The results of a recent study found that closer proximity to cannabis dispensaries in a community leads to a lower rate of opioid prescription. The study entitled “Recreational cannabis dispensary access effects on prescription opioid use and mortality,” was made available online in June but will be published in Regional Science and Urban Economics in its September 2024 issue.

Steven J. Dundas of Oregon State University and Jason W. Beasley of Western Michigan University (a former student of Dundas’) used Oregon as an example to examine opioid prescriptions and mortality rates and how they changed based on the number of cannabis dispensaries nearby. The data they used stemmed from the Oregon Health Authority’s Public Health Division from January 2014-December 2017, which researchers explained “captures nearly two years of data pre- and post-RCL [recreational cannabis legalization] in Oregon.”

“This paper addresses the question of whether access to recreational cannabis is a relevant factor impacting demand for prescription opioids within a community,” researchers explained. “We combine neighborhood-scale opioid prescription data and recreational cannabis dispensary locations in the U.S. state of Oregon (OR) to investigate the impact of changes to cannabis access on opioid prescriptions.”

Dundas and Beasley reviewed Oregon-based communities that are within one mile of a licensed cannabis dispensary and found that prescription opioid rates were lower compared to areas without dispensaries close by. “Using distance bins to identify the non-linear effect of recreational dispensary access, our empirical results suggest mean prescription opioids per capita fell by 1.0–3.9% after recreational legalization in communities near cannabis dispensaries,” the study stated. “Our results show that the further individuals must travel to a recreational dispensary, the higher the rates of prescription opioids per capita.”

In contrast, communities that had a dispensary located within one to four miles had higher prescription opioid rates. As the radius distance increased to a range of a dispensary being located four to 10 miles away from a community, or 10 to miles away, the prescription rates continued to increase.

This evidence suggests that if there are close alternatives to cannabis products from dispensaries that can be used to opioid prescriptions, residents are more likely to consider switching to cannabis for treatment. However, they also noted that while opioid-related mortality rates have quadrupled between 2005-2022, these results don’t have much of an effect on opioid-related mortality. “Despite the reduction, we find no evidence that reducing barriers to cannabis access and subsequent declines in prescription opioids are associated with meaningful changes in opioid mortality,” the researchers wrote.

Other studies have previously examined the opioid mortality rates associated with exposure to medical and/or recreational cannabis. A study published on June 5 in JAMA Network Open examined the case of 175,734 patients and why they consumed cannabis within the past three months. “While most patients (76.1%) reported using cannabis to manage a health symptom, very few patients identified as medical cannabis users.” Those consumers still used cannabis for common conditions such as pain, stress, and as a sleep aid. “Less than half the patients who used cannabis reported using it for medical reasons, even though the majority of patients reported cannabis use to manage a health-related symptom,” that report stated.

Another study published at the start of the year in BJM Open found evidence that cannabis has potential in acting as a substitute for opioids, specifically when helping patients manage pain. A total of 22,028 patient’s profiles were reviewed across 84 randomized controlled trials, which showed that cannabis offered similar relief that opioids provided without any negative side effects. “Our findings suggest that both opioids and cannabis for medical use may provide benefits for a minority of chronic pain patients,” researchers wrote. “Furthermore, cannabis does not cause respiratory depression which can result from opioids consumption and lead to non-fatal or fatal overdose.”

In February, another study published in the Harm Reduction Journal developed a clinical framework to help patients use cannabis to treat chronic pain if they are opioid-dependent. “Based on a comprehensive review of the literature and epidemiological evidence to date, cannabinoids stand to be one of the most interesting, safe, and accessible tools available to attenuate the devastation resulting from the misuse and abuse of opioid narcotics,” researchers explained. 

Research published earlier in May in the journal Pain also shared that injecting terpenes is more effective than injecting morphine-based chemo medications, and there are far fewer adverse effects. “What we found is that terpenes are really good at relieving a specific type of chronic pain with side effects that are low and manageable,” said researcher John Streicher. The study used five terpenes (alpha-humulene, beta-caryophyllene, beta-pinene, geraniol, and linalool) and tested on mice with a focus on neuropathic pain (a common condition that is developed by chemotherapy medications). All of the terpenes showed signs of pain reduction, especially when combined. “We looked at other aspects of the terpenes, such as does this cause reward? Is this going to be addictive? Is it going to make you feel awful?” Streicher said. “What we found was yes, terpenes do relieve pain, and they also have a pretty good side effect profile.”

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In an interview with Taste of Country published on May 24, Grammy Award-nominated country artist Jason “Jelly Roll” DeFord said that he smokes weed to stay away from hard drugs that he’s used in the past—namely opioids and benzodiazepines.

Given his past as an addict and his role in speaking against the use of fentanyl sweeping the country, the interview quickly shifted on the topic of drugs. But Jelly Roll doesn’t see weed the same way as hard drugs which can tear families apart and lead to deadly overdoses.

“I get in trouble for this, all the time, but my stance on marijuana will always be the same: I believe marijuana has helped me in so many regards, with my anxiety,” Jelly Roll told Taste of Country. “This is a hot button topic, but, truly, marijuana has kept me sober.”

The country superstar paused for a moment, then added, “I think a world without weed, Jelly Roll’s drinking codeine and popping Xanax and snorting cocaine again, but a world with weed, I’ll be alright.”

Jelly Roll abandoned hip-hop for a career in country music—which turned out to be a wise and lucrative decision. Jelly Roll’s album Whitsitt Chapel hit number 1 on the Billboard Top Rock Albums chart and number 2 on the Billboard Top Country Albums in 2023. In November 2023, he won the award for New Artist of the Year at the 57th Annual Country Music Association Awards. He’s won three CMT Music Awards and several other accolades.

TMZ reports that Jelly Roll has been a huge voice against fentanyl use and an example for people dealing with drug addiction. Last January, he appeared in front of Congress to back anti-fentanyl legislation called the Fentanyl Eradication and Narcotics Deterrence (FEND) Off Fentanyl Act.

Jelly Roll gave an opening statement at a Senate Banking, Housing, and Urban Affairs Committee hearing about fentanyl awareness and legislative solutions to stop illegal smuggling of fentanyl. “Fentanyl transcends partisanship and ideology…this is a totally different problem,” he started the hearing with in a speech that was described by many as “powerful.”

‘The sad news is that narrative is changing, too, because the statistics say that in all likelihood almost every person in this room has lost a friend, family member of colleague to the disease known as addiction,’ DeFord told the committee chaired by Cleveland Democrat Sherrod Brown. ‘I could sit here and cry for days about the caskets I’ve carried of people I love dearly.’”

His messages about fentanyl and hard drug use, and the potential of replacing them with a less dangerous substance such as pot, have made a lasting impact.

Cannabis for Addiction

Cannabis has been explored for its potential role in fighting addiction of hard drugs. Some studies have focused on CBD for treating addiction disorders, some of which are caused by compulsive cravings, while others focused on THC as well.

While many studies have focused on cannabis to curb opioid use with some looking more broadly at stimulants, new research suggests that it could prove useful for those with crack use disorder (CUD). In fact, the popular non-psychoactive CBD, or cannabidiol, seems to be the key element.

The study, published recently in the International Journal of Mental Health and Addiction, utilized a double-blind randomized clinical trial comparing CBD to three drugs commonly used to treat CUD: fluoxetine, valproic acid and clonazepam. Authors represent a number of Brazilian academic and official institutions, comprising various departments at the University of Brasília, the Brazilian Federal District’s secretary of health and forensic institute and the Federal University of São Paulo.

The research ultimately found that participants who took CBD had better health outcomes and fewer adverse effects compared to those who underwent traditional pharmaceutical options.

In another study published in the journal Addictive Behaviors, researchers found that cannabis is not only widely used to manage stimulant cravings but that it may be an effective strategy to reduce stimulant use.

To further analyze how cannabis use may affect people using stimulant drugs, researchers collected data from three cohorts in Vancouver, Canada: the At-Risk Youth Study (ARYS), the Vancouver Injection Drug Users Study (VIDUS) and the AIDS Care Cohort to Evaluate Exposure to Survival Services (ACCESS).

Researchers used a cross-sectional questionnaire alongside logistic regression models to analyze the relationship between cannabis use to manage stimulant cravings as well as self-reported changes in the frequency of stimulant use. 

Many others say cannabis replaced their daily alcohol use.

The studies seem to back up some of the claims about cannabis and sobriety. Jelly Roll, like country outlaw Willie Nelson, are helping to spread the good word on cannabis to the country music world.

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The House of Representatives in Missouri has approved a budget bill that allocates $10 million from the state’s opioid settlement funds for research grants. But not just any research grants. These are intended to explore the effectiveness of psilocybin in treating opioid use disorder, which is currently considered a public health crisis in the United States.

Originally, thanks to an addition to the bill that came up in a House committee last week, the bill, HB 2010, would have used the $10 million to actually study ibogaine for treating opioid use disorder. However, on Tuesday, that was modified to redirect the funds towards psilocybin research instead. Currently, the measure would allocate a one-time sum of $10 million from the state’s Opioid Addiction Treatment and Recovery Fund to pay for grants for research universities. These grants are created to finance the study of the role of psilocybin in healing for substance use disorder.

Rep. Cody Smith (R), who introduced the original budget bill, noted that the shift in funding towards psilocybin research stemmed from a discussion he had with the state Department of Mental Health last week.

“They had concerns about the ibogaine research they had read, and there are concerns about the dangers involved in that research,” Smith said. “However, they are interested in the psilocybin piece. And we’ve seen many other states use their opioid settlement funds to that end.”

Smith isn’t the only Republican who backed the original ibogaine research plan. Rep. Chad Perkins (R), another supporter of the ibogaine research plan, told Marijuana Moment in an email: “I had several concerned individuals reach out and provide me with information regarding the potential benefits of ibogaine. After some research, I believed it was a worthy and prudent investment for the state to combat opiate addiction.”

Missouri is expected to get hundreds of millions of dollars in opioid-related settlement funds, which were collected through various lawsuits against the opioid industry and related entities, over the next several decades, And psychedelic advocates are working to allocate that money toward treatment models to help stop the opioid crisis through treatment.

Last year, Kentucky also considered putting money towards researching ibogaine for opiate use disorder. However, they ultimately also backed away from that plan, and advocates set their sights on other states, such as Missouri. Research indeed shows that ibogaine could be revolutionary for healing addiction. One study found that just a single ibogaine treatment not only reduced opioid withdrawal symptoms but “achieved opioid cessation or sustained reduced use in dependent individuals as measured over 12 months.” However, ibogaine is still illegal in the U.S., and unlike psychedelics like psilocybin, it can lead to cardiac arrest and death, which is likely why the lawmakers opted for psilocybin. 

While many folks believe that the risks of a single ibogaine treatment are worth kicking a deadly opioid addiction, Perkins told Marijuana Moment that he’s satisfied with the shift towards psilocybin. “I’m not disappointed,” he said. “I believe that bringing more exposure to the benefits of psychedelics has been an ancillary effect of the pursuit of this budget item. This issue will hopefully raise the profile of psychedelics and provide a foundation on which we can base future policy decisions.”

Psilocybin is also indicated for opiate use disorder. As TIME reports, a 2022 study featured in Scientific Reports analyzed data from 214,505 U.S. adults whose information was gathered in the National Survey on Drug Use and Health (NSDUH) spanning 2015 to 2019. This investigation uncovered a link between a history of psilocybin usage (at any point in a person’s life) and a diminished risk of developing opioid use disorder. 

The study examined 11 criteria used by scientists to identify opioid use disorder (such as dedicating considerable time to acquiring and consuming drugs) and discovered that previously taking psilocybin actually was significantly associated with a reduced chance for seven of these criteria, and slightly reduced odds for two additional criteria, giving folks a pretty awesome excuse to enjoy some magic mushrooms. 

Missouri sets a precedent for even more conservative governments embracing psychedelic therapies to combat the ongoing opioid crisis. In just a handful of examples, recently, the Governor of Indiana signed legislation that included measures to support clinical research trials investigating psilocybin. And in Utah, the Governor established a pilot program that allows hospitals to offer psilocybin and MDMA as alternative treatments. Furthermore, a committee in the Arizona House endorsed a bill that would legalize psilocybin service centers, where folks use the psychedelic under medical supervision.

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The DEA issued a letter Monday directed at online retailers selling pill presses, informing them that they are required to report sales of these presses to the DEA.

According to the DEA, pill presses are commonly used to disguise the deadly opioid fentanyl by replicating existing prescription medications. These replicated pills are then sold to people who are typically unaware they’re buying fentanyl. These pill presses are incredibly easy to find online and sell for as little as 40 dollars. This, in part, has fueled a scourge of overdoses in the last several years, 110,757 in 2022 alone by the DEA’s count.

“With these tools, criminal actors are able to produce pills that look like legitimate prescription medication—like oxycodone, Xanax, and Adderall—but are not,” the DEA said. “Those pills actually contain fentanyl and other deadly drugs.  Criminals then sell those pills on social media and in our communities, often to people who do not know that the pills are not real or that they contain deadly drugs.”

The DEA implicitly stated that pursuant to the Controlled Substances Act, e-commerce retailers responsible for selling these pill presses are required to keep records of everybody who buys and sells a press, and also required to report this information to the DEA.

“DEA has found that pill presses and stamps that can be used to make fentanyl pills are being offered for sale on various e-commerce platforms.  E-commerce entities selling pill press machines are generally ‘regulated persons’ under the Controlled Substances Act, 21 U.S.C. § 802(38), and therefore, subject to the recordkeeping, identification, and reporting requirements of 21 U.S.C. § 830,” the DEA said. “As regulated entities, e-commerce platforms are required to comply with CSA recordkeeping and reporting requirements on the distribution, importation, and exportation of pill press machines.  This means that they must collect information on the buyer and seller and provide notice to the DEA of any sale, import, export, or transfer.”

The DEA said that the vast majority of these fake pills are produced by two particular Mexican cartels. The United States government has put increasing pressure on Mexico in recent years to curb the flow of fentanyl, including fentanyl disguised in these fake pills, from crossing over the United States Mexico border. Even after signs were posted all over Sinaloa appearing to ban the production and sale of fentanyl by the authority of the cartels, fentanyl overdoses and seizures have not slowed down at all.

“The drug cartels primarily responsible for manufacturing fentanyl and smuggling it into the United States are the Sinaloa Cartel and Jalisco Cartel.  These cartels, their members and associates, and other drug traffickers are using pill presses to shape fentanyl powder into pills, and they are using stamps to imprint markings and logos onto those pills as they are pressed,” the DEA said.

According to the DEA, over 79 million fake fentanyl-containing pills were seized in 2023, which marked a 33% increase over pill seizures in 2022. DEA lab tests have shown that 70% of seized pills are pressed and contain fentanyl. Seventy percent of all drug overdoses in 2022 were also due to ingestion of fentanyl.

“Drug traffickers are killing Americans by selling fentanyl hidden in fake pills made to look like real prescription medicines. This is possible because drug traffickers are able to buy the tools they need, like pill presses and stamps, online,” said DEA Administrator Anne Milgram. “E-commerce platforms cannot turn a blind eye to the fentanyl crisis and to the sale of pill presses on their platforms.  They must do their part to protect the public, and when they do not, DEA will hold them accountable.”

The DEA said that they launched the Industry Liaison Project in 2019, in which they communicated with over two dozen of the largest online retailers about pill press sales on their websites. They said that several, including Amazon and Etsy, banned the sale of pill presses on their platforms outright. However, as the hyperlink I included at the top of this article proves, dozens and dozens of pill presses are very much still for sale on Amazon. I also found several pill presses for sale on Etsy with about five seconds of effort on Google.

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A higher dose version of naloxone, the nasal spray used to reverse opioid-induced overdoses, did not lead to more saved lives, according to a new study published earlier this month.

The findings, published by the Centers for Disease Control and Prevention, indicated that “no significant differences were found in the survival of aided persons” in the new eight-milligram naloxone.

According to the study, there were likewise no significant differences in “the number of doses administered by law enforcement by formulation, suggesting that, in this field test, the increased dosage did not provide added benefit, even in light of the increased prevalence of synthetic opioids, including fentanyl, in the drug supply.”

“Other studies have also found that [the] number of naloxone doses administered in response to overdose has not changed over time, even with 4-mg and other lower-potency formulations,” the study said. 

“In this study, persons who received the 8-mg product were more than twice as likely to experience postnaloxone opioid withdrawal signs and symptoms including vomiting, compared with those who received the 4-mg intranasal naloxone product. When vomiting was analyzed as an isolated sign, no significant differences between formulations were found. However, the high prevalence of vomiting as an isolated sign in both groups is concerning because of the risk of aspiration in sedated persons.”

Dr. Michael Dailey, one of the authors of the study, told the Associated Press that what “was really remarkable was the survival was the same, but the amount of withdrawal symptoms was significantly larger in the people that got the 8-milligram dose.”

The study was conducted between March 2022–August 2023, when the  “New York State Department of Health (NYSDOH) supplied some New York State Police (NYSP) troops with 8-mg intranasal naloxone” and “other troops continued to receive 4-mg intranasal naloxone to treat suspected opioid overdose,” the authors explained in the study’s abstract. 

“NYSP submitted detailed reports to NYSDOH when naloxone was administered. No significant differences were observed in survival, mean number of naloxone doses administered, prevalence of most postnaloxone signs and symptoms, postnaloxone anger or combativeness, or hospital transport refusal among 4-mg and 8-mg intranasal naloxone recipients; however, persons who received the 8-mg intranasal naloxone product had 2.51 times the risk for opioid withdrawal signs and symptoms, including vomiting, than did those who received the 4-mg intranasal naloxone product (95% CI = 1.51–4.18),” they explained. 

“This initial study suggests no benefits to law enforcement administration of higher-dose naloxone were identified; more research is needed to guide public health agencies in considering whether 8-mg intranasal naloxone confers additional benefits for community organizations.”

The authors noted that although the 8-mg naloxone was first approved by the Food and Drug Administration for emergency use in 2021, “no real-world data on use of the 8-mg product are available.”

“Harm reduction advocates and medical professionals have noted potential harms of higher-dose naloxone, including severe withdrawal signs and symptoms, which can result in refusal of medical care, rapid reuse of opioids, reluctance to use naloxone if witnessing an overdose, and respiratory complications, including pulmonary edema and consequences of aspiration of vomitus,” they said. 

“To evaluate this potential risk, in 2022, NYSDOH partnered with NYSP to field test 8-mg intranasal naloxone use by some NYSP troops. The aims of the study were to conduct real-world comparisons of survival, the average number of doses administered, presence of postnaloxone signs and symptoms, and hospital transport refusal among persons receiving the 8-mg or the 4-mg intranasal naloxone products.”

According to the Associated Press, “Dailey said the study did not lead him to endorse one product over another,” but he added that it is “important for us to recognize that the potential for increased side effects is real.”

The authors of the study also pointed out that their research was “subject to at least four limitations.” 

“First, responding law enforcement personnel are not medical providers, and inconsistencies in their classification of postnaloxone symptoms or behaviors might have occurred. However, NYSP personnel have been reporting using a similar form for several years and are experienced in assessing symptoms and behaviors. Second, the number of 8-mg intranasal naloxone administration reports included was limited because only three of 11 NYSP troops received this formulation. With an increased sample size, additional differences in outcomes between groups might have been observed,” they explained. “Third, no information could be compared about differences between groups on the type or dose of substance used before suspected overdose, vital signs, or demographics. Finally, because the data were gathered from New York State only, the opioid potency might not reflect that in other areas.”

Although the “study suggests that there are no benefits to law enforcement administration of higher-dose naloxone,” the authors said that “additional data are needed to guide public health agencies in considering whether the 8-mg intranasal naloxone product provides benefits compared with the usual 4-mg intranasal naloxone product among community organizations, including law enforcement, given the lack of difference in survival rates or number of naloxone doses administered and the increased prevalence of opioid withdrawal signs and symptoms, including vomiting, in 8-mg recipients, when compared with recipients of 4-mg intranasal naloxone.”

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The DEA has rescinded a 2023 directive which previously ordered a pharmaceutical company to shutter operations after they were found to have helped perpetuate the nationwide opioid crisis.

Morris & Dickson, a multi-billion dollar Big Pharma giant which has been in business since 1841 will be permitted to continue selling drugs to Americans as per the result of a settlement reached with the DEA on Wednesday. This comes just under a year after the pharmaceutical wholesaler had their license revoked for continuing to produce and distribute suspicious shipments of controlled substances for years after a judge recommended their license be revoked for “cavalier disregard” of controlled substance laws. They also failed to report thousands of shipments of hydrocodone and oxycodone to the DEA. 

“Of all the cases I handled as an administrative law judge for the DEA, Morris & Dickson’s violations were the most blatant and egregious,” Judge Charles Dorman told the Associated Press. “In addition, I saw no real acceptance of responsibility for their violations.”

According to the DEA, Morris & Dickson will pay a $19 million fine and submit to heightened reporting requirements for five years as well as forfeit one of their two DEA Certificates of Registration, but they will be permitted to continue producing controlled substances from schedule two to five of the Controlled Substances Act. They also admitted all wrongdoing for their past actions.

“Drug distributors like Morris & Dickson have a responsibility to protect the safety and health of customers and maintain effective controls against diversion of highly addictive controlled substances. At the height of the opioid crisis, Morris & Dickson failed to uphold that responsibility, and turned a blind eye as thousands of unusually large orders for hydrocodone and oxycodone went out the door,” said DEA spokesperson Katherine Pfaff. “Today, Morris & Dickson takes an important first step by admitting wrongdoing and paying for its misconduct, and today’s settlement will ensure that such irresponsible practices will not continue in the future.”

Morris and Dickson’s legal wrongdoing came to light as the result of an Associated Press investigation in 2023 which not only found that the nation’s fourth largest drug distributor was playing it fast and loose with dangerous opioids, but also that the four-year delay in DEA action may have been the result of the so-to-speak “revolving door” between public entities and private companies which can lead to biased decision making at the government level.

In the case of Morris and Dickson one such DEA employee, Louis Milione, spent 21 years working with the DEA in the Office of Diversion Control before retiring in 2017. After that, the Associated Press found that Milione became a consultant for the companies he was previously a regulator of, including Morris and Dickson, who hired him on a $3 million contract to essentially save their ability to produce and supply painkillers after the DEA accused the company of turning a blind eye to large suspicious orders of opioids. 

Milione advocated for Morris & Dickson in court to little or no avail as the judge presiding over the case wrote a long scathing 159-page report recommending Morris and Dickson have their license revoked. According to the Associated Press, it was not until four years later when the AP asked the DEA to comment on their investigation into Morris and Dickson that the DEA finally followed through on what the judge recommended and revoked their license, only to reinstate it with this recent order less than a year later.

“If the DEA had issued its order in a timely manner, one could then credibly believe that its second-in-command was not involved despite an obvious conflict of interest,” said Craig Holman, an ethics expert at the watchdog group Public Citizen in Washington to the Associated Press in 2023. “The mere fact that its action has been delayed four years just raises red flags. It casts the entire process under grave suspicion.”

Morris & Dickson released a brief statement on their website regarding the DEA’s decision to reverse the original license revocation, choosing to give a very general thank you to the DEA rather than going into specifics about the case.

“Morris & Dickson wants to thank the DEA for their recognition of our extensive efforts over the past five years to expand and improve our compliance system for suspicious order monitoring. We appreciate the DEA’s collaboration with us on our shared commitment to patient safety, and we are pleased that the DEA’s actions acknowledge both our current state-of-the-art compliance program and our commitment to continued enhancements into the future,” Morris & Dickson said.

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A pharmaceutical company unveiled an experimental new drug that is being touted as a less dangerous alternative to opioids. To date, few drugs have demonstrated enough power to manage higher levels of pain often associated with post-surgery recovery.

WXYZ Detroit, an ABC affiliate, reports that Vertex Pharmaceuticals said Tuesday the drug’s use in late-stage clinical trials resulted in “clinically meaningful reduction in pain,” without many of the risks associated with opioids. The new drug is called VX-548 and it’s showing promise in early stages.

Two trials demonstrated that patients who recently came out of surgery who received Vertex’s new drug had statistically significant pain relief. Phase 2 trial results were published Dec. 13, 2023, noting its effects on painful diabetic peripheral neuropathy. Researchers in a third trial observed a wider range of pain-related conditions. Phase 3 trial results were published on Jan. 30, 2024 and showed “clinically meaningful reduction in pain from baseline in both the abdominoplasty and bunionectomy randomized controlled trials,” as well as many other surgery-related conditions. 

Participants who used the drug for up to 14 days also noted positive results, with over 83% of patients saying VX-548 was “good” to “excellent” at managing pain.  

Vertex noted VX-548 was “safe and well-tolerated in all three studies,” but it failed to work better than hydrocodone bitartrate/acetaminophen, aka Vicodin. The National Library of Medicine notes that pain is a complex phenomenon, and that one type of painkiller won’t work for all situations.

Vertex plans to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) by mid-2024 regarding VX-548’s treatment of moderate-to-severe acute pain. Vertex’s Phase 1-3 trials move the company closer to gaining approvals from the FDA. If they are successful, it could  provide people in the U.S. with another pain treatment option.

Opioids Main Driver of U.S. Drug Overdoses

The vast majority of drug overdoses in the U.S. continues to be dominated by opioids. And to make things worse, the confusion over addiction leads to making it harder for patients who actually need opioids to get them prescribed.

According to The National Center for Health Statistics (NCHS) under the U.S. Centers for Disease Control and Prevention, drug overdose deaths rose from 2019 to 2021 with over 106,000 drug overdose deaths reported in 2021. Deaths involving synthetic opioids—primarily fentanyl and excluding methadone—continued its death march with 70,601 overdose deaths reported in 2021. Fentanyl in particular kills 150 Americans per day.

Many other attempts to develop alternatives to opioids that effectively dull pain, but they typically fail. If Vertex’s drug is ultimately deemed to be safe, it could introduce a new class of acute pain medicine for the first time in about 20 years, Dr. Jessica Oswald told WXYZ.

“As a physician treating patients suffering from pain for many years, I know firsthand the critical need for new, efficacious and safe treatment options,” Oswald said. “The Phase 3 safety and efficacy across the three studies are impressive and demonstrate VX-548’s potential to change the paradigm of pain management.”

Opioids kill more Americans than car crashes or gun violence. An alternative to effective, but highly dangerous opioids, some of which having the power to stop breathing, is sorely needed.

History of Opioid Alternatives

Bayer introduced heroin in 1898 and called it a “wonder drug” meant to be less addictive than morphine, which was ravaging America at the time with drug addicts. It wasn’t until over 10 years later that an army of heroin addicts emerged.

Cannabis itself has been explored as an opioid alternative, but it works in very different ways. One study is taking a closer look at the specific holistic effects that both medical cannabis and opioids provide to get more insight on the efficacy of each substance as it pertains to chronic pain management.

The recent study, “The holistic effects of medical cannabis compared to opioids on pain experience in Finnish patients with chronic pain,” was conducted by a team of researchers from Åbo Akademi University, who looked into the effects of medical cannabis and opioids for chronic pain treatment.

Published in the Journal of Cannabis Research, the study aimed to take a closer look at how effective medical cannabis is compared to traditional opioids in treating chronic pain, as cannabis use for symptom management has become increasingly more common in recent years. Results suggested that opioids and cannabis are both “equally efficacious” at mitigating pain intensity in patients with chronic pain, while cannabis offered more “holistic” relief in improving sleep, focus and emotional wellbeing.

Vertex Pharmaceuticals could help provide a safer alternative compared to typical opioids that have created an epidemic of drug overdoses in the U.S.

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Cannabis use around the world continues to eclipse other drugs––and is increasing. Opioids, meanwhile, continue to cause the most harm.

Those are just some of the takeaways from the United Nations’ annual “World Drug Report” for 2023.

“Drug use continues to be high worldwide. In 2021, 1 in every 17 people aged 15–64 in the world had used a drug in the past 12 months. The estimated number of users grew from 240 million in 2011 to 296 million in 2021 (5.8 per cent of the global population aged 15–64). This is a 23 per cent increase, partly due to population growth,” the report’s “executive summary” said. 

According to the report, cannabis “continues to be the most used drug, with an estimated 219 million users (4.3 per cent of the global adult population) in 2021.” 

That number is also trending upward––perhaps a byproduct of legalization in the United States and elsewhere. But the report also showed a gender divide when it comes to pot use.

“Use of the drug is increasing and although globally cannabis users are mostly men (about 70 per cent), the gender divide is reducing in some subregions; women account for 42 per cent of cannabis users in North America,” the report said.

Opioids, meanwhile, “continue to be the group of substances with the highest contribution to severe drug-related harm, including fatal overdoses,” according to the report. 

That will come as little surprise to those in the United States, which has been mired in an opioid epidemic for more than two decades. According to the Centers for Disease Control and Prevention, the number of people in the U.S. who died from a drug overdose in 2021 “was over six times the number in 1999” and the “number of drug overdose deaths increased more than 16% from 2020 to 2021.”

Among the nearly 107,000 drug overdose deaths in the United States in 2021, more than 75% involved an opioid, according to the CDC.

The CDC says that the “rise in opioid overdose deaths can be outlined in three distinct waves.”

“The first wave began with increased prescribing of opioids in the 1990s, with overdose deaths involving prescription opioids (natural and semi-synthetic opioids and methadone) increasing since at least 1999. The second wave began in 2010, with rapid increases in overdose deaths involving heroin. The third wave began in 2013, with significant increases in overdose deaths involving synthetic opioids, particularly those involving illicitly manufactured fentanyl. The market for illicitly manufactured fentanyl continues to change, and it can be found in combination with heroin, counterfeit pills, and cocaine,” according to the CDC.

The UN’s report said that an “estimated 60 million people engaged in non-medical opioid use in 2021, 31.5 million of whom used opiates (mainly heroin).” Opioids remain “the leading cause of deaths in fatal overdoses,” the repot said, accounting “for nearly 70 per cent of the 128,000 deaths attributed to drug use disorders in 2019.” 

“Opioid use disorders also accounted for the majority (71 per cent of the 18 million healthy years of life lost owing to premature death and disability in 2019,” the UN report said.

According to the report, “most drug use disorders are related to cannabis and opioids, which are also the drugs that lead most people to seek drug treatment, but opioids remain the most lethal drug.”

“Among all countries that ranked the drugs leading to drug use disorders, the majority (46 per cent of countries) reported cannabis in first place, 31 per cent of countries reported opioids in first place, mainly heroin, whereas amphetamine-type stimulants, in particular methamphetamine, were reported in first place by 13 per cent of countries. The ranking in each country is determined mainly by two factors: prevalence of use and dependence potential,” the report said.

The UN report also provided a regional breakdown of drug use.

“There are clear regional differences in the primary drug reported by people entering drug treatment: in most of Europe and most of the subregions of Asia, opioids are the most frequent primary drug of people in drug treatment, whereas in Latin America it is cocaine, in parts of Africa it is cannabis, and in East and South-East Asia it is Methamphetamine,” the report said.

The report also identified an uptick in intravenous drug use.

“An estimated 13.2 million people were injecting drugs in 2021,” the report said. “This estimate is 18 per cent higher than in 2020 (11.2 million). This increase is due to newly available estimates in the United States of America and in some other countries. Eastern Europe (1.3 per cent of the adult population) and North America (1.0 per cent) remain the two subregions with the highest estimated prevalence of people who inject drugs, and, in absolute terms, North America now has the highest number of individuals that report injecting drugs, ahead of East and South-East Asia.”

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Fentanyl caused a majority of fatal overdoses in Los Angeles County for the first time last year, with nearly 60% of the area’s overdose deaths attributed to the increasingly popular opioid. Fentanyl replaced methamphetamine as the county’s most common drug cited as the cause of accidental drug or alcohol overdose deaths, according to a new report from the L.A. County Department of Public Health.

“It’s absolutely heartbreaking,” Amanda Cowan, executive director of Community Health Project Los Angeles, told the Los Angeles Times, adding, “These communities are just being decimated.”

In 2022, Los Angeles County reported 3,220 accidental overdoses. Of those, more than 1,900 deaths were caused at least in part by fentanyl, according to county data. Under the county’s reporting protocols, more than one drug may be listed as the cause of an overdose death.

L.A.’s spike in overdose deaths caused by fentanyl comes at a time of record overall overdose deaths nationwide. In 2021, 107,573 people died of an overdose in the United States, according to data from the Centers for Disease Control and Prevention. The number dropped slightly last year, falling to 105,452 in 2022, a decrease of 2%

“We’re still amid the worst overdose crisis in history, and that’s obviously an emergency situation,” said Dr. Gary Tsai, director of Los Angeles County’s Substance Abuse Prevention and Control program. “We’re doing a lot of work to improve our system, but there’s obviously still a lot of work that we have to do.”

Contaminated Drug Supply Puts Lives At Risk

In its report, the County of Los Angeles Department of Public Health noted that fentanyl has permeated the supply of illicit street drugs, endangering the lives of casual drug users and those with substance misuse disorders alike. Illicitly manufactured fentanyl (IMF) “is cheap and easy to make quickly and in large quantities. It has been found in nearly all forms of illegal street drugs and counterfeit pills, as drug traffickers intentionally add fentanyl to their drugs to reduce costs, to enhance the effect of an existing drug, and/or to make their drugs more addictive,” the health department wrote in the report. 

“Fentanyl can also be a contaminant when handling multiple drugs with the same equipment or in unclean environments,” the report continues. “Thus, drugs containing IMF have variable and high potency, and can be more dangerous than often perceived, especially for youth who may experiment with drugs or pills.”

The county data showed a sharp disparity in the number of fentanyl overdose deaths. The largest number of fatal fentanyl overdoses were among white people and in more affluent areas of the county. But when adjusted for population, Black people and those living in high-poverty areas died of a fatal fentanyl overdose at significantly higher rates. 

“In the case of race/ethnicity, Black people account for 8% of the [county] population, and disproportionately accounted for 21% of fentanyl overdose deaths in 2022,” the report said.

Ricky Bluthenthal, a professor of population and public health sciences at the University of Southern California’s Keck School of Medicine, said that the racial disparities in fentanyl overdose deaths are concerning, noting they have gotten worse in recent years. But he added that the problem is a national one that illustrates the need to target resources such as the lifesaving drug naloxone, a nasal spray that can reverse an opioid overdose.

“It speaks to a national challenge that we have in the United States, related to making sure that both medication for opiate use disorder and naloxone is readily available for people who live in predominantly African American and Latino neighborhoods,” Bluthenthal said.

Through his research, Bluthenthal has determined that L.A.’s supply of heroin has mostly been replaced by fentanyl, which is about 50 times more potent. 

“We are facing this really dramatic change in the illicit drug supply; looking at the figure over time, it sort of makes you want to cry,” Bluthenthal said.

The more than 1,900 overdose deaths caused by fentanyl represent a jump of nearly 1,700% in the number of fatal overdoses caused by the drug in just six years.

“This transition is wreaking havoc on people,” he added.

Tsai said that the report included some positive data points. Overdose deaths among children fell for the first time in two years. Additionally, the rate of increase in the number of fentanyl deaths dropped significantly, possibly indicating that the number of deaths may be beginning to level off. But health officials warn the community must remain vigilant to the dangers of the illicit drug supply.

“On the fentanyl front, we might be slowing down, just looking at the numbers, but there’s still so many things that can happen between now and when we get the 2023 data,” said Tsai. “All it takes is another more potent substance to come into the drug supply for that number to then shoot up.”

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It’s time for Big Pharma companies that were caught lying to the public to pay up. 

A new report compiled by ConsumerShield suggests the past decade was defined by record-high settlements and penalties in the pharmaceuticals sector, totalling over $80 billion in fines and penalties.

ConsumerShield’s report, “The Pharmaceutical Industry: Balancing Profits, Penalties, and Public Safety,” was published on Oct. 17, and it shows that the lion’s share of violations involve synthetic opioids that clearly cause dependence and are powerful enough to stop breathing.

London Loves Business reports that the study shows that since 2010, the pharmaceutical industry has incurred $82.8 billion in penalties during over 500 instances of recorded violations due to drug and medical device safety non-observance, unapproved promotion of medical products, breaches of the False Claims Act, and other violations.

The biggest culprit—Johnson & Johnson—clocked in with over 45 violation records during the study period, leading to a total of  $24.5 billion in penalties. Johnson & Johnson paid $18 billion USD in penalties over the past five years in opioid and talc cases alone. Next is Teva Pharmaceuticals with penalties of $8.5 billion, AbbVie with penalties of $7.1 billion, GSK plc with penalties of $5.6 billion, and Pfizer with penalties of $3.2 billion.

The report also lists significant settlements, with one case standing out: the Purdue Pharma case, resulting in an order to pay $8.3 billion. On Oct. 21, 2020, the Department of Justice announced a massive fine culminating its criminal and civil investigations into the opioid manufacturer Purdue Pharma, and a civil resolution of its civil investigation into individual shareholders from the Sackler family.  

Purdue and the Sacklers continued to market OxyContin and opioid products to over 100 health care providers despite the company knowing there was good reason to believe they were diverting opioids and reporting misleading information to the DEA to boost Purdue’s manufacturing quotas. 

Hundreds of thousands of people overdosed and died in the process. Nearly 88% of opioid-involved overdose deaths involved synthetic opioids, and opioids were the cause of 80,411 overdose deaths in 2021—75.4% of all drug overdose deaths, the CDC reported in 2021 when overdoses peaked. Compare that to heroin overdoses, which caused just 9,000 overdoses in 2021 unless they were mixed with opioids. Almost ten times more OD’d on synthetic opioids.

“The abuse and diversion of prescription opioids has contributed to a national tragedy of addiction and deaths, in addition to those caused by illicit street opioids,” said Deputy Attorney General Jeffrey A. Rosen.  “With criminal guilty pleas, a federal settlement of more than $8 billion, and the dissolution of a company and repurposing its assets entirely for the public’s benefit, the resolution in today’s announcement re-affirms that the Department of Justice will not relent in its multi-pronged efforts to combat the opioids crisis.”

Most of us know about the ravages of the opioid epidemic, but what’s the deal with talc? Pharmaceuticals can kill you in other ways. Talcum powder lawsuits claim consumers were diagnosed with cancer after using talc-based Johnson & Johnson baby powder.

A Solemn Warning

The ConsumerShield report kicks off with a solemn warning:

“It is with a sense of urgency and responsibility that we delve deep into the prevailing paradigms of the pharma industry,” the report reads. “Our investigation is geared towards understanding whether the soaring profits are inadvertently overshadowing the paramount need for consumer safety, ethical promotions, and pioneering research initiatives.

“The stark discrepancy between R&D investments and marketing expenditures, coupled with the persistence of unethical practices despite soaring penalties, necessitates a comprehensive examination of the industry’s commitment to ethical practices and consumer well-being.”

ConsumerShield representatives say that what the data shows is disturbing.

“The juxtaposition of soaring revenues and escalating penalties is alarming,” ConsumerShield Senior Analyst Jane Doe told London Loves Business. “But what’s even more disturbing is the obvious disparity between companies’ spending on research and development (R&D) and their enormous marketing budgets.”

The False Claims Act is the federal government’s primary litigation tool in combating fraud against the government, and part of that includes consumer protections.

“Pharmaceutical companies that have engaged in illegal off-label marketing or promotion of their drugs have paid the Government hundreds of millions of dollars as a result of Federal False Claims Act cases, often times brought by pharmaceutical sales representatives, sales managers, compliance officers, other pharmaceutical company employees, physicians, nurses and/or employees of hospitals or physician practices,” the False Claims Act Pharmaceutical Fraud summary reads.

The report shows the repercussions of marketing opioids despite receiving warnings about its enormous deadly impact, notwithstanding the people who actually need opioids to deal with high levels of pain.

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