No matter how you slice it, the opioid epidemic is poison. Literally, in the wrong hands, the drugs themselves are poison. The rash of broken homes and deaths caused by their over-prescription is social poison. The after-effects of the epidemic were so severe that they handed Democrats the House when Republicans fumbled the ball, which, for the party in power, made them political poison.
And yet, somehow, not only are pharmaceutical companies making more of this poison, but the FDA is rolling over in the face of Pharma pressure and letting them come to market, sometimes without adequate safety review. In other words, not only is more poison being produced, but the FDA isn’t even bothering to check whether it’s anything other than poison.
Such is the alarming finding of a report from the FDA’s own opioids adviser, who accused his colleagues of massaging results of FDA tests to favor Big Pharma in the pages of the Guardian. That adviser, Dr Raeford Brown, lists the approval of the controversial new drug Dsuvia – an opioid ten times stronger than Fentanyl, the infamous drug that started the opioid crisis in the first place. According to Brown, FDA leadership has “learned nothing” from the opioid crisis, and remains committed to putting the interests of big pharmaceutical companies over real issues of public health – you know, the very thing that it’s the FDA’s mission to protect? This is exactly the sort of thing that gave Pharma the sociopathic confidence required to create the Opioid crisis in the first place.
It gets worse. Dsuvia may have been approved following a decision by FDA Chairman Scott Gottlieb that new opioids should be approved not based solely on their effectiveness, but also based on the “need” for them. By implication, then, the FDA thinks that what America needs is an opioid ten times stronger than Fentanyl. What bizarre, convoluted thought process could have led them to this conclusion is anyone’s guess, and Gottlieb himself should hold his colleagues to account.
Under any other FDA Chairman, this could well be a lost cause. But in this case, it wouldn’t be the first time Gottlieb stood up to Pharma companies. In November of 2017, Gottlieb issued a shot across the industry’s bow, warning them to try to stop gaming the FDA’s REMS process, by which generic drugs are approved. “End the shenanigans,” Gottlieb commanded, warning that if brand name companies didn’t come to the table on developing shared guidelines by which generics could pass muster, he’d start issuing waivers to generic companies to develop their own guidelines. In other words, play ball or I let the other team win.
Whether Pharma listened is a matter of some debate, and indeed, a cynic could argue that Gottlieb’s critique was no more than Kabuki theater, especially given the alarms some have raised about his own connections to the pharmaceutical industry. This opioid alarm bell is his chance to prove that he was serious about taking the industry one, and remains committed to the kind of tough reforms recently embraced by President Trump, Health and Human Services (HHS) Secretary Alex Azar, and even Senate Majority Leader Mitch McConnell and House Speaker Nancy Pelosi.
So hold your industry to account, Dr. Gottlieb. Stand athwart the pharma gravy train yelling “STOP.” Because America does not need more poison. And therefore, America does not need more opioids.