FDA changes painkiller labels to warn expectant mothers, after 2,500% growth in number of Ky. babies born addicted to drugs

The U.S. Food and Drug Administration (FDA) announced Tuesday drug-safety labeling changes and new post-market study requirements for all extended-release and long-acting opioids, and Kentucky political leaders applauded these measures to curb prescription drug abuse.

Long-acting opioids are intended to treat pain but may also lead to drug abuse, dependence or other complications if taken during pregnancy or misused. Now, as part of new FDA safety measures, the boxed warning labels on these drugs will warn expectant mothers that “the use of the products during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS),” says the FDA release.

NOWS is among a group of problems called Neonatal Abstinence Syndrome (NAS) that occur in a newborn exposed to addictive drugs while in the mother’s womb. The baby's addiction can lead to birth defects, low birth weight, sudden infant death syndrome and other health conditions.

Attorney General Jack Conway and his counterparts in other states asked the FDA to act after several states reported an increase in the number of babies born addicted to prescription drugs. In Kentucky, "Instances of NAS have risen 2,500 percent over the past decade – from 29 incidents in 2001 to 730 in 2011," says a Conway release.

“I applaud the FDA for making this change that will better alert physicians and patients about the dangerous consequences of using these powerful prescription painkillers during pregnancy,” Conway said. Also as part of these safety labeling changes, certain educational materials for patients and health care professionals will be modified to reflect the new labeling.

U.S. Senate Republican Leader Mitch McConnell also praised the FDA's decision, saying it is a positive step forward in the fight against the state's prescription drug abuse problem.

Because little is known about the risks of long-term use of long-acting opioids, the FDA is also requiring the drug companies that make these products to conduct further studies and clinical trials to assess the known serious risks of misuse, abuse, increased sensitivity to pain (hyperalgesia), addiction, overdose and death, says the FDA.

"Altogether, the actions we're now announcing are part of FDA's efforts to make opioids as safe as possible for those who need them," said Dr. Douglas Throckmorton, deputy director of regulatory programs in FDA's Center for Drug Evaluation and Research. "This is not the first or last initiative, and we will continue supporting broader efforts to solve the serious public health problems associated with the misuse and abuse of opioids."

Obamacare hearing highlights employers' worry and uncertainty; Yarmuth says repeal and defunding bids block needed changes

Three of Kentucky's congressmen agreement at a field hearing in Lexington Tuesday that the Patient Protection and Affordable Care Act needs changing, but had no a consensus on how it should be fixed.


From left, U.S. Reps. John Yarmuth, D-3rd District; Andy Barr, R-6th District; and Brett
Guthrie, R-2nd District, listen to Rep. Phil Roe, R-Tennessee, who chaired the hearing.

Business leaders at the hearing also called for a fix, saying the law creates challenges for employees, workers and the economy.

Republican Reps. Brett Guthrie of Bowling Green and Andy Barr of Lexington said the law should be repealed. Democratic Congressman John Yarmuth of Louisville said efforts to change the law are hindered by efforts to repeal or defund it, reports Ryan Alessi of cn|2's "Pure Politics."

Yarmuth supports changes to the law's definition of a full-time employee as one that averages 30 hours of work a week, which he says has led to unintended consequences. Many of the 130 hearing attendees also expressed concern about the 30-hour employees, Alessi reports.

The law includes a mandate that companies 50 or more full-time employees must provide those workers with health insurance or pay a $2,000 penalty per employee. Although this mandate has been delayed a year by the Obama administration, the employee mandate and complex regulations of the law has created "massive uncertainty" for U.S. employers, said Barr.

Several business owners complained about the looming mandate and uncertainty as well as the harmful financial consequences of Obamacare at the hearing, which was held by the U.S. House's Subcommittee on Health, Employment, Labor and Pension. Six of the eight speakers were Republicans expressing opposition to the law.

"What we know is what the administration is now admitting — that this massive piece of legislation is unworkable,” said Barr, who also said that the law should be permanently delayed, reports Alessi.

A majority of Americans (57 percent) disapprove of "defunding" Obamacare as a way to stop the law from being implemented, says an August poll from the Kaiser Family Foundation.  Almost 70 percent of respondents said defunding would be "using the budget process to stop a law is not the way our government should work."

Long-time Lexington restaurant owner Joe Bologna said he is concerned that Obamacare will impact people's ability to eat out.  To prepare for this and rising health costs faced by the business, he has reduced his staff from 54 to 47 and is closed on Mondays, reports Jack Brammer of the Lexington Herald-Leader. Other business people shared similar stories about the law's negative consequences.

On the other hand, Carrie Banahan, executive director of the Kentucky Health Benefits Exchange, the state's online insurance marketplace, said the law will improve Kentucky's health. There were many supporters of the law at the hearing, and some even hissed at critics of the law, reports Alessi.

“If we could get a bipartisan agreement to actually work on tweaks legislatively, I think we could dramatically improve the law and eliminate a lot of uncertainty,” said Yarmuth. Click here to read more about testimonies form the hearing or to watch cn|2 videos.

Kids' excessive salty snacks are linked to obesity, high blood pressure; new limits on school vending items may help

As new research shows that America's child-obesity epidemic is linked to eating too many salty snacks,  new federal regulations could ensure that vending-machine snacks in Kentucky's schools are healthier and lower in sodium.

Spurred by children eating too much salt and being too fat, "blood pressure in America's kids and teens has gone sky-high," creating a young generation at risk for serious health problems, including heart disease, stroke, reports Brian Alexander of NBC News.

“Kids eat far too much sodium,” the study's co-author, Dr. Stephen Daniels told NBC. “And they aren’t adding it at the table, and their parents aren’t putting it into food; they’re getting it through processed foods.” The research, published Monday in the journal Hypertension, links this rising blood pressure to children's increasing bod- mass index and sodium intake.

The "Smart Snacks in Schools" nutrition standards, announced last month by the Department of Agriculture, require any food sold in public schools to meet calorie, fat, sugar and sodium limits. The changes shouldn't be very significant for Kentucky students because the state already prohibits vending machine sales during the school day. And, a few existing state regulations, like fat content, are tougher than the federal changes and will remain in place, Sue Bartenfield, nutrition program manager for the Kentucky Department of Education, told Stu Johnson of the Kentucky Public Radio bureau in Frankfort. The new federal limits on calories and sodium are tighter, and the federal law will also keep vending machines shut down for a half-hour after school, Bartenfield told Johnson.

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

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."

FDA could require tamper-resistant painkillers; without such action, prescription-drug abuse problem would worsen

UPDATE, Jan. 14 : Laura Ungar of The Courier-Journal reports, "Addicts by the scores used to get a quick and easy high from snorting or shooting up the powerful narcotic OxyContin — until manufacturer Purdue Pharma developed a new version that’s harder to abuse. But with the company’s patent on its original drug set to expire in April, activists, lawmakers and doctors are worried that cheaper, easily crushable generic versions will flood Kentucky and worsen the state’s already-devastating prescription drug abuse problem."

The Food and Drug Administration will force generic manufacturers of powerful pain pills to switch to a tamper-resistant composition if it finds evidence the composition curbs prescription drug abuse and addiction, Alan Rappeport of The Financial Times reports. Public-health advocates worry that if generic versions of opiate pills are not made tamper-resistant, the prescription drug abuse epidemic may worsen.

If the agency finds tamper-resistance significantly deter abuse, it has legal authority to require generic drug makers to switch their opiate formulas. Just as manufacturers of some pain pills began switching formulas to make the pills harder to crush, easily crushable, generic forms of OxyContin and Opana were released. Purdue Pharma and Endo Pharmaceuticals, which make Opana, have hoped to extend patent life of their drugs by pushing the FDA to prevent generic makers from using old versions of their drugs. Generic makers argue this will keep patients from buying cheaper drugs.

The FDA said it will take a "flexible" approach to determining the effectiveness of tamper-resistant drugs because abusers are constantly finding new ways to avoid deterrents. (Read more)

Kentucky to get $811,000 from drug company as settlement of federal suit alleging unfounded promotion of three medications

Attorney General Jack Conway has confirmed that the state will receive almost $811,000 for its share of recoveries in a settlement reached in a lawsuit filed by the federal government against Boehringer Ingelheim Pharmaceuticals Inc. In all, the drug company has agreed to pay $95 million to settle allegations that it promoted three drugs for uses in Kentucky and other states that were not medically accepted.  The Associated Press reports that the stroke-prevention drug Aggrenox, the chronic obstructive pulmonary disease drug Combivent, and the high-blood-pressure drug Micardis are the drugs named in the suit. The Justice Department said the company also promoted the use of the heart drug Atrovent at doses exceeding those covered by federal health programs. (Read more)

New tool allows analysis of nursing-home deficiencies across the country; Kentucky seems to rank high in serious problems

Reporters now have a tool at their fingertips that will allow them to find nursing home problems in facilities across Kentucky, which appears to ranks high in serious problems.(iStock photo)

The tool was launched this week by ProPublica, a nonprofit, investigative news group, and allows "anyone to easily search and analyze the details of recent nursing home inspections, most completed since January 2011," report Charles Ornstein and Lena Groeger.

The tool has features that the federal government's Nursing Home Compare doesn't have, including the ability to search using any keyword. Results can also be sorted according to the severity of the violation and by state.

About 1.5 million people still live in nursing homes nationwide, though more seniors are living at home or in assisted-living facilities. The reports show there were almost 118,000 deficiencies cited against 14,565 homes. According to the Centers for Medicare and Medicaid Services, the average number of deficiencies for a nursing home inspected in the U.S. is eight and the average in Kentucky is seven.

ProPublica's analysis shows Kentucky ranked fourth nationwide for the most "K" and "L" deficiencies, considered the most serious kind. The state had 45 in the analysis, as did South Carolina. Texas had the most in the country by far, however, with 183. 

While ProPublica does rank the states, nursing home industry officials say "inspectors in different regions of the country have different thresholds for issuing a citation, and that could unfairly make one state's homes appear worse than another's," Ornstein and Groeger report. (Read more)

What would solve primary-care crisis, create jobs and help banks? Building community health centers, writer contends

The federal health-care reform law will mean a glut of new patients who will be newly insured and bog down the primary-care system. Thousands of construction workers are out of jobs as the economy remains stagnant. And the banking sector is still reluctant to lend. The answer to all three problems? Build more community health centers, writes Jeffrey Leonard in an opinion piece in The Washington Monthly. (Photo: Vista, Calif., Community Clinic)

"The way to meet the flood of new patients coming down the pike is to expand the nation's existing network of community health centers — nonprofit clinics that offer primary care to the medically under-served, often in rural areas or inner cities," writes Leonard, CEO of the Global Environment Fund and chairman of the magazine's board of directors. "But to get this done, there's no need to appropriate billions more in direct government spending. Rather, there is a way to lure skittish banks in lending private capital to finance a health-center construction boom in all 50 states, simply by tweaking the language of an existing federal lending program."

Though community health centers generally have difficulty raising their own funds to expand or build facilities, in part because they serve uninsured, low-income patients who can't donate to building projects, they are sound investments, Leonard contends, pointing out only "one or two" of the 1,200 community health centers in America today have ever defaulted on a loan.

Still, they have trouble getting loans from banks, even once they have been able to raise a chunk of funds, in large part because centers "in an economically distressed inner-city neighborhood serving a mixture of Medicaid patients and the uninsured, or one in a depressed heartland town where real estate prices are spiraling downward" are seen as a risk, Leonard explains.

Leonard suggests the centers be eligible for the Small Business Administration's 504 loan program, in which a small business asks a non-profit lender to issue "low-interest, fixed-rate, government-backed bonds to finance up to 40 percent of the project," Leonard writes. As of now, the loan program is only open to some for-profit businesses. But Congress could change that, thus opening up possibilities. Moreover, the loan program is "routine and efficient to process" and the "interest rates are among the lowest on the market," Leonard contends.

Another option would be for construction companies and real estate developers to put up the equity themselves, build the facilities and then rent them out to nonprofits "on a long-term lease or through various lease-to-own arrangements." "Indeed, hungry developers and construction firms would find any number of ways to get the hammers swinging," Leonard writes.

Overall, it's a win-win, Leonard argues."It's hard to imagine Congress appropriating any more direct spending to fuel the construction of health centers," he writes. "But there's no good reason why they shouldn't change a few words in a statute to achieve the same end. Not only would it quickly create much-needed jobs in the construction trades, it would also spark economic activity over the long run in some of the places in America that need it most." (Read more)

Studies conclude cigarette packaging misleading, needs changes

Tobacco manufacturers have misled consumers about the risks of their products and action is needed to help consumers make informed decisions about the products they intend to buy, three studies published in the American Journal of Preventive Medicine have concluded.

"Tobacco companies have used attractive packaging and persuasive images to market their products for decades," said lead author Maansi Bansal-Travers, a behavioral research scientist at the Roswell Park Cancer Institute. "These studies support efforts by the Federal Food and Drug Administration to regulate cigarette pack labeling."

Tobacco manufacturers have used design, colors and wording that create the illusion that filtered or "light/mild" cigarettes are safer, which is not the case, research-reporting news service Newswise reports. Since June 2010, tobacco companies have been prohibited from using "light" or "mild" terms on their packaging, according to provisions in the Family Smoking Prevention and Tobacco Control Act. "While the removal of these obviously misleading terms was a good first step, we discovered that cigarette manufacturers have circumvented the regulation by using different terms such as 'gold' and 'silver' and changing the colors on the pack to continue to mislead consumers about their products," Bansal-Travers said.

The first study, "What Do Cigarette Pack Colors Communicate to Smokers in the U.S.?", recommended color-coding be restricted. The second paper found "larger graphic health warnings that convey negative messages are the most effective in communicating health risks to adults," Newswise reports. The third study, "Correcting Over 50 Years of Tobacco Industry Misinformation," found putting statements on tobacco packaging that correctly warn of the use of tobacco products makes a different in correcting false beliefs about smoking and health. (Read more)