intended and unintended consequences…

Posted on Wednesday 24 February 2016


Pharmalot @ STAT
What a good compromise. Is it possible that Congressmen might wake up from their long sleep and do something so clearly sensible as this? As I read it, I thought, "And maybe require that they have to add the price per pill to the ad." The pharmaceutical companies moan about all the hoops they have to jump through, but I have a hard time generating any sympathy for their complaints. They can’t imagine the burden they’ve added to the practice of medicine with the ubiquitous "ask your doctor if ____ is right for you." Beside the direct effect of specific requests, it seems to me like it’s part of a change in many patients’ approach to medicine in general.

In the past, I was used to patients presenting their symptoms with a question mark. "Is something wrong?" "If so, what’s wrong?" "What can be done about it?" These days, many patients present with an agenda. While that’s just an impression with no p-value, it’s a strong impression. One get’s used to the drug seeking patient whose symptoms and presentation are aiming you to the inescapable conclusion that they should be prescribed some particular controlled substance. People often use the term sociopath to describe such people. I’m talking about something different – the person who has seen some ad and thinks "I’d like to try that." As the doctor, you are then the hurdle between the patient and Cymbalta  ®  or Rexulti® [but you don’t know that]. Occasionally, that’s fine and good, but it’s not the rule. It’s one of the reasons I’ve become more fluent in drug prices, a language I have never been drawn to particularly.

One might see this state of affairs as including the patient in the decision about treatment. I’m fine with including the patient in decisions about treatment. But I’m not at all fine with those ads ability to create patients, or to suggest that there’s magic in antipsychotics for people who tried to find magic in the antidepressants that came before them, when the actual problem is in the "psycho-social" domain. I don’t like thinking these thoughts particularly, but this "agenda trend" is very real and it’s coming from someplace. The ads may well be aimed at creating a market for specific drugs, but they reinforce the idea that the solution to life’s woes comes in a potion of some kind. And I recurrently wonder how much that contributes to things like this article in my local paper.

That’s not an idle thought. I’ve heard too many times people in drug trouble say, "I tried those antidepressants and they didn’t do the job. But the Meth did." Whatever the case, These are not thoughts for a practitioner, they’re for policy makers who don’t seem to realize that all this talk of integrating behavioral health with primary care is almost guaranteed to accelerate the CNS drug epidemic. The most recent HHS bulletin to appear in my box combined that story line with one about doing the same thing with substance abuse – offering webinars for both. I had the fantasy of countering with a webinar on the dangers of unintended consequences…
  1.  
    James O'Brien, M.D.
    February 24, 2016 | 3:10 PM
     

    I have to respectfully disagree here. If this proposal is based on the idea that “a freeze would prevent consumers from receiving inaccurate information and also hold down health care costs.” Is the information in the ads less complete and cost-conscious than what their doctors are doing? As I have pointed out, I have never had a doctor tell me once about a medicine or procedure and list multiple adverse reactions that are listed in those ads.

    This is basically “save us from ourselves” legislation that won’t work because of what I call the ignorance paradox. If a person is not smart enough to decide what to put in their body, the are not smart enough to elect a politician to appoint a bureaucrat who’s smart and honest enough to do what’s best.

    All of this wishing and hoping and praying (apologies to Dusty Springfield) for the right government man or woman to make things right is folly. The FDAs track record is not good.

    I’d point out that in a minarchist or anarchocapitalist model of drug regulation, the Shkrelis of the world couldn’t exist (competition would kill their plans, that depend on regulation exploitation) and sites like 1BOM and Pharmalot would instantly become 1000X more important as people look for well-informed guidelines about what to take and not to take.

  2.  
    Catalyzt
    February 24, 2016 | 10:29 PM
     

    I don’t have the same problem with government regulation that a lot of my friends and colleagues do. Point taken about the FDA, but the IEEE worked pretty damn well for a long time, and I’m glad that the voltage coming out of the socket in every house on my block is more or less the same.

    It is certainly true that there should be some kind of protection for people’s ability to decide what they put into their bodies. But those waters are getting awfully murky these days.

    I’ve noticed that this forum has hosted a lot of (sometimes vague, sometimes specific) comparisons between illicit drugs and psychopharmaceuticals of late. And I have found that very thought-provoking, because my opinions on this topic are really in flux. Until about eight months ago, I was a feverish proponent of drug legalization, but recently…

    I don’t know, I am just having this bizarre feeling of hating the marijuana lobby almost as much as I hated Just Say No or drug company ads– it almost seems like they all lead to different flavors of hell.

    I don’t want kids to get locked up for smoking weed. But legalization (let’s call it what it is) has really changed the character of Los Angeles completely. I hate walking out of the library downtown and smelling that crap– it’s not a damn rock concert or a rehearsal studio. But what I really resent is being robbed of what little pleasure was left in driving, thanks to the clouds of cannabis wafting out of so many vehicles on the streets and freeways.

    I used to pride myself on being able to cheat death with a nimble car and fast reflexes, but now it’s just a crap shoot, like the difference between a good poker game and a slot machine.

    The cure for life’s woes is not in a potion– that’s really well put. But it’s not in propaganda, either, and I know most people here appreciate that.

    Cannabis can be good medicine. Narcotics and benzos can be, too– giving someone sertraline for anxiety or chronic pain seems almost like malpractice when there are less dangerous medications available.

    But we can’t seem to sensibly regulate even drugs that have been around for centuries. And there’s a firehose pumping information about cannabis online 25-8-366. How would a consumer make an informed choice? I certainly couldn’t. I smoked a lot more of that crap than I should have, I’m not in a position to criticize anyone else who couldn’t sort it out.

    It gets a little depressing. Sorry to ramble, I know that I’m just circling around some vague idea that isn’t really congealing.

  3.  
    1boringyoungman
    February 25, 2016 | 12:32 AM
     
  4.  
    James O'Brien, M.D.
    February 25, 2016 | 2:08 AM
     

    Speaking of electric appliances, Underwriters Laboratories, which rates safety on such is a private organization around more than a century.

    I don’t really believe that large new groups of clueless people are going to suddenly go out and poison themselves if the FDA magically disappeared. They didn’t before the FDA. There are a certain number of people who do that anyway, and they are doing it now despite all the regulation. Certainly before the Pure Food and Drug Act plenty of people were using laudinum and cocaine, but they did anyway after they tried to ban patent medicines and stimulants.

    Of course the failed American experiment with Prohibition speaks for itself.

    This isn’t an easy topic with easy solutions. Addicts and former addicts get cancer too. David Bowie’s social history shouldn’t have prevented him from getting opioids and benzos in the last eighteen months of his life.

    One can live with the ambiguity and accept the reality as part of the tragic human condition. It may be the only way to be intellectually honest. I’m for pot legalization but I don’t think doctors should be prescribing it and I think many of the promoters of it for every medical ill are complete charlatans.

    I’m still ticked off at the FDA for its completely inexcusable ban of 23andme.com’s genetic testing for 99 bucks.

  5.  
    CLC
    February 26, 2016 | 5:22 AM
     

    Was that ban to protect us from worrying about ourselves?

    My concern with 23andme is privacy. Laws already ban certain possessions and forbid some activities based on past behavior. How long those and more until more are off limits based on propensities suggested by our DNA?

    “giving someone sertraline [or Cymbalta or Effexor [or disguised Paxil as Noven does*], for anxiety or chronic pain seems almost like malpractice when there are less dangerous medications available.” It does. A doctor who prescribes it A sparingly used benzo or opioid has got to be safer.

    About meth: People with ADHD rating their drugs on sites like drugs.com and rxlist speak very highly of the prescribed stuff. Many claim “zero side effects” and the word “smooth” is used often enough for me to have noticed. I read a study called “Characterizing methamphetamine withdrawal in recently abstinent methamphetamine users: a pilot field study” made it look like a cakewalk, symptom-wise.

    Because Noven’s Brisdelle is 8 mg, and the lowest dose sold of paroxetine/Paxil is 10 mg, Noven is allowed to market Brisdell and “not a psychiatric medication.”

  6.  
    CLC
    February 26, 2016 | 5:24 AM
     

    (Context: Brisdelle is paroxetine for hot flashes)
    And link to meth withdrawal study:
    https://www.ncbi.nlm.nih.gov/pubmed/21219261

  7.  
    Catalyzt
    February 27, 2016 | 11:45 PM
     

    Agreed, Dr. O’Brien. That very ambiguity happens to be one of the “givens” of the human experience I’ve been struggling with of late.

    Now that I’ve given up so many other bad habits, perhaps that’s one of the last ones I’m left with– splitting, polarized thinking, etc.

    CLC, I had no idea that drug companies could relabel and reclassify a drug just by changing the dosage– or that any company could be cynical and depraved enough to do that. Paxil at 10 mg. and Brisdelle at 7.5?

    What is the idea– are we not supposed to know that they are the same drug? Could there be any other rationale for changing the name?

    Where does it end? Can someone release it at 6 mg. and call it, say, Neutralon, and say it’s clinically effective in that dose for… oh, I don’t know, maybe some kind of low-level impulsivity, like over-collecting at the sub-hoarding level… for people who replace their cell phones too often, or buy lots of Japanese diving watches?

    Are there any rules at all? Can paroxetine be marketed as something else again at 4.5 mg.? And again at 9.5? Do we even have to bother changing the dosage? How about if prescribers just make up names in the consulting room– would that be okay?

    Okay. Catalyzt will stop now. Deep breath.

  8.  
    James O'Brien, M.D.
    February 28, 2016 | 11:59 AM
     

    Well there are places in the world where they do have this issue under control.

    Saudi Arabia and North Korea.

    Not worth it.

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