DC Medical Malpractice & Patient Safety BlogPsychedelic drugs gets serious clinical consideration in PTSD, cancer care
Mental health experts aren’t suffering Sixties flashbacks. But they are seeing a new day for Molly (aka MDMA, Ecstasy, or 3,4-Methylenedioxymethamphetamine) and magic mushrooms (psilocybin). These hallucinogenic drugs are getting serious consideration in helping those with post-traumatic stress disorder (PTSD) and depression and anxiety due to cancer.
The federal Food and Drug Administration, which won’t comment on the matter, has approved Phase 3 clinical trials (large-scale human research) of MDMA for treatment of PTSD, according to Multidisciplinary Association for Psychedelic Studies (MAPS).
It says it will spend $25 million to win federal approval to make MDMA a legal and prescribed drug to treat PTSD, which the National Institute for Mental Health describes as “a disorder that develops in some people who have experienced a shocking, scary, or dangerous event.”
Two Phase 2 clinical trials in Charleston, S.C., showed that 130 PTSD patients—including combat veterans, sexual assault victims, and police and firefighters—experienced major reductions in the severity of their symptoms after receiving limited doses of MDMA. They previously had not gotten such relief after, on average, 17 years of struggling with their condition years and undergoing traditional drug and psychotherapy treatments.
The New York Times quotes a participant in the trial—a military veteran who said his PTSD after tours in Iraq and Afghanistan left him alone in the backwoods, divorced, and often suicidal—extolling the effectiveness of MDMA. The newspaper also says experts fear that allowing the party drug’s legal use could lead to its significant abuse, as has occurred with powerful, pain-killing opioid drugs.
Opioids, the federal Centers for Disease Control and Prevention reports, killed 28,000 Americans in 2014. Ecstasy has become a popular drug at electronic music concerts known as raves, where, the Los Angeles Times reports, there have been 29 confirmed, drug-related deaths at events organized by Southern California firms.
Ecstasy users say they prize the sense of well-being and closeness the drug can generate. Combined with other drugs affecting potency, MDMA can lead to unsafe sexual behaviors. It also can throw off the body’s thermal regulation, causing temperature spikes in which users can either become dehydrated or, inversely, consume so many liquids that they upset their metabolic balances.
As for psilocybin, two trials at New York University (29 patients) and Johns Hopkins University (51 patients) showed that cancer patients taking “magic mushrooms” experienced significant improvement in their depression and anxiety. Results of both studies from the two sites were published in the peer-reviewed Journal of Psychopharmocology.
It also editorialized about how psychedelic drugs got caught up in negative press related to the social tumult of the Sixties. The journal says that a who’s who of psychotherapy reviewed the latest studies, and that the harms of depression, anxiety, and other mental disorders are sufficiently great that no drug automatically should be ruled out. Indeed, separately, the online news site Vox has examined psychedelic drugs’ slow return from illicit status to more mainstream clinical consideration. Meantime, I’ve written how marijuana advocates advanced legalization across the country in the just-ended elections.
In my practice, I see the huge negative effects that powerful drugs can have on people’s lives, health, and well-being. I’m not sanguine that, even in the restricted status as prescription-only medications, hallucinogens won’t get out of the medical establishment’s control. The nation’s existing prescription drug abuse crisis has all too clearly shown doctors’ fallibilities, including their susceptibility to being swayed by Pharma-pushed swag and meals costing as little as $20.
At the same time, I’m no blue nose, and I think it’s bad for us all for politicians and partisans to impose biases on serious, rigorous, medical-scientific research that benefits humanity. Congress has barred the funding of research that would examine gun violence that claims 33,000 American lives annually as a public health issue. This approach, applied to road deaths, resulted (with the huge role, too, of crusaders like lawyer Ralph Nader) in safer streets and vehicles, and fewer highway fatalities. It’s interesting and notable that the early studies of psychedelic drugs in PTSD or cancer care suggest that effective doses can be few and not large, with benefits sustaining. The suffering of those with PTSD and serious cancers can’t be ignored. But researchers and regulators would be well advised to proceed with major caution with novel treatments.
