Princess Health and AMA, led by Ky. doctor, says gun violence is public-health crisis; calls for research, background checks, waiting periods for all guns. Princessiccia

Princess Health and AMA, led by Ky. doctor, says gun violence is public-health crisis; calls for research, background checks, waiting periods for all guns. Princessiccia

Congress doctors guns lobbying physicians

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The American Medical Association, led by a Kentucky emergency-room physician, declared gun violence a public-health crisis last week and endorsed waiting periods an background checks for purchases of all firearms, not just handguns.

"The AMA, the country's largest doctor group, also vowed to lobby Congress to overturn a decades-old ban on gun violence research by the Centers for Disease Control and Prevention," two days after the Orlando shooting that left 49 dead and 53 wounded, reports Kimberly Leonard of U.S. News and World Report. "The AMA joins the American College of Physicians in its position, which has been calling gun violence an epidemic since 1995."

Dr. Steven Stack

AMA President Steven Stack of Lexington said the research "is vital so physicians and other health providers, law enforcement and society at large may be able to prevent injury, death and other harms to society resulting from firearms. . . . With approximately 30,000 men, women and children dying each year at the barrel of a gun in elementary schools, movie theaters, workplaces, houses of worship and on live television, the United States faces a public-health crisis of gun violence."

Leonard notes, "Federal law doesn't technically outlaw the CDC from studying gun violence, but prohibits the agency from using federal dollars to advocate or promote gun control. Though President Barack Obama lifted the research ban through executive order nearly three years ago, Congress has blocked funding for these studies."

The National Rifle Association has called the public-health approach a back-door path to more gun control, Leonard writes, and "has said that doctors shouldn't be asking patients about gun ownership because they are not gun safety experts."

"Who will Congress listen to now: the healers or the merchants of death?" Lexington Herald-Leader columnist Tom Eblen asked to start his Sunday column. "The AMA's stand is unlikely to change anyone�s mind about gun control. But it underscores the absurdity of Congress� two-decade effort to block legitimate scientific research that could reduce gun deaths and injury."

Suicides accounted for about two-thirds of the 33,390 firearms deaths in the U.S. in 2014. The CDC "said 627 people were killed in Kentucky that year with firearms, a rate of 13.8 per 100,000 population, higher than the national average of 10.2," Eblen reports. He said research on gun violence could reduce those figures, just as research into auto accidents has reduced such fatalities.

Read more here: http://www.kentucky.com/news/local/news-columns-blogs/tom-eblen/article84482382.html#storylink=cpy

Read more here: http://www.kentucky.com/news/local/news-columns-blogs/tom-eblen/article84482382.html#storylink=cpy

Princess Health and Obama asks public to tell Congress to fund the $1.9 billion Zika fight he wants; Senate passed $1.1 billion, House $622 million. Princessiccia

Princess Health and Obama asks public to tell Congress to fund the $1.9 billion Zika fight he wants; Senate passed $1.1 billion, House $622 million. Princessiccia

birth defects Congress federal spending infectious diseases insects mosquitoes politics research vaccines viral infections

Gusty 12:14 Add Comment

The Zika funding package of Appropriations Committee Chair Hal Rogers and other House Republicans "doesn't make a lot of sense" and the somewhat larger Senate package backed by Majority Leader Mitch McConnell and a bipartisan Senate majority falls well short of what is needed, President Obama told reporters Friday.

The Senate has passed a $1.1 billion package and the House approved $622 million. Obama wants more than three times the House figure, $1.9 billion, to fight the virus that causes a serious birth defect.

"We didn�t just choose the $1.9 billion from the top of our heads," Obama said. "This was based on public-health assessments of all the work that needs to be done. And to the extent that we want to be able to feel safe and secure, and families who are of childbearing years want to feel as if they can have confidence that when they travel, when they want to start a family that this is not an issue -- to the extent that that's something that we think is important, then this is a pretty modest investment for us to get those assurances."

Obama said the House package is not only inadequate, "That money is taken from the fund that we're currently using to continue to monitor and fight against Ebola. So, effectively, there�s no new money there. All that the House has done is said, you can rob Peter to pay Paul. And given that I have, at least, pretty vivid memories of how concerned people were about Ebola, the notion that we would stop monitoring as effectively and dealing with Ebola in order to deal with Zika doesn�t make a lot of sense."

The president added, "This is something that is solvable. It is not something that we have to panic about, but it is something we have to take seriously. And if we make a modest investment on the front end, then this is going to be a problem that we don't have to deal with on the back end." He said each child who has a small brain as a result of Zika "may end up costing up to $10 million over the lifetime of that child in terms of that family providing that child the support that they need. . . .  It doesn�t take a lot of cases for you to get to $1.9 billion. Why wouldn't we want to make that investment now?"

Part of the money would go to develop a vaccine for Zika, and part of that work is going on at the University of Kentucky. "You don't get a vaccine overnight," Obama said. "You have to test it to make sure that any potential vaccine is safe. Then you have to test to make sure that it's effective. You have to conduct trials where you're testing it on a large enough bunch of people that you can make scientific determinations that it's effective. So we've got to get moving."

Obama said the Centers for Disease Control and Prevention and the National Institutes of Health are "taking pots of money from other things -- universal flu funds or Ebola funds or other funds -- just to get the thing rolling. But we have to reimburse those pots of money that have already been depleted and we have to be able to sustain the work that�s going to need to be done to finish the job. So, bottom line is, Congress . . . needs to get me a bill that has sufficient funds to do the job."

The president said that should happen before the summer congressional recess in August, "to provide confidence to the American people that we're handling this piece of business." He said the money would be insurance for young families or couples thinking about having children.

"To the extent that we're not handling this thing on the front end, we're going to have bigger problems on the back end," Obama said. "Tell your members of Congress, get on the job on this. This is something we can handle. We should have confidence in our ability to take care of it. We've got outstanding scientists and researchers who are in the process of getting this done, but they�ve got to have the support from the public in order for us to accomplish our goal."

Princess Health and Rogers says House Republicans want $622 million for Zika; McConnell, Senate plan $1.1 billion; Obama wants $1.9 billion. Princessiccia

Princess Health and Rogers says House Republicans want $622 million for Zika; McConnell, Senate plan $1.1 billion; Obama wants $1.9 billion. Princessiccia

Congress epidemic federal spending infectious diseases

Gusty 19:13 Add Comment

UPDATE, May 16: The Republican package totals $622 million. May 17: Obama calls that "woefully inadequate," says he would veto it.

House Republicans' funding to fight the Zika virus will be about half the $1.9 billion President Obama requested, but still "adequate," U.S. Rep. Hal Rogers of Kentucky's Fifth District, chair of the House Appropriations Committee, said Friday.

Dierdre Walsh and Ted Barrett report for CNN, "Ever since they sent the request to Capitol Hill, the White House has complained that Republicans are ignoring a public health crisis and need to sign off on more money soon, especially before the potential risks from the mosquito-borne virus increase with the summer months."

Rogers told reporters the bill he plans to introduce Monday will provide "less than a billion" for Zika but will be "adequate funding to face the problem." Also, "the money will be targeted for agencies to spend right away," Walsh and Barrett report. Rogers said the House could vote on the bill as early as Wednesday, May 18.

"Rogers and other congressional Republicans said they hadn't acted before now because the Obama administration wasn't giving Congress the details on how they would spend" the money, CNN reports, "and they were working through their own analysis on how much the various agencies needed to deal with the immediate needs. House conservatives also demanded that any new money for Zika needs to be paid for with cuts to other programs."

His bill is "fully offset" with cuts, Rogers said, but he declined to say where, "saying his committee was still finalizing those details," CNN reports. "But the White House and congressional Democrats argue in these cases Congress doesn't traditionally specify cuts to pay for additional funding. An unnamed Democratic aide on the appropriations staff told the network, "We don't offset emergency funding, period. And this is the definition of a public health emergency."

Meanwhile, Senate Majority Leader Mitch McConnell, R-Ky., and Democrats in that chamber "worked out a bipartisan $1.1 billion Zika proposal that they plan to attach to a separate spending bill" and scheduled it for a vote Tuesday, May 17, CNN reports. "The Senate will also vote on two competing proposals -- one from the two Florida senators, Bill Nelson, a Democrat, and Marco Rubio, a Republican. It would fully fund the President's request. The second is from Sen. John Cornyn, R-Texas, that would provide about $1 billion and be offset with cuts elsewhere. Those last two proposals are not expected to pass."

Princess Health and Insurance commissioner sues contractor for failed Kentucky Health Cooperative, alleging gross negligence in handling claims. Princessiccia

Princess Health and Insurance commissioner sues contractor for failed Kentucky Health Cooperative, alleging gross negligence in handling claims. Princessiccia

Congress courts health insurance health reform obamacare politics state government

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State Insurance Commissioner Brian Maynard, acting as liquidator of the failed Kentucky Health Cooperative, filed suit in Franklin Circuit Court Friday against against the company that the co-op hired to process and pay claims. The suit contends that CGI Technologies and Solutions Inc. was "grossly negligent" in processing and paying claims and thus breached its contract.

The co-op, created by federal health reform to compete with insurance companies and hold down premium costs, had financial problems from the start. This year Republicans accused former Gov. Steve Beshear, a Democrat who embraced health reform, of holding down co-op premiums to make the reforms look good. Beshear denied the charge.

The co-op announced in October 2015 that it would close because Congress did not provide sufficient "risk corridor" payments to insurers with disproportionately sick policyholders and the Obama administration was unwilling or unable to make up the difference. The co-op, which had a deficit of $50 million in 2014, was expecting a risk-corridor payment of $77 million but got only $9.7 million. Most other co-ops also failed.

�We have a duty to investigate the causes of the co-op�s collapse and to hold responsible those individuals who caused the collapse,� Maynard said in a press release. �This includes recovering funds from responsible parties so that the doctors, nurses, and hospitals that treated Kentuckians insured by the co-op are fairly compensated for their services.�

Thousands of patients and thousands of providers will have to wait until Oct. 15 or later to find out how much of their medical bills sent to the co-op will be paid, Kentucky Health News reported in February. The co-op "left thousands of providers waiting for payment," Stephanie Armour reported for The Wall Street Journal. It covered about 51,000 people through the end of 2015. Franklin Circuit Judge Phillip Shepherd will decide how much will be paid to whom.

Princess Health and Zika update: Local anti-mosquito action needed; McConnell, Rogers at center of debate over Obama's request for more funds. Princessiccia

Princess Health and Zika update: Local anti-mosquito action needed; McConnell, Rogers at center of debate over Obama's request for more funds. Princessiccia

birth defects Congress federal spending mosquitoes pregnancy prevention public health virus

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Mosquitoes can carry Zika. (NPR photo)

By Melissa Patrick
Kentucky Health News

While all 388 Zika virus cases confirmed in the continental U.S., including six in Kentucky, have been in people who were infected abroad and then returned to the states, a health official said on "Fox News Sunday" that it is likely the U.S. will have its own outbreak.

"It is likely we will have what is called a local outbreak," said Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, Diane Bartz reports for Reuters.

Fauci said he did not expect a large number of people to become ill: "We're talking about scores of cases, dozens of cases, at most."

Dr. Ardis Hoven, infectious disease specialist for the Kentucky Department for Public Health, agreed and said the potential exists for Kentucky to have a local outbreak.

"I think it would be unreasonable for us to assume that we would not be at risk," she said in a telephone interview. "So therefore, we have to plan accordingly."

Hoven said mosquito control in the state is a "top priority," but said the bulk of this will have to happen at a local level.

She encouraged Kentuckians to talk about mosquito prevention with their friends and family and ask themselves, "What can I do in my community, in my yard, on my street to prevent mosquitoes from hatching and infecting those around me?"

Zika virus prevention strategy: Dress, Defend and Drain

The state has adopted a "3 D" approach to decrease the risk of infection by mosquitoes: Dress in light-colored long sleeved shirts and pants; Defend against mosquitoes with approved insect repellents; and Drain all standing water.

"If we can control mosquitoes in our region, we will go a long way to minimize the potential risk from infected mosquitoes," Hoven said.

The World Health Organization declared Zika a global health emergency in February. Those who have traveled to affected areas, such as Central and South America, are at the highest risk of contracting the virus, which is spread primarily by infected Aedes aegypti mosquito. It can also be spread through sexual intercourse. Aedes aegypti can be found in about 30 U.S. states, including Kentucky.

Zika virus is especially dangerous to pregnant women because it has been linked to thousands of cases of microcephaly, a condition where the infants head is smaller than normal, as well as other severe fetal brain defects, according to the federal Centers for Disease Control and Prevention. The state health department has reported that one of the confirmed Zika cases in the state is a pregnant woman.

The CDC is investigating the link between Guillain-Barre syndrome, a rare disorder in which the body's immune system attacks its nerves. And Fauci said there could be other neurological conditions caused by Zika that affect adults, Bartz reports.

"There are only individual case reports of significant neurological damage to people, not just the fetuses, but an adult that would get infected. Things that they call meningoencephalitis, which is an inflammation of the brain and the covering around the brain, spinal cord damage due to what we call myelitis," Fauci said. "So far they look unusual, but at least we've seen them and that's concerning."

Common symptoms of the virus are fever, rash, joint pain and red eyes, with symptoms lasting for about a week, though many with the virus have no symptoms. Currently there is no vaccine for Zika.

Funding to fight Zika held up in Congress

In February, President Obama asked Congress for an additional $1.9 billion in emergency funds to fight the Zika virus, including funds to develop a vaccine. This is in addition to $589 million in previously appropriated funds that have already been transferred to the effort.

That money should last through Sept. 30, the end of the federal fiscal year, but "There's going to need to be additional money, I don't think there's any doubt about that," Rep. Tom Cole, R-Okla., who chairs the House health appropriations subcommittee, told Susan Cornwell of Reuters April 13.

Top senators from both parties said "they are getting close to a deal to provide at least some emergency funding to fight the Zika virus, making it likely that the Senate will move ahead on the issue without waiting for the House," David Nather writes for STAT, an online health journal.

Senate Majority Leader Mitch McConnell, R-Ky., said at a news conference April 19 that congressional Republicans were working with the administration on the funding details, Peter Sullivan reports for The Hill.

�We're working with them on it to figure out exactly the right amount of money,� McConnell said at a press conference. �You know, how is it going to be spent? And I don't think, in the end, there will be any opposition to addressing what we think is going to be a fairly significant public health crisis."

Nevertheless, House Republicans kept saying they don't have enough information to approve the request.

On April 20, House Appropriations Committee Chairman Hal Rogers, R-Ky., said the Obama administration �continues to delay response efforts by refusing to provide basic budgetary information to Congress on their Zika funding request. This includes not answering our most basic question: �What is needed, right now, over the next 5 months in fiscal year 2016, to fight this disease?� In the absence of this information, the House Appropriations Committee will work with our colleagues in the House and the Senate to make our own determinations on what is needed and when, and to provide the funding that we believe is necessary and responsible.�

Five days earlier, White House Press Secretary Josh Earnest said Republicans have all the information they need to move forward, ABC reports. He said, �They've had ample opportunity to collect information, to ask questions of senior administration officials, to read letters, to read the legislative proposal that was put forward by the administration.� 

Princess Health and Rural drug-overdose rates, high in Kentucky, blamed partly on limits on treatment medication and mental-health services. Princessiccia

Princess Health and Rural drug-overdose rates, high in Kentucky, blamed partly on limits on treatment medication and mental-health services. Princessiccia

Appalachia behavioral health Congress drug abuse drugs health rankings mental health

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"People in rural areas of Appalachia are more likely to die early deaths than in other parts of the country," and a big reason is that they "die from drug overdoses at greater rates than the rest of the country," writes Kery Murakami, the Washington, D.C., reporter for Community Newspaper Holdings Inc.'s CNHI News Service.

Murakami notes that in Leslie County, Kentucky, 7.9 of every 10,000 residents overdosed each year in 2012-14. "That�s six times the national rate," and third in the nation, he writes, citing the annual County Health Rankings done for the Robert Wood Johnson Foundation by the University of Wisconsin Population Health Institute. Several other Appalachian counties in Kentucky and West Virginia rank high.

The rates are high partly because "addicts in some parts of the country get turned away by doctors and are not given a drug called buprenorphine that is used to kick opioid addictions," Murakami reports, citing addiction experts. "Buprenorphine causes less euphoria and physical dependence and can ease withdrawal and cravings."

However, "Federal law caps the number of patients to whom a doctor is allowed to prescribe the drug, out of concern of creating places where large numbers of addicts receive opioid-based medication. Such treatment hubs, much like methadone clinics, bring unwanted community opposition, said Mark Parrino, president of the American Association for the Treatment of Opioid Dependence. That limits treatment choices in rural areas, where one doctor might be the only one licensed to prescribe buprenorphine for hundreds of miles."

The Department of Health and Human Services is moving to ease the limits, and Sens. Ed Markey, D-Mass., and Rand Paul, R-Ky., want to go even further. "But some addiction experts are concerned that raising the caps on buprenorphine will nudge the country toward treating addiction with medication rather than counseling, Murakami reports. The department�s proposed rules would require mental-health care, which is often hard to get in rural areas. The senators� bill would not.

�Turning people away from the most evidence-based treatment we have for a chronic, life-threatening disease is heart wrenching for a doctor,� Dr. Kelly Clark, president-elect of the American Society of Addiction Medicine, told CNHI. �Rural areas have been hit hardest by this round in overdoses, which is the worst round of overdose deaths in our country.� She said medication is especially important in rural areas because opioid use spreads among families. �In rural areas, you�re treating the person, their parents and grandparents,� she said. �Entire families are addicted. It�s not like saying, �Stay away from certain friends,� if they�re shooting up with their sister and their mother.�

Princess Health and McConnell touts bill to fight opioid abuse; blocks extra funding, says money is available and more should require cuts elsewhere. Princessiccia

Princess Health and McConnell touts bill to fight opioid abuse; blocks extra funding, says money is available and more should require cuts elsewhere. Princessiccia

Congress drug abuse drugs federal spending pain politics prescription drug abuse prescription drugs

Gusty 13:04 Add Comment

The U.S. Senate passed a bill 94-1 March 10 aimed at "the growing epidemic of painkiller and heroin abuse," Karoun Demirjian reports for The Washington Post. "Drug abuse has been in the spotlight this political season, with presidential candidates recalling personal stories about relatives and friends who struggled with addiction and lawmakers from states dealing with the crisis highlighting their efforts to address the problem legislatively."

Kentucky Sen. Mitch McConnell, as majority leader, helped lead the effort to pass the bill, along with fellow Republicans who "face tough re-election battles" and whose losses could cost the GOP its majority, Demirjian notes. Sens. Kelly Ayotte (R-N.H.) and Rob Portman (R-Ohio) "supported a Democratic-led, and ultimately unsuccessful, effort last week to add $600 million to the bill to support the treatment and prevention programs it would create." So did Sen. Mark Kirk (R-Ill.), "who is also facing a formidable election challenge."

McConnell opposed the funding amendment, saying there is enough money for the programs already and extra funding must be offset with budget cuts elsewhere. "Senators are now eyeing the appropriations process as the next place they intend to appeal for more drug abuse treatment and prevention funding," Demirjian reports.

McConnell said in a press release, "At a time when more Kentuckians now die from drug overdoses than car crashes, it�s clear that more action is needed."

Van Ingram, executive director of the Kentucky Office of Drug Control Policy, told Beth Warren of The Courier-Journal, �One of the nice things this bill does is sets some standards around treatment.�

"The legislation would establish grant programs to help state and local governments improve education and treatment for drug abuse, encourage medical providers to reduce unnecessary prescriptions, commit resources to help veterans deal with addiction, and give local law enforcement and mental health officials tools to lower the death rate from overdoses," the Post reports. "A key provision would provide states with incentives to make naloxone, which can counteract overdoses, more widely available by offering liability protections to officials who distribute it. The bill�s fate in the House remains unclear."

Princess Health and Princess Health andSuccess of Kynect puts both Senate candidates in a pickle.Princessiccia

Princess Health and Princess Health andSuccess of Kynect puts both Senate candidates in a pickle.Princessiccia

Congress elections health insurance health reform insurance exchange Patient Protection and Affordable Care Act politics

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"The early success of Kentucky�s health care exchange, Kynect, is creating quandaries for both Mitch McConnell and Alison Lundergan Grimes as they address Obamacare" in Kentucky's U.S. Senate race," James R. Carroll reports for The Courier-Journal.

"For McConnell, the Senate minority leader, continued attacks on Obamacare � i.e., the Affordable Care Act � pose risk because the law�s implementation under Kynect has produced 421,000 enrollees in the Bluegrass State, and more public support than opposition," Carroll writes. "For Grimes, the issue is whether to fully embrace the exchange�s success as she tries to rally key elements of the Democratic base that is largely for the health-care law � while still separating herself from President Obama, who is unpopular in the state."

Carroll quotes Susan Zepeda, president of the Foundation for a Healthy Kentucky: �Campaign politics does not lend itself to a deep-dive into the complexities of multifaceted issues of what access to health care and payment for health care means to Kentucky communities and to Kentuckians,� so the debate is more complicated than �repeal Obamacare� or �support Kynect,� Carroll writes, in a story that goes on to explain it all.

Princess Health and Princess Health andHealth foundation chief objects to bill that would allow school districts to get waivers from recent nutrition standards.Princessiccia

Princess Health and Princess Health andHealth foundation chief objects to bill that would allow school districts to get waivers from recent nutrition standards.Princessiccia

children's health Congress diet fruit obesity school lunch schools vegetables

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The president of Kentucky's public-interest health foundation is objecting to legislation recently approved by the U.S. House Appropriations Committee to allow waivers from the school nutrition enacted by the Department of Agriculture in 2010.

Susan G. Zepeda, Ph.D.

Susan G. Zepeda of the Foundation for a Healthy Kentucky says in a statement sent to Kentucky news media that the foundation's polls show that Kentuckians "want healthier foods in the schools," but fewer than one in four Kentucky adults "described the meals at their children's school or daycare as 'very nutritious'."

Zepeda notes that the Data Resource Center for Child and Adolescent Health showed that 35.7 percent of Kentucky children were either overweight or obese in 2011-12, that children living in poverty are more likely to be obese, and that polls show Kentucky adults think childhood obesity is a serious issue, and 78 percent of them approved of the new USDA meal standards, Zepeda notes.

The legislation would allow school districts that have lost money on meals for six months to ask for a waiver from the standards. Zepeda said "the major voice" for the bill was the School Nutrition Association, "a trade group of school food officials backed by such food companies as Coca-Cola, Domino�s Pizza and PepsiCo," but "19 of the association�s former presidents have called on Congress to reject the waiver. We add our voice to this call."

Princess Health and Princess Health andPoll: Kentuckians still oppose Obamacare, but favor fixes, not repeal, and think state insurance exchange works well.Princessiccia

Princess Health and Princess Health andPoll: Kentuckians still oppose Obamacare, but favor fixes, not repeal, and think state insurance exchange works well.Princessiccia

Congress elections governor health insurance health policy heath reform insurance exchange obamacare politics state government

Gusty 06:47 Add Comment

Most Kentuckians still oppose the federal health-reform law, but think it should be changed rather than repealed, and most think the state health-insurance exchange created under the law is working well. So says a poll taken for The New York Times and the Kaiser Family Foundation in four Southern states with key U.S. Senate races this year: Arkansas, Kentucky, Louisiana and North Carolina.

"Debate over the law is expected to dominate the midterm elections. Attacks on the law are featuring prominently in campaigns across the country, and Republican lawmakers have continued to push for the law�s replacement," Sabrina Tavernise and Allison Kopicki write. "Questions about it may evoke associations with an unpopular president, the remoteness of Washington from ordinary Americans and extra costs in family budgets. But majorities say they do not want it taken away, even in states that lean Republican in presidential elections."

Among the four states, Kentucky is the only one that is running its own exchange, and the only one in which a majority said it is working well. In Arkansas, which has a combined state-federal exchange, a plurality said it was working well. The other two states use the federal exchange, which had a troubled rollout.

Kentucky is the only Southern state that created its own exchange and expanded Medicaid to include people in households with incomes up to 138 percent of the federal poverty level. The poll found support for Medicaid expansion in all four states, and 55 percent in Kentucky gave Gov. Steve Beshear, who made both decisions, a positive job rating.

The poll, done with landline and cellphone interviews April 8-15, has a margin of sampling error of plus or minus 4 percentage points in each state. (Read more)

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

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

Congress drug abuse drug companies drugs Opana Oxycontin pain pain management prescription drug abuse

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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 FDA requires OxyContin pills to be non-crushable to deter abuse.Princessiccia

Princess Health and FDA requires OxyContin pills to be non-crushable to deter abuse.Princessiccia

Congress narcotics prescription drug abuse prescription drugs

Gusty 18:42 Add Comment

The Food and Drug Administration announced Tuesday that it would block generic, crushable versions of OxyContin from coming to the market and approve the reformulated, non-crushable OxyContin, which deters abuse of the powerful painkiller.

U.S. Senate Republican Leader Mitch McConnell applauded the move. �Given the public health epidemic of prescription drug abuse and the ravaging effects it has on families all across Kentucky, this announcement is great news and will prevent an influx of crushable, generic OxyContin from coming to market,� McConnell said in a release.
 
OxyContin is a potent drug designed to treat severe pain. Without abuse-deterrent formulas, addicts can crush the pills to get an immediate heroin-like high. The reformulated product has properties that make the tablet harder to crush, break, or dissolve and that prevent it from being injected in order to achieve a quick high, an FDA press release said.

Drug overdoses are now the leading cause of death in Kentucky, and law enforcement, lawmakers and health providers have expressed their concerns that crushable, generic versions would worsen the problem.

The FDA decision came on the same day manufacturer Purdue Pharma�s patent on the original drug was set to expire, and McConnell has been actively meeting with federal officials on behalf of those concerned. Rep. Hal Rogers, R-5th, also lobbied for it. (Read more)

In an editorial, the Lexington Herald-Leader points out that the move means a continued OxyContin monopoly and more profits for Purdue Pharma, which "paid $600 million in fines in 2007, and three of the company's executives paid a total of $34.5 million, after they pleaded guilty to misleading doctors and the public about OxyContin's addictiveness. . . . We wonder why Rogers and McConnell aren't calling for Purdue to voluntarily share its new formulation."

Princess Health and Invisible health panel could help Ky., if it had money and met.Princessiccia

Princess Health and Invisible health panel could help Ky., if it had money and met.Princessiccia

Affordable Care Act Barack Obama Congress health care health care access health care law primary care rural health

Gusty 11:32 Add Comment

A panel charged with helping devise solutions to the nation�s health-care workforce crisis, which includes ensuring rural areas have enough health-care providers, is having a workforce crisis of its own: It hasn�t been funded, and it�s never met, writesKyle Cheney of Politico. 

The National Health Care Workforce Commission was created by Congress nearly three years ago under the Affordable Care Act, the panelists were appointed, but that�s about it. The lack of action was noted at a hearing Tuesday of a subcommittee of the Senate Special Committee on Aging, convened by Sen. Bernie Sanders (I-Vt.), chairman of the Subcommittee on Primary Health and Aging.

Sanders issued a report estimating that 57 million Americans lack ready access to primary care. Since  millions are expected to gain coverage when the reform law goes into full effect next year, there is a looming concern over whether there are enough doctors, physicians' assistants, nurse practitioners, nurses and so on. Most of the worry relates to the lack of primary-care providers in underserved areas, which could be a huge problem for Kentucky.

In addition to exploring the health workforce needs in rural and �medically underserved� settings, the commission was supposed to address the capacity of the nursing workforce, graduate medical education policies, education and loan programs for health-care professionals and the �mental and behavioral health care workforce capacity,� writes Cheney.

Since the 15-member panel was appointed in September 2010 by the U.S. comptroller general, 10 members� terms have expired, and they�ve been reappointed for another three years each, Cheney reports. No funding has been approved, although both Senate Democrats and President Barack Obama have proposed $3 million funding packages.

�In order for the promise of expanded coverage passed into law by ACA to become a reality, the provisions designed to reach those goals must be fully funded and implemented,� Sanders said. �We need to make sure that our health care system has the infrastructure in place to provide the care necessary to prevent diseases and improve the health of all Americans.� (Read more)

Princess Health and McConnell helped Amgen delay price limits on dialysis drug.Princessiccia

Princess Health and McConnell helped Amgen delay price limits on dialysis drug.Princessiccia

Congress lobbying lobbyists pharmaceuticals politics

Gusty 10:40 Add Comment

Senate Republican Leader Mitch McConnell of Kentucky, whose public statements usually emphasize the need to cut federal spending on entitlement programs, as they did in Lexington Friday, apparently passed up an opportunity to rein in Medicare spending when he signed off on a big favor for a significant campaign contributor in the fiscal-cliff deal.

The deal delayed for two years price controls on a class of drugs including Sensipar, used by kidney-dialysis patients and manufactured by Amgen, "the world's largest biotechnology firm," Eric Lipton and Kevin Sack of The New York Times reported Jan. 19.

"The news was so welcome that the company�s chief executive quickly relayed it to investment analysts," the Times reported. "But it is projected to cost Medicare up to $500 million over that period. Dennis J. Cotter, who studies the cost and efficacy of dialysis drugs, told the newspaper, �Everybody is carving out their own turf and getting it protected, and we pass the bill on to the taxpayer.�

McConnell spokesman Robert Steurer said the senator did not push for the provision. The Times story did not focus on McConnell, saying "Supporters of the delay, primarily leaders of the Senate Finance Committee who have long benefited from Amgen�s political largess, said it was necessary to allow regulators to prepare properly for the pricing change." And it noted the firm "also has worked hard to build close ties with the Obama administration." It did note that former McConnell chief of staff Hunter Bates is among "a small army of 74 lobbyists for Amgen, which was "the only company to argue aggressively for the delay, according to several Congressional aides of both parties."

According to the Center for Responsive Politics, which analyzes lobbying and campaign contributions, Amgen's political action committee gave McConnell $7,000 during the 2011-12 election cycle, an amount exceeded by only seven other senators, none of them in the Senate leadership. McConnell was the main negotiator on the fiscal-cliff deal with Vice President Biden.

UPDATE, Jan. 25: Writing on BillMoyers.com and then on Salon, Bill Moyers and Michael Winship report that since 2007, "Amgen employees and its political action committee have contributed $73,000 to Senator McConnell�s campaigns," almost $68,000 to Sen. Max Baucus, D-Mont., chairman of the Finance Committee, and $59,000 to Sen. Orrin Hatch, R-Utah. They also note that Republican Rep. Richard Hanna R-N.Y., and Democratic Reps. Peter Welch of Vermont and Jim Cooper of Tennessee have introduced a bill "to repeal the half billion-dollar giveaway to Amgen. The story includes Moyers' video interview with Welch.

Princess Health and Obama administration spent $25 million on health-care law publicity campaign, part of it exaggerating, McConnell complains.Princessiccia

Princess Health and Obama administration spent $25 million on health-care law publicity campaign, part of it exaggerating, McConnell complains.Princessiccia

Congress health reform Patient Protection and Affordable Care Act politics

Gusty 13:44 Add Comment

The Obama administration spent nearly $20 million on mailings to seniors touting the federal health-care reform law and another $5 million on postcards to small business owners informing them of a tax credit under the law, Senate Minority Leader Mitch McConnell, R-Ky., said in a floor speech today. He said the Government Accountability Office found that the mailing to seniors "overstated the law�s benefits."

"These are just a few of the way the administration is quietly promoting its own failed policies; how it's trying to change people's minds about the president's policies with their own money," McConnell said. "The larger point is the fact that we've got a nearly $16 trillion debt, the largest tax hike in history right around the corner, chronic unemployment, and sky-high gas prices, and this President things it's a good idea to spend $20 million to promote Obamacare."

McConnell's remarks can be heard in their entirety by clicking on the video above.

Princess Health and What will high court do on health law? 4 most possible scenarios.Princessiccia

Princess Health and What will high court do on health law? 4 most possible scenarios.Princessiccia

Congress courts federal legislation health insurance health reform Patient Protection and Affordable Care Act

Gusty 20:32 Add Comment

Last week, U.S. Supreme Court justices heard arguments about the constitutionality of the federal health-care reform law. At the center of the debate is whether the government can force people to buy health insurance, a provision often referred to as the individual mandate. There are four likely scenarios that will be the outcome of the justices' decisions, asserts Jennifer Haberkorn for Politico, all of which come with their own problems.

Scenario 1: The individual mandate is struck down, as well as insurance reforms: If these parts of the Affordable Care Act are scrapped, "Insurance companies will still be able to deny coverage based on customers' costly pre-existing conditions and charge more to older and sicker � or female patients," Haberkorn reports.

If that happens, the Obama administration and Democrats would likely blame Republicans for promoting a lawsuit that puts insurance companies in charge again. If reaction from the public is strong, Republicans may feel obligated to enact insurance reforms without an individual mandate. Ideas for doing this include "charging more if a person buys insurance at the last minute, tax incentives and a promise that if a person buys coverage, that person wouldn't lose it if he or she were to get sick and need it," Haberkorn reports.

Scenario 2: The mandate is struck down, but insurance reforms stay intact: Part of the reason why insurance companies agreed to stop denying coverage based on pre-existing conditions is they could offset the losses because the law would enlarge their insurance pool by 30 million people � the number of Americans who lack coverage.

If insurance companies are still required to stop denying coverage based on pre-existing conditions but the individual mandate is struck down "They could start a mini revolt over having to cover expensive patients without the mandate," Haberkorn reports.

Scenario 3: The entire law, or the majority of it, is axed: That would mean unpopular parts of the law would be trashed, but so would popular ones, including the pre-existing conditions piece as well as a provision that allows young adults to stay on their parents' health insurance until the age of 26.

In 2010, 26 provisions took effect and another 17 did last year. Nine new provisions are taking place this year. "Lawmakers designed the phase-in, in part, with the thought that the public would become more supportive of the law once certain provisions began to take hold," report Michael Doyle and David Lightman for McClatchy Newspapers.

Scrapping the law entirely could cause the most political fallout. "Republicans would try to move quickly to enact a small-scale health reform legislation aimed at restoring some of the popular pieces of the health law," Haberkorn reports. "But Democrats won't want to support something far less comprehensive than the Affordable Care Act, not with some 50 million Americans uninsured."

Scenario 4: The law stands: Though this is the hope of the Obama administration, "The mandate is considered relatively weak: The penalty for not obeying it starts at $95 in 2014 � that's nothing compared with the cost of insurance premiums," Haberkorn reports. The amount increases to $695 by 2016.

As for what the justices will do, "at least some of the court's conservatives seem prepared to kill the whole bill," report Doyle and Lightman. "My approach would be, if you take the heart out of the statue, the statute is gone," Justice Antonin Scalia said.

Justice Elena Kagan countered, "Half a loaf is better than no loaf," while Justice Ruth Bader Ginsburg suggested, "It's a question between a wrecking operation and a salvage job."

Some justices said the whole bill should be sacked, "on the theory that members of Congress would not have voted for it without the mandate," Adam Liptak reports for The New York Times. But Justice Sonia Sotomayor said killing the whole law "would be too broad an assertion of judicial power," Liptak notes. Justice Anthony Kennedy, the likely swing vote, said "We would be exercising the judicial power, if one provision was stricken and the others remained, to impose a risk on insurance companies that Congress had never intended."

The justices probably decided the future of the law Friday morning, reports Mark Sherman for The Associated Press. Typically, an initial vote is "followed soon after by the assignment of a single justice to write a majority opinion, or in a case this complex, perhaps two or more justices to tackle different issues. That's where the hard work begins, with the clock ticking toward the end of the court's work in early summer," Sherman writes.

In Kentucky, health advocates and officials are watching closely to see what happens. "I think the entire health-care sector and insurance sector are watching this closely because it has significant implications on both industries," said Stephen Williams, chief executive officer of Norton Healthcare. "This is very far-reaching."

In Kentucky, the law extends coverage for 35,000 young adults, reports Laura Ungar for The Courier-Journal. (Read more)