Over the past decade, the number of prescriptions for the strongest opioids has increased nearly fourfold, with only limited evidence of their long-term effectiveness or risks, federal data show.
It was the type of conversation that Dr. Claire Trescott dreads: telling physicians that they were not cutting it.
But Seattle’s Group Health, which Trescott helps manage, has placed controls on how painkillers are prescribed, like making sure doctors do not prescribe too much. Doctors on staff have been told to abide by the guidelines or face the consequences.
So far, two doctors have decided to leave, and two more have remained but are being closely monitored.
“It is excruciating,” said Trescott, who oversees primary care at Group Health. “These are often very good clinicians who just have this fatal flaw.”
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High-strength painkillers, known as opioids, represent the most widely prescribed class of medications in the United States. And over the past decade, the number of prescriptions for the strongest opioids has increased nearly fourfold, with only limited evidence of their long-term effectiveness or risks, federal data show.
“Doctors are prescribing like crazy,” said Dr. C. Richard Chapman, the director of the Pain Research Center at the University of Utah.
Medical professionals have long been on high alert about powerful painkillers such as OxyContin because of their widespread abuse by teenagers and others for recreational purposes.
Now the alarm is extending from the street to an arena where the drugs had been considered legitimate and safe: doctors’ offices where they are prescribed — and some say grossly overprescribed — for the treatment of long-term pain from back injuries, arthritis and other conditions.
Studies link narcotic painkillers to a variety of dangers, including sleep apnea, sharply reduced hormone production and, in the elderly, increased falls and hip fractures. The most extreme cases include fatal overdoses.
Data suggest that hundreds of thousands of patients nationwide may be on potentially dangerous dosages, and there is a growing resistance to their creeping overuse.
But changing old habits can be difficult — for doctors and patients alike.
The most aggressive effort is under way here in Washington, where lawmakers last year imposed new requirements on doctors to refer patients taking high dosages of opioids — which include hydrocodone, fentanyl, methadone and oxycodone, the active ingredient in OxyContin — for evaluation by a pain specialist if their underlying condition is not improving.
Even before the new provisions took effect, some doctors had stopped treating pain patients, and more have followed suit. Christine Link, 50, said that several doctors had refused to refill the prescription for painkillers she had taken for years for a degenerative joint disease.
“I am suffering, and I know I am not the only one,” she said.
Washington state officials acknowledge some of the law’s early deficiencies, including its sometimes indiscriminate application, and they are seeking to address them. The federal Centers for Disease Control and Prevention has urged doctors to use opioids more judiciously, pointing to the easy availability of the drugs on the street and a mounting toll of overdose deaths; in 2008, the most recent year with available data, 14,800 people died in incidents involving prescription painkillers.
The Departments of Defense and Veterans Affairs are trying new programs to reduce use among active-duty troops and veterans. Various states are experimenting with restrictions, including Ohio, which is considering following the Washington model.
The long-term use of opioids to treat chronic pain is relatively new. Until about 15 years ago, the drugs were largely reserved for postoperative, cancer or end-of-life care. But based on their success in those areas, pain experts argued the medications could be used to treat common kinds of long-term pain with little risk of addiction.
At the same time, pharmaceutical companies began to promote newer opioid formulations like OxyContin for chronic pain that could be used at greater strengths than traditional painkillers. Sales of painkillers reached about $8.5 billion last year, compared with $4.4 billion in 2001, according to the consulting firm IMS Health.
Along with Purdue Pharma, the maker of OxyContin, other producers include Johnson & Johnson and Endo Pharmaceuticals.
Dr. Russell K. Portenoy, who championed the drugs’ broader use, said the new data about the potential high-dose risks were concerning. But he added that the medications were extremely valuable and that their benefits needed to be factored into policies such as the one in Washington state.
“I don’t think opioids need to be thought of any differently than any other therapies,” said Portenoy, chairman of the pain-medicine and palliative-care department at Beth Israel Medical Center in New York. “It is just that right now, they have got our attention.”
A pain expert in Seattle, Dr. Jane C. Ballantyne, said she once agreed with Portenoy, but she now finds herself in the role of former believer turned crusading reformer.
“We started on this whole thing because we were on a mission to help people in pain,” she said of the medical profession’s embrace of opioids. “But the long-term outcomes for many of these patients are appalling, and it is ending up destroying their lives.”
The clues were buried in the dullest of places: thousands of workers’ compensation claims.
In 2006, a Washington state official, Dr. Gary Franklin, called together 15 medical experts to discuss some troubling data found in the records.
Thirty-two injured workers who were prescribed opioids for pain had died of overdoses involving the drugs. In addition, in just a few years, the strength of the average daily dose of the most powerful opioids prescribed to patients treated through the workers’ compensation program had shot up by more than 50 percent. The number of patients taking the drugs in large quantities had grown to 10,000.
Doctors often increase opioid dosages because patients can adjust, or develop tolerance, to the drugs and need greater amounts to get the same effect. Pain specialists, including Portenoy of Beth Israel, had argued that it was safe to increase dosages so long as doctors made sure that patients were improving.
But the Washington data suggested that doctors were not monitoring patients; they were simply prescribing more and more. Such practices are common, said Trescott, the official at Group Health in Seattle, because treating pain patients, who are often also depressed or anxious, is time-consuming and difficult.
“Doctors end up chasing pain” instead of focusing on treating the underlying condition, she said.
In 2007, the Washington state panel approved a guideline that urged doctors to refer patients on large dosages for evaluation if they were not improving. Two professional groups representing pain specialists had already taken a similar step. But the Washington action had an important difference that soon proved contentious: It set a dosage level meant to prompt the referral.
A cycle of abuse
The state law has transformed the clinic at the University of Washington into a pain-treatment center of last resort — and Ballantyne, the pain expert, into an appeals judge of sorts because she sees patients referred for evaluation under the law. On a recent day, she was seeing a stream of castoff patients, including Link, who sat hunched in a wheelchair, suffering from a degenerative joint disease.
“They all said that I can’t treat you; you need to see a specialist,” Link said of her other doctors.
Before the widespread use of opioids, the University of Washington’s medical school was known for an approach to chronic pain that emphasized nondrug treatments such as physical therapy and counseling. Some specialists, like Ballantyne, are now determined to revive that tradition.
“If doctors understood how hard it is to get patients off of these drugs, they would not prescribe them to begin with,” she said.
Ballantyne, 63, once embraced the wider use of opioids. Her transition to skepticism began about a decade ago, when she noticed that hospitalized patients taking high dosages screamed when they were examined — as if the drugs had increased their sensitivity to pain.
She decided to research long-term data about the drugs and published a medical journal article in 2003 with her findings. It concluded that high doses might not be safe or effective.
Other experts accused her of undercutting years of effort to erase stigmas about the drugs. Since then, other researchers have published papers about the drugs’ medical dangers. Studies have shown, for example, that the drugs greatly suppress the production of sexual hormones.
“It is not just our sex lives that go away; it is our ability to get things done,” said Chapman, of the University of Utah.
Portenoy, the expert in New York, agreed that doctors needed to be aware of such risks. But he said that the dosage threshold used by Washington officials was arbitrary and that the state had failed to put a system in place to evaluate the law’s impact on patients.
A patient advocacy group, the American Pain Foundation, which receives much of its financing from drugmakers, has continued to oppose the law, calling it “inhumane.” And even some supporters believe it needs reworking.
Big health-care systems such as Group Health, which treats 420,000 patients at 25 clinics throughout Washington state, can oversee how doctors prescribe drugs and provide patients with alternative treatments. Over the last four years, Group Health has cut the percentage of patients on high opioid dosages in half, the system says, and reduced the average daily dose among patients who regularly take opioids by one-third.
The system is now examining how those changes have affected patients. Studies elsewhere suggest the benefits of lower opioid use may be significant for many patients. For example, Danish researchers have published a study indicating that chronic pain patients getting nondrug treatments recover at a rate four times as high as those on opioids.
“These drugs don’t seem to be even doing what they are supposed” to do, said Dr. Per Sjogren, a pain expert in Copenhagen who led the study.
The obstacles to lower opioid use remain formidable, however; both insurers and public agencies must be willing to pay for other treatments, which can be costly.
“You can’t just take things away,” said Dr. Roger Chou, an associate professor at Oregon Health and Science University in Portland. “You have to give patients alternatives.”