Guinevere Gets Sober

Recovery news, reviews and stories, by Jennifer Matesa.

Tag: methadone (page 2 of 2)

Coming to a Doctor’s Office Near You: Buprenorphine Implants!

Titan Pharmaceuticals, the California manufacturer of a product designed to release a steady stream of buprenorphine over a period of six months, yesterday released what they called positive results of a study of this product in yesterday’s Journal of the American Medical Association.

There’s lots of stuff that none of the journalists have reported about this study.

Beginning with the funding. The JAMA piece said Titan Pharmaceuticals funded this study. What it didn’t say was that last year Titan was awarded $7.6 million in federal funds from the National Institutes on Drug Abuse to study this product over three years. So a big chunk of federal money was awarded to a private pharma corporation.

Also: Titan and the UCLA study authors are calling the implants a success, but more than two-thirds of the implant participants received supplementary Suboxone tablets. That’s like saying, We gave them extra heroin to curb the cravings, but hey! the implants still worked. People do not understand: buprenorphine is an opioid, no matter what formula it comes in, no matter whether you call it an “implant” or a “medication” or a “drug.”

The product, which Titan has named Probuphine, is a 26-mm rod impregnated with the opioid buprenorpine. It’s designed to be surgically placed underneath the skin on the non-dominant arm. (Women have long used technology like this with contraceptive hormone implants.) Over time it keeps drug levels at a steady state in the bloodstream.

Titan’s people are calling this steady-state release one of the big advantages of Probuphine—no fluctuations in drug-plasma levels, the way there are with pills like Suboxone, or liquids like methadone.

Suboxone pills

Suboxone, the dissolving orange tablet whose drug sticks like super-glue to your mu receptors

They may have a point here. Suboxone has a 37-hour half-life. Let me explain how half-life works: When the drug is orally dosed every 24 hours, many physicians believe, Suboxone stacks up in the bloodstream—the body does not metabolize it faster than it’s dosed. But if it can be released in a steady trickle dose, then it might not stack up.

Titan and NIDA are also saying that because the drug is implanted, it’s impossible to divert. This is the big selling-point for the rods. Patients can’t hawk it on the black market, the way they do with Suboxone or other drugs. Code for this: they say it “improves patient compliance,” which means patients simply have no choice other than to take the drug, because it’s stuck inside the body.

How the study worked

The study involved a group of patients that received four Probuphine rods, and another group that received placebo rods. Both groups could also receive Suboxone pills if they were experiencing withdrawal or craving (up to 12 or 13mg per day!—an equivalent of about 525mg morphine. I mean, why even give your patients implants if you’re going to let them take an extra 12mg of Suboxone?) in the first 16 weeks of the study; for the last eight weeks, participants who elected to get an extra implant were limited in the amount of extra Suboxone they could receive. And everyone had to go to “counseling.”

Results of the study that everybody’s reporting (source: JAMA—I wish I could provide a link to the entire study, but the link above only gives you the abstract):

  • “Success” was measured solely in terms of urine tests free of illegal opioids (i.e., heroin). Results: 40 percent of implanted patients dropped “clean” urine, as opposed to 28 percent of the placebo group.
  • Withdrawal and craving scores for the implant patients were “significantly lower” (whatever that means) than those for the placebo patients.
  • Biggest result touted by the study’s lead author, Walter Ling, M.D. of UCLA’s Integrated Substance Abuse Programs: two-thirds of the implant patients stuck with the program (that is, continued to receive counseling—either that, or continued to receive their Suboxone), while only one-third of the placebo patients finished.

RESULTS NOBODY’S REPORTING:

  • Conflicts of interest in the researchers: Dr. Ling, the lead author of the study, is receiving research money from both Reckitt Benckiser (maker of Suboxone) and Titan (maker of Probuphine), and speaker fees from Reckitt. The other authors are also receiving either research money or speaker fees from these and many other big pharma companies, as well as NIDA (the federal government, whose projects are supposed to remain independent of commercial influence).
  • How these earnings influence the market: Buprenorphine, especially in maintenance form, is huge business. It is The Biggest Drug Treatment for opioid addicts right now, with sales of more than $900 million in the U.S. alone. That’s a 2010 statistic—it’s certainly grown since then. Reckitt and Titan are targeting not only “treatment resistant” addicts such as IV heroin users, chronic relapsers, and so on, but also to chronic pain patients who have become addicted to opioid medications—the fastest growing sector of addiction today. Enormous markets they’re mining. (In fact lots of curious investors read this post and come away with the conviction that, no matter what happens to the drug addicts, they better invest in Titan.)
  • Treatment assumptions: Built into Probuphine is the assumption that the only “real” way to treat addicts is to give them a drug for the rest of their lives.
  • Induction doses: All participants were inducted at fixed doses of 12-16mg per day of Suboxone over three days before they were randomized. Why give them this much to begin with? 12-16mg is an enormous dose of Suboxone. As in, equivalent to bags and bags of heroin, or around 525-750mg of morphine. Most people do not understand how powerful buprenorphine is.
  • How much bupe were they really getting? Finally, the authors admitted that with the way the study was conducted, it’s difficult to know exactly how much buprenorphine is getting into the body with the implant vs. Suboxone supplements. They say that their blood tests were consistent with “a constant buprenorphine release of 1 to 1.3mg/d from 4 to 5 implants.” If it’s true that the implant patients were getting only one milligram per day, then that would be brilliant, because that’s a low dose for addicts trying to get off junk … but it might also explain why nearly two-thirds of the implant group wanted extra Suboxone.

Especially if “counseling” was the only other solution offered to them.

Time magazine piece: “Addiction by prescription”

Time drug art

Stephen Lewis for TIME

Jeffrey Kluger has a story about the boom in prescription drug addiction in the Sept. 13 issue of Time magazine. Full story not on the website, but here are some tidbits from the issue that came in the mail:

  • In 15 states and the District of Columbia, unintended drug overdose is now the leading cause of accidental death, having surpassed car wrecks—and in three more states, it’s almost a tie. … No telling which drugs are doing it, he writes, but most experts agree that the “exploding availability of opioids could be behind the exploding rate of death.”

Written in true Time alarmist style, but consider the statistics Kluger lines up:

  • In 2007 (the most recent year for which data are available!! for godsake) 3.7 million people filled 21 million legal prescriptions for opioid painkillers
  • 5.2 million people 13 and older said they used these drugs “nonmedically” in the previous month.

Which is probably an underreport. Just taking my own case as an example: if you’d asked me back in 2000 whether I was using my Lorcet “nonmedically”? I’d have said, “No indeed,” despite the fact that I was chewing the pill that I took every day, which is a “nonmedical” way of using an opioid painkiller. I had pain, and I was taking one pill a day—one pill a day! how could that do anyone any harm—was my thinking. I had been to meetings where drug addicts had talked about selling the entire contents of their houses, selling their bodies, risking their lives for drugs… I couldn’t relate. I thought, Surely I can’t be an addict… I take one pill.

Here’s what I wish had happened: I wish a physician had asked me point-blank, “Do you chew your medication?” (I wish I could tell you how many people get here by Googling “chew Vicodin” or “chew Lorcet.” It’s a lot. I’m sure Analytics could give me the exact number… it’s hundreds.) Not the nurse, not the fellow-in-training—the physician. The prescriber. … I might have blinked too many times, or stuttered, or sweated, or given some clue. (I’m a terrible liar. Both my blood pressure and heart rate were sky-high at my doctor visits toward the end of my active addiction.)

And then I wish the doctor would have said, “You know, G, chewing pills is a way of taking medication ‘not as prescribed,’ and it’s a sign that your behaviors have changed from appropriate use into inappropriate, dangerous use. I’m concerned that you could be addicted. Addiction is a fatal illness. I’d like you to see an addictions specialist for an evaluation, and I have the names of some here that I trust. But don’t worry about being kicked out, because we’re going to make sure that you’re taken care of throughout this process so that you can keep doing your life to the best of your ability. It might be difficult for a while but we’ll help you.”

This is my dream for pain patients who cross the line into addiction. I would have gone along with the above scenario and saved myself a lot of pain. I’m not naive enough to believe that everyone would… But I think there are a lot of people suffering actual pain and actual addiction, who simply don’t know how to get out of the bind.

Anyhow, I saw my own story in the history Kluger outlines. He talks about how the “epidemic” had its roots in the campaign to make pain the “fifth vital sign.” In the late 1990s the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO), the body that accredits hospitals, nursing homes and other facilities, wanted to get staff to treat pain more assertively, so they developed methods to evaluate pain along with the other vital signs—temperature, blood pressure, heart rate, and respiratory rate. As a result, these days, during assessment, nurses will quite often ask you to rate your pain on a scale of zero to ten (sometimes, I notice, nurses get it wrong and say “one to ten”), with zero being no pain and ten being the worst pain you can imagine.

So, over time, more attention was brought to the phenomenon of pain. And to the treatment of pain. The sensibility that developed was that pain was an illness in and of itself, and as such it should be treated aggressively with medications tailored specifically for that purpose.

During this time I was in the position of talking with people who had participated in the writing of JCAHO’s fifth-vital-sign policies—as well as prominent physicians and policy analysts who were trying to bring attention to pain treatment. During my reporting, I happened to mention to a few of them that I was having intractable migraines and other pain. And they encouraged me to get myself to a pain clinic. And I did. And I was given daily opioids in great quantity: hydrocodone to morphine to OxyContin to fentanyl.

At that first appointment, as I recall, the physician and her fellows asked me if I’d ever used street drugs, and I hadn’t, so I said no. Good girl that I was, I’d never even smoked pot. They asked if I drank and I said no, because I didn’t—not then. This apparently proved to everyone’s satisfaction, even mine, that I had no problem with addiction. Meanwhile, if you’d turned over the rock of my life, you’d have found crawling under there the facts that my mother had died of lung cancer having failed ever to quit nicotine, and my father was well on his way to a nasty end via cirrhosis and GI cancer due to alcoholism. And I myself was chewing Lorcet—which I thought (insisted to myself during lengthy subconscious arguments even then) was no problem, because it was Just One Pill Per Day.

I was a white professional middle-class mom with two neurological disorders. Hell, I remember being down with a migraine during my first appointment at the clinic. I was practically prostrate with pain—truly. But it was all good because, says one source in Kluger’s piece:

When you’re well dressed and you have insurance, they don’t think of you as an addict.

More importantly, I didn’t think of myself as an addict.

So I saw myself in Kluger’s story. It had unrolled just as he said, and I could hear the voices of the players.

Do I blame them? Hell no. As they say, nobody shoved anything down my throat. I did it my own self.

Even so, I can hear the voices of the blowback, the chronic pain patients and those in the same bind as I was in, as well as the drug companies…  wanting to protect patients’ sources of medication (and profits) by vilifying and calling to lock up the “junkies” who “just can’t control themselves.” When in fact we should all be able to work together.

A final point: Kluger did get the drugs wrong. OxyContin/OxyIR and Vicodin/Lorcet were much more widely prescribed than any fentanyl preparation during the 1990s. And he misses methadone altogether. Some pain clinics were using methadone exclusively: they believed it to be “unabusable” because they thought its long half-life would prevent people from using it to chase a high. But people with addiction will always use ANY opioid (yes: even Suboxone) to chase some kind of feeling. And the data show that many overdoses (perhaps not always fatal, but nevertheless) are due to methadone.

CDC: Oxycodone ER visits up 152 percent in five years

The Centers for Disease Control and Prevention (CDC) director is calling for “urgent action” due to a sharp increase in emergency-room visits—in other words, overdoses—for illicit prescription opiate use.

Oxycodone (the active ingredient in OxyContin) is the most-abused pain drug—visits for nonmedical use have jumped 152 percent from 2004 to 2008 to 105,214 visits.

Hydrocodone (the active ingredient in Vicodin, the most commonly prescribed drug in the U.S. by about twentyfold) is second on the list—ER visits rose 123 percent to about 89,000.

Methadone came third, with a 73 percent increase to 63,629 overdoses.

Reuters reported this story a few days back. Statistics from the Drug Abuse Warning Network (DAWN); in all the reporting I did about end-of-life care, I never understood why DAWN’s stats couldn’t be more recent, I mean here we are halfway through 2010 and we can only get ER data from 2008?—but hey. … What’s provocative are the comments: As in the story about the Kansas doctor on trial for causing 68 fatal opiate ODs, the remarks are divided largely into two camps: those advocating for pain patients’ rights to opiate treatment, and those advocating for/against “enforcement.”

One or two stray comments call for allowing as many “junkies” as possible to OD fatally (!!), as the “natural consequence” of their poor choices. For fook’s sake, as they say here in Yorkshire.

What we need is more compassion for both pain patients and addicts.

Just today I was responding online to the partner of an addict who wanted to know whether addiction could really be considered a disease. “A ‘disease’ implies that people have no control over the substance abuse,” this person said, “when, in fact, substance abuse is a choice.”

Do people who get diabetes by eating too many boxes of Krispy Kremes despite a family history of diabetes not have a disease?

Do people who get cancer by smoking too many cartons despite the surgeon general’s warning not have a disease?

Do people who get heart disease by eating too many burgers and steaks on top of a genetic predisposition toward heart disease not have a “real” disease?

Do people who get high blood pressure by indulging in too many pizzas and bags of junk food on top of a family history of hypertension not have a disease?

Do people who get addicted by eating too many drugs or drinking too many beers/scotches/vodkas on top of “bad genes” not have a disease?

These are not rhetorical questions. I really wanna know what you think.

Milwaukee Journal-Sentinel investigates Rx drug-abuse

A Milwaukee Journal-Sentinel investigation has found that prescription drugs were involved in 70 percent of the fatal overdoses in the Milwaukee area from 2002 through 2009.

Of the drugs most often involved in overdoses, three out of four are opiates—in order of number of deaths caused: methadone, oxycodone (including OxyContin), and morphine. The other is diazepam (trade name Valium).

In Milwaukee, more than 600 people died from prescription drug overdoses in this time period, the paper found, and fewer than a dozen area doctors were disciplined by the state for their prescription-writing practices.

One wonders what the trend is nationwide.

The paper is pushing disciplining physicians for writing prescriptions to addicts… as though “pain patient” and “addict” are two separate beasts. As an editorial in the Annals of Internal Medicine said recently, physicians need help in recognizing pain patients who have become addicted.

A very interesting series.

And P.S.: what is up with the Valium tablets being pierced with those little hearts? Really weird, imo.

Where is the word “addiction”?

For this first post I was planning on introducing myself but instead I’m sitting here reading the New York Times and being gobsmacked all over again about the fact that folks STILL don’t get addiction.

The New York Times’s “Well” column today tells us we really, really shouldn’t be afraid of the Tylenol in Vicodin and Percocet. All we have to do is take it as prescribed.

BTW today’s column is a followup to a July 1 piece about a federal advisory panel’s recommendation to the Food and Drug Administration to ban Vicodin and Percocet, “two of the most popular prescription painkillers in the world,” because of the toxic effect on the liver of massive doses of Tylenol.

I was floored when I read this. Banning Vicodin for the Tylenol would be like banning hot dogs for the preservatives. There would be a strong outcry, especially from the owners of, say, baseball teams?

One wonders how much influence a possible complaint from McNeil, Tylenol’s wealthy manufacturer, could wield over the editorial content of the NYT’s website. Because a statement on www.tylenol.com, issued last week by the senior medical director, Edwin K. Kuffner, M.D., offers pretty much the same viewpoint as today’s “Well” column: Don’t worry about Tylenol.

But a word of caution: if you are someone who has ever used Vicodin or Percocet “not as prescribed”—notice how little this physician’s statement either understands (or admits) why enough folks are taking too much to worry the federal government.

Where is the word “addiction” in all these statements?  Absent, as usual.

The word “addict,” in the public imagination, conjures a low-life waste-case heroin junkie cooking and shooting under a bridge. A sad-sack patient in an early-morning queue at the methadone clinic that nobody wanted in their neighborhood. Even yuppie partiers snorting coke off a toilet lid in a dirty downtown club might not be “real addicts”—they’re just “having fun.”

An addict surely can’t be an ordinary person with a very common illness that has psychological, neurological and behavioral components, who buys her drugs at—a drugstore.

It is very difficult to get good statistics on how many people use drugs because of the stigma still surrounding drug addiction. The Monitoring the Future survey, which the federal government claims is one of the most reliable, polls school kids ages 12 and up. The 2007 results on Vicodin: 2.7% of 8th graders, 7.2% of 10th graders, and 9.6% of 12th graders had used Vicodin for “nonmedical purposes” at least once in the previous year. Which, if anything, points to how accessible the drugs are. All that stuff’s just out there, waiting to be picked up.

And our society has become so used to taking a pill for every condition.

Why we take too much Vicodin or Percocet: our head hurts; the site of our injury/surgery/chronic condition hurts; it helps us deal with stress; it calms us and stimulates us; it helps us sleep; it helps us wake up; it helps us get through boring parts of the day; it helps us not explode in impatience when our spouse or kids irritate us—

I invite you to add your own below.

If you want to stop taking these drugs but can’t imagine how, I post on a forum with tons of experience. One of the best and most popular spots is the board about Detoxing from Pain Meds.

If you’re already free of opioids or other substances, please tell us how you did it.

And tomorrow I’ll tell you who I am, what I do, and why I’m here…

—G

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