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

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."