Archive for the ‘Buprenorphine’ Category

The Opioid Lawsuits

 

 

 

 

Around twenty-seven hundred plaintiffs, composed of states, counties, and cities, have joined the lawsuit against drug manufacturers, distributors, and some pharmacy chains. Their lawsuit alleges these companies acted illegally and contributed to the opioid epidemic. Last month, some of the organizations being sued offered a common-sense solution that would benefit people with opioid use disorder. [1]

The actual lawsuit is similar to lawsuits against Purdue Pharma, manufacturer of OxyContin. Purdue filed for bankruptcy in September of 2019, offering a settlement to twenty-five hundred or so plaintiffs which included states, cities, counties, and tribes. The proposed settlement, announced in September of 2019, totaled around $12 billion, with $3 billion coming from the Sackler family directly.

Proponents of the Purdue Pharma settlements say it avoids wasting time and money on protracted litigation, which usually provides maximum benefits to the the lawyers on each side, rather than the plaintiffs. A quick settlement also – in theory – makes money available more quickly to people suffering from the opioid epidemic.

On the other side, some lawyers point out this money won’t be enough to cover the damage caused by the opioid epidemic. Some doubt that those who need it will receive much of the $12 billion. They also object to the fraction paid by the Sackler family, owners of Purdue Pharma, made rich by the sales of OxyContin over the years. The settlement, as it stands now, has no provision for admission of guilt by the pharmaceutical company, which does not sit well with some of the plaintiffs.

Both sides make good points. However, I don’t think there’s a settlement large enough to cover all the damages caused by the opioid epidemic, so that’s not a realistic demand. Deciding who benefits from a settlement needs to be determined by representatives of the plaintiffs, not the defendants.

But now last month, a group of pharmaceutical companies, drug distributors, and pharmacy chains proposed a settlement of the lawsuit being brought by states, counties, and cities across the nation. Teva Pharmaceutical, Johnson& Johnson, McKesson, Amerisource Bergen, and Cardinal Health. and announced recently a proposed settlement amounting to $23 billion including some interesting provisions.

Teva, an Israeli company, agreed to provide their part of the settlement of the lawsuit in the form of generic buprenorphine/naloxone tablets to treat opioid use disorder. They would also pay $250 million over ten years. They claim to be capable of providing all the treatment medication needed by patients in the U.S., after a few years to ramp up production.

The drug distributors agreed to distribute this medication for free, which would allow patients access the treatment medication for next to nothing except a small dispensing fee from the pharmacy, which might also be waived by the lawsuit agreement.

The common sense of this settlement is astounding. This settlement would directly benefit the people who need it most. That’s always a challenge in this sort of lawsuit; even when money is won, distribution of the money can be contentious. I’m sure we all could imagine ways the money could be mis-managed and end up in pockets of people who haven’t been extremely affected by the opioid epidemic. But the people who developed opioid use disorder – they deserve help accessing treatment.

Medication-assisted treatment is the gold standard of treatment for opioid use disorder, so this settlement idea is based in good science and supported by tons of literature. Besides the reduction in overdose death seen in treatment with methadone and/or buprenorphine, medication to treat opioid use disorder is also associated with better physical health, lower rates of crime, lower suicide rates, and higher employment rates.

This settlement makes sure an evidence-based treatment gets funded, instead of over-used treatments that are outdated and ineffective, such as detoxification episodes. The relapse rates for patients with opioid use disorder are greater than 90% with detoxification, yet we see patients cycle in and out of detox, over and over. Detox alone also increases the risk of death. After patients leave detox, tolerance for opioids is reduced, creating a dangerous risk for overdose death when the relapse does happen. Can you think of any other treatment in the field of medicine that increases the risk of death, yet remains standard practice in many communities? If you did a procedure or prescribed a medication that increased the risk of death to people with diabetes, malpractice lawsuits would sprout all over the place.

Not so with the treatment of opioid use disorder.

Teva has made a common sense offer that allows them to do what they do best – make pharmaceuticals – in order to help people with opioid use disorder. The distributors would do what they do best – distribute – in order to help people with opioid use disorder.

Rarely in civil litigation do we see such meaningful settlements with the potential to help the people who suffer most from corporate wrongdoing. This could be a great example of corporate amends…when you break something, do your best to fix it.

Also, this solution would allow Teva and other pharmaceutical companies and distributors to stay in business. Demanding an unreasonable payday might push these big companies to declare bankruptcy and go out of business. These companies provide employment for people and provide services to our nation. We need them to stay in business, while still acknowledging the harm they did and taking financial responsibility for helping clean up the mess

Only the combination product would be donated. This means patients who are prescribed the monoproduct purely for economic reasons could be switched to the less-divertible combination product. That would be wonderful for facilities like the opioid treatment program where I work. Right now, our OTP buys monoproduct because it’s the cheapest form of buprenorphine on the market. Since we do directly observed dosing, diversion is less of an issue, though still an issue. With this sort of agreement, we would switch to the combination product, since not only would the combo product be less expensive, but it would be free.

What would this mean for opioid treatment programs? I’m not sure, but if OTPs could obtain buprenorphine/naloxone treatment medication for free, there should be a corresponding drop in treatment fees. Perhaps instead of a patient having to pay $15 per day for buprenorphine 16mg, they might pay less than $8 per day. I don’t know how much our OTPs pay per pill now, so I’m estimating. I do know that a bigger chunk of what OTP patients pay each day goes to medication costs with buprenorphine, compared to patients on methadone.

For patients who dose at OTPs who are now covered by the recent SORs and CURES grants, that’s money that could be saved, and spread farther to cover more patients. It’s a direct benefit to the taxpayers.

Some patients now on methadone for the treatment of opioid use disorder would switch to buprenorphine/naloxone if it were cheaper. At the opioid treatment program, some patients start methadone because it costs about three dollars per day less than buprenorphine. Again, it doesn’t sound like much of a cost savings, but $3 per day adds up over time. With this proposal, choosing buprenorphine/naloxone would be the cheapest (and often safest) option for treatment.

Of course, there are nay-sayers regarding the settlement. Already, I found online articles complaining that the $23 billion was based on Teva’s retail price for the medication and not their cost of producing the medication.

I suspect lawyers representing plaintiffs won’t be happy about the settlement. If they take cases like this on contingency fees, they would be happier with a big settlement where they take their percentage off the top. This solution wouldn’t benefit lawyers as much as the people who have opioid use disorder, and their families.

I’m proud that my home state of North Carolina is one of four states supporting this innovative settlement proposition along with Tennessee, Pennsylvania, and Texas. The other states, not to mention numerous counties and cities, have not – yet – agreed to the proposed settlement.

There are sure to be talks about pros and cons of the settlement, but I’m hoping this proposed settlement moves forward, because I love a common-sense solution.

  1. https://www.biopharmadive.com/news/teva-opioid-settlement-offer-23-billion-suboxone/565493/

Novel Idea for Buprenorphine Access

 

 

 

 

I still occasionally read medical journals with articles relating to general adult medicine; I consider it a task, not as enjoyable as reading medical journals about Addiction Medicine.

So, imagine my surprise and delight to read a thoughtful opinion piece in the most recent issue of the Journal of the American Medical Association (August 13, 2019, Vol. 322, No. 6, pp 501-502.)

This article, written by Payel Roy M.D. and Michael Stein M.D., both from Boston University School of Medicine, puts forth the idea of increasing access to life-saving buprenorphine by making it available behind the counter at pharmacies with no prescription required.

The article describes the scope of our problem in the U.S: we have around two million people with opioid use disorder, most of whom aren’t getting any treatment. We have around 130 people die from opioid overdose deaths each day. Though we have medication for opioid use disorder available, it’s often hard to access. The authors acknowledge the cumbersome process of prescribing buprenorphine, both for the patient and the provider. The provider must take a special course and get a special DEA license. Patients have difficulty locating and getting appointments with these rare providers, and then must wait for their appointment and be able to pay the provider.

The authors of this viewpoint piece say that having emergency buprenorphine available behind the counter at pharmacies would eliminate some of the problems with access to this life-saving medication.

They say that making buprenorphine available on an emergency basis makes sense, because we’ve done the same thing with other medications that are relatively safe and effective for the conditions they treat. They compared the use of emergency buprenorphine to that of emergency contraception medication, and to pseudoephedrine. The authors feel that a three-day supply of buprenorphine could encourage people with opioid use disorders an opportunity to try buprenorphine legally, and to follow up with a physician provider for long-term treatment.

They also say that uninsured patients could access this emergency treatment more easily than they can at present, since there wouldn’t be provider-based costs. They feel pharmacists could observe the dosing to watch for precipitated withdrawal symptoms.

The authors suggest we define in advance the conditions where emergency buprenorphine could be obtained, perhaps limited to situations where a patient has an upcoming appointment but has severe withdrawal symptoms prior to the appointment. Another indication for emergency use would be if a patient, previously on buprenorphine but tapered off, has a relapse or feels as if she may relapse and wants to get back on buprenorphine to prevent a serious event.

The authors realize this idea is bound to be controversial. They acknowledge that use of buprenorphine with other sedating agents could be harmful but say warning labels are already on buprenorphine medication fills. They also considered accidental pediatric exposure but say that limiting the medication to behind-the-counter would provide monitoring by pharmacists.

They also acknowledge the concerns for buprenorphine becoming a gateway drug. People without physical opioid dependence can experience euphoria with buprenorphine, but the authors say that since it tends to me only a modest euphoria, it’s unlikely to become a drug of choice. They point to literature suggesting that illicit use of buprenorphine is usually seen in people who already have an opioid use disorder, not people just starting to misuse opioids.

They argue that having buprenorphine available behind-the-counter without a prescription might reduce diversion. Rather than having people with opioid use disorder buy buprenorphine from people who already have prescriptions, they can buy their own legally, with the behind-the-counter arrangement.

They point out that having pharmacists monitor use of this emergency buprenorphine would switch some of the burden of safe initiation of treatment from physicians and onto the pharmacists. They say this would require pharmacists to become better education about buprenorphine and improve the counseling that patients receive from pharmacists

They conclude that their idea of emergency buprenorphine could benefit individual and the population overall, by treating withdrawal symptoms and preventing further illicit opioid use. They feel this could reduce health care costs and criminal activity related to obtaining illicit opioids. They also say it would reduce transmission of infectious diseases. They say the risks would be low, given buprenorphine’s safety relative to other illicit opioids, and people could access this medication at night and on weekends, when doctor’s offices are closed.

What do I think of this idea?

I like it.

I think we could define conditions under which buprenorphine could be provided. However, I think the biggest problem could be getting pharmacists to go along.

My patients see plenty of kind, helpful, and well-informed pharmacists, eager to help them with their recovery from opioid use disorder by using buprenorphine products. And other patients have pharmacists that…well…aren’t like that.

Last week, I had a pharmacist call me about a patient of mine who had tapered from 16mg to 8mg over a month. I didn’t recommend she do this; I thought it was a little too fast. But she was optimistic, and asked I write for only #30 films. That’s what I did, but I got a phone call from my patient on day 25 of her month, saying she’d taken more than 8mg per day and she was out of medication, and could I call in a few days of medication until she could see me at her scheduled appointment on day 28?

I didn’t see a problem with this. Yes, she had been overly optimistic about her ability to taper, but I saw no reason to let her go into withdrawal from day 25 to day 28. I called the pharmacist but couldn’t reach a live human. I left a message, saying it was fine with me for them to dispense enough medication for three days, since we had tried to taper, and it hadn’t gone as well as we’d hoped.

The patient called later in the day, crying, saying the pharmacist refused to fill any buprenorphine/naloxone films early, and that she intended to report me, the physician, presumably for careless prescribing.

Sheesh.

I tried again to call the pharmacist, to explain the situation and try to work it out. I was put on hold for eleven minutes, when it occurred to me that this pharmacist had no intention of coming to the phone. I hung up and called my patient back, telling her to go to a different pharmacy and I’d call in three days, which is what I did.

This emergency buprenorphine could be a wonderful thing, but some pharmacists in my area are extremely cautious about buprenorphine products. I think it’s weird that after practically throwing OxyContin and Xanax and Opana medications at patients for fifteen years, now pharmacists are worried about an established buprenorphine patient filling a prescription three days early.

Swallow a camel, strain at a gnat, as the biblical saying goes.

So yes, I’d like to see some pilot programs try this novel idea, but you’d better make sure the pharmacists are all on board first. Perhaps in Massachusetts, it would be easier than in rural North Carolina.

Opioid Use Disorder: Then and Now

 

 

 

 

I started working at an opioid treatment program in 2001, by accident. It’s a long story that I’ve told elsewhere, but once I saw data about the improvements for patients who start medications to treat opioid use disorder, I knew this was the field for me.

After a few weeks working in an opioid treatment program (OTP), I could help patients make huge and productive changes to their lives. Prescribing medications to treat opioid use disorder can have tremendous impact on the lives of people with this illness. Medications like methadone and buprenorphine reduce the risk of dying from an overdose at least three-fold, according to a recent study. [1] Methadone and buprenorphine used for opioid use disorders are also associated with improvements in physical and mental health, reduced risk of suicide, improvement in employment status, reduction in criminal activities, and increased life satisfaction for patients.

I started as a physician at a not-for-profit program in a southern city. I saw mostly patients using heroin, but also pain pills. We had patients drive from hours from more rural areas, and eventually this program expanded into seven additional programs, mostly located in the western part of the state.

By 2004, on Wednesdays I worked at a town of around 40,000 people. I saw patients who drove an hour or more for help. Some patients drove several hours from Tennessee. At this time, methadone was the only medication this OTP used. DATA 2000 had passed, and a few Suboxone providers prescribed in cities, but buprenorphine products weren’t widely available in smaller towns and rural areas.

Wednesdays were busy. We had dozens of people show up seeking admission, but because I was the only physician, I asked that we admit no more than 20 people per day. My requests were not honored, and I worked many long days, admitting up to 25 to 30 people on these days.

These were complicated patients, and it took time to unravel their medical, psychiatric, and drug use histories. We had limited staff, who already had more than fifty patients on their caseload. This exceeded state limits on the number of patients assigned per counselor and kept us under scrutiny by state authorities. It felt like the wild west.

I knew it wasn’t safe to admit so many people, but what was the alternative? There were no other opioid treatment programs around. That small city had one or two inpatient detoxification units, but as we know, the relapse rate is very high, as is the overdose death risk, for patients leaving these five -to -seven-day programs. Inpatient residential programs were difficult to access and weren’t acceptable to most patients anyway. If these patients didn’t get help with us, they probably couldn’t get any help. So, I worked long hours and did my best.

I felt a continued tension between trying to get people into treatment and taking good care of them once they were in treatment.

These people did not get the attention they deserved, but I’m comforted by data from “low threshold” methadone programs. These are programs that don’t require that patients participate in counseling services, and that don’t dismiss patients for positive drug screens. Data shows that patients entered in these programs do relatively well, despite receiving treatment that lacks the usual counseling requirements. [2]

That Wednesday waiting room was packed with urgency and misery. Imagine twenty or thirty people, in various stages of opioid withdrawal, impatient to see the doctor and get a dose of methadone that will help ease their suffering. I hated making people wait, but had to spend enough time with each of these complicated patients. Hiring additional physicians or physician extenders would have helped, but this program had a hard time keeping providers.

Almost all these patients were using OxyContin brand of pain pills. Patients described how easy it was to file off the time-release coating from “oxys,” as they were called, freeing the entire 20mg, 40mg, 80mg, (and for a time, 160mg) pill to be used at once. Most patients crushed the pill and either snorted it or injected it. Apparently, it easily dissolved in water, making it easy to shoot.

That’s a lot of opioid firepower to release all at once, and misused OxyContin killed many people. Sometimes people, not aware of how harmful this medication could be, thought that since it was prescription medication, it couldn’t hurt them.

Patients couldn’t be expected to know what their doctors didn’t even know. OxyContin was prescribed freely in most communities at this time. Some of it was prescribed by pain management physicians, but mostly it was prescribed by small-town physicians with little training in pain management. These physicians had been told by the so-called pain management experts that the risk of developing addiction was low, less than 1%. How wrong they were…

Our opioid treatment program never advertised services. We didn’t need to. Patients showed up because they were referred by friends or relatives. We had whole families in treatment. We might admit a husband and wife one week, only to admit their adult children the next week, plus cousins, an uncle, or a grandparent. Sometimes we would have three generations of a family in treatment.

Whole neighborhoods seemed to come for help. Addiction appeared to be part of the social fabric of the region, binding people together like a fondness for playing cards or baseball.

I remember in 2004, I admitted so many people from Gray, Tennessee, that I asked the rhetorical question, “What is going on in Gray, Tennessee? It looks like everyone in that town must have opioid use disorder.” As it turns out, the first opioid treatment program in Eastern Tennessee was opened in Gray, Tennessee…in 2017.

Benzodiazepines were freely prescribed back then, and we had patients overdose and die while on methadone. I struggled then, as now, trying to decide if a patient using benzodiazepines heavily can safely be admitted to treatmen. Current recommendations say we shouldn’t limit access to methadone and buprenorphine for patients with co-occurring benzodiazepine use disorder, but I’ve had such patients die, and remain wary. Each patient’s risk must be carefully assessed. If patients have taken benzodiazepines regularly for years, a taper could take weeks or months, and sometimes can be done in an outpatient setting, while the patient is getting treatment with medications for opioid use disorder. Other patients can’t control their use of benzodiazepines in an outpatient setting and must be admitted to an inpatient medical detox unit. They must be monitored carefully while reducing or stopping benzodiazepines. Patients can have seizures during withdrawal, just like patients withdrawing from alcohol

Back in 2004, we didn’t have a prescription monitoring program in North Carolina. Our program didn’t become functional until 2007. By then, I was medical director for this program that had around 3100 patients scattered over their eight opioid treatment programs. In December of 2007, when I got authorized to use our PMP, I spent most nights and weekends looking at patients on the system. In the end, around twenty-three percent of all our patients were filling another major controlled substance. Those medications varied from methadone, OxyContin, Xanax, and clonazepam.

I was asked to submit a narrative of my experience to Brandeis’ Center of Excellence. This narrative was later sent to OTP prescribers in a SAMHSA “Dear Colleague” letter and can be read here: https://www.pdmpassist.org/pdf/Resources/methadone_treatment_nff_%203_2_11.pdf

Once we could see what other medications patients were taking, our overdose death rates came down rapidly. I will always believe PMPs are life-saving.

Now I check all entering patients on our state’s prescription monitoring program and check all established patients once per quarter. I don’t get very many surprises these days on the PMP.

Compared to 2004, patients have more options for treatment for opioid use disorders. Still, financial barriers are considerable, especially in office-based setting prescribing buprenorphine products, and far too few people who need treatment can get it.

Many more OTPs in this state now take Medicaid, helping more patients get treatment. We also have grant programs for patients with no Medicaid or other insurance, funded through the CURES program in the past, and now by the state opioid response grants. Most new patients can get started in treatment even if they have no money, thanks to these grants.

Our OTP was lucky to be asked to participate in a MAT PDOA grant. I forget what the initials stands for, but this grant pays for treatment for patients on probation or parole who have opioid use disorder. This grant, which lasted three years, is ending soon, and we’ve treated hundreds of patients with it. For many, it was their first treatment experience. Some did very well, and some not so well, but the recovery seed has been planted. Some patients need a few tries at treatment before they get traction into recovery.

In the OTP where I work now, I have tons more contact with established patients and know them much better than I did at the OTP where I worked in 2004. There’s still much room for improvement, but today I do more than just admit patients. I also have time to talk with the staff, which I think helps all of us understand our patients better and provide better care.

Now, almost no patient mentions the brand name OxyContin. Some patients are using oxycodone, but not one brand. There’s still some Opana use, and certainly heroin is used by many entering patients. Some patients come for help because they prefer using illicit buprenorphine over heroin or other opioids, because buprenorphine can keep them out of withdrawal for a day or longer. Instead of paying $30 for one 8-milligram tablet on the street, they come to treatment programs to get cheaper, legal help. Most, though not all, patients are also happy they receive counseling.

I’ve change since 2004. I’m much more tolerant of continued drug use by patients. I cringe to remember that in the past, I tapered patients off medications to treat opioid use disorder because they wouldn’t stop using marijuana. I don’t do that now. I tell patients that though I’m not happy about their use of an illicit (in my state) drug, it’s not a deal-breaker for treatment. I still stress over patients’ use of benzodiazepines and alcohol, especially if they are on methadone.

Things change quickly in this field, and our OTP may look very different in the future than it does now. I pray that we continue to improve the quality of care for our patients and continue to reach ever more of the people who need help. I love my job, and after eighteen years, still believe I can do more to help people in one day at my OTP than I did in a week doing primary care.

  1. Sordo et al., “Mortality risk during and after opioid substitution treatment: systematic review and meta-analysis of cohort studies,” British Medical Journal, 2017.
  2. Christie et al., 2013

The Sacklers: Rich People Problems and a Possible Solution

Heroin Spoon sculpture left outside Purdue Pharma

 

 

The Sackler family is having rich- people problems. No, let me correct that: they are having ultra-rich -people problems. They can’t find museums to accept their financial donations.

This family made its fortune, estimated into the billions, by making and promoting sales of OxyContin, the drug that started the opioid epidemic in North American.

I know some readers will quibble about that statement and tell me there are other reasons for our opioid epidemic. I know there were other factors: an FDA that was perhaps too cozy with drug companies, a nationwide push to do a better job of treating pain, so-called pain experts who used shaky data to support their safety claims for long-term opioid prescribing, and few prescription monitoring programs that could identify patients who were developing opioid use disorders by doctor-shopping. These were factors. But the opioid firepower in OxyContin tablets, easily available by removing a coating, fueled our opioid epidemic for more than ten years.

In April 2019, the New York Times ran an article about the Sackler family, their wealth, and their legal problems. [1]

Purdue Pharma, the drug company owned by the Sacklers, has been sued by various entities claiming OxyContin caused harm. As I’ve written about in previous blog posts, Virginia won a $600 million award against the drug company and its three top executives in 2007, after the company and executives pled guilty to criminal charges of misbranding. It’s a big verdict, but perhaps not so big, given the wealth of the Sackler family, estimated by Forbes to be about $13 billion.

In the past, the Sackler family distanced itself from the problems of their pharmaceutical company. Now, individual family members are being sued for their part in pushing OxyContin inappropriately. New York, Massachusetts, Utah, Connecticut and Rhode Island have all filed suits against members of the Sackler family. The New York Times says more than 500 cities, counties, and tribes have coalesced to sue members of the Sackler family.

These agencies claim some of the Sacklers are more involved in sales decisions that they would like the courts to believe. For example, according to the NYT, two years after the Virginia guilty plea, Mortimer Sackler, who was on Purdue Pharma’s board, wrote a memo inquiring why Purdue’s sales force wasn’t selling more opioids.

Either this man either didn’t understand his company’s guilty plea two years earlier, which is unlikely, given all he’s achieved in life, or he didn’t care. He wanted to make more money, at any cost.

The family, well-known for their philanthropy, has made big donations to various cultural and educational institutions. They’ve donated large sums to the Metropolitan Museum of Art, where they financed an entire wing: The Temple of Dendur. They’ve donated to the Louvre in Paris, the Guggenheim, and to colleges and universities.

Earlier this year, activists targeted several of these locations as protest sites, and asked museums to refuse money from the Sacklers, tainted as it is by association with the opioid epidemic. In February, protesters at the Guggenheim dropped paper slips made to resemble prescriptions from upper floors of that museum to protest acceptance of the Sackler’s money. Protesters also staged a “die-in” to represent the lives lost to opioid use disorder, and the Sackler family’s role in those deaths.

Last year, sculptor Domenic Esposito placed an 800-lb sculpture of a bent spoon containing heroin outside Purdue Pharma’s headquarters in Stamford, Connecticut, to protest the Sackler’s role in the opioid epidemic. The spoon was confiscated by police and eventually returned to its creator.

Because of the political pressure from protesters, this summer, the Metropolitan Museum of Art decided not to accept further money from the Sackler family, as did the Guggenheim and the National Portrait Gallery in London.

Thus the ultra-rich problem of having no outlet to make charitable contributions.

The Sacklers defend their actions in manufacturing and promoting sales of OxyContin, saying they were mislead like everyone else into thinking that prescription opioid pain pills, when prescribed for pain, put patients at very low risk for developing opioid use disorder. They say they were taken in with the bad science of the age like other health agencies, and that it’s not fair to blame them for the opioid epidemic.

I find the Sackler’s proclamations of ignorance to be implausible, for several reasons. I can remember attending a course called “Pain and Addiction: Common Threads,” around 2004. At that course, a physician associated with Purdue Pharma chided physicians in the meeting who were trying to tell the presenters about how easy it was to inject or snort OxyContin. My memory may be inaccurate, but I know those meetings were recorded. I think I once possessed cassette tapes of a 2003 meeting, made by a company working for the American Society of Addiction Medicine. I surely wish I hadn’t discarded these old tapes; it would make for some interesting listening, given all that has happened since.

In Barry Meier’s prescient book, “Pain Killer,” he described how small-town physician Dr. Art Van Zee tried very hard to tell Purdue Pharma representatives about the devastation he was seeing and treating in opioid-addicted patients. Meier’s book was published in 2005, so Dr. Van Zee’s efforts had to be taking place around 2003.

In 2003, a Purdue Pharma representative testified before Congress that the company knew people were misusing their medication, and that they were re-formulating their medication to make it more abuse-resistant. But Purdue Pharma didn’t make that change until 2010, seven years of profit later.

Richard Sackler, once Purdue Pharma’s CEO, called people who misused OxyContin “scum of the earth,” “criminals,” and “victimizers,” in an article in the New York Daily News published in May of this year. Sackler has since said he made those uninformed statements decades ago, and that he understands more about opioid use disorder now and recognizes his lack of sensitivity to people suffering with opioid use disorder. [2]

This evidence indicates Purdue Pharma knew about the problem of misuse. The Sackler’s claim they had no knowledge of the death and destruction associated with their medication just isn’t credible. If the Sackler family didn’t know about the destruction their medication was causing, they’d have to be stupid or living under a rock. You don’t get to be billionaires by being stupid.

However, the Sacklers may be politically tone-deaf. In one of the biggest shows of chutzpah in the world, Purdue Pharma at one point considered getting into the opioid use disorder treatment market by manufacturing buprenorphine products to sell.

Yes, that’s right. In a full circle of greed, Richard Sackler got a patent in 2018 for a new form of buprenorphine in a wafer form. Since it dissolves in only a few seconds, it claims an advantage over tablet and film forms of the product now on the market.

This incredible development leads to the point of this blog: I have a solution for the unfortunate Sacklers, who have a bunch of money they want to give away but can’t. They say they want to help fix this opioid epidemic, and they now have a patented form of the product.

I say let the Sacklers, through Purdue Pharma, manufacture buprenorphine for the treatment of opioid use disorder and provide it free of charge to any patient who needs treatment. All the patient would have to do is see a physician, who prescribes Purdue’s buprenorphine product. The patient takes this prescription to any pharmacy to receive free treatment medication. Purdue could pay the small pharmacy fee for stocking and dispensing the medication. More patients could access treatment this way.

Everyone wins with my idea. The Sacklers get to give away money in a method that provides direct amends to the very patients they have harmed. Physicians no longer have to agonize over which form of buprenorphine to prescribe so that the patient can afford it. Patients get treatment that saves lives.

My idea has the advantage of removing middle-men. If Purdue Pharma and/or the Sackler family are found guilty in future lawsuits, they could pay their fine in the form of free treatment medication. This method avoids pitfalls with money gathered from civil fines that must be filtered through layers of government. Sometimes such money gets spent well, and sometimes not. With my method, it all goes to benefit the patients.

I love my idea, both for its practicality and for its poetic justice.

What do you think?

 

  1. https://www.nytimes.com/2019/04/01/health/sacklers-oxycontin-lawsuits.html
  2. http://www.nydailynews.com/news/national/ny-news-richard-sackler-opioid-addicts-scum-criminals-emails-20190507-ujfmvpphqjc77icemxafbjhlai-story.html

Don’t Sweat It

 

 

 

 

It’s that time of the year: it’s getting warmer, and patients are asking about ways to relieve the sweating that is sometimes a side effect of taking methadone or buprenorphine. I thought this would be a good time to re-run a past entry about this topic.

All opioids can cause sweating and flushing, but methadone is perhaps worse to cause sweating than other opioids. Buprenorphine also can cause sweating, but it is usually less of a problem than for patients on methadone.

We don’t know exactly why opioids make people sweat, but it is related to opioids’ effects on the thermoregulatory centers of the brain.

Excess sweating can also be caused by opioid withdrawal. If other withdrawal symptoms are present, like runny nose, muscle aches, or nausea, an increase of the methadone dose may help reduce the sweating.

At least half of all patients on methadone report unpleasant sweating, but some patients have sweats that are more than just inconvenient. These patients report dramatic, soaking sweats, bad enough to interfere with life.

What can we do about this sweating?

First, non-medication methods can be attempted. These methods include common sense things like wearing loose clothing, keeping the house cool, and losing weight. Regular exercise helps some people. Talcum powder, sprinkled on the areas that sweat, can help absorb some of the moisture. Antiperspirants can be used in the underarm area, but also in any area that routinely becomes sweaty. The antiperspirant can be applied at bed time so sweating won’t interrupt sleep. There are prescription antiperspirants, like Drysol or Xerac, but these sometimes can be irritating to the skin. Avoid spicy foods, which can also cause sweating.

Make sure the sweating isn’t coming from any other source, like an overactive thyroid, and check your body temperature a few times, to make sure you don’t have a fever, indicating the sweating could be from a smoldering infection. A trip to the primary care doctor should include some basic blood tests to rule out medical causes of sweating, other than the dose of methadone.

Some prescription medications can help, to varying degrees, with sweating.

Clonidine, a blood pressure medication that blocks activation of part of the central nervous system, blocks sweats in some patients.

Anti-cholenergic medicines, drugs block the effect of the neurotransmitter acetylcholine in the involuntary nervous system, block sweating. Anticholinergics tend to dry all secretions, causing such common side effects as dry mouth and dry eyes. These medications can cause serious side effects, so they must be prescribed by a doctor familiar with the patient’s medical history.

Some examples of anticholinergics include oxybutynin (also used for urinary leakage), bipereden (used in some Parkinson patients), scopolamine (also used for sea sickness), and dicyclomine (used for irritable bowel syndrome). All of these have been used for excessive sweating with various degrees of success, in some patients.

For unusually bad situations, Botox can be injected under the skin of the most affected areas, like armpits, palms and soles. Obviously, this is somewhat of a last-resort measure.

Patients affected with severe sweats, unresponsive to any of the above measures, need to decide if the benefit they get from methadone outweighs the annoyance of the side effects. In other words, if being on methadone has kept them from active drug addiction, which is a potentially fatal illness, it would probably be worth putting up with sweating, even if it’s severe.

Of course, discuss your symptoms with the provider prescribing buprenorphine or methadone. She can help you decide if your dose needs adjustment, if you need further medical workup, or some of the medications listed above are worth a try.

Treating Acute Pain in Patients Prescribed Buprenorphine Products for Opioid Use Disorders

 

 

 

 

 

 

 

Many physicians still get confused about how to treat acute pain in patients who are prescribed buprenorphine products for opioid use disorder.

While buprenorphine products (whether Suboxone, Subutex, Zubsolv, Bunavail, or the generic forms of these) are partial opioids, when they are prescribed long-term for treatment of opioid use disorder, they don’t work very well for moderate or severe pain. These patients usually also need treatment with short-acting opioids.

Buprenorphine has a high affinity for the opioid receptors in the brain, which means this medication sticks to those receptors like glue. Other opioids, with lower affinities, have more difficult time exerting their effects in the central nervous system. This high affinity for receptors is one feature of buprenorphine that makes it work so well for patients with opioid use disorder, but we’ve worried that it also can complicate the treatment of acute pain in those patients.

If the pain is mild, sometimes pain relief can be improved by splitting the dose of buprenorphine. The anti-withdrawal effect of buprenorphine usually lasts longer than 24 hours. That’s why once -daily dosing works fine for this purpose. However, the analgesic (anti-pain) effect lasts from eight to twelve hours. That’s why patients with both opioid use disorder and chronic pain issues may feel better when they split their doses and take half in the morning and half at night. This approach may also help patients when experiencing mild to moderate acute pain.

Sometimes when patients on medication-assisted treatment for opioid use disorder have mild pain, non-opioid measures can help the patient. For example, many dental procedures are well-treated with anti-inflammatories like ibuprofen, rather than with opioids. Or a long-acting version of Novocain can give sustained numbness to the area.

Any of the three following methods can be used to treat acute pain in buprenorphine patients:

In the past, many experts recommended patients stop their dose of buprenorphine 24-36 hours prior to an expected painful procedure. (Of course, many things happen without warning, so this option isn’t always possible.) Patients were then treated with short-acting opioids such as oxycodone or hydrocodone until the pain situation resolved or improved. After the patient stopped taking short-acting opioids for 12-24 hours, the patient re-started buprenorphine.

Currently, a simpler process is being used. Many experts recommend buprenorphine patients stay on their usual dose and add short-acting opioids on top of the maintenance medication. Patients still get some analgesia, because buprenorphine rarely blocks the effects of other opioids completely.

A third option is to reduce the dose of buprenorphine to 2-8mg per day, then use short-acting opioids on top of this reduced dose. This way, reduction of the buprenorphine allows for some open opioid receptors, but the patient doesn’t have to come off buprenorphine completely. Plus, the buprenorphine still available appears to block some of the euphoria that short-acting opioids may cause.

Some patients do better with one of these options than the others, so I always ask about past experiences.

Years ago, one of my patients dosing on Suboxone films 24mg per day had to have emergency cardiac bypass surgery. I was worried, fearful that he would have inadequate pain relief after this big surgery. But he did very well. He had no significant pain post-operatively, and decided he only needed 8mg per day. He has done very well on this lower dose with no withdrawal.

Problems do arise. Some of my patients tell their other doctors, surgeons for example, that they are taking buprenorphine for pain. Perhaps they are embarrassed to tell these physicians that they are being treated for opioid use disorder, or maybe they are confused. But that information makes the surgeons think I’m going to manage pain postoperatively, which will not be the case. Most times a phone call can straighten out the misunderstanding.

Providers prescribing buprenorphine products need to help their patients manage the supply of short-acting opioids which may be prescribed by other physicians for acute pain. For example, I ask my patients if a dependable person in their household can hold on to the pill bottle and give medication to the patient as prescribed. We don’t want that person to be stingy or to overmedicate – merely to give out the medication as directed on the bottle’s label.

Buprenorphine prescribers can ask the patient to come back earlier than planned, perhaps a few days after a procedure, to check in about how things are going and get an extra counseling session if any cravings are triggered by either the short-acting opioids or the pain.

As I tell other physicians, just because my patients have opioid use disorder doesn’t mean they can never have opioids for acute pain. In some situations, pain medications are essential. But we can mitigate the risk with careful, short-term prescribing and good communication.

Product Review: Generic Buprenorphine/Naloxone tablets

 

 

I’m thrilled to be able to present an in-depth review, compiled by one of my patients, of the generic forms of the buprenorphine/naloxone combination tablets. My patient thoughtfully composed this to help other people prescribed these products, and to share his own experience and opinion:

In active recovery it is extremely important to maintain a predictable and consistent titration of dosage in the slowest possible manner to reduce withdrawal. One patient has mostly eliminated the debilitating and relentless effects of withdrawal over a course of many years.

Years ago, this patient’s plan for recovery involved incredibly slow and methodical reduction of the suboxone tablets milligrams at a rate which would be monitored and progressively smaller. However, over the course of 2 years of slowly reducing the dosage, another factor came into play: that is the reported and vastly different half-life and strength in generic Suboxone.

At the beginning, this patient had been taking 2 of the 8mg tablets, or 16mg per day, for several months, after ending a habit which at its worst exceeded 120-140mg per day of OxyContin. Each year since ending any opiate pills, the suboxone was gradually reduced over the course of 12 years from 16mg per day to one-half of a 2mg/.5mg buprenorphine/naloxone tablet per day.

In August of 2018, Walgreens pharmacy reported to the patient that the Amneal NDC #65162-0416-03 became “unavailable for refill.” The reasons for this are unclear but it set into motion a series of trials of the several available 2mg/.5mg buprenorphine/naloxone tablets which resulted in the following analysis based on this patient’s experience:

NDC #65162-0416-03 is Amneal 2mg/.5mg buprenorphine/naloxone tablets. They are orange, small and compact with an “A” embossed on one side and a “14” on the other. Their price is about $8 per pill before insurance. Their taste is distinctive, not sweet nor bitter but a tolerable attempt most comparable to Saint Joseph’s baby aspirin, like a sweet and low version that is far less sweet. The half life is reported to be consistently close to 18 to 22 hours. The only real downside is that these little pills take an incredibly strong finger grip to manually break into a clean and even one-half pill. Even the most expensive pill cutter machines take great manual strength and accuracy to evenly break into halves without crumbs. This pill overall is an 8 on a ten scale largely due to its consistent half-life.

NDC #50383-0294-93 is from Akorn Inc. which produces a very low cost 2/.5mg buprenorphine/naloxone tablet, which are about $2 per pill. They are very small, white and come in a blister pack. They are so small and compact that it is all but impossible to cut in half. Their taste is bitterly distinctive and hardly tolerable as a sublingual. They taste as if the sublingual aspect was not considered at all. The half-life is reported to be consistently bad at no more than 6-8 hours at best. Strangely, these little pills are sometimes completely ineffective, and one wonders if there is any medicine at all in these pills. It would be disconcerting to think that these pills would be administered in a controlled, prison or public health environment as their bitter taste and ineffectiveness may lead one in recovery to compare this pill’s experience to one of all Suboxone pills and thereby keep one from seeking this type of maintenance. This pill is a 2 on a ten scale only because it might help one for a few hours.

NDC #00406-8005-03 is from SpecGX Inc. which produces a lower cost 2mg/.5mg buprenorphine/naloxone sublingual tablet which are about $3.50 per pill. They are smallish and orange and come shaped as a stop-sign. Their taste is also distinctive, not sweet nor bitter but very similar to the AMNEAL described above. Their taste is also a less sweet version of Saint Joseph’s baby aspirin. The half-life is reported to be less than AMNEAL version at only 10 to 12 hours, however. The same breakability issues pervade this orange pill as they are compact and hard to divide. This pill is a 5 on a ten scale only because it helps consistently but only for up to 10 hours.

NDC #00054-0188-13 is from Hikma 2mg/.5mg buprenorphine/naloxone tablets. They are a shade lighter orange, a bit larger than the other orange pills but with a “54/122” embossed on one side and blank on the other. Their price is about $5 per pill before insurance. Their taste is a bit less bitter than the others; however, still distinctive, and a tolerable orange taste. The half life is reported to be very consistent at 20 to 24 hours. They easily and manually break into a clean and even one-half pills without much crumbling at all. This pill overall is a 9 on a ten scale because it does what it is supposed to: be consistently manufactured to be predictably effective to keep withdrawal symptoms to a manageable minimum.

I hope my readers find this information useful. This is not a scientific evaluation but rather a patient’s rather extensive experience with generic buprenorphine/naloxone products. I am grateful to him for the time and trouble it took him to compile this.