We encourage you to ask your psychiatrist, or even your PCP (Primary Care Provider), about ketamine. It’s not that we expect them to be responsive. Some will be sympathetic but will not consider providing ketamine themselves. Many will be hostile. Nevertheless, we hope that by asking your psychiatrist and PCP that you will spread the word about ketamine. You will become an evangelist.
But to explain why your psychiatrist won’t prescribe ketamine, we need to explain something about the practice of medicine. Doctors work a minimum of 7 years to earn their degrees, become licensed, and able to practice medicine. This enormous investment makes them very conservative about what prescriptions and procedures they will perform. If they stray outside whatever is considered the “standard of care” for their specialty, they risk lawsuits and disciplinary action by their state board of professional conduct.
In any field, most practitioners are reluctant to innovate. It’s much more comfortable to do whatever it is that is conventional in that particular field. When the practitioner’s professional license is on-the-line, the motivations to remain conservative are intense.
Ketamine for mental health only began to be recognized in the US around 2000. Its efficacy became well-established around 2010. FDA’s approval of esketamine (Spravato) for TRD in 2019 helped. However, FDA approval of Spravato didn’t extend to racemic ketamine to the extent warranted by the science. Spravato is no more effective than racemic ketamine; it might be less effective than racemic ketamine.
Doctors, like most other people, are busy and content to do whatever it is that they have always done. To do something new, they must be inspired by some new input.
Pharmaceutical companies employ armies of sales representatives to call on doctors to inform them of new products. Companies promote their new products at conferences, conventions, cruises, and like forums. Since racemic ketamine is off-patent, it is produced by manufacturers of generic drugs. No such manufacturer has any financial incentive to promote any of its products. It can’t enjoy any monopoly profit from doing so. If generic manufacturer A of drug X sends a salesman to call on doctors, those doctors might write prescriptions for drug X. But the pharmacist will be just as likely to fill the prescriptions from products offered by manufacturers B or C or D.
Doctors read journal articles about topics important to their fields of practice. They attend continuing education programs about topics in their fields. However, there aren’t a lot of journal articles and very few continuing education programs about ketamine. And these few compete for the doctors’ attention against a flood of information about other topics.
Ketamine is prescribed “off-label” for mental health indications. Off-label prescribing is commonplace. Twenty percent of prescriptions written by doctors are for off-label applications. Prescribing for an off-label application is perfectly legal and normal. So common, in fact, that doing so is the standard of practice for many such drug+indication combinations. When, eventually, a particular drug+indication combination becomes routine, there is no more risk to the doctor in writing that off-label prescription because it is the established standard of care.
Ketamine hasn’t quite reached that stage of widespread recognition. So, any doctor who prescribes racemic ketamine off-label does so outside both: FDA Approval (CYA); and established standard of care conventions. In such a case, at a minimum, the doctor needs to be prepared to defend his decision (to prescribe ketamine off-label) by referencing journal articles, books, and other research to show why it was reasonable. He must become a self-studied expert on this particular off-label prescription. This requires real work or an intrepid spirit. Most doctors are unwilling to invest this much work into preparing to defend their decisions to write an off-label prescription before it has already become the standard of care for that doctor’s field.
How much evidence is “enough” to justify the doctor’s decision? This is never clear. By the time it is perfectly clear, the treatment has become part of the standard of care. Until that point, any doctor using that treatment for an off-label indication is treading on thin ice. His regulators can, at a minimum, audit his practice attempting to build a case that his use of this treatment is inappropriate: the next stage is an investigation for a regulatory review of the doctor’s license. Doctors need to build a library of journal articles supporting their protocols to defend themselves. And accumulate records of patient progress and success under these protocols. All are time-consuming, expensive, and still never dispositive of the question of appropriateness.
Ketamine is a Federally slated “Controlled Substance.” Therefore, there is vastly more scrutiny by the DEA (Drug Enforcement Agency) and state regulatory boards for writing an off-label prescription outside the established standard of care protocols. Any doctor who writes such a prescription (for a Controlled Substance outside the standard of care) risks intense scrutiny by DEA or his state regulatory board.
The OxyContin scandal of the late 1990s made the situation vastly worse. Purdue Pharma aggressively marketed its FDA-approved opioid product as a safe, less addictive pain reliever. Doctors bought into the claims of this product’s safety and non-addictive nature and wrote prescriptions. Users soon discovered they could doctor-shop and obtain multiple prescriptions from multiple doctors. Some doctors imprudently wrote prescriptions for OxyContin with little or no restraint. These attracted the accusations of being “pill-mills.” No responsible physician wants to risk being accused of participating in any potentially similar scandal.
We hasten to add that ketamine is highly unlikely to devolve into a similar “pill-mill” scandal as was the case for OxyContin. Ketamine has a very low potential for addiction. Moreover, as a Controlled Substance, prescription writing is monitored state-by-state such that it’s difficult for one patient to obtain multiple prescriptions from multiple providers successfully. Pharmacists report to the patient’s state database, and providers are required to check the patient’s state database before writing a new prescription.
Ketamine is a “psychadelic”. While psychedelic psycho-pharmacology is rapidly emerging as promising, it’s not yet the standard of care. And this situation probably won’t be achieved for another 5 to 10 years. Accordingly, doctors are reluctant to begin prescribing psychedelics outside the cover of both FDA Approval and established standard of care.
As a consequence of all the foregoing influences, almost all doctors, even psychiatrists, remain unwilling to prescribe ketamine off-label. PCPs and other specialties – outside psychiatry – may lend a sympathetic ear to a patient’s request for ketamine. Nevertheless, these doctors will (justifiably) explain that they don’t want to extend their practice to include prescribing ketamine. That’s understandable.
Psychiatrists do not deserve a pass for refusing to prescribe ketamine. Psycho-pharmacology is squarely within the scope of their practice. Any pharmaceutical reasonably applicable to a mental health condition ought to be within their field of practice – at least a potential candidate. Nevertheless, for the considerations enumerated above, most psychiatrists will be openly hostile to a patient’s request for ketamine. The list of excuses includes:
– ketamine for mental health is experimental
– ketamine is only used for TRD
– ketamine is only FDA-Approved for anesthesia and analgesia
– ketamine for mental health is off-label
– ketamine is not FDA-Approved for any mental health condition (except for Spravato, which he will never acknowledge)
– ketamine is a drug that I have not studied (and ‘I’m unwilling to undertake a study)
– I might have to defend my license if I write a ketamine prescription off-label
– ketamine is addictive
– ketamine is a “club drug”
– I can write you prescriptions for other drugs that are FDA-Approved or at least are standard of care
In our opinion, none of these excuses holds water for a psychiatrist whose practice includes psycho-pharmacology; and that covers virtually all psychiatrists. It speaks poorly – scandalously – of the psychiatric profession as a whole to exhibit hostility to ketamine for mental health on such flimsy pretexts. If there were a rationale with a legitimate basis to justify blanket reluctance, we would cite it.
We do not regard ketamine as the absolute last resort. Instead, we think ketamine should be among the first alternatives considered for the indications enumerated elsewhere.
Any psychiatrist who is reluctant to prescribe ketamine himself should, nevertheless, offer patients a referral to another provider who does prescribe ketamine. There is no legitimate excuse for reluctance to refer a patient to a ketamine provider.
The result is that it is rare that a psychiatrist writes an occasional prescription for ketamine for mental health. The overwhelming majority of ketamine for mental health is prescribed by providers who:
– specialize in ketamine for mental health
– In-clinic providers who can readily manage their risk of contingencies by having the patient under their immediate control during the administration
– tele-ketamine providers who are willing to put their patient’s health at a higher priority over their risk of defending their licenses
– anesthesiologists who became familiar with ketamine in the operating room and know perfectly well how safe it is
Each mental health patient is left to decide for him/herself:
‘Will I put my personal interest in relieving my disease above my doctor’s professional interest in avoiding defending his decision to prescribe me ketamine?’
It is our intention, through the content of this website, to make it perfectly clear which is the appropriate choice for you.
Expanding on the flimsy excuses enumerated above, consider the following arguments:
– ketamine for mental health is experimental – That was true in 1970. It was true when Iranian psychiatrists first used it to treat MDD. It was true when the Mexican psychiatrist Salvador Roquet, in collaboration with the famous magic mushroom shaman Maria Sabina, first began using ketamine among diverse other psychedelics. A half-century ago. It was true in the US in 2000 when psychiatrists first began ketamine infusion therapy on TRD in America, a quarter century ago. It is now perfectly well established that ketamine therapy for mental health is both safe and effective. Anyone who claims it is experimental is unwilling to look at the evidence readily available to anyone with a web browser.
– ketamine is only used for TRD – This excuse is mutually incompatible with the excuse that ketamine for mental health is experimental. If it is used for TRD, it’s no longer experimental. But this is merely a logical quibble. The real issue is whether ketamine therapy is safe and effective. If it is safe and effective for TRD, then it’s almost certainly safe and effective for other indications, particularly MDD which is not arguably TRD. It is absurd to assert that a therapy that was first used to treat X can never be found useful in treating Y.
– ketamine is only FDA-Approved for anesthesia and analgesia
– ketamine for mental health is off-label – Racemic ketamine is FDA-Approved for anesthesia and analgesia; that’s true. It is used “off-label” for any other indication. So what? One fifth of all prescriptions in the US are written off-label. If this excuse had any merit, it would apply equally to countless other off-label prescriptions.
– ketamine is not FDA-Approved for any mental health condition (except for Spravato, which he will never acknowledge) – This is the classical half-truth. As explained elsewhere, Spravato is the trademarked name for esketamine, the isomer molecule representing 1/2 of the two isomer molecules of racemic ketamine. The other is arketamine. So, FDA-Approval of Spravato is imprimatur of 1/2 of racemic ketamine. That’s the 1/2 truth that tends to support the probable efficacy of racemic ketamine, which is 1/2 Spravato/esketamine and 1/2 arketamine.
Moreover, FDA granted approval to Spravato after it passed just 2 of five Phase III clinical trials. Two FDA panelists voted against the approval of Spravato. The clinical evidence was that weak. Subsequent studies have shown evidence that Spravato is no more effective than racemic ketamine. And, there is some evidence that arketamine is more effective than is Spravato/esketamine.
Johnson & Johnson never ran clinical trials of Spravato vs. racemic ketamine; the trials were against a placebo. Their trials were never intended to show that Spravato was better than racemic ketamine; only that Spravato is better than a placebo. And, they only nearly satisfied the FDA on this point. If anything, we should doubt the efficacy of Spravato and have confidence in the efficacy of racemic ketamine.
– ketamine is a drug that I have not studied (and ‘I’m unwilling to undertake a study) – Psychiatrists are humans like the rest of us. They invested 7+ years in their medical educations and decades more as overworked practitioners. They are tired. They are understandably unwilling to undertake further study. Even so, this does not speak well of such members of a profession that expects to be regarded as composed of scientists and scholars. It’s not hard to learn how to prescribe ketamine for mental health indications. There is ample literature on commonly used protocols. Those who are candid enough to admit that they are unwilling to undertake such a study ought to be regarded as lazy. At a minimum, they ought to refer patients to other psychiatrists who are willing to to make the effort that they eschew.
– I might have to defend my license if I write a ketamine prescription off-label – This is a valid excuse. And most psychiatrists hide behind it. Too few of them are intrepid enough to read the literature and do the right thing for their patients. They would rather protect their licenses and their comfortable living by prescribing far less effective psychotropic medicines.
Here, the real fault lies with us as voters. We consent to be governed as we are. By our Federal Congress and our respective state legislatures. We consent to be governed by the DEA and the state medical boards. And we pay the price.
Science is marching on. Psychedelic-assisted psychotherapy is being actively studied and proving to be safe and effective. And yet, Congress has listed 200 drugs on the prohibited Schedule I of the Controlled Substances lists. Ketamine is on the much less stringently regulated Schedule III (along with testosterone). Even so, as a “psychedelic” it is prescribed under a dark cloud of suspicion. And DEA, with the cooperation of state medical boards, flex its regulatory muscle to enforce this societal taboo. This threat to psychiatrists will end only when we, the voters, withdraw our consent from Congress to regulate ketamine as a Controlled Substance.
– ketamine is addictive – That’s true; it can be. It’s not particularly addictive, not for most users. But it is for some. And for this reason – as well as for concern for ketamine cystitis – we are cautiously supportive of ketamine being regulated as a Schedule III Controlled Substance with state monitoring of patients and their prescriptions.
But we need to put ketamine’s addictiveness into perspective. Caffeine is addictive, particularly the so-called “energy drinks”. Gambling and alcohol are addictive. Netflix is addictive. Yet we never think of regulating these vices because of their addictiveness.
Recreational users sometimes become addicted to ketamine. But there is hardly a hit of reporting of therapeutic ketamine patients becoming addicted. Psychiatrists refusing to prescribe ketamine serves no other purpose than driving desperate mental health patients into the arms of illegal drug dealers who do nothing to regulate their customers’ consumption.
Furthermore, therapeutic ketamine users take this drug to treat debilitating diseases. Often, ketamine is the only effective drug to treat their diseases. Especially suicidal ideation. Ketamine is the only drug that reliably and promptly mitigates suicidal ideation. It makes no sense to deny a patient with SI access to ketamine because he might – someday – become addicted. If psychiatrists refuse to prescribe this lifesaving drug a patient suffering from SI will probably – someday – suicide. Which is worse?
– ketamine is a “club drug” – So what? Where is it written that if a drug tends to put a user in a celebratory, festive mood it must be forbidden? We must say the same thing about alcohol. Shall we forbid serving alcohol in bars and ballrooms? Because consumption of alcohol reduces one’s inhibitions to “cut a rug”?
MDMA was first put on Schedule I of the Controlled Substances list because it became a popular “club drug”; it made young people dance! Horror of horrors! And, MAPS.org has just completed FDA-Approved Phase III clinical trials proving that dreaded “club drug” magnificently effective in treating PTSD. It will soon (probably 2024) win FDA Approval for PTSD.
– I can write you prescriptions for other drugs that are FDA-Approved or at least are standard of care – Yes, and 31% of conventional psychotropic drugs are written off-label. Why are nearly a third of psychotropic drugs considered standard-of-care without FDA Approval but ketamine can never be considered eligible for standard-of-care off-label prescription?
But the most absurd aspect of this excuse is that psychiatrists are very well aware that their FDA-Approved and standard-of-care conventional antidepressants are only about 30% effective. Some critics argue that this 30% figure is significantly over-estimated. These critics – relying on this “other drugs” excuse – refuse to acknowledge that ketamine is 60% or more effective than conventional anti-depressants. And it’s the only drug that shows efficacy in treating PTSD; other than MDMA and psilocybin which remain on the prohibited Schedule I list of Controlled Substances.
Psychiatrists using this “other drugs” excuse can’t explain why they insist on a series of trials of their preferred conventional drugs – one failure after another – with hope of efficacy 1/2 of that promised by ketamine.
Finally, another strange phenomenon exists in the ketamine for mental health “industry.” Hundreds of ketamine clinics have opened throughout the US in recent years. These operate with little criticism compared to psychiatrists prescribing ketamine to be self-administered at-home. Why the distinct treatment?
One might imagine that the ketamine clinics are all operated by psychiatrists. But this seems to be the exception, not the rule. There are probably more anesthesiologists running ketamine clinics than psychiatrists. Why anesthesiologists? What do anesthesiologists know about psychiatry? None of them have done a psychiatry residency, but less a fellowship in psychiatry. Anesthesiologists know little to nothing about mental illness. What they know about ketamine is its use as an anesthetic, administering 1 – 4 grams to a patient to knock him out completely. Ketamine IV doses for mental health are typically on the order of 100 mg.
The only rational explanation is that the clinic is in absolute control over the drug’s administration in the context of clinic administration. The patient doesn’t have the opportunity to take a larger dose or share it with friends. But this is a thin excuse. There is a negligible risk, if any at all, of a patient over-dosing on ketamine at-home. And little risk that a prescribed patient being willing to share some of his limited quantity with friends.
We don’t expect any other Schedule III Controlled Substance to be administered only in clinics. In fact, we prescribe Adderall and similar substances to children with ADHD to self-administer at-home. Why special consideration for ketamine?
Theoretically, any psychiatrist could administer ketamine to his patients in his clinic. But, as a practical matter, this isn’t feasible. Psychiatrists don’t operate in a clinic environment. They operate from offices that are not staffed by nurses nor do they have Lazy-Boys where patients can lounge for a couple of hours taking their ketamine doses.
We shouldn’t expect a psychiatrist – operating out of an office – to be willing to find new quarters and hire nurses to administer ketamine in-clinic. If the vast majority of psychiatrists were to prescribe ketamine, it would have to be for at-home self-administration.
Suppose one psychiatrist was to consider prescribing ketamine for at-home self-administration. What would his colleagues think? They would all be aghast. If one colleague were to break ranks with all his fellows, that maverick would create pressure for the rest to explain why they wouldn’t prescribe ketamine for at-home self-administration. None of them wants to turn his psychiatric office into an iV ketamine clinic. None of them wants to risk auditing by DEA or his medical board. None of them wants to be criticized for prescribing an off-label drug, not yet standard-of-care, and a psychedelic as well. So, to maintain solidarity, psychiatrists need to resort to the thin excuses enumerated above.
Ketamine is needlessly hard to access in the US. And, it’s unnecessarily expensive. Ketamine would be much easier to access and be much less expensive if our neighborhood psychiatrists would step-up-to-the-plate and prescribe ketamine for at-home self-administration. Tragically, there are still too few psychiatrists willing to do so.
We fear that accessibility and costs will drive mental health patients to seek ketamine, MDMA and psilocybin (magic mushrooms) outside established medical channels. Unlicensed guides will supply these medicines and guide their use to patients who can’t otherwise afford the medical dispensing model. This won’t be in the best interest of patients. It will serve only the regulatory agencies who can no longer chase-down consumers with a few pot plants in their basements.
Well written. Now I know why my psych was reluctant when I asked him. LOL. I love my psych and love talking to him…but now I see where he’s coming from. I’ll ask again and even maybe send him the link to this. Thank you so much! This was very much needed.