By Rob Verkerk PhD, executive & scientific director, ANH-Intl and ANH-USA

Our ability to exercise free will is deeply under threat as the Western world creeps ever further from civilised democracies that value human flourishing, towards one controlled by a technocratic corporatocracy driven by a clutch of billionaires. Under these emerging conditions, we’re ever more likely to see the shutting down, banning, marginalisation or demonisation of things that are good for people, but not good for the corporatocracy.

That’s likely the process driving a recent decision by a government health department to shut down the arm of a high quality trial evaluating the effects of a ketogenic diet (KD) on schizophrenia inpatients in the psychiatry unit of a hospital on the outskirts of Baltimore, Maryland, USA.

>>> Read Metabolic Mind newsletter piece on the halted study

>>> US readers can read the full op-ed in the Baltimore Sun.

Terminating arms of trials with safety signals is one thing. But as the veteran, principal investigator of the landmark Maryland trial at the Spring Grove Hospital Center, Dr Deanna Kelly, said in a recent interview, there were no safety signals whatsoever. What’s more, she wasn’t given a reason for the termination of the ketogenic arm of her trial, while the clozapine (antipsychotic drug) arm was allowed to continue.

This is what’s got metabolic psychiatry professionals, local communities, the families of mental health patients, and the Twittersphere up in arms. There were no safety signals. The trial was innovative in that it compared a plausible approach (KD) with standard of care for those with treatment-resistant schizophrenia (clozapine). Based on a rapidly increasing body of evidence, it may have provided validation of a modality that would have offered the best possible outcomes for schizophrenic patients. It was run by a veteran researcher who ran an intricate informed consent procedure, and it was fully approved by the relevant institutional review board.

>>> Watch (below) principal investigator Dr Deanna Kelly discuss the abrupt closure of the keto arm of what would have been a landmark study on the effects of keto diet on inpatients with treatment resistant schizophrenia.

The study, its promise, and the shutdown

The study in question, which was the only inpatient trial of its kind in the United States, aimed to explore innovative treatments for schizophrenia through metabolic psychiatry and compare it against the standard of care, the anti-psychotic medication clozapine. The study led by Dr Deanna Kelly was designed as a single-blind, randomized trial involving a ketogenic diet. This diet, known for its high-fat and low-carbohydrate content, has shown great promise in treating various neurological disorders. This was a well-designed, rigorously conducted trial on a plausible natural treatment for schizophrenia.

By the time the study was cut, 12 participants had been enrolled on the trial, all being inpatients at the Spring Grove psychiatric hospital. This inpatient setting could have provided incredibly valuable data because it is a uniquely controlled setting: all participants would adhere to the same diet and exercise patterns, providing a controlled environment for observing the diet's effects on schizophrenia.

According to a belated letter from Maryland’s Secretary of Health that was sent just 5 days ago, the decision to stop the study was apparently “due to a fresh look at the approval and consent process associated with privately funded studies taking place at Spring Grove Hospital Center with almost exclusively court-committed patients".

For context: Most of the patients at Spring Grove were charged with minor crimes but deemed by a judge “incompetent to stand trial.” Because they are prisoners under US federal research laws, these patients are afforded more protections than other study participants. Yet by all accounts these more stringent research protocols were being followed to a tee by Dr Kelly and her team:

• There was a lengthy informed consent process in Dr Kelly’s study—something the medical establishment cannot reasonably claim when it comes to routine vaccinations, much less COVID vaccination.
• Thorough examinations were conducted to determine if a patient had the capacity to consent to participate in the research. Patients were not recruited; they were either referred by a doctor or they volunteered.
• Several committees, including the hospital research committee and several institutional review boards, were closely monitoring the research.

Given these protocols, the justification given by the Health Department for halting the trial is more than strange. The belated reason given appears to be nothing other than an excuse that attempts to mask the likely real justification: to stop keto diets being studied head-to-head against the standard of care drug, clozapine.

Not only that, is the idea of only supporting federally funded projects part of the trend towards ever greater centralization of power and authority that aims to cut out smaller, private funders like the Baszucki Group, which were supporting such work while also being aligned with regenerative agriculture and the values of ANH? Will big private entities like the Bill & Melinda Gates Foundation and the Welcome Foundation just route their funds through federal funds such as those operated through the National Institutes of Health (NIH)?

>>> Examples of promising research on the ketogenic diet and its beneficial effects on serious mental health disorders here, here and here.

Double-edged attack on keto

There appear to be multiple ongoing attacks on keto diets, whether they’re used for serious conditions like cancer, epilepsy, schizophrenia or bipolar disorder, or simply for weight loss, improved endurance or general health promotion. On the one hand, Big Tech is moderating content from experts promoting the value of keto diets for health (see here) and, on the other, funding for keto and other non-pharmacological approaches is dwarfed by that for drugs. This creates a very distorted picture of the value of the contrasting approaches, and that’s reflected in the dominant approach to clinical care, involving drugs as the mainstay.

The Maryland case is an example of just how difficult it is to run a parallel comparison of drug and non-drug approaches. This has long been the challenge with vaccination studies, as exemplified by the 2021 retraction of James Lyons-Weiler and Paul Thomas’ research article that did just this.

Keto Kibosh ‘Speaker Salon’

Listen to Maryland Keto Kibosh podcast with ANH’s Rob Verkerk PhD and Meleni Aldridge, on Twitter Space 'The Speaker Salon’, hosted by Alana Newman.

Help reverse the decision

Please sign Chris Palmer MD’s petition calling on the Maryland Secretary of Health to reconsider her recent decision to halt a trial of the medical ketogenic diet for the treatment of schizophrenia. There are nearly 20,000 signatories so far – let’s try to double that!

Please share widely.

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