Pharma gamesmanship in addiction

 

Reckitt Benckiser (Photo credit: Wikipedia)

Points offers a post summarizing the history of Suboxone up to the present.

Including the role of NIDA in helping Reckitt:

Reckitt brought Subutex and Suboxone to market with part of the costs of development absorbed by NIDA “to ease the burden to Reckitts” (Campbell and Lovell 2012: 135). They note that Reckitt had also obtained “orphan drug status” using the Cost Recovery principle “that the company risked not recuperating what it invested” given relatively high manufacturing costs, even though the size of the target market was greater than the 200,000 potential patients for so-called “orphan” drugs. This status resulted in seven years of patent exclusivity.

Their maneuvers to maintain control of the drug:

Ed Silverman, in an article at Forbes.com, noted that Reckitt was manipulating the cost of the tablet to encourage insurers to switch patients over to the film. According to his data, Reckitt raised the price of the bottle of 30 tablets from $140 to $1

61.70 for the 2 mg dose and from $252 to $289.80 for the 8 mg dose, while the film version cost $117.85 for 30 2 mg films and $211.15 for the 8 mg version. They also offered a $45 monthly subsidy (Bloomberg reported it as a “Coke-style coupon”) for a patient’s typical $50 co-pay for the film. Within six months of the introduction of the film, 40% of patients had been switched over to this new formulation, and by the end of 2012, it was 64%.

Hours after announcing their plan to take the tablets off the market, Reckitt announced in a press release that they had filed a “citizen’s petition” urging the FDA to “require all manufacturers of buprenorphine-containing products for the treatment of opioid dependence to implement national public health safeguards involving pediatric exposure educational campaigns and child resistant, unit-dosed packaging to reduce the risk of pediatric exposure.” They asked the FDA to reject any new drug applications for generic suboxone tablets.

And their future plans:

Reckitt continues to look for greener pastures, including trying to develop an injectable, long-acting depot version of buprenorphine (they also just hired a veteran of SAMSHA to help them navigate the federal regulations). Their story is testament to the new pharmaceutical economies built up around managing the poor and the sick. It also speaks to the booming business of addiction treatment and the increasingly larger part that Big Pharma wants to play in shaping and legislating notions of risk, safety, and public health. Would this situation have been possible if Reckitt had not been able to play on the unique cultural and moral attitudes that our country has towards drug addiction, such as the fear of children overdosing on drugs meant for drug addicts?

Related articles

• Reckitt loses bid to change US drug packaging rules (telegraph.co.uk)
• Generic drug makers get green light to make Reckitt’s heroin substitute (guardian.co.uk)
• Reckitt hurt as rivals steal heroin march (independent.co.uk)
• Reckitt Benckiser faces inquiry over move to block heroin substitutes (guardian.co.uk)

The “decline effect” hits naltrexone

Ritalin (Photo credit: Wikipedia)

The “decline effect” hits naltrexone.

Background

Oral naltrexone is an FDA-approved medication for treating alcohol use disorders. Although its efficacy has been supported in multiple clinical trials, an earlier review found that its effect sizes (ESs) on relapse to heavy drinking and, to a lesser extent, percent days drinking were smaller in more recent trials and in multicenter than in single-site studies. We examined whether these findings held when studies from 2004 to 2009 were taken into account, and whether single-site versus multicenter trials, the use of placebo run-in periods, and placebo group improvement accounted for variation in naltrexone effects and decreasing effects over time.

Methods

A multivariate meta-analysis of naltrexone pharmacotherapy trials for alcohol use disorders was conducted. All analyses simultaneously modeled ESs on outcomes of percent days abstinent and relapse to heavy drinking. Potential moderators of medication effects that were examined included publication year, multicenter design (vs. single site), placebo run-in period, and placebo group improvement.

Results

Statistically significant between-group differences on percent days abstinent (the inverse of percent days drinking) and relapse to heavy drinking favored naltrexone over placebo. Year of publication was a significant moderator for both outcomes, with more recent trials having smaller ESs. Neither multi- versus single-site study, the interaction between multi- versus single-site study and year of publication, nor placebo run-in period was a significant moderator of naltrexone effects. Although placebo group improvement was modestly associated with smaller between-group naltrexone versus placebo ESs, only 21 studies provided usable information on placebo group improvement. Within those studies, there was no relationship between naltrexone ESs and time, so placebo group improvement was not examined as a moderator of that relationship.

Conclusions

Naltrexone ESs have attenuated over time. Moderators that explain why effects have been decreasing remain to be determined.

The benefits of harm reduction are not as obvious as they seem

Warning: This Area Contains Tobacco Smoke (Photo credit: tbone_sandwich)

Theodore Dalrymple points out the inconsistency in the British Medical Journal’s vigorous advocacy for harm reduction where heroin is concerned and its squeamishness with harm reduction for nicotine. He pulls a passage from BMJ and inserts comments:

What, then, does the BMJ, so much in favour of harm reduction for heroin addicts, say about harm reduction for smokers?

A broad perspective suggests potential problems [from a public health perspective].

Firstly, the new nicotine containing products are not intuitively appealing; smokers will need to be persuaded of their benefits. For public health there is a key benefit: it is easier to use them than to   quit. Here I interject that the same is true of the methadone or other substitute for heroin. But for most smokers quitting is the best option and should be presented as achievable and attractive.

   So rolling out harm reduction puts public health in the contradictory position of having to emphasise both the difficulties and attractions of quitting. Why should harm reduction for heroin addiction be any different, one might ask? A related danger is that children will pick up on this apparent confusion. While previous generations were told simply that tobacco is bad, new ones would learn that nicotine is acceptable – just be careful how you access it. This is precisely the burden of public health “education” with regard to heroin and other drug addiction. Moreover, promotion of harm reduction might reduce the perceived “cost” of uptake. Would not the same effect apply to the medical treatment of drug addiction, to say nothing of the provision of free needles? Finally, the fact that e-cigarettes deliberately mimic conventional ones (even to emitting fake smoke) may result in the inadvertent modelling of smoking. Would not the prescription of injectable methadone not do the same? More broadly, the media, which in the UK have become a reliable supporter of comprehensive control measures, might also struggle with this more complex position. How much media effort, one is inclined to ask, ‘reliably’ goes into supporting ‘comprehensive control measures’ with regard to illicit drugs? Thus the benefits of harm reduction are not as obvious as they seem.

The article goes on to criticise harm reduction in tobacco because of the obvious, if not entirely consistent, commercial interests that the tobacco and pharmaceutical industries have in it.

I also recently saw this article on syringes that are muh less likely to transmit HIV.

… according to a new paper in the International Journal of Drug Policy, another option should be investigated: Distributing so-called “low-dead-space syringes,” which in laboratory settings have been show to dramatically reduce the likelihood of HIV transmission.

Dead space is the part of the syringe where fluid is retained once the plunger is fully depressed. High-dead-space syringes retain fluid both in the syringe itself and in the needle; low-dead-space syringes expel all the fluid in the syringe, retaining only a small amount of fluid. (In low-dead-space syringes, the needle is not detachable.)

In experiments that mimicked drug injections, the high-dead-space syringes retained 1,000 times as many microliters of blood, even after rinsing. For people carrying HIV with viral loads between one million copies and 2,000 copies per milliliter, the capacious syringes could carry multiple copies of HIV, “whereas,” William A. Zule and his coauthors write, “low-dead-space syringes would retain even a single copy only a fraction of the time.”

What’s interesting here, is that needle exchange advocates have been so busy arguing that they are the obvious answer to injection disease transmission on pragmatic and moral grounds, while insisting that there are no social costs (ignoring the fact that needle sharing persists among exchange users, discarded syringes are a problem, they often ignore treatment access problems and that they make convey despair to addicts and communities), that they seem to have never stopped to ask if we could make syringes safer.

These low-dead-space syringes in universal use might be much more effective than needle exchanges and prevent transmissions tough accidental pokes. If so, will they follow the evidence?

Related articles

• Even professional harm reduction workers have issues with tobacco harm reduction (smokles.wordpress.com)

Michigan’s medical marijuana business

Crain’s Detroit has an article on the state’s medical marijuana business from the grow side to the physicians. The article says that there have been 344,000 patient applications in the state since 2009 and that doctors often charge around $150 to certify patients, that’s $51,600,000 in revenue for the docs. Here’s a little from the article about one of them:

“I discovered the medical benefits of marijuana in 2007 when I was doing suboxone therapy for narcotics addiction,” said Townsend, who holds a bachelor’s degree in biological sciences from Michigan State University and a medical degree from the Southeastern College of Osteopathic Medicine in North Miami Beach, Fla.

“I began to notice that as I was weaning people off of narcotic pain medications, those that were using marijuana illegally, and then with medical marijuana cards after 2008, weaned very, very well.”

After seeing thousands of patients over the past five years, Townsend has concluded that marijuana has a deserved place in a doctor’s black bag.

“I discovered that people were coming off using handfuls of Vicodin a month — high doses of Vicodin every day — strictly through the use of medical marijuana,” said Townsend, who termed himself one of the biggest advocates for it in the state — but never has used it.

“It’s very good for the treatment of Crohn’s disease, excellent for nausea, very useful for treatment of glaucoma and Parkinson’s disease,” he said. “I’ve seen it stop a seizure in front of me.”

Of the approximately 30,000 active doctors in Michigan, only about 1,900 have written a single medical marijuana certification, Townsend said. When analyzed further a year ago, 55 doctors in Michigan wrote 70 percent of the certifications, with Townsend being in that group.

55 docs wrote 70%? Let’s see, 70% of $51.6 million is $36,120,000 and let’s divide that by 55 docs. That’s $656,727.27 per doc!

I wonder what other kinds of care they provide to these patients?

 

$2.2 billion invested in addiction treatment and behavioral health companies

 

photo credit: ntoper

Businessweek has a damning investigation of for-profit methadone treatment. And, who knew that Bain Capital is such a player?

Since Jan. 1, 2009, CRC’s clinics haven’t met staffing standards more than 50 times, regulatory records from 15 states show. Clinics were cited 80 times for failing to document that they gave patients enough counseling. In response, the company agreed to hire more, recruit more aggressively and increase supervision. Competition for qualified workers is intense, CRC said in its 2011 annual report.

CRC didn’t pay well enough to attract or keep experienced counselors, said Malaysia Williams, who worked at its clinic in Huntington, West Virginia, from June 2009 through March 2010. “Nobody stayed there,” she said. “It paid poorly.”

…

High turnover meant large caseloads, Williams said. Her initial caseload was 120, she said; about a quarter of those files were in disarray. Patients’ positive drug screens — which are supposed to result in their losing take-home privileges — fell through the cracks for some counselors as they struggled to keep pace, she said.

“When you have that much of a backlog it’s impossible to be on top of all the stuff,” she said.

Until recently, there was little difference between the operations of for-profit and non-profit methadone clinics, said Thomas D’Aunno, a professor of health policy and management at Columbia University who has tracked the treatment centers for years. That changed in 2011 survey data, which showed “significant differences,” he said: For-profit clinics had fewer staffers than public clinics.

As Williams struggled to catch up in Huntington, the clinic pushed its revenue up almost 8 percent to $5 million in 2010 — while expenses increased less than 1 percent to $2.6 million, according to state regulatory documents. That January, inspectors found that eight patients in a random sample of 13 hadn’t received the counseling they were supposed to. The company agreed to hire four full-time counselors and a supervisor, records show.

Inspectors reviewed six patients’ charts and found that three hadn’t met with a doctor in more than a year, according to the inspection report — though annual medical screenings are required. Clinic managers pledged to add hours for a doctor and a physician’s assistant, according to the report.

A November 2010 inspection found that nine out of 10 patients hadn’t met with a doctor in more than a year. In March 2011, 16 out of 25 hadn’t. In September 2011, two out of five new patients hadn’t met with a doctor or physician’s assistant weekly, as required, based on the state’s review of clinic records.

…

Nurtured by government spending, methadone clinics spread nationwide in the 1960s and ’70s until strapped state and local governments began decreasing their outlays. By 2010, for-profit providers controlled 52.8 percent of the 1,200 U.S. clinics.

Over the past seven years, private equity firms have invested more than $2.2 billion in substance-abuse treatment and behavioral health companies in 62 deals, according to PitchBook Data Inc., a Seattle-based research firm.

Addiction-treatment companies are “some of the most sought-after — and valuable — acquisition candidates in health care,” partly because of profit margins that can top 20 percent, according to the Braff Group, a Pittsburgh-based mergers and acquisitions advisory firm.

In fairness, there’s a lot of shady drug-free treatment providers too. I’m on the inside of the drug-free treatment world, but it’s my impression that there problems are much more endemic to the methadone treatment world.

Read the whole thing here.

 

 

Related articles

• Drug Users Turn Death Dealers as Methadone From Bain Hits Street (bloomberg.com)
• Two-year methadone treatment cap, quietly passed in DHHS supplemental budget, starts Jan. 1 (bangordailynews.com)
• Methadone clinic doctor faces hearing over allegations of misconduct (updatednews.ca)
• Methadonia (addictionandrecoverynews.wordpress.com)

Sentences to ponder

“My best advice to clinicians, to the press, and to the general public—be skeptical and don’t follow DSM-5 blindly down a road likely to lead to massive over-diagnosis and harmful over-medication.” –Allen Frances, Chair of the DSM-IV Task Force

Methadonia

When Methadonia was first released, there was quite a bit of hand wringing over whether the film inaccurately presented methadone maintenance treatment in a negative light.

Cassie Rodenberg, at The White Noise, who has been spending time with and blogging about homeless addicts in the Bronx says [emphasis mine]:

Some on the streets find methadone worse than an original heroin addiction, while others find the maintenance system workable. The documentary “Methadonia” interviews those in NYC recovery. For those curious, this is the closest thing I’ve seen to those I speak with every day, an accurate portrayal of life for low-income residents struggling with heroin addiction and recovery. Take a look for the stories.

What’s interesting is that anyone who’s spent time around heroin addiction has seen what we see in Methadonia, yet advocates insist it is not the reality of methadone. Yet, the reality they discuss is invisible to us. If we’re to believe them, it has to be on faith.

Related articles

• Watch “Methadonia,” Doc Film on Heroin and Poverty (blogs.scientificamerican.com)
• Recovery advocates argue… (addictionandrecoverynews.wordpress.com)

Dead addicts don’t recover, but…

Naloxone (Photo credit: intropin)

This has gotten a lot of press. There’s naloxone distribution doubt this will reduce overdose deaths. However, some pretty important questions remain:

• What happens after the overdose?
• What services/interventions might have prevented the overdose in the first place?

The article references placing defibrillators in public places. What happens after someone is saved by one of those defibrillators? An ambulance comes and takes them to receive treatment. (Often treatment that costs tens of thousands of dollars.)

0 = Number of times the word “treatment/treat/treatable” appears in the article

0 = Number of times the word “recovery/recover” appears in the article

So … dead addict don’t recover, but why do we seem to care so little about treating what nearly killed the patient?

Number one cause of death among the homeless

Homeless man in Anchorage, Alaska (Photo credit: Wikipedia)

 

Wow.

 

Overdoses of drugs, particularly prescription painkillers and heroin, have overtaken AIDS to become the leading cause of death of homeless adults, according to a study of homeless residents of Boston released on Monday.

The finding came from a five-year study of homeless adults who received treatment from the Boston Health Care for the Homeless Program, though its broad conclusions apply to homeless populations in many urban parts of the United States, the study’s author and homeless advocates said.

The tripling in the rate of death by drug overdose reflects an overall rise in pain-killer abuse, said Dr. Travis Baggett of Massachusetts General Hospital, the lead author of the study, to be published next month in the journal JAMA Internal Medicine.

“This trend is happening across the country, in non-homeless populations too,” Baggett said. “Homeless people tend to experience in a magnified way the health issues that are going on the general population.”

The study, which tracked 28,033 homeless adults from 2003 through 2008, found that of the 17 percent who died during the study period died of drug overdoses while 6 percent died of causes related to HIV, the virus that causes AIDS.

 

Related articles

• Drug Overdose Is Now Leading Cause Of Death Among Homeless (medicalnewstoday.com)
• Drug Overdoses Top AIDS As Main Cause of Homeless Deaths (nlm.nih.gov)
• Drug Overdoses Are Now Leading Killer Of Boston’s Homeless (wbur.org)
• Overdoses No. 1 cause of death among homeless (triblive.com)
• Drug overdose now the leading cause of death among homeless adults in Boston (eurekalert.org)

 

Recovery advocates argue…

The NY Times has a story on a jail terminating methadone maintenance for inmates. There have been a lot of stories like this over the years. Nothing new.

What grated me about the article was this line:

Recovery advocates and community members argue that cutting people off from methadone is too dangerous, akin to taking insulin from a diabetic.

I don’t expect newspapers to pick up and convey the nuances of the diversity of thought within the recovering community. They do the same thing with all sorts of other movements. I’m sure I’ve heard sentences like, ”civil rights activists argue…”, a million times.

Now, because someone identifying themselves as a recovery advocate criticized the policy, the casual reader will have the impression that the rest of us identified with the recovery movement share this position. Grrr.