It’s the Illegal Products, Stupid

It’s the Illegal Products, Stupid

There’s an old joke about the drunk who’s hunting for his lost keys under the streetlamp, not because he thinks they’re there, but because the light is good. Well, that’s what federal and state officials are doing to address two recent major public health threats: opioid overdoses and vaping-related illnesses.

While creating the illusion that they’re “doing something” positive, policymakers and elected officials are looking for solutions in the wrong places. And not unwittingly, either.

The opioid problem is quite real, but legislators and regulators are making incorrect assumptions and adopting flawed strategies. In addition, there are some flawed clinical studies and statements by the U.S. surgeon general that conspire to create misapprehensions.

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 percent, a decline driven by a decreasing number of prescribers.

A February article in the journal JAMA provided additional evidence, concluding 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 for solutions in the wrong place.

The Real Problem Is Exacerbated By Unfocused Efforts

The actual 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.

Further, the feds misunderstand the role of opioids in providing relief from significant pain—such as from kidney stones, sciatica, broken bones, or cancer, which can be excruciating—but they are not entirely to blame. Academics have also contributed—for example, a widely read 2017 article in JAMA Network. 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 (Tylenol) and ibuprofen (Advil) are as effective pain relievers as opioids alone or opioids in combination with acetaminophen. They’re not.

Contributing to the misinformation, U.S Surgeon General Jerome Adams touted in a tweet the benefits of intravenous acetaminophen, citing a 54-person randomized clinical trial of pain control following rib fractures, which are notoriously painful.

The trial, which was conducted in an emergency department in Iran, compared intravenously administered Tylenol (1000 mg) and morphine (0.1 mg per kilo of body weight). Supposedly, the results showed that Tylenol relieved pain as well as intravenous morphine in patients with rib fractures—but even a cursory reading of the article, which was published in the obscure Iranian journal Emergency, reveals that it demonstrates no such thing. After being repeatedly ridiculed, Adams deleted the misleading tweet.

Bust Criminals, Not Patients

What the feds should be doing is cracking down on illegal prescribing and importation of opioids, not looking for solutions where the light is good.

A similar situation is to be found in the state and federal governments’ responses to the recent reports of vaping-related illnesses. There have been at least eight deaths and more than 500 severe acute pulmonary illnesses nationwide, from vaping a variety of black-market drugs. Vaping devices are used to inhale nicotine but some can also be used to deliver cannabis-derived substances such as THC- and CBD-containing oils, and butane hash oils, known colloquially as “dabs.”

Vaping devices, including e-cigarette hardware, are simply devices for delivering an aerosolized solution. E-cigarettes, which serve as a substitute for deadly cigarettes that burn tobacco, typically contain a solution of nicotine, flavorings, and vegetable glycerin or propylene glycol.

Globally, tens of millions of adult smokers have used billions of e-cigarettes such as Juul without any acute ill-effects. In fact, the FDA told state health officials that its lab testing of legal nicotine vape products obtained from sick patients (who likely also used black-market THC oil) found nothing unusual.

It’s a very different story, however, when a vaporizer is used to deliver black market street drugs like the cannabis-derived oils that are being dangerously adulterated with vitamin E acetate (as a thickening agent), which has been found in a very high percentage of the vaping devices used by people who have become ill.

A recent article in the New York Times described how the black-market cartridges for the devices are produced: “The operations buy empty vape cartridges and counterfeit packaging from Chinese factories, then fill them with THC liquid that they purchase from the United States market. Empty cartridges and packaging are also available on eBay, Alibaba and other e-commerce sites.” The THC liquid is then often cut with oily thickening agents like vitamin E acetate, before the cartridges are filled.

First Do No Harm

In announcing a ban on most nicotine-containing, flavored vaping devices, President Trump cited the first lady’s concerns about their teenage son being exposed to vaping devices. She is being misled. Vaping is an effective approach to harm reduction—choosing the less harmful among alternatives—and appealing flavors reduce the likelihood of backsliding to smoking cigarettes.

Exposure to nicotine is not healthy, to be sure, and kids should not vape (unless they already smoke cigarettes and want to transition to a less harmful alternative). But the parade of federal and state officials advancing their vendetta against e-cigarettes is irresponsible.

They cite the high percentage of teenagers who vape—a recent survey found that 27.5 percent of high school students had used an e-cigarette in the past 30 days—but fail to acknowledge FDA data showing that cigarette smoking, which carries a high risk of pulmonary disease and cancer, is only about 6 percent in that age group, a decrease of more than 80 percent since 1997.

That is epic harm reduction, but many public health officials and politicians continue to recommend the cessation of all vaping. That puts vapers’ lives at risk.

Why do politicians and public health officials behave so badly? They want to show that they’re “doing something,” even if it’s the wrong thing. Analogous to the opioid crisis, in order to curb vaping-related illnesses, we need aggressive enforcement by the FDA, DEA, FBI, and U.S. Postal Service against illegal products.

Henry I. Miller, a physician and molecular biologist, was the founding director of the Office of Biotechnology at the FDA. 

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Nothing contained in this blog is to be construed as necessarily reflecting the views of the Pacific Research Institute or as an attempt to thwart or aid the passage of any legislation.