Scientists with a new research center at the University of Washington are working on a vaccine to help fight the opioid epidemic in a bid to stem the tide of overdose deaths that has swept the nation over the past two decades.
Marco Pravetoni, the head of the new UW Medicine Center for Medication Development for Substance Use Disorders, is leading the effort to develop the vaccine. Similar to immunization against an invading pathogen, the vaccine under development would stimulate the body’s immune system to attack and destroy opioid molecules before they can enter the brain.
Such a vaccine would not prevent drug cravings commonly experienced by those with opioid abuse disorder. But the treatment, if successful, would block the effects of opioids including euphoria, pain relief and even overdose, thus likely reducing abuse.
The new research center opened this month and has raised more than $2 million in initial funding. Pravetoni hopes to raise enough money to complete further research on the vaccine under development.
“What I’m hoping to achieve is pretty much every year, we’re going to start a new clinical trial,” Pravetoni told the Seattle Times in early January.
An Epidemic of Opioid Overdoses
In November, provisional data from the U.S. Centers for Disease Control and Prevention showed that during the 12-month period ending April 2021, 100,306 Americans died of drug overdoses. Synthetic opioids were involved in nearly two-thirds of the overdose deaths reported.
The overdose-reversal drug naloxone has been shown to save lives in emergencies. Additionally, treatments for opioid abuse disorder including methadone and buprenorphine can help those struggling with addiction, although opioid replacement therapy drugs have their own risk of addiction. New treatments could increase the chances of success for those struggling with opioid abuse, according to Rebecca Baker, director of the National Institutes of Health’s Helping to End Addiction Long-term Initiative, a program that has helped fund Pravetoni’s research.
“(Existing medications) don’t work for everyone. And a lot of people don’t stay on them in the long term,” Baker said. “Would the outcomes be better if we had more options?”
The University of Washington’s opioid vaccine project is building on research published in the journal Nature in 1974. In that study, a rhesus monkey had been trained to self-administer heroin and cocaine. After being given an experimental vaccine to block the effects of heroin, the monkey continued to use cocaine but greatly reduced its use of heroin, suggesting the vaccine had done its job.
That study led to further research into the possibility of creating a vaccine for nicotine addiction. Although early results appeared promising, human trials showed the treatment was only as effective as a placebo. A vaccine developed to fight cocaine addiction saw a similar fate, and neither treatment received approval from the Food and Drug Administration.
Kim Janda, a chemistry and immunology professor at Scripps Research Institute in California, has spent decades researching vaccines against addictive drugs. He believes that continued research could eventually produce an effective vaccine.
“We’ve learned a lot more [about] what is possible, what’s maybe not going to be as fruitful,” Janda said, adding that vaccines may not work against all drugs of abuse. “But if there’s enough money to put behind these vaccines, and you had the infrastructure to do it, then you could move it along fairly quickly.”
This year, Pravetoni and a researcher with Columbia University have launched the first Phase 1 clinical trial of a vaccine to prevent opioid abuse. The safety and efficacy of the vaccine, which is designed to block the effects of oxycodone, is being tested in people who are already addicted but not receiving the disease.
Is an Opioid Vaccine Worth the Cost?
But human drug trials are expensive. Pravetoni estimates that bringing an effective opioid vaccine to market could cost up to $300 million. Some addiction experts, including Dr. Ryan Marino, an emergency medicine physician and medical toxicologist at Case Western Reserve University in Ohio, wonder if the money could be better spent.
“It is true that more treatment options are generally better,” Marino told Filter. “But what doesn’t make sense to me—as someone who treats both overdose and addiction—is putting so much funding towards this when we already have an antidote for opioids, a long-acting opioid blocker and two other evidence-based treatment options for opioid use disorder that both reduce opioid use and prevent overdose.”
Harm reduction activists working on the ground with people who have substance abuse disorders say that limited funds could be spent more effectively. Jessica Blanchard, the founder of Georgia a mobile harm reduction program called 229 Safer Living Access, distributes safer sex supplies and naloxone provided by other groups. But she personally covers the other costs to administer the program, which limits its operations substantially.
“With funding, not only could I afford to buy in bulk, greatly reducing cost, but I could also give participants more supplies to share with those unable to make contact with the program,” Blanchard said. “I would pay program participants to do secondary distribution. (They) are the experts here. They express a desire to participate in distributing supplies and educating their peers. But without the ability to compensate them for their time and lived-experiential knowledge, I simply can not ask them to help.”
New Washington, D.C. Policy Lets Adults ‘Self-Certify’ for Medical Cannabis
City lawmakers in Washington, D.C. adopted an emergency ordinance on Tuesday designed to ease access to the medical cannabis program in the nation’s capital by allowing all adults to “self-certify” their eligibility to use medicinal pot. Under the proposal, adults 21 and older would no longer be required to submit a recommendation to use medicinal pot from a health care provider when they apply for a medical cannabis identification card.
Supporters of the measure maintain that the bill will make it simpler for patients to gain access to medical cannabis, particularly for those who have difficulty seeing a doctor. Out of thousands of physicians practicing medicine in Washington, D.C., only 620 are registered to issue medical pot recommendations. In January, the city council passed a similar measure that allowed adults 65 and older to self-certify for medical cannabis card eligibility, but that ordinance expired on May 1.
“This self-certification is urgently needed for consumers and dispensaries alike,” said Councilmember Janeese Lewis George, as quoted by the DCist. “Expanding our patient base is a necessary first step to putting them on an equal playing field.”
Washington, D.C. Dispensaries Face Competition From Illicit Businesses
The emergency ordinance passed on Tuesday was introduced by Councilmembers Kenyan McDuffie and Mary Cheh. Proponents of the bill also hope that it will help regulated medical dispensaries compete with the illicit cannabis economy.
“Due to the lower barriers to access in the gray market, a significant number of medical marijuana patients have shifted from purchasing their medical marijuana from legal medical dispensaries to the illicit gray market, creating a significant risk to the long-term viability of the District’s legal medical marijuana industry,” McDuffie and Cheh said in a statement accompanying the emergency bill. “If this trend continues, it is possible that gray market sales could wipe out the District’s legal marijuana dispensaries.
Cheh and McDuffie went on to state that given the “benefits that regulated and safe legal dispensaries provide to medical marijuana users in the District, it is vital that the industry survive until the District can stand up a regulated recreational market and transition toward full regulation of recreational marijuana products.”
The council members noted that Washington, D.C.’s permitted medical marijuana dispensaries face stiff competition from the city’s gray market for cannabis, which takes advantage of recreational cannabis decriminalization loopholes to operate with virtual impunity. One popular scheme features businesses who sell cheap merchandise at hyper-inflated prices and include what is ostensibly a gift of cannabis with the purchase.
“Savvy business owners have pushed the legal limits on the gifting industry,” McDuffie said ahead of the vote. “I’ve had medical dispensaries that have reached out to me and my staff and say that if we don’t pass this measure, it could put their businesses into jeopardy.”
Although possession of cannabis has been legalized since the passage of a 2014 ballot measure, the federal government has blocked implementation of the law that would allow for the opening of recreational pot retailers. At Tuesday’s meeting, Council Chairman Phil Mendelson said that he would still like to see additional legislation that targets Washington D.C.’s cannabis gifting shops, noting that the business will be vital infrastructure for a potential legalized adult-use cannabis market.
“It’s not an equal playing field and will never be as long as there are illegal cannabis gifting shops,” he said. “As long as there are these businesses, the legal industry won’t be there to step in [when legalization happens].”
The city council passed the ordinance by a unanimous vote at its meeting on Tuesday. The bill is now headed to the office of Mayor Muriel Bowser for her consideration. In a letter sent to the council on Tuesday, Bowser said that she is in favor of the legislation, according to media reports.
The impact of cannabis use on COPD and COVID-19
Tobacco use is associated with reduced air flow rate and lung volume; however, this association is not observed with cannabis use. In fact, one 2012 study found no association to exist between occasional and minimal cumulative cannabis usage and poor pulmonary function.
To determine the different effects of cannabis and/or tobacco, it is crucial to know the quantity of how much was smoked. Those who frequently use tobacco will typically smoke between ten and twenty cigarettes each day, whereas the average cannabis user will smoke two to three times per month.
Many people first try cannabis in their late teens or early twenties, with some continuing to use cannabis for several years at modest doses. Since heavy cannabis users were comparatively uncommon in the study population, accurate estimates of the consequences of excessive usage were not available in the aforementioned 2012 study, despite the fact that heavy exposure to cannabis may harm the lungs.
In a recent Chronic Diseases and Translational Medicine study, researchers evaluated the effects of smoking cannabis on coronavirus disease 2019 (COVID-19) test positivity, as well as potential risk factors associated with cannabis-induced lung damage and COVID-19.
About the study
Approximately 500,000 men and women participated in the United Kingdom Biobank (UKB), which is a sizable prospective observational study that was conducted between 2006 and 2010. UKB participants were selected from 22 centers throughout England, Wales, and Scotland and are still being longitudinally monitored to record any subsequent health occurrences.
Study participants were asked several questions upon their enrolment in the UKB. For example, participants were asked whether a doctor had ever informed them that they have a certain health condition, such as chronic obstructive pulmonary disease (COPD).
The subjects were then asked whether they had consumed cannabis. If the response was “yes,” cannabis usage was entered in the UKB data field. The participants were also asked at what age they had last consumed cannabis.
Subsequently, study participants were asked the frequency to which they used cannabis. The available response options included less than once a month, once a month or more, but not every week, once a week or more, but not every day, and once a day.
The researchers also incorporated COVID-19 laboratory-confirmed cases that were reported between March 16, 2020, to April 26, 2020, with the UKB data. A positive test result was regarded as a reliable indicator of severe COVID-19 during this time, as the testing of older groups was primarily restricted to individuals who were hospitalized as a result of their infection.
The mean age of the study participants was about 57 years old. Taken together, 54% of the study participants were women, whereas the remaining 46% were men.
Increased cannabis use was associated with an increased incidence of both COPD and COVID-19 positivity. Packs-years smoking was also found to correlate with COVID-19 incidence.
In general, smoking tobacco increases an individual’s risk of lung infections like COVID-19. Although the data is limited in establishing an association between the smoking of cannabis and its effects on the lungs, previous research has shown that cannabis smoke causes respiratory symptoms such as increased cough, sputum, and hyperinflation, all of which are also observed in tobacco smokers.
In the current study, both smoking packs of cigarettes and cannabis had significant effects on the likelihood of testing positive for COVID-19. This observation insinuates that although cannabis had not been used for at least ten years, its ability to cause damage to the lungs is additive.
Although it is challenging to correctly predict and separate the consequences of cannabis usage from those associated with smoking cigarettes, smoking cannabis can nevertheless cause significant harm to the lungs.
With prolonged cannabis use, significant lung problems can develop, such as chronic bronchitis symptoms. Cannabis use has also been linked to weakened immune systems and pneumonia.
Excessive cannabis use can also worsen COVID-19 outcomes and restrict the airways. However, cannabis use may reduce lung inflammation and inhibit viral replication in COVID-19 patients, which may improve certain prognoses.
There are several notable weaknesses of the current study. For example, cannabis usage was only linked to positive COVID-19 test results. Furthermore, the frequency of cannabis usage and its ability to alter an individual’s susceptibility to COVID-19 was not explored.
The high prevalence of Caucasian participants may have also impacted the current findings. Future studies that incorporate more independent variables in the logistic regression would be beneficial.
Viridis Laboratories Continues to Fight for Safety of Michigan Cannabis Consumers
Viridis Chief Operations Officer and Founder Todd W. Welch sent an email on June 17 with a statement addressing the company’s values and recent information that has come to light regarding the CRA.
“These CRA allegations against Viridis are from last August and continue to be baseless, meritless and totally detached from science, facts and data,” said the statement. “We intend to defend our business against these false claims during the court process and show the vindictive and retaliatory nature of the CRA’s actions which are clearly designed to cause maximum disruption and damage.”
“Court-ordered proficiency test results that Viridis is in possession of, which the CRA had been withholding, will directly contradict these findings, and we’re confident the truth will prevail when all facts come to light,” the statement continued. “We hope these legal proceedings will pave the way for more transparency, accountability, and reforms at the CRA. Our hope is that the CRA can one day fulfill its true mission of promoting patient and product safety instead of unfairly targeting Michigan businesses trying to grow, compete and create jobs.”
The email also shared that nearly all of the company’s customers have returned, with an added 63 new customers. The company supports testing for approximately 62% of the state’s flower.
The CRA (formerly called the MRA, or Marijuana Regulatory Agency, as of April 2022) issued a recall for products tested by Viridis Laboratories and Viridis North in November 2021, with claims that Viridis products contained “inaccurate and/or reliable results,” for products analyzed within the range of August 10 and November 16, 2021. This resulted in the recall of an estimated $229 million in product value.
The MRA claimed that Viridis’ methods of testing were “unreliable” and “inaccurate,” which Viridis responded to by filing a Court of Claims lawsuit against the MRA on November 23.
By December 3, the court ruled that the CRA must release half of the accused products, which were tested by Viridis North, LLC. Viridis Attorney Kevin Blair praised the court decision, even if “the entire recall was completely without merit.” “This ill-advised recall has caused irreparable harm not only to Viridis but to growers, retailers and consumers throughout the state. The MRA needs to be held fully accountable for violating state law, ignoring the advice of respected national experts and causing mass disruption to the Michigan cannabis industry,” he said in a press release.
Months later in February 2022, more news came forward regarding the CRA’s conduct. Judge Thomas Cameron released a court opinion that “the issuance of the recall against the Bay City facility was, on the Court’s review of the record, arbitrary and without basis.”
Shortly after this, it was revealed that CRA had instructed its agents not to seize illegal cannabis found at CRA-licensed facilities. New evidence from CRA depositions shared troubling truths about the inner workings of the MRA when it comes to following its own policies.
In March, Senator Aric Nesbitt questioned the CRA and its management. “I think it was poorly communicated to your licensees and it didn’t seem like you had thought through the impact on the wider marketplace before acting on the recall, and I thought it was very poorly done and very clumsy in the implementation of the recall,” Nesbitt said at a Senate Appropriations Subcommittee on Licensing and Regulatory Affairs/Insurance and Financial Services.
Most recently in May, the CRA filed formal complaints about the accuracy of Viridis’s THC test results. According to Viridis CEO Greg Michaud, described that allegations from the CRA “continue to be baseless, meritless and totally detached from science, facts and data.”
Furthermore, Michaud shared that the CRA’s Inter-Laboratory Proficiency Test, which was obtained via a court order, reveals some shocking finds about other lab testing facilities in Michigan. The test results are not yet public, but Welch’s email suggests that more news will be announced soon.
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