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November 15, 2010

Pursuing the pain problem

Rochester leads FDA initiative to speed development of pain-treatment therapies


While scientists have made great strides in understanding the physical and chemical processes that occur when people feel pain, new treatments with improved safety and effectiveness are still needed for the more than 76 million Americans with acute and chronic pain.

The U.S. Food and Drug Administration recently selected the Medical Center to lead a new initiative to accelerate the identification of improved pain treatments. Rochester was awarded a $1 million contract to launch the program—a partnership in which public and private organizations, including professional societies, patient advocacy groups, industry, and government, will collaborate on multiple projects to help bring more treatment options to patients.

“Today, the state of pain treatment is in crisis, as we continue to rely heavily on medications that have been around for thousands of years (opioids and nonsteroidal anti-inflammatory drugs) and that leave much to be desired in terms of safety and effectiveness,” says Dennis Turk, the John and Emma Bonica Professor of Anesthesiology and Pain Research at the University of Washington, who will work closely with researchers at Rochester on the new initiative.

Many studies testing experimental therapies have been conducted or are under way. The problem is that many trials fail because they are unable to show a new medication provides meaningfully greater pain relief than a placebo. Researchers believe the disappointing results of many recent studies can be partially attributed to the way pain treatment clinical trials are designed and carried out, which may hinder or limit their ability to distinguish effective pain treatments from less effective treatments or placebos.

“Clinical trials come at a great cost, take a substantial amount of time to carry out, and require significant effort from the patients who participate,” says Robert Dworkin, a professor in the Department of Anesthesiology and the Center for Human Experimental Therapeutics and director of the new initiative. “We need to understand why so many pain studies have failed to show efficacy so we can make changes that will increase the likelihood that future studies will identify new treatment options for patients who are suffering from pain.”

The partnership, known as Analgesic Clinical Trial Innovations, Opportunities, and Networks (ACTION), will analyze a wide range of clinical trials of treatments for acute and chronic pain, looking specifically at the approach and procedures used in each trial. Researchers hope to identify problems or gaps in trial design and implementation and find ways to bridge these gaps to speed the development of new safe and effective medications.

“One of the issues with pain is that it cuts across so many specialties—anesthesiologists, rheumatologists, emergency department physicians, and others are all interested in pain—and the result is that pain doesn’t really have a single home,” says Denham Ward, chair of the Department of Anesthesiology. “This initiative is crucial because it is bringing together all the key players in pain research and treatment, and the University of Rochester is proud to be leading this charge.”

In addition to the Medical Center, researchers and physicians from the American Academy of Neurology, American Academy of Pain Medicine, American Pain Society, American Society of Anesthesiologists, International Association for the Study of Pain and Outcome Measures in Rheumatology, as well as representatives from the National Institutes of Health, the U.S. Department of Veterans Affairs, patient advocacy organizations, and pharmaceutical companies such as Endo, Johnson & Johnson, NeurogesX, and Pfizer are participating in the initiative.

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