Archive for the ‘Government Behaving Badly’ Category

Where Did All the Pills Go?

On the left, number of pills per capita by county
On the right, opioid overdose death rates by county

 

The Washington Post has written some amazing stories this month about our present opioid epidemic. One of their articles described how they accessed data about the distribution of all the prescription opioid pills manufactured and consumed in the U.S. https://www.washingtonpost.com/graphics/2019/investigations/dea-pain-pill-database/?utm_term=.f9fb5fdb26b7

This data is amazing. There’s a box where you can enter your state or county and learn how many pain pills were sold, how many that averages per person, and which pharmacy sold the most.

For my state of North Carolina, around 2.5 billion pills were sold from 2006 until 2012. Most of these pills were distributed by Cardinal Health. Omnicare Pharmacy of Hickory, NC sold the most pills of any pharmacy, at over 9 million pills.

In my county, 26 million pills were prescribed from 2006 until 2012, enough for 55 pills per person. SpecGx pharmaceutical company manufactured the most pills sold in our county. (They make Roxicodone, called “roxies” by the patients I admit to treatment.)

The data, while interesting, needs to be interpreted with caution. For example, we could jump to the conclusion that Omnicare Pharmacy of Hickory, NC, which sold more pain pills than any other pharmacy in NC, is doing something wrong or inappropriate. But this pharmacy doesn’t sell directly to the public. It supplies opioid pain medications to assisted and skilled nursing facilities. This means the pharmacy may supply pain pill to facilities where patients stay to recuperate after orthopedic surgeries, for example. For such patients, opioid pain pills may be not only appropriate but necessary. The data is also seven years old, but that’s the way data is obtained; it takes time to collect and process information.

But the data gives overall trends and shows the staggering numbers of opioid pain pills consumed by residents of certain areas.

The Washington Post website also published two maps: one shows the number of opioid pills sold, and the other shows opioid deaths by county. The overlap, though not absolute, is striking.

The Washington Post’s recent articles contain valuable information for us, if we chose to learn from them and act on them. To me, they have given us maps of where to concentrate opioid use disorder treatment programs. Unfortunately, some of the most severely affected counties are rural, with few providers who know how to treat opioid use disorder. We’ve got to continue to focus resources on these areas.

The Washington Post also published an article about which pharmaceutical companies made the most opioid pills, which corporations distributed the most prescription opioid pills, and which pharmacy chains sold the most pills. Right now, lawsuits are proceeding against all these participants in the opioid epidemic.

The biggest manufacturers include Janssen Pharmaceutical, Purdue Pharma, Endo Health Solutions, Teva Pharmaceuticals, Allergan, and Mallinckrodt. Some of the biggest distributors were AmerisourceBergen, Cardinal Health, and McKesson Corp. The biggest pharmacy chains are CVS, Rite Aid Corp., Walgreen’s, and Walmart Inc.

The lawsuits against these companies allege that they should have notified the DEA of suspicious orders for large amounts of opioids, and that they violated the Controlled Substances Act by failing to report. Some lawsuits against pharmacies allege the pharmacies had to know that medications were being diverted to the street.

Other than that, I’m not sure I understand the basis of these lawsuits.

For sure, if a company mislead physicians in its marketing, as many people feel that Purdue Pharma did, I understand that as a crime.

But I don’t know enough about what manufacturers and distributors and pharmacies are supposed to do when supplying opioids. This must be driven by physicians’ prescriptions, I would think. I doubt drug companies would manufacture opioids unless there was a demand, or that distributors would distribute and pharmacies would sell, unless there are legitimate physicians’ prescriptions.

I don’t understand how we can expect manufacturers, distributors and pharmacies to know more about good prescribing than physicians should. And physicians surely did underestimate the dangers of these medications, thanks in part to the so-called experts, who downplayed the risks of long-term opioid prescribing for chronic pain. Also, the “under-treatment of pain” movement accused doctors of being callous to suffering and encouraged them to view pain as the “fifth vital sign.”

At any rate, Washington Posts’ series of articles bring some facets of the opioid epidemic to light.

 

 

 

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Driving on Methadone

 

 

 

 

“How can you let those people get behind the wheel and drive after you shoot ‘em up with methadone?”

This question, frequently asked by law enforcement and other people, reveals key misunderstandings about the pharmacology of methadone. That’s OK; I don’t expect laypeople to know methadone pharmacologic principles. Oh, and we don’t “shoot them up.” We give them controlled oral doses of methadone measured to the nearest milligram of liquid, and observe our patients consume this medication on site.

While laypeople may not have a reason to understand medication-assisted treatment, I think it’s essential for law enforcement officers to understand. They need to know why our patients are not impaired when they leave our parking lots after dosing.

When patients on methadone (or buprenorphine) are dosing every day, they have a tolerance to the drowsiness that opioids cause opioid-naïve people. Our patients, assuming they have reached a stable dose and aren’t using any other drugs, have blood levels of medication that don’t fluctuate much through the day. Because methadone is such a long-acting medication, the blood level doesn’t even reach its peak until around three hours after dosing.

Because of the frequent misunderstandings and assumptions of law enforcement personnel, I’ve composed a sample letter that opioid treatment programs may forward to the law enforcement officer of their choice.

Dear Officer Zealous:

First of all, thank you for patrolling our streets and highways and for your efforts to keep them safe. I know you have a difficult job and I deeply appreciate your willingness to take on this responsibility.

However, please stop arresting my patients for whom I’ve prescribed methadone and buprenorphine (better known under the brand names Suboxone, Subutex, or Zubsolv). You mistakenly think all people taking these medications have no right to be driving, and you are wrong. I’m writing this letter to give you better information, so you can do your job more efficiently.

Our nation is in the middle of a crisis. Opioid use disorder is an epidemic, and too often its sufferers die of overdoses. Treatment of this disease with methadone and buprenorphine works very well to prevent overdose deaths, and it’s been proven to help patients have a better quality of life in recovery.

I doubt you’ve been provided any information about this type of treatment, so I want to offer data to you.

Methadone has been around for fifty years and has a proven track record. It’s been studied more than perhaps any other medication, and we know it does a great job of treating opioid use disorder. Buprenorphine has only been available in the U.S. for about 17 years, but has been used in Europe for decades with success.

With both methadone and buprenorphine, the proper dose of medication should make the patients feel normal. Patients should not feel intoxicated or high, and should not feel withdrawal symptoms as the day wears on. Methadone and buprenorphine are both very long-acting opioids, and can be dosed once per day. They both can provide our patients with a relatively steady level of medication, compared to short-acting opioids usually used for intoxication. Therefore, using methadone to treat opioid addiction is not “like giving whiskey to an alcoholic,” as has incorrectly been asserted. The valid difference lies in the unique pharmacology of methadone. Opioid addicts can lead normal lives on this medication, when it is properly dosed.

In addition, both of these medications block other opioids at the opioid receptor. When a patient is on an adequate dose of methadone or buprenorphine, if she relapses and uses an illicit opioid, the medication blocks the effects of the illicit opioid. The patient feels no euphoria, which reduces the urge to use illicit opioids in the future. Both methadone and buprenorphine work in this way to deter use of other opioids for the purpose of getting high.

Treatment of opioid addiction with methadone and buprenorphine is endorsed by the CSAT (Center for Substance Abuse Treatment) branch of SAMHSA, by the U.S.’s Institute of Medicine, by ASAM (American Society of Addiction Medicine), by AAAP (American Association of Addiction Psychiatry), and by NIDA (National Institute of Drug Addiction. In study after study, methadone has been shown to reduce the risk of overdose death, reduce days spent in criminal activities, reduce transmission rates of HIV, reduce the use of illicit opioids, reduce the use of other illicit drugs, produce higher rates of employment, reduce commercial sex work, and reduce needle sharing. Medication-assisted therapy is also high cost effective.

Indeed, the current debate of government officials at the highest levels has been how best to expand medication-assisted treatment with methadone and buprenorphine, not to make it less available. So please don’t do anything which may discourage opioid addicts from receiving life-saving treatment.

Over the years, many studies have been done on methadone and buprenorphine to see if patients are able to drive safely on either of them. In study after study, data show patients on stable doses of both medications can safely drive cars, operate heavy equipment, and perform complex tasks. Please see the list of references at the bottom of this letter if you wish to investigate for yourself.

I’m not saying, however, that patients on methadone or buprenorphine can’t become impaired. Impairment can occur if patients are given too high a dose of methadone or buprenorphine, which most often occurs during the first two weeks of treatment. For that reason, patients are warned not to drive if they ever feel sedated or drowsy.

Patients on medication-assisted treatment can also become impaired if they mix other drugs or medications with their methadone or buprenorphine. In fact, benzodiazepines (like Xanax, Valium, Klonopin) and alcohol act synergistically with maintenance opioids. They can cause impairment with smaller amounts of alcohol or benzos than expected. And of course, patients can still become impaired with other drugs, such as marijuana.

As you probably know, a urine drug screen won’t detect impairment. The urine screen only tells you if a person has taken a given drug or medication over the last few days to weeks. Drugs are detectable in the urine long after the impairing effect wears off.

You can do blood tests, but these aren’t useful for patients on methadone. The dose required to stabilize one of my patients would impair or even kill a person who’s never taken opioids, so the meaning of the blood level depends on the patient’s experience and history.

My family and I drive these roads too, and I don’t want impaired drivers on our highways any more than anyone else. However, due to your desire to do a good job, you have mistakenly targeted patients on medication-assisted treatment for the disease of opioid addiction.

I know you have formed bad opinions about methadone and buprenorphine patients from seeing both drugs misused on the street. I hate that, because you probably rarely get to see our more typical patients on medication-assisted treatments.

The vast majority of my patients have jobs, families, and responsibilities that they meet, despite having this potentially fatal illness of opioid addiction. If you are fortunate enough to encounter one of my patients on a random traffic stop, please don’t give them a hard time. Please congratulate them on having the courage to find recovery from addiction, and tell them to do what works for them. In some patients, that means medication-assisted treatment.

Thanks for reading this long letter and thanks for all you do in the name of keeping our roads safe. If you want to know more about how we treat opioid use disorder at our facility, please call our program manager at xxx-xxx-xxxx and we would be happy to provide you with an after- hours tour and lots of information.

Sincerely,

 

Jana Burson M.D.

Member of the American Society of Addition Medicine

Board certified in Internal Medicine

Certified by the American Board of Addiction Medicine

P.S. And please don’t attempt to intimidate patients from coming to get help for this fatal illness of opioid use disorder by parking your squad car just outside our facility’s entrance. Some of these patients may have old warrants, but by stalking them where they come for help, you discourage people who want to escape addiction and want to better their lives. If you do park near us, you should expect a staff member to approach you with a smile, a cup of coffee, and a pile of information about opioid addiction and its treatment.

 

Methadone and Driving Article Abstracts

Brief Literature Review

Institute for Metropolitan Affairs

Roosevelt University 2/14/08

  1. DRIVING RECORD OF METHADONE MAINTENANCE PATIENTS IN NEW YORK STATE

BABST, D., NEWMAN, S., & State, N. (1973). DRIVING RECORD OF METHADONE MAINTENANCE PATIENTS IN NEW YORK STATE. DRIVING RECORD OF METHADONE MAINTENANCE PATIENTS IN NEW YORK STATE,

When a comparison was made within specific age groups, it was learned that the accident and conviction rates were about the same for methadone maintenance clients as for a sample of New York City male drivers within the same period. The findings from other related studies discussed in this booklet are consistent with the results in this study.

2. The effects of the opioid pharmacotherapies methadone, LAAM and buprenorphine, alone and in combination with alcohol, on simulated driving.

Lenné, M., Dietze, P., Rumbold, G., Redman, J., & Triggs, T. (2003, December). Drug & Alcohol Dependence, 72(3), 271.

These findings suggest that typical community standards around driving safety should be applied to clients stabilized in methadone, LAAM and buprenorphine treatment.

3. Maintenance Therapy with Synthetic Opioids and Driving Aptitude.

Schindler, S., Ortner, R., Peternell, A., Eder, H., Opgenoorth, E., & Fischer, G. (2004). Maintenance Therapy with Synthetic Opioids and Driving Aptitude. European Addiction Research, 10(2), 80-87

Conclusion: The synthetic opioid-maintained subjects investigated in the current study did not differ significantly in comparison to healthy controls in the majority.

4. Methadone-substitution and driving ability
Forensic Science International, Volume 62, Issues 1-2, November 1993, Pages 63-66
H. Rössler, H. J. Battista, F. Deisenhammer, V. Günther, P. Pohl, L. Prokop and Y. Riemer

The formal assertion that addiction equals driving-inability, which is largely practiced at present, is inadmissible and therefore harmful to the therapeutic efforts for rehabilitation.

5. Methadone substitution and ability to drive. Results of an experimental study.

Dittert, S., Naber, D., & Soyka, M. (1999, May).

It is concluded that methadone substitution did not implicate driving inability.

6. Functional potential of the methadone-maintenance person.

Gordon, N., & Appel, P. (1995, January). Functional potential of the methadone-maintenance person. Alcohol, Drugs & Driving, 11(1), 31-37.

Surveys on employability and driving behavior of MTSs revealed no significant differences when compared to normal population. It is concluded that MM at appropriate dosage levels, as part of treatment for heroin addiction, has no adverse effects on an individual’s ability to function.

7. Influence of Peak and Trough Levels of Opioid Maintenance Therapy on Driving Aptitude. Baewert, A., Gombas, W., Schindler, S., Peternell-Moelzer, A., Eder, H., Jagsch, R., et al. (2007). European Addiction Research, 13(3), 127-135.

This investigation indicates that opioid-maintained patients did not differ significantly at peak vs. trough level in the majority of the investigated items and that both substances do not appear to affect traffic-relevant performance dimensions when given as a maintenance therapy in a population where concomitant consumption would be excluded.

8. The influence of analgesic drugs in road crashes.

Chesher, G. (1985, August). The influence of analgesic drugs in road crashes. Accident Analysis & Prevention, 17(4), 303-309.

Methadone, as used in treatment schedules for narcotic dependence, produces no significant effect on measures of human-skills performance.

9. Influence of narcotic drugs on highway safety.

Gordon, N. (1976, February). Influence of narcotic drugs on highway safety. Accident Analysis & Prevention, 8(1), 3-7.

A review of the literature on narcotic drug use and driver safety indicates that narcotic users do not have driving safety records that differ from age-matched individuals in the general population. Maintenance on methadone also does not appear to increase driving risk.

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.

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

Depraved Indifference or Reckless Disregard?

 

 

 

 

 

I have a weird affinity for old “Law and Order” reruns. I’m not talking the lesser “Law and Order” spin offs like Criminal Intent and SVU…I prefer the originals. With a total of twenty seasons, there’s almost always an episode being broadcast on one channel or another.

I recently watched – for perhaps the third or fourth time – an episode about a man with serious mental illness who killed a woman by hitting her on the head with a rock. This man had auditory hallucinations due to schizophrenia. As he described it, his “bad uncle up in Yonkers” told him to kill people. Of course, he wasn’t guilty, by reason of insanity.

But the show rambled on, and detectives discovered this person was recently released from jail at Riker’s Island, where he hadn’t received much in the way of medical care. He hadn’t been properly treated for his schizophrenia, due to cost containment strategies of the company that provided medical care for prisoners. After he served his sentence, this sick man was dropped off with no medication and no plans for follow up medical care.

Jack McCoy, indignant and outraged (as he so often is on “Law and Order”), decided to charge the owner of the healthcare company with manslaughter. The physician assigned to treat the schizophrenic man was initially investigated, but he was able to prove he was threatened with being fired if he used expensive drugs or sent patients to the hospital. So then the owner of the company became the focus of Jack’s ire.

I don’t remember the exact count he was charged with, but the jury found him guilty, and he was sentenced to about a year’s incarceration. – in the very jail that his company contracted with to provide healthcare. The chief District Attorney, Nora Lewin, jokes that his immune system had better be good, because prisoners there don’t receive good health care.

I was thinking again about numerous news reports of patients with substance use disorders who die in jail, and it made me wish we had a few Jack McCoys in various locations.

Do you remember the case of David Stojcevski? I blogged about this horrible case on 10/20/2015, and again 2/25/2016. As a reminder, David was sentenced to thirty days in jail for non-payment of traffic tickets. He died on the seventeenth day of his sentence from what the autopsy said was “Acute withdrawal from chronic benzodiazepine, methadone, and opiate medication.” He had been on physician-prescribed methadone, clonazepam, and alprazolam, but was denied all of these medications during his incarceration. He was also not treated for the predictable withdrawal from these medications.

The family released videotape of his immense suffering (he had been moved to a “monitored” cell when he began to exhibit delirium) and are suing Macomb County, Michigan, where this jail was located. They are also suing Correct Care Solutions, the healthcare provider contracted to attend to the health of inmates.

The Justice Department investigated to see if criminal charges should be levied against the people who allowed David to die by denying him medical care. They investigated the charge of “deliberate indifference” on the part of jail staff and Correct Care Solutions personnel. Last year, the U.S. Attorney for that area announced they couldn’t find evidence for criminal intent on the part of jail workers and Correct Care Solutions that met the standard of beyond a reasonable doubt, so criminal charges were not brought.

Several days ago. the FBI was forced to release part of the documents regarding their investigation.

From the little that was released, the FBI discovered David had no intake of food during the last five days of his life, and that there were no medical visits from medical staff for the last 48 hours of his life. One guard said he got the impression from medical staff that they believed he was “faking” withdrawal symptoms.

The physician employed by Correct Care Solutions, after observing David, said he was not having seizures, and that he was faking those symptoms. An FBI physician said David should have been started on a withdrawal protocol, and that his fifty-pound weight loss and dehydration should have raised alarms. His opinion was that David died because of deliberate indifference to his medical needs.

The FBI’s records on their investigation showed there were medical visits that weren’t documented, or had poor documentation. Other news reports say 12 people have died in that county jail since 2012.

Even though there will be no criminal charges against the people who should have prevented David’s death by providing routine medical care, and the family’s civil case will proceed – at a snail’s pace.

I don’t understand the decision of the Justice Department. How can jails and prisons legally deny medical care to inmates? Isn’t that against the law? And if an inmate dies from lack of medical care from a completely preventable cause, shouldn’t that be illegal? Doesn’t this violate the 8th Amendment?

There’s a phrase I learned from “Law and Order.” It is res ipsa loquitor, and means “the thing speaks for itself.”

Surely the death of David Stojcevski from a treatable condition speaks for itself.

My question is this: how much louder do similar tragedies need to speak before changes are made to the disgraceful way inmates are treated?