The controversial ketamine-like drug that Trump is pushing on veterans

[EleanorR]

Personal interest from Donald Trump appears to have put a controversial anti-depressant on a fast track at the Department of Veterans Affairs (VA) that shoved aside usual protocols, even though experts inside and outside the government have serious concerns the drug is effective and say it may be dangerous.

The discussion has revealed some unsettling issues:

The FDA abandoned a longstanding procedure of requiring two successful short-term trials before approving anti-depression drugs. Instead, when this drug showed itself to be no better than placebo in two of three short-term trials, the FDA accepted the third trial alone, adding on another and different type of trial that some say was deeply flawed. The FDA admitted it had not previously done this, but said it was not “unreasonable”. The FDA committee member Erick Turner of the Oregon Health and Science University, who did not make the advisory committee meeting, called the FDA’s position “bull”. “It’s not a reason,” he said. “That’s like a parent saying, “Because I said so.’”

The dangers of treatment – mainly dissociation, sleepiness and blood-pressure hikes – are so significant that patients must stay in the doctor’s office for two hours after receiving their Spravato infusion. The office must be equipped with equipment to deal with hallucinatory, cardiac and respiratory problems. The patient cannot drive for 24 hours after taking the drug. “A wonder drug? I think it’s a wonder that’s anybody thinks it’s a wonder drug,” said Diana Zuckerman, president of the National Center for Health Research in Washington DC.

The article also raises concerns about the involvement of trump's three Florida buddies who seem to be advising him on veteran's issues.

https://www.theguardian.com/us-news/2019/jun/17/spravato-ketamine-like-drug-that-experts-doubt-and-trump-is-pushing-on-veterans

[nykym]

1. Sounds like

another of his get rich schemes.

[ananda]

6. Yep. He must have a financial interest in it.

Gawd, when will all of this stupidity and atrocity end ???

[fescuerescue]

2. Another article of impeachment

Practicing medicine without a license.

Add it to the list and let Pelosi know.

[dhill926]

3. so who's making money off this shit...

jesus christ....

[babylonsister]

5. That's the big/only question. nt

[EleanorR]

7. From the Wiki page about Janssen and Johnson & Johnson

Juries in several US states have found that Janssen Pharmaceutical and its parent company Johnson & Johnson deceptively promoted the antipsychotic drug Risperdal (risperidone). By 2012, four states had been awarded damages, including Louisiana ($258 million in 2010), South Carolina ($327 million in 2011), Texas ($158 million in 2012), and most notably Arkansas ($1.2 billion in 2012) - whose Attorney General stated: “These two companies put profits before people, and they are rightfully being held responsible for their actions".[16]

In a related issue, Risperdal sales practices resulted in a 2012 provisional settlement totaling $2.3 billion.[17] The United States Department of Justice began investigating Risperdal sales practices in 2004, and in 2010 joined a whistleblowers suit alleging bribes paid to Omnicare, the largest company supplying pharmaceutical drugs to nursing homes.[18][19] The allegations include that Johnson & Johnson and Janssen were warned by the U.S. Food and Drug Administration (FDA) not to promote Risperdal as effective and safe for elderly patients when in fact it is associated with early death, but they did so; and that they in fact bribed Omnicare pharmacists tens of millions of dollars to promote the drug to care home physicians for this unapproved use. A settlement was provisionally agreed with Johnson & Johnson of around $2.2 billion for this and related allegations, with Omnicare having already settled for around $100 million.[17] Former head of sales and president of Janssen, Alex Gorsky, who the Dept of Justice say “was actively involved” in the fraud, nevertheless become the new CEO of Johnson & Johnson in 2012.[20]

[dhill926]

11. thanks for all this....

good god....

[EleanorR]

9. but after trump takes over, this happens-

In September 2017 it was announced that Janssen teamed up with the Biomedical Advanced Research and Development Authority (BARDA), a unit of the U.S. Department of Health and Human Services, to create pandemic flu vaccines. BARDA is giving Janssen $43 million in the first year and $273 million over five years for the contract. One of the projects in the contract is the development of a universal flu vaccine. The intent of the vaccine would be to protect people against all or most flu strains.[5]

[babylonsister]

4. Trance-like state, memory loss

Yea, that's the ticket.


Ketamine
From Wikipedia, the free encyclopedia


Ketamine is a medication mainly used for starting and maintaining anesthesia.[18] It induces a trance-like state while providing pain relief, sedation, and memory loss.[19] Other uses include for chronic pain, sedation in intensive care, and depression.[20][21][13][22] Heart function, breathing, and airway reflexes generally remain functional.[19] Effects typically begin within five minutes when given by injection and last up to about 25 minutes.[18][23]

https://en.wikipedia.org/wiki/Ketamine

[backtoblue]

8. From Spravato website.

snip.



SPRAVATO™ nasal spray was evaluated for safety in both short- and long-term clinical trials of adults diagnosed with treatment-resistant depression.
Do not take SPRAVATO™ if you have a blood vessel disease (aneurysm), an abnormal connection between your blood vessels (arteriovenous malformation), a history of bleeding in the brain or are allergic to esketamine, ketamine or any of the ingredients in SPRAVATO™. Talk to your doctor to learn more.

SPRAVATO™ Side Effects

Serious side effects include sedation, dissociation, abuse, increased risk of suicidal thoughts and actions, increased blood pressure, problems with thinking clearly and bladder problems. The most commonly observed side effects in adults taking SPRAVATO™ and an oral antidepressant for treatment‑resistant depression were:

Dissociation (41%)§


Dizziness (29%)


Nausea (28%)


Sedation (23%)‖


Spinning sensation (23%)


Reduced sense of touch and sensation (18%)


Anxiety (13%)


Lack of energy (11%)


Increased blood pressure (10%)


Vomiting (9%)


Feeling drunk (5%)

§Dissociation was reported in two ways in the clinical studies: through adverse event reports (41% of patients) and by using a standardized scale (61%–75% of patients).
‖Sedation was reported in two ways in the clinical studies: through adverse event reports (23% of patients) and by using a standardized scale (49%–61% of patients

https://www.spravato.com/what-is-spravato

[EleanorR]

10. There were 6 deaths during the long trials, 3 suicides

Zero in the placebo group.

[backtoblue]

12. Profits over human life

Profits over science.
Profits over people.

Corporate greed is sickening and I wish there was a pill/cure for greediness..

[dvan]

13. A friend of mine

recently told me he’s going to start administering these treatments. $500 per session, no insurance. He’s hoping to make a killing.

[MineralMan]

14. The web design company I work with recently turned down

a clinic that was about to open, offering ketamine treatments. I did some research into the drug and its side effects and efficacy, based on clinical trials. I recommended that we turn down the project, because nobody involved in the clinic was a physician. The web design company did turn it down. The clinic never opened. Probably we'd have never been paid for the project, either.

Sadly, there is some promise in this medication. It's poorly understood, so far, though, and not enough research has been completed yet, through larger studies. While ketamine therapy may turn out to be very useful for some, haphazard use of it, as that clinic was planning, does not seem like a good idea.

[blue neen]

15. You make some valid points.

Ketamine can be very useful for depression. For some people, it's the last hope. As you pointed out, however, skilled doctors need to be involved in its utilization.