Pubdate: Thu, 19 May 2016
Source: New York Times (NY)
Page: A1
Copyright: 2016 The New York Times Company
Contact: http://www.nytimes.com/ref/membercenter/help/lettertoeditor.html
Website: http://www.nytimes.com/
Details: http://www.mapinc.org/media/298
Authors: Gardiner Harris and Emmarie Huetteman

CONGRESS MIXES OPIOID MESSAGES

WASHINGTON - Ed White has had a devilish time getting his painkiller 
prescription filled for intense back pain since a federal crackdown 
on opioid sales battened down the pharmacy shelves at the Walgreens 
near his home in Port Richey, Fla.

Across the state in Fort Lauderdale, Maureen Kielian just put her son 
into a residential treatment facility to try to break his 
life-threatening opioid addiction. To suggest that the federal 
authorities have been too aggressive amid an opioid epidemic killing 
29,000 people a year is absurd, she said.

Faced with these competing stories, Congress has whipsawed between 
ensuring access to narcotic painkillers for people like Mr. White and 
addressing the addiction epidemic linked to those drugs, one that has 
become the leading cause of injury death, surpassing motor vehicle 
fatalities in 2013, according to the Centers for Disease Control and 
Prevention.

For now, Washington appears ready to allow opioid prescriptions to 
remain widely accessible, a victory for pharmacies, drug makers and, 
lawmakers say, consumers - and instead focus on the treatment of 
addiction, not its source.

The House and the Senate passed bills this spring that would, among 
other things, bolster prescription drug monitoring and treatment and 
abuse-prevention programs; fund drug disposal efforts; and assist 
states that want to expand the availability of the drug naloxone, 
which helps reverse overdoses. Even though their differences have yet 
to be worked out, lawmakers in both chambers are trumpeting those 
actions, banking on them to bolster their re-election prospects.

More quietly, Congress passed and President Obama signed a very 
different measure last month that curtailed Drug Enforcement 
Administration powers to pursue pharmacies and wholesalers that the 
agency believes have contributed to the epidemic.

Mr. White, 67, said the law was crucial. "The crackdown by the D.E.A. 
has gone too far," he said.

Advocates of a stronger response are incredulous.

"I'm shocked that Congress and the president would constrain D.E.A. 
from taking on corporate drug dealers in the midst of the worst 
addiction epidemic in U.S. history," said Dr. Andrew Kolodny, the 
director of Physicians for Responsible Opioid Prescribing and an 
addiction specialist. "This law allows opioid distributors to reap 
enormous profits and operate with impunity at the public's expense."

Congress's actions have sought to balance the conflicting demands of 
deep-pocketed chain pharmacies such as CVS and Walgreens and drug 
distribution companies like Cardinal Health and McKesson with the 
victims of an epidemic that has ravaged some of the poorest parts of 
the country - but also some of the most politically sensitive, like 
Ohio and New Hampshire.

Chain pharmacies and drug distributors say their businesses have been 
disrupted and profits hurt by D.E.A. investigators who have ordered 
immediate closures of pharmacies deemed regional destinations for 
addicts seeking a fix.

"The D.E.A. has employed the same disrupt-and-dismantle tactics to 
take down international drug cartels and other criminals as it does 
to combat prescription drug abuse," said John Gray, the president of 
the Healthcare Distribution Management Association, a trade 
organization for drug wholesalers.

But past and present agency officials complain that they were 
steamrollered by a powerful lobby.

"Under this law, the bad actors simply have to promise to be good, 
and we won't take them to court to punish them for what they've 
already done," said Joseph T. Rannazzisi, who retired in October 
after 11 years of directing the D.E.A.'s office of diversion control. 
"It's obvious that industry had a very strong hand in crafting this bill."

To its sponsors, the new law is an uncontroversial clarification of 
when the right to distribute controlled substances can be suspended 
or revoked, a matter separate from the opioid addiction fight. It 
also establishes a process for federal agencies to go through in many 
cases before distribution centers can be shut down, giving them 30 
days to rectify issues as they crop up in an attempt to reduce 
disruptions to patients.

Written by Representatives Tom Marino, Republican of Pennsylvania, 
and Peter Welch, Democrat of Vermont, it passed the House in April by 
unanimous consent, a month after the Senate approved its version 
without objection. The Senate measure was equally bipartisan, drafted 
by Senator Orrin G. Hatch, a conservative Republican from Utah, and 
Senator Sheldon Whitehouse, a liberal Democrat from Rhode Island.

"The D.E.A. has a big job," Mr. Welch said. "I'd like to see them not 
having to waste their time on protocol issues with distribution 
centers, because that's not where the problem exists."

In a statement, Mr. Marino said, "Until now, clear comprehensive 
legislation that protected patients' right to access necessary 
medication while stopping those who might abuse such drugs did not exist."

For all the self-congratulations over a recent rash of opioid abuse 
bills - the House passed 18 measures last week after the Senate's 
comprehensive version in March - Congress has yet to send a treatment 
measure to the president.

And lawmakers are steeling themselves for the real fight: how to pay 
for it. The issue has become a surprisingly potent one, with some 
vulnerable Senate Republicans running for re-election on their 
efforts to fight addiction and siding with Democrats in their chamber 
over House Republicans to make their point.

Senator Rob Portman, Republican of Ohio and a sponsor of the Senate 
bill, said his version was superior to the House's in two areas: 
addiction prevention and new sources of funding that do not siphon 
money from other programs.

And because many opioid addicts begin with prescription drugs, he 
said, Congress needs to approve some restrictions on who can write 
and fill prescriptions. The "one doctor, one pharmacy" provision in 
the Senate bill would cut down on doctor shopping and could counter 
any ill effects of curbing the D.E.A.'s enforcement power.

"That's really narrowing your choices to people who know you, know 
what you need," he said.

Trying to strike a balance between access for the needy and 
restrictions to prevent abuse has bedeviled the fight against the 
opioid crisis since its beginnings. But as the annual death toll from 
the epidemic soared, those calling for greater restrictions seemed to 
have gained the upper hand, with new guidelines from the C.D.C. and 
greater restrictions on popular narcotics finalized by the Food and 
Drug Administration.

The one law that has been enacted, called Ensuring Patient Access and 
Effective Drug Enforcement Act of 2016, gives those arguing for 
greater access to these medications an unlikely lift.

"It's a significant blow to D.E.A.'s enforcement authority, and that 
doesn't make any sense to us," said Carmen Catizone, the executive 
director of the National Association of Boards of Pharmacy.

As the lead agency in prosecuting a drug war that liberal and 
conservative politicians see as flawed, the D.E.A. has lost clout. 
The agency's growing efforts to combat opioid abuse have also meant 
clashes with the powerful lobbies of drug makers and pharmacists.

On Capitol Hill, Mr. Rannassizi became a symbol of the D.E.A.'s 
recalcitrance, particularly after he suggested that lawmakers would 
be "supporting criminals" if they passed the measure.

"This offends me immensely," Mr. Marino, a former prosecutor, 
responded to Mr. Rannassizi at a 2014 hearing on an earlier version 
of the legislation.

By passing the law, "Congress is sending the D.E.A. a message," Mr. 
Marino said to the agency's administrator, Michele M. Leonhart. "You 
should take a serious look at your regulatory culture and seek 
collaboration with legitimate companies that want to do the right thing."
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MAP posted-by: Jay Bergstrom