Cash only

Outside of very rural areas, I’ve often scratched my head when advocates express concern about access to buprenorphine. I mean, there are a lot of prescribers in most areas.

I had a conversation yesterday that prompted a google search that led me to this. (OBT refers to office-based treatment with buprenorphine.)

Access to OBT in Ohio is far lower than what the 466 listed physicians suggests. Nearly 1 in 5 of those physicians are not active OBT prescribers, and 1 in 2 active prescribers do not accept insurance for OBT. Further research is needed to determine whether practices who do not accept insurance provide care consistent with CSAT guidelines and whether such practice patterns contribute to buprenorphine diversion. [emphasis mine]

50% of prescribers do not accept insurance? (And, Ohio’s a big state, which makes it a lot less likely that there’s a small ‘n’ that skews strangely.)

So what is going on? Why are so many prescribers not accepting insurance?

Since the introduction of office-based therapy (OBT), the number of eligible prescribers has increased from 9000 in 2006 to more than 20 000 in 2012, and the total sales of buprenorphine/naloxone have increased 10-fold to peak at $1.4 billion (28th best-selling prescription drug in the United States).13

Nationally, there is increasing concern that buprenorphine misuse and abuse are on the rise.14 Even the lay press is reporting on buprenorphine abuse.5,6 Concern is increasing over a pattern of excessive doses of buprenorphine being prescribed, either by design or because of exaggeration of withdrawal symptoms by the patients, enabling this abuse phenomenon. There is the obvious risk that physicians can charge high fees for office visits, whereas the patients can divert the excess medication.2,7,8 There is greater concern that practices who do not accept insurance for OBT and require direct payment from patients may be over-represented in this diversion phenomenon.5

This study is important because the news reports expressing concern about this are dismissed as unjustly disparaging, anecdotal, bourgeois stigmatizingfearmongering, and tragically discouraging legitimate prospective prescribers.

50%!

That is not a small problem. That’s not an anecdote. It’s a real story.

A quick search turns up a lot of stories in local media. Here, here and here are a few examples.

It’s striking that the national media is not covering this story when they are putting so much time and coverage into the opioid crisis.

There’s a lot of media and institutional pressure on non-maintenance treatment providers and mutual aid groups to change and integrate maintenance treatments and maintenance patients into their programming, residences, and groups. It’s appropriate to ask questions and encourage people/programs to interrogate themselves. That’s healthy. And, it’s important for us to remember that there are a lot of shady practices among non-maintenance providers.

However, it’s worth asking, why is there so little pressure on maintenance providers to provide recovery housing, social support, and other services to promote recovery and improve quality of life?

At any rate, this also helps shed some light on why there may be access issues when there are a lot of prescribers.

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U.S. joins lawsuits against manufacturers over drug Suboxone

Reckitt Benckiser and Invidor, the manufacturers of Suboxone are back in the news.

The Justice Department in filings last week in federal court in Abingdon, Virginia, said it was intervening in four separate whistleblower lawsuits related to the Britain-based companies’ marketing of Suboxone and the related drug Subutex.

. . .

Among the complaints unsealed on Aug. 2 was one filed by former Reckitt employee Ann Marie Williams.

Her 2013 lawsuit alleged the companies marketed unapproved dosages and uses of Suboxone and Subutex and claimed Reckitt made misleading claims to the U.S. Food and Drug Administration to obtain approval for a dissolvable film version of Suboxone.

You may recall that Reckitt’s rationale for switching to the film version was to protect children from accidental ingestion. This change occurred as Reckitt’s patent was about to expire. They also said that the film version would prevent misuse. They ended up getting a new patent for the film version and left a cloud of safety concerns over the new generic tablets coming to market.

One of the lawsuits alleges that the film actually poses an increased risk to children and is easier to misuse.

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Alternative endpoints

The FDA issued a new set of draft guidelines for pharmaceutical manufacturers the presents what has previously been referred to as “alternative endpoints.”

I posted about this in March. Here’s that previous post.

“alternative endpoints”? 

I caught a few minutes of the White House opioid summit yesterday and the phrase “alternative endpoints” caught my attention.

That’s Alex Azar speaking. He’s the Secretary of Health and Human Services.

Here’s what he said [emphasis mine]:

At the NGA (National Governors Association) we also highlighted two forthcoming Food and Drug Administration guidances that will expand and accelerate medication-assisted treatment. One of them will help the development of long-acting depot formulations like the monthly shot that was approved this past fall, and one that will open up new ways of assessing medically-assisted treatment effectiveness by looking at metrics besides just achieving abstinence, complete abstinence, so alternative endpoints.

I have two problems with that statement.

  1. The idea that complete abstinence is the metric for medically-assisted treatment (MAT) effectiveness is just not true. I reviewed some of the most frequently cited evidence for MAT here. Most studies don’t even report information on abstinence.MAT With Methadone or Buprenorphine Assessing the Evidence for Effectiveness – Addiction Treatment Forum
  2. I have no objection to measuring outcomes like reduced drug use, mortality, criminal activity, or disease transmission. Those are important public health outcomes. I also have no objection to providing treatments to patients who do not choose abstinence as a goal. However, these measures as endpoints for researchers and treatment providers? Creating systems focused on these as “endpoints”? If that’s what they are proposing, that’s neglect.

I do not know the contents of Secretary Azar’s mind and I do not claim to know his  motives. However, it’s important to be aware of his perspective. Here’s a portion of his bio:

From 2001 to 2007, Azar served at the U.S. Department of Health and Human Services – first as its General Counsel (2001–2005) and then as Deputy Secretary. During his time as Deputy Secretary, Azar was involved in improving the department’s operations; advancing its emergency preparedness and response capabilities as well as its global health affairs activities; and helping oversee the rollout of the Medicare Part D prescription drug program.

In 2007, Azar rejoined the private sector as senior vice president for corporate affairs and communications at Eli Lilly and Co. From 2012 to 2017, he served as president of Lilly USA LLC, the company’s largest affiliate.

That doesn’t mean he’s an evil Pharma shill, but it does say something about his worldview, his networks, and it may be considered a conflict of interests.

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😜 Recovering Addict

More here.

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Headlines that bother me

All three of these were in my inbox this morning from one list or another.

Recovery=missed work?

I don’t know anything about this guy, but I doubt he’s missing work because of his recovery. He may be missing work because of his addiction, or because of addiction treatment, or to get through a period of time with a high risk of relapse. That’s not missing work because of recovery.

Recovery is about a restoration of functioning in life domains like employment. People in recovery get better than well. This headline misses the point.

The limitations of “opioid recovery”

There’s actually nothing wrong with the article, though it’s doesn’t really say much about opioids or recovery. It does, however, illuminate some of the limitations of focusing on the particular drug in a drug crisis.

When we’re talking about people with opioid addictions (recognizing that not everyone with an opioid problem has an opioid addiction), we should focus on addiction recovery rather than opioid recovery.

Relapse is part of recovery?

Is a recurrence of cancer part of recovery from breast cancer? No.

Relapse is part of addiction. Relapse is not uncommon. Relapse does not have to spell doom (though the OD crisis makes it increasingly dangerous and scary). Relapse may teach us something that can help us stabilize and maintain recovery. Relapse should be met with support and compassion (rather than judgement and blame).

Relapse is not part of recovery.

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Headlines that make you go, “hmmmm”

I recognize that these are from two different countries but, really.
 

Invidor's shares soar 32% after US court blocks sale of rival generic (buprenorphine) "Implications of the buprenorphine shortage"

 

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Sentences to ponder

Food for thought from Keith Humphreys.

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