America has a serious problem with prescription pain medication. According to the Department of Health and Human Services, a staggering 78 Americans die every day -- around 28,600 a year -- from overdoses involving opioid-based painkillers. Those deaths are the most obvious human toll of an epidemic with healthcare and social costs to the country topping a whopping $55 billion each year.
On Thursday, the Food and Drug Administration took an unprecedented step in an attempt to finally stem that lethal and expensive tide. Specifically, the FDA requested that Endo Pharmaceuticals (ENDP) voluntarily remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. If Endo refuses this request, the FDA plans to withdraw the drug's approval.
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This hard line stance comes after a review of Opana ER's post-marketing data that revealed a shift from nasal to injected routes of abuse after the drug's reformulation. As an added kick in the pants, this uptick in injection abuse was also tied to a serious outbreak of HIV and hepatitis C infections among users, according to the agency.
As Opana ER provided about 4% of Endo's annual revenues last year, the drugmaker's shares dropped by as much as 13% in afterhours trading on the back of this news. But the arguably more pressing issue is the FDA's questionable decision to go as far as removing an approved pain medicine from the market due to its wholly unintended use by some patients -- especially since there is no clear-cut replacement for individuals who suffer from chronic pain that doesn't respond to other medications.
Is cannabis the answer to America's raging opioid epidemic?
Where available, medical cannabis is already being used to treat a variety of conditions, including chronic pain. Most importantly, though, a recent study found that medical cannabis use was associated with a jaw-dropping 64% decrease in opioid use, a sizable decrease in unwanted side effects stemming from prescription painkillers, as well as a healthy uptick in quality of life among the study's participants. The researchers also noted that patients were essentially substituting cannabis for their prescribed opioid-based drugs in large numbers.
Equally as important, the peer-reviewed scientific research so far has shown that medical cannabis is also far less prone to abuse than opioid-based painkillers. A study conducted by two leading pain clinics in Israel, for instance, found that chronic pain sufferers were far more likely to engage in problematic levels of use with opioids than with medical cannabis.
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Of course, the real question is whether medical cannabis can effectively treat chronic pain, and thus displace highly addictive pain medications. While the jury is still out on this because of the political and regulatory roadblocks that make cannabis research nearly impossible in the United States, the fact of the matter is that opioids don't have a great track record at controlling pain over the long term.
In fact, the physiological tolerance most patients eventually build up to opioid-based painkillers is one root cause in doctors prescribing ever more potent drugs like Endo's Opana ER that are indicated for patients who have essentially run out of other options.
What's next?
The current political climate in the U.S. doesn't seem to make this country fertile ground for research into medical cannabis for any indication. Even if it was, though, biopharma companies may not readily plow hundreds of millions of dollars into the clinical studies required to define its risk-reward profile in chronic pain suffers. Most ongoing studies, after all, have focused on cannabis-based derivatives aimed at conditions like epilepsy, where patients can't readily dose themselves during an attack.
For example, GW Pharmaceuticals and Insys Therapeutics both have active cannabis-based clinical programs in place, but each has chosen to pursue rare pediatric epilepsy disorders as their lead indications. And neither has delved deeply into the multi-billion dollar chronic pain market for a cannabis-based medicine -- presumably because of the ease with which patients can already obtain high-quality medical cannabis in areas where's it's legal to do so.
The cost of pursuing a cannabis-based medication that might displace opioids in the chronic pain setting, and make a real dent in the ongoing opioid crisis, likely outweighs any potential commercial benefits by a wide margin. If the numbers did work, after all, GW Pharmaceuticals and Insys, among others, would probably have robust clinical studies underway already, based on the sheer size of the chronic pain market.
Summing up, the FDA's decision to force Endo to take Opana ER off the market might be a popular move to make in light of America's out-of-control prescription painkiller problem. But it ultimately will do little to change the situation on the ground. After all, the one obvious alternative that already has some compelling scientific evidence in its favor -- medical cannabis -- currently lacks the support of politicians, regulators, and the pharma industry as a whole.
The FDA's unexpected and dramatic action against Opana ER therefore doesn't appear likely to be a terribly significant catalyst for the emerging medical cannabis industry -- even though, in an ideal world, it probably would be.
