Open Letter to the FDA
Women's Health, Psychedelic Clinical Trials & the Psychedelic Drug Approval Process
The Dysphoric Project has been working hard to draft a letter to the U.S Food and Drug Administration regarding psychedelic research and the menstrual cycle. In Partnership with Dr. Grace Blest-Hopley from Hyselica, we are happy to report that we have finalized it, published it, and notified most of the 64 stakeholders listed.
The full letter and a link to sign, can be referenced here: https://dysphoricproject.org/open-letter-to-the-fda
Stakeholders include the general public including U.S taxpayers, U.S Universities studying psychedelics, for-profit companies in the psychedelic space, and several women’s health offices (FDA, NIH and VA).
In our preliminary analysis, we have found that the menstrual cycle is largely ignored in research, despite the related policies and guidelines. This appears to be a systemic issue that is not isolated to psychedelic research. That said, we believe that psychedelic research teams can be held to a higher standard.
We are counting on them to lead the way, and show the others how it can be done. It is difficult to consider the menstrual cycle in research, but if anyone can do it, we believe it’s the highly talented scientists and research teams studying psychedelics.
Although it may be difficult, studying us is not an option. Women pay taxes, and purchase drugs manufactured by pharmaceutical companies. We fully expect for our dollars to be reinvested in research that considers us, including but not limited to the menstrual cycle.
Side note: One of the for-profit stakeholders has already requested to be removed from the stakeholder list. Firm boundaries are important here, and I’m fresh out of empathy for companies who are not willing to invest in researching women, but are planning to market their drugs to us.
While this is a hard problem to solve, women with PMDD are no strangers to hard problems. If we can pick ourselves back up every month, after being on the brink of psychological disaster, research teams and investors can figure out how to include the menstrual cycle in their research. Mental fortitude is a real thing. If they need help, there is a small army of qualified women seeking work in women’s health research. There is plenty of talent available to solve this problem efficiently and effectively.
Research Funding
recently consulted with a mentor who works in women’s health. The mentor highly encouraged her NOT to pursue women’s health research because of the severe lack of funding. The mentor noted financial struggles despite holding two related Ph.Ds.Although governmental organizations like the FDA and NIH have policies and guidelines requiring this research, they do not often fund this research:
“The funding agencies, such as NIH and the Canadian Institutes of Health Research (CIHR), which are mandating inclusion of both sexes are, for the most part, not providing additional funds to study both sexes.”
Laws and guidelines in research mean nothing if they are not enforced AND funded. As part of this advocacy project, we will also highlight the inequality in research funding. There are researchers who want to study us, but research requires funding. If the FDA and NIH are committed to equality in research, they should put their money where their mouth is.
If you support our open letter and wish to sign, more details can be referenced here: https://dysphoricproject.org/open-letter-to-the-fda.
BIG HUGS,
Tina