For marketing an off label use of Zyprexa, Lilly has agreed to to pay 1,42 billion .
The medication has FDA approval for treatment of schizophrenia and bipolar disease but it is alleged that Lilly vigorously promoted its use to control agitation in the demented elderly as well as in children with certain behavior disorders.A number of physicians, academic and otherwise, took part in various of these promotional activities.One promotional campaign was cutely named "Viva Zyprexa".
In 2007,sales for Zyprexa reached 4.8 billion with total Lilly drug sales of 18.6 billion.
As interns, we carried around black bags that were given to us on graduation from medical school.Lilly gave out those bags and they came with our names on the bag and I think a reflex hammer and tuning fork inside.Big pharma was known as the "ethical drug industry" back then.How the adjective became part of their designation I don't know. It seemed similar to the House Ways and Means Committee always being referred to as the Powerful Ways and Means.The later adjective still applies, not so much for the former one.
I have written about the Zyprexa saga before and in that blog quoted Dr. Patricia Illingworth:
"some commonly accepted principles of business ethics are fundamentally incompatible with medical ethics"
I believe that is true but what ethics precept could Lilly have possibly adhered to in regard to the Zyprexa promotional activities.
Thursday, January 15, 2009
Organized Medicine jumps into the "lets Jump start" the economy bandwagon
Dr. Nancy H. Nielsen, president of the AMA, said at a recent press conference
" Health care reform is a key component to jump starting our national economy.....quality,affordable health care is..good for business."
For some reason, I am reminded of the old quote that "what's good for general Motors is good for the country" That quote , of course, has taken on new meaning in the bailout or bridge loan requested by GM. Now we have what's good for health care is good for the economy.
With the degree of direness indicted by the media regarding the financial mess some have suggested that health care issue might have to be put on the back burner for a while.The recent ad campaign by AMA and others ( PhRMa, Blue Cross- to name two) might appear to be an effort to put it back up front, to exactly what ends is not made clear. What is that big pharma and the AMA suggest that will reform health care and somehow also jump-start things? Stay tuned, the ads to come may clarify their goals.
If vague generalities can help jump-start the economy we are off to a good start.Everyone is lining up in Washington for their share of the "recovery" package. We should not be surprised that the AMA does not want to be left out .
" Health care reform is a key component to jump starting our national economy.....quality,affordable health care is..good for business."
For some reason, I am reminded of the old quote that "what's good for general Motors is good for the country" That quote , of course, has taken on new meaning in the bailout or bridge loan requested by GM. Now we have what's good for health care is good for the economy.
With the degree of direness indicted by the media regarding the financial mess some have suggested that health care issue might have to be put on the back burner for a while.The recent ad campaign by AMA and others ( PhRMa, Blue Cross- to name two) might appear to be an effort to put it back up front, to exactly what ends is not made clear. What is that big pharma and the AMA suggest that will reform health care and somehow also jump-start things? Stay tuned, the ads to come may clarify their goals.
If vague generalities can help jump-start the economy we are off to a good start.Everyone is lining up in Washington for their share of the "recovery" package. We should not be surprised that the AMA does not want to be left out .
Wednesday, January 14, 2009
Randomized Trial comparing lung scan and CT angio
In the tradition of many,worthwhile and very well done clinical trials from Canada investigating various aspects of thromboembolic disease, we now have a head to head comparison between the venerable ventilation/perfusion (v/q) lung scan and the upstart CT pulmonary angio (CTPA). See here for an abstract from JAMA.
Out patients with a Wells Score of 4.5 or higher were randomized to either undergoing the CT angio or a v/q lung scan. There were 700 plus in each group and there was a three month followup.
After reading the article a few thoughts come to mind:
One can with good confidence rule out PE if both the CTPA and lower extremity ultra sound are normal.
It still seems to be true than a normal v/q rules out PE .In this study, 35% of of the patients had a normal study. The majority of v/q scans are non-diagnostic (54 % in this study) and in those patients there is a strong tendency for clinicians to order a CTPA.
More instances of PE are diagnosed by CTPA than v/q but the significant of peripheral defects remains a work in progress,particularly those in sub-segmental arteries. In this study 7% of the positive CTPAs involved the sub-segmental arteries alone.
The earlier concerns about published data indicating low sensitivity of the CTPA seems to have been only the case for the older technique as the new and now in general use multidetector CT has excellent (some might argue too much so) sensitivity.
Both tests have value but the clinical momentum (i.e. beliefs and tendencies of clinical docs) is to favor the CTPA, in part, because so many v/q s are non-diagnostic clinicians reason that it is better to go to the CTPA first. Also as pointed out by Dr. RW the v/q interpretive skills of the radiologists may be on the decline and their skills with angiographic interpretation are on the ascendancy. Even back in the day of flurry of interest in and lucrative nature of nuclear medicine the house officers called it "unclear medicine".
Out patients with a Wells Score of 4.5 or higher were randomized to either undergoing the CT angio or a v/q lung scan. There were 700 plus in each group and there was a three month followup.
After reading the article a few thoughts come to mind:
One can with good confidence rule out PE if both the CTPA and lower extremity ultra sound are normal.
It still seems to be true than a normal v/q rules out PE .In this study, 35% of of the patients had a normal study. The majority of v/q scans are non-diagnostic (54 % in this study) and in those patients there is a strong tendency for clinicians to order a CTPA.
More instances of PE are diagnosed by CTPA than v/q but the significant of peripheral defects remains a work in progress,particularly those in sub-segmental arteries. In this study 7% of the positive CTPAs involved the sub-segmental arteries alone.
The earlier concerns about published data indicating low sensitivity of the CTPA seems to have been only the case for the older technique as the new and now in general use multidetector CT has excellent (some might argue too much so) sensitivity.
Both tests have value but the clinical momentum (i.e. beliefs and tendencies of clinical docs) is to favor the CTPA, in part, because so many v/q s are non-diagnostic clinicians reason that it is better to go to the CTPA first. Also as pointed out by Dr. RW the v/q interpretive skills of the radiologists may be on the decline and their skills with angiographic interpretation are on the ascendancy. Even back in the day of flurry of interest in and lucrative nature of nuclear medicine the house officers called it "unclear medicine".
Tuesday, January 13, 2009
Rebroadcast of" Not your father's medical ethics any more"
With the beginning of a new year and the promised changes offered by a new administration in Washington and new players on the scene whose seem to be tasked to "reform"medical care, I brazenly am re-posting an offering discussing the changes that have occurred/are occurring in medical ethics. I have added some and deleted some from the original in an effort to make the thoughts more clear.
__________________
Can the traditional, medical-ethical prime directive of placing the individual patient's interest first survive in a financial environment in which physician autonomy is greatly diminished and income for most physicians is controlled by third party payers?
More broadly put, Dr. Edmund D. Pellegrino asked in 1995 (JAMA,May 24/31,1995,Vol 273,no 20,)
" Is medical ethics a social, historical, or economic artifact? Or are there some universal , enduring principles?"
In 1988, Hall and Berenson writing in the Annals of Internal Medicine said that "the traditional [ethical ] ideal" was no longer compatible with the changed practice reality that "existing insurance contracts and manged care arrangements define for physicians."
We propose that devotion to the best interests of each individual be replaced with an ethic of devotion to the best interests of the group for which the physician is personally responsible."
Incredibly, the authors claimed that this shift in ethical focus would actually increase patient trust, an attribute that even in the late 80's was in decline as patients tried to live (sometimes literally) with the HMO's restrictions to medical care. Incredibly, they claimed that by not having the patient's interest as the prime directive there would be increased trust in their physician.
The expected wave of letters to the Annals editors expressed the belief that advocacy for the individual patient was the prime directive and what it was all about and to replace it was to effectively do away with medical ethics as it had been known and practiced for a very long time. This is what would be expected from an audience of internists who had grown up medically inculcated with an ethic which was the polar opposite of what the authors proposed. Practicing internists at that time were reared to believe that the physician was completely and ultimately responsible for their patients and that their primary duty was to the patient.
The average practicing internist if they read the article at all may have thought this was the contrived advocacy of someone who was attempting to make manged care appear ethical. All that was required was to turn medical ethics on its head.When I read that article I thought "you've gotta to be kidding me".
A few years later ,I saw no one was kidding as the ACP, ABIM and the European Federation of Internal Medicine joined forces to formulate what was called the New Professionalism in which physicians were admonished to do more than maximize the health of all the patients in their HMO, which was as far as the Annals authors went. Now, physicians were told that they had an ethical obligation to strive for Social Justice. This joint effort by several medical organizations was said to be necessary as the "old ethic" needed to be revised to align itself with the new economic environment in which physicians now lived and "medicine's commitment to the patient was being challenged by external forces of change within our society".
While the 1988 article's authors stopped short of suggesting physicians should conserve resources for others in society at large and not just concern themselves with their own HMO's population, the new ethics or professionalism as it was now called, headlined social justice raising it to the level of the big three ethical precepts-patient welfare, patient autonomy and social justice.More than one observer has asked does precept three conflict with precept one?
The era from 1963 to about 1990 has been termed the time of "retail medical care". Physicians and patients enjoyed the situation in which a patient's insurance followed the patient so that he could choose any physician and the physicians' fees were not set by the insurer but largely were set by what the physician considered and the payer agreed to be "reasonable,customary,and prevailing".
Things were good for physicians in those days as not only was physician autonomy largely unchallenged,but also Medicare had brought about a large influx of money to be spent largely at the discretion of the doctor and their patients and exciting new diagnostic and therapeutic tools were available. More could be done for your patients and more patients could afford medical care. Referrals could be based on the physician's knowledge of the area consultants and prescriptions were written without concern for some third party's list of permissible choices. But soon things were to change as the era of "wholesale medicine" replaced the old ways with the HMO now being a middleman-a very powerful middleman- and Medicare imposed wage and price controls on medical services.
A series of articles was published in 1995 in JAMA authored by Dr. David Eddy that discussed the metrics and merits of decision analysis which he hailed to be a mechanism that could perform magic. The magic was to increase quality of medical care while reducing cost. But it was all merely playing with words and defining words to suit the argument. Eddy defined quality as the greatest medical good for the greatest number within the eco-medical collective (aka HMO). It did not go unnoticed to the skeptical reader that Dr. Eddy listed his affiliation as "Kaiser Permanente of Southern California")
Pellegrino in 1995 also asked ...can physicians change the ethics of the profession at will ( as proposed by Berenson and Hall) or is there a more fundamental and universal foundation for the ethics of medicine in the special nature of the physician-patient relationship?
Pellegrino's quotes are found in an article entitled "Guarding the Integrity of Medical Ethics-Some Lessons from Soviet Russia" . The subversion of medical ethics in Russia suggested to Pellegrino two lessons. 1) corruption will afflict any health system not designed with care of the patient as the its primary driving force. 2) medical ethics must be independent of political exigency. "... a morally responsive profession is an indispensable safeguard for the sick against the statistical morality of utilitarian politics, even in democracies."
The statistical morality of utilitarian analysis seems to be increasingly unopposed as the group outcome derived data plays an increasingly large role in the decisions regarding the individual patient exhibited in part as guidelines executed by mid level practitioners as well as physicians. In this new day, the physician has more to worry about that just her patient, she must be concerned for everyone (as allegiance to social justice would demand) but at least she has been removed from the impossible role of being responsible for every aspect of his patient's well being as she is now (merely) a member of a team or perhaps the host of a medical home and part of a system of health care. It takes a village now to treat a patient.
______________
With increasing pressure for a single payer health care system and talk about a federal health board to determine what should/shall be done, the statistical morality of utilitarianism seems more and more on the ascendancy. As much as I do not want to believe it, more and more I am afraid that the old medical ethics may well have been and is now the "artifact of economics" about which Pelligrino speculated.
__________________
Can the traditional, medical-ethical prime directive of placing the individual patient's interest first survive in a financial environment in which physician autonomy is greatly diminished and income for most physicians is controlled by third party payers?
More broadly put, Dr. Edmund D. Pellegrino asked in 1995 (JAMA,May 24/31,1995,Vol 273,no 20,)
" Is medical ethics a social, historical, or economic artifact? Or are there some universal , enduring principles?"
In 1988, Hall and Berenson writing in the Annals of Internal Medicine said that "the traditional [ethical ] ideal" was no longer compatible with the changed practice reality that "existing insurance contracts and manged care arrangements define for physicians."
We propose that devotion to the best interests of each individual be replaced with an ethic of devotion to the best interests of the group for which the physician is personally responsible."
Incredibly, the authors claimed that this shift in ethical focus would actually increase patient trust, an attribute that even in the late 80's was in decline as patients tried to live (sometimes literally) with the HMO's restrictions to medical care. Incredibly, they claimed that by not having the patient's interest as the prime directive there would be increased trust in their physician.
The expected wave of letters to the Annals editors expressed the belief that advocacy for the individual patient was the prime directive and what it was all about and to replace it was to effectively do away with medical ethics as it had been known and practiced for a very long time. This is what would be expected from an audience of internists who had grown up medically inculcated with an ethic which was the polar opposite of what the authors proposed. Practicing internists at that time were reared to believe that the physician was completely and ultimately responsible for their patients and that their primary duty was to the patient.
The average practicing internist if they read the article at all may have thought this was the contrived advocacy of someone who was attempting to make manged care appear ethical. All that was required was to turn medical ethics on its head.When I read that article I thought "you've gotta to be kidding me".
A few years later ,I saw no one was kidding as the ACP, ABIM and the European Federation of Internal Medicine joined forces to formulate what was called the New Professionalism in which physicians were admonished to do more than maximize the health of all the patients in their HMO, which was as far as the Annals authors went. Now, physicians were told that they had an ethical obligation to strive for Social Justice. This joint effort by several medical organizations was said to be necessary as the "old ethic" needed to be revised to align itself with the new economic environment in which physicians now lived and "medicine's commitment to the patient was being challenged by external forces of change within our society".
While the 1988 article's authors stopped short of suggesting physicians should conserve resources for others in society at large and not just concern themselves with their own HMO's population, the new ethics or professionalism as it was now called, headlined social justice raising it to the level of the big three ethical precepts-patient welfare, patient autonomy and social justice.More than one observer has asked does precept three conflict with precept one?
The era from 1963 to about 1990 has been termed the time of "retail medical care". Physicians and patients enjoyed the situation in which a patient's insurance followed the patient so that he could choose any physician and the physicians' fees were not set by the insurer but largely were set by what the physician considered and the payer agreed to be "reasonable,customary,and prevailing".
Things were good for physicians in those days as not only was physician autonomy largely unchallenged,but also Medicare had brought about a large influx of money to be spent largely at the discretion of the doctor and their patients and exciting new diagnostic and therapeutic tools were available. More could be done for your patients and more patients could afford medical care. Referrals could be based on the physician's knowledge of the area consultants and prescriptions were written without concern for some third party's list of permissible choices. But soon things were to change as the era of "wholesale medicine" replaced the old ways with the HMO now being a middleman-a very powerful middleman- and Medicare imposed wage and price controls on medical services.
A series of articles was published in 1995 in JAMA authored by Dr. David Eddy that discussed the metrics and merits of decision analysis which he hailed to be a mechanism that could perform magic. The magic was to increase quality of medical care while reducing cost. But it was all merely playing with words and defining words to suit the argument. Eddy defined quality as the greatest medical good for the greatest number within the eco-medical collective (aka HMO). It did not go unnoticed to the skeptical reader that Dr. Eddy listed his affiliation as "Kaiser Permanente of Southern California")
Pellegrino in 1995 also asked ...can physicians change the ethics of the profession at will ( as proposed by Berenson and Hall) or is there a more fundamental and universal foundation for the ethics of medicine in the special nature of the physician-patient relationship?
Pellegrino's quotes are found in an article entitled "Guarding the Integrity of Medical Ethics-Some Lessons from Soviet Russia" . The subversion of medical ethics in Russia suggested to Pellegrino two lessons. 1) corruption will afflict any health system not designed with care of the patient as the its primary driving force. 2) medical ethics must be independent of political exigency. "... a morally responsive profession is an indispensable safeguard for the sick against the statistical morality of utilitarian politics, even in democracies."
The statistical morality of utilitarian analysis seems to be increasingly unopposed as the group outcome derived data plays an increasingly large role in the decisions regarding the individual patient exhibited in part as guidelines executed by mid level practitioners as well as physicians. In this new day, the physician has more to worry about that just her patient, she must be concerned for everyone (as allegiance to social justice would demand) but at least she has been removed from the impossible role of being responsible for every aspect of his patient's well being as she is now (merely) a member of a team or perhaps the host of a medical home and part of a system of health care. It takes a village now to treat a patient.
______________
With increasing pressure for a single payer health care system and talk about a federal health board to determine what should/shall be done, the statistical morality of utilitarianism seems more and more on the ascendancy. As much as I do not want to believe it, more and more I am afraid that the old medical ethics may well have been and is now the "artifact of economics" about which Pelligrino speculated.
Monday, January 12, 2009
If you discuss health care reform you cannot ignore RUS
If you profess to analyze health care financing-with or without offering a fix to whatever problem(s) you believe to be present-you cannot leave out consideration of the role of the mysterious and powerful RUS. (The RUS is the RBRVC Update Committee .Here is a link to the AMA description of that entity.)
Yet,this seem to be exactly what one of the most widely quoted health care economists has done. Dr. Roy Poses discusses this interesting omission in another of one of his home run blog entries.
The economist is Professor Uwe Reinhardt of Princeton and the discussion at issue can be found here. Reinhardt places at least some of the blame for the high cost of medical care on the fee for service system.Interestingly, he does not mention that the current fee-for -service system has- since 1990- become one that is characterized by wage and price controls -at least as for as payments for Medicare is concerned.
Dr Poses says that there are strong positive incentive for procedures and strong negative incentives for cognitive services ( this includes much of what primary care consists of) and there are many interested "stakeholders" favoring the growth of procedures. These incentives in large measure can be traced back to the mysterious and only recently talked about RUC. that advises Medicare what to pay for various medical services. They provide a major input to Medicare in that regard.
If we regress further back in the causative chain, we note that the RUS is a child ( born in 1991) of the changes that took about 1990 in Medicare payments from what was called customary, reasonable and prevailing payments for medical services to a Medicare determined price control system. With such a price control system there was a need for a mechanism to set the prices and somehow the AMA was able to insert a committee into the system that would enjoy a powerful position that is virtually invisible to scrutiny.
Poses raises the question as to why Reinhardt would apparently omit the effect of the RUS on medical costs and I would additionally ask why he ignores the effect of wage and price controls on medical care. He then presents some interesting associations of Professor Reinhardt including the fact that he is on the board of an insurance company and a medical device company.
So, are we just playing around with an ad hominem fallacy.The fact that Reinhardt is on the board of and holds stocks in these companies does not necessarily mean that his analysis would be biased in favor of a conclusion beneficial to those entities even though he owes them fiduciary duty.One should evaluate his analysis without considering how those relationships might bias his conclusions. Fair enough. I challenge his conclusion based on his not explicitly taking into account wage and price controls and the power of the RUC and that the use of the term " fee for service" is misleading as the fees are basically set by the federal government for Medicare and for practical purposes (other than retainer medicine practices) adopted by the other third party payers.
What is not an ad hominem argument but a question regarding transparency is Poses's exposition of how those relationship do not appear in his Reinhardt's Princeton website CV nor in his disclosures in a Princeton Bioethics Forum ( give me a break- in an ethics forum he does not disclose possible conflicts of interests) nor when he discussed health care finance on NPR. Interestingly, Reinhardt is also on the editorial board of JAMA. (My web search efforts to locate the listing of possible conflicts of interests for those folks was unsuccessful.If anyone has that link,please let me know.)
To discuss the problems with medical care and medical care financing without substantively considering the role of price controls and the pivotal role of the RUC is not limited to Reinhardt's commentary. A NEJM round table discussion that purported to talk about redesigning primary care did the same thing. If you want to know what is happening with medical care, Roy Poses's discussion of that NEJM article is required reading.
Yet,this seem to be exactly what one of the most widely quoted health care economists has done. Dr. Roy Poses discusses this interesting omission in another of one of his home run blog entries.
The economist is Professor Uwe Reinhardt of Princeton and the discussion at issue can be found here. Reinhardt places at least some of the blame for the high cost of medical care on the fee for service system.Interestingly, he does not mention that the current fee-for -service system has- since 1990- become one that is characterized by wage and price controls -at least as for as payments for Medicare is concerned.
Dr Poses says that there are strong positive incentive for procedures and strong negative incentives for cognitive services ( this includes much of what primary care consists of) and there are many interested "stakeholders" favoring the growth of procedures. These incentives in large measure can be traced back to the mysterious and only recently talked about RUC. that advises Medicare what to pay for various medical services. They provide a major input to Medicare in that regard.
If we regress further back in the causative chain, we note that the RUS is a child ( born in 1991) of the changes that took about 1990 in Medicare payments from what was called customary, reasonable and prevailing payments for medical services to a Medicare determined price control system. With such a price control system there was a need for a mechanism to set the prices and somehow the AMA was able to insert a committee into the system that would enjoy a powerful position that is virtually invisible to scrutiny.
Poses raises the question as to why Reinhardt would apparently omit the effect of the RUS on medical costs and I would additionally ask why he ignores the effect of wage and price controls on medical care. He then presents some interesting associations of Professor Reinhardt including the fact that he is on the board of an insurance company and a medical device company.
So, are we just playing around with an ad hominem fallacy.The fact that Reinhardt is on the board of and holds stocks in these companies does not necessarily mean that his analysis would be biased in favor of a conclusion beneficial to those entities even though he owes them fiduciary duty.One should evaluate his analysis without considering how those relationships might bias his conclusions. Fair enough. I challenge his conclusion based on his not explicitly taking into account wage and price controls and the power of the RUC and that the use of the term " fee for service" is misleading as the fees are basically set by the federal government for Medicare and for practical purposes (other than retainer medicine practices) adopted by the other third party payers.
What is not an ad hominem argument but a question regarding transparency is Poses's exposition of how those relationship do not appear in his Reinhardt's Princeton website CV nor in his disclosures in a Princeton Bioethics Forum ( give me a break- in an ethics forum he does not disclose possible conflicts of interests) nor when he discussed health care finance on NPR. Interestingly, Reinhardt is also on the editorial board of JAMA. (My web search efforts to locate the listing of possible conflicts of interests for those folks was unsuccessful.If anyone has that link,please let me know.)
To discuss the problems with medical care and medical care financing without substantively considering the role of price controls and the pivotal role of the RUC is not limited to Reinhardt's commentary. A NEJM round table discussion that purported to talk about redesigning primary care did the same thing. If you want to know what is happening with medical care, Roy Poses's discussion of that NEJM article is required reading.
Friday, January 09, 2009
Hospitalists,nocturnalists,admitologists,anyone rember personal physicians
A recent perceptive,poignant, essay has attracted the attention of two of my favorite medical bloggers. Dr. RW and DB have both blogged about this entry by Dr. Cherie Glazner.
At least the patient described in the narrative saw a physician. While jogging last week I was listening to a local call-the-doc talk show. The first caller's narrative was that he was recently seen by a cardiologist (actually he was not seen by a cardiologist but by his PA). He was told that his aortic aneurysm has grown from 3.5 to 4.5cm in diameter over the last year and if it grew to 5.0 cm he would need to have surgery. The caller did not indicate displeasure at not being able to discuss this with his doctor but was calling for more information about what would need to be done if the growth continued.
The second caller was also asking for information. He had a heart scan as part of a "wellness" evaluation and had a score of 600. He "saw" a cardiologist at a local heart center (actually had appointments at the doctor's office, he never saw him).An isotope stress test was done and he was told by the nurse that he had "no significant blockages" and he
should return in a year or so for followup.
Yesterday, I saw my dentist and following the hygienist poking about and cleaning, he poked about a bit and we briefly discussed a bridge issue. He then talked at some length about how he really didn't like the situation with his allergist with whom he had appointments but never was seen by anyone other than his NP. He pointed out that he always "sees" his patients.
My urologist is a dinosaur.I saw him last month.Yes,I actually saw him and talked to him and he actually examined me. When in practice i frequently referred him patients. Back then he would schedule both the patient and his wife for the last visit of the day so there would be time to describe exactly what the treatment options and complications for prostate cancer would be. He said he still does that. His economic situation was such that he and his 3 partners merged with 3 other practices and partnered in some way I did not understand with a therapeutic radiologist in the hope that their practice would still be viable.
My brother-in-law has coronary angiography following an episode of chest pain and an EKG that "showed some problem." After the cath, he was seen by someone in a white coat that he had not seen before . The white coated,scrub suited man explained the procedure very briefly ( there were " no significant blockages"),gave him several prescriptions and told him to call the office for a followup visit in 6 weeks. My sister said that somehow he didn't seem like a doctor.I told her he wasn't, he was a PA ( I looked him up on the state board's web site).He was later seen by the PA for the office visit.
I was having lunch yesterday with another retired doc.We talked about things like the above and he said "it is amazing, isn't it? It is really all about economics.When we began practice (35 plus years ago) we could afford to be generalists and take time to talk to patients and not delegate to NP and PAs (where they even around then?) but now we couldn't." He said "you just don't get paid enough to do what we used to do.The image in your head of the type physician you think you were trained to be cannot realistically exist under the current economic situation."
At least the patient described in the narrative saw a physician. While jogging last week I was listening to a local call-the-doc talk show. The first caller's narrative was that he was recently seen by a cardiologist (actually he was not seen by a cardiologist but by his PA). He was told that his aortic aneurysm has grown from 3.5 to 4.5cm in diameter over the last year and if it grew to 5.0 cm he would need to have surgery. The caller did not indicate displeasure at not being able to discuss this with his doctor but was calling for more information about what would need to be done if the growth continued.
The second caller was also asking for information. He had a heart scan as part of a "wellness" evaluation and had a score of 600. He "saw" a cardiologist at a local heart center (actually had appointments at the doctor's office, he never saw him).An isotope stress test was done and he was told by the nurse that he had "no significant blockages" and he
should return in a year or so for followup.
Yesterday, I saw my dentist and following the hygienist poking about and cleaning, he poked about a bit and we briefly discussed a bridge issue. He then talked at some length about how he really didn't like the situation with his allergist with whom he had appointments but never was seen by anyone other than his NP. He pointed out that he always "sees" his patients.
My urologist is a dinosaur.I saw him last month.Yes,I actually saw him and talked to him and he actually examined me. When in practice i frequently referred him patients. Back then he would schedule both the patient and his wife for the last visit of the day so there would be time to describe exactly what the treatment options and complications for prostate cancer would be. He said he still does that. His economic situation was such that he and his 3 partners merged with 3 other practices and partnered in some way I did not understand with a therapeutic radiologist in the hope that their practice would still be viable.
My brother-in-law has coronary angiography following an episode of chest pain and an EKG that "showed some problem." After the cath, he was seen by someone in a white coat that he had not seen before . The white coated,scrub suited man explained the procedure very briefly ( there were " no significant blockages"),gave him several prescriptions and told him to call the office for a followup visit in 6 weeks. My sister said that somehow he didn't seem like a doctor.I told her he wasn't, he was a PA ( I looked him up on the state board's web site).He was later seen by the PA for the office visit.
I was having lunch yesterday with another retired doc.We talked about things like the above and he said "it is amazing, isn't it? It is really all about economics.When we began practice (35 plus years ago) we could afford to be generalists and take time to talk to patients and not delegate to NP and PAs (where they even around then?) but now we couldn't." He said "you just don't get paid enough to do what we used to do.The image in your head of the type physician you think you were trained to be cannot realistically exist under the current economic situation."
Thursday, January 08, 2009
SNIP associated with statin related myopathy
The August 21,2008 issue of the NEJM published an interesting paper entitled " SLCO1B1 and statin-induced myopathy" by the Search Collaborative Group.
They found a SNIP (Single nucleotide polymorphism) that is "strongly associated with an increased risk of statin-induced myopathy" .They used 300,000 markers -a genome wide scan- and ferreted out a SNIP on chromosome 12 that is related to the liver uptake of statins (I am not sure if this is all or just some statins) and a certain allele was associated with a odds ratio of an impressive 16.9.
This beats the heck out of the relative risk in the range of 1 to 2 that from time to time stirs up inappropriate concern and sophomoric media attention derived from a quick and dirty case control study.
The primary data source was from the SEARCH trial of over 12,000 participants from the UK who had a history of myocardial infarction and received either 80 mg or 20 mg of simvastatin daily. Definite myopathy (CK greater than 10 times the upper limit of normal plus muscle pain occurred in 49 of the 6031 subjects receiving the 80 mg dose, with 2 occurring in the 20 mg dose group. The odds ratio was 16.9 for those who were homozygous for the C allele. 60 % of the simvastatin associated myopathy cases were attributed to the gene variation. For the other 40% other cause or causes remain undetected. In those patients with myopathy using a high throughput technique about half a million genetic markers were screened. The results were replicated when applied to subjects from the Heart Protection trial with myopathy and an elevated but less impressive relative risk of 2.6 was demonstrated.
Note that presence of this particular mutation does not mean the patient will necessarily develop a myopathy and a number of patients without the SNIP will develop myopathy. So why is that? The physicist John Wheeler is quoted as saying:
"As the island of knowledge grows so does the shore of our ignorance."
but at least we seem to be making progress and the occurrence of myopathy related to statin use is now a bit less random and a bit more deterministic but we still have not squeezed all the randomness out.
In this age of the mega randomized trials and the chanting of treat- to- goal based on group data we might want to sit back sit back and remember the ecologic fallacy , what seems true for the group may not be true for any given individual.
They found a SNIP (Single nucleotide polymorphism) that is "strongly associated with an increased risk of statin-induced myopathy" .They used 300,000 markers -a genome wide scan- and ferreted out a SNIP on chromosome 12 that is related to the liver uptake of statins (I am not sure if this is all or just some statins) and a certain allele was associated with a odds ratio of an impressive 16.9.
This beats the heck out of the relative risk in the range of 1 to 2 that from time to time stirs up inappropriate concern and sophomoric media attention derived from a quick and dirty case control study.
The primary data source was from the SEARCH trial of over 12,000 participants from the UK who had a history of myocardial infarction and received either 80 mg or 20 mg of simvastatin daily. Definite myopathy (CK greater than 10 times the upper limit of normal plus muscle pain occurred in 49 of the 6031 subjects receiving the 80 mg dose, with 2 occurring in the 20 mg dose group. The odds ratio was 16.9 for those who were homozygous for the C allele. 60 % of the simvastatin associated myopathy cases were attributed to the gene variation. For the other 40% other cause or causes remain undetected. In those patients with myopathy using a high throughput technique about half a million genetic markers were screened. The results were replicated when applied to subjects from the Heart Protection trial with myopathy and an elevated but less impressive relative risk of 2.6 was demonstrated.
Note that presence of this particular mutation does not mean the patient will necessarily develop a myopathy and a number of patients without the SNIP will develop myopathy. So why is that? The physicist John Wheeler is quoted as saying:
"As the island of knowledge grows so does the shore of our ignorance."
but at least we seem to be making progress and the occurrence of myopathy related to statin use is now a bit less random and a bit more deterministic but we still have not squeezed all the randomness out.
In this age of the mega randomized trials and the chanting of treat- to- goal based on group data we might want to sit back sit back and remember the ecologic fallacy , what seems true for the group may not be true for any given individual.
Wednesday, January 07, 2009
COPD-Should we consider it one disease ?
Dr. J.J. Reilly authored a thought provoking editorial in the October 9,2008 issue of the NEJM,entitled " COPD and Declining FEV1-Time to Divide and Conquer?"
The editorial was a commentary in part on the publication of the results of the large,multi- center, UPLIFT trial which examined the effects of tiotropium on several outcomes in patients with COPD whose FEV1 values were 70% or less of predicted. Involving some 5993 subjects, the trial authors concluded that there were tiotropium related improvements in lung function and quality of life and fewer exacerbations. However, as has been the case with other trials investigating the effect of pharmacological interventions, there was no reduction in the rate of decline of FEV1., which seems to have become the golden grail of COPD clinical trials.Only smoking cessation and oxygen therapy and -in highly selected patients- lung volume reduction surgery have been shown to conclusively reduce mortality.
Dr. Reilly wonders in we have perhaps over simplified and COPD with a inclusive definition that recognizes only the FEV1. Are there important subtypes and clinical phenotypes lost in the movement to lump all patients with reduction in FEV1 into one category?
Whatever happened to the pink puffers and blue bloaters as described by Fletcher and Peto in the 1970s and taught to students and pulmonary fellows in that era? We thought of non-asthmatic, obstructive chronic lung disease as a spectrum with the prototypical blue bloater at one extreme and the pink puffer at the other with the plurality of patients falling in between having some feature of both.
The PP was thought of as having mainly pan-acinar emphysema with loss of the alveolar-capillary surface area as reflected by a decreased diffusing capacity test and overinflated lungs on x-ray with lung fields bereft of normal arterial lung markings while maintaining nearly normal arterial oxygen levels allegedly at the price of dyspnea.The BB patient typically had a radiograph with "dirty lungs", more sputum production and centrilobular emphysema and was more likely to be hypercapneic and develop right sided heart failure.
Reading the recent large clinical trials you cannot determine if there were subgroups, i.e. maybe those more like the BB patients, who did better.It was always difficult to conceive that any inhaled therapy would improve the PP patients since they had less airway disease and more air space destruction.
The editorial's main point is that thinking about COPD as a singular entity is misleading. There are likely a number of subgroups whose response to therapy may well vary as may their natural history. Perhaps, such groups can be defined on the basis of combinations of clinical,x-ray, physiological and even genetic factors. Post hoc subgroups analysis may be helpful to hypothesis generate. We may be under estimating the value of certain therapies by too much lumping.
The editorial was a commentary in part on the publication of the results of the large,multi- center, UPLIFT trial which examined the effects of tiotropium on several outcomes in patients with COPD whose FEV1 values were 70% or less of predicted. Involving some 5993 subjects, the trial authors concluded that there were tiotropium related improvements in lung function and quality of life and fewer exacerbations. However, as has been the case with other trials investigating the effect of pharmacological interventions, there was no reduction in the rate of decline of FEV1., which seems to have become the golden grail of COPD clinical trials.Only smoking cessation and oxygen therapy and -in highly selected patients- lung volume reduction surgery have been shown to conclusively reduce mortality.
Dr. Reilly wonders in we have perhaps over simplified and COPD with a inclusive definition that recognizes only the FEV1. Are there important subtypes and clinical phenotypes lost in the movement to lump all patients with reduction in FEV1 into one category?
Whatever happened to the pink puffers and blue bloaters as described by Fletcher and Peto in the 1970s and taught to students and pulmonary fellows in that era? We thought of non-asthmatic, obstructive chronic lung disease as a spectrum with the prototypical blue bloater at one extreme and the pink puffer at the other with the plurality of patients falling in between having some feature of both.
The PP was thought of as having mainly pan-acinar emphysema with loss of the alveolar-capillary surface area as reflected by a decreased diffusing capacity test and overinflated lungs on x-ray with lung fields bereft of normal arterial lung markings while maintaining nearly normal arterial oxygen levels allegedly at the price of dyspnea.The BB patient typically had a radiograph with "dirty lungs", more sputum production and centrilobular emphysema and was more likely to be hypercapneic and develop right sided heart failure.
Reading the recent large clinical trials you cannot determine if there were subgroups, i.e. maybe those more like the BB patients, who did better.It was always difficult to conceive that any inhaled therapy would improve the PP patients since they had less airway disease and more air space destruction.
The editorial's main point is that thinking about COPD as a singular entity is misleading. There are likely a number of subgroups whose response to therapy may well vary as may their natural history. Perhaps, such groups can be defined on the basis of combinations of clinical,x-ray, physiological and even genetic factors. Post hoc subgroups analysis may be helpful to hypothesis generate. We may be under estimating the value of certain therapies by too much lumping.
Tuesday, January 06, 2009
Duration of anticogulation after PE, a work still in progress
The first lecture I ever gave to medical students was in my first year of a pulmonary disease fellowship and the topic was DVT and PE. The ventilation perfusion scan had recently become available and the two anticoagulants, heparin and coumadin, were used and remained unchallenged in that category until relatively recently.Duration of therapy was not part of my lecture as I probably did not know what to say.
Much effort and research has been devoted to venous thromboembolic disease since then and through the efforts of the American College of Chest Physicians guidelines on virtually every aspect of DVT and PE appear with some regularity and are widely quoted. Here is a link to a brief review of some of the highlights of the latest (8 th) version by the ACCP.
Information continues to accumulate and a recent paper concerning the issue of duration of therapy has been published from Canada (as much the literature on this topic has been) and this editorial from the CMAJ discusses their findings.
While the authors could discern no pattern of risk factors that predicted likelihood of recurrence in men their data suggested that could be the case in women. Younger, thin women with no elevation of d-dimer and no clinical signs of post phlebitis syndrome were thought to at a low enough risk to possibly justify stopping earlier rather than later the anticoagulant.They generated a so-called clinical decision rule which the authors emphasize is not ready for prime time.It is a post hoc rule and the age and body weight risk factors they identified have not been usually implicated.
How long to treat a patient with a unprovoked DVT or PE continues to be a perplexing clinical problem. The longer you treat the greater the likelihood of a serious bleeding complication, the shorter the period of anticoagulation, the greater the risk of thrombotic events. Six months for an unprovoked DVT seems like the usual recommendation and shorter for a provoked event.
The September 2, 2008 issue of the Annals of Internal Medicine has a useful section regarding DVTs (their "In the Clinic" section entitled "Deep Venus thrombosis" and if you want a single reference to read on the topic that looks like a good place to start.
To my way of thinking, if the D-dimer remains elevated it may be too soon to stop the coumadin.
Much effort and research has been devoted to venous thromboembolic disease since then and through the efforts of the American College of Chest Physicians guidelines on virtually every aspect of DVT and PE appear with some regularity and are widely quoted. Here is a link to a brief review of some of the highlights of the latest (8 th) version by the ACCP.
Information continues to accumulate and a recent paper concerning the issue of duration of therapy has been published from Canada (as much the literature on this topic has been) and this editorial from the CMAJ discusses their findings.
While the authors could discern no pattern of risk factors that predicted likelihood of recurrence in men their data suggested that could be the case in women. Younger, thin women with no elevation of d-dimer and no clinical signs of post phlebitis syndrome were thought to at a low enough risk to possibly justify stopping earlier rather than later the anticoagulant.They generated a so-called clinical decision rule which the authors emphasize is not ready for prime time.It is a post hoc rule and the age and body weight risk factors they identified have not been usually implicated.
How long to treat a patient with a unprovoked DVT or PE continues to be a perplexing clinical problem. The longer you treat the greater the likelihood of a serious bleeding complication, the shorter the period of anticoagulation, the greater the risk of thrombotic events. Six months for an unprovoked DVT seems like the usual recommendation and shorter for a provoked event.
The September 2, 2008 issue of the Annals of Internal Medicine has a useful section regarding DVTs (their "In the Clinic" section entitled "Deep Venus thrombosis" and if you want a single reference to read on the topic that looks like a good place to start.
To my way of thinking, if the D-dimer remains elevated it may be too soon to stop the coumadin.
Monday, January 05, 2009
Is medical literature not to be trusted at all?
Are medical publications so corrupted and biased by special interests ( i.e. drug and medical device companies to name just two) that physicians no longer can rely on the medical literature to learn how to manage patients and prescribe medications? That seems to be the conclusion reached by Dr. Marci Angell in her commentary in JAMA. ( subscription required for all but the extract) Here is a no-punches- pulled summary in her words:
Looking at this picture altogether, it would be naive to conclude that bias is only a matter of a few isolated instances. It permeates the entire system. Physicians can no longer rely on the medical literature for valid and reliable information. This is the conclusion I reluctantly reached toward the end of my 2 decades as an editor of the New England Journal of Medicine, and it has been reinforced in subsequent years. Clinicians just do not know anymore how safe and effective prescription drugs really are, but these products are probably nowhere near as good as the published literature indicates.
This are not the words of an- over- the hill, bitter, retired doctor who has been accused of being biased against academics, and of longing for the good old days when docs did whatever the hell they wanted and has protested against the misuse of evidence based medicine to further the aims of big pharma and fellow travelers.Rather they are those of someone who has spend twenty years of editing one of the (if not the-most prestigious) medical journal in the country.
All journal articles do not have to be biased or misleading or down right fraudulent to taint the entire endeavor so that the end result may be a marked diminution is the reliability of medical journal articles in general.
As bleak as Dr. Angell's analysis was, Dr. Roy Poses, of Health Care Renewal, wonders if she might not have been too optimistic. I am afraid what was too optimistic in her paper was her suggestion that there be an independent body (perhaps an institute in the NIH) to administer all clinical trials with drugs.
Why would not the same influences and pressures that, according to her analysis, have corrupted some (much?) of academic medicine not have the same effect in a governmental body ? I cannot believe that medical ( or at least drug ) research overseen by the government would be immune to the biases and incentives that government agencies generally are subject to.
For example, the FDA has been subject to increasing criticism regarding actions seemingly orchestrated-or at least influenced to a large degree-by both the drug companies they are alleged to regulate and well as bending to political pressure to make decisions that mix well with certain philosophical stances taken by the executive branch. There is a rather large and I think convincing body of evidence that demonstrates the degree to which governmental regulatory agencies often act more as facilitators for those they purport to regulate than as policemen .
Dr. Poses would prefer a non-governmental, independent body to a governmental one. I would also have problem with that notion including:
Considering the big bucks involved in medical care-how could independence be maintained?
How could an independent body have the necessary power to function and control research without being in effect " government".
And, perhaps most importantly would not this panel ( governmental or non-governmental) have to deal with the same suspect body of medical literature whose reputation is impugned by Dr. Angell's analysis.
Such a body, a Med-Fed sort of thing, is gaining traction as it is apparently part of Senator Baucus's medical reform plan.My cynicism is that regard may be misplaced and as suggested by DB in his blog this type of explicit rationing may well be better than the current state of covert rationing as described by DrRich in his blog and in his book.
Looking at this picture altogether, it would be naive to conclude that bias is only a matter of a few isolated instances. It permeates the entire system. Physicians can no longer rely on the medical literature for valid and reliable information. This is the conclusion I reluctantly reached toward the end of my 2 decades as an editor of the New England Journal of Medicine, and it has been reinforced in subsequent years. Clinicians just do not know anymore how safe and effective prescription drugs really are, but these products are probably nowhere near as good as the published literature indicates.
This are not the words of an- over- the hill, bitter, retired doctor who has been accused of being biased against academics, and of longing for the good old days when docs did whatever the hell they wanted and has protested against the misuse of evidence based medicine to further the aims of big pharma and fellow travelers.Rather they are those of someone who has spend twenty years of editing one of the (if not the-most prestigious) medical journal in the country.
All journal articles do not have to be biased or misleading or down right fraudulent to taint the entire endeavor so that the end result may be a marked diminution is the reliability of medical journal articles in general.
As bleak as Dr. Angell's analysis was, Dr. Roy Poses, of Health Care Renewal, wonders if she might not have been too optimistic. I am afraid what was too optimistic in her paper was her suggestion that there be an independent body (perhaps an institute in the NIH) to administer all clinical trials with drugs.
Why would not the same influences and pressures that, according to her analysis, have corrupted some (much?) of academic medicine not have the same effect in a governmental body ? I cannot believe that medical ( or at least drug ) research overseen by the government would be immune to the biases and incentives that government agencies generally are subject to.
For example, the FDA has been subject to increasing criticism regarding actions seemingly orchestrated-or at least influenced to a large degree-by both the drug companies they are alleged to regulate and well as bending to political pressure to make decisions that mix well with certain philosophical stances taken by the executive branch. There is a rather large and I think convincing body of evidence that demonstrates the degree to which governmental regulatory agencies often act more as facilitators for those they purport to regulate than as policemen .
Dr. Poses would prefer a non-governmental, independent body to a governmental one. I would also have problem with that notion including:
Considering the big bucks involved in medical care-how could independence be maintained?
How could an independent body have the necessary power to function and control research without being in effect " government".
And, perhaps most importantly would not this panel ( governmental or non-governmental) have to deal with the same suspect body of medical literature whose reputation is impugned by Dr. Angell's analysis.
Such a body, a Med-Fed sort of thing, is gaining traction as it is apparently part of Senator Baucus's medical reform plan.My cynicism is that regard may be misplaced and as suggested by DB in his blog this type of explicit rationing may well be better than the current state of covert rationing as described by DrRich in his blog and in his book.
Does the pretest probablity of a condition really determine which test you should do?
The December 25, 2008 issue of NEJM has a excellent article on "Acute Pulmonary Embolism."
It seems that standard practice has become to use (or at least to say that one should use,I am not sure how often that really happens)) one of the clinical prediction rules or "CPRs" ( in this case the Wells or the Geneva criteria) to make an assessment of how likely is the diagnosis of PE .
Of historical note, the early studies on how best to diagnose PE included a global assessment by the physician and the clinical prediction rules came on the scene later in part, it was said, to aid the less experienced physician.
In one version of this game plan, one determines if there is high,intermediate or low pretest probability of PE. Then the test you order depends on into which risk category the patient is placed. In the first two instances, one then proceeds to obtain a highly sensitive D-dimer test ( e.g.,enzyme-linked immunosorbent assay).If this test is less than some cut-off value (usually 0.5m/liter) the diagnosis is said to be effectively ruled out.However, if there is a high pretest probability of PE then one should not order the D-dimer but proceed directly to a multidetector chest CT .(This is basically the recommendations made by the PIOPED ii investigators in their 2007 summary article.)
This is said to be the case because-according to the NEJM review- clinical data have indicated that in patients with a high pretest likelihood of PE the negative predictive value of the D-dimer is too low to be safely determinative. Interestingly, when one reviews the quoted reference in the Archives of Internal Medicine for that advice it turns out the study involved only 13 instances of high probability PE cases all of whom had a elevated d-dimer. To my perhaps antiquated way of thinking this is a bit strange that we can determine the predictive value of a negative test from data that seems to contain no negative tests.There may well be other studies which I have not yet found that, in fact, provide enough data to conclude the negative predictive value is too low.
Ignoring that anomaly for the time being, what about the advice for those patients in the intermediate risk category. There are some data indicating that about 5% of such patients have false negative D-dimer tests.See the Wikipedia article for that reference.
I think a better reason not to rely on the D-dimer a high probability case is , is concern that a potentially fatal condition may be missed because of one erroneous negative biological lab test considering all the many ways lab tests can get screwed up.Plus you have to feel more confident that clots are in the pulmonary arteries when you can point to the their images plugging up segmental or larger vessels (seeing sub-segmental occlusions may be a bit more iffy).
In any event, I have some lingering trouble in getting my brain around the notion for that for a given condition there is not one most accurate and reliable test but that the test of choice varies with the pretest likelihood. My unease is not made better by the fact that one of the more heavily weighted Wells criteria (a value of 3) is credited to the patient's risk score when PE is thought to be "more likely" that an alternative diagnosis,such determination being made by undefined criteria and can not be standardized. ( O.K., the Geneva criteria seem to fixed that problem.)
Nevertheless, the above discussed game plan seems to work most of the time. The importance of not allowing the D-dimer's negativity to exclude PE is emphasized in this 2008 article from Holland in the journal CHEST.The authors reported data that indicated that almost 10% (9.3%) of patients with a likely diagnosis (they used a version of the Wells criteria that had only two categories, "likely" or "unlikely") and a negative D-dimer had evidence of thrombotic disease in the subsequent 3 months.
I have written about the D-dimer and Pulmonary embolism prediction rules before in a discussion about an earlier larger study from Holland which is generally considered to validate the rule of thumb that says "low likelihood Wells score plus negative high sensitivity D-dimer test equals no PE." As thumb rules go this one does seem pretty good but as an example of brazen self absorption let me quote a paragraph from an earlier posting.
" I wonder if the "dichotomized"version of the Wells decision rule is too simple.All patients in the "unlikely" category are not equally unlikely to have PE. I have a problem with reducing a physician's assessment of how likely the diagnosis may be to a mechanistic rule and apparently excluding any and all other elements that a physician may call upon to decide the likelihood of a diagnosis, for example a decreased 02 saturation. A clinician's "global assessment"( i.e. considering the overall clinical picture not just the check list from Wells) should trump the decision rule.If you believe PE or DVT is a reasonable diagnosis to pursue,testing should be done even if the Wells rule suggests low risk or unlikely and the d-dimer is negative.(show me a blood test that can't be wrong)."
It seems that standard practice has become to use (or at least to say that one should use,I am not sure how often that really happens)) one of the clinical prediction rules or "CPRs" ( in this case the Wells or the Geneva criteria) to make an assessment of how likely is the diagnosis of PE .
Of historical note, the early studies on how best to diagnose PE included a global assessment by the physician and the clinical prediction rules came on the scene later in part, it was said, to aid the less experienced physician.
In one version of this game plan, one determines if there is high,intermediate or low pretest probability of PE. Then the test you order depends on into which risk category the patient is placed. In the first two instances, one then proceeds to obtain a highly sensitive D-dimer test ( e.g.,enzyme-linked immunosorbent assay).If this test is less than some cut-off value (usually 0.5m/liter) the diagnosis is said to be effectively ruled out.However, if there is a high pretest probability of PE then one should not order the D-dimer but proceed directly to a multidetector chest CT .(This is basically the recommendations made by the PIOPED ii investigators in their 2007 summary article.)
This is said to be the case because-according to the NEJM review- clinical data have indicated that in patients with a high pretest likelihood of PE the negative predictive value of the D-dimer is too low to be safely determinative. Interestingly, when one reviews the quoted reference in the Archives of Internal Medicine for that advice it turns out the study involved only 13 instances of high probability PE cases all of whom had a elevated d-dimer. To my perhaps antiquated way of thinking this is a bit strange that we can determine the predictive value of a negative test from data that seems to contain no negative tests.There may well be other studies which I have not yet found that, in fact, provide enough data to conclude the negative predictive value is too low.
Ignoring that anomaly for the time being, what about the advice for those patients in the intermediate risk category. There are some data indicating that about 5% of such patients have false negative D-dimer tests.See the Wikipedia article for that reference.
I think a better reason not to rely on the D-dimer a high probability case is , is concern that a potentially fatal condition may be missed because of one erroneous negative biological lab test considering all the many ways lab tests can get screwed up.Plus you have to feel more confident that clots are in the pulmonary arteries when you can point to the their images plugging up segmental or larger vessels (seeing sub-segmental occlusions may be a bit more iffy).
In any event, I have some lingering trouble in getting my brain around the notion for that for a given condition there is not one most accurate and reliable test but that the test of choice varies with the pretest likelihood. My unease is not made better by the fact that one of the more heavily weighted Wells criteria (a value of 3) is credited to the patient's risk score when PE is thought to be "more likely" that an alternative diagnosis,such determination being made by undefined criteria and can not be standardized. ( O.K., the Geneva criteria seem to fixed that problem.)
Nevertheless, the above discussed game plan seems to work most of the time. The importance of not allowing the D-dimer's negativity to exclude PE is emphasized in this 2008 article from Holland in the journal CHEST.The authors reported data that indicated that almost 10% (9.3%) of patients with a likely diagnosis (they used a version of the Wells criteria that had only two categories, "likely" or "unlikely") and a negative D-dimer had evidence of thrombotic disease in the subsequent 3 months.
I have written about the D-dimer and Pulmonary embolism prediction rules before in a discussion about an earlier larger study from Holland which is generally considered to validate the rule of thumb that says "low likelihood Wells score plus negative high sensitivity D-dimer test equals no PE." As thumb rules go this one does seem pretty good but as an example of brazen self absorption let me quote a paragraph from an earlier posting.
" I wonder if the "dichotomized"version of the Wells decision rule is too simple.All patients in the "unlikely" category are not equally unlikely to have PE. I have a problem with reducing a physician's assessment of how likely the diagnosis may be to a mechanistic rule and apparently excluding any and all other elements that a physician may call upon to decide the likelihood of a diagnosis, for example a decreased 02 saturation. A clinician's "global assessment"( i.e. considering the overall clinical picture not just the check list from Wells) should trump the decision rule.If you believe PE or DVT is a reasonable diagnosis to pursue,testing should be done even if the Wells rule suggests low risk or unlikely and the d-dimer is negative.(show me a blood test that can't be wrong)."
Friday, January 02, 2009
What type Universal Health Care for U.S. is on the way?
DrRich applies his usual insight, keen analytic skills and puckish literary charm to the issue of Universal Health Care (UHC) in this post and believes that it will happen and the only questions involve the details. The major issue is will people be "allowed to pay" for services not covered by the government plan. Will it be like Canada or like Great Britain? DrRich is pessimistic and believes we will go the way of the Canadians
That question should not have to be asked in a country based on individual freedom but as DrRich points our, things could well go the way of Canada,even as there are indications that the Canadians are trying to retrench in that regard. See here for some developments regarding our northern neighbors.
Those who favor a no-opt-out system seem to put much importance to there being no "two-tiered system". The proximity of the U.S. health care facilities has made a quasi two tiered system in Canada a reality much to the vexation of those who find solace in the equality of deprivation.
Physicians may well differ in regard to UHC, some being so fed up with the current wage controls imposed by Medicare and insurance company hegemony that they now favor it (like Medicare for all will be better) but there should be nothing but opposition to a Canada like prohibition of private off-the-grid care.
The current renewal of free-market bashing may well bring along with it a renewed belief in the government as solution to whatever problem(s) flash on the volatile public consciousness.
What is there to suggest the U.S. will follow Canada?
1.There are rumblings, e.g. in the state of Maryland, that concierge medicine might be made illegal.
2.The libertarian prop 101 was defeated in Arizona.(You might want to follow the money there to see who funded the opposition.So why was a Realtors association a big donor to the fight against prop 101? see here for a reference.)
3.Hilliary care contained a provision to penalize docs who dared to treat patients off the grid.
But on the other hand.
1.Obama care , at least as promoted during the election, does not explicitly mention outlawing off the grid care.
2.Obama care seems to propose a subsidy for private insurance as well as an option to sign up for some Medicare-like public plan. And Medicare itself does not exactly preclude patients making private arrangements with physicians.
3.The British NHS coexists with a private insurance medical care system. Further we may look to France.Their health care system is a mixture of private and public elements and citizens can elect to buy a little more care and there seems to be a bit of choice.This might be a more viable role model now that we seem to be emulating the French approach to buying into industries and businesses that have problems, remember Renault.
That question should not have to be asked in a country based on individual freedom but as DrRich points our, things could well go the way of Canada,even as there are indications that the Canadians are trying to retrench in that regard. See here for some developments regarding our northern neighbors.
Those who favor a no-opt-out system seem to put much importance to there being no "two-tiered system". The proximity of the U.S. health care facilities has made a quasi two tiered system in Canada a reality much to the vexation of those who find solace in the equality of deprivation.
Physicians may well differ in regard to UHC, some being so fed up with the current wage controls imposed by Medicare and insurance company hegemony that they now favor it (like Medicare for all will be better) but there should be nothing but opposition to a Canada like prohibition of private off-the-grid care.
The current renewal of free-market bashing may well bring along with it a renewed belief in the government as solution to whatever problem(s) flash on the volatile public consciousness.
What is there to suggest the U.S. will follow Canada?
1.There are rumblings, e.g. in the state of Maryland, that concierge medicine might be made illegal.
2.The libertarian prop 101 was defeated in Arizona.(You might want to follow the money there to see who funded the opposition.So why was a Realtors association a big donor to the fight against prop 101? see here for a reference.)
3.Hilliary care contained a provision to penalize docs who dared to treat patients off the grid.
But on the other hand.
1.Obama care , at least as promoted during the election, does not explicitly mention outlawing off the grid care.
2.Obama care seems to propose a subsidy for private insurance as well as an option to sign up for some Medicare-like public plan. And Medicare itself does not exactly preclude patients making private arrangements with physicians.
3.The British NHS coexists with a private insurance medical care system. Further we may look to France.Their health care system is a mixture of private and public elements and citizens can elect to buy a little more care and there seems to be a bit of choice.This might be a more viable role model now that we seem to be emulating the French approach to buying into industries and businesses that have problems, remember Renault.
Thursday, January 01, 2009
Medical Home the abstact ideal meets the bureacratic reality?
I had doubts about the concept of a Medical Home as a solution to the primary care crisis from the first time I read about it and you would have thought my spleen was fully vented in this verbose posting but...When I learned that the RUC would be making the payments rules my doubt titer went off the chart . Now when I read about how one such program is being introduced I can only say "you have got to be kidding me". Thanks to Kevin for the reference.
Dr. Douglas Farrago of Placebo Journal fame tells us about a plan in his home state that is recruiting docs for a program that cannot disclose how you will be paid or on what criteria you will be judged but there a lot of forms to fill out. That is an offer you do not want to pass up.
Dr. Douglas Farrago of Placebo Journal fame tells us about a plan in his home state that is recruiting docs for a program that cannot disclose how you will be paid or on what criteria you will be judged but there a lot of forms to fill out. That is an offer you do not want to pass up.
Tuesday, December 30, 2008
The Medical Matrix,the iPatient and does anyone remember the physical exam?
The December 25, 2008 issue of NEJM has a brilliant Perspective written by Dr. A. Verghese entitled "Culture Shock-Patient as Icon, Icon as Patient".
Dr. Verghese, a professor at Stanford Medical School, writes about the world of the computer screen patient or as he puts it so well- speaking of the world of internal medicine training- the iPatient.
"The patient is still at the center but more as an icon for another entity clothed in binary garments,the "iPatient".
He explains that after the ER docs work up or perhaps define the patient the " interns meet a fully formed iPatient long before seeing the real patient." Quoting the semanticist Alfred Korzbski, Verghese reminds us that the "map is not the territory".
The reality or virtual reality of the iconic patients may overwhelm the person from whom the iPatient is constructed. The CT report or lab test may not be correlated with the history or physical exam as neither may be done as the reality of the full developed iPatient arrives "on the ward".
"If one eschews the skilled and repeated examination of the real patients, then simple diagnosis are overlooked, while tests, consultations and procedures that might not be needed are ordered."
He speaks of two approaches, the traditional way where in the body is the text and the new way or the expedient or Ipatient way. The first approach is a needed remedy for the development of "chartomas"-which are disease labels that become the iTruth by "being cut and pasted into every note".
This is a great commentary and Dr. Verghese tells us that at Stanford an effort is underway to revise and strengthen bedside skills. Good for them. My medicine chief during training, George Burch, preached that if you are uncertain or uneasy as to what is going on clinically go back talk to the patient again and examine him again. When the house staff receives a patient fully iDefined patient, they may never know if that are uncertain or not and they probably would have no reason to be uneasy, but the patient may.
Dr. Verghese, a professor at Stanford Medical School, writes about the world of the computer screen patient or as he puts it so well- speaking of the world of internal medicine training- the iPatient.
"The patient is still at the center but more as an icon for another entity clothed in binary garments,the "iPatient".
He explains that after the ER docs work up or perhaps define the patient the " interns meet a fully formed iPatient long before seeing the real patient." Quoting the semanticist Alfred Korzbski, Verghese reminds us that the "map is not the territory".
The reality or virtual reality of the iconic patients may overwhelm the person from whom the iPatient is constructed. The CT report or lab test may not be correlated with the history or physical exam as neither may be done as the reality of the full developed iPatient arrives "on the ward".
"If one eschews the skilled and repeated examination of the real patients, then simple diagnosis are overlooked, while tests, consultations and procedures that might not be needed are ordered."
He speaks of two approaches, the traditional way where in the body is the text and the new way or the expedient or Ipatient way. The first approach is a needed remedy for the development of "chartomas"-which are disease labels that become the iTruth by "being cut and pasted into every note".
This is a great commentary and Dr. Verghese tells us that at Stanford an effort is underway to revise and strengthen bedside skills. Good for them. My medicine chief during training, George Burch, preached that if you are uncertain or uneasy as to what is going on clinically go back talk to the patient again and examine him again. When the house staff receives a patient fully iDefined patient, they may never know if that are uncertain or not and they probably would have no reason to be uneasy, but the patient may.
HL Mencken,National Health Coverage Council and Public Choice Theory
Recently, Dr. Donald J. Boudreaux in a commentary in his column,"Eonomics in Many Lessons", featured some quotes from one of my all time favoties, H.L. Mencken. Mencken's comments suggests that he understood the core thoughts illuminated by Tullock and Buchanan in their writings that informed us of what has become known as Public Choice Theory.
Mencken said:
"the survival into our enlightened age of a concept hatched in the black days of absolutism the concept, to wit, that government is something that is superior to and quite distinct from all other human institutions ... a transcendental organism composed of aloof and impersonal powers, devoid wholly of self-interest and not to be measured by merely human standards."
Mencken struck the key note of the ideas behind Public Choice Theory, namely that public officials-elected,civil service or appointed- act, at least in part in their own interests. These people, members of the same species as those not in government employment, tend to be motivated by salaries and other perks,lust for power and prestige and easy of managing their bureaucracy.The ideal from our eight grade civics class of a selfless public official wisely acting for the good of society is seldom achieved.
With that in mind, the"independent Health Coverage Counsel" proposed in Max Baucus's health reform plan should scare the heck out you.See here for one critique of that plan.
The danger of placing the power to make economic decisions in the hands of a governmental or quasi-governmental organizations should be obvious to all.
In fact, it scares me so much that I awoke from my blogging hiatus.
Mencken said:
"the survival into our enlightened age of a concept hatched in the black days of absolutism the concept, to wit, that government is something that is superior to and quite distinct from all other human institutions ... a transcendental organism composed of aloof and impersonal powers, devoid wholly of self-interest and not to be measured by merely human standards."
Mencken struck the key note of the ideas behind Public Choice Theory, namely that public officials-elected,civil service or appointed- act, at least in part in their own interests. These people, members of the same species as those not in government employment, tend to be motivated by salaries and other perks,lust for power and prestige and easy of managing their bureaucracy.The ideal from our eight grade civics class of a selfless public official wisely acting for the good of society is seldom achieved.
With that in mind, the"independent Health Coverage Counsel" proposed in Max Baucus's health reform plan should scare the heck out you.See here for one critique of that plan.
The danger of placing the power to make economic decisions in the hands of a governmental or quasi-governmental organizations should be obvious to all.
In fact, it scares me so much that I awoke from my blogging hiatus.
Tuesday, October 14, 2008
Time for retired doc to retool,meditate and do the sabatical thing
What with the downtime imposed by a hurricane and the confluence of a bunch of other family and personal stuff, I think it best to-at least for a while-take blog writing off the table.I probably can't resist posting a few wonderfully cogent comments on some of my favorite medical blogger sites but little more than that for a while. I have beaten to death a number of my favorite themes and I need to re-fire the belly. I promise not to reappear in a new role as a political pundit.That market is super saturated anyway. So for a while, so long and thanks for all the fish.
Wednesday, September 24, 2008
Power outage from Hurrican Ike
Now 12 days since Hurricane Ike and still no power to my part of the Houston area. So no blogs for a while and for a short while to come. I only have access to a friend's computer or the wi-fi at a mall. Maybe next week things will be up and running again. Hopefully, my three readers will be patient.
Tuesday, September 09, 2008
More news on the fall out from restricted house officer work hours
Every time I mention there may possibly be some problems with the work hours restriction regarding house officers, I receive a barrage ( OK, 1 or 2 comments) from folks who consider me to be a old jerk who just wants a return to the good old days and that I want nothing more than to deny house officers time with their families so to better achieve the nebulous work life balance.
Thanks to Kevin for alerting me to this news item. In part, it seems like some surgery residents have been caught working too much in their misdirected efforts to try and learn to be good surgeons. Shame on them.
To disabuse these rebellious surgeon in training from their anachronistic aversion to shift work for physicians, efforts should begin earlier, i.e. in medical school. Rules should be implemented to limit the hours of study allowed for medical students.
Thanks to Kevin for alerting me to this news item. In part, it seems like some surgery residents have been caught working too much in their misdirected efforts to try and learn to be good surgeons. Shame on them.
To disabuse these rebellious surgeon in training from their anachronistic aversion to shift work for physicians, efforts should begin earlier, i.e. in medical school. Rules should be implemented to limit the hours of study allowed for medical students.
Saturday, September 06, 2008
work-life balance,shift worker physicians and paradigms lost
Sometime in the 1980s the term "work-life balance " ( which I will abbreviate as "wlb" to save key strokes) began to seep into the universe of conversational and literacy discourse. I suggest the term itself may be a bit of a self contradiction or at least a poorly constructed notion. Work for the great majority of human adults is part of life so would not "work-non-work balance" be more to the point.
And the point seems to be basically that there is said to be some appropriate distribution of the hours in a week or day so that the proper of amount of time is spent working and in the other various domains of existence, which would including family time,recreation,and you fill in the blank with religion or community service or duck hunting.WLB had become a buzz word particularly in the business world wherein it is widely believed that companies must make some highly visible effort to help their employee achieve this wlb or at least appear to do so.
It is a modern concept and a concept that makes sense only when folks achieve a certain degree of affluence. It would have made no sense to talk to our ancestors who worked the land from dawn to dusk and then collapsed in bed to talk about balance. Pretty much every thing was work. Similarly millions of people who eek out a barely adequate living in those parts of the world now call developing (formerly known a underdeveloped) are not too concerned with discussion about the best way to balance their lives. In the 1970s and before medical students and house officers did not lobby their trainers, teachers and exploiters for a better balance in the work and non work lives.I don't know why we didn't , maybe we just were not that evolved yet or maybe we thought we could not get away with it.
When I did consultation work for a large international corporation, I frequently did examinations for overseas travel and executive physicals for the top small percentage of the employees. One such person was tasked to consult with high level managers to work out ways in which those managers could make it to happen that their employee would achieve this wlb. This individual traveled around the world visiting various general managers and vice presidents and noted that most could be fairly described an "workaholics". He told several of them that they would never achieve the alleged goal of more wlb without the leaders serving a role models. Almost to a man (or woman), the reply was basically : Look if I slow down or work less, some sob will take my job." The wlb manager soon retired early and moved to a ranch in Montana ( I am not making this up ).
Government officials and politicians who get into some type of hot water such as accusations of wrong doing often decide to retire and give as reason " spend more time with my family". Nothing like getting caught to convince one to balance their work and life.
For some, their work is their life even though their position is such that they could opt to fish more, be ushers at church or have regular meals with their spouses. For them the balance is heavily shifted to the work side. Consider the degree to which physicians in their training shift much of their lives to the studying and working for a prolonged period of time. Do they accumulate a great unmet need for other activities so that when they finally finish training they are ready to catch up and re balance their wlb ratio, in part by becoming shift workers? Maybe so. Or since the income rewards are getting less and less and the prestige of physician work is diminishing and the autonomy is getting harder and harder to even find and when the pride of being physician gets to some personally determined tipping point maybe it is more politically correct to say you need more time on the life side of work life balance than to say screw it.
And the point seems to be basically that there is said to be some appropriate distribution of the hours in a week or day so that the proper of amount of time is spent working and in the other various domains of existence, which would including family time,recreation,and you fill in the blank with religion or community service or duck hunting.WLB had become a buzz word particularly in the business world wherein it is widely believed that companies must make some highly visible effort to help their employee achieve this wlb or at least appear to do so.
It is a modern concept and a concept that makes sense only when folks achieve a certain degree of affluence. It would have made no sense to talk to our ancestors who worked the land from dawn to dusk and then collapsed in bed to talk about balance. Pretty much every thing was work. Similarly millions of people who eek out a barely adequate living in those parts of the world now call developing (formerly known a underdeveloped) are not too concerned with discussion about the best way to balance their lives. In the 1970s and before medical students and house officers did not lobby their trainers, teachers and exploiters for a better balance in the work and non work lives.I don't know why we didn't , maybe we just were not that evolved yet or maybe we thought we could not get away with it.
When I did consultation work for a large international corporation, I frequently did examinations for overseas travel and executive physicals for the top small percentage of the employees. One such person was tasked to consult with high level managers to work out ways in which those managers could make it to happen that their employee would achieve this wlb. This individual traveled around the world visiting various general managers and vice presidents and noted that most could be fairly described an "workaholics". He told several of them that they would never achieve the alleged goal of more wlb without the leaders serving a role models. Almost to a man (or woman), the reply was basically : Look if I slow down or work less, some sob will take my job." The wlb manager soon retired early and moved to a ranch in Montana ( I am not making this up ).
Government officials and politicians who get into some type of hot water such as accusations of wrong doing often decide to retire and give as reason " spend more time with my family". Nothing like getting caught to convince one to balance their work and life.
For some, their work is their life even though their position is such that they could opt to fish more, be ushers at church or have regular meals with their spouses. For them the balance is heavily shifted to the work side. Consider the degree to which physicians in their training shift much of their lives to the studying and working for a prolonged period of time. Do they accumulate a great unmet need for other activities so that when they finally finish training they are ready to catch up and re balance their wlb ratio, in part by becoming shift workers? Maybe so. Or since the income rewards are getting less and less and the prestige of physician work is diminishing and the autonomy is getting harder and harder to even find and when the pride of being physician gets to some personally determined tipping point maybe it is more politically correct to say you need more time on the life side of work life balance than to say screw it.
Sunday, August 24, 2008
More reason to be wary of meta-analyses
A tip of the blogging hat to DB's Medical Rants for this reference.
This article by Ian Shrier and others from McGill investigated the subjectivity of meta-analyses and concluded the following:
The interpretation of the results of systematic reviews with meta-analyses includes a subjective component that can lead to discordant conclusions that are independent of the methodology used to obtain or analyse the data. And things get even more mushy when the statistical experts differ as to what methodology should be used.
In their discussion this paragraph says it well :
Our results suggest that a systematic review with a meta-analysis must be viewed with the perspective that it represents one study conducted by specific investigators with a specific methodology. At each step of the methodology (defining the general criteria, search strategy, inclusion/exclusion criteria, data abstraction, and analysis), subjective decisions are required that could affect the validity of the study; the relative importance of each will likely depend on the topic of inquiry and the data acquired. Our study demonstrates that disagreements in the conclusions of systematic reviews with meta-analyses can also be due to subjective interpretations of the results and not only of the methodology. The inclusion-exclusion criteria often are determinative of the outcome.Meta-analyses can be thought of as observational studies in which the subjects are trials.
Of course meta-analyses involve subjective judgment calls and various type of personal bias that the investigators bring to the table. How could it possibly be otherwise?
This gives me still another opportunity to reference the classic editorial in the Annals of Internal Medicine by Steve Goodman of Johns Hopkins which I discussed at some length here. To sum it I can do no better than to quote Goodman:
Judgment determines what evidence is admissible and how strongly to weigh different forms of admissible evidence. When there is consensus on these judgments and the data are
strong, an illusion is created that the evidence is speaking for itself and that the methods are objective. But this episode[ the mammogram controversy mentioned above] should raise awareness that judgment cannot be excised from the process of evidence synthesis and that the variation of this judgment among experts generates uncertainty just as real as the probabilistic uncertainty of statistical calculations.
I never tire of repeating my rant that meta-analyses should never have been placed at the top of the evidence based medicine evidence hierarchy.And for that matter biological plausibility should never have relegated to lower rings of the ladder.
This article by Ian Shrier and others from McGill investigated the subjectivity of meta-analyses and concluded the following:
The interpretation of the results of systematic reviews with meta-analyses includes a subjective component that can lead to discordant conclusions that are independent of the methodology used to obtain or analyse the data. And things get even more mushy when the statistical experts differ as to what methodology should be used.
In their discussion this paragraph says it well :
Our results suggest that a systematic review with a meta-analysis must be viewed with the perspective that it represents one study conducted by specific investigators with a specific methodology. At each step of the methodology (defining the general criteria, search strategy, inclusion/exclusion criteria, data abstraction, and analysis), subjective decisions are required that could affect the validity of the study; the relative importance of each will likely depend on the topic of inquiry and the data acquired. Our study demonstrates that disagreements in the conclusions of systematic reviews with meta-analyses can also be due to subjective interpretations of the results and not only of the methodology. The inclusion-exclusion criteria often are determinative of the outcome.Meta-analyses can be thought of as observational studies in which the subjects are trials.
Of course meta-analyses involve subjective judgment calls and various type of personal bias that the investigators bring to the table. How could it possibly be otherwise?
This gives me still another opportunity to reference the classic editorial in the Annals of Internal Medicine by Steve Goodman of Johns Hopkins which I discussed at some length here. To sum it I can do no better than to quote Goodman:
Judgment determines what evidence is admissible and how strongly to weigh different forms of admissible evidence. When there is consensus on these judgments and the data are
strong, an illusion is created that the evidence is speaking for itself and that the methods are objective. But this episode[ the mammogram controversy mentioned above] should raise awareness that judgment cannot be excised from the process of evidence synthesis and that the variation of this judgment among experts generates uncertainty just as real as the probabilistic uncertainty of statistical calculations.
I never tire of repeating my rant that meta-analyses should never have been placed at the top of the evidence based medicine evidence hierarchy.And for that matter biological plausibility should never have relegated to lower rings of the ladder.
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