It was only a matter of time before someone published an article using a different meta-analytic technique from that used in the now famous rosiglitazone study by Nissen that failed to confirm Nissen's findings. George Diamond is the senior author of such an article in the Oct. 16, 2007 issue the Annals of Internal Medicine in which by using different techniques from Nissen neither an increased nor a decreased risk from the use of rosiglitazone in diabetic patients was demonstrated.( a subscription is required for full text )
No one should be surprised. The tools of the meta-analysis trade are arcane and the average or even way above average physician reading a meta-analysis either has to accept the findings at face value or ignore the thing entirely because he basically does not understand what was done and is in no position to meaningfully critique the techniques.If the issue is important and/or major economic forces have an interest there will soon be what we have here namely dueling statisticians.(I am not implying that the authors of the Annals article were motivated by those forces and would be surprised if they were)
Is the technique used by Nissen correct or is the method used by Diamond or is that even a meaningful question? It may be the case that combining disparate, incomplete sets of data, often without patient level data cannot ever answer certain questions such as the one posed by the rosiglitazone data analyses. It may well be a randomized clinical trial is the only way to possibly generate a meaningful answer which is what , at least in regard to the "rosi" question, is what Diamond et al suggested.
I have ranted on and on about meta-analyses (MAs) before and have borrowed heavily from the powerfully instructive writings of Dr. Steve Goodman. Medical students should have the following sentence grafted into their frontal lobes. The outcome of a meta-analysis is a function of the studies that one decides to include and the summary statistic used and various experts differ in regard to what statistic to use and the method of inclusion of studies.
They are basically observational studies in which the "subjects" are studies or trials and the "truth obtaining" value of observational studies is well recognized to be several notches lower that the randomized trial. Statistically combining two or three randomized trials does not always magically generate a higher degree of truth ( ie. correspondence to reality) than does the individual trials although sometimes it might. The trick is how to figure how when it does and it is a trick I have not learned.When are we dealing with apples and oranges and when are we merely seeing apples with minor and insignificant variations in color and consistency?
There is an editorial in the same issue of the Annals by Mulrow et al that says in part:
The analyses by GlaxoSmithKline,Nissen and Wolski and Diamond and colleagues and the FDA teach us that summarizing data about scarce adverse events is difficult. Summary estimates, confidence bounds and statistical significance can vary depending on analysis techniques.
This means that well meaning, honest investigators can reach completely opposite conclusions based on how they decide to analyze the data and there can be honest disagreements about how to decide on which technique to use.
But in regard to rosi I believe we cannot get the cats back in the bag. With what has been published and magnified in the news and on the web to prescribe rosi to a new type 2 diabetic would be to pin a large target on your back with a sign that says sue me please even if we really are not sure if rosi increases risk of cardiovascular events or not and we may never "really know". Sometimes issues are just dropped and we move on to something else.
Tuesday, October 16, 2007
Thursday, October 11, 2007
Even PAs are moving away from primary care?
An article that can be found here suggests that my prediction that not too far down the road primary care will be delivered mainly by "mid level" practitioners may not be on target. It seems that fewer PAs are opting for primary care mirroring a trend in med students to shun primary care. Low pay, shrinking prestige ,cost of education and low level of job satisfaction are factors said to push docs away from primary care and the same factors may have a similar effect on PAs .
Thanks to KevinMD for calling attention to the article referenced above.
Maybe "mid levels" will be replaced by something like PA assistants (PAAs) or NPAs ( nurse practitioner assistants). The third party payer spin doctors will need a better name than "lower levels" to refer to them, however.
Thanks to KevinMD for calling attention to the article referenced above.
Maybe "mid levels" will be replaced by something like PA assistants (PAAs) or NPAs ( nurse practitioner assistants). The third party payer spin doctors will need a better name than "lower levels" to refer to them, however.
Wednesday, October 10, 2007
The 2007 Chicago marathon-a hot weather wipeout
The weather is not supposed to be hot for the Chicago marathon which is held in October. This year it was hot and so hot that things seemed to get out of hand. One news report described what took place as "havoc".
The race directors at some point canceled the race in mid course due to the excessive heat which should not have been a surprise as the preceding week had been unusually hot. Many runners continued ,however, ignoring barriers and the shut down of the watering stations. One runner died but the official report is that he did not die from heat related cause but from a pre-existing cardiac condition. Some runners blamed the race directors for poor planning and at least one person connected with the race blamed the runners for pouring water over their head instead of drinking the water. He was quoted as saying he had never seen runners pour water over their heads. He should watch runners in the summer and fall in Houston.Apparently some runners left the course to get drinks at local stores. Things did not go smoothly.
Many runners were treated by the medical teams set up for the race. This brings to mind the issue of medical management of the collapsed runner, an issue of personal and professional interest to me. Professional because internists are supposed to know all about electrolytes and the like and personal because I continue to participate in marathons and if I ever collapse I hope someone knows what to do.
I have posted before on this subject quoting the work of Dr. Noakes from South Africa who is a well known authority in this area who has emphasized the importance of hyponatremia and the critical necessity to know the serum sodium level in a collapsed runner and has urged race directors to arrange for access to point-of-care serum sodium determinations. The point has been made that determining the sodium level should precede the reflex starting of normal saline as that is not the appropriate treatment for severe hyponatremia.
This sodium issue has to be raised in regard to the death of the young runner concerning whom news reports indicate he died from mitral value prolapse (MVP).
I was puzzled as to how MVP would be the mechanism of death and my doubt was reinforced by a very recent posting by a cardiologist, Dr. Wes. He knows much more cardiology than I and he expressed his doubt about the putative cause of death.You have to wonder about electrolyte problems and arrhythmias.There are well documented deaths in marathoners due to severe hyponatremia . After the 2000 Houston marathon ,during which temperature was as high as 86 degrees, which was only slightly cooler than Chicago, there was a report of four young female runners were hospitalized with severe, life threatening hyponatremia , all of whom were successfully treated.
I bet there will be many calls from patients with the diagnosis of MVP- many of whom have in fact very little wrong with their hearts- to their primary care doctors or to cardiologists.
The race directors at some point canceled the race in mid course due to the excessive heat which should not have been a surprise as the preceding week had been unusually hot. Many runners continued ,however, ignoring barriers and the shut down of the watering stations. One runner died but the official report is that he did not die from heat related cause but from a pre-existing cardiac condition. Some runners blamed the race directors for poor planning and at least one person connected with the race blamed the runners for pouring water over their head instead of drinking the water. He was quoted as saying he had never seen runners pour water over their heads. He should watch runners in the summer and fall in Houston.Apparently some runners left the course to get drinks at local stores. Things did not go smoothly.
Many runners were treated by the medical teams set up for the race. This brings to mind the issue of medical management of the collapsed runner, an issue of personal and professional interest to me. Professional because internists are supposed to know all about electrolytes and the like and personal because I continue to participate in marathons and if I ever collapse I hope someone knows what to do.
I have posted before on this subject quoting the work of Dr. Noakes from South Africa who is a well known authority in this area who has emphasized the importance of hyponatremia and the critical necessity to know the serum sodium level in a collapsed runner and has urged race directors to arrange for access to point-of-care serum sodium determinations. The point has been made that determining the sodium level should precede the reflex starting of normal saline as that is not the appropriate treatment for severe hyponatremia.
This sodium issue has to be raised in regard to the death of the young runner concerning whom news reports indicate he died from mitral value prolapse (MVP).
I was puzzled as to how MVP would be the mechanism of death and my doubt was reinforced by a very recent posting by a cardiologist, Dr. Wes. He knows much more cardiology than I and he expressed his doubt about the putative cause of death.You have to wonder about electrolyte problems and arrhythmias.There are well documented deaths in marathoners due to severe hyponatremia . After the 2000 Houston marathon ,during which temperature was as high as 86 degrees, which was only slightly cooler than Chicago, there was a report of four young female runners were hospitalized with severe, life threatening hyponatremia , all of whom were successfully treated.
I bet there will be many calls from patients with the diagnosis of MVP- many of whom have in fact very little wrong with their hearts- to their primary care doctors or to cardiologists.
Tuesday, October 09, 2007
Yet another reason why students do not choose primary care-from DrRich
Primary care providers-at least those with a M.D. degree- are seemingly moving along a path leading to extinction. In The Covert Rationing Blog, DrRich gives us an important essay describing another reason why docs will not be going into primary care and those who in doing it now will be more likely to opt out.
The latest reason is the rise ( I am not sure how widespread the practice really is) of something called care management consultants.
Go to his blog and read his comments and the reference to a Wall street Journal article on that topic.
This is still another chapter in the book entitled "Medicine is too important (read costly)to be left in the hands of the physicians and their patients".
Cynics would say that these management consultants are just another mechanism to decrease the expenditures of insurance companies while the "vision " statements of the companies proudly state they are trying to improving the quality of health care. To read details about how the big three insurers are improving quality for folks who signed up for the Medicare funded health plans go to this essay by Dr. Roy Poses.
The latest reason is the rise ( I am not sure how widespread the practice really is) of something called care management consultants.
Go to his blog and read his comments and the reference to a Wall street Journal article on that topic.
This is still another chapter in the book entitled "Medicine is too important (read costly)to be left in the hands of the physicians and their patients".
Cynics would say that these management consultants are just another mechanism to decrease the expenditures of insurance companies while the "vision " statements of the companies proudly state they are trying to improving the quality of health care. To read details about how the big three insurers are improving quality for folks who signed up for the Medicare funded health plans go to this essay by Dr. Roy Poses.
Tuesday, October 02, 2007
Are physicians no longer "proud" and "Ethical"
The Covert Rationing Blog's author DrRick uses the phrase "Once-proud,once ethical" to refer to the medical profession. I certainly do not want to believe that the modifier "once" is correct.
However, there seems to be much awash in the land to push the vectors in the direction of less pride and less ethical behavior.
When a doc has to depend on a clerk in some distant place to tell her if she can order a certain test or prescribe a certain drug or perform a certain operation, obviously pride will suffer. What does it do to the ethical framework when a doc in tempted to game the system to make it possible that that test or that drug can be ordered or that operation be perform? How much pride can you feel when you rush through a 7 1/2 minute patient encounter when you realize there are issues that the patients brought up that you can only brush off and move on to the next overly-hurried,doomed to be incomplete patient encounter?
What happens to pride when your medical group agrees to mandate 32 patient encounters per day rather than the leisurely 30 you now plow through? Does your spider-sense ethics tingle
annoyingly when you realize you are setting the stage for even more inadequate medical practice solely because of the perceived need to increase volume? Does your pride titer decrease when you agree to no longer attend patients in the hospital, even though a major part of your internal medical training and to date professional experience has been caring for seriously ill,complicated patients in the hospital and you know that you can do a better job than the recently hired internist-self proclaimed hospitalist who is one year out of training solely because it appears to be economically advantageous to do so?
Does your pride suffer when you see the latest survey of professional compensation that illustrate that your years of training as a internist or psychiatrist or pediatrician or family physician earns you about the same as a CRNA?
What is the effect on your pride when you are labeled a "disruptive" physician because you repeatedly pointed out that the four-hour rule for treatment of pneumonia is wrong headed and likely to cause more harm than good?
I personally am not proud of the-what I consider to be a sea change-in the stated principles of medical training for internists? I refer to the deletion of what was the touchstone of an internist's training- "... in no case should the resident go off duty until the proper care and welfare of the patient is ensured."
I personally am not the proud of the concepts slithered into the new medical professionalism.I have written about this before .I refer to an attempt to substitute for the time honored and pride generating fiduciary duty to the patient a collectivist view of conserving society's resources.
Having said all of that, the really big elephant in the room derives from the fact that much of medical care is paid for with other people's money and as expected those other people want to spend less money and much of their concern seems manifest -as DrRich has eloquently explicated-by covert rationing. With those economic forces at work pride and traditional medical ethics are not likely to enjoy any resurgence any time soon.
However, there seems to be much awash in the land to push the vectors in the direction of less pride and less ethical behavior.
When a doc has to depend on a clerk in some distant place to tell her if she can order a certain test or prescribe a certain drug or perform a certain operation, obviously pride will suffer. What does it do to the ethical framework when a doc in tempted to game the system to make it possible that that test or that drug can be ordered or that operation be perform? How much pride can you feel when you rush through a 7 1/2 minute patient encounter when you realize there are issues that the patients brought up that you can only brush off and move on to the next overly-hurried,doomed to be incomplete patient encounter?
What happens to pride when your medical group agrees to mandate 32 patient encounters per day rather than the leisurely 30 you now plow through? Does your spider-sense ethics tingle
annoyingly when you realize you are setting the stage for even more inadequate medical practice solely because of the perceived need to increase volume? Does your pride titer decrease when you agree to no longer attend patients in the hospital, even though a major part of your internal medical training and to date professional experience has been caring for seriously ill,complicated patients in the hospital and you know that you can do a better job than the recently hired internist-self proclaimed hospitalist who is one year out of training solely because it appears to be economically advantageous to do so?
Does your pride suffer when you see the latest survey of professional compensation that illustrate that your years of training as a internist or psychiatrist or pediatrician or family physician earns you about the same as a CRNA?
What is the effect on your pride when you are labeled a "disruptive" physician because you repeatedly pointed out that the four-hour rule for treatment of pneumonia is wrong headed and likely to cause more harm than good?
I personally am not proud of the-what I consider to be a sea change-in the stated principles of medical training for internists? I refer to the deletion of what was the touchstone of an internist's training- "... in no case should the resident go off duty until the proper care and welfare of the patient is ensured."
I personally am not the proud of the concepts slithered into the new medical professionalism.I have written about this before .I refer to an attempt to substitute for the time honored and pride generating fiduciary duty to the patient a collectivist view of conserving society's resources.
Having said all of that, the really big elephant in the room derives from the fact that much of medical care is paid for with other people's money and as expected those other people want to spend less money and much of their concern seems manifest -as DrRich has eloquently explicated-by covert rationing. With those economic forces at work pride and traditional medical ethics are not likely to enjoy any resurgence any time soon.
Wednesday, September 26, 2007
Who is at risk for venous thrombosis on long haul flights?
A large international study from Leiden attempts to answer some of the questions regarding venous thrombosis in air travelers and is available here in PLOS.This was a large (n=8755) follow-up study (over a five year period) involving employees from a number of companies.
First on all, short flights-less than 4 hours-seem to not be an issue while longer ones may be.
Some interesting observations were made.
Shorter travelers ( less than five five) and taller ones(over six one) seemed at greater risk and- perhaps surprisingly- so did younger folks (less than 30 years of age). So, it seemed best to not be too young, short or tall. Some speculations regarding vein compressions in the short and not enough room for the legs in the tall seemed plausible but why younger travelers. The investigators suggested that one of the many epidemiological traps for the unwary might be in play.This may be an example of the "attrition of the susceptibles". Individuals who are susceptible to a given event are likely to experience it soon after the start of exposure.The younger travelers likely had not been doing long haul flights for very long while the older employees had and those with clotting tendencies may have been deselected-i.e. no longer traveling or perhaps even taking prophylactic measures.
The relationship between risk and "extremes" of height had been made previously as had their other major observation that women on oral contraceptives had an increased thrombosis risk (Incidence rate ratio of 3.6). I had blogged previously about a 2006 JAMA article which presented some evidence that a major factor in the pathogenesis was blood flow alterations as opposed to coagulation system changes brought about by the flight.
The best advice still seems to be to get up and walk around as much as you can on long plane trips. What about the patient who has previously experienced a thrombotic event in temporal proximity to a long air flight and who is ready to travel again? Should they take low molecular weight heparin pre- flight? I think I would.
First on all, short flights-less than 4 hours-seem to not be an issue while longer ones may be.
Some interesting observations were made.
Shorter travelers ( less than five five) and taller ones(over six one) seemed at greater risk and- perhaps surprisingly- so did younger folks (less than 30 years of age). So, it seemed best to not be too young, short or tall. Some speculations regarding vein compressions in the short and not enough room for the legs in the tall seemed plausible but why younger travelers. The investigators suggested that one of the many epidemiological traps for the unwary might be in play.This may be an example of the "attrition of the susceptibles". Individuals who are susceptible to a given event are likely to experience it soon after the start of exposure.The younger travelers likely had not been doing long haul flights for very long while the older employees had and those with clotting tendencies may have been deselected-i.e. no longer traveling or perhaps even taking prophylactic measures.
The relationship between risk and "extremes" of height had been made previously as had their other major observation that women on oral contraceptives had an increased thrombosis risk (Incidence rate ratio of 3.6). I had blogged previously about a 2006 JAMA article which presented some evidence that a major factor in the pathogenesis was blood flow alterations as opposed to coagulation system changes brought about by the flight.
The best advice still seems to be to get up and walk around as much as you can on long plane trips. What about the patient who has previously experienced a thrombotic event in temporal proximity to a long air flight and who is ready to travel again? Should they take low molecular weight heparin pre- flight? I think I would.
Wednesday, September 19, 2007
Policy side effects:thinking beyond Stage One
DB 's MEDICAL RANTS recent comments about the need to consider the potential "side effects" of health policy decisions stimulated me to revisit Thomas Sowell's Applied Economics-Thinking beyond Stage One. Economics seems to be much about effects and side effects.
In this book Dr.Sowell examines economic policies in terms of their "later repercussions" not just their immediate effects of their apparent aim or their "hoped-for" result.For Sowell, a program's "unintended consequences" are often foreseeable if the processes involved were considered in terms of the incentives and constraints and not in terms of the desirability of the goals. Rent control brings abut housing shortages,black markets and poor quality housing not the
readily available, affordable housing promised for the poor.The caps on earning found in some Canadian provinces predictably brings about shortages and long waiting lines as described by the former Canadian, The Physician Executive. Tendency to cherry pick patients and treat the chart and emphasize quality measures while ignoring other important features of patient care were clearly foreseeable consequences to P4P.
The seasoned physician knows he may have to wait a while to learn about the problems that may occur with use of a new drug (i.e. those side effects not evident in the randomized trials that are done for drug approval). However,the shortages and other problems that are well recognized with socialized systems such as Canada and Great Britain are things that should not surprise us when they appear if similar systems were put into place in this country.
With relatively uncommon,non-acute side effects we often just have to wait and see if in the long term a new drug will cause harm while with certain policy moves using knowledge of human nature, history of how things have worked in the past and analyzing the relevant incentives and constraints we may well know what to expect.
In this book Dr.Sowell examines economic policies in terms of their "later repercussions" not just their immediate effects of their apparent aim or their "hoped-for" result.For Sowell, a program's "unintended consequences" are often foreseeable if the processes involved were considered in terms of the incentives and constraints and not in terms of the desirability of the goals. Rent control brings abut housing shortages,black markets and poor quality housing not the
readily available, affordable housing promised for the poor.The caps on earning found in some Canadian provinces predictably brings about shortages and long waiting lines as described by the former Canadian, The Physician Executive. Tendency to cherry pick patients and treat the chart and emphasize quality measures while ignoring other important features of patient care were clearly foreseeable consequences to P4P.
The seasoned physician knows he may have to wait a while to learn about the problems that may occur with use of a new drug (i.e. those side effects not evident in the randomized trials that are done for drug approval). However,the shortages and other problems that are well recognized with socialized systems such as Canada and Great Britain are things that should not surprise us when they appear if similar systems were put into place in this country.
With relatively uncommon,non-acute side effects we often just have to wait and see if in the long term a new drug will cause harm while with certain policy moves using knowledge of human nature, history of how things have worked in the past and analyzing the relevant incentives and constraints we may well know what to expect.
Sunday, September 16, 2007
Applying group data to individual patients-the problem revisited and perhaps a solution sugested
How does one apply the results of even the very best designed and executed randomized clinical trials (RCT) to the individual patient? I guess the answer is very carefully and not too literally.
I have written about this issue here in discussing the classic,everyone-must-read, article from the 2004 Milbank Quarterly by Kravitz, Duan and Braslow entitled "Evidence-based Medicine;Heterogeneity of treatment effect and the trouble with averages". It can be found here.
The basic fact is that everyone does not react the same to a given medication.The summary statistic of a clinical trial does not reveal that there is a mixture of
"substantial benefit for some, little benefit for many and harm for a few"
In other words you cannot expect the average effect to occur in your patient.
In the Sept 12, 2007 issue of JAMA, David Kent and Rodney Hayward revisit this issue and offer what they believe to be a solution to the problem. ( "Limitations of Applying summary results of clinical trials to individual patients-The need for risk
stratification",JAMA vol 298, no 10, pg 1209.
They propose that the answer is risk-stratified analysis which will greatly increase the power of the detecting the critical differences in treatment effect but ,the authors suggest is rarely used. I am not sure I have ever seen it used in a major clinical trial publication.This risk stratification is supposed to be a definite improvement over the simple sub-group analysis which typically takes one characteristics( e.g. gender or some co-mobidity) at a time,the problems of which are well known including lack of power and increased likelihood of false positive associations.
Had the authors treated us to a few good examples it would have been more convincing;the one graphical illustration of how this method improves things probably will not turn the heads of many readers.But it is good that folks who know more about statistics and analysis than I do are thinking seriously about improving the way we use group data to manage the patients who have a pernicious tendency to be individuals.
I have written about this issue here in discussing the classic,everyone-must-read, article from the 2004 Milbank Quarterly by Kravitz, Duan and Braslow entitled "Evidence-based Medicine;Heterogeneity of treatment effect and the trouble with averages". It can be found here.
The basic fact is that everyone does not react the same to a given medication.The summary statistic of a clinical trial does not reveal that there is a mixture of
"substantial benefit for some, little benefit for many and harm for a few"
In other words you cannot expect the average effect to occur in your patient.
In the Sept 12, 2007 issue of JAMA, David Kent and Rodney Hayward revisit this issue and offer what they believe to be a solution to the problem. ( "Limitations of Applying summary results of clinical trials to individual patients-The need for risk
stratification",JAMA vol 298, no 10, pg 1209.
They propose that the answer is risk-stratified analysis which will greatly increase the power of the detecting the critical differences in treatment effect but ,the authors suggest is rarely used. I am not sure I have ever seen it used in a major clinical trial publication.This risk stratification is supposed to be a definite improvement over the simple sub-group analysis which typically takes one characteristics( e.g. gender or some co-mobidity) at a time,the problems of which are well known including lack of power and increased likelihood of false positive associations.
Had the authors treated us to a few good examples it would have been more convincing;the one graphical illustration of how this method improves things probably will not turn the heads of many readers.But it is good that folks who know more about statistics and analysis than I do are thinking seriously about improving the way we use group data to manage the patients who have a pernicious tendency to be individuals.
New COPD guidelines-the guideline epidemic continues unbated
Here is a link to comments about the new GOLD COPD guidelines and here are the guidelines. Even with references it is only a merciful 26 pages.
The category of Stage 0 was eliminated which makes sense to those among us who wondered abut the logic of defining the first stage of a disease as a condition that poses the increased risk of that disease.
I was glad to see that mention was made of the problem of overestimating the degree of impairment using spirometry in elderly patients, particularly if one uses the percent predicted methods. This method designates a given FEV1 , for example, as 76 or some other number percent of predicted. This method works fairly well, although it never had sound statistical basis, it just happens to work reasonably well but older folks and shorter people tend to get short shrift and appear to be more imparted that they should be. Further there is a normal decrement in lung function which is incompletely "Corrected for" when one use the percent predicted formula.I don't have a solution for that other than be aware that the old folks' pulmonary function impairment may not be a severe as the percent predicted value would indicate.
Some of the old time lung doctor treatments are not recommended including mucolytic agents and continuous antibiotic prophylaxis.
The category of Stage 0 was eliminated which makes sense to those among us who wondered abut the logic of defining the first stage of a disease as a condition that poses the increased risk of that disease.
I was glad to see that mention was made of the problem of overestimating the degree of impairment using spirometry in elderly patients, particularly if one uses the percent predicted methods. This method designates a given FEV1 , for example, as 76 or some other number percent of predicted. This method works fairly well, although it never had sound statistical basis, it just happens to work reasonably well but older folks and shorter people tend to get short shrift and appear to be more imparted that they should be. Further there is a normal decrement in lung function which is incompletely "Corrected for" when one use the percent predicted formula.I don't have a solution for that other than be aware that the old folks' pulmonary function impairment may not be a severe as the percent predicted value would indicate.
Some of the old time lung doctor treatments are not recommended including mucolytic agents and continuous antibiotic prophylaxis.
Tuesday, September 11, 2007
P4P and Covert rationing
DrRICH's posting on P4P is a masterpiece and it is only Part One. I have ranted on and on about P4P here wherein I seconded the notion that it was unethical and as such physicians should not be negotiating about the details of the process and here wherein I discussed the disastrous results of an insurance carriers P4P program in Seattle. His posts delve into more sweeping and fundamental aspects.
He tackles the Axiom of Industry that states:
Standardization of any process improves quality and reduces cost.
The axiom may make some sense in processes involving making widgets and it that setting may be able to actually increase quality and decrease cost but for the most part medicine involves processes involving living human beings and their diseases both of which vary widely along multiple dimensions making , for example, treating someone with heart failure as different as it could be from making widgets.
P4P is only part of the current landscape of medical practice which is dominated by managed care. DrRich offers a description of and an insight into this world in which words may not mean what they seem or are usually taken to mean and one in which the goals of the physicians and the managed care companies could not be more in opposition. Simply put, if physicians do their job they may well spend the insurance company's money, while if the insurance company is doing its job it will not spend money.
Practicing physicians who take the time to read his "Manged Care in an age of covert rationing" will never look at what they do in the same way again and if medical educators do not make its reading mandatory they have little defense against the accusation of dereliction of duty.
He tackles the Axiom of Industry that states:
Standardization of any process improves quality and reduces cost.
The axiom may make some sense in processes involving making widgets and it that setting may be able to actually increase quality and decrease cost but for the most part medicine involves processes involving living human beings and their diseases both of which vary widely along multiple dimensions making , for example, treating someone with heart failure as different as it could be from making widgets.
P4P is only part of the current landscape of medical practice which is dominated by managed care. DrRich offers a description of and an insight into this world in which words may not mean what they seem or are usually taken to mean and one in which the goals of the physicians and the managed care companies could not be more in opposition. Simply put, if physicians do their job they may well spend the insurance company's money, while if the insurance company is doing its job it will not spend money.
Practicing physicians who take the time to read his "Manged Care in an age of covert rationing" will never look at what they do in the same way again and if medical educators do not make its reading mandatory they have little defense against the accusation of dereliction of duty.
MEDICARE taketh away and giveth back -sorta
Recently, various Government agencies have been very active in regulating the use of erythropoiesis stimulating agents (ESAs) . The major ESA players are recombinant human erthropoietin (Epogen,Procrit) darbepoetin (Aranesp). In several groups of patients (mainly renal patients and patients with head and neck cancers receiving radiation therapy) clinical studies indicated increased mortality and thrombotic events in patients in whom the targeted hemoglobin was greater than 12. This lead the FDA to issue safety warnings and guidelines regarding the target level of hemoglobin and then CMS to propose limitations on Medicare and Medicaid coverage for the use of ESAs. This is a follow up to an earlier posting regarding this issue bearing some limited "good news".
Unfortunately, not only were renal patients the focus of proposed Medicare coverage restrictions but also were other clinical groups who have received ESAs with clinical benefit. Of particular concern to hematologists were patients with myelodysplastic syndromes (MDS). There is a ten year history of safe use of ESAs in MDS and evidence that there is improved survival and decreased progression of MDS to leukemia as well as decreased transfusion requirements .
Several professional groups ( including the American Society of Hematology, SWOG and ASCO) protested to CMS regarding possible restrictions regarding use of ESAs in MDS patients and apparently CMS listened and made no national coverage determination (NCD in CMS jargon) limiting its use in MDS patients.This gives the green light to its use if there are no limitations imposed by regional Medicare carriers.
So, it is at least a partial victory for the physicians and their patients but battles may still have to be fought with the local Medicare contractors.
Some of us can still remember from the early days of Medicare when the powers that be needed the cooperation of both physicians and hospitals to make the thing work and they promised to not interfere with patient treatment and the physician and hospital fees were not directly determined by the government. The days of " reasonable and customary" charges are long gone and doctors now have to refer to the latest CMS decision memo to see what medications they can use.
Unfortunately, not only were renal patients the focus of proposed Medicare coverage restrictions but also were other clinical groups who have received ESAs with clinical benefit. Of particular concern to hematologists were patients with myelodysplastic syndromes (MDS). There is a ten year history of safe use of ESAs in MDS and evidence that there is improved survival and decreased progression of MDS to leukemia as well as decreased transfusion requirements .
Several professional groups ( including the American Society of Hematology, SWOG and ASCO) protested to CMS regarding possible restrictions regarding use of ESAs in MDS patients and apparently CMS listened and made no national coverage determination (NCD in CMS jargon) limiting its use in MDS patients.This gives the green light to its use if there are no limitations imposed by regional Medicare carriers.
So, it is at least a partial victory for the physicians and their patients but battles may still have to be fought with the local Medicare contractors.
Some of us can still remember from the early days of Medicare when the powers that be needed the cooperation of both physicians and hospitals to make the thing work and they promised to not interfere with patient treatment and the physician and hospital fees were not directly determined by the government. The days of " reasonable and customary" charges are long gone and doctors now have to refer to the latest CMS decision memo to see what medications they can use.
Sunday, September 09, 2007
New Asthma guidelines-some more some less
Here is the latest version of asthma guidelines. The full report is 487 pages and is entitled " Guidelines for the diagnosis and management of asthma." Asthma specialists can be appropriately proud because this report is longer than the 304 page tome penned by a joint group (ACC/AHA) dealing with the 2007 guidelines for the management of patients with unstable angina/non-ST segment elevation myocardial infarction. Both overshadow in bulk the rather brief (88 page) guideline publication from GOLD (Global Initiative for Chronic Obstructive Lung Disease) and the 2004 86 page treatise (JNC 7) which still incites seemingly irreconcilable differences between blood pressure experts regarding how to treat blood pressure and can be found here.
Not only are there more guidelines published all the time they seem to get bigger and bigger.The dominate paradigm seems to be "more is better". Recent discussions regarding asthma are suggesting that in regard to mild persistent asthma less may be about as good as more in terms of intensity of therapy even while the guideline verbiage grows and grows.
It will take sometime to contrast the details with earlier versions of the asthma guidelines but one difference I noticed was that there it is permissible ( or mandatory) to not only increase treatment when control is not adequate but it is also allowable to actually decrease treatment intensity when asthma is well controlled.
I will need a little more time to try and wrap my understanding around what I might really need to know after the fluff is filtered out (you can't have a paper that long without some fluff) but here is what the reviewer for Med Page Today had to say about it and here is an overview with some details from Medscape. Long acting beta agonist (LABAs) are not recommended as mono therapy for persistent asthma nor for treatment of acute exacerbations. Lip service is given to long acting theophylline oral medications as an alternative but I suspect the docs using them are hard to find. Fortunately, the panel was not frightened off by the meta-analysis published by the Salpeters,which I ranted about over and over, and continue to recommend the use of the combo treatment of LABA plus inhaled steroids.
The idea that we may not need to treat mild persistent asthma as aggressively (intensely) as we now recommend has been written about recently in two clinical trials in the NEJM and in the form of an editorial in the Annals of Internal Medicine. The NEJM articles can be found here and here.
One of the reason for use of so-controller ( as opposed to rescue therapy) in persistent asthma is the expectation (hope? theory?) that chronic mediation will control or minimize the inflammatory processes so that long term lung function loss will not occur. Short term trials of such therapeutic ploys such as use of rescue combo inhaler of an ICS plus a LABA ( as was done in one such trial ) cannot address the long term concerns and I suspect that ICS will continue to be the mainstay of the treatment of persistent asthma for some time to come.
Not only are there more guidelines published all the time they seem to get bigger and bigger.The dominate paradigm seems to be "more is better". Recent discussions regarding asthma are suggesting that in regard to mild persistent asthma less may be about as good as more in terms of intensity of therapy even while the guideline verbiage grows and grows.
It will take sometime to contrast the details with earlier versions of the asthma guidelines but one difference I noticed was that there it is permissible ( or mandatory) to not only increase treatment when control is not adequate but it is also allowable to actually decrease treatment intensity when asthma is well controlled.
I will need a little more time to try and wrap my understanding around what I might really need to know after the fluff is filtered out (you can't have a paper that long without some fluff) but here is what the reviewer for Med Page Today had to say about it and here is an overview with some details from Medscape. Long acting beta agonist (LABAs) are not recommended as mono therapy for persistent asthma nor for treatment of acute exacerbations. Lip service is given to long acting theophylline oral medications as an alternative but I suspect the docs using them are hard to find. Fortunately, the panel was not frightened off by the meta-analysis published by the Salpeters,which I ranted about over and over, and continue to recommend the use of the combo treatment of LABA plus inhaled steroids.
The idea that we may not need to treat mild persistent asthma as aggressively (intensely) as we now recommend has been written about recently in two clinical trials in the NEJM and in the form of an editorial in the Annals of Internal Medicine. The NEJM articles can be found here and here.
One of the reason for use of so-controller ( as opposed to rescue therapy) in persistent asthma is the expectation (hope? theory?) that chronic mediation will control or minimize the inflammatory processes so that long term lung function loss will not occur. Short term trials of such therapeutic ploys such as use of rescue combo inhaler of an ICS plus a LABA ( as was done in one such trial ) cannot address the long term concerns and I suspect that ICS will continue to be the mainstay of the treatment of persistent asthma for some time to come.
Wednesday, September 05, 2007
Efficient claims payments is the last thing Medical insurers want
Everyone who has ever been stooged by Insurance carriers regarding medical claims, patients and physicians alike, has to read this entry in the Covert Rationing Blog and , of course, everyone has been stooged. DrRich has this great comment describing how insurance companies screw docs out of their fees.
They accomplish this by employing byzantine rules, by strictly enforcing unintelligible requirements that shift like the sands, by establishing arcane appeals processes, and, when all else fails, by generating a series of black holes into which claims mysteriously disappear, so that (if the doctor still insists on being paid) the claims process must be initiated all over again. Call it the “Shoots and Ladders” model of claims processing.
If we need to squeeze just one more sentence into the medical school curriculum, it should be that one.
DrRick refers the readers to details written by Dr. Stanley Feld in the blog Repairing the HealthCare System.
Go there to learn more alarming and infuriating details.
They accomplish this by employing byzantine rules, by strictly enforcing unintelligible requirements that shift like the sands, by establishing arcane appeals processes, and, when all else fails, by generating a series of black holes into which claims mysteriously disappear, so that (if the doctor still insists on being paid) the claims process must be initiated all over again. Call it the “Shoots and Ladders” model of claims processing.
If we need to squeeze just one more sentence into the medical school curriculum, it should be that one.
DrRick refers the readers to details written by Dr. Stanley Feld in the blog Repairing the HealthCare System.
Go there to learn more alarming and infuriating details.
Friday, August 31, 2007
Consequences of Medicare's new don't pay for certain problems policy
Dr. RW discusses some of the problems associated with Medicare's latest ploy to decrease costs. You can bet there will be predictable consequences and some others we might not be smart enough to predict.
In my consultative foray into certain limited aspects of occupational medicine, I had the opportunity to see some consequences of a OSHA program which on the face on it was designed to improve workplace safety. Employer are supposed to record on a form (at the time the OSHA 200 form) certain injuries at work. Plant managers looked at the statistics and the safety officers were either given high marks or trouble depending on the numbers. If the safety officer were imaginative enough he could turn a real injury into one that did not require recording but the event still occurred. If an employee twisted his ankle on a slick walkway it would not be recorded if he could accompany the employee to the ER and convince, cajole the ER doc to treat the worker without using a prescription medication as that would trigger a recording. Basically the record was treated and more time was spent playing the game than working to improve workplace safety ( at least in some instances).
You can be certain that hospitals will be as least as devious and clever as some workplace safety officers and will devise ways to treat the record or spin the facts or something to minimize the "occurrence" of those complications the treatment of which will be no longer paid for by CMS. Hospitals will find ways to cheat and it is very unlikely that those ways will improve patient care.
In my consultative foray into certain limited aspects of occupational medicine, I had the opportunity to see some consequences of a OSHA program which on the face on it was designed to improve workplace safety. Employer are supposed to record on a form (at the time the OSHA 200 form) certain injuries at work. Plant managers looked at the statistics and the safety officers were either given high marks or trouble depending on the numbers. If the safety officer were imaginative enough he could turn a real injury into one that did not require recording but the event still occurred. If an employee twisted his ankle on a slick walkway it would not be recorded if he could accompany the employee to the ER and convince, cajole the ER doc to treat the worker without using a prescription medication as that would trigger a recording. Basically the record was treated and more time was spent playing the game than working to improve workplace safety ( at least in some instances).
You can be certain that hospitals will be as least as devious and clever as some workplace safety officers and will devise ways to treat the record or spin the facts or something to minimize the "occurrence" of those complications the treatment of which will be no longer paid for by CMS. Hospitals will find ways to cheat and it is very unlikely that those ways will improve patient care.
Monday, August 27, 2007
If we required evidence before initiating quality projects, there would be many fewer such projects
This thoughtful and -I think-spot-on commentary in the NEJM is worth reading.I always like to read things that make me say, "I wish I had said that", things that fit my current set of biases and beliefs.
The authors' main message is that in the rush to do the "right things" regarding improving medical quality and improving safety in health care, sometimes ( probably many times) the rules of evidence have been suspended. We are not demanding the same evidence we would to use adopt a new therapy. Quality measures are put into place without proof of efficacy and safety and often after they are in place no systematic evaluation of their value is done and to suggest that they should be is likely to evoke accusations of not being a team player or even worse being disruptive. It seems as if the skeptical analysis of the scientific approach has been pushed aside by blind belief in and allegiance to the paradigm of continuous improvement and other management buzz words of the month.
The authors list and refute a number of pseudo reasons used to justify programs that lack evidence of their effectiveness . Here are some of them.
Argument 1: We cannot wait.
Argument 2: Anything we do to improve something must be better than what we have now (my paraphrase)
Argument 3: Company X did it and it was great.
I can particularly relate to number 3. I had the occasion to do consultative work for 2 large corporations over the years and had the opportunity to be a bemused fly on the wall on some of the quality projects . Since it widely believed you have to quantify something to show how much you have improved, a early session with the highly paid outside consultant quality experts involved a mini course in how to draw a x-y graph. The pupils in the class I sat in on were from the company research center and were in fact senior scientists there most of whom had a PhD
in some hard science area. They were all made to do a "quality" project and then everyone had to agree how helpful it was. Later the company claimed how valuable their quality project was.
Some of the baseless medical quality efforts may not be as blatantly hypocritical as this one but the nurses and doctors who often get caught up in these programs feel the same type pressure to be a team player and not "disrupt" the effort with thoughtful criticism or healthy skepticism.
Twenty years ago when I began to do some consultative work with the corporate world,I felt rather smug that my field (medicine) was immune to the Dilbert like silliness that seemed to pervade the corporate culture. However,medicine has become more and more corporate and the business school belief that one does not need know a business to run it is increasingly applied to medical practice . The business-speak jargon now echoes through the hospitals and clinics and we talk about vision statements and leveraging this and that and the suits with MBAs are no longer minor distractions but are in control. What the Dilbert cartoons depict are as applicable to much of medicine as they are to the bureaucratic world of big business.
The authors' main message is that in the rush to do the "right things" regarding improving medical quality and improving safety in health care, sometimes ( probably many times) the rules of evidence have been suspended. We are not demanding the same evidence we would to use adopt a new therapy. Quality measures are put into place without proof of efficacy and safety and often after they are in place no systematic evaluation of their value is done and to suggest that they should be is likely to evoke accusations of not being a team player or even worse being disruptive. It seems as if the skeptical analysis of the scientific approach has been pushed aside by blind belief in and allegiance to the paradigm of continuous improvement and other management buzz words of the month.
The authors list and refute a number of pseudo reasons used to justify programs that lack evidence of their effectiveness . Here are some of them.
Argument 1: We cannot wait.
Argument 2: Anything we do to improve something must be better than what we have now (my paraphrase)
Argument 3: Company X did it and it was great.
I can particularly relate to number 3. I had the occasion to do consultative work for 2 large corporations over the years and had the opportunity to be a bemused fly on the wall on some of the quality projects . Since it widely believed you have to quantify something to show how much you have improved, a early session with the highly paid outside consultant quality experts involved a mini course in how to draw a x-y graph. The pupils in the class I sat in on were from the company research center and were in fact senior scientists there most of whom had a PhD
in some hard science area. They were all made to do a "quality" project and then everyone had to agree how helpful it was. Later the company claimed how valuable their quality project was.
Some of the baseless medical quality efforts may not be as blatantly hypocritical as this one but the nurses and doctors who often get caught up in these programs feel the same type pressure to be a team player and not "disrupt" the effort with thoughtful criticism or healthy skepticism.
Twenty years ago when I began to do some consultative work with the corporate world,I felt rather smug that my field (medicine) was immune to the Dilbert like silliness that seemed to pervade the corporate culture. However,medicine has become more and more corporate and the business school belief that one does not need know a business to run it is increasingly applied to medical practice . The business-speak jargon now echoes through the hospitals and clinics and we talk about vision statements and leveraging this and that and the suits with MBAs are no longer minor distractions but are in control. What the Dilbert cartoons depict are as applicable to much of medicine as they are to the bureaucratic world of big business.
Friday, August 24, 2007
UnitedHealth Group's "Medical Home" -Old wine new bottle?
DrRich in his latest commentary in The Covert Rationing Blog delves into the Medical Home as it is being put into motion by Unitedhealth Group. I am glad to see someone else expressing concern about this latest effort to control costs using a different rhetorical smokescreen. I had had my say about that here.
Dr. Rich says it well:
Whether you call it medical home, pay for performance, or just plain managed care, as long as the big insurers (and the feds) are the ones who determine the doctor’s viability as a practitioner, and as long as patients are the individuals who cause doctors to risk their viability as practitioners, the genuine practice of medicine - and the fabled doctor-patient relationship - must remain fond dreams.
I continue to be puzzled about the role of ACP in all of this.Is the leadership naive or is this nudge,nudge wink, wink or do they want to be the power position of making the rules that the rank and file physicians will play by? The family docs might be asking similar questions about their self appointed leaders. Is refusing to participate in all plans and Medicare the only way to maintain the doctor-patient relationship that some of us remember ?
Dr. Rich says it well:
Whether you call it medical home, pay for performance, or just plain managed care, as long as the big insurers (and the feds) are the ones who determine the doctor’s viability as a practitioner, and as long as patients are the individuals who cause doctors to risk their viability as practitioners, the genuine practice of medicine - and the fabled doctor-patient relationship - must remain fond dreams.
I continue to be puzzled about the role of ACP in all of this.Is the leadership naive or is this nudge,nudge wink, wink or do they want to be the power position of making the rules that the rank and file physicians will play by? The family docs might be asking similar questions about their self appointed leaders. Is refusing to participate in all plans and Medicare the only way to maintain the doctor-patient relationship that some of us remember ?
Friday, August 17, 2007
United Health Care Teams with internist,peds, and FP groups for medical home-for whose benefit
Health Care Renewal raises important concerns and asks pertinent questions regarding the recently announced alliance of Unitedhealth Group and ACP( and AFP,AAP and AOA) here and I will not repeat all of Dr. Poses's points but wish to add a few concerns of my own.
The press release talks about how the physician in the medical home will be responsible for the patient's total health picture. How does that work if/when the patient goes to see another physician for a medical condition outside of the internist's area of competence? This pesky problem of freedom has always vexed planners of medical care systems.Will the patients have to sign some sort of exclusivity care arrangement.?
When I first read about the concept of medical home, I thought it was just another lame attempt by ACP to try and do something to salvage the dwindling away of internists ( I remembered their slogan of internists as "doctors for adults) but although available details (while quality platitudes are plentiful) are still sketchy we can get some sense of what operationally this medical home concept might be-at least in the version involving a major health insurance company. My early assessment is that we will see more of a third party's attempt to save money on health care and exert more control over physicians using a new rhetorical cover .
Let's look at what the press release says about the role that United Health Care will play.
UHC will support it by integrating its extensive quality improvement and care management programs into the practices's infrastructure. I imagine this will include practice guidelines and algorithms and flow charts designed by UHC by some process that mere private practitioners could never generate the mental juice to conceive which will be more efficient (translate save more money) and of course, improve quality.
In regard to the payoff we learn the following:
Unitedhealth Group will pay participating practices a monthly management fee based on projected savings for all patients that select a medical home...the company will share any excess saving (excess saving is an interesting concept) that accrue from the pilot program and by way of premium reductions with employers.
This looks like a combination of capitation and reward for being a compliant doc. Does this sound like an HMO? Is this an early effort to set up the "integrated delivery systems" that I have ranted about before and have been hyped by leaders of ACP and the medical insurance industry.
Apparently some medical groups have agree to go with this. I cannot conceive of agreeing to a set of practice guidelines approved of by a major third party payer and to compensated in part by how well I complied with these guidelines, most if not all of which are not likely to be made known before the agreement and the basis and origin of which are probably proprietary . Talk about selling your soul to the devil and probably for not much of a good price. All this with the blessing and cooperation and encouragement of the ACP and the other professional groups.With friends like the ACP, practicing internists......
I suppose the same could be said for pediatricians and family docs because
the leadership of pediatric and family practices organizations seem to be fellow travelers in this journey to what sounds something that makes regular managed care a pretty good deal.
Dr. David Dale, President of the American College of Physicians offers reassuring words:
Primary care practices should exemplify ...dedication
to team care,...clinical information systems, ...coordination of care ,and (we should never forget) continuous performance assessment and improvement.
The press release talks about how the physician in the medical home will be responsible for the patient's total health picture. How does that work if/when the patient goes to see another physician for a medical condition outside of the internist's area of competence? This pesky problem of freedom has always vexed planners of medical care systems.Will the patients have to sign some sort of exclusivity care arrangement.?
When I first read about the concept of medical home, I thought it was just another lame attempt by ACP to try and do something to salvage the dwindling away of internists ( I remembered their slogan of internists as "doctors for adults) but although available details (while quality platitudes are plentiful) are still sketchy we can get some sense of what operationally this medical home concept might be-at least in the version involving a major health insurance company. My early assessment is that we will see more of a third party's attempt to save money on health care and exert more control over physicians using a new rhetorical cover .
Let's look at what the press release says about the role that United Health Care will play.
UHC will support it by integrating its extensive quality improvement and care management programs into the practices's infrastructure. I imagine this will include practice guidelines and algorithms and flow charts designed by UHC by some process that mere private practitioners could never generate the mental juice to conceive which will be more efficient (translate save more money) and of course, improve quality.
In regard to the payoff we learn the following:
Unitedhealth Group will pay participating practices a monthly management fee based on projected savings for all patients that select a medical home...the company will share any excess saving (excess saving is an interesting concept) that accrue from the pilot program and by way of premium reductions with employers.
This looks like a combination of capitation and reward for being a compliant doc. Does this sound like an HMO? Is this an early effort to set up the "integrated delivery systems" that I have ranted about before and have been hyped by leaders of ACP and the medical insurance industry.
Apparently some medical groups have agree to go with this. I cannot conceive of agreeing to a set of practice guidelines approved of by a major third party payer and to compensated in part by how well I complied with these guidelines, most if not all of which are not likely to be made known before the agreement and the basis and origin of which are probably proprietary . Talk about selling your soul to the devil and probably for not much of a good price. All this with the blessing and cooperation and encouragement of the ACP and the other professional groups.With friends like the ACP, practicing internists......
I suppose the same could be said for pediatricians and family docs because
the leadership of pediatric and family practices organizations seem to be fellow travelers in this journey to what sounds something that makes regular managed care a pretty good deal.
Dr. David Dale, President of the American College of Physicians offers reassuring words:
Primary care practices should exemplify ...dedication
Thursday, August 16, 2007
Multi "generational" agreement -it is all about time (and money)
Health Care Renewal called my attention to a Over My Med Body posting suggesting another force pushing in the direction of fewer docs going into primary care, time spent with the patient during the clinical rotations in medical school. He points out that in the teaching clinics the primary care patient are zipped through in 15 minutes-never mind they might have 5 different illnesses and 10 different meds and three new complaints-while at the specialty clinics 30 minutes is allowed.The student has more time to understand what is going on and naturally feels better about the encounter there than in the primary care clinics which may well influence his choice of career path.
Dr. Robert Centor in his blog, DB'S Medical Rants, has repeatedly emphasized the importance of having adequate time as have I. So, we have medical students, physicians in practice and even retired physicians all agreeing about the importance of time.Yet third party payers and managed care have pushed to allow less time(more throughput) per patient encounter and it is the practicing and retired physicians who have allowed this to happen.
Of course, the even bigger driver in the demise of primary care physician and the underlying reason for the time crunch is the paying-with-someone else's-money- reimbursement issue which is discussed brilliantly by Dr. Roy Poses here.
Dr. Robert Centor in his blog, DB'S Medical Rants, has repeatedly emphasized the importance of having adequate time as have I. So, we have medical students, physicians in practice and even retired physicians all agreeing about the importance of time.Yet third party payers and managed care have pushed to allow less time(more throughput) per patient encounter and it is the practicing and retired physicians who have allowed this to happen.
Of course, the even bigger driver in the demise of primary care physician and the underlying reason for the time crunch is the paying-with-someone else's-money- reimbursement issue which is discussed brilliantly by Dr. Roy Poses here.
Friday, August 10, 2007
The FDA's deliberations on Avandia-worthwhile insights
Dr. Clifford Rosen speaks candidly in the NEJM about the multi-faceted situation regarding the issue of cardiovascular risk of Avandia and how hard it is to pluck out the "truth" from often conflicting and incomplete data.
His full text comments are available here from the NEJM.
One of the important points he makes is that is more than just very hard to discern small increases in risk between groups when the disease or event of interest is fairly common such as myocardial infarction. I have written before about how statistics works well to find big difference but struggles to differentiate between small things and nothing at all.
Dr.Rosen provides a good overview of the various data sets that were analyzed in the FDA panel's effort to reach a decision about what to do with Avandia. I believe at the end of the day public sentiment and physician assessments of the risk has for the most part lead to the end of the road for Avandia.
He also speaks of several guiding principles to apply in regard to drug approval.
Two of which are :
the pathogenesis must be "fully understood"
treatment options should be clarified through an evidence based system.
Worthy aspirations to be sure, but I doubt we can wait for the pathogenesis to be "fully understood" to make judgments. What diseases can you think of in which we fully understand their pathogenesis, certainly not hypertension, heart failure,diabetes, depression for which many drugs have received FDA approval.
The Avandia saga and the panel's deliberations illustrate how difficult it can be and usually is to discern the truth from conflicting and incomplete data. At the end of the day someone has to decide something. It is commonly said of trials and court decisions that they do not produce justice so much as they settle the issue and the participants can move on. FDA's decisions are sort of like that.
His full text comments are available here from the NEJM.
One of the important points he makes is that is more than just very hard to discern small increases in risk between groups when the disease or event of interest is fairly common such as myocardial infarction. I have written before about how statistics works well to find big difference but struggles to differentiate between small things and nothing at all.
Dr.Rosen provides a good overview of the various data sets that were analyzed in the FDA panel's effort to reach a decision about what to do with Avandia. I believe at the end of the day public sentiment and physician assessments of the risk has for the most part lead to the end of the road for Avandia.
He also speaks of several guiding principles to apply in regard to drug approval.
Two of which are :
the pathogenesis must be "fully understood"
treatment options should be clarified through an evidence based system.
Worthy aspirations to be sure, but I doubt we can wait for the pathogenesis to be "fully understood" to make judgments. What diseases can you think of in which we fully understand their pathogenesis, certainly not hypertension, heart failure,diabetes, depression for which many drugs have received FDA approval.
The Avandia saga and the panel's deliberations illustrate how difficult it can be and usually is to discern the truth from conflicting and incomplete data. At the end of the day someone has to decide something. It is commonly said of trials and court decisions that they do not produce justice so much as they settle the issue and the participants can move on. FDA's decisions are sort of like that.
Quality can be hazardous to your health
"No man's life,liberty or property are safe when the legislature is in session".
This thought has been attributed to various sources but according to this website, it originated in a court decision in the 19 th century. Having read about the harmful and probably unintended consequences of some quality rules ( the word guideline has become a euphemism) I believe you could as well say : " When the quality rule makers are at work, no patient's well being is safe".
The four hour pneumonia antibiotic treatment rule has lead to patients without pneumonia getting antibiotics within four hours of arrival in the E.R. A recent posting by Dr. RW pointed out the weak evidence supporting rigid blood sugar control in sick hospitalized patients is poorly suited to mandate such an approach to all sick hospitalized patients yet guidelines mandating just that seem to be being prepared if not already proposed.Peri-operative use of beta blockers became a guideline but now there is more than a little doubt about the utility universal application.
The evidentiary best of the quality rules are supported to varying degrees by randomized clinical trials but even here one should proceed slowly as the reality of the well known efficacy-effectiveness gap tolerates simplistic approaches poorly. RCTs are often small and fail to capture the rich and perplexing diversity of relevant pathophysiological variables (known and unknown) that coexist in complex, hospitalized patients. It is in the sickest patients that rules formulated by committees based on what-ever that the most harm can be done and in whom the pathophysiological diversity is likely to overwhelm premature generalizations and an overly eager rush to mandate treatment rules.
The hubris,arrogance and naivete that I believe characterize those who make rules for how to treat individuals based solely on group data ignoring the input of the physicians on the scene is even worse that the folks who simplistically sprout out coarse grain outcome data quality indicators such as percentages of patients with HbA1c less than 7 %. In the later they are just counting beans in the former they are making rules about treatment decisions that might be determinative of the outcome. It all seems to be part of the notion that medicine is too important to be left to the individual physicians and patients.
The mandatory and quasi mandatory nature of guidelines or quality indicators as wielded by the CMS mandarins become even more dangerous with the spreading use of the "disruptive physician" doctrine. Not only must you go by the rules you can't complain about them without incurring the wrath of the hospital's disruptive physician committee.
In a recent post Dr. Robert Centor , of DM's Medical Rants quotes from a thoughtful article that correctly states that black and white answers are rare in clinical research and those that may seem clear cut today may not be as more data are accumulated. Committee derived quality indicators mandate that the grey be magically transformed into black and white and CMS and other third party payers give powerful financial valence to the process .
This thought has been attributed to various sources but according to this website, it originated in a court decision in the 19 th century. Having read about the harmful and probably unintended consequences of some quality rules ( the word guideline has become a euphemism) I believe you could as well say : " When the quality rule makers are at work, no patient's well being is safe".
The four hour pneumonia antibiotic treatment rule has lead to patients without pneumonia getting antibiotics within four hours of arrival in the E.R. A recent posting by Dr. RW pointed out the weak evidence supporting rigid blood sugar control in sick hospitalized patients is poorly suited to mandate such an approach to all sick hospitalized patients yet guidelines mandating just that seem to be being prepared if not already proposed.Peri-operative use of beta blockers became a guideline but now there is more than a little doubt about the utility universal application.
The evidentiary best of the quality rules are supported to varying degrees by randomized clinical trials but even here one should proceed slowly as the reality of the well known efficacy-effectiveness gap tolerates simplistic approaches poorly. RCTs are often small and fail to capture the rich and perplexing diversity of relevant pathophysiological variables (known and unknown) that coexist in complex, hospitalized patients. It is in the sickest patients that rules formulated by committees based on what-ever that the most harm can be done and in whom the pathophysiological diversity is likely to overwhelm premature generalizations and an overly eager rush to mandate treatment rules.
The hubris,arrogance and naivete that I believe characterize those who make rules for how to treat individuals based solely on group data ignoring the input of the physicians on the scene is even worse that the folks who simplistically sprout out coarse grain outcome data quality indicators such as percentages of patients with HbA1c less than 7 %. In the later they are just counting beans in the former they are making rules about treatment decisions that might be determinative of the outcome. It all seems to be part of the notion that medicine is too important to be left to the individual physicians and patients.
The mandatory and quasi mandatory nature of guidelines or quality indicators as wielded by the CMS mandarins become even more dangerous with the spreading use of the "disruptive physician" doctrine. Not only must you go by the rules you can't complain about them without incurring the wrath of the hospital's disruptive physician committee.
In a recent post Dr. Robert Centor , of DM's Medical Rants quotes from a thoughtful article that correctly states that black and white answers are rare in clinical research and those that may seem clear cut today may not be as more data are accumulated. Committee derived quality indicators mandate that the grey be magically transformed into black and white and CMS and other third party payers give powerful financial valence to the process .
Subscribe to:
Posts (Atom)