A report is out regarding a government study that demonstrated patients do not always take their medications as they should.Earlier work has suggested they do not always eat their vegetables. Not only do patients fail to take their medications regularly , they often take them incorrectly and stop medications that are supposed to be long term treatment, take them with food when they shouldn't and take them on a empty stomach when they should take them with food. There are even reports of patients not filling their prescriptions at all.
Dr. Carolyn Clancy, Director of the Agency for Healthcare Research and Quality , in announcing the results of the trial proposes an "in your face" campaign . Help seems to be on the way.
The success of previous government educational programs is the stuff of legends. Drunk driving,teenage sex, teenage use of drugs, to name just a few, have all been virtually eliminated.
Public Services Announcements have resulted in highways free of litter and it has become nearly impossible to find someone who does not floss or use sunscreen or a pregnant woman who smokes or drinks alcohol.A campaign to urge or cajole everyone to take their medications correctly will likely have similar impact.
Tuesday, July 31, 2007
Sunday, July 29, 2007
Shorter, more focused CPR course sounds better
Kudos to these folks who tried out a shorter version of the CPR course and found it worked better in terms of retention of concepts ( and less wasted time). Waste of time was always the main thing in my mind as I went through these courses on multiple occasions.The Red Cross and American Heart Association have padded their courses with so much fluff that it gets in the way of learning what folks need to learn from these courses. The key to learning things is practice, practice, practice and these courses typically let the filler material take time away from potential practice time. The use of the AEDs involves very simple techniques and I believe the traditional courses are less successful because they try to say too much.
Wednesday, July 25, 2007
American Heart Association gets on band wagon for pumping weights
Even since I heard the term "sarcopenia" I began to worry about this muscle loss that accelerates as we get older. I began to counsel patients about the changes described when the sex hormones begin to fall and that their weight could stay the same but the muscles mass decreases and the subtle increase in body fat replaces the muscle weight and little net weight gain occurs .
I became convinced that we all-regardless of gender-should add some resistance exercise to the aerobic programs that we all advocate for general health and sometimes do. Now the American Heart Association has seen the wisdom of this approach.
The story of what goes on mechanistically as our muscles wither away is of course still being worked out but some interesting aspects have been investigated.
There is disconcerting evidence that at least one factor in the diminution of muscle mass as we age is loss of motor neurons in the spinal cord. Until I read this review I had not considered that the muscle atrophy of old age could be neurotrophic but there is considerable evidence suggesting just that. Details can be found in Dr. Lexell's review linked above.
At least two lines of evidence is presented. First, there have been a fairly limited number of morphological studies involving the human lumbosacral cord showing loss of motor neurons after age sixty. One such study demonstrated an alarming 50% decrement in motor neurons in some subjects while the average was only 25% and another study reported a more reassuring loss of only 5%. The small numbers of subjects in these studies limits the accuracy of percentages that are quoted and we have to wonder how much individual variation in this process occurs. Secondly, the histological pattern of muscle loss is of the type seen when nerve fibers or nerve cells fail. As motor units drop out a process of compensatory reinnvervation kicks in and interestingly there is a tendency to replace some of the fast twitch fibers units with slow twitch units, a process referred to a motor unit remodeling. The muscle loss with aging is both in number and size of muscle cell and the fast twitch fibers are disproportionately involved. The remodeled motor units are less efficient, slower and generate less force.
Data also point to decreased numbers of fast twitch muscle fibers even in regular joggers and swimmers at least in the thigh muscles which are those usually tested and biopsied. This is not surprising as the the quadriceps do little more than contract on foot strike to stabilize the patella when we run on level ground and swimming is more a shoulder activity that a quad workout. So jogging or swimming will not immunize against sarcopenia.
Decreased muscle protein synthesis and various hormonal decrements also characterize aspects of the aging sarcopenic process. Replacement of growth hormone-which declines with aging-has not improved muscle strength and function. Muscle protein synthesis does increase with regular resistance training even in the very elderly and muscle function improves along with muscle strength and fiber size.
In short, the only thing to date that can mitigate sarcopenia is resistance training (RT). There are no data to indicate that we can stop motor neuron death but RT is all we've got.
I became convinced that we all-regardless of gender-should add some resistance exercise to the aerobic programs that we all advocate for general health and sometimes do. Now the American Heart Association has seen the wisdom of this approach.
The story of what goes on mechanistically as our muscles wither away is of course still being worked out but some interesting aspects have been investigated.
There is disconcerting evidence that at least one factor in the diminution of muscle mass as we age is loss of motor neurons in the spinal cord. Until I read this review I had not considered that the muscle atrophy of old age could be neurotrophic but there is considerable evidence suggesting just that. Details can be found in Dr. Lexell's review linked above.
At least two lines of evidence is presented. First, there have been a fairly limited number of morphological studies involving the human lumbosacral cord showing loss of motor neurons after age sixty. One such study demonstrated an alarming 50% decrement in motor neurons in some subjects while the average was only 25% and another study reported a more reassuring loss of only 5%. The small numbers of subjects in these studies limits the accuracy of percentages that are quoted and we have to wonder how much individual variation in this process occurs. Secondly, the histological pattern of muscle loss is of the type seen when nerve fibers or nerve cells fail. As motor units drop out a process of compensatory reinnvervation kicks in and interestingly there is a tendency to replace some of the fast twitch fibers units with slow twitch units, a process referred to a motor unit remodeling. The muscle loss with aging is both in number and size of muscle cell and the fast twitch fibers are disproportionately involved. The remodeled motor units are less efficient, slower and generate less force.
Data also point to decreased numbers of fast twitch muscle fibers even in regular joggers and swimmers at least in the thigh muscles which are those usually tested and biopsied. This is not surprising as the the quadriceps do little more than contract on foot strike to stabilize the patella when we run on level ground and swimming is more a shoulder activity that a quad workout. So jogging or swimming will not immunize against sarcopenia.
Decreased muscle protein synthesis and various hormonal decrements also characterize aspects of the aging sarcopenic process. Replacement of growth hormone-which declines with aging-has not improved muscle strength and function. Muscle protein synthesis does increase with regular resistance training even in the very elderly and muscle function improves along with muscle strength and fiber size.
In short, the only thing to date that can mitigate sarcopenia is resistance training (RT). There are no data to indicate that we can stop motor neuron death but RT is all we've got.
Monday, July 23, 2007
Still more on house staff duty restrictions-faculty angst
I have written before about the changes in house staff medial education in the post duty hour restrictions era and evoked some critical comments by house officers. Also, more recently I commented on articles in the Annals of Internal Medicine which seemed to provide some reassurance that at least there had been no negative effects on patient safety with the restrictions (some had feared that increased hand offs might lead to fumbles and more patient risk).
Well, the wheel is still in spin and now we have a different slant on the issue, one that is less reassuring in regard to the effects on resident education and medical school faculty job satisfaction which could affect faculty retention particularly in the already waning area of general internal medicine.
The July 23, 2007 issue of the Archives of Internal Medicine has a very interesting and I believe important article discussing the views of a number of medical school faculty members who have a list of what they believe to be significant negative aspects of the new resident educational landscape in internal medicine. Th WSJ medical blog covers this article here.
(Effect of Residency Duty-Hour Limits, Reed DA et al. Arch Int Med/Vol167 (no 14),p 1487)
140 key clinical faculty at 39 internal medicine residency programs were surveyed and 111 replied. The article give the results of that survey.
While no evidence of patient safety problems were presented the faculty reported worsening communication with patients and diminution in overall quality of care ( I am not sure how quality was defined). While there was said to be lower levels of resident fatigue and improved personal-professional life balance the faculty believed generally that resident education suffered as did the accountability of the residents to their patients along with decrease in the resident-patient relationship and according to some faculty there was worsening professionalism among the residents. As faculty did more work while house staff did less work, faculty satisfaction decreased. There seemed to be less time for teaching and learning.
This is not a hard data article but a presentation of the impressions of IM resident training program teachers most of whom trained in a era that was very different. One difference is that many faculty likely grew up medically with their limbic cortices branded with the concept that as a professional obligation they should place the needs of the patient above their needs and the primacy of that directive seems no longer to hold the same exhaled position in the medical ethical scheme.
The authors say this:
...with the increasing focus on safety and the advent of duty hour restrictions, our understanding of professionalism may be evolving to include greater valuation of personal needs.
I am still trying to figure out what that means but I do not think the major driver in the sea changes that have taken place in the medical education of residents is concern about work-life balance on the residents. As to what is, I hope to say more later.
Well, the wheel is still in spin and now we have a different slant on the issue, one that is less reassuring in regard to the effects on resident education and medical school faculty job satisfaction which could affect faculty retention particularly in the already waning area of general internal medicine.
The July 23, 2007 issue of the Archives of Internal Medicine has a very interesting and I believe important article discussing the views of a number of medical school faculty members who have a list of what they believe to be significant negative aspects of the new resident educational landscape in internal medicine. Th WSJ medical blog covers this article here.
(Effect of Residency Duty-Hour Limits, Reed DA et al. Arch Int Med/Vol167 (no 14),p 1487)
140 key clinical faculty at 39 internal medicine residency programs were surveyed and 111 replied. The article give the results of that survey.
While no evidence of patient safety problems were presented the faculty reported worsening communication with patients and diminution in overall quality of care ( I am not sure how quality was defined). While there was said to be lower levels of resident fatigue and improved personal-professional life balance the faculty believed generally that resident education suffered as did the accountability of the residents to their patients along with decrease in the resident-patient relationship and according to some faculty there was worsening professionalism among the residents. As faculty did more work while house staff did less work, faculty satisfaction decreased. There seemed to be less time for teaching and learning.
This is not a hard data article but a presentation of the impressions of IM resident training program teachers most of whom trained in a era that was very different. One difference is that many faculty likely grew up medically with their limbic cortices branded with the concept that as a professional obligation they should place the needs of the patient above their needs and the primacy of that directive seems no longer to hold the same exhaled position in the medical ethical scheme.
The authors say this:
...with the increasing focus on safety and the advent of duty hour restrictions, our understanding of professionalism may be evolving to include greater valuation of personal needs.
I am still trying to figure out what that means but I do not think the major driver in the sea changes that have taken place in the medical education of residents is concern about work-life balance on the residents. As to what is, I hope to say more later.
Friday, July 20, 2007
ABIM proposes certification in "comprehensive internal medicine"
The American Board of Internal Medicine (ABIM) is proposing still another piece of sanctified paper for internists to strive for and jump through hoops to obtain.
According to a news article in the July 1,2007 issue of Internal Medicine News, ABIM's Board of Directors has approved the concept and is moving forward awaiting the report of a committee,due in Feb. 2008, charged with the development of requirements.
This certification is to be optional and is called a Recognition of Focused Practice.
Apparently the board has endorsed the idea that "comprehensive internal medicine is different from what is recognized by the underlying general internal medicine certificate."
We get little information about exactly how this differs from what internists do typically.The article gives few hints. We are told that preliminary discussions about this certification lead to, according to Dr. Richard Baron, a "remarkably consistent vision". But as to specifics we are told only that the comprehensive internist should communicate effectively and have a deep knowledge of medicine and the patient.So far it sounds like what we thought we trained to do as internists and what I still think internists should do. So we need a specific certificate for that? There must be more to it. A Google search for "certification comprehensive internal medicine" lead to no useful hits. I could not find any further details on the ABIM's website. I guess if we approve of "bribing doctors" to do their job ( AKA P4P) we might as well give them an extra certificate for knowing their business and talking to patients.
This along with a similar certification for hospital medicine still awaits approval from the American Board of Medical Specialists. I don't know what the final requirements will be but I'll bet we will heard about performance indicators, electronic medical records and more hype about the "advanced medical home" and a team approach.
According to a news article in the July 1,2007 issue of Internal Medicine News, ABIM's Board of Directors has approved the concept and is moving forward awaiting the report of a committee,due in Feb. 2008, charged with the development of requirements.
This certification is to be optional and is called a Recognition of Focused Practice.
Apparently the board has endorsed the idea that "comprehensive internal medicine is different from what is recognized by the underlying general internal medicine certificate."
We get little information about exactly how this differs from what internists do typically.The article gives few hints. We are told that preliminary discussions about this certification lead to, according to Dr. Richard Baron, a "remarkably consistent vision". But as to specifics we are told only that the comprehensive internist should communicate effectively and have a deep knowledge of medicine and the patient.So far it sounds like what we thought we trained to do as internists and what I still think internists should do. So we need a specific certificate for that? There must be more to it. A Google search for "certification comprehensive internal medicine" lead to no useful hits. I could not find any further details on the ABIM's website. I guess if we approve of "bribing doctors" to do their job ( AKA P4P) we might as well give them an extra certificate for knowing their business and talking to patients.
This along with a similar certification for hospital medicine still awaits approval from the American Board of Medical Specialists. I don't know what the final requirements will be but I'll bet we will heard about performance indicators, electronic medical records and more hype about the "advanced medical home" and a team approach.
Tuesday, July 17, 2007
Great source for Travel Medicine reference
CDC has recently made available its "Yellow Book". This is free and is on line and is an invaluable source of authoritative information regarding travel medicine. For a number of years I did my fair share of travel medicine for several international companies and this publication is a necessity.
More on medical house staff work hour restrictions
I evoked a good deal of rather strong comments when I wrote about the ACGME mandated resident work restrictions. Let me go on the record and say I am not an advocate of having residents perform important medical tasks while in effect stoned from sleep deprivation. Sleep deprivation is a bad thing and when folks have to make decisions when they are fatigued and sleep deprived bad things will follow.
Medical educators all of whom have thought more and more deeply about it than I have expressed some of the same concerns that I did in a previous post. Simply put-will there be unintentional consequences and will some of those consequences not be a good thing. This would included errors involving hand offs, less educational opportunities for house staff, disruption of the typical work routines for other hospital personnel,even more fragmented patient care .
Two articles and an editorial in the recent issue of the Annals of Internal Medicine provide some reassurance for the older generation of physicians who in the twilight of their careers live mainly to ensure that the current generation of medical trainees suffer at least as much as they did during training. These two investigations found no evidence of significant harm to patients and while saying there is no evidence of harm is not equivalent to saying there is no harm, the editorial writers seemed convinced that the Hippocratic oath maxim of doing no harm had not been violated.
The editorial mentioned a new "ist" that I had not previously heard about. The term is "noturnalist". This seems to refer to attending hospitalists and moonlighting senior residents who fill in at night on the teaching service to make up for the restricted work hours of the house staff. This development is one probably of many to come as the residency programs and the institutions continue to adapt and make the new ACGME rules work better for all concerned.
Medical educators all of whom have thought more and more deeply about it than I have expressed some of the same concerns that I did in a previous post. Simply put-will there be unintentional consequences and will some of those consequences not be a good thing. This would included errors involving hand offs, less educational opportunities for house staff, disruption of the typical work routines for other hospital personnel,even more fragmented patient care .
Two articles and an editorial in the recent issue of the Annals of Internal Medicine provide some reassurance for the older generation of physicians who in the twilight of their careers live mainly to ensure that the current generation of medical trainees suffer at least as much as they did during training. These two investigations found no evidence of significant harm to patients and while saying there is no evidence of harm is not equivalent to saying there is no harm, the editorial writers seemed convinced that the Hippocratic oath maxim of doing no harm had not been violated.
The editorial mentioned a new "ist" that I had not previously heard about. The term is "noturnalist". This seems to refer to attending hospitalists and moonlighting senior residents who fill in at night on the teaching service to make up for the restricted work hours of the house staff. This development is one probably of many to come as the residency programs and the institutions continue to adapt and make the new ACGME rules work better for all concerned.
Tuesday, July 10, 2007
Eugenics-an idea whose time has (hopefully) gone
The July 9, 2007 issue of AMANEWS (subscription required) features a two page piece on the eugenics movement in the United States, highlighting the sterilization practices in the state of Indiana which has the unfortunate distinction of being the first state( and the first government entity in any country ) to enact a eugenic sterilization law. This may come as a surprise to some that the U.S. did this before Nazi Germany did.
Those who were complicit, directly or indirectly, included several past presidents of the AMA who were described by the article as being "affiliated with the ..movement" and Justice Oliver Wendell Holmes who in his opinion upholding the 1927 Indiana law stated " Three generation of imbeciles are enough."
A key element in the Nazification of German doctors was the acceptance of the notion that they were the physicians of the Volk and that their loyalty and duty was to the collective and not the individual. Once the idea that the individual should be sacrificed for the good of the group, there is no limit to the atrocities that may follow.
2,400 persons from Indiana were sterilized without their consent as well a total of 64,000 throughout the country as some 31 other states passed similar laws.
The article's author states:
"One important brake on a resurgence of eugenics, experts agree, is physicians' insistence on putting the welfare of individual patients before society's interest"
Also quoted is Dr. Paul. A. Lombardo who has written about the eugenics saga:
"The ethical grounding of the medical profession is in treating disease and caring for people,not caring, as the Nazis did , for the state or the larger collective."
Those who were complicit, directly or indirectly, included several past presidents of the AMA who were described by the article as being "affiliated with the ..movement" and Justice Oliver Wendell Holmes who in his opinion upholding the 1927 Indiana law stated " Three generation of imbeciles are enough."
A key element in the Nazification of German doctors was the acceptance of the notion that they were the physicians of the Volk and that their loyalty and duty was to the collective and not the individual. Once the idea that the individual should be sacrificed for the good of the group, there is no limit to the atrocities that may follow.
2,400 persons from Indiana were sterilized without their consent as well a total of 64,000 throughout the country as some 31 other states passed similar laws.
The article's author states:
"One important brake on a resurgence of eugenics, experts agree, is physicians' insistence on putting the welfare of individual patients before society's interest"
Also quoted is Dr. Paul. A. Lombardo who has written about the eugenics saga:
"The ethical grounding of the medical profession is in treating disease and caring for people,not caring, as the Nazis did , for the state or the larger collective."
Monday, July 09, 2007
A no-insurance practice works for one internist
I attended a dinner "CME"talk a month or so ago. Across the table was a physician who I knew as an oncologist with whom I had patients in common 10-12 years ago. He was a partner in a local clinic at the time but now he had changed to a solo private practice.
"I ain't gonna work on Maggie's farm no more"
He still sees some oncology patients, some left over from his old practice which he had left 3 years ago but basically he does general internal medicine which he said he enjoys a great deal. He said he accepts no insurance at all including Medicare.He spends as much time as he needs/wants with each patient.Typically one one hour plus with a new patient and typically 30-45 minutes with an old patient but often an hour if he hasn't seen them for a while. He tells me he gets almost no calls at night or on the weekend. He has a receptionist and a nurse and the receptionist collects most of the fees at the time of the appointment and for the rest he has a contract with a local accounting company to do the followup billing.There is no back room of three clerks calling insurance companies which my dermatologist needs to run his practice.Almost all of of his new patients are referred by former patients or their families.
The clinic where he had formerly worked had progressively restricted the time he could spend with a patient.It was down to fifteen minutes but right before he left the administrator and the executive committee agreed to require three additional patients per 9 hour day.
There are no insurance company clerks to call to approve a test, he feels no pressure to report to Medicare his quality indicators and he does not worry that one day he will be told by one of his patients that he has been delisted by their insurance company because of quality issues.
He tells me that every day for the last five or six years in his old practice he went to work mad and came home madder as third party payers demanded more and paid less and as his partners tried to adapt to it all by making more demands on everyone. Now he goes to work and looks forward to the day much as he did fifteen or more years ago.
His practice is not the concierge practice in which patients may pay a yearly fee to have ready access to their physician rather his is all pay per encounter.
His practice may not be for everyone but he seems to have made it work.More power to him.
"Well, he hands you a nickle
he hands you a dime
he asks you with a grin
if you're having a good time" ....
"No I ain't gonna work on Maggie's farm no more."
Quoted Lyrics are ,of course, from Bob Dylan ( copyright 1965)
"I ain't gonna work on Maggie's farm no more"
He still sees some oncology patients, some left over from his old practice which he had left 3 years ago but basically he does general internal medicine which he said he enjoys a great deal. He said he accepts no insurance at all including Medicare.He spends as much time as he needs/wants with each patient.Typically one one hour plus with a new patient and typically 30-45 minutes with an old patient but often an hour if he hasn't seen them for a while. He tells me he gets almost no calls at night or on the weekend. He has a receptionist and a nurse and the receptionist collects most of the fees at the time of the appointment and for the rest he has a contract with a local accounting company to do the followup billing.There is no back room of three clerks calling insurance companies which my dermatologist needs to run his practice.Almost all of of his new patients are referred by former patients or their families.
The clinic where he had formerly worked had progressively restricted the time he could spend with a patient.It was down to fifteen minutes but right before he left the administrator and the executive committee agreed to require three additional patients per 9 hour day.
There are no insurance company clerks to call to approve a test, he feels no pressure to report to Medicare his quality indicators and he does not worry that one day he will be told by one of his patients that he has been delisted by their insurance company because of quality issues.
He tells me that every day for the last five or six years in his old practice he went to work mad and came home madder as third party payers demanded more and paid less and as his partners tried to adapt to it all by making more demands on everyone. Now he goes to work and looks forward to the day much as he did fifteen or more years ago.
His practice is not the concierge practice in which patients may pay a yearly fee to have ready access to their physician rather his is all pay per encounter.
His practice may not be for everyone but he seems to have made it work.More power to him.
"Well, he hands you a nickle
he hands you a dime
he asks you with a grin
if you're having a good time" ....
"No I ain't gonna work on Maggie's farm no more."
Quoted Lyrics are ,of course, from Bob Dylan ( copyright 1965)
Wednesday, July 04, 2007
Clinical trials-another aspect of their complexity
The randomized clinical trial proudly sits atop the evidence based medicine (EBM) epistemological hierarchy. The RCT's ability to minimize known and unknown confounders suits it well (when done well) to identify efficacious treatments and to identify common side effects.
However ,subtleties lurk under the surface.One seemingly simple issue turns out to be more complicated and nuanced that it seems at first analysis. that issue is "when to stop a trial"? If the treatment under study is shown to be efficacious before the trial's planned end point, is it ethical to continue the trial while depriving those who receive the placebo for the test drug's benefit? Is it ethical to stop a trial early- possibly before there has been enough experience to find out about common adverse reactions? Will "premature" conclusions prematurely limit future research into that topic? Will any harm from premature erroneous conclusions be amplified by over-reaching ,zealous guideline authors leading to economic sanctions to those physicians who shun the dogma of the day?
Two articles in the June 19, 2007 issue of the Annals of Internal Medicine explore this issue.Dr. Mueller et al have written a Perspective piece entitled "Ethical Issues in Stopping Randomized Trials Early Because of Apparent Benefit" and Steven Goodman offers an editorial that provides a counterpoint.
Like other issues that seem to be on the front burner in current medical care discussion the underlying theme is the conflict between the individual's benefits and the benefit of the group or the collective.
Mueller and co-authors in presenting the theme that early stopping of a trial may give an overestimate of the drug's benefit use the example of a RCT using bisoprolol in patients undergoing noncardiac surgery which was stopped early because of an apparent large relative risk reduction in the treatment arm.The AHA and American college of cardiology jumped on the finding and issued recommendations. Subsequently two larger trials failed to show any cardiac risk reduction.
Mueller also quotes a systematic analysis that demonstrated that early stopped trials often lead to a significant overestimation of benefit. Goodman ,however, in his rejoinder states that the analysis only looked at that trials that stopped early whereas he contends that the proper denominator should have all trials that used stopping rules and when that is considered much of the overestimation of benefit seems to evaporate.
Rather than simply not stopping trials early Goodman believes that proper use of Bayesian analysis would go a long way to mitigate the problem raised by Mueller.The Bayesian approach basically is using prior experience and context to help decide if a trial should be stopped .
There is much more to each side that I have presented so far; the issue is complex.On the one hand, we have the issue of doing what is right for those trial participants and on the other what would be right for future patients .
Goodman ( Goodman, SN, "Stopping at Nothing?Some Dilemmas of Data Monitoring in Clinical Trials", Annals Internal Medicine, 2007;146:882-887) states it this way:
This is an extraordinarily difficult question, as scientists will differ in their assessment of both how much we have learned and how much we need to learn. There is no clear ethical guidance on the matter;the utilitarian perspective will put more weight on future patients ,whereas ethical theories that place more value on obligations and individual dignity will favor the interests of patients in the trial.
Even when my caffeine titer is maximized I have difficulty sorting out conflicting arguments of the epidemiologist-statisticians. I read Goodman and he seems right , I read Mueller and his arguments are also convincing even though his are more Utilitarian based and those ideas fare less well with my libertarian biases. My simplistic conclusion is that I need to be even more skeptical ( if that is possible) when RCTs are stopped early.
However ,subtleties lurk under the surface.One seemingly simple issue turns out to be more complicated and nuanced that it seems at first analysis. that issue is "when to stop a trial"? If the treatment under study is shown to be efficacious before the trial's planned end point, is it ethical to continue the trial while depriving those who receive the placebo for the test drug's benefit? Is it ethical to stop a trial early- possibly before there has been enough experience to find out about common adverse reactions? Will "premature" conclusions prematurely limit future research into that topic? Will any harm from premature erroneous conclusions be amplified by over-reaching ,zealous guideline authors leading to economic sanctions to those physicians who shun the dogma of the day?
Two articles in the June 19, 2007 issue of the Annals of Internal Medicine explore this issue.Dr. Mueller et al have written a Perspective piece entitled "Ethical Issues in Stopping Randomized Trials Early Because of Apparent Benefit" and Steven Goodman offers an editorial that provides a counterpoint.
Like other issues that seem to be on the front burner in current medical care discussion the underlying theme is the conflict between the individual's benefits and the benefit of the group or the collective.
Mueller and co-authors in presenting the theme that early stopping of a trial may give an overestimate of the drug's benefit use the example of a RCT using bisoprolol in patients undergoing noncardiac surgery which was stopped early because of an apparent large relative risk reduction in the treatment arm.The AHA and American college of cardiology jumped on the finding and issued recommendations. Subsequently two larger trials failed to show any cardiac risk reduction.
Mueller also quotes a systematic analysis that demonstrated that early stopped trials often lead to a significant overestimation of benefit. Goodman ,however, in his rejoinder states that the analysis only looked at that trials that stopped early whereas he contends that the proper denominator should have all trials that used stopping rules and when that is considered much of the overestimation of benefit seems to evaporate.
Rather than simply not stopping trials early Goodman believes that proper use of Bayesian analysis would go a long way to mitigate the problem raised by Mueller.The Bayesian approach basically is using prior experience and context to help decide if a trial should be stopped .
There is much more to each side that I have presented so far; the issue is complex.On the one hand, we have the issue of doing what is right for those trial participants and on the other what would be right for future patients .
Goodman ( Goodman, SN, "Stopping at Nothing?Some Dilemmas of Data Monitoring in Clinical Trials", Annals Internal Medicine, 2007;146:882-887) states it this way:
This is an extraordinarily difficult question, as scientists will differ in their assessment of both how much we have learned and how much we need to learn. There is no clear ethical guidance on the matter;the utilitarian perspective will put more weight on future patients ,whereas ethical theories that place more value on obligations and individual dignity will favor the interests of patients in the trial.
Even when my caffeine titer is maximized I have difficulty sorting out conflicting arguments of the epidemiologist-statisticians. I read Goodman and he seems right , I read Mueller and his arguments are also convincing even though his are more Utilitarian based and those ideas fare less well with my libertarian biases. My simplistic conclusion is that I need to be even more skeptical ( if that is possible) when RCTs are stopped early.
Thursday, June 28, 2007
Medical "Air quality" in airplane cabins and resistant TB
I have held for a long time an erroneous idea of the risk of disease transmission aboard airplanes.I envisioned the passenger cabin as some sort of 3-d Petri disk crammed full of various viruses and other pathogens.
An excellent article in the July 2007 issue of Mayo Clinic Proceedings corrected my misconceptions. The editorial " Dealing with threat of Drug-resistant Tuberculosis" written by Dr. Priya Sampathkumar is an excellent review of the basics of drug resistant TB and the quality of air in a plane from a medical point of view and can be found free, full text here.
The recent news stories of a person with XDR-TB (extensively drug resistant TB) traveling repeatedly by air from country to country greatly increases the interest level of this article.
He tells us that the recommended rate of air exchanges in a hospital isolation room for TB is 6-12 exchanges per hour. Modern aircraft have 20-30 exchanges per hour.Further,there are high efficiency particular air filters that remove 99.9% of particles that are between 0.1 and 0.3 micra. Mycobacterium is about 0.5 to 1.0 micra. More reassurance comes from the fact that air enters and leaves the cabin at the same seat row so that there is little flow from the front to the back of the plane. Of course, all of this assumes everything is working as it should and as always anything that can work can break down.
Consistent with this description of how the air is handled in planes is the observation that in all instances of transmission of TB on board a commercial airliner occurred to passengers who were seated within 2 rows of the index case.
The scary factor of the Andrew Speaker case was greatly enhanced by the fact he had XDR-TB. Regular-that is drug sensitive TB-is no longer a scary disease. Treatment with first line drugs for six to nine months results in a cure in 95% of patients.MDR-TB is defined as TB being resistant to both INH and Rifampin and treatment with the less effective,often poorly tolerated second line drugs for 18 to 24 months results in cure anywhere from 50% to 70% of the time.
MDR-TB burst on the scene in the early 1990s mainly in patients who were infected with HIV in whom the mortality rate approached 80% and there were reported instances of transmission to health care workers and prison guards.In 2005 there were 95 cases reported in the U.S but according to the National Jewish website 450,000 cases worldwide.
XDR-TB appeared in 2005 in an outbreak in South Africa and is characterized by resistance to INH,Rifampin,a fluroquinolone, and at least one of the three injectable drugs.From 1993 to 2006 in the United states, 49 cases have been reported with 12 deaths and 12 loss to followup.National Jewish has treated a small number of cases and states that their treatment including resectional surgery may result in a 50% cure rate.Until MDR-TB and XDR-TB came on the scene, surgery for TB was largely a history book chapter, not so now.
An excellent article in the July 2007 issue of Mayo Clinic Proceedings corrected my misconceptions. The editorial " Dealing with threat of Drug-resistant Tuberculosis" written by Dr. Priya Sampathkumar is an excellent review of the basics of drug resistant TB and the quality of air in a plane from a medical point of view and can be found free, full text here.
The recent news stories of a person with XDR-TB (extensively drug resistant TB) traveling repeatedly by air from country to country greatly increases the interest level of this article.
He tells us that the recommended rate of air exchanges in a hospital isolation room for TB is 6-12 exchanges per hour. Modern aircraft have 20-30 exchanges per hour.Further,there are high efficiency particular air filters that remove 99.9% of particles that are between 0.1 and 0.3 micra. Mycobacterium is about 0.5 to 1.0 micra. More reassurance comes from the fact that air enters and leaves the cabin at the same seat row so that there is little flow from the front to the back of the plane. Of course, all of this assumes everything is working as it should and as always anything that can work can break down.
Consistent with this description of how the air is handled in planes is the observation that in all instances of transmission of TB on board a commercial airliner occurred to passengers who were seated within 2 rows of the index case.
The scary factor of the Andrew Speaker case was greatly enhanced by the fact he had XDR-TB. Regular-that is drug sensitive TB-is no longer a scary disease. Treatment with first line drugs for six to nine months results in a cure in 95% of patients.MDR-TB is defined as TB being resistant to both INH and Rifampin and treatment with the less effective,often poorly tolerated second line drugs for 18 to 24 months results in cure anywhere from 50% to 70% of the time.
MDR-TB burst on the scene in the early 1990s mainly in patients who were infected with HIV in whom the mortality rate approached 80% and there were reported instances of transmission to health care workers and prison guards.In 2005 there were 95 cases reported in the U.S but according to the National Jewish website 450,000 cases worldwide.
XDR-TB appeared in 2005 in an outbreak in South Africa and is characterized by resistance to INH,Rifampin,a fluroquinolone, and at least one of the three injectable drugs.From 1993 to 2006 in the United states, 49 cases have been reported with 12 deaths and 12 loss to followup.National Jewish has treated a small number of cases and states that their treatment including resectional surgery may result in a 50% cure rate.Until MDR-TB and XDR-TB came on the scene, surgery for TB was largely a history book chapter, not so now.
Wednesday, June 27, 2007
Some of the unintended consequences of restrictions on house officer hours
The NEJM (June 28,2007) has two commentaries regarding the fall out and continuing analysis of the effects of the changes in house officer hours and rules governing how much time the trainees can work at the hospital.One of the two is available full text for free and can be found here. There is also an audio file interviewing Dr. Ethan Fried, a residency program director.
There is a tension between the hoped-for reduction in errors by having better rested residents and the fear of increased errors and dropped balls by having frequent hand-offs between teams of residents. Dr. Fried believes there may be more risk of the latter in the first day of admission to a hospital but also believes that the supervision and backup by more senior residents can mitigate that tendency.
In addition to the issue of is-the -new- system -less- error prone, there is the fact that since house officers are working less someone else has to. Accordingly, there is a trend to having non-teaching services maned by hospitalists and NPs and PAs at a cost some institutions are hard pressed to bear.
But, in my view even more important is what the new system might do to the evolving competency and mind set of the residents. This issue is discussed by Dr.Wes with his usual insightful analysis.
He wonders if an error free residency what we really want? Do we not learn in part by making errors in an environment where we are buffered and protected by our mentors and more senior colleagues?How will this cohort of residents fare when they are truly out on their own and there will be no team to hand off to when they have been up most of the night taking care of patients and fielding phone calls? Will they call their office and tell them they won't be in until noon because they need their protected ten hours post call ?.
The ACGME kicked off this major change in post graduate medical education in July 2003 and now four years later we seem to be seeing the fall out of a program that may have been initiated and mandated without sufficient planning regarding what now seems obvious collateral effects.The jury is still out regarding if this restricted duty plan actually improves safety or paradoxically has the opposite effect while increasing costs.
When I am old (OK, older) and sick will I want my medical advocate (wife) to insist on a physician who finished his training before July 2003? I have ranted before about the effects of changes in the IM program brought about by ACGME that in my opinion result in a marked loss of the sense of personal responsibility by the doctor for the patient. Teams and systems and protocols and flow charts are no substitute for a physician who believes she is personally responsible for the medical welfare of her patient even if she may be tired. A shift work mentality may be fine for a factory worker but when I grew up medically it was unthinkable for a physician.
There is a tension between the hoped-for reduction in errors by having better rested residents and the fear of increased errors and dropped balls by having frequent hand-offs between teams of residents. Dr. Fried believes there may be more risk of the latter in the first day of admission to a hospital but also believes that the supervision and backup by more senior residents can mitigate that tendency.
In addition to the issue of is-the -new- system -less- error prone, there is the fact that since house officers are working less someone else has to. Accordingly, there is a trend to having non-teaching services maned by hospitalists and NPs and PAs at a cost some institutions are hard pressed to bear.
But, in my view even more important is what the new system might do to the evolving competency and mind set of the residents. This issue is discussed by Dr.Wes with his usual insightful analysis.
He wonders if an error free residency what we really want? Do we not learn in part by making errors in an environment where we are buffered and protected by our mentors and more senior colleagues?How will this cohort of residents fare when they are truly out on their own and there will be no team to hand off to when they have been up most of the night taking care of patients and fielding phone calls? Will they call their office and tell them they won't be in until noon because they need their protected ten hours post call ?.
The ACGME kicked off this major change in post graduate medical education in July 2003 and now four years later we seem to be seeing the fall out of a program that may have been initiated and mandated without sufficient planning regarding what now seems obvious collateral effects.The jury is still out regarding if this restricted duty plan actually improves safety or paradoxically has the opposite effect while increasing costs.
When I am old (OK, older) and sick will I want my medical advocate (wife) to insist on a physician who finished his training before July 2003? I have ranted before about the effects of changes in the IM program brought about by ACGME that in my opinion result in a marked loss of the sense of personal responsibility by the doctor for the patient. Teams and systems and protocols and flow charts are no substitute for a physician who believes she is personally responsible for the medical welfare of her patient even if she may be tired. A shift work mentality may be fine for a factory worker but when I grew up medically it was unthinkable for a physician.
Tuesday, June 19, 2007
Alternative Medicine-homeopathy allowed in ACCP's journal, Chest
I was thumbing through a older issue of the journal, Chest and by looking at the summary and title of a particular article nothing much seemed unusual or really very interesting. However, the last paragraph of the discussion section gave me a very different view .
The title was "Influence of Potassium Dichomate on Tracheal secretions in Critically Ill Patients". Nothing out of the ordinary there. But go down to the affiliation of the authors and we see that three are from a School of Homeopathy in Austria. (Chest/127/3/March 2005, p. 936).
Here is a link to the article.
Then, in the material and methods section we are told that:
"we used a preparation of C30,which is equivalent to a potentiation of 30 dilutions in which each of the 30 dilutions steps is foll0wed by subsequent succussions.Therefore the [well known toxic effects of chromium if undiluted] were eliminated". Certainly at that dilution (a 30C dilution is dilution by a factor of 100 to the 30th power), the test liquid is very unlikely to have any K dichomate in the liquid at all.It is just water. Apparently, in the homeopathy belief system one can make a solution so dilute as to make it non toxic but somehow allow it to retain-or gain-some therapeutic effect.
But the discussion section is best of all. It ends with the following:
While the mechanism of potentized ( diluted and vigorously shaken )drugs remains subject to research...the effect may be best explained by cybernetics,which means that the information of the homeopathic drugs act consensually on the regulator.Thereby, the body regains its original property to regulate physical parameters
This is not written in the language of science but in the language of woo. It is hard to believe that the editors of the journal of the American College of Chest Physicians,none of whom claim to be homeopathic practitioners,would publish such an article.The final paragraph does not even make sense to a non-homeopathic believer and no effort is made to even try and explain what the heck they are taking about when they refer to a drug acting consensually on the regulator or regaining one's original property.
The Journal does a disservice to its readers when it presents a homeopathic jargon filled discussion as if a scientific discussion is taking place. There was no editorial explaining the reasoning behind publishing such an article.One of the characteristics of science is its coherence.The sciences of pharmacology,physiology and toxicology build upon and are consistent with the laws of chemistry and physics.To talk about diluting a substance to the point where it is undetectable and then explaining how it works to heal flies in the face of the principles of those disciplines.It is too late to write a letter to the editor but I hope someone did.
The title was "Influence of Potassium Dichomate on Tracheal secretions in Critically Ill Patients". Nothing out of the ordinary there. But go down to the affiliation of the authors and we see that three are from a School of Homeopathy in Austria. (Chest/127/3/March 2005, p. 936).
Here is a link to the article.
Then, in the material and methods section we are told that:
"we used a preparation of C30,which is equivalent to a potentiation of 30 dilutions in which each of the 30 dilutions steps is foll0wed by subsequent succussions.Therefore the [well known toxic effects of chromium if undiluted] were eliminated". Certainly at that dilution (a 30C dilution is dilution by a factor of 100 to the 30th power), the test liquid is very unlikely to have any K dichomate in the liquid at all.It is just water. Apparently, in the homeopathy belief system one can make a solution so dilute as to make it non toxic but somehow allow it to retain-or gain-some therapeutic effect.
But the discussion section is best of all. It ends with the following:
While the mechanism of potentized ( diluted and vigorously shaken )drugs remains subject to research...the effect may be best explained by cybernetics,which means that the information of the homeopathic drugs act consensually on the regulator.Thereby, the body regains its original property to regulate physical parameters
This is not written in the language of science but in the language of woo. It is hard to believe that the editors of the journal of the American College of Chest Physicians,none of whom claim to be homeopathic practitioners,would publish such an article.The final paragraph does not even make sense to a non-homeopathic believer and no effort is made to even try and explain what the heck they are taking about when they refer to a drug acting consensually on the regulator or regaining one's original property.
The Journal does a disservice to its readers when it presents a homeopathic jargon filled discussion as if a scientific discussion is taking place. There was no editorial explaining the reasoning behind publishing such an article.One of the characteristics of science is its coherence.The sciences of pharmacology,physiology and toxicology build upon and are consistent with the laws of chemistry and physics.To talk about diluting a substance to the point where it is undetectable and then explaining how it works to heal flies in the face of the principles of those disciplines.It is too late to write a letter to the editor but I hope someone did.
Saturday, June 16, 2007
Old wine-new bottles-you have to be a doctor to the whole village?
Dr. David Eddy authored a series of articles in JAMA ( Eddy DM. Rationing resources while improving quality.How to get more for less.JAMA.1994:272,817-824) promising to tell the great unwashed cadre of trench dwelling physicians how they could increase quality and save money at the same time. The trick was the utilitarian imperative-do the greatest good for the greatest number. In his moral calculus it was not only appropriate but it was ethically demanded that, for example, one would not waste money by for example offering yearly mammograms to women between 40 and 50 if a greater bang for the buck could be achieved by offering smoking cessation session to pregnant women. Cost effectiveness analysis was to guide what was offered to the group It was the health of the collective that mattered and that was true even if the collective was a thrown together bunch of strangers whose employers happened to sign up to a given HMO. The traditional fiduciary duty of the doctor to the patient as well as the legal manifestation of that relationship and the aspect of human nature that says I want what is best for my health and my family's health not for some alleged aspect of a fictional collective would have to moved past and we would be on the road to the solution for all that ails American medicine and health care. Doctors should not be hoarding resources for their patients.
Policies create winners and losers , a point that Dr. Eddy did not deny.He spoke of the consequences of "allocating a limited pool of resources to maximize the health of all of the people[in the]pool"even if that meant some would loose out on a benefit. The argument that the "insurance pool" or HMO population or some other organizational collective would gain if the net gains would outweigh the net loses is to endorse a utilitarian ethic but also relies on the cost-benefit assumption that everyone is the same so that costs and benefits can be appropriately aggregated.
In a recent JAMA commentary, the President of the American College of Physicians and the Chief Medical Officer of Aetna ( Dr. Christine K Cassel and Dr. Troyen E.. Brennan) expound on how the ails of American medical care can be remedied. Their exposition seems to me a rehash of Eddy's series although I missed where the authors admitted that there are some who would loose out in the collective cost benefit analysis driven policy decisions.(JAMA ,June 13, 2007, Vol 297, no. 22, p. 2518, "Managing Medical resources.Return to the Commons"
They speak of an abstract hypothetical " medical commons" and how the current emphasis by the physician on the welfare of the individual patient will spoil the commons much as the farmer who selfishly grazes his cattle on public land without regard for depleting the resource will destroy the resource.Physicians are implored to "reconstitute the medical commons" and think in terms of resource conservation and allocation so at the end the greatest medical good can be done for the greatest number of patients.They admit there is not currently such a commons. There never has been so I am unsure how a return is possible.
The medical commons figure of speech seems particularly lame.While a grassy knoll for the villager's sheep can be defined by a specific surveyor description, the "medical commons" is a extremely large amorphous array,the elements of which almost defy enumeration, and every changing, with some elements growing ,others contracting and innovations cropping up constantly.There is no easily defined entity called "medical resources";it is an amorphous abstraction.Further, to speak of allocation means some one or some elite group will be the "allocator in chief ". Decisions will not be made by thousands of individual physician-patient pairs.
Cassel and Brennan assert that a market based or a regulatory approach will allocate resources without the caring and wisdom that clinicians can bring to the endeavor. In their analysis the only choice is a medical commons with physicians and patients moving hand in hand willing to put aside the petty concerns of the individual when necessary for the greatest good of the group.Collectivism has been so successful in the past, why would it not work here?
Does American medicine have many troublesome problems? Yes, it does. I cannot see a rehash of Utilitarian ethics and a very bad analogy and some pie-in-the sky medical collective farm fixing much of anything.
Policies create winners and losers , a point that Dr. Eddy did not deny.He spoke of the consequences of "allocating a limited pool of resources to maximize the health of all of the people[in the]pool"even if that meant some would loose out on a benefit. The argument that the "insurance pool" or HMO population or some other organizational collective would gain if the net gains would outweigh the net loses is to endorse a utilitarian ethic but also relies on the cost-benefit assumption that everyone is the same so that costs and benefits can be appropriately aggregated.
In a recent JAMA commentary, the President of the American College of Physicians and the Chief Medical Officer of Aetna ( Dr. Christine K Cassel and Dr. Troyen E.. Brennan) expound on how the ails of American medical care can be remedied. Their exposition seems to me a rehash of Eddy's series although I missed where the authors admitted that there are some who would loose out in the collective cost benefit analysis driven policy decisions.(JAMA ,June 13, 2007, Vol 297, no. 22, p. 2518, "Managing Medical resources.Return to the Commons"
They speak of an abstract hypothetical " medical commons" and how the current emphasis by the physician on the welfare of the individual patient will spoil the commons much as the farmer who selfishly grazes his cattle on public land without regard for depleting the resource will destroy the resource.Physicians are implored to "reconstitute the medical commons" and think in terms of resource conservation and allocation so at the end the greatest medical good can be done for the greatest number of patients.They admit there is not currently such a commons. There never has been so I am unsure how a return is possible.
The medical commons figure of speech seems particularly lame.While a grassy knoll for the villager's sheep can be defined by a specific surveyor description, the "medical commons" is a extremely large amorphous array,the elements of which almost defy enumeration, and every changing, with some elements growing ,others contracting and innovations cropping up constantly.There is no easily defined entity called "medical resources";it is an amorphous abstraction.Further, to speak of allocation means some one or some elite group will be the "allocator in chief ". Decisions will not be made by thousands of individual physician-patient pairs.
Cassel and Brennan assert that a market based or a regulatory approach will allocate resources without the caring and wisdom that clinicians can bring to the endeavor. In their analysis the only choice is a medical commons with physicians and patients moving hand in hand willing to put aside the petty concerns of the individual when necessary for the greatest good of the group.Collectivism has been so successful in the past, why would it not work here?
Does American medicine have many troublesome problems? Yes, it does. I cannot see a rehash of Utilitarian ethics and a very bad analogy and some pie-in-the sky medical collective farm fixing much of anything.
Friday, June 15, 2007
Oncologists accused of giving chemo.for profit not patient benefit
I do not want to believe that oncologists would give chemotherapy(CMT) to patients who they do not believe would likely benefit simply because they can make a profit on their mark-up on the drugs they administer. I have always had nothing but admiration for oncologists who day by day deal with seriously ill and dying patients and manage to be current and proficient in the variety of cancers they treat and the multiplicity of drug regimens and toxicities and complications.
The ones I have practiced with deserve to be called physicians with all the positive connotations that term can garner.
A recent article in the NYT paints a different picture of some oncologists. Here is some background.For a number of years CMT has been given in oncologists offices. The CMS and third party payers fees exceeded the costs to the docs so there is a make up profit involved. Recently, changes in CMS rules have cut the margin .
The gist of the NYT article is that oncologists are making up for the shortfall with an increase in volume of patients treated with CMT implying that some patients are being given CMT inappropriately.
NYT quotes Dr. Richard Deyo ,a professor at the University of Washington,describing him as a"expert in health care spending" as saying:
There's pretty good evidence at this point that there are plenty of patients for whom there's little hope,who are terminally ill,whom chemotherapy is not going to help, who get chemotherapy
That comment, like most of the NYT article, is heavy on accusations and generalizations and light on supporting data and facts. Dr. Deyo may have analyzed numerous cases and determined that in many instances the CMT was inappropriate but if so I would like to see that analysis. What is the nature of the evidence for his statement? I would be very surprised if Deyo's comments are based on patient level data in which cases are analysed by physicians expert in CMT and wherein inappropriate treatment was found in "plenty of patients". I would not be surprised if that type thing has happened in some cases but I doubt that level of data is what Deyo's statements is based on. Broad brush, coarse grain data is the more likely currency for the type outcomes research that Deyo has been known for (and has gained a well deserved reputation for his work in low back pain treatment outcomes). He may have well done some outcomes research in the CMT area and his comments may have based on that but if there is such data he should have made that fact known to the NYT reporter so the article would appear less like a typical drive-by-media encounter. If he does not have that data, then he may have done disservice to the thousands of patients now receiving CMT who may now wonder if it is avarice and not likelihood of benefit that formed the basis of the decision to treat them.
The ones I have practiced with deserve to be called physicians with all the positive connotations that term can garner.
A recent article in the NYT paints a different picture of some oncologists. Here is some background.For a number of years CMT has been given in oncologists offices. The CMS and third party payers fees exceeded the costs to the docs so there is a make up profit involved. Recently, changes in CMS rules have cut the margin .
The gist of the NYT article is that oncologists are making up for the shortfall with an increase in volume of patients treated with CMT implying that some patients are being given CMT inappropriately.
NYT quotes Dr. Richard Deyo ,a professor at the University of Washington,describing him as a"expert in health care spending" as saying:
There's pretty good evidence at this point that there are plenty of patients for whom there's little hope,who are terminally ill,whom chemotherapy is not going to help, who get chemotherapy
That comment, like most of the NYT article, is heavy on accusations and generalizations and light on supporting data and facts. Dr. Deyo may have analyzed numerous cases and determined that in many instances the CMT was inappropriate but if so I would like to see that analysis. What is the nature of the evidence for his statement? I would be very surprised if Deyo's comments are based on patient level data in which cases are analysed by physicians expert in CMT and wherein inappropriate treatment was found in "plenty of patients". I would not be surprised if that type thing has happened in some cases but I doubt that level of data is what Deyo's statements is based on. Broad brush, coarse grain data is the more likely currency for the type outcomes research that Deyo has been known for (and has gained a well deserved reputation for his work in low back pain treatment outcomes). He may have well done some outcomes research in the CMT area and his comments may have based on that but if there is such data he should have made that fact known to the NYT reporter so the article would appear less like a typical drive-by-media encounter. If he does not have that data, then he may have done disservice to the thousands of patients now receiving CMT who may now wonder if it is avarice and not likelihood of benefit that formed the basis of the decision to treat them.
Thursday, June 14, 2007
JAMA commentary: Medical commons -conflict of interest?
The journal of the American College of Physicians (ACP), the Annals of Internal Medicine, in 2006 featured a five page article in which the former CEO, and then current board member of Aetna, Dr. John W. Rowe, pontificated on the "moral basis for physicians..to participate in...[P4P]." I commented on that article at the time and noted that Aetna's reputation among practicing physicians was such that Dr. Rowe might not have been the most credible witness to present the case for P4P , a movement which the ACP has tended to favor.
More recently, the current President and CEO of the ACP, Dr. Christine K. Cassel, has teamed with another officer of Aetna, Dr. Troyen E. Brennan, to offer further ethical and moral pronouncements regarding the "responsibility" of physicians. This commentary, " Managing Medical Resources-return to the Commons?", can be found in the June 2003,2007 issue of JAMA (vol.297,no.22 pg 2518).
I will leave a more detailed analysis of their apparent proposal for the establishment of "integrated delivery systems" as "accountable care organizations" (sound like big HMO-like entities to me) and the assumption of those groups of responsibility for a population to another time and focus now on what seems to be a major conflict of interest regarding Dr. Brennan.
Early in the article the authors correctly point out that the inclusion of the duty on the part of physicians to "manage medical resources" that is found in the Physician's Charter on Medical Professionalism is controversial as it conflicts with the primary duty of the physician to the patient. They then ask is "this [responsibility] really our duty?
"Our" is used by Dr. Brennan to apparently speak as a member and express commonality with the group of physicians who "live and work in [what he describes] as a medical commons and bear responsibility for it". Dr. Brennan does hold a M.D. degree and has practised medicine but he is currently an officer (A senior vice president) of large insurance company involved in medical insurance and managed care and as such has a fiduciary duty to foster that organization and work to improve its profits.
The authors , later in the commentary, again correctly note that practicing physicians are skeptical about any savings generated by "quality" or P4P programs will find its way to actually improving or expanding medical care. Would not this firmly based skepticism regarding the motives and actions of insurance companies not also target any proposal made by a officer of Aetna?
I cannot understand how officers of ACP and editors of their journal believe that their case for whatever changes they recommended in U.S. health care will be moved forward by having as a partners in that advocacy officers of a insurance company whose business practices ultimately lead to a very large settlement in a class action brought by a number of state medical societies. (Details of that settlement can be found here). When one argues for a given proposal tactical concerns would seem to favor presenting a credible spokesman.
The capitation type system proposed is unlikely to gain traction as long as physicians continue to believe and act as if their primary duty is to the individual patient and not to the collective.This article seems , in part, an effort to disabuse physicians of this ethical imperative which the authors may consider an obstacle to their scheme to "ensure proper allocation of health care resources".
Both Dr. Cassel and Dr. Brennan close their disclosure statement stating that the views expressed are those of the authors and do not necessarily reflect the opinions of either institution. It would be hard to believe that Aetna would allow one of its officers to publish an article in a widely read medical journal without agreeing with its contents.
More recently, the current President and CEO of the ACP, Dr. Christine K. Cassel, has teamed with another officer of Aetna, Dr. Troyen E. Brennan, to offer further ethical and moral pronouncements regarding the "responsibility" of physicians. This commentary, " Managing Medical Resources-return to the Commons?", can be found in the June 2003,2007 issue of JAMA (vol.297,no.22 pg 2518).
I will leave a more detailed analysis of their apparent proposal for the establishment of "integrated delivery systems" as "accountable care organizations" (sound like big HMO-like entities to me) and the assumption of those groups of responsibility for a population to another time and focus now on what seems to be a major conflict of interest regarding Dr. Brennan.
Early in the article the authors correctly point out that the inclusion of the duty on the part of physicians to "manage medical resources" that is found in the Physician's Charter on Medical Professionalism is controversial as it conflicts with the primary duty of the physician to the patient. They then ask is "this [responsibility] really our duty?
"Our" is used by Dr. Brennan to apparently speak as a member and express commonality with the group of physicians who "live and work in [what he describes] as a medical commons and bear responsibility for it". Dr. Brennan does hold a M.D. degree and has practised medicine but he is currently an officer (A senior vice president) of large insurance company involved in medical insurance and managed care and as such has a fiduciary duty to foster that organization and work to improve its profits.
The authors , later in the commentary, again correctly note that practicing physicians are skeptical about any savings generated by "quality" or P4P programs will find its way to actually improving or expanding medical care. Would not this firmly based skepticism regarding the motives and actions of insurance companies not also target any proposal made by a officer of Aetna?
I cannot understand how officers of ACP and editors of their journal believe that their case for whatever changes they recommended in U.S. health care will be moved forward by having as a partners in that advocacy officers of a insurance company whose business practices ultimately lead to a very large settlement in a class action brought by a number of state medical societies. (Details of that settlement can be found here). When one argues for a given proposal tactical concerns would seem to favor presenting a credible spokesman.
The capitation type system proposed is unlikely to gain traction as long as physicians continue to believe and act as if their primary duty is to the individual patient and not to the collective.This article seems , in part, an effort to disabuse physicians of this ethical imperative which the authors may consider an obstacle to their scheme to "ensure proper allocation of health care resources".
Both Dr. Cassel and Dr. Brennan close their disclosure statement stating that the views expressed are those of the authors and do not necessarily reflect the opinions of either institution. It would be hard to believe that Aetna would allow one of its officers to publish an article in a widely read medical journal without agreeing with its contents.
Wednesday, June 13, 2007
Whole new ball game-case in point Avandia
The spin-off as well as the spin seems endless in regard to the Avandia issue.Nissen's NEJM article catalyzed various reactions many of which were predictable at least in direction if not in intensity. Predictable downstream effects included the reactions by GSK,by pro and anti Pharma blogs and Grass root and astro turf patient-interest groups and by plaintiff attorneys. Also expected are thoughtful posts by medical bloggers such as the one entitled "Avandia:two questions" by Dr. RW. and "The Avandia spin cycle" found at Health Care Renewal.
One of the latest developments is a class action suit by stock holders of GSK accusing the directors of withholding information about the cardiac risk of Avandia. The directors are accused of not providing adequate data to stockholders regarding the company's meta-analysis of cardiovascular deaths that was reported to the FDA.
Over thirty years ago another medical publication dealt with a purported increase in cardio vascular deaths from an oral diabetic medication. The University Group Diabetes Program (UGDP) was presented at the June 1970 meeting of the American Diabetes Association. Data presented indicated that tolbutamide increased cardiovascular deaths by over two and a half times.( R.R of 2.61, C.I.-1.29-5.27 It did not take long for the UGDP study to be referred to as the "controversial" UGDP.
The dispute over methodological issues was played out largely out of the public eye and patients and physicians alike had to largely rely on medical journal hard copy publications to follow the events that they unfolded in what would be considered slow motion in today's frenetic internet pace.Today with the Web within minutes the word spreads over the world and quickly bloggers and news sites and lawyers post messages. It is not long before a Senate hearing is held.
The UGDP study in many ways presented more robust evidence that the Nissen article.It was a randomized clinical trial ( Yes Virginia, clinical trials were done before the folks from Canada descended from the mountain with the precepts of EBM carved into stone) and the R.R. was greater than 2, a number less than which many epidemiologists put little weight as small RR's can be pushed around by small biases.Putting too much emphasis on medical analyses which derive RR's less than 2 has been a issue of interest to me for some time and I have ranted on about that before.
In time, the reputation of the class of diabetic drugs to which tolbutamide belonged was salvaged to some degree by proposing that tolbutamide might interfere with a purported pathophysiologic mechanism called "ischemic preconditioning" while others drugs in this family might not. At the end of the day, a PDR sulfonylurea family warning was issued. As new drugs have been developed to treat type 2 diabetes little discussion seems to take place about these drugs while they continue to be used with little alarm about causing heart attacks.
Sometimes controversies just die out without really being settled with apodictic medical certainty.I think that was the case with tolbutamide.Many articles critical and supportive of the UGDP were generated and for the most part probably largely unread and were it not for the internet amplified and magnified Avandia issue few would even currently think about a possible increase in c-v risk from the sulfonylureas which are still widely used in the early treatment phases of type 2 diabetes. The dogs bark and the caravan moves on.Today with the internet the dogs seem to be able to do much more than just bark.
One of the latest developments is a class action suit by stock holders of GSK accusing the directors of withholding information about the cardiac risk of Avandia. The directors are accused of not providing adequate data to stockholders regarding the company's meta-analysis of cardiovascular deaths that was reported to the FDA.
Over thirty years ago another medical publication dealt with a purported increase in cardio vascular deaths from an oral diabetic medication. The University Group Diabetes Program (UGDP) was presented at the June 1970 meeting of the American Diabetes Association. Data presented indicated that tolbutamide increased cardiovascular deaths by over two and a half times.( R.R of 2.61, C.I.-1.29-5.27 It did not take long for the UGDP study to be referred to as the "controversial" UGDP.
The dispute over methodological issues was played out largely out of the public eye and patients and physicians alike had to largely rely on medical journal hard copy publications to follow the events that they unfolded in what would be considered slow motion in today's frenetic internet pace.Today with the Web within minutes the word spreads over the world and quickly bloggers and news sites and lawyers post messages. It is not long before a Senate hearing is held.
The UGDP study in many ways presented more robust evidence that the Nissen article.It was a randomized clinical trial ( Yes Virginia, clinical trials were done before the folks from Canada descended from the mountain with the precepts of EBM carved into stone) and the R.R. was greater than 2, a number less than which many epidemiologists put little weight as small RR's can be pushed around by small biases.Putting too much emphasis on medical analyses which derive RR's less than 2 has been a issue of interest to me for some time and I have ranted on about that before.
In time, the reputation of the class of diabetic drugs to which tolbutamide belonged was salvaged to some degree by proposing that tolbutamide might interfere with a purported pathophysiologic mechanism called "ischemic preconditioning" while others drugs in this family might not. At the end of the day, a PDR sulfonylurea family warning was issued. As new drugs have been developed to treat type 2 diabetes little discussion seems to take place about these drugs while they continue to be used with little alarm about causing heart attacks.
Sometimes controversies just die out without really being settled with apodictic medical certainty.I think that was the case with tolbutamide.Many articles critical and supportive of the UGDP were generated and for the most part probably largely unread and were it not for the internet amplified and magnified Avandia issue few would even currently think about a possible increase in c-v risk from the sulfonylureas which are still widely used in the early treatment phases of type 2 diabetes. The dogs bark and the caravan moves on.Today with the internet the dogs seem to be able to do much more than just bark.
Monday, June 04, 2007
Seafood, x-ray contrast material allergies and Iodine
A long standing dogma is that seafood allergies and radiologic contrast material (RCM) allergies are both due to an iodine allergy and therefore a history of seafood allergy places a person at high risk of an allergy reaction to RCM.
Dr. Andrew D.Berry gave a talk at a recent meeting of the American Academy of Allergy,Asthma and Immunology (reported in the may 11,2007 edition of www.internalmedicinenews.com) that should disabuse doctors of what seems to be a medical myth.
According to the article-seafood allergy is due to a IgE mediated antibody to certain proteins in the seafood and the severe RCM reactions are not mediated by IgE at all.
Dr. Berry reported on a survey in which many radiologists and cardiologists would recommend pretreatment with antihistamines and/or steroid for a patient with a history of seafood allergy before injecting a RCM.
Dr. Andrew D.Berry gave a talk at a recent meeting of the American Academy of Allergy,Asthma and Immunology (reported in the may 11,2007 edition of www.internalmedicinenews.com) that should disabuse doctors of what seems to be a medical myth.
According to the article-seafood allergy is due to a IgE mediated antibody to certain proteins in the seafood and the severe RCM reactions are not mediated by IgE at all.
Dr. Berry reported on a survey in which many radiologists and cardiologists would recommend pretreatment with antihistamines and/or steroid for a patient with a history of seafood allergy before injecting a RCM.
Sunday, June 03, 2007
Pneumonia guidelines-Europe versus U.S.
The American Thoracic Society (ATS) and the Infectious Disease Society of America (IDSA) agree that the empiric therapy of mild community acquired pneumonia (CAP) should include coverage for the atypical pathogens.These are Mycoplasma,Chlamydia and Legionella.
In Europe, although ID physicians agree that about 40% of CAP is due to the atypicals,that beta-lactam antibiotics alone should be used anyway even though they have no activity against the atypicals. They argue that these pathogens (except for Legionella)usually cause mild, self-limiting illnesses and that adding broader coverage medications will exacerbate the public health problem of increasing antibiotics resistance.In the U.S, typically, a macrolide would be included in the treatment of CAP.
ID docs in the U.S. argue that the illnesses are shortened by broader coverage and there is also data showing a decreased mortality in hospitalized patients with CAP.One could argue that if hospitalization is needed that the CAP is more than mild.
The European approach seems to place a theoretical concern above individual patient concerns.Further a chest x ray is apparently not required to diagnose pneumonia so it can be argued they over treat viral bronchitis and add to the growing resistance problem. It is hard to argue against the view that more antibiotic use may lead to more pathogen resistance but you have to wonder how much effect under treating CAP would have to mitigate that trend.
In Europe, although ID physicians agree that about 40% of CAP is due to the atypicals,that beta-lactam antibiotics alone should be used anyway even though they have no activity against the atypicals. They argue that these pathogens (except for Legionella)usually cause mild, self-limiting illnesses and that adding broader coverage medications will exacerbate the public health problem of increasing antibiotics resistance.In the U.S, typically, a macrolide would be included in the treatment of CAP.
ID docs in the U.S. argue that the illnesses are shortened by broader coverage and there is also data showing a decreased mortality in hospitalized patients with CAP.One could argue that if hospitalization is needed that the CAP is more than mild.
The European approach seems to place a theoretical concern above individual patient concerns.Further a chest x ray is apparently not required to diagnose pneumonia so it can be argued they over treat viral bronchitis and add to the growing resistance problem. It is hard to argue against the view that more antibiotic use may lead to more pathogen resistance but you have to wonder how much effect under treating CAP would have to mitigate that trend.
Monday, May 28, 2007
Recognition of adverse effects-no quick and dirty way
The recent flurry of scientific comment, speculation, 6 o'clock news type hype, accusations about everyone concerned-except perhaps patients- and thoughtful commentary about the possibility that Avandia increases the risk of ischemic events makes me sit back and think about how did we get to where we are.
The randomized clinical trial is unrivaled in its ability-when properly done-to defy the confounders and the biases and point to a treatment that is efficacious and provides some information about adverse effects and can compare fairly the treated and untreated groups. It deserves its place as king of the hill in the realm of evidence and evidence based medicine because of its ability to eliminate selection bias and ideally chase away the known and unknown confounders that seem to lurk everywhere.
However, in regard to adverse effects (AE) detection RCTS are imperfect and not the most powerful tool in the shed. RCTs are typically short lived and even the larger ones often are too small to have adequate power to detect low frequency AEs. Further,RCTs are designed to demonstrate efficacy-or in some cases the much weaker standard of proof- non-inferiority. The patients in the trial often are less diverse and complicated that a typical subset of patients from real clinical life that will likely be taking the medication.This commentary by Ioannidis,Goodman and Mulrow in the Annals of Internal Medicine speaks more authoritatively that I can in regard to this point emphasizing the limitations of randomized trials in this regard. Further, they make suggestion to make postmarketing surveillance more "routine and efficient".
"Routine and efficient" certainly seems lacking as lately alarm about AEs associated with two blockbuster drugs was sounded by cardiologists and statisticians at Cleveland Clinic rather than the drug manufacturers or the FDA. Regardless of how correct or misleading their analysis may ultimately turn out to be (if there is ever an "ultimately"), I doubt we can always rely or a Dr. Nissen or whoever to oversee the vast drug related adverse effect data set.
It falls on the shoulders of case reports and observational data and meta-analyses to fill in the gaps regarding those less common AEs and those that only develop after the patient has been on the medication for a longer period of time.Sometimes these AEs burst on the headline news with alarming findings as with drug eluting stents,Vioxx, Ketek, and now,it seems, Avandia. They certainly can be alarming but they should not be surprising.
With more patients, and more time, more AEs will become apparent but the AEs have to be plucked out of a data which is plagued by potential confounders, the management of which has generated various statistical techniques which ,in my opinion,exceeds the level of statistical expertise possessed by most physicians and medical journal editors. I have written before about the difficulty in choosing between competing techniques proposed to tame the observational data.
So the RCT may just be the beginning of the data accumulation. The RCT is also the beginning of the onslaught of information,dis-information, useful educational material, misleading spin and well thought out marketing efforts of the drug manufacturer,educational efforts by patient organizations, guidelines from various groups and delicious "educational company"sponsored dinners punctuated by "thought leader" physicians showing slides typically prepared by the company.
Hopefully, postmarketing trials will come more efficient and routine and timely (Nissen's Avandia meta-analysis appeared about 8 years after FDA approval), but this will require a greater or more forceful role for the FDA-an agency which currently enjoys a reputation only slightly less tarnished than big Pharma. Something positive may come out of congressional hearings into various activities of the FDA and then perhaps remedial legislation but is not the current FDA the product of earlier congressional efforts to mitigate what was considered at the time by some a dangerously slow medication approval process?
Meanwhile, until a new day appears, we need to not be overly reassured by "negative findings" regarding side effects derived from RCTs. Ioannidis and co-authors included this quote in the above referenced commentary:
"It is almost always inappropriate to make statements about "no difference"in adverse event rates between groups on the basis of nonsignificant P values. Rates of adverse events that are derived from single,modest sized trials that are not statistically different typically do not exclude with certainty the possibility of major, clinically important differences in harms between groups."
The randomized clinical trial is unrivaled in its ability-when properly done-to defy the confounders and the biases and point to a treatment that is efficacious and provides some information about adverse effects and can compare fairly the treated and untreated groups. It deserves its place as king of the hill in the realm of evidence and evidence based medicine because of its ability to eliminate selection bias and ideally chase away the known and unknown confounders that seem to lurk everywhere.
However, in regard to adverse effects (AE) detection RCTS are imperfect and not the most powerful tool in the shed. RCTs are typically short lived and even the larger ones often are too small to have adequate power to detect low frequency AEs. Further,RCTs are designed to demonstrate efficacy-or in some cases the much weaker standard of proof- non-inferiority. The patients in the trial often are less diverse and complicated that a typical subset of patients from real clinical life that will likely be taking the medication.This commentary by Ioannidis,Goodman and Mulrow in the Annals of Internal Medicine speaks more authoritatively that I can in regard to this point emphasizing the limitations of randomized trials in this regard. Further, they make suggestion to make postmarketing surveillance more "routine and efficient".
"Routine and efficient" certainly seems lacking as lately alarm about AEs associated with two blockbuster drugs was sounded by cardiologists and statisticians at Cleveland Clinic rather than the drug manufacturers or the FDA. Regardless of how correct or misleading their analysis may ultimately turn out to be (if there is ever an "ultimately"), I doubt we can always rely or a Dr. Nissen or whoever to oversee the vast drug related adverse effect data set.
It falls on the shoulders of case reports and observational data and meta-analyses to fill in the gaps regarding those less common AEs and those that only develop after the patient has been on the medication for a longer period of time.Sometimes these AEs burst on the headline news with alarming findings as with drug eluting stents,Vioxx, Ketek, and now,it seems, Avandia. They certainly can be alarming but they should not be surprising.
With more patients, and more time, more AEs will become apparent but the AEs have to be plucked out of a data which is plagued by potential confounders, the management of which has generated various statistical techniques which ,in my opinion,exceeds the level of statistical expertise possessed by most physicians and medical journal editors. I have written before about the difficulty in choosing between competing techniques proposed to tame the observational data.
So the RCT may just be the beginning of the data accumulation. The RCT is also the beginning of the onslaught of information,dis-information, useful educational material, misleading spin and well thought out marketing efforts of the drug manufacturer,educational efforts by patient organizations, guidelines from various groups and delicious "educational company"sponsored dinners punctuated by "thought leader" physicians showing slides typically prepared by the company.
Hopefully, postmarketing trials will come more efficient and routine and timely (Nissen's Avandia meta-analysis appeared about 8 years after FDA approval), but this will require a greater or more forceful role for the FDA-an agency which currently enjoys a reputation only slightly less tarnished than big Pharma. Something positive may come out of congressional hearings into various activities of the FDA and then perhaps remedial legislation but is not the current FDA the product of earlier congressional efforts to mitigate what was considered at the time by some a dangerously slow medication approval process?
Meanwhile, until a new day appears, we need to not be overly reassured by "negative findings" regarding side effects derived from RCTs. Ioannidis and co-authors included this quote in the above referenced commentary:
"It is almost always inappropriate to make statements about "no difference"in adverse event rates between groups on the basis of nonsignificant P values. Rates of adverse events that are derived from single,modest sized trials that are not statistically different typically do not exclude with certainty the possibility of major, clinically important differences in harms between groups."
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