As discussed in recent Pain-Topics UPDATES [here] and [here], on July 25, 2012, Physicians for Responsible Opioid Prescribing, or PROP, submitted a Citizen Petition to the United States Food and Drug Administration (FDA) requesting labeling changes for all opioid analgesics when it comes to their prescription for noncancer pain. In fair balance, we extended to Andrew Kolodny, MD — president of PROP and a principal signer of the Petition — an invitation to submit for publication a rebuttal article commenting on our UPDATES and/or further presenting his group’s perspectives.
Dr. Kolodny promptly responded and we thank him for that. Following, is the text of an e-mail received from him this afternoon (8/8/2012, reprinted with permission), as well as the press release that he requested we reprint.
Stew [Stewart B. Leavitt, MA, PhD],
I would greatly appreciate if you could post the PROP/Public Citizen Press Release on the FDA petition [see below]. I think the press release makes clear that the purpose of this effort is to prohibit drug companies from promoting long-term use of opioids for conditions where use has not been proven safe and effective.
Please also let your readers know that the petitioners are not making a statement that long-term use of opioids for chronic pain or high dose opioids is always inappropriate. Several of the signers (myself included) prescribe long-term opioids. Our petition should NOT be interpreted as a manifesto on the appropriateness of long-term opioid prescribing for chronic pain. Instead, it should be understood as a request to FDA to better regulate the claims that opioid manufacturers can make about their products.
Stew — Your post (as well as others that have been critical of the factual statements included in the petition) suggests to me that you may be unfamiliar with the relevant federal law. The law places the burden on drug companies to prove that their products are safe and effective for the conditions that they promote them for. If drug companies want to make claims that opioids are safe and effective for long-term use in fibromyalgia, low back pain, migraines, etc., then they should do their homework and prove their case. It’s not the public’s responsibility to demonstrate the specific conditions where medications may not be safe and effective.
— Andrew [Kolodny, MD]
Here is the press release, posted at the Public Citizen website [here] on July 25, 2012…
Doctors, Researchers and Health Officials Call on FDA to Change Labels on Opioid Painkillers to Deter Misprescribing
Drug Companies Should Not Be Permitted to Advertise Long-Term Opioids for Non-Cancer Pain, Experts Say
WASHINGTON, D.C. – Labels on opioid pain medications should be revised to prevent overprescribing, a broad coalition of doctors, researchers and public health officials said in a petition filed today with the U.S. Food and Drug Administration (FDA). If the requested changes were adopted, drug companies would not be able to claim that the pain medications are safe and effective for long-term use by non-cancer patients.
According to the petition, opioid labels are overly broad because they fail to limit opioid use to severe pain, to include a time frame for use and to specify a maximum dose. Presently, the label on opioid analgesics simply states that they’re approved for “moderate to severe pain.”
The petition, available at http://www.citizen.org/documents/2048.pdf, is signed by 37 prominent experts, including leaders in the fields of pain medicine, addiction and primary care; health commissioners; researchers; and program directors at public interest groups.
The requested changes relate specifically to when opioids are used for non-cancer pain. The petition calls for striking the term “moderate,” adding a suggested maximum dose equivalent to 100 milligrams of morphine and adding a suggested duration of use. The petition’s co-signers believe that preventing drug companies’ aggressive promotion of these medications for moderate pain will help curtail overprescribing. According to the Centers for Disease Control and Prevention, excessive prescribing of opioid analgesics is fueling an epidemic of addiction and overdose deaths.
Drugmakers prefer a non-specific FDA-approved label because it allows them to encourage use of opioids for an indefinite period of time and for a wide range of common problems. The proposed label changes would have serious implications for drugmakers because federal law prohibits “off-label” advertising. Drugmakers wouldn’t be able to promote opioids for continuous long-term use by people who don’t have cancer.
The coalition of experts who signed the petition believes that the label must be changed to reflect existing medical evidence. The long-term effectiveness and safety of opioid analgesics has not been established by scientific studies, and recent research calls into question the safety and effectiveness of these drugs when used long-term, particularly at higher dosage levels.
The FDA typically approves conditions that a drug can be used to treat on the basis of clinical trials that are 12 weeks in length. In the case of opioid analgesics, Dr. Edward Covington, director of the Neurological Center for Pain at the Cleveland Clinic, believes that short-term studies like this are inadequate. According to Dr. Covington, “It’s clear that the short-term effects, on the basis for which they are approved and marketed, do not mirror their effects in long-term use. In the absence of long-term studies demonstrating safety and effectiveness, we need limits on what drug companies can claim about opioids.” Covington also believes that suggested dose limits must be added to the label “given the lack of experimental support for using high doses.”
Although the proposed label changes would limit the way drug companies promote opioid analgesics, doctors would continue to be able to make prescribing decisions based on their clinical judgment, assessment of patient needs and response to treatment. “Off-label” prescribing is considered appropriate, even though “off-label” advertising is prohibited. According to Dr. Jane Ballantyne, a pain specialist at the University of Washington in Seattle and a co-signer of the petition, “A form of constraint that controls overuse while preserving opioids for patients in need can only be a positive step towards more rational and safer prescribing.”
Dr. Lewis Nelson, an emergency physician and medical toxicologist at NYU Langone Medical Center, explained that “It’s time to close the loophole on opioid labels,” which he says amounts to “a mechanism that allows drug companies to promote opioids for unproven uses.” Physicians are wrong to assume that “on-label” indications are evidence-based with regard to safety and efficacy.
Over the past 15 years, Purdue Pharma, maker of OxyContin, and other opioid manufacturers have sponsored a campaign to encourage wide-scale, long-term prescribing of opioids for common chronic conditions like fibromyalgia and low back pain. Previously, doctors had been reluctant to use opioids long-term because they were worried about causing addiction. But company-sponsored education misled doctors to believe that addiction was rare and that withholding opioids was cruel.
“Over-prescribing of opioids is harming many chronic pain patients,” Covington said. “The label change is a way for the FDA to let the medical community know that risks may outweigh benefits when used long-term.” He continued, “The issue is tricky, because a subset of chronic pain patients benefit from chronic opioids, usually in low to moderate doses, and it is important that access is not restricted for those who show lasting benefit. The label change we’re requesting balances the need to preserve access for these patients with the need to reduce overprescribing.”
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