Friday, 14 March 2014

Princess Health and Princess Health andRogers, other drug-caucus chair file bill to reverse FDA's approval of new painkiller; competing company has alternative.Princessiccia

Illustration from PainAndDepression.com
U.S. Reps. Hal Rogers of Somerset and Stephen Lynch of Massachusetts have introduced a bill to withdraw federal approval of a new formulation of hydrocodone that is highly addictive and produced in crushable pills, which they say threatens to start a new wave of prescription drug abuse. They are the Republican and Democratic co-chairs, respectively, of the Congressional Caucus on Prescription Drug Abuse.

But the Food and Drug Administration might act against Zohydro ER on its own, because Purdue Pharma LP has completed testing of a competing, non-crushable drug and will ask for "a priority review that would cut two to three months off the 10 months the agency sets as a goal to examine applications" for regulatory approval, Drew Armstrong of Bloomberg News reports. "Purdue�s pill is hard to crush and snort or inject."

That is important to the FDA. �If and when they, or another manufacturer, are able to create an abuse-deterrent formulation that remains safe and effective for patients, we would certainly give serious consideration to assuring that any non-abuse formulations are removed from the market,� FDA pain-drug director Bob Rappaport said in his Oct. 25 review of Zohydro�s approval.

Zohydro ER is an extended-release hydrocodone medication made by Zogenix Inc. for patients who need round-the-clock, long-term pain treatment and have found other treatments to be inadequate. Unlike recent formulations of the popular painkillers OxyContin and Opana, is not crush-resistant, but the company has said it is working on a crush-resistant version.

Citing concerns about abuse, the FDA's scientific advisory panel voted 11-2 against approving Zohydro ER, and a coalition of more than 40 health, consumer and other organizations urged the FDA to revoke its approval. Attorney General Jack Conway was among 28 attorneys general who sent the FDA a letter asking it to reconsider. Sen. Joe Manchin, D-W.Va., has introduced a companion bill to the one filed by Rogers and Lynch.

Hal Rogers (Associated Press photo)
Rogers said in a press release, "�While the FDA continues to send mixed signals to drug companies about the need to invest in abuse deterrent technologies, the Act to Ban Zohydro will make it abundantly clear � life saving measures are critical to the development of powerful painkillers like Zohydro. . . . In Southern and Eastern Kentucky, we lost nearly an entire generation when crushable OxyContin was first prescribed, and I fear this crushable, pure hydrocodone pill will take us backwards with a new wave of addiction and tragic, untimely deaths."

Kentucky ranks third in the nation for overdose deaths, with more than 1,000 Kentuckians dying each year from prescription drug overdoses. The number has leveled off following passage of laws that target pill-pushing clinics and doctors, and put stricter regulations on painkillers.

Zogenix has said it is committed to exceeding FDA requirements to make sure the drug is used appropriately, will monitor for misuse, and will allow an outside group to monitor and analyze its data. It noted that Zohydro ER will be regulated as a Schedule II drug, which means it can only be dispensed through a physician�s written prescription, with no refills, and does not contain acetaminophen, longtime use of which can cause liver failure.

Princess Health and Princess Health andHospitals try to do more with less while not compromising quality as they adjust to changes in the health-care marketplace.Princessiccia

A. B. Chandler Medical Center at the University of Kentucky
Hospitals are laying off employees and cutting budgets because of changes in the marketplace and the ways consumers seek care, Editor Mark Green reports in an in-depth article for The Lane Report.

Now that consumers are paying more direct costs, they are paying more attention to prices and more likely to use out-patient procedures, which are cheaper, Green writes. Also, consumers are increasingly using wellness programs to avoid health problems, and "Taxpayer-funded government compensation models are making better medical outcomes and financial efficiency important bottom-line issues."

Less inpatient treatment means fewer employees are needed at Kentucky hospitals, but not all are financially burdened, Green reports; those who provide the best service at the least cost are increasingly reaping the profits.

While the Patient Protection and Affordable Care Act may make care more affordable, it also "puts pressure on health-care providers to keep costs in check,� Carl Herde, chief financial officer for Baptist Health, told Green. �However, many of the issues facing health care were in place before the ACA came into effect.�

Dr. Michael Karpf, administrator of UK HealthCare since 2003, told Green that hospitals are adjusting from a model that was based on volume to one that is based on value. Karpf has said for years that the "health-care industry is on an unsustainable financial course."

�There is a real need to decrease utilization to get healthcare costs under control. It just puts pressure on institutions,� Karpf told Green. �We won�t be doing business the same old-fashioned way we�ve been doing it.�

Some hospitals are still showing a healthy profit, but are also cutting costs and looking for increased efficiency, like UK HealthCare, whose $920 million hospital budget is producing a seven to eight percent cash flow, Green reports. But KentuckyOneHealth expects a $218 million deficit in its $2.5 billion budget, laid off 500 of its 15,000 workers last month, says that it won't fill 200 openings and will close the emergency room at Medical Center Jewish Northeast in Louisville on April 1. The company told Green that it might close an entire hospital, without telling which one.

KentuckyOne CEO Ruth Brinkley told Green, �The recession has come to health care, and that is causing the industry to transform. There are many causes for the changes, among them: the economy, reduced payments from government and commercial payers, increasing consumerism, and shifts in how care is organized and delivered. We have seen large and respected healthcare organizations announcing restructuring, budget cuts and layoffs. Among them are Vanderbilt University Medical Center and Cleveland Clinic. This situation is even more acute in Kentucky, with steep declines in inpatient volumes.�

Baptist Health, a Louisville-based system that has the most hospital beds in Kentucky, had a $22 million operating loss in fiscal 2013, but $78 million in investment income erased that deficit, Herde told Green: �There is increasing pressure for hospitals to do more with less without sacrificing quality, so we are exploring creative ways to contain costs, but we are financially sound now � and we are confident that we will remain so in the future.�

Owensboro Health's hospital (HGA.com photo)
When the state turned management of Medicaid over to insurance companies, that created higher administrative costs for hospitals, said John Hackbarth, chief financial officer for Owensboro Health, which in 2013 opened a $385 million medical center.

�After movement to a managed-care model, we have five insurance plans, plus some patients remaining on Kentucky Medicaid indemnity,� Hackbarth said. �This has increased costs in many areas such as contracting, compliance, billing, IT and case management because we are dealing with five times the amount of rules and hoops to jump through for a slower payment and ultimately less reimbursement.�

State officials say the expansion of Medicaid under health reform, to those with incomes up to 138 percent of the federal poverty level, is forecast to bring Kentucky providers an extra $15 billion for care and create 17,000 new jobs. But not yet.

Green reports that the most common response from five major hospital operators was that "Medicaid expansion eventually should lower their annual charity care and bad-debt burden, which is hundreds of millions of dollars." But first they are focused on adjusting their services to meet an increased demand for care by the formerly uninsured.

The Louisville region's biggest provider, non-profit Norton Healthcare expects that when the federal subsidy for expanded Medicaid is reduced, to 90 percent, the state will have to cut the number of Medicaid enrollees or reimbursements to providers. The reform law's overall impact to date, Gough said, is �decreases in Medicare reimbursements.�

Princess Health and Food Reward Friday. Princessiccia

This week's lucky "winner"... the Taco Bell waffle taco!!


Read more �

Thursday, 13 March 2014

Princess Health and Princess Health andPoll: Kentuckians who report excellent or very good sidewalks and road shoulders are more likely to be physically active.Princessiccia

Princess Health and Princess Health andPoll: Kentuckians who report excellent or very good sidewalks and road shoulders are more likely to be physically active.Princessiccia

Kentucky adults who ranked their neighborhood sidewalks and road shoulders as excellent or very good are more likely to be physically active, but only 26 percent of Kentuckians rank them that highly, according to the latest Kentucky Health Issues Poll.

"Adults who report excellent or very good neighborhood sidewalks/shoulders are more likely to report being very or somewhat physically active (84 percent) than residents who report fair to poor sidewalk/shoulder conditions (74 percent)," says a press release from the Foundation for a Healthy Kentucky, which sponsors the poll with Interact for Health, formerly the Health Foundation of Greater Cincinnati.

"This finding stresses the impact of environment on activity choices," Susan Zepeda, president and CEO of the foundation, said in the release.

Despite the relatively poor rating for sidewalks and shoulders, more than half of those surveyed said their neighborhoods are excellent or very good locations to walk, jog, or bike.

Of those whose incomes are at or below 200 percent of the federal poverty threshold, 74 percent said they feel somewhat or very safe being physically active outside in their neighborhoods, but only 45 percent reported walking, jogging, and biking conditions as excellent or very good.

Only 11.9 percent of Appalachian Kentuckians rated their sidewalks and shoulders as excellent or very good. The poll defines Appalachian Kentucky as the 46 counties in the Big Sandy, Buffalo Trace, Cumberland Valley, Fivco, Gateway, Kentucky River and Lake Cumberland area development districts. Just 18.9 percent of Western Kentucky residents rated their sidewalks and shoulders as excellent or very good.

To see the full geographic breakouts, click here.

Wednesday, 12 March 2014

Princess Health and Princess Health andWith smoking ban dead for this year, its Senate sponsor holds a last-ditch discussion as she looks to another office.Princessiccia

By Melissa Patrick
Kentucky Health News

Republican Sen. Julie Denton, sponsor of the Senate bill for a statewide smoking ban, held a last-ditch discussion Wednesday with the committee she chairs about why Kentucky needs such a law.

It was a discussion with no action possible because Senate President Robert Stivers, R-Manchester, who opposes Senate Bill 117, assigned it to the Judiciary Committee, of which he is a member, instead of the Health and Welfare Committee, headed by Denton, who is running for the Louisville Metro Council rather than re-election.

A frustrated Denton opened the discussion with personal stories about growing up with a grandfather who smoked heavily and the effects this has had on her father who has asthma and frequent respiratory infections. She said her daughter, who has asthma, cannot tolerate exposure to any smoke.

Denton (Legislative Research Commission photo)
"This is a public health issue, not about personal rights," Denton argued.

She said governments infringe on personal liberties "all the time" to support public health. She gave examples of speed-limit laws, seat-belt laws, laws that prohibit texting while driving, laws that prohibit drinking and driving, building codes and car-seat law requirements.

"To say this is different than all the others is disingenuous," she said.

As for the argument that non-smokers did not have to enter establishments that allow smoking, she said that is not an option for many who work in places that allow smoking: "People can't afford to just go to another job."

Denton said if the bill had been sent to her committee it would have been sent to the full Senate for a vote, but "Politics is standing in the way." Not only is Stivers against it, leaders of the House's Democratic majority blocked a vote on the House smoking-ban bill, citing members' concerns about political repercussions in the fall elections, when Republicans hope to take over the House.

Democratic Sen. Julian Carroll, a former governor, commended Denton, saying her comments were both "relevant and very important."

Carroll said "I am strongly in support of this bill" because of the cost Kentucky pays for people who smoke. He said the current state budget spends $9.5 billion on health care, and smoking is a strong contributor to that number.

Ashli Watts of the Kentucky Chamber of Commerce said smoking costs Kentucky $1.5 billion every year, creates work absenteeism, raises tax and insurance costs and is bankrupting the state. She said more than 90 percent of Chamber members in a 2013 survey supported a ban, and it is time to join the other 24 states with such laws.

Dr. Sylvia Cerel-Suhl of the American Heart Association gave a long list of reasons to support the bill. "There is no longer any debate that second hand smoke causes death," she said, adding later, "Just in Kentucky, we are losing 1,000 people a year to secondhand smoke." Sherri Irwin of the Kentucky Rural Health Association cited the same number.

Smoke-Free Kentucky map; click on it for larger version
As a parting suggestion, Denton said Kentucky might consider allowing local governments to opt out of a statewide ban. Dozens of localities have bans, thought some have significant exemptions.

Denton acknowledged a collective frustration in the committee and said, "I won't be here next year; hopefully, you all will push through."

Sen. Reginald Thomas, D-Lexington said, "Perseverance does pay off. We will make this bill law one of these days."
Princess Health and Princess Health andSenate OKs bill to fund pediatric cancer and autism research.Princessiccia

Princess Health and Princess Health andSenate OKs bill to fund pediatric cancer and autism research.Princessiccia

With the backing of Republican Leader Mitch McConnell, the U.S. Senate has passed a bill designed to assist in funding research of pediatric cancer and autism, funded by money now used to pay for presidential campaigns and party conventions.

The proposed Gabriella Miller Kids First Research Act authorizes $12.6 million a year for 10 years, McConnell press secretary Robert Steurer said in an email.

McConnell's likely Democratic opponent in the November election, Secretary of State Alison Lundergan Grimes, said he delayed passage of the bill, but McConnell's office blamed Democratic objections.

McConnell said in a floor speech, "As a survivor of polio as a child, I have always empathized with children battling life-threatening or disabling disorders," and it is "about time" this bill passed. It goes to President Barack Obama for his signature, reports Joseph Gerth of The Courier-Journal.

Grimes found fault with McConnell's written reply to an inquiry about the bill, telling the constituent he would "keep your support in mind." Gerth reports,  "McConnell's Senate office on Tuesday said that the Senate Republican Caucus had agreed to unanimously support the measure on Jan. 7."

Princess Health and Princess Health andStudents in 2 Appalachian Ohio high schools help reduce classmates' consumption of sugary drinks, a bane in the region.Princessiccia

In a region where sweet-tea and soda is more popular than water, student-led groups in Appalachian Ohio were successful in reducing the amount of sugary drinks students consumed, reports The Ohio State University's Center for Clinical and Translational Science.

As part of the study, student-led teen advisory councils in the two Southern Ohio high schools implemented a 30-day intervention called "Sodabriety" to reduce the amount of sugary drinks students consumed. Results of the study were published in the March issue of the Journal of School Health.

The councils informed students about the risks of sugary drinks, put green ribbons on students' cars to remind them of the dangers, offered daily "sugar facts" during the morning announcements, performed soda-themed rap songs at student events and gave away water bottles with a "What's in your cup?" slogan.

The efforts paid off. Not only did some teens completely give up sugared drinks, but water consumption nearly doubled. Some students even reported weight loss, less acne and increased energy, Smith said.

A typical 20-ounce soda contains 15 to 18 teaspoons of sugar and upwards of 240 calories. A 64-ounce fountain cola drink could have up to 700 calories, says a fact sheet from the Harvard School of Public Health.

Kentucky high-school students rank third in the U.S. in obesity, with 33.4 percent overweight or obese, according to the federal Centers for Disease Control and Prevention. Consumption of sugary beverages is a problem in Appalachia, where obesity contributes heavily to the region's health issues.

�Teens who grow up in this region are ultimately more likely to die from cancer, diabetes and heart disease than any other place in the nation, and obesity is the common risk factor for all of those illnesses,� said nurse Laureen Smith, one of the researchers. �A child�s odds of becoming obese increases almost two times with each additional daily serving of a sugar sweetened drink, and Appalachian kids drink more of these types of beverages than kids in other parts of the country.�

Smith added, �Sugar sweetened beverages are the largest source of sugar in the American diet. For some teens, they account for almost one-third of daily caloric intake, and that amount is even higher among Appalachian adolescents. If we can help teens reduce sugared-beverage intake now, we might be able to help them avoid obesity and other diseases later in life.�