GETTING a drug trial off the ground is never easy: regulatory approvals, funding, logistical issues all have to be resolved.
But each of those challenges is multiplied exponentially if the potential therapeutic agent just happens to also be an illicit recreational drug.
An editorial in the February edition of Scientific American argues that it’s about time we did away with what has effectively been a 50-year international ban on researching therapeutic applications of illicit drugs.
Potential uses include MDMA (ecstasy) for intractable post-traumatic stress disorder, LSD and other psychedelics for cluster headaches or obsessive-compulsive disorder, and cannabis for a host of conditions including attention deficit hyperactivity disorder, nausea, sleep apnoea and multiple sclerosis.
It’s about time we detached research on psychoactive chemicals from “the hyperbolic rhetoric that is a legacy of the war on drugs”, the editorial says.
“Innovation would likely accelerate if pharmacologists did not have to confront an antiquated legal framework that, in effect, declares off-limits a set of familiar compounds that could potentially serve as the chemical basis for entire new classes of drugs.”
Why are we so completely incapable of taking a rational approach when it comes to these particular chemical compounds?
A NSW cross-party parliamentary committee, including representatives of all major political parties, last year unanimously recommended decriminalising the medical use of cannabis. Although the state government accepted some of the recommendations, that was a step too far, as the Sydney Morning Herald reported.
NSW is not the only political jurisdiction reluctant to allow expanded medical use of substances like cannabis.
Governments around the world have taken similar approaches, perhaps based on a misguided fear that any admission of benefits could undermine the often overstated claims made about harms.
“It seems it is difficult for some politicians to understand that a psychoactive drug (like any substance) can have both beneficial and adverse effects”, neuropsychopharmacologist David Nutt* and colleagues wrote in Nature Neuroscience last year.
Classifications of drugs can be unclear and inconsistent, sometimes appearing to have been made for political rather than health-related reasons, they wrote.
In the US, cannabis and ecstasy are classed as more dangerous than cocaine or methamphetamine, while in the UK Misuse of Drugs Regulations cannabis receives a higher rating than heroin.
Researchers are forced to navigate extraordinary obstacles if they wish to investigate the potential benefits of the drugs: regulators are scared, funding bodies are reluctant to chip in and the logistical challenges can be almost insurmountable.
A Canadian group researching post-traumatic stress disorder, for example, took more than 4 years to obtain approval to import MDMA from Switzerland despite having government approval for the trial protocol.
American cancer researchers trialling psilocybin (the hallucinogen found in magic mushrooms) were required to have the drug weighed daily by two people to protect against theft — even though they were only holding a few milligrams of the substance.
For researchers who can overcome those barriers, there remains the difficulty of accessing the drugs at an affordable price since they’re not exactly available from standard suppliers.
Professor Nutt himself was quoted a minimum of ₤100 000 ($A188 000) for custom supply of 100 doses of psilocybin to be used in a clinical trial on treatment-resistant depression.
All this leads him and his colleagues to ask why the scientific community has not protested against “the effective ban of research on drugs that could offer so many insights into human brain function and such great opportunities for new treatments”.
It’s a good question. Perhaps it’s time.
Jane McCredie is a Sydney-based science and medicine writer.
*Professor Nutt has appeared in this blog before. In 2009, he wrote in the Journal of Psychopharmacology about an addictive behaviour that caused injury once in every 350 uses, including traffic accidents, neurological damage and death. He found the risks of this addictive behaviour compared unfavourably with use of ecstasy, which led to acute injury in only one in 10 000 uses. The behaviour? Horse riding or, as Professor Nutt termed it, “equasy”. He soon found out the consequences of appearing “soft on drugs”, being forced to apologise and eventually being sacked from a high-profile government job.