in 2012 by the U.S. Court of Appeals for the District of Columbia in R.J. Reynolds Tobacco Company v. FDA, which argued the proposed rule violated the First Amendment by not justifying why there is a need to issue regulation on commercial speech. In March, however, a federal court ordered FDA to issue the proposed rule by Aug. 15, and a final rule by March 15, 2020."

The Family Smoking Prevention and Tobacco Control Act of 2009 "required nine new health warning statements to be included on cigarette packages and in cigarette advertisements, and it directed FDA to develop color graphics depicting the negative health consequences of smoking to accompany warnings," Wang notes. "After having their initial proposed rule rejected by the court in 2012, FDA undertook a research and development process to consider whether the TCA’s textual warning statements would promote greater public understanding of the risks associated with smoking. Through that process, FDA determined there was support to propose adjusting some of the TCA statements. FDA ended up with 16 statement-and-image pairings to test in a final quantitative consumer research study, which resulted in the 13 cigarette graphic health warnings listed in the proposed rule."

The poorer the household, the more likely its kids are to inhale secondhand smoke; Ky. is poor and has 2nd highest smoking rate

Study charts show less exposure among older youth, who tend to spend more time outside the home.
Children who live in poverty are nearly three and a half times more likely to be exposed to secondhand cigarette smoke than their counterparts in high-income households, a new study says.

The National Health and Nutrition Examination study, released by the National Center for Health Statistics, found that from 2013 to 2016, nearly 55 percent of children aged 3 to 17 whose families are below the federal poverty level were exposed to secondhand smoke. That was the case for only 16 percent of those living in well-to-do households, those with incomes at or above 400% of the poverty level, which for a family of four is income of $103,000 a year.

Secondhand smoke exposure is defined by the presence of a metabolite of nicotine, in blood, urine or saliva. African American youth, at all income levels, had the highest levels of exposure; overall, 62% were exposed. After declining for decades following the 1980s, these percentages have remained steady in recent years; Kentucky has the nation's second-highest adult-smoking rate, 26%, and its household-poverty rate of 17.2% is the fifth highest among the states.

"These children and teens are sicker, they miss more days of school, and they're at higher risk for heart disease, stroke and lung cancer as adults," said Ben Chandler, president and CEO of the Foundation for a Healthy Kentucky. "One of the most important health benefits of Kentucky's new tobacco-free schools law is that it reduces kids' exposure to secondhand smoke where they spend a significant chunk of their time, both during the school day and at after-school events. We urge every Kentucky school district to move quickly to adopt and implement a tobacco-free policy in compliance with the new law." The law takes effect statewide in August 2020, except in school districts that opt out of it.

Federal grant will let former Gov. Fletcher start treatment and housing for addicts in 101 rural counties in 8 states, 47 in Ky.

Dr. Ernie Fletcher spoke in Owensboro last year about
his plan to take the Recovery Kentucky concept beyond
Kentucky. (Photo by Alan Warren, Messenger-Inquirer)
An organization headed by former Kentucky governor Ernie Fletcher will get $6.6 million in federal funds "to establish a center of excellence for substance-abuse disorder and . . . provide treatment and housing options for low-income and high-risk individuals in 47 Kentucky counties," Senate Majority Leader Mitch McConnell of Kentucky said in a press release Aug. 15.

The money comes from the Rural Communities Opioid Response Program of the Department of Health and Human Services. It will go to the Fletcher Group, "which has partnered with the University of Kentucky to establish an opioid response program and will maintain its headquarters in rural Kentucky, the release said. "Its work will target 101 rural counties in eight states."

The group's chair and chief medical officer is Fletcher, a physician and Republican who was governor in 2003-07. He said in the release, “Leader McConnell has been a tireless champion fighting against the opioid crisis facing Kentucky and many other parts of the country. His support for this new funding opportunity will enable the Fletcher Group to establish a Rural Center of Excellence on Substance Use Disorder to continue to spread the successful Recovery Kentucky model to other parts of the commonwealth and beyond. The center will provide technical assistance to rural communities seeking to establish evidence-based treatment and recovery housing options for at-risk populations.” Fletcher, as governor, helped start Recovery Kentucky.

The Kentucky counties to be served are mainly in Appalachia: Adair, Bath, Bell, Breathitt, Carter, Casey, Clay, Clinton, Cumberland, Elliott, Estill, Floyd, Garrard, Green, Harlan, Johnson, Knott, Knox, Laurel, Lawrence, Lee, Leslie, Letcher, Lewis, Lincoln, McCreary, Magoffin, Martin, Menifee, Monroe, Owsley, Perry, Pike, Powell, Robertson, Rockcastle, Russell, Wayne, Whitley and Wolfe.

The non-Appalachian Kentucky counties to be served are Boyle, Breckinridge, Carroll, Grayson, Hickman, Mercer and Taylor.

Baby born fine after mother monitors fetal heartbeat for doctors, to make sure he doesn't develop deadly disease in the womb

Tim and Greta Wright and family (UK photo by Hilary Brown)
By Hilary Brown
University of Kentucky

In 2018, Greta Wright and her husband Tim, of Lexington, received two surprises. The first surprise was finding out she was pregnant with their second child. The second, less joyous surprise was that Greta had a rare auto-immune disease called Sjorgren's Syndrome, and it could be fatal to her unborn son.

"Needless to say, we were frightened and felt completely defenseless," she said.

Sjorgren's Syndrome is an autoimmune disease that attacks the glands that make tears and saliva. It's a rare disease, affecting somewhere between five and 40 people out of 100,000. During pregnancy, certain proteins in the mother's blood can cross the placenta and damage certain organs in the fetus, and the heart is especially susceptible. In a condition known as fetal heart block, the baby's heartbeat can slow to a dangerously low rate or even stop completely.

"The fetal heart is at risk to be affected, especially the nerve wiring system, which might lead to fetal heart block," said Dr. Majd Makhoul, pediatric cardiologist in the Kentucky Children's Hospital Congenital Heart Clinic. "If this happens, the heart top and lower chambers don’t communicate with each other and that leads to decreased cardiac function and heart failure. This can lead to serious fetal complications and sometimes fetal death."

"One to three percent of women with Sjorgren's will have babies affected with this electrical condition," said Dr. Wendy Hansen, an obstetrician in UK HealthCare's Department of Maternal-Fetal Medicine and chair of the Department of Obstetrics and Gynecology. "Although Sjorgren’s was a new diagnosis, she could have had when she was pregnant with her first child, and she simply didn’t know."

In order to ensure a safe pregnancy, the UK fetal-cardiology team applied for a grant from the National Institutes of Health to participate in a large-scale national study of fetal heart block. The study seeks better understanding of its risks and causes, and to find medical interventions that can reverse fetal heart block if caught early enough.

Traditionally, pregnant women with Sjorgren's have weekly appointments with fetal cardiologists to assess for fetal heart block during the critical period of pregnancy. However, a complete fetal heart block can develop in as little as 24 hours, and there is no effective treatment for it. Some medications can reverse it, but only in the early stages.

So, Hansen had Greta use a listening device two to three times a day to monitor the fetal heartbeat. Using sound clips of both normal and abnormal heartbeat as reference, she sent recordings to both Makhoul and Hansen if she had questions about the heartbeat's regularity. Once, an irregular heartbeat concerned Makhoul enough that he had Greta to come to the hospital, where she was proactively treated as if the fetus was being affected by the syndrome. Less than 12 hours later, the heartbeat stabilized and stayed normal throughout the rest of the pregnancy.

"Greta would come into each visit with a list of questions and articles she had read, makes me smile when I think about it," said Hansen. "Her and Tim's openness, sense of humor, positivity and great communication were their defining qualities."

In April, Greta and Tim's son Asa was born healthy with no complications. Makhoul attributes Asa's strong start to his dedicated and conscientious parents.

"Greta and Tim made our job easy by asking the right questions from early on and being deeply engaged at every step of the process," said Makhoul. "They were appropriately concerned and anxious at times but approached the situation with the right attitude and maximized their chance of having a healthy baby by adhering to our recommendations to the letter."

"Doctors Makhoul and Hansen made what could have been a horrible experience a great one," said Greta. "We felt like we were part of the UK family. We also knew that we didn’t have to worry about two separate teams of doctors – the Maternal-Fetal Medicine and the Pediatric Congenital Heart Clinic­­ – communicating with each other as we saw it happening proactively every day."

Wednesday, August 14, 2019

University of Louisville is buying Jewish Hospital after all, with the help of an unusual $50 million loan to be backed by Ky. taxpayers

The University of Louisville is buying Jewish Hospital and associated facilities after all, with help from the state and two foundations, to head off a threatened closure of the hospital, which is an important transplant center.

"U of L has searched for months for ways to save Jewish Hospital, which has been losing money for years but is also home to valuable clinical and research programs intertwined with U of L's academic mission," reports Grace Schneider of the Louisville Courier Journal.

KentuckyOne Health's "parent company, CommonSpirit Health, accelerated efforts by U of L and the state to save Jewish when the company's executives notified them early this month that they intended to shut down the facility in about two months – and to go public with the plans on Thursday, Aug. 15," Schneider reports. The school's trustees endorsed the deal Aug. 14.

U of L said in June that it had failed to find a necessary partner to buy the hospital. Now, instead of a partner, it has a friendly lender – the Commonwealth of Kentucky – and two philanthropic benefactors: a foundation controlled by CommonSpirit, and one created when the hospital was bought by the old Catholic Health Initiatives firm in 2012.

Because the hospital's main tower is estimated to have a life expectancy of only three years, U of L plans to merge Jewish with nearby University of Louisville Hospital. U of L will also own Sts. Mary and Elizabeth Hospital in south Louisville, Our Lady of Peace psychiatric hospital, Jewish Hospital Shelbyville, "four outpatient centers and a 740-employee medical group," the CJ reports. "The health system has operating losses of about $43 million a year in earnings before interest, taxes, depreciation and amortization."

"U of L will pay $10 million for the local KentuckyOne facilities and have CommonSpirit forgive a $19.7 million promissory note," Schneider reports. "The sellers, which include KentuckyOne and certain affiliates, are expected to provide $76.4 million in 'net working capital,' including accounts receivable," and the purchase price is to be adjusted if that amount is different, the CJ's Morgan Watkins reports in another story.

The two foundations "have committed a total match of $50 million toward the effort," Schneider reports. "The state is to loan U of L another $50 million," through an unusual loan from the Kentucky Economic Development Finance Authority.

The loan will be for 20 years, "with no principal payments or interest accrued for the first five years," and "is contingent on gaining the after-the-fact authorization for an additional appropriation from the fiscal 2019-20 budget with a bill prefiled at the start of the General Assembly's 2020 session," Schneider reports.

The authorization is needed because the loan amount "far exceeds the agency's maximum of $500,000," as does the length of the loan, and KEDFA "usually doesn't provide financing up front," Schneider reports. "Not all Kentucky lawmakers are on board, despite the insistence of House Speaker David Osborne, R-Prospect, that the plans have gained broad bipartisan support."

Gov. Matt Bevin "said U of L's search for an industry partner to help buy KentuckyOne's facilities led to a dead end because the prospective companies took a 'buffet' approach," Schneider reports. "They wanted to pick and choose properties they'd like to own and leave others, and that wasn't going to work, the governor said. Bendapudi acknowledged that the university's board of trustees had similar concerns about taking on a money-losing venture and turning it around."

However, a combined hospital run as "a true non-profit, not subject to the whims of the markets, should [be] less costly to operate and less pressured to post large profits, she said."

The combined operation will be huge, and the deal is "fueled by an ambitious vision to create a top-notch academic medical center," Schneider writes. "KentuckyOne's payroll is 4,539 employees and there are more than 3,100 working at U of L Hospital, for a total of 7,639. KEDFA listed full-time Kentucky resident jobs for the combined venture at 6,736. That doesn't include Hoosiers and people from other states who work at the facilities. The state list shows that between the years 2025 and 2039, the combined health system should have at least 5,880 full-time Kentucky resident jobs to meet the wage and payroll requirements."

Rule expanding definition of 'public charge' criteria to Medicaid draws fire from hospitals and advocates for immigrant families

Acting Citizenship and Immigration Director Ken Cuccinelli
announced the final rule at a White House press conference.
Adult immigrants would find it harder to remain in the United States if they signed up for Medicaid benefits, under a rule that the Department of Homeland Security finalized Aug. 12.

The rule brought "outcry from stakeholders across the health-care industry who say the policy will drive up the number of uninsured patients and increase the cost of uncompensated care," reports James Romoser of Inside Health Policy. "Immigration advocates and the California attorney general have already indicated they intend to sue to stop the so-called public-charge rule, which is scheduled to take effect Oct. 15."

The rule "is in some respects not as harsh as the proposed rule released last fall," Romoser writes. "The administration backed off its proposal to penalize immigrants who receive Medicare Part D low-income subsidies, and it also decided not to penalize immigrants who receive Medicaid while they are pregnant or under the age of 21."

Still, six major hospital lobbies said in a joint statement, “This rule could undermine access to care for legal immigrants by discouraging the use of critical public programs like Medicaid. We are concerned that this could lead to delays in care that would negatively impact the health of the communities we serve. We ask the administration to withdraw this harmful rule.” The statement came from the American Hospital Association, America’s Essential Hospitals, the Association of American Medical Colleges, the Catholic Health Association of the United States, the Children’s Hospital Association and the Federation of American Hospitals.

"The Trump administration said the rule will better enforce provisions in immigration law meant to deny permanent legal residency to any immigrant likely to become a 'public charge,' a term used for people who depend on government assistance," Romoser reports. The term has been used as a criterion since Congress passed the first immigration law in 1882.

However, the term has historically "focused on cash welfare programs, Romoser notes. "The new rule broadly expands the definition to include food stamps, housing vouchers and Medicaid. Under the rule, even a short stint on Medicaid could doom an immigrant’s chance to remain in the country legally, immigration advocates say."

Sara Rosenbaum writes for The Commonwealth Fund, "Whereas before only nursing home care counted toward public-charge status, now a host of services, from preventive care to treatment of chronic conditions like diabetes, could render someone a public charge after 12 months."

Kaiser Family Foundation chart; click on it for a larger version
Other critics fear a chilling effect on immigrants with U.S.-born children, who are citizens. "Enrolling their children in Medicaid is not supposed to trigger any penalties," Romoser reports, "but widespread fear about the rule is already causing many immigrant families to avoid seeking Medicaid or any other government assistance even for children who are U.S. citizens, stakeholders say."

"Researchers at the Georgetown University Center for Children and Families said in a May report that fears in the immigrant community contributed to a 2.2% decline in children enrolled in Medicaid and CHIP last year," Romoser notes. "In an analysis of the proposed rule, the Kaiser Family Foundation estimated that between 2.1 million and 4.9 million Medicaid and CHIP enrollees living in a household with a noncitizen would disenroll from the insurance programs."

Ken Cuccinelli, acting director of U.S. Citizenship and Immigration Services, said at a White House announcement, “President Trump’s administration is re-enforcing the ideal of self-sufficiency and personal responsibility, ensuring that immigrants are able to support themselves and become successful in America.”

Tuesday, August 13, 2019

Interactive map of DEA database makes it easy to spot major sources of pain pills in 2006-12; Ky. had No. 1, and 18 of top 100

Screenshot of Post map shows how to get individual pharmacy data. Added to screenshot are Ky. towns with pharmacies in top 100 of pain pills per person per county in 2006-12. Click on it for larger version; click here for interactive version.
Last month The Washington Post published a story and interactive map about the Drug Enforcement Administration database that reveals the distribution patterns of opioid painkillers from 2006 through 2012, when the opioid epidemic was surging. The first map showed the number of pills by county; a new map makes them easily visible by store, and the Post did a story about the data, with a list of the pharmacies that handed out the most pills per person in its county.

Shearer Drug of Albany, Ky., ranked first in the nation, dispensing 6,778,550 pills, or enough to give every person in surrounding Clinton County 96 pills a year. No. 4 was Booneville Discount Drugs in Owsley County, with 2,850,040 pills, or 86 per person per year. No. 6 was Glenn's Apothecary of Marion, with 5,171,800 pills, 80 per year for each person in Crittenden County.

Other Kentucky pharmacies in the top 50, their total pills and the amount per year for each resident of the county were: No. 16, Value-Med of Paintsville, 10,449,480, the third largest number of pills in the country (64); No. 18, Capps Pharmacy of Burkesville, 3,106,950 (64); No. 21, Hometown Pharmacy of Hyden, 4,935,500 (61); No. 22, Three Forks Apothecary of Beattyville, 3,307,670 (61); No. 25, Prescription Center of Morgantown, 5,128,760 (57); No. 26, Medicine Cabinet Pharmacy, Paintsville, 9,183,940 (56); No. 38, Mount Vernon Drug in Rockcastle County, 5,848,170 (49); and No. 42, Lyon Drug Store, Eddyville, 2,835,670 (48).

Those in the second 50, ranked by pills per person in the county, were No. 57, PEJ Inc. of Jackson in Breathitt County, 4,317,280 (43); No. 67, Rice Drugs of Beaver Dam, 6,716,610 (40); No. 75, Campton Pharmacare, 1,983,500 (39); No. 84, Weathers Drugs of Elkton, 3,227,880 (38); No. 94, Beringer Drug Center of Warsaw, 2,144,650 (37); Community Drug of Manchester, 5,691,230 (36); and No. 100, Evans Drug Co. of Fulton, 1,751,200 (36).

"While the crisis makes it clear that many of the opioids were diverted to the black market, the DEA database obtained by the Post does not track the pills after they reach the pharmacies," the newspaper reports. "There are legitimate reasons small pharmacies can have outsize volumes, including proximity to surgical centers." In Albany, Shearer Drug is next door to the building that once housed the office of former physician Michael Cummimngs; he was sentenced July 24 to 30 months in prison and fined $400,000 after pleading guilty to 13 counts of illegally prescribing controlled substances, the Clinton County News reports.

In a separate story, the Post reports that journalists in more than 30 states have published more than 90 stories based on the data, and uses an example from Pikeville: "In Kentucky, where the flow of pain pills left behind a trail of deaths from opioids, the DEA data didn’t come as a surprise to Russ Cassady, regional editor of the Appalachian News-Express. But he was still shocked by the magnitude of the figures. From 2006 to 2012, there were 66,785,120 prescription pain pills supplied to Pike County — 146 pills per person per year." Maria Sanchez Diez quotes Cassady: “We knew the numbers were bad, but it definitely gives some perspective," Cassady said. “The epicenter of the map you guys posted, the deep red counties, that’s us.” The story also notes coverage by The News Journal of Corbin and Lexington's WKYT-TV, as well as The Paintsville Herald's Aaron Nelson, which was previously reported by Kentucky Health News.

Monday, August 12, 2019

Jury awards family of Paducah nursing-home patient $2.2 million for negligence; defense attorney says the case isn't over

A jury ordered a Paducah nursing home Aug. 9 to pay more than $2.2 million in damages "for gross negligence and failure to provide proper care to a 92-year-old woman with dementia," reports Dave Thompson of The Paducah Sun.

Mary Opal Moore
Mary Opal Moore lived at Superior Care Home for "just over three months in 2014 and 2015," Thompson reports. The lawsuit by her family alleged that she received inadequate care and was evicted after she qualified for Medicaid, which generally pays less than providers' costs, and that those acts led to her death less than a month later, by accelerating her mental and physical decline.

Louisville attorney Tad Thomas told Thompson after the trial that the family took Moore to the home at a cost of more than $9,000 a month partly because it advertised a new "memory-care facility" with "specialists who knew how to care for people with dementia and Alzheimer's" disease, but the treatment was inadequate.

"She was needing more care, and at the same time the facility was going to make a lot less money," Thomas said.

The McCracken Circuit Court jury awarded $1,625,000 in punitive damages and more than $580,000 in compensatory damages for pain, suffering and medical expenses.

"Paducah attorney Eddie Jones, who represented the nursing home and its owners Helen Sims and Michael Sims, said expert witnesses testified the nursing home provided 'exceptional care,' and also disputed the idea that Moore was kicked out due to her Medicaid status," Thompson reports. "Jones said . . . the facility was attempting to transfer her to another facility's geriatric unit with her doctor's agreement."

Jones told the Sun that he expects post-trial litigation. That could include an appeal to the state Court of Appeals or a motion to set aside the verdict.

Sunday, August 11, 2019

McConnell, other senators targeted by misleading ads about legislation written to protect patients from surprise medical bills

The ad's spokeswoman criticizes a bill that she claims will help insurance companies hurt patients.
Kentuckians have been seeing lots of TV ads from a group that calls itself Doctor Patient Unity and says insurance companies are out to hurt patients by setting rates for health care. But that's a misleading description of what's going on, and the group "doesn’t list its members or disclose its funding," reports the Center for Responsive Politics, which tracks political spending.

The group, which was incorporated in Virginia on July 23, has bought at least $2.3 million in air time from late July through mid-August. Its ads are aimed at killing legislation written to reduce the amount and instances of surprise medical bills, that hit out-of-network patients "with exorbitant costs because the physician or hospital does not have a contract with the patient’s insurer," the center reports. "These unexpected bills, which can be hefty enough to bankrupt some Americans, often result from emergency room visits or ambulance rides," including expensive air ambulances.

Sen. Mitch McConnell at the Fancy Farm
Picnic (Photo by The Associated Press)
The bill "appears primed to pass the Senate," and the ads are aimed at mainly senators on the ballot in 2020, the center reports. In Kentucky, they mention Senate Majority Leader Mitch McConnell, who favors the bill, but also Sen. Rand Paul, an ophthalmologist who is up for re-election in 2022.

"Hospital and physician trade groups are opposed to the same kind of 'rate setting' mentioned in the ad as a giveaway to insurers, while insurers are eager to accuse providers of charging too much for emergency-room visits," the center notes. "Members of Congress had hoped to address surprise medical bills before the August recess but were unable to finish the job."

At issue is the proposed Lower Health Care Costs Act, a bipartisan bill that would establish the rates for reimbursement of providers for out-of-network emergency care. McConnell has said that the bill is a top priority for him.

"Doctor Patient Unity is effectively a counterbalance to the Coalition Against Surprise Medical Billing, a group publicly supported by some of the biggest insurance companies and groups, including the Blue Cross Blue Shield Association and America’s Health Insurance Plans" insurers' main lobbying group, the center reports.

"In addition to a multi-million dollar TV ad campaign, Doctor Patient Unity has also spent tens of thousands on radio ads and Facebook ads. Their Facebook ads mention numerous House members from both parties in addition to senators, urging users to contact their congressperson to “side with patients, not insurance companies.”

Saturday, August 10, 2019

Workshop offers tips to keep kids safe on farms; biggest injury-causers are falls (often from tractors), animals and machinery

By Melissa Patrick
Kentucky Health News

Growing up on a farm gives children the opportunity to play in ways that few others get to experience, and gain a set of useful skills, but agricultural safety experts caution that farm life also comes with safety challenges that all too often can result in injury or even death.

According to the National Ag Safety Database, 33 children sustain agriculture-related injuries every day, and every three days a child dies from an agriculture-related incident.

"A lot of these ag-related injuries, work-related injuries in ag, are related to the fact that children are doing work that does not match their capabilities or their abilities," youth agricultural safety specialist Marsha Salzwedel said at the Child Agricultural Injury Prevention Workshop in Lexington Aug. 6-7.

The three most common causes of non-fatal injuries are falls, animals and machinery, such as tractors; and the top three causes of fatal injuries are machinery, other vehicles and drowning.

Salzwedel, of the National Children's Center for Rural and Agricultural Health and Safety, added that advances in technology are changing the types of farm injuries found in children. She told the story of a child who lost an eye after being hit by a drone.

Page from guidelines book; for a larger version, click on the image.
Salzwedel suggested that parents use the Agricultural Youth Work Guidelines to help determine whether a youth has the physical and cognitive abilities to safely perform a job.

The guidelines have a checklist for 51 ag-related jobs detailing what youth between 7 and 16 need to perform a job safely. The list also gives adult responsibilities, suggestions for the level of adult supervision, and hazards and protective strategies.

Salzwedel noted that tractors are the leading cause of fatalities for youth and children, but added that all-terrain vehicles and skid-steer loaders "are coming up fast behind them."

The National Children's Center for Rural and Agricultural Health and Safety reports that tractors are responsible for more than 40% of unintentional farm-injury deaths of children under 15. It also reports that four out of five farm children regularly ride on them.

Tractors are notorious for turning over, but CultivateSafety.org says there are many ways a rider can fall and be injured while riding on a tractor, including "sudden stops, driving over holes, stumps and debris, or a sharp turn." It adds that tractors with cabs are no guarantee of injury prevention, because children have fallen out cabs after hitting a door than then opened.

The Childhood Agricultural Safety Network, a 60-member coalition that includes the American Farm Bureau Federation, has launched a "Keep Kids Away from Tractors" campaign with the message: "It's easier to bury a tradition than a child."

Dennis Murphy, a professor emeritus at Penn State University, said ATVs present a number of safety challenges when it comes to keeping kids safe on farms. For example, he noted that all too often young children are at risk of getting hurt on them because they are driving a machine that is too big for them, riding with passengers, not wearing helmets, operating on paved roads, which they are not designed for, or driving on slopes and uneven ground.

He added that a recent survey shows that upwards of 90% of youth say they drive an adult-sized machine and that another study found that 90% of kids have never received any training on ATV use.

Murphy also noted that 60% of child ag-related injuries happen to children who are not working, including infants, toddlers and pre-schoolers. He stressed that "childcare is the best option" to keep children safe on farms, but said when this isn't possible it's important to provide a "safe play area."

The National Children's Center for Rural and Agricultural Health and Safety offers an online book that shows how to create safe play areas on farms. Suggestions include making sure the area has designated physical boundaries and is away from traffic and machinery; age-appropriate equipment for the children using it; and competent supervision.

Several speakers noted that some obstacles to a safer farming culture for children is that parents and farm supervisors often underestimate the risk of injury or assume that decisions about safety are "obvious" or are "common sense," and believe "It will happen to someone else."

Joe Grzywacz, a Florida State University professor who has researched immigrant farmworkers and their families, told the workshop attendees, "Families don't think of this as an occupational risk; they are thinking about this as . . . this is the way we live our lives."

Friday, August 9, 2019

FDA probes 127 reports of seizures or other neurological symptoms possibly related to e-cigarettes, asks for more reports

By Melissa Patrick
Kentucky Health News

The U.S. Food and Drug Administration is investigating 127 reports of seizures, tremors, fainting or other neurological symptoms that may be related to electronic cigarettes, and is asking people to report if they have such symptoms, the agency announced Aug. 7.

Photo from Healthline 
"The FDA is continuing its scientific investigation to determine if there's a direct relationship between the use of e-cigarettes and a risk of seizure or other neurological symptoms," Dr. Ned Sharpless, the acting FDA commissioner, said in a news release.

"We still don't have enough information to determine if e-cigarettes are causing these reported incidents," which occurred from 2010 to 2019. Sharpless said. He strongly encouraged the public to continue submitting new or follow-up reports with as much detail as possible.

"Additional reports or more detailed information about these incidents are vital to help inform our analysis and may help us identify common risk factors and determine whether any specific e-cigarette product attributes, such as nicotine content or formulation, may be more likely to contribute to seizures," Sharpless said.

The release notes that users can report any unexpected health or product issues experienced with e-cigarettes or any other tobacco products through its Safety Reporting Portal. The FDA wants all submissions to include detailed information such as the brand name; whether the product had been modified in any way; if any other tobacco products, medications or substances were being used at the same time; underlying medical conditions; and usage patterns.

When the FDA announced its investigation in April, it noted that varying levels of nicotine concentration in e-cigarettes could have contributed to some of the cases. Since then, the agency has received about 92 new reports of people experiencing seizures after vaping.

E-cigarette liquids contain high concentrations of nicotine. For example, one pod made by Juul Labs has as much nicotine as a whole pack of cigarettes. Juuls are one of the most popular e-cigarette brands with teens, largely because they look like an oversized computer flash drive, are easy to conceal and come with flavorings.

Symptoms of nicotine poisoning include nausea, vomiting, dizziness, tremors, sweating and quickened heart rate.  In severe cases, nicotine poisoning can cause seizures and death, according to the National Capital Poison Center.

Kentucky teens are using e-cigarettes at alarming rates, with use nearly doubling from 2016 to 2018. Kentucky's high-school seniors report the highest use, with 27% reporting in 2018 that they had tried the product, according to the Kentucky Incentives for Prevention survey. 

Kentucky is aggressively working to curb teen use of these products. The legislature this year passed a new law to ban the use of tobacco products in all Kentucky public schools, effective next school year (with a local opt-out), and the Foundation for a Healthy Kentucky has sponsored a social media campaign to warn youth and educate adults about the dangers of these products.

Kentucky lawmakers plan to pre-file a  bill for the 2020 legislative session to tax electronic cigarettes just like other tobacco products as a way to curb youth use.  At the federal level, U.S. Sen. Mitch McConnell has a bill to raise the legal age to buy tobacco products to 21 nationwide.