Randomised clinical trials led and organised by patients might be an excellent way to test claims made for medical marijuana, according to UK-based physician, academic and author Ben Goldacre.
Goldacre has made a career from skilfully dissecting flaws in the way clinical trials are conducted. He is a strident advocate for reforming the protocols surrounding information gleaned by such trials. In particular, he wants to ensure that all results – not simply those which further the interests of companies that fund them – are made public.
In the matter of medical marijuana, the situation is more complicated than usual. Because until recently it was illegal in many countries to possess, let alone experiment with, cannabis, properly conducted trials to test claims made for its therapeutic benefits have only recently got underway.
Experiments followed by three phases of clinical trials, interspersed by lengthy peer reviews and publication cycles, and followed by a long battle to win the favour of regulators, takes many years – and a lot of money.
One possible route to expedite the process, says Goldacre, involves getting the people making the therapeutic claims – the users and patients themselves – to organise a clinical trial. After all, they are already doing the experiments – taking the drug to alleviate this or that symptom – only without recording the results. Patient-organised trials can be formalised without the long approval, recruitment, and funding processes that university research requires.
“With a drug like cannabis that is available to a lot of people, regardless of what the law says, if there is a large number of people who feel that it is helpful to them, I’d really love to see groups of patients coming together to run their own randomised control trials,” he says.
“Perhaps cannabis isn’t, in regulatory terms, the safest area in which for me to do this – as a doctor and an academic researcher – but I think I would be very happy to give study design advice to anyone who would be wanting to do patient-led randomised trials.”
He points out that trials into the efficacy of many types of therapeutic intervention – from the value of cannabis in reducing nausea to the effect of hot curries on inducing pregnant women to go into labour – don’t really need to be conducted only by fully tenured scientists.
“The basic design of a randomised controlled trial is very simple and has been around for decades,” he says.
“A group of patients who are tracking their symptoms, in particular through an online platform, could very straightforwardly run a randomised trial for themselves.”
There is, of course, no guarantee that a group of citizen scientists would be any happier than Big Pharma to release negative findings.
If people who believe marijuana helps them better manage some symptoms can legitimately run a clinical trial – perhaps, a massive one, involving thousands of people recording data over several years – what is to stop those who favour other “natural” remedies following suit?
This could this open the door to, say, cancer patients trialling apricot kernels, or people testing homeopathic flu remedies, and potentially harming themselves in the name of self-appointed research.
To Goldacre, the idea doesn’t sound half bad.
“I’m not sure I would object if patients chose to conduct a robust trial of apricot kernels and cancer, or of homeopathy,” he says.
“The concern with apricot kernels and cancer would be if they were at the same time depriving themselves of effective evidence-based treatments, but it’s not the trial that’s making them do that. It’s their pre-existing disposition.”
Any such trial, he says, would need a large number of people. Randomising participants into active and control cohorts could be done automatically via a website. And there are companies that specialise in “blinding” substances to be tested – packaging up actual and placebo drugs such that no one in the trial can know which they are taking.
With all that taken care of – and perhaps some sound advice on proper practice from Dr Goldacre himself – a brave new age of citizen trialling could then begin.
“I would be perfectly happy to see any patient who wants to do a trial of homeopathy or apricot kernels,” he says. “That seems like an admirable thing to do, to my mind.”
Ben Goldacre will be a guest at the 2018 Global Atheist Convention, to be held in Melbourne, Australia, February 9-11, 2018.