The thrust of a campaign to address the emerging Australian medicinal cannabis landscape. Despite neighbouring countries, TGA has conducted little to no safety investigations or assessments of most medicinal cannabis products, despite receiving hundreds of adverse event reports. From July 2022 to June 2023, the TGA recorded 615 such adverse events related to these products. Of these reports, 50 troubling cases of psychosis and 14 involving suicidal ideation or behavior were counted. This absence of regulatory oversight is very troubling to many in the medical community, as well as potential patients.
Teresa Nicoletti, chair of the Australian Medicinal Cannabis Association, called the haul of adverse event data “very, very scary stuff.” She emphasized that this data should not be alarming by itself. She noted that a large number of wary patients dabbling in medicinal cannabis are polypharmacy patients. Yet this overlap prevents FDA from knowing the root cause of any adverse event reported.
“When you start to look at a lot of the adverse events for which information is available, medicinal cannabis was not the only medicine that was prescribed,” – source unknown
The TGA announced a review into the safety and regulatory oversight of unapproved medicinal cannabis products, acknowledging the growing concerns within the medical community. This review follows on the heels of a dramatic uptick in reported adverse events. Gee and Professor Brett Emmerson, a longtime and vocal critic of controversial regulatory measures. He suspects that the 615 reported cases are only “the tip of the iceberg.”
Adverse Events and Patient Experiences
Reports of adverse events related to the use of medicinal cannabis have raised concerns about serious mental health adverse events. In addition to developing psychosis, other cases have presented with schizophrenia, homicidal ideation, bipolar disorder, and delusions of parasitosis.
Alice Davy, who has been using medicinal cannabis since 2020 to manage her endometriosis pain and treat her multiple sclerosis. She expressed exasperation that no safety testing is done on these products.
“How are we supposed to be able to know what’s safe and what’s not if there’s no tests being done?” – Alice Davy
Davy is only one of the many veterans who have had great experiences with the use of medicinal cannabis. Like her patients, she’s worried about the safety of their treatments. Until now, the TGA has not approved or assessed any medicinal cannabis products for quality, safety, or efficacy. This glaring omission leaves countless patients feeling exposed.
Nicoletti pointed out that 24 percent of all adverse events submitted since 2016 were marked serious by the event submitters. She stressed that these incidents account for a tiny percentage of units sold.
“The percentage of adverse events are really rare compared to the number of units that have been actually sold with medicinal cannabis,” – Teresa Nicoletti
Nicoletti says that about 13 million units of medicinal cannabis were sold during the reporting period. This indicates that we should address adverse events, but they may be less frequent than some have come to believe.
Calls for Regulatory Reform
This call for stronger regulatory scrutiny is resonating with public health advocates. During the briefing, Professor Emmerson emphasized the risks posed by unregulated items that have already flooded the market.
“This is not a drug that can be just regarded as a natural product,” – Brett Emmerson
According to Emmerson, medicinal cannabis should be handled with as much care and precaution as traditional medicine. This is especially important since it can result in addiction and life-threatening adverse effects. He contended that the increasing reports of patient harm from cannabis usage, particularly psychosis, warrant immediate attention from regulatory bodies.
“It’s a drug of dependence with serious side effects and it’s having a tragic impact on a large number of people in this country,” – Brett Emmerson
Danielle McMullen, president of the Australian Medical Association, warned it was creating a “sick care” landscape in Australia. She remarked that, in terms of public opinion, it has flipped completely. These regulatory settings should be updated to prevent future gaps in oversight, especially with respect to medicinal cannabis.
“Clearly, the health landscape has changed dramatically in Australia, so it is vital we look at our regulatory settings and find out what needs to be done to address any gaps, including in the medicinal cannabis space,” – Danielle McMullen
McMullen emphasized the increasing incidents of patient harm being reported. He underlined the need for urgent systemic reviews of all medicinal cannabis prescriptions.
“We are seeing increasing reports of patient harm from cannabis, including psychosis, so this current surge in prescriptions is highly concerning,” – Danielle McMullen
The Future of Medicinal Cannabis Regulation
This has left Australia with more than 1,000 unapproved medicinal cannabis products available on the market. Finally, many healthcare advocates and experts are urging us to design a new and more robust regulatory framework. The TGA’s continued review could ignite important reforms. Doubt remains over the speed these transitions will take and their ultimate success.
The industry continues to face criticism for marketing medicinal cannabis for various conditions without substantial evidence supporting its efficacy outside a select few medical applications.
“This is despite the reality there is very little evidence to support the use of medicinal cannabis other than in a small number of conditions,” – Danielle McMullen
As Emmerson concluded, “Patients deserve appropriate, plain-language guidance about the range of treatment options available to them. He argued for stricter regulations to prevent misleading marketing practices that could exploit vulnerable individuals seeking relief from their ailments.
“They market it because people take it and that’s their business,” – Brett Emmerson
Patients such as this week’s A Patient Like Me, Alice Davy, point out the benefits and the dangers of using medicinal cannabis. Although she has lived 80% free of debilitating pain since starting her treatment, her safety worries come first and foremost.
“I’m no longer in debilitating pain. I eat. I sleep. I don’t have any nausea,” – Alice Davy
