The December 25, 2008 issue of NEJM has a brilliant Perspective written by Dr. A. Verghese entitled "Culture Shock-Patient as Icon, Icon as Patient".
Dr. Verghese, a professor at Stanford Medical School, writes about the world of the computer screen patient or as he puts it so well- speaking of the world of internal medicine training- the iPatient.
"The patient is still at the center but more as an icon for another entity clothed in binary garments,the "iPatient".
He explains that after the ER docs work up or perhaps define the patient the " interns meet a fully formed iPatient long before seeing the real patient." Quoting the semanticist Alfred Korzbski, Verghese reminds us that the "map is not the territory".
The reality or virtual reality of the iconic patients may overwhelm the person from whom the iPatient is constructed. The CT report or lab test may not be correlated with the history or physical exam as neither may be done as the reality of the full developed iPatient arrives "on the ward".
"If one eschews the skilled and repeated examination of the real patients, then simple diagnosis are overlooked, while tests, consultations and procedures that might not be needed are ordered."
He speaks of two approaches, the traditional way where in the body is the text and the new way or the expedient or Ipatient way. The first approach is a needed remedy for the development of "chartomas"-which are disease labels that become the iTruth by "being cut and pasted into every note".
This is a great commentary and Dr. Verghese tells us that at Stanford an effort is underway to revise and strengthen bedside skills. Good for them. My medicine chief during training, George Burch, preached that if you are uncertain or uneasy as to what is going on clinically go back talk to the patient again and examine him again. When the house staff receives a patient fully iDefined patient, they may never know if that are uncertain or not and they probably would have no reason to be uneasy, but the patient may.
Tuesday, December 30, 2008
HL Mencken,National Health Coverage Council and Public Choice Theory
Recently, Dr. Donald J. Boudreaux in a commentary in his column,"Eonomics in Many Lessons", featured some quotes from one of my all time favoties, H.L. Mencken. Mencken's comments suggests that he understood the core thoughts illuminated by Tullock and Buchanan in their writings that informed us of what has become known as Public Choice Theory.
Mencken said:
"the survival into our enlightened age of a concept hatched in the black days of absolutism the concept, to wit, that government is something that is superior to and quite distinct from all other human institutions ... a transcendental organism composed of aloof and impersonal powers, devoid wholly of self-interest and not to be measured by merely human standards."
Mencken struck the key note of the ideas behind Public Choice Theory, namely that public officials-elected,civil service or appointed- act, at least in part in their own interests. These people, members of the same species as those not in government employment, tend to be motivated by salaries and other perks,lust for power and prestige and easy of managing their bureaucracy.The ideal from our eight grade civics class of a selfless public official wisely acting for the good of society is seldom achieved.
With that in mind, the"independent Health Coverage Counsel" proposed in Max Baucus's health reform plan should scare the heck out you.See here for one critique of that plan.
The danger of placing the power to make economic decisions in the hands of a governmental or quasi-governmental organizations should be obvious to all.
In fact, it scares me so much that I awoke from my blogging hiatus.
Mencken said:
"the survival into our enlightened age of a concept hatched in the black days of absolutism the concept, to wit, that government is something that is superior to and quite distinct from all other human institutions ... a transcendental organism composed of aloof and impersonal powers, devoid wholly of self-interest and not to be measured by merely human standards."
Mencken struck the key note of the ideas behind Public Choice Theory, namely that public officials-elected,civil service or appointed- act, at least in part in their own interests. These people, members of the same species as those not in government employment, tend to be motivated by salaries and other perks,lust for power and prestige and easy of managing their bureaucracy.The ideal from our eight grade civics class of a selfless public official wisely acting for the good of society is seldom achieved.
With that in mind, the"independent Health Coverage Counsel" proposed in Max Baucus's health reform plan should scare the heck out you.See here for one critique of that plan.
The danger of placing the power to make economic decisions in the hands of a governmental or quasi-governmental organizations should be obvious to all.
In fact, it scares me so much that I awoke from my blogging hiatus.
Tuesday, October 14, 2008
Time for retired doc to retool,meditate and do the sabatical thing
What with the downtime imposed by a hurricane and the confluence of a bunch of other family and personal stuff, I think it best to-at least for a while-take blog writing off the table.I probably can't resist posting a few wonderfully cogent comments on some of my favorite medical blogger sites but little more than that for a while. I have beaten to death a number of my favorite themes and I need to re-fire the belly. I promise not to reappear in a new role as a political pundit.That market is super saturated anyway. So for a while, so long and thanks for all the fish.
Wednesday, September 24, 2008
Power outage from Hurrican Ike
Now 12 days since Hurricane Ike and still no power to my part of the Houston area. So no blogs for a while and for a short while to come. I only have access to a friend's computer or the wi-fi at a mall. Maybe next week things will be up and running again. Hopefully, my three readers will be patient.
Tuesday, September 09, 2008
More news on the fall out from restricted house officer work hours
Every time I mention there may possibly be some problems with the work hours restriction regarding house officers, I receive a barrage ( OK, 1 or 2 comments) from folks who consider me to be a old jerk who just wants a return to the good old days and that I want nothing more than to deny house officers time with their families so to better achieve the nebulous work life balance.
Thanks to Kevin for alerting me to this news item. In part, it seems like some surgery residents have been caught working too much in their misdirected efforts to try and learn to be good surgeons. Shame on them.
To disabuse these rebellious surgeon in training from their anachronistic aversion to shift work for physicians, efforts should begin earlier, i.e. in medical school. Rules should be implemented to limit the hours of study allowed for medical students.
Thanks to Kevin for alerting me to this news item. In part, it seems like some surgery residents have been caught working too much in their misdirected efforts to try and learn to be good surgeons. Shame on them.
To disabuse these rebellious surgeon in training from their anachronistic aversion to shift work for physicians, efforts should begin earlier, i.e. in medical school. Rules should be implemented to limit the hours of study allowed for medical students.
Saturday, September 06, 2008
work-life balance,shift worker physicians and paradigms lost
Sometime in the 1980s the term "work-life balance " ( which I will abbreviate as "wlb" to save key strokes) began to seep into the universe of conversational and literacy discourse. I suggest the term itself may be a bit of a self contradiction or at least a poorly constructed notion. Work for the great majority of human adults is part of life so would not "work-non-work balance" be more to the point.
And the point seems to be basically that there is said to be some appropriate distribution of the hours in a week or day so that the proper of amount of time is spent working and in the other various domains of existence, which would including family time,recreation,and you fill in the blank with religion or community service or duck hunting.WLB had become a buzz word particularly in the business world wherein it is widely believed that companies must make some highly visible effort to help their employee achieve this wlb or at least appear to do so.
It is a modern concept and a concept that makes sense only when folks achieve a certain degree of affluence. It would have made no sense to talk to our ancestors who worked the land from dawn to dusk and then collapsed in bed to talk about balance. Pretty much every thing was work. Similarly millions of people who eek out a barely adequate living in those parts of the world now call developing (formerly known a underdeveloped) are not too concerned with discussion about the best way to balance their lives. In the 1970s and before medical students and house officers did not lobby their trainers, teachers and exploiters for a better balance in the work and non work lives.I don't know why we didn't , maybe we just were not that evolved yet or maybe we thought we could not get away with it.
When I did consultation work for a large international corporation, I frequently did examinations for overseas travel and executive physicals for the top small percentage of the employees. One such person was tasked to consult with high level managers to work out ways in which those managers could make it to happen that their employee would achieve this wlb. This individual traveled around the world visiting various general managers and vice presidents and noted that most could be fairly described an "workaholics". He told several of them that they would never achieve the alleged goal of more wlb without the leaders serving a role models. Almost to a man (or woman), the reply was basically : Look if I slow down or work less, some sob will take my job." The wlb manager soon retired early and moved to a ranch in Montana ( I am not making this up ).
Government officials and politicians who get into some type of hot water such as accusations of wrong doing often decide to retire and give as reason " spend more time with my family". Nothing like getting caught to convince one to balance their work and life.
For some, their work is their life even though their position is such that they could opt to fish more, be ushers at church or have regular meals with their spouses. For them the balance is heavily shifted to the work side. Consider the degree to which physicians in their training shift much of their lives to the studying and working for a prolonged period of time. Do they accumulate a great unmet need for other activities so that when they finally finish training they are ready to catch up and re balance their wlb ratio, in part by becoming shift workers? Maybe so. Or since the income rewards are getting less and less and the prestige of physician work is diminishing and the autonomy is getting harder and harder to even find and when the pride of being physician gets to some personally determined tipping point maybe it is more politically correct to say you need more time on the life side of work life balance than to say screw it.
And the point seems to be basically that there is said to be some appropriate distribution of the hours in a week or day so that the proper of amount of time is spent working and in the other various domains of existence, which would including family time,recreation,and you fill in the blank with religion or community service or duck hunting.WLB had become a buzz word particularly in the business world wherein it is widely believed that companies must make some highly visible effort to help their employee achieve this wlb or at least appear to do so.
It is a modern concept and a concept that makes sense only when folks achieve a certain degree of affluence. It would have made no sense to talk to our ancestors who worked the land from dawn to dusk and then collapsed in bed to talk about balance. Pretty much every thing was work. Similarly millions of people who eek out a barely adequate living in those parts of the world now call developing (formerly known a underdeveloped) are not too concerned with discussion about the best way to balance their lives. In the 1970s and before medical students and house officers did not lobby their trainers, teachers and exploiters for a better balance in the work and non work lives.I don't know why we didn't , maybe we just were not that evolved yet or maybe we thought we could not get away with it.
When I did consultation work for a large international corporation, I frequently did examinations for overseas travel and executive physicals for the top small percentage of the employees. One such person was tasked to consult with high level managers to work out ways in which those managers could make it to happen that their employee would achieve this wlb. This individual traveled around the world visiting various general managers and vice presidents and noted that most could be fairly described an "workaholics". He told several of them that they would never achieve the alleged goal of more wlb without the leaders serving a role models. Almost to a man (or woman), the reply was basically : Look if I slow down or work less, some sob will take my job." The wlb manager soon retired early and moved to a ranch in Montana ( I am not making this up ).
Government officials and politicians who get into some type of hot water such as accusations of wrong doing often decide to retire and give as reason " spend more time with my family". Nothing like getting caught to convince one to balance their work and life.
For some, their work is their life even though their position is such that they could opt to fish more, be ushers at church or have regular meals with their spouses. For them the balance is heavily shifted to the work side. Consider the degree to which physicians in their training shift much of their lives to the studying and working for a prolonged period of time. Do they accumulate a great unmet need for other activities so that when they finally finish training they are ready to catch up and re balance their wlb ratio, in part by becoming shift workers? Maybe so. Or since the income rewards are getting less and less and the prestige of physician work is diminishing and the autonomy is getting harder and harder to even find and when the pride of being physician gets to some personally determined tipping point maybe it is more politically correct to say you need more time on the life side of work life balance than to say screw it.
Sunday, August 24, 2008
More reason to be wary of meta-analyses
A tip of the blogging hat to DB's Medical Rants for this reference.
This article by Ian Shrier and others from McGill investigated the subjectivity of meta-analyses and concluded the following:
The interpretation of the results of systematic reviews with meta-analyses includes a subjective component that can lead to discordant conclusions that are independent of the methodology used to obtain or analyse the data. And things get even more mushy when the statistical experts differ as to what methodology should be used.
In their discussion this paragraph says it well :
Our results suggest that a systematic review with a meta-analysis must be viewed with the perspective that it represents one study conducted by specific investigators with a specific methodology. At each step of the methodology (defining the general criteria, search strategy, inclusion/exclusion criteria, data abstraction, and analysis), subjective decisions are required that could affect the validity of the study; the relative importance of each will likely depend on the topic of inquiry and the data acquired. Our study demonstrates that disagreements in the conclusions of systematic reviews with meta-analyses can also be due to subjective interpretations of the results and not only of the methodology. The inclusion-exclusion criteria often are determinative of the outcome.Meta-analyses can be thought of as observational studies in which the subjects are trials.
Of course meta-analyses involve subjective judgment calls and various type of personal bias that the investigators bring to the table. How could it possibly be otherwise?
This gives me still another opportunity to reference the classic editorial in the Annals of Internal Medicine by Steve Goodman of Johns Hopkins which I discussed at some length here. To sum it I can do no better than to quote Goodman:
Judgment determines what evidence is admissible and how strongly to weigh different forms of admissible evidence. When there is consensus on these judgments and the data are
strong, an illusion is created that the evidence is speaking for itself and that the methods are objective. But this episode[ the mammogram controversy mentioned above] should raise awareness that judgment cannot be excised from the process of evidence synthesis and that the variation of this judgment among experts generates uncertainty just as real as the probabilistic uncertainty of statistical calculations.
I never tire of repeating my rant that meta-analyses should never have been placed at the top of the evidence based medicine evidence hierarchy.And for that matter biological plausibility should never have relegated to lower rings of the ladder.
This article by Ian Shrier and others from McGill investigated the subjectivity of meta-analyses and concluded the following:
The interpretation of the results of systematic reviews with meta-analyses includes a subjective component that can lead to discordant conclusions that are independent of the methodology used to obtain or analyse the data. And things get even more mushy when the statistical experts differ as to what methodology should be used.
In their discussion this paragraph says it well :
Our results suggest that a systematic review with a meta-analysis must be viewed with the perspective that it represents one study conducted by specific investigators with a specific methodology. At each step of the methodology (defining the general criteria, search strategy, inclusion/exclusion criteria, data abstraction, and analysis), subjective decisions are required that could affect the validity of the study; the relative importance of each will likely depend on the topic of inquiry and the data acquired. Our study demonstrates that disagreements in the conclusions of systematic reviews with meta-analyses can also be due to subjective interpretations of the results and not only of the methodology. The inclusion-exclusion criteria often are determinative of the outcome.Meta-analyses can be thought of as observational studies in which the subjects are trials.
Of course meta-analyses involve subjective judgment calls and various type of personal bias that the investigators bring to the table. How could it possibly be otherwise?
This gives me still another opportunity to reference the classic editorial in the Annals of Internal Medicine by Steve Goodman of Johns Hopkins which I discussed at some length here. To sum it I can do no better than to quote Goodman:
Judgment determines what evidence is admissible and how strongly to weigh different forms of admissible evidence. When there is consensus on these judgments and the data are
strong, an illusion is created that the evidence is speaking for itself and that the methods are objective. But this episode[ the mammogram controversy mentioned above] should raise awareness that judgment cannot be excised from the process of evidence synthesis and that the variation of this judgment among experts generates uncertainty just as real as the probabilistic uncertainty of statistical calculations.
I never tire of repeating my rant that meta-analyses should never have been placed at the top of the evidence based medicine evidence hierarchy.And for that matter biological plausibility should never have relegated to lower rings of the ladder.
Tuesday, August 19, 2008
Merck replies to the criticism of the Advantage trial
Dr. Jonathan M. Edelman, Director of Scientific affairs for Merck, has offered this reply to the charges leveled in the Annals of Internal Medicine article which had characterized the Advantage trial as a "seeding trial".
Dr. Edelman denies that it was, in fact, a seeding trial and that it was designed to answer a significant, scientific question describing the trial as one in which Vioxx was compared with a widely used drug Naproxen in a "real life" setting and involving patients who were allowed to take aspirin as well and - as such- answered questions that were relevant and pertinent to practicing physicians. He also denies that participants were not properly informed about the purpose of the trial.
Edelman also says that the trial "was designed, conducted, analyzed and interpreted by the scientific department of Merck." I had implied otherwise in my comments in an earlier entry on this subject perhaps inappropriately embellishing this following statement from the Annals article, "Merck's marketing division, ...handled the scientific and marketing data including collection, analysis and dissemination." However, which group or groups within the company designed the trial does not settle the question of if this a seeding trial or not.
Dr. Carlat has also taken up this topic and interviewed one of the authors of the Annals article.See here for the interview. The WSJ.Com Health Blog also writes about this issue here. The Med Page Today blog tackles this topic also.
Details of how much and what was disclosed to the patients and the participating physicians is not made clear by either the Annals article or the Merck reply.
Dr. Edelman denies that it was, in fact, a seeding trial and that it was designed to answer a significant, scientific question describing the trial as one in which Vioxx was compared with a widely used drug Naproxen in a "real life" setting and involving patients who were allowed to take aspirin as well and - as such- answered questions that were relevant and pertinent to practicing physicians. He also denies that participants were not properly informed about the purpose of the trial.
Edelman also says that the trial "was designed, conducted, analyzed and interpreted by the scientific department of Merck." I had implied otherwise in my comments in an earlier entry on this subject perhaps inappropriately embellishing this following statement from the Annals article, "Merck's marketing division, ...handled the scientific and marketing data including collection, analysis and dissemination." However, which group or groups within the company designed the trial does not settle the question of if this a seeding trial or not.
Dr. Carlat has also taken up this topic and interviewed one of the authors of the Annals article.See here for the interview. The WSJ.Com Health Blog also writes about this issue here. The Med Page Today blog tackles this topic also.
Details of how much and what was disclosed to the patients and the participating physicians is not made clear by either the Annals article or the Merck reply.
Monday, August 18, 2008
Annals Internal Medicine article dissects the "seeding trial" aka "Marketing trial"
A number of e-mails and other internal Merck documents became fair game for analysis and critique when they became available as part of the discovery process of a civil suit involving the cardiovascular safety of Vioxx and this analysis is published in the August 19,2008 issue of the Annals of Internal Medicine . (The Advantage Seeding Trial: A review of Internal Documents, Hill KP et al, Annals Int Med. 2008;149;251-258).
The documents discussed in this article are concerned with a trial called ADVANTAGE which was said to assess the differences between Vioxx and Naproxen regarding side effects and effectiveness in the treatment of osteoarthritis.The trial involved 600 investigators and 2785 patients and was ultimately published in the Annals of Internal Medicine giving the results of a 3 month followup.
The current Annals article(needs subscription) takes the reader into the real life example of the world of a clinical trial that is designed and executed by the marketing ( not the research) division of a pharmaceutical company. This type of trial has been referred to as a "marketing trial" or a "seeding trial". The term " seeding trial" is actually used by involved employees although one company e-mail advised against the use of the term even in in-house writings.Although it has been suspected and alleged that drug companies sponsor these marketing trials this article is said to be the first documentation of at least some of what goes on in the company as the trial is planned and carried out.
Perhaps new to some physicians the seeding trial is nothing new at all in the world of marketing as explained in great detail in this reference which puts the idea in the context of opinion leaders, the Hawthorne effect and the tipping point. (for some reason I could only pull up the cached version.)
If the idea worked for Post-Its-as the above reference explains-why not for prescription drugs?
Psaty and others have decried the use of these low quality ( from a scientific or statistical point of view) trials and I wrote about in 2006 with some fairly unkind words about the physician opinion leaders who participate and make these marketing trials possible.
Doctors Harold Sox and Drummond Rennie wrote the editorial in the August Annals entitled "Seeding trials: Just say "no" " They wrote that the key to a successful seeding trial is deception. I would like to believe that many or most of the physician investigators were deceived as the alternative is that they knew it was wink-wink-nudge-nudge pretense of a trial and the term co-conspirator would apply.
Sox and Rennie said the Annals published the trial because no one told them it was a seed trial.One has to wonder why the editors had to be told. A 1994 NEJM special article made clear the characteristics of such trials and the Advantage trial was published in the Annals in 2003.David Kessler and co-authors in their NEJM article said the following about these marketing trials.
Features that distinguish such trials from scientifically rigorous studies include the use of a design that does not support the stated research goals, the recruitment of investigators not because they are experts or leading researchers but because they are frequent prescribers of competing products in the same therapeutic class, disproportionately high payments given to "investigators" for their work (although the only work may be to write prescriptions for the drug), sponsorship of the studies by the company's sales and marketing division rather than its research department, minimal requirements for data, and the collection of data that are of little or no value to the company. Typically, these trials involve introducing a new drug in a crowded therapeutic class. The success of such a new product may depend on undoing physicians' comfortable habits of prescribing a competing, more established product.
Hopefully with the spotlight of the current Annals article and editorial, editors,review boards and potential physician investigators will be less likely to be deceived and will "say no"and protect the real victims of these trials namely the patients who often in good faith thought they were furthering science and helping other people with the disease under study while in fact they may put themselves at risk for side effects for no reason other than increasing the sales of the medication.
The documents discussed in this article are concerned with a trial called ADVANTAGE which was said to assess the differences between Vioxx and Naproxen regarding side effects and effectiveness in the treatment of osteoarthritis.The trial involved 600 investigators and 2785 patients and was ultimately published in the Annals of Internal Medicine giving the results of a 3 month followup.
The current Annals article(needs subscription) takes the reader into the real life example of the world of a clinical trial that is designed and executed by the marketing ( not the research) division of a pharmaceutical company. This type of trial has been referred to as a "marketing trial" or a "seeding trial". The term " seeding trial" is actually used by involved employees although one company e-mail advised against the use of the term even in in-house writings.Although it has been suspected and alleged that drug companies sponsor these marketing trials this article is said to be the first documentation of at least some of what goes on in the company as the trial is planned and carried out.
Perhaps new to some physicians the seeding trial is nothing new at all in the world of marketing as explained in great detail in this reference which puts the idea in the context of opinion leaders, the Hawthorne effect and the tipping point. (for some reason I could only pull up the cached version.)
If the idea worked for Post-Its-as the above reference explains-why not for prescription drugs?
Psaty and others have decried the use of these low quality ( from a scientific or statistical point of view) trials and I wrote about in 2006 with some fairly unkind words about the physician opinion leaders who participate and make these marketing trials possible.
Doctors Harold Sox and Drummond Rennie wrote the editorial in the August Annals entitled "Seeding trials: Just say "no" " They wrote that the key to a successful seeding trial is deception. I would like to believe that many or most of the physician investigators were deceived as the alternative is that they knew it was wink-wink-nudge-nudge pretense of a trial and the term co-conspirator would apply.
Sox and Rennie said the Annals published the trial because no one told them it was a seed trial.One has to wonder why the editors had to be told. A 1994 NEJM special article made clear the characteristics of such trials and the Advantage trial was published in the Annals in 2003.David Kessler and co-authors in their NEJM article said the following about these marketing trials.
Features that distinguish such trials from scientifically rigorous studies include the use of a design that does not support the stated research goals, the recruitment of investigators not because they are experts or leading researchers but because they are frequent prescribers of competing products in the same therapeutic class, disproportionately high payments given to "investigators" for their work (although the only work may be to write prescriptions for the drug), sponsorship of the studies by the company's sales and marketing division rather than its research department, minimal requirements for data, and the collection of data that are of little or no value to the company. Typically, these trials involve introducing a new drug in a crowded therapeutic class. The success of such a new product may depend on undoing physicians' comfortable habits of prescribing a competing, more established product.
Hopefully with the spotlight of the current Annals article and editorial, editors,review boards and potential physician investigators will be less likely to be deceived and will "say no"and protect the real victims of these trials namely the patients who often in good faith thought they were furthering science and helping other people with the disease under study while in fact they may put themselves at risk for side effects for no reason other than increasing the sales of the medication.
Friday, August 15, 2008
Physicians who are confused and mislead by drug companies can rest easy-maybe, the government is coming to help
Enticed by pizza and promotional pens and mugs, enchanted by attractive, tricky drug reps and hoodwinked by cleverly crafted medical articles that have been funded by Big Pharma the woefully undereducated and incredibly gullible and naive medical doctors may look forward to having help from the government . At least that is being proposed, see here for news about that.
The plan is for the government to hire unbiased docs who will go forth and detail the office docs but this time the detailing will be done by folks who know the truth. It has become very difficult for someone with only a college degree, four years of med school and from 3-8 years of further education to sort the truth from the hype in regard to medication use. Fortunately, once the government hires someone with similar educational background to disseminate the unbiased truth they apparently- through the magic of government funding- become able to pluck the nuggets of truth from the dung of pharma manufactured propaganda and the razzle-dazzle of the traveling hired guns.
There are some cynics who believe that government decisions themselves have an unfortunate but predictable tendency to be biased, confused and self interested but the high-school civics class notion of the governmental agency or agent who is free of self interest and serves only the public good has considerable currency in spite of overwhelming evidence to the contrary.
As suggested by "The Last Psychiatrist" blog -does it not worry anyone that Congress believes or claims that physicians are so clueless that the government has to send out "academic detailers" to instruct the docs as to proper patient care?
I also wonder how have they been able to practice medicine before without that help?
Were not the "academic detailers" hired by the medical education companies hired by the drug companies thought to be part of the problem? Well, with a different source of funding things will change.
The plan is for the government to hire unbiased docs who will go forth and detail the office docs but this time the detailing will be done by folks who know the truth. It has become very difficult for someone with only a college degree, four years of med school and from 3-8 years of further education to sort the truth from the hype in regard to medication use. Fortunately, once the government hires someone with similar educational background to disseminate the unbiased truth they apparently- through the magic of government funding- become able to pluck the nuggets of truth from the dung of pharma manufactured propaganda and the razzle-dazzle of the traveling hired guns.
There are some cynics who believe that government decisions themselves have an unfortunate but predictable tendency to be biased, confused and self interested but the high-school civics class notion of the governmental agency or agent who is free of self interest and serves only the public good has considerable currency in spite of overwhelming evidence to the contrary.
As suggested by "The Last Psychiatrist" blog -does it not worry anyone that Congress believes or claims that physicians are so clueless that the government has to send out "academic detailers" to instruct the docs as to proper patient care?
I also wonder how have they been able to practice medicine before without that help?
Were not the "academic detailers" hired by the medical education companies hired by the drug companies thought to be part of the problem? Well, with a different source of funding things will change.
Tuesday, August 05, 2008
Physicians learning to be shift workers?
In a recent Medscape edition (July 1,2008) we find a disturbing essay by a practicing academic pediatrician who expresses concern about some of the unexpected consequences of the restrictions placed on medical house staff work hours. I find it disturbing in part because what the author describes could not be further from the notion that the physician (house staff) should not leave until his patient is taken care of.
Dr. Jane R. Gilsdorf, from the University of Michigan Medical Center, pulls no punches with this sentence:
The current system is creating a legion of shift-worker physicians who leave when the clock strikes a certain hour rather than when the job has been completed.
In discussing this with a former partner, who taught internal medicine residents for over 30 years and retired one year after the work rule changes were implemented, he had this cynical comment to make:
"Maybe it is good that the residents learn that approach early on because it seems that most docs are becoming shift-workers. Consider how things often work. You have a primary care doctor who has defined office hours and when you call his number after hours you either get a "triage nurse" or a recording that basically says call back tomorrow if it is not an emergency or go to the ER if it is an emergency. At the ER you see an ER doc who is working a shift and if you are admitted you are likely seen by a hospitalist who also is a shift worker. The notion of a personal physician whose role transcends duty hours is dead in the water."
Dr. Gilsdorf opines that more funds are needed to help correct the problems brought about by the ACGME work restriction rules. Basically, someone needs to be paid to do much of what the house staff used to do and now cannot. Dr. R. Centor discusses some of the problems brought about by the ACGME work rules and suggests with good planning,teaching and hard work many of them can be at least to a significant degree mitigated and I believe he is probably right.
However,how the broader "shift-workerization" of physicians can be reversed is another matter.Major shifts in the economic forces regarding physician and hospital compensation have brought that about and that big ship will be hard to turn around.
Dr. Jane R. Gilsdorf, from the University of Michigan Medical Center, pulls no punches with this sentence:
The current system is creating a legion of shift-worker physicians who leave when the clock strikes a certain hour rather than when the job has been completed.
In discussing this with a former partner, who taught internal medicine residents for over 30 years and retired one year after the work rule changes were implemented, he had this cynical comment to make:
"Maybe it is good that the residents learn that approach early on because it seems that most docs are becoming shift-workers. Consider how things often work. You have a primary care doctor who has defined office hours and when you call his number after hours you either get a "triage nurse" or a recording that basically says call back tomorrow if it is not an emergency or go to the ER if it is an emergency. At the ER you see an ER doc who is working a shift and if you are admitted you are likely seen by a hospitalist who also is a shift worker. The notion of a personal physician whose role transcends duty hours is dead in the water."
Dr. Gilsdorf opines that more funds are needed to help correct the problems brought about by the ACGME work restriction rules. Basically, someone needs to be paid to do much of what the house staff used to do and now cannot. Dr. R. Centor discusses some of the problems brought about by the ACGME work rules and suggests with good planning,teaching and hard work many of them can be at least to a significant degree mitigated and I believe he is probably right.
However,how the broader "shift-workerization" of physicians can be reversed is another matter.Major shifts in the economic forces regarding physician and hospital compensation have brought that about and that big ship will be hard to turn around.
Thursday, July 31, 2008
Still more possible benefits from statins-the list goes on and on
Dementia prevention and statins are again in the news with this study. Previous studies offered contradictory data , some showing an benefit in risk reduction in the development of dementia from statin use while others did not.
The current study is a bit more robust than some of the previous ones as patients were followed over time and periodic tests of cognitive ability were performed and the statins users scored higher.
Another study (a meta-analysis-and thanks to Dr. RW for that reference) offered evidence that post operative onset of atrial fibrillation can be reduced by statins. I guess we could use something new now after those unpleasant, unintended consequences noted from giving almost everyone beta-blockers pre op.
I have marveled before about how many good things can be attributed to statins all of which make me feel good about taking one of them even though my LDL wasn't all that high anyway.
I have written before about the contradictory results regarding statins and risk of colon cancer and commented that another case-control study will not settle that issue (for that matter,any issue) but that is exactly what the NEJM published in the face of previously published dueling case controls studies addressing that issue.
The story of dementia and statins is still being written but maybe in the meanwhile we can keep exercising in the hope that it will keep our hippocampi big and healthy and our frontal lobes relatively free of white matter bright spots.Anyway it would be nice to think so.
The current study is a bit more robust than some of the previous ones as patients were followed over time and periodic tests of cognitive ability were performed and the statins users scored higher.
Another study (a meta-analysis-and thanks to Dr. RW for that reference) offered evidence that post operative onset of atrial fibrillation can be reduced by statins. I guess we could use something new now after those unpleasant, unintended consequences noted from giving almost everyone beta-blockers pre op.
I have marveled before about how many good things can be attributed to statins all of which make me feel good about taking one of them even though my LDL wasn't all that high anyway.
I have written before about the contradictory results regarding statins and risk of colon cancer and commented that another case-control study will not settle that issue (for that matter,any issue) but that is exactly what the NEJM published in the face of previously published dueling case controls studies addressing that issue.
The story of dementia and statins is still being written but maybe in the meanwhile we can keep exercising in the hope that it will keep our hippocampi big and healthy and our frontal lobes relatively free of white matter bright spots.Anyway it would be nice to think so.
Wednesday, July 23, 2008
The really, really dark side of P4P (maybe the only side)
Comments by an Hawaii physician,called to our attention by the prolific Sandy Suracz, should do more than raise a few eyebrows.I have characterized P4P as, among other things,bribing physicians for doing their job. It seems to be worse than that.There may be instances of docs being bribed to use certain medications.
Now we seem to have more reason to believe that some health plans are being bribed by drug companies to prescribe certain medications and then the health plans bribing and coercing the physicians in the plan to prescribe those medication under the feel-good facade of
quality care and guidelines.
Dr.Catey Shanahan from Hawaii is the whistle blower in this instance describing what went on in the plan for which she works and alleged comments from a management person in another plan where she interviewed for a position. Details can be found here in her letter to the editor of a newspaper. The guidelines that Dr.Shanahan found questionable involved the dictum that all type 2 diabetics should be treated with a statin medication to drive the LDL below some magic number.I hope the usual fate of whistle-blowers does not await Dr. Shanahan.
One can argue about the validity of the conclusion that all such patients be treated to that target with that class of medication and can question the robustness of the data that suggest that such treatment is both safe and efficacious, let alone effective. ( I'll admit I have/had firmly bought into that line of thinking but am rethinking that now) However, there is no argument, as far as any reasonable or even conceivable interpretation of medical ethics, about bribing physicians to prescribe certain medications. DrRich sent me (and everyone who reads his blog and book) the message that medical ethics and pride are in a downward spiral and if medical ethics is in a crisis, trust is next to fall.
Three years ago my brother-in-law received a prescription for simvastatin ( not the generic) because of his slightly elevated LDL. He was of the belief-without any specific supporting data- that the doctor was getting some type of "kick back" for using that medication. In my naivete,I told him in no uncertain terms that that sort of thing just does not happen.The conversation would have to be a bit different now.
This same general issue attracted a bit of attention when the "EPO" stories broke and the question of rebates for physicians and health care plans came to light at that time.I wrote about that here.
Fortunately the shattering of the trust in doctors which such activities will bring about will be mitigated by knowledge that no longer will pharma firms hand out the mind altering pens and mugs decorated by the names of medications. That should restore trust in physicians.
Now we seem to have more reason to believe that some health plans are being bribed by drug companies to prescribe certain medications and then the health plans bribing and coercing the physicians in the plan to prescribe those medication under the feel-good facade of
quality care and guidelines.
Dr.Catey Shanahan from Hawaii is the whistle blower in this instance describing what went on in the plan for which she works and alleged comments from a management person in another plan where she interviewed for a position. Details can be found here in her letter to the editor of a newspaper. The guidelines that Dr.Shanahan found questionable involved the dictum that all type 2 diabetics should be treated with a statin medication to drive the LDL below some magic number.I hope the usual fate of whistle-blowers does not await Dr. Shanahan.
One can argue about the validity of the conclusion that all such patients be treated to that target with that class of medication and can question the robustness of the data that suggest that such treatment is both safe and efficacious, let alone effective. ( I'll admit I have/had firmly bought into that line of thinking but am rethinking that now) However, there is no argument, as far as any reasonable or even conceivable interpretation of medical ethics, about bribing physicians to prescribe certain medications. DrRich sent me (and everyone who reads his blog and book) the message that medical ethics and pride are in a downward spiral and if medical ethics is in a crisis, trust is next to fall.
Three years ago my brother-in-law received a prescription for simvastatin ( not the generic) because of his slightly elevated LDL. He was of the belief-without any specific supporting data- that the doctor was getting some type of "kick back" for using that medication. In my naivete,I told him in no uncertain terms that that sort of thing just does not happen.The conversation would have to be a bit different now.
This same general issue attracted a bit of attention when the "EPO" stories broke and the question of rebates for physicians and health care plans came to light at that time.I wrote about that here.
Fortunately the shattering of the trust in doctors which such activities will bring about will be mitigated by knowledge that no longer will pharma firms hand out the mind altering pens and mugs decorated by the names of medications. That should restore trust in physicians.
Sunday, July 20, 2008
More deserved criticism of P4P
I welcome attacks on the dangerous and muddled headed concept and practice of P4P. There is so much wrong with it that I hardly know where to begin. A good place to begin is this most recent entry by Dr.Roy Poses of Health Care Renewal. He summarizes most of the problems with pay for performance in this posting. To his excellent essay I would only add never forget Goodhart's Rule, which tell us that once a measurement becomes a target or a goal it is no longer a valid measure or more accurately phrased
Once a measure is made a target for the purpose of conducting policy, it will loose the information content that would qualify it to play such a role.
Dr. Robert Centor in his blog sends us to an extremely well written article in JAMA. You need a subscription but he gives us at least a hint of the flavor of that satire here.Ridicule sometimes is a sharper sword than thoughtful critiques.
I am afraid that in spite of biting satire and the elucidation of valid arguments against P4P, too many of our fellow physicians continue to collaborate with this travesty that can only serve to further accelerate the downward spiral to the ethics and pride of the medical profession.
Critics of the gate-keeper version of managed care were often told that the train had already left the station and now critics of P4P are being told that as well. The gate-keeper train ultimately derailed and I believe docs should let the P4P express train leave without them being aboard.
Once a measure is made a target for the purpose of conducting policy, it will loose the information content that would qualify it to play such a role.
Dr. Robert Centor in his blog sends us to an extremely well written article in JAMA. You need a subscription but he gives us at least a hint of the flavor of that satire here.Ridicule sometimes is a sharper sword than thoughtful critiques.
I am afraid that in spite of biting satire and the elucidation of valid arguments against P4P, too many of our fellow physicians continue to collaborate with this travesty that can only serve to further accelerate the downward spiral to the ethics and pride of the medical profession.
Critics of the gate-keeper version of managed care were often told that the train had already left the station and now critics of P4P are being told that as well. The gate-keeper train ultimately derailed and I believe docs should let the P4P express train leave without them being aboard.
Friday, July 18, 2008
More things too important for individuals to manage for themselves
I have ranted before about those who think and want everyone to think that medical care is far too important to be left to uninformed, selfish egotistical decisions that physicians and patients are likely to make when they meet secretly in the former's office away from the watchful eyes of third party payers and conspire to spend some one else's money.The last thing a rationing unit would want to happen is to allow the unfettered actions of doctors and patients to prevail. DrRich's writings have made that point with great literary skill.
That activity makes sense if you consider the "pay with other people's money principle" but groups other than third party payers also share in similar movements and I am less sure of their motives. Case in point are the activities of several local public health units in moving to monitor the blood sugar levels - as surrogated for by the Hemoglobin A1C levels-of citizens without their consent.They would have us believe that the public health imperative is so strong that diabetes treatment cannot be left to willy-nilly, half hearted efforts of individual physicians and their patients.
We are seeing more and more of that same type of thinking in regard to "managing" the food intake and other activities of children. There are major efforts out there by groups who believe that what a child eats and what activities they do are too important to be left to the uniformed,almost-negligence proclivities of parents.After all it is those parents who are to blame for the current ever growing epidemic of fat kids.
Great Britain and Canada seem to be a bit ahead of the U.S. in this nanny-state nutritional impetus but we are closing fast.Sandy Szwarc in her July 15,2008 entry give us this instance of how far it is going in one region of England where parents may not be "allowed" to send lunches to school with their children.
Hayek writes of the "Fatal Conceit" of those who not only believe they know what is best for everyone but also see fit to take measures to insure that their wisdom becomes operational even it means the power of the state will enforce it.
That activity makes sense if you consider the "pay with other people's money principle" but groups other than third party payers also share in similar movements and I am less sure of their motives. Case in point are the activities of several local public health units in moving to monitor the blood sugar levels - as surrogated for by the Hemoglobin A1C levels-of citizens without their consent.They would have us believe that the public health imperative is so strong that diabetes treatment cannot be left to willy-nilly, half hearted efforts of individual physicians and their patients.
We are seeing more and more of that same type of thinking in regard to "managing" the food intake and other activities of children. There are major efforts out there by groups who believe that what a child eats and what activities they do are too important to be left to the uniformed,almost-negligence proclivities of parents.After all it is those parents who are to blame for the current ever growing epidemic of fat kids.
Great Britain and Canada seem to be a bit ahead of the U.S. in this nanny-state nutritional impetus but we are closing fast.Sandy Szwarc in her July 15,2008 entry give us this instance of how far it is going in one region of England where parents may not be "allowed" to send lunches to school with their children.
Hayek writes of the "Fatal Conceit" of those who not only believe they know what is best for everyone but also see fit to take measures to insure that their wisdom becomes operational even it means the power of the state will enforce it.
Tuesday, July 08, 2008
WSJ editorial carries foward theme of Medicare as a harbinger of what a single payer would be like
Recently, I wrote that if you wonder what a single payer for medical care in this country would be like, all you need to study is how Medicare is working now. This same idea is expressed in this editorial from the Wall Street Journal. If you want to look at a real life example in the U.S. of what you may have learned in your Economics 101 class about price controls, all you need to study in how Medicare works.
WSJ says this:
The fight over doctor fees [the current annual dance over cuts in Medicare physician payments] is merely an appetizer for such a system, where competing interest groups would clash for their share of the spending pie. Highly politicized Medicare-like price controls on providers and services would spread to every health decision. The result would be rationing and declines in quality of care.
The writer explains:
As a virtual monopoly, Medicare uses a complex formula to set reimbursement rates for thousands of services. In short, it controls prices. That's why doctors are supposed to eat a pay cut, even though everyone knows this would prompt more doctors to stop seeing Medicare patients. But price fixing is the way that an open-ended entitlement like Medicare – which gobbled up $432 billion in 2007 – tries to control spending.
Thomas Sowell said that ignoring basic economic ideas is about as realistic as ignoring gravity in this essay on price controls. Medicare is all about price controls and rationing.
WSJ says this:
The fight over doctor fees [the current annual dance over cuts in Medicare physician payments] is merely an appetizer for such a system, where competing interest groups would clash for their share of the spending pie. Highly politicized Medicare-like price controls on providers and services would spread to every health decision. The result would be rationing and declines in quality of care.
The writer explains:
As a virtual monopoly, Medicare uses a complex formula to set reimbursement rates for thousands of services. In short, it controls prices. That's why doctors are supposed to eat a pay cut, even though everyone knows this would prompt more doctors to stop seeing Medicare patients. But price fixing is the way that an open-ended entitlement like Medicare – which gobbled up $432 billion in 2007 – tries to control spending.
Thomas Sowell said that ignoring basic economic ideas is about as realistic as ignoring gravity in this essay on price controls. Medicare is all about price controls and rationing.
Monday, July 07, 2008
Pediatric organization issues proactive recommendations re use of stains in children
Several years ago, Dr. Antonio Gotto, noted lipid researcher, jokingly suggested putting statins in the drinking water. While we are not quite there yet, we are closer to that facetious goal with the latest recommendations from the American Academy of Pediatrics. Go here to read their paper.
I found their recommendations more than a bit surprising in light of the following: 1) an apparent reversal from their earlier pronouncements, 2) the lack of evidence presented in their paper addressing the issues of long term safety and long term efficacy regarding decrease in clinical coronary artery disease events. The emphasis on surrogate measurements on which they had to rely given the paucity of long term outcome data is in contrast to the bad press surrogate measurements have recently received in diabetes drug trials.
So what group of children should be considered for prescription drug therapy.Here is what the AAP said:
I found their recommendations more than a bit surprising in light of the following: 1) an apparent reversal from their earlier pronouncements, 2) the lack of evidence presented in their paper addressing the issues of long term safety and long term efficacy regarding decrease in clinical coronary artery disease events. The emphasis on surrogate measurements on which they had to rely given the paucity of long term outcome data is in contrast to the bad press surrogate measurements have recently received in diabetes drug trials.
So what group of children should be considered for prescription drug therapy.Here is what the AAP said:
- For patients 8 years and older with an LDL concentration of
190 mg/dL (or
How will a government single payer work?Go to the Happy Hospitalist to see how it did/does work for Medicare
Everyone who is a physician or is training to be one,everyone who is a patient or who might someday be one (that really is almost everyone) needs to go now and read and re-read one of the latest essays by the Happy Hospitalist. Physicians to whom the education of physicians is entrusted should either copy that post and hand it out or send all of their students to the the link on the web .Would anyone like to wager that it will not find its way into any publication from a major medical organization?
Physicians who are so fed up with what medical practice has become and are so desperate that they are now recommending a single payer should read his article and see if their views about a single payer will change.
Happy explains what the CMS system is. If he is right,and I believe him to be right, the ship will sink in a few years and there will be not enough primary care docs to care for those folks who will need their services. Of course, many have prophesied that as well but the professional organizations such as ACP who also forecast disaster have not offered a viable solution, in my opinion.
The die was cast in 1989 with the passage of the Omnibus Budget Reconciliation Act. Wage controls were enacted for Medicare services, something that was promised to not ever happen when the Medicare bill was passed. With price controls one can expect shortages, increased demand , poor service and even black markets. All of the expected consequences did not occur overnight, but most (I don't think there is much of a black market yet) are very evident now and are getting worse.
The system that HH expertly explains so far has damaged the primary care physicians most but one can see effects moving up the doctor food chain. We are seeing ob-gyns offering botox and selling vitamins and are told there it is easier to get a vascular surgery fellowship than a dermatology residency. We read that a nurse anesthetist (CRNA) is averaging higher incomes than an internist or family doc or peds doc. Orthopedists are using PAs to do some of the non-procedural stuff (e.g. actually talking to patients) so their time can be spent with the higher paying activities like sawing and sewing.When you read how the system works much makes more sense: why we suddenly can't get by without hospitalists while 20 years ago there were no such entities, why the old medical ethics of putting the patient first had to be replaced by social justice concerns and a utilitarian viewpoint.It is the covert rationing so cogently explained by DrRich.
We all should know what wage and price controls do but the CMS system is worse than that. It is structured so that it will self destruct. Go to HH's post to see how that works.It is a death spiral of ever increasing volume and decreasing payment per unit of service that is crushing primary care and those docs who do the procedures will survive only a little longer.
He references his proposed solution in his blog. I don't know if his cure is the right medicine or not but he sure has done everyone a great service by explicating the pathophysiology of the problem.
Physicians who are so fed up with what medical practice has become and are so desperate that they are now recommending a single payer should read his article and see if their views about a single payer will change.
Happy explains what the CMS system is. If he is right,and I believe him to be right, the ship will sink in a few years and there will be not enough primary care docs to care for those folks who will need their services. Of course, many have prophesied that as well but the professional organizations such as ACP who also forecast disaster have not offered a viable solution, in my opinion.
The die was cast in 1989 with the passage of the Omnibus Budget Reconciliation Act. Wage controls were enacted for Medicare services, something that was promised to not ever happen when the Medicare bill was passed. With price controls one can expect shortages, increased demand , poor service and even black markets. All of the expected consequences did not occur overnight, but most (I don't think there is much of a black market yet) are very evident now and are getting worse.
The system that HH expertly explains so far has damaged the primary care physicians most but one can see effects moving up the doctor food chain. We are seeing ob-gyns offering botox and selling vitamins and are told there it is easier to get a vascular surgery fellowship than a dermatology residency. We read that a nurse anesthetist (CRNA) is averaging higher incomes than an internist or family doc or peds doc. Orthopedists are using PAs to do some of the non-procedural stuff (e.g. actually talking to patients) so their time can be spent with the higher paying activities like sawing and sewing.When you read how the system works much makes more sense: why we suddenly can't get by without hospitalists while 20 years ago there were no such entities, why the old medical ethics of putting the patient first had to be replaced by social justice concerns and a utilitarian viewpoint.It is the covert rationing so cogently explained by DrRich.
We all should know what wage and price controls do but the CMS system is worse than that. It is structured so that it will self destruct. Go to HH's post to see how that works.It is a death spiral of ever increasing volume and decreasing payment per unit of service that is crushing primary care and those docs who do the procedures will survive only a little longer.
He references his proposed solution in his blog. I don't know if his cure is the right medicine or not but he sure has done everyone a great service by explicating the pathophysiology of the problem.
Monday, June 30, 2008
More on rivaroxaban trials
Recently, I referenced two clinical trials published in the NEJM which compared a new oral anticoagulant,rivaroxaban, with the low molecular weight heparin enoxaparin for thromboprophylaxis in patients undergoing hip arthroplasty and knee replacement surgery.Both studies showed an advantage for rivaroxaban over the comparison drug in terms of fewer thrombotic events and showed no real difference in bleeding.
Dr. RW pointed out that the dose of enoxaparin was lower than the standard recommended dose,that is the dose recommended in the United States. In both studies, the dose of enoxaparin was 40 mg. daily.This is in contrast to the 30 mg. every 12 hours which is the standard dose used. Could the use of the lower dose of the drug to which rivaroxaban was compared be an instance of "stacking the deck"? In the hip surgery study, there were 33 patients out of 1678 with major venous thromboembolism events versus 4 in 1686 patients in the rivaroxaban arm seemingly indicating the superiority of "riva".
Would the higher enoxaparin dose that is typically given resulted in fewer cases making the comparison less favorable to rivaroxaban? Maybe, but in a 1994 dose finding study the outcomes with 40 mg once daily and 30 mg twice daily were not statistically different.There were 27/199 (14%) patients with clots in the 40 mg dose and 22/208 (11%) in the 30 mg twice a day dose, a difference not statistically significant. Admitedly this was not a mega trial so a false negative could have occurred but the 40 mg dose has been used in other trials.The PDR gives the 30 mg. twice daily dose as the recommended dose but also suggests that in hip surgery patients the 40 mg regimen is reasonable alternative.After all of that, it seems to me that the 40 mg. used is not a unreasonable dose and has been used in other trials with enoxaparin .
In regard to the knee surgery study, the authors stated that the enoxaparin dose used was the dose approved in Europe and not the 30 mg twice daily dose approved in the U.S. for that application. Further, they started that a trail is currently in progress with the 30 mg. twice daily dose.
With those considerations in mind my speculation or veiled accusation that the deck was stacked has little evidential support.It may be best to shoot after aiming.
In a thoughtful followup to his first posting Dr RW makes the important fact that you need to look at the facts of how the trial was designed and executed rather than basing any decision regarding the validity of the trial by simply looking at who paid for it. With some of the drug trials scandals (the Ketex studies come to mind)and the possibility that some data has been withheld in some trials I have become so jaded and distrustful that my objectivity titer has diminished and his suggestion to look at trial critically and then look at the funding makes sense.
Dr. RW pointed out that the dose of enoxaparin was lower than the standard recommended dose,that is the dose recommended in the United States. In both studies, the dose of enoxaparin was 40 mg. daily.This is in contrast to the 30 mg. every 12 hours which is the standard dose used. Could the use of the lower dose of the drug to which rivaroxaban was compared be an instance of "stacking the deck"? In the hip surgery study, there were 33 patients out of 1678 with major venous thromboembolism events versus 4 in 1686 patients in the rivaroxaban arm seemingly indicating the superiority of "riva".
Would the higher enoxaparin dose that is typically given resulted in fewer cases making the comparison less favorable to rivaroxaban? Maybe, but in a 1994 dose finding study the outcomes with 40 mg once daily and 30 mg twice daily were not statistically different.There were 27/199 (14%) patients with clots in the 40 mg dose and 22/208 (11%) in the 30 mg twice a day dose, a difference not statistically significant. Admitedly this was not a mega trial so a false negative could have occurred but the 40 mg dose has been used in other trials.The PDR gives the 30 mg. twice daily dose as the recommended dose but also suggests that in hip surgery patients the 40 mg regimen is reasonable alternative.After all of that, it seems to me that the 40 mg. used is not a unreasonable dose and has been used in other trials with enoxaparin .
In regard to the knee surgery study, the authors stated that the enoxaparin dose used was the dose approved in Europe and not the 30 mg twice daily dose approved in the U.S. for that application. Further, they started that a trail is currently in progress with the 30 mg. twice daily dose.
With those considerations in mind my speculation or veiled accusation that the deck was stacked has little evidential support.It may be best to shoot after aiming.
In a thoughtful followup to his first posting Dr RW makes the important fact that you need to look at the facts of how the trial was designed and executed rather than basing any decision regarding the validity of the trial by simply looking at who paid for it. With some of the drug trials scandals (the Ketex studies come to mind)and the possibility that some data has been withheld in some trials I have become so jaded and distrustful that my objectivity titer has diminished and his suggestion to look at trial critically and then look at the funding makes sense.
Friday, June 27, 2008
This time,new oral anticoagulants may well make it to the market
I had my hopes that ximelagatran would be the replacement for warfarin. That did not happen because of liver toxicity problems with the drug. Now several new drugs are traveling through the clinical trial pathways.Most of these are in a new class of anticoagulants known as Factor Xa inhibitors.
The medication leading the pack, in terms of being closest to approval, is rivaroxaban. Clinical trial results are found in the June 26,2008 issue of NEJM for the hip arthroplasty and total knee replacement studies. Both found fewer episodes of thrombosis in the rivaroxaban group and no statistical difference in bleeding when compared with enoxaparin. The liver toxicity that killed ximilagatran so far has not been a problem. Another Factor Xa inhibitor,apixaban, is in trials as is a direct thrombin inhibitor,dabigatran.
If and when the clinical trial(s) comparying "riva" with warfarin in chronic atrial fibrillation demonstrates similar good results we may finally have a new oral anticoagulant than does not require frequent blood test monitoring and may be free of much of the vexing vagaries of trying to get the dose of warfarin right and keeping it there.
The medication leading the pack, in terms of being closest to approval, is rivaroxaban. Clinical trial results are found in the June 26,2008 issue of NEJM for the hip arthroplasty and total knee replacement studies. Both found fewer episodes of thrombosis in the rivaroxaban group and no statistical difference in bleeding when compared with enoxaparin. The liver toxicity that killed ximilagatran so far has not been a problem. Another Factor Xa inhibitor,apixaban, is in trials as is a direct thrombin inhibitor,dabigatran.
If and when the clinical trial(s) comparying "riva" with warfarin in chronic atrial fibrillation demonstrates similar good results we may finally have a new oral anticoagulant than does not require frequent blood test monitoring and may be free of much of the vexing vagaries of trying to get the dose of warfarin right and keeping it there.
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