Battle heating up over prescribing painkillers

By Matthew Perrone, AP

WASHINGTON — 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 this month. 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 “low-quality evidence.” They said they planned to file a formal complaint.

The CDC 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 Andrew Kolodny, co-founder of Physicians for Responsible Opioid Prescribing, a group working to reduce painkiller prescribing.

CDC Director 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 four-fold since 1999.

But industry-funded groups like the U.S. 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.”

The Washington Legal Foundation — a conservative group which frequently represents pharmaceutical interests in court — says CDC is in “blatant violation of federal law” for not disclosing its advisers. The foundation wants the CDC to scrap its current guidelines and start over.