Latest MDMA Research Fails to Convince FDA to Legalize It

MDMA is awesome; you don’t need to graduate from medical school to know that.  If you want to see the wonders of MDMA, just attend any rave and see people who are the age where misanthropy is the essence of cool dancing together and thoroughly enjoying themselves.  MDMA is also a Schedule I controlled substance, which means that it has no legally accepted medical applications; legally, it is a universally bad drug, like heroin.  For decades, the government seemed to base its cannabis laws on the movie Reefer Madness while stoners of all ages knew that it could take the edge off of an array of physical and psychological symptoms.  Anyone who has lived with a mental illness knows that managing symptoms is a marathon, not a sprint, even with state-of-the-art treatments.  Especially in the wake of cannabis law reform, the more open-minded medical researchers have been investigating a variety of illicit drugs as potential treatments for psychiatric illnesses that give meaning to the saying, “The cure is worse than the disease.”  Here, our Miami drug crimes defense lawyer explains how the latest attempt at getting MDMA approved as a pharmaceutical drug fell short.

Why Research Methodology Matters in Legal Cases

Even though the purveyors of clickbait can easily spin this into a general distrust of science, the fact remains that some professionally conducted scientific studies do a better job of proving, or not proving, their hypotheses.  Policymakers rely on published research to inform a wide variety of policies; they care not only about what the studies show and how many studies show the same thing (this is called replication or replicability, and it is an important aspect of scientific research), but how they show it.  The best scientific experiments, including but not limited to clinical trials in medical research, provide detailed information about the design of the experiment and the variables for which the researchers controlled.  They summarize the data in detail, analyze it according to relevant metrics, and make the raw data available to other researchers upon request.  In the discussion section of the article, they mention possible factors that might have affected the outcome of the experiment in unforeseen ways.

When expert witnesses cite published studies in civil or criminal cases, they must follow the Daubert standard.  This means that the lawyers must let the judge read the study before the jury hears testimony about it.  The study must state its methodology and its rate of error clearly, and it must be published in a peer reviewed journal.

What Went Right With the MDMA Study, and What Went Wrong

The most recent bid to get FDA approval for MDMA focused on its potential to treat post-traumatic stress disorder.  It was based on a clinical trial where one group of PTSD patients received an MDMA pill and the control group received a placebo pill that contained no MDMA.  It was a double blinded study, so the patients did not know which pill they were getting, or at least they weren’t supposed to.  The patients in the MDMA group had fewer PTSD symptoms at the end of the study than the control group.  The trouble is that most patients correctly guessed whether their pills contained MDMA; if the placebo effect could make you feel like you are rolling on ecstasy, the world would be a very different place.

The bigger problem is that some of the MDMA patients experienced the same adverse effects that people who take ecstasy at raves experience.  These include heart palpitations and spikes in blood pressure.

Rock on With Your Ketamine for the Time Being

The good news is that another club drug, ketamine, is not a controlled substance.  Ketamine, the active ingredient in minion chic, is commonly used as an anesthetic in outpatient surgery clinics.  Some doctors prescribe it off label for the treatment of mental illnesses.  One can only hope that, in the coming years, psychedelics such as MDMA and psilocybin will receive FDA approval so that they can be rescheduled so that they can be used in clinical practice.  For the time being, a visit to the ketamine clinic, of which there are many in Florida, may be the best way to manage your symptoms until better studies on MDMA make it through the peer review process.

Contact Our Criminal Defense Attorneys

A South Florida criminal defense lawyer can help you if you are facing criminal charges for possession of MDMA.  Contact Ratzan & Faccidomo in Miami, Florida for a confidential consultation about your case.

Source:

health.wusf.usf.edu/health-news-florida/2024-06-04/psychedelic-drug-mdma-faces-questions-as-fda-considers-approval-for-ptsd