* DEA launches broadside against wholesalers, pharmacies
* Lawmakers, patients, physicians question strategy
* Critics say strategy is causing pain pill shortages
By Toni Clarke
June 16 (Reuters) - Pamela Storozuk, a petite 59-year-old, spent most of her career as a sales representative, dragging heavy suitcases filled with presentation materials. When her husband developed prostate cancer, she cared for him, often helping to lift him out of the bath or into bed.
Eventually, the strain on her back caught up with her. Today she has five herniated discs and relies on painkillers to function.
Over the past six months, however, the Fort Lauderdale, Florida, resident has found it increasingly difficult to get her medications. Her regular pharmacy is often out of stock, and others refuse to dispense painkillers to new patients.
“They look at you like you’re an addict, a lowlife,” she said.
Storozuk is one of thousands of Americans caught up in the U.S. government’s latest front in the war on drugs: prescription painkillers. From 1999 to 2009, the number of deaths from narcotic pain pills nearly quadrupled to 15,597, more than those from heroin and cocaine combined, according to the latest figures from the U.S. Centers for Disease Control and Prevention.
In response, the U.S. Drug Enforcement Administration has beefed up its efforts to block the diversion of prescription drugs to the black market, using many of the techniques it employs to combat illegal drug use: wire taps, undercover operations and informants.
Such efforts have helped it dismantle hundreds of “pill mills” - sham pain clinics that write thousands of prescriptions with few questions asked - as well as dozens of rogue Internet pharmacies.
Now the agency is using the same tactics to prosecute the legitimate pharmaceutical supply chain, which is required to maintain certain record-keeping and security protocols to prevent drug diversion.
Over the past three years, the DEA has stepped up its inspections and levied millions of dollars in fines against drug wholesalers for what it said were breaches of those rules.
In February, the DEA suspended the license of drug wholesaler Cardinal Health Inc to sell narcotic painkillers and other controlled substances from its center in Lakeland, Florida, saying it had failed to detect suspicious order volume from several pharmacy customers. Under a settlement, Cardinal has agreed not to ship controlled substances from the facility for two years.
Shortly afterward, the agency raided two CVS pharmacies and issued inspection warrants at a half-dozen Walgreen Co drugstores and a Walgreen distribution center.
“The techniques that law enforcement uses to combat drug traffickers, whether they’re Colombian organizations or Mexican cartels or Afghan drug lords, those techniques are very, very essential in combating prescription drug abuse,” DEA Administrator Michele Leonhart said in an interview.
But critics say applying the same strategy to the legitimate supply chain as to Colombian drug lords is ineffective and is also causing supply shortages that hurt pain patients.
“Going after a pharmaceutical manufacturer is not like going after the Medellin cartel,” said Adam Fein, president of Pembroke Consulting, which advises pharmaceutical manufacturers. “I don’t believe it is appropriate for the DEA to shrink the supply of prescription drugs, because it has unanticipated effects that have nothing to do with the problem.”
Florida has long been considered the epicenter of painkiller abuse, due to the spread of pill mills. But experts say those are only a small part of the problem.
“The majority of drugs that end up in the illicit trade come from otherwise well-meaning physicians who do not understand the consequences of their prescribing habits,” said former DEA agent Robert Stutman, whose Stutman Group management consulting firm designs substance abuse prevention programs.
Between 1991 and 2010, prescriptions for narcotic painkillers rose to 209.5 million from 75.5 million, according to National Institute on Drug Abuse.
Leonhart said that physicians, however, “now understand the problem.”
As prescription drug abuse has risen, the DEA has come under increasing pressure from Congress to show it is containing the problem. A report last year from the nonpartisan Government Accountability Office said the DEA had not shown its strategy was working and called for clearer performance measures.
Leonhart said the best benchmarks were and should be “quite similar to what we use on the nondiversion side, which is the disruption and dismantlement of the organizations and the networks, and we’re going in that direction.”
That has meant some changes at the agency. For one thing, Leonhart has begun breaking down barriers between the DEA’s nearly 5,000 special agents, who have focused on the illicit drug trade for most of their careers, and about 500 diversion investigators, who enforce rules covering handlers of controlled substances.
The agency has expanded its use of tactical diversion squads, which combine special agents, diversion investigators and local law enforcement officers to track down and prosecute prescription drug dealers.
Forcing the two sides to come together was not easy at first, Leonhart said, since special agents initially were reluctant to work on “pill cases.”
But the effort has shown some results. Asset seizures on the diversion side rose to $118 million in 2011 from about $82 million in 2009, Leonhart said.
Still, sending in tactical diversion squads to break up pill mills does not address the leaks occurring from medicine cabinets at home or the drugs passed along from friends and family. That is one reason the DEA is attempting to squeeze supplies at the wholesale level.
“Going after Cardinal has sent shivers up the distributor grapevine,” said John Coleman, a former DEA chief of operations. “Close a CVS pharmacy in Florida, and I guarantee every pharmacy within 500 miles will be checking their records.
“You don’t have to hit a horse with a whip,” he said. “You just have to show it to them once in a while.”
Pharmacists confirm that they are indeed fearful. Some are reluctant to take new painkiller customers. Others will only accept patients within a certain geographic area or refuse to accept cash.
“We turn away five or six people a day,” said Steven Nelson, owner of the Okeechobee Discount Drugs store in Okeechobee, Florida, and chairman of governmental affairs for the Florida Pharmacy Association.
Even large chains are leery. Walgreen spokesman Michael Polzin said that after looking into everything going on in Florida, “we’ve decided not to comment on our operations there at this time.”
CVS pharmacies across the state stopped filling prescriptions written by 22 of the top-prescribing physicians pending a review of their dispensing practices, according to court documents filed as part of the company’s dispute with the DEA.
The company declined elaborate on its actions, except to say that it will continue to monitor prescriptions for controlled substances and is “committed to supporting efforts to prevent drug abuse and keep controlled substances out of the wrong hands.”
Physicians are equally nervous. Many have stepped up patient monitoring, according to Storozuk’s physician, Dr. Martin Hale. That means more urine tests, more documentation, and more frequent “pill count” checks, where patients must go to the doctor’s office with their pill bottle to prove they have not sold or misused their medication.
“Every hour of the day I have concerns I’ll be audited, that my ability to take care of my patients and my family can be taken away, and I’m as legitimate as you can get,” said Hale, who has a private orthopedic practice a few miles from Fort Lauderdale and is an assistant professor at Nova Southeastern University. “You’re constantly watching over your shoulder, and it takes a toll.”
Over the past five years, Cardinal has cut supplies of controlled substances to more than 375 customers nationwide, including 180 pharmacies in Florida, it says.
Other wholesalers are similarly cautious. Rival AmerisourceBergen Corp says it now monitors orders for suspicious spikes of 20 percent to 30 percent in volume.
“All of us want to make sure that abuse is curtailed,” Chief Executive Officer Steven Collis said. But when it comes to the DEA’s requirements, he added, the rules have not always been clear.
Other wholesalers, pharmacists and physicians say they are also keen to help, but would welcome more communication from the DEA.
Leonhart rejects the notion that the DEA is uncommunicative. The agency repeatedly lays out its requirements in meetings and presentations, she said.
But John Burke, president of the nonprofit National Association of Drug Diversion Investigators, says the DEA behaves as though those it monitors are the enemy.
“The mindset is, these are folks we have to keep at arm’s length,” said Burke, whose organization tries to foster communication between law enforcement, regulators and industry.
The DEA’s strategy is also prompting new questions from Congress. Senators Chuck Grassley of Iowa and Sheldon Whitehouse of Rhode Island recently asked the GAO to study whether the agency’s actions are contributing to shortages of medications for pain patients.
Others say the DEA should not be in the business of regulating industry at all.
Scott Gottlieb, former deputy commissioner of the Food and Drug Administration, publicly fulminated against the DEA recently for tackling prescription drugs in the same way it pursues drug cartels.
“The problem is, the DEA may be the wrong enforcer here. It’s very difficult to separate appropriate use from illicit use with law-enforcement tools alone,” Gottlieb, who now sits on the board of biotechnology company CombiMatrix Corp, wrote in an opinion piece in the Wall Street Journal.
The DEA’s confrontation with wholesalers and pharmacies follows a public dispute with manufacturers over who was responsible earlier this year for shortages of certain stimulants used to treat attention deficit disorder.
The DEA strictly controls the amount of an ingredient in a potentially addictive drug that its manufacturer can obtain each year, based on projected needs of legitimate patients. Makers of the stimulants said the agency did not always authorize enough material in time for them to supply customers.
For its part, the DEA said the shortages resulted from unspecified business decisions made by the companies.
With all sides in the prescription drug fight blaming each other, nothing will be achieved without more communication and cooperation, Stutman says.
“We need to take some really bright people on each side of the issue and say: ‘Where do we start today to make this problem better?’” he said.
In the meantime, patients like Pamela Storozuk are struggling to function. She has not been able to find oxycodone for five months. Replacement drugs have made her sick and even those are now hard to come by. She has lost 20 pounds and is frequently in pain.
“It’s a horrendous problem down here for people like me who need the medication,” she said. “You can’t even imagine.”