Researchers decry insistence on RCTs, calls for better education
Limited education, stubbornness, and insistence on seeing results from randomized controlled trials (RCTs) keep most British physicians from prescribing medical cannabis, despite a new national law permitting it, researchers argued.
“Given the substantial evidence of utility of [medical cannabis] in many disorders as identified in the U.S. National Academy of Sciences review in 2017 this failure of delivery in the U.K. seems odd and, to many, inexcusable,” David Nutt, DM, of Imperial College London, and colleagues wrote in BMJ Open.
“The failure of the medical and pharmacy professions to embrace [medical cannabis prescriptions] despite their being made ‘legal’ over 18 months ago is a great worry to patients and will already likely have led to preventable deaths from conditions such as epilepsy,” they wrote.
Providers should consider other published evidence, listen to patient experiences, and be more open-minded while meeting the increasing patient demand, according to the group.
Nutt has long advocated for a more lenient attitude toward cannabis. In 2009, he was dismissed as a government adviser on drug policy after he criticized a decision to reclassify cannabis into a category with amphetamines and cocaine. The government reversed course in 2018, allowing medical use of cannabis.
But over the first year following legalization, “almost no National Health Service (NHS) prescriptions have been issued and less than a hundred have been made available from private providers at a cost of at least £1,000 a month,” Nutt and colleagues wrote in the BMJ Open paper.
By Nutt’s account, only 20 people have been prescribed medical cannabis via NHS since cannabis was legalized for medicinal use (recreational cannabis remains illegal in the country). Many of the estimated 1.4 million medical cannabis patients in the country instead pay heavily for private treatment with black-market products.
The evidence base and the “thousands” of British patients self-medicating with cannabis “suggest these new medical products offer a significant advance in treatment for many in whom current medicines are either ineffective or poorly tolerated,” the authors wrote. “They also offer the potential of significant cost savings to the NHS.”
“It is utterly deceitful for people who need it not to be offered medical cannabis,” said Nutt, who also serves on the scientific oversight board for Project Twenty21, “Europe’s first and biggest national medical cannabis registry,” according to its founders, Drug Science.
“I’ve never seen anything like it in medicine,” Nutt told MedPage Today.
Providers, usually specialists, often cite the lack of RCTs of medical cannabis in terms of their reticence to prescribe it, the authors reported.
But “[t]he major criticism of the lack of placebo-controlled trials is misplaced. Prescribers often mistakenly state that without these they cannot prescribe,” Nutt’s group wrote. More than 50 medicines and indications were licensed by the FDA and/or European Medicines Agency from 1999 to 2014 without RCT data, they noted.
Clinicians should evaluate other published evidence, including observational studies and patient-focused trials, the authors wrote.
“While tens of thousands of individual patient reports of the therapeutic value of [medical cannabis]… do not equate to the so-called gold-standard double-blind [RCT] level of proof, they are highly suggestive of a pattern of evidence which should be taken seriously rather than summarily dismissed,” they stated. “These large-scale databases could be further interrogated and systematically analysed to collate patient-reported outcomes and other existing evidence for peer reviewed publications.”
Limited education, stubbornness, and insistence on seeing results from randomized controlled trials (RCTs) keep most British physicians from prescribing medical cannabis, despite a new national law permitting it, researchers argued.
“Given the substantial evidence of utility of [medical cannabis] in many disorders as identified in the U.S. National Academy of Sciences review in 2017 this failure of delivery in the U.K. seems odd and, to many, inexcusable,” David Nutt, DM, of Imperial College London, and colleagues wrote in BMJ Open.
“The failure of the medical and pharmacy professions to embrace [medical cannabis prescriptions] despite their being made ‘legal’ over 18 months ago is a great worry to patients and will already likely have led to preventable deaths from conditions such as epilepsy,” they wrote.
Providers should consider other published evidence, listen to patient experiences, and be more open-minded while meeting the increasing patient demand, according to the group.
Nutt has long advocated for a more lenient attitude toward cannabis. In 2009, he was dismissed as a government adviser on drug policy after he criticized a decision to reclassify cannabis into a category with amphetamines and cocaine. The government reversed course in 2018, allowing medical use of cannabis.
But over the first year following legalization, “almost no National Health Service (NHS) prescriptions have been issued and less than a hundred have been made available from private providers at a cost of at least £1,000 a month,” Nutt and colleagues wrote in the BMJ Open paper.
By Nutt’s account, only 20 people have been prescribed medical cannabis via NHS since cannabis was legalized for medicinal use (recreational cannabis remains illegal in the country). Many of the estimated 1.4 million medical cannabis patients in the country instead pay heavily for private treatment with black-market products.
The evidence base and the “thousands” of British patients self-medicating with cannabis “suggest these new medical products offer a significant advance in treatment for many in whom current medicines are either ineffective or poorly tolerated,” the authors wrote. “They also offer the potential of significant cost savings to the NHS.”
“It is utterly deceitful for people who need it not to be offered medical cannabis,” said Nutt, who also serves on the scientific oversight board for Project Twenty21, “Europe’s first and biggest national medical cannabis registry,” according to its founders, Drug Science.
“I’ve never seen anything like it in medicine,” Nutt told MedPage Today.
Providers, usually specialists, often cite the lack of RCTs of medical cannabis in terms of their reticence to prescribe it, the authors reported.
But “[t]he major criticism of the lack of placebo-controlled trials is misplaced. Prescribers often mistakenly state that without these they cannot prescribe,” Nutt’s group wrote. More than 50 medicines and indications were licensed by the FDA and/or European Medicines Agency from 1999 to 2014 without RCT data, they noted.
Clinicians should evaluate other published evidence, including observational studies and patient-focused trials, the authors wrote.
“While tens of thousands of individual patient reports of the therapeutic value of [medical cannabis]… do not equate to the so-called gold-standard double-blind [RCT] level of proof, they are highly suggestive of a pattern of evidence which should be taken seriously rather than summarily dismissed,” they stated. “These large-scale databases could be further interrogated and systematically analysed to collate patient-reported outcomes and other existing evidence for peer reviewed publications.”
Only about 90 providers have been trained nationally, Nutt told MedPage Today, noting that they have to solicit training. “You would be a better specialist if you did become educated about medical cannabis, but that would take effort,” he said.
Another obstacle: Most medical education is sponsored by pharmacuetical companies, he said, and only one now has a medical cannabis product on the market. Without much incentive, they are offering few training opportunities on medical cannabis.
Medical students and younger providers are more open to considering medical cannabis, Nutt said, whereas older providers are less so.
“Perhaps one reason for resistance to [medical cannabis] is that for nearly 50 years the medical profession focused on the risks of cannabis with extreme claims of harms, including male sterility, lung cancer and schizophrenia. Though these have now been largely debunked and were generally the result of recreational rather than prescribed medical use, many practitioners may not know this,” according to the group’s BMJ Open paper. “Even if they do, there can be significant concern in prescribing a drug that has been vilified for decades as toxic.”
“Cannabis is so stigmatized,” Nutt said, “if you want a reason not to prescribe cannabis, you can find one.”
Nutt and colleagues made a similar argument recently in the Journal of Psychopharmacology.
Original Article: https://www.medpagetoday.com/publichealthpolicy/healthpolicy/88753
