Executive Order Rescheduling Cannabis Won’t Help Pain Patients Anytime Soon

By Crystal Lindell

This week, President Donald Trump signed an executive order that aims to reclassify cannabis as a less dangerous drug, but the move stopped short of making it federally legal.

The order directs Attorney General Pam Bondi to complete the process of reclassifying cannabis from an illegal Schedule I controlled substance to a Schedule III drug with lower abuse potential and accepted medical uses, in the same category as codeine and ketamine. President Biden started that process three years ago.

It’s important to note that moving cannabis to Schedule III will not legalize it for recreational use nationwide. And it will be up to the FDA to determine what an “accepted medical use” is for cannabis-based medicines.

The White House specifically mentioned chronic pain as one of the medical conditions that cannabis could help treat, noting that six in 10 people who use medical marijuana in the states where it is legal do so to manage pain.

"We have people begging for me to do this, people that are in great pain for decades," President Trump said. "I'm not gonna be taking it. But a lot of people do want it. A lot of people need it.

"The facts compel the federal government to recognize that marijuana can be legitimate in terms of medical applications when carefully administered. In some cases, this may include the use as a substitute for addictive and potentially lethal opioid painkillers. They cause tremendous problems. [Cannabis] can do it in a much lesser way. It can make people feel much better that are living through tremendous pain and problems." 

In addition to rescheduling, the Trump Administration is trying to expedite medical research so that CBD and hemp-based cannabis products can be legally sold nationwide. Those products are not FDA-approved, putting them in a legal limbo under federal law.

“In short, the current legal landscape leaves American patients and doctors without adequate guidance or product safeguards for CBD,” Trump said in a statement. “It is critical to close the gap between current medical marijuana and CBD use and medical knowledge of risks and benefits, including for specific populations and conditions.”

My hope is that pharmaceutical companies will finally be able to tap into cannabis’ full potential as a medical treatment and develop new drugs. Once they find the best ways to produce it, dose it, conduct clinical trials, and get FDA approval, then cannabis-based drugs could potentially help millions of pain patients. . 

Of course, that process could take years or perhaps even decades, so the odds are that many pain patients will remain reliant on CBD, hemp-based products, and marijuana dispensaries. That’s if cannabis is even legal in their state. 

Plus, whenever we do get pharmaceutical cannabis products, the next barrier will likely be price. Medical and recreational cannabis sold in dispensaries is more expensive than street supply, and I’m sure pharmaceutical companies will mark it up even more. But at least then it could be covered by insurance. 

Looking back, it seems obvious that cannabis should have never been classified as a Schedule I substance to begin with, as there are clearly multiple medical uses for it.

I am old enough to remember a time before any states had even legalized it, when the idea of it even being re-classified federally was a pipe dream.

I remember guys I knew in college in the early 2000s puffing away and going on and on about how one day marijuana would be legal. I would look at them with extreme skepticism. But as it turns out, they were basically right – at least in states like California and Colorado where recreational cannabis is legal. 

The Trump administration still has not made cannabis fully legal, but we are on track to see it happen.

Any time there’s a major change in the U.S. drug policy like this, it is worth noting how arbitrary much of it can be. Very little of it seems based on actual medical reasoning. It’s more about law enforcement and turning substances into villains.  

After all, if the stroke of a pen can move a drug from one controlled substances category to another — suddenly making them legal — perhaps the categories themselves are poorly designed. That logic follows when you see how the federal government handles things like opioids and kratom. You should not accept their reasoning at face value. 

We should all remain skeptical whenever the government tries to say any drug is inherently bad – especially when it tries to enforce such a classification with jail time and fines. Because clearly, their definition of “bad” and a medically-backed definition of “bad” are not the same thing.

What Rescheduling Will Mean for Marijuana

By Dr. Chris Meyers

The Drug Enforcement Administration announced in early 2024 that it would act on President Joe Biden’s call to reclassify marijuana, moving it from the tightly controlled Schedule I category that it has been in since 1970 to the less restrictive Schedule III status of the Controlled Substances Act. That triggered a long process of hearings and reviews that will not be completed until after the presidential election in November.

The news drew strong reactions from critics: 25 Republican lawmakers sent a letter to Attorney General Merrick Garland protesting any changes to federal marijuana laws. They argued that the decision “was not properly researched … and is merely responding to the popularity of marijuana and not the actual science.”

As a philosopher and drug policy expert, I focus on assessing arguments and evidence rather than politics or rhetoric. So, what are the arguments for and against rescheduling cannabis?

Scheduling Under Controlled Substances Act

The Controlled Substances Act places each prohibited drug into one of five schedules based on known medical use, addictive potential and safety. Schedule I drugs – which, along with marijuana, also includes heroin, LSD, psilocybin, ecstasy (MDMA) and quaaludes – is the most restrictive category.

Schedule I substances cannot be legally used for any purpose, including medical use or research, though an exception for research can be made with special permission from the DEA. The criteria for inclusion in the Schedule I category is that the substance has a high potential for abuse, is extremely addictive and has “no currently accepted medical use.”

Schedule II, which is slightly less restrictive than Schedule I, includes drugs that are addictive and potentially unsafe but also have some accepted medical use. These include strong opioids such as fentanyl, as well as cocaine, PCP and methamphetamine. Though they are still tightly regulated, Schedule II drugs can be used medically with a prescription or administered by a licensed physician.

Schedule III is much less restrictive and is intended for substances with legitimate medical use and only moderate risk of abuse or dependency. This category includes low-dose morphine, anabolic steroids and ketamine.

Schedule IV – which includes the sedative Valium, the weak opioid tramadol and sleep medicines such as Ambien – is even less restrictive.

The least restrictive category is Schedule V, which includes cough syrups with codeine and calcium channel blockers such as gabapentin and pregabalin. All scheduled drugs require a doctor’s prescription and can be distributed only by licensed pharmacies.

Schedule III Would Only Legalize Some Medical Use

The push to reschedule is largely to make federal laws consistent with state medical marijuana programs that – as of October 2024 – are legal in 38 states plus the District of Columbia.

Moving marijuana to Schedule III would not change its legal status in states where it is banned. It would make marijuana legal at the federal level but only for medical use. Recreational use would still be federally prohibited, even though it is currently legal in 24 states plus Washington.

Rescheduling, however, might not make medical marijuana any easier for patients to access and could even make it much harder for some. Currently, getting a medical marijuana card is quite easy in most states. In Washington D.C., where I live, patients can self-certify.

If marijuana is reclassified as Schedule III, medical marijuana programs will have to start requiring a doctor’s prescription, just like with all other scheduled substances. And it could be distributed only by licensed pharmacies, which would put medical dispensaries that are now selling it without a license from the Food and Drug Administration out of business.

Rescheduling, however, would give medical marijuana legitimacy as a bona fide medicine. And the intent of the move is to increase access, even if it is unclear how rescheduling would achieve that.

So, assuming that rescheduling would have the intended effect of expanding access to medical marijuana, should it be rescheduled?

Medical Uses of Marijuana

Though there are three criteria for Schedule I in the Controlled Substances Act, the DEA in fact relies on only the medical use criterion. This was the basis of the DEA’s proposal to reschedule marijuana. The fact that almost 75% of Americans live in a state with a medical marijuana program suggests that marijuana has an accepted medical use.

More importantly, Schedule III of the Controlled Substances Act already includes dronabinol, which is delta-9 THC, the active ingredient in marijuana. Although dronabinol is synthesized in the lab rather than extracted from the cannabis plant, it is the exact same molecule. The FDA approved THC in the form of dronabinol in 1985 for treating anorexia caused by HIV/AIDS as well as nausea and vomiting due to chemotherapy. Placing marijuana in the same schedule as its primary active ingredient makes a lot of sense.

Another argument in favor of rescheduling is that it would open up new opportunities for medical research into marijuana’s effects, research that is currently hampered by its Schedule I status. This work is critical because the system of cannabinoid receptors through which marijuana causes its therapeutic and psychoactive effects is crucial for almost every aspect of human functioning.

Research has shown that cannabis is effective not only in treating nausea and AIDS but also chronic pain and some symptoms of multiple sclerosis.

There is also good evidence that marijuana can help treat other conditions, including Lou Gehrig’s disease (amyotrophic lateral sclerosis, or ALS), glaucoma, irritable bowel syndrome, insomnia, migraine, post-traumatic stress disorder and Tourette syndrome. Keeping marijuana in the Schedule I category severely hampers research that might establish more effective treatments for these conditions.

Balancing Risks and Benefits

Those opposed to rescheduling cite possible health risks associated with marijuana consumption. Heavy use is linked to an increased risk of developing schizophrenia. However, the increased risk of schizophrenia from cannabis use is comparable to that caused by watching excessive television, eating junk food or smoking cigarettes.

Long-term marijuana use can also lead to sleep problems and diminished visuospatial memory. It can also cause gastrointestinal trouble, such as cannabis hyperemesis syndrome, which is characterized by nausea, vomiting and abdominal pain. The symptoms, while extremely unpleasant, are temporary and occur only after consuming marijuana. The condition disappears in people who stop using.

Marijuana use can also be addictive. According to the Centers for Disease Control and Prevention, about three out of every 10 regular marijuana users meet the diagnostic criteria for cannabis use disorder.

All of the concerns above are legitimate, though it is worth noting that virtually no effective medicine is free from undesirable side effects. And although marijuana can be habit-forming, it is not as addictive as alcohol, tobacco, oxycodone, cocaine, methamphetamine or benzodiazepines. None of those other drugs are categorized as Schedule I, and alcohol and tobacco are not scheduled at all.

Unlike most other prescription medications, marijuana use is associated with many benefits. For example, in states where marijuana has been legalized, worker’s compensation payments have fallen by an average of 21% among people over 40. Researchers think that this is because marijuana helps workers better manage chronic pain. The use of marijuana for pain management also helps to reduce dependency on opioids. One study found that U.S. counties with one or two marijuana dispensaries had an average of 17% fewer opioid-related fatalities compared with counties with no dispensaries.

Research also shows that marijuana use can help to prevent Alzheimer’s by blocking the enzymes that produce amyloid plaques. It also shows promise for reducing a person’s risk of developing Type 2 diabetes by helping the body regulate insulin and glucose levels.

All of these benefits add up to marijuana users having an overall lower rate of premature death than nonusers.

Chris Meyers, PhD, is an Adjunct Professor of Philosophy at George Washington University. His main area of research is in moral psychology, moral theory, and applied ethics/public policy. Meyers is the author of “Drug Legalization,” a textbook that looks at the pros and cons of prohibiting recreational drugs.

This article originally appeared in The Conversation and is republished with permission.

DEA Delays Decision on Reclassifying Marijuana Until After the Election

By Crystal Lindell

The Drug Enforcement Administration has likely eliminated any possibility of marijuana being rescheduled until after a new president is sworn into office next year. The agency will hold a public hearing on the matter on December 2nd —  nearly a month after the presidential election —  according to a notice published yesterday in the Federal Register. 

The hearing will help determine if marijuana should be re-classified under Schedule III of the Controlled Substances Act (CSA) from its current status as an illegal Schedule I substance. 

Moving marijuana to schedule III would place it in a category of drugs that are considered to have an accepted medical use. Rescheduling would also indicate that cannabis has less potential for abuse than Schedule I and II substances, with only moderate to low risk of physical or psychological dependence. 

But the DEA has also made it clear that rescheduling does not equal legalization, noting that “the manufacture, distribution, dispensing, and possession of marijuana would remain subject to the applicable criminal prohibitions of the CSA.” 

To make a cannabis-based medicine legal under Schedule III, the Food and Drug Administration would first have to approve it for a specific medical condition, which would likely require a lengthy clinical trial process that could take years to complete.

The National Organization for the Reform of Marijuana Laws (NORML), an advocacy organization that has long fought for cannabis to be legalized, says it’s not surprised that the DEA wants to have public hearings. 

“Hearings are an integral part of the rescheduling process. To think that the DEA, which historically has opposed any changes to cannabis’ prohibitive status, would sign off on the most significant proposed change in federal marijuana policy in over fifty years absent such hearings was always wishful thinking,” said NORML Deputy Director Paul Armentano.

“That said, the scientific evidence in favor of removing cannabis from Schedule I remains overwhelming. Cannabis clearly has legitimate therapeutic value and it possesses a superior safety profile compared to other Schedule I or Schedule II controlled substances.”

The Biden Administration initiated the regulatory process to review the scheduling of cannabis in late 2022, a review that has dragged on for nearly two years. The Department of Health and Human Services (HHS) recommended marijuana be moved to Schedule III in August 2023.

But the Justice Department and DEA Administrator Anne Milgram – who has the final say on rescheduling – have yet to approve the HHS recommendation.  The DEA published the proposed change in cannabis’ classification in May in the Federal Register. That notice drew over 43,000 responses during a 60-day public comment period, with numerous requests for a public hearing.

Seeing the process take so long is frustrating. With 38 states and the District of Columbia allowing medical cannabis, it’s clear that marijuana has a legitimate medical use – a fact confirmed by the HHS recommendation to reschedule. So why are the DOJ and DEA dragging their feet?  

Holding the public hearing after the presidential election also risks that it won’t be done at all, depending on who wins and what their policy preference is on the matter. 

Although Democratic nominee Kamala Harris is likely to continue President Joe Biden’s push to have marijuana reclassified, we can’t be sure what she would do. Republican nominee Donald Trump has also indicated in recent days that he favors “decriminalizing” marijuana, but we also don’t know with certainty what he would do. 

With so many states having already legalized the medical and recreational use of marijuana, it’s become increasingly clear that there are no compelling health-related reasons to continue classifying cannabis as a Schedule I controlled substance. And the longer the DEA delays changing marijuana’s status, the more it should make all of us question how much health concern there really is behind the Controlled Substances Act.

Public Comments Sought on Marijuana Rescheduling

By Pat Anson, PNN Editor

The U.S. public is finally getting a chance to comment on the federal government’s historic decision to reclassify marijuana from a Schedule I substance with a “high potential for abuse” to a less restrictive Schedule III drug with “moderate to low potential for physical and psychological dependence.”

After months of foot dragging, the Justice Department published a notice in the Federal Register today giving the public 60 days to comment on the proposed rescheduling. Written comments must be submitted or postmarked on or before July 22. Online comments can be made here.

Every step in this process has been fraught with delays. And there may be more.

The Food and Drug Administration completed a review last August – nearly a year after it was requested by President Biden -- finding “credible scientific support” for marijuana’s rescheduling. But the FDA report was not made public until January, after a lawsuit was filed by two pro-cannabis lawyers seeking its release when the agency didn’t respond to requests under the Freedom of Information Act (FOIA).

Another four months passed before the Justice Department, which oversees the Drug Enforcement Administration, submitted to the Federal Register a notice about the proposed rescheduling. Since the DEA is charged with enforcing the Controlled Substances Act (CSA) and determines how drugs are scheduled, public notices involving the CSA are almost always signed by the DEA administrator.

This one, however, is signed by Attorney General Merrick Garland, not DEA Administrator Anne Milgram – a sign that her agency is not yet on board with marijuana’s rescheduling.

“DEA has not yet made a determination as to its views of the appropriate schedule for marijuana,” Garland wrote. “The CSA vests the Attorney General with the authority to schedule, reschedule, or decontrol drugs… The Attorney General has delegated that authority to the DEA Administrator, but also retains the authority to schedule drugs under the CSA in the first instance.”

According to an Associated Press report, Milgram told her staff in March that marijuana’s rescheduling “had been taken over” by Garland and the DOJ. The DEA wanted more time for studies to determine whether marijuana has an accepted medical use, a request that was rejected.

Former DEA Administrator Tim Shea believes the rescheduling process was hijacked by DOJ for political reasons.

“If she (Milgram) had supported it she would have signed it and sent it in,” Shea told the AP. “DEA was opposed to this and the politics entered and overruled them. It’s demoralizing. Everybody from the agents in the streets to the leadership in DEA knows the dangers this brings.”   

Asked recently during a congressional hearing what her views are on marijuana. Milgram ducked the question.

“Since DEA is ultimately the decider of scheduling and rescheduling, and the DEA administrator is in that role, it would be inappropriate for me to make comments about this process or parts of that process,” Milgram said.

‘Evidence Supports Marijuana for Pain’

Reclassifying marijuana as a Schedule III substance – in the same category as codeine and ketamine – may be historic, but it’s not the full “legalization” that many cannabis supporters have been calling for.  

Under the CSA, legal access to Schedule III substances requires a prescription from a licensed doctor that is filled at a licensed pharmacy. Any new medical marijuana products would also have to go through a lengthy and costly clinical trial process to assess their safety and effectiveness. Even if they pass that test, they would likely only be approved by FDA for certain conditions.  

Garland’s notice in the Federal Register is largely based on the FDA’s 2023 review, which states there is good evidence that marijuana is helpful in treating chronic pain and mixed evidence it could be useful in relieving nausea, anxiety, epilepsy and PTSD.

“FDA’s review of the available information identified mixed findings of effectiveness across indications, ranging from data showing inconclusive findings to considerable evidence in favor of effectiveness, depending on the source. The largest evidence base for effectiveness exists for marijuana use within the pain indication (in particular, neuropathic pain). Numerous systematic reviews concluded that there exists some level of evidence supporting the use of marijuana for chronic pain,” Garland wrote.

As for marijuana’s potential for abuse, Garland cited findings that marijuana poses less of a health risk than illicit drugs and even some legal medications such as oxycodone and benzodiazepines.

“The rank order of the comparators in terms of greatest adverse consequences typically ranked heroin, benzodiazepines, and cocaine first or in immediately subsequent positions, with marijuana in a lower place in the ranking,” Garland wrote.

“For overdose deaths, marijuana is always in the lowest ranking among comparator drugs. These evaluations demonstrate that there is consistency across databases, across substances, and over time. HHS thus concluded that although abuse of marijuana produces clear evidence of a risk to public health, that risk is relatively lower than that posed by most other comparator drugs.”

The opening of a public comment period does not mark the end of the rescheduling process. The DEA/DOJ will need time to review and evaluate thousands of comments, which will be followed by an administrative hearing and a final ruling that is subject to presidential review. Even then, the final rule has to be published in the Federal Register, followed by a 30 or 60-day wait period before the rule takes effect. 

During that process, and until a final rule is published, marijuana remains a schedule I controlled substance that is illegal under federal law. About three-quarters of states have already legalized marijuana for medical or recreational purposes.

Rescheduling Won’t End Conflict Between Federal and State Marijuana Laws

By Paul Armentano, Guest Columnist 

Ten months after the Biden administration requested the Department of Health and Human Services (HHS) “to initiate the administrative process to review expeditiously how marijuana is scheduled under federal law,” Secretary Xavier Becerra confirmed that the agency has recommended cannabis be removed from its Schedule I classification and placed in a lower schedule.

While the explicit details of HHS’ recommendation are not public, Bloomberg reports that the agency seeks to have cannabis moved to the less restrictive Schedule III of the federal Controlled Substances Act. 

The HHS recommendation now goes to the Drug Enforcement Administration, which will conduct its own scientific review. In the past, the DEA has employed its own five-factor test (which differs from HHS’ criteria) to determine whether or not cannabis ought to be rescheduled. On four prior occasions, most recently in 2016, the agency determined that cannabis failed to meet any of its five criteria.  

While it remains unknown at this time how the DEA will ultimately respond to HHS’ request, many are already speculating about the potential implications of such a policy change. And while some entities, particularly those involved in the commercial cannabis industry, have lauded the proposed change as a “giant” step forward, others – like myself – have been far more restrained.

That’s because reclassifying cannabis from Schedule I to Schedule III is neither intellectually honest, nor does it sufficiently address the widening chasm between state and federal marijuana laws. 

Specifically, reclassifying cannabis to a lower schedule within the CSA continues to misrepresent the plant’s safety relative to other controlled substances such as oxycodone and hydrocodone (Schedule II), codeine and ketamine (Schedule III), benzodiazepines (Schedule IV), or alcohol (unscheduled). More importantly, rescheduling marijuana fails to provide states with the explicit legal authority to regulate it within their borders as best they see fit, free from federal interference.  

To date, 38 states regulate the production and distribution of cannabis products for medical purposes. Twenty-three of these states regulate the possession and use of marijuana for adults. All of the state laws are currently in conflict with federal marijuana laws. Rescheduling cannabis to Schedule III will not change this reality. 

That’s because Schedule III substances are regulated only for prescription use by the federal government. That means legal access to these substances is limited to patients who possess a prescription from a licensed physician and who have obtained the product from a licensed pharmacy.

Currently, no state government regulates cannabis in such a manner – nor is it likely that any state will reconstruct their existing laws and regulations to do so in the future. 

Simply put, if marijuana is rescheduled, state laws authorizing citizens to possess cannabis for either medical or social purposes will continue be in violation of the federal law, as would the thousands of state-licensed dispensaries that currently serve these markets. And the DEA would still possess the same authority it has now under federal law to crack down on these state-regulated markets should it elect to do so. 

Some have suggested that rescheduling the cannabis plant may provide greater opportunities for investigators to conduct clinical research into its eventual drug development, but this result is also unlikely. That is because many of the existing hurdles to clinical cannabis research, such as the limits placed upon scientists’ access to source materials, are marijuana-specific regulations and predate cannabis’ Schedule I classification.

Other impediments, such as requiring the US Attorney General to approve marijuana-specific research protocols are statutory and are not specific to marijuana’s scheduling in the CSA. 

For these reasons, the National Organization for the Reform of Marijuana Laws (NORML) holds the position that the only productive outcome of the current scheduling review would be a recommendation to deschedule cannabis – thereby removing it from the Controlled Substances Act altogether and providing states with greater discretion to establish their own distinct marijuana policies. (A case in point: In 2018 Congress removed from the CSA hemp plants containing no more than 0.3 percent THC, as well as certain cannabinoids derived from them.)

Descheduling would remove the threat of undue federal intrusion in existing state marijuana programs and would respect America’s longstanding federalist principles allowing states to serve as “laboratories of democracy.”

By contrast, rescheduling simply perpetuates the existing contradictions between state and federal cannabis laws, and it fails to provide any necessary legal recognition from the federal government to either the state-licensed cannabis industry or those adults who use the plant responsibly in compliance with state laws.

Paul Armentano is the Deputy Director for NORML, the National Organization for the Reform of Marijuana Laws.

HHS to DEA: Marijuana Is Not Heroin

By Pat Anson, PNN Editor

The top U.S. health agency is asking the Drug Enforcement Administration to reclassify marijuana as a Schedule III drug under the Controlled Substances Act, putting cannabis in the same risk category as codeine, ketamine and steroids. Marijuana is currently classified as a Schedule I substance, the same as heroin and LSD.  

Bloomberg News was first to report that a top administrator in the Department of Health and Human Services (HHS) wrote a letter to DEA Administrator Anne Milgram asking for the change. Although 38 states and the District of Columbia have legalized recreational or medical marijuana, it remains illegal under federal law.

President Biden asked HHS Secretary Xavier Becerra nearly a year ago to review marijuana’s legal status, saying the classification of marijuana on the same level as heroin “makes no sense” and that people shouldn’t go to jail for marijuana possession.

“I can now share that, following the data and science, @HHSGov has responded to @POTUS’ directive to me for the Department to provide a scheduling recommendation for marijuana to the DEA. We’ve worked to ensure that a scientific evaluation be completed and shared expeditiously,” Becerra posted on Twitter Wednesday.

Although the Biden administration favors the move, rescheduling will not be a slam dunk. Marijuana falls under the jurisdiction of the Department of Justice, not HHS, and Milgram reports to Attorney General Merrick Garland, not Becerra. Conservative states where marijuana remains illegal are also likely to oppose the move.

Rescheduling has long been the goal of marijuana advocates, but some are disappointed that HHS is recommending it be moved to Schedule III, where it will still be regulated as a controlled substance.

“The goal of any federal cannabis policy reform ought to be to address the existing, untenable chasm between federal marijuana policy and the cannabis laws of the majority of US states. Rescheduling the cannabis plant to Schedule III of the US Controlled Substances Act fails to adequately address this conflict,” said Paul Armentano, Deputy Director of NORML, a marijuana advocacy group.

“Just as it is intellectually dishonest to categorize cannabis in the same placement as heroin, it is equally disingenuous to treat cannabis in the same manner as anabolic steroids. The majority of Americans believe that cannabis ought to be legal and that its hazards to health are less significant than those associated with federally descheduled substances like alcohol and tobacco. Like those latter substances, we have long argued the cannabis plant should be removed from the Controlled Substances Act altogether.”

The DEA will now conduct its own scientific review of marijuana. On at least four previous occasions, the DEA has refused to reschedule marijuana because there were inadequate safety studies and little scientific evidence supporting its use.

Another major hurdle under federal regulations is that before a substance can be used for a medical purpose, its “chemistry must be scientifically established to permit it to be reproduced in dosages which can be standardized.” That would imply that cannabis or pharmaceutical companies would need to produce marijuana medication in measured doses that are FDA approved and only available by prescription.

There is little consistency in labeling, regulating or testing of cannabis.products sold in states where it is legal. Many products are mislabeled, with concentrations of CBD (cannabinoids) and THC (tetrahydrocannabinol) that are well above or below their label claims.

“It will be very interesting to see how DEA responds to this (HHS) recommendation, given the agency’s historic opposition to any potential change in cannabis’ categorization under federal law,” said Armentano. “Since the agency has final say over any rescheduling decision, it is safe to say that this process still remains far from over.”

Although nearly a third of U.S. adults with chronic pain have used cannabis as a pain reliever, professional medical associations have been reluctant to endorse its use. In 2021, the International Association for the Study of Pain (IASP) released a position statement saying it could not endorse the use of cannabinoids to treat pain, citing too many “uncertainties” about the clinical evidence.

Hydrocodone Rescheduling Fueled Online Drug Sales

By Pat Anson, Editor

Hydrocodone was once the most widely prescribed and one of the most abused drugs in the United States. Over 135 million prescriptions were filled in 2012 for hydrocodone combination products such as Vicodin, Lortab and Norco.

Then in 2014 the Drug Enforcement Administration rescheduled the opioid painkiller from a Schedule III controlled substance to the more restrictive category of Schedule II. The move was intended to reduce the prescribing of hydrocodone – and it quickly had the desired effect.  By 2017, only 81 million prescriptions for hydrocodone were filled.  

But while legal prescriptions for hydrocodone have gone down, the DEA’s 2014 rescheduling may have fueled a surge in illegal online sales of hydrocodone and other opioids, according to a new study in the British Medical Journal.    

“The scheduling change in hydrocodone combination products coincided with a statistically significant, sustained increase in illicit trading of opioids through online US cryptomarkets. These changes were not observed for other drug groups or in other countries,” wrote lead author Jack Cunliffe, PhD, a lecturer in data analysis and criminology at the University of Kent.

Cunliffe and his colleagues studied these online cryptomarkets – also known as the “dark web” – by using web crawling software that scans the internet looking for websites dedicated to online sales of illicit drugs. From October 2013 to July 2016, they found that sales of prescription opioids on the dark web nearly doubled, from 6.7% to 13.7% of all online drug sales.  

“Our results are consistent with the possibility that the schedule change might have directly contributed to the changes we observed in the supply of illicit opioids,” said Cunliffe. “One explanation is that cryptomarket vendors perceived an increase in demand and responded by placing more listings for prescription opioids and thereby increasing supply.”

‘Iron Law of Prohibition’

The increase in supply and demand wasn’t just for hydrocodone. The researchers also noted a growing number of online listings for more potent opioids, such as oxycodone and fentanyl. They attribute that to the “iron law of prohibition” – banning or reducing the supply of one drug encourages users to seek more potent drugs from new sources.

“We found that users were first buying oxycodone followed by fentanyl. Drug users adapt to their changing environment and are able to source drugs from new distribution channels if needed, even if that means by illegal means. In a context of high demand, supply side interventions are therefore likely to push opioid users towards illicit supplies, which may increase the harms associated with their drug use and make monitoring more difficult,” Cunliffe wrote.

As PNN has reported, business is booming for illegal online pharmacies. As many as 35,000 are in operation worldwide and about 20 new ones are launched every day. About half are selling counterfeit painkillers and other medications. Overdoses involving fentanyl and other synthetic opioids – most of them purchased on the black market – have also increased and now outnumber those linked to prescription opioids.

"The study’s findings are troubling but not surprising. As you’ve well reported, there are often unexpected and negative externalities resulting from well-intended anti-addiction interventions," Libby Baney, Principal, Faegre Baker Daniels Consulting and senior advisor to Alliance for Safe Online Pharmacies said in an email to PNN. 

"What’s worse still, when buying medicine online - whether from dark or surface web sellers - it is virtually impossible for the consumer to know if the product is what it claims (in this case, an opioid like oxycodone) or is a dangerous counterfeit laced with a deadly dose of elephant tranquilizer or poison. As too many victims have shown, even one pill can kill."

A recent study at the University of Texas Medical Branch also found an association between hydrocodone's rescheduling and increased opioid abuse.  Researchers found that hydrocodone prescriptions for Medicare patients declined after rescheduling, but opioid-related hospitalizations increased significantly for elderly patients who did not have a prescription for opioids.

Rescheduling Hydrocodone May Have Increased Abuse

By Pat Anson, Editor

Four years ago that the U.S. Drug Enforcement Administration ordered the rescheduling of hydrocodone from a Schedule III controlled substance to the more restrictive category of Schedule II.  The move was intended to reduce the diversion and abuse of hydrocodone, which at one time was the most widely prescribed drug in the United States.

It turns out the rescheduling may have had the unintended effect of increasing the diversion and abuse of opioid medication by elderly Americans.

According to a new study by researchers at the University of Texas Medical Branch (UTMB), hydrocodone prescriptions for Medicare beneficiaries declined after the rescheduling, but opioid-related hospitalization of elderly patients increased for those who did not have a prescription for opioids.

"The 2014 federal hydrocodone rescheduling policy was associated with decreased opiate use among the elderly," said lead author Yong-Fang Kuo, PhD, a professor of Preventive Medicine and Community Health at UTMB.

"However, we also observed a 24 percent increase in opioid-related hospitalizations in Medicare patients without documented opioid prescriptions, which may represent an increase in illegal use."

Kuo and her colleagues say Medicare beneficiaries are among the largest consumers of prescription opioids. They speculated that opioid abuse by the elderly may be a coping mechanism to deal with poor health and depression, and that opioid diversion may be a sign of drug dealing.

“An economic purpose may relate to monetary gains from the diversion and sale to others,” Kuo wrote. “It is important for prescribers to understand that their elderly Medicare beneficiaries might be obtaining opioids from sources that are not documented in their medical records. There is a need for additional research on why, where, and how these Medicare enrollees are obtaining opioids.”

The UTMB research team analyzed a large sample of Medicare Part D enrollment and claims data from 2012 through 2015. Their study was published in the Journal of the American Geriatrics Society.

The reclassification of hydrocodone to a Schedule II controlled substance limited patients to an initial 90-day supply and required them to see a doctor for a new prescription each time they need a 30-day refill. Prescriptions for Schedule II drugs also cannot be phoned or faxed in by physicians.

In 2012, over 135 million prescriptions were written in the U.S. for hydrocodone products such as Vicodin, Lortab and Norco.  That fell to 90 million prescriptions by 2016.

Overall Opioid Prescribing Down

Hydrocodone isn't the only opioid medication to see steep declines in prescribing. The volume of opioid prescriptions filled last year dropped by 12 percent, the largest decline in 25 years according to a new report by the IQVIA Institute.  Opioid prescriptions have been falling since 2011, while dispensing of addiction treatment drugs like buprenorphine (Suboxone) and methadone have risen sharply.

“The U.S. opioid epidemic is one of the most challenging public health crises we face as a nation," said Murray Aitken, IQVIA senior vice president and executive director of the IQVIA Institute for Human Data Science.

“Our research and analytics revealed that 2017 saw new therapy starts for prescription opioids in pain management decline nearly 8 percent, with a near doubling of medication-assisted therapies (MATs) for opioid use dependence to 82,000 prescriptions per month. This suggests that healthcare professionals are prescribing opioids less often for pain treatment, but they are actively prescribing MATs to address opioid addiction."

All 50 states and Washington DC had declines in opioid prescribing of 5 percent or more in 2017, with some of the states hardest hit by the opioid crisis -- like West Virginia and Pennsylvania --  showing declines of over 10 percent. Nevertheless, the number of Americans overdosing continues to rise due to increased use of black market drugs like illicit fentanyl, heroin and cocaine, which now account for about two-thirds of all drug deaths.