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Post by Deleted on Jun 22, 2019 23:30:02 GMT -5
I just found out that I'm referenced in a New York Times article published yesterday by Benedict Carey.*
Carey was researching the VA's recent approval of Janssen's new proprietary intranasal Ketamine product for depression. The new Janssen drug will cost about $6,000 + per month. I wrote to Ben a few weeks ago to tell him that I had been prescribing intranasal Ketamine, off-label, for the past several years, at a cost of only $35 per month-- through a local compounding pharmacy in Denver. I was disappointed that the new FDA-approved Janssen product was so outrageously over priced!! Ketamine is a cheap anesthetic that has been around for years. I talked to Ben Carey for about half an hour last week, and never heard back from him. But his article was published in the NYT yesterday.
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Post by Walter on Jun 23, 2019 14:02:56 GMT -5
Dang, Willie...Way to go.
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Post by Deleted on Jun 23, 2019 15:04:25 GMT -5
Dang, Willie...Way to go. Benedict Carey has always been highly critical of Big Pharma-- something that he and I have in common. |
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Post by oujour76 on Jun 23, 2019 20:06:59 GMT -5
Dang, Willie...Way to go. Not a subscriber so couldn’t read it. |
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Full Season 2022 Douche Champion
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Post by Deleted on Jun 23, 2019 20:36:04 GMT -5
Dang, Willie...Way to go. Not a subscriber so couldn’t read it.
Here's a reprint.
Veterans Agency to Offer New Depression Drug, Despite Cost and Safety Concerns
The agency is struggling to contain rising rates of suicide among veterans.
by Benedict Carey and Jennifer Steinhauer
June 21, 2019
Confronted by a rising rate of suicides in some groups of veterans., the Department of Veterans Affairs on Friday decided to approve the use of a new and costly depression drug, despite concerns among doctors and other experts about the drug’s effectiveness.
The decision to endorse the drug — called Spravato, and manufactured by Janssen, a unit of Johnson & Johnson — came days after President Trump offered to negotiate a deal between the drug maker and the agency. Johnson & Johnson reportedly was working with associates at Trump’s Mar-a-Lago club, and the company has been supporting V.A. suicide-prevention efforts.
A spokesman for the V.A. said that the decision to approve the drug, which would cover its use by doctors in its nearly 1,000 clinics nationwide, was a medical one. In a statement, the agency said, “V.A. will closely monitor the use of esketamine” — the generic name for Spravato — “in veterans to more fully understand its relative safety and effectiveness as compared to other available treatments. Based on this information, V.A. may revise its clinical guidance” and the availability of the drug.
The V.A. stopped short of putting Spavato on its formulary, the list of drugs it requires to be carried in its 260 or so pharmacies. The approval enables V.A. doctors to offer the drug to patients they believe could benefit.
Some Congressional Democrats expressed concern at the fast approval process. “I am incredibly alarmed by reporting today that suggests Spravato, a controversial new drug, is being rushed through critical reviews and may be prescribed to veterans before fully vetting the potential risks and benefits,” said Mark Takano, Democrat of California and chairman of the House Committee on Veteran’s Affairs, in a prepared statement released Wednesday.
The top Republicans on the House and Senate Veteran’s Affairs committees said this week that they had yet to take a position on the issue.
The V.A. has rushed to distribute Spravato through its system ever since the Food and Drug Administration approved the drug, in March, for severe depression. The approval stirred excitement among doctors, because it represented a new direction in depression treatment: Spravato is a nasal-spray derived from an old and widely used anesthetic, ketamine, rather than an iteration of commonly used antidepressants like Prozac.
The spray contains esketamine, an active portion of the ketamine molecule, and the recommended course is twice a week, for four weeks, with boosters as needed, along with one of the commonly used oral antidepressants.
But psychiatrists, pharmacologists and suicide experts who have seen the data presented to the F.D.A. are far from persuaded that the drug will be a game-changing addition.
“It’s doing something, all right, but it’s not all it’s cracked up to be,” said Dr. Erick Turner, a former F.D.A. reviewer and an associate professor of psychiatry at Oregon Health & Science University. “I just don’t think it’s going to live up to all the hype.”
Cost is another issue. Janssen is charging the public from $4,720 to $6,785 for a course of treatment, and clinic costs will add more to the bill, not to mention monthly boosters, if needed. The V.A., not veterans, would foot the bill for whatever price it negotiates with Janssen. But nasal-spray formulations of generic ketamine are already cheaply available from compounding pharmacies, which mix individually tailored doses to order for doctors.
F.D.A. approval requires that people taking Spravato be monitored in a doctor’s office for at least two hours, and their experience entered in a registry. Like ketamine, the drug often causes out-of-body sensations and hallucinations. It is unclear how much of that cost insurers would cover.
The V.A. and the Department of Defense have been trying to reverse an alarming trend of suicide among veterans and members of the military since the late 2000s, when rates began to rise. Suicide rates in the V.A. system have been higher than in the general population for at least a decade, according to Robert Bossarte, an associate professor in the department of behavioral medicine at West Virginia University, in Morgantown. The overall veteran suicide rate decreased recently, from 30.5 per 100,000 in 2015 to to 30.1 per 100,000 in 2016, but longer-term trends are alarming in some groups. In 2015, the suicide rate for male veterans age 18 to 34 rose to 44 in 100,000 per year, from 25 in 100,000 in 2005.
“I’ve tried the generic ketamine nasal spray in about 20 patients with treatment-resistant depression, and a handful of them have done very well on it,” said Dr. William nWunderlich, a psychiatrist in private practice in Denver. Dr. nWunderlich had the patients take four or five doses over a month, making sure a friend or family member was present, given the disorienting effects. He had the spray made at a local compounder.
The development of Spravato followed a number of small studies over the past decade, which found that doses of the generic anesthetic ketamine could provide fast relief to some severely depressed people who hadn’t responded to other treatments. Generic ketamine has been available for years, at hundreds of clinics around the country; these provide a course of intravenous doses, at $400 to $500 a dose, usually a half dozen over a couple weeks with boosters as needed, for mood problems.
The V.A. is already running its own trials of IV ketamine for severe depression, and the agency could easily have the nasal spray made very cheaply, experts said. Ketamine and esketamine seem to have similar benefits and risks, although careful comparisons have not been done. For depression, esketamine has been studied far more rigorously than generic ketamine.
“It cost me $35 for five doses” of generic ketamine, said Dr. nWunderlich, who recently retired. “That’s $7 a dose. I don’t know why anyone would pay thousands of dollars, or whatever they’re charging, when you can get the generic spray for $7.”
“The V.A. has prioritized suicide prevention at every level, and it is in a unique position to address it in a way no one else can,” Dr. Bossarte said. “In this case, they could perform trials of this drug, so we can see who benefits and who has unintended reactions to fast-track studies, rather than have a blanket rollout policy” where everyone deemed at risk of suicide gets the drug.
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Post by daleko on Jun 23, 2019 20:53:48 GMT -5
Dang, Willie...Way to go. Benedict Carey has always been highly critical of Big Pharma-- something that he and I have in common. |
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THE BIGGEST DOUCHE OF THE FULL SEASON TOURNAMENT - 2021
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Post by Deleted on Jun 24, 2019 0:59:53 GMT -5
Benedict Carey has always been highly critical of Big Pharma-- something that he and I have in common. Daleko, I've never had anything bad to say about DOs. As for ketamine, it has been used for years as an anesthetic, but was only approved by the FDA for the treatment of depression this year. What bothers me is that the FDA has approved it (for depression) as an expensive proprietary product-- rendering it unaffordable for many Americans who could benefit from it. |
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Post by daleko on Jun 25, 2019 22:47:05 GMT -5
Perhaps DOs and MDs ought to get together instead of casting scorn at the one. DOs, like you, many times, don't have an issue with applying meds off application. Ldn for one. Daleko, I've never had anything bad to say about DOs. As for ketamine, it has been used for years as an anesthetic, but was only approved by the FDA for the treatment of depression this year. What bothers me is that the FDA has approved it (for depression) as an expensive proprietary product-- rendering it unaffordable for many Americans who could benefit from it.
Re the other I had a family sit that could have benefited and current studies seem to suggest would have benefited had a "Harvard edu" MD conversed w a "lowly edu DO, who happened to be a highly rated GI. But perhaps I'm just biased. |
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THE BIGGEST DOUCHE OF THE FULL SEASON TOURNAMENT - 2021
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Post by Deleted on Jun 27, 2019 21:37:04 GMT -5
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Post by Deleted on Jun 27, 2019 22:28:45 GMT -5
Mutt, Do you even read your own references? Geez... Schatzberg probably invested in IV ketamine clinics. I was prescribing intranasal ketamine for a few years, based on Zarate's original IV ketamine research, and some case reports from Mt. Sinai Hospital by a guy named Dennis Charney. In a "K-hole" people feel out-of-body for about 45 minutes. Big deal. My first patient to try it was a physician here in Denver who said that he felt like he was watching 2001-- A Space Odyssey. None of my patients experienced any serious side effects. |
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Post by Deleted on Jun 28, 2019 15:29:49 GMT -5
Mutt, Do you even read your own references? Geez... Schatzberg probably invested in IV ketamine clinics. I was prescribing intranasal ketamine for a few years, based on Zarate's original IV ketamine research, and some case reports from Mt. Sinai Hospital by a guy named Dennis Charney. In a "K-hole" people feel out-of-body for about 45 minutes. Big deal. My first patient to try it was a physician here in Denver who said that he felt like he was watching 2001-- A Space Odyssey. None of my patients experienced any serious side effects.
That's why we are in bad shape, now. Everyone wants to treat problems with DRUGS. Kid have behavior problems in school? Don't give him the spanking he needs .......... DRUG HIM OUT.
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Post by Deleted on Jun 28, 2019 17:03:33 GMT -5
Mutt, Do you even read your own references? Geez... Schatzberg probably invested in IV ketamine clinics. I was prescribing intranasal ketamine for a few years, based on Zarate's original IV ketamine research, and some case reports from Mt. Sinai Hospital by a guy named Dennis Charney. In a "K-hole" people feel out-of-body for about 45 minutes. Big deal. My first patient to try it was a physician here in Denver who said that he felt like he was watching 2001-- A Space Odyssey. None of my patients experienced any serious side effects.
That's why we are in bad shape, now. Everyone wants to treat problems with DRUGS. Kid have behavior problems in school? Don't give him the spanking he needs .......... DRUG HIM OUT.
Time for you to study the valid scientific research data on ADHD. In the case of ADHD, the problem isn't over-treatment, but under-treatment. Effective, appropriate treatment of true ADHD makes a YUGE difference in people's quality of life-- in educational, vocational, and social outcomes. It also reduces the incidence of accidents, traffic tickets, and even substance abuse. |
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Post by Deleted on Jun 28, 2019 17:12:13 GMT -5
So far.
That's why we are in bad shape, now. Everyone wants to treat problems with DRUGS. Kid have behavior problems in school? Don't give him the spanking he needs .......... DRUG HIM OUT.
Time for you to study the valid scientific research data on ADHD. In the case of ADHD, the problem isn't over-treatment, but under-treatment. Effective, appropriate treatment of true ADHD makes a YUGE difference in people's quality of life-- in educational, vocational, and social outcomes. It also reduces the incidence of accidents, traffic tickets, and even substance abuse. |
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Post by Deleted on Jun 28, 2019 17:49:25 GMT -5
Time for you to study the valid scientific research data on ADHD. In the case of ADHD, the problem isn't over-treatment, but under-treatment. Effective, appropriate treatment of true ADHD makes a YUGE difference in people's quality of life-- in educational, vocational, and social outcomes. It also reduces the incidence of accidents, traffic tickets, and even substance abuse. Appropriate pharmacologic treatment of ADHD is like giving the correct pair of eye glasses to a person with myopia. It's life-altering. The key is to prescribe the correct doses that correct the problem during a person's work day. I treated people (lawyers, execs, and even pharmacists) who went from almost getting fired to getting promoted, once their ADHD was treated correctly. |
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