Pubdate: Wed, 16 Mar 2016
Source: New York Times (NY)
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
Author: Sabrina Tavernise

NEW STANDARDS FOR PAINKILLERS AIM TO STEM OVERDOSE DEATHS

WASHINGTON - In an effort to curb what many consider the worst public 
health drug crisis in decades, the federal government on Tuesday 
published the first national standards for prescription painkillers, 
recommending that doctors try pain relievers like ibuprofen before 
prescribing the highly addictive pills, and that they give most 
patients only a few days' supply.

The release of the new guidelines by the Centers for Disease Control 
and Prevention ends months of arguments with pain doctors and drug 
industry groups, which had bitterly opposed the recommendations on 
the grounds that they would create unfair hurdles for patients who 
legitimately have long-term pain.

In the end, the agency softened the recommendations slightly but 
basically held its ground, a testament to how alarmed policy makers 
have become over the mounting overdoses and deaths from opioid 
addiction. Opioid deaths - including from heroin, which some people 
turn to after starting with prescription painkillers - reached a 
record 28,647 in 2014, according to the most recent federal statistics.

"It would be hard for me to overstate how thrilling it is to read 
these guidelines after all these years," said Dr. Carl R. Sullivan 
III, director of the addictions program at West Virginia University, 
whose state has been a center of the epidemic. "This is a very big 
deal. These prescribing practices have been an embarrassment for so long."

The guidelines are part of a growing backlash against practices 
developed two decades ago, when doctors across the country began 
prescribing opioids for routine pain amid claims by pharmaceutical 
companies and some medical experts that they could be used to treat 
common conditions like back pain and arthritis without addiction. 
Those claims ended up in court and were found to be false.

Since then, opioid painkillers like OxyContin, Percocet and Vicodin 
have become the most widely prescribed drugs in the country, with 
sales of nearly $2 billion a year, according to IMS Health, a 
research firm that collects prescribing data.

But the thinking about the drugs has changed, and the guidelines reflect that.

"It has become increasingly clear that opioids carry substantial risk 
but only uncertain benefits - especially compared with other 
treatments for chronic pain," Dr. Thomas R. Frieden, director of the 
C.D.C., said on a phone call with reporters.

"We lose sight of the fact that the prescription opioids are just as 
addictive as heroin," he said. "Prescribing opioids is really a 
momentous decision, and I think that has been lost."

The federal government has lagged the states in its response to the 
opioid epidemic. Many have already set out rules for doctors to 
follow, as have some professional medical societies. So proponents of 
national guidelines applauded their release, which they said was overdue.

"This is the first time the federal government is communicating 
clearly to the medical community that long-term use for common 
conditions is inappropriate," said Dr. Andrew Kolodny, the head of 
Physicians for Responsible Opioid Prescribing. "It's one of the most 
significant interventions by the federal government."

Although the federal guidelines are nonbinding, they are important 
because they are now the broadest blueprint in place addressing 
opioids use. Some observers said doctors, fearing lawsuits, would 
reflexively follow them, and insurance companies could begin to use 
them to determine reimbursement.

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"These will not be seen as voluntary," said Myra Christopher, the 
director of the Pain Action Alliance to Implement a National 
Strategy, a coalition of medical and patient advocacy groups focused 
on chronic pain care that had opposed the guidelines. "These will 
become the definition of the standard of care, because of the clout 
of the Centers for Disease Control."

The guidelines recommend what many addiction experts have long called 
for: that doctors first try ibuprofen and aspirin to treat pain, and 
that opioid treatment for short-term pain last for three days, and 
rarely longer than seven. That is far less than current practice, in 
which patients are often given two weeks' or a month's worth of pills.

The recommendations are meant for primary care doctors, who prescribe 
about half of all opioids but often have little training in how to 
use them. They call for patients to be urine tested before getting 
prescriptions and for doctors to check prescription tracking systems 
to make sure patients are not secretly getting medicine somewhere 
else. They do not apply to prescriptions for patients receiving 
cancer or end-of-life treatment, or to patients who have had surgery.

Supporters said the guidelines could also affect dental practices. In 
a study of more than two million patients undergoing surgical tooth 
extractions covered by Medicaid, the government insurance program for 
the poor, researchers at Harvard University found that nearly half of 
the patients were dispensed an opioid, including 61 percent of teenagers.

But some doctors groups were worried the guidelines would have 
unintended consequences for people like cancer survivors with 
continuing pain who were no longer able to get their medicine. The 
American Medical Association said in a statement "we remain 
concerned," saying the science justifying some of the recommendations 
was sparse, and that the guidelines conflict with some state laws. 
(The C.D.C. said state laws would pre-empt the national guidelines 
because the guidelines are nonbinding.)

Many groups who have vociferously opposed the development of the 
guidelines struck muted tones after their release.

Robert Twillman, the executive director of the American Academy of 
Pain Management, said "the numbers are still arbitrary," referring to 
the recommended limits for daily dosage and days of treatment, but 
added that "on the whole, it's not bad."

The Washington Legal Foundation, a conservative group that has 
represented pharmaceutical companies in legal cases, had threatened 
to sue the C.D.C. to block it from issuing the guidelines, saying 
that the agency had failed to follow federal rules in developing the 
proposal. Richard A. Samp, the group's general counsel, said Tuesday 
that it was still reviewing its legal options but did not believe 
that the C.D.C. had addressed its concerns.

Dr. Frieden said the guidelines were meant to be "a tool for doctors 
and for patients to chart a safer course," describing them as a 
benchmark for medical practice, not an unbending dictate.

For years, doctors, regulators and pain treatment advocates were 
deadlocked over how to address the opioid crisis. But a soaring death 
toll - and new data showing risk - seems to have broken that logjam.

Dr. Frieden cited one study that found one of every 32 patients 
started on opioid therapy at very high doses died of opioid-related 
causes about two and a half years after the first prescription.

"The urgency of the epidemic, its devastating consequences, demands 
interventions that, in some instances, may make it harder for some 
patients to get their medication," said Dr. Nora Volkow, the director 
of the National Institute of Drug Abuse. "We need to set up a system 
to make sure they are covered. But we cannot continue the 
prescription practice of opioids the way we have been. We just can't."

Jan Hoffman and Barry Meier contributed reporting from New York.
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MAP posted-by: Jay Bergstrom