How FDA & DEA Failures Contributed To The Opioid Crisis
The pharmaceutical companies have received their share of blame for the opioid addiction crisis—maybe not as much as they deserve, and maybe without the consequences that should have ensued—but they are not the only bad players responsible.
The reason we have regulators and regulations is that when a for-profit company is allowed to go about its business without oversight, then it tends to shade the line of acceptable and unacceptable behavior in its favor. We expect a company beholden to stockholders who want to see a quarterly profit each and every quarter to be more concerned with the bottom line than the good of consumers.
So it’s understandable that Big Pharma oversold its new, “safer” opioids. That doesn’t make it right, and it doesn’t excuse any wrongdoing if it happened, but if you stick your bare hand into a beehive, you can’t complain that you got stung.
What is not as understandable is why the Food and Drug Administration and the Drug Enforcement Agency let us stick our hand in the beehive, maybe even encouraged us to do so, by not doing more to monitor them, test their claims, and respond more quickly when it was clear that in practice there were more problems than they admitted.
How did this happen? First, when FDA and DEA officials leave their bureaus, they often go to work for the companies they used to oversee. Second, the bureaus in question get a lot of input from the companies in devising regulations—in some cases, they actually let the companies write the actual regulations and only rubber-stamp them.
Who is more to blame? The company who tried to get away with something, or the idiot who allowed it, aided it, abetted it?
According to The Associated Press, “In 2007, executives at Purdue, the maker of OxyContin, pleaded guilty to misleading the public about the drug’s addictive nature and agreed to pay $600 million in fines.”
That’s a lot for you or me but is a drop in the bucket for a company like Purdue. And they haven’t been as willing to admit responsibility in state lawsuits, citing its FDA approval as a shield for its conduct.
There’s a classic definition of chutzpah—the Yiddish term for extreme gall—that goes like this: a man kills his parents, then asks for leniency because he is an orphan. In like manner, Purdue funded an organization called the American Pain Society, which successfully lobbied the FDA for less restrictive OxyContin prescribing regulations. Then Purdue used the FDA regulations as a defense for the lax regulations for which it had lobbied.
The New York Post reported that Purdue ignored red flags—such as continuing to sell drugs to “two providers 48 times after law enforcement told Purdue the pair was responsible for significant interstate OxyContin diversion”, and to “another provider 31 times after the provider’s license was placed on restrictive probation related to high prescribing of controlled substances” according to a lawsuit.
It happens on the substance use disorder treatment side, too, with Alkermes, the maker of the drug Vivitrol—an injectable, monthly version of the opioid antagonist naltrexone—lobbied drug court judges to only allow use of its drug for medication-assisted treatment (MAT) despite two other drugs—methadone and Suboxone, a version of buprenorphine—having better overall drug rehab results.
Government critics frequently complain about government regulations. Some want less, some want more. What we need is better regulation. Keeping the entities to be monitored away from the regulators, and vice versa, both before and after government service, would be a start.
