Drug Policy

American Psychiatric Association Says Ketamine Can Treat Depression, But Don't Expect the FDA to Approve It

The cost of getting FDA approval doesn't bode well for ketamine's therapeutic potential.

|

The anaesthetic ketamine has been a popular party drug for decades due to its ability to put users in a blissful mood. Earlier this month, the American Psychiatric Association released a consensus statement acknowledging that the drug might also be a breakthrough treatment for severe depression.

The statement authors write that seven studies–all placebo-controlled, double-blind, and randomized–provide evidence that ketamine therapy is a "rapid and robust, albeit transient" response to severe clinical depression. The treatment is effective within hours, while conventional antidepressants generally take weeks to work. The transient nature of the drug, meanwhile, suggest it works best with twice-weekly dosing.

Ketamine hasn't been approved for treating depression, but Yale psychiatrist Gerard Sanacora succinctly explained to NPR why the drug's off-label status hasn't deterred him:

Sanacora says other doctors sometimes ask him, "How can you be offering this to patients based on the limited amount of information that's out there and not knowing the potential long-term risk?"

Sanacora has a simple answer.

"If you have patients that are likely to seriously injure themselves or kill themselves within a short period of time, and they've tried the standard treatments, how do you not offer this treatment?"

It certainly seems that the long-term risks of ketamine therapy, regardless of how severe they may be, are preferable to the short-term risk of a successful suicide attempt.

The APA paper closes with the hunch that "economic factors make it unlikely that large-scale, pivotal phase 3 clinical trials of racemic ketamine will ever be completed," which means patients with treatment-resistant depression who'd like to give ketamine a shot will need an appointment at one of a handful of clinics offering ketamine treatment. Or, they can apply for enrollment in a philanthropic or federally funded ketamine study, of which there don't appear to be many.

This is a rather strange fate for a drug that the APA says has "generated much excitement and hope for patients with refractory mood disorders and the clinicians who treat them," but it's also an indictment of the Food and Drug Administration's regulatory process. Ketamine is off patent, which means no pharmaceutical company is going to spend several million dollars per phase to get approval for a drug formulation that any company could turn around and sell, no matter how many lives it might save.

Advertisement

NEXT: 'No Such Thing as a Republican Judge' Says Gorsuch, Older Folks More Politically Polarized, How the Web Has Been Good to Mail-Order Brides: P.M. Links

Editor's Note: We invite comments and request that they be civil and on-topic. We do not moderate or assume any responsibility for comments, which are owned by the readers who post them. Comments do not represent the views of Reason.com or Reason Foundation. We reserve the right to delete any comment for any reason at any time. Report abuses.

  1. Can’t doctors prescribe things for off-label uses? Or is some new, unapproved form of the drug required for this?

    1. Since it’s a veterinary drug, I wonder if human doctors are even allowed to prescribe it.

      1. Can a licensed horse masseusse legally obtain it?

      2. There is a veterinary version, but also a human version – solution for injection (it’s a dissociative anesthetic.)

        So yes, any physician with a DEA license (it’s also a controlled substance) could prescribe it, but most won’t.

        Not that that’s necessarily a bad thing. As the article notes, it’s really only short term effective at best, and due to associated risks use really should be limited to people with severe depression who need urgent therapy.

        Which basically means that those people should probably be treated by a psychiatrist. The question for psychiatrists will be: Does it offer any advantages over electroconvulsive therapy?

        1. From what I’ve read the memory issues make it preferable but it does not sound like it is as effective for extremely profound depression.

      3. NO IT’S NOT. This is a myth perpetuated because it is often diverted from veterinary sources. It was developed as a replacement of PCP (of all things) as an anesthetic during the Vietnam War. Most hospitals carry it as an anesthetic for when the more usual anesthetics can’t be used, because of blood pressure concerns. And in fact the usual medical anesthetic use is SEVERAL TIMES the amount used recreationally or for depression. The veterinary use has been used as anti-drug propaganda for years. It’s just another way the Drug War spreads information about actual medical and therapeutic uses.

    2. Doctors can prescribe anything they want. Even non-doctors can. A prescription is simply an instruction, “do this”, usually conceived as health advice to a patient.

      What you’re probably interested in is whether a prescription can legally be filled off-label. The answer to that is also “yes”. What’s really at issue in most cases is insurance reimbursement.

      Anything, whether it is or is not licensed as a drug, medical device, or other bioaffecting thing that would need a gov’t license to be marketed legally, can be used by anyone as anything (a putative exception existing in the case of pesticides in the USA, whose labels are required to say off-label use is federally illegal, but which usually is not really illegal). They can be marketed for non-medical uses too, and nothing forbids the customer to use them medically.

  2. Given the fact that it’s been a popular party drug for decades, somebody must be profitably manufacturing the stuff. “That One Dude” might not be quite as reputable a drug company as Merck or Pfizer, but it’s a much more widely-known drug company.

    1. It’s manufactured as an anesthetic. Good luck getting a doctor to prescribe it to you as an antidepressant off label without being part of some sort of study. Easy way for a doctor to lose a lawsuit.

  3. …it’s also an indictment of the Food and Drug Administration’s regulatory process.

    Enter Trump.

  4. Both veterinarian and human pharmaceutical manufacturers make ketamine chloride, usually made in one gram units, dissolved in 10 ml of water (thus, ketamine hydrochloride.) It is a generic compound, and very inexpensive to a vet (probably about $10 per 10ml bottle.) As far as I know, there is no medicinal purpose for which a physician could prescribe it for a human. It is used only in a hospital setting, and virtually all hospitals stock it, as a very safe anesthetic. Almost all, if not all, of the recreational use is diverted from the vet pharma supply. The compound is very difficult to make, and only a properly equipped pharma company could make it. Thus, there is no such thing as a clandestine K lab. Thus, it is dispensed in pure, properly measured units, making it probably the safest recreational drug obtainable. There is absolutely no reason it should be scheduled by the DEA Nazis.

    1. There is absolutely no reason it should be scheduled by the DEA Nazis.

      If you limit the scope of reasons to things like logic and individual freedom, I’d agree. If you allow in concepts as mission expansion and maintaining of control, then things become more clear.

      1. The reason is always the same: BFYTW

  5. The cost of getting FDA approval doesn’t bode well for ketamine’s therapeutic potential.

    In a free country, the peasants wouldn’t have to get government approval to take medicine.

  6. As long as shrinks can prescribe it off-label, there is not a tremendous need for FDA approval.

  7. We are top suppliers Marijuana, pain pills, sex pills and anxiety meds available (we have meds like xanax, tramadol, percs, oxy, roxy, valium, actavis syrup, etc… +1 (724) 470-0553. Call: +1 (419) 299-6124
    Email Us Via : discreetsales2015(@)gmail.com

  8. Special K, Vitamin K, etc. as Ketamine was/is known… take it from a child of the 60s who tried just about everything… no thanks!

    But I can see why abusive-type psychiatrists would like it… they love drugs that make you into a docile vegetable… also makes it easy for them to rape their patients.

Please to post comments

Comments are closed.