Friday, April 11, 2008

"Study" results

I just read a headline that said "Inhaled insulin linked to lung cancer". Ladies and gentlemen, the trial lawyers have reached the starting gate, post time in 1 minute.

But let's look a little closer at this "headline". To some Enquirer reading troglodyte who can't or wouldn't read the fine print, the exclamation "Oh my God, how could they have approved that medicine. I know someone who knows a friend whose cousin might have taken that!".

Just because you have A and B and C, it doesn't mean that A caused C or even that A plus B caused C. You see, causation is a difficult thing to prove, especially in a drug trial like this. What the "headline" didn't tell you is that ALL of the patients in the study that developed lung cancer were current or former smokers. So let's see, 6 out of 4,700, or 0.12% (an extremely low number to begin with) in the drug arm developed lung cancer, and 1 out of 4,200, or 0.023% (also an extremely low number) in the control group developed lung cancer. I wonder if the smoking had any thing to do with it? Hmmm. Could it be that they were just unfortunate enough to put 5 extra patients with tiny undetected neoplasms due to smoking in the drug arm? No, it couldn't be the smoking that caused the cancer, could it? Oh, to be John Edwards, with tongue hanging out and drool from the mouth, knowing how easy it is to dupe 12 barely literate folks into giving him millions, all the while handing out coupons for $10 to the thousands of suckers in the class action suit.

On a lighter note, I am in the long process getting out of ED. 911, I hope to beat you to the punch, but it will probably take a year or so. I'll keep you posted.


  1. Does this mean CAT won't be a doctor any more? Or just a different kind of doctor. Too bad. It sucks that we're burning out people before they barely get going.

  2. It's truly sad that emergency medicine will be losing you and 911Doc. My double-insured 19yr. old is in the ED as we speak, with a terrible tattoo infection that he's been hiding from me for awhile, apparently. Who will be left to treat my moron teenagers? The docs who just haven't burned out yet? The ones with no family or personal life? Sad. Good luck to you.
    PS You're right about causation: Proximate cause is the issue, not "causation" suggested by the mere presence of A, B and C.

  3. I'd also like to point out that Exubera was contraindicated with smokers... And it was removed from the market on Pfizer's own free will for financial reasons; it wasn't making enough money. I actually sorta feel sorry for the company, as they're probably super gun-shy now, from all the -coxib hubub.

  4. It's me, Anonymous, again. But not size two anonymous.

    Heavy sigh.

    Drugs change physiology. By changing physiology, there can be some unanticipated side effects. No, we don't want drugs that are obviously bad for the public health out there, but drugs WILL have side effects, some of which will be detrimental by their very nature (that's why it is called a side effect).

    The causal nature of those side effects is not clear. Right now, there is a huge controversy in the world of oncology over the use of erythroid stimulating agents for anemia induced by chemotherapy thanks to the CMS. First, the CMS comes down with restrictions on ESA use, that go a little contrary to the way the drugs should be dosed. This controversy began primarily because of literature from the nephrology side -- that OVER-use of ESA's (to drive the hgb to 13-14) may increase the risk of heart attack and stroke. I'll give them that one...but that is inappropriate dosing. Now, there is a study out that people who develop anemia during treatment for breast cancer have a higher risk of recurrence -- I haven't seen data that tells us that it is the ESA use vs. the possibility that physiology that causes one to develop the anemia in the first place increases the risk of cancer.

    Now, since we won't be able to use ESA's, did you catch the NEJM article that patients transfused "old" blood post CABG have a higher rate of complications? (March 20, 2008; transfusions of RBC stored for more than 2 weeks was associated with a significantly increased risk of postoperative complications). Ahhh...make certain you only write for "fresh" blood banked blood or the lawyers will be coming. There are likely immune/cell signal mediated events causing the increased morbidity....perhaps, older blood with cells that are losing viability does induce some sort of systemic trigger. I don't see how our blood banks are going to be able to meet the demand if they can only release blood that is two weeks old.

    And while I'm on my soap box (I really should not be writing the first thing in the morning after a night of not enough sleep, but here I am).....When are we going to go after the food makers? Huh? Obesity is a HUGE health risk. Obesity is associated with ALL SORTS of pre-mature morbidity and mortality: CAD, PVD, DM, obesity hypoventilation syndromes, some cancers etc, etc. Lawyers rev up your marketing machines "if you or a loved one has ever eaten a Twinkie, Snickers bar or M&M and suffered weight gain and subsequently had a heart attack, cancer, diabetes, or death, you may be entitled to compensation." That is obviously written tongue in cheek. Our society seems to have become one where there is little personal responsibility...we want to blame bad outcomes on someone else, but shit happens, death happens and that is the nature of living. When you are sick enough to need some drug, some intervention....bad things may continue to happen despite the interventions. (BTW, for all those drug seekers in the ER...did you know that narcotics have significant complications including constipation, respiratory depression, CNS depression, hallucinations, and even death? Sorry, can't write for them anymore....)

    Thank you. I'm done. For now. :D

  5. Causation has lined many a lawyers pocket.
    It would be just as easy to link McDonalds to obesity....oops, that's been done.
    Or maybe milk to cancer...yes, most all cancer sufferers have ingested milk in their lifetimes.


    Pirates and global warming. Who knew?

  7. Oh the pirate graph! I love it. Etotheipi posted this some months ago here. Since global temps have dropped dramatically this year I am now afraid of pirates.

    'Cat, re your exit, let's me and you and families move to some tres chere mountain town and open up a boutique practice with waterfalls, new age music, aromatherapy, botox, and massage therapy. We'll get stylish haircuts, wear armani suits, and lavish attention on people with money. We won't even have to do medicine! We will sell our own brand of 'supplements' and recommend leaching and high colonics for everything. People actually pay a lot of money for this crap!

  8. I never liked Exubera, the drug rep looked like Tony Soprano and wanted me to deep throat an apparatus that looked like my 4th grade ant farm. If that wasn't enough, it was expensive, and you still needed to use a long acting injectable Insulin. Sometimes common sense isn't common.

  9. Amy - Cat will still practice medicine (just not on the "front lines" where he is beaten down into a barely recognizable human being when coming off a string of miserable shifts). As his wife and a fellow physician, I have to say after a decade + of watching how the practice of ER medicine has altered him (his personality, his outlook on life in general and on humanity as a whole). I look forward to a new horizon for him. It really is a shame to lose excellent, caring, common sense-filled MD's like 911 and Cat from our Emergency Departments. Oh, 911, I am all for the boutique practice you described - sounds like a great plan. My only question is would there be a position for me at this mountain oasis? Wife O' Cat

  10. Hi ya' wife O' Cat. How bout we change your name to Cat O' Nine-Tails? That sounds cooler?

    I'm so sorry that you've had to watch him go through changes like that. I sort of know what you're talking about.

    My husband recently graduated grad school working for a super bitch, in high risk science, you know huge grants from the NIH, lots of pressure. He was 5 years into a PhD which was killing him, and basically destroying his life. He's bipolar so this lady kept screwing with his head more than it was naturally on its own. He got out with a masters because that lady was just sucking the life out of him.

    We moved to a mountain oasis, he got his dream job, and here we are. He's HAPPY. And on only one med. Which keeps him managed beautifully.

    You know ya'll could move out here and set up one of those celebrity rehab clinics and make bank off of the stupid movie stars. Sure they're all junkies, but the paycheck's gotta be better. Or how about a patch 'em up skier boutique shop. They're always injuring themselves.

    You know really, the good stuff is being a gas passer. My friend gets 17 weeks paid vacation, a sweet salary, and no on call. And that's his first year out of residency.


    Here's my mountain oasis.

  12. Amy - glad you guys are "livin' the dream" and that your husband is happy. Life is too short not to be at least most of the time. Hope the changes we are going to make put some joy back in the eyes of Cat. It's actually painful right now to watch him leave for a shift. Of note, he's not wimpy or lazy and works w/ a great group of ER MDs and compensation is good. ER medicine in general is tough for numerous reasons which is why the burnout rate is quite high for this specialty after about 15 years of practice. W o' C

  13. "It's actually painful right now to watch him leave for a shift."

    GAH. That would be so hard for as a wife. At least my husband only had one person crapping on him daily, and not a whole subset of the population.

    I don't know that we're living my dream exactly, but it's kind of funny in a way, like he just skipped to the end of his life plans. The origianl plan was to get the PhD, then go to law school, do biotech patent law make a wad of dough so he could have his own nursery/plant store when he retired.

    He doesn't own the nursery he works for, but he's the grower and wholesaler and he can't wait to get to work every day. And, it will eventually pay about what a lawyer makes (not a patent attorney) so it's a very liveable income too.

    It's funny that all of the skills and knowledge that he uses at work, he didn't learn in school, he learned them through his hobbies. But he's tons more marketable with his degrees. And he can always go back to science if the plant thing doesn't work out. He's the primary author on a work coming out in June or so in a really good journal, so it's not like he didn't get something out of the masters. It really taught him so many things, not just academic, but lots of things about academia, science, people, etc. Probably most importantly, it taught us the value of doing something you love vs. doing something because you think you have to.

  14. I am the "other" Amy

    Glad (for his familly) that SC is leaving ER. It seems like he was in a pissy mood most of the time, maybe sunshine will re-appear on his horizon.... :-)

  15. Wife-O-Cat (It has a nice rings to it), why don't you go ahead and get yourself a name. I think Will-Da-Beast would be fitting...Toodles.

  16. My mood peaks about 5 minutes after leaving the ED and is at a nadir 5 minutes prior to walking in. This is a global problem, as I have had partners leave for greener pastures, only to find those pastures covered with an enormous amount of cow shit. It wasn't always this way, but has worsened severely over the last 20-30 year with the "entitlement" generation. I really don't think I would be as miserable if people were appreciating that at 5:00 a.m. with cortisol levels waning I am still able to provide care with a smile (well, nearly a smile). And money be damned, they could pay me twice as much, life is too short for this shit. I could whistle digging ditches and be happy, if all those jobs are already taken by undocumented near-citizens. Having to answer to 50 different people/organizations/bitchy-needy ungrateful patients/nurse managers and having near zero autonomy to practice how I was trained takes a toll. Example-get a call the other night from admitting nurse saying the 88 year old wasn't anemic enough to justify admitting to hosp. at midnight, could she come back as outpatient and get transfused? (Hgb 7.8) WTF?

  17. I am feeling really really glad I didn't stay in the ER. It was a tip off when one of the patients said "you are the nicest person I have met here." I had to answer with "I am new."

    During residence my sister in-law said she would put herself on anti depressants when she had to go rotate thru the ER. I thought she was kidding. Now I am not so sure.

  18. "And money be damned, they could pay me twice as much, life is too short for this shit."

    Right here is the secret of happiness and your family will thank you for that, because in the end, it is your family that matters most.

    All the best,


  19. Peter - taking your advice, but can't go w/ Will-Da-Beast. Too many painful memories! Henceforth my nom de plume is "Cat Scratch Fever". I'm out there, Peter, and I'm lovin' it. Toodles to you!

  20. Sorry to hear about your impending departure Dr. Cat, but from the looks of these numbers (which I can only assume are 100% accurate as there are formulas involved):

    full-time med blogging seems to be the key to "financial independence," "building wealth," or whatever the hell other euphemisms investment companies use in their commercials for being flat out filthy rich. Do it for your readers. Do it for yourself.

    P.S.- "Dr. Cat Scratch Fever," love the moniker. Ted Nugent doesn't take crap from anyone. With my first choice, Charlton "COLD DEAD HANDS" Heston recently cold, and more recently dead, the Nuge gets my nod for AMA chairman. Every time I hear "Stranglehold," I wish I could play guitar, just for the opportunity to kick down the door on some stuffy office meeting and lay down that main riff. Rock on Drs. Cat, hopefully your change is for the better.

  21. Yall are all makin' it damn hard to want to go be an ER doc.

    Maybe I'll just play mom.

  22. EE: Yes, being en ED doc is clearly really hard, but so is being a full time Mom. I was one of those women that had a baby about 5 min. before the bar exam, and though I passed, i got home and the baby wouldn't look at me--he turned his head away. I shelved my career plans for several years and stayed home, and that was not only the best but the hardest job I EVER had. My hat is off to the full time Moms!

  23. devorrah,
    no argument there. God bles.

  24. Thanks, Doc, and love the avatar (-:

    I want to additionally acknowledge the legions of women who would love to stay home and aren't financially able to do so. My hat's off to you, too, for doing what needs to be done for your kids. I actually only went back to work because my husband flipped out with combat PTSD and was abusing the kids. Been on both sides. God bless everyone who is doing the best they can for their kids. I know that's true of the docs, too--they keep at it to support their families.

  25. Thanks Devorrah for the reminder. Sometimes it gets hard to remember that what I am doing is important as far as the world is concerned. You know I should be out there finishing my degree, and being productive.

    Then I have to remind myself that I am raising human beings to be intelligent and responsible individuals, and maybe even an orthopedic surgeon. My daughter came to me yesterday saying that her stuffed giraffe had broken all of his bones sideways and she was going to cut him open and put them back together. LOL. I suppose her orthopedic surgeon would be proud.

  26. Ah, yea, well, by the time I'm a doctor my kid will be 7ish, so...I suppose everything will be cool. I still want to be an ER's gotta be more fun than being an EMT, hah.

  27. 'cat,

    as a wise old veteran once told me (through his nebulized albuterol),

    "doc, it ain't the tobakee that kills ya, it's them damned chemicals the guv'mnt sprays on it..."

    i thought you knew that?

    john edwards is the kind of guy that was the rush chairman at omega house and had the shit kicked out of him once in high school (but had his daddy hire someone to beat up the kid that did it). i can't diss his hair though. it's perfect and luxurious.

  28. Cat:
    Run for the fucking hills!

    ER seems like a toxic wasteland.. I'm amazed you guys have lasted this long.

  29. I'm uneducated, but....
    seems to me that a clinical trial is a randomized, statistically analyzed collection of anecdotes. Inasmuch as an anecdote is defined as the experience of one person.
    (Hi Devorrah! This one is not meant to spew fire, it's just a thought.)

  30. Although, it does makes sense to collect anecdotes. The experience of one person does not mean much, and it would not be generalizable to the general population. So, if a clinical trial is an attempt to collect and generalize experience, then that makes sense.
    There is a difference between one person and the general population. Vaccinations are a good example of this difference. For one person, a vaccine may potentially cause a drastic negative effect. For example, *you* may be that 0.001% that does get autism from your vaccine. OTOH, vaccinating everybody does protect the general population. Small pox was eradicated by vaccinating the population, although there I imaging there were isolated negative events.
    (Heh. This is my attempt to think, not spew. Go check out the vaccine debate at Respectful Insolence blog.)

  31. Richter:

    The point of a clinical trial it the point of any science. It is the collection of data points across a subset so that one can draw conclusions to characterize the subset as a whole, and characterize the probabilities of certain occurences.

    If think it's all anecdotal, you shouldn't go into science because all it is: the same thing as clinical trials only with different variables.

    Don't get too existential on us sweetie.

  32. People can debate whether mercury causes autism all they want, but time and time again, it has been proven to have no effect.

    It is much more likely that autism is genetic in causation with environmental triggers in a few cases, like many other mental illnesses.

  33. Amy: My point is that one specific data point in the subset *is* an anecdote.
    IF an anecdote is a fact about 1 person.
    I guess in the study it would be a documented anecdote, as opposed to an urban legend anecdote?

  34. Hi Amy,
    Actually, autism is a developmental disability, though autism can lead to mental illness, and autism may be coexistent with mental illness. I've had so many autistic students, and my younger son works with autistic children. Do you have any autistic children or friends with autistic kids?

  35. Sorry Devorrah, once again I am guilty of a lack of clarity. I was merely pointing out that autism as well as various mental illnesses are almost certainly genetic in causation. Not saying that autism is a mental illness.

    Sorry for making that clear as mud.

  36. And drawing it together (with very little clairity) that mental illnesses are often genetic in causation, but triggered by something environmental, be it a traumatic brain injury, drug use, use of a certain prescription, etc. There is the possiblity that autism is much more common in individuals with the genetic predisposition for it who are also lacking the ability to remove heavy metals.

  37. There is definitely a genetic component to autistic spectrum disorder. Aunt Jane may have Asperger's Syndrome, her sister has PDD and her nephew is severely impacted. I had a wonderful day with my autistic (PDD) student yesterday: He got to be "helper" for the first time, and he did everything perfectly. His aide and I cried, as he's come so far. He's actually my best student academically, and he's so cute.

  38. My husband graduated for his undergrad with a guy who was autistic. He didn't talk until he was 17. It took him 10 years, and he didn't go an easy route. It was a science major. My husband would help him by reading tests to him, and helped him with some assignments. We had to lay out some ground rules, like no you cannot call at 5 am. Occasionally he would quack in class LOL. And his comments caused for some memorable lectures in a good way.

  39. Hi Amy,
    I once dated a veterinarian who I later suspected had Asperger's syndrome because he just didn't understand social conventions that other people take for granted. He had a Phd and DVM, but he didn't understand why it bothered me when he wanted me to sit in the back seat of his car so his bulldog could ride in the front.