Institutes Of Medicine Pain Report May Aid Medical Device Makers

When the Institute of Medicine (IOM) released its report on chronic pain late last month, medical device makers cheered.

“A landmark report,” a Boston Scientific press release gushed.

“Chronic pain is a major public health issue, and we applaud Congress [and] the IOM…for their thoughtful recommendations,” Medtronic senior vice president Tom Tefft said in a statement.

Mandated by President Obama’s healthcare reform law, the IOM report laid out ways for the country to improve research and treatment of chronic pain, a condition that affects 116 million Americans.

So why such a big deal to medical device companies?

First, let’s start with the obvious. Pain management, through neuromodulation devices that shoot electricity into the nervous system, has become big business for medical device industry, especially its Big Three: Boston Scientific, Medtronic, and St. Jude Medical. Any high profile report that highlights a potential market of 100 million-plus patients is a good thing for those companies, especially as sales in core devices like pacemakers and implantable cardioverter defibrillators (ICDs) slows considerably.

Take Boston Scientific, based in Natick, MA. Neuromodulation was one of the few bright spots for the company in an otherwise dismal fiscal 2010. Sales of neuromodulation devices, including Precision Plus spinal cord stimulation (SCS) therapy, rose seven percent to $304 million from 2009 while cardiac rhythm management sales (pacemakers and ICDs) dropped 10 percent to $2.1 billion.

Medtronic, headquartered in Fridley, MN, has high hopes for its RestoreSensor SCS device, set to launch in the United States the first quarter of fiscal 2012. The company estimates a potential worldwide market of $1 billion for the device, which can adjust the amount of electricity it shoots into the spine depending on the patient’s position (walking, standing, lying down).

And earlier this week, St. Jude Medical, based in Little Canada, MN, said the Food and Drug Administration approved a limited release of its Epiducer lead (wire) system for SCS therapy. The system allows doctors to insert multiple leads into patient through one entry point.

But the IOM report is noteworthy for two other reasons.

First, the report declares chronic pain to be a “significant public health problem.” While this may seem fairly obvious to anyone who has ruptured a disc or endured arthritis, the declaration places the disease, which costs the country $560 million to $635 million a year, near the top of the country’s medical to do list .

Controlling chronic pain is of “enormous value to individuals and society,” the report says. “People with chronic pain should be recognized by family, employers, health insurers, and others as having a serious condition…The biomedical research community should pursue pain research with the same vigor expended on other serious and disabling chronic conditions.”

On that last point, the report recommends the federal government devote more research dollars to the National Institutes of Health. Perhaps more importantly to device makers, the report says the FDA should more quickly greenlight new treatments.

In case you haven’t heard, the FDA has not been too friendly to medical device makers these days. Ironically, the IOM is expected to issue a report this summer that calls for greater FDA scrutiny of new medical device applications.

The IOM pain report could nudge the agency to move faster on approving devices or at least new neuromodulation treatments. Some medical device makers, for example, are examining whether SCS can help treat migraine pain.

Don’t think so? Earlier this week, the Alzheimer’s Association Research Roundtable said it successfully lobbied the FDA to ease rules on clinical trials on promising drug candidates. In December, Congress passed a law (which Obama signed) that created a national strategy “to accelerate the development of treatments that would prevent, halt or reverse the course of Alzheimer’s” and “improve the early diagnosis of Alzheimer’s disease and coordination of the care and treatment of citizens with Alzheimer’s.”

The law’s language mirrors the IOM pain report’s recommendations nearly word for word.

The IOM report also seeks to broaden the country’s options beyond drugs, which have arguably dominated pain therapies. While recognizing the value of opiates like oxycontin and vicodin, the report acknowledged that some patients abuse the popular pain killers and that there are questions over their long term efficacy.

The report also criticized the lack of pharmaceutical innovation in pain relief.

“Academia and industry should develop novel agents for the control of pain,” the report says. “This does not mean simply recycling current drugs.”

Medical devices are unlikely to supplant drugs as the primary treatment for pain relief. However, suggesting patients have options beyond drugs can only help device makers.

“This report will be integral in raising awareness and removing barriers to appropriate care for Americans suffering from acute and chronic pain,” Michael Onuscheck, president of Boston Scientific’s neuromodulation division, said in a statement. “It also validates the positive clinical and patient outcomes we see every day that allow thousands of pain sufferers to return to more normal and productive lives.”

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