Comment from Max Greenwald

The Office of Management and Budget ,I am a 5th year MD/PhD student at Yale School of Medicine conducting research to understand the mechanisms through which psychedelics improve mental illness to make them safer and more effective. My lab has numerous NIH-funded grants focused on earlier detection of psychotic illnesses like Schizophrenia -- one of the most devastating and disabling forms of mental illness -- for prevention and early intervention. I am writing to respectfully urge you to eliminate or completely revise several sections in the newly proposed OMB-2026-0034 rule:[§200.205] - I strongly, strongly believe that giving political appointees the discretion to award or deny research grants will significantly reduce the desired outcomes of science funding for the American people and raises the risk for harm. I have trained as a scientist for more than a decade-and-a-half and have more training ahead. Science is extremely hard, and the body of scientific knowledge has continued to grow, making the expertise required to actually understand scientific methods and assess their ability to 1) meaningfully answer scientific questions and also 2) benefit society with discoveries IMMENSE. As a psychedelics researcher, I would stand to benefit from a rule that "ensur[es] that discretionary awards advance the President's policy priorities." I am still extremely opposed to this provision. Though I believe that psychedelics have the potential to seriously help people, I know that they have considerable harms -- I have seen participants in my work who have developed new onset regular panic attacks after psychedelic use. I do not believe that this -- or other documented risks of psychedelic administration -- is sufficient to suspend all research, but I do believe that it means that this work must be conducted extremely carefully, with trained clinicians and researchers who can properly weigh what research is going to get is to an acceptable, safe, effective therapy fastest for the smallest cost. Put another way, I believe that this decision puts adverse incentives on scientific research that hinder the scientific project — when I submit my next grant, I will have to consider whether or not a grant focused on safety in psychedelic therapy will be funded and may be discouraged against my belief of what will best advance the therapy. While I believe that the vast majority of scientists have the integrity to not succumb to this temptation, I think that inevitably some bad actors will be influenced, and if this increases the probability of non-meritocratic work getting funded to the exception of scientifically valid, clincially-motivated work it will be a tremendous inefficiency or even harm. Allowing political operators without scientific expertise to make these decisions will slow this effort or -- even worse -- result in research that causes harm to human subjects and potentially jeopardizes the project of improving psychotherapeutics altogether. I note that non-academic promoting of psychedelic use in the 1960s led to their illegalization (motivated by genuine harms that came from people taking high doses in unsupervised settings). Even if OMB members fully dismiss this argument and instead believe that appointees from the administration are better trusted to make these decisions than scientists -- I ask them to consider if they believe also that political appointees from the Biden administration would be better trusted also. [§200.220] - While I agree with the OMB's motivation for trying to reduce the risk of information that could be leveraged for the purpose of harming the United States (eg. in the case of ai or infectious diseases), I strongly, strongly urge members to remove this as an absolute rule. While additional scrutiny may be wise, some research — like factors that help us predict onset of psychosis in adolescents with early psychotic symptoms — can very reasonably be trusted to pose no risk. Our principal investigator just compiled a grant desperate to get more sites to track individuals at risk for psychosis for just this purpose. The rate limiting factor in human subjects research is — overwhelmingly — subject rrecruitment and personnel to collect data from those ssubjects. Adding barriers to this process without common-sense review straightforwardly causes harm by limiting what research can be done — including extrmely important research like ours’! [§200.340] - While I believe that — in the abstract — it is very reasonable to not fund research that is contrary to “national interest,” I think it is completely unacceptable to pass a rule with this vague of a definition of “national interest.” As written, this rule could be used to cancel