When it comes to research on promising new classes of pain therapies, the agency must weigh its understandable caution regarding safety concerns against the unmet needs of millions of patients suffering with pain
By Michael C. Barnes
September 9, 2011
An estimated 116 million adults in the United States experience chronic pain, according to a report released in June by the Institute of Medicine of the National Academies. At the same time, the Centers for Disease Control and Prevention (CDC) has officially labeled prescription drug abuse a national epidemic. These dual public health concerns both of which cause inestimable human suffering in the United Statesare multifaceted and complex, and require serious, immediate attention.
The Food and Drug Administration (FDA) recently required the manufacturers of long-acting and extended-release opioid pain relievers to address the abuse, addiction, and overdose risks of their products by implementing coordinated Risk Evaluation and Mitigation Strategies (REMS). Communities can expect to begin seeing the results of these new requirements in the second quarter of 2012. The FDA action came after the agency undertook extensive yet time-consuming public consultations, and it reflected responsiveness to stakeholder input. Care and consideration are crucial to our nation’s success in reducing undertreated pain and prescription drug abuse, but so is speed. In that area, the FDA must improve.
Industry researchers are hopeful that a new class of pain therapies may be the most important development in pain treatment since aspirin came into general use at the end of the nineteenth century. The new treatments are injectable antibodies that block a protein called nerve growth factor (NGF), which is associated with pain and is often present in inflamed tissues, such as arthritic joints. Accordingly, the class is known as NGF-targeting antibodies, or anti-NGF drugs.
Pharmaceutical companies are conducting trials of NGF-targeting antibodies in treating cancer pain and chronic pancreatitis, though research suffered a setback in December 2010. The FDA placed a hold on clinical trials for other conditions, such as osteoarthritis, chronic low back pain, and diabetic nerve pain, after some patients in the trials needed joint replacements. Industry representatives speculate that the pain relief the therapies provided was so significant that patients increased their physical activity and accelerated damage to their joints.
In July, the FDA announced that it would meet with outside experts on its Arthritis Advisory Committee to seek their guidance on whether the reports of joint destruction represent a safety signal related to the anti-NGF class, and whether the FDA should permit industry to continue developing these drugs for use as analgesics. A month later, the agency postponed the meeting, citing a need for additional time to review new information. The FDA fulfills a crucial role in the United States by ensuring that the benefits of drugs outweigh their risks, but the agency’s sluggishness and risk aversion with respect to anti-NGF drugs are excessive in light of the urgent public health crises of undertreated pain and prescription drug abuse.
No one knows now what the experts on the Arthritis Advisory Committee will ultimately recommend to the FDA, but the public will also be permitted to comment at the rescheduled meeting. The perspectives of two vital stakeholder groups are already clear.
People in recovery, overdose survivors, and aggrieved families of victims of overdoses will eagerly tell the FDA that products showing promise toward treating pain without exposing patients and their communities to the risks of opioid diversion, abuse, addiction, and overdose must be researched with a sense of urgency. Similarly, people living with pain will urge the FDA to authorize and expedite research on therapies that could provide health care professionals another tool with which to help patients regain the ability to bathe and dress themselves, prepare their own meals, earn a living, enjoy their time with their families, and engage in other activities of daily living. Both of these communities stand to benefit when new FDA-approved medications whose risks are known and reported become available to prescribers and patients.
Individuals recovering from substance-related disorders are often counseled to strive for “progress, not perfection” in addressing the complex and multi-faceted issues that contribute to their disease. The FDA should heed that simple guidance as it seeks to address our nation’s dual maladies of undertreated pain and prescription drug abuse. Time is of the essence.
Michael C. Barnes is an attorney and policy advisor with DCBA Law & Policy, and serves as interim executive director of the not-for-profit Center for Lawful Access and Abuse Deterrence.
© 2011 Michael C. Barnes. All rights reserved. Printed with permission.
