DEA's Hypocritical Marijuana Decision Ignores The Evidence

Do you know where caffeine comes from? What about acetylsalicylic acid, otherwise known as aspirin? How about digitalis? If you said “plants,” you get a gold star. Many plants make caffeine, the active ingredient in aspirin derives from willow bark, and digitalis, along with its cousin digoxin, are both used for heart conditions and come from foxglove.

These plants obviously had much to offer in terms of clinically effective therapeutics. Like any medical intervention, each one also has its side effects. Yet none of these side effects—which range from gastric bleeding to death—has led to these plants being classified as a Schedule I drug by the US Drug Enforcement Agency (DEA). And all of them are approved by the US Food and Drug Administration (FDA), sometimes in combination with each other. You can even grow the plants that make them in your yard, legally.

Of course, aspirin, caffeine and digoxin were never subjected to a relentless, decades-long “war” that marginalized nonviolent citizens from specific socioeconomic groups and led to mandatory sentencing laws that destroyed the lives of people using a drug that is less harmful than alcohol or tobacco. That war on cannabis really began in the early 20th century with strong racial overtones that have persisted to this day.

Relying on the fear tactics and uninformed attitudes of a century ago, the DEA—reportedly leaning heavily on the FDA’s conclusions about cannabis—has rejected a 5-year-old petition to reclassify the drug from Schedule I, which lists drugs like heroin, to Schedule II, which includes oxycodone.

Whether or not the decision helps or harms patients in the long run remains unclear, but it certainly reflects a dangerous and hypocritical throwback attitude about cannabis that will only add to distrust of governmental oversight agencies, making their decisions look like political or moral judgments rather than being evidence based.

After all, more than half of registered voters think cannabis should be legalized, and more than 89% favor allowing it to be medically prescribed. Popular vote shouldn’t determine these decisions, of course. But the public long ago saw through the smoke screen the government used for decades to justify criminalization. When promises of dire outcomes from use didn’t become reality and reports of benefits moved beyond anecdote and into dataland, the public in this case could see the evidence.

But DEA chief Chuck Rosenberg couldn’t. According to him, the long-delayed decision relied on the FDA’s conclusion that cannabis has no “currently accepted medical use” in the US. The DEA laid out its rationale in a letter:

… drug scheduling is unlike the Saffir-Simpson scale or the Richter scale. Movement up those two scales indicates increasing severity and damage (for hurricanes and earthquakes, respectively); not so with drug scheduling. It is best not to think of drug scheduling as an escalating “danger” scale – rather, specific statutory criteria (based on medical and scientific evidence) determine into which schedule a substance is placed.

I’m sure the governors of Washington and Rhode Island, among the addressees of the letter, appreciated that helpful note that the Richter scale is used for earthquakes. A governor of Washington State, in particular, might need this information.

But the important claim here is that this scheduling is based on medical and scientific evidence. A rundown of how different entities view the current evidence and their conclusions is available here. The general conclusion of the Canadian researchers who curated the information is:

There is sound evidence from animal experiments and well-designed clinical trials involving humans that cannabis and cannabinoids are effective for the relief of nausea/vomiting and certain types of pain, as well as for the stimulation of appetite. However, the evidence to date does not indicate that they are the best drugs to use for these purposes. Many studies have shown, for example, that for treating nausea and vomiting, cannabinoids are more effective than older medications such as phenothiazines (e.g., Stemetil®) or antihistaminics (e.g., Dramamine®), but appear to be less effective than newer antinauseants such as ondansetron and similar drugs.

So the evidence is good, but maybe they aren’t the best drugs, in the way that maybe acetaminophen is a good painkiller but maybe not the best for pain because, after all, we have oxycodone—which is Schedule II. Of course, acetaminophen is cheap and accessible and more often than not does the trick. Kind of like cannabis would if people could purchase it legally.

Two cannabis-derived drugs (dronabinol and nabilone) are already FDA approved for these uses, but both are orally administered. They work fine:

Many clinical trials have shown that both dronabinol and nabilone worked as well as or better than some of the weaker FDA-approved drugs to relieve nausea and vomiting.

The National Cancer Institute, which must not chat much with the DEA, also says:

Cannabis and cannabinoids may have benefits in treating the symptoms of cancer or the side effects of cancer therapies. There is growing interest in treating children for symptoms such as nausea with Cannabis and cannabinoids, although studies are limited.

So, yeah. There’s evidence. Without the counterweight of its sociocultural history, this evidence would be enough to propel cannabis into OK-ness and Schedule II status. In its letter, though, the DEA wrote that marijuana:

… does not have a currently accepted medical use in treatment in the United States, there is a lack of accepted safety for its use under medical supervision, and it has a high potential for abuse.

Meanwhile, everyone can continue to buy physiologically active and frequently contraindicated St. Johns’ Wort and even grow Hypericum perforatum, the plant from which we get it, legally in their yards.

Rosenberg, a former prosecutor, made waves in late 2015 when he referred to the potential medical use of marijuana as “a joke.” He contradicted his future 2016 self at the time, acknowledging that that “joke” actually does have medicinal promise:

There are pieces of marijuana — extracts or constituents or component parts — that have great promise” medicinally, he said. “But if you talk about smoking the leaf of marijuana — which is what people are talking about when they talk about medicinal marijuana — it has never been shown to be safe or effective as a medicine.

Rosenberg clearly isn’t comfortable with the scientific terminology here, struggling to find even the right word to describe active ingredients in cannabis: “pieces” or “extracts” or “constituents” or “component parts.” So it’s no surprise that he might not understand evidence or how inhalation delivery is, in fact, a legitimate therapeutic route that can minimize time to results and maximize systemic delivery and effects. Inhaling a drug for maximum efficacy isn’t by default “a joke.”

In many cases, that rapid systemic access and the reduced dose it allows are the critical factors that make the drug preferable. An example is the potential intranasal administration of benzodiazepines as a “rescue” intervention for intractable epileptic seizures. Basically, if you want fast-acting, fast-effective, fast-relief therapy without dropping directly into a vein, your options are the rectal route or the nasal/inhalation route. Which would you prefer?

Going through the nose gets straight to the brain in minutes, without having to go through processing in the liver and the delay oral administration can entail. With seizures, that kind of rapid effectiveness is important.

And guess what has been used for hundreds of years in seizure treatment? Yep. Cannabis. Yet somehow, the FDA is unaware of any “currently accepted medical use” of cannabis.  The “piece” of interest in epilepsy, as Evan Rosenberg (presumably no relation to Chuck) and colleagues note in a recent review, is cannabidiol, or CBD. Indeed, just a few days ago, Zynerba Pharmaceuticals announced enrollment of its first patients in Australia in a phase 2 trial of a CBD gel (ZYN002) for intractable focal seizures. In this case, the dosing is via skin, which, like nasal dosing, bypasses metabolism and gut breakdown and facilitates use of lower drug doses. No joke.

And then there’s the nausea and vomiting associated with cancer treatments. Have you ever tried to swallow anything in the midst of intense nausea and vomiting? The ability to inhale cannabis smoke or vapor bypasses that obstacle for those on cancer treatment, along with bypassing the liver, where metabolic products with side effects would otherwise be produced.

When taken orally, the effective “pieces” of cannabis don’t get into the system very easily, but they do so easily, rapidly and effectively through inhalation. The upshot is that people whose bodies desperately need nutrition and whose quality of life is vastly improved by an ability to eat … can eat. This administration route also allows rapid mitigation of the neuropathic pain that can accompany some treatments. A drug that lets people on cancer treatment eat and reduce pain and does so far more effectively with fewer side effects when inhaled is not a joke.

Meanwhile, any huckster can call something a supplement and imply that it “boosts the immune system” or cures cancer and do so with near impunity.

The possibility of getting a therapeutic into the system rapidly, without worrying about metabolic products and side effects or about delay in effectiveness, may be a “joke” to Chuck Rosenberg, but for people having seizures or pain or cancer-therapy-induced nausea, not one thing about it is amusing. The potential for cannabis-derived compounds as seizure medications deserves to be taken seriously, with more than a hand wave calling such a development “wonderful and welcome,” which is what the DEA says in its letter describing the current decision.

One welcome shift is that the DEA will no longer limit research production of marijuana to a single supplier, a facility run by the National Institute on Drug Abuse (NIDA), which has, according to the Drug Policy Alliance, interfered with researchers’ access through various logistical roadblocks:

We will continue to work with NIDA to ensure that there is a sufficient supply of marijuana and its derivatives (in terms of quantity and the variety of chemical constituents) to support legitimate research needs. This includes approving additional growers of marijuana to supply researchers. Details of this proposal to support legitimate research will be published in the Federal Register.

There’s nothing funny about the DEA’s decision to continue to make it difficult for people to access medical marijuana nationwide by prescription, which a shift to Schedule II would have achieved. Currently, federal law directly conflicts with laws in 24 states and the District of Columbia allowing medical marijuana prescription.

And there’s nothing funny about treating cannabis hypocritically as a plant in a class by itself, forcing it to meet a higher evidentiary standard than many many other physiologically active, easily purchased substances while still weighing it down with the fearmongering of the past.

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