Australia to prescribe MDMA and psilocybin for PTSD and depression in world first
Decision to make the previously illicit drugs available is dogged by suggestions the decision was rushed.
In a controversial move, Australia will become the world’s first country to allow the drugs psilocybin and MDMA to be prescribed by doctors to treat psychiatric conditions including depression and post-traumatic stress disorder. But many scientists are concerned that research has not yet conclusively shown that these drugs are safe or effective. And some clinicians fear that the regulation that will govern access to the drugs is insufficient.
Australia’s drug regulator, the Therapeutic Goods Administration (TGA), which approved the move, says that the decision followed a nearly three-year process and included extensive consultation with experts.
Research over the past few decades1 has shown that some drugs that are illicit, but are often used recreationally, are effective in treating certain mental-health disorders when combined with psychotherapy. MDMA is widely known as the party drug ecstasy, and psilocybin is the active ingredient in hallucinogenic mushrooms. A phase II trial, published late last year2, showed that a 25 mg dose of psilocybin was twice as effective as a 1 mg dose in combating treatment-resistant depression, although significant side effects were noted. And a report on a phase III trial of MDMA described it as a “potential breakthrough treatment” for PTSD. The drugs have also shown potential in treating anxiety, anorexia and substance addiction.
Nations including the United States, Canada and Israel allow individual use of these drugs on compassionate grounds or in clinical trials, but on 1 July Australia will be the first to regulate the drugs as medications, to be prescribed by approved psychiatrists.
Risks of a bad experience
Among researchers’ concerns is that research has yet to show which patients are best suited to the treatments. “It’s not for everybody. We need to work out who these people are that are going to have bad experiences, and not recommend it,” says Susan Rossell, a psychiatrist at Swinburne University of Technology, Melbourne, who is working on Australia’s only active clinical trial testing psilocybin-assisted psychotherapy for treatment-resistant depression. Rossell fears that, administered improperly, the drugs could give people bad trips and leave them with increased psychological issues. “That’s the worst-case scenario,” she says. Her own unpublished research suggests that 10–20% of trial participants have a “really terrible time” with these drugs.
Read the whole article here.
