Archive for the ‘Governmental solutions to addiction’ Category

The Billionaire Pill

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In a recent Forbes magazine article about this nation’s twenty richest families, the Sackler family was number sixteen on the list. The Sacklers are estimated to be richer than the Mellons, Rockefellers, and Busches. (http://www.forbes.com/sites/alexmorrell/2015/07/01/the-oxycontin-clan-the-14-billion-newcomer-to-forbes-2015-list-of-richest-u-s-families/

You say you don’t know the Sackler family? I’ll remind you. They own one-hundred percent of Purdue Pharma, a pharmaceutical company best known for manufacturing their block-buster drug OxyContin.

This is a bitter pill for me to swallow.

I started working in the field of opioid addiction treatment in 2001. At that time, nearly every opioid addict I saw was using OxyContin as their main drug. Opioid addiction in general and OxyContin addition in particular plagued many small towns and rural areas where I worked.

OxyContin was widely prescribed for pain. This powerful drug was advertised as “The one to start with and the one to stay with,” during sales pitches to rural physicians. OxyContin flooded the black market. Opioid addict quickly discovered OxyContin’s time-release coating could be easily defeated, and the pill was often snorted or injected for the rush of opioid euphoria it produced.

I was certainly not the only doctor to notice the rise of OxyContin addiction.

Barry Meier’s book Pain Killer: A “Wonder” Drug’s Trail of Addiction and Death (Rodale Books, 2003), tells the story of small town doctors trying to get the attention of Purdue Pharma, the government, or anybody else who could help change the destruction OxyContin was doing to Appalachia around that time.

I remember attending a pain and addiction conference around sometime around 2003 or 2004. At the end of the lecture explaining how opioids could be prescribe safely, a doctor from Virginia dared to ask the experts something along the lines of, “What are we going to do about OxyContin?” I thought to myself that I was glad someone had finally said what I was thinking.
This was a long time ago; I don’t remember exact words, but my memory is that he was soundly rebuffed for daring to mention one specific drug by name. He was scolded and told that the real problem was with opioids in general, and one drug company (who happened to have some of the lecturers on their payroll) should not be singled out as the problem.

I remembered wishing those experts could spend a day at my treatment program talking to the OxyContin addicts.

Eventually, the U.S. General Accounting Office asked for a report about the promotion of OxyContin by Purdue Pharma. By 2002, prescriptions written for non-cancer pain accounted for 85% of the OxyContin sold, despite a lack of data regarding the safety of this practice. By 2003, primary care doctors, with little or no training in the treatment of chronic non-cancer pain, prescribed about half of all OxyContin prescriptions written in this country. By 2003, the FDA cited Purdue Pharma twice for using misleading information in its promotional advertisements to doctors. [1, 2] Purdue Pharma also trained its sales representatives to make deceptive statements during OxyContin’s marketing to doctors. [3]

Testifying before Congress in 2002, a Purdue Pharma representative said the company was working of re-formulating OxyContin, to make it harder to use intravenously. This representative claimed it would take several years to achieve this re-formulation. The re-formulated OxyContin was finally approved by the FDA in 2010, eight years later. Currently, this medication forms a viscous hydrogel if someone attempts to inject or snort the medication. It isn’t abuse-proof; probably no opioid will ever be so, but it is much more abuse-deterrent than the original.

Did Purdue Pharma drag their feet in this re-formulation? Experts like Paul Caplan, executive director for risk management for the drug company, said there were issues about the safety of incorporating naloxone into the pill to make it less desirable to intravenous addicts. He also pointed out that some delay in approval was due to the FDA.

For comparison, Sterling Pharmaceutical, when it became widely known patients were abusing their pain medication Talwin, re-formulated within a year, adding naloxone to the medication and reducing its desirability on the black market. Since this was in the 1980’s, I would assume there was less technology to help back then, compared to 2002.

I’ll let readers draw their own conclusions.

In May of 2007, three officers of Purdue Pharma pled guilty to misleading the public about the drug’s safety. Their chief executive officer, general counsel, and chief scientific officer pled guilty as individuals to misbranding a pharmaceutical. They did no jail time but paid $34.5 million to the state of Virginia, where the lawsuit was brought.

The Purdue Pharma Company agreed to pay a fine of $600 million. Though this is one of the largest amounts paid by a drug company for illegal marketing, Purdue made 2.8 billion dollars in sales from the time of its release in 1996 until 2001.

None of the Sackler family members were charged, because they were not involved in the day to day running of the company.

And now the Sackler family is worth billions.

1. General Accounting Office OxyContin Abuse and Diversion
report GAO-04-110, 2003.
2. United States Senate. Congressional hearing of the Committee
on Health, Education, Labor, and Pensions, on Examining
the Effects of the Painkiller OxyContin, 107th Congress, Second
Session, February, 2002.
3. Washington Times, “Company Admits Painkiller Deceit,”
May 11, 2007, accessed online at http://washingtontimes.
com/news/2007/may/10/20070510-103237-4952r/prinnt/ on
12/18/2008.

New Book About the War on Drugs

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I’ve got a great new book to recommend to anyone interested in the U.S.’s failed war on drugs. It’s “Chasing the Scream: The First and Last Days of the War on Drugs,” by Johann Hari. Published in 2015, I heard about this book at an Addiction Medicine conference when it was highly recommended by one of my colleagues.

As the title implies, the first part of the book describes how the war on drugs was initiated, not by the Reagans, but by Harry Anslinger, our first drug war general, back in the 1930’s. Anslinger is portrayed as an arrogant man, close-minded, filled with hubris, and lacking in compassion. He played on the public’s worst prejudices in order to get draconian drug laws passed, and showed no mercy enforcing them. He fanned the flames of public fears of drug-intoxicated minorities in order to expand his scope of power and prestige. His statements, preposterous from a medical point of view, still echo in the mouths of politicians today.

The author says Anslinger helped to create U.S.’s first drug lord, Arnold Rothstein, who is only the first of many ruthless gangsters to follow. Demand for drugs in the face of strict drug laws creates irresistible opportunities for criminals. The book describes how the war on drugs re-incarnated Anslinger and Rothstein with each generation; the names change but the tactics and destruction remain the same.

It’s an interesting concept.

Part Two of the book describes the lives of drug addicts. The author shows how people with addiction are forced to behave like sociopaths in order to maintain their supply of drugs. For example, many addicts deal drugs on a small scale to help finance their own drug use, an action they would be unlikely to undertake without the strong motivation of their own addiction.

The author goes on to illustrates how police crackdowns on drug dealers actually lead to increased gang violence. When top drug-dealing gang members are jailed, it creates a power vacuum, which leads to increased violence as rival gang members jockey for positions of power. Ultimately, the amount of drug dealing remains the same.

His reasoning does make sense, and is backed by interviews from urban bystanders in the violence of drug wars, both in the U.S. and Mexico.

This section of the book also discusses the inequalities of the drug war. The war on drugs is really a war on people who use drugs, and minorities are much more likely to targets of the drug war. Black drug dealers are more likely to be arrested than white dealers. People with money and influence aren’t targeted, while police go after the downtrodden, less likely to mount legal defenses if treated unfairly. Police do this in order to meet arrest quotas with less trouble from those targeted.

I could believe this, but then in the same section, the author also accuses police of expanding their budgets by confiscating high-dollar cars and homes from the rich people caught in the drug wars. So that was a little contradictory.

The author points out how a youngster who gets arrested for a drug offense is unemployable for the rest of his life, and how he can’t get student loans or public housing. To me that sounded a little overblown, since I know people who have managed to go to school, get their GED, then get a college education and even an advanced degree. I’m sure having a crime in one’s background makes this more difficult, but not impossible. That makes me question the accuracy of the author’s other assertions. For example, I have no idea if a drug charge eliminates all possibility of public housing.

Part three of the book is hard to read. In it, the author describes inhumane treatment of addicts who have been jailed. Arizona is noted for being a particularly brutal state for addicted inmates.
Inmates in general in the U.S. are treated horribly but no one seems to care, since few people have compassion for criminals.

This same section of the book also describes the horrible violence in Mexico brought about by the U.S. demand for illicit drugs. With so much profit to be made, drug cartels become ruthless. The author says in order to make sure other potential rivals stay in fear, dealers must engage in ever-increasing violence and depravity.

The fourth section of the book presents interesting ideas. First of all, the author claims the desire to get high is nearly universal. Far from being a deviant desire, the author advances the theory that the desire for intoxication is found in all humans in all civilizations at all times of human existence. He questions the goal of eliminating all drug use, and says it isn’t realistic.

I agree with him. The desire for euphoria is hard-wired into humans. When that urge runs amok, we may seek to satisfy that desire incessantly with drugs or other destructive behaviors.

The author then describes how life events affect the risk of addiction as if this were something new, but we’ve known for years that stress affects addiction risk. People who have experienced abuse and deprivation as children are more susceptible. But then the book connects our society’s present method of dealing with addiction, which is to shame addicts and cause them more pain. This approach is, predictably, counterproductive.

He says the more drug addicts are stressed, forced to live in poverty, are ostracized and shamed, the less likely they are to be able to find recovery.

Then the book goes into a weird tangent, saying that opioid withdrawal really isn’t all that bad, and the withdrawal is mostly mental in nature. He quotes some scientists who say that people living interesting and productive lives don’t get addicted, because they are happy. The book implies that the biological model has been overblown and scientists ignore the psychosocial components that cause addiction.

He’s wrong. Experts in addiction and its treatment haven’t forgotten the psychosocial components of addiction. But for decades, people have argued addiction is just bad behavior. They say addicts need punishment, rather than coddling in treatment programs. These people completely denied scientific components of the disorder. As a result, scientists interested in treating addiction poured money, time, and energy into proving the scientific portion of the disease. But now the same people who said there was no science to support addiction as a disease complain that scientists ignore the role of psychosocial factors that cause addiction.

In reality, both biologic AND psychosocial factors influence who becomes addicted. It isn’t either/or but both/and. It isn’t productive to argue about which is more important, because both types of causative factors need to be addressed in the disease of addiction.

The fifth part of the book is the most interesting. Chapters in this section describe the changes that occurred when drug addiction was treated more as a public health problem and less like a crime.

In a grass roots organization in Vancouver, Canada, a heroin addict managed to mobilize people to approach heroin addiction in a completely new way. This addict unified addicts and the people who care about them to create political pressure. This group attended town meetings, protested, and organized people who cared about the marginalized addicts of Downtown Eastside of Vancouver. Eventually, this organization managed to create such a stink that the mayor of Vancouver met with this addict-leader, and was so impressed by the insights and arguments that he authorized the establishment of a safe injection house.

Ultimately, Vancouver had one of the most progressive and harm-reduction oriented policies on drug addiction. Their overdose death rate plummeted. Health status of addicted people improved.

Similar harm reduction policies were enacted in Great Britain and in Switzerland, with similar reduction in overdose death rates and in improved health status for drug addicts. In Great Britain, physicians could legally prescribe heroin for opioid addicts for a period of time, from the mid-1980’s until 1995, when this program was ended. All of the health gains – reduced overdose deaths, reduced crime, reduced gang activity, and improved physical health for the addicts – were instantly reversed as soon as the program was stopped.

An entire chapter is dedicated to the changes seen in Portugal, where drugs are now decriminalized, but not legalized. This means thought drug use is not a crime, selling these drugs is still illegal. This chapter describes the changes that happened in Portugal, where harm reduction and public health strategies were enacted beginning in 2001. The nation has one of the lowest rates of illicit drug use in the world, though it’s important to understand that heroin has traditionally been the main drug of this country. Addicts’ lives are more productive and death rates are down. Crime rates dropped, and now the whole country supports these harm reduction strategies to the draconian drug laws that Portugal had in the past.

Near the end of the book is a chapter about what is happening in Uruguay, a small South American country where drugs are now not only decriminalized but legalized.

Anyone interested in the creation of a sound drug policy needs to read this book. It’s extensively researched, and the author spoke with many of the key individuals responsible for changes in drug policy all over the world. I haven’t critically researched all data he quotes in his book about the results of drug decriminalization and legalization, but he gives references for much of what’s contained in the book so that any interested reader can do so.

This book is uniquely interesting because the author combines data and statistics with personal stories of various addicts and their families. This technique combines the power of individual story with the facts of a more objective and detached view.

I don’t agree with all of the authors conclusions. For example, when he tries to say addiction is more about a person’s socioeconomic and emotional status rather than about the drugs…nah. Addiction is not all about the addictive nature of the drug itself, but it is a major factor. When you discount the euphoric attraction of opioids, cocaine, and the like, you risk misunderstanding a huge part of addiction. When a substance produces intense pleasure when ingested, it’s more likely to create addiction. After all, we don’t get addicted to broccoli…

It’s important to know this author has been in hot water in the past, accused of plagiarism. Knowing this made me a little distrustful of his interviews with people throughout the book, but I think the ideas illustrated by the interviews are still valid.

It’s a book filled with food for thought.

Durham, North Carolina: First in the South to Provide Naloxone to Departing Inmates

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The county jail’s addiction treatment program in Durham County, North Carolina, just started giving naloxone overdose prevention kits to inmates leaving their program.

This program, called STARR (Substance Abuse Treatment and Recidivism Reduction) consists of around 83 hours of group therapy, addiction treatment education, and weekly 12-step meetings. STARR participants are also taught how to respond to an overdose, and how to use naloxone. Inmates completing this program are also eligible to enter an additional voluntary four-week program known as GRAD. All graduating inmates are offered a naloxone kit.

At any one time, the STARR program has about 40 inmates in treatment.

Only three county jails in North Carolina offer addiction treatment services. Besides Durham County, Mecklenburg and Buncombe Counties have similar addiction treatment programs, but neither of the latter two offer naloxone kits. The development of education and prevention of overdose was achieved only after long efforts by the STARR program’s director, Randy Tucker, collaboration with the Harm Reduction Coalition.

Durham County is setting the right example for the rest of the nation.

It’s important to teach inmates with addiction how to avoid overdose. Inmates with addiction are at high risk for a fatal overdose during the first few weeks after their incarceration. While in jail, their tolerance has dropped. If they leave jail and relapse using the same amount as before they went to jail, an overdose is likely, particularly if they are using opioids.

Studies on all continents show this marked increase in overdose death among opioid addicts leaving incarceration. The degree of increased risk is debatable. Some sources say the risk is increased four-fold and others estimate a hundred-fold increase in overdose deaths risk, mostly within the first two weeks after leaving incarceration.

Last year, four people leaving the Durham County jail had fatal overdoses.

If the US treated addiction as the public health problem that it is, all state, county, and federal jails would provide naloxone upon dismissal from incarceration. (I won’t even get into the arguably more important issue of providing adequate addition treatment to inmates whose main problem is addiction). But we don’t do that in this country, still preferring to see addiction as bad behavior by deviants.

Ferguson, Missouri…Baltimore, Maryland…think how the attitudes and outlook of citizens could change, if jailers started handing out naloxone kits to departing arrestees.

Even without words, this action would go a long way toward giving arrestees the message that law enforcement saw their lives are valuable and worth saving.

New OTP Guidelines Issued by SAMHSA

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Our nation’s Substance Abuse and Mental Health Services Administration just published new guidelines for opioid treatment programs, released in late March. SAMHSA updates the guidelines in order to re-interpret the existing federal regulations in the face of changing medical issues faced by opioid treatment programs in this country.
I can’t list all the updates in a single blog entry, but I’ll comment on those I find most interesting and relevant. If you want to read the entire SAMHSA document, you can get a free download at: http://store.samhsa.gov/product/PEP15-FEDGUIDEOTP

First of all, near the beginning of the document, it says the new guidelines reflect the responsibility that OTPs have to deliver “patient-centered, integrated, and recovery oriented standards of addiction treatment and medical care in general.”

I’ve long marveled at how, in the mental health and addiction treatment field, so many words can be used without saying much of anything. (I once heard the head of a federal government agency talk for forty-five minutes and say absolutely nothing. That is a gift.) Also, words and phrases in this field take on meaning beyond what those words traditionally mean. Innocent-looking phrases take on coded meanings.

For example, “recovery-oriented”…what does that mean? Part of what this phrase seems to mean is the same as what “harm reduction” meant in the past, except it became so controversial that we needed a new phrase.

Recovery-oriented means a patient’s recovery program may not look like what we’ve imagined in the past. Maybe the patient isn’t fully abstinent from all drugs, but if the patient is doing better than in the past, we accept that as a worthy accomplishment. Rather than black and white thinking of abstinence as the only recovery and any drug use as a full relapse failure, recovery-oriented approach means accepting any change for the better as a worthy goal.

I am fine with this. The field of medicine is harm-reduction. At least, that’s what it’s like in primary care. It may be different in surgery, where the diseased gall bladder can be cut out and the patient is permanently cured of gallstones. But much of primary care is all about keeping the patient as healthy and functional as possible, for the longest time possible, despite some non-compliance on the patient’s part. It makes sense to view the treatment of addiction in the same way.

Integrated: the bane of my existence…it means all people caring for the patient, plus the patient, TALK to one another. I’ve whined on this blog before about the difficulty of talking to my patient’s other doctors so I agree it’s a big problem but SAMHSA’s kind of preaching to the choir with that one.

It also means getting the patient’s family and/or friends involved if possible and if OK with the patient, along with other supports available in the community.

These new SAMHSA guidelines also tackled new technologies, like telemedicine.

Patients in remote locations can now communicate with care providers using new technology, sometimes called telemedicine, or e-therapy, or telehealth. This technology can make care more convenient for patients who live in remote areas, and encourage more participation in care by making it easier to access. These are worthy goals, but of course there are also risks.

Since Medicaid and Medicare services already has guidance for this type of care, the new OTP guidelines remind us of we have to do if we treat patients with Medicaid or Medicare… and want to get paid.

The new OTP guidelines make several points. They remind us that providers need to follow their own states’ laws around telemedicine, and to make sure transmissions of data during telemedicine are secure, relatively resistant to hacking. The guidelines also remind us telemedicine can’t expand a provider’s scope of practice (what the provider is allows to do, medically speaking), and that telemedicine can’t be used in situation where physical exam is necessary.

At first, I interpreted this to mean that admission to opioid treatment programs cannot be done by telemedicine, since a physical exam is required. But then I read this sentence: “…[telemedicine] may be used to support the decision making of a physician when a provider qualified to conduct physical examinations and make diagnoses is physically located with the patient.”

So can a physician assistant do the exam and relate finding to a physician who then can order the starting dose? I think that’s allowed by this sentence, at least by federal standards. State standards may vary, though.

This discussion naturally leads to another big expected change in the new guidelines. Many people working at OTPs expected these new guidelines to permit physician extenders like nurse practitioners and physician assistants to do admission history and physical exams for OTP patients, give induction orders, and do dose change orders.

This did not happen. Apparently, according to discussion at the AT Forum (http://atforum.com/2015/04/new-otp-accreditation-guidelines-will-not-allow-mid-levels/ ) SAMHSA’s lawyers put a halt to this, and said physician extenders could not do these things. The lawyers said that implementation regulations say “dosing and administration decisions shall be made by a program physician familiar with the most up-to-date product labeling.”

I have mixed feelings about allowing physician extenders, by which we mean nurse practitioners and physician assistants, to do admission orders. Often, patients presenting for OTP admission are complex, with both chronic pain and addiction issues, sometimes also with severe mental health disorders. I don’t think a new nurse practitioner graduate with little experience could do the job without a whole lot of special training. On the other hand, I know a physician assistant, working in the Addiction Medicine field for years, who is as good if not better than many doctors in the state. He’s competently been doing admissions and dose changes for years.

Thankfully, a sort of compromise has been proposed. Treatment programs can ask their state opioid treatment authority (SOTA) for an exemption from usual regulations, to allow a qualified physician extender to do admission orders and dose changes. Both the program’s medical director and program sponsor must give a clear reason why an extender is necessary to improve care. Then SOTA decides if allowing this particular physician extender enhances the care of patients at that treatment center.

For example, a program in a remote area may have problems finding physicians to work as many hours as the program needs. In that case, the medical director may know a physician extender who is experienced and mature, who could safely meet patients’ needs. That program could explain all of this to their SOTA and get an exemption, permission for the extender to do work ordinarily not allowed by state and federal regulations.

This seems like the best of both perspectives. Well-trained and competent physician extenders can get permission to do this work, while the state can withhold approval for an extender with little experience or training. Hopefully exemptions will be given for legitimate need, and not just because extenders are cheaper to hire than physicians.

Finally, I was pleased this version of the OTP guidelines frankly discusses the dangers of benzodiazepines: “…Benzodiazepines are highly associated with overdose fatalities when combined with opioids. Patients known to be using benzodiazepines even by prescription should be counselled as to their risk and provided with overdose prevention education and naloxone.” The guidelines go on to recommend providers consult IRETA’s best practices guidelines around how to manage the benzo issue without overreacting in either a too permissive or too restrictive manner.

Regular readers of my blog will recall I did several blog posts, in 1/26/14 and 2/2/14, about the IRETA guidelines when they were first published.

In the past, SAMHSA guidelines didn’t speak to the dangers of mixing benzos with MAT, leading some doctors to underestimate the dangers to MAT patients. In some areas, where benzos are prescribed appropriately, it’s not a big issue. However, in geographic areas (like the South) where benzos are commonly prescribed outside of accepted guidelines, it’s a huge problem. I often see patients prescribed benzos literally for years, despite guidelines which say benzodiazepine usefulness is limited to a few weeks to months. There’s no evidence benzodiazepines are of benefit past that, and mounting evidence indicates that they can be harmful (overdose, increased risk of falls and motor vehicle accidents, broken bones especially in the elderly, etc.)

I did find one sentence on naloxone, the medication that reduces opioid-overdose deaths, under the section on orientation to treatment. It says OTPs should provide patient education, including “Signs and symptoms of overdose, use of the naloxone antidote (prescriptions should be given to patients on entry into treatment), and when to seek emergency assistance.”
It’s not much, but it’s a start.

Use of prescription monitoring programs was mentioned repeatedly in these new guidelines. In 2007, when the last guidelines were published, many states didn’t have prescription monitoring programs. My state’s PMP was just becoming available in 2007, so it was a new and exciting tool.

Sections of the present SAMHSA guidelines strongly recommended the PMP be used upon admission to an opioid treatment program, and periodically during OTP treatment. The guidelines suggest the PMP be checked quarterly, which should be do-able.

I think SAMHSA’s new guidelines bravely addressed some of the problem areas of OTPs and gave some direction to programs about these issues. It’s not a perfect document, but it appears much thought and discussion was given to these issues.

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 “Protect Our Infants Act”

Rate of neonatal abstinence syndrome per 1,000 live births, by mother's county of residence

Rate of neonatal abstinence syndrome per 1,000 live births, by mother’s county of residence

(This map can be seen at:http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6405a4.htm )

I just read an interesting news piece about new legislature named “Protecting Our Infants Act.” This bill was sponsored last year by Rep. Katherine Clark of Massachusetts, but died during the session. Then she got support from other congressmen, including Rep. Steve Stivers from Ohio (who happens to represent the area of the country where I was raised, in Southeastern Ohio), and Sen. Bob Casey of Pennsylvania. When Majority leader Senator McConnell got onboard as a sponsor of the bill this year, it gained momentum, and is now in a congressional committee, waiting to be sent to the house or Senate.

When I first heard about this new bill, and that Senator McConnell was backing it, I worried it might be something weird and unscientific that would send us backward in time. But after reading the bill online for myself, I’m in favor of it: https://www.congress.gov/bill/113th-congress/senate-bill/2722/text

This bill asks the Secretary of Health and Human Services to collect and evaluate all of the best evidence-based information available about how to prevent and treat babies born dependent on opioids. The bill’s actual wording is that the secretary of HHS “shall conduct a study and develop recommendations for preventing and treating prenatal opioid abuse and neonatal abstinence syndrome, soliciting input from nongovernmental entities, including organizations representing patients, health care providers, hospitals, other treatment facilities and other entities, as appropriate.”

The bill asks for Health and Human Services to identify and also report on any gaps in our knowledge, where more research is needed. The bill also requests an evaluation of medical use of opioids during pregnancy, and an assessment regarding access to treatment for opioid-addicted pregnant women and post-partum women. The bill asks for an evaluation of the risk factors for opioid addiction, and the barriers to treatment.

According to the bill, the Secretary of Health and Human Services will collect all this information and post it on a website, available healthcare providers in the U.S., in no less than one year after the bill (hopefully) passes.

Our present Secretary of Health and Human services is Sylvia Mathews Burwell, who replaced Kathleen Sibelius last summer. I didn’t know much about her, so I went to the website for HHS, and found a blog post of hers, addressing our epidemic of opioid addiction: http://www.hhs.gov/blog/2015/03/26/its-time-act-reduce-opioid-related-injuries-deaths.html

I really like what I read. In her blog post, she emphasizes three areas which need attention: wider distribution of naloxone to prevent opioid overdose deaths, better prescribing practices by doctors, and…“using medication-assisted treatment to slowly move people out of opioid addiction.”

What a relief. She supports MAT. I mean, one would hope and expect such support for evidence-based treatments, but as my readers know, sometimes politicians take strong positions on matters about which they know little (oh yes I’m talking about Tennessee).

If the Secretary does a good job, this is a golden opportunity to promote evidence-based treatment of opioid addiction in pregnancy: MAT.

I also think some politicians could learn things they didn’t expect.

Is it possible that with such a prominent seal of approval, both methadone and buprenorphine treatment of opioid addiction will move out of the dark ages? Perhaps politicians will say, “Oh I now see I don’t know what I’m talking about when I limit access to treatment at methadone and buprenorphine programs! How foolish of me!”

Is it possible that someday in the future I’m going to call a certain obstetrician in my area about the methadone dose of a patient we both treat, and he will say, as he’s said before, “It’s wrong to treat pregnant patients with methadone. You need to get them off that stuff!”

And I will say…please go to the Health and Human Services website, to read what the experts say, since you won’t believe me. And he will read. And he will change his mind. He will begin to encourage all his opioid-addicted patients to seek effective, evidence-based treatment… And the health of the whole community will improve as we come to agree on evidence-based solutions to medical problems.

So my first train of thought was a happy engine, chugging along with optimism and relief. Then came the caboose of negativity.

Why do doctors need to have the Secretary of Health and Human Services research this issue for them? For prevention, yes, that’s a public health issue and more research would be valuable. But to find out how to treat a medical issue?? If doctors have a question about how to deal with a medical issue, we have sources that summarize and review best data to date. We go to a reliable source, to the experts in the field. For the topic of opioid addiction in pregnancy, one would ask obstetricians and addiction medicine doctors.

Oh wait. The American College of Obstetrics and Gynecology, along with the American Society of Addiction Medicine, already have published a position paper of best practices in this area. It is titled, “Opioid Abuse, Dependence, and Addiction in Pregnancy.” They didn’t hide their report in a dark cave. They published it. They posted it on the internet:

In fact, if you Google “pregnancy and opioid addiction,” one of the first options is ACOG’s paper: http://www.acog.org/Resources-And-Publications/Committee-Opinions/Committee-on-Health-Care-for-Underserved-Women/Opioid-Abuse-Dependence-and-Addiction-in-Pregnancy
And for those people who are deeply puzzled by how to treat opioid addiction in pregnancy, this is the summary sentence of the report, published in 2012: “The current standard of care for pregnant women with opioid dependence is referral for opioid-assisted therapy with methadone, but emerging evidence suggests that buprenorphine also should be considered.”

That wasn’t so hard, was it?

Then I Googled “american academy of pediatrics and neonatal abstinence syndrome,” because I figure who knows kids better than pediatricians, and my first choice was a state of the art review article from 2014 describing NAS and its treatment in detail.

After considering the “Protecting our Infants Act,” I have several observations. First, it’s not terribly hard to find state of the art information about the treatment of opioid addiction in pregnancy, and the treatment of neonatal abstinence syndrome, if the healthcare worker really wants to find it. But if the healthcare worker can’t or won’t accept these answers due to ideology, a report from the Secretary of HHS may carry more weight than the science that’s already available.

I also believe we have a whole lot more to learn in this field. This new Act’s best feature is the mandate to assess areas where we need more research, and to investigate barriers to treatment, because there are many. For example, Eastern Tennessee has one of the highest rates of NAS in all the country, yet that state denied a certificate of need for a methadone clinic to be established to serve that area. I do believe that history will judge those politicians harshly.

I hope the bill passes. It would be interesting to see what the Act’s current sponsor, Senator Mitch McConnell, would think about the DHH report.

North Carolina Pregnancy & Opioid Exposure Project

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Imagine being in a room filled with more than four hundred people: social workers, nurses, substance abuse counselors, and doctors specializing in obstetrics, pediatrics, and addiction medicine. Every one of them are there to learn how to care for pregnant women using opioids or addicted to opioids.

This actually happened earlier this month at the POEP conference in Greensboro, NC. (POEP stands for Pregnancy & Opioid Exposure Project. You can learn more about this organization at their website: http://www.ncpoep.org )

This organization, funded through a federal block grant through the NC Department of Mental Health, is run by the UNC School of Social Work. The organization has managed to bring together many of the people in our state who take care of pregnant women with opioid addiction. The goal of POEP is to disseminate information, resources, and technical assistance regarding all aspects of opioid exposure in pregnancy. The organization was formed in 2012 in response to concerns about the problem of pregnant women being exposed to opioids.

This organization is talking about all opioid use in pregnancy, not only about addiction in pregnancy. Some pregnancy women are prescribed opioids for the treatment of pain. These women may have physical dependence on opioids, though they may not have the mental obsession and compulsion to take opioids. However, the same problems can be seen in the newborn whatever the reason the woman takes opioids, so there is overlap in the problems faced.

This conference had renowned speakers; Marjorie Meyer, an expert in maternal-fetal medicine from Vermont, was the keynote speaker. This doctor participated in the MOTHER trials, and also set up an innovative treatment method in Vermont for mothers addicted to opioids. She has written about her data, and contributed greatly to our knowledge about buprenorphine in pregnancy (see my blog post of February 28, 2015).

Dr. Hendree Jones, lead author of the MOTHER study, did an excellent session on myths about medication-assisted treatment in pregnancy. She’s also a world-renowned leader in the field of addiction in women.

Dr. Stephen Kandall was there, and spoke about the challenges of advocating for women with addiction, with some historical perspective. He wrote an outstanding book, “Substance and Shadow: Women and Addiction in the United States,” which is one of my all-time favorites. It’s one of the best books about females and addiction. This conference was the first time I met Dr. Kandall, and I got all creepy-gush-y, and dithered about how much I loved his book. I can be such a nerd at times, but he was very polite and gracious.

There were many sessions going on at the same time, so it was impossible to go to all of the sessions that I wanted to attend. Other speakers talked about how best to coordinate care for pregnant women when they go to the hospital to deliver their babies, how to work with the court system if the pregnant woman has legal problems, and how to work with female patients on opioids about family planning.

I was honored to be one of the four-doctor panel that was organized to answer audience questions about medication-assisted treatment with buprenorphine and methadone during pregnancy. We got some great questions, like how to deal with co-occurring benzodiazepine use during pregnancy. Our session was only forty-five minutes long, and we probably could have spent a few hours answering all their questions. I was also impressed by the thoughtful opinions and recommendations from the other three doctors, all leaders in our state.

This conference was a great experience. I felt like many of the attendees got a better view of what opioid-dependent pregnant women need, and where and how to direct them for the best care. I’m pleased people in our state cared enough to start the difficult work of informing families and care providers about the problem of opioid use and addiction during pregnancy.

POEP has a great website that I’ll recommend to the pregnant women I treat, and I’ll also recommend it to their obstetricians. That site has clear information not only for families, but also for care providers. Here are the fourteen important points for infant care providers, taken directly from the POEP website:

“Key Messages for Infant Care Providers Working with Families of an Opioid-Exposed Newborn
________________________________________
1. Parents should be counseled as early as possible (preferably well before delivery) about the need for close monitoring of an opioid-exposed infant.[2]
2. Parents should be encouraged to disclose any maternal opioid use that occurred during pregnancy and should be treated in a nonjudgmental manner.[3]
3. Hospital care of the newborn should be family-centered, meaning that the parents should be a driver in the care plan.
4. Parents should receive education about how opioid-exposed infants are monitored and how neonatal abstinence syndrome (NAS) is treated at their delivery hospital.
5. There are various approaches to monitoring for neonatal abstinence syndrome in opioid-exposed infants, such as the use of the Finnegan Scoring tool.[2],[3]
6. Monitoring for the onset of NAS may mean the infant will be monitored in the hospital for up to 5 days.
7. Infants at risk of NAS may be monitored in the mother’s room, in the newborn nursery, special care nursery or neonatal intensive care, depending on hospital protocols and resources.
8. There are various approaches to the management of NAS including non-pharmacologic interventions and pharmacologic therapy, depending on the needs of the infant. Approaches include:
• Non-pharmacologic management of NAS: environmental controls emphasizing quiet zones, low lighting, and gentle handling. Loose swaddling, as well as holding and slow rocking of infant may be helpful. The use of a pacifier for excessive sucking is also helpful.[2],[6],[7]
• Pharmacologic management of NAS: the use of a variety of medication to ease the withdrawal symptoms of the infant. Common medications include opioids (dilute tincture of opium, morphine, or methadone) and phenobarbital.[2],[6],[7]
9. Breastfeeding is encouraged for women in medication assisted treatment, unless there are medical reasons to avoid it. Reasons to avoid breastfeeding include an HIV infection or specific medication for which breastfeeding is not safe.[2],[3]
10. Infants experiencing NAS may have difficulty establishing breastfeeding or bottle-feeding. Women may need additional encouragement and lactation consultation to support breastfeeding.[2],[3]
11. Whenever possible, having the newborn room-in with the mother while in the hospital is encouraged. Benefits include opportunity to initiate breastfeeding, bonding and decreased need for treatment of NAS.[1]
12. Some infants will experience NAS as a result of maternal opiate use through a treatment program (such as a methadone maintenance program) or by prescription (such as buprenorphine for an opioid use disorder or prescription narcotics for pain management). The opioid exposure alone in situations where the mother was adherent to a prescribed treatment plan would not constitute an appropriate reason for referral to Child Protective Services. See structured intake 1407 http://info.dhhs.state.nc.us/olm/manuals/dss/csm-60/man/
13. Not all infants at risk of NAS are identified in the hospital, particularly in situations where maternal use of opioids has not been disclosed. This may be due to women not disclosing legal or illegal use of opioids.[2]
14. Withdrawal symptoms from opioids may appear in the infant after discharge to home. It is important for providers working with the infant and the family in the community (pediatricians, CC4C, Early Intervention) to be aware of signs and symptoms of NAS. If the infant displays any of these signs or symptoms, the family should be encouraged to seek pediatric care promptly.[2]”

North Carolina has a great start in addressing the problem of opioid-exposed newborns. The organizers of POEP can stand as an example of how other states can begin to address this challenging situation. Neighboring states (you know I’m talking about Tennessee!) have walked in the opposite direction, preferring to view opioid use during pregnancy as a crime rather than the medical problem that it is. That’s sad, because an aggressive attitude of judgment is correlated with poorer outcomes for both mother and infant.

Congratulations to the organizers of the POEP conference. Hopefully it was the first of many more to come.

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