Archive for the ‘Governmental solutions to addiction’ Category

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.

Expanding Access to Buprenorphine

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My last blog post stimulated some lively debate, and I thought this topic deserved further discussion. However, I would like to ask commenters to talk about the issue and please refrain from mentioning specific names of previous commenters. Please and make your points in a thoughtful and respectful manner. Thanks for your cooperation.

Given our present epidemic of opioid addiction and opioid overdose deaths, authorities are considering lifting the 100-patient limit for physicians who prescribe buprenorphine from office-based settings. Some people in the addiction treatment field oppose expanding access to buprenorphine in the office setting, saying some of these patients don’t get the counseling that they need, but only medication. They say there aren’t enough regulations to prevent shady physicians from opening buprenorphine mills.

Experts on both sides of the debate make good points. It’s a tough topic, but let’s explore the issues further.

1. “You don’t provide enough counseling.”

Weirdly, this used to be a main complaint against OTPs, but now OTP personnel are directing the same complaint toward office-based buprenorphine physicians.

Is there any data to help us decide how much counseling is enough for opioid-addicted patients who are started on medication, either buprenorphine or methadone?

The POATS trial gives some information on this topic. (Weiss et al, 2010, http://ctndisseminationlibrary.org/protocols/ctn0030.htm )

POATS showed that opioid-addicted patients maintained on buprenorphine/naloxone were likely to reduce illicit opioid use during treatment with the medication, but most relapsed after being tapered off the medication at twelve weeks. So this part of the study supported keeping patients on medication longer, just like the older data with methadone for heroin users. No surprises so far.

Now comes the interesting part: POATS showed similar outcomes for patients getting standard medical management versus standard medical management plus fairly intense counseling. The group with added counseling didn’t do any better than the standard medical management group.

However, the standard medical management consisted of an hour-long first visit with the doctor, and a fifteen- to twenty- minute visit per week for the first four weeks, then every two weeks.
This may be more than an average buprenorphine doctor provides in real life. It’s a little more than I do for my office-based patients. My first visit with new patients is one hour, and usually I see them back in one week for a twenty-minute visit. But then, if they are doing well, I see them every two weeks, until the patient is established in counseling. After that, if all is going well, I cut down to monthly visits. I conclude that the average buprenorphine doctor may have to increase visit frequency to get the results seen in the POAT study.

The group with enhanced counseling treatment got 45 minutes with a counselor twice per week for the first four weeks, then twice per month. At present, patients of OTPs must have two counseling sessions per month, even at the beginning of treatment. Opioid clinic opponents say twice per month isn’t even close to enough counselling, and use this point as a reason to say opioid treatment programs deliver bad care.

The POAT study was relatively short. Twelve weeks may not be long enough to detect an improvement in patients getting enhanced counseling. We know life changes usually don’t happen quickly. Maybe it is unfair to say the counseling didn’t help, because the patients weren’t followed long enough.

Now let’s look at interim methadone. Interim methadone was proposed as an alternative to long waiting lists for patients to enter an opioid treatment program. People were concerned about the welfare of opioid addicts who wanted help, but had to wait for a treatment slot to open. Interim methadone is a short-term, simplified treatment where methadone medication is started for the opioid addict, until the patient can be admitted to an OTP. With interim methadone, some counseling given, but only for emergency situations. Drug screening is still done, but is more limited than for OTP patients. These interim patients can transition to a traditional opioid treatment program when a slot opens for them.

It appears that starting just methadone, with limited other services, still helps the patients. Studies show these patients are less likely to continue to use heroin, are less likely to commit crimes, and more likely to enter a full-service OTP when admission is offered. [1]

Would “interim buprenorphine” work as well? I don’t think there are any studies to give us data, but it seems logical that it would.

2. “Just apply to be an OTP”

Government officials have said that if office-based physicians wish to see more than one hundred buprenorphine patients, the physician should apply to become an opioid treatment center.

When I first read this suggestion, I laughed, because it sounded so silly to me. Well-intentioned though this statement might be, it starkly exposed a lack of knowledge of the average physician’s economic circumstances.

I don’t know many doctors like me who have the necessary capital to do this. Some professionals in the field estimate it takes starting capital of around a quarter of a million dollars. I’ve seen one OTP fold due to inadequate financial support and management, and another escape closure by a narrow margin. These days, it takes deep pockets to afford the eighteen to twenty-four month process to establish an OTP. Getting the certificate of need alone can take years. (Just look at Crossroad’s struggles to get a CON in Eastern Tennessee, an area with arguably more opioid addiction per capita than most other states!)

OTP sites must be approved by multiple agencies: the DEA, CSAT, SOTA, and local authorities to name a few. The pharmacy has to meet strict regulations, as do personnel. If you want to accept Medicaid, that’s another avalanche of regulation and paperwork.

I’m not saying it’s impossible for a physician to open an OTP, but I am saying that it would cost so much that most doctors who treat opioid addiction wouldn’t consider it. I could be wrong – maybe my colleagues are making a whole lot more than me…

3. “In it for the money.”

Experts in the field who work for opioid treatment programs oppose expansion of office-based treatment, saying doctors charge exorbitant fees for their patients. Sadly, in some cases, they are right. But many office-based doctors charge reasonable fees. If we allowed doctor to treat more than one hundred opioid-addicted patients at one time with buprenorphine, wouldn’t that reduce demand for services? And when demand decreases, shouldn’t cost of treatment drop too?

For example, let’s take a community where one buprenorphine doctor is price gouging, and charging $500 per month for only one doctor’s visit. The second buprenorphine doctor charges $250 per month for the same service plus addiction counseling. Both are at their one- hundred patient limit. If both were allowed to increase the number of their patients, wouldn’t the second, more reasonably-priced doctor get some of the more expensive doctor’s business?

Conversely, some advocates for office-based treatment say that opioid treatment programs are upset because they have lost money in recent years. They accuse organizations like AATOD of wanting to limit further expansion of office-based programs because it cuts into their business. With more access, more patients would abandon OTPs for these less restrictive programs

DATA 2000 changed the landscape of opioid addiction treatment. OTPs aren’t the only option for patients seeking treatment for their opioid addiction.

My point is, both OTPs and buprenorphine doctors can accuse the other group of being in it for the money. But as I pointed out in my last blog…no medical treatment in this country is free.

4. “My medication is better than your medication.”

Patients entering opioid addiction treatment often ask me, “Which is better, buprenorphine or methadone?” I say, “Both.” Each has its advantages, and I’ve discussed this in previous blog entries. Briefly, buprenorphine is safer, since there is a ceiling on its opioid effects, but it’s more expensive. Patients on buprenorphine also seem to leave treatment prematurely more often than methadone patients. This isn’t a good thing, since the majority of these patients relapse back to illicit opioid use.

Methadone, as a full opioid agonist, may be more difficult to taper off of, and maybe fewer patients leave treatment prematurely because of that feature. Methadone has been around for fifty years now, with a proven track record. It works, and it’s dirt cheap. Methadone does have more medication interactions, but those can usually be managed if all the patient’s doctors communicate with each other.

Buprenorphine isn’t strong enough for all opioid addicts. Because it’s a partial agonist, there’s a ceiling on its opioid effect. This property means it’s much safer than methadone, but it doesn’t work for everyone.

Buprenorphine is safer than methadone, which to me is its best quality. I’ve started hundreds of patients on buprenorphine and never had an induction death. Sadly, I cannot say the same of methadone. I am not saying overdose death is impossible with buprenorphine…I’m saying it’s much less likely, and that’s worth a lot to me.

Buprenorphine’s superior safety profile is one reason it was approved for use in an office setting. Methadone is riskier to prescribe from an office, because misuse and diversion is more likely to be fatal with this drug. That’s why buprenorphine has fewer restrictions on it. Neither medication is good or bad; the difference between the medications is pharmacologic, not moral.

Next week, I’ll describe my OTP, where we provide methadone, buprenorphine under the OTP license, and buprenorphine under my office-based license, all on the same premises. I think we’ve created a continuum of care that’s able to meet the needs of patients as their recovery evolves.

At our program, it’s not one program versus another. Difference patients need different things, and the same patient may need different things at different points in recovery.

1. Schwartz et al, “A Randomized Control Trial of Interim Methadone,” Archives of General Psychiatry, 2006

Office-based Opioid Addiction Treatment: Raising the One-hundred Patient Limit

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The hearts of addiction medicine doctors nationwide are aflutter at rumors that the limit on office-based buprenorphine patients may be raised or lifted. As it is now, the DATA 2000 law says each doctor who prescribes buprenorphine from an office setting for the treatment of opioid addiction can have no more than one hundred patients at any one time.

DATA 2000 was a big deal. Until it passed, it was illegal for any doctor to prescribe any opioid to treat opioid addiction, unless they worked at a specially licensed opioid treatment program. In other words, doctors in an office setting had to refer opioid-addicted patients to opioid treatment centers for medication-assisted treatment. And the only medication available was methadone.

Then DATA 2000 allowed Schedule 3 opioids to be prescribed from physicians’ offices for the purpose of treating opioid addiction, as long as these medications were FDA-approved for this purpose. Thus far, buprenorphine is the only medication that meets the DATA 2000 requirements.

But the law had other limitations. For example, each physician had to get a special DEA number to prescribe buprenorphine. And as above, no physician could have any more than one hundred patients on buprenorphine at any one time.

My office gets multiple calls each week from people seeking treatment for opioid addiction in an office setting. These callers say they’ve already been to the websites that list doctors. (http://buprenorphine.samhsa.gov and http://suboxone.com . They’ve made multiple calls and discovered these doctors aren’t taking new patients because they’re already at their one hundred patient limit. This is happening all over the country; patients want treatment but can’t get it. For many such people, opioid treatment centers are geographically impractical, so that’s not an option either.

Since addiction is a devastating and potentially fatal disease, government officials feel pressure to do something to help our nation’s opioid addiction problem. Lifting the one- hundred patient limit has been suggested as one option to improve the situation. This would seem to be the best, easiest, and quickest way to get more people into treatment. At least, most Addiction Medicine doctors like me think it makes sense.

Not everyone agrees.

Opposition has come from some unexpected sources. I went to an opioid addiction treatment conference in a neighboring state lately and heard the president of AATOD (American Association for the Treatment of Opioid Dependence), Mark Parrino, MPA, speak against lifting the limit.

First let me say I admire Mr. Parrino immensely. He has been and continues to be a huge advocate for this field. He’s done more good in the field of opioid addiction treatment than most people I can think of, and has been doing this good work long before I ever even entered the field.

But that doesn’t mean I agree with him on everything.

When he spoke at the conference, he said he was opposed to expanded buprenorphine treatment in the office-based setting because patients don’t get the counseling that they need, so it really isn’t medication-assisted treatment, it’s just medication assistance. He says opioid treatment programs provide on-site counseling, drug testing, and other services that can help patients, and that most office-based programs don’t offer such comprehensive services. He also said diversion of buprenorphine from office-based practices is a huge problem, and that much of the black market use is actually abuse of the medication. He raised the uncomfortable issue of price gouging by some unscrupulous buprenorphine doctors who charge large fees and deliver little care.

You can read a statement on the AATOD website that fully describes their opposition – or at least call for caution – regarding raising the one hundred patient office based treatment limit:

http://www.aatod.org/policies/policy-statements/increasing-access-to-medication-to-treat-opioid-addiction-increasing-access-for-the-treatment-of-opioid-addiction-with-medications/

I don’t completely disagree with the points Mr. Parrino made at the conference, but I do think the same arguments can be made against OTPs if one were inclined to do so.

What about opioid treatment programs that pay lip service to the counseling needs of the patients? What about OTPs that hire people to be counselors with little or no experience in the counseling field? Just as Mr. Parrino can point to the worst examples of office-based buprenorphine treatment, I can point to OTPs who aren’t doing a great job. How can an OTP counselor provide Motivational Interviewing as a therapeutic technique if that counselor has never even heard of MI? Yet I’ve seen these problems at opioid treatment programs.

Don’t paint all office-based practices with the same brush. Many of us want to provide good treatment with adequate counseling. For example, my office has a therapist who is a Licensed Professional Counselor with a Master’s in Addiction Counseling. He does a great job, and as an added bonus has great legs. (He’s my fiancé, before you assume I’m sexually harassing him at the workplace).

Alternatively, if the patient prefers to do only 12-step meetings, I’m OK with that, so long as they provide me with a list of meetings they’ve attended each month. Or if they’re already working with a therapist, it’s OK with me if they want to continue, as long as they agree to allow me to speak with their therapist about issues directly relating to the treatment of their addiction.

Diversion of buprenorphine to the black market is a big problem. Not all office-based buprenorphine doctors are as careful as we should be. We will never be able to get rid of all diversion of any controlled substance that we prescribe, but all buprenorphine doctors should be doing drug screens and have diversion controls in place to limit the problem.

Not as much methadone is diverted, but only because of the very strict regulations on methadone take- home doses at the OTP. Many patients – and OTP personnel – feel present regulations on methadone take- home doses are overly strict and limit flexibility of treatment for patients who are doing well. Is the answer then to regulate take -home doses of buprenorphine as closely as methadone?

What about the predatory doctors who prescribe buprenorphine just for a quick buck, sensing they can charge exorbitant fees from desperate opioid addicts? I can’t say anything in their favor. They embarrass me. As with many things in life, the actions of a few give the rest of us a bad reputation. But I do think these doctors are in the minority.

And don’t believe everything you are told about office-based practices; I’m sometimes told by patients that I’m in it “for the money” though I charge the same for an office visit for a buprenorphine patient as I would for any other medical ailment. Some patients feel like their treatment should be free, but the U.S system of medical care is not usually free for any disease.

In short, though I recognize there’s some truth in many of Mr. Parrino’s statements, I still think most buprenorphine doctors try very hard to do things right so that they provide good care for opioid addicts who can’t or won’t go to an opioid treatment program. Expanding access by raising the one-hundred patient limit will allow more people to get addiction treatment.

Criminally Pregnant In Tennessee, Part II

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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!

aaazohydro

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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