Archive for the ‘Governmental solutions to addiction’ Category

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
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Criminally Pregnant, Again: Tennessee’s Fetal Assault Law Won’t Die

 

 

Tennessee lawmakers are trying to revive a version of the Fetal Assault Law, originally passed in 2014 but allowed to sunset in 2016, after the state saw worsening outcomes for pregnant moms and babies. [1, 2]

I wrote two blog entries when this law was first passed – you can read “Criminally Pregnant in Tennessee” Parts 1 and 2 from April 12, 2014 and April 26, 2014. The second blog entry was supposed to be satirical. (I won’t try that again, after two out of six commenters thought I was being serious about putting the “addicted babies” in jail.)

This is the proposed law, in part: Notwithstanding subdivision (c)(1), nothing in this section shall preclude prosecution of a woman for assault under §39-13-101 based on the woman’s illegal use of a narcotic drug, as defined in Section 39-17-402, while pregnant, if the woman’s child is born addicted to or harmed by the narcotic drug and the addiction or harm is a result of the woman’s illegal use of a narcotic drug while pregnant,”

To summarize, the Fetal Assault Law says that a pregnant woman can be criminally charged if her baby is born addicted to or harmed by an illegal drug used by the woman.

The wording of the bill is scientifically wrong, of course. Babies can’t be born addicted, since addiction is diagnosed only in the presence of obsession and compulsion to use the drug despite adverse consequences. Babies don’t have obsessions or compulsions, and even if they did, we wouldn’t know it. But I know what lawmakers meant. The lawmakers likely meant to say, “physically dependent,” but lack knowledge about substance use disorder science to know the proper terms.

These types of laws are nothing new. We know the problems that occur with these laws, and Tennessee should learn from examples from the past – their own recent past.

Amnesty International released a 69-page report in 2017, titled “Criminalizing Pregnancy: Policing Pregnant Women Who Use Drugs in the U.S.” This report summarizes research about laws that criminalize behaviors during pregnancy and give some overall data, but the report focused on two states: Tennessee and Alabama.

https://www.amnesty.org/en/documents/amr51/6203/2017/en/

It’s an interesting report, and worth a read. I wish Tennessee lawmakers would read it, because they would have more information about what happened during the two years the Fetal Assault Law was enacted in the years 2014 – 2016.

According to the Amnesty International report, here are the biggest problems seen under the law:

Deterrence of prenatal care: Predictably, pregnant women are less likely to seek prenatal care if they are using drugs and fear being arrested. Even the women who did seek prenatal care were sometimes drug tested without their consent and even without their knowledge.

Uneven application of the law: Some areas of Tennessee had far more cases charged than others, because of the decisions of the local prosecutors. A total of around one hundred women were charged under the Fetal Assault Law, mostly in the eastern part of the state, where there are few treatment facilities available for pregnant women, and in Memphis, in the far western part of the state.

Also, nearly all the women charged in Tennessee were either poor, minorities, or both. The county with the highest number of women charged under the Fetal Assault Law (Shelby County, where Memphis is located), was also ironically a county with lower rates of drug-exposed newborns than other parts of the state. However, that county’s residents are predominantly African-American. It looks as if the prosecutor in that county was more zealous about charging women under the Fetal Assault Law.

Adding to the problem, drug testing policy during pregnancy isn’t uniform. Poor and minority women are more likely to be drug tested, with one study showing that black women were 1.5 times more likely to be tested than non-black women, despite drug use rates that are approximately equal between races. Black women testing positive were ten times more likely to be reported to authorities than non-black women. (Kinins et al., 2007, Chasnoff et al., 1990)

Lack of availability of treatment: Ironically, more women were charged under the Fetal Assault Law in areas with fewer available treatment options. Even when pregnant women with substance use disorders desired treatment, there were few options. Only 19 of Tennessee’s 177 treatment centers open during 2014-2016 treated pregnant women. At the time this law was active, there were no opioid treatment programs in Eastern Tennessee. Even in parts of the state that had opioid treatment programs, the state-funded TennCare program doesn’t pay for methadone treatment during pregnancy, which is the standard of care as noted by experts in the Addiction Medicine field.

The Amnesty International report tells of one woman in Tennessee who tried for three months to access treatment but was turned down repeatedly. She was charged under the Fetal Assault Law.

According to calculations, even if all available treatment beds were set aside for pregnant women with substance use disorders, those resources wouldn’t cover even half of the existing need.

I hope Tennessee doesn’t go backward and re-enact this Fetal Assault law. Since substance use disorders are illnesses, it makes more sense for these women to get treatment, not jail time.

After all, that’s how we treat alcohol abuse and cigarette smoking during pregnancy. We have far more data about harm done to the fetus from maternal smoking and drinking alcohol. But because these substances are legal, they are dealt with as a public health issue. Obesity also affects the outcome of pregnancies. In one article, the dangers of maternal obesity were outlined, and the authors concluded, “Even modest increases in maternal BMI were associated with increased risk of fetal death, stillbirth, and neonatal, perinatal, and infant death.” [3]

I doubt lawmakers would be comfortable setting laws around how much weight a pregnant woman can gain. But if their main concern is fetal well-being, and if they think criminalizing behavior is a way to fix problems, who knows? Maybe next year Tennessee will be patrolling obstetricians’ office for obese pregnant ladies.

  1. http://www.wmcactionnews5.com/2019/02/12/tennessee-bill-revive-fetal-assault-law-would-prosecute-women-who-use-drugs-during-pregnancy/
  2. https://www.npr.org/2016/03/23/471622159/tennessee-lawmakers-discontinue-controversial-fetal-assault-law
  3. Aune, et al, “Maternal Body Mass Index and the Risk of Fetal Death, Stillbirth, and Infant Death: a Systematic Review and Meta-analysis,” JAMA, 2014; 311(15):1536-1546.

Advice for New Prescribers

 

 

 

The medical care providers of this nation are being encouraged get training necessary to prescribe buprenorphine products (brand names Suboxone, Zubsolv, Bunavail, Sublocade, and the generics) for the treatment of opioid use disorder in their patients. We need more good prescribers, because even after twenty years into this opioid situation, only about twenty percent of patients who need treatment can get it.

I’ve written on this topic a few times in the past, but this blog entry will contain some advice directed to new prescribers of buprenorphine products. Hopefully it will help them have good experiences prescribing medication-assisted treatment.

Here are some ideas that work for me at my office:

Treat the patient with opioid use disorder with the same attitude and compassion that you would for any other patient with a potentially fatal chronic illness. If you can’t do that, then don’t treat patients with substance use disorders. Patients detect negative attitudes such as distain and dislike even when those attitudes are communicated non-verbally. For whatever reason, if you can’t put judgment aside, then work on your own issues before you attempt to treat suffering people trying to get well.

Patients will resent a physician with a bad attitude. That will contaminate the relationship with predictable results.

For example, I talked to one physician who had his waiver to prescribe buprenorphine from an office setting. I asked him why he wasn’t using his waiver to treat patients, since there were so many in our community that needed help.

He told me the visits with the first two patients went poorly. He said both these patients threatened his life and the lives of his family members. After that, he decided not to risk treating anyone with opioid use disorder.

I was shocked. I’ve never, in the thirteen years I’ve been prescribing from an office practice, had any patient threaten my life, though I’ve made some angry at me. I had to wonder what kind of bedside manner this doctor had, for his first two patients to want to kill him. That sounds like I’m blaming the doctor, and maybe I am, but his experience was so contrary to my own that I had to wonder what was going on. I suspect his patients didn’t feel respected by him.

I’ve had one patient threaten me with bodily harm, but that was at an opioid treatment program in Gastonia, NC, more than a decade ago. The patient was an avowed KKK member, tall and large, with tattoos of hate groups on his muscular arms. I might have been worried, except at the time he threatened me, he was so impaired on benzos that I could have pushed him over with a finger. I’d just told him he couldn’t dose with methadone that day, due to impairment. The next week, he greeted when we passed in the hall. I assume he had been in a blackout from his benzodiazepine ingestion the week before and didn’t remember our previous interaction.

Be clear with your patients about your expectations. At the first visit, I sit with the patient and go over a patient agreement form. I adapted it from a SAMHSA website where you can find helpful forms, tools, and ideas.

https://pcssnow.org/resources/clinical-tools/

https://www.samhsa.gov/medication-assisted-treatment/training-resources/publications

In that agreement, I outline my expectations. I have paragraphs indicating that disruptive or violent behavior won’t be tolerated and are grounds for immediate dismissal from my practice. In thirteen years, I’ve never had one patient become rowdy or disruptive. Having said that, I do realize other prescribers have had different experiences.

I ask patients to keep and be on time for appointments, and if they don’t show up and don’t call, they will be charged for the missed visit. I tell patients I won’t call in prescriptions if they miss a visit. Having said that, I’m also flexible enough to know that things do come up – cars break down, traffic jams occur, etc. In the winter, travel can be treacherous, so that’s another factor to be dealt with. All I ask is that the patients communicate problems early so we can find a reasonable solution.

Patients who miss appointments, don’t call, and won’t answer our calls to find out what’s going on will have problems at my practice. It may or may not be their fault, but if it doesn’t work out they will need to find a new provider.

My agreement also says I won’t “fire” a patient before I talk to them face-to-face. Patients tell me they’ve been dismissed by a practice by letter, for some issue or another. I think that’s cowardly, and disrespectful to the patient. If there’s a reason I feel I can no longer to continue treatment as we are, I owe it to the patient to tell them exactly what the problem is. Sometimes we can find solutions short of termination and sometimes we can’t. At least the patient will know I respect them enough to talk to them, and they will know the basis of my decision. They will also get a referral to a new provider, or at least a recommendation.

Be careful with patient selection and try to match the patient with the best level of care.

Not every patient will do well in an office-based setting. For example, if a patient has been using buprenorphine products illicitly by insufflation or injection, that patient probably is best treated in an opioid treatment program, where observed dosing is done.

Most patients need to be on the combination products buprenorphine/naloxone. Adverse reactions do occur with the monoproduct, but they are rare, and drug diversion is not. If a new patient needs the monoproduct, I refer them to an opioid treatment program where they can be properly observed.

If that patient has been treated in another office-based setting with medical records that support their progress and compliance on the monoproduct, my recommendation would be different. Many factors influence my treatment decisions, so I need all the information I can get to make the best decisions.

This leads me to my next recommendation: get old records. Make the effort to get records from a previous practice. Sometimes patients, to curry favor with a new prescriber, will tell tales about how awful their last prescriber was. That may be true…or there may be more to the story, so get records to get a better idea of what happened at the last practice.

Don’t falsify your own records. It’s unethical and probably illegal to bill for services you document but don’t provide. To get higher insurance reimbursements, physicians sometimes chart long review of systems and/or physical exams than were performed. This is called “up-billing.” I suspect up-billing when I see records with four pages of single-spaced type for each visit, but then notice the same four pages for each monthly visit, with no changes.

I blogged before about a patient whose records recorded an exam saying “consistent with eight-month pregnancy” for every monthly visit for over a year. Yeah…kind of suspicious…using that cut-and-paste feature, I think.

If you do telemedicine, make sure you have some sort of medical personnel on site with the patient to look for physical finding you may miss with telecommunications. I just admitted a patient to our opioid treatment program who had been on Suboxone for six months from a provider he only saw online. This patient was injecting his medication, but his prescriber couldn’t see it. His most prominent tracks were on the side of his neck, which could be hidden with a high collar. Obviously, this could have ended in disaster had the patient not realized he needed a higher level of care.

Be careful about lab schemes. If a laboratory diagnostic service is charging patients $500 for one drug screen, it’s probably a scam. In past years, these organization popped up like mushrooms in manure, saying they could do extensive lab testing for all patients, but only charge those with insurance. Uninsured would get free testing.

As it turns out, some of those companies charged outrageous fees to the insurance companies, including Medicaid and Medicare, for expensive and unnecessary testing, in get-rich-quick schemes. Here’s a link to an article that explains how this works:

https://www.healthcarefinancenews.com/news/report-urine-based-drug-tests-helping-some-doctors-soak-profits

Good providers don’t want to sully their name by associating with shady laboratory service providers. Physicians can do good point-of-care testing on site for $10 or less. Sometimes patients need more extensive testing, and this can be decided on a case-by-case basis rather than testing every patient for dozens of drugs that aren’t commonly used in the community where you practice.

Be aware of what drugs are trending in your area and make sure they are included in your drug testing protocol. In the past, heroin was rare in rural areas, but that’s changed. As I’ve discussed on this blog, heroin frequently contains fentanyl, a much more powerful opioid that’s responsible for many overdose deaths.

Ask your new patients what drugs are being used in your community. They can be great sources of information, as can local addiction medicine educational conferences, and your local law enforcement officials.

Make friends with the medical director at your local opioid treatment program. Most physician medical directors at opioid treatment programs are happy to work collaboratively with office-based providers. We share patients all the time and need to do what’s best for the patient. We don’t need to look at each other as competitors, because there are more than enough patients for everyone, unfortunately. Let’s work together to get people into treatment, and to match the patient with the right level of care.

It can be a relief for an office-based provider to know they have a facility willing to deliver a higher level of care when necessary. Sometimes the patient may need inpatient treatment, but at other times it might be an opioid treatment program, where the patient may come daily for dosing and oversight.

Again, some patients, in an effort to curry favor with a new prescriber, may talk disparagingly about another treatment facility, so don’t take a patient’s word that an opioid treatment program does an awful job.

Decades ago in my previous life as a primary care physician, I learned that the new patient who tells me how wonderful I am compared to their last terrible doctor will soon be saying the same thing to another new doctor, about how terrible I am. I know there are terrible doctors, but there are also some patients that can’t be pleased no matter how good the physician.

Finally, get involved with organizations that can help you. You don’t need to re-invent the wheel; as I mentioned above, help is available from several sources.

Go to the SAMHSA website mentioned above and you will find helpful resources. Or you can go to the American Society of Addiction Medicine website for information: https://www.asam.org/  You may decide to go to one of their excellent conferences.

Go to the Providers’ Clinical Support System (PCSS) website and search their educational offerings at https://pcssnow.org/ They have archived webinars, mentoring programs, and other great things available.

If you work in North Carolina, there is the UNC ECHO program, which offers live teleconferences three days per week on issues surrounding medication-assisted treatment of patients in the office setting. You can hear cases presented and listen to input from experts and other prescribers, while getting free (yes I said free) CME hours. Once involved, you can present your own difficult cases to get help with difficult patient situations. You can go to their website at: https://echo.unc.edu/ or leave me a comment with your email and I can connect you to the organization.

It can be difficult to persuade new prescribers that treating patients with opioid use disorder is rewarding and fun. I became a physician because I wanted to help people, sappy as that sounds. I didn’t feel the sense of satisfaction during the decade I worked in primary care, for whatever reason, that I now feel working in the field of Addiction Medicine.

ACLU Sues to Allow MAT During Incarceration

 

 

 

I was sent a link to this article that made my day:

https://bangordailynews.com/2018/07/26/mainefocus/aclu-lawsuit-demands-maine-man-get-addiction-treatment-in-jail/

This article reports that the ACLU (American Civil Liberties Union) has taken the case of a man in recovery on medication-assisted treatment who must serve a nine-month jail sentence starting in September in Maine. This man, Zachary Smith, has been in recovery on a buprenorphine product for the past five years. Ordinarily, the jail has a policy of NOT continuing medication-assisted treatment to inmates, leading to forced withdrawal from these medications.

Opioid withdrawal doesn’t (usually) kill healthy adults but can be fatal to people in fragile health. Acute withdrawal does cause significant suffering, and it leaves the person at increased risk of death from overdose upon release from incarceration.

The ACLU says there are two reasons why denying this medical care is against the law. First, denying medical treatment to inmates violates our 8th amendment against cruel and unusual punishment. Second, the Americans With Disabilities Act recognizes opioid use disorder as an illness covered by that Act. This means denying appropriate medical treatment for this condition is discrimination.

The ACLU filed a preliminary injunction to speed up a hearing of the case prior to the beginning of the jail sentence. This means the case will be heard – hopefully – before Mr. Smith must show up for his sentence in early September.

I was so happy to see this case. I think it could be a watershed moment for this nation, one way or the other. I have never understood how it could be legal for a person to be denied medical care while incarcerated, yet it happens across this country every day. In most jails, patients in treatment for opioid use disorder with medication-assisted treatment are denied their medication.

I’ve blogged about this before. I’ve even called the NC chapter of the ACLU myself, many years ago, to ask for help, but was told I had no standing, and that it needed to be the patient to contact the ACLU for help. But my patients sentenced to jail are often reluctant to bring an action against their local jail, feeling they might receive retribution of some sort – a very realistic concern, at least in my area.

Can you imagine the uproar if any other group of patients with chronic illness were denied medical treatment? What if patients with heart disease were denied life-sustaining medications during incarceration? What if diabetics were denied their insulin? For all I know, this may be happening. If it is, citizens of this country should not stand for this. We shouldn’t stand for it for people with substance use disorders, either.

Since all of this is happening in Maine, I was curious if North Carolina has any similar cases pending. I went to the website of the North Carolina chapter of the ACLU and found nothing advocating for inmates to be continued on medication-assisted treatment for opioid use disorder.

However, I did find that our state chapter of the ACLU filed a federal class action lawsuit against North Carolina’s Department of Public Safety’s policy of denying treatment for Hepatitis C to incarcerated people with the virus. The current class action suit was filed on behalf of all people incarcerated in NC with Hepatitis C.

https://www.acluofnorthcarolina.org/en/press-releases/aclu-incarcerated-people-sue-nc-failure-provide-life-saving-treatment

Current expert recommendations are that all incarcerated people receive Hep C testing, since according to data from the Center for Disease Control, around one-third of all prisoners are infected with Hepatitis C.

In the past, recommendations were to wait until the person with the Hep C virus developed liver damage before treating. Those expert recommendations have changed. The current recommendation is that all people with active Hep C infection should be treated. Experts now also recommend treatment even if the patient has not stopped illicit drug use.

The NC Department of Public Safety’s present policy is that incarcerated people with Hep C infection that’s caught early, when at its most treatable, are forbidden to receive treatment while incarcerated.

This article says there’s no law for universal testing of prisoners for Hep C, and the decision to test is left up to personnel at each jail site.

Both issues are important, though to me, continuing access to medication-assisted treatment appears more pressing, and could prevent more deaths in the short term.

I will follow these cases, and give updates to my readers.

 

 

Update on Jail Death Lawsuits

 

 

 

 

Long-time readers of my blog will remember the story of Eric Stojcevski, a young man who died from withdrawal from prescribed medication while in jail in Macomb County, Michigan, for unpaid traffic tickets in 2014.

I blogged about this case on November 3, 2017, February 5, 2016, and October 20, 2015.

I’ve given readers periodic updates because to me, this case is the most extreme example of how poorly sick inmates are treated by jailers. I feel this is one of our country’s biggest moral failings, because it goes on all the time, usually with little to no publicity.

Someone once said we can judge the quality of a society by how we treat the most vulnerable members of that society. Incarcerated people are among the most vulnerable, since they can’t take themselves to a hospital for medical care if they get sick. They are dependent on the jailers to get them care when ill.

This did not happen in the case of David Stojcevski. In June of 2014, he went to jail for failure to pay parking tickets, and it turn into a death sentence. According to news sources, he was being prescribed methadone, clonazepam, and alprazolam by a physician. He was not given any of these prescribed medications when he was in jail.

According to his autopsy, he died from acute drug withdrawal on the seventeenth day of his thirty-day sentence. Despite intense suffering, his pleas for medical attention were ignored. When he exhibited bizarre (withdrawal) behavior, he was sent to a mental health cell, where his last eleven days on earth were videotaped. His family, livid at the lack of medical care that resulted in his death, released the videotape online, where it went viral. The recording showed him naked, having repeated seizures on the jail floor as he died.

His family filed a civil case against jail personnel, and against Correct Care Solutions, the health organization that was contractually obligated to provide medical care to prisoners in the Macomb County jail.

There was a criminal investigation that went nowhere.

The Department of Justice investigated, and said they found no evidence of criminal intent on the part of jail personnel or personnel of Correct Care Solutions. The FBI had to be forced by the family to release its investigation records, and only released part of them.

These records should be helpful to the family’s civil case, and now depositions for this civil case are underway.

According to news reports, [1] Sheriff Wickersham’s sworn testimony revealed that David lost forty pounds in his last seventeen days, spent in the county jail. Over the last three days of his life, he drank almost no water. Of the thirty-three meals served to him over the last eleven days of his life, he ate perhaps three of them.

According to news reports, jail guards thought the medical staff was responsible for deciding when a patient should go to the hospital. Medical staff thought it was the guards’ responsibility to monitor the amount of food and water inmates are consuming.

Sheriff Wickersham admitted he was responsible for the well-being of the inmates, but also admitted he rarely enters the jail. Even though his office is located a few feet from the jail, he enters the jail perhaps once per month. He said he delegated oversight of medical care to another employee, who had no medical training.

News reports didn’t say whether Correct Care Solutions employees had been contacted about the state of health David was in during his last days.

News reports did say that David’s prescribing physician, Dr. Bernard Shelton, was charged with unlawful delivery of controlled substances. [2] This report says he prescribed four million “addictive pills” to Macomb County residents, though it didn’t specify over what period of time or what type of pills they were. From what he prescribed David Stojcevski, it appears to have been opioids and benzodiazepines.

In 2017, according to the state of Michigan’s medical board documentation, Dr. Shelton lost his medical license for inappropriate prescribing of controlled substances that were outside acceptable practice. His charts were reviewed by other physicians, who have the knowledge to judge such things. They said he didn’t check patients on the Michigan prescription monitoring website, he didn’t keep complete records, and lacked essential documentation.

The medical board suspended his medical license for fifteen months, fined him $10,000, and said he wouldn’t be considered for license re-instatement unless he could prove, with clear and convincing evidence, that he had good moral character, the ability to practice medicine with reasonable skill and safety, the ability to follow the guidelines of re-instatement, and for it to be in the public interest that he be licensed again. At present, he does not have a license to practice in Michigan.

Now it appears Dr. Shelton will face criminal charges as well as losing his medical license.

But getting back to David Stojcevski’s case…even if his doctor prescribed opioids recklessly and inappropriately, it doesn’t release the sheriff of his obligation to make sure inmates receive medical care. Watching David suffer on the recordings made by the jail, I can’t help but wonder why no one took any action to help a man obviously in serious need of medical attention.

What if Sheriff Wickersham (or one of his deputies) walked down the street of whatever town is in Macomb County, Michigan, and he came to a man lying on the sidewalk, barely conscious, having a seizure. What would he do? I expect he would squat down beside the sick man, check for a pulse, and summon 911 for help. That’s what most citizens would do, out of common decency and concern for a fellow human.

In other words, it did not take any medical knowledge to know David was in serious need of medical help, yet no one in the whole jail called 911.

You can believe I’ll be watching this case unfold. It has the potential to be a multi-million -dollar case. In other similar cases, awards were in the three-million-dollar range. It’s sad that is takes a large financial award to change the way people do things, but in this case, it appears necessary.

It’s too late for David, but a large settlement or award against Macomb County and against Sheriff Wickersham could be another paving stone on the road of appropriate medical care for vulnerable inmates.

  1. https://www.clickondetroit.com/news/defenders/sheriff-answers-questions-under-oath-about-death-of-inmate-at-macomb-county-jail (accessed 7/4/18)
  2. https://www.clickondetroit.com/news/defenders/doctor-charged-with-distributing-opioids-to-inmate-who-died-from-withdrawal-at-macomb-county-jail (accessed 7/4/18)

When the DEA Raids Buprenorphine Doctors

 

 

I had another blog post ready to go this week, but I’m postponing it to blog about another situation.

So far this year, two well-known and respected Addiction Medicine physicians have had their offices raided by the DEA.

The first one occurred in March of this year. Dr. Stuart Gitlow, the past president of ASAM (American Society of Addiction Medicine), who has a small buprenorphine (Suboxone and other name brands) practice in Woonsocket, Massachusetts, was raided by the DEA.

According to news reports, [1] the DEA raided his home and office, looking at patient records for evidence of wrongdoing. They wouldn’t tell him what they were looking for, and wouldn’t comment to reporters later because, they say, the raid was part of an ongoing investigation.

I searched the internet for some sort of follow up story, but found none.

Dr. Gitlow is an unlikely target for a DEA raid. He is so famous for his work in the field of Addiction Medicine that he has a Wikipedia page. According to that page, he is a psychiatrist specializing in the treatment of addiction. He earned an MBA from University of Rhode Island, and went to Mt. Sinai School of Medicine where he earned his M.D. degree. He did a psychiatry residency at University of Pittsburgh, along with a Master’s degree in Public Health. Then he went to Harvard University for a forensic fellowship.

I’ve heard him give lectures at ASAM meetings and he’s as good as lecturers get. He teaches at the University of Florida, and he’s on the editorial board of the Journal of Addictive Diseases.

Dr. Gitlow confirmed in an interview that the DEA looked at patient records, but he had no idea what they were looking for.

Then in early May of this year, the offices of Dr. Tom Reach were raided by the DEA. Dr. Reach, like Dr. Gitlow, is an outspoken advocate of medication-assisted treatment.

A news article [2] described how Dr. Reach’s nine treatment centers were closed for the DEA inspection, disrupting patient care. Dr. Reach’s home was also raided. In the interview, he said he heard the DEA thought he was doing something wrong, but he had no idea what it could be.

They also looked for controlled substances, but Dr. Reach, like most buprenorphine physicians, has never stored these drugs on-site. The record keeping that is necessary for storing controlled substances is considerable. He doesn’t contract with public insurance, so it couldn’t be problem with that.

Dr. Reach said the DEA took hard drives and cell phones, making it harder to continue with patient care.

Dr. Reach was the past president of the Tennessee chapter of ASAM. Dr. Reach was one of several physicians who were on the expert panel convened last year to draft Tennessee’s new guidelines around physician prescribing of buprenorphine. He’s spent his own time at the Tennessee statehouse, advocating for patients with opioid use disorder and their physicians.

Thus far, no charges have been filed against either physician.

Both physicians are politically active. Dr. Gitlow ran unsuccessfully, twice, for state representative in Massachusetts, as a Democrat. Dr. Reach contributes money – some would say a large amount of money – to political candidates he supports. [3]

These two leaders in addiction medicine are far from the only doctors being raided. Dr. Larry Ley, who had several treatment programs in Carmel, a suburb of Indianapolis, was ultimately acquitted of felony drug charges that he faced. Law enforcement personnel, posing as patients, lied about their need for opioid use disorder treatment. Dr. Ley was then charged when he issued prescriptions for Suboxone. [4]

I thought it was a felony to obtain a prescription for a controlled substance under false pretenses. How can a DEA agent pose as a patient and lie about their substance use history to obtain a prescription? Wouldn’t that be an illegal act? Maybe that’s why Dr. Ley was acquitted.

In this case, it seems the county’s head of drug task force didn’t agree with the idea of medication-assisted treatment, saying, ““This type of ruse of a clinic perpetuates the problem because people are still addicted to the drug, and this is what is happening,” said the head of the drug task force, in a press conference held after Ley’s arrest. “This is not fixing the problem.” [4]

Dr. Ley had to close his treatment centers, was left penniless due to legal fees, and is now suing both the city of Carmel and the DEA for conspiring to force him out of business.

Meanwhile, the opioid overdose death rate in Indiana has risen by double digits.

The DEA is authorized to inspect buprenorphine practices at any time. If you are a long-time reader of my blog, you’ll recall my office was inspected in late 2012. I wrote about the experience in a blog post on 12/16/12. The agents were pleasant and cordial. They were willing to meet with me when patients were not scheduled, so it didn’t interrupt my practice at all. They asked about how many patients I had, asked to see copies of patient prescriptions, and asked if I stored any controlled substances on site (of course not). The two agents were polite and cordial.

What happened to Drs. Reach and Gitlow was very different. They were both raided by the DEA, with a warrant that says material can be seized. In a raid, the DEA is so convinced that there’s criminal activity that they take computers, cell phone, and records. Inevitably this disrupts the medical treatment of patients. For both Dr. Reach and Dr. Gitlow, patients had to be turned away from scheduled appointments because of the raids. As Dr. Reach pointed out in a newspaper interview, this can have very real and possibly fatal outcomes for patients depending on buprenorphine to provide stability and keep them from using illicit opioids like heroin.

For a DEA raid to take place, investigators have expectations of finding criminal activities. They would not raid for issues like overprescribing, substandard care and the like. These types of problems would be handled by the state’s medical board.

Of course, I don’t know the circumstances that lead to these DEA raids. It’s remotely possible that a Harvard-educated physician leader of ASAM is slinging dope on some corner of Woonsocket, Massachusetts, in his free time…but I doubt it.

The trouble with these DEA raids is that while they make the papers when they happen, no news releases state what was found. If no wrongdoing was discovered in the masses of material seized by the DEA, the public won’t hear about this. All that remains is the taint of criminal investigation.

I’ve been working with some organizations to try to get more office-based physicians interested in treating patients with opioid use disorder with buprenorphine, a potentially life-saving medication. I’ve reassured worried doctors that they won’t become DEA targets just because they prescribe buprenorphine. I told them that unless they store medication on premises, the chances of getting raided are very small.

I hope I haven’t erred in telling new doctors this. I legitimately thought the nation’s leading health experts are pushing treatment for opioid use disorders, to stem the tide of opioid overdose deaths we’ve been having oer the past twenty years.

Now, with raids on well-respected practitioners, I don’t know what to think.

  1. http://www.woonsocketcall.com/news/city-doctor-s-home-office-raided-by-fbi/article_1e4270a0-2bb5-11e8-be84-b7f0c2501d63.html
  2. http://www.wjhl.com/local/dea-agents-raid-watauga-recovery-centers-in-tn-va-and-nc/1156361147
  3. http://doctorsofcourage.org/ralph-thomas-reach-md/
  4. https://www.thedailybeast.com/addiction-doctor-dea-shut-me-down-so-mayor-could-clean-up-town?ref=scroll

Buprenorphine Regulations

Map is from vox.com

In response to the rise of opioid use disorders in this country, lawmakers in heavily affected states are passing laws they hope will help. But well-intentioned laws may have unintended consequences, requiring re-evaluation of those laws.

Nearly one year ago, The Virginia legislature asked the Virginia Board of Medicine to regulate prescribing of buprenorphine. Legislators were worried about the diversion of prescribed monoproduct buprenorphine to the streets. You can read about this in more detail in my blog entry dated February 24, 2017.

It’s been a year since that blog entry, and I have a little bit of data regarding some of the consequences of Virginia’s new rules.

Initially, the new Virginia Board of Medicine (VBOM) regulations said the buprenorphine monoproduct could only be prescribed for pregnant ladies and nursing mothers. They did this because the monoproduct, containing only buprenorphine and no naloxone, has a higher street value and is more likely to be injected and misused than the combination product.

The VBOM received so many complaint letters that they finally changed the regulations to say that each buprenorphine physician could prescribe buprenorphine monoproduct to up to three percent of their patients. Each of these patients must have documentation of their intolerance in their chart.

It was hoped that this compromise would limit the amount of buprenorphine monoproduct being prescribed, while still making allowances for some patents with intolerance to naloxone in the combination product.

The VBOM didn’t stop there. They passed regulations about care at opioid treatment programs (OTPs), which are already the most heavily regulated medical providers in the nation. The VBOM said if buprenorphine monoproduct was used, the patient had to consume it on site, with observed dosing, and that no take home doses could be allowed for the monoproduct.

To clarify, this meant that OTP patients dosing with buprenorphine monoproduct had to either switch to the combination product, buprenorphine/naloxone, to get their usual take homes, or dose daily at the OTP on the monoproduct and forfeit all the take homes they had earned.

Or they could switch to methadone, where take homes are still allowed, following standard guidelines.

This is the irony – methadone is a heavier and stronger opioid than buprenorphine, and more likely to cause overdose death if taken illicitly or diverted. Virginia patients can get methadone take home doses, after they have a period of stability and meet the guidelines which have been in place for decades.

OTPs must follow both state and federal guidelines, and must obey the stricter of the two. The federal guidelines dropped the time in treatment requirement for buprenorphine, meaning the federal agency decided to allow the admitting physician to decide how many take home doses were appropriate, from day one, for a buprenorphine patient.

Essentially, Virginia went the opposite direction, and eliminated take homes, at least for the monoproduct.

At the time the new regulations were implemented, there were 600 Virginia patients on buprenorphine at OTPs. Monoproduct was used because was about half the price of the combination product, and kept treatment more affordable for patients. Also, because OTPs already followed stricter regulations than office-based programs, the risk of diversion was felt to be lower than at office-based programs.

Of those 600 patients, 384 patients attended one of the four OTPs owned by Acadia Healthcare in Virginia. They collected data on what happened to their Virginia patients after these new regulations were implemented. Since I work for Acadia, that data was released to me for an upcoming presentation, but I’ll give my readers an early view.

Of those 384 patients, 260 made the switch to the combination product so that they could continue to get take home doses. In other words, two-thirds of the patients switched, and one-third did not.

The cost of medication doubled, but rather than pass this on to the patients, Acadia Healthcare absorbed all the extra cost. The patients paid the same as if they were getting the cheaper monoproduct. This was fortunate, since an overnight doubling of costs could have caused hundreds of patients to leave treatment.

To some lawmakers, an extra couple of hundred dollars per month might not seem like much. But to many patients, it’s the difference between being able to stay in treatment or having to leave and go back to illicit drug use.

So, what happened to the patients who didn’t make the switch?

  • 15 switched to methadone, and will be able to get take home doses once they meet criteria. It’s takes a while, but at least they can get take homes eventually.
  • 21 transferred to out-of-state opioid treatment programs because they had an intolerance to the combination product.
  • 24 (6%) patients dropped out of treatment.
  • 58 remained on the monoproduct and accepted that they will have to dose every single day that they are in treatment. Since all these clinics are in rural areas of Southwestern Virginia, I suspect some of these people are driving long distances daily, and incurring extra expenses for that travel.
  • 6 patients were lost to follow up, and couldn’t be contacted to see what happened.

Studies show the risk of death increases as much as eight-fold for patients who leave treatment, so those 24 people are at high risk. I suspect the 6 people who couldn’t be found are also in that risk group.

I have a little bit of data about what’s happened on the receiving end with patients on buprenorphine at Virginia OTPs. One OTP located in Boone, NC, received 12 patients in transfer from Virginia. Those patients could have been OTP patients or office-based patients; I don’t have that data.

I have my own office-based buprenorphine practice in the Lake Normal area of North Carolina, which is 73 miles from the North Carolina-Virginia border. My practice got around twenty phone calls last year, just after Virginia’s law changed. These patients were willing to drive from Virginia to my office if I would prescribe buprenorphine monoproduct. I declined to accept any of those patients, both because it is unworkable in the long run to come from such a distance, and because I was concerned about regulatory scrutiny in my own state.

You can draw your own conclusions based on this limited data. It appears that roughly two-thirds of patients, if forced to switch to the combination product, can do so and remain in treatment.

But remember, costs weren’t increased for those patients enrolled at Acadia OTPs.

That would not have been the case for office-based self-pay patients, who would have paid roughly double each month for their prescriptions for combo products at the pharmacy. Community pharmacies would not have absorbed the extra cost.

I combed the internet, trying to discover data on what happened to office-based patients in Virginia on the monoproduct. If data is out there, I haven’t found it. Or perhaps it’s still being collected and analyzed. I also looked to see if overdose death data changed much in 2017, but it’s likely too early for this.

The American Society of Addiction Medicine has written a public policy statement addressing regulations on office-based buprenorphine policy. This document outlines the most reasonable approach to assure appropriate care for patients while limiting onerous regulations for providers. State legislators would do well to read this policy and abide by its specific recommendations.

https://www.asam.org/docs/default-source/public-policy-statements/statement-on-regulation-of-obot.pdf?sfvrsn=df8540c2_2

I’m tempted to give a summary of ASAM’s statement, but ASAM warns against this, at least without their permission. They don’t want people to use just a section of their policy to justify a position; they want their statement to be read in full.

I think that’s smart of ASAM. I encourage interested readers to check it out.