Statement by the leadership of MAPS at their recent conference that they were solidly on track with regards to the FDA approval process. They are doing it by the book, are getting results showing high safety/efficacy, and the FDA is probably not going to be able to defy the data and keep MDMA illegal.
MDMA may well turn out to be highly safe and effective, but MAPS is excessively optimistic in this assessment. See, for instance, their characterization of Dr. Halpern’s response to the NHS critique as a “careful and well-reasoned response”. In many of the instances, Halpern invents defenses to legitimate criticism. For instance:
*They reported his study was underpowered. His response should have been a power calculation demonstrating adequate study power; instead he simply noted that his was the largest study yet performed.
*NHS noted a lack of followup over time to investigate cognitive decline, and he claimed that the includion of only long-term users solved this problem. It does not, because he looked at current ravers only. Had he looked at “people who raved 5 years ago, regardless of current multidrug use, current death or disability, etc” this would be acceptable.
*Asking participants to refrain from taking ecstasy is nonstandard in a medical study. I understand that he did it to distinguish between acute and chronic effects, but it’s not nearly as easy as that.
*Exclusion of polysubstance users is totally unacceptable in a study of drug safety. If MDMA and cocaine used together lead to more cognitive decline than cocaine alone, then that must be counted as “MDMA causes cognitive decline”.
In order to obtain FDA approval despite multiple small studies showing a poor safety profile, a much larger and better-designed safety study will be required. Even then, the FDA has a history of rejecting medications that really ought to be approved. See Sugammadex.
Statement by the leadership of MAPS at their recent conference that they were solidly on track with regards to the FDA approval process. They are doing it by the book, are getting results showing high safety/efficacy, and the FDA is probably not going to be able to defy the data and keep MDMA illegal.
MDMA may well turn out to be highly safe and effective, but MAPS is excessively optimistic in this assessment. See, for instance, their characterization of Dr. Halpern’s response to the NHS critique as a “careful and well-reasoned response”. In many of the instances, Halpern invents defenses to legitimate criticism. For instance:
*They reported his study was underpowered. His response should have been a power calculation demonstrating adequate study power; instead he simply noted that his was the largest study yet performed.
*NHS noted a lack of followup over time to investigate cognitive decline, and he claimed that the includion of only long-term users solved this problem. It does not, because he looked at current ravers only. Had he looked at “people who raved 5 years ago, regardless of current multidrug use, current death or disability, etc” this would be acceptable.
*Asking participants to refrain from taking ecstasy is nonstandard in a medical study. I understand that he did it to distinguish between acute and chronic effects, but it’s not nearly as easy as that.
*Exclusion of polysubstance users is totally unacceptable in a study of drug safety. If MDMA and cocaine used together lead to more cognitive decline than cocaine alone, then that must be counted as “MDMA causes cognitive decline”.
In order to obtain FDA approval despite multiple small studies showing a poor safety profile, a much larger and better-designed safety study will be required. Even then, the FDA has a history of rejecting medications that really ought to be approved. See Sugammadex.