High Wire is Maia Szalavitz's reported opinion column on drugs and drug policy.
The Drug Enforcement Administration (DEA) has one job: to keep controlled substances out of the hands of people who might misuse them. Admittedly, it’s an impossible job, given that the choice of which drugs are prohibited wasn't made rationally and they're left to enforce laws that are routinely flouted by nearly half of the adult population.
Still, there is one area in which they actually do control the supply of drugs—and that’s medicine. Here, the agency literally sets quotas that determine how many doses of controlled substances drug companies can sell each year.
Indeed, on September 11, the DEA announced that it will cut the prescription opioid supply by 53 percent for 2020, compared to the opioid supply that it allowed in 2016 .
(The supply has already been cut by 25 percent between 2016 and 2017 and another 20 percent between 2017 and 2018, meaning that this latest cut would likely be around 10 percent less than last year).
Yet even at this apparently easy part of drug control, they’ve failed utterly. The DEA allowed a massive expansion of opioid pain reliever sales over the last two decades—while keeping a stranglehold over medications used to treat addiction.
They’ve prosecuted hundreds of doctors but very few pharmaceutical executives. They’ve delayed and distorted cannabis research for decades. And, as the Washington Post revealed on Friday, the genuine efforts they did make to go after drug distributors were hamstrung by deep connections between an alliance of pharma companies and former DEA regulators, as well as highly effective lobbying. The process was corrupted.
We need a new and better way of regulating controlled drugs.
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The Post—which has been absolutely relentless on opioids lately—also showed in an extensive investigation, how, while the opioid crisis grew, the DEA continued to raise its opioid production threshold. Some expansion was likely necessary for improved treatment of pain and our aging population—but the supply didn’t expand proportionately or in any way in line with those needs.
Instead, certain regions—mainly the same ones that suffered outbreaks of overdose deaths and addiction—were inundated with staggering numbers of pills compared to the number of residents, even taking into account population variance in age and pain. Overall, the volume of opioid pills produced more than doubled between 2006 and 2012.
And the DEA knew exactly where the drugs were going: The Post’s reporting is based on data from a DEA database that it fought a year-long legal battle to keep it hidden from public view.
“It’s inexcusable that the DEA held onto data that would have been very helpful in terms of knowing where prescriptions were at the highest,” said Grant Smith, deputy director of national affairs for the Drug Policy Alliance, which supports modernizing drug laws.
“I think it’s willful neglect,” said Ronald Libby, professor emeritus of political science at the University of North Florida and author of The Criminalization of Medicine: America’s War on Doctors, which looks at how the DEA has historically targeted doctors rather than drug companies.
While pharma greed can certainly be blamed for much of the problem, far less attention has been given to the complete regulatory failure of the DEA.
The agency boasts of its pill-mill busts and increased prosecutions of physicians—but the data shows that it exerted precious little oversight higher up the chain. In street terms, it went after the guys selling $10 bags on the corner—not the kingpins or major distributors. And some of the docs they targeted were genuinely treating pain, not selling drugs.
“I think it’s horrendous that the DEA put all of its energy behind intimidating prescribers, which has been harmful,” Smith said. Targeting physicians has led scared doctors to cut off pain patients who need medication—while leaving people with addiction to turn to street drugs.
Libby added, “They go for the low-hanging fruit.”
Even worse, while allowing most medical opioids to flow freely, the agency has kept a death grip on the medications that treat addiction—enforcing regulations that keep methadone prescribing restricted to specialized clinics and that require strict oversight of physicians who prescribe buprenorphine. They have actually specifically targeted prescribers of the best addiction treatment medications we have.
Methadone and buprenorphine are the only two treatments for opioid addiction proven to lower the mortality rate from overdose by 50 percent or more.
Right now, any physician can legally prescribe all the Oxycontin she determines to be necessary. But if she prescribes buprenorphine to more than a specified number of patients, she can expect a visit from the narcs.
In fact, in going after addiction docs, the Federal Bureau of Investigation (which, in a redundancy with the DEA, also has some drug enforcement agents) raided the medical offices of the former head of the American Society for Addiction Medicine last year. In other words, even the guy who led the medical specialty society on addiction can’t be trusted to prescribe appropriately.
“Having the DEA involved in oversight related to opioid prescribing for pain and office-based opioid use disorder treatment with buprenorphine can have a chilling effect on physicians that risks harming both patients with pain and those with addiction,” said Sarah Wakeman, medical director of the Substance Use Disorders Initiative at Massachusetts General Hospital and an assistant professor of medicine at Harvard University.
Across the board, the DEA’s focus is wrong-headed. And I’ve not even mentioned the fact that drug policy experts (including me) predicted that simply cutting the medical supply of opioids without providing access to effective pain or addiction treatment would harm people—shifting some to a more dangerous street market, which would grow to meet their needs. That, of course, is exactly what happened.
The whole fiasco makes clear that a law enforcement agency is not an effective regulator of medicine. Yes, the medical opioid supply needs to be controlled—but the people who determine how much is necessary need to be physicians and public health experts, not cops. Cutting this supply must also done carefully—doing it too fast and without regard for population trends like aging can result in shortages that harm patients and even push some to the streets.
Yes, there needs to be oversight on the prescribing of opioid medications like methadone and buprenorphine—but, again, health professionals, not police, need to be in charge.
The Food and Drug Administration would be an obvious choice to regulate the entire controlled drug supply—and yet, they failed during the opioid crisis, too. By allowing excessive marketing and approving new drugs without appropriate warnings, the FDA, too, showed too much deference to industry.
At least they actually have the relevant expertise, however—and they recognize that addiction and pain are medical rather than moral problems. For the FDA, regulating pharma isn’t a backwater that takes a back seat to busting gangsters—as it has reportedly been seen by the DEA. It’s the agency’s entire mission.
An overhaul of drug regulation that puts public health professionals in charge—and gives them the power to determine medication quotas, tighten marketing and advertising rules and oversight of addiction treatment is long overdue. The influence of pharma on regulators needs to be much, much, much better checked, of course—but it’s not like the DEA even did that.
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