Nation/World

New painkiller standards intended to stem alarming rise in 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 ibuprofen and aspirin 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 federal Centers for Disease Control and Prevention ends months of arguments with pain doctors and drug industry groups, who had bitterly opposed the recommendations on the grounds that they would pose unfair hurdles for legitimate patients who have long-term pain.

In the end, the agency softened the recommendations slightly but basically held its ground, a testament to how alarmed policymakers 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, the director of the addictions program at West Virginia University, whose state has been a center of the epidemic.

"This is a very big deal," he added. "These prescribing practices have been an embarrassment for so long."

The national 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.

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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 CDC, 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, head of Physicians for Responsible Opioid Prescribing, which supported the guidelines. "It's one of the most significant interventions by the federal government."

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

"These will not be seen as voluntary," said Myra Christopher, director of the Pain Action Alliance to Implement a National Strategy, an alliance 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 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 drug tracking systems to make sure patients are not secretly getting medicine somewhere else. They do not apply to prescriptions for patients who are receiving cancer or end-of-life treatment, or to patients who have had major surgery.

Supporters said the guidelines could also affect dental practices. In a study of more than 2 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 example, 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 CDC said state laws would pre-empt the national guidelines because they are nonbinding.)

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

Robert Twillman, 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 previously threatened to sue the CDC 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 the organization was still reviewing its legal options but did not believe that the CDC had addressed its concerns.

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, arguing over whether tighter prescribing rules would penalize patients who need the drugs. But a soaring death toll — and new data showing risk — seems to have broken that logjam.

Frieden cited one study that found 1 out 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, 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."

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