Bold bid to rein in painkiller prescriptions hits roadblocks

Drug overdose deaths surge across US

WASHINGTON, Dec 19, (Agencies): A bold federal effort to curb prescribing of painkillers may be faltering amid stiff resistance from drugmakers, industry-funded groups and, now, even other public health officials.

The Centers for Disease Control and Prevention was on track to finalize new prescribing guidelines for opioid painkillers in January. The guidelines — though not binding — would be the strongest government effort yet to reverse the rise in deadly overdoses tied to drugs like OxyContin, Vicodin and Percocet.

But this highly unusual move — the CDC rarely advises physicians on medications, a job formally assigned to the Food and Drug Administration — thrust the agency into the middle of a longstanding fight over the use of opioids, a powerful but highly addictive class of pain medications that rang up over $9 billion in sales last year, according to IMS Health.

Critics complained the CDC guidelines went too far and had mostly been written behind closed doors. One group threatened to sue. Then earlier this month, officials from the FDA and other health agencies at a meeting of pain experts bashed the guidelines as “shortsighted,” relying on “lowquality evidence.” They said they planned to file a formal complaint. The CDC a week later abandoned its January target date, instead opening the guidelines to public comment for 30 days and additional changes.

Anti-addiction activists worry the delay could scuttle the guidelines entirely.

“This is a big win for the opioid lobby,” said Dr Andrew Kolodny, co-founder of Physicians for Responsible Opioid Prescribing, a group working to reduce painkiller prescribing.

Guidelines

CDC Director Dr Tom Frieden said politics did not play a role and the guidelines remain a priority.

“We want to make sure we don’t go so fast that there are questions about our process, but we certainly don’t want to see any further delay,” Frieden told The Associated Press.

Frieden said the FDA and other agencies support his effort, despite the negative comments from some officials. The Department of Health and Human Services, which oversees both the CDC and the FDA, said the guidelines are critical to “tackling the opioid epidemic.”

Frieden acknowledged the limited evidence comparing various treatments. “But there is no way we can wait for better evidence while so many people are dying.” Under the proposed guidelines, doctors would prescribe these drugs only as a last choice for chronic pain, after non-opioid pain relievers, physical therapy and other options. The CDC also wants doctors to prescribe the smallest supply of the drugs possible, usually three days or less for acute pain. And doctors would only continue prescribing the drugs if patients show significant improvement.

The CDC’s logic: Reshaping how primary care doctors use painkillers would result in fewer prescriptions and, therefore, fewer deaths. By its estimation, deaths tied to these drugs have surged more than fourfold since 1999.

But industry-funded groups like the US Pain Foundation and the American Academy of Pain Management warn that the CDC guidelines could block patient access to medications if adopted by state health systems, insurers and hospitals. Such organizations often look to the federal government for health care policies.

The CDC decision to delay its guidelines followed months of lobbying by physician and patient groups aligned with the pharmaceutical industry, who have almost always had a seat at the table in federal discussions on painkillers. As a result, they have had far more influence over federal policy than addiction activists, according to experts.

“They’re very well-funded and they have a lot of pharma money behind them,” said Dr Lewis Nelson of New York University, an FDA adviser who is also advising the CDC on its guidelines. “And then you have the anti-addiction groups on the other side, which is clearly much less funded and organized.”

Debate

Behind the CDC controversy is a decades-long debate over the use of opioids, which include medications like morphine and codeine and illegal narcotics like heroin. For most of the 20th century, doctors reserved opioids for severe, short-term pain — such as after surgery — or chronic pain from deadly diseases like cancer.

But in 1990s that changed, as some specialists argued the drugs could be used safely to treat common ailments like back pain and arthritis. The message was amplified by multimillion-dollar promotional campaigns for new, long-acting drugs like OxyContin, which was promoted as less addictive.

That drug’s maker, Purdue Pharma, later agreed to plead guilty and pay over $600 million in fines for misleading the public about OxyContin’s risks. But prescriptions continued to rise — along with deaths. Purdue declined to comment for this story. Deaths linked to misuse and abuse of prescription opioids climbed to 19,000 last year, the highest figure on record, according to the CDC. Heroin and opioid painkillers caused 28,650 fatal overdoses in 2014, or 61 percent of all drug-related overdose deaths.

CDC’s Frieden says more Americans are “primed” for heroin use because of their exposure to painkillers.

US deaths from drug overdoses hit a record high in 2014, propelled by abuse of prescription painkillers and heroin, the US Centers for Disease Control and Prevention said on Friday. Drug overdoses increased 6.5 percent in 2014 from a year earlier, killing 47,055 people. The highest rates of death from overdose were seen in West Virginia, New Mexico, New Hampshire, Kentucky, and Ohio, the CDC report said. Deaths from opioids such as prescription pain killers and heroin accounted for 61 percent of overdose deaths and increased 14 percent in 2014, the CDC said. “The increasing number of deaths from opioid overdose is alarming,” CDC Director Tom Frieden said Friday in a statement. “The opioid epidemic is devastating American families and communities.” Since 2000, deaths overall from drug overdoses have increased 137 percent while those from opioids have jumped 200 percent, the agency said. Half a million people in the United States have died from drug overdoses since 2000, according to the CDC. Deaths from prescription painkillers have been increasing for 15 years and there has been a recent surge in heroin-related deaths, tripling in the last four years, the CDC said. Lower heroin prices, wider availability and higher purity are causing more overdoses, the agency reported. It recommends stricter guidelines for prescribing pain killers, expanded availability and wider access to naloxone, an antidote for opioidrelated overdoses.