Friday, March 24, 2006

FWIW

While waiting for the littlest surgling to finish lacrosse practice today, I caught the last part of Hugh Hewitt's show on the radio. Normally on Fridays he has Emmett of the Unblinking Eye on to talk about movies, and generally it's pretty funny. But, today, Emmett must have been taking in a double feature, so Mr. Hewitt was reviewing a list of the "15 Essential Protest Songs" put out by Context magazine.

OK, I'm not much of a "protest" song kind of guy. I think Secretary Rumsfeld and I would get along swimmingly, thank you very much, and I suspect the same could be said for Mr. Hewitt. But, music has its own charms, so I kept listening.....until MUSICAL BLASPHEMY was committed. On the list was one of my favorite songs -- For What It's Worth, by Buffalo Springfield -- and Mr. Hewitt said it was really just a drug song! Am I the only one that caught that? Judge for yourself -- here are most of the lyrics:

There's something happening here
What it is ain't exactly clear
There's a man with a gun over there
Telling me I got to beware
I think it's time we stop, children, what's that sound
Everybody look what's going down
There's battle lines being drawn
Nobody's right if everybody's wrong
Young people speaking their minds
Getting so much resistance from behind
I think it's time we stop, hey, what's that sound
Everybody look what's going down
What a field-day for the heat
A thousand people in the street
Singing songs and carrying signs
Mostly say, hooray for our side
It's time we stop, hey, what's that sound
Everybody look what's going down
Paranoia strikes deep
Into your life it will creep
It starts when you're always afraid
You step out of line, the man come and take you away
We better stop, hey, what's that sound
Everybody look what's going down
Acutally, when you hear the words "Nobody's right if everybody's wrong" and " Singing songs and carrying signs; Mostly say, hooray for our side," I think this is the one so-called protest song that really expresses the difficulties of disagreement, rather than today's rent-a-mob staged events.

Oh, well --- now that I got that off my chest, it's time to fire up the turntable and spin a little Pink Floyd and sip a little vino. And I'm positive that Mr. Hewitt would not feel Another Brick in the Wall is a protest song, either.

Dilemmas, dilemmas

Work hour restrictions for residents have created a conundrum for everyone involved. Some educators worry that the residents they are responsible for teaching have too little clinical time to get all of the training they need, and often worry that we are creating a generation of trainees that do not have the necessary dedication to patient care that is required in many clinical settings. Some residents worry that they are not getting enough clinical experience to be competent upon completion of training. Patients ---- they probably should worry the most ---- have fears about being cared for by exhausted residents; they may also fear that their newly minted physicians don't have enough clinical expertise by the time they hang up their shingles.

There have been a series of articles relating to the implementation of the 80 hour work restrictions for residents ---- I would say that the majority of the articles that have been published have been favorable towards the regulations, which is 180 degrees opposite the opinion of the physicians I speak with (both academic and non-academic). Two that were not so positive that were in the surgical literature were reviewed by myself and by my colleague to the east, Dr. Bard Parker.

This month's American Journal of Surgery contains yet another take on the work hour restriction debate. Work-hour restrictions as an ethical dilemma for residents comes from the Dept. of Surgery at Vanderbilt (subscription required for entire article). The authors basically approached the problem from what they described as an ethical dilemma --- are residents reporting their work hours honestly? If not, why?

The results were interesting. Of the eighty-one percent of responders to the survey, eighty percent reported exceeding their work hour restrictions, against policy and without reporting the transgression. The reason most commonly cited for this was concern for patient care (80%); junior level residents were more likely to exceed work hour restrictions than their senior level counterparts (86% vs. 63%), and surgical residents were more likely to exceed work hour restrictions than non-surgeons (89% vs. 74%).

Actually, I have to confess that the numbers were higher than I suspected -- being an older, curmudgeonly surgeon, I have a tendency to believe the next generation of surgeons will be lazier than an NBC reporter chasing down good news about Pres. Bush. And, actually, I am greatly encouraged to see that concern for patient care trumped the artificiality of the work hour restrictions. The authors of the study, however, don't necessarily share my enthusiasm. They feel that there is a conflict that has arisen between the work hour requirements and a culture in residency training that equates professionalism with, well, working longer hours rather than "passing off" one's patient care responsibilities to another resident. Some of this is attributable to differences between surgeons and non-surgeons (see the statistics above):

Medicine resident teams enter and exit daily patient care as a unit. Passing on responsibility for longitudinal patient care to an oncoming team has been their operational norm for many years. The tradition and dogma of surgical resident education continues to emphasize individual responsibility and a sense of personal patient "ownership". Although, in the past, such sense of duty has been promoted as professional conduct, this paradigm may further suppress team development and hinder actual work hour compliance within surgical training programs.
In the eyes of the authors, the desire of these residents to provide some continuity of care to their patients --- which has been traditionally emphasized as paramount in physician training --- creates an ethical dilemma for the residents, and it "hinders" the development of team building solutions to the work hour constraints.

I empathize with the program directors' plight in this difficult situation, which is I think reflected in the tone of this article. They have no choice. It's not as if they can say "piss off" to the Residency Review Committee and set their own work hour rules to suit the educational needs of their residents. Having spoken with a number of surgery program directors, I suspect the majority of them feel that the rules are really not in the best interests of resident education. But, what are they to do?

IMHO, both the residents and the faculty are faced with a different dilemma than the one proposed by this paper. It is the dilemma presented by the desire to teach/learn what is required to take the best possible care of one's patients when faced with an arbitrary rule that occasionally prevents the same. It is the dilemma faced by those who understand that the idea of "ownership" of patients is a better model for patient care than "shiftwork" provided by rotating teams of residents. It is the dilemma faced by the surgeon who is tired but at 6PM finds that one of his postop patients is not doing as well as expected --- who else knows what occurred during that surgery? Who did the preop evaluation, and understands that the patient has some underlying coronary disease/history of thromboembolism/anxiety disorder/etc.? The "team" that gets a verbal handoff? Not. Very. Likely.

I cannot speak for any professional occupation other than general surgery, but I will throw in my two cents about this topic as often as possible. It is not advisable to develop a system that encourages a shiftwork mentality amongst surgeons. The "ownership" mentality that was damned with faint praise in this article provides, once again IMHO, the best possible, most cost effective, and most error-free care for surgical patients. As somebody who might resemble an aggravated surgeon once wrote:
I have always felt that continuity of care is one of the most important hallmarks of general surgery; basically, the surgeon shoulders the responsibility to see his or her patient through the perioperative period, and be the one responsible for returning the patient to the OR in the case of an adverse event if at all possible. In fact, the surgeon's ability to deal with postoperative complications is perhaps his/her most important asset.
Contrast that with the conclusion of the article:
Ongoing clarification of this proposed social model would better enable program directors and their residents to attain compliance at their particular program through precise intervention. True compliance would relieve residents of the ethical dilemma associated with hours reporting. This level of intervention will likely require both education and system changes.
I don't see much there that reflects the ideals of continuity of patient care, education, and preparation for the difficult times when surgeons must get out of bed in the middle of the night to make sure a patient receives the appropriate level of attention and care.

Tuesday, March 21, 2006

Grand Rounds

Grand Rounds is up and running at HealthyConcerns.com --- a nice break from the regular work day, take a tour of the best of the medical blogosphere.

Sunday, March 19, 2006

Get My Gun!

SWIMBO came home from the gym the other day and let me know the gal that helps her work out more effectively (alternately known as Frau Blucher, the sadist) sent her to get a free demonstration of the Migun Bed.

What, I asked innocently, is a Migun Bed? According to the flier given to the fetching Mrs. DocSurg, it is a thermal massage system. Sounds nice, relaxing, soothing; kind of like a hot tub with magic fingers. But wait 'til you find out the rest ---"What does thermal massage do?" -- according to the flier:

Detoxifies
Reduces stress
Increases energy
Relieves constant aches & pains
Improves blood circulation
Ding ding ding ding! My BS detector just went off, and the meter is reading that the BS titer is critical and rising! Once you see the word "DETOXIFIES," you can bet your last bottle of ginseng that there is a more quackery to be found here than in a pond full of mallards. But here is the best part of the flier:
FDA Migun Thermal Massage System is approved by FDA as a Class II medical instrument under the 510k regulation, and can be used without a prescription.
Okey dokey. This is the kind of cr&p that gets under my skin and doesn't quit bothering me for days on end. Being a true novice when it comes to the FDA process, I did the obvious, and went to the source --- FDA Device Advice abut 510K approval process:

A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval(PMA). Applicants must compare their 510(k) device to one or more similar devices currently on the U.S. market and make and support their substantial equivalency claims. A legally marketed device is a device that was legally marketed prior to May 28, 1976 (preamendments device), or a device which has been reclassified from Class III to Class II or I, a device which has been found to be substantially equivalent to such a device through the 510(k) process, or one established through Evaluation of Automatic Class III Definition. The legally marketed device(s) to which equivalence is drawn is known as the "predicate" device(s). Applicants must submit descriptive data and, when necessary, performance data to establish that their device is SE to a predicate device. Again, the data in a 510(k) is to show comparability, that is, substantial equivalency (SE) of a new device to a predicate device.

In other words, the 510(k) approval means that a device is substantially similar to another product, so that a separate approval for a completely "new" device is not necessary. In even other words, there's nothing revolutionary about this product, since its own advertisement must be substantially equivalent to some other, already approved device ---- and there are a number of devices that provide heated massage.

But wait! It's the F-FRICKIN'-DA! That must mean some kind of sanction for this fantastique device, which, as we can all see, relies on the "5 Migun Principles:"
Chiropractic: Restores structural integrity and relieves nerve interference by restoring vertebrae alignment with its patented technology.
Far-Infrared: Increases function of tissue cells and enhances blood circulation.
Acupuncture: Stimulates specific points of the body to recharge life force and bring proper balance.
Acupressure: Temporarily blocks the circulation of Qi and the release jump starts the Qi movement to flush out the toxins.
Massage: May ease chronic pain, speed recovery from sports injuries, and make your muscles more agile.
Ding ding ding ding (see BS meter above)! Step right up folks! We've got your chiropractic, your far infrared, your acupuncture, and your acupressure quackery right here, provided by the all-important "new external 15 way jade massage heads and 2 way jade massage heads" --- of course, "According to oriental medicine, jade has always been known to have mysterious healing affects, promoting longevity, and discharging toxins from our bodies." Can't forget about the critical effects of jade, now can we?

Let's just say that I am a bit, well, jaded. Why? From the original FDA approval letter for this device, here are the indications for its use:
The intended use of the Migun Model HY-7000 Thermassage Energy Product is to
provide patients with muscle relaxation therapy by delivering heat and soothing massage.
Additionally, the infrared lamps provide topical heating for;
o temporary relief of minor muscle and joint pain, and stiffness
o the temporary relief of minor joint pain associated with arthritis
o the temporary increase in local circulation where applied
o relaxation of muscles
Well. Um, let's see. Where's the jade in all of that? The Qi? The increased function of tissue cells and enhanced blood circulation? The recharging of life force? Proper balance? The de-frickin'-toxification?!!!!! How the HEDOUBLEHOCKEYSTICKS do you get from the FDA's own approval letter to this?:
Many people suffering from the following symptoms reported varying degrees of relief after using The Migun Thermal Massage Bed:
Parkinson's disease / stroke kidney /• prostate /• diarrhea /constipation /• expansion of abdominal region /• stomach /• ulcers /• lungs /• asthma /• yellow jaundice /• heart / liver sclerosis /• fatty liver / arteriosclerosis / hypertension /• sore hands / eye diseases / deafness / headaches / cataract / tonsillitis / thyroid insufficiency / emphysema / insomnia / nervous prostration / diabetes / menstrual irregularities / loss of energy, etc.
Look, I think that this thing looks pretty relaxing and might be a soothing alternative to a massage for some folks. In practical terms, at a cost of around 2 grand, it's probably not a whole lot more effective than my late great uncle Bill's vibrating green naugahyde barcalounger. If you got the cash, and it sounds good to you, buy one. But I hope somehow, somewhere, in some dimension, people who advertise this kind of quackery -- that a massage table helps diabetes! -- find themselves not nicely laid out on a comfy massage table, but meeting up with Procrustes for all of eternity.


For them, the torture should not be the comfy chair, it should be the rack.

Thursday, March 16, 2006

Er, WTF?

I guess this sort of begs the question ---- why?

Tuesday, March 14, 2006

Grand Rounds

Grand Rounds is being hosted by Geek Nurse --- it's a wild and wooly collection this week. Take a few minutes to peruse the best medical blogging this week.

Monday, March 13, 2006

Plavix & Aspirin -- Fusion or Fission?

There was some interesting data presented yesterday at the American College of Cardiology's annual meeting regarding the use of the combination of aspirin and Plavix. For years, good old fashioned aspirin has been touted as the best medication for the average person to take to reduce their risk of heart attack and stroke. More recently, the advent of statins has greatly influenced the treatment and outcomes of these diseases --- but these are meant only for those patients with established hyperlipidemia. Aspirin was initially thought to be good for everybody; it affects platelet function by blocking the production by platelets of thromboxane A-2, the chemical that causes platelets to clump, theoretically decreasing the likelihood of development of a thrombotic event in all who take it. More recently, however, there has been good research that shows aspirin is best reserved for those patients at highest risk for cardiovascular disease --- those with a prior history of MI or stroke, those with hyperlipidemia, etc. Interestingly, the benefits of aspirin use are clearly different depending upon one's gender, with men getting a bit more bang for the buck.

There is a "dark side" to aspirin -- the risk of the development of bleeding ulcers, which may require endoscopic treatment or occasionally surgery. That risk is known with all of the NSAIDS, whether they are COX-1 or COX-2 inhibitors. While my own experience is only anecdotal, most of the patients I have been called to operate upon with bleeding (or more commonly, perforated) ulcers due to aspirin use have been aspirin abusers, not simply taking a baby aspirin for the prevention of MI or stroke.

With the antiplatelet effect of aspirin seen as a good thing, and its GI side effects seen as a bad thing, researchers looked for other ways to inhibit platelet function. The thienopyridines were developed to block ADP receptors on platelets, thereby inhibiting platelet clumping. The most widely prescribed thienopyridine is Plavix --- which may be a well-known drug to non-medical folks due to the aggressive ad campaign waged by its manufacturer. A combination of aspirin and Plavix has been shown to significantly reduces the risk in patients being treated for an acute MI of a second MI or death. Initially approved for use in 1997, Plavix is currently approved for the following uses (from the Sanofi web site):

Recent MI, Recent Stroke, or Established Peripheral Arterial Disease --For patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral artery disease, PLAVIX has been shown to reduce the rate of a combined end point of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death.
Acute Coronary Syndrome -- For patients with acute coronary syndrome (unstable angina/nonĂ‚–Q-wave MI), including patients who are to be managed medically and those who are to be managed with percutaneous coronary intervention (with or without stent) or CABG, PLAVIX has been shown to decrease the rate of a combined end point of cardiovascular death, MI, or stroke as well as the rate of a combined end point of cardiovascular death, MI, stroke, or refractory ischemia.
What is hidden in that mass of medical gumbo is that Plavix is a good drug when used for the above-mentioned situations, and there is some pretty good science available to endorse its utilization in those circumstances.

And therein lies the problem. Plavix has become the "go to" drug for many physicians who are looking for something that will decrease the stroke or MI risk in the patient who comes with those concerns, but who does not fit into the above categories of indicated usage. In particular, I have seen a huge increase in patients given Plavix for a history of TIA, despite the clear statement in the prescribing information:
PLAVIX is not indicated for TIA
This is important, because Plavix is a long-lasting drug that does not have a readily available antidote --- once you take it, your platelets are pretty much out of commission for about 7-10 days, the time it takes for your body to get rid of the old platelets and make new ones. That's why I, as a surgeon, really, really (REALLY) don't like this drug --- an emergency big operation on a patient taking Plavix can be either a death-defying highwire act above Niagara Falls, or a death-producing disaster.

To come full circle, the study from the Cleveland Clinic was designed to determine whether expanding the use of the aspirin/Plavix combination was a good thing. Kudos to the investigators, who reported the exact opposite, despite being funded by Sanofi:
The drug combination not only didn't help most people in a newly released study, but it unexpectedly almost doubled the risk of death, heart attack or stroke for those with no clogged arteries but with worrisome conditions like high blood pressure and high cholesterol. "They actually were harmed," said Dr. Eric Topol. "This was a trial to determine the boundaries of benefit, and it did. You don't use this drug for patients without coronary artery disease." Nothing in the study changes recommendations that people who recently have had heart attacks or a procedure to unclog an artery take those medicines. This study dealt with expanding use of the drug to other people....doctors thought the drug combination might prevent "heart attacks waiting to happen" in people with very clogged arteries or lots of risk factors like heavy smoking, diabetes and high cholesterol....Adding Plavix made little difference for the group as a whole except for slightly reducing hospitalizations. But for the 20 percent with no signs of heart disease, the drug combination proved dangerous. Heart-related deaths almost doubled, from 2.2 percent of those taking only aspirin to 3.9 percent of those who added Plavix.

The only people even modestly helped by adding Plavix were those with established heart disease. Their risk of heart attack, stroke or death was about 7 percent versus 8 percent for those taking aspirin alone.

The study results will be published in the April 20 edition of the New England Journal of Medicine, and apparently there will be a strong editorial accompaniment to the article. My hope is that it will mirror my bottom line for Plavix:
  1. It's a good drug, but may be only marginally better than aspirin.
  2. Use it for, and only for, the right indications.
  3. Please understand that it has some pretty big problems for patients who may require surgery, so go back and read number [2] a few more times.

Wednesday, March 08, 2006

Dr. Caligari and the Lexi

Following my most recent post about the P4P system, there was a rather interesting comment left by a "Dr. Caligari:"

hmmmm . . . . so you docs are all upset that medicare is going to use a payment system that has yet to be tested in rigorous studies. And, how may of the things that YOU do on your patients, have, in fact, been tested in nice, randomized double blind studies? Not that much, I suspect . . . (the percentages I hear are between 15-35%). Oh, but that doesn't stop you irresponsible quacks from doing episiotomies (do you enjoy slicing women from the vagina to the anus?), removing tonsils, even doing physicals--none of which have strong evidence based support.

AHH--but when it comes to something that cuts into your INCOME--and may prevent you from getting that third Lexus--why we're all evidence-based now!

Vile hypocrites.
Observe when confronted with their own logical inconsistencies, doctors just get nasty and personal. And so lacking in senses of humor--apparently the Lexus remark was too close for comfort . . . .

As I said, its hypocritical to demand evidence based payment system, but not practice evidence based medicine. If anything, I would think you should have lower standard (i.e., more open to experimenting) on payment systems than human beings.
If Dr. Caligari really believes that physicians in the US are dead set against improvement in patient care, preferring to practice only by the light provided by anecdotal evidence and the occasional "experimentation" on patients, he may need a short stay in the lunatic asylum so aptly displayed in the movie he takes his name from. And as for the "humor" remark, I kind of think that the epithet "vile hypocrites" displays a certain lack of wittiness that even a third grader might hope to achieve with a "knock-knock" joke. I suspect that many would charitably describe the phrase "irresponsible quacks" as a "nasty and personal" remark as well (and not so charitably as something else altogether).

I did get a good laugh out of all of this, however. SWIMBO occasionally reads my blog, and paged me earlier today to demand not her third, but just ONE Lexus!! Dammit, Dr. Caligari, now you've blown my cover! I'm just a rich as sin surgeon, generating tons of cash from experimenting on patients, but I have tried to hide it all from SWIMBO so I can retire at 45 and enjoy drinks with parasols in them on the beach every day! But noooooo, now I need to go buy a few Lexuses just to make the little woman feel like she's keeping up with all of the other fabulously wealthy doctors' wives --- or is it "Lexi?" I'll have to call my old Latin teacher, Fr. Bayhi, to find out.

Tuesday, March 07, 2006

Grand Rounds at Emergiblog

Check out this week's best of the medical blogs over at Emergiblog -- a rather expansive collection this time, with something for everyone!

Friday, March 03, 2006

A(nathe)MA, part the second

I received a very interesting e-mail in response to the AMA rant I posted a few days ago. It came from Dr. Richard Dolinar, an Arizona endocrinologist who is a senior fellow in health care policy for the Heartland Institute. He pointed me towards a few excellent articles he has penned for the Heritage Foundation that have a lot more factual information regarding Medicare's P4P plans. They are well worth the time to read, and basically say (in a much more eloquent fashion than my rant) that we will gain nothing from the current plan being promulgated by Medicare with the back door assistance of the AMA. Another article he wrote with S. Luke Leininger of the Heritage foundation can be found here.

What is particularly insulting about the whole P4P initiative is that this is an exercise in "pseudo" market reform; the folks who are promoting it state that undoubtedly, care will improve (and we physicians will be rewarded) when a whole series of "quality" benchmarks are achieved. Unfortunately, as Dr. Dolinar points out, that has never been shown to be the case:

While federal lawmakers are rushing to implement “values-based purchasing” in Medicare, they ought to take a closer look at the professional literature on the topic, including the limited uses of “evidence-based medicine” underlying this approach. For example, Harvard University’s Meredith B. Rosenthal and her colleagues recently published “Early Experience with Pay for Performance from Concept to Practice” in the Journal of the American Medical Association in an attempt to fill the void of published research on this physician payment strategy. Curiously, the accompanying JAMA editorial rightly notes that in health care there have been “only nine randomized controlled trials of Pay For Performance…reported in the literature.” In reviewing those studies, we note that the review by the Agency for Healthcare Research and Quality (AHRQ) concluded that “little unequivocal data” supported this approach.
In my experience, the physicians and nurses who provide the best, and most cost effective, care are those who spend the least amount of time worrying about whether all of the little boxes in their sheets have checkmarks in them. We are in the business of caring for sick people, not of filling out forms in the realm of "cookbook" medicine. To put it another way, if 80-year-old diabetic GrandMa shows up in the ED with an INR of 6 because she is taking too much Coumadin, which she was prescribed for "evidence-based" reasons, bleeding from a newly diagnosed colon cancer, and needs a whole lot of intense care to get her through her hospitalization, do you really think her survival depends upon whether or not she is on the antihypertensive that some guideline has decreed is "appropriate" for her --- which she will be given in a "cookbook" fashion, just so that the physician and hospital won't get dinged in a review?

What is most disheartening to me is that Medicare, and the AMA, has already won the PR battle. There is no question that our current system does not allow every patient to receive the best and most cost effective care; nobody is more concerned about this than the physicians and nurses who are caring for them. With the inevitable imposition of the P4P plan, I predict that we will see reporting of ever-improving "results" but no true improvements --- sort of how the Soviet bureaucrats would report "record" production each year, while utterly failing by any reasonable calculation. In my opinion, until market forces are allowed to be applied to the field of health care, we will continue to see spiraling costs, poor reporting of bad outcomes, poor quality improvement and process improvement, and a culture of increasing government regulation in physicians' offices and in hospitals --- all masked, albeit temporarily, by a false sense of security generated by the "quality benchmark achievement" buzz. It has been said many times, but the old adage is true: if you like how the Post Office is run, you will love government-run health care.

I learned one additional thing from Dr. Dolinar --- AMA membership has fallen to 24% of practicing physicians in the US. Are you one of the 24%, and if so, why?