The president of the British Neuroscience Association has warned that work on potentially useful drugs for problems such as depression are being stymied by the plethora of bureaucracy surrounding clinical trials.
In a talk at his association’s biennial meeting – covered by news outlets across the world – pharmacologist David Nutt complained that his plans to test psilocybin, the active ingredient in ‘magic mushrooms’ has foundered.
Nutt, who was previously sacked from a government advisory role in a clash over illegal drug policy, says it has “proved impossible” to find a manufacturer prepared to “go through the regulatory hoops” to supply psilocybin.
Much of the coverage has focused on the fact that the proposed trial is of a component of an illegal drug. But the situation is even more complicated and bureaucratic than it might first appear.
There are heavy restrictions placed on drugs on ‘schedule 1’ of the act that governs illegal substances in the United Kingdom. Researchers wishing to work with these must obtain a licence from the Home Office. Nutt has previously written that “Schedule 1 regulation, a dustbin category for controlling drugs with no medical use, may prevent medical advances that could help relieve depression and pain”.
A totally separate issue is that any drugs used in a clinical trial must come from a factory compliant with ‘good manufacturing practice’ (GMP). This means that trials must obtain substances produced under expensive ‘GMP’ conditions, even when there are off the shelf versions. The Academy of Medical Sciences outlined this problem in its 2011 report, noting that a trial of fish oil had similar problems.
In the case of psilocybin, it seems, this double whammy has proven too much. “We have not given up but it is proving very difficult,” the Guardian quotes Nutt as saying.