The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) recently published collected data on CBD safety, placing the information under its Yellow Card alert system, which lists various adverse reactions to drugs in general.
In the report, the agency notes that as many as 10 people have died from CBD and more than 870 experienced adverse reactions.
Following the issuance of the report, the Committee on Toxicity (CoT), which offers scientific consultation to the UK Food Standards Agency (FSA) used the death data when explaining its position on the safety of CBD, reported Business Cann.
“It is not true to say that there have been no adverse reactions reported in the Community,” said CoT chair Prof Alan Boobis. “Please see link to the MHRA Yellow Card Adverse Drug Reaction (ADR) scheme which includes CBD products and not just medicines.”
Industry Exerts Rise
Now, there’s a rising fear among the hemp community that CBD’s status can be changed to medical-only. Industry representatives and advocates are standing up to fight this possible change.
“This data is not supportive of either the CoT or FSA position and in fact undermines them,” Steve Oliver of Canna Consultants told BusinessCann. “Referring to data which when examined does not relate to the CBD products they claim to be assessing is disingenuous at best.”
“There have been no deaths and there is no consumer detriment that I am aware of in respect of safety. Mislabeling and poor product quality, yes, but the current regime does nothing to address that,” Oliver said.
UK Cannabis Industry Council chief executive Mike Morgan-Giles blasted the report, saying “these claims about CBD are virtually meaningless on the clarifications listed on the MHRA webpage, and nor do they withstand any serious analysis.”
According to Oliver, the CoT’s presented data has the goal to sabotage the CBD industry and back FSA policy, under which all non-medical CBD products must be approved under the agency’s rules for “novel” foods, which is a very expensive process.
What’s more, industry stakeholders are arguing that one large pharmacy company played an important part in all of this. Ireland-based Jazz Pharmaceuticals JAZZ acquired cannabinoid drug company GW Pharmaceuticals in 2021 and with it the right to Epidiolex the first and only FDA-authorized CBD medicine for treating children with severe forms of epilepsy.
The medicine was first approved for treating seizures connected to Lennox-Gastaut syndrome and Dravet syndrome, and last July for treating seizures related to tuberous sclerosis complex. Epidiolex's net product sales were $463 million in 2021, whereas in just the first three quarters of 2022 sales surpassed $529 million.
Epidiolex was authorized by MHRA for marketing in the UK, in September 2019.
“GW saw the CBD industry start to take off, and they must have thought we need to stop this,” Oliver told BusinessCann in February.
While the CoT argues that CBD exposes health risks, hemp and CBD advocates say the data used to reach such a conclusion came from tests based on doses of CBD at 20mg per one kilogram of body weight, which is much higher than the recommended daily intake of 1mg per 1 kg of body weight, writes Hemp Today.
Jazz Already Has A Reputation
Jazz is known as a passionate lobbyist across the various markets in which it operates. For example, the company is registered to lobby on CBD policy with the U.S. Congress and has helped shape medical marijuana rules in Brazil, which do not allow physicians to prescribe raw cannabis for medical marijuana, as well as any derivatives other than CBD. “Policy in Brazil further prohibits doctors from prescribing CBD for any other therapeutic indications and even from giving lectures or courses on the use of CBD or other cannabis-derived products outside the scientific community,” writes the outlet.
What’s more, Jazz was recently welcomed to a working group in France launched by the General Directorate of Health, which included medical marijuana companies supplying the country’s cannabis trial, like Canadian producers Aurora Cannabis ACB, Tilray Brands TLRY, Israel’s Panaxia Pharmaceuticals and Australia’s Little Green Pharma.
Benjamin Alexandre-Jeanroy, of Paris-based Augur Associates, expressed concerns about the impact of pharmaceutical businesses like Jazz on the development of European cannabis markets, reported the outlet.
“Jazz is trying to restrict the access of extracts to a solely pharmaceutical model, but is this the right path for cannabis as its focus is on patenting a plant?” Alexandre-Jeanroy asked.
Furthermore, Jazz lost cases in court over its strategy in the US, with a federal court in Delaware ruling that the pharmacy company tried to prevent the introduction of a rival’s narcolepsy treatment. While Jazz appealed the ruling, a federal circuit court recently upheld the lower court’s ruling.
It’s All About The Money
The New York Times also reported about Jazz's activities in a piece titled ‘A Drug Company Exploited a Safety Requirement to Make Money,’ saying it has found a way to push the boundaries even further, demonstrating “the lengths to which drug makers go to eke out extra profits and that two federal courts have now ruled was improper.” As Times reporter Rebecca Robbins pointed out, for every month that Jazz succeeded in postponing the introduction of a rival’s product, the company and its shareholders meet their goal - earn more money.
Photo: Benzinga edit with images from J Dennis and IRA_EVVA on Shutterstock
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