Monday, May 16, 2005
New Criteria for Metabolic Syndrome
The IDF has published new criteria for the Metabolic Syndrome. Obesity as defined by waist circumference is required plus two more criteria out of a possible 4. The waist sizes are smaller than the NCEP criteria.For Europids ( a term I had not heard before) it is 94 cm for men and 80cm for women.Different criteria are used for South Asians and Chinese and different for Japanese as well. The BP and blood tests criteria are the same for all for all races, BP 130/85, HDl-40 for men, 50 for women, FBS 100, and TGs 150.
Friday, May 13, 2005
Retired Doc's opinion on "Big Pharma" at all time low and falling
The first medical memory I have of what- at the time- were known as "ethical drug companies" was actually part of the rites of passage from medical student to doctor. It was the doctor black bag that Lilly gave to graduating medical students .
For years,I considered the detail men who brought samples and doughnuts to the office as basically benign and took their brief promotional comments re their drugs superiority over competitors with healthy skepticism.
But now, once I read alleged details of Merck's action re the VIGOR study and its marketing of Vioxx, I cannot think of Merck and- by extrapolation and belief there may be no difference among large pharma entities-other large drug companies with any thing but suspicion and distrust.
The gist of the "Kaiser Health Report" linked above describes marketing techniques that seem, at best, misleading in turn leading physicians to prescribe Vioxx, which a number of doctors now wish they had never done. If this was merely one company misleading physicians and the public about side effects of a drug, that would be bad enough.But there appears to be more.
There is reason to believe that in some instances drug companies have manipulated study results so that when they are published ( in main line journals) the results do not represent all of the data in such a way that opposite conclusions may have been reached if more of the data set were presented to the journal. Case in point: The 2000 JAMA article regarding celecoxib (Pfizer's Celebrex) which published 6 month data showing a better side effect profile re: GI concerns than older NSAIDs while they withheld the 12 month data which painted a different picture.
You have to worry that this is a ice berg tip and how many of the drug industry- financed and designed RCTs if carefully analyzed ( with data even journal editors do not have access to) may not really demonstrate what the articles concluded. And it is the RCTs which are the gold standard of information feed into various consensus and guidelines writing committees.
A number of professional organizations have warned physicians about undue influence regarding free meals and trips etc. If the manipulative antics of two of the drug industry giants are any thing but two isolated aberrations, the influence we need to be concerned about is much more serious than a free dinner at a toney establishment. We need to worry about how much of the "evidence" in "evidence based medicine" is suspect and how many well intentioned, honest hardworking academic physicians may have been conned as well. A recent Health Care Renewal posting links to a detail filled Wall Street Journal article dealing in part with discrepancies between the data obtained and the data reported in a number of articles at least some of which were drug company designed and managed. There is also the issue of "ghost writing, which has been well blogged about, in which drug companies hire "medical information" companies to write articles promoting a given product or group of products and then enlisting academic docs to add a bit of prestige veneer to the publication.
I don't know when Lilly stopped giving out the black bags, but I don't think many med schools would favor resumption of the practice. About forty years ago when I began to carry around my black bag as an intern, the descriptor "ethical" attached to " drug company" would have seemed quite reasonable if anyone would have given it any thought, which we didn't. But now...By the way news articles still use that term.
For years,I considered the detail men who brought samples and doughnuts to the office as basically benign and took their brief promotional comments re their drugs superiority over competitors with healthy skepticism.
But now, once I read alleged details of Merck's action re the VIGOR study and its marketing of Vioxx, I cannot think of Merck and- by extrapolation and belief there may be no difference among large pharma entities-other large drug companies with any thing but suspicion and distrust.
The gist of the "Kaiser Health Report" linked above describes marketing techniques that seem, at best, misleading in turn leading physicians to prescribe Vioxx, which a number of doctors now wish they had never done. If this was merely one company misleading physicians and the public about side effects of a drug, that would be bad enough.But there appears to be more.
There is reason to believe that in some instances drug companies have manipulated study results so that when they are published ( in main line journals) the results do not represent all of the data in such a way that opposite conclusions may have been reached if more of the data set were presented to the journal. Case in point: The 2000 JAMA article regarding celecoxib (Pfizer's Celebrex) which published 6 month data showing a better side effect profile re: GI concerns than older NSAIDs while they withheld the 12 month data which painted a different picture.
You have to worry that this is a ice berg tip and how many of the drug industry- financed and designed RCTs if carefully analyzed ( with data even journal editors do not have access to) may not really demonstrate what the articles concluded. And it is the RCTs which are the gold standard of information feed into various consensus and guidelines writing committees.
A number of professional organizations have warned physicians about undue influence regarding free meals and trips etc. If the manipulative antics of two of the drug industry giants are any thing but two isolated aberrations, the influence we need to be concerned about is much more serious than a free dinner at a toney establishment. We need to worry about how much of the "evidence" in "evidence based medicine" is suspect and how many well intentioned, honest hardworking academic physicians may have been conned as well. A recent Health Care Renewal posting links to a detail filled Wall Street Journal article dealing in part with discrepancies between the data obtained and the data reported in a number of articles at least some of which were drug company designed and managed. There is also the issue of "ghost writing, which has been well blogged about, in which drug companies hire "medical information" companies to write articles promoting a given product or group of products and then enlisting academic docs to add a bit of prestige veneer to the publication.
I don't know when Lilly stopped giving out the black bags, but I don't think many med schools would favor resumption of the practice. About forty years ago when I began to carry around my black bag as an intern, the descriptor "ethical" attached to " drug company" would have seemed quite reasonable if anyone would have given it any thought, which we didn't. But now...By the way news articles still use that term.
Monday, May 09, 2005
Retired Doc's suggestion for Medical Curriculum,Part 9, The Nazi transformation for Healing to Killing,
Media coverage of the 60th anniversary of the end of world war II has focused on various events including the anniversary of the liberation of Auschwitz (Jan 27,1945). A few blogs ago I wrote about the transformation of a lay person into a physician. The anniversaries highlighted this year made me think of another transformation; the transforming of more than a few German physicians into mass murderers. Some teaching time needs to be spent to make medical students aware of the major role that doctors played in state sponsored killing of unbelievable magnitude and genocide. Robert Jay Lifton's " The Nazi Doctors-Medical Killing and the Psychology of Genocide" would be a good reference source.It available on Amazon.com
(also the AMA has teamed with the US Holocaust Memorial Museum to sponsor a series of lectures.)
Students will learn of the major role doctors played at Auschwitz and of the progression from the compulsory sterilization movement (to rid the German nation of inferior(Jewish) blood to the children's "euthanasia" program to the T4 program which focused on killing adult patients judged"not fit to live" providing the preliminary "learning curve" of perfecting the mass killing techniques later used in the camps. Lifton explains how the T4 program involved "virtually the entire German psychiatric community and the related portions of the general medical community" It was not just a few psychopaths.The processes became bureaucratized and participants could think of themselves as just "cogs" and maybe thereby lessen guilt.
It still seems inconceivable that there could have been this transformation of many physicians from healers to killers. Dr. Lifton discusses factors involved in the specificity of the Jewish genocide and provides material that might help illuminate broader questions of life and death and state control that are of enduring interest to physicians including the sacrifice of the individual to the state.The malignant racism and Anti-Semitism cannot be over emphasized but medical students need to know there were also large killing programs managed by physicians that murdered non-Jewish German children and adults who were labelled a burden to society.
The philosophical underpinnings of the "nazification of the medical profession" is discussed by Lifton. The influential manual of Rudolf Ramm proposed that physicians be the "Physicians to the Volk". The physician was to be concerned with the health of the Volk and was to overcome the old individualistic principle of the right to one's own body and the embrace the duty to be healthy and the physician duty was to the collectivity.The physician was the cultivator of the genes.National socialism was thought of as an "applied biology".Physicians were to be the technicians and engineers of the pseudoscience of race hygiene.
Some of the factors leading to the transformation from healing to killing emphazied by Lifton are:the acceptance of the notion that the state was the patient and not the individual human being,the belief or rationalization that the physician was just a cog in a machine and not to blame and that they were powerless to stop the evil because the orders came from someone else and ultimately the Fuhrer.
How all the medical ideals were betrayed and physicians became key players in unprecedented horror, murder and torture should be worth a few hours of instruction and discussion among medical students.
(also the AMA has teamed with the US Holocaust Memorial Museum to sponsor a series of lectures.)
Students will learn of the major role doctors played at Auschwitz and of the progression from the compulsory sterilization movement (to rid the German nation of inferior(Jewish) blood to the children's "euthanasia" program to the T4 program which focused on killing adult patients judged"not fit to live" providing the preliminary "learning curve" of perfecting the mass killing techniques later used in the camps. Lifton explains how the T4 program involved "virtually the entire German psychiatric community and the related portions of the general medical community" It was not just a few psychopaths.The processes became bureaucratized and participants could think of themselves as just "cogs" and maybe thereby lessen guilt.
It still seems inconceivable that there could have been this transformation of many physicians from healers to killers. Dr. Lifton discusses factors involved in the specificity of the Jewish genocide and provides material that might help illuminate broader questions of life and death and state control that are of enduring interest to physicians including the sacrifice of the individual to the state.The malignant racism and Anti-Semitism cannot be over emphasized but medical students need to know there were also large killing programs managed by physicians that murdered non-Jewish German children and adults who were labelled a burden to society.
The philosophical underpinnings of the "nazification of the medical profession" is discussed by Lifton. The influential manual of Rudolf Ramm proposed that physicians be the "Physicians to the Volk". The physician was to be concerned with the health of the Volk and was to overcome the old individualistic principle of the right to one's own body and the embrace the duty to be healthy and the physician duty was to the collectivity.The physician was the cultivator of the genes.National socialism was thought of as an "applied biology".Physicians were to be the technicians and engineers of the pseudoscience of race hygiene.
Some of the factors leading to the transformation from healing to killing emphazied by Lifton are:the acceptance of the notion that the state was the patient and not the individual human being,the belief or rationalization that the physician was just a cog in a machine and not to blame and that they were powerless to stop the evil because the orders came from someone else and ultimately the Fuhrer.
How all the medical ideals were betrayed and physicians became key players in unprecedented horror, murder and torture should be worth a few hours of instruction and discussion among medical students.
Saturday, May 07, 2005
More thoughts on Older doctor bashing,
Dr. Philip R. Alper has a regular column in Internal Medicine World Report. In the April 2005 issue, he discussed the Annals of Internal Medicine article Entitled " The Relationship between Clinical Experience and Quality of Health Care" (Ann Intern Med 2005:142;260-273.) He was critical of the article and the trailing editorial as was Medical Metamusings in an earlier blog and was Dr.Roy Poses (hcrenewal.blogspot.com) in his excellent analysis of the Annals article in his blog. Basically, the article, a systematic review, concluded that older doctors provided lower quality of care.
The editorial in the Annals accepted the article at face value-even though as Poses, Medical Metamusings and Alper point out the study had serious methodological problems-and used the article to claim that "quality improvement interventions" were needed.The editorialists, at least some of whom are members of the American Board of Internal Medicine, used the article to bolster their campaign for recertification giving the perception that their friendly acceptance of the flawed article might be self-serving.,
I bring this issue up again though it has been well blogged already to be able to quote a great insight Dr. Alper wrote in his column.
"...most of guideline surveillance should be automated.It is the subtleties of diagnosis and treatment and the establishment of a therapeutic relationship with the patient that cannot so readily automated.Everything is important but the notion of placing global responsibility on the primary physician's shoulders make sense only to those who seek to be their superiors.
Dr. Alpers also says in regard to recertification and other control measures "The absence of proof that uniform central planning in medicine will achieve the goals desired by its proponents (and may even be counterproductive) adds to my discomfort"
Not only is there absence of proof there is much proof demonstrating how badly central planning in general works.But,at least for some of the people who advocate it it is not about proof it is about power and control.
The editorial in the Annals accepted the article at face value-even though as Poses, Medical Metamusings and Alper point out the study had serious methodological problems-and used the article to claim that "quality improvement interventions" were needed.The editorialists, at least some of whom are members of the American Board of Internal Medicine, used the article to bolster their campaign for recertification giving the perception that their friendly acceptance of the flawed article might be self-serving.,
I bring this issue up again though it has been well blogged already to be able to quote a great insight Dr. Alper wrote in his column.
"...most of guideline surveillance should be automated.It is the subtleties of diagnosis and treatment and the establishment of a therapeutic relationship with the patient that cannot so readily automated.Everything is important but the notion of placing global responsibility on the primary physician's shoulders make sense only to those who seek to be their superiors.
Dr. Alpers also says in regard to recertification and other control measures "The absence of proof that uniform central planning in medicine will achieve the goals desired by its proponents (and may even be counterproductive) adds to my discomfort"
Not only is there absence of proof there is much proof demonstrating how badly central planning in general works.But,at least for some of the people who advocate it it is not about proof it is about power and control.
Thursday, May 05, 2005
Cost effectiveness of X, , how can a doctor possibly interpret what that means?
A typical cost-effectiveness article appears in the May 2, 2005 Annals of Internal Medicine. The summary states in part "alendronate ... is not cost effective."
When I was doing research on pulmonary function testing in diffuse lung disease, I could read an article , plow into the methods section and learn what technique of certain tests were done, what prediction equation was used, etc etc and could understand to a reasonable level of knowledge what it was all about.
Try that with the Annals article.
You will read that " We used a QALY value estimated with the EuroQul questionnaire and ...we derived the QALY value ...from direct prospective estimate of Kanis and colleagues" And " we constructed a Markow cost-utility model that contained 8 health states and compared 5 years of treatment with alendronate with no drug therapy..." and "We assumed relative risk for incident vertebral fractures of 0.54 and 0.82 for those with femoral neck T-scores of -2.0 t0 2.4 and -1.5 respectively..." And on and on the methods section goes through an elaborate mathematical exercise.
How could a hypothetical well informed general internist-the hypothetical ideal target of Annals articles- possible analyze what was done procedurally.How could she know if the assumptions are reasonable or biased towards some particular outcome?.How would he know if the Markow model was done correctly or more basically how valid is that approach or any of the particular details are in the first place?
You wonder who is the targeted audience of this type article. Is it an internist who would, armed with this latest research,inform his patient that they should not take X because it has been "shown to be" not cost effective. Is it aimed that a benefits manager who who would love some more quasi-justification to save money?
And even if you could understand- or give up and just accept- what they actually did, then you have to deal with the following statement."Assuming a social willingness to pay $ 50,000 per QALY gained...our results indicate that alendronate is not cost effective..."
I don't claim to be expert in Markow chain nuances but I do know that the authors or any one else cannot "determine" societal willingness " because that is not a thing you can determine.It is a meaningless abstraction.
Cost effectiveness articles should not be considered Evidence based medicine. They are calculations based on stacks of assumptions and typically end by concluding that something is or is not cost effective based on whether the indicator of interest is above or below an arbitrary dollar value that other authors have decided will be the threshold value.(The magic number,typically,is $50,000 per QALY,which is treated as a constant of nature rather than a contingent construct based on a stream of guesses) I ranted about this general topic few blogs ago but keep returning to it as articles appear and I see so little criticism of these pseudo-scientific papers.
When I was doing research on pulmonary function testing in diffuse lung disease, I could read an article , plow into the methods section and learn what technique of certain tests were done, what prediction equation was used, etc etc and could understand to a reasonable level of knowledge what it was all about.
Try that with the Annals article.
You will read that " We used a QALY value estimated with the EuroQul questionnaire and ...we derived the QALY value ...from direct prospective estimate of Kanis and colleagues" And " we constructed a Markow cost-utility model that contained 8 health states and compared 5 years of treatment with alendronate with no drug therapy..." and "We assumed relative risk for incident vertebral fractures of 0.54 and 0.82 for those with femoral neck T-scores of -2.0 t0 2.4 and -1.5 respectively..." And on and on the methods section goes through an elaborate mathematical exercise.
How could a hypothetical well informed general internist-the hypothetical ideal target of Annals articles- possible analyze what was done procedurally.How could she know if the assumptions are reasonable or biased towards some particular outcome?.How would he know if the Markow model was done correctly or more basically how valid is that approach or any of the particular details are in the first place?
You wonder who is the targeted audience of this type article. Is it an internist who would, armed with this latest research,inform his patient that they should not take X because it has been "shown to be" not cost effective. Is it aimed that a benefits manager who who would love some more quasi-justification to save money?
And even if you could understand- or give up and just accept- what they actually did, then you have to deal with the following statement."Assuming a social willingness to pay $ 50,000 per QALY gained...our results indicate that alendronate is not cost effective..."
I don't claim to be expert in Markow chain nuances but I do know that the authors or any one else cannot "determine" societal willingness " because that is not a thing you can determine.It is a meaningless abstraction.
Cost effectiveness articles should not be considered Evidence based medicine. They are calculations based on stacks of assumptions and typically end by concluding that something is or is not cost effective based on whether the indicator of interest is above or below an arbitrary dollar value that other authors have decided will be the threshold value.(The magic number,typically,is $50,000 per QALY,which is treated as a constant of nature rather than a contingent construct based on a stream of guesses) I ranted about this general topic few blogs ago but keep returning to it as articles appear and I see so little criticism of these pseudo-scientific papers.
Monday, May 02, 2005
Retired Doc's Suggestion for Medical Curriculum,Part 8,Meta-Analysis -know its limitations
The twin pillars of the epidemiologic-statistical foundations of the "best evidence " part of Evidence based Medicine (EBM) are the randomized controlled trial (RCT) and the quantitative systematic review AKA meta-analysis (MA).
In a earlier blog, I suggested that a major insight of the RCT is that everyone does not react the Same to a given treatment.
That is one of the basic facts of life in MAs as well since a systematic review typically reviews RCTs.
Two others are:
The conclusion of a MA is dependent on the published (or unpublished) studies included in the pooled analysis and the outcome statistic chosen.
Just as clinical advice needs to be linked to cases to give them limbic valence,these abstractions can be made meaningful with a real life case of different MAs reaching conclusions that would have very different implications for clinical medicine.
Two Danish researchers (Olsen and Gotsche-Cochrane data base Sys Rev. 2001;CD0018777) concluded that screening mammography was not effective.In the same time frame the USPSTF concluded the opposite:both groups based their conclusion on MAs.
Dr. Steven Goodman's explanation of that discrepancy should be part of handouts to medical students in their course on EBM. In an editorial in the Annals of Internal Medicine, sept 2002,volume 137 issue 5, pages 363-365 (He explains that a MA is basically an observational design wherein the subjects are published studies.Those studies that are considered but eliminated from the analysis can make a big difference.Why studies are kept or not rests on "competing claims" of methodologic validity.In this regard the average or for that matter super doctor is challenged to know which expert is correct.The Danish epidemiologists excluded more trials from their analysis than did USPSTF and reached a different conclusion.Another reason for the difference was that the US group used breast cancer mortality while the Danes chose all cause mortality as a summary statistic.
So ,the choice of studies to include and the summary statistic chosen determine the outcome. This example alone should convince medical students that meta-analysis are not infallible. There are context dependent.
I became aware of Goodman's Annals of Internal Medicine editorial in the blog "Medical Metamusings"and I later learned of two other publications that would be good additions to the study list given medical students to illustrate the limitations of MAs.
LeLorier et al from Montreal published an article in NEJM in 1997 in which they described discrepancies between MAs and subsequent large RCTS. An editorial by John Bailar followed, entitled "The Promise and Problems of Meta-Analysis"(NEJM-volume 337:559-561,aug 21,1997).
A major point made by Bailar and LeLorier is that while a well done MA can be helpful in presenting disparate studies on a common scale - using odds ratios- the problem may arise when all of the data is summarized into one odds ratio which is supposed to capture the entire issue but actually may oversimplify a complex issue and lead to erroneous conclusions. Simple answers to complex problems are welcomed but life is so messy they are often just wrong. Meta-analysis is not rocket science-its techniques and particulars are still being working out to some degree and reputable researchers may disagree over operational issues.There is still a lot to learn about the best way to do them.
In a earlier blog, I suggested that a major insight of the RCT is that everyone does not react the Same to a given treatment.
That is one of the basic facts of life in MAs as well since a systematic review typically reviews RCTs.
Two others are:
The conclusion of a MA is dependent on the published (or unpublished) studies included in the pooled analysis and the outcome statistic chosen.
Just as clinical advice needs to be linked to cases to give them limbic valence,these abstractions can be made meaningful with a real life case of different MAs reaching conclusions that would have very different implications for clinical medicine.
Two Danish researchers (Olsen and Gotsche-Cochrane data base Sys Rev. 2001;CD0018777) concluded that screening mammography was not effective.In the same time frame the USPSTF concluded the opposite:both groups based their conclusion on MAs.
Dr. Steven Goodman's explanation of that discrepancy should be part of handouts to medical students in their course on EBM. In an editorial in the Annals of Internal Medicine, sept 2002,volume 137 issue 5, pages 363-365 (He explains that a MA is basically an observational design wherein the subjects are published studies.Those studies that are considered but eliminated from the analysis can make a big difference.Why studies are kept or not rests on "competing claims" of methodologic validity.In this regard the average or for that matter super doctor is challenged to know which expert is correct.The Danish epidemiologists excluded more trials from their analysis than did USPSTF and reached a different conclusion.Another reason for the difference was that the US group used breast cancer mortality while the Danes chose all cause mortality as a summary statistic.
So ,the choice of studies to include and the summary statistic chosen determine the outcome. This example alone should convince medical students that meta-analysis are not infallible. There are context dependent.
I became aware of Goodman's Annals of Internal Medicine editorial in the blog "Medical Metamusings"and I later learned of two other publications that would be good additions to the study list given medical students to illustrate the limitations of MAs.
LeLorier et al from Montreal published an article in NEJM in 1997 in which they described discrepancies between MAs and subsequent large RCTS. An editorial by John Bailar followed, entitled "The Promise and Problems of Meta-Analysis"(NEJM-volume 337:559-561,aug 21,1997).
A major point made by Bailar and LeLorier is that while a well done MA can be helpful in presenting disparate studies on a common scale - using odds ratios- the problem may arise when all of the data is summarized into one odds ratio which is supposed to capture the entire issue but actually may oversimplify a complex issue and lead to erroneous conclusions. Simple answers to complex problems are welcomed but life is so messy they are often just wrong. Meta-analysis is not rocket science-its techniques and particulars are still being working out to some degree and reputable researchers may disagree over operational issues.There is still a lot to learn about the best way to do them.
Friday, April 29, 2005
Paradigms can turn on a dime,or maybe a data-dredge,Case in point digitalis
With in memory (ok, a long memory) we did not worry about should we give digitalis to heart failure patients, the only issue was how much of which preparation.Some of us even remember digitalis leaf being talked about.
The earlier-day paradigm envisioned the heart as a failing pump and drugs to increase contractility seemed to make sense and digitalis was considered an inotrope and it still is but is now thought to do more good as a renin inhibitor and to tone down over- exuberant sympathetic activity.
Decades of observed improvement from digoxin were in part validated by two clinical trials that gave enough data for the FDA to approve it as a treatment for CHF. But there were problems and the results were not nearly as conclusive as those demonstrating the value of ACE inhibitors. The ACE inhibitors did it all, decreased symptoms, increased exercise tolerance and improved survival. Digitalis did not increase survival in the large DIG trial but did decrease the need for hospitalizations.The RADIANCE trial interestingly showed that patients on digoxin worsened when it was discontinued.
The data seemed sound enough for the AHA/ACC 2001 guidelines to recommend its use,either early on while the ACE inhibitors were taking their time to work or later in the progression of disease when the patients had already been treated with diuretics, ACE inhibitors and beta blockers.And-after 200 years of use-the FDA had approved its use as a treatment for CHF.
Then in October 2002, a retrospective analysis of the DIG trial was published in NEJM. There was a 4.2 % increase in mortality in women in the DIG trial. The AHA/ACC guidelines had made no distinction based on gender, but the authors of the analysis suggested perhaps they should rethink that.
In the same issue a "Perspective" was offered pointing out that perhaps higher digitalis levels may have played a role in the findings as after one month of treatment they were higher in women.However, an adjustment was not made in their analysis for digitalis levels. The authors cautioned against abandoning a therapy that may help women in heart failure but that greater attention was needed in doses and monitoring.
I do not really know how much the digitalis paradigm was turned around by this one article; there are other arguments for using it sparingly if at all. But when a paper really turns around a practice or a mindset, I hope it will usually be something more substantive that a retrospective sub set analysis of data. Perhaps something like the Woman's Health Initiative which took HRT from a means of decreasing heart attack risk, maintaining bone density,healthy skin and urogenital structures to posing a risk of heart attack, stroke blood clots and breast cancer. On the other hand,just because sub set analysis is more vulnerable to biases it does mean that the conclusions based on it could not be correct. This seems to be still another instance in which we have large clinical trial-the DIG study (randomized,etc,etc)-and various analysis of the data, and we still are not sure what to do. Do you give digitalis to women with CHF or not?
The earlier-day paradigm envisioned the heart as a failing pump and drugs to increase contractility seemed to make sense and digitalis was considered an inotrope and it still is but is now thought to do more good as a renin inhibitor and to tone down over- exuberant sympathetic activity.
Decades of observed improvement from digoxin were in part validated by two clinical trials that gave enough data for the FDA to approve it as a treatment for CHF. But there were problems and the results were not nearly as conclusive as those demonstrating the value of ACE inhibitors. The ACE inhibitors did it all, decreased symptoms, increased exercise tolerance and improved survival. Digitalis did not increase survival in the large DIG trial but did decrease the need for hospitalizations.The RADIANCE trial interestingly showed that patients on digoxin worsened when it was discontinued.
The data seemed sound enough for the AHA/ACC 2001 guidelines to recommend its use,either early on while the ACE inhibitors were taking their time to work or later in the progression of disease when the patients had already been treated with diuretics, ACE inhibitors and beta blockers.And-after 200 years of use-the FDA had approved its use as a treatment for CHF.
Then in October 2002, a retrospective analysis of the DIG trial was published in NEJM. There was a 4.2 % increase in mortality in women in the DIG trial. The AHA/ACC guidelines had made no distinction based on gender, but the authors of the analysis suggested perhaps they should rethink that.
In the same issue a "Perspective" was offered pointing out that perhaps higher digitalis levels may have played a role in the findings as after one month of treatment they were higher in women.However, an adjustment was not made in their analysis for digitalis levels. The authors cautioned against abandoning a therapy that may help women in heart failure but that greater attention was needed in doses and monitoring.
I do not really know how much the digitalis paradigm was turned around by this one article; there are other arguments for using it sparingly if at all. But when a paper really turns around a practice or a mindset, I hope it will usually be something more substantive that a retrospective sub set analysis of data. Perhaps something like the Woman's Health Initiative which took HRT from a means of decreasing heart attack risk, maintaining bone density,healthy skin and urogenital structures to posing a risk of heart attack, stroke blood clots and breast cancer. On the other hand,just because sub set analysis is more vulnerable to biases it does mean that the conclusions based on it could not be correct. This seems to be still another instance in which we have large clinical trial-the DIG study (randomized,etc,etc)-and various analysis of the data, and we still are not sure what to do. Do you give digitalis to women with CHF or not?
Thursday, April 28, 2005
Retired Doc's suggestion for Medical Curriculum, Part 7-how to apply population data to individual patients
The basic message is "everyone does not react the same to a given treatment".
This should be obvious but in the frenzy of jumping on the Evidence Based Band wagon, it may have been forgotten or overlooked.
An excellent article that should be part of medical school teaching was published in a journal that no one would have ever read in the pre-internet era and even now probably languishes on the shelves of unread papers. ( I would not have found it had it not been mentioned in a December 2004 blog on Health Care Renewal).
The Journal is Milbank Quarterly and the article is " Evidence-based Medicine;Heterogeneity of treatment effects and the trouble with averages" by Kravitz,RL,Duan N, and Braslow J.
Here is a brief outline of the main points but the entire article is worth reading and should be handed out to medical students as part of their course in Statistics or EBM or something.
Heterogeneity of treatment effects (they abbreviate it as HTE) simply means
that the basic fact of life in a clinical trial is that everyone does not respond the same to the treatment.If , for example the average blood pressure decrease is x, there will be patients whose BP change is greater than that, less than that and in some patients some type of harm actually occurs.
The clinical problem is how to apply this population data to the individual patients.
The corresponding statistical problem is heterogeneity of treatments effects.
This variation in turn is due to the following three factors, acting alone or interacting with each other: 1) the degree to which an individual disease is likely to progress (i.e.the risk without treatment) 2) the responsiveness of the patients to treatment (this sounds a bit circular,but refers to how well does the drug favorably work in a given patient), 3) vulnerability to side effects.In the future to a greater degree than now we may be aware of various genetic polymorphisms that might explain some that variation and allow us to predict better who will respond to what.Additonally-in deciding should a particular treatment be recommended- there is the issue of utilities for different outcomes, meaning various patients value the same outcome differently.
All of this means you cannot expect the "average effect" to occur in the given patient you are treating. This is the basic clinical conundrum.
On the one hand the RCT may be the best information the doctor has since he lacks specific information on the patients' risk without treatment and susceptibility to positive or negative effects on treatment.
So what do you do? 1.Realize that the RCT is better guidance that just "winging it" completely, 2. As best you can try and determine to what degree your patient is like the average of the group treated and/or like or dissimilar from any subgroup that was analyzed in the study ( yes, we know subgroup analysis can be fallacious but..) and remember that your patient who is at greatest risk from the disease is likely to get the greatest net benefit from treatment. Also ask would your patient even been eligible for the trial and if not was the reason likely to be clinically important.It is a clinical judgment issue and for that there is no meta-algorithm.The physician's ability to predict how a given patient will respond to treatment X depends on our knowledge of those 3 factors.
So the student should remember that the often modest benefit that occurs on average in a RCT typically reflects a mixture of significant benefit for some, slight change for many and harm for some. There is a lot of clinical context and patient preference to factor in and blind adherence to guidelines - be it for pay-for performance or some sort of quality ranking-is not the way to go.
There are obvious implications for guideline makers and the pay- for- performance issues and even FDA approval for drugs,to all of which the authors address comments.
This should be obvious but in the frenzy of jumping on the Evidence Based Band wagon, it may have been forgotten or overlooked.
An excellent article that should be part of medical school teaching was published in a journal that no one would have ever read in the pre-internet era and even now probably languishes on the shelves of unread papers. ( I would not have found it had it not been mentioned in a December 2004 blog on Health Care Renewal).
The Journal is Milbank Quarterly and the article is " Evidence-based Medicine;Heterogeneity of treatment effects and the trouble with averages" by Kravitz,RL,Duan N, and Braslow J.
Here is a brief outline of the main points but the entire article is worth reading and should be handed out to medical students as part of their course in Statistics or EBM or something.
Heterogeneity of treatment effects (they abbreviate it as HTE) simply means
that the basic fact of life in a clinical trial is that everyone does not respond the same to the treatment.If , for example the average blood pressure decrease is x, there will be patients whose BP change is greater than that, less than that and in some patients some type of harm actually occurs.
The clinical problem is how to apply this population data to the individual patients.
The corresponding statistical problem is heterogeneity of treatments effects.
This variation in turn is due to the following three factors, acting alone or interacting with each other: 1) the degree to which an individual disease is likely to progress (i.e.the risk without treatment) 2) the responsiveness of the patients to treatment (this sounds a bit circular,but refers to how well does the drug favorably work in a given patient), 3) vulnerability to side effects.In the future to a greater degree than now we may be aware of various genetic polymorphisms that might explain some that variation and allow us to predict better who will respond to what.Additonally-in deciding should a particular treatment be recommended- there is the issue of utilities for different outcomes, meaning various patients value the same outcome differently.
All of this means you cannot expect the "average effect" to occur in the given patient you are treating. This is the basic clinical conundrum.
On the one hand the RCT may be the best information the doctor has since he lacks specific information on the patients' risk without treatment and susceptibility to positive or negative effects on treatment.
So what do you do? 1.Realize that the RCT is better guidance that just "winging it" completely, 2. As best you can try and determine to what degree your patient is like the average of the group treated and/or like or dissimilar from any subgroup that was analyzed in the study ( yes, we know subgroup analysis can be fallacious but..) and remember that your patient who is at greatest risk from the disease is likely to get the greatest net benefit from treatment. Also ask would your patient even been eligible for the trial and if not was the reason likely to be clinically important.It is a clinical judgment issue and for that there is no meta-algorithm.The physician's ability to predict how a given patient will respond to treatment X depends on our knowledge of those 3 factors.
So the student should remember that the often modest benefit that occurs on average in a RCT typically reflects a mixture of significant benefit for some, slight change for many and harm for some. There is a lot of clinical context and patient preference to factor in and blind adherence to guidelines - be it for pay-for performance or some sort of quality ranking-is not the way to go.
There are obvious implications for guideline makers and the pay- for- performance issues and even FDA approval for drugs,to all of which the authors address comments.
Wednesday, April 27, 2005
Medical Ghost Writing-you just don't know who to trust
The blog,(hcrenewal.blogspot.com) has featured several excellent pieces on the topic of the practice of drug companies planting articles in medical journals and recruiting academic medical authors to adorn the articles with a venere of scholarly credibility. What seems to be happening in this propaganda exercise is courageously outlined by Dr. Adriane Fugh-Berman in a comment in the Journal of General Internal Medicine. I had noticed that in some of the "throwaway" publications, an occasional article seemed to be a subtle or not so subtle ad for a particular medication or class of medication. It seems that even respected, main stream journals may not be immune to that type of manipulation.
The Health Care Renewal blog is one I recently discovered and recognize it as a great source of well researched information of health care issues. I have added it to my Bloglines feeds for daily reading. I hope that the author(s) of that blog add its feed to Medlogs listings so more medical bloggers can lock on to it.
The Health Care Renewal blog is one I recently discovered and recognize it as a great source of well researched information of health care issues. I have added it to my Bloglines feeds for daily reading. I hope that the author(s) of that blog add its feed to Medlogs listings so more medical bloggers can lock on to it.
Tuesday, April 26, 2005
"Cultural Competency" courses required for N.J. medical licensure
The April 24, 2005 issue of American Medical News reports that New Jersey has passed a law requiring "cultural competency training" to be licensed to practice medicine.Details of the training are yet to be determined by the State Board of Medical Examiners.Often the devil is in the details, but here we have enough devil by the proposal and passage of the law itself. The N.J. legislator who proposed the bill said it "was the first step in eliminating disparities in medical care among minority groups." It was not explained how doctors receiving lectures or handouts will accomplish that goal.From the reactions of medical school representative and the Medical society's president,we get a glimpse of a town-gown gap.The VP of NJ's med school said "the new law has the potential of actually working".I have no idea of what actually working might mean in this context. The president of the med society said, " You really don't teach people cultural competency in a classroom learn it in the lap of your grandmother".I found the content of a cultural competency program on the AMSA website to be very much like what is found in "diversity" training programs that virtually all large corporations have bought into.
Thursday, April 21, 2005
The "Transformation " of a lay person into a physician
Dr. Lawrence G.Smith, writing in the April 3, 2005 issue of the American Journal of Medicine speaks of this transformation. Professionalism has been written about extensively as it relates to doctors. Smith maintains the core of professionalism is the "personal transformation of self that takes place in stages during the early years of medical training and practice" When transformed the person now interacts with society in a new and different manner.
I have no doubt that happened to me. I can still remember comments made by teachers now over thirty years ago which were part of that process. I remember the attitude of respect and seriousness that was passed to me from the professors of gross anatomy as it related to behavior to the cadavers and behavior in the lab. I remember the pathology professor who told us that when we saw patients at night in the hospital how important it was for us to look and behave like physicians.I remember the chief of surgery who insisted that his residents wear shirts and ties in the hospital and clean coats and that his definition of a surgeon was a physician who knew how to operate.I remember how the clinical faculty typically treated the patients in the county hospital always with courtesy and respect, even though at time residents might have not.
In the first few months after I completed training I was doing a locum tenens and had the occasional to call the chief of medicine, with whom I had trained, to see a private patient at 3 am. She had end stage lupus and he had seen her several years before. He arrived soon after I called him at home. He was well shaven and well dressed in a suit. He spent over a hour with the patient and family, completed a page and half note and spent another 10 minutes with me.The family was greatly relieved that all that could be done was done. I was greatly relieved and felt that the chief had taught me another lesson;how a physician can do things the way that should be done in the real world.
These are just a few snap shots of the events and attitudes that lead to my transition from a college kid who really had no idea what to expect in med school or beyond to a person who felt he was trained to do serious, important work and that it all was a privilege and a great obligation and that doing the right thing for the patient was what it was all about. Much of what my high school friends had done while I was in training, I had missed and in the years of training much of transpired in the world I had also missed. And much of the everyday concerns of relatives seemed to be so much less important.I believe part of that transformation process is the isolation from the daily events of the world that seems required by the intense study and training lasting for years past the usual time an adult joins the work force. Part of that transformation occurs because most of your waking hours are spent with other physicians and professionals doing what doctors do and talking about things doctors talk about.Role models are everywhere.
As Dr. Smith said, once the transformation occurs you cannot think of being a physician as just a job.And it is difficult to think of yourself as any thing but a physician.
And because of that transformation it becomes very hard for a physician to retire or to be forced to leave practice because of illness. Are you transformed back into a lay person or are you still a physician who ...?
I have no doubt that happened to me. I can still remember comments made by teachers now over thirty years ago which were part of that process. I remember the attitude of respect and seriousness that was passed to me from the professors of gross anatomy as it related to behavior to the cadavers and behavior in the lab. I remember the pathology professor who told us that when we saw patients at night in the hospital how important it was for us to look and behave like physicians.I remember the chief of surgery who insisted that his residents wear shirts and ties in the hospital and clean coats and that his definition of a surgeon was a physician who knew how to operate.I remember how the clinical faculty typically treated the patients in the county hospital always with courtesy and respect, even though at time residents might have not.
In the first few months after I completed training I was doing a locum tenens and had the occasional to call the chief of medicine, with whom I had trained, to see a private patient at 3 am. She had end stage lupus and he had seen her several years before. He arrived soon after I called him at home. He was well shaven and well dressed in a suit. He spent over a hour with the patient and family, completed a page and half note and spent another 10 minutes with me.The family was greatly relieved that all that could be done was done. I was greatly relieved and felt that the chief had taught me another lesson;how a physician can do things the way that should be done in the real world.
These are just a few snap shots of the events and attitudes that lead to my transition from a college kid who really had no idea what to expect in med school or beyond to a person who felt he was trained to do serious, important work and that it all was a privilege and a great obligation and that doing the right thing for the patient was what it was all about. Much of what my high school friends had done while I was in training, I had missed and in the years of training much of transpired in the world I had also missed. And much of the everyday concerns of relatives seemed to be so much less important.I believe part of that transformation process is the isolation from the daily events of the world that seems required by the intense study and training lasting for years past the usual time an adult joins the work force. Part of that transformation occurs because most of your waking hours are spent with other physicians and professionals doing what doctors do and talking about things doctors talk about.Role models are everywhere.
As Dr. Smith said, once the transformation occurs you cannot think of being a physician as just a job.And it is difficult to think of yourself as any thing but a physician.
And because of that transformation it becomes very hard for a physician to retire or to be forced to leave practice because of illness. Are you transformed back into a lay person or are you still a physician who ...?
Retired Doc's suggestion for Medical Curriculum,Part 6 ( cost benefit analysis)
Cost-Benefit Analysis and cost effectiveness are frequent topics in medical articles.Students should have a basic understanding of what they are. They should also have exposure to a body of thought that argues that such procedures-as they apply to public policy decisions- are basically invalid and offer simplistic, pseudo-scientific solution to complex basically moral issues.
For a medical procedure the CBA would purport to aggregate the "costs", aggregate the benefits and if the benefits are greater than the cost(s), then a case for utilization of the procedure would be made.To choose between procedures one could then do a cost effectiveness analysis wherein the costed quality adjusted life years (QALY) would be "computed"for each and and on that basis choose one over the other or -as is sometimes done-a procedure would be dismissed because the cost per QALY is greater than some arbitrary value is exceeded. To ascribe a numerical value to someone's "quality" of life, may be thought of as more of an act of hypertrophied hubris than scientific precision.
An excellent critique of the assumptions involved in CBA ( which also apply to QALY) can be found in a book by Robert Formaini entitled "The Myth of Scientific Public Policy" and is available at Amazon.Com.
CBA is based on Neoclassical economic theory and much of Formaini's effort is aimed at pointing out the fallacies of that approach.
CBAs etc are usually presented in medical journals as "scientific papers", physicians writing editorials often assume the role of policy consultants based on these analysis.
R. Gillion writing in the British Medical Journal ( BMJ 1994:309:184 (16 July) describes QALY and being tempting in its "Definitiveness and simplicity" and warns against being seduced by "systems that seek to convert these essentially moral choices into apparently scientific, numerical methods and formulas"
Medical authors often speak of a given treatment or medical program as " being ( or not being) cost effective as if that were an invariant property of a system whose value had been determined by scientific methods (" invariant"is meant here in the sense of a property that independent of the point of view-or choice of coordinates-) when actually its foundational validity is assumed to exist without evidence. A basic unit of "measurement" in these studies is "cost", but cost is really an income transfer and is a "cost" only when considered from a certain view point.
In the late 1970s and early 1980s, medical CBAs began to be published. Authors such as Alvin Feinstein and Wm Schwartz spoke out against what thought to be a simplistic, artificial and pseudo-scientific approach. (see an excellent article by Asch and Hershey in Annals of Internal
Medicine ( 1995: 122;846;) entitled " Why Some Health Policies Don't Make sense at the Bedside" Medical students should be aware that there is a point of view that maintains that these policies may not make sense at all.
The arguments of Feinstein and others seem to have been forgotten and the proponents
of CBA seemingly have won due largely to their persistence and perhaps from a conscious or unconscious preference for utilitarian statistical ethics by journal editors. Medical students need to think about these procedures critically before accepting the whole package deal as strong scientifically based "evidence based medicine"and perhaps when someone say that procedure x or treatment Y is not "cost effective" questions might be " what is the nature of the evidence?" and from whose point of view is it not cost effective?
For a medical procedure the CBA would purport to aggregate the "costs", aggregate the benefits and if the benefits are greater than the cost(s), then a case for utilization of the procedure would be made.To choose between procedures one could then do a cost effectiveness analysis wherein the costed quality adjusted life years (QALY) would be "computed"for each and and on that basis choose one over the other or -as is sometimes done-a procedure would be dismissed because the cost per QALY is greater than some arbitrary value is exceeded. To ascribe a numerical value to someone's "quality" of life, may be thought of as more of an act of hypertrophied hubris than scientific precision.
An excellent critique of the assumptions involved in CBA ( which also apply to QALY) can be found in a book by Robert Formaini entitled "The Myth of Scientific Public Policy" and is available at Amazon.Com.
CBA is based on Neoclassical economic theory and much of Formaini's effort is aimed at pointing out the fallacies of that approach.
CBAs etc are usually presented in medical journals as "scientific papers", physicians writing editorials often assume the role of policy consultants based on these analysis.
R. Gillion writing in the British Medical Journal ( BMJ 1994:309:184 (16 July) describes QALY and being tempting in its "Definitiveness and simplicity" and warns against being seduced by "systems that seek to convert these essentially moral choices into apparently scientific, numerical methods and formulas"
Medical authors often speak of a given treatment or medical program as " being ( or not being) cost effective as if that were an invariant property of a system whose value had been determined by scientific methods (" invariant"is meant here in the sense of a property that independent of the point of view-or choice of coordinates-) when actually its foundational validity is assumed to exist without evidence. A basic unit of "measurement" in these studies is "cost", but cost is really an income transfer and is a "cost" only when considered from a certain view point.
In the late 1970s and early 1980s, medical CBAs began to be published. Authors such as Alvin Feinstein and Wm Schwartz spoke out against what thought to be a simplistic, artificial and pseudo-scientific approach. (see an excellent article by Asch and Hershey in Annals of Internal
Medicine ( 1995: 122;846;) entitled " Why Some Health Policies Don't Make sense at the Bedside" Medical students should be aware that there is a point of view that maintains that these policies may not make sense at all.
The arguments of Feinstein and others seem to have been forgotten and the proponents
of CBA seemingly have won due largely to their persistence and perhaps from a conscious or unconscious preference for utilitarian statistical ethics by journal editors. Medical students need to think about these procedures critically before accepting the whole package deal as strong scientifically based "evidence based medicine"and perhaps when someone say that procedure x or treatment Y is not "cost effective" questions might be " what is the nature of the evidence?" and from whose point of view is it not cost effective?
Sunday, April 17, 2005
AMA's American Medical News for a change has good news -HMOs are in trouble
The March 18, 2005 issue reports news from the annual National Managed Health Care Congress where speakers gave bad news to those who might think HMO's are the way to save money and improve quality of care. In that regard, one speaker talked about "broken promises". HMO members are down from 80.9 mllion in 2000 to 68.8 million in 2004 and the remaining HMOs are talking less about gatekeeping and more about open access. Richard Nixon in 1971 talked about HMOs as an alternative to the "illogical incentives" of the then status quo wherein he alleged that doctors and hospitals profited from illness not health and HMOs would reverse that incentive. The rhetoric was HMOs would profit from health, the reality has been they profit from not spending money on illness. The bad news from the meeting was the fact that Disease Management programs are still being sold as means of -guess what-saving money and improving quality and Pay for Performance is still on the front burner.
Wednesday, April 13, 2005
With the AMA's Pay for Performance principles and $ 4 you can get a grande Frappuccino at Starbucks
In my most recent post I mentioned the AMA's pay for performance (PFP) principles. They are reasonable, well thought out and have no relationship to what managed care companies will do.
If you are looking for principles to construct a program that would reward physicians for quality care (I know that begs the question of can you even measure quality), the AMA list would be a good place to begin. Such a program would actually cost more money. If you look at the incentives and constraints under which managed care operates, spending more money is not in their interest.
Can anyone recall a program initiated and supported by managed care that was designed to increase quality care by spending more money? Is there really anyone who is fooled by managed care's talk about pay for performance? Both the AMA and ACP talk about PFP but seem to mean something entirely different from what recently was imposed by United Healthcare. Do the folks at either doctor's organization really believe that their talking about PFP will have any impact on what the insurers do ?
I am reminded of Charlie Brown running still again to place kick the football with Lucy holding,this time-he thinks-she won't let go.
If you are looking for principles to construct a program that would reward physicians for quality care (I know that begs the question of can you even measure quality), the AMA list would be a good place to begin. Such a program would actually cost more money. If you look at the incentives and constraints under which managed care operates, spending more money is not in their interest.
Can anyone recall a program initiated and supported by managed care that was designed to increase quality care by spending more money? Is there really anyone who is fooled by managed care's talk about pay for performance? Both the AMA and ACP talk about PFP but seem to mean something entirely different from what recently was imposed by United Healthcare. Do the folks at either doctor's organization really believe that their talking about PFP will have any impact on what the insurers do ?
I am reminded of Charlie Brown running still again to place kick the football with Lucy holding,this time-he thinks-she won't let go.
Tuesday, April 12, 2005
"Pay for Performance", now we know what they mean
This is the third blog I've written on this topic.The current issue (April 11, 2005) of the AMA Medical News reports on United Healthcare 's "Performance Program". They have implemented some type of measurement system which designated physicians as "performers".
If you are not so designated, according to the AMA News report, you are virtually delisted.Critics of the program,which is almost everyone,(included the AMA and several local medical societies) claim that the classification is based on cost- not quality. Many (actually most)of the physicians on the UHC plan don't meet the volume criteria to be ranked and if they not ranked they cannot be "performers".If you are not a performer,so defined,patients have to pay more to see you.
Doctors affiliated with the Barnes-Jewish Hospitals in St. Louis have threatened to drop UHC as only 18% of its 4,000 doctors were designated as performers.
This is exactly the type of semantic smoke and mirrows maneuver that one has come to expect from insurance plans.Pay for Performance was touted as rewarding physicians for quality work and what we get is some non transparent system which punish doctors based on cost issues and sugar coats the program with performance rhetoric.
An editorial in the same issue says in part "the physician community has the opportunity to help shape its (pay for performance) direction." Wouldn't it be nice to think so? The physicians who are part of the UHC plan had about as much opportunity to shape that plan as the UHC patients did, namely none and both groups will be the losers.
The AMA has proposed 5 principles for pay-for-performance programs.They are: ensure quality of care,foster the Dr-Patient relationship,offer voluntary participation,use accurate data and fair reporting (wherein docs are allowed to appeal results prior to the use of the results for programmatic reasons), and provide fair and equitable program incentives.Details of each element are found on the AMA website and they seem to bear no resemblance to what UHC has rolled out, surprising to only the very naive.(Remember the quality enhancement that resulted from the gate keeper initiative of the managed care companies)
After the fact the AMA and others complain about it.As the saying goes "The dogs bark but the caravan moves on".
If you are not so designated, according to the AMA News report, you are virtually delisted.Critics of the program,which is almost everyone,(included the AMA and several local medical societies) claim that the classification is based on cost- not quality. Many (actually most)of the physicians on the UHC plan don't meet the volume criteria to be ranked and if they not ranked they cannot be "performers".If you are not a performer,so defined,patients have to pay more to see you.
Doctors affiliated with the Barnes-Jewish Hospitals in St. Louis have threatened to drop UHC as only 18% of its 4,000 doctors were designated as performers.
This is exactly the type of semantic smoke and mirrows maneuver that one has come to expect from insurance plans.Pay for Performance was touted as rewarding physicians for quality work and what we get is some non transparent system which punish doctors based on cost issues and sugar coats the program with performance rhetoric.
An editorial in the same issue says in part "the physician community has the opportunity to help shape its (pay for performance) direction." Wouldn't it be nice to think so? The physicians who are part of the UHC plan had about as much opportunity to shape that plan as the UHC patients did, namely none and both groups will be the losers.
The AMA has proposed 5 principles for pay-for-performance programs.They are: ensure quality of care,foster the Dr-Patient relationship,offer voluntary participation,use accurate data and fair reporting (wherein docs are allowed to appeal results prior to the use of the results for programmatic reasons), and provide fair and equitable program incentives.Details of each element are found on the AMA website and they seem to bear no resemblance to what UHC has rolled out, surprising to only the very naive.(Remember the quality enhancement that resulted from the gate keeper initiative of the managed care companies)
After the fact the AMA and others complain about it.As the saying goes "The dogs bark but the caravan moves on".
Sunday, April 10, 2005
Does managing a given disease constitute a "Burden" on health-care systems?
It is almost mandatory in the introduction to medical articles that the author(s) point out that the disease at hand is common and important, often considered a "public health problem" and in the March 2005 Pulmonary perspectives (which is attached to the March issue of Chest) places a huge "burden" on ... health care systems." (this said in regard to caring for patients with lower respiratory infections)
The diseases at hand were the constellation of lower respiratory infections. Patients with pneumonia and acute exacerbation of COPD (AECB) are seen in ERs, some admitted to hospitals, treated by physicians, given antibiotics have lab tests and x-rays done, in short all of the usual things that happen when patients with various medical problems seek care. These are the things that happen in what is called " the health care system" which is not really even a system . Why is that a burden?
The dictionary give several definitions to "burden": something difficult to bear, a worry or a duty or responsiblity. Which does the author mean? Is managing AECB a worry for a pulmonolgist or is that just her job?.Certainly it is a responsibility. Filling out insurance forms may be characterized as a burden but treating patients with real diseases is what physicians do.Why do we not speak of changing oil as a burden on the car care industry?
The diseases at hand were the constellation of lower respiratory infections. Patients with pneumonia and acute exacerbation of COPD (AECB) are seen in ERs, some admitted to hospitals, treated by physicians, given antibiotics have lab tests and x-rays done, in short all of the usual things that happen when patients with various medical problems seek care. These are the things that happen in what is called " the health care system" which is not really even a system . Why is that a burden?
The dictionary give several definitions to "burden": something difficult to bear, a worry or a duty or responsiblity. Which does the author mean? Is managing AECB a worry for a pulmonolgist or is that just her job?.Certainly it is a responsibility. Filling out insurance forms may be characterized as a burden but treating patients with real diseases is what physicians do.Why do we not speak of changing oil as a burden on the car care industry?
Thursday, April 07, 2005
What has Justice got to do with it? Recent paper suggests little if any in clinical decisions
A recent Archive of Internal Medicine article ( " Physician's Responses to Resource Constraints , Hurst, SA et al. Arch Intern Med 2005;165:639-644) reports results of a survey inquiring about "resource constraints" in practice. In regard to what they describe as "resource allocation", reasoning about "justice" appears to play only a small role.( Only about 10% of responding physicians indicating it played a role in an allocation situation) This finding appeared to be a cause for concern to the authors as they describe this situation as a "gap" that could be bridged in fostering allocation of resources in difficult cases. I found the survey replies encouraging as typically in a resource allocation issue the answers revealed a strong concern for the patient's' welfare. Physicians in the real world,thank goodness, still seem to be more concerned with what it right for the individual patient,to whom they owe a fiduciary duty, than to some nebulous, poorly defined distributive justice, which seems to be mainly the concern of some academic bioethics departments. The constraints on resources typically is from HMO and other managed care entities' efforts to control costs. In that setting, pontificating about distributive justice, seems to be just a smokescreen.In this setting the unmodified term "justice" as typically discussed by certain bioethicists means "distributive justice" which by no means is the dominant secular view of what justice is-at least in this country.Medical Metamusings has a blog entry that I believe is worth reading and broaches the issue of "justice" as a medical ethical imperative.I would be very interested in a historical account of the origins of that concept's position in medical ethics becasue I can remember a time when it was not talked about.
ALLHAT Redux: Diuretics "best" for black and Nonblack patients but stay tuned
The data regarding blacks are analyzed in the April 6, 2005 issue of JAMA.The conclusion is that diuretics and CCBs are preferred to ACE inhibitors as initial single drug therapy.The authors in the editorial in the same issue state that -in regard to comparisons of diuretics with other classes of BP lowering drugs-"the issue has been settled". But, it is not settled. ALLHAt compared chlorthalidone, lisinopril and amlodipine but JNC VI and the current editorialists construe the finding broadly to the classes of drugs to which each of the comparison drugs belong.There are problems with that. Cholorthalidone is not widely used (HZCT is), there are several classes of CCBS, and are we really sure that all ACEs are created equal.
The ASCOT trial was recently halted and early reports indicate that the combination of an ACE inhibitor and a CCB was superior to a beta-blocker and a diuretic. When the data are published from this trial, the debate over which BP pills to use will start again, if it ever ended.
The debate should not end because there are scientific questions left to answer and ALLHAT is not the answer to everything for all time.The debate will not end because drug companies have much to gain from sales of ACE inhibitors and ARBs and likely other drugs as well in the future.
There are at least two interesting omissions from the JAMA editorial; 1) the issue of can-or should- the data be extrapolated to other members of the classes of drugs, 2) the issue of low versus high renin hypertension .
The consensus statement of a working group of the International Society on Hypertension in Blacks is -in my opinion-a more reasoned approach than is found in ALLHAT and the above editorial and is more in keeping with the overarching principle that our approaches are provisional, subject to change and are rarely annnoited with apodictic clarity.
The ASCOT trial was recently halted and early reports indicate that the combination of an ACE inhibitor and a CCB was superior to a beta-blocker and a diuretic. When the data are published from this trial, the debate over which BP pills to use will start again, if it ever ended.
The debate should not end because there are scientific questions left to answer and ALLHAT is not the answer to everything for all time.The debate will not end because drug companies have much to gain from sales of ACE inhibitors and ARBs and likely other drugs as well in the future.
There are at least two interesting omissions from the JAMA editorial; 1) the issue of can-or should- the data be extrapolated to other members of the classes of drugs, 2) the issue of low versus high renin hypertension .
The consensus statement of a working group of the International Society on Hypertension in Blacks is -in my opinion-a more reasoned approach than is found in ALLHAT and the above editorial and is more in keeping with the overarching principle that our approaches are provisional, subject to change and are rarely annnoited with apodictic clarity.
Monday, April 04, 2005
Mandatory reading for authors of medical articles,med students and anyone who thinks Government will solve their problems
The following quote is so good ( it consititutes one of the all time major insights) that it definitely should be included somewhere in the medical student's reading list. It is the opening sentence of Chapter five, in Thomas Sowell's classic "Knowledge and Decisions" (Basic Books ,Inc.1980)
" The government as a decision maker is often regarded as simply the institutional personification of "society". But the diversities,conflicts and disparate incentives and constraints which make "society "a meaningless abstraction as a decision making unit also make government a fragmentary aggregation of decision makers." This is why "throwing the rascals out" won't work.(the replacments will likely become rascals as well as they face the same incentives and constraints). This is one of those insights with great explanatory power.
This statement came to mind, when I posted the comments about Medicare paying for glaucoma screening and the USPSTF concluding there was not evidence enough to recommend for or against screening.
" The government as a decision maker is often regarded as simply the institutional personification of "society". But the diversities,conflicts and disparate incentives and constraints which make "society "a meaningless abstraction as a decision making unit also make government a fragmentary aggregation of decision makers." This is why "throwing the rascals out" won't work.(the replacments will likely become rascals as well as they face the same incentives and constraints). This is one of those insights with great explanatory power.
This statement came to mind, when I posted the comments about Medicare paying for glaucoma screening and the USPSTF concluding there was not evidence enough to recommend for or against screening.
Friday, April 01, 2005
Government and Medicine, re glaucoma screening and mixed messages
In November, 2004 The DHHS announced its preventive medicine initiative for Medicare patients.This included glaucoma screening. The USPSTF recently published its recommendations regarding glaucoma screening and - as seems usually the case for this organization-found there was insufficient evidence to recommend for or against such screening.
It seems Medicare offers screening and USPSTF says they don't know if you should or not.
Thomas Sowell has correctly described the government as a " fragmentary aggregation of decision makers" so we should not be surprised with this current example of the left-hand- right- hand consistency gap. And we should not be surprised with the USPSTF 's recommendations as it seems they rarely find the evidence adequate to conclude anything .Unfortunately, physicians in the real world of giving advice to patients often do not have that luxury.
It seems Medicare offers screening and USPSTF says they don't know if you should or not.
Thomas Sowell has correctly described the government as a " fragmentary aggregation of decision makers" so we should not be surprised with this current example of the left-hand- right- hand consistency gap. And we should not be surprised with the USPSTF 's recommendations as it seems they rarely find the evidence adequate to conclude anything .Unfortunately, physicians in the real world of giving advice to patients often do not have that luxury.
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