Mapping the psychedelic bubble
Abstract
Hallucinogens are heavily promoted as “game changers” for the treatment of various psychiatric diseases. However, those psychedelics have known safety issues that are linked with effects such as hallucinations, paranoia, and mood changes. Therefore, these drugs should be carefully evaluated in studies. In a series of 12 news stories by Nature, an article on psilocybin for pain relief notes that researchers are trying to avoid repeating the mistakes that contributed to the opioid crisis. There are strong parallels: prescription of psychedelics and of opioids is rising as a result of aggressive marketing, whereas the evidence for effectiveness comes mostly from small, short-term trials involving highly selected patients in secure settings, without adequate comparators. And attention to safety issues such as tolerance and drug dependence is crucial, particularly over the long term. The US Food and Drug Administration has designated many psychedelics as a “breakthrough therapy”, thus lowering the bar for approval. Esketamine, for example, was controversially approved for treatment-resistant depression without adequate monitoring to assess its long-term harm-to-benefit ratio.
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