San Diego VA Medical Center

Veteran Suicide Follows Change To Controversial Depression Treatment

Many suicidal veterans were despondent and one committed suicide after being informed VA would no longer approve their current course of ketamine treatment.

One psychiatrist familiar with the matter said the decision was like “watching a train wreck in slow motion.” Suicidal veterans were receiving ketamine injections to treat antidepressant resistant PTSD, depression, and suicide.

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The Department of Veterans Affairs is swiftly transitioning suicidal veterans to a new course of treatment using either Spravato (esketamine) or IV ketamine. Though, affected veterans report the agency is only using Spravato and not ketamine.

According to the Johnson & Johnson website for Spravato, common side effects of Spravato when used with an oral antidepressant include, but are not limited to: “dissociation, dizziness, nausea, sedation, spinning sensation, reduced sense of touch and sensation, anxiety, lack of energy, increased blood pressure, vomiting, and feeling drunk.”

The website also states Spravato “may cause worsening of depression and suicidal thoughts and behaviors, especially during the first few months of treatment and when the dose is changed.”

From https://www.spravato.com/

Do you think VA had taken into account the increased risk of depression and suicidal thoughts during the first few months of the sudden treatment change?

What you are about to read may remind you of how VA pulled veterans off opioids without taking proper steps to minimize risk of withdrawal of veterans prescribed the drugs for severe pain.

For years, veterans received ketamine injections and IV ketamine from community care providers due to a lack of capacity at VA to provide the treatment course. Now, allegedly without proper warning or consultation, the agency is cutting off suicidal veterans from the clinicians they know followed by at least one veteran suicide.

While a CBS article on this transition did not mention if the veteran’s completed suicide is linked to the use of Spravato, the transition away from the mental health provider did precipitate her suicide. We address this further below.

Backstory On FDA Approval

Following an announcement by President Donald Trump that a new “incredible” treatment manufactured by Johnson & Johnson, the agency is moving swiftly to pull back proven treatment in favor of the new private market therapy.

The Food and Drug Administration (FDA) fast-tracked the ketamine derivative March 5, 2019. “Special K” is the name of the illicit form of ketamine, which known as a date-rape drug. For veterans with severe depression, ketamine injection therapy has demonstrated some success in helping veterans suffering from extreme cases of PTSD.

Over the past year, VA has moved at lightning speed to approve and implement treatments to combat veteran suicide including use of the nasal spray Spravato, an FDA fast-tracked treatment for antidepressant resistant depression.

The treatment with Spravato as well as IV ketamine is reportedly replacing ketamine injection therapy from community providers.

The market cost of Spravato may surprise you:

People starting on this medication will need twice-a-week dosing for the first month. The list price is roughly $600 to nearly $900 per dose. That means the initial month could cost as much as $6,800.

After that, people will require once weekly or twice monthly nasal spray administration. Those costs would range from $2300 to $3500. At the end of a year, Spravato could end up costing $45,000.

Controversy

While VA leadership is fully on board, apparently, with transitioning veterans with severe depression onto Spravato, the research is still developing.

It does not appear VA has performed any published comparative studies comparing treatment options for these veterans comparing Spravato with other known therapies.

A quick search on ClinicalTrials.gov revealed no published trials into the use of Spravato to treat suicidal veterans with PTSD complications. One of my research consultants was unable to locate an IRBs for current research on veterans.

A report of published research and clinical trials in the Journal of Psychiatric Research highlighted part of the controversy:

Notably, other phase III RCTs assessing the acute antidepressant effects of esketamine were negative, with significant methodological limitations in all phase III studies, raising concerns about the FDA decision to approve esketamine, as further discussed by numerous experts (Mahase, 2020; Sial et al., 2020; Wei et al., 2020). As such, there remains significant controversy over the actual antidepressant effects of IN esketamine compared to IV racemic ketamine, that has consistently shown robust antidepressant effects with large effect sizes (Turner, 2019; Zheng et al., 2020).

The authors of the report suggest additional phase II studies should be used to “replicate the small number of ongoing” studies into PTSD using esketamine:

More definitive phase III studies are also needed to assess the antidepressant effects of IV ketamine, as the majority of registered trials are phase II proof-of-concept studies for mood disorders. Conversely, for PTSD, OCD and anxiety disorders, there is likely still merit for additional phase II studies to replicate the small number of ongoing and completed studies in these areas. Understanding the effects of ketamine on completed suicide also remains an unanswered research question, whereas the effect of ketamine and esketamine on suicidal ideations has numerous ongoing and completed studies.

I bought a PDF copy of the above research article for $36 to write this story.

VA Lauds New Nasal Spray Treatment

VA officials lauded the drug once it received FDA approval to treat unmanaged depression, but many VA clinicians were reluctant to include the drug on VA’s formulary for widespread use by the agency.

In a press release, VA stated “Spravato will be available through a restricted distribution system under an FDA-approved Risk Evaluation and Mitigation Strategy (REMS). The purpose of the REMS is to mitigate the risks of serious adverse outcomes and the potential abuse and misuse of Spravato.”

This begs the age-old question.

Is VA offering up some veterans for human experimentation to private industry before the treatment is ready?

It is common knowledge DOD, and later VA, have allowed veterans to be experimented on in the name of science or God and Country, however you want to spin it.

A CBS News Report

The veterans affected by the transition were reportedly stunned. According to Channel 8 CBS News in San Diego:

“Some of the vets had heard about Spravato but were nevertheless stunned when the VA cut off their ketamine at Kadima without giving advance notice to them, their psychiatrists at the VA or Feifel. In some cases, vets were told less than 24 hours before a scheduled appointment that the treatment they’d relied on for years would no longer be an option.”

A CBS news article extensively covered the experience of many veterans who relied on the ketamine injection therapy from Kadima Neuropsychiatry Institute in La Jolla.

Dr. David Feifel founded Kadima to provide treatment to individuals suffering from antidepressant resistant PTSD. Since 2017, San Diego VA has referred at least 32 high-risk veterans to Feifel, a recognized expert in the use of ketamine for mental illness.

That was at least until President Donald Trump was confronted with alarming veteran suicide numbers. The president announced Spravato was an “incredible” treatment to help with veteran suicides.

But the president’s enthusiasm appears to end with him.

Not Everyone Agrees

VA doctors were not necessarily on board.

VA doctors, medical experts, and researchers have questioned the efficacy and safety of Spravato after Trump spoke so glowingly about the treatment. There is little research to support its use to address veteran suicide.

Veterans were also concerned.

“I was basically told that it was either their way or the highway,” said AJ Williams. The Army veteran said she was sexually assaulted during her 14 months in service and developed anxiety and major depression as a result. “I was not consulted. I was not asked if I wanted to do this. I was not given a choice.”

Did VA Lie?

According to a VA spokesperson, the agency informed impacted veterans and Kadima leadership that the agency would transition all veterans back to VA for treatment with Spravato and IV ketamine.

Veterans and Kadima leadership say the claim by VA is false.

Veterans contacted by CBS report they are not receiving IV ketamine, which many would like instead of Spravato.

And, both Kadima leadership and veterans say the agency failed to provide proper notice of the treatment course change and were not consulted in the same.

The counter-narrative is supported by at least one VA psychiatrist’s promises.

CBS reported at least one VA psychiatrist even reassured one of his patients that the agency had no intention of removing those veterans from ketamine injection treatment at Kadima.

Slow Motion ‘Train Wreck’

In April, Feifel chastised the agency for its decision.

In a communication to VA leadership, he wrote, “We were under the impression that the VA learned from its mistake and under no circumstance would it follow the same catastrophic path that resulted in that tragic outcome. And yet, here we are, watching a train wreck in slow motion … AGAIN!”

“It’s just unconscionable that the VA would take the action that they have,” said Dwight Stirling, founder, and CEO of the Center for Law and Military Policy, a nonprofit think tank in Huntington Beach.

“The thought of taking patients off of a treatment without first consulting with their doctors is simply indefensible,” he said.

A Brief Backtrack

After one of Feifel’s patients committed suicide, VA quickly renewed its contract with the Kadima clinic. The contract move was likely made for a show of support, only, as the agency began ignoring requests for Kadima patients to renew their authorizations.

Congressional Investigation

In June 2019, the House Committee on Veterans Affairs called for a review of the contracting process for Spravato following an investigation by the Center for Public Integrity.

The Center found the pharmaceutical company behind Spravato was working with Trump associates from his Mar-a-Lago Club. The investigation also found the president offered to help the VA negotiate purchases of the drug from the manufacturer, Johnson & Johnson.

“Questions remain about the ultimate impact on the health and safety of veterans, who should not be made into a ‘test case’ while the clinical community continues to gather data about this treatment,” said House Committee Chairman Mark Takano (D-Ca).

Ten of VA’s 170 medical centers are administering Spravato with an estimated 43 veterans receiving the drug as of May 13 according to a VA spokesperson.

One veteran receiving the drug, Joel Andrews, did not give high marks to the treatment.

“It didn’t really do anything,” he said. Andrews previously received ketamine at Kadima two years before he was notified in early May by a VA psychiatrist that he was being cut off.

“I have been getting IV ketamine for approximately two years now, it has helped me tremendously. I receive treatment on a weekly basis. I believe this lesser treatment will not be beneficial for the vets already going to Kadima. I am really frustrated with the VA and the way in which they treat the mental health patients like pawns.”

VA says the reason for the transition since January 2020 was based on improving health care integration by “transitioning Veterans receiving the treatment back to VA care for better integration with the other VA services they already receive. This is being done in a phased manner and providers have discussed this decision with their patients who receive this type of care.”

Where Are We?

Here is my opinion on the transition to Spravato.

There is not enough research to justify transitioning veterans suddenly from their current course of treatment. I would bet there exists a significant disconnect between leadership and VA doctors working with these veterans.

What do you think? Have you used Spravato? How about ketamine injections? Is VA letting private industry leaders run tests on veterans as research without proper protocol including IRBs?

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14 Comments

  1. Wow! Ben, you’ve opened up Pandora’s box on this one.
    For many years, and many drug trials, VAMC patients have been the preferred human test dummies for the FDA. It is nearly impossible for an uninsured sc VA patient to be approved for a NAME BRAND version of any prescripted medication unless they are among the “chosen” to experiment the side effects. But don’t worry… they’ve got more pills for that, too!

    In my many years of VA prescriptions and also as told by others, when “they” choose to change your outpatient meds, it may well be so that “they” can trial some FDA ‘accepted’ but not yet ‘approved’ hurry up and get ‘er done new drug. Moreover you will very likely be treated as they do with an inpatient, thereby, having no voice in your treatment(s) that “they” have planned for your case. I caution here, if your provider VA or otherwise wants to change your meds, do your research before you take that first dose!

    Now before I am slammed by the “outsiders”, are you aware, of how many of these GLOBAL in-hospital C-19 deaths occurred as a result of HCQ (hydroxychloriquine sulfate) overdosing? {Search for the Age of Autism article “WHO ‘Solidarity’ and UK ‘Recovery’ clinical trials of hydroxychloriquine using potentially fatal doses” to get more information} Or what of excessive ventilator pressure causing injury to lungs like in altitude illness? Or who knows what else will come to light. There are many nurses having tried with every ounce of their knowledge and determination to keep patients alive while the PTB instruct which patients get to die, and how. It has often been stated from many sources, that HCQ @600mg daily + azithromyacin + zinc over a few days has been used safely in treating many C-19 patients. The HCQ half-life is about one month! ONE MONTH! The WHO had a consultant research HCQ toxicity in 1979, so then why the have the PTB designed a toxic protocol to treat C-19 patients in the 21st Century? To realize my proof, just search this name Didier Raoult, Ph.D and read what he has been trying to impress on the medical establishment about HCQ and C-19.

    All MSM news is paid for and controlled by big pharma, (as is what makes it to publication in some of the prized medical journals). Look closely at the MSM wording regarding the rising “related to coronavirus”, “complications of coronavirus”, etc. death tolls. I have not heard or read ever, through MSM that COVID-19 is the main cause of death to anyone.

    The only REAL problem here is that this C-19 was blown into some deadly “pandemic” that is only “cured” with some mercury, formaldehyde, aluminum, cow, monkey, pig, glyphosate, and only God knows what else, containing FORCED vaccine. Paraphrasing Maria Van Kerkhove Ph.D an American infectious disease epidemiologist from WHO saying recently, “we have become a vaccine dependent society”. Think on that for a minute. For thousands of years herd immunity worked just fine, even though some people did succumb to the illnesses. Maria Van Kerkhove is also the person forced (within 24hrs) to take back her revelation that it would be very rare for an asymptomatic person to be C-19 contagious.

    Now that Trump has pulled US funding out of WHO, Gates & Feinds are the largest financiers of this Mengala Medicine Model he wants to FORCE vax on everybody, and oh goody! RFID chipping is gratis. Not so long ago we all discussed that many of the computer tech/search, etc. companies and their getting involved in medical matters of all sorts, well, are you seeing the bigger picture yet? Have you noticed far more “eyes in the sky” after lockdown at places that had none before? Add in all of those temp monitoring devices and associated imaging. Don’t even get me started on the insanity of computer controlled vehicles and the impositions and/or rationing that it will cause on travel plans of every sort!
    Contact tracing for health protection! Riiight! Truthfully, we wanna know all about you and everyone else, too!
    Six feet apart for health protection! Riiight! We’re watching you from one of 34,000 Tesla launched satellites!
    Mask up for health protection! We wanna get those irises and pore patterns nice and clear! And just stop hogging up all of the oxygen, we’ve got fewer trees ya know!
    No sunshine for you! Keep off of the grass! Stock up on junk food! Don’t shake hands and never hug people!

    Illness is caused by a weak immune system. Hippocrates, remember him? The guy the oath is named after, he wisely stated centuries ago, “Let food be thy Medicine!”. Our soil has been ravaged to near worthless back before the 1930’s dust storm! Just eat the best healthy and/or organic food you can afford at least 90% of the time. Skip processed food and empty calories! Your tastebuds will adjust and you won’t want to eat the advertised crapfood. We are a perfect creation designed to survive on this planet. FACT — Viruses are created inside your own body and are no more contagious than dandruff! I promise, that is true. Go do your own research, while truth can still be found! Viruses in humans number in the tens of thousands and are normal and very necessary for us to function in this world. They don’t need killed because they are already dead!

    Someone in essence said, “Gates couldn’t keep viruses out of computers, so now he’ll try it with humans!”

  2. How many veterans have we destroyed to side effects? Most cause delusions paranoia and suicide

  3. While my wife was losing her battle with breast cancer, her uncle gave her some capsules of cannabis oil. I was 5 years deep in failed VA treatment so took one myself. About 30 minutes later I felt like I swallowed a hug. I wasn’t wasted, euphoric or stupid. I was simply comfortable. For the first time in years I could sit still, take a break from trying to outrun my own suicide.
    That was in California though. I’m in NJ now and despite my eligibility for the state’s MMJ program, my shrink can’t give me the recommendation needed because the VA is a federal agency.
    They would rather fill us with synthetic poisons for profit than grant us access to naturally occurring, truly effective, safer alternatives. So much for, “Do no harm”. Greedy, hypocritical cowards.
    These aren’t suicides, they’re passive/aggressive homicides.

  4. Ketamine infusions saved my life with chronic pain due to CRPS – Complex Regional Pain Syndrome and Fibromyalgia and PTSD.

    The VA does not want to do the cheap easy per se drug of $10/ 500mg! SPravato is only half the molecule of ketamine! Most need the whole drug ketamine not half of it called esketamine/Spravato, let alone in office treatment and must be on 1 if not 2 other pysch drugs to get Spravato.

    The only reason is ketamine is “an old drug” no money to made off it and “not worth doing new drug trails for either. Whereas, Spravato is a new drug high costs and money can be made on clinical trials etc!

    IV Ketamine for mental health is usually a “6-pack” for initial treatment then with once per month to every 6-weeks 1 treatment of IV or IM ketamine.

    IV Ketamine for chronic pain (CRPS, Fibro, Lyme pain, etc) has a loading dose in the 500mg over 4 hours average per outpatient setting from 3 to 10 days for true loading dose. Then having a booster on average for 3-days every 3-months to less or longer. Again these are basic averages.

    The following VAs have done or are still doing ketamine infusions for chronic pain and/or mental health reasons: (The VA will refuse to acknowledge to your US Senator or US Congressperson or heck or VA PCP! many times leaving he veteran to figure the maze out to get true help.
    Audry Murphy VAMC, San Antonio, Tx was the first nationwide to do ketamine infusions (the actually did the only known in a VA coma-induced ketamine infusion! around Sept 2010.)
    West Los Angelse, CA VAMC
    Baltimore VAMC’
    Philadelphia VAMC
    Pittsburgh VAMC
    Minneapolis VAMC
    Gainsville VAMC
    LAs VEgas VAMC
    San FRansico VAMC
    Tennessee Valley Healthcare System – Alvin C. York (Murfreesboro) Campus
    SEattle VAMC
    these are the ones I am aware of by other veterans telling me they get there IV Ketamine there.
    —–
    DoD Faculties (can be done via DoD/VA Sharing agreement) doing proper protocols for IV Ketamine especially for pain (most also do for mental health): Walter Reed NNMC, Bethesda, Md
    Ft Gordon, Army Medical Center, Ga
    Brooks Army Medical Center, San Antonio, Tx
    Portsmouth Naval Medical Center, Portsmouth, Va

    ————————–

    Ketamine has put my pain into basic remission for 2 years now after 34 years of severe chronic pain. Not everyone gets this result from ketamine but you/pone will never know without trying. The plus side for me is my PTSD is almost zero now from the ketamine infusions. I have to fight every time I am due for my infusions. I have to go to my US SEnator to get h the infusions. I have been sent all over the USA it seems as no VA that does ketamine infusions refuses to treat me. Oh that VA would have to pay my travel, lodging, and food bills which they will not.

    My VA is a rural even though it is a “VAMC” it only rates a one (1) CRNA! To properly do/have IV ketamine ideally would need an actual MD/DO Anesthesiologist . Sadly, at this time no one in my state even does ketamine no clinics no nothing so I have to travel be it me trying to get insurance to pay (sometimes yes other times ??) My travel is anywhere from 8 hours to 30 hours one-way for care. I bet if ketamine was in my local community for pain, and my VA Care in the Community Dr said ketamine my VA would not balk or VISN 23 PAin HQ for me either!

    When I was there last year , they (VISN23 Pain Mgmt) put in my records they did not like my ketamine Dr that I went to last under the VA care (been there 3 times now with the VA paying!)

    I had been following IV Ketamine for CRPS pain since 1999 when I first read about it. Until one of my best/favorite pain management Drs got trained for ketamine (though sadly not allowed to do proper dosages for pain, per base CO, hence I did not list her location.) Did I truly start going for finding a location and Dr who would do IV ketamine for me in 2009.

    I have lots of medical info and know where to get more for those truly interested in IV Ketamine.

    Basically, the VA is scared of actual IV Ketamine it is a cheap drug. True you need to be monitored, pulse ox, EKG, and blood pressure cuff while getting ketamine administered and O2 ready if pulse ox shows low saturation. Pain Mgmt does not like it in the VA it seems as it truly lowers our needs from opioids, and all the other drugs the VA throws at us vets to keep us drooling in a stooper

    I have been to a few places or seen via pictures you can have true privacy and still have 8 to 10 vets in the AM or PM getting ketamine infusions with minimal staff but still properly staffed for safety for all!

    IF the VA was truly concerned about suicide every VA would be doing IV ketamine! Let alone every ER in the USA VAs and others would have intra-nasal ketamine (not that half crap Spravato) in the ER for anyone presenting with suicidal ideations. There have been enough medical studies to date that shows within 1 hour of being given intra-nasal ketamine the thoughts of suicide stop! still need to be admitted for talk therapy stuff but the big part would at least stop!

    1. Fibromyalgia is a fraud. Arthritis and Fibro are cons by doctors. Science cannot and will not back up their con. They say it is Gout.

      Gout is what everyone suffers from to different degrees. Gout was discovered in the 1780s and 90s due to the patients suffering extreme pain especially in the joints and muscles. Gout is curable.

      Uric Acid is the culprit because it builds up and crystallizes especially in the joints more so in the toes, feet, ankles and knees. When it crystallizes it causes unbelievable pain.

      Have your Uric Acid checked.

      I cured my Gout. It was very bad and extremely painful. I do not have to take any pain medication at all ever. Mostly because I cured my debilitating migraine headaches and all headaches to include the dreaded ‘hang-over’ headache.

      I cured my herpes too.

      The v.a. is the absolute WORST health care in the world!

  5. just a thought has anyone thought of trying cannabis many tests done on this for depression and it is not lethal.

  6. You have to give credit to Johnson and Johnson. They bypassed the upper echelon VA minions and went straight to POTUS to expedite. Why bother lobbying those pesky VA administrators and pokey tools in Congress?

    Another fine example of Amerikan innovation.

    1. I read at the time about a surgeon in the second gulf war experimenting with small does of morphine as a diffusing method of counteracting all that adrenaline and it was showing results and of course discontinued.

  7. I think it is just as damaging to give this drug a bad rap right out of the gate but that is solely speaking of the drug not the inept way the VA uses it. I have followed this drug very closely even before approval because I know ketamine as an RN not a patient and it is a drug that can put you into another space and time. I think this drug is safer but transitioning is whole other thing that I have no experience with. In this case I do not think we are test subjects. Am I sticking up for the VA? someone slap me!

  8. I am a disabled Vet, female. I was assaulted a couple of times and sexually harassed . I was diagnosed with severe PTSD. I was too on pain medicine, due to chronic pain. I had a double fusion 10 years ago that didn’t come out that great. I was then given Percoset, and i watched my doses very carefully. I was addicted after being on them for several years. The VA, decided to take everyone off if them. I suffered greatly going through withdrawals. The VA, didn’t care, i tried talking to my new doctor and sat in the waiting room for 2 hours with my husband who was also a Veteran. He was a nurse also and very concerned, I talked to the advocate, and nothing, i talked to the Manager of the clinic, (civilian), and was rude and didn’t care. My chart was flagged i think. So, Veterans have been treated this way, I was in the medical field too. I was appalled at the treatment the Veterans received. I have sought out my own modalities for healing. I have a Psychologist i see for the last couple years. My husband recently died of Glioblastomas, brain cancer. He lasted 2 months. I found a horse ranch that helps Veterans. That was a blessing, and met many friends through this program. I got off pain meds myself, after PT, massage, acupuncture, chiropractic (gentle traction). I was going to a therapy pool with warm water, and that really helped. It takes a lot of time and therapy to become somewhat functional. Veterans need more access to these modalities. They may not even know about them. Karin

  9. ketamine works on the opioid receptors. It’s a bad option based on the va’s own research, vets and active duty are facing an omega3 deficiency and lipid deficiency which are derived from omega3s, the lipid (cannabinoids) production is also damaged/slowed by PTSD and TBI

    It’s no wonder the endocannabinoid system isn’t being taught in schools

  10. The mental health clinic in the Cheyenne v.a. is nonexistent. It was destroyed by one manager who was fired last year and replaced by someone who is just as inept or corrupt.

    1. Mental health treatment for me at the McGuire VA is virtually non existent. I filed several complaints with the VA and the White House. Unfortunately the White House forwarded my complaints back to the VA and I was told all of my concerns were lies. I then requested outside care. This was denied by the VA. Patient advocate never followed up with the denial. It’s been 15 months since I’ve seen a provider. My PMD is prescribing meds for me.

      1. The law states that they cannot deny you care. Contact a Senator and give that person as much information as you can about your dilemma. Quote the law. Title 38 of the United States Code or Code of Federal Regulations which basically states, ‘VA must offer the full range of needed medical care to which a patient is eligible under title 38 of the United States Code or Code of Federal Regulations.’

        I hope this helps.

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