* DEA launches broadside against wholesalers, pharmacies
* Lawmakers, patients, physicians question strategy
* Critics say strategy is causing pain pill shortages
By Toni Clarke
June 16 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
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
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
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
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
NOT THE MEDELLIN CARTEL
"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
PRESSURE FROM CONGRESS
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
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.
CULTURE OF FEAR
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
"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
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
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
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
Other wholesalers, pharmacists and physicians say they are
also keen to help, but would welcome more communication from the
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."