Opioids: Bad Science, Bad Policy, Bad Outcomes

Henry I. Miller and Josh Bloom: There’s an old joke about the drunk who’s hunting for his lost keys under the lamppost, not because he thinks they’re there, but because the light is good. Well, that’s what the feds and state governments are doing to try to quell the epidemic of opioid addiction and overdoses.

The problem is quite real, but legislators and regulators are making incorrect assumptions and adopting flawed strategies. And then, there are some flawed clinical studies and statements by the U.S. surgeon general that conspire to create misunderstanding of the landscape.

For a start, the problem isn’t currently prescribed opioids, such as fentanyl, morphine, oxycodone, and hydrocodone. A study published earlier this year in the New England Journal of Medicine found that from 2012 to 2017, a time when the overdose death rate was markedly accelerating, the rate of opioid prescriptions in patients who had not previously used opioids fell 54%, a decline driven by a decreasing number of prescribers.

More evidence was provided by a February article in the journal JAMA, which concluded that “under current conditions, the opioid overdose crisis is expected to worsen — with the annual number of opioid overdose deaths projected to reach nearly 82,000 by 2025, resulting in approximately 700,000 deaths from 2016 to 2025.” But here’s the rub: In the predictive model, preventing prescription opioid misuse alone would have only a modest effect — a few percent — on lowering overall opioid overdose deaths in the near future.

In spite of such findings indicating that the crux of the problem is not physician-prescribed opioids but illicit fentanyl and its analogs smuggled from abroad, like the drunk in the parable the feds and state governments are looking in the wrong place.

The extant problem has been exacerbated by the law of unintended consequences and the law of supply and demand. As a result of federal policies, some of our most important and potent analgesics, including fentanyl, morphine, and hydromorphone, which are commonly used in patients with advanced cancer and for pain control after surgery, are now in shortage, according to the FDA. All of these drugs had their manufacturing quotas reduced by the DEA, as if, in any case, it’s the government’s business to tell companies what and what not to manufacture.

The feds misunderstand the role of opioids in providing relief from significant pain — such as from kidney stones, sciatica, cancer, or broken bones, which can be excruciating — but they are not entirely to blame. Academics have also contributed — for example, a 2017 article in JAMA Network by Chang, et al. The study is so poorly designed that we can only conclude that the investigators intended to get a desired, albeit inaccurate, result — namely, that acetaminophen (brand name: Tylenol) and ibuprofen (brand name: Advil) are as effective pain relievers as opioids alone or opioids in combination with acetaminophen.

If they were real, these findings would be hugely important, because opioids could be supplanted by widely used, over-the-counter analgesics. For that reason, it is worth enumerating the flaws — or, more precisely, tricks — in the study.

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The evidence continues to accumulate that the government’s opioid policies — and pronouncements — need adult supervision. We are not optimistic that it will materialize.
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Henry I. Miller, a physician and molecular biologist, is a senior fellow at the Pacific Research Institute. He was the founding director of the FDA’s Office of Biotechnology. Josh Bloom is the director of chemical and pharmaceutical science at the American Council on Science and Health. He has a Ph.D. in chemistry. Issues & Insights is a new site formed by the seasoned journalists behind the legendary IBD Editorials page.

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