Suboxone Maker Indicted for Fraud and Racketeering

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drusso

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"Prosecutors now say the company knew the dissolvable film version of Suboxone was potentially more dangerous, more susceptible to abuse, and included a higher risk that children might be exposed to the drug. The firm also developed a program that allegedly connected opioid-dependent patients with doctors who prescribed Suboxone "in high doses and in suspect circumstances."

Many Suboxone "cheerleaders" are likely to get caught up in this and have their reputations on the line.
 
Thankfully I am not one of them. I wonder if we will have a buprenorphine epidemic in a few years.
 
Thankfully I am not one of them. I wonder if we will have a buprenorphine epidemic in a few years.

I knew .something was up when the Indivior rep pulled up to the office in an Escalade...

Other clues, hospitals/health systems employing Suboxone doctors and paying them 50%tile IPM for basically NP level E&M work. Most of these guys never touched a Quincke or a Trochar but were pulling in BC fellowship-trained IPM salaries...cross-subsidized by SOSdf and ancillary service line revenue. Then, IRS documents show Kolodny is making almost half-million per year working for a NON-PROFIT addiction center. Money doesn't grow trees...

I worry about how the relationships between buprenorphine thought leaders and the 2016 CDC Guidelines Core Expert Group were vetted and about the trust factor in the whole arrangement in terms of COI and ideological biases.


"In 2016, while working for Phoenix House, Kolodny made $463,000. (That doesn't include his Brandeis University salary.)"

I can't think of a good defense of any of it.
 
Article from ACSH....

Who do you think they get support from?

The data out there - from Europe- still suggests that buprenorphine is safer than heroin or illicit fentanyl.

There is no justification for supporting big Pharma that abuses the system.

But don’t conflate the use of buprenorphine with the company.

You are still prescribing oxycodone, hydrocodone, morphine, hydromorphobe, oxymorphone, right? Each of those chemicals have had unscrupulous companies associated with them....
 
Article from ACSH....

Who do you think they get support from?

The data out there - from Europe- still suggests that buprenorphine is safer than heroin or illicit fentanyl.

There is no justification for supporting big Pharma that abuses the system.

But don’t conflate the use of buprenorphine with the company.

You are still prescribing oxycodone, hydrocodone, morphine, hydromorphobe, oxymorphone, right? Each of those chemicals have had unscrupulous companies associated with them....

This is not a political matter. Everyone is entitled to a point of view. This is about ideological & financial COI, fraud, and maintaining the public trust.
 
With regards to Indivior. Not with regards to buprenorphine.

The feds are not saying that buprenorphine doesn’t work.

Read the filing. The issue involves how suboxone film was marketed.
 
As the above poster mentioned, this suit isn't about the efficacy of buprenorphine. It's about Indivior's claim that films are safer and less prone to abuse than other forms of the medication. And this isn't new news:


Nobody should blindly trust a drug company and if there's merit to the indictment than Indivior should pay through the nose. From my view as an ED doc, the patients I see who are prescribed buprenorphine tend to be significantly more functional and productive members of society (ie employed) compared to those on methadone or not getting any treatment. The former group rarely comes into my ED for addiction-related issues (overdoses, skin/soft tissues infections, being brought in by police for a screening exam on their way to jail for robbery etc) while I see plenty of addiction-related issues in the latter two groups.
 
As the above poster mentioned, this suit isn't about the efficacy of buprenorphine. It's about Indivior's claim that films are safer and less prone to abuse than other forms of the medication. And this isn't new news:


Nobody should blindly trust a drug company and if there's merit to the indictment than Indivior should pay through the nose. From my view as an ED doc, the patients I see who are prescribed buprenorphine tend to be significantly more functional and productive members of society (ie employed) compared to those on methadone or not getting any treatment. The former group rarely comes into my ED for addiction-related issues (overdoses, skin/soft tissues infections, being brought in by police for a screening exam on their way to jail for robbery etc) while I see plenty of addiction-related issues in the latter two groups.

Indivor (the maker of Suboxone) has been paying off high-profile addiction specialists playing politics with opioid addiction and chronic pain treatments for a long time. They've abused the regulatory process by taking advantage of the Orphan Drug Tax Credit claiming that OUD is a "rare disorder." If you don't follow the inside baseball of the "opioid wars" you don't realize how much $$ is on the line with this issue.


"Subutex, an earlier Indivior UAD drug, received an Orphan Drug Designation under that exception, according to the Braeburn petition, and the 'grandfathered' the Subutex's designation to Sublocade without a review of the data because both product have the same developer.
Braeburn argues "extraordinary changes" occurred in the opioid abuse disorder following the enactment of the Drug Addiction Treatment Act in 2000. The act, the company said, resulted in an enormous expansion of the use of Subutex, resulting in hundreds of millions of dollars of sales."


So, let's recap: 1) Paying off high-profile addiction specialists/thought-leaders to create urgency about an opioid epidemic; 2) Fraudulent marketing; 3) Abusing tax credits for treatments for "rare diseases" to promote access to blockbuster drugs for common disorders.
 
1. i am not arguing that Indivior is a great ethical company. they are not.

I don't think I have ever typed any Big Pharma and the term "ethical" without "NOT" in between the two (except now 😎 )


2. you keep telling us how bad Indivior is. I Agree.

but please don't imply is that suboxone therapy is bad. with that, I disagree.


3. finally, you brought up Kolodny. you used a biased source for as support; I am only calling you out on the fact that ASCH is biased, that the criticism of Kolodny is industry sponsored. in essence, as bad as Indivior.
 
1. i am not arguing that Indivior is a great ethical company. they are not.

I don't think I have ever typed any Big Pharma and the term "ethical" without "NOT" in between the two (except now 😎 )


2. you keep telling us how bad Indivior is. I Agree.

but please don't imply is that suboxone therapy is bad. with that, I disagree.


3. finally, you brought up Kolodny. you used a biased source for as support; I am only calling you out on the fact that ASCH is biased, that the criticism of Kolodny is industry sponsored. in essence, as bad as Indivior.


No actual truth exists in your world. Smh. Stop prescribing heroin pills.
 
So, let's recap: 1) Paying off high-profile addiction specialists/thought-leaders to create urgency about an opioid epidemic; 2) Fraudulent marketing; 3) Abusing tax credits for treatments for "rare diseases" to promote access to blockbuster drugs for common disorders.

I think we agree on your 2nd and 3rd points here, but I'm confused about your first one. Are you saying you don't think there's a significant OUD problem in this country? Or are you saying something different?
 
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