Texas Medical Association skeptical of UHC's "Premium Designation Program"

UnitedHealthCare representatives have met with the Texas Medical Association's (TMA) leaders to introduce their program designated as Premium Designation Program which will hand out stars to good doctors. I still remember the stars I was awarded on my grade school papers. Physicians who meet either the quality standards or the efficiency standards that UHC devises with be designated as either having one or two stars (two if both criteria are met) and a triangle will be the scarlet letter for those whose data is insufficient to analyze or if their specialty is not included in the program. Apparently the grading system will be based on claims data.UHC said that initially the program won't be used to penalize or reward physicians monetarily. Writing in the September 2005 issue of Texas Medicine , the senior editor quoted a 7/21/05 letter from the TMA General Counsel to UHC in which the TMA wanted to make it clear they did not endorse the program. Several physicians who attended UHC briefing sessions complained that UHC either implied or stated that their program was endorsed by the TMA. A program in which a star is given on the basis of claims reviews for "efficiency" is not a quality initiative. It is a cost containment mechanism. The program as currently touted by UHC seems to contain none of the AMA 's five requirements for a quality improvement type P4P program. Typically, TMA has been a strong advocate for physicians and patient care and so far it is willing to point out exactly how the emperor is dressed. The insurance industry's Trojan horse of quality seemed to have been welcomed within the walled city of the American College of Physicians (ACP) and perhaps other national medical organizations. While I continue to hope that national organizations can make a difference, I believe that meaningful resistance to this latest cost containment-profit enhancing- initiative of big insurance will be at the level of the state and local medical societies.

No reduction in GI cancers from antioxidant supplements-caraway extract for IBS?

The Sept. 6 issue of the Annals Internal Medicine reviews an earlier Lancet article ( Bjelakovic, G et al-Lancet 2004:364;1219-1228) which not only concluded that antioxidants do not prevent GI cancers but may increase the risk. The data clearly did not show cancer reducing benefit form the supplements included (various vitamins and selenium) but the conclusion of possible increased risk seems unwarranted as the Annals reviewer explains in his analysis. The increased risk (R.R=1.06) was found in a fixed-effects model which is said to be used if the data appear to be homogeneous but 7 of the trials seemed to be heterogeneous. The random effects model analysis did not show an increase in all-cause mortality and that type of analysis is usually what is employed with heterogeneous data.
The same review section ( Update in Gastroenterology and Hepatology) includes an article of a RCT evaluating the use of herbal preparation for the treatment of IBS. 208 patients were assigned to receive 1 of 4 regimens. An abdominal symptom score was the endpoint of interest. 2 of the 4 regimens were said to bring about significant improvement in symptoms scores.Both regimens contained peppermint and caraway fruit. The reviewer concludes that practitioners "should consider" these herbal preparations to their armamentarium for IBS. I know there is considerable energy in the efforts to make respectable complementary and alternative medicine but one small RCT seems to me inadequate evidence to include these herbs in your treatment choice bag just yet. (There are a few other small trials using the combination of these two herbs for treatment of "non-ulcer dyspepsia" but are we seeing a type of affirmative action for alternative medicine . FDA approval would not be granted for a prescription medication based entirely on one RCT.)

Disease Mongering-One more obstacle in the search for medical knowledge?

Recently, the American Diabetes Association (ADA) issued a statement casting doubt on the validity and usefulness of the concept of metabolic syndrome and suggesting that physicians not make that diagnosis. One of the news articles about this statement used the term disease mongering.I had not previously been aware of that term. Mongering has two dictionary definitions:
1) to deal in a commodity 2) to promote something undesirable or discreditable. A 2002 BMJ article deals with disease mongering which describe as follows: " Some forms of "medicalization" may now be better described as " disease mongering"- extending the boundaries of treatable illness to expand markets for new products.
A 1992 book entitled "Disease-Mongers" by Lynn Payer, health editor of the New York Times, provides an early application of that characterization.Two years earlier, Ivan Illich's often quoted "Limits to Medicine" had dealt in part with that subject.
The BMJ article speaks of disease awareness campaigns that are linked to companies' marketing strategies and company sponsored advisory boards, risk conceptualized as diseases and disease prevalence estimates constructed to maximize the impact and importance of a given medical issue.
Osteoporosis was given as a example of a risk conceptualized as a disease. A diagnosis of osteoporosis can be made on the basis of a bone mineral density (BMD) test if the patients' test results vary sufficiently from that of a normal young woman. BMD is one of the risk factors for osteoporotic fractures but in this formulation a low BMD becomes a disease worthy of ICD coding, prescription medication and continuing followup with more BMD determinations. The authors reference the role of drug companies in sponsoring meetings where the disease was defined, and funded studies of therapies and patient groups and and disease foundations.There has definitely been a paradigm shift, patients at some higher level of risk for fracture have been defined as having osteoporosis and there is widespread knowledge of the test, the new definition and patient acceptance of prescription medication.
All of this has to give a physician some cause for concern. Have we been bamboozeled by Big Pharma, have patients and physicians been sold a bill of goods? The authors would say yes, but I do not believe it is that simple. Trying to disentangle the facts from drug company hype and spin in a literature so often highly influenced by those drug companies is no easy task.
The treatment of osteoporosis has a sound foundation. 25 years ago we had no treatment for the painful complications of osteoprosis, we do now. That is not the issue. The issue is are we preemptively " treating" a low BMW to prevent clinical osteoporosis because we have been convinced that this is the appropriate thing to do by pharma hype. Maybe so, but that does not necessarily mean we shouldn't do it. Risk of fracture is clearly reduced by bisposphonates. Bisphosphonates appear safe and effacious and for a patient at an increased risk of osteoporotic fracture it is reasonable to offer that patient the option of prescription medication to mitigate that risk even though we may have not reached that point if not for the promotional efforts of drug companies. With the spotlight that has been focused on Pharma's antics, I want to believe there will be less disease mongering and both physicians and patients will be more skeptical and immune to influence.
Specifically in regard to the metabolic syndrome and relevant to disease mongering discussions, at least one drug company cannot be pleased with ADA's recent statement challenging the validity of the concept. I read today a two page ad from Sanofi Aventis in which "a newly discovered physiologic system" is highlighted, namely the endocannabinoid system which is alleged to be overactive in the metabolic syndrome Their drug, rimonibant is an antagonist of this system and FDA approval for treatment of the metabolic syndrome would be more valuable than treatment for obesity alone an application for which it has demonstrated some usefulness.
Fox Mulder believed the truth is out there somewhere.Physicians typically do as well, but it is harder to grasp the truth when we have serious doubts about the veracity of the data underlying our practice decisions.

The doctors and Nurses of New Orleans Charity Hospital

Fox News interviewed a nurse at New Orleans Charity Hospital last night. She and her fellow nurses and the physicians had been fighting against everything for the last few days, disease, injury, diminishing supplies and food and water living and working in a island without outside help.
She said they kept it all going because that is what doctors and nurses do and what they accomplished was done without help from the city, state, FEMA or anyone else. That dedication and focus on patient care is what doctors and nurses are all about. Making patient care and welfare first is what was imprinted in my limbic cortex at the same institution over 35 years ago. My wife and I became doctors there at LSU and Tulane Medical School and "Big Charity" and our hearts are breaking as we sit glued to the TV and Web absorbed in the misery as memories flood our minds of a time of youth and promise as we underwent the transformation from young adults in our early twenties to physicians. We are so proud of the current generation of faculty and students at the two med schools fighting the good fight in the face of impossible conditions and risk to themselves. Dr. Roy Poses and others on their web sites do a great service by pointing out and fighting against the outside forces that erode the core values of physicians but , by God, when the chips are down, the core values are there as the actions of the doctors at Charity and other N.O. hospitals illustrate so heroically.

ADA statement- metabolic syndrome not a useful concept any longer

In what will be to many a surprising comment,The American Diabetes Association issued a statement challenging the value of the metabolic syndrome label. Their chief scientific and medical officer was quoted in USA-Today as saying "We don't believe there 's a syndrome"
The ADA is quoted as saying that each of the conditions that make up the syndrome are potentially life threatening but there is no evidence to suggest that someone with multiple factors is any sicker . Headlines aside, the ADA position is put forth in an ADA Statement published in Diabetes Care 28:2289-2304, 2005. It is a length and scholarly review of the subject and is worth plowing through because this clustering of cardiovascular disease (CVD) risk factors has reached "disease equivalent" status replete with a ICD-9 code and has become part of the medical vocabulary of patients as well as physicians. Here are some of the key points of the statement.
Although certain CVD risk factors are prone to cluster, there is considerable doubt as to the predictive value of the syndrome, i.e. does the syndrome impart any risk greater than its individual components.
In regard to whether metabolic syndrome is a coronary risk equivalent, the authors quote a study by Wilson et. al. which showed that when an elevated blood sugar is taken out of the definition, the 10 yr. Framingham risk does not reach the ATP III's threshold for risk
equivalent. So using the NCEP definition of Metabolic Syndrome, it matters which of the 3 out 5 criteria are present as data suggest that all combination of factors leading to the syndrome diagnosis do not convey equal risk.
There is considerable uncertainty regarding the syndrome's pathogenesis, i.e.everyone with the label-and there are various definitions proposed-may not have the putative underlying mechanism which is thought to be insulin resistance.
In short, the syndrome lacks a precise definition, is of doubtful value as a CVD marker and its underlying pathophysiology is dubious.
The ADA therefore recommends for physicians to treated all CVD risk factors per se and not label patients with the term metabolic syndrome because that may give the impression that the syndrome denotes a greater risk than its components which is a conclusion for which the evidence is not convincing. The term has been a useful paradigm to the extent that atttention was drawn to the fact that some CVD risk factors cluster in patients so predisposed and doctors need to evaluate a patient who has one major CVD risk factor for other risk factors.
The statement is likely to have wide impact as ADA is well respected and their European cohorts (European Association for the study of Diabetes) published the same statment in the journal Diabetologia.
One of the news reports mentioned the term "disease mongering" referring to drug companies' promotion of the syndrome to develop markets for its treatment. This is a concept that has received considerable interest in Australia and in the pages of the BMJ and that deserves a posting of its own at a later date.

A follow up to restless leg syndrome post and comments

Medscape has an article explaining new warnings issued by the FDA on Requip.RebelDoctor Weblog had commented on my earlier blog indicating that he too felt RLS was probably under-diagnosed and mentioned his approach to therapy . Unfortunately, I had to delete the comments for that blog- including his- as my site was bombarded with spam-comments. (I also put up the usual anti-spam- comments protections.) I did not want the good Doctor from Mississippi to think that I did not appreciate his comments.
Medscape indicates the reason for the new warnings on Requip relate to the sudden
"falling asleep" apparently without warnings that have been reported in patients taking Requip. Physicians in Canada had been alerted to this issue as early as 2000. (for some reason I have been unable to get back to Medscape to set up a link). The major issue, here, is should patients on that medication be driving. The PDR section on Requip indicates that patients should not drive until they determine that the drug does not cause drowsiness and if they do experience drowsiness doing everyday activities they should not drive.

Homeopathy-Lancet article critical-NHS pays for it

A recent article in Lancet appropriately criticizes homeopathy and concludes there is no scientific basis for it and it does not work. This is no surprise. It is surprising that the NHS pays for it and the Lancet article ( registration required) quotes a WHO draft report supporting homeopathy claiming there is valid evidence of its efficacy. For some reason I would expect better from WHO.

Restless leg syndrome-unrecognized epidemic or drug company hype

This sounds a lot like my recent posting on bipo*r disease and allegation of physician underdiagnosis and it should since it is another example of the same issue.
This time we look at an article in a recent Archives of Internal medicine and a reporting of that article in Internal Medicine World Report ( August 2005).16,00 patients were given questionnaires re:RLS. Weekly symptoms were reported by 773 patients ( 5 % of the 15, 391 patients who completed the questionnaires.) Apparently 337 reported discussing their symptoms with their physician but only 21 had received a diagnosis of RLS.
Realizing full well that the plural of anecdote is not data, I still have a urge to relate my experience in seeing patients in an internal medicine practice for over 35 years. No patient had a complaint that could be referable to RLS diagnosis ( not to say they didn't have it , they just didn't complain of it) and only two gave me the history of that disorder having been diagnosed elsewhere and were on treatment. One of the two gave me a web site to learn about the disorder. A 3/4 page ad is found in the same issue of Internal Medicine World report informing the reader about the "first and only FDA-approved treatment for moderate to severe Primary RLS", namely ropinirole- trade name Requip which is a dopamine agonist.FDA gave approval in May 2005. The manufacturer of ropinirole is listed as a source of funding for the study; its name is not mentioned in the article. To the extent that patients complain of RLS symptoms and are not counseled about it and perhaps offered the option of medication and have their serum iron levels measured, the physicians are not doing their job.(articles and lectures on RLS-locally there have been a number of "free" dinner lectures on RLS by a local movement disorder specialist-seem to not emphasize in their mentioning of the association of RLS and low iron that at least post menopausal women and all men should be evaluated for GI bleeding if the iron is
low.)
Maybe there is an almost epidemic of RLS and maybe docs are fairly clueless about the whole thing, but in light of the events of the last few years regarding revelations about drug company manipulation of the medical informational process, you just have to be a little skeptical.
On a possibly related note, there seems to be a flurry of recent publications-typically from the medical education companies-about the putative mechanistic reason(s) behind the reported increased prevalence of macrolide resistance and the apparent theoretical advantage of a new antibiotic class-the ketolides- in that regard.

Canadian Supreme Court ruling,CMA recent vote-is private care on the way in Canada?

Delegates at the Canadian Medical Association 's recent meeting voted to not reject the alternative of private care in Canada if waiting times are prohibitive. A recent CBC article describes various medical services already in Canada that seem more private than public including employer based health insurance that may provide ammenities outside of the benefits covered by the provencial plans. Canadians who can afford it sometimes also vote for private care. They vote when they buy insurance that will help pay for surgeries south of the border if the wait is too long. Many Canadian physicians also voted already when they left home and moved to the U.S. to practice pirvate medicine.

Dueling medical mathematical models- to choose- An act of faith?

The August 16, 2005 issue of the Annals of Internal Medicine published an article by Dr. David M. E. Eddy et al using a mathematical model called the Archimedes model. This computer based model was applied to the question of is it more cost effective to give metformin or to employ the methods of the Diabetes Prevention program (DPP) of lifestyle modification to prevent or delay the onset of diabetes in high-risk individuals.

 The DPP had shown that over the almost three years of the trial there was a relative risk reduction of 58% from life-style and 31% for metformin. An earlier article in the same journal used a different model (Markow model) to attempt to answer the same question. The authors concluded that the lifestyle modification was more cost effective. The Eddy article found the opposite to be the case.

The views of two editorialists were sought and published in the August Annals issue in an apparent attempt to place things in context.

One editorial author was Dr. Michael M. Engelgau who was one of the researchers in earlier study that found lifestyle modifications more cost effective. Not surprisingly he criticizes the Eddy model saying in part " I believe Eddy and colleagues' criticisms [of his model] are based on inaccurate descriptions of the DPPRG model". Eddy et al in their introduction state their method is " more thorough,clinically realistic and independently validated".
So whose model is better? Whose conclusion is correct? Is there a "correct"? Dueling experts with opposing conclusions.

The Archimedes model also found that it would be more cost effective to wait until a person developed diabetes before instituting either metformin or lifestyle modification. It will be interesting to see what the folks at the America Diabetes Association or Joslin Clinic say about that.
In real life, of course, a physician will attempt to convince the "pre-diabetic" to loose weight and exercise and may even in addition suggest metformin. But these models are less used to aid individuals docs and individual patients decide what to do that they are to make policy decisions for large organizations in regard to how to allocate funds.

The line between "pre diabetes" and diabetes is arbitrary and the definitions of these two conditions change with the edicts of the ADA and the physiological processes that Eddy claims to model with differential equations are poorly understood and always in flux as new biological insight are gleaned. The output of these models is quality-adjusted life-years (QALY) in which researchers claim to be able to measure and average the "quality" of a person's life. I have posted before on the topic of QALY and cost effectiveness articles.

These models have assumptions on top of assumptions, offer little transparency, are essentially mysterious black boxes to all but a few of the researchers who are expert in such matters and for physicians , or for that matter, policy makers to accept these at face value ( and here how can you when two studies are so contradictory?) requires faith.

"Addicted" to sun bathing ? Arch. Dermatology article

A recent study published in the Archives of Dermatology investigated the use of the CAGE-alcohol abuse screening too, somewhat modified- and another similar tool in beachgoers on a Texas beach. The authors reported that 26% of participants could be classified as having a "substance-related disorder" on the basis of the CAGE screening tool and 53% using the modified DSM-IV-R diagnostic criteria
Some skeptics might say that this is really a stretch and one more example of a hypertrophied tendency to medicalize every human behavior and trait and a rampant nanny-ism wherein we must figure out a way to stop everyone from doing anything that might be considered foolish, unhealthy or contrary to what the nagging nannies would have us do or not do.
The Archives article suggested that the recognition of tanning as substance-related disorder opens the door to possible new techniques to curb the practice, particularly in regard to tanning salons and the legal prohibition of children using them. They say outdoor UV exposure control might be more problematic ( Ya think).
Hello, I'm Kevin, I'm a u-v light exposure holic. Hello Kevin. (And another thing is U-V light exposure a substance?

Bipol*r disease, unrecognized epidemic or drug company hype

Several months ago at a local internist's club meeting we had a presentation by a psychiatrist about bipolar disorder. He is a co-director of a mood disorder program at a local medical school. (yes, it was sponsored by a pharmaceutical company)The take home messages appeared to be, it is far more common than generally recognized, suspect it if a young person is "depressed" or has a history of depression as a teenager, or has ' racing thoughts" and some of these newer atypical antipsychotic drugs are useful.In 35 plus years of practice, in one form or another, I have probably been aware of less than 10 patients with manic-depressive disorder.The other five internists at my table expressed a similar experience. I do realize that these patients can be very difficult to manage and may impose considerable burden on their family and friends. Typically,internists do not come home at the end of the day saying "another day, another 4 bipolars in the office". Ads from a major drug company (Astr*Zen**ca) tell us that 49% of people with bipolar disorder are undiagnosed and send the reader to a web site for a "validated screener" This screen is 13 questions ending with "have you ever been told you have bipolar disease?" It is said to be based on a paper by PM Hirschfield in Am. J. Psy 2000: 157 (11) 1873- 1875).That web site then can send you to a dosing schedule for an atypical antipsychotic manufactured by that drug company.I cannot imagine an internist or FP doctor taking on the assignment of treating a bipolar patient with a relatively new drug which it is very likely that he has only recently heard of. At the meeting re bipolar, a number of the internists were surprised to learn that if a patient with bipolar disorder is clinically depressed that the treatment is not an antidepressant but a mood stablizer. This might give you some hint as to the general level of expertise an internist has in this area.
But I cannot but wonder that if we see a obviously depressed patient in the office maybe we should use that or some other screen for bipolar and if there is any hint of it on the answers get the patient off to a psychiatrist rather than reaching for the SSRI prescription.
If any psychiatric bloggers out there could offer a puzzled internist some thoughts on this I would appreciate it.

IM and EM residents and EKG reading-overall competency score is low-AJM article

A disconcerting article appeared in the August 2005 issue of the American Journal Of Medicine.
87 internal medicine residents and 33 emergency medicine residents were given 12 test ekgs to read. The residents were from two institutions and all residents were exposed to formal training in EKG reading. Unfortunately the manner in which the results are displayed is a bit confusing, it uses a"proficiency score",which to me obscures more information than it illuminates, but the bottom line is that neither group did very well. One table shows that of all the residents (IM and EM in one grouping) only 40% had the correct answer for an acute MI.(52% had a partially correct answer-what ever that is and only 8 percent had it wrong, apparently they gave partial credit.) So it is hard to figure out how many could or could not recognize an acute MI. But the authors, who we assume did understand the data, concluded the overall competency score was low. Further,they reported that their results were similar to several other studies that evaluated EKG reading skills in house staff.
I find it amazing that any number of IM residents greater than zero were unable to diagnose a typical acute MI or V. Tach. In medical school, our senior year we had a course in EKG interpretation and we all purchased a small text by Dr.George Burch on that subject. As IM residents we were conversant in the details of the proposed minutiae of the differential diagnoses of V. Tach. vrs supraventricular tachycardia with aberration.Interestingly, we had no formal courses on EKG interpretation as residents. Further,The chief of surgery made sure that his residents could recognize the EKG patterns of acute MI as he walked the walk of his theme that surgeons were physicians who knew how to operate.
I am reminded of a blog reference to an article in which it was noted that of 259 IM residents who were tested regarding ventilator use, about half did not know how to set the tidal volume in an ARDS patient. I also recall an Annals of Internal Medicine article which-although it emphasized other aspects of the story-revealed the apparent ignorance of house staff in realizing the importance of evaluating a upper lobe infiltrate in an alcoholic with weight loss and cough for TB.
I realize these are limited, possibly biased samples and from them it may be not appropriate to hypothesize a trend that suggests woefully inadequate training in internal medicine. I really do not want to believe that. I read about an IM program that is now two years post internship rather than three. I read that ACGME has devised requirements that necessitate more being crammed into this shorter time frame. Residents must now learn "system based practice" and quality improvement projects may be required and the time they can spend in the hospitals is restricted and , yes, there is simply more medical knowledge out there to learn.
I know that older professionals in many fields seem to always think the newer generations cannot live up to the standards that the old guard set, that the new kids have it easier, are soft and do not know as much. I'm sure I am guilty of that mind set, but-my goodness-an internist has to know how to read a EKG and if I were an EM resident knowing I would see chest pain patients every day, I would make sure I could recognize an acute MI ekg pattern and not wait to have a lecture on the topic to become proficient. I hope that this article does not accurately reflect the ekg interpretation skills of residents in IM and EM.
And another thing, sometimes I think that physicians believe that reference to evidence based medicine must always be made even if the application seems gratuitous. The authors of the article say in the purpose section " yet there are no evidence based guidelines for assessing [ekg reading] competency". How about just giving them ekgs and seeing if they can interpret them? We really don't need and will never have EBM guidelines for everything.

Practice guidelines in patients with multiple diseases not just inappropriate -may be harmful-JAMA article and editorial

That single disease guidelines may be harmful in multi-disease patients is a topic I have talked about before. Dr. Mary Tinetti published an excellent article on that topic in the NEJM in 2004.
An important and hopefully influential article on this same general issue was published in the August 10, 2005 issue of JAMA by Dr. Cynthia Boyd and colleagues. Their bottom line,take home message is The use of practice guidelines as the basis for pay-for-performance initiatives that focus on single disease treatments are not suited for patients with multiple diseases may well be harmful and this particularly impacts the elderly. Current single disease guidelines as applied to multi-disease patients are not ready for prime time and because of their naive simplicity will never be.
I would put it this way : The fact that a given treatment for a given disease in a certain selected study population is demonstrated to be efficacious and safe is not sufficient reason to apply that treatment to a given patient with co-existing other diseases. It follows that a physician should not be subject to economic sanctions on the basis of adherence to single disease practice guidelines in a patient with multiple comorbidities.
The editorialist, Dr. Patrick J. O'Conner,makes recommendations for guidelines that clearly imply guidelines as they currently exist are not adequate. He says, " Strategies to address the limitations of current CPG's (clinical practice guidelines) need to be developed and implemented,including providing recommendations based on level of evidence for particular patient groups and considering the potential economic and personal burden on the patient and caregiver as well as potential interactions with comorbid conditions".
Representatives of organized medicine who will meet with and negotiate with representatives of big insurance and Medicare have a very strong argument to make. As Dr. Dr. Boyd et. al. said:
the guidelines are not designed for quality assessment,they are recommendations based on varying levels of evidence by committees largely dominated by specialty groups for the management of single diseases, their application could lead to " perverse" economic incentives to emphasize the wrong aspects of care and the guidelines assume that clinical judgment and patient preferences will be incorporated into clinical decisions and yet when these guidelines are applied for quality grading no allowance is made for clinical judgement or patient preference. To apply single disease guidelines to patients with multiple diseases should not be negotiable.
The arguments of Dr. Boyd et al and Dr. O'Conner are cogent, important and should be acted on by resisting on whatever fronts present themselves any pay-for-performance schemes which ignore the complexity of human illnesses and desires and circumstance and judge clinical quality by adherence to simplistic single disease management rules and guidelines which themselves may be limited by the often flawed evidence underlying them.
As much as I agree with the arguments of the two articles, I am troubled by the assumption that both authors seem to make, namely that pay-for-performance is inevitable. I am reminded of the flurry of articles in the early years of the "gate-keeping" fallacy that it will occur, it is occurring and you doctors out there better get on the bandwagon or be left out. There was no shortage of players in medical academia who-for whatever motivations and some may have been well intended-who were complicit with the insurance industry. Pay-for performance may be one of those things that we would be better off being left out.

AMA News: Docs urged to detect RX drug abuse

The war on drugs continues.New theaters of operation are always opening up even though the enemy in older venues of combat have not been defeated.Emphasis is currently on the amphetamine issue and more recently CASA ( Center on Addiction and Substance Abuse) targeted prescription drug abuse, said by them to involve 15.1 million Americans in 2003.Since this is an activity that the perpetrators strive to keep secret and admittedly use all manner of lying, cheating and subtifuge to evade detection one cannot help but question the accuracy of this number particularly when done by an agency who has no interest in underestimating the number. This number appears, however, without editorial critique, in the August 8, 2005 issue of AMA News (no link given as this publication is now open to AMA members only). For some reason I cannot hear the term "drug abuse" without thinking of someone hitting a capsule with a hammer or shouting at a pill saying "you dumb SOB, you made me nauseated".I mention this CASA news article only to highlight a recent rant by DB's Medical Rants on the drug war.I agree with his comments completely.
William F. Buckley Jr., of National Review fame,lead a symposium in July 1996 which concluded that the war on drugs had failed. Thomas Szasz in that symposium said that Dr. William Bennett-former drug czar(It was never explained why a government official in the U.S. would be referred to as a czar)-was right when he said that drug use and drug controls were primarily moral issues. Bennett saw self medication as wicked and criminalization of that behavior as virtuous while Szasz saw self medication as a basic right and drug use criminalization as hypocritical and unenforceable.Everyone will not agree with Szasz's libertarian views but Buckley is no libertarian. You do not have to agree with Szasz's views on what he describes as the "myth of mental illness" to appreciate his thoughts on the drug war.
Decades earlier Dr. Milton Friedman said that the deleterious effects of the drug war would be the same or worse that those noted in the Prohibition, which finally got so bad the law was repealed.
The AMA news article was replete with suggestions for doctors to better detect Rx drug abuse such as calling the patient's old doctor, asking the patient if he has a history of drug abuse ( that should work) and medical educators were admonished to do a better job teaching medical students how to detect such behavior.

NEJM editorial: Modafinil about as good as coffee

The August 4, 2005 issue of the NEJM has an interesting article on the new "alertness" drug, modafinil, and an editorial that expressed skepticism about its value.
5-10% of shift workers exhibit daytime sleepiness and on shift drowsiness to a significantly greater degree than most other workers.That sub group is the current target for the proposed use of modafinil which would hopefully improve the quality of life for these folks and increase productivity as well as perhaps have a favorable effect regarding safety issues.If the disturbance are deemed severe enough the diagnosis of shift-work sleep disorder is made replete with an ICD code. ( Since this has become a codable disease,one wonders if an employer firing a worker for being too sleepy at work would be at risk for an EEOC action.)
The authors conclude that modafinil is "of some value in the clinical management of sleepiness associated with shift-work disorder".It has been approved by the FDA for the treatment of excessive sleepiness associated with shift-work sleep disorder.The editorialist, Dr. Robert C. Basner,quotes a 2002 published comparison with caffeine saying that improvements in performance and vigilance with modafinil were similar to 600 mg of caffeine. For reference,a Pepsi has 55 mg of caffeine,Red Bull, 80 and drip coffee, 110-175.Max strength No Dose is a 200 mg caffeine tablet.
So the results from modafinil are less than spectacular.
Perhaps more interesting were the comments made by the authors that data was fully accessible to all of the authors and the sponsor(in this case the manufacturer of modafinil) placed no limits on the interpretation or publication of the data.This type of reassurance will likely become part of the boilerplate of medical articles.This hopefully represents more evidence that there is a bit of meaningful push-back to the alarming role that some drug manufacturers have had in the control and manipulation of data from clinical trials. Certaintly there is much more awareness of that possibility now and journal editors and journal readers look at drug trials in different way.

Skepticism about ACP's initiative in Quality and P4P

Dr. Philip R. Alper,Fellow at the Hoover Institution,in a recent column in Internal Medicine World Report expresses concerns about ACP's recent efforts to- in their own words- "quickly engage[ed]to ensure that the interests of internists are represented in this national issue" The issue is the intersection of quality of care and pay-for-performance.Visible evidence of this adroit move is the "partnering" of ACP with AAFP,and AHRQ(Agency for Healthcare Research and Quality) and America's Health Insurance Plans.This union of collaborators is called AQA ( Ambulatory Health Quality Alliance). Let me quote and paraphase some of Alper's concerns.
The AQA announced a "starter" set of 26 clinical performance measures.Dr.Alper wonders if the starter set is 26, how many will we finally have to deal with. Evidence changes constantly and therefore the measures would have to be in constant flux but there is always a lag-sometimes a long lag-between changes in evidence and re-adjustments of guidelines.He says "few if any authoritative advisory systems can be trusted without question, let alone applied blindly to individual patients." He asserts that "the real driver behind the quality movments are the payers." Thus, only as much quality as Medicare or private insurers are willing to pay for will get done-unless of course it is to come out of the doctor's pocket". These two sentences are what it is all about.ACP will function to supply the veneer of concern for patient care to the process and will become an even more powerful controller of who gets to be and to continue to be an internist.
Dr. Alper is also skeptical of ACP motives."...the eagerness of the ACP to seek a place at the quality table may do more good for the ACP that for its members of their patients". He says we already have clinical quidelines to spare "But knowing how to keep performance measure implementation from turning physicians into compliers rather than thinkers and robbing us all of the ability to recognize a sick patient remains to be determined".
Alper asserts that the power base of ACP is in large institutions while most internists are scattered in small practices and that ACP has made a business of medical education and maintenance of standards. Whose interests will ACP represent as they swim with the sharks of the insurance industry?

New report on NHS speaks poorly for the single payer system

A recent lengthy report on the British NHS is a good source of ammunition for those who believe that a single payer system for health care is not the way to go. If you live in Wales private insurance may be the way to go if you can afford it as 36 % of patients have a six month wait for an operation. Wales also seems a poor choice of place to have a heart attack as the report indicates no hospital in Wales administered the thrombolytic agent within the hour time guidelines suggest.The report documents considerable regional variation in health quality indicators indicating that single payer system are not immune to this phenomenon of variation which has received much criticism this side of the Atlantic.

When hypertension mega-trials disagree-what do you do?

The topic of conflicting results from BP treatment trials was considered in a roundtable discussion in the July 2005 issue of The Journal of Clinical Hypertension by Drs.Thomas Giles,Marvin Moser and Suzanne Oparil.The JCH is on line but not all articles are available including this one. Here are some of the highlights and my thoughts.The starting point is the assertion that there are major differences between the outcome of ALLHAT, the second Australian National BP Study (ANBP2),and ASCOT. Giles said they all actually show the same thing,namely lowering BP is a good thing and the benefits derive from the BP lowering per se. This is not to say phenotypic differences may not be important.There were apparent phenotypic differences evident in ALLHAT. 36% of the 42,000 participants(when we say mega trial for ALLHAT we really mean MEGA)were African Americans and in that group the diuretic was better in regard to stroke and heart falure than was an ACE inhibitor. Dr. Oparil said that in ALLHAT African Americans from the southeastern United states were "over-sampled" and many of that group had higher BMIs (the average was almost 30).In ANBP2,an ACE inhibitor seemed better and the participants were mostly white.So the population from which these two trial recruited participants was clearly different and that could explain some of the apparent differences in outcomes.These trials are context dependent,ie. which drugs,which dose of the drugs, which combination(often the combination and the sequencing of additions of drugs seems contrived and not realistic) to which group of patients for how long.It should also be remembered that with large numbers, small difference in outcomes become statitstically - but not necessarily clinically -significant and when multiple subgroups are analyzed statistically significant differences always are found. Another issue is are the drugs always compared fairly.
For example, in ASCOT the beta-blocker (atenolol) was begun at a 50 mg per day dose, which -according to Dr. Giles- is not an adequate dose. Dr. Oparil pointed out that another issue is the duration of the trials ( often 3- 4.5 years) may not allow adequate time to discern the longer term metabolic effects e.g. diuretics and glucose intolerance risks.
The bottom lines may be: 1)the lowering of BP may be more important that the particular drugs used (with the proviso that in certain groups of patients a particular class of drugs may be important to use as in ACE inhibitors in diabetics)
2.Mega-trials are complex both in design, interpretation and in selection of participants.The devils really are in the details and overblown pretentious "final" conclusions re choice of BP medications made today and codified in guidelines may well seem naive and silly to future students of Blood Pressure.
Some- but not all- patients with HBP are salt sensitive which might serve to remind us that maybe we should take over-emphasized conclusions taken to be universally true with a grain of salt.

A new medical blog on the scene

Notes from Dr. RW is the name of a new blog by a hospitalist and the entries so far are well worth reading. I suggest you add his blog to your list of regular reads.I seem to write a lot about hospitalists and it will be good to perhaps get some input from someone in the business as I tend to be a bit skeptical of the movement.

Do inhaled steroids cause osteoporosis? One case control article does not answer the question

A nested case control study published in The January 2005 issue of Chest and commented on in the July/August issue of the ACP Journal Club found no increase in non-vertebral fractures in a group of United Health Care patients. Although a nested case control study has theoretical advantages (limiting selection and recall bias) over a plain vanilla case control, the design of this study seemed destined to provide no new useful information to an important question. I say this because we are given data about low dose, short term use of inhaled corticosteroids (ICS) and only consider non-vertebral fractures. The concern with osteoporosis and fractures is with longer term steroid treatment in patients some of whom already are at higher risk of bone loss (COPD patients).
The commentary by Dr. Frank Thien correctly points out that "the endpoint of a nonvertebral fracture as a risk out come with[the time frame chosen] is unrealistic". "Realistic safety data require longer-term follow-up with accurate estimation of the effective delivered dose". It seems to me this article "answers" a question we really did not need to ask. We do not worry particularly about short term, low dose steroid in regard to osteoporosis less alone fractures.
The editorial in Chest quotes a meta-analysis regarding this issue which found increased risk of fractures and increased frequency of several surrogate markers of bone loss. It should not go unnoticed that the authors of the article failed to mention that systematic review.One could easily come away from the chest article ( not the editorial) with the impression that ICS are not a problem in regard to bones. This is clearly not the case and the editorial makes that clear. Patients on long term ICS for asthma or osteoporosis should be assessed for risk of bone loss, bone density measurements made when appropriate and preventive measures instituted. The complication of a painful spinal compression fracture in COPD patient is very serious and something doctors want to avoid. In this new day of greatly increased skepticism regarding articles sponsored by drug manufacturers, it should be noted that a manufacturer of an ICS product sponsored the Chest article. Two years ago I'll admit that the source of funding was not a fact that I looked for in medical articles but now I've gotten paranoid about it.

Another VItamin E lesson-statistics experts do not agree on how to analyze a meta-analysis

There were 11 letters to the editor published in the July 19,2005 issue of the Annals of Internal Medicine critical of the methodology used in the meta-analysis by Miller et al that concluded high dose vitamin E supplements may increase all-cause mortality.

I do not believe a non-statistician could weigh the various arguments and then the counterarguments offered in reply to the critiques.

Here are some to give a sense of this (the letters in the Annals require a subscription)

Dr. Antonio Possolo says in part " instead of the authors' spline (if you Google 'spline' you will harvest a long list of also incomprehensible articles) I employed a nonparametric, locally quadratic, weighted regression to model the relationship between relative risk and the logarithm of dose" He found no statistical significance.

 Dr. Kent J DeZee et. al criticized Miller's use of the " hierarchical logistic regression rather than traditional meta-analytic approaches, reanalyzed some of Miller's data and found a non significant result. Miller answers point-for-point the criticisms but I challenge a non-statistician to plow through it all with anything close to an understanding.

Here's the thing. We have a meta-analysis ( 19 trials with 135,000 subjects) that found a slight
increase in all cause mortality ( the risk ratio for " high dose" Vitamin E was 1.03 !) In the other corner we have a crowd of epidemiologists and statisticians who put forth arguments that the methodology is inappropriate and the conclusions reached are not justified. Clearly the matter is in dispute because experts cannot agree on how we should analyze the data.

There is very little evidence that the high hopes some had for Vitamin E have been fulfilled. But when we are asked, "Doctor, should I stop my Vitamin E, I have read it may kill me ?", I think we can say the benefits we believed might be forthcoming do not seem to be likely but I do not believe we have good reason for you to worry about having hurt yourself.The researchers cannot agree if there was or was not a very slight increase in risk.

The first Vitamin E lesson is don't get carried away with preventive measures based on observational and case control studies. The second lesson is we have a lot to learn about how to do the analysis part of meta-analysis and at this point the experts don't seem to agree on how to do it except in the simplest, most straight-forward situations.

Prominent academic hospitalist expects growth driven-in part-by desire for "through-put"

Dr. Robert Wachter, Professor of Medicine at UCSF, gave a "state of hospital medicine" address at the annual meeting of the Society of Hospital Medicine (SHM). Wachter listed 3 reasons he believes hospital administrators will continue to promote the hospitalist movement; resident work-load limits, nurse shortage and retention and hospital efficiency (the through-put issue).

The first is only an issue in academic hospitals which is a tiny minority of the country's hospitals, the second is a issue that only time will tell. We do not know if hospitalists will help nurse retention and I am not sure why that would be the case. Working conditions and salary are major issues with all who work and I don't quite see how salaries would change and working conditions are more under the control of hospital administrators than the doctors. If hospital administrators want more nurses they should pay them more money, that makes more sense than hiring hospitalists.

The third reason is probably the driver which is in keeping with the rarely wrong follow-the-money concept. Administrators want hospital beds filled-briefly-with surgical patients. They want Medicare patients with medical illnesses out of the hospital as soon as possible. This what is meant by efficiency. That is where the profits lie. I have talked before about the degree to which salaried hospitalists may be conflicted with that imperative. It will continue to be a empirical question whether hospitalists make more money for the hospitals than they cost. If they make more, the trend will grow. Talk about efficiency seemed louder than talk about quality of care. Thomas Sowell says if you want to see what a organization is all about, do not look to their stated goals or values but rather to their incentives and constraints. I cannot believe that through-put concern of hospital administrators is all about quality.

Another speaker, Dr. Tom Baudendistal used the term "ambulist" in his statement that hospitalists were ideally suited to the role of "championing efficient care". I mention that seemingly self serving statement only to point out the neologism.

Another item which could be a sign of the success of the hospitalist movement is that reports are appearing of burnout.
Kevin, MD has a post linking to a Chicago Tribune article regarding some of the pros and cons of the hospitalist movement and speaks of the economic forces driving the movement.

It is all about time-not enough time and the best doctors do poorly

DB's Medical Rants recently wrote about his observation of a waning of intellectual interest in house officers which he at least partially attributed to the pressure of too much to do in too little time. I do not know if the waning he observes is entirely due to time pressure but that is a major factor. You can be the best trained, the best informed , the smartest, the most caring physician in the world and if you are seeing 4 new complaints in a hour, you will screw up. It is only a question of how often and how badly. I agree too much to do in too litle time does not work out well.

A few years ago I was in the unusual and fortunate situation of seeing patients in the same manner I saw them 20 plus years ago. I had 45 minutes for a new patient and saw a patient who was in the office for the periodic "health consultation" and physical exam. He was 53 years old, previously healthy with the complaint of " losing strength". He noticed it mostly in his arms as he had embarked on a strength building program several months earlier and now could not now do as many reps with as much weight as he could a few weeks earlier. He had seen his insurance plan's  PCP who fielded the complaint, focusing on the hand ( i guess thinking the patient was complaining of hand pain rather than weakness, ordered a hand x ray  exam (did no PE ) saw him back in a week and told him he was "probably getting old".

There is no doubt he was getting old unless the laws of the universe were abrogated in his case,but on the exam in my office, he had no DTR's in the lower extremities, and decreased sensation in the legs. DTR's were decreased in the arms. I referred him to a neurologist in a anarchronistic clinic where in the neurologist still has one hour for a new patients and quickly the dx of chronic inflammatory demyelinating polyneuropathy was made and treatment begun with impressive clinical improvement. I knew the PCP and knew him to be a well trained , well respected seasoned physician. I believe it was a matter of time.

Physicians have allowed their practice terms of engagement to be dictated by others either directly as in some HMOs or large clinics or indirectly by insurance plans controlling the fees to the point where physicians decide that in order to survive economically they have to increase their output by seeing more patients in less time. Their job satisfaction plummets, patients get short changed if they get any change at all and the error rate accelerated with the risk of malpractice rising with it and patient satisfaction tanks. This may not apply to all physicians and practices but it is closer to the rule than the exception.

I do not know if DB's observation of decreasing curiosity in trainees is all a function of time pressure or not. I have also seen in recently trained IM docs and FPs in a practice setting in which time pressure was not the rule and the main thing they are curious about is what is the latest guideline. If it is seen in house officers, who are time and task pressured now, what will happen in private practice when the time crunch is worse because their income may depend on it?

addendum minor addtions made 4/6/2016

Two studies give discordant verdicts on value of Wells' DVT prediction rule

Clinical prediction rules when they work best can give physicians an estimate of the likelihood of the disease at issue. The famous Ottawa ankle rules seem to work very well and have decreased the need for ankle x-ray in many patients.Rules regarding the diagnoses of DVT's have generated many articles and much research and lead to several clinical decisions rules the most widely talked about being the Wells' criteria. The criteria can be placed on a PDA and in the best of times an intern with 2 days clinical experience can with the aid of his thumb arrive at the same answer as the seasoned senior chief of the service. However, in regard to DVT diagnosis how often does the intern find himself in the best of times?. According to one of the two conflicting articles in the latest issue of the Annals of Internal Medicine he may be wrong far too often if he relies on the Well's criteria and a normal d-dimer test. The thinking is that if the Wells rules derived probability is low and the d-dimer is normal, then there is no need to do an ultra sound exam. The whole exercise is basically to avoid doing a u/s exam just as the Ottawa ankle rules exist to decrease the number of "unnecessary" ankle xrays. Two articles in the July 19, 2005 issue of the Annals of Internal Medicine give different assessments of the value of the Wells prediction rules. One, from Holland finds there are too many cases of DVT missed. This study involved a number of primary care doctors in Holland seeing real patients in primary care settings. They found 12% of patients with DVT had a low probability Wells score and 3% had a normal d-dimer. The second article, a meta-analysis concludes that if Wells probability is low and the d-dimer is normal, there is no need to do a u/s. The editorialist, Dr. James Douketis, sides with the pro-Wells rule rule article but importantly says the physician should retain the option of overriding a low Wells score by doing venous ultrasonography. He also says the purpose of the Well score is to complement rather than displace the clinician who will use her clinical judgment to fine tune the estimate of disease. I would add -it is more important not to miss a DVT than it is to avoid "avoid" an ultrasound exam. The Wells score was more important when the gold standard test was venography, a procedure that could ironically cause the problem-phlebitis- you were trying to diagnose. I cannot really understand the imperative to "avoid" a test that is the most definitive we have for DVT and is non-invasive, safe and is widely performed and is very sensitive.The last case of DVT I managed was in a 54 year old previously healthy man who had traveled to New Zealand and had a one week history of a tender, swollen calf. I ordered a u/s which showed a popliteal clot and treatment was begun. What would have been gained by wasting time on a d-dimer test? With the various versions of d-dimer of varying sensitivities you are more likely to be mislead by the d-dimer than with an u/s. Why not go with a test that can demonstrate the clot rather than one that might imply a clot might be present?

data collection without theory is not science

Noted epidemiolgist , Dr. Diana B. Petitti, wrote in 1988 (from Kenneth Rothman's book, Causal Inference, p 149-152) that " the literature of epidemiology increasingly is becoming an archive of information derived from mechanical applications of multivariate analysis. ..tabulating every exposure against every disease...investigators are more interested in the mechanics of data analysis than in the substance of the issue being addressed."

It seem even more the case now that in 1988. A non-systematic, non random plunge into a recent ( May 1, 2005) issue of Internal Medicine News found two articles which may illustrate this point. One analyzed incidence cases of type 2 diabetes. Moderate drinkers of alcohol fared best in terms of not becoming diabetic, heavy drinkers and light drinkers had about the same risk. No comment was made re mechanisms. The second article is announced with a headline saying " Bone density screen tied to fewer hip fractures". This is presented as evidence that screening decreases fractures, not that preventive treatment perhaps arising out of the screening prevents fractures.It seem to prevent falls as well ( 16% versus 20%). Participants were screened for 31 variables.

Contrast these with an article from a recent Archive of Internal Medicine from Holland. The researchers postulated that based on the physiology of bladder contraction and the pharmacology of NSAIDs that there might be a relationship between acute urinary retention and NSAID use which is what they found in their data analysis. They studied the issue, formulated an hypothesis and tested it and found supporting data. The study did not falsify their thesis. A Popperian approach was followed in the NSAID article. Petitti says the opposing approach is the "inductivist" approach wherein " knowledge resides in accumulating data, and more data means more knowledge"
She continues " The crucial distinction is the difference between scientific knowledge and factual knowledge. Science is better described as a system of abstract theories than as an agglomeration of factual observations."

John L Casti in his book " Reality Rules" says "...in many ways there is nothing more useful and practical than a good abstraction. This calls to mind Hilbert's dictum that "there is nothing more practical than a good theory' ".

 I remember cramming for my internal medicine written exam ( back when there was a written and a oral for IM certification.) One of the other pulmonary fellows looked up from a pile of yellow, legal pads on which he had hundreds of notes and announced a epiphany. "Every thing is associated with everything else and whatever finding is described in whatever illness happens 20- 80% of the time".

Evidence Based Medicine can never provide all the answers

Evidence Based Medicine (EBM) 's broad "official" definition is the integration of the best evidence with clinical expertise and patient's values. The popular or limited meaning seems to be EBM is the evidence derived from RCTs and meta-analysis and if all fails observational data or case control studies. It is EBM used in that second sense that I maintain will never, can never provide the answers to all of the questions and decisions that arise in the practice of medicine. There are simply far too many questions and issues that there is time, energy or funds to do all the RCTs to answer all of the questions posed. The Herculean task of gathering all the data necessary to characterize unique patients for Bayesian prior probability determinations is likely one that will never be completed. It is worse that that because as new medications, surgical techniques and diagnostic techniques are devised more and more questions are raised. As new modalities appear, previous RCTs may become no longer relevant. RCTs sometimes are contradictory ( remember ALLHAT, and the Australian BP study and now ASCOT). sometimes a RCT concludes something and as time goes by the data is dissected and analyzed further and the once solid conclusion melts away.Case in point was the DIG trial in which, although no morality benefit was evident , fewer hospitalizations were needed and symptoms relief occured. Later upon more analysis we learn that digitalis may not help women and that the patients whose dig levels were in the acceptable blood levels were harmed.Further, a RCT does not provide all the answers . Consider a RCT that shows a new ACE inhibitor decreases stroke and cv disease risk by X %. There are many questions raised by that. To what degree can we go beyond the data to apply the new treatment to patients whose characteristics would have made them not eligible for the trial. How do we use the drug in patients who may have several or many co-morbidities which -for the most part or the entire part-the study subjects did not have.Further, many of the day-to-day mini-decisions physicians make will never likely fall under the analytic eye of the clinical trial or even the coarse grain data gathering of observational data (aka data dredging).These are such things as when to have the patient return for followup under a myriad of endlessly varied conditions. (A lab test is slightly abnormal, when to repeat it, if at all, or do confirmatory tests, if at all,etc. etc.)
Further as I mentioned before the application of group data or population data to individual patients involves more than knowing the bottom line of the article. It is only the beginning of the decision process for a given patient. You cannot expect the average effect to occur in every given patient you are treating. Even in the circumstance when for a given clinical treatment decision there at least one RCT or meta-analysis that is relevant to the issue a clinician still has to apply the data to the particular case and that often involves much more than" give drug x because a RCT showed that x brings about 30% decrease in mortality".
Why bother saying that RCTs and MAs cannot provide all the answers? Am I just saying the obvious. I believe it is worth mentioning for at least two reasons.
1) the medical students of today may plunge into the real world thinking that all the answers will be revealed through EBM-used in the limited definition given above- much as some of the older generation of doctors may have believed that the truth lay in the wisdom imparted to us by our venerated role models 2) some of the medical and some of the lay literature seem to believe that the answer to all of medicine's real or alleged problems lay in EBM. Some of the answer do lie there, but not all and many will never be addressed.
As is true of all human endeavor many times physicians will fall back on various heuristics for guidance and use human judgment to sort it all out.
EBM will provide the answers if we take the official definition to "really" be EBM because sometimes the integration or application of the "best available" evidence is to apply little or no evidence at all, at least not evidence in the sense of RCT's or even case control studies. Here the individual doctor-not the health care team-has to give individual advice to an individual patient. The physician will be aided with ready computer access to the latest information but as Dr. Thomas Giles-president of the American Society of Hypertension- recently said "we'll need a thinking physician and [a] thinking patient to come up with the best regimen for every individual".

Medical errors and role of premature closure

Dr. Mark Graber and his colleagues published an interesting article in the July 11, 2000 issue of the Archives of Internal Medicine involving diagnostic medical errors. Diagnostic error was defined for purposes of the study as a diagnosis that was unintentionally delayed,wrong, or missed. Errors were categorized as no fault, system related errors, or cognitive errors.

Cognitive errors were either due to faulty knowledge, faulty data gathering or faulty synthesis. Examples of system related errors included 1) biopsy report of cancer not communicated to the patient who missed a clinic appointment 2) consultation request for work up of pulmonary nodule lost 3) radiologists not available to read ER x-rays. The most common cognitive error was faulty information synthesis usually manifest as "premature closure" which is the tendency to stop considering other possible diagnoses after a diagnosis was reached. This is also referred to as a type of anchoring heuristic error.

The authors state that defective knowledge as a cause of error was rare and more commonly reflected problems with synthesis of available information.This refers to a formulation of how humans solve problems namely by searching for an explanation that best fits and then the search stops. Physicians at all levels of training and experience do this.

Are there take-home messages here? With premature closure, the suggestion is to make a conscious effort to not completely stop after you reach a diagnosis but ask " what alternatives should be considered?" This could be done initially and from time to time as the clinical case plays out. Some times things seem so obvious we do not do that but that practice seems like a good mental back up mechanism to minimize errors.

System problems can be varied and the particulars and the particular solutions may vary locally but one problem seemed prominent;radiologists not interpreting films in real time particularly in a emergency setting. Non-radiologist clinicians have been complaining about this since forever.
Personally, I have found this more of a problem in academic settings than in private practice, though it occurs there as well. With digitalization of imaging and broad band internet much of the interpretation could be done at home by the radiologist on call ( and this happens in some settings already). If the clinical doc is awake at 2 in the morning trying to unravel a clinical problem so should the radiologist.

The mechanism(s) of what cognitively occurs with missed diagnoses is not just of academic interest. Dr. Donald A Redelmeier wrote an excellent article entitled " The Cognitive Psychology of Missed Diagnoses" in the Annals of Internal Medicine, Jan 18, 2005. The full text is available by subscription. Cognitive psychology deals with how humans-including physicians-think and he presents basic concepts from that field in the context of a real life clinical case which give them practical significance.

The Graber article dealt with cases collected from 5 academic, tertiary case centers in which there was probably reasonable time to see patients and often with faculty oversight. With physicians in some managed care settings seeing patients every 5-10 minutes, we may well need to develop a revised taxonomy of error generation. Or perhaps most of the errors would be placed in the systems error section under "not enough time spent to figure out the problem."

Retired doc's suggestion for medical curriculum,Part 12, Beware the language we teach you

Still another mandatory item for the retired doc's medical student's reading list is a 1997 Annals of Internal Medicine article, "The Language of Medical Case Histories" by Dr. William J.Donnelly. The idiosyncratic language of the medical case presentation, particularly, as demonstrated to and executed by physicians in training not only communicates certain facets of a patient's medical problem(s) but it also affects the thoughts and actions of the players who speak those lines.
Dr. Donnelly tells us about medical "Language Maladies". He lists seven, I found number 3 particularly interesting. He speaks of the "agentless passive". An example is " the spleen was palpable" as opposed to I ( Dr. X.) palpated the spleen. This rhetorical device gives the observations of physicians an objective, authoritative status. The case is presented as a view from a " depersonalized nowhere" which obscures the narrator's role and her potential failures in gathering and interpreting the information and obscures the fact that all clinical "knowledge", from the history to the lab tests, to the biopsy and autopsy is less than certain, incomplete, provisional and subject to change. It gives a degree of solidarity to tentative analyses and conclusions.
Number 4 speaks to the loss of standing for a forum for the patient's understanding or lack thereof and the patient's fears and sufferings. ( Note I seem obligated to say patient and not person, another symptom of how our language influences how we think).
Dr. Donnelly explains how verbs are used to establish and maintain a hierarchy of credibility and reliability with patients at the bottom rung, physicians in the middle and laboratory tests at the top. Patients "claim" and ""deny", doctors "observe" and " find" and lab tests "reveal" ( as in the Chest x-ray revealed".)
As Dr. Donnelly says not all of the practices are the "deadliest of sins" but collectively they tend to ignore the "person of the patient" and are at odds with the probabilistic, observer-mediated, provisional nature of all clinical knowledge. He offers some suggestions to mitigate all of this. His first listed suggestion is to introduce the patient as a person, e.g. Mr. Jones and regularly refer to him in that way rather than always as the patient. The entire article is worth reading and thinking about at whatever level of medical training or experience you find yourself.

Prominent cardiologist expresses serious concerns re: use of nesiritide

The July 14, issue of NEJM has an important perspective by Dr. Eic J. Topol, head of cardiology at Cleveland Clinic. Fortunately the Journal has made this free on line and should be read by anyone who has concerns about the FDA's approval record, drug company's promotional activities and the safety and efficacy of a drug that apparently is being widely used. Topol explains that Natrecor was approved by the FDA for acute treatment of decompensated heart failure. He expresses concern, however, that even in this application there are real concerns about its safety and quotes data to support that position. Further concern is expressed that the drug is being promoted for the " maintenance" therapy of chronic HF . This would consist of periodic outpatient infusions, a treatment for which there is no FDA approval nor, according to Dr. Topol, adequate evidence of its safety and efficacy in that context. There are some data from an outpatient trial reference to which can be found at this drug company website. Apparently another trial is underway. More details about the outpatient, non-acute use of nesiritide can be found in a May 17, 2000 NYT article.
With the high profile status of Dr. Topol's article in the NEJM, we are certain to hear much more about this and to the extent that Dr. Topol's characterization of the situation is correct we should. Serious questions are raised.

AMA Delegates take strong stand re" P4P, specialty societies cave

At the recent AMA annual meeting, delegates acted contrary to the wishes of their Board of Trustees and said they oppose private-payer or Medicare inititiatives if they do not meet the AMA guidelines for P4P. These include focus on improving performance and not cost control, allows docs to opt out without finanacial penalty and the programs must provide new funds-not just divide the pie differently. The Grassley-Baucus bill that was recommended by MedPac does not meet their standards. In that bill 1%-2% of physician payments would be withheld in a bonus pool to be redirected to the " top performers". Physicians who participate would have to essentially get a EMR system in place to allow performance data collected from their practices.
ACP, AAFP, ACOG and the AAP have all signed a letter to Bill Frist supporting the MedPac proposal . We all saw how "Go along to get along" worked with the gatekeeper Trojan Horse, it will work as badly with the P4P programs. Those who opposed the delegates' position argued that if the delegates ' hard line stance were accepted then physicians would not be in a leadership position. Who really believes physicians will be in a leadership position in any event?

NPR's June 9 article on Merck's pressure on Med School re Vioxx

The NPR broadcast on June 9 has a disturbing feature on a drug company's pressure on med schools to reign in criticism on one of the company's products. In this article Dr. James Fries, a professor of Medicine at Stanford, relates the details of a phone call he received from Dr. Louis Sherwood of Merck complaining about a Stanford's researcher's ( Dr. Gurkirpal Singh) comments about Vioxx. Details are found at NPR in the transcript of the reporter's interview with Fries. HCRENEWAL on June 6 described the Fries incident as well as other alleged instances of Merck attempting to silence Vioxx critics at medical schools. Merck and Sherwood deny they were trying to silence critics. As is often the case, news items such as these end up being a " he said-he said" situation but this type of negative publicity is certaintly not what Merck (and others in the Big-Pharma fraternity) need and I doubt current public relations advertising programs will be very convincing to the public that drug companies care about their health. Medical Schools receive significant amounts of funding from drug companies and it would be very easy for the public to believe that whoever pays the orchestra is likely to at least attempt to call the tunes.

Will primary care become a team sport ?Thoughts on The Society of General Internal Medicine's task force on the Future of General Internal Medicine

The Society of General Internal Medicine organized a task force to "redefine the domain of general internal medicine" The final report was released on Sept.20, 2003 and is available in full text on line. In the introductory section the authors state " Chaos may be the word that best characterizes American medicine for many patients and doctors today"
Having said that, the stage is set to make suggestions as that implies something has to be done. One of their recommendations was that " general internists should usually work in teams" I found this intriguing as I had never really worked on a team nor do any of my colleagues do so now except perhaps in some metaphorical or virtual sense. One could count the internist and his rounding partner(s) and the receptionist and the nurse and the various folks in the medical field who from time to time play a role as being on a team but that seems a stretch. Because of this emphasis the task force recommends changes in the residency training program to include leadership training to lead these teams.
The task force report does not present a strong case for the team concept. The closest to that I could find in the paper was the following. Although the authors admit that for some types of patients specialists may provide better care than the generalist they quote one paper suggesting that generalists working with specialists appear to" provide better care". While this may be true in some settings it need not be so generally and at most this data point points in the direction of the benefit derived from cooperation not necessarily from formal teams.
No other footnotes are referenced in the context of teams but one citation dealing with the importance of focusing on what patients want did discuss the value of teams.That citation is:
Dr. Dana Safran from the Health institute at Tufts-New England Medical Center writing in the Feb. 4 2003 Annals of Internal Medicine. One of the elements Safran believes are essentiall to secure primary care is " adapting of the current functioning of primary care team so that they become visible, meaningful and valued from the patient's perspective."
The only argument for this presented by Safran provides indirect evidence ( ie evidence which if believed requires an inference on the part of the "trier of fact" to accept the matter asserted- to use the words of a law book-). It involves comparison of patient satisfaction in a closed model HMO versus an open model practice. A characteristic of the former is the place of "invisible" teams and emphasis on having the patients seen sooner rather than necessarily having the patient seen by the same physician each time. Patient seem to prefer the open model. They would rather see their doctor than be seen sooner by someone they do not know.
Rather than concluding teams are not well received, Dr. Safran interprets these data to mean that teams need to be made visible and the patients educated to their role and then presumably better care will result. Safran quotes three articles said to provide " considerable empirical evidence" that links the performance of care teams to improved health care and decreased costs. Two of the studies involve intensive care medicine and post op care which seem not relevant to primary care. The third article deal with newborn health care delivery. There is also some data indicating that rapid response teams in hospitals may be worthwhile. However,I see little data available indicating the value of teams in primary care,certainty much less than I would think is needed to state that "visible" primary teams are essential .
I am aware that "teams" is one of the politically medically correct terms to which to pledging allegiance seems required. A body no less august that the Institute of Medicine has placed its imprimatur on it. IOM lists "working as part of interdisciplinary teams" as one of the five core areas which medical professionals should ensure proficiency. In the era of evidence based medicine, I do not know what energizes this team concept movement but it seems to be something other that than sound evidence. No one opposes cooperation and prima donnas are not held in high esteem, but I think a patient in the middle of the night wants to call Dr. Jones not the "health care team".
I worry that with the emphasis on teams, team work , team player etc that we may loose in the shuffle or at least not adequately emphasize a physician's prime directive "The individual physician is responsible for the individual patient and the patient's welfare". The incorporation of that concept into a person's makeup is a major part of the transformation of a lay person into a physician.More and more it seems disabusing physicians of that archaic concpet is a prominent and recurring theme in the speeches and writings of medical academia and the leadership of various professional organizations.

Randomized trial-treatment of essential thrombocythemia-hyroxyurea better than anagrelide

The July 7, 2005 issue of NEJM reports a RCT in which cases of essential thrombocythemia at risk for thrombosis were treated with either hydroxyurea plus ASA or anagrelide plus ASA. The hydroxyurea arm was better in almost everyway. There were fewer arterial thromboses, fewer serious hemorrhages and fewer withdrawals from therapy in the hydroxyurea group while the anagrelide group had fewer venous thromboses. Essential thrombocythemia manages to pose a risk of both hemorrhage and thrombosis, the former occurring at the higher platelet counts. Concern about the potential leukemogenic effect of alkalating agents lead to the development and clinical application of anagrelide which apparently only affects the platelets, doing little or no harm to the red and white cells. Anagrelide seemed a reasonable replacement from hydroxyurea. However, this RCT strongly suggests otherwise. This was the first head- to- head comparison of the two treatments and although urea was not better in every measured way,
on balance it appears a better choice.

Harvard professors critical of fellow Harvard prof's article's conclusion re: older physicians

The July 05, 2005. issue of the Annals of Internal Medicine contains several letters critical of an earlier Annals article by Choudhry,Fletcher and Soumerai, the accompanying editorial and even raises questions of "conflicts of interest". The article in question concluded that older physicians may provide lower quality care and need quality improvement interventions.

The journal requires a subscription for full text viewing so here are some of the highlights.
Dr. Martin Samuels of Harvard ( to whom I will always be grateful for his classic "dizzy patient" lecture) and Dr. Allan Ropper question the method of article selection used by Choudhry but more than that he accuses the author of writing a "potentially destructive" article. They go on to say "... age brings 2 things: graciousness and time to realize that fads in treatment and medical reform come and go".

They continue to say "Choudhry and colleagues' review glorifies information, algorithms, and consensus statement and has the unfortunate, probably unintended effect of diminishing experience and judgment. However, its publication is not unexpected. It is part and parcel of an unfortunate course of events in medicine where quantification inadvertently undermines quality while masquerading as evidence. ( ref: clinical experience and quality of health care. Samuels, MA and Ropper, Allan H. Annals of Internal Medicine Vol. 143 number 1 pg 84 5 july 2005.)

Dr. Poses (of HCRENEWAL) and Dr. Joseph Diaz also lists point by point methodological weaknesses of the paper. (ref. same as above pg 84-85)
A similar critique from Poses is available here.
Conflicts of interest have attracted much attention of late, mainly focused on the antics of Big Pharma and their purported manipulation of the medical literature. Dr. Elizabeth W. Loder, also on the Harvard Medical School faculty in her letter( same reference as above,pg 86) raises interesting questions regarding one of the authors -Dr. Robert Fletcher-and his role as co-editor of a section of the product known as UpToDate .Dr. Loder expresses surprise that no potential conflict of interest was reported with the article. Where is the conflict? Loder goes on to say that in interviews following the article's publication, Fletcher, identified computerized databases as a principal solution to the quality problems recognized by the publication in the annals. UpToDate is self described on its web site as a comprehensive evidence-based clinical information source available on the webl and CD-ROM. While the failure to disclose may be no more than an oversight, some may be concerned with the perception of self interest and conflict of interest.

Coincidently, the day I read Dr. Loder's letter, my wife-also a physician-received a promotional letter for UpToDate from Dr. Robert H. Fletcher. The second paragraph says " Old habits of keeping up do not serve us well enough. This is what I found in a recently published study in the Annals of Internal Medicine. The longer the time since graduation from medical school, the less physicians knew about and used new, evidence-based practices." I have not had the opportunity to use UpToDate. It may well live up to the promotional claims. One wonders what is the evidence that use of this product will lead physicians to engage in more " evidence-based practices." (Fletcher's letter does quote a survey of subscribers that found 91 plus % changed "management based on their use" of the product.)
The Annals deserves credit for publishing these and other letters critical of the article and the editorial. However, the headlines generated by the article and the interviews by the press with the authors are not neutralized by the rebuttal and critiques expressed in the letters.

The thoughts of Samuels and Ropper expess a vision of what a good physician should be that looks beyond the simplistic reliance on conformity with guidelines as a measure of quality care and places value on maturity and judgment and experience.

Statins may be put in the water supply yet

If we can believe the epidemic of case-control studies, we may yet have to put statins in the drinking water because they seem to do everything. NEJM recently published a case control study that indicated protection from colon cancer with the use of statins. More recently, Dr. Vikas Khurana of the VA Medical Center in Shreveport, La. reported an analysis of a large database that claimed a reduction in the risk of 7 types of cancer by 50% including colon cancer. The records of 1,400,000 veterans from 10 VAs were analyzed.
These were, of course, retrospective case control studies and the author admitted that the duration and dose and type of statin was not factored in the analysis.

I believe the comments I made regarding the NEJM article apply here as well.
It has now been 20 years since NEJM published back to back articles dealing with the incidence of cardiovascular disease in women taking hormone replacement therapy. One paper was from the Framingham group, the other from Harvard reporting from the Nurse's Health Study. One reported a two fold increase in risk, the other a 50% decrease. Had either paper been published alone in such a high profile, widely read and quoted journal the results would have likely been widely accepted. The editors, however, did the medical community a great service by their article juxaposition choice. Dr. John C. Bailar iii has a excellent chapter in his book " Medical Uses of Statistics" ( NEJM Books, Boston, 1992) in which he discusses Uncertainty about Confounders. Bailar asks the question why did these articles disagree so sharply.His answer was he did not know, an admission he also made in the editorial that followed these two articles. He could not give a specific reason for the difference, but in his book he says that the general reason involves unrecognized and perhaps unrecognizable differences in the study groups. You cannot control for unrecognized confounders in a case control or observational study.The scientific process involves drawing inference from information that is inevitably subject to error. The usual statistical measures of uncertainty ( p values and confidence limits) capture only that part of the uncertainty attributed to random variability in the context of the particular statistical model used.

Every study - even the cream of the crop, the RCT -is subject to those limitations of the statistical method. Of course, the RCTs- unlike the case control studies- control for even unrecognized confounders by the randomization process. So, case control studies and observational studies are much more vulnerable to limitations and the results of those studies need to be viewed with appropriate skepticism and restraint. Analyzing large data bases with outcomes against a battery of potential risk factors or risk modifiers always yeilds a set of statistically significant correlations. The trick is to know what to do with them and what leads to follow. So it may still be premature to add simvastatin to the water supply.

How does Vitamin D prevent falls? ( if it does)

Bischoff-Ferrari et al published a meta-analysis in the April 28, 2004 JAMA indicating an approximately 20% decrease in falls in elderly patients treated with vitamin D ( 800 - 1000 u/day).The authors quote several lines of evidence indicating a beneficial muscle strengthening effect of Vitamin D.The effect was evident fairly quickly- noted in 2-3 months in 2 of the 5 studies including in the analysis. A more recent study from a Boston nursing home showed results in the same direction but claimed a 70% reduction in risk of falls.If the only evidence of efficacy were this single study,few would be convinced.However,when placed in the context of the 2004 meta-analysis ,a reasonably possible mechanistic explanation,vitamin D safety in the dose range used, and the importance of falls in the elderly I feel confident that supplementation of 800 U vit. D/day in nursing home residents makes sense. Besides it is necessary for the bones. The meta-analysis was helpful, taking several fairly small RCTs that showed results in the same direction but not all statistically significant and combining them into a composite result that was significant.

American Society Hypertension proposes new definition of hypertension

The American Society of Hypertension (ASH-actually the other ASH, as the American Society of Hematology is also ASH) announced at its recent meeting a new definition of hypertension, criticized ALLHAT and emphasized global risk rather than rigid BP categories. A more precise definition and explanation of ASH's position awaits publication. However, the president of ASH Dr. Thomas Giles of LSU Medical School in New Orleans, said that the new definition incorporates the presence or absence of risk factors and target organ damage markers . The current BP classification uses cut points to define the various stage of hypertension without assessing the patient's actual risk based on other factors. Giles characterizes JNC 7's "prehypertension"as a transitional category and says that if a person with a low BP - in the prehypertension range- has no signs of vascular disease, they should be considered normal.
The ALLHAT trial received criticism as well by Dr. Richard Devereau of Cornell who pointed out some of the methodologic problems with the study. He is certainly not the first to do this:see here and here. The importance of determing global risk of patients and placing BP within that context was a topic discussed at the 2003 ASH meeting and JNC7 was faulted for moving to BP numbers to guide therapy rather than the overall risk assessment approach.
The ASCOT trial ,which showed that the combination of a CCB and an ACEi was superior to the beta blocker-diuretic combination, should prompt a redoing of the JNC recommendation regarding mediation choices. These views of the ASH leader stand in contrast to a recent JAMA editorial. published April 6, 2005.The editorialists say " It is now time to move beyond comparison of diuretics with other classes of BP lowering drugs -that issue has been settled." The issue of the best combination of BP pills is not settled.The ASCOT trial may well bring about a shift in thinking.
Rethinking concepts of disease and treatment is much of what the science part of the art and science of medicine is about.Settled issues have a way of becoming unsettled as we learn more.Stone is a poorly suited medium to record recommendations for treatment.