McConnell helped Amgen delay price limits on dialysis drug

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.

Pike court will keep lawsuit county and attorney general filed against Purdue Pharma over damage done by its OxyContin

A state court will hear the Kentucky attorney general's 2007 lawsuit against OxyContin manufacturer Purdue Pharma, against the wishes of the company. The U.S. Court of Appeals for the 2nd Circuit affirmed a lower court's order returning the suit to Kentucky from New York's Southern District, where Purdue wanted the case heard. The suit was filed in Pike Circuit Court, in Kentucky's easternmost county.

"After years of delay tactics, Purdue will now answer to a Kentucky court and a Kentucky jury," Attorney General Jack Conway said. Purdue Pharma spokeswoman Libby Holman said the company is disappointed by the decision, but now it is "fully prepared to vigorously defend this action on its merits, and we expect to prevail."

Then-AG Greg Stumbo and Pike County sued Purdue Pharma in October 2007, alleging that the company's "aggressive and deceptive marketing campaign saddled taxpayers with millions of dollars in social, health care and other costs," Laura Ungar of The Courier-Journal in Louisville reports. The suit also alleges the company misled health-care providers, consumers and the government about the highly addictive nature of OxyContin. The suit is largely based on admissions of guilt made by the company and several top-ranking company officials in a May 2007 Virginia federal court settlement. Purdue Pharma, its president, chief legal counsel and former medical director pleaded guilty to misleading doctors, regulators and patients about OxyContin during that case.

The nation's prescription-drug epidemic apparently began in the region, largely because of the introduction and high rate of prescription of OxyContin. Kentucky has nearly 1,000 overdose deaths a year. Conway's office said the suit against Purdue Pharma seeks reimbursement for drug-abuse programs, law-enforcement actions and prescription payments through Medicaid and the Kentucky Pharmaceutical Alliance Program. (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

Medicaid recipients displaced by tornadoes can get emergency 30-day refills of prescriptions

Kentuckians on Medicaid who were displaced by last week's storms can get a 30-day supply of needed medicine from their pharmacy, the Department of Medicaid Services announced yesterday.

The right to receive an emergency refill applies to residents living in Ballard, Bath, Carroll, Campbell, Grant, Grayson, Hardin, Johnson, Kenton, Laurel, Lawrence, McCracken, Magoffin, Martin, Menifee, Montgomery, Morgan, Muhlenberg, Ohio, Owsley, Pendleton, Rowan, Russell and Trimble counties. Those counties have declared a state of emergency.

The state's four managed-care organizations are informing pharmacies of the policy, which was part of an executive order signed by Gov. Steve Beshear last weekend. Medicaid recipients who are not enrolled with an MCO can also receive replacement medications at their pharmacy. Co-payments will be waived.

"Many Kentuckians depend on regular maintenance medications, like blood pressure pills, and skipping a few days could cause unnecessary hardship or possible poor health outcomes for some citizens," Beshear said. "This order will allow people to contact a pharmacist to restore their regular medications." (Read more)

Legislators hear from new managed-care firms; lawmaker rates their performance with a show of hands from pharmacists

Kentucky Health News

The three companies recently hired to manage Kentucky's Medicaid program outside the Louisville region defended themselves yesterday against complaints that they are squeezing independent pharmacies to the breaking point. One of the three firms, Kentucky Spirit, fared better in a hearing held by a House-Senate committee before a crowd that included many pharmacists.

When Sen. Vernie McGaha, R-Russell Springs, "asked for a show of hands from pharmacists in the audience to learn which of the three pharmacy-benefits companies they think underpay on generic drugs, nearly everyone raised their hands for Medco Health Solutions, which is Coventry [Cares]'s partner, and Catalyst Rx, which is WellCare [of Kentucky]'s. No one seemed to object to US Script, which is Kentucky Spirit's partner," reports John Cheves of the Lexington Herald-Leader.

Kentucky Spirit is the only firm that continues to pay pharmacists a dispensing fee of $4.50 to $5 per prescription, the rate that had been paid by the state. WellCare pays $3, and CoventryCares $1 to $1.50, the pharmacists told Deborah Yetter of The Courier-Journal. "Pharmacists have told lawmakers at previous hearings that pharmacy-benefits companies sometimes pay less for generic drugs than it costs pharmacies to acquire them," Cheves notes.

Read more here: http://www.kentucky.com/2012/02/13/2067444/medicaid-managed-care-companies.html#storylink=cpy

Rep. John Will Stacy, D-West Liberty, left, whose business interests include co-ownership of at least two pharmacies, got into it with G. William Strein, Medco's vice president for provider relations. "Stacy cut off Strein several times while he was attempting to answer," Cheves reports.

“Why is it fair that you can reimburse us below costs?” Stacy asked Strein, who "disputed Stacy’s assertion and said managed care attempts to strike a balance between its estimated cost of the drug and the costs of the pharmacy to buy and dispense it," Yetter reports. "But that claim was disputed by some of the roughly 30 pharmacists at the hearing who operate independent drugstores. Though the hearing ended before they got a chance to testify, several said afterward that they intended to keep making their case before lawmakers."

Jason Wallace, owner of Grant County Drugs, told Yetter, “It’s a real burden for Kentucky pharmacists. That’s why I’m here.” All the companies told members of the Joint Program Review and Investigations Subcommittee that they are committed to resolving the problems.

"Much of Monday’s testimony was devoted to the complex pricing formula known as the maximum allowable cost, or MAC, that managed care companies consider proprietary," Yetter writes. "Under the Medicaid plan before managed care, the formula was provided to pharmacists, who said they knew what they would be paid. Now, they said, they don’t find out what a company will pay for a specific drug until they file claims. And too often, they say, it’s less than they paid to buy the drug.

“How would you like to go to a gas station and fill your car up with gas and then be told what the charge is?” Breckinridge County pharmacist Jonathan Van Lahr asked after the hearing. (Read more)

Kentucky Health News is a service of the Institute for Rural Journalism and Community Issues, based in the School of Journalism and Telecommunications at the University of Kentucky, with support from the Foundation for a Healthy Kentucky.

Pure hydrocodone pain pill in testing; critics worry about abuse

A new pain pill, one more powerful than OxyContin and 10 times stronger than Vicodin, is being tested on patients by four drug companies and could be out as early as 2013. The new medicine, which is a pure form of hydrocodone, has law enforcement in Eastern Kentucky worried, reports Ralph B. Davis of the Floyd County Times.

"In my personal opinion, a drug like that shouldn't be a prescription medication," Floyd County Coroner Greg Nelson told the Times. "It should strictly be an in-house medication."

Drug maker Zogenix of San Diego plans to apply early next year to begin marketing Zohydro, a time-released drug intended to manage moderate to severe pain, reports Chris Hawley of The Associated Press. The drug has completed three rounds of testing.

Critics worry abusers will simply crush the pill to get an intense, immediate high. "I have a big concern that this could be the next OxyContin," said April Rovero, president of the National Coalition Against Prescription Drug Abuse.

The companies defend the drug by saying pure hydrocodone "would avoid liver problems linked to high doses of acetaminophen, an ingredient in products like Vicodin," Hawley reports. "They also say patients will be more closely supervised because, by law, they will have to return to their doctors each time they need more pills."

But critics remain unconvinced and are worried about the larger ramifications of the pills being on the market. "Hydrocodone abuse is already a tremendous problem in Southern and Eastern Kentucky," Karen Kelly, executive director of the government-funded anti-drug program UNITE, told Davis. "When used properly, these medications help many who are experiencing moderate to severe pain. Unfortunately, we have seen how easily the system can be abused."

Davis expressed his own views in an editorial that ran earlier this week. "The pharmaceutical companies developing Zohydro and other copycat drugs clearly must know that their products will kill people," he wrote. "They see it happening every single day. And they have been warned that the problem is growing worse."

Davis referred to a report by the Centers for Disease Control and Prevention, which found that in 2008, an average of 40 people a day in the United States died as a result of prescription painkiller overdoses, a 400 percent increase over 10 years. "Meanwhile, the pharmaceutical companies raked in billions in profits, and financial speculators are taking note," Davis writes. "Since stories about concerns over Zohydro first began appearing over the weekend, Zogenix's stock has skyrocketing nearly 70 percent ... To put it bluntly, this is horrifying." (Read more)

As meds-for-meth bill languishes, some seek compromise, but bill's sponsor says proposals would render it ineffective

By Al Cross and Tara Kaprowy
Institute for Rural Journalism and Community Issues

As the bill to require prescriptions for three widely used decongestants remains short of votes to pass the Senate, there is talk of a compromise measure to thwart the use of the medicines for making methamphetamine. But the bill's sponsor says he is not open to the compromises he's heard.

"We want to go with something that works," said Sen. Tom Jensen, R-London. "What has worked is what they've done in Oregon and Mississippi. What they have done is make a controlled substance out of pseudoephedrine, ephedrine and phenylpropanolamine," and greatly reduced the number of meth labs.

Lobbyists for drug manufacturers are circulating alternative proposals, such as applying the prescription rule only to the estimated 5,500 people convicted of a drug-related crime. Another industry proposal would cut the annual non-prescription purchase limit by more than half, from 108 grams per year to 50.

Jensen dismissed those proposals, saying they would do nothing to curtail "smurfing," meth makers' use of people who are paid to buy ingredients. "Some of them are homeless, some of them are college kids, some of them come from poor backgrounds," Jensen said of the buyers. "They've got fake IDs, they've got GPS systems showing all the pharmacies in the area, and they'll hit them very quickly." He added, "Even trying to limit (per-month consumption) has created a whole other problem. We have a whole lot of people who are getting involved in criminal activity who probably don't even know it."

The current monitoring system keeps the decongestants behind the counter and requires buyers to register. Under federal law, individuals may not buy more than 9 grams of pseudoephedrine in a 30-day period.

Last week on the Jack Pattie Show on Lexington's WVLK-AM, Louisville drug officer Stanley Salyards said he would accept a bill that would require prescriptions only for pills containing the three decongestants, since making meth from gelcaps and liquid preparations is very difficult. Two other police officers on the program indicated agreement.

Jensen rejected that idea today, saying his Senate Bill 45 would apply to only 15 products, and "All the other cold and flu medicines are still out there."

A Senate committee approved the bill on a 6-4 bipartsan vote last week, but the full Senate has passed over it for more than a week, and Jensen acknowledged in today's interview that it lacks the votes to pass.

He said manufacturers of the 15 cold remedies "have spent a tremendous amount of money opposing it and getting a lot of misinformation out there ... We, unfortunately, don't have the funds to get out and make full-page ads and radio statements and TV commercials that say 'That's just not true.'" For example, the ads say the registration and tracking system is effective, but the law-enforcement officers on the radio show last week said it is not.

Opponents of the bill say having to get prescriptions would increase costs for cold and allergy sufferers, and meth makers would simply cross state lines to get their supplies. The opponents are backed not only by heavy spending, but by the Kentucky Chamber of Commerce. The Chamber has suggested "banning all online retail sales, distribution and shipment of products containing ephedrine and/or pseudoephedrine from non-Kentucky licensed pharmacies to individuals in Kentucky."

Rep. David Floyd, R-Bardstown, filed a bill last week to make the pill forms of the three substances “legend” drugs, those that are "available through the determination of a pharmacist or by prescription," reports The Kentucky Standard of Bardstown. "It would not be classified as a controlled substance." The bill would also prohibit purchases of any of the three medicines by anyone under 18 without a prescription.

“While many of us are sympathetic to those who have been adversely affected by the meth trade in Kentucky, I don’t believe making pseudoephedrine only available via a doctor’s prescription will curtail the meth problem in our commonwealth,” Floyd said in a press release. “By placing more responsibility on pharmacists who already have a monitoring system for pseudoephedrine sales, we can gain better control on those who are purchasing the product to make meth while not punishing those who need pseudoephedrine for legitimate health purposes.”

Floyd's House Bill 376, which he said he wrote after consulting with Bardstown pharmacists, would allow pharmacists to dispense the drugs to "a person evidencing physical symptoms treatable by those products," according to the bill summary, and "would require pharmacists to ask a series of questions to those trying to purchase a pseudoephedrine product," the Standard reports. It would also require thrm to put the information into the state's electronic tracking system for prescriptions.

"Local pharmacist Leon Claywell already uses a screening system to determine why a customer is buying medicine containing pseudoephedrine, Floyd said. If he thinks it is not for a legitimate purpose, he refuses to sell it," the Standard reports.

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)