Who Killed Prince?: Update – Buprenorphine Implant Approved by FDA

FDA Approves Titan Implant - photo: Titan

FDA Approves Titan Implant – photo: Titan

The FDA has finally approved Titan Pharmaceutical’s buprenorphine implant after years of unnecessary delay, letting doctors have another useful weapon in treating opioid addiction. The background is here:
Who Killed Prince? Restrictions on Buprenorphine.

The implant provides a smooth low level of buprenorphine sufficient to relieve opioid cravings, but not enough to degrade mental functions; patients on the implant testify that, unlike opioids or pill forms of buprenorphine, it makes them feel normal so they can function in their daily lives.

The Reuters story mentions the neo-Puritan objections:

The first-ever implant to fight addiction to opioids, a class of drugs that includes prescription painkillers and heroin, was approved by the U.S. Food and Drug Administration on Thursday. The matchstick-sized implant, developed by Titan Pharmaceuticals Inc and privately owned Braeburn Pharmaceuticals, is by design less susceptible to abuse or the illicit resale that plagues existing oral therapies. Fewer than half of the estimated 2.2 million Americans who need treatment for opioid abuse are receiving help, according to the U.S. Centers for Human and Health Services (HHS).

Currently, two drugs are predominantly used to treat opioid addiction — methadone, which is dispensed only in government-endorsed clinics, and the less-addictive buprenorphine, which exists as a pill or strip of film. While effective, a pill or film may be lost, forgotten or stolen. Evidence suggests that the use of these medicines as part of the overall treatment program are more effective than short-term detoxification programs aimed at abstinence, the FDA said on Thursday….

“I intend to make this the most successful implant that’s ever been marketed … and I think it’s absolutely possible given the unmet need,” Braeburn Chief Executive Behshad Sheldon said in an interview ahead of the FDA decision.

However, some doctors are concerned that the implant may incentivise patients to rely solely on medication, and ignore the lifestyle changes they need to make.

This is the neo-Puritan impulse — if you lack the ability to get off entirely, you should just suffer and die because you don’t deserve a normal life. Addiction is not a “lifestyle choice,” it’s an addiction, and those prone to addiction are generally going to be addicted to something, or many things — the goal of treatment should be to move the addict to habits which don’t interfere with leading a productive and satisfying life. I am, for example, addicted to coffee, working out, eating well, and getting a good night’s sleep…

Since it’s an implant, if it isn’t replaced after six months the patient will taper off the drug fairly slowly, and it might well be easy enough to go off it completely as a result. But even if viewed as permanent maintenance, it is much better for the patient and society than allowing the peaks and valleys of opioid addiction to wreck the patient’s life and possibly kill them.

We are also seeing these perfectionists in the current effort to outlaw vaping, which is one of the best ways to get smokers off the much more damaging cigarette smoking habit — see FDA Wants More Lung Cancer.

The implant has a bright future now. Too bad tens of thousands of people died without treatment in the three years the FDA delayed it. The Reuters story continues:

Braeburn estimated the U.S. market for opioid addiction treatments at about $2 billion, excluding methadone and Vivitrol, Alkermes Plc’s treatment for the prevention of relapse after opioid detoxification.

CEO Sheldon declined to specify a price for the implant on Thursday, but said it would be substantially cheaper than Vivitrol. “We are hoping that our first patient will have received the implant by the first day of summer or June 21,” she added.

The market for long-acting therapies such as Probuphine could be even larger if attempts to raise the limit on the number of opioid addicts a doctor can treat are successful. Under the current law, a doctor can treat only 30 opioid addicts within a year of obtaining a waiver, rising to a maximum 100 after procurement of a second waiver. The Congress and the HHS are working toward increasing this limit. Of particular interest is a proposal that exempts from the patient limit any treatment directly administered by a physician, such as an implant or injection.

UPDATED 2 JUNE 2016:

The preliminary autopsy report has been released showing cause of death as an overdose of Fentanyl, an opioid stronger than morphine or heroin. The report is minimal and gives no hint of what investigators might have found or what legal actions Prince’s doctors may face.


Death by HR: How Affirmative Action Cripples OrganizationsDeath by HR: How Affirmative Action Cripples Organizations

[From Death by HR: How Affirmative Action Cripples Organizations,  available now in Kindle and trade paperback.]

The first review is in: by Elmer T. Jones, author of The Employment Game. Here’s the condensed version; view the entire review here.

Corporate HR Scrambles to Halt Publication of “Death by HR”

Nobody gets a job through HR. The purpose of HR is to protect their parent organization against lawsuits for running afoul of the government’s diversity extortion bureaus. HR kills companies by blanketing industry with onerous gender and race labor compliance rules and forcing companies to hire useless HR staff to process the associated paperwork… a tour de force… carefully explains to CEOs how HR poisons their companies and what steps they may take to marginalize this threat… It is time to turn the tide against this madness, and Death by HR is an important research tool… All CEOs should read this book. If you are a mere worker drone but care about your company, you should forward an anonymous copy to him.

 


More reading on other topics:

Update on: Who Killed Prince? Restrictions on Buprenorphine
Death by HR: EEOC Incompetence and the Coming Idiocracy
Regulation Strangling Innovation: Planes, Trains, and Hyperloop
Captain America and Progressive Infantilization
The Great Progressive Stagnation vs. Dynamism
FDA Wants More Lung Cancer
Corrupt Feedback Loops: Public Employee Unions
Jane Jacobs’ Monstrous Hybrids: Guardians vs Commerce
Death by HR: How Affirmative Action is Crippling America
Death by HR: The End of Merit in Civil Service
Death by HR: History and Practice of Affirmative Action and the EEOC
Civil Service: Woodrow Wilson’s Progressive Dream
Bootleggers and Baptists
Corrupt Feedback Loops: Justice Dept. Extortion
Corrupt Feedback Loops, Goldman Sachs: More Justice Dept. Extortion
Death by HR: The Birth and Evolution of the HR Department
Death by HR: The Simple Model of Project Labor
Levellers and Redistributionists: The Feudal Underpinnings of Socialism
Sons of Liberty vs. National Front
Trump World: Looking Backward
Minimum Wage: The Parable of the Ladder
Selective Outrage
Culture Wars: Co-Existence Through Limited Government
Social Justice Warriors, Jihadists, and Neo-Nazis: Constructed Identities
Tuitions Inflated, Product Degraded, Student Debts Unsustainable
The Morality of Glamour

On Affirmative Action and Social Policy:

Affirmative Action: Chinese, Indian-Origin Citizens in Malaysia Oppressed
Affirmative Action: Caste Reservation in India
Diversity Hires: Pressure on High Tech<a
Title IX Totalitarianism is Gender-Neutral
Public Schools in Poor Districts: For Control Not Education
Real-Life “Hunger Games”: Soft Oppression Destroys the Poor
The Social Decay of Black Neighborhoods (And Yours!)
Child Welfare Ideas: Every Child Gets a Government Guardian!
“Income Inequality” Propaganda is Just Disguised Materialism

The greatest hits from SubstrateWars.com (Science Fiction topics):

Fear is the Mindkiller
Mirror Neurons and Irene Gallo
YA Dystopias vs Heinlein et al: Social Justice Warriors Strike Again
Selective Outrage
Sons of Liberty vs. National Front
“Tomorrowland”: Tragic Misfire
The Death of “Wired”: Hugo Awards Edition
Hugos, Sad Puppies 3, and Direct Knowledge
Selective Outrage and Angry Tribes
Men of Honor vs Victim Culture
SFF, Hugos, Curating the Best
“Why Aren’t There More Women Futurists?”
Science Fiction Fandom and SJW warfare

More reading on the military:

US Military: From No Standing Armies to Permanent Global Power
US Military: The Desegration Experience
The VA Scandals: Death by Bureaucracy

2 comments

  1. I use the buprenorphine patch for chronic pain due to ankylosing spondylitis. Prior to that, I was taking 135 mg of morphine per day. One day in March 2012, I had enough of the dullness the morphine brought into my life – it had been seven years at that point – and quit cold turkey. A shivering and shaking five days later, I met my pain clinic doc, and scared him with what I had done. I was too far along with the withdrawal for medical intervention at that point. So, with the addition of an intense anti-inflammatory drug called meloxicam, and an average 5 mg of hydrocodone per week, I lived the next year with a relatively clear head. Then, the anti-inflammatories started tearing up my gut, and it was no longer possible for me to take them in any form. And that’s when my pain doc introduced me to the Butrans patch.
    Once a week, I put a different patch on my back. I handle break-through pain by up to three 10 mg hydrocodone tablets per day. I more-or-less have my life back, and the idea that ANY combination of government drones and drug company interest would deny me a less destructive choice of pain relief for MONEY? That is …words fail me. And that doesn’t happen often.

    Like

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