Painkiller crackdown sparks industry blow back

http://thehill.com/regulation/healthcare/257204-painkiller-crackdown-sparks-industry-blowback

Healthcare industry groups are launching a preemptive strike against soon-to-drop federal guidelines meant to tamp down on the prescription of powerful painkillers.
 
The forthcoming guidelines from the Centers for Disease Control and Prevention are meant to combat the abuse of drugs like Hyrdocodone, Oxycontin and Percocet, which many medical experts believe are dangerously overprescribed.
 
Prescriptions for the drugs, known as opioids, increased by 300 percent from 1999 to 2013, according to the CDC, which cites statistics showing 16,000 people died from overdoses during that time.
As currently drafted, the guidelines recommend physicians use opioids as a last resort after non-pharmacologic therapies like exercise and a lower level pain reliever like Ibuprofen have been tried, according to a copy obtained by The Hill. They do not, however, pertain to treatments for end-of-life care.
 
But the American Cancer Society Cancer Action Network (ACS CAN) is pushing back against the effort, contending that the guidelines were developed with insufficient evidence and questioning the methodology and the transparency of the entire process.
 
“Our concerns are so serious that we cannot endorse the proposed guidelines in any way and suggest suspending the process until the methodological flaws are corrected and more evidence is available to support prescribing recommendations,” ACS CAN’s President Christopher Hansen wrote in a letter to the CDC earlier this month after the group was asked to weigh in.
 
Mark Fleury, policy development principal on emerging sciences for the group, said the guidelines might ultimately make it more difficult for people, like cancer patients who have legitimate pain, to get the opioids they need.  He said insurance companies will likely use the guidelines to set policies on when opioids will and won’t be covered.
 
He said they could even be used in litigation. If a patient, for example, sues a healthcare provider, the court might turn to the guidelines as the defacto expectation for treatment.
 
Though Fleury said he’d love to see doctors prescribe painkillers that aren’t as addictive or harmful as opioids to address chronic pain, they just don’t exist.
 
“This is what we have,” he said.
 
Other groups, like the American Academy of Pain Management, are raising concerns about conflicts of interest among the experts CDC used to draft the guidelines.
 
Bob Twillman, the group’s executive director, said some of CDC’s experts are members of Physicians for Responsible Opioid Prescribing (PROP), a group that advocates for more cautious opioid use.
 
“I don’t mind if people against opioids help draft the guidelines, but there needs to be a balanced representation of those against them and those that use them on a daily basis to treat patients,” he said. “They are dangerous, but it’s also true that there are many people who benefit from them and couldn’t live their lives if they didn’t have them, including many people with cancer.”
 
PROP, however, said its board members were asked to be part of the expert panel because they are experts in opioid use.
 
“The story here is how the opioid lobby is using the Cancer Action Network to discredit a public health effort to limit opioid prescribing,” Dr. Andrew Kolodny, the group’s executive director said.
 
The goal behind the guidelines is to recommend a more cautious approach to prescribing opioids, he said, not to try and take opioids away from the 10 to 12 million people who are taking them for chronic pain.
 
“There’s a lot of fear mongering that’s making these people panic and think that CDC wants to take opioids away from them and that’s not at all true,” he said.
 
In a statement to The Hill, CDC Spokeswoman Courtney Lenard said the core expert group members and peer reviewers were asked to disclose any circumstances that could represent a potential conflict of interest, meaning any interest that may affect, or may reasonably be perceived to affect, the expert’s objectivity and independence.
 
“Peer Reviewers disclosed no financial interests or other promotional relationships with the manufacturers of commercial products, suppliers of commercial services, or commercial supporters,” she said, adding that those who did report interests related to intellectual property, public statements and positions were “carefully” reviewed by the CDC’s guideline development staff.
 
Other pain experts said the guidelines are good, but only for treating patients who have never been prescribed opioids before.
 
“I don’t think a single policy will adequately deal with people currently taking opioids and those newly put on opioids,” Dr. Daniel Clauw, a professor of anesthesiology at the University of Michigan Medical School, said “They’re good guidelines for the latter.”
 
From a public health standpoint, Clauw said the federal government needs to do something, but it should be careful in taking a one-size-fits-all approach.
 
“I think the rules are really spot on for new opioid starts, but I think we need a different set or rules for people already on opioids,” he said.
 
The CDC said the guidelines are currently in development and are not intended to be use by clinicians until reviews are complete and the guidelines are released publicly. The agency said the final report will be published in CDC’s Morbidity and Mortality Weekly Report in early 2016.
 
“Prescription drug abuse and overdose is a serious public health issue and improving the way opioids are prescribed through clinical practice guidelines can ensure patients have access to safer, more effective chronic pain treatment while reducing the number of people who misuse, abuse or overdose,” Lenard said.

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