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Keto Kibosh: The Keto Schizophrenia Study They Had to Shut Down

Keto Kibosh: The Keto Schizophrenia Study They Had to Shut Down
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Is the medical establishment too afraid to see natural, non-pharmacological medicine go head-to-head against Big Pharma’s ‘standard of care’?

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THE TOPLINE

  • A promising study on the ketogenic diet for treating schizophrenia was halted by the Maryland Health Department, highlighting a bias in the health system that favors pharmaceutical treatments over natural ones.
  • Government agencies like the FDA and FTC often restrict access to natural medicines, citing a lack of evidence. This bias makes it difficult to conduct and fund necessary research on natural treatments, which aren’t profitable because they can’t be patented.
  • The federal government allocates minimal funding for natural medicine research. In 2021, the National Center for Complementary and Integrative Health received only 0.3% of NIH’s budget, perpetuating a cycle where natural therapies are excluded from medical care despite their safety and effectiveness.

Recent controversy over a study on how ketogenic diets might help schizophrenic patients illustrates why medicine is so broken in this country. This study was halted by the Maryland Health Department with no reasonable justification given. In a health system that is heavily slanted toward pharmaceutical treatments for every disease under the sun, research on natural treatments is few and far between. Then, when it does happen against all odds, it gets blackballed and suppressed. What better way to keep natural treatments from competing with drugs!

The study, its promise, and the shutdown decision

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 was led by Dr. Deanna Kelly at Spring Grove Hospital Center and 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 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.

So why was the study halted? According to a letter from Maryland’s Secretary of Health, the decision to stop the study was “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 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 are more than strange.

It’s also telling that another study that was being conducted at Spring Grove was allowed to continue: a federally funded, multisite study looking at how clozapine, a powerful antipsychotic medication with many known nasty side effects, might reduce violent and aggressive behavior in schizophrenic patients.

Impact on research, patients, and beyond

The termination of this study has far-reaching implications. Schizophrenia affects approximately 2.8 million Americans, with about one-third of patients labeled treatment-resistant. Traditional antipsychotics often fail to provide relief and come with severe side effects. The ketogenic diet represents a novel approach that could offer hope to these patients. The Maryland Health Department’s decision not only stifles scientific progress but also directly affects the lives of millions of patients, including those who volunteered for the study, many of whom come from economically disadvantaged backgrounds and lack alternative treatment options.

This is also indicative of a much broader problem. We’ve long argued that the government has an inherent bias against natural medicines, as evidenced by the actions of agencies like the FDA and the FTC to ban or restrict access to products or information about them. These agencies often cite a lack of evidence backing natural medicines to justify restricting access: we see it with regard to compounded bioidentical hormones, homeopathy, peptides, and dietary supplements.

Funding research on natural products is already challenging since natural treatments like the ketogenic diet are not patentable and, therefore, not profitable. The medical establishment is now throwing further obstacles in front of this necessary research by targeting privately funded studies, as we’re seeing unfold in Maryland.

Adding insult to injury, federal funding for natural medicine research is pitifully small. The National Center for Complementary and Integrative Health (NCCIH) received only $154 million of NIH’s $43 billion budget in 2021, just 0.3 percent. Why would Big Pharma and their government cronies want to fund research on the competition?

This all creates a vicious cycle: natural therapies are shut out of medical care because conventional “experts” claim there isn’t high-caliber evidence to support their effectiveness, knowing full well it is nearly impossible for that research to be funded and conducted; drug companies can afford this research, and so become accepted as the “standard of care” for disease treatment. The irony is, of course, that drugs are still often quite ineffective and very dangerous, whereas food and supplements are both effective and extremely safe.

Despite all of these barriers and hostility from mainstream medicine, there has been a lot of quality research done on natural medicines. ANH’s Pulse of Natural Health newsletter has strived over the years to report on the important and impressive research demonstrating the therapeutic effects of humble vitamins and minerals—and we will continue to do so. 

The status quo that keeps us hooked on pharmaceutical drugs that treat the symptoms of preventable chronic illnesses must change. The proof of the failure of this paradigm is all around us.

Listen to Maryland Keto Kibosh podcast with ANH-USA and executive and scientific director, Rob Verkerk PhD, and board member, Meleni Aldridge, on Twitter Space ‘The Speaker Salon’, hosted by Alana Newman.

Please also support Christopher Palmer, MD’s petition to persuade Maryland’s Health Secretary to reconsider her stance and permit this promising study to move forward.

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