Why the Recent FDA Decision About MDMA Is Wrong

Why the Recent FDA Decision About MDMA Is Wrong

In case you haven’t heard, the FDA advisory panel recently rejected MDMA (aka “Ecstasy”) therapy for the treatment of PTSD. This is very unfortunate for the many who could have benefited. Dozens of studies — even ones designed by the FDA, have shown MDMA to be safe and effective for the treatment of PTSD. 

Despite these studies, the FDA advisory panel downplayed the proven benefits of MDMA because they said it was too challenging to do a blinded study with such a substance. Consequently, studies showing the benefits of psilocybin and LSD will aIso likely be rejected. In short, big pharma and bias won, and science and people in need of effective mental health treatments lost.

Here's what happened: The FDA advisory panel basically said that because MDMA made people feel good, it was too challenging to do a placebo-controlled study. So, even though a placebo control group was used, the fact that people usually knew when they had been given the drug made any conclusions invalid. Never mind that the people in the placebo group didn’t heal nearly as well as the MDMA group. Never mind that the people in the MDMA group kept improving over several months, while the placebo group did not. According to the advisory panel, if people felt good and knew they were on a drug, their healing shouldn't count.

Why did the panel disregard the fact that MDMA has been shown to be the most effective treatment for PTSD ever studied? There could be many reasons. First, big pharma had helped fund papers touting the potential problems of making this illegal drug something that could be medically prescribed. In fact, big pharma stands to lose billions of dollars if psychedelics are approved as legal medicines. After all, they would compete with the billions of dollars they now earn from peddling largely ineffective anti-depressants.

People are naturally risk-averse, and governments can be particularly so. Perhaps that’s why the FDA has never in its history rescheduled an illegal drug. Even marijuana is still in the same category as heroin. Insurance companies also don’t like the idea of this illegal drug being made into a legal medicine because they would then have to pay out a lot of money for such treatments.

The U.S. government’s fight against MDMA and other drugs such as LSD and psilocybin is nothing new. They’ve been resisting these treatments for decades. About 40 years ago, Rick Doblin created an organization called MAPS (Multidisciplinary Association for Psychedelic Studies) to fund scientific studies into the benefits of various psychedelics. He figured that if studies could show their benefits, science would ultimately prevail. Yet, it’s hard to change a closed mind, especially when there are a lot of vested interests and money helping to keep those minds closed.

In 1985, the subject of my master’s degree was the therapeutic effects of MDMA on trauma at U.C. Santa Barbara; the study I conducted produced incredible results. However, the government made MDMA illegal two weeks later, and no more studies could be done until MAPS raised money to fund their own studies. The results of that research were so good that it led to FDA-sponsored studies, and in 2017, the FDA granted MDMA “breakthrough therapy” status.

Yet, the US government has long spotlighted and amplified misinformation, put up roadblocks, and even sabotaged studies to create the impression that MDMA and psychedelics are dangerous and ineffective. But the truth is, these substances work extremely well under the right conditions and guidance. Unfortunately, we’re now in the situation of knowing they work, but governments around the world are blocking their use.

Fortunately, there is now a large “underground” movement of MDMA facilitators helping people in need. Although patients are getting healed by people who are trained to guide sessions, it would be ideal if they could do so in a way that is legal, regulated, and more available to a wider audience. We are in the midst of a mental health crisis. Being overly cautious, invalidating solid studies, and driving desperate people to break the law to get their needed help is a broken path. We need to do better.

In the last several years, I’ve trained hundreds of people on how to use these substances with their patients in a way that’s safe, effective, and inexpensive. The results are often incredible. I get emails from people every day saying I’ve saved their life. I’m booked a year in advance for offering such help. In fact, many of my clients are police officers, veterans, and firefighters who suffer from PTSD. Yet, it seems the FDA will continue to block access to these substances from people who could greatly benefit from their use. In my opinion, that’s a tragedy. We need to heal people suffering from PTSD, and MDMA is proven to do that.


Jonathan Robinson is a psychotherapist, author of 15 books, and the lead teacher for the upcoming MDMA Couples Facilitator Training offered by The Shift Network. Click here to register for a free one-hour online event with Jonathan, or click on the image below: 

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