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Sunday, December 21

Part 6, Shoot Yourself in the Foot health care: Death as an effective pain remedy

"It usually began with a back sprain."

This situation is horribly complex don't you dare laugh Pundita it's not a bit funny.  But from a long distance there is something funny -- not about the specifics but how democratic governments typically react to an outcry from the public that can be politically ruinous. The elected legislative body -- in this case, the U.S. Congress -- after being told by voters  to "do something" right away, turns to the federal bureaucracy and says "do something right away."  Then the frantic hunt launches for a government agency, any agency, that has a little budget and manpower to spare and can be hurled into doing something this minute. 

That's how the Secret Service, which is supposed to guard the U.S. President and other high-ranking government officials, got roped into helping the FBI chase down pyramid scheme scammers.  The flimflam artists proliferated like rabbits after 9/11, when the FBI got roped into fighting terrorism, leaving the agency few resources to go after pyramid schemes.  The upshot was that many Americans were being conned out of their life's savings, with the attendant hue and cry from the public to do something.

At least from what I saw of the Secret Service efforts, which were depicted in CNBC's documentary series Greed:  Scams, Scoundrels, and Suckers, the Service did a surprisingly good job at cooperating with the FBI and helped bring many pyramid schemers to justice, which is harder than it sounds. 

The government's duct tape approach to problem solving didn't work out as well when the U.S. Drug Enforcement Agency (DEA) was roped into doing something right away about misuse of opioid prescription painkillers. By the start of this decade the misuse was killing a surprising number of Americans. Perhaps not the "epidemic" as it was characterized in the press but the most alarming part is that many of the people who die in this way aren't knowingly abusing the drugs they're prescribed.
 
As an ER physician in Seattle noted to Dr Sanjay Gupta (CNN's Chief Medical Correspondent) for Gupta's 2012 CNN documentary, Deadly Dose:  Let's End the Prescription Drug Death Epidemic, " often it starts with a person being prescribed an opioid for severe pain due to a back sprain.  But because opiates depress the lung and heart functions, if taken with alcohol, which is also a depressant, death can easily result -- particularly if a person inadvertently takes a pill too soon after the previous dose.  

Take a pill, have a couple beers a few hours later, go to sleep and not wake up.  It can  happen.  But hurling the DEA into dealing with the problem just because it involves drugs was like sequestering  a logger to perform an emergency appendectomy. You cut down trees, right?  So you should have no problem cutting out appendix.  

The DEA typically deals with violent criminal drug cartels. When it turned its scorched-earth methods to legitimately prescribed opiates, by gum it quickly got a handle on the worst of the problem. And if I recall, put some of the illegal operators and counterfeit opioid pill manufacturers out of business 

But in the process the agency so greatly terrified respectable pharmacies, physicians, and law-abiding pill takers that for a time the prescribing of opiate painkillers ground to a virtual halt. Doctors who prescribed opiates and drug stores that filled the prescriptions were frightened that the DEA would descend on them in full body armor with automatic weapons drawn. And patients trying to get their legitimate prescriptions filled were treated by their local pharmacy like drug addicts or illegal pill dealers.

The upshot was that everyone involved in the muddle -- doctors, pharmacists, legal opiate manufacturers, pain-ridden patients. etc.  -- pointed fingers of blame at everyone else.  

All this greatly upset another U.S. agency, the Food and Drug Administration.  Hey the FDA also had "drug" in its name. So why was the DEA chosen to handle the opioid overdose problem?  (Maybe because the FDA never tires of complaining that it's grossly understaffed and under budgeted?)  

There's much more to the story, which as I noted is complex. If you're a sucker for jigsaw puzzles you can read a yeoman attempt by Reuters in 2012 to clearly explain all parts of the issue.  If you combine that report with the 2012 CNN transcript that discusses Dr Gupta's very dramatic and emotional documentary, you'll have a fairly clear picture.

What that picture is today, I don't know; I haven't followed up.  But it was in the course of my reading Radley Balko's 2012 discussion of the Reuters report, which while praising it cherry-picked a little too much for my taste, that I stumbled across a situation which is in some ways worse than the prescription opioid misuse, and which is colloquially known as drug bundling. 

The bundling was mentioned by a reader in the comment section on Balko's blog, more as a question to other readers about the practice than a comment.  The sum total of the replies, and their implications, dropped my jaw.
  
I didn't come across the discussion at Balko's blog until the other day. Until then I'd never known about drug bundling. This is despite the fact that I stared straight at an indication of bundling on the label of a prescription opioid I'd briefly taken same years ago for a bout of severe pain.  I just hadn't paid any attention to the verbiage on the prescription bottle label, didn't bother to read the warnings included with the bottle, and wouldn't have made anything out of it, if I had. 

And while I check the headlines at Google News at least three times a day, and until July 2013 kept close track of news on national TV stations, I'd never come across mention of bundling.  So to the extent it's been publicized in the USA I think only certain segments of the American population, such as physicians and the patients who routinely take painkillers, have paid attention. 

This ignorance works out to societies shooting themselves in the foot in the name of compassion. It seems one of the few comparable situations is the ongoing practice in several developing countries of injecting medications and vaccines with disease-contaminated hypodermic syringes. On the one hand the injections are saving lives, on the other the jabs are killing people or making them sick for life.  

But the bundling is mostly directed to pain management.  And right now it seems the only way to stop the severe medical consequences of bundling is by warning the public not to accept at least certain types of bundled medication prescriptions. And then informed individuals, on a case by case basis, refusing bundled medication.  

Granted, this can be hard when a person is in severe pain. One just wants the pain too stop by any means necessary. I've been in that situation once; if I ever went through it again I'd take any painkiller I'm handed by an ER nurse and without demanding to know the ingredients.  

And for emergency or short-term purposes, unless the person has a prior medical condition that could be affected I can't see great or lasting harm -- although whether bundling for painkiller pills is necessary is another question.

There is an element to this story that reminds me of sugar, which over time was added to more and more processed foods even when the recipe doesn't call  for it. I mean, who adds sugar to mayonnaise and ketchup?  But it seems that it's the routine, ongoing use of bundled prescription painkillers that becomes increasingly harmful to the pill taker's health. The effect seems to be cumulative. 

Without further introduction here are the relevant responses to the reader's query at Balko's blog, by comment number. They're certainly not a definitive analysis, and a caveat is that Balko's readers tend to be in the libertarian camp, which looks askance at government efforts to do just about anything, But the information and links provided by the commenters are enough to sound a clear warning and prompt further inquiries:


#4 |  C. S. P. Schofield |  
I have read the assertion that many of the overdoses associated with prescription pain meds are, in fact, kidney failure due to the DEA mandated inclusion of Acetominophen(sp?). While this sounds like the kind of bone-headed idiocy I expect from the government, the assertion was made in a comment on a Blog, and without reference. Does anybody here know anything about this? Is there any basis for it, or am I drifting into Area 51 territory?
  1. #11 |  David Jones |  
    As a physician, I can tell you I am pretty sure there is no mandate to include acetaminophen in these pain medications. While many narcotics are available in combination with acetaminophen, you can get the narcotic alone in most (perhaps all) cases. There is a real problem with prescription diversion, and it is amazing what lengths some people will go to as they try to get multiple prescriptions filled at different pharmacies, go by the emergency room and try to get meds, etc. This needs to be controlled, but we need to find a way to address this that doesn’t limit supplies to legitimate users.


  1. #13 |  el coronado |  
    #4 [Schofield], you’re right on about adding acetominophen & ibupfofen to high-powered pain drugs to “help them work better.” I’m a chronic pain guy, and have been aware that acet. isn’t the magic pill it’s made out to be ever since NFL stud Kenny Easley fried his kidney on them (and almost died) 20+ years ago. Adding ‘em to Lortab/Vicodin/Etc is like taping a BB gun on a 30.06 to “make it more effective”…..but that’s what they did. Why?
    Because that’s what the drug warriors DO. It goes back a long way: have read somewhere, maybe even on this blog, that back in Prohibition, the Booze Ninjas added (actual, for-real) *poison* to alcohol, and quite a few folks died from it. So y’all might wanna think about tossing your Tylenol and going back to aspirin. Just sayin’.
    Served ‘em right, really: they were breaking the *law*, you see. Promotions and commendations for everyone!!

  1. #19 |  Highway |  
    CSP Schofield: Regarding the issue of acetaminophen in painkillers – yes, it is a significant hazard. Here’s an article from the NY Times in 2009 describing some of the issues around acetaminophen poisoning:
    And it mentions that Vicodin and Percocet are both mixes with acetaminophen, and that Hydrocodone is not available by itself, and Oxycodone is, but is *much* harder to get. The government is far less restrictive (not unrestrictive, just less restrictive) regarding prescriptions of Vicodin and Percocet. So why the discrepancy? Because of the belief that the acetaminophen is a limiting factor in the dose, not because it ‘works better’. It’s bullshit to say it works better. If it did, then just prescribe Oxycodone and a Tylenol. But no, they want it together so that you can’t take more than a certain amount of the narcotic.
  2. #20 |  SJE |  
    CSP Schofield: acetominophen is seriously hepatotoxic (liver damage), responsible for 48% of acute liver failure in adults (FDA ref below). According to 2004 paper, acetiminophen and is the #1 cause of overdose (over 100,000 calls, 56,000 emergency room visits, 2,600 hospitalizations, and est 458 deaths: http://onlinelibrary.wiley.com/doi/10.1002/hep.20293/pdf
    In 2011, the FDA asked manufacturers to limit acetominophen in combo products, including oxycontin, because of the dangers:  http://www.fda.gov/Drugs/DrugSafety/ucm239821.htm
  3. #28 |  Pi Guy |  re: use of acetaminophen in conjunction with narcotic pain relievers  I’m pretty certain that part of the reason for adding acetaminophen to, say, oxycodone to make make percocet (percodan isn’t so common any more but is oxy + aspirin) is that it allows it to be scheduled differently on DEA’s list. For example, [marijuana] pot’s a Schedule I drug – no medicinal value (according to the DEA) but percs, I believe because of the combination of the two pain relievers, are Schedule II.
    1. #30 |  DoctorT |  
      “… From 1999 to 2009, the number of deaths from narcotic pain pills nearly quadrupled…”
      These are the usual bullshit statistics the government uses to justify its war on drugs. The CDC changed the way it classifies death reports from medical examiners and coroners. If a person dies of any cause and has detectable levels of opiates, cocaine, amphetamines, barbiturates, tranquilizers, alcohol, etc., then it now is classified as a drug-related death. That’s where the quadrupling comes from. (The CDC pulled the same stunt with obesity: change the criteria and suddenly we have an obesity epidemic.)
    2. #31 |  DoctorT |  
      @27: Adding acetaminophen or ibuprofen-like drugs to an opiate painkiller does NOT alter its classification or its DEA reporting requirements. The reason for combining the drugs is to reduce both pain and inflammation. If a patient has severe pain without inflammation, the use of an opiate alone is better. 
    3. I am unable to verify this but seem to think it made sense when I heard (read?) it.
      1. #32 |  Other Sean |  
        DoctorT,
        Of course patients could simply take two pills, if inflammation control is that important. Given the massively different rates of tolerance between APAP and opioids, you must admit it’s medically irrational to bind them together.
        I think the larger point is: if lots of people were spoiling their livers on a non-narcotic medicine that was unnecessarily bundled with APAP, there would be a massive outcry, denunciations of big pharma, 60 Minutes special reports, etc.
        One reason the public may tolerate such dangerous bundling here is because they have a moralistic reason to feel indifferent to the victims. [Pundita comment:  Again, I think the general public tolerates the bundling practice because it knows little or nothing about it.]  
      2. #34 |  Katie |  
        1. Dr T,
          Since acetaminophen is not an anti-inflamatory, I fail to see how it can be included. To the best of my knowledge, the principal effects of long-term acetaminophen use are kidney and/or liver damage, the pain of which often renders any minimal previous pain relief moot. It is, however, an excellent means of suicide – long slow and painful – but effective when taken with a glass of scotch. I watched a friend die that way and I won’t put acetaminophen in my ear, let alone my mouth.
          1. #59 |  Elaine |  
            @ Doc T. I never said it did. A schedule 1 narcotic is a schedule 1 narcotic no matter what you add to it. Oxycodone and hydrocodone are both schedule 1 with or without acetaminophen. The DEA will not specify how much of a schedule 1 drug qualifies as “potential dealer”. Therefore you can’t know if you are over their arbitrary number or not.

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