Read on for context about our recent petition to FDA; Lykos' response to ICER's report of "low confidence" in its research; and instructions for submitting testimony to the upcoming ad comm meeting.
Really great work. After reading through the ICER comment report and seeing all of the experts in this field who are raising the same concerns it is obvious you are in good company.
Physician here, looking forward to prescribing MDMA soon. Thank you, Neşe, for all your work! We can't ethically prescribe if we willfully ignore potential harms. That's so basic to the practice of medicine and science that I have trouble seeing why practitioners would sincerely argue with it, although I share the enthusiasm for the end result. And, of course, there's plenty of risk of bias in all research, which is why confirmatory studies by different groups is so important for any "new" medicine and why transparent peer review is so necessary. I hope we'll find a way to change the scheduling of this and others in an open and evidence-based manner, soon.
This needs to happen! Thank you so much for the work you’re doing on behalf of survivors. We need a voice. We need to be heard. This isn’t just about industry — all stakeholders need to be included in the conversation.
It is possible to be critical of psychedelics and not be anti-psychedelics just as it’s important to know that there are survivors who are critical of psychiatry and not entirely anti- psychiatry.
Nuance and distinction is important. If an institution cannot handle critical feedback I suppose they are not exercising institutional courage (a term coined by Jennifer Freyd, a survivor and trauma researcher).
There are survivors who have felt betrayed by this institution that has been tasked with protecting and not causing harm and retraumatization of a highly vulnerable population.
How is MAPS demonstrating sensitivity around this in their MDMA clinical trials. I’m not seeing it nor a vote of confidence in Lycos providing mental health services in an ethical manner when the primary motive seems to be profit and catering to the veterans administration who has a vested interested in promoting war.
There are 10 times the number of survivors of childhood trauma than veterans. Where is the justice when the needs of a special interest group supersede the needs of a greater number of survivors that cannot leverage the same level of clout and political power?
Dear Dr. Devenot, I am perplexed by your insistence that MDMA and its therapy model as proposed by MAPS are harmful. I fail to see how your degree in literature and your writing career justify your ability to criticize social science research for a serious mental health disorder that is very difficult to treat. I have a several PTSD patients who are seriously suicidal even with therapy and medication. If I could find a way to offer them MDMA therapy legally I would refer them to a clinic easily and they would likely go. If you look at the work on CBT and prolonged exposure for PTSD, you will see that the dropout rates are incredibly high as the treatment is intolerable for many. You have no clinical background or training and seem to be intent on making YOUR career as a medical critic. The dropout rate for MAPS studies is seriously less than any other treatment. Suicidality is a prominent feature of both PTSD and BPD and it is not unusual that they fall into a comorbid relationship that is difficult to tease out. The harm you cite is from a small sample of participants. I would suggest that you balance your work by also contacting the many ethical therapists and participants of these studies and present their side of the story. In any event, rescheduling MDMA so that it can be legally accessed by the many desperate patients who want and need it is a sensible step forward. The therapy model proposed is not harmful to patients and is actually much more comprehensive and safe than any current treatment for PTSD. It is easy to mock the way the label "inner healing intelligence" has been labeled but it actually refers to the part of the self that wants to get better and looks for help....a part that has been an important concept of humanistic psychology for many many decades. This is simply the current label utilized. I would strongly suggest that you consider a degree in clinical psychology to add to your literary credential and some work at the VA also to see that what you are doing in your critiques is unbalanced and poorly informed as to the comparison of what is currently available for PTSD patients. Sincerely, Dr. Mary Gresham
Well said and well written. The intent may be good here from ND but the naivety and practicality of the situation at hand was completely ignored in filing this petition, as is common in academics.
I've noticed that the ICER report, along with others' criticisms of MDMA-therapy, sometimes report new psychological symptoms as bad. IMO, these apparently new symptoms are actually suppressed schemas being uncovered/made explicit. This is a well-established phenomena. While they're certainly unpleasant, and great care should be taken to manage their effect on a client's life, their presence is a sign of therapeutic progress. Destabilization is actually associated with better long-term outcomes. https://www.tandfonline.com/doi/full/10.1080/10503307.2019.1633484 If clients are confused about this then the therapists possibly didn't sufficiently explain the process of therapy.
I've worked in pharma as a medicinal chemist. Drugs will sometimes be approved without the mechanism being fully understood (Modafinil). Sometimes the proposed mechanism is wrongly understood for years (Gabapentin). To propose that psychedelics catalyze the body's natural healing processes is not inherently unscientific at all. Electroshock has shown efficacy for a variety of ailments. So has progressive relaxation. Both of these could also be said to activate a form of "inner healing". Covering the mechanistic description with new age drapery doesn't reduce efficacy, and neither do utopian dreams, though these things may be off-putting to some. In the meantime, receptors and brain networks will continue to be mapped, though IMO it's questionable whether a purely reductionist, hard scientific model will possess as much explanatory power as simply saying that the body's natural healing has been activated. We may know which brain networks or receptors to target for future development, however.
Congrats Nese!
Really great work. After reading through the ICER comment report and seeing all of the experts in this field who are raising the same concerns it is obvious you are in good company.
Physician here, looking forward to prescribing MDMA soon. Thank you, Neşe, for all your work! We can't ethically prescribe if we willfully ignore potential harms. That's so basic to the practice of medicine and science that I have trouble seeing why practitioners would sincerely argue with it, although I share the enthusiasm for the end result. And, of course, there's plenty of risk of bias in all research, which is why confirmatory studies by different groups is so important for any "new" medicine and why transparent peer review is so necessary. I hope we'll find a way to change the scheduling of this and others in an open and evidence-based manner, soon.
This needs to happen! Thank you so much for the work you’re doing on behalf of survivors. We need a voice. We need to be heard. This isn’t just about industry — all stakeholders need to be included in the conversation.
It is possible to be critical of psychedelics and not be anti-psychedelics just as it’s important to know that there are survivors who are critical of psychiatry and not entirely anti- psychiatry.
Nuance and distinction is important. If an institution cannot handle critical feedback I suppose they are not exercising institutional courage (a term coined by Jennifer Freyd, a survivor and trauma researcher).
For more information on Institutional Courage see: https://www.institutionalcourage.org/
There are survivors who have felt betrayed by this institution that has been tasked with protecting and not causing harm and retraumatization of a highly vulnerable population.
How is MAPS demonstrating sensitivity around this in their MDMA clinical trials. I’m not seeing it nor a vote of confidence in Lycos providing mental health services in an ethical manner when the primary motive seems to be profit and catering to the veterans administration who has a vested interested in promoting war.
There are 10 times the number of survivors of childhood trauma than veterans. Where is the justice when the needs of a special interest group supersede the needs of a greater number of survivors that cannot leverage the same level of clout and political power?
Great work!
Dear Dr. Devenot, I am perplexed by your insistence that MDMA and its therapy model as proposed by MAPS are harmful. I fail to see how your degree in literature and your writing career justify your ability to criticize social science research for a serious mental health disorder that is very difficult to treat. I have a several PTSD patients who are seriously suicidal even with therapy and medication. If I could find a way to offer them MDMA therapy legally I would refer them to a clinic easily and they would likely go. If you look at the work on CBT and prolonged exposure for PTSD, you will see that the dropout rates are incredibly high as the treatment is intolerable for many. You have no clinical background or training and seem to be intent on making YOUR career as a medical critic. The dropout rate for MAPS studies is seriously less than any other treatment. Suicidality is a prominent feature of both PTSD and BPD and it is not unusual that they fall into a comorbid relationship that is difficult to tease out. The harm you cite is from a small sample of participants. I would suggest that you balance your work by also contacting the many ethical therapists and participants of these studies and present their side of the story. In any event, rescheduling MDMA so that it can be legally accessed by the many desperate patients who want and need it is a sensible step forward. The therapy model proposed is not harmful to patients and is actually much more comprehensive and safe than any current treatment for PTSD. It is easy to mock the way the label "inner healing intelligence" has been labeled but it actually refers to the part of the self that wants to get better and looks for help....a part that has been an important concept of humanistic psychology for many many decades. This is simply the current label utilized. I would strongly suggest that you consider a degree in clinical psychology to add to your literary credential and some work at the VA also to see that what you are doing in your critiques is unbalanced and poorly informed as to the comparison of what is currently available for PTSD patients. Sincerely, Dr. Mary Gresham
Well said and well written. The intent may be good here from ND but the naivety and practicality of the situation at hand was completely ignored in filing this petition, as is common in academics.
I've noticed that the ICER report, along with others' criticisms of MDMA-therapy, sometimes report new psychological symptoms as bad. IMO, these apparently new symptoms are actually suppressed schemas being uncovered/made explicit. This is a well-established phenomena. While they're certainly unpleasant, and great care should be taken to manage their effect on a client's life, their presence is a sign of therapeutic progress. Destabilization is actually associated with better long-term outcomes. https://www.tandfonline.com/doi/full/10.1080/10503307.2019.1633484 If clients are confused about this then the therapists possibly didn't sufficiently explain the process of therapy.
I've worked in pharma as a medicinal chemist. Drugs will sometimes be approved without the mechanism being fully understood (Modafinil). Sometimes the proposed mechanism is wrongly understood for years (Gabapentin). To propose that psychedelics catalyze the body's natural healing processes is not inherently unscientific at all. Electroshock has shown efficacy for a variety of ailments. So has progressive relaxation. Both of these could also be said to activate a form of "inner healing". Covering the mechanistic description with new age drapery doesn't reduce efficacy, and neither do utopian dreams, though these things may be off-putting to some. In the meantime, receptors and brain networks will continue to be mapped, though IMO it's questionable whether a purely reductionist, hard scientific model will possess as much explanatory power as simply saying that the body's natural healing has been activated. We may know which brain networks or receptors to target for future development, however.