Conway, other AGs ask FDA to require generic prescription pain pills to be abuse-resistant, tamper-resistant

Generic versions of popular pain relievers must be made harder to abuse, in order to curb prescription drug abuse that is epidemic in many states, Attorney General Jack Conway and 47 other attorneys general said in a letter sent to federal officials Monday.

The National Association of Attorneys General letter encourages the Food and Drug Administration to adopt standards requiring manufacturers and marketers of generic prescription painkillers to develop tamper- and abuse-resistant versions of their products, because the attorneys general are concerned that non-medical users are shifting to non-tamper-resistant formulations of generic opioids.

“Prescription drug abuse is an epidemic that kills more than 1,000 Kentuckians each year,” Conway, who co-chairs NAAG’s Substance Committee, said in a news release. “The development of tamper-resistant and abuse-deterrent opioid drug products is a valuable aid to the law enforcement, legislative and public awareness initiatives many of us have implemented in our states to combat prescription drug abuse.”

Prescription drugs can be deadly when abused, and fatal drug overdoses are now the leading cause of death due to unintentional injury in the United States and Kentucky, exceeding even motor vehicle deaths, according to the Centers for Disease Control and Prevention. Federal data show that U.S. drug overdose deaths totaled 38,329 in 2010, rising for the 11th straight year, and accidental deaths involving addictive prescription drugs overshadow deaths from illicit narcotics.

In Kentucky, the number of drug-overdose deaths in Kentucky rose a staggering 296 percent from 2000 to 2010, according to the Kentucky Injury Prevention and Research Center. Kentucky is one of the most medicated states in the country, and has the sixth highest overdose rate. Last year, 220 million doses of the highly addictive painkiller hydrocodone were dispensed in the state -- that’s 51 doses for every man, woman and child in the state, says the AG release.

The news release from Conway's office said he led the effort to reach out to the FDA, along with Attorneys General Luther Strange of Alabama, Pam Bondi of Florida and Roy Cooper of North Carolina. Click here to read the letter; for a news release, click here.

Deadly, recalled pills still circulating in Pennyrile Region

A pain reliever that has been recalled and declared dangerous by the Federal Drug Administration is still circulating around southern Kentucky.

The drug marketed under the name Reumofan Plus is being distributed in Elkton and the broader Pennyrile Region, despite being recalled, and a local doctor's office says patients on the drug have had dangerous side effects, reports Nick Tabor of the Kentucky New Era.

Dr. Keith Toms of Generations Primary Care told Tabor three of his patients have taken the drug and had bad side effects. One patient had dangerous elevations of liver enzymes, and two diabetic patients had dangerous spikes in blood sugar.

The Food and Drug Administration has received reports of deaths, strokes, severe internal bleeding, dizziness, insomnia, high blood sugar and other problems associated with the drug since June. The manufacturer, operating under the names Reumofan Plus USA, LLC and Reumofan USA, LLC, announced a voluntary product recall last month, reports Tabor.

According to the FDA, undeclared ingredients in the drug, which is used as a treatment for muscle pain, arthritis, osteoporosis, bone cancer and other conditions, could result in serious illness. Tabor reports a FDA laboratory analysis of Reumofan Plus found that it contains diclofenac sodium, a non-steroidal anti-inflammatory drug, and methocarbamol, a muscle relaxant.

Tabor reports the FDA has issued an alert telling consumers to stop taking the drug immediately and consult a health-care professional. The agency also said it may follow up on the Reumofan recall with warning letters, seizure, injunction requests or criminal charges. (Read more)

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 leads nation in drug-fraud prosecutions and settlements

Kentucky leads the U.S. in pursuing pharmaceutical fraud, according to a report by the Washington, D.C.-based consumer group, Public Citizen. Since 1991, the state has pursued the most claims against pharmaceutical companies and reached more than 30 settlements. It pursued 17 single-state settlements, the most of any state.

The most common violation was overcharging Medicaid programs for services, mostly for drugs, Beth Musgrave of the Lexington Herald-Leader reports. The violations that netted the biggest penalties were for improper promotion of drugs. Attorney General Jack Conway oversees the Office of Medicaid Fraud and Abuse Control; his spokeswoman, Shelley Catherine Johnson, told Musgrave the agency has recovered or been awarded more than $265 million since Conway took office in January 2008. (Read more)

Meds-for-meth bill drew record lobbying expenses, not even including radio and newspaper ad campaigns

Makers of over-the-counter drugs spent more than any lobbying interest ever had during a single Kentucky legislative session in their effort to defeat a bill requiring prescriptions for the key ingredient in methamphetamine, Bill Estep reports for the Lexington Herald-Leader.

"The Consumer Healthcare Products Association spent $457,053 on lobbying activities in the first three months of this year's legislative session, according to reports filed with the state Legislative Ethics Commission," Estep writes. "The group's lobbying effort was so dominant that it spent more than the next five groups combined in that period, January through March, according to spending reports."

And the figure doesn't even included hundreds of thousands of dollars that the trade group spent on radio and newspaper campaigns, because the lobby-reporting requirements do not apply to messages aimed only at the general public. The group did report spending on "a phone-bank operation to put people in contact with legislators to voice concerns about legislation to require a prescription for medicine containing pseudoephedrine, which is now available over the counter," Estep writes.

Read more here: http://www.kentucky.com/2012/04/30/2170495/makers-of-cold-medicines-set-new.html#storylink=cpy

The efforts, dating back to 2010, were partly successful. The legislature passed a bill "that will require a doctor's prescription for pseudoephedrine, but only after someone has bought 24 grams of the medicine a year," Estep notes. "A 48-count box of the generic medicine with 30-milligram pills contains 1.44 grams of pseudoephedrine. The bill excludes limits on gel caps and liquid pseudoephedrine." (Read more)

The lobbying effort wasn't only about Kentucky. The makers of Sudafed and other pseudoephedrine preparations are trying to stave off similar efforts in other states, and viewed Kentucky as a sort of firewall after seeing prescription-only laws pass in Oregon and Mississippi.

Read more here: http://www.kentucky.com/2012/04/30/2170495/makers-of-cold-medicines-set-new.html#storylink=cpy

Read more here: http://www.kentucky.com/2012/04/30/2170495/makers-of-cold-medicines-set-new.html#storylink=cpy

Prescription Lawsuits in Abroad - Do They Really Affect You?

If an unsafe drug lawsuit is taken out in a country you don’t live in, does it affect you? Yes, if the drug in question is also prescribed or available in your country. Such a lawsuit can also have a knock on effect where it raises the issue of a certain drug or type of drug: so ultimately it depends on the precise kind of lawsuit that is being brought.

If a person successfully sues a company as a result of taking one of its prescription drugs or over the counter drugs, and either that drug or that type of drug is pending for approval in your country of residence – then you probably aren’t going to see it in a hurry. So if you were waiting for it to be approved so you could start taking it, the unsafe drugs lawsuit we give example of here is clearly going to affect you.

That said, of course, if the drug you wanted is proven to be dangerous then it will affect you in a good way – by protecting you from that potential danger.

If the drug is causing secondary side effects – i.e. side effects that occur as a result of the effect of the drug, rather than a result of the actual physical components of the drug – then a foreign lawsuit may also affect you, because it will raise awareness of a type of drug as being more dangerous than was previously supposed. You also find drugs with unknown long term side effects come into this area – Thalidomide being a major example. Without the unsafe drug lawsuit brought by thousands of Britons against the manufacturers of Thalidomide, the extraordinarily dangerous long term effects of its use would still be un-ratified.

That’s an important point, actually. Ratification is a big part of the efficacy of unsafe drug claims: once one is successful, the public suspicion of that drug or kind of drug is confirmed. Ultimately the unsafe drug trial, from this point of view, becomes a way for the public to protect itself against less scrupulous drug manufacturers as well as against the unlooked for side effects of particular drugs.

In other words: all dangerous drug claims, made anywhere in the world, have a bearing on your life. From this wider viewpoint, we all need unsafe drug lawsuits simply so that we can maintain a world in which it is possible to bring an unsafe drug lawsuit into being. Because without them we would have no sure fire way of taking the drug companies to account when something goes wrong, or is suspected of going wrong.

Drug companies are often driven by profit – we all know that. And in a world where the companies that make the pills and potions we rely on to stay healthy (and in some cases even to save our lives when things go wrong) are as motivated by money as they are by the urge to cure and palliate, then it’s up to us to fight for our rights as consumers. The best way to do that? By keeping the drug manufacturers afraid of losing big money if an unsafe drugs lawsuit is brought against them.

Kentucky court hearing more than 100 cases about drug that caused heart arrhythmia

More than 100 lawsuits filed by people who say they or their family members were hurt by Darvon, Darvocet or other drugs that contain the ingredient propoxyphene have been heard in U.S. District Court of the Eastern District of Kentucky since August. So far, none of the cases originated in Kentucky, but stem from people living in other parts of the country.

The effort is the result of U.S. District Judge Danny Reeves being selected by a federal panel to handle all cases pertaining to the subject, reports Jennifer Hewlett of the Lexington Herald-Leader. "It's basically in the interest of judicial economy so that multiple judges aren't handling the same issue," said deputy U.S. District Clerk Susan Baker.

Last last year, the U.S. Food and Drug Administration asked Xanodyne Pharmaceuticals to withdraw Darvon and Darvocet from the market after receiving evidence propoxyphene can cause serious or fatal heart rhythm abnormalities. Now, thousands of suits are being filed by people who took the drug. "Our issue is people took a bad drug that hurt people and they want to have their day in court," said attorney Richard Schulte of Dayton, Ohio, whose firm is dealing with 2,000 cases or potential cases. "We're looking for justice for our clients. You're not supposed to die when you take a pill for mild pain." (Read more)

Former official: DEA failed to slow prescription drug abuse epidemic by not limiting production

At a time when Oxycontin abuse was rapidly increasing, the Drug Enforcement Agency had the power to slow production of the drug and perhaps stave off what is now a prescription drug abuse epidemic in rural areas across the country, reports Guy Taylor of Salon. However, the agency allowed production of Oxycodone, the non-generic form of Oxycontin, to increase by 1,200 percent over a decade.

After the Food and Drug Administration approves a drug for production and sale, a section of the DEA known as the Office of Diversion Control decides how much of a drug can be manufactured. By law, the makers of Oxycodone and its generic forms have to present a quota approval application to Diversion Control. The office decides whether the amount requested can be manufactured. With the help of statistics provided by a former head of Diversion Control, Gene Haislip, Taylor discovered that in 1997 when Purdue Pharma first introduced Oxycontin, it was allowed to make 8.3 tons. This year, the DEA approved the manufacture of 105 tons.

Haislip tells Taylor DEA approved the increase in production in the face of a growing drug abuse epidemic, showing a "serious lack of accountability and oversight." Says Haislip: "The DEA is the lone federal agency with the power to decide how much of the drug gets made and put out there; it alone has had all the responsibility to do something about this problem." He told Taylor the agency should have learned from two examples in the 1970s and 1980s, when Diversion Control reduced quota requests for pill-based amphetamines and Methaqualone, the main ingredient in Quaaludes. When the quotas were reduced, illicit use of those drugs significantly decreased.

Asked why the agency allowed the production quota of Oxycodone to increase so much, DEA supervisory special agent Gary Boggs told Taylor the agency is required to set quotas at a level that "ensures an uninterrupted supply for the legitimate medical and scientific research needs of the United States, and that those needs are always changing as the population grows and as medical science finds different needs for products." He said there are patients who need the drug for medical purposes and the agency cannot limit their access because of those who abuse it.

Taylor opines: "The fact is that the U.S. government has adopted a position on prescription painkillers that differs from its policy toward other controlled substances such as cocaine, heroin and marijuana: Unlike those drugs, the DEA says limiting the supply of the prescription painkillers will not reduce abuse." He reports the agency's lack of oversight in the production of Oxycodone is "perplexing" to state and local governments now battling prescription pill abuse crises in their areas. Ohio Department of Alcohol and Drug Addiction Services director Orman Hall told Taylor the "the loss of life and the carnage associated" with prescription drug abuse could have been prevented had the DEA limited the production of Oxycodone. (Read more)

Law enforcement and allies getting ducks in row in 2nd bid to pass bill to require a prescription to buy pseudoephedrine

By Tara Kaprowy
Kentucky Health News

With police finding 20 percent more meth labs in Kentucky than a year ago, they and others are again encouraging state legislators to make pseudoephedrine less available by requiring a prescription for it. And the senator who tried that last year says he is talking with his colleagues to see what can pass in the 2012 General Assembly.

Supporters of the bill to quash "meds for meth" met in Laurel County last week, where the incidence of meth labs recently became the state's highest, Bill Estep of the Lexington Herald-Leader reports. They unveiled an educational campaign intended to teach people about the dangers and costs of the deadly drug. Their campaign includes a video produced by the Kentucky State Police, Operation UNITE, the High Intensity Drug Trafficking Areas Program and the Kentucky National Guard.

"They're going to try to show that video as often as they can between now and January across the state to try to get a grassroots effort behind this bill," Estep said on KET's "Comment on Kentucky" Friday night. "They didn't start off early enough last time to get that to happen." Meanwhile, the number of reported meth labs in the state climbed to nearly 1,100 in 2010 and is on track to exceed 1,400 in 2011.

Pseudoephedrine is the key ingredient in manufacturing methamphetamine, which can be made by combining a few ingredients in a pop bottle. Last year, Sen. Tom Jensen, R-London, sponsored a bill to make "pseudo" available only by prescription. Jensen told Kentucky Health News Monday he is planning on introducing a bill in the upcoming session that "deals with pseudoephedrine and how to control that." "The details of that are not ready to be sent out yet," he said. "I'm negotiating with some other members to see if we can get support."

Pseudoephedrine is also a main ingredient in cold and allergy medicine. Opponents say making it a prescription-only medicine is unnecessarily inconvenient and could be costly. In a legislative brief, the Kentucky Chamber of Commerce said the proposed law would drive up insurance premiums for Kentucky employers and the taxpayers' cost of Medicaid. Their estimates show the new law would result in 17,000 more doctor visits per year. The chamber and other opponents are backed by the Consumer Healthcare Products Association, which was the top-spending lobby against Jensen's bill.

Only Oregon and Mississippi have passed laws making pseudoephedrine available only by prescription; both have seen the number of meth labs fall sharply. Mississippi, where a ban took effect in 2010, has seen a 66 percent drop, according to the Mississippi Bureau of Narcotics. Oregon has seen a 96 percent drop in meth labs in the five years since its law passed, said Jackie Steele, commonwealth's attorney for Laurel and Knox counties and a proponent of limiting pseudoephedrine access.

Opponents say the drops in Oregon and Mississippi have led to surges in adjoining states, and Steele said "They're probably correct. But I'm looking out for Laurel and Knox and the Commonwealth of Kentucky. I hope that everybody else gets on board so we don't have to worry about shuffling problems to another county or another state."

Though several individual municipalities in Missouri have made pseudoephedrine available only by prescription, Steele said that is not likely to happen in Kentucky counties since there would be "constitutional issues."

At the meeting in Laurel County last week, Abby Hale, co-director of the Laurel County Department of Public Safety and Emergency Management, said cleanup of a meth lab can cost up to $2,100 just in manpower and disposal, reports Nita Johnson of The Sentinel-Echo in London. If meth labs are inside a home, homeowners have to get the building decontaminated at their own expense, which can cost up to $3,000.

Statewide, Steele said the cost of meth is in the millions because of the expense of corrections; local health departments dealing with skin irritations and rashes; loss of learning time for kids in school; and putting children in foster care. "The Kentucky State Police spent $2 million in meth lab cleanups, not to prosecute them, just to clean the toxic dumps up," Steele said. "So you can see that the cost per year is staggering."

Decongestant prescription bill passes panel; both parties split

After hearing an endorsement from Kentucky's senior member of Congress, and opposition from the wife of another Republican congressman, a state Senate committee voted 6-4 to require precriptions for decongestants that are often used to make methamphetamine.

Fifth District Rep. Harold "Hal" Rogers of Somerset made what the Lexington Herald-Leader called "a rare Frankfort appearance" for the bill, at two committee meetings and a Capitol rotunda rally, but perhaps the rarer event was the contrary testimony of a colleague's spouse -- Pat Davis, wife of 4th District Rep. Geoff Davis of Hebron.

Rogers, accompanied by House Speaker Greg Stumbo, D-Presonsburg, and Senate President David Williams, R-Burkesville, told the Senate Judiciary Committee that prescription laws in Mississippi and Oregon greatly reduced the number of meth labs in those states. "Our future is gravely at stake here," Rogers said. He said he was testifying to counter the heavy advertising and lobbying by decongestant manufacturers, who are running full-page newspaper ads and heavy flights of radio commercials.

The radio ads say the MethCheck electronic tracking system designed to prevent multiple purchases of decongestants for meth making "is working" and "effective," and some law-enforcement officials testified likewise yesterday, "but others in law enforcement said that the number of meth labs in Kentucky has skyrocketed even with MethCheck and that most law enforcement officers find meth labs through regular police work, such as traffic stops, not with MethCheck," Jack Brammer writes for the Herald-Leader.

On the other hand, Pat Davis "told the committee that, as a mother of six and grandmother of one, she is concerned the bill will lead to more trips to the emergency room and to the doctor," Brammer reports. Davis said all her children have allergies or asthma, and "This will drive already high medical costs higher."

The two Republican senators on the committee from Davis's district, Jack Westwood of Erlanger and John Schickel of Union, voted against the bill, along with Democrats Perry Clark of Louisville and Jerry Rhoads of Madisonville. Voting for the bill were four Republicans Carroll Gibson of Leitchfield, Tom Jensen of London, Robert Stivers of Manchester and Dan Seum of Louisville, and Democrats Ray Jones of Pikeville and Robin Webb of Grayson.

The division among Republicans appeared to short-circuit Williams' plan to have the full Senate vote on the bill later in the day. No vote was held. (Read more) Jessie Halliday of The Courier-Journal expects a Senate vote next week. (Read more)

Health advocacy organizations reluctant to acknowledge grant money from drug companies, study finds

A study by the American Journal of Public Health shows not-for-profit groups like the American Diabetes Association get grant money from drug companies but don't necessarily acknowledge it.

Marian Wang of ProPublica, the nonprofit investigative news service, highlighted the results of the study, which examined 160-plus health advocacy organizations that got funding in 2007 from Eli Lilly & Co., a global pharmaceutical company.

The report found that, as a whole, "25 percent of health advocacy organizations acknowledged Lilly funding anywhere on their Web site. Eighteen percent acknowledged Lilly in their 2007 annual report, 1 percent acknowledged Lilly on a corporate sponsors page, and 10 percent acknowledged Lilly as the sponsor" of a grant event reported in the Lilly Grant Registry. (Read more)