HealthLawProf Blog

Editor: Katharine Van Tassel
Case Western Reserve University School of Law

Friday, August 3, 2012

Legal Barriers to Effective Pain Control (Part One)


The under-treatment of pain continues to be a significant public health problem in the United States.  According to a 2008 article in the Annals of Oncology, “Nearly one of two patients with cancer pain is undertreated. “   Moreover, according to a report issued by the Institute of Medicine in in June 2011, “the medical costs of pain care and the economic costs related to disability days and lost wages and productivity amount to at least $560 billion to $635 billion annually.  Because the range does not include costs associated with pain in children or military personnel, it is a conservative estimate.”  Unfortunately, even as both acute and chronic pain is under-treated, opiods continue to be abused.  According to FDA Commissioner Margaret A. Hamburg, MD, ““Misprescribing, misuse, and abuse of extended-release and long-acting opioids are a critical and growing public health challenge,” 

Although the actual treatment of pain is a medical issue,  the law plays a significant role.  The FDA’s recent announcement of a risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioid medications” highlights the problem.     The initiative “calls on 20 companies that manufacture painkillers to fund training courses for doctors that will be taught by medical education companies. The goal is to reduce the risk of addiction and other health problems associated with opioids, while ensuring access to the drugs for patients in pain.”   These guidelines are, however, voluntary which is just fine with the American Academy of Family Physicians (AAFP) which rejects “mandatory “continuing medical education in pain control.   But it doesn’t go far enough according to “a coalition of doctors and public health officials” which is “petitioning the Food and Drug Administration” to go beyond education and actually “change the prescription guidelines for opioid medicines” to make it much more difficult for doctors to prescribe  “narcotic painkillers …in inappropriate cases.   “The petitioners say the prescribing of opioids has increased over the past 15 years, in response to a campaign by Purdue Pharma and other pharmaceutical companies that exaggerated the benefits of painkillers, while minimizing the risk of their long term use.”  The petition notes that, “Unfortunately, many clinicians are under the false impression that chronic opioid therapy is an evidence-based treatment for chronic non-cancer pain,” the petition says. “These misperceptions lead to over-prescribing and high dose prescribing. By implementing the label changes proposed in this petition, FDA has an opportunity to reduce harm caused to chronic pain patients as well as societal harm caused by diversion of prescribed opioids.”

The many conflicts of interest between the companies which manufacture these drugs, the doctors who want broad authority to use them, and the patients in need of pain control represent a serious problem and, I suggest, yet another example of the difficulty of providing wide-scale, quality care absent any ability to directly regulate the health care system.


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