Most Recent Attempt To Get FDA Approval For MDMA Is Unsuccessful

There is no vilified drug that was not once considered a panacea, and no wonder drug that was not once considered a gateway to evil and death.  People used to buy cocaine and morphine over the counter at pharmacies and use them to treat all manner of nonspecific ailments.  Cannabis is officially a Schedule I controlled substance, as illegal as heroin, but today, many state and local laws treat it as a drug that, with a doctor’s permission, you can buy over the counter and use to treat all manner of nonspecific ailments; a medical cannabis card is not a prescription, where a doctor says to chew two cannabis gummies per day, one in the morning and one in the evening, for relief of anxiety.  When you ask whether a drug is beneficial or harmful, the answer is often both.  There is a growing belief among the public, supported by some in the medical establishment, that psychedelic substances popular for recreational use, have potential for the treatment of mental illnesses.  A recent attempt to get MDMA, popularly known as ecstasy, approved by the Food and Drug Administration (FDA) as a pharmaceutical drug was unsuccessful.  For the time being, if you are facing criminal charges for possession of MDMA, contact a Pittsburgh drug crime lawyer.

Research Methodology Matters in Drug Laws

You have probably heard of the Daubert standard, which is how judges determine whether published research cited by expert witnesses at trial is legally admissible.  The studies must state their methodology clearly; in other words, they must describe how they selected patients for inclusion in a clinical trial, and which variables they controlled for in the experiment, among other matters.  They must also describe ways in which the results of the experiment may not prove the hypothesis as clearly as they appear to, such as variables for which the experiment was unable to control.  It was issues with research methodology, as well as with the outcome of the study, that led the FDA to refuse to approve MDMA as a pharmaceutical drug.

In the News

This year, the FDA refused to approve MDMA for medical use.  The study cited in the proposal for the approval included patients with a pre-existing diagnosis of post-traumatic stress disorder (PTSD).  Some of the patients received a dose of MDMA, while others received a placebo; both groups underwent talk therapy.  By the end of the study, the MDMA patients improved more than the placebo patients.  The trouble was that, even though patients were not supposed to know which pill they were getting, they figured it out because of how they felt after taking the pill.  Another reason for the FDA’s rejection was that some patients in the MDMA group experienced severe side effects such as heart palpitations and elevated blood pressure.

Contact Gary E. Gerson About Criminal Defense Cases

A criminal defense lawyer can help you if you are facing criminal charges for MDMA possession.  Contact the law offices of Gary E. Gerson in Pittsburgh, Pennsylvania 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