Archive for the ‘Government Behaving Badly’ Category

North Carolina Prepares to Step Off a Cliff…

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The first time I saw a copy of North Carolina bill S297, it was from a prankster friend. I thought I was being punk’d. I thought someone, knowing how crazy it makes me when politicians play doctor, wrote this phony bill and said it was up for consideration in the NC legislature.

When more reputable people sent me similar notices, I found out this bill is for real.

Republican Brent Jackson presented this bill, which reads, “A woman may be prosecuted for assault under G.S. 14-33(a) for the illegal use of a narcotic drug as defined in G.S. 90-87, while pregnant, if her child is born addicted to or harmed by the narcotic drug and the addiction or harm is a result of her illegal use of a narcotic drug taken while pregnant. “

The bill goes on to say that the pregnant woman has a defense to prosecution if she is involved in a treatment program before delivery, stayed in the treatment program after delivery and – get this – completed the program.

This is not a good law.

While it may make politicians and voters feel like they are doing something to stop reckless drug-addicted women from using drugs during pregnancy, it demonstrates a lack of knowledge about what addiction is, how it is treated, and the few treatment options open to opioid-addicted pregnant women.

Here are the ways in which this law is bad, and will worsen the health of addicted women and their babies:
1. Addicted women who become pregnant will shun pre-natal care. They won’t want to take the risk of being sent to jail. While proponents of the bill say it should encourage addicted women to seek help, that’s not realistic. It’s contrary to human nature for a sick person to get medical care if that illness it a crime.

Women with addiction who become pregnant are no different from other women. They want all the best things for their baby, and especially want that baby to be healthy. Most women will have already tried desperately to stop using drugs, and are unable to do so. The inability to stop using is one of the symptoms of the disease of addiction, after all. They are loaded down with shame and guilt over using drugs while pregnant. They feel like bad people, and they feel hopeless. They do what humans do when they feel bad about themselves – they hide. They don’t go to doctors.

Fewer and later prenatal visits directly correlate with worse outcomes. Best results for the mom and babies are seen when addiction is treated as the public health problem that it is.

2. Let’s say the woman IS able to stop using drugs on her own somehow. If the woman is addicted to opioids, her pregnancy can be endangered if she stops suddenly. We know, from years of studies, that opioid withdrawal in pregnancy increases the risk for complications such as pre-term labor, miscarriage, placental abruption, and other conditions. Even if nothing catastrophic happens, the baby is more likely to be born early or have a low birth weight. Even if she’s able to stop without calamity, we know that relapse rates are consistently in the 90% range.

3. If the opioid-addicted pregnant woman came to her OB and asked for help with her addiction, what do you think would happen? I’ve seen such patients shuffled around from place to place with no one willing to take responsibility to treat this high-risk patient. Opioid treatment programs, some teaching hospitals, and one of the state-run inpatient facilities in the state, Walter B Jones in Greenville, NC, are the only places I’ve seen that are willing to take care of these women.

I had one pregnant patient who went to our local hospital emergency department to ask for help with her addiction, as soon as she found out she was pregnant. She talked to the doctor there, who called our local management entity (our equivalent of county mental health system). That LME sent a worker to interview her and the worker recommended she get an appointment with an obstetrician to get help. The ER sent her home with the names of OB’s in the area, which, by the way, she already had. On Monday morning she called them, and was told she could be seen in a few weeks, after she got approved for her pregnancy Medicaid, since she had no insurance at present.

Frustrated, she called that doctor’s office back, and explained that she had an addiction and needed help more quickly. She was directed to go to the emergency department but when she told them she’d already gone there, they recommended she go to a detox.

She went to the local detox unit in our area and they would not admit her because, you guessed it, she was pregnant and they said they weren’t equipped to treat pregnant patients. They recommended she go back to the local emergency department.

She did go to an emergency department, but had the good sense to go to Forsyth Medical Center in Winston-Salem. She was admitted to their detox unit and started on buprenorphine. Workers there arranged for her to be admitted to our opioid treatment program immediately after she was stabilized and discharged from their hospital.

She spent four days trying to negotiate the confusing network of care in our state. Some patients may not be that willing to persist after getting no help from three or four sources.

4. Women may be more likely to consider abortion as an option, even if they would like to have the baby. Think about it – if you commit a crime by becoming pregnant while addicted, what’s the quickest way to remain within the law, prevent arrest with its public humiliation? Get rid of the pregnancy. I suspect it’s easier to get an abortion than to get inpatient drug addiction treatment in this state, but I do not know this for sure.

5. The bill lacks knowledge of addiction as a chronic illness. When farmers become politicians and think they can play doctor, we get these nonsense laws. Since addiction is a chronic illness, the treatment won’t have a “completion.” It makes as much sense as saying a diabetic who gets pregnant won’t be prosecuted for eating sugar if she “completes” the treatment for her diabetes.

It reminds me of my patient in primary care who got angry when I told him he would have to keep taking his blood pressure pills in order for them to work. He thought blood pressure pills should cure the disease. He told me he was taking his business elsewhere, to a better doctor who would prescribe something to cure his hypertension, not just keep taking a pill every day to treat it. He could not grasp the concept of a chronic illness.

6. Second, I hate this term “narcotic.” It’s become more of a legal term than medical. In the doctor world, narcotic means anything that could put someone to sleep. “Narco” in Greek, means sleep, thus the association with sleep and sedation. So I went to GS 90-87 to see what the state’s definition is for this word. Turns out they mean cocaine and opioids.
Sleeping pills and benzodiazepines are not mentioned, and neither is marijuana or methamphetamine. Will these drugs also be illegal in pregnancy?

7. These types of laws attempting to punish “bad” women who use drugs while pregnant are unevenly enforced. You won’t see an affluent opioid-addicted pregnant woman incarcerated under this law, but you may see poor or minority women incarcerated. They have fewer resources to avoid prosecution and less voice to speak out against bad laws like these. One only need look at other states with similar laws to see this is true. Just look at the first person to be jailed in Tennessee after their harsh new law was passed last year.

Plus, these laws are not upheld by higher courts. In Ferguson versus City of Charleston, the Supreme Court held that it was an illegal search when hospital workers sent urine samples for drug tests without consent from the mothers.

If North Carolina passes this bill, we will be the second state, after Tennessee, to pass laws making drug use during pregnancy a crime. Do we really want to model ourselves after Tennessee, with all of their mess?

8. If politicians want to take action to prevent harm to babies, they should focus on nicotine. We know smoking in pregnancy is very harmful to the fetus and newborn, and far more women smoke than use drugs. You can read a summary of current knowledge at this CDC site: http://www.cdc.gov/reproductivehealth/tobaccousepregnancy/
Why does the NC legislature treat smoking during pregnancy as a public health issue? Why not criminalize smoking while pregnant, since we know much more about the harm caused by cigarettes? I could ask the same question about alcohol as well.
Of course I know the answer to my own question. Alcohol and cigarettes are legal, and have much less stigma than other drugs, even though both kill more people per year than all other drugs combined.

Can’t we please let common sense and medical science drive the bus on this issue? Even if you are mad at pregnant women who use drugs and have a desire to punish them, please refrain from doing so, if only for the sake of the babies, who WILL suffer if this law passes.

Policies that inflict criminal penalties on pregnant women with the treatable disease of addiction cause harm to everyone. Hospitals have higher costs when a mom with no prenatal care arrives on their door step ready to deliver, with much higher rates of perinatal complications. Taxpayers end up paying the high costs of incarceration for these women. But most of all, the babies and their moms are harmed.

The Broken System

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I’m feeling discouraged this week, due to a recent vivid display of my state’s broken mental health/substance abuse treatment system.

Details of this encounter have been changed to protect identities.

One of our former opioid treatment program patients returned to us, asking to be admitted again to methadone maintenance. In previous admissions, this patient struggled with repeated bouts of benzodiazepine addiction and had several near overdoses. He also had months at a time when he did relatively well, with little benzo use. I felt we were helping him – to some degree – until late last summer, when his condition worsened after his son died from an overdose. He was distraught and using all types of drugs in order to push away the pain of his loss. I became worried he would die of an overdose if we didn’t do something different. We really wanted him to go to inpatient care, because he’d become too sick for outpatient, medication-assisted treatment. He rejected this option and left treatment.

He was back last week, asking for help. He admitted to using a wide variety of drugs, including benzos, illicit methadone, cocaine, alcohol, and marijuana. He knew he was still grieving for his son, and he too had come to fear that he would die from his addiction. He was now ready to go to an inpatient residential treatment center. Even though we don’t offer that service, he came to us when he couldn’t find help anywhere else.

He’d already gone to our local hospital emergency department two days prior, asking for help, but he said he was turned away with no evaluation and no medication. Our patient told us the emergency department personnel told him he could be put on a waiting list for an inpatient program, and that it could take weeks for a bed to open up for him. Our patient left the emergency department feeling like personnel there didn’t care about what happened to him. He suspected they judged him as a bad person, not a sick person. He got no further referrals for treatment and wasn’t even offered clonidine, a blood pressure medication that can help with some of the opioid withdrawals.

Granted, our patient may be leaving out part of the story, or too sick to remember accurately. I know better than to take every patient report as completely accurate, but what this patient said had the ring of truth to it, and I tend to believe he gave an accurate account of his emergency department experience.

After this disappointment, he came to our program, saying he knew we did care about what happened to him. For the next five or more hours, our OTP counselor tried to get help for this patient.

First, she called our local management entity, or LME. This is a weird, non-descriptive term for local governmental agencies in North Carolina that contract with other mental organizations to provide care for any patient with substance abuse and/or mental health issues. LMEs are the safety net…but the net is broken.

The counselor called the LME and they offered to send a mobile crisis team. This is a grand term implying quick, on-site help for resolution of crises facing the service recipient. Service recipient is the new term for patient, by the way.

The mobile crisis management team consisted of a young woman with a bad attitude and little idea how to talk to patients who were sick and suffering. After an assessment of about forty-five minutes, which necessarily consisted of questions that we had already asked her, this mobile crisis management worker told our patient that he was in opioid withdrawal, and it was likely to get worse instead of better.

At this epiphany of the obvious, our patient thrust his face towards the worker and said sarcastically, “Ya think??” It was obvious our patient did not regard this revelation as particularly helpful. It was also obvious he had offended the worker, who angrily started to pack up her belongings. She said the only thing she had to recommend was going to the emergency room. When our patient informed her he had already gone there two days ago and no help had been forthcoming, the mobile crisis worker said that if he didn’t want to take her advice, she couldn’t make him. She said she could put on the list for a bed at an inpatient program, but it could take weeks for a bed to open. Then she left.

So…I was not at all impressed with the mobile crisis management team.

Our tenacious OTP counselor flew into action again, and called our favorite inpatient treatment program directly. This is a state-run program that’s also an opioid treatment program, named Walter B Jones ADATC (alcohol, drug addiction treatment center). It’s affectionately called “Walter B” by us. It’s the only inpatient program in the state that I know of that will admit patients with opioid addiction and keep them on their maintenance meds or start them on maintenance meds.

I felt that starting the patient on methadone as an inpatient, while benzodiazepine withdrawal was being managed, would be much safer. His mental health status could also be addressed, or at least begin to be addressed. A few weeks as an inpatient won’t fix everything, but it is a start, and the best option we could think of.

Walter B said they wouldn’t have a bed for at least a week, and that they needed an EKG and various labs prior to admission. This is because they don’t want to admit a medically unstable patient. Our patient would still have to go back to the hospital emergency department for the EKG and labs, since our OTP doesn’t have the capacity to do those. But our local emergency department sometimes refuses to do lab tests for inpatient admissions. I don’t know why, but I’m guessing it’s because most of these patients have no insurance, and the hospital assumes they’ll get stuck with the bill.

Next, our OTP counselor called a local detox facility. This facility does not “believe” in methadone maintenance and doesn’t even use buprenorphine to ease opioid withdrawal symptoms. But they do administer phenobarbital to help with benzodiazepine withdrawal, and they could perform the labs this patient needed for admission to Walter B. It wasn’t an ideal solution either, but an option.

No one answered the phone at this detox facility. The counselor left several voice mail messages, but didn’t get any calls back.

Frustrated but by no means willing to give up, our tenacious counselor called Project Lazarus. This is a program in Wilkes County that has received accolades for its work at preventing opioid addiction, overdose deaths, and promoting evidence-based treatments for opioid addicts. People who work at Project Lazarus have connections. They tend to know everybody in the treatment field, so they are often a valuable resource for us. One of their employees did know someone at the detox, and was able to call them through a back channel. That person finally called our counselor back.

Finally, a plan emerged. Our patient would go to this private detox that day or the next, where he could get the labs Walter B wanted. In a perfect world, our patient would leave the detox on the day a bed opens at Walter B. However, if that can’t be worked out, I will admit our patient to methadone as a stop-gap until the inpatient bed opens up. After treatment at Walter B., our OTP will accept him back into treatment and continue efforts to stabilize him.

This isn’t the best plan and it isn’t the safest plan. It’s piecemeal at best, and the plan could still fall through.

Ideally, our LME would contract with an agency that could do all of this for the patient. Ideally, detox beds could be offered on the same day the patient asks for help, with a seamless transition to inpatient treatment to continue patient stabilization. Inpatient treatment programs would offer patients medication-assisted treatment of opioid addiction or abstinence-based treatment and the patient could participate in the choice. Instead, most inpatient facilities don’t even mention the possibility of medication-assisted treatment, so there is no informed consent about which type of treatment is given.

If it took a dedicated and savvy counselor five hours and multiple phone calls to work out a plan for this patient, how would he have been able to access care on his own? Indeed, he did try to access care on his own, and failed to get timely help.

I wish all of the people who recommend inpatient abstinence-based treatment of patients with opioid addiction should be made to try to navigate our present labyrinth of care. This wasn’t even a non-insured person; he had Medicaid, and we still couldn’t find a bed for him.

I know our state has little money with which to treat mentally ill and addicted patients. Budgets for mental health and substance abuse treatments have been cut to the bone and then deeper. The public expects a safety net to appear without having to pay for it. The state-funded facilities do miraculous things with the little money that they have. But no one should have the misperception that our system of care is anything but broken.

Methadone and Buprenorphine During Incarceration

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I recently got this comment to my blog and I hope the writer won’t mind that I’m highlighting his comment. This comment represents one of my pet peeves: patients in recovery from opioid addiction who dose with methadone/buprenorphine are frequently denied their medication if incarcerated.

“Hello, i was recently convicted of an addiction related crime that happened over a year ago, since the indecent I’ve cleaned up my act, have been taking suboxone for over 12 months, 8mg, 3 times a day and now have to go to jail were I’m going to be denied my medication by jail officials/laws, I’ve been in jail before and i kno they do next to nothing for withdrawing opioid patients? From what i hear, it could take months for that type of dosage to get out of my system? Now being a former i/v heroin user of about 7 years, I’ve done a#on my body and feel my health isn’t exactly top notch, i am legitimately concerned about this withdrawal! Should there be sum kind of law protecting us patients? Aren’t these dangerous withdrawal symptoms? Thanks in advance for your response in this matter!”
I am so sick of hearing about patients on methadone or buprenorphine being denied their treatment while incarcerated! I’d love to see someone sue the excrement out of a jail or prison for denying this life-saving medical treatment.

Most counties jails in rural North Carolina won’t allow patients who are prescribed methadone or Suboxone for opioid addiction to take their medication while in jail. I hear (second-hand) that some jails allow chronic pain patients with opioid prescriptions to take their medication, though this may vary according to the county.

As a health care provider, of course I’m opposed to any refusal to treatment a patient while incarcerated. I think it’s a violation of the 8th Amendment about cruel and unusual punishment, but since I’m no legal scholar, I’ve searched the internet for more information about this situation. I found a great article co-authored by a doctor and a lawyer. They make the point that opioid addiction is a complex illness, and forced withdrawal causes severe physical and psychological suffering. Also, because opioid withdrawal makes people especially vulnerable, they may be coerced into giving testimony that incriminates themselves. They are less able to make decisions. (1)

Prisons are charged to provide as much care as is available to prisoners as general population, yet opioid addicts are denied access to medication-assisted treatments for addiction. These treatments are, as you probably know if you’re a regular reader of this blog, one of the most evidenced-based medical treatments in all of medicine.

Jails face legal implications for the prisoners under their control if adverse health consequences occur during withdrawal. A healthy young person usually won’t die from opioid withdrawal, but a medically fragile patient may die. Then the jail can be sued successfully for wrongful death, as happened in Orange County, Florida. But what a shame that it has to come to that to see any change in jail protocol.

A few years ago, I wrote to both the Tennessee and North Carolina chapters of the ACLU (American Civil Liberties Union), thinking if any legal organization would be willing to take up this issue, it may be them. One person with the NC chapter wrote back that in order to take up a case, they need a specific person with a specific case, and that person needs a local lawyer with whom they can work.

I other words, as a physician, I can’t get something stirred up. It has to be a person who is denied treatment with methadone or buprenorphine while in jail.

That’s what I’m hoping to do with my blog post. My readers know many people. If you are reading this and know someone facing incarceration who will be denied their usual medical treatment of methadone or buprenorphine while incarcerated, encourage them to get a lawyer, and ask that lawyer to ask for outside help.

Here’s the website for North Carolina: http://www.acluofnc.org/

As one might imagine, Tennessee’s chapter of the ACLU has many issues to keep them busy, so check it out at http://www.aclu-tn.org/ On their homepage, there’s an article about Tennessee’s contract with a corrections company that operates facilities in that state. It’s interesting reading, and may help us make sense of some of Tennessee’s horrible decisions around addiction issues (follow the money!). Also check out the TN ACLU’s article of protest against the recent law that makes using drugs during pregnancy a crime instead of a health issue.

I know that AATOD (American Association for the Treatment of Opioid Dependence) works with the Legal Action Center in New York, and they have a great website: http://www.lac.org You can read about their advocacy efforts nationwide, and check out their blog, which has advocacy information about this specific issue of medication-assisted treatment behind bars. I believe that the Legal Action Center works with local lawyers nationwide to serve as a resource. I don’t think the LAC actually takes on the cases of patients in states other than New York, but they also may be able to offer help and resources to other lawyers.

My patients tell me it’s difficult to find a local lawyer willing to take on the case of medication-assisted treatment behind bars. Often, such patients are seen as “bad” for having the disease of addiction. Some lawyers may not want to risk the working relationships they have with the judges in their area by advocating for an issue that the lawyer may not find compelling.
Additionally, it’s easy to intimidate many patients on MAT because they already feel shame and stigma. They have a legitimate fear of making their situation worse if they protest poor treatment by the criminal justice system.

I understand all of that, and I’d probably feel the same way. But what’s being done to patients on MAT – forced withdrawal from life-saving treatments of methadone/buprenorphine – isn’t right, and it’s an abomination to human rights. Let’s support these patients in every way possible. Get lawyers, ask them to advocate for you. If they won’t, contact some of the above resources and write back to me about what their response was.

If you are a friend or relative of a person in such a situation, make noise. Write politicians, call the jails, and call judges, particularly those that are elected. Tell jailers how appalled you are at the senseless suffering of patients denied their usual medical treatment.

Most importantly for this issue and others: register to vote. Find out your elected officials’ positions on the legal issues surrounding addiction, and vote accordingly. If you are an addict in recovery, vote. If you are a friend or family member of someone in recovery or in addiction, vote. Let politicians know you will vote against them if they fail to make good laws based on science.

As for me, I have a standard letter I’m willing to send to my patients’ lawyers and to the judges hearing their cases, advocating strongly for them to be allowed to continue their evidence-based treatment with methadone/buprenorphine.

And yes, I vote.

1.Bruce RD and Schleifer, RA, “Ethical and Human Rights Imperatives to Ensure Medication-Assisted Treatment for Opioid Dependence in Prisons and Pre-trial Detention, International Journal of Drug Policy, 2008, February; 19(1): 17-23.

Criminally Pregnant In Tennessee, Part II

pregnant caucasian woman portrait attached with handcuffs isolated studio on white background

Today my guest blogger Dr. Fedup weighs in on my last entry, “Criminally Pregnant,” with his own unique point of view. He gives counterpoints to my arguments, as he feels Tennessee’s law is a good idea. I’ll let him explain his reasoning. His political leanings are somewhat right of center, as you will read.

“I applaud Tennessee’s new law, which makes it a crime to expose a pre-born baby (I don’t believe in using that word fetus, since life begins at conception) to drugs. Too many babies are born with neonatal abstinence syndrome, so obviously Tennessee has grown too soft on crime for this to be happening.

“Bill number 1391, already passed by the state’s legislature, needs only the governor’s signature to become law. In short, this bill says a mother can be prosecuted for “an assaultive offense or homicide if she illegally takes a narcotic drug while pregnant and the child is born addicted, is harmed, or dies because of the drug.”

“Their governor, Bill Haslam, goofed last year when he passed that Safe Harbor Law, which eliminated criminal charges for pregnant women who went into treatment. This new law corrects and cancels that law. Some people have said that’s inconsistent, and not enough time passed since the Safe Harbor Law to see if it was going to work or not.

“I say it’s OK to be inconsistent so long as you are putting people in jail.

“There’s nothing in the new bill to prevent pregnant, opioid addicted women who are in methadone or buprenorphine programs from being prosecuted as well, though bill 1391 does say, “Illegally take a narcotic drug while pregnant.” Women who enter such treatments have already taken illegal narcotics while pregnant, or they wouldn’t need treatment.

“My only problem with the new bill, SB 1391, is that it doesn’t go far enough. We should put the drug addict babies in jail, too.

“Think about it. You know those little suckers enjoyed the drugs they were getting through the placenta, and they need to be punished for that. They’re born addicts. Start punishing them right out of the womb. That way, the state can teach them right from wrong as they grow up, right there in the prison system, like we do with all other inmates in Tennessee jails.

“Some people criticize my idea. Some people say we already put too many people in jail. But I say if U.S. history teaches us anything, it’s that taxpayers are always happy to spend more money on jails.

“We must be willing to incarcerate more people, because U.S. citizens are more evil and criminal than people in other parts of the world. They must be, because we put more people in jail per capita than anywhere else. Circular logic? I don’t care, as long as it puts bad people in jail.

“It was a happy day when the U.S. could finally brag that we incarcerate more people per capita, than even Russia or Rwanda. We’re Number One! We put 716 people out of 100,000 into jails or prisons, and Russia only puts 484 out of 100,000 in prisons. We’re beating them almost two to one! [1]

“Lots of bleeding heart liberals will complain about how Tennessee jails aren’t set up for infants. I say we can fix that. After all, aren’t play pens just jail cells, only prettier? These addict babies don’t deserve anything too pretty, and they’ll get used to the bars soon enough.

“No measure is too severe if it will fix the drug problem. My critics point to all the information collected since the 1950’s which indicates incarcerating addicts does nothing to help addiction rates. But I’m telling you that this new send-an-addict-baby-to-jail program will work.

“While we are on the topic of evil pregnant women who harm their babies, let’s discuss nicotine addiction. There’s more medical evidence to show tobacco smoking harms babies than there is to show cocaine harms babies. Let’s put all those mothers who smoke into jail, too, since they are intentionally harming their pre-borns.

“Then let’s take this train of thought to its logical conclusion. In the latest issue of the Journal of the American Medical Association, there was a great article about the harm maternal obesity does to the fetus. This article reviewed all of the studies of how obesity affects fetal death and infant death. The conclusion was, “Even modest increases in maternal BMI were associated with increased risk of fetal death, stillbirth, and neonatal, perinatal, and infant death.” [2]

“Sounds to me like it’s time to build jails for the fatties, too. Because the state of Tennessee believes that jail time corrects bad behavior.

1. http://en.wikipedia.org/wiki/List_of_countries_by_incarceration_rate
2. 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.

Criminally Pregnant

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I usually don’t post a new entry so soon after the last, but this topic is time-sensitive.

I’m getting tired of writing about Tennessee’s crazy politicians but this time their insanity is so egregious that I can’t let it pass without comment.

The Tennessee house and senate passed a bill that allows a woman to be criminally charged if her baby is born drug dependent. If their Governor Haslam signs this bill, it will become law.

As we know, Tennessee has a terrible opioid addiction problem with one of the highest overdose death rates in the nation. Opioid addiction afflicts men and women in nearly equal numbers, and most of those women are in their child-bearing years. Thus, Tennessee has many pregnant women who have the disease of drug addiction.

Naturally, hospitals have seen a growing number of infants born with opioid withdrawal. Small rural hospitals may not have physicians who are educated about how to treat these babies. It’s a frightening situation, and the response is fear-based: make drug use during pregnancy a crime.
Politicians promote draconian laws that will punish these women, who are probably the most vilified segment of society, and gain favor with voters who don’t understand the underlying issues.

So now Tennessee has a law that makes getting pregnant a crime, if you have the disease of addiction. (By the way, there are other illnesses that can harm the fetus if the mom becomes pregnant, but we have no laws making pregnancy illegal for those patients.)

Supporters of this new insane law probably say it should encourage pregnant addicts to get help before their babies are born. That could be true, if Tennessee had adequate treatment programs in place. As we know, methadone and buprenorphine are the best treatments for opioid-addicted pregnant women, yet under this law, this gold-standard of treatment may also be considered illegal.

So should pregnant moms “just say no” and stop using opioids? We know that going through opioid withdrawal while pregnant is associated with bad outcomes for mom and fetus, what with increased risks of preterm labor, placental abruption, and low birth weights. Over the last fifty years, multiple studies repeatedly show better outcomes when you maintain the mom of a stable dose of methadone, or more recently buprenorphine, during the pregnancy.

If this bill is signed into law by Tennessee’s governor, we can predict what will happen.

After all, what would you do, if you are a pregnant addict and know you will be prosecuted if anyone discovers you’re drug user? You avoid prenatal care. Maybe you get an abortion, even if you really want a baby, because you don’t want to go to jail. Maybe you try to stop using opioids on your own, go into withdrawal, and have one of the complications we know to be common in such a situation. Maybe you have preterm labor at 30 weeks and your baby ends up in the intensive care unit for many months. Worse, maybe your baby doesn’t make it. Or your baby does make it, but is taken away from you at birth, because authorities say an addict can’t care for a baby. Your baby enters the foster care system, with its pitfalls.

In short, this law discourages medical care in the very population of women who can benefit the most from medical care and treatment of addiction!

But wait…this law says the woman can be charged if the baby is born dependent. What about pregnant women who smoke? The infants are technically dependent on nicotine, so that meets this law’s criteria. These women can also be criminally charged. Probably Tennessee would have to build a new jail just for those women, and of course Tennessee’s taxpayers would be happy to pay for their incarceration, right?

In the past, laws against drug use in pregnancy have been unevenly implemented. If you look at the cases that have been prosecuted, nearly all involved poor, non-white mothers. Maybe that’s because law enforcement knows that people of higher socioeconomic status can afford hire a lawyer to defend themselves against these ridiculous laws, which always get struck down on appeal, though that can take years.

Policies that inflict criminal penalties on pregnant women with the treatable disease of addiction cause harm to everyone. Hospitals have higher costs when a mom with no prenatal care arrives on their door step ready to deliver, with much higher rates of perinatal complications. Taxpayers end up paying the high costs of incarceration for these women. But most of all, the babies and their moms are harmed.

Let Governor Haslam know how you feel by writing to him: bill.haslam@tn.gov or call at: (615-741-2001)

Oh No! Zohydro!

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Zohydro ER was approved by the FDA for production and sale in the U.S late last year, and will be available in pharmacies this month. This new medication is an extended-release version of hydrocodone, the same opioid contained in Vicodin, Lortab, and many other generics. But unlike these others, Zohydro is composed only of hydrocodone, without acetaminophen (Tylenol). Zohydro is a schedule II controlled substance, putting it in the same category as oxycodone products like OxyContin.

See my post of January 20, 2012, for my original post on this issue, when a hydrocodone monoproduct was first proposed. Back then, I doubted such a product would ever be released in the U.S., especially if it didn’t contain tamper-resistant features.

I was wrong.

Zohydro comes in multiple strengths of 10, 15, 20, 30, 40, and 50 milligram capsules. These hard gelatin capsules hold beads containing the medication. The manufacturer recommends patients do not crush the capsules, since that would defeat the extended-release feature, and lead to rapid release and absorption of the hydrocodone. This, of course, would place the patient at risk for an overdose.

Some of you are asking why I’m telling people that, since opioid addicts may read this and get the idea to start crushing their medication. Trust me. They’ve already thought of it.

Many experts in the fields of addiction and pain management worry about this powerful new medication, manufactured for the Zogenix pharmaceutical company by Alkermes’ pharmaceutical company. Interestingly, Alkermes also manufactures Vivitrol, the extended-release version of naloxone, now marketed for the treatment of opioid addiction.

More than forty experts sent a letter to the FDA, imploring them to reconsider their approval for Zohydro. These experts worry the release of this new powerful opioid medication, during one of the worst epidemics of opioid addiction in our country, will cause even more opioid medication misuse and overdose deaths. Zohydro has no abuse-deterrent features to make it harder to misuse, heightening fears of misuse and overdose.

In their letter to Margaret Hamburg, M.D., commissioner of the U.S. Food and Drug Administration, the experts reminded the FDA that the U.S. population, which accounts for 5% of the world population, presently consumes 99% of the world’s hydrocodone.

Great point. If we already take 99% of the world’s hydrocodone, do we need to approve a new medication that will give up to five times more hydrocodone per dose?

This letter wasn’t authored by a group of anti-opioid nuts. Indeed, it was signed by some of the most intelligent and thoughtful experts in the field of opioid addiction and treatment. People like Stuart Gitlow M.D., president of the American Society of Addiction Medicine, understand that there are times when opioids are needed, and do not want to eliminate safe treatment for pain. Other respected experts included Andrew Kolodny M.D., the president of PROP, Physicians for Responsible Opioid Prescribing, and Mel Pohl M.D., Medical Director of the Las Vegas Recovery Center, an excellent inpatient program that helps patients with both addiction and chronic pain find satisfactory treatments for both problems. Marvin Seppala, Chief Medical Officer of Hazelden/Betty Ford, also signed the letter.

The FDA’s own advisory committee voted 11 to 2 against approving Zohydro.

Because it doesn’t contain acetaminophen, the drug company argues it’s safer than hydrocodone medications currently available. Many opioid addicts develop tolerance to meds like Lortab and Vicodin and often end up taking ten or fifteen pills per day, giving such addicts a potentially lethal dose of acetaminophen in the process.

While it’s true Zohydro won’t cause acetaminophen toxicity in opioid addicts, it also contains much higher total doses of hydrocodone. Instead of 10mg per pill/capsule, the highest dose in Lortab or Vicodin brands, Zohydro will contain up to five times that amount.

Wait…this sounds familiar…where have we heard this before? Oh yeah. OXYCONTIN! Have we learned nothing from the recent past? The release and inappropriate marketing of OxyContin was one of the driving forces behind our current mess of opioid addiction, which started late last century and coincided with the market release of OxyContin.

If the FDA doesn’t listen to its own advisory panel or a group of forty- plus experts in the field of addiction and drug misuse, who will they listen to? And why?

What’s up with this?

Some people have voiced concern over the current trend of federal employees who leave their posts to become employees of the companies they formerly regulated. This HAS NOT occurred, to my knowledge, in this particular situation. But you can be sure I’m going to have my eyes on current FDA employees and any job changes they may make in the next year.

Johnson City, Tennessee: Department of Justice Decision Due Soon

doj

Last week’s issue of Alcoholism and Drug Abuse Weekly carried an article about the battle to start a much-needed opioid treatment program in Johnson City, Tennessee. As most regular readers of this blog know, many efforts to start a clinic in that area have been shot down by both NIMBYism and poorly informed government officials.

After the state denied a certificate of need, necessary to open an opioid treatment program, the company seeking to start the OTP and other advocates complained to the Department of Justice. The complaint says both the state’s certificate of need process and local ordinances violate the Americans with Disabilities Act because they make it impossible for opioid addicts to be able to access an evidence-based form of treatment, that of methadone maintenance.

Zac Talbott, of NAMA’s Tennessee chapter, was quoted in the ADAW article. He’s also a frequent commenter to this blog, and in the ADAW article, he made the point that Tennessee’s certificate of need process discriminates against the opioid addict, and is literally killing people.

I was also quoted:

“And Jana Burson, M.D., a North Carolina internist who treats opioid addiction with buprenorphine and also works in an OTP, said medication-assisted treatment of
opioid addiction with methadone and “is one of the most evidence-based treatments in all of medicine, yet government officials in Tennessee have repeatedly interfered
with the delivery of this essential treatment to its citizens.”

Noting that Tennessee has a high rate of overdose deaths, Burson said “you’d think they would welcome help to treat opioid-addicted citizens instead of thwarting efforts to establish and opioid treatment program.”

Johnson City and other towns of Eastern Tennessee re-wrote their zoning laws in an effort to prevent methadone clinics from being established, said Burson. Even
though Johnson City’s attorney said there was no intentional discrimination against drug addicts, “history speaks for itself,” said Burson. “Multiple facilities have tried
and failed to get permission for a methadone clinic in that town over the last ten years.” Future generations will likely judge state and local officials harshly for
preventing the treatment of opioid addiction with methadone, since this treatment has been proven to save lives, she said.”

So we wait for the final word of the DOJ decision, which may be made public soon…

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