Archive for the ‘Governmental solutions to addiction’ Category

Criminally Pregnant In Tennessee, Part II

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

1. http://en.wikipedia.org/wiki/List_of_countries_by_incarceration_rate
2. Aune, et al, “Maternal Body Mass Index and the Risk of Fetal Death, Stillbirth, and Infant Death: a Systematic Review and Meta-analysis,” JAMA, 2014; 311(15):1536-1546.

Criminally Pregnant

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Oh No! Zohydro!

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

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

I was wrong.

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

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

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

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

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

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

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

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

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

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

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

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

What’s up with this?

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

Johnson City, Tennessee: Department of Justice Decision Due Soon

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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…

A Really Good Book – For Free

aaaaaabook

If you haven’t read CASA’s (Center on Addiction and Substance Abuse, at Columbia University) masterpiece publication from June, 2012, titled “Addiction Medicine: Closing the Gap between Science and Practice,” you should do so. This publication can be downloaded for free, and has essential information about addiction and its treatment. http://www.casacolumbia.org/addiction-research/reports/addiction-medicine

Casa also has other free and informative publications about other issues, like how to reduce the risk of addiction in teens (“The Importance of Family Dinners” series), the cost and impact of untreated addiction on society (“Shoveling Up”), substance abuse and the U.S. prison population (“Behind Bars” series), and the availability of drugs on the internet ( “You’ve got Drugs” series). All of these contain useful and thought-provoking data.

“Addiction Medicine: Closing the Gap between Science and Practice” outlines all aspects of what is wrong with addiction treatment in the U.S., along with recommendations about how we can fix this broken system. When it was published in June of 2012, I thought it would be would be widely read and discussed. However, I’ve only heard it mentioned once, and that was at an ASAM meeting. I wish popular press, so eager to write sensationalistic pieces about addiction, would write more fact-based information.

Every politician should read it. Every parent should read it. Physicians and treatment center personnel should read it. Anyone who is concerned about the extent of addiction and its poor treatment in the U.S. should read it.

CASA describes their key findings of the drawbacks of the U.S. system – or non-system – of addiction treatment. This nation is doing many things wrong, to the detriment of people afflicted with addiction, their families and their communities. Our mistakes are based on ignorance, misperceptions, and prejudice. All of these impede our ability to help our people with addiction. The CASA report describes these factors and how they have contributed to our present situation.
Our nation hasn’t waged a war on drugs, but rather on people who use drugs.

The CASA report describes how public opinion about addiction isn’t based on science. Science proves addiction is a brain disease, yet this fact is still debated. We know that continued use of addicting substances alters the structure and function of the brain, affecting judgment and behavior about the continued use of drugs even when bad consequences occur. We know that half of the risk for developing addiction is determined by genetic makeup. Yet surveys show that about a third of U.S. citizens still feel addiction is due to lack of willpower and self-control. Why are public attitudes so disconnected from science?

Addiction is a complicated diagnosis, existing as it does at the end of the continuum from occasional drug use to regular use to compulsive use. People often compare a drug user with a drug addict. They say that since the drug user was able to stop when he wanted that the drug addict should be able to stop when he wanted. This compares apples to oranges. If someone can comfortably stop using drugs when given a good enough reason to do so, this person isn’t an addict. They may be a drug abuser, a problem user, and at high risk for addiction, but they haven’t crossed the line into uncontrollable use.

The CASA report pointed out that most addiction treatment and prevention isn’t done by physicians and health professionals. Most addiction treatment is provided by counselors who, for the most part, aren’t required to have any medical training. Only six states require a bachelor’s degree to become an addiction counselor, and only one (Alabama, go figure) requires a master’s degree.

Even when physicians are involved in the treatment of addiction, most of us have very little, if any, training in medical school or residencies about addiction prevention or treatment. Ironically, most of our training focuses on treating the consequences of addiction.

In medical school and residency, I spent countless hours learning about the proper treatment of cirrhosis, gastritis, anemia, pancreatitis, dementia, and peripheral neuropathy from alcohol addiction. I had little if any training about how to treat alcohol addiction, and none about how to prevent it.

We know brief interventions by physicians during office visits can reduce problem drinking and are an effective way to prevent problems before they occur. Yet few physicians are trained to do this brief intervention. Even if they are trained, primary care physicians and physician extenders are being asked to do more and more at each visit with patients, and asked to do it with less and less time. Primary care providers may not be adequately paid for screening and brief intervention for problem drinking and drugging, and valuable opportunities are lost. Yet that same patient may consume hundreds of thousands of healthcare dollars during only one hospital admission for medical consequences of problem alcohol use.

When I practiced in primary care, I often thought about how I never got to the root of the problem. I would – literally – give patients with serious addiction strikingly absurd advice. “Please stop injecting heroin. You got that heart valve infection from injecting heroin and you need to quit.” I could see it was ineffective, but I didn’t know any better way at the time. I assumed if there was a better way to treat addiction, I’d have learned about it in my training.

Wrong. The doctors who trained me couldn’t teach what they didn’t know themselves.

In my Internal Medicine residency, I admitted many patients to the hospital for endocarditis (infected heart valve) contracted from IV heroin use. Each time, this required six month of intravenous antibiotics. Back then we kept such patients in the hospital the whole time. You can imagine the cost of a six week hospital stay, not that these addicts had any money to pay. Just a fraction of that amount could have paid for treatment at a methadone clinic, the most effective way to treat heroin addiction, and prevent dozens of medical problems.

But I never referred them to the methadone clinic available in that city. I didn’t know anything about methadone or the medical-assisted treatment of opioid addiction, and apparently my attending physicians, responsible for my training, didn’t know about it either. It was a shame, because in those years, the late 1980’s, we were making new diagnoses of HIV almost daily among IV drug users. Since then, a study showed a patient using IV heroin drops his risk of contracting HIV by more than threefold if he enrolls in a methadone clinic.

I didn’t learn about the evidence-based treatment of opioid addiction until I agreed to work at a methadone clinic for a few days, covering for a friend of mine when he wanted to go on vacation. I was amazed to learn about decades of evidence showing the benefits of such treatment.

Most addiction-related medical expenses are paid for from public funds. In fact, over ten percent of all federal, state, and local government dollars are spent on risky substance use and addiction problems. Sadly, over 95% of this money is spent on the consequences of drug use and abuse. Only 2% is spent on treatment or prevention.

Untreated addiction costs mightily. People with untreated addiction incur more health care costs than nearly any other group. An estimated one third of all costs from inpatient medical treatment are related to substance abuse and addiction. Untreated addicts (I include alcohol addicts with drug addicts) go to the hospital more often, are admitted for longer than people without addiction, and require more expensive heath care than hospitalized non-addicts. The complications these people suffer could be from underlying poor physical health and lack of regular preventive healthcare, but most of the cost is incurred treating the medical problems directly caused by addiction and risky substance use.

Family members of people with untreated addiction have higher health costs, too. Families of people with addiction have 30% higher health care costs than families with no addicted member. I presume that’s from the stress of living and dealing with a loved one in active addiction. Often family members are so caught up in trying to control the chaos caused by active addiction that they don’t take time for routine health visits.

The costs of untreated addiction aren’t only financial. Addiction and risky drug use are the leading causes of preventable deaths in the U.S. Around 2.9 million people died in 2009, and well over a half million of these deaths were attributable to tobacco, alcohol, and other drugs. Overdose deaths alone have increased five-fold since 1990.

We know addiction is a chronic disease, yet we spend far less on it than other chronic diseases.
For example, the CASA report says that in the U.S., around 26 million people have diabetes, and we spend nearly 44 billion dollars per year to treat these patients. Similarly, just over 19 million have cancer, and we spend over 87 billion for treatment of that disease. In the U.S., 27 million people have heart disease, and we spend 107 billion dollars on treatment.

But when it comes to addiction, we spend only 28 billion to treat the estimated 40.3 million people with addiction, and that includes nicotine!

Most of the money we do spend is paid by public insurance. For other chronic diseases, about 56% of medical expenses are covered by private payers, meaning private insurance or self-pay. But for addiction treatment, only 21% of expenses are paid from private insurance or self-pay. This suggests that private insurance companies aren’t adequately covering the expense of addiction treatment. Indeed, patients being treated with private insurance for addiction are three to six times less likely to get specialty addiction treatment than those with public insurance such as Medicaid or Medicare. Hopefully we will see a change since the parity law was passed. (which told insurance companies they had to cover mental health and substance addiction to the same degree they cover other health problems)

In the U.S., we don’t treat addiction as the public health problem that it is. Some people still don’t believe it’s an illness but rather a moral failing. Doctors, not knowing any better, often have an attitude of therapeutic nihilism, feeling that addiction treatment doesn’t work and it’s hopeless to try.

Families and medical professionals often expect addiction to behave like an acute illness. We may mistakenly think addiction should be resolved with a single treatment episode. If that episode fails, it means treatment is worthless. Families want to put their addicted loved one into a 28-day treatment program and expect them to be fixed forever when they get out. They’re disappointed and angry if their loved one relapses.

This reminds me of an elderly man I treated for high blood pressure many years ago. I gave him a month’s prescription of blood pressure medication, and when he came back, his blood pressure was good. I was pleased, and I wanted to keep him on the medication. He was angry. He said he was going to find another doctor. He thought the one prescription should have cured his high blood pressure so that he would never have to take pills again, and was disappointed with my treatment.
If we keep our same attitude toward addiction treatment, we are doomed to be as disappointed as my patient with high blood pressure. Addiction behaves like a chronic disease, with period of remission and episodes of relapse.

We have a lot of work to do. As this CASA publication shows, we have to change public attitudes with scientific information and do a much better job of training physicians and other health care providers. We should pay for evidence-based, high-quality addiction treatment, rather than spend billions on the medical problems caused by addiction as we are now doing.

Check out this landmark publication at CASA’s website: http://www.casacolumbia.org

Government Behaving Badly: Tennessee does it Again

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I just read Tennessee’s new law regulating the treatment of opioid addiction with buprenorphine in office-based practices, due to take effect July 1, 2014.

I repeatedly criticize Tennessee’s policies on addiction treatment, but they keep doing weird and counterproductive things, so I must blog about them. I don’t even blog about every little stupid thing Tennessee lawmakers say or do (like the comment by a Republican state senator that HIV can’t be transmitted by heterosexual sex), partly because my blog would have room for little else.

But this latest law relates directly to the treatment of addiction treatment with buprenorphine, a medication better known as one of its brand names, Suboxone. One of the state legislators, Mr. Kelsey, sponsored a bill that regulates how doctors can prescribe this medication. No, Mr. Kelsey is not a doctor. No, he has no special qualifications that would indicate he has any scientific knowledge about addiction or its treatment.

To be fair, some parts of this bill contain good ideas. For example, one part of the bill says that sublingual buprenorphine can be prescribed only for addiction, and not for pain. Addiction is the only FDA-approved indication for the sublingual form of buprenorphine. However, some unscrupulous Tennessee doctors have been avoiding the federally mandated one hundred buprenorphine patient limit per doctor by claiming many of their patients are being treated for pain, and don’t have addiction. These doctors may be helping patients, but they are flaunting their ability to get around federal law. That gives addiction treatment a bad name and reputation with law enforcement. Dutiful and law-abiding physicians like me, careful to have no more than their one hundred office-based patients at any one time, get their reputations damaged by these doctor scofflaws.

The bill also dictates that every physician who prescribed buprenorphine has to check the state’s prescription monitoring program prior to issuing a prescription. Well, duh. That’s the standard of care, so if doctors aren’t doing that, they will have to start.

The bill goes on to say that only physicians with the proper DEA “X” number can prescribe buprenorphine to treat addiction, and that nurse practitioners and physician assistants can’t be granted permission to prescribe sublingual buprenorphine. That’s already federal law, so it’s a little redundant, but OK. I know some great NPs and PAs who could do a good job, but the law is what it is.

Now we come to the parts of the bill that I don’t agree with.

The bill says the mono-product buprenorphine (equivalent to the name brand product Subutex) should only be prescribed to pregnant women and patients with proven allergies to naloxone. I do acknowledge the problem this part of the law is intended to address; the mono-product is somewhat more desirable on the black market, and more subject to diversion and misuse. I agree that the combination product, containing both buprenorphine and naloxone, is preferable, since it is less likely to be abused by injection, and less desirable on the black market.

However, cost of treatment medication has prevented many patients from entering or staying in treatment. Yes, opioid addicts do spend more each day on illicit opioids that they would spend to be in treatment, but many opioid addicts finance active addiction with crime: theft of property, minor drug dealing, prostitution and the like. We hope patients in treatment don’t have to maintain a life of crime to afford treatment!

The generic mono-product is about half the price of even the generic buprenorphine/naloxone combination product. That puts the combo product out of financial reach for many people without health insurance. Name brand combination products like Suboxone and Zubsolv are priced even higher than the generic combo product.

I’ve had patients, doing wonderfully in treatment, suddenly lose their health insurance. They couldn’t afford to pay $400 per month for the name-brand Suboxone film, and the generic combination product was nearly as expensive. So I switched them to the generic mono-product and they were able to remain in treatment. I’m fine with that, as long as I know the patient well, and don’t believe they are in danger of relapsing to IV drug use.

However, I’m not willing to prescribe a month of generic mono-product buprenorphine to a patient I’m seeing for the first time. It’s a judgment call, and I need to be assured of the patient’s stability before I’d prescribe the generic mono-product.

Our opioid treatment program uses the mono-product, because the combo product costs so much. People have criticized us for this, but the other option is methadone. My experience tells me the risk of complications, overdose, or death from diversion is much greater with methadone compared to mono-product buprenorphine. Buprenorphine is much safer, and since we are an OTP, we can administer the medication once a day, with observed dosing.

It is a judgment call…but it should be MY judgment call, as their physician. I don’t think a legislator has the expertise to decide which patients are appropriate for which medication. If I were an oncologist, I wouldn’t want state legislator to decide which chemotherapy drug I can prescribe. Call me crazy, but wasn’t that the whole point of medical school?

It gets much worse. This bill dictates that patients on sublingual buprenorphine can be on no more than 16mg per day for the first six months, and no more than 12 mg per day for the second six months.

This decision is stunning in its hubris. I suspect some misinformed doctor told the legislators that patients don’t need more than sixteen milligrams, while that’s true for most patients, some patients do benefit from higher doses. Some patients feel better at twenty-four milligrams. And even if the patient doesn’t get any benefit, more medication won’t hurt the patient, because of the ceiling effect of buprenorphine. Once a patient’s opioid receptors are blocked with buprenorphine, the patient won’t feel any different at a higher dose. Unlike methadone, more medication doesn’t have more effect, a nice safety feature of buprenorphine.

I suspect the law giving dose ceilings is meant to keep patients from asking for a higher dose, and then selling part of their prescription. I admit the problem, but I don’t think legislated dose limits are the best answer, to say the least. Treatment programs do have to be careful of medication diversion for patients who say they need the higher doses, in case there are plans to divert the medication.

In the POATS (Prescription opioid Addiction Treatment Study, Weiss et.al) (1) study secondary analysis, drop-out rates were better with higher doses of buprenorphine, leading some doctors to conclude we may be under-dosing patients somewhat. But I’m sure Tennessee’s legislators won’t let a little detail like FACTS get in their way of dictating medical care, because it hasn’t stopped them in the past.

This bill also says that if a patient tests positive for opioids three or more times while in treatment, the physician must discontinue treatment.

What a spectacularly ill-advised decision…Tennessee doesn’t have enough opioid treatment programs to admit patients who fail the office-based treatment Tennessee is regulating with this law, and doesn’t have affordable inpatient treatment for opioid addicts (believe me, I’ve tried getting a opioid-addicted patient into an inpatient drug addiction treatment program in Tennessee and it is next to impossible). Death rates for people with untreated opioid addiction are estimated to be eight to sixty-three times higher than non-addicted age-matched controls. What will become of these people? Does a government have the right to tell people they will be refused treatment for their medical illness?

The logical extension of Tennessee’s reasoning can extend to other chronic illnesses with behavioral components. What if you have high cholesterol, but you fail to improve after starting a cholesterol-lowering medication? Will the government refuse to allow you to be prescribed any more medication if you fail to improve after three months? How about if you have high blood pressure, and fail to lose weight and exercise within a reasonable time period? Will the government tell your doctor he has to stop treating you, because you refused to do the right things to help your illness? How about if you have one heart attack, but continue to eat bad foods and don’t quit smoking and eating red meat? Is there some point at which your state government will tell your doctor he can no longer treat your heart disease? Will you be cut loose from medical care completely because of your non-compliance?

The ignorance exposed by the passage of this bill takes my breath away. How did legislators come to believe they had the requisite knowledge and experience to know what dose of buprenorphine opioid-addicted patients need, and how long they need it?

We all know what a mess Tennessee has on its hands. Its doctors prescribe more grams of opioids per capita for its citizens than 48 other states. The entire state, but especially the Eastern portion of the state, has one of the highest rates of opioid overdose deaths in the entire country.
Yet Tennessee’s answer to this vital problem is to pass regulations that limit the treatment of addiction!

I suspect the American Society of Addiction Medicine and/or the Tennessee Society of Addiction Medicine will have official responses to this draconian law that has passed, and maybe also the Tennessee chapter of NAMA and AATOD too. I look forward to their statements.

And Tennesseans, you’ve got to get organized. Every patient in opioid addiction treatment, all of their family members, all other concerned members of the community, medical and otherwise…register to vote. Stay aware of who is sponsoring these harmful laws, and if you can, speak to legislators with your vote.

1. http://www.drugabuse.gov/sites/default/files/files/BupPOATS_Factsheet.pdf

Bad Science on “Homeland”

Bad Science on "Homeland"

Bad Science on “Homeland”

I’d like to announce my willingness to serve as a media consultant on topics relating to opioid addiction. I’m prompted to do this after another bit of bad science on TV.

There I was, catching up on recorded episodes of “Homeland,” one of my favorites. One of the main characters, Brody, was on the run since he was suspected of planting the bomb that blew up the CIA. He survived an abdominal gunshot wound, and then was imprisoned in a weird high rise for the homeless in Venezuela by a mysterious group of people who may or may not have his best interests at heart. To treat both his physical and mental pain, he was encouraged to shoot up opioids, and he became addicted.

Saul, acting head of the CIA, flies to Venezuela to fetch Brody back to the U.S. for a top secret mission. He found Brody, strung out of opioids, living in squalor, and in terrible shape. He’s so appalled by the smell in Brody’s cell that he does the male equivalent of a pearl clutch…he puts a handkerchief to his nose. Brody is transported back to the states, where he goes into terrible opioid withdrawal. He’s screaming, groaning, and stewing in secretions.

Saul needs him to be well in order to take part in a clandestine mission in Iran. Saul asks his staff if there’s any way to get Brody back into shape and out of withdrawal faster. One of the team mentions methadone, and Saul says something like no, we need for him to be functional.

No one mentions buprenorphine.

Shifty CIA operative Dar Adal pipes up that ibogaine will cure Brody but will have bad side effects like hallucinations. A sidekick adds, “Yes, violent, mind-bending hallucinations.” Adal then mysterious says (everything he says is mysterious) “Take my word for it.”

So they give poor Brody ibogaine, and he has violent, mind-bending hallucinations. He screams. He cries. He has terrifying hallucinations of his old war buddy, now dead. At one point presses his face to the window of his cell, screaming, “What did you give me??”

I guess such histrionics make better TV than seeing Brody look normal after several days of methadone or buprenorphine.

After the agony of the ibogaine, Brody is well enough to start running and getting back into shape.

Now for the truth: Ibogaine is a hallucinogenic psychoactive substance found in some species of plants that grow in Africa. It’s been used in religious ceremonies, chewed to give a mild stimulant effect. With increased doses, this substance has hallucinogenic effects. Ibogaine has effects on at least three types of brain receptors. Ibogaine’s metabolite, noribogaine, has serotonin reuptake inhibition properties, like found in many antidepressants. It also has a weak opioid effect on the mu opioid receptors and a stronger effect at the kappa opioid receptors, causing less dopamine to be released. It also has effects on at least two other receptor types.

Limited studies show that since the drug does block the release of dopamine, it may have some benefit in the treatment of addiction. Both animal studies and case reports suggest ibogaine may reduce withdrawal symptoms of opioid addiction and craving for cocaine. But so far there have been no good scientific trials of the drug. This drug has been outlawed in the U.S. and in most European countries due to concerns about the drug’s side effects and case reports of death. (See my blog post of June 1, 2013) Ibogaine’s supporters claim this drug can cure addiction to alcohol, cocaine, opioids, and nicotine.

In other words, there are case reports of possible benefits of ibogaine, but it is not at present an evidence-based treatment for opioid addiction.

I’m really getting annoyed with Homeland. It was my favorite show in the past, but started to drag this season. (Don’t get me started on the booooring Dana storyline.) Now it has me snorting in disgust at bad science.

Thin ice, Homeland…you are on thin ice with me. If you need a medical consultant, I’m available.

Overdose Death Rates in the U.S…..by County

fig1.jpg

I read this great journal article about overdoses in the U.S., and since it had a map, I must include it in my blog. The actual article is of course interesting, and free to the public at this web address: http://www.ajpmonline.org/article/S0749-3797(13)00490-X/fulltext

I love maps. In a glance, a map can tell a story.

This article deals with drug overdose deaths, which are now the most common cause of injury death in the U.S. Most people know drug overdose deaths, fueled by the increased availability of prescription opioid medications, have increased over 300% in the U.S. over the past thirty years.

We’ve had data at state levels about rates of drug overdose deaths, but this article was unusual because it reported death rates from drug overdoses by county in each state in the U.S. Overdose death rates by county can be misleading, because the data deal with smaller sample sizes. Several overdoses can skew the data significantly, making the data unstable. This study used statistical techniques to reduce this problem. Because some age groups have higher overdose death rates than others, this study also controlled for age in their calculation of overdose deaths.

Several things struck me as I looked at the article. Even though I know the Western part of the U.S. has had increasing problems with overdoses, the map drove that home. Vast expanses of red cover large parts of large states. This shows it isn’t just Appalachia dealing with overdoses.

I was also struck by New York State’s relatively lower rates of overdose than its surrounding states. I wonder if their lower rates of drug overdose deaths have anything to do with better acceptance of opioid treatment programs in that state.

After all, methadone treatment for heroin addiction started in New York City, at Rockefeller University, by Drs. Dole, Nyswander, and Kreek in 1964. Dr. Dole even won the Lasker Award in Medicine for this life-saving treatment innovation. At the AATOD (American Association for the Treatment of Opioid Addiction) conference earlier this month, I was honored to hear a lecture by Dr. Kreek, who still works at Rockefeller University, about the last fifty years of opioid addiction treatment with methadone.

New York’s prescription monitoring program has been operating since 1983, considerably earlier than the majority of states in the U.S. New York’s Medicaid program covers opioid addiction treatment with methadone and buprenorphine. New York has some of the most prestigious medical schools and teaching hospitals in the U.S. Overall, New York is usually considered more progressive than, say….. a state like Tennessee.

And of course I’m going to take my usual poke at Tennessee’s Department of Mental Health. Just last summer, a certificate of need for an opioid-addiction treatment program for Eastern Tennessee was rejected by this department. State officials said there was no need for additional treatment for opioid addiction in this area.

Take a look at the map. Tennessee is a red state in more ways than one. Once again, objective data indicates Tennessee’s opinions are not fact-based. The addicts of Tennessee continue to pay the ultimate price for this close-minded approach.

Each State Gets a Report Card

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You have got the check this out…an organization called Trust For America’s Health, or TFAH, supported by the Robert Wood Johnson foundation, has released a report called, “Prescription Drug Abuse 2013: Strategies to Stop the Epidemic.” You can find the report at their website at: http://www.healthyamericans.org

This report grades each state on its policies for managing the prescription pain pill epidemic.

The report begins with a description of the scope of the problem: current estimates say around 6.1 million U.S. citizens are either addicted to or misusing prescription medications. Sales of prescription opioids quadrupled in the U.S. since 1999, and so have drug overdose deaths. In many states, more people die from drug overdoses than from motor vehicle accidents. The costs of addiction and drug misuse are enormous; in 2011, a study estimated that the nonmedical use of prescription opioids costs the U.S. around 53.4 billion dollars each year, in lost productivity, increased criminal justice expenditures, drug abuse treatment, and medical complications.

The report identifies specific groups at high risk for addiction. Men aged 24 to 54 are at highest risk for drug overdose deaths, at about twice the rate of women, although the rate of increase in overdose deaths in women is worrisome. Teens and young adults are at higher risk, as are soldiers and veterans. (Please see my blog of October 19th for more information about veterans.) Rural residents are twice as likely to die of an overdose as urban residents.

TFAH’s report declares there are ten indicators of how well a state is doing to fix the opioid addiction epidemic. This report grades each of the fifty states by how many of these indicators each state is using. TFAH says these ten indicators were selected based on “consultation with leading public health, medical, and law enforcement experts about the most promising approaches.”

Here are their ten indicator criteria:
 Does the state have a prescription drug monitoring program?
 Is use of the prescription drug monitoring program mandatory?
 Does the state have a law against doctor shopping?
 Has the state expanded Medicaid under the ACA, so that there will be expanded coverage of substance abuse treatment?
 Does the state require/recommend prescriber education about pain medication?
 Does the state have a Good Samaritan law? These laws provide some degree of immunity from criminal charges for people seeking help for themselves or others suffering from an overdose.
 Is there support for naloxone use?
 Does the state require a physical examination of a patient before a prescriber can issue an opioid prescription, to assure that patient has no signs of addiction or drug abuse?
 Does the state have a law requiring identification to pick up a controlled substance prescription?

 Does the state’s Medicaid program have a way to lock-in patients with suspected drug abuse or addiction so that they can get prescriptions from only one prescriber and pharmacy?

I thought several of these were bizarre. Several are great ideas, but others…not so much. For example, I think a law against doctor shopping leads to criminalization of drug addiction rather than treatment of the underlying problem. The addicts I treat knew that doctor shopping was illegal, but still took risks because that’s what their addiction demanded of them. Such laws may be a way of leveraging people into treatment through the court system, however.

And where are the indicators about addiction treatment? Toward the very end of this report, its authors present data regarding the number of buprenorphine prescribers per capita per state, but make no mention of opioid treatment program capacity per capita for methadone maintenance. Buprenorphine is great, and I use it to treat opioid addiction, but it doesn’t work for everyone. And there’s no data about treatment slots for prolonged inpatient, abstinence-based treatment of opioid addiction.

Expanded Medicaid access for addiction treatment is a nice idea… but not if doctors opt out of Medicaid because it doesn’t pay enough to cover overhead. If expanded access is not accompanied by adequate – and timely! – payment to treatment providers for services rendered, having Medicaid won’t help patients. Doctors won’t participate in the Medicaid system. I don’t. I have a few Medicaid patients whom I treat for free. It’s cheaper for me to treat for free than pay for an employee’s time to file for payment and cut through red tape.

In one of the more interesting sections in this report, each state is ranked in overdose deaths per capita, and the amount of opioids prescribed per capita.

The ten states with the higher opioid overdose death rates are: West Virginia, with 28.9 deaths per 100,000 people; New Mexico, with 23.8 deaths per 100,000; Kentucky with 23.6, then Nevada, Oklahoma, Arizona, Missouri; then in eighth place is Tennessee, with 16.9 deaths per 100,000. In ninth and tenth places are Utah and Delaware. Florida came in at number 11, with 16.4 deaths per 100,000.

North Carolina placed 30th in overdose death rates. We’ve had a big problem with prescription drug overdose deaths. From 1999 until 2005, the death rate rose from4.6 per 100,000 to 11.4 per 100,000. But at least our rate has not increased since 2005. The rate in 2010 was still 11.4. It’s still way too high, but many agencies have been working together over the past six years to turn things around. In a future blog, I intend to list the factors I think helped our state.

Use of the ten indicators does appear to correlate with reduced rate of increase of overdose deaths. In other words, states with more laws and regulations have had a slower rise in overdose deaths than states with fewer laws and regulations, though there are some exceptions.

This report also compares states by the amount of opioids prescribed per year, in kilograms of morphine equivalents per state per 10,000 people. Florida, not surprisingly, came in at number one, with 12.6 kilograms per 10,000 people. Tennessee and Nevada tied for second and third place, with 11.8 kilos per 10,000 people. The next seven, in order, are: Oregon, Delaware, Maine, Alabama, West Virginia, Oklahoma, and Washington. Kentucky was 11th, with 9.0 kilos per 10,000. North Carolina doctors prescribe 6.9 kilos of opioids per 10,000 people per year, in 27th place and less than the national average of 7.1 kilos.

It appears to me that amount of opioid prescribed per capita does correlate, somewhat, with overdose death rates.

Let’s look closer at Tennessee, the state who, just a few months ago, rejected a certificate of need application for an opioid treatment program to be established in Eastern Tennessee. In 1999, Tennessee had an overdose death rate that was relatively low, at 6.1 per 100,000 people. By 2005, it zoomed to 10.4 per 100,000 people, and by 2010, rocketed to 16.9 per 100,000 people, to be in the top ten states with highest overdose death rates. Furthermore, Tennessee is now second out of fifty states for the highest amount of opioids prescribed per 10,000 people. Only Florida beat out Tennessee. And lately Florida has made the news for its aggressive actions taken against pill mills, which may leave the top spot for Tennessee.

West Virginia is no better. It was the worst state, out of all fifty, for overdose deaths, at 28.9 per 100,000 people in 2010. Wow. If you think lawmakers are asking for help from addiction medicine experts…think again.

West Virginia legislators recently passed onerous state regulations on opioid treatment programs. That’s right, lawmakers with no medical experience at all decided what passed for adequate treatment of a medical disease. For example, they passed a law that said an opioid addict had to be discharged from methadone treatment after the fourth positive urine drug screen. In other words, if you have the disease of addiction and demonstrate a symptom of that disease, you will be turned out of one of the most evidence-based and life-saving treatments know to the world of medicine. West Virginia passed several other inane laws regulating the medical treatment of addiction.

Getting back to the TFAH study, the report calculates that there are 21.6 million people in the U.S. who need substance treatment, while only 2.3 million are receiving it. This report identifies lack of trained personnel qualified to treat addiction as a major obstacle to effective treatment.

This report makes the usual recommendations for improving the treatment of addiction in the U.S… They recommend:

 Improve prescription monitoring programs. Nearly all states have them, except for Missouri and Washington D.C.

States should be able to share information, so that I can see what medication my North Carolina patients are filling in Tennessee. Right now, I have to log on to a separate website to check patients in Tennessee, so it takes twice as much time. Tennessee is already sharing data with several other states, but not with North Carolina, or at least not yet.

TFAH also recommends linking prescription monitoring information with electronic health records.

 Easy access to addiction treatment.

Duh. The report accurate describes how underfunded addiction treatment has been, and says that only one percent of total healthcare expenditures were spent on addiction treatment. We know how crazy that is, given the expense of treating the side effects of addiction: endocarditis, alcoholic cirrhosis, hepatitis C, gastritis, cellulitis, alcoholic encephalopathy, emphysema, heart attack, stroke, pancreatitis, HIV infection, gastrointestinal cancers, lung cancer…I could go on for a page but I’ll stop there.

Access to treatment is limited by lack of trained addiction professionals. Doctors abandoned the field back in 1914, when it became illegal to treat opioid addiction with another opioid. Even with the dramatic success seen with methadone and buprenorphine treatment of opioid addiction, there are relatively few doctors with expertise in this treatment.

This reports shows that two-thirds of the states have fewer than six physicians licensed to treat opioid addiction with buprenorphine (Suboxone) per 100,000 people. Iowa has the fewest, at .9 buprenorphine physicians per 100,000 people, and Washington D.C. had the most, at 8.5 physicians per 100,000 people.

North Carolina has 3.2 buprenorphine physicians per 100,000 people, while Tennessee has 5.3 physicians per 100,000. This makes Tennessee look pretty good, until you discover than many of Tennessee’s physicians only prescribe buprenorphine as a taper, refusing to prescribe it as maintenance medication. If these doctors reviewed the evidence, they would see even three month maintenance with a month-long taper gives relapse rates of around 91% (1)

I’m really bothered by the lack of attention to the number of methadone treatment slots per capita. That’s information I’d really like to have. But the authors of this report did not deign to even mention methadone. Even with forty-five years’ worth of data.

**Sigh**

 Increased regulation of pill mills.

 Expand programs to dispose of medications properly. In other words, make sure citizens have a way to get rid of unused medication before it’s filched by youngsters trying to experiment with drugs.

I know many tons of medications have been turned in on “drug take-back” days. But I’ve never seen any data about how much medication is addictive and subject to abuse, versus something like outdated cholesterol lowering pills.

 Track prescriber patterns. Another benefit of prescription monitoring programs is that officials can identify physicians who prescribe more than their peers. Sometimes there’s a very good reason for this. For example, a doctor who works in palliative care and end-of-life care may appropriately prescribe more than a pediatrician.

I get uneasy about non-physicians evaluating physicians’ prescribing habits, though. I think this is best left up to other doctors, enlisted by the state’s medical board to evaluate practices. Other doctors are better able to recognize nuances of medical care that non-physicians may not understand.

 Make rescue medication more widely available. In this section, the report’s authors make mention of Project Lazarus of Wilkes County, NC, a public health non-profit organization dedicated to reducing opioid overdose deaths, not only in that county, but state-wide. Project Lazarus is well-known to me, since I work at an opioid treatment program in Wilkes County.

 Ensure access to safe and effective medication, and make sure patients receive the pain medication they need. Obviously, we want opioids available to treat pain, especially for acute pain. Hey, you don’t have to convince me – read my blog from this summer about how grateful I was for opioids after I broke my leg. Opioids were a godsend to me in the short-term, and knowing what I do about opioids, I didn’t use them after the pain subsided.

It was an interesting report, though I saw some unfortunate gaps in their information, particularly regarding opioid addiction treatment availability.

But at least this is another agency looking at solutions and making some helpful recommendations.

1. Weiss et al, “Adjunctive Counseling During Brief and Extended Buprenorphine-Naloxone Treatment for Prescription Opioid Dependence,” Archives of General Psychiatry, 2011;68 (12):1238-1246.

It’s That Time of Year! NSDUH is Here!

NSDUH past month illicit drug use 12 and older

Every year, the National Survey on Drug Use and Health (NSDUH) is performed by a research group out of Raleigh, NC. The NSDUH report is released each fall, compiling data collected about drug and alcohol use in the nation and in individual states, from the previous year. This annual survey of around 70,000 people in the U.S. over age 12 also collects data on mental health in the U.S. This research information is collected from phone calls to individual households and is the primary source of data on the abuse of drug including alcohol in the U.S.

Since this survey is conducted on household members, some scientists say the data underestimates drug use since its methods exclude populations living in institutions such as prisons, hospitals and mental institutions. Such populations are known to have the highest rates of drug use and addiction. But the annual NSDUH report is still one of the best sources of information we have at present. This data can be evaluated for new trends of drug use and abuse, and can help direct funding toward problem areas. Researchers use this data to assess and monitor drug use, as well as the consequences.

This report contains data from 2012, and there were no big surprises.

23.9 million people in the U.S. over age 12 used illicit drugs over the past month. That’s around 9.2% of the population. By no means are all these people addicted, but they certainly are at risk for addiction. It’s not much different than the last NSDUH study. Just as in the past, the primary illicit drug used was marijuana, with 18.9 million people saying they used it during the previous 30 days.

nsdus2012psy

Psychotherapeutics were a distant second, with 6.8 million people in the U.S. over age 12 saying they’ve used these drugs non-medically over the past thirty days. This group of drugs contains opioids, stimulants, sedatives and tranquilizers. (Don’t ask me why sedatives and tranquilizers have two separate categories. It doesn’t make any sense to me either). In this survey, non-medical use is defined as use of a drug not in accordance with instructions from a physician. These are scary numbers, but again, it’s not significantly different from last year.

nsduh2012heroin<a

Overall nonmedical use of prescription opioids has remained fairly steady over the last ten years, but the above graph shows the steady increase in heroin use. This correlates with what I’ve been seeing in opioid treatment programs. This last week I admitted six people to an opioid treatment program in the mountains, and half were using heroin. They all described the heroin as being called “China white,” rather than the more usual black tar heroin that comes from Mexico and South America. This so-called China white has been seen in the Northeast, so I’ve been surprised to see addicts using it in rural mountain communities.

Read the study for yourself, since your tax dollars paid for it:http://www.samhsa.gov/data/NSDUH/2012SummNatFindDetTables/NationalFindings/NSDUHresults2012.htm

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