Archive for the ‘Governmental solutions to addiction’ Category

DATA 2000: I’m Not Bitter!

Denial

Recently discussion of expansion of the one hundred patient limit has been in the news. I lost interest in this topic several years ago, when I saw DATA 2000 standards being violated with impunity in my community. Given lack of adherence to DATA 2000 requirements, people who want buprenorphine have no problem getting it.

Is this good or bad? Maybe a bit of both.

At least three physician extenders in my area prescribe buprenorphine for patients with addiction on a regular basis, despite having no “X” number. I don’t know how this happens, but I do know the North Carolina Medical Board investigated this practice, took no action, and these same extenders, still with no “X” number, continue to prescribe buprenorphine for addiction.

Since present DATA 2000 regulations are being ignored, changes in those regulations are moot in my state, or at least in my area.

Do I sound bitter? Yes, I am, or at least I am intermittently. On most days, I’ve got my own patient challenges to deal with, so I don’t have time to worry about other doctors’ practices. But occasionally I do feel some resentment. It’s hard not to fret when other practices get away with things, while I follow regulations.

I also grumble when I’ve got to pick up the pieces for patients expelled from other buprenorphine practices for doing exactly what people with addiction do – take drugs.

I’ve had multiple patients seek admission to our opioid treatment program after they were “fired’ by these other practices. Now, I know I’ll do a better job than they ever did, but it’s a real pain in the ass to try to find out exactly what went wrong. I’ve been hesitant to believe patients’ versions, since they sound incredible, but so far, my patients have told the absolute truth.

Recently I admitted several patients after they were dismissed from the other practice for misuse of their opioids. These patients had been prescribed buprenorphine by the physician extenders, and were apparently doing well. Then on one visit, the nurse practitioner or physician assistant asked the patient about pain, and after being told some pain did remain, these patients were taken off buprenorphine and prescribed powerful opioids instead.

Even the patients thought this action was odd. These patients said they knew they would relapse, but due to their disease of addiction, were unable to refuse this jackpot of opioids when offered.

Events unfolded in a predictable manner. The patients went back into active addiction, and injected the oxymorphone they were prescribed. They ran out early, and when a pill count was demanded, they of course failed. Dismissed for being a bad patient, the confused patients came to the opioid treatment program where I’m left to try to figure out what the hell has gone on.

Thankfully, the people I’ve seen survived their relapses, and were able to re-stabilize on either buprenorphine or methadone. But I wonder how many other people have had worse outcomes.

Perhaps if buprenorphine prescribers had better education about addiction, such relapses could be avoided. That’s one big downside of ignoring DATA 2000 requirements.

After the Overdose

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I just read an astounding and completely believable study in a recent issue of the Annals of Internal Medicine. [1]

This study, done by Dr. Larochelle and associates at Boston University Medical Center, did a retrospective study of prescription opioid overdoses. They looked at patients who were being prescribed opioids long-term for non-cancer pain who had a non-fatal overdose. The study lasted from May 2000 until December 2012, and included over twenty-eight hundred patients. All of these patients had commercial insurance, and were between 18 to 65 years old.

This study found that after having a non-fatal overdose, 91% of these patients resumed getting prescription opioids, and that 70% got them from the same doctor.

The lead author said he was shocked to find so many survivors continue to be prescribed opioids after having an overdose from these very opioids. He had hoped after a near-fatal experience, prescribers would do something different to address pain, in order to prevent future overdose.(https://hereandnow.wbur.org/2016/01/13/opioid-prescriptions-after-overdosing)

From other studies, we know that the best predictor of a future overdose is a past overdose, which is why I ask every patient entering the opioid treatment program (OTP) if he has ever had an overdose.

The author of this study postulated that with our fragmented healthcare system, the prescribers may not have known the patient had an overdose. Not knowing about any problems, the doctor continued to prescribe opioids.

I have no problem envisioning how this happens.

Not long ago, one of my opioid treatment program (OTP) patients missed two days of dosing. Per our protocol, her counselor called her on the first day she missed dosing. The patient told her counselor that she had been admitted to the hospital for trouble breathing, and was being treated for asthma.

Also per out protocol, we request hospital records for every patient of ours who gets admitted to the hospital, and our patient gave permission for this.

When I got the records four days later, imagine my surprise when I read that she had respiratory failure due to an overdose. Her drug screen at the hospital was positive for methadone and also benzodiazepines, and indeed she was now positive for benzos at the OTP too. This information lead to a drastic change in this patient’s treatment plan.

If we had not called to see where our patient was, she could have returned in several days and not told us about her hospital admission.

Our local hospital did not call our OTP to tell us our patient was hospitalized with an overdose. Indeed, they didn’t call to tell us she was in the hospital. To my patient’s credit, she did tell them she was a patient of ours, since it was recorded in her hospital record.

When our patients are admitted to the hospital for medical reasons, the admitting doctors continue to prescribe the usual dose of methadone, and I am happy about that, but they don’t call us to confirm the dose. They take the patient’s word for what the dose has been, instead of making a quick phone call. I worry that someday, one of our patients, in a misguided effort to feel an opioid effect, will tell his hospital doctor he’s been dosing at a higher dose than he actually is, and catastrophe could ensue.

In contrast, the big teaching hospital an hour away, which is where our patients go when they are really sick, routinely calls to confirm each patient’s dose.

The Larochelle study seems to indicate there’s a lack of communication in other medical communities as well. Emergency department physicians may administer Narcan and revive a patient, but no one thinks to take the next essential step: call that patient’s prescriber about the drug overdose.

We can’t assume the patient, now revived from a near-death experience, will tell her doctor about what happened. If that patient has an addiction, she might keep quiet about prescription mishaps, fearing her supply of opioids may be cut off.

Family members might tell the prescribers, and that’s very helpful, but often patients are told the doctor can’t release any information. That is true, but the family can certainly give information to the doctor.

I know hospitals and emergency departments are busy. Healthcare professionals are all busy. We are being asked to do more and more in less and less time. But this is a communication issue, and it need not be a physician- to- physician communication. A nurse or even a social worker from the hospital could call or fax valuable information quickly. Privacy laws can be blamed for some lack of communication, but there are exceptions in life-threatening situations.

And please, let’s make medical records readable. Even when I finally get local emergency department records about one of my patients, I have a hard time deciphering them. I’ll admit to being a bit of a Luddite when it comes to electronic medical records, but partly because most electronic records are not all that helpful.

For example, on our local emergency department records, I quickly can find the results for Ebola screening (it’s on the first page, at the top), but often I am left scratching my head about what the doctor’s final diagnosis and treatment plan was for the patient.

We’ve got to fix this communication problem. It’s great when an overdose is treated and prevented. But let’s do just a little more, and communicate to the prescriber of the overdose medications.

It is life and death.

  1. Ann Intern Med. 2016;164(1):1-9. doi:10.7326/M15-0038

Purdue Pharma Settles Kentucky Lawsuit

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Since 2007, Kentucky has been litigating a case against Purdue Pharma, the manufacturer of OxyContin. Kentucky was the only state to opt out of a prior settlement offered by Purdue Pharma in 2007, preferring to litigate separately against the company, due to the devastation that state has endured from the opioid addiction epidemic.

Kentucky was offered $500,000 to settle with Purdue in 2007 lawsuit. Last month Purdue agreed to pay Kentucky $24 million to settle the case. This money is earmarked to pay for addiction treatment and prevention.

This does sound like a large sum of money, but it’s a drop in the sea of money Purdue has raked in from sales of OxyContin.

The turning point in the case may have been when Purdue Pharma lawyers were unable to get the case moved out of Pike County, Kentucky. Those lawyers probably knew county residents were likely to be bitter about the drug company’s antics, since the county’s overdose death rate is still extremely high.

In 2014, 51 people out of every 100,000 died from drug overdose, according to data on the state’s website (http://odcp.ky.gov/Pages/Overdose-Fatality-Report.aspx ) Of course, OxyContin is not the only reason for the overdose deaths, but citizens selected as jurors may have jumped at the chance to blame someone. Who better than a drug company? The company lawyers were facing the potential for an astronomically high judgement from jurors with the case heard in Pike County.

The drug company lawyers decided to play it safe, and settled for 24 million dollars. Purdue Pharma and its officials did not admit any guilt in this settlement.

This isn’t Purdue Pharma’s first legal loss. As you will recall from my July 8, 2015 blog post, Virginia won an award of $634 million from Purdue and from its top three executives after they pleaded guilty in May of 2007 to misleading the public about the drug’s safety. It was one of the largest awards against any drug company for illegal marketing…though Purdue made 2.8 billion dollars in sales from the time of its release in 1996 until 2001. How much the company made since 2001 is anyone’s guess but it has to be in the billions.

When I started working at my first opioid treatment program (OTP) in 2001, the only drug I heard about was OxyContin. The majority of the patients entering treatment used only Oxy’s, as they called them. Patients told me how easy it was to remove the time release coating, then crush the pills to snort or inject. All during this time, Purdue Pharma was touting their product as abuse-resistant.

Needless to say, their claims rang hollow in my ears, and the ears of other doctors treating addiction

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 for 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.

No one in the Sackler family, owners of Purdue Pharma, has been criminally charged with any crimes.

  1. General Accounting Office OxyContin Abuse and Diversion report GAO-04-110, 2003.
  2. 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. 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.

Update

aaanger

Last week, I told my readers about a letter I sent to my local newspaper, trying to explain the usefulness of methadone (and buprenorphine) treatment for opioid addiction. Happily, my entire letter was published in our local paper under the heading of “Guest Columnist.”

I was elated, especially since this piece of writing was on a topic about which I’m passionate.

I checked Friday’s paper to see if anyone had responded to my column. There were no replies, but there was another article in that issue, titled, “Task Force Targets Schools.”

This article was about the meeting of a drug abuse task force formed earlier this year by local people. Before you ask, yes, this is in the same county where Project Lazarus, founded in 2008 in response to high drug overdose death rates, has its headquarters. And no, I do not know why people in this new task force feel the need to re-invent the wheel, particularly in an area where the prior inventors of the wheel have had such success and nationwide praise. Indeed, many other areas of the country have copied the Project Lazarus model of addressing the multifactorial causes and contributors of addiction

Anyway, I don’t know the motivations of this new task force. Interestingly, this quote was found early in the article: “Education and dissemination of information appears to be the greatest way the task force can make a difference.” This was said one of the co-chairmen of the organization. This quote was in the context of providing information to youths to prevent drug use and drug addiction.

I sure as hell wish that statement also applied to facts around treatment of addiction.

At some point, methadone apparently became the topic of discussion, which was a shame, because task force members sound like they don’t know anything about methadone. I wish they would have read my guest column two days prior!

Here’s a quote from the paper from one of the task force members: “From the way I understand it, the methadone clinics are not weaning these people off methadone. They’re going for treatments and they’re just going and going and going,” According to the article, he also said that state government should be involved in requiring plans that give people certain amounts of time to be off methadone and then with helping them.

Then the co-chair of the task force, a law enforcement trainer at the local community college, said methadone clinics are supposed to have personalized plans for people who come in for treatment. “It doesn’t appear that those plans are followed exactly the way they should be,” he added. “It’s a business model.”

I’m not sure what qualifies this man to know how long methadone should be prescribed for the purposes of treating opioid addiction. He’s not a doctor.

Then another person in the task force said the goal is for a person going to one of the clinics to be off methadone in a year, “but that doesn’t happen…. It’s a business.” She said only a small percentage kick their addictions.

Who is this second person? She is – wait for it – a Licensed Clinical Addiction Specialist. She works for a program where we have referred patients in the past.

As all my readers know, I am a calm and patient person who never takes things personally (yeah that’s sarcasm). Even more fortunately, I’m not the litigious type, because when someone says at a public forum that the local methadone clinic keeps patients on methadone because it’s a business model, that’s a defamatory statement. That implies I prescribe methadone to make money and not to help patients. This statement attacks my character as the medical director of that program, and cast dispersions on my professional integrity.

Drug addiction treatment should be about science, not opinion.

I know the right thing to do, the grown-up thing to do… call task force members and politely offer to educate them about MAT.

I’ll get there. But right now, I’m not ready to be a grown up.

Heroin Epidemic versus Pain Pill Addiction Epidemic

aaaaaaaaaaaaaaaaaagraph of heroin deaths

I’m surprised at all the coverage heroin addiction has received in the past few months. Breathless headlines are appearing in all forms of media about our “new” addiction problem. Friends send me links to articles about addiction since they know that’s the field I work in. I’m as surprised to see all the media coverage now as I used to be puzzled about the lack of coverage five years ago. I’ve been treating opioid addiction for the last fourteen years, and the opioid addiction epidemic isn’t new. It’s been very well established for years.

Perhaps the idea of using heroin jolts people more than the idea of using prescription opioids. Maybe people don’t understand that prescription opioid addiction has the same physiologic process as heroin addiction. Manufactured pain pills have less variation in content than balloons of black tar heroin, so there may be less risk of overdose. However, the body responds the same to both types of opioids. The body develops addiction and physical dependency in the same way to both heroin and prescription opioids, and withdrawal symptoms and cravings are the same. Both overdose and death happens with both types of opioids.

Perhaps heroin is perceived as the hardest of hard drugs, and therefore data about heroin addiction captures more attention than pain pill use. Maybe the use of heroin crosses a line that’s not perceived by prescription opioid addiction.

Can it be that there are still people who believe if it is a prescription medication, that it’s safe? Or is it just easier to justify the misuse of a pain pill? Communities with years of rampant pain pill addiction are only now wringing their hands because of heroin addiction. These communities are now demanding action from our government.

I’m glad for the attention to the problem of opioid addiction because I’ve seen way too much complacency about this issue for way too long.

I’m also irritated.

In 2009, I wrote a book about pain pill addiction. I was extremely lucky to get an agent, and she shopped my book to four or five mid-level publishing houses. They weren’t interested because they felt the book didn’t have a broad enough appeal. I ended up self-publishing, and sold around 500-600 copies. That’s not too bad for a self-published book, but distribution could have been much broader through a publishing house. Having my book turned down by publishers with an utter lack of interest in the subject matter undoubtedly causes some of my irritation.

I went to the ASAM conference where the head of the CDC pledged to get involved in the treatment and prevention of opioid addiction. Don’t get me wrong; that’s a wonderful thing to hear. The problem is, that was in 2012.

For all who’ve just joined the movement to help opioid addicted people get help, welcome. I’m glad you’re here, and we can use your help. And forgive me for wishing you had been interested in this problem ten years ago.

Mandating Physician Education

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In May of this year, Massachusetts Senator Ed Markey proposed a new bill titled the Safe Prescribing of Controlled Substances Act. This Act, among other things, calls for mandatory education of the nation’s physicians about, as the name implies, safer prescribing of controlled substances. It also calls for mandatory education about identifying patients with substance use disorders.

Physicians get very little education about this tremendously important problem. Some medical schools and residencies have added addiction trainings, but change happens slowly. Plenty of doctors in the U.S. are still mis-prescibing

Physicians are not going to like this legislation. We hate being told we have to do anything, especially by politicians. But obviously, the present generation of physicians is NOT able to prescribe controlled substances properly, as evidenced by our epidemic of prescription drug addiction.

The bill extends to any prescriber of controlled substances, meaning that physician assistants and nurse practitioners will also be required to take this training, at least in states where they are allowed to prescribe controlled substances.

Senator Markey’s bill says the Department of Health and Human Services is responsible for producing this training and that it will be free and available online.

The bill specifies the training should include, “methods for diagnosing, treating, and
managing a substance use disorder, including the use of medications approved by the Food and Drug Administration and evidence-based non-pharmacological therapies.”

If everyone interprets this paragraph as I do, this would mean all doctors who want to prescribe controlled substances should be educated about medication-assisted treatments of opioid addiction, among other things.

That would be wonderful. How nice it would be for my patients to go to their other doctors, and hear, “So glad you are on methadone for the treatment of addiction. Good job.” instead of the usual insults about being on of MAT. How nice for me to be able to call other doctors who don’t think I’m a drug pusher for prescribing MAT!

Also, Senator Markey sent letters to the VA, Defense Department, and IHS, urging them to included prescribing information to their patients on their state’s prescription monitoring program. Many patients being cared for by these agencies are prescribed controlled substances, but doctors outside those systems have no way to know what is being prescribed. Presently, they don’t report to the prescription monitoring programs. I hope these military agencies chose to participate in the PMPs. It would be a way to keep those patients safer when they seek care outside the military system.

On May 15, 2015, the Huffington Post had an online article about another bill, the Recovery Enhancement for Addiction Treatment Act, also sponsored by Senator Markey and Senator Rand Paul. This legislation would lift the one-hundred patient limit placed on office-based buprenorphine doctors.

In the past, I supported lifting the one-hundred patient cap, but I’ve come to believe the cap isn’t all that relevant, at least in my area. Around here, I think the only physicians who honor the cap are conscientious doctors who would do a good job without legislation.

Around here, physicians have more than one hundred buprenorphine patients, and skirt the regulations by saying some of them are prescribed it “for pain.” Physician extenders without DEA “X” numbers already prescribe buprenorphine in this state. When the North Carolina medical board was notified about this, they declined to take any action.

In other words, the present regulations are flouted without consequence, so lifting them isn’t going to make a big difference. (That may not be the case in all areas of the country.) But mandating education about addiction and its treatment may help treatment providers deliver better care.

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.

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