For the first time, the FDA is requesting that a drug maker remove its product from the market for public health reasons. Endo Pharmaceuticals’ Opana ER—an opioid designed to continuously manage moderate to severe pain—has already faced scrutiny for being easy to abuse via snorting. Turns out addicts aren’t too fond of the ‘extended’ aspect of the drug. To combat this, the company added a coating that made the drug harder to crush… so abusers injected it instead. Not only did this reformulation not meet the FDA’s standards of officially being abuse-deterrent, but the rise in injection abuse is also tied to an HIV/Hep C outbreak caused by needle sharing. God save us from people who mean well.
The formula for rising healthcare costs in the US is filled with a bunch of pointed fingers lately. One finger is being pointed at drug maker Kaléo (no, not that Kaleo) by pharmacy benefit manager Express Scripts. They’re suing Kaléo over its price hikes on a heroin/painkiller overdose treatment. According to Express Scripts, these hikes triggered price protection rebates owed to Express Scripts, which total around $14 million—most of the lawsuit. The PBM has successfully sued larger drug companies like Horizon, so Kaléo may be at a bit of a disadvantage here. Especially since Express Scripts could use the extra cash to deal with the fingers pointed at it, including one $15B lawsuit by its (soon-to-be former) largest customer, the insurance provider Anthem.
Like this guy, Ohio is not happy with a handful of drug-makers. On Wednesday, the state filed a lawsuit stating the drug-makers “helped unleash a health care crisis that has had far-reaching financial, social, and deadly consequences in the State of Ohio.” The targets of the lawsuit are Purdue Pharma, Endo Health Solutions, Teva Pharmaceutical Industries, Johnson & Johnson, and Allergan. The reason behind the lawsuit, according to the office of state Attorney General Mike Dewine, is that “the drug companies engaged in fraudulent marketing regarding the risks and benefits of prescription opioids which fueled Ohio’s opioid epidemic.” Lawsuits including this one could shape up similarly to those that hit tobacco companies in the 90’s, which saw states win settlements of over $200 billion.
A study published in Pediatrics last week demonstrated that many teens who abuse opioids start out being prescribed them for legitimate medical use. The bad side of that is pretty obvious, but there’s a good side to this revelation as well—knowing that physicians are integral to an important piece of this problem means that we can go about designing effective solutions for it. Like those “careful prescribing practices” we keep hearing about. Some more good news, this study and another published last week both report a decline in opioid misuse among youth. Keep fighting the good fight docs, and one day we’ll celebrate that the kids are alright.
One of the best ways to solve a problem is to remove the source. While the opioid epidemic will not be solved in one fell swoop (here’s where the term “fell swoop” came from), China is attempting to do its part, effective March 1. According to CNN, the country will ban four variations of the synthetic drug fentanyl, which can be “25 to 50 times stronger than heroin and up to 100 times more potent than morphine.” DEA officials have labeled this a “game-changer” as China is a primary supplier of illegal imports of the drug to the US. Another idea to stop illegal drug imports – we could just build a wa…never mind.