ARPO Response to the Obama Administration “Epidemic” Prescription Drug Plan

The recently released Obama Administration prescription drug abuse plan, correctly entitled “Epidemic” and appropriately labeling the problem a “crisis”, was sorely needed and long overdue. While the plan’s inclusion of enhanced education, monitoring, disposal, and enforcement is commendable, its failure to incorporate several critical components of truly effective prescription opioid reform is troubling to a number of medical and advocacy groups, including ARPO (Advocates for Reform of Prescription Opioids). These omissions are similar to those of the FDA’s earlier REMS proposal which was termed “inadequate” by its own Advisory Committee, and unless they are corrected, will significantly limit achievement of the Administration’s stated goals.

The first deficiency is the plan’s intent to assign the development of mandatory physician education in proper prescribing and management of these drugs to the relevant drug manufacturers. Many of these companies have already been disciplined by the government for product misrepresentation and unethical marketing practices, and the recent expose’ of their involvement with the University of Wisconsin Pain Group reinforces the reality that trusting drug manufacturers to ignore their obvious profit motive in designing physician training protocols is akin to the fox guarding the henhouse. Instead, only an independent, unbiased, credible, and scientifically expert entity such as Physicians for Responsible Opioid Prescribing (PROP) should be given this important task, one which should include non-pharmacologic treatment methods that have also been proven effective. 

An even more bothersome aspect of the Administration’s new plan is that it essentially ignores the central issue of the prescription opioid epidemic--the horrendous over-supply and over-availability of these drugs. Current prescribing indications permitting use of opioids for chronic non-cancer pain are not supported by research demonstrating effectiveness, while these drugs are known to embody significant lethality and addiction potential and many adverse side effects. The linear relationship over the last ten years between the relentless increase in prescribed opioid drugs and the rising morbidity and mortality attributable to them clearly demonstrates the fallacy of a plan focusing on the end of the “pipeline” rather than the beginning--ie, the supply. Restricting use of prescription opioids to short-term severe and cancer pain, and limiting their off-label use would effectively address this oversight without compromising availability of these drugs to those pain patients who meet evidence-based criteria and whose benefit from them outweighs their drawbacks.

Setting a goal of reducing the non-medical use of prescription opioid drugs by only 15% is the third disconcerting part of the Administration’s new plan. Even as a short-term objective, this anemic figure calls into serious question the government’s understanding of and commitment to reducing the public health and societal devastation represented by the prescription opioid crisis. It also raises anew the issue of the nature and extent of the relationship between the federal government and the pharmaceutical industry. Considering the degree of the prescription opioid crisis’ negative impact on the nation, the only acceptable goal should be to eliminate the non-medical and inappropriate medical use of these drugs. 

ARPO firmly believes that implementing the above two recommendations would constitute a good first step toward a degree of reduction more in keeping with the magnitude of the prescription opioid drug epidemic. ARPO, as a bi-national non-profit organization comprised of families, medical professionals, and other advocates in the U.S. and Canada, is dedicated to the regulation, marketing, prescribing, and use of prescription opioid drugs in an evidence-based and ethical manner. Its members have testified before Congress and the FDA, submitted Citizen Petitions and formal REMS proposals to the FDA, and formed coalitions with other similar groups to educate the public and the media about the myths and realities of prescription opioids. ARPO is irrevocably committed to eliminating the epidemic of death, addiction, and devastation caused by these drugs. 

Most recently, ARPO has collaborated with U.S. Representative Mary Bono Mack (Calif.), who has supported Congressional involvement as a needed and productive mechanism for prescription opioid drug reform, convened hearings on the opioid crisis, and introduced legislation to favorably impact the opioid epidemic.  www.rxreform.org 

Sponsor

Links