Missing the Obvious

The LA Times recently ran a front-page special report on the toll taken by overdoses of narcotic prescription pain meds–15,500 deaths per year in the US, according to CDC figures. The report focused on the issue of physicians who overprescribe, and the need to identify those whose prescribing patterns may put patients at risk. That is a valid concern, some physicians may unintentionally overlook problems associated with combinations of painkillers, while there are some physicians who turn their practices into ‘pill mills.’ But the steps taken to circumscribe such practices can also make it difficult for patients with extreme pain conditions–associated with terminal cancer for example–to consistently access the pain meds they need to maintain even a minimal quality of life.

The annual toll taken is now roughly half the number of deaths due to automobile accidents in the US (32,310 in 2011). The auto death rate has in fact been greatly reduced (43,000 in 2005), largely through the development of vehicles that are safer, and protect their occupants more effectively. Yet this same strategy has been largely overlooked by the pharma industry.

The pharma industry has devoted some energy to devising narcotic med formulations that are less vulnerable to abuse, but that does not address the problems that come from analgesic combinations that can additively produce respiratory depression and death. The obvious answer would be to develop safer analgesics, but identifying nonnarcotic painkillers that can equal opioid efficacy has yet to pan out. The alternative is to add a molecule that makes narcotic analgesics less likely to produce respiratory depression–and in fact, Cortex Pharmaceuticals has Phase II data showing that one of their compounds does just that. Biovail saw enough promise in this project to partner with Cortex  back in 2010, only to have the program scuttled months later when Valeant acquired Biovail and divested their R&D. Since then, Cortex has been unable to find a partner–which is baffling, because it is a valid approach to a significant public health problem that has been otherwise unsolved. When NIR has occasionally brought this up in conversations with pharma companies, one could see their eyes glaze, or they would respond with concerns about the Cortex compounds that were based on outdated information.

This is not to outright dismiss the challenges of developing a combination narcotic/RD-preventing drug that will pass regulatory muster, but the FDA has in fact stated that the development of safer painkillers is a priority. This is a multi-billion dollar painkiller market, and a safer option would have clinical and regulatory advantages. Given that the pharma industry is allegedly seeking new opportunities for growth, they seem to be missing an obvious one here.

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