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)