No matter how cynical you become . . .

No matter how cynical you become, it’s never enough to keep up.

—Lily Tomlin

From the Financial Times:

A billionaire pharmaceuticals executive who has been blamed for spurring the US opioid crisis stands to profit from the epidemic after he patented a new treatment for drug addicts.

Richard Sackler, whose family owns Purdue Pharma, the company behind the notorious painkiller OxyContin, was granted a patent earlier this year for a reformulation of a drug used to wean addicts off opioids.

The invention is a novel form of buprenorphine, a mild opiate that controls drug cravings, which is often given as a substitute to people hooked on heroin or opioid painkillers such as OxyContin.

This is like a conspiracy theory playing out in real life front of us. Oy.

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New study casts doubt about injection site effectiveness

UPDATE: looks like this study has been retracted. I’ll post more, when I know more about why.

UPDATE 2: German Lopez has an update here.

A new meta-analysis of research on supervised injection sites delivers some disappointing conclusions for advocates:

One of the aims of MSICs (Medically Supervised Injection Centres) is to reduce harms associated with injecting illicit drugs such as heroin under unhygienic conditions. The current research suggests that the extent to which these aims have been achieved are at best modest.

How can this be?

Here’s what the authors say:

How can these surprising and sometimes counter-intuitive results be explained? There are at least two potential explanations. First, MSICs have been found to attract the most problematic heroin users . . . Second, MSIC clients might remain part of local injecting subcultures. In other words, they might be obtaining the benefits of MSICs, while at the same time continuing to inject in public and semi-public environments. There is some evidence to support this assumption.

Why is this noteworthy?

Insite, North America’s first MSIC, was opened about 15 years ago.

Over that 15 years, the approach has enjoyed vigorous support from public health, harm reduction advocates, and drug policy experts. There’s been a steady stream of publications to support their effectiveness.

Observers who questioned their effectiveness or whether they were the best use of scarce resources were often met with dismissive responses about science, evidence, empiricism, compassion, and challenges to presumed moralizing impulses.

This reaction has only intensified, despite other potential explanations for reduced disease transmission rates, reasonable questions about whether other approaches might save more lives, acknowledged “slight” drops in mortality rates, the absence of a recovery orientation in the coverage, and increasing OD rates in the region. There’s also been little willingness to discuss their animating beliefs and assumptions.

Why the discrepancy with past studies?

Well, first off, maybe the rhetoric hasn’t matched the actual evidence. Their description of the evidence is more mixed and narrow than you’d expect from coverage:

The results of the current review have shown that MSICs tend to have either a small effect or no effect on outcomes. The findings of the three reviews and one meta-analysis reviewed in the introduction were also mixed. McNeil and Small (2014) concluded that MSICs were effective in minimising client exposure to risk environments. Potier et al. (2014) concluded that MSICs were effective in reducing harm and providing health benefits to clients. MacArthur et al. (2014) concluded that, at best, there was tentative evidence of MSICs reducing IRB, but little or no evidence of MSICs reducing HIV/HCV incidence. Finally, Milloy and Wood (2009) concluded that MSICs were effective in reducing syringe sharing.

German Lopez got reactions from various researchers and ended with this observation from Keith Humphreys:

“If you are an advocate, you could say correctly that if we assume these are effective, we do not have sufficient information to confidently overturn that presumption,” Humphreys said. “But it’s equally true if you took another view — just look at it as a cold, scientific question — you could say we also don’t have the evidence to overturn the presumption that these don’t make any difference.”

Advocacy

That word “advocate” is important. It’s worth stepping back and considering what they advocate for. They are advocating for a philosophy, an approach, and a program.

This gets lost in a lot of these discussions and they get framed as advocates for science, research, evidence, empiricism, and compassion. A problem is that this framing sets up questioners as opposed or indifferent to those things.

Turns out that hasn’t been fair.

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The treatment hustle behind the scenes

So, the other night I posted about cash-only buprenorphine practices.

The next morning I find this in my mail.

Consulting services to help establish turn-key buprenorphine clinics with cash revenue models that use toxicology services to generate revenue and provide aggressive risk management. (It’s worth noting that I also get emails about treatment valuation conferences/services several times a week. That’s not a typo. Treatment valuation, not evaluation.)

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Vaping draws strong support — from bots

Apparently, twitter-bots are targeting more than elections:

Social media accounts run by internet robots may be driving much of the discussion around the health threats posed by e-cigarettes, according to a study led by San Diego State University researchers, who also found most of the automated messages were positive toward vaping.

More than 70 percent of the tweets analyzed in the study appeared to have been put out by robots, also known as bots, whose use to influence public opinion and sell products while posing as real people is coming under increased scrutiny.

Who the heck cam up with the idea of researching robo-tweets about vaping? They stumbled upon it.

The discovery of the apparent bot promotion of vaping was unexpected. The team originally set out to use Twitter data to study the use and perceptions of e-cigarettes in the United States and to understand characteristics of users discussing e-cigarettes.

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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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