Kentucky Senator Rand Paul, who has previously appeared on The HighWire to discuss critical health and regulatory issues, and 18 other U.S. Senators have signed a joint letter to FDA Commissioner Robert Califf, urging the FDA to reconsider its rejection of MDMA as a therapy for veterans with Post Traumatic Stress Disorder (PTSD).

The letter states that the last medicine that was approved to treat PTSD was approved 25 years ago, and the number of veteran suicides has not decreased.

The letter said, “As a nation, we cannot allow our veterans to continue to suffer in silence and must identify treatments proven to drastically decrease the adverse effects of PTSD.” The senators refer to 6,000 veteran suicides that occur each year and a total of 150,000 that have happened since the World Trade Center attacks on 9/11/2001. The FDA recognized the promise of MDMA-AT (assisted therapy) in 2017 when it was designated as a breakthrough therapy. Despite that designation, there has been little to no progress in bringing this therapy to fruition for veterans suffering from PTSD.

The letter continued by saying, “The FDA is internationally recognized as the gold standard for drug safety and efficacy review, and we urge the Agency to continue upholding this rigorous standard of safety, quality, and effectiveness, especially for therapies targeting conditions like PTSD, which is alarmingly prevalent among our nation’s veterans.”

The HighWire has previously reported on the revolving door between industry and regulatory agencies. The previous FDA Commissioner, Scott Gottlieb, went from a pharmaceutical position to the government and returned to serve on Pfizer’s board. Director Califf has been criticized for his close ties with the pharmaceutical industry as he received consulting fees from multiple companies, including Johnson and Johnson, GlaxoSmithKline, AstraZeneca, and Eli Lilly.

Calley Means, a former pharmaceutical and food consultant, has been highly critical of the FDA for its rejection of MDMA treatment for PTSD. In a 2021 tweet, Means shared a study that found 67% of the study’s participants “no longer met the criteria for their diagnosis of PTSD” after just three sessions with MDMA. Means added, “Pharma is going to fight this with everything they have, because SSRIs are the largest drug category and they depend on patients staying sick (recurring revenue).” In June, an FDA panel rejected MDMA before it was entirely rejected this month. Means said MDMA is “the highest efficacy / lowest side effect intervention for depression and PTSD ever studied. Helps those suffering get to the root cause of trauma.”

A Time Magazine article published the day before the FDA’s decision touted the benefits of using MDMA for treating PTSD. The article also stresses the importance of the medication to treat women who suffer from PTSD following sexual abuse, which one out of six women

experience. There is a study from 2023 that overturned the PTSD diagnosis of 71% of the participants who took the MDMA-AT treatment.

A group of 26 researchers and clinicians signed a letter in July urging the FDA to approve MDMA for PTSD treatment. The letter states that there is a global mental health crisis that includes “an estimated 13 million Americans suffering from PTSD.”

Studies on SSRI effectiveness in treating PTSD find that 60% can achieve positive results, but only 20-30% will achieve “complete remission of symptoms.” Murray B. Stein, one of the study’s authors, has a conflict of interest statement. It says, “He has also been paid as a consultant by Janssen, Pfizer, and Tonix Pharmaceuticals, and by Care Management Technologies.”

Jeffrey Jaxen discussed the risks of SSRIs in April after it was revealed that the pandemic caused an increase in poor mental health. The media and medical establishment called for the use of SSRI medications to help solve this problem. Jaxen explained that there is “An association between long-term antidepressant usage and elevated risks of CHD (Coronary Heart Disease), CVD (Cardiovascular Disease) mortality, and all-cause mortality.”

Zoloft says, “Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients.” Host Del Bigtree suggested the large number of mass shootings in America could be connected to the psychological impacts of SSRI medications.

Jaxen went on to share information from a 2022 study that says research on “the serotonin hypothesis has not produced convincing evidence of a biochemical basis to depression.” It also states, “We suggest it is time to acknowledge that the serotonin theory of depression is not empirically substantiated.”

Jaxen’s report goes on to describe “brain zaps” as a side effect of the medication. Also, sexual dysfunction and “emotional numbness” have been revealed as a common side effect for users after they discontinue the use of SSRIs. Medical providers often dismiss these symptoms as being caused by the underlying depression rather than the medication. The same drug is prescribed to sex offenders to reduce their sexual drive.

Bigtree suggested a connection between SSRI usage and the increase in children who have “gender dysphoria.”

Tucker Carlson reported on Fox News in 2022 that SSRI prescriptions increased by 3,000% from 1991 to 2018. During the same period, mass shootings and suicides also increased substantially.

A Business Insider report diminished these claims and said the cause of mass shootings is lax gun laws. The report points to WebMD to explain SSRIs, including the side effects and safety profile. The report also includes statements from David Rettew, an author for Psychology Today. WebMD and Psychology Today receive their funding from pharmaceutical ad placements.

The FDA has known conflicts of interest with pharma companies with the revolving door, including Director Robert Califf’s long list of previous financial connections with the industry. The media receiving ad dollars from pharmaceutical companies also has a clear financial incentive to tamp down harmful reports about pharma products while denouncing treatments that cut into the bottom line. Senator Paul and others are attempting to get MDMA therapy access to people who need it, including women and veterans with PTSD.