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Proposed Patent for Ketamine Treatment Challenged by Clinicians

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Proposed Patent for Ketamine Treatment Challenged by Clinicians

A Salt Lake City doctor who intends to patent what he claims is a new mental health therapy using high dose intramuscular injections of ketamine is being challenged by clinicians who say that his methods are not a new discovery. 

Providers of rapidly evolving ketamine-assisted therapies say efforts to patent this protocol overlook decades of prior research and could block their ability to offer similar treatments. 

This controversy is taking place as clinicians debate the role of intellectual property in shaping the economics of the field. 

Dr. Robert Hiemstra, a former emergency room doctor who founded the Salt Lake City-based clinic Ketamine SLC, says his tiered ketamine dosing strategy and compressed course of therapy extends the benefits of his treatment, often by months. 

In an earlier Lucid News story, Hiemstra said that SLC Ketamine has treated more than 8,000 patients with Post Traumatic Stress Disorder (PTSD), Treatment Resistant Depression (TRD) and other mental health conditions, with no adverse events. 

Hiemstra now says he is being investigated by the Utah Division of Occupational and Professional Licensing (DOPL) for complaints against his clinic, which he says were prompted by a competing ketamine provider. DOPL did not reply to repeated requests to confirm the  investigation or the precise nature of the complaints.

Hiemstra’s claims bring into sharp focus both competition and collaboration among ketamine providers who follow a range of dosing protocols. 

Patients at Hiemstra’s clinic receive increasingly higher dose intramuscular (IM) injections of approximately 1 milligram of ketamine per kilogram of body weight (1.0 mg/kg) spread over two hours. 

This is markedly different than the widely used 0.5 mg/kg per 40 minutes IV dosage that is typically repeated over the course of six treatments in two or three weeks. Developed by the Yale University School of Medicine, this is known as the NIMH protocol because the National Institute of Mental Health (NIMH) investigated ketamine for treatment of depression. 

Hiemstra says patients who receive high dose IM ketamine therapy metabolize twice as much ketamine as an intravenous dose and double the number of neural pathways in the brain. The tiered dosing strategy varies based on a patient’s reaction and is increased if necessary. According to Hiemstra, forty percent of his patients receive three months of relief after the first treatment.

Hiemstra asserts that he is not seeking a patent solely to claim ownership over his protocol. He says he is attempting to prevent the pharmaceutical giant Johnson & Johnson from patenting the method first and possibly barring him from using the technique or being required to license it. 

Johnson & Johnson did not reply to a request for a comment about whether they intend to file a patent for Hiemstra’s treatment. 

If granted a patent, Hiemstra says he will license his therapy to other ketamine therapists and clinics at no cost if they use the same protocol. “My thing about getting a patent really isn’t to protect the protocol, it’s to protect me,” says Hiemstra. 

Psychologist Dr. Raquel Bennett, who has studied the therapeutic properties of ketamine since 2002, founded the KRIYA Institute and the KRIYA Conferences where clinicians present and examine research into therapeutic ketamine. Bennett disputes Hiemstra’s claim that he alone developed high dose IM ketamine treatment, which she says was pioneered by Dr. Salvador Roquet, Dr. Eli Kolp, Dr. Evgeny Krupitsky, and Dr. Karl Jansen, among others. 

“My understanding is that in order to qualify for a patent on an existing medication, you have to make a change to its chemical composition, route of administration, or indication,” says Bennett. “Heimstra has done none of these things, so his claims to have invented a new therapy are without merit.” 

Hiemstra says he intends to document his treatment in a forthcoming book that questions the efficacy of Johnson & Johnson’s ketamine nasal spray, Spravato, which is presently the only FDA-approved ketamine compound developed for treatment-resistant depression. “What they really ought to do is hire me as a consultant helping to train all of their doctors,” says Hiemstra. 

Decades of Ketamine Research

Hiemstra is just one of many clinicians and researchers who have investigated the use of ketamine for the treatment of mental health conditions. 

Ketamine was first synthesized in 1962 by chemist Calvin Stevens, who worked for Parke-Davis Laboratories. Patented in 1966 for human use under the name Ketalar, it has a long history of use as an anesthetic beginning with the treatment of soldiers during the Vietnam War. 

The patent for racemic ketamine, which contains two spatial variations of the ketamine molecule, has expired and ketamine is now available as a generic medication. The World Health Organization (WHO) includes ketamine on its WHO Model List of Essential Medicines

In the 1970s, Mexican psychiatrist Dr. Salvador Roquet was one of several clinicians around the world using IM ketamine in combination with psychotherapy to treat a variety of mental health conditions. 

Research institutions began investigating ketamine in the 1990s when Dr. John Krystal, a psychiatrist at the Yale School of Medicine, used ketamine as a research tool for understanding and treating schizophrenia. Yale University was the first major academic institution to conduct extensive research into the possible uses of ketamine for psychiatric indications. This opened the door for researchers to examine ketamine and related chemicals for their therapeutic potential. 

The Yale ketamine research influenced Dr. Carlos Zarate, a psychiatrist working at the National Institute of Mental Health (NIMH). Together with a team of investigators, Zarate published in 2006 seminal research on the use of IV ketamine as a therapy for treatment-resistant depression. 

In 2013, Janssen Pharmaceuticals, which is owned by Johnson & Johnson, received a patent for its Spravato ketamine nasal spray. 

Spravato contains S-ketamine or esketamine, which is one of two spatial variations of the molecule found in racemic ketamine. The other variation, known as R-ketamine or arketamine, is also in development as a commercial product. 

Spravato is the only form of ketamine therapy presently covered by insurance after it was granted both fast-track and breakthrough designation for accelerated drug development by the FDA. 

Clinicians Dispute Claims of Innovative Therapy

While Hiemstra says his protocol represents a novel approach, established providers of ketamine-assisted therapy say Hiemstra’s use of high dose IM ketamine has long been established. 

Bennett says she has been teaching a method of hybrid dosing for six years that provides multiple doses of IM ketamine of 1.0 mg/kg or higher for certain patients. She says she created the term “hybrid dosing” because this protocol offers the ease of IM administration, while extending the length of exposure to ketamine that is more similar to IV delivery. 

According to Bennett, many clinicians in the KRIYA community use this dosing strategy. Some also use lower dose protocols, including the system developed by Zarate and his team at NIMH. 

Bennett says she presented her hybrid dosing approach in a 2015 talk at KRIYA conference where her colleague, Dr. Phil Wolfson, noted that he used a similar technique for ketamine-assisted psychotherapy. 

“Phil Wolfson and I came up with the same thing independently, which we discovered at the KRIYA Conference 2015,” says Bennett. “So this has been in the ketamine community for sure since 2015. I think Heimstra didn’t do his homework.”

Wolfson is co-editor of The Ketamine Papers, a collection of essays published in 2016 that documents the therapeutic use of ketamine. Director of the Center for Transformational Psychotherapy, Wolfson is also a Principal Investigator for a Phase 2, FDA-approved study sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) which is investigating MDMA-assisted psychotherapy for people with anxiety due to life threatening illness. 

Wolfson rejects Hiemstra’s claim that he developed a completely unique approach to high dose IM ketamine therapy. “There’s no route of administration that’s truly patentable because of prior art – all have been tried,” says Wolfson.

Clinicians Call For Additional Research 

As ketamine has been an FDA-approved medication for anesthesia, and by extension analgesia since the early 1970s, it was assigned to DEA Schedule 3 status which recognized its medical use for sedation and pain. Ketamine is currently used “off-label” for depression and other psychiatric indications, outside of its approved use by the FDA.  

Dr. Cole Marta, a psychiatrist and co-founder of the California Center for Psychedelic Therapy, trains physicians to provide ketamine treatment and has reviewed the scientific literature on ketamine and depression, including clinicians working at the 1.0 mg/kg dosage. Marta says the granting of a patent for Spravato reflects the unique status of ketamine in the FDA approval process.

“I believe they were lax on providing that patent because of the phenomenon already happening in the ketamine community – because it was off-patent for 50-plus years,” said Marta. “The clinical trials for FDA approval are extremely expensive, and no one was going to pay to get it on-label. So how do we get a drug company to prove what we already know, so that the FDA can finally say, on record, ‘Ok, everyone waiting on approval, you can use this now?’ The majority of clinicians are not risk takers.”

Hiemstra says he hopes to convince UnitedHealthcare, a Texas-based insurance company, to support a clinical investigation comparing his IM ketamine therapy results against outcomes from patients using Spravato. 

According to Hiemstra, Ketamine SLC is compiling its patient treatment data, which he plans to present for peer review. Hiemstra confirms, however, that he has not discussed his proposed study with either UnitedHealthcare or Johnson & Johnson. 

“A whole lot of clinicians have been offering high dose IM ketamine,” says Bennett. “If Hiemstra is an emergency room physician who has provided 8,000 treatments with a lack of adverse events, that is notable.” 

Johnson & Johnson did not reply to a request for comment about Hiemstra’s proposed study. UnitedHealthcare said they were not aware of Hiemstra’s work and did not follow up on a request for comment. 

While there is no comparative research that examines the efficacy of the treatment he is using, Hiemstra remains confident that this protocol produces more effective outcomes for patients. “If they do the study they’re suddenly going to see my system is way more effective than any kind of nasal spray,” says Hiemstra. “I’d be fearful that I’d show them how to use my protocol, and then they’d just start doing it. Without the patent, they wouldn’t have to reimburse me.” 

Mike “Zappy” Zapolin and Warren Gumpel, who co-founded the nonprofit Ketamine Fund, are helping to personally finance the development of Hiemstra’s patent claim. Gumpel notes that Hiemstra’s proposed patent is also motivated by the presence of a competitor – the Treatment Resistant Mood Disorders Clinic run by University Neuropsychiatric Institute at the University of Utah Health system, which offers lower dose ketamine IV infusion treatments.

“He was concerned that the university, which started doing IV treatment at $1,000 a session, was moving into IM therapy and charging significantly more,” says Gumple. “He doesn’t want to be stopped.” 

The Ketamine Fund is providing $60,000 in funding to support 400 free treatments at Ketamine SLC for veterans who make up many of the clinic’s patients and staff. SLC Ketamine typically offers ketamine treatments for approximately $300 per session. A six-treatment regime costs $1,500, which does not include integration therapy or aftercare costs. 

Hiemstra alleges that the University of Utah Health system pushed for an investigation of Ketamine SLC by the Utah Division of Occupational and Professional Licensing (DOPL) because the clinic competes with the university’s ketamine services. 

“In general, academic institutions are frightened of ketamine,” says Hiemstra. “They may know it works, but it threatens their pharmacological tools – in particular, SSRIs. If ketamine moves in, it challenges not only the depression and anxiety industry, but it could also be moved over to help with the opioid crisis.”

According to Hiemstra, the lower-dose IV ketamine treatment offered through the university’s Treatment Resistant Mood Disorders Clinic is ineffective and patients are moved on to other more expensive insured treatments. Hiemstra says he suspects that the data he shared with the university about the low rate of adverse reactions to his therapy is the catalyst for a proposed study by the university for higher-dose IM ketamine treatment. 

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“This would not only suggest their use of my idea, but also the fact that they’re trying to prosecute me through the local medical board, a double hypocrisy,” says Hiemstra. 

Of the six complaints against his practice being investigated by the DOPL, Hiemstra says that only one is the result of a medical mistake that he committed. “The other five are, for the most part, simply normal side-effects of ketamine that the patient misinterprets – as a consequence of the psychedelia – as elements that the clinic could and should have controlled,” says Hiemstra. “They weren’t and will never be.” 

DOPL did not reply to repeated requests to confirm that it was investigating Hiemstra. The DOPL website lists Hiemstra as having “no disciplinary actions.”

Hiemstra further alleges that Dr. Jeremy Kendrick, Assistant Professor at the University of Utah’s Department of Psychiatry and a practitioner in the University Neuropsychiatric Institute and Treatment Resistant Mood Disorders Clinic, served as an expert witness in the DOPL investigation against his clinic. According to Hiemstra, Kendrick runs a competing ketamine therapy practice which lowered its prices to match Ketamine’s SLC’s fee structure. 

Kendrick declined to comment on Hiemstra’s allegations. He says in a statement that the Treatment Resistant Mood Disorders Clinic at the University Neuropsychiatric Institute provides ketamine “for the treatment of refractory depression in a safe, evidence-based manner” which adheres to A Consensus Statement on the Use of Ketamine in the Treatment of Mood Disorders presented in JAMA Psychiatry in 2017. 

While the university is presently adhering to the NIMH protocol of 0.5 mg/kg per 40 minutes IV and other treatment guidance in the document, Kendrick says it is developing a study to investigate the effectiveness of higher dose IM ketamine therapy.

“The use of higher-dosed intramuscular ketamine administration for the purpose of providing a psychedelic-assisted psychotherapeutic experience is an exciting area of developing research for which the university is currently developing an [Institutional Review Board (IRB)] IRB-approved research study to contribute to the growing body of evidence for much needed options for severely depressed patients,” says Kendrick. “First and foremost, we adhere to principles of safety and ensure our patients are delivered this medication in a manner that limits the potential for harm.”

Competition Versus Collaboration 

While some ketamine providers support more research into higher dose IM ketamine therapy, they remain skeptical of Hiemstra’s reasons for seeking a patent – and his intention to license this treatment to other clinics at no cost. Once a patent is granted, it is often difficult to overturn and patent holders may be pressured by investors or donors to change conditions for use. 

Marta says he’s confused by Hiemstra’s position, not because of the existence of prior art, but specifically the doctor’s intention to offer the protocol without licensing fees. “The ‘Why patent?’ is a huge question,” says Marta. “If he did patent it, I’d still want to see really great results before using it. And then, I don’t understand why he wants to patent it if he’s not going to charge something. So what if other people steal it if he’s already giving it away for free? It’s weird.” 

Bennett also questions Hiemstra’s assertion that securing a patent for his treatment will be beneficial for ketamine patients and providers. “We are modifying and continuing what we have learned from our colleagues, not trying to patent it or own it,” says Bennett. ‘There are no quibbles about who are the owners of these ideas. That is a waste of time and energy. It’s all of our ideas together.” 

Bennett and other ketamine practitioners are advocating for a cooperative approach to exchange research findings and treatment information. According to Bennett, this collaboration can help secure FDA approval for off-label use of therapeutic ketamine and inform patients about treatment options.  

“We need to educate patients so they understand the spectrum of ketamine services that are available and can ask intelligent questions about their options,” says Bennett. “And we need more education for clinicians, so that they can work with ketamine in a competent, skillful, and ethical way.”

Dr. Alexander Belser, a psychologist and researcher at Yale University and New York University, is dismayed by the challenges clinicians encounter when attempting to establish protocols for the administration of medications such as ketamine. 

“I don’t have a specific conflict with anyone trying to patent the medication from a dosage strategy perspective,” says Belser. “I’m just lamenting that patent law has potentially made people feel like they can’t practice the art of protocol dosing for particular patients. I think we need an open field. Making methods of medical treatment patentable is a race to the bottom.”

Dr. Will Barone, a ketamine-assisted therapy practitioner based in the San Francisco Bay Area, says he was surprised when he heard about Hiemstra’s patent proposal. 

“I didn’t really see this as patentable territory up until then,” says Barone. “In my experience there’s a very collegial attitude among ketamine therapy providers and programs, and KRIYA has done a lot to develop that. It’s been a hub for creating a collaborative atmosphere. We have strengths and refer to each other because we all do slightly different things, and that’s worked so far.” 

Gumpel, of the Ketamine Fund, which is backing Hiemstra’s patent effort, says he is in favor of UnitedHealthcare conducting a comparative investigation of the outcomes of Hiemstra’s protocol against Spravato. 

“In an ideal world we’d love to have a side-by-side study between Spravato and IM therapy, with nothing on docket except of a lot of people’s desires – including insurance companies – for a cheaper and more effective product,” says Gumpel. 

According to Bennett, the development of a collaborative data collection tool would assist providers in collecting data on the efficacy of generic ketamine treatment, which could then be collated and submitted to the FDA. 

Bennett notes that FDA approval is intimately tied to medical insurance coverage for ketamine therapies. She argues that when therapeutic ketamine is routinely covered by insurance, this will lower the cost barrier and increase accessibility to this treatment in the U.S.

“The key in all of this is to figure out how to get FDA approval for generic ketamine for depression or another psychiatric indication,” says Bennett. “We all know that it works, and there is a substantial body of literature that supports it. The only way that we are going to get there is by working together.”

Correction: This story has been updated to report that Mike “Zappy” Zapolin and Warren Gumpel, co-founders of the Ketamine Fund, are helping to personally finance the development of Dr. Robert Hiemstra’s proposed patent for ketamine-assisted therapy. The Ketamine Fund is not providing financial support for Hiemstra’s proposed patent as was originally stated.

Image: KRIYA Institute

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