I have criticized the "New" ( sixth edition of the ACP's ethics manual) before. I stand by that criticism, however, I was at least 14 years late in my comments. The 4th edition of the ACP Ethics Manual also speaks of parsimonious care and the concern for distributive justice. I was not paying attention. The forces of advocacy for social justice in the ACP were busy long before the 6th edition of the ethics manual went to press and also preceded the publication of The New Professionalism.
In an earlier posting I talked about the New Ethics Manual as a game changer as if there had been a major change in the ethics put forth by the ACP.I guess the game changed much sooner than I had realized.
Monday, July 23, 2012
Friday, July 20, 2012
Hormone Replacement Therapy (HRT) another update, but does it matter
Dr. HR Nelson and her colleagues have updated the continuing data accumulation regarding HRT ,largely from the Women's Health Initiative, and can be found in the July 17 Annals of Internal Medicine.Menopausal Hormone therapy for the Primary Prevention of Chronic Conditions. Ann Int Med 17 July 2012:;157(2) 104-113.
The hope was ( back in the early 1990s) that menopause could be "treated" with female hormones; estrogen and progesterone in women with a uterus and estrogen alone for women who had a hysterectomy.Anticipated benefits would include relief of menopausal vasomotor symptoms ( this could legitimately be called treatment) and in addition various other beneficial effects would occur which would be considered preventive. This list included prevention of osteoporosis and even coronary artery disease and stoke plus preservation of vaginal tissue health and maybe even smooth skin.
Hot flashes are prevented by HRT but as far as the preventive aspects the results have been confusing, mixed and seemingly changing every time an update of data analysis is performed and may not apply at all or only tangentially to the early post menopausal woman.
Although it was hypothesized that HRT would decrease the risk of coronary artery disease data showed that the combination of estrogen and progesterone (combo treatment) increased the risk but now the revised data indicate that the earlier report of increased risk has to be revised because now the hazard ratio is no longer statically significant.HR =1.22 with range of 0.99 to 1.51. Estrogen alone had no effect on heart attack risk.
Since breast cancer is an estrogen hormone dependent there was initial concern that prolonged estrogen use would lead to an increase risk of breast cancer. However, the data upon reanalysis shows that estrogen alone actually decreased breast cancer risk while it is the combo therapy that increased breast cancer risk. The HR for combo therapy and breast cancer is 1.25 with a range from 1.07-1.46. The HR for estrogen alone is 0.77 (0.62--0.95)
Both combo and estrogen alone are associated with an increased HR for stroke, both about 1.35.
On a positive notes both the combo and estrogen alone were associated with a decreased HR for hip and vertebral fractures, with HR s in the 0.70 range.
So the latest analysis would suggest that both treatment regimens will decrease fracture risk and both increase the risk of stroke.Neither currently seems to change heart attack risk.Combo therapy increased risk of breast cancer while estrogen alone decreases it.
The really big caveat to all of this is that is might not really apply meaningfully to a discussion with a women beginning menopause. The discussion section of the article captured that thought with an understatement:
"The participants were generally aged 60 -69 years ,which restricts the applicability of our findings."
You wonder how applicable it is at all.
For the most part the elevated hazard ratios were less than 1.5 and I have blogged more than once about the significance or lack thereof of relative risks or hazard ratios less than 2 and will shamelessly quote myself again:
... great quote, from Michale Thun, VP of Epidemiology and Surveillance Research at the American Cancer society:
With epidemiology you can tell a little thing from a big thing.What's very hard to do is to tell a little thing from nothing at all.
Gary Taubes in his widely cited article,"Epidemiology Faces Its Limits",Science, Vol 269,p. 164,July 1995, followed that quote with this comment:
...journals today are full of studies suggesting that a little risk is not nothing at all.
So much of what we have is a collection of hazard ratios of less than 2 largely from studies involving women in an age group which now would not be considered candidates for HRT anyway.
The hope was ( back in the early 1990s) that menopause could be "treated" with female hormones; estrogen and progesterone in women with a uterus and estrogen alone for women who had a hysterectomy.Anticipated benefits would include relief of menopausal vasomotor symptoms ( this could legitimately be called treatment) and in addition various other beneficial effects would occur which would be considered preventive. This list included prevention of osteoporosis and even coronary artery disease and stoke plus preservation of vaginal tissue health and maybe even smooth skin.
Hot flashes are prevented by HRT but as far as the preventive aspects the results have been confusing, mixed and seemingly changing every time an update of data analysis is performed and may not apply at all or only tangentially to the early post menopausal woman.
Although it was hypothesized that HRT would decrease the risk of coronary artery disease data showed that the combination of estrogen and progesterone (combo treatment) increased the risk but now the revised data indicate that the earlier report of increased risk has to be revised because now the hazard ratio is no longer statically significant.HR =1.22 with range of 0.99 to 1.51. Estrogen alone had no effect on heart attack risk.
Since breast cancer is an estrogen hormone dependent there was initial concern that prolonged estrogen use would lead to an increase risk of breast cancer. However, the data upon reanalysis shows that estrogen alone actually decreased breast cancer risk while it is the combo therapy that increased breast cancer risk. The HR for combo therapy and breast cancer is 1.25 with a range from 1.07-1.46. The HR for estrogen alone is 0.77 (0.62--0.95)
Both combo and estrogen alone are associated with an increased HR for stroke, both about 1.35.
On a positive notes both the combo and estrogen alone were associated with a decreased HR for hip and vertebral fractures, with HR s in the 0.70 range.
So the latest analysis would suggest that both treatment regimens will decrease fracture risk and both increase the risk of stroke.Neither currently seems to change heart attack risk.Combo therapy increased risk of breast cancer while estrogen alone decreases it.
The really big caveat to all of this is that is might not really apply meaningfully to a discussion with a women beginning menopause. The discussion section of the article captured that thought with an understatement:
"The participants were generally aged 60 -69 years ,which restricts the applicability of our findings."
You wonder how applicable it is at all.
For the most part the elevated hazard ratios were less than 1.5 and I have blogged more than once about the significance or lack thereof of relative risks or hazard ratios less than 2 and will shamelessly quote myself again:
... great quote, from Michale Thun, VP of Epidemiology and Surveillance Research at the American Cancer society:
With epidemiology you can tell a little thing from a big thing.What's very hard to do is to tell a little thing from nothing at all.
Gary Taubes in his widely cited article,"Epidemiology Faces Its Limits",Science, Vol 269,p. 164,July 1995, followed that quote with this comment:
...journals today are full of studies suggesting that a little risk is not nothing at all.
So much of what we have is a collection of hazard ratios of less than 2 largely from studies involving women in an age group which now would not be considered candidates for HRT anyway.
Friday, July 13, 2012
Three cheers to Dr.RW for his summary review of New ACCP Thrombosis guidelines
The current edition of the ACCP guidelines is big and filled with much that is important. I thank Dr. RW Donnell ( aka the blogger, Dr RW) for his review of this imposing document. ( So I don't have to).See here. See here for an executive summary of the 9th edition of the ACCP recommendations.
First let me echo his concern for the downplaying of subject matter experts in formulating a set of guidelines while emphasizing the role of "methodologists." I believed that one of the strengths of the ACCP efforts in this regard was the inclusion of both since the context that subject matter experts bring to the committee table is critical. Sometimes subject matter experts can mitigate the enthusiasm of the methodologist to make too much of a single RCT that might not seem to conform with clinical experience or generally accepted pathophysiological reasoning. If we could give recommendations based on a single or a small RCT we would be recommending homeopathy for various things
Here are some bits that caught my interest:
If INR is above 3: If no bleeding and INR less than or equal to 10, no treatment, if over 10 and no bleeding give oral vitamin K.
INR can be checked as infrequently as every three months.
Avoid quinolones for out patient on warfarin due to interaction.In hospitalized patient, can use quinolones with frequent monitoring of INR.
Anti-coagulation not recommended for knee arthroscopy.
Two years of compression stocking for DVT. The frequency of this actually happening must be very low.
There is much more in Dr. RW's summary and much much more in the actual document.
First let me echo his concern for the downplaying of subject matter experts in formulating a set of guidelines while emphasizing the role of "methodologists." I believed that one of the strengths of the ACCP efforts in this regard was the inclusion of both since the context that subject matter experts bring to the committee table is critical. Sometimes subject matter experts can mitigate the enthusiasm of the methodologist to make too much of a single RCT that might not seem to conform with clinical experience or generally accepted pathophysiological reasoning. If we could give recommendations based on a single or a small RCT we would be recommending homeopathy for various things
Here are some bits that caught my interest:
If INR is above 3: If no bleeding and INR less than or equal to 10, no treatment, if over 10 and no bleeding give oral vitamin K.
INR can be checked as infrequently as every three months.
Avoid quinolones for out patient on warfarin due to interaction.In hospitalized patient, can use quinolones with frequent monitoring of INR.
Anti-coagulation not recommended for knee arthroscopy.
Two years of compression stocking for DVT. The frequency of this actually happening must be very low.
There is much more in Dr. RW's summary and much much more in the actual document.
Thursday, July 05, 2012
Affordable Care Act (ACA) as example of The Bootlegger and the Baptist phenomenon
In 1993, economist Bruce Yandle wrote a noteworthy commentary in the journal Regulation.
In it he coined the term "Baptist and the Bootlegger" ( B and B) which explicates the marriage of high sounding values with narrow self interest to bring about regulation.
The B and B theory takes its name to instances in which Baptists were opposed to alcohol consumption on Sunday and were joined in their promotional and lobbying efforts by the bootleggers realizing that they, being skilled in criminal acts, would enjoy a comparative advantage in illegal alcohol sales.Of course, they urged prohibition of the sale and not the consumption of alcohol. With regulations passed the Baptists were happy about the incremental decrease in sin and the bootleggers enjoyed a Baptist originated cartel ( if only for one day a week).
Years later, Yandle offers this retrospective assessment of the "B and B"theory with discussion of the spotted owl episode of the 1990s leading to increased profits for timber growers and how the 1977 Clean Air Act's mandating scrubbers on newly constructed coal fired electrical plant favored the eastern coal companies and their high sulfur coal at the expense of the low sulfur coal producers in the west. In each instance the special interests joined forces with the environmentalist organizations to urge for regulations that were to ostensibly (or actually) further the public interest.
B and B theory is not just of historical interest.It was alive and well in the run up to the Affordable Care Act (ACA).
Candidate Obama distinguished himself from his rivals in the democratic primaries by opposing an individual mandate to purchase health insurance and favoring ultimately a health care system with a single payer.
Ron Williams , then the CEO of Aetna, met on numerous occasions with the President Obama and testified to a number of congressional committees.Others in the health insurance industry played less visible but still active roles in lobbying for the individual mandate. So here we have health insurance carriers lobbying for a law that would require people to buy their product. It is clear who plays the role of the bootlegger here. The Baptists are various spokes people who adhere to the progressive vision,favor redistribution and believe that health care is a right that should be provided by the government.Many are sincere,though in my opinion misguided,but some are likely bootleggers in Baptist robes as in astro turf advocacy groups.
See here for further details about the antics of Mr. Williams in lobbying for ACA as well as his intriguing and perhaps ill advised recanting of his position just prior to the SCOTUS decision.
The outrageous length and complexity of ACA makes it likely that the insurance industry was not the only bootlegger at work in planning and promotion of the bill. Big Pharma and Big Hospital comes to mind. Question: Should AMA in its role in supporting ACA be considered a bootlegger?
Professor Yandle has the following subtitle on his retrospective:
"The marriage of high flowing values and narrow interests continue to thrive"
In it he coined the term "Baptist and the Bootlegger" ( B and B) which explicates the marriage of high sounding values with narrow self interest to bring about regulation.
The B and B theory takes its name to instances in which Baptists were opposed to alcohol consumption on Sunday and were joined in their promotional and lobbying efforts by the bootleggers realizing that they, being skilled in criminal acts, would enjoy a comparative advantage in illegal alcohol sales.Of course, they urged prohibition of the sale and not the consumption of alcohol. With regulations passed the Baptists were happy about the incremental decrease in sin and the bootleggers enjoyed a Baptist originated cartel ( if only for one day a week).
Years later, Yandle offers this retrospective assessment of the "B and B"theory with discussion of the spotted owl episode of the 1990s leading to increased profits for timber growers and how the 1977 Clean Air Act's mandating scrubbers on newly constructed coal fired electrical plant favored the eastern coal companies and their high sulfur coal at the expense of the low sulfur coal producers in the west. In each instance the special interests joined forces with the environmentalist organizations to urge for regulations that were to ostensibly (or actually) further the public interest.
B and B theory is not just of historical interest.It was alive and well in the run up to the Affordable Care Act (ACA).
Candidate Obama distinguished himself from his rivals in the democratic primaries by opposing an individual mandate to purchase health insurance and favoring ultimately a health care system with a single payer.
Ron Williams , then the CEO of Aetna, met on numerous occasions with the President Obama and testified to a number of congressional committees.Others in the health insurance industry played less visible but still active roles in lobbying for the individual mandate. So here we have health insurance carriers lobbying for a law that would require people to buy their product. It is clear who plays the role of the bootlegger here. The Baptists are various spokes people who adhere to the progressive vision,favor redistribution and believe that health care is a right that should be provided by the government.Many are sincere,though in my opinion misguided,but some are likely bootleggers in Baptist robes as in astro turf advocacy groups.
See here for further details about the antics of Mr. Williams in lobbying for ACA as well as his intriguing and perhaps ill advised recanting of his position just prior to the SCOTUS decision.
The outrageous length and complexity of ACA makes it likely that the insurance industry was not the only bootlegger at work in planning and promotion of the bill. Big Pharma and Big Hospital comes to mind. Question: Should AMA in its role in supporting ACA be considered a bootlegger?
Professor Yandle has the following subtitle on his retrospective:
"The marriage of high flowing values and narrow interests continue to thrive"
Monday, July 02, 2012
The revolving door turns for health care agencies and health care business as well
Kudos again to Dr. Roy Poses for his tireless efforts to battle the forces that are destroying health care core's values.
See here on his blog Health Care Renewal for his investigative report on just two instances of the revolving door between government agencies regulating health care and the big players who provide various aspects of health care.
Here is Dr. Poses' next to last paragraph:
As we wrote before health policy in the US, in particular, has become an insiders' game. Unless it is redirected to reflect patients' and the public's health, facilitated by the knowledge of unbiased clinical and policy experts rather than corporate public relations, expect our efforts at health care reform to just increase health care dysfunction.
"Insider's game" is the exact appropriate characterization.
See here on his blog Health Care Renewal for his investigative report on just two instances of the revolving door between government agencies regulating health care and the big players who provide various aspects of health care.
Here is Dr. Poses' next to last paragraph:
As we wrote before health policy in the US, in particular, has become an insiders' game. Unless it is redirected to reflect patients' and the public's health, facilitated by the knowledge of unbiased clinical and policy experts rather than corporate public relations, expect our efforts at health care reform to just increase health care dysfunction.
"Insider's game" is the exact appropriate characterization.
Friday, June 29, 2012
How do you turn a mandate into a tax-just say the magic words
If you are the Chief Justice of the Supreme Court you have the power of magic words.
The individual mandate of ACA was called a mandate because , well, it was considered by the legislators as a mandate. The supporters of ACA claimed it was perfectly constitutional under the commerce clause because it-and as best I can tell almost everything-has something to do with interstate commerce and congress has the authority to regulate interstate commerce.
The Court ruled that the mandate was not constitutional under the commerce clause but it was when considered to be covered by the taxing authority of congress.But what about the Anti-injunction Act that says you cannot appeal a tax before it is paid?Well, in that regard it is not a tax.
When I use a word,' Humpty Dumpty said in rather a scornful tone, 'it means just what I choose it to mean — neither more nor less."
"The question is," said Alice, "whether you can make words mean so many different things."
"The question is," said Humpty Dumpty, "which is to be master— that's all."
George Will , in his commentary, argued that the limitation of the commerce clause that he believed occurred with the Court's ruling was actually a major victory for the forces that are striving to limit the power of the federal government since so much of the growth of federal power has been carried out under the cover of generous interpretations of the commence clause. Will is hopeful that that trend may now be thwarted by this ruling.
On the other hand it may be the case that now the court has offered a precedent that allows a mandate to stand because the penalty for failure to comply with the mandate is a tax and congress can tax pretty much anything it wants and thereby makes mandates willy-nilly if they can be construed to "really" be a tax. Law Professor Ilya Somin makes that argument here.
Quoting Professor Somin:
The individual mandate of ACA was called a mandate because , well, it was considered by the legislators as a mandate. The supporters of ACA claimed it was perfectly constitutional under the commerce clause because it-and as best I can tell almost everything-has something to do with interstate commerce and congress has the authority to regulate interstate commerce.
The Court ruled that the mandate was not constitutional under the commerce clause but it was when considered to be covered by the taxing authority of congress.But what about the Anti-injunction Act that says you cannot appeal a tax before it is paid?Well, in that regard it is not a tax.
When I use a word,' Humpty Dumpty said in rather a scornful tone, 'it means just what I choose it to mean — neither more nor less."
"The question is," said Alice, "whether you can make words mean so many different things."
"The question is," said Humpty Dumpty, "which is to be master— that's all."
George Will , in his commentary, argued that the limitation of the commerce clause that he believed occurred with the Court's ruling was actually a major victory for the forces that are striving to limit the power of the federal government since so much of the growth of federal power has been carried out under the cover of generous interpretations of the commence clause. Will is hopeful that that trend may now be thwarted by this ruling.
On the other hand it may be the case that now the court has offered a precedent that allows a mandate to stand because the penalty for failure to comply with the mandate is a tax and congress can tax pretty much anything it wants and thereby makes mandates willy-nilly if they can be construed to "really" be a tax. Law Professor Ilya Somin makes that argument here.
Quoting Professor Somin:
Pretty much any other mandate could be magically converted into a tax by the same sleight of hand - so long as the penalty for violating it is a fine similar to the one that enforces the individual mandate. The danger here is not just theoretical. Numerous interest groups could potentially lobby Congress to enact a law requiring people to buy their products, just as the health insurance industry did.
In rejecting the federal government’s argument that the mandate is authorized by the Commerce Clause, the chief justice emphasized that the Constitution denies Congress the power to “bring countless decisions an individual could potentially make within the scope of federal regulation and ... empower Congress to make those decisions for him.” Yet he has allowed the government to claim that same power under the Tax Clause
Monday, June 25, 2012
AMA joins the "gangwaggon" to guilt doctors to become stewards of society's resources
Kudos to Dr Doug Perednia,author of the blog Road to Hellth, for his denunciation (see here) of AMA's latest egregious attack on traditional medical ethics which is a sell out of both physicians and patients. They join the bandwagon,(gangwagon) initiative to destroy the traditional physician-patient relationship which had already been rocked by the alarmingly successful attack from the New Medical Professionalism-New Medical Ethics spearheaded by the folks at the ACP and ABIM and some of their internist colleagues in Europe.
Dr. Perednia quotes Med Page regarding AMA's actions.
Are they are throwing the fiduciary duty of the physician to the patient out of the window?Patients seek medical help to get the best advice for their given condition not to engage in some self sacrificial exercise in forgoing the optimal treatment for the nebulous and undefinable good of society . How much concern do you think a worried parent in the physician's office with a sick child cares about some abstract conservation of society's resources or furtherance of social justice.
In contrast to the gobbledygook of such phrases as "doesn't mesh with reality of clinical practice" and the gratuitous assertion of an operationally meaningless obligation. and the unwarranted assumption that physicians all have a collectivist philosophical mindset, Dr. Perednia makes these valid arguments:
The New Professionalism brainchild of ACP and friends did not quite say that social justice and the equitable allocation of scarce medical resources was an ethical obligation of physicians but the New Ethics Manual of the ACP made it explicit. It was a definite ethical game changer.See here for earlier comments on that development.
With many (most) professional medical associations mindlessly signing on to the New Professionalism and now with the AMA imprimatur I have little hope that the next generation of newly minted physicians will enter the field inculcated with the (now obsolete) notion that the physician's primary and fiduciary duty is to the patient.
I offer the following in partial proof on this fear as one "leader with ideas" has suggested
that "cost-consiousness and stewardship of resources be elevated by the ACGME and the ABMS to the level of a new seventh general competency." In other words, residents should be schooled and graded on their mastery of the skill set necessary to be good stewards of [society's] resources. ( reference, The Idea and Opinions Section, Annals of Internal Medicine,20 Sept 2011,Vol.155 no.6, by Dr. Steven E. Weinberger,of the American College of Physicians.
What could be more advantageous to the HMOs,ACOs and medical insurance companies than to flimflam the medical profession into accepting an new ethical paradigm that conveniently coincides with the bottom line of those organizations?
The concept "physicians as stewards of society's medical resources" is , in one sense a meaningless abstraction, and in another, a useful fiction. Useful to the HMOs,ACOs and insurers who now can enjoy to a much greater degree than before, physicians working to bolster their bottom line but decreasing costs also known as providing less to patients.
The socially conscientious physician might feel somewhat at loss as to how he might carry out the massive,pretentious and ambiguous task of stewarding society's resources.He should feel reassured ,though, because all it will take will be "follow the guidelines" and by doing so he will do what it right for that patient and for society as a whole. Wasn't that easy.
Dr. Perednia quotes Med Page regarding AMA's actions.
CHICAGO — Providing effective medical care includes an “obligation” to prudently manage healthcare resources, according to a report approved by the American Medical Association’s House of Delegates on Monday.
In fact, managing healthcare resources “is compatible with physicians’ primary obligation to serve the interests of individual patients,” the report reads. It further states that considering the welfare of only the patient currently being treated when making recommendations does “not mesh with the reality of clinical practice.”…
So the obligation (whenever the hell that obligation came from) to manage healthcare resources seems to preclude "considering the welfare of only the patient currently being treated".Are they are throwing the fiduciary duty of the physician to the patient out of the window?Patients seek medical help to get the best advice for their given condition not to engage in some self sacrificial exercise in forgoing the optimal treatment for the nebulous and undefinable good of society . How much concern do you think a worried parent in the physician's office with a sick child cares about some abstract conservation of society's resources or furtherance of social justice.
In contrast to the gobbledygook of such phrases as "doesn't mesh with reality of clinical practice" and the gratuitous assertion of an operationally meaningless obligation. and the unwarranted assumption that physicians all have a collectivist philosophical mindset, Dr. Perednia makes these valid arguments:
The first principle is that, in Western democratic cultures, when any of us seek out a physician for care, our primary goal is finding a solution to our own particular medical problems rather than a cure for the ills of society. In this role and in our minds, a doctor is supposed to be the equivalent of our “medical lawyer”:
- We provide the facts of the case as we know them.
- Our physician is supposed to gather any other relevant evidence and, using his special knowledge, outline all of the possible courses of action we might take and suggest the one that is most compatible with our goals and the resources available to us.
- He is supposed to looking out for our best interests rather than the interests of others. When a doctor or lawyer takes your case, he is supposed to be working for you: not your opponent, not insurers, not government, not world peace or society as a whole.
The New Professionalism brainchild of ACP and friends did not quite say that social justice and the equitable allocation of scarce medical resources was an ethical obligation of physicians but the New Ethics Manual of the ACP made it explicit. It was a definite ethical game changer.See here for earlier comments on that development.
With many (most) professional medical associations mindlessly signing on to the New Professionalism and now with the AMA imprimatur I have little hope that the next generation of newly minted physicians will enter the field inculcated with the (now obsolete) notion that the physician's primary and fiduciary duty is to the patient.
I offer the following in partial proof on this fear as one "leader with ideas" has suggested
that "cost-consiousness and stewardship of resources be elevated by the ACGME and the ABMS to the level of a new seventh general competency." In other words, residents should be schooled and graded on their mastery of the skill set necessary to be good stewards of [society's] resources. ( reference, The Idea and Opinions Section, Annals of Internal Medicine,20 Sept 2011,Vol.155 no.6, by Dr. Steven E. Weinberger,of the American College of Physicians.
What could be more advantageous to the HMOs,ACOs and medical insurance companies than to flimflam the medical profession into accepting an new ethical paradigm that conveniently coincides with the bottom line of those organizations?
The concept "physicians as stewards of society's medical resources" is , in one sense a meaningless abstraction, and in another, a useful fiction. Useful to the HMOs,ACOs and insurers who now can enjoy to a much greater degree than before, physicians working to bolster their bottom line but decreasing costs also known as providing less to patients.
The socially conscientious physician might feel somewhat at loss as to how he might carry out the massive,pretentious and ambiguous task of stewarding society's resources.He should feel reassured ,though, because all it will take will be "follow the guidelines" and by doing so he will do what it right for that patient and for society as a whole. Wasn't that easy.
Tuesday, June 19, 2012
The litigation to allow seniors to refuse Medicare Part A goes deeper in the rabbit hole
I have written in amazement about this lawsuit before.Several plaintiffs are attempting to assert what they believe to be their right to refuse Medicare Part A without losing their social security benefit payments.See here. The case is Hill v. Sebelius.Of course,I agree you should be able to decline Medicare without penalty.But the trial court and now the appellate court see things differently.
The case has proceed slowly through the legal system and now a three judge panel has ruled against the plaintiffs. It seems that there is a CMS rule book regulation that states if a person refuses Medicare Part A he will not receive the social security benefits he would have otherwise be eligible for. If one accepts Medicare A and then later decides to decline this "entitlement"he will stop receiving SS payments and have to repay what he had previously received. Earlier a judge in the case said in effect that Medicare benefits were a "mandatory entitlement".
Note this draconian rule was not written into the Medicare law or anything else that should have statuary power and came into existence in something called the Program Operations Manuel System (POMS) which apparently is simply advice for the program administrators and never went through any formal rule making process.
See here for the latest development in this case.
The case has proceed slowly through the legal system and now a three judge panel has ruled against the plaintiffs. It seems that there is a CMS rule book regulation that states if a person refuses Medicare Part A he will not receive the social security benefits he would have otherwise be eligible for. If one accepts Medicare A and then later decides to decline this "entitlement"he will stop receiving SS payments and have to repay what he had previously received. Earlier a judge in the case said in effect that Medicare benefits were a "mandatory entitlement".
Note this draconian rule was not written into the Medicare law or anything else that should have statuary power and came into existence in something called the Program Operations Manuel System (POMS) which apparently is simply advice for the program administrators and never went through any formal rule making process.
See here for the latest development in this case.
Sunday, June 17, 2012
Obamacare's IPAB is not just unconstitutional but is anti-constitution -Cato
An important Cato policy paper can be found here .Among many other important comments in the paper is the charge that Obamacare is not just unconstitutional;it is" anti-constitutional".
I have written about IPAB on several occasions. See here for some of my comments about IPAB and the concept of an "entrenchment provision" which a legal scholar discusses here offering tepid assurance that such a thing could not really happen. Entrenchment means that a legislature passes a law and includes within that statute a provision that prohibit future legislature from repealing or altering the law. There is such wording in ACA.
According to the Cato paper referenced above, the Obama administration has said that of course, IPAB could be abolished by congressional action even though Cato's paper said that statement conflicts with the clear wording of ACA. The legal analysis quoted above does say that apparently the Supreme Court has said they will not allow entrenchment.Whether IPAB is really entrenched on not,one has to assume that the authors of that section wanted IPAB to be an immutable,eternal entity.
So maybe (hopefully) that aspect of IPAB is just a tempest in a teapot but there is much more to be very,very worried about with IPAB . The Cato paper written by Diane Cohen and Michael Cannon discusses those issues in detail.If their analysis is correct the power that this appointed body will have is more than mind numbingly frightening.
Here is a good summary on Cato's web site giving a brief summary of the paper referenced above.
I have written about IPAB on several occasions. See here for some of my comments about IPAB and the concept of an "entrenchment provision" which a legal scholar discusses here offering tepid assurance that such a thing could not really happen. Entrenchment means that a legislature passes a law and includes within that statute a provision that prohibit future legislature from repealing or altering the law. There is such wording in ACA.
According to the Cato paper referenced above, the Obama administration has said that of course, IPAB could be abolished by congressional action even though Cato's paper said that statement conflicts with the clear wording of ACA. The legal analysis quoted above does say that apparently the Supreme Court has said they will not allow entrenchment.Whether IPAB is really entrenched on not,one has to assume that the authors of that section wanted IPAB to be an immutable,eternal entity.
So maybe (hopefully) that aspect of IPAB is just a tempest in a teapot but there is much more to be very,very worried about with IPAB . The Cato paper written by Diane Cohen and Michael Cannon discusses those issues in detail.If their analysis is correct the power that this appointed body will have is more than mind numbingly frightening.
Here is a good summary on Cato's web site giving a brief summary of the paper referenced above.
Wednesday, June 13, 2012
The gift that keeps giving-the stimulus to the electronic medical record industry
The American Recovery and Reinvestment Act had a number of beneficiaries.Part of the legislation was money for physicians to use to purchase electronic health record systems.
Stimulus for whom? Physicians do receive a relatively small payment ( about 40 -60 k) for agreeing to install EHR systems (electronic Medical records system) but were there large numbers of the rank and file physicians out lobbying for that part of the stimulus bill? I think not.But legislative packages do not arise at random out of thin air,there are folks at work lobbying for things that provide them favors.Economists call this behavior rent seeking. .There was much rent seeking going on the stimulus bill .
Maybe we should look to companies that sell the products and services that the goverment was giving money to physicians to purchase. Several of them worked with former Republican presidential candidate N. Gingrich's consultancy known as "Center for Health Transformation" which among other initiatives championed the electronics health record as a means of improving health care. These including Allscripts,Microsoft,Siemens and GE Health Care.
The underlying principle of the universe,there is no free lunch,applies to the faux beneficiaries- the physicians. The golden rule applies .He who has the gold makes the rules. The gift to the docs comes with strings,lots of them linked to Medicaid and Medicare payments. The 19 billion ( or 27 billion,depending on what source you read )given to the EHR companies through the physician checkbooks is just a drop in a big bucket as physicians will now have the obligation to keep the soft and hardware running and of course update regularly with new versions of the various software packages and update their systems as Federal requirement evolve.
Docs will also be tasked with proving their new system are demonstrating "meaningful use" a goverment term of art with very specific details that physicians practices will have to learn and try to comply with.See here for a reference for an explanation of the 25 criterion for meaningful use. Failure to achieve this level of use will at the end of the day ( a five year day) result in decrease in the CMS payments for services to the physicians who are meaninglessly utilizing their EHR.
Many- if not most- examples of rent seeking simply involves transferring tax payer money to a
the entity that successfully lobbyed for the favor. That happened here , of course, but additionally physicians will obliged to keep the systems running providing a continuing income stream to the EHR industry in perpetuity and providing a means of increasing control of the physicians practices.Part of the meaningful use requirements is to maintain a data base registry of patients with a given condition so that the doc can then demonstrate to the central authority the degree to which his practice complies with this or that guideline.
As if that all were not enough to push the older docs to decide right now to retire, part of the stimulus bill ( AKA American Recovery and Reinvestment Act of 2009) contains more stringent and detailed requirement and new penalties under HIPPA, See here for that.
We are the from the government ,we are here to help .
Stimulus for whom? Physicians do receive a relatively small payment ( about 40 -60 k) for agreeing to install EHR systems (electronic Medical records system) but were there large numbers of the rank and file physicians out lobbying for that part of the stimulus bill? I think not.But legislative packages do not arise at random out of thin air,there are folks at work lobbying for things that provide them favors.Economists call this behavior rent seeking. .There was much rent seeking going on the stimulus bill .
Maybe we should look to companies that sell the products and services that the goverment was giving money to physicians to purchase. Several of them worked with former Republican presidential candidate N. Gingrich's consultancy known as "Center for Health Transformation" which among other initiatives championed the electronics health record as a means of improving health care. These including Allscripts,Microsoft,Siemens and GE Health Care.
The underlying principle of the universe,there is no free lunch,applies to the faux beneficiaries- the physicians. The golden rule applies .He who has the gold makes the rules. The gift to the docs comes with strings,lots of them linked to Medicaid and Medicare payments. The 19 billion ( or 27 billion,depending on what source you read )given to the EHR companies through the physician checkbooks is just a drop in a big bucket as physicians will now have the obligation to keep the soft and hardware running and of course update regularly with new versions of the various software packages and update their systems as Federal requirement evolve.
Docs will also be tasked with proving their new system are demonstrating "meaningful use" a goverment term of art with very specific details that physicians practices will have to learn and try to comply with.See here for a reference for an explanation of the 25 criterion for meaningful use. Failure to achieve this level of use will at the end of the day ( a five year day) result in decrease in the CMS payments for services to the physicians who are meaninglessly utilizing their EHR.
Many- if not most- examples of rent seeking simply involves transferring tax payer money to a
the entity that successfully lobbyed for the favor. That happened here , of course, but additionally physicians will obliged to keep the systems running providing a continuing income stream to the EHR industry in perpetuity and providing a means of increasing control of the physicians practices.Part of the meaningful use requirements is to maintain a data base registry of patients with a given condition so that the doc can then demonstrate to the central authority the degree to which his practice complies with this or that guideline.
As if that all were not enough to push the older docs to decide right now to retire, part of the stimulus bill ( AKA American Recovery and Reinvestment Act of 2009) contains more stringent and detailed requirement and new penalties under HIPPA, See here for that.
We are the from the government ,we are here to help .
Cahoots ,Obamacare and Big Pharma
Dr. Richard Fogoros in his blog,The Covert Rationing Blog,made the observation that big health insurance companies were on board with Obamacare and helped get that statute passed because the way thing were going that was their only chance to be at least viable for awhile longer and then perhaps exist as a more or less regulated utility.See here for his cogent observations
Now, we have good reason to believe that Big Pharma was in cahoots with the democrats to pass Obamacare.What did Big Pharma get out it? Eliminating the part of the proposed legislation that would allow reimporting of prescriptions drugs and at least resisting price controls for a while. See here for the comments from the blog Health Care BS. See here for the WSJ report for details of the involvement of drug companies in pushing for the passage of ACA using astro turf type front groups (i.e two 501(c)(4) organizations).
WSJ points out that at least Big Pharma got something for their support.What AMA is alleged to have been lobbying for (the doc fix) was not part of the bill.Well,swimming with the sharks (also known as "a seat at the table") has its risks but at least the AMA leadership was able to have claimed a victory for social justice.
Now, we have good reason to believe that Big Pharma was in cahoots with the democrats to pass Obamacare.What did Big Pharma get out it? Eliminating the part of the proposed legislation that would allow reimporting of prescriptions drugs and at least resisting price controls for a while. See here for the comments from the blog Health Care BS. See here for the WSJ report for details of the involvement of drug companies in pushing for the passage of ACA using astro turf type front groups (i.e two 501(c)(4) organizations).
WSJ points out that at least Big Pharma got something for their support.What AMA is alleged to have been lobbying for (the doc fix) was not part of the bill.Well,swimming with the sharks (also known as "a seat at the table") has its risks but at least the AMA leadership was able to have claimed a victory for social justice.
Thursday, June 07, 2012
Muscle soreness after marathon-what do the muscle biopsies show?
I have completed marathons for 35 years and an interesting ( at least to me) change in the pattern of post marathon recovery time has emerged. When I as younger and more foolish I would train faster ( a relative term) and attempt to hit a target time for the race. For several years, I would strive to finish in under 3 1/2 hours. In the 2-4 days after those races, my quadriceps were sore and tender , the soreness peaking on day 2 and was particularly evident on attempting to walk downstairs.
This phenomenon is called delayed onset muscle soreness (DOMS).Although lactic acid buildup was once said to be the cause now the thinking is that the key element is eccentric exercise with damage to the muscle fibers and lactic acid exonerated.Neither post exercise icing nor use of NSAIDs seem to help but there is some fairly unconvincing data suggesting that post run massage might mitigate the soreness a bit.Well it feels good anyway.
In recent years there is no significant post race soreness in the thighs at anything near the level experienced earlier in my running odyssey. I developed the habit (obsession) of typically covering a long training distance on the weekends, running about 20 miles on a typical Saturday with no soreness on Sunday.
What do muscle biopsies demonstrate after marathons?
Here is a full text article from the American Journal of Pathology 1985 by M.J. Warhol. Muscle biopsies were done on the lateral gastrocnemius muscle of forty runners 48 hours after a marathon and again at one week, one month and 8-10 weeks. Light and electron microscopy were done.
At 48 hours there was damage to the myofibrils with abnormal findings evident in the mitochondria and sarcoplasmic reticulum. The damage was patchy and quite variable in extent from one runner to the next, with some demonstrating very little damage. Type II ( fast-twitch) fibers seemed to be more damaged. By day seven, "ghost cells" (empty muscle cells) were seen and satellite cells appeared. By one month there was continuing evidence of muscle cell regeneration but the pathological changes had largely resolved. There was no inflammatory cellular response reported in this paper but another report did describe some inflammatory cells.Some runners showed evidence of fibrosis. By 12 weeks there was continued electron microscopic evidence of muscle cell regeneration.
Similar light microscopy findings were reported earlier by RS Hikida ( with senior author D Costell ) in the Journal of Neuro Science 1983,May 59(2),195-203. However, their results differed in that they reported evidence of inflammation while Warhol suggested those changes were due to the trauma of the biopsy. Hikada also did pre-race biopsies showing some of the same changes prompting the suggestion that the intensive training for the marathon may have caused similar cellular changes.
A pattern emerges of damage to muscle cells that drop out and are replaced by new cells.
If the type II fibers are disproportionately affected perhaps my slower times and less participation by my type II fibers might account for the lack of post race soreness. Type II fibers kick in as the energy output increases moving toward the maximal oxygen uptake and when glycogen stores are depleted.Further the sarcopenia of aging also disproportionately targets type II cells so I may have less muscle cells at risk and I run so slowly that my fast twitch fibers for the most part have the day off.
What data are available regarding morphological changes in the muscles of athletes who exercise at high levels for many years? So far I have been unable to find any.
This phenomenon is called delayed onset muscle soreness (DOMS).Although lactic acid buildup was once said to be the cause now the thinking is that the key element is eccentric exercise with damage to the muscle fibers and lactic acid exonerated.Neither post exercise icing nor use of NSAIDs seem to help but there is some fairly unconvincing data suggesting that post run massage might mitigate the soreness a bit.Well it feels good anyway.
In recent years there is no significant post race soreness in the thighs at anything near the level experienced earlier in my running odyssey. I developed the habit (obsession) of typically covering a long training distance on the weekends, running about 20 miles on a typical Saturday with no soreness on Sunday.
What do muscle biopsies demonstrate after marathons?
Here is a full text article from the American Journal of Pathology 1985 by M.J. Warhol. Muscle biopsies were done on the lateral gastrocnemius muscle of forty runners 48 hours after a marathon and again at one week, one month and 8-10 weeks. Light and electron microscopy were done.
At 48 hours there was damage to the myofibrils with abnormal findings evident in the mitochondria and sarcoplasmic reticulum. The damage was patchy and quite variable in extent from one runner to the next, with some demonstrating very little damage. Type II ( fast-twitch) fibers seemed to be more damaged. By day seven, "ghost cells" (empty muscle cells) were seen and satellite cells appeared. By one month there was continuing evidence of muscle cell regeneration but the pathological changes had largely resolved. There was no inflammatory cellular response reported in this paper but another report did describe some inflammatory cells.Some runners showed evidence of fibrosis. By 12 weeks there was continued electron microscopic evidence of muscle cell regeneration.
Similar light microscopy findings were reported earlier by RS Hikida ( with senior author D Costell ) in the Journal of Neuro Science 1983,May 59(2),195-203. However, their results differed in that they reported evidence of inflammation while Warhol suggested those changes were due to the trauma of the biopsy. Hikada also did pre-race biopsies showing some of the same changes prompting the suggestion that the intensive training for the marathon may have caused similar cellular changes.
A pattern emerges of damage to muscle cells that drop out and are replaced by new cells.
If the type II fibers are disproportionately affected perhaps my slower times and less participation by my type II fibers might account for the lack of post race soreness. Type II fibers kick in as the energy output increases moving toward the maximal oxygen uptake and when glycogen stores are depleted.Further the sarcopenia of aging also disproportionately targets type II cells so I may have less muscle cells at risk and I run so slowly that my fast twitch fibers for the most part have the day off.
What data are available regarding morphological changes in the muscles of athletes who exercise at high levels for many years? So far I have been unable to find any.
Tuesday, May 29, 2012
More on earlier blog regarding statins,primary prevention,drinking water
My earlier blog commentary on the recent Lancet meta-analysis on outcomes of primary prevention trials in patients designated as "low risk"was done hastily and driven largely by my basic skepticism regarding meta-analyses and betting the farm on a single such study. A much more thoughtful and important analysis can be found here.
It was written by Dr. David Newman,an ER physician who authored the book entitled
Hippocrates Shadow:Secrets from the House of Medicine.
What apparently made the results of the recent Lance Meta-analysis different from a number of meta-analyses which found contradicting results was that the current study looked at the mortality data on those low risk patients who experienced a 40 mg or more decrement in the LDL following the institution of statin therapy.So the measure of interest was not the outcome of all low risk subjects treated with statins just those who had a favorable response to statins.
in Dr. Newman's words:
"Perhaps never has a statistical deception been so cleverly buried, in plain sight. The study answers this question: how much did the people who responded well to the drug benefit? This is, by definition, a circular and retrospective question: revisiting old data and re-tailoring the question to arrive at a conclusion. And to be fair they may have answered an interesting, and in some ways contributory, question. However the authors’ conclusions imply that they answered a different, much bigger question. And that is not a true story."
h/t to the tireless Dr. Roy Poses whose comments on my earlier posting alerted me to this line of thinking.
addendum: added 5/31/2012. I should have known Dr. Newman's comments were not go unchallenged and all such challenges not from hired guns at Pharma. Here are some arguments raised by Newman's critique.Thanks to the always informative and up to date web site ,Cardiobrief.
It was written by Dr. David Newman,an ER physician who authored the book entitled
Hippocrates Shadow:Secrets from the House of Medicine.
What apparently made the results of the recent Lance Meta-analysis different from a number of meta-analyses which found contradicting results was that the current study looked at the mortality data on those low risk patients who experienced a 40 mg or more decrement in the LDL following the institution of statin therapy.So the measure of interest was not the outcome of all low risk subjects treated with statins just those who had a favorable response to statins.
in Dr. Newman's words:
"Perhaps never has a statistical deception been so cleverly buried, in plain sight. The study answers this question: how much did the people who responded well to the drug benefit? This is, by definition, a circular and retrospective question: revisiting old data and re-tailoring the question to arrive at a conclusion. And to be fair they may have answered an interesting, and in some ways contributory, question. However the authors’ conclusions imply that they answered a different, much bigger question. And that is not a true story."
h/t to the tireless Dr. Roy Poses whose comments on my earlier posting alerted me to this line of thinking.
addendum: added 5/31/2012. I should have known Dr. Newman's comments were not go unchallenged and all such challenges not from hired guns at Pharma. Here are some arguments raised by Newman's critique.Thanks to the always informative and up to date web site ,Cardiobrief.
Monday, May 28, 2012
PSA and "moderate certainty" Don't screen says the central authority
See here for the latest pronouncement of the USPSTF regarding PSA screening.In a word "don't"
I suppose "moderate certainty" is a notch or two below"absolute certainty" The USPSTF made their dictum on the basis of moderate certainty.
Dictum is the correct noun since it seems according to ACA the determinations of the USPSTF will become the rules for CMS and how long will the other third party payers take to follow their lead?
DrRich ( aka Dr. Richard Fogoros of the blog, The Covert Rationing Blog,)seems to actually have read much if not most of the lengthy ACA and said this about the new role of USPSTF quoting chapter and verse.
Obamacare, which is now the law of the land, makes the USPSTF the final arbiter of which preventive services are to be covered by private insurers (Section 2713), by Medicare (Section 4105), and by Medicaid (Section 4106). Only those that have achieved a grade of A or B by the USPSTF will be covered. And if you believe you will be able to purchase for yourself PSA screening (or any other medical service which Obamacare has decided not to cover) you have not been paying attention. Perhaps you can do so today (if you’re not on Medicare or Medicaid), but probably not for long.
The conclusions of the USPMTF in regard to PSA are presented as a scientific conclusion although one that apparently only reaches the level of moderate certainty. However, opponents of that conclusion have made cogent arguments. See here.
There is in fact evidence that PSA can save some lives but the disagreement is in how to determine ( or who shall determine) if the benefit exceeds the cost or is the ratio inverted. In the judgement of the panel the benefit does not exceed the risk. This is a value judgement not a scientific judgement. It is not an argument raised only by those who are ignorant of statistical concepts or driven by financial concerns as was claimed recently by the chair of the panel.( See here for my comments regarding that.)
Thomas Sowell has written that in the last fifty or more years there has been a major shift in the " locus of decision making" moving toward a more centrally located site.It has taken several forms; from the family to the state,from the local government to the central government and now from the individual patient with counseling from his physician to a panel whose pronouncements will be determinative.
I suppose "moderate certainty" is a notch or two below"absolute certainty" The USPSTF made their dictum on the basis of moderate certainty.
Dictum is the correct noun since it seems according to ACA the determinations of the USPSTF will become the rules for CMS and how long will the other third party payers take to follow their lead?
DrRich ( aka Dr. Richard Fogoros of the blog, The Covert Rationing Blog,)seems to actually have read much if not most of the lengthy ACA and said this about the new role of USPSTF quoting chapter and verse.
Obamacare, which is now the law of the land, makes the USPSTF the final arbiter of which preventive services are to be covered by private insurers (Section 2713), by Medicare (Section 4105), and by Medicaid (Section 4106). Only those that have achieved a grade of A or B by the USPSTF will be covered. And if you believe you will be able to purchase for yourself PSA screening (or any other medical service which Obamacare has decided not to cover) you have not been paying attention. Perhaps you can do so today (if you’re not on Medicare or Medicaid), but probably not for long.
The conclusions of the USPMTF in regard to PSA are presented as a scientific conclusion although one that apparently only reaches the level of moderate certainty. However, opponents of that conclusion have made cogent arguments. See here.
There is in fact evidence that PSA can save some lives but the disagreement is in how to determine ( or who shall determine) if the benefit exceeds the cost or is the ratio inverted. In the judgement of the panel the benefit does not exceed the risk. This is a value judgement not a scientific judgement. It is not an argument raised only by those who are ignorant of statistical concepts or driven by financial concerns as was claimed recently by the chair of the panel.( See here for my comments regarding that.)
Thomas Sowell has written that in the last fifty or more years there has been a major shift in the " locus of decision making" moving toward a more centrally located site.It has taken several forms; from the family to the state,from the local government to the central government and now from the individual patient with counseling from his physician to a panel whose pronouncements will be determinative.
Saturday, May 26, 2012
Is aspirin the new warfarin regarding venous thrombosis-No,but.....
I had thought that aspirin was for the most part not considered very useful as a medication that could prevent venous thrombosis but had an important role in preventing arterial thrombosis .Now we have evidence from a clinical trial that aspirin may be useful in prevention of venous thrombosis.See here. As the discussion section of the NEJM article (linked below) indicated there had been previous published data suggesting aspirin's value in venous thrombosis prevention but for some reason aspirin never seemed to achieve a reputation as a useful venous thrombosis prevention.
The trial,WARFASA,studied patients who had received 6-18 months of standard therapy for venous thromboembolism (VTE) .The treatment group received 100 mg aspirin per day and the recurrence of VTE was significantly less in the treatment group. The recurrence rate was 11.2 events/years in the control group versus 6.6 in the aspirin group with one instance of major bleeding in each group. The recurrence rate seen in the control group is compatible with the usually quoted 10% per year recurrence in patient with unprovoked VTE after anticoagulation therapy is discontinued. See here for the study published in NEJM.
The study was done in Italy where the 100 mg aspirin tablet is available.As far as I can tell in the US,we have only a 80 mg. aspirin.and the regular strength aspirin.
Of course, aspirin is not the new warfarin but might it have a role in the longer term treatment of a patient with unprovoked VTE? Dr. Stephen Moll, a hematologist with special interest in thrombosis offers his take on this study and how he plans to use aspirin in some of his VTE patients. See here for the commentary on his blog ClotConnect.
Another similar trial is underway ( the ASPIRE trial ) is scheduled to offer some results later in 2012 and hopefully will be able to offer confirmation of this rather small trial.
Interestingly,the 9th edition of the ACCP clinical guidelines on antithrombolic therapy and prevention recommends against the use of aspirin in the prevention of VTE in long haul flights.See here.
The trial,WARFASA,studied patients who had received 6-18 months of standard therapy for venous thromboembolism (VTE) .The treatment group received 100 mg aspirin per day and the recurrence of VTE was significantly less in the treatment group. The recurrence rate was 11.2 events/years in the control group versus 6.6 in the aspirin group with one instance of major bleeding in each group. The recurrence rate seen in the control group is compatible with the usually quoted 10% per year recurrence in patient with unprovoked VTE after anticoagulation therapy is discontinued. See here for the study published in NEJM.
The study was done in Italy where the 100 mg aspirin tablet is available.As far as I can tell in the US,we have only a 80 mg. aspirin.and the regular strength aspirin.
Of course, aspirin is not the new warfarin but might it have a role in the longer term treatment of a patient with unprovoked VTE? Dr. Stephen Moll, a hematologist with special interest in thrombosis offers his take on this study and how he plans to use aspirin in some of his VTE patients. See here for the commentary on his blog ClotConnect.
Another similar trial is underway ( the ASPIRE trial ) is scheduled to offer some results later in 2012 and hopefully will be able to offer confirmation of this rather small trial.
Interestingly,the 9th edition of the ACCP clinical guidelines on antithrombolic therapy and prevention recommends against the use of aspirin in the prevention of VTE in long haul flights.See here.
Tuesday, May 22, 2012
Coarse grain data aka Big Data medicine and risk of the z-Pak
The EP cardiologist and long time medical blogger, Dr Wes, hits a home run with this commentary about the recent study that claimed a relationship between cardiac death and the use of azitromycin and some of the bigger issues with what he calls "Big Data Medicine".
The article in question appeared in a recent issue of the big impact medicine journal the, NEJM.
See here.
The authors reported an increased risk of cardiovascular death with a hazard ratio of 2.49 (1.38--4.5) and an overall mortality risk of 2.02 (1.24 --3.30). The ratios are a bit too high for me to make my usual comments ( see here ) about relative risks less than 2.
Azitromycin has been associated with a prolonged Q-T interval so the door is open to speculate about a pathophysiological mechanism that could explain the results if the association is real and not the artifact of crunching large numbers through the filters of a cascade of assumptions. How long will it be before we will be treated to an alternative statistical story from the epidemiologists at Pfizer which has been marketing Zithromax since 1991. Meanwhile the FDA promises to take the matter under consideration.
The article in question appeared in a recent issue of the big impact medicine journal the, NEJM.
See here.
The authors reported an increased risk of cardiovascular death with a hazard ratio of 2.49 (1.38--4.5) and an overall mortality risk of 2.02 (1.24 --3.30). The ratios are a bit too high for me to make my usual comments ( see here ) about relative risks less than 2.
Azitromycin has been associated with a prolonged Q-T interval so the door is open to speculate about a pathophysiological mechanism that could explain the results if the association is real and not the artifact of crunching large numbers through the filters of a cascade of assumptions. How long will it be before we will be treated to an alternative statistical story from the epidemiologists at Pfizer which has been marketing Zithromax since 1991. Meanwhile the FDA promises to take the matter under consideration.
More data to recommend putting statins in the drinking water?
There seems to be little controversy regarding treating patients with coronary artery disease with statins,what we call secondary prevention. Primary prevention, treating patients, who have no clinical evidence of heart disease,with statins is another matter being more than a little controversial.
Now we have a new meta-analysis that concluded primary prevention is a good idea. See here for a discussion of that study which reported a reduction in cardio-vascular mortality and all cause mortality in so called low risk patients. On the other hand (clinicians may yearn for the mythical one handed epidemiologist) a large meta-analysis by Dr. K. Ray and colleagues found no benefit in terms of all cause mortality.see here.
A few years ago I felt reasonably confident that I could a)determine a person's cardiac risk with a risk equation and b) advise that person about taking statins to lower his risk. I am much less sure about both those two things now but I still obstinately take pravastatin. In regard to risk equations I said all I can say about that in this several years old post entitled "Individual risk assessment,a peculiar,elusive,ambiguous concept." I would add another modifier, "faith based".
So how good can the risk equations ( yes there are more than one for predicting risk of coronary heart disease events and death ) be when studies perched on the highest rung on the ladder of evidence based medicines give contradictory results?
Now we have a new meta-analysis that concluded primary prevention is a good idea. See here for a discussion of that study which reported a reduction in cardio-vascular mortality and all cause mortality in so called low risk patients. On the other hand (clinicians may yearn for the mythical one handed epidemiologist) a large meta-analysis by Dr. K. Ray and colleagues found no benefit in terms of all cause mortality.see here.
A few years ago I felt reasonably confident that I could a)determine a person's cardiac risk with a risk equation and b) advise that person about taking statins to lower his risk. I am much less sure about both those two things now but I still obstinately take pravastatin. In regard to risk equations I said all I can say about that in this several years old post entitled "Individual risk assessment,a peculiar,elusive,ambiguous concept." I would add another modifier, "faith based".
So how good can the risk equations ( yes there are more than one for predicting risk of coronary heart disease events and death ) be when studies perched on the highest rung on the ladder of evidence based medicines give contradictory results?
Monday, April 09, 2012
Can experts really answer all our health questions?
Drs.Pamela Hartzband and Jerome Groopman offer their views on the advice of health care experts, the too often discordant answers to health care questions and the role of "mind sets" or subjectivity on what is portrayed by some as scientific and objective answers.
See here for their comments in the WSJ Lifestyle section on line corresponding to versions of the column appeared in some of the print versions of the print WSJ on 3/31/2012. The title is "Rise of Medical Expertocracy"
The authors suggest that voices from both sides of what is usually ( and inadequately) labelled the political spectrum are claiming that they have the experts to answer all of our health care questions.They question the assumption that there is a right answer for all such questions and that "best practices" as formulated by a panel of experts will be based entirely on a scientific,objective impartial determination.
"For patients and experts alike, there is a subjective core to every medical decision. The truth is,despite many advances, much of medicine still exists in a gray zone where there is not one right answer"
Of course, expert panels use to varying degrees the available data sets, sophisticated statistical methods and epidemiological reasoning, but at the end of the process some one or some group has to make a value judgment.They have to say the risks are or are not worth the benefit.
The authors talk about "mind sets";the maximalists who tend to prefer doing everything or at least a lot and the "doubters" who worry that many (most?) treatments will be worse that the disease.They suggest that experts , as well, have mind sets that will influence the value judgment that they make after their objective analysis. So two experts can look at the same data and reaching opposite conclusions.Patients do this as well.
Since much of medical care is paid for by third parties,the advice of expert panels will likely have a major impact on their policies.
'Patients and doctors can differ with experts and not be ignorant or irrational.Policy makers need to abandon the idea that experts know what is best.In medical care, the "right" clinical decisions turn out to be those that are based on a patient's goals and values."
Amen, but that flies in the face of the over arching principal of the progressive medical mind set which is "Medicine is too important and too complicated to be left to the individual patient with advice from her patient".
My mind set or "priors" tends to warmly resonate with these views of Drs. Hartzband and Groopman and bristles when faced with the lamentations of some of the experts who accuse those whose advice differs from theirs as being ignorant of statistical concepts and seem themselves to be ignorant of the fact that their own mind sets may influence their conclusions and advice.
Dr. Viriginia Moyer was the Chair of the U.S. Preventive Services Task Force at the time of the release of their recommendations regarding PSA screening for prostate cancedr. In her editorial in the Annals of Internal Medicine ( 6 March 2012,Vol 156,number 5, pg 392-393) she offers a dissection of the reasons why there is opposition to the Task Force's recommendation which advised against PSA screening.
While she mentions the possibility of some financial interests-both from companies and physicians whose daily work is to diagnose and treat certain screened-for conditions- playing a role in promotion of screening,her principal explanation is "physician Innumeracy". Simply put-those opposing the USPTF's PSA position just don't understand statistics. She also neglects to mention the possibility of financial interests ( third party payers) opposing screening. The Mafia rule of"follow the money" might just apply to both sides of that disagreement. Let's see, who would benefit from fewer tests or treatments? Perhaps the third party payers.
Dr. Moyer does not seem to recognize-or at least does not mention- the possibility that experts who know their way around NNTs (number needed to treat) and other statistical metrics and techniques as well or better than she might just look at the same data and reach a different value judgment. In fact they do and have even in regard to the issue of PSA screening.
Drs Hartzband and Groopman speak of a new form of paternalism "based on the assumption that Americans are not receiving "quality medical care".
" A lucrative industry has grown up to generate ever more medical metrics,to give report cards to doctors and hospitals, and to base payments on compliance with the "best practices".Yet beyond safety protocols, there is scant evidence that such measures improve our health"
See here for their comments in the WSJ Lifestyle section on line corresponding to versions of the column appeared in some of the print versions of the print WSJ on 3/31/2012. The title is "Rise of Medical Expertocracy"
The authors suggest that voices from both sides of what is usually ( and inadequately) labelled the political spectrum are claiming that they have the experts to answer all of our health care questions.They question the assumption that there is a right answer for all such questions and that "best practices" as formulated by a panel of experts will be based entirely on a scientific,objective impartial determination.
"For patients and experts alike, there is a subjective core to every medical decision. The truth is,despite many advances, much of medicine still exists in a gray zone where there is not one right answer"
Of course, expert panels use to varying degrees the available data sets, sophisticated statistical methods and epidemiological reasoning, but at the end of the process some one or some group has to make a value judgment.They have to say the risks are or are not worth the benefit.
The authors talk about "mind sets";the maximalists who tend to prefer doing everything or at least a lot and the "doubters" who worry that many (most?) treatments will be worse that the disease.They suggest that experts , as well, have mind sets that will influence the value judgment that they make after their objective analysis. So two experts can look at the same data and reaching opposite conclusions.Patients do this as well.
Since much of medical care is paid for by third parties,the advice of expert panels will likely have a major impact on their policies.
'Patients and doctors can differ with experts and not be ignorant or irrational.Policy makers need to abandon the idea that experts know what is best.In medical care, the "right" clinical decisions turn out to be those that are based on a patient's goals and values."
Amen, but that flies in the face of the over arching principal of the progressive medical mind set which is "Medicine is too important and too complicated to be left to the individual patient with advice from her patient".
My mind set or "priors" tends to warmly resonate with these views of Drs. Hartzband and Groopman and bristles when faced with the lamentations of some of the experts who accuse those whose advice differs from theirs as being ignorant of statistical concepts and seem themselves to be ignorant of the fact that their own mind sets may influence their conclusions and advice.
Dr. Viriginia Moyer was the Chair of the U.S. Preventive Services Task Force at the time of the release of their recommendations regarding PSA screening for prostate cancedr. In her editorial in the Annals of Internal Medicine ( 6 March 2012,Vol 156,number 5, pg 392-393) she offers a dissection of the reasons why there is opposition to the Task Force's recommendation which advised against PSA screening.
While she mentions the possibility of some financial interests-both from companies and physicians whose daily work is to diagnose and treat certain screened-for conditions- playing a role in promotion of screening,her principal explanation is "physician Innumeracy". Simply put-those opposing the USPTF's PSA position just don't understand statistics. She also neglects to mention the possibility of financial interests ( third party payers) opposing screening. The Mafia rule of"follow the money" might just apply to both sides of that disagreement. Let's see, who would benefit from fewer tests or treatments? Perhaps the third party payers.
Dr. Moyer does not seem to recognize-or at least does not mention- the possibility that experts who know their way around NNTs (number needed to treat) and other statistical metrics and techniques as well or better than she might just look at the same data and reach a different value judgment. In fact they do and have even in regard to the issue of PSA screening.
Drs Hartzband and Groopman speak of a new form of paternalism "based on the assumption that Americans are not receiving "quality medical care".
" A lucrative industry has grown up to generate ever more medical metrics,to give report cards to doctors and hospitals, and to base payments on compliance with the "best practices".Yet beyond safety protocols, there is scant evidence that such measures improve our health"
Thursday, March 29, 2012
More on medical guidelines being hazardous to your health
A subset of pneumonia patients -those considered at risk of having a multi-drug bacterial etiology-did worse if their physician complied with ATS-IDSA guidelines according to a recent study. See here for reference to the article that was published on Lancet online.
I have blogged before about the dangerous tendency of guidelines tendency to cause unintended consequences and talked about the idiotic four hour pneumonia rule, one unintended consequence of which was the treatment of non-pneumonia patients for pneumonia within the four hour deadline.Well at least the treatment was started within 4 hours.
My longest screed about guidelines can be found here.
Guidelines can be considered part of the mind that says " medicine is too important and too complicated to be left to the individual physician and individual patient." This dangerous mind set was made explicit and championed by the former header of CMS, Dr. Don Berwick who said :
"Today, this isolated relationship [ed. the individual doctor-patient ] is no longer tenable or possible… Traditional medical ethics, based on the doctor-patient dyad must be reformulated to fit the new mold of the delivery of health care...Regulation must evolve. Regulating for improved medical care involves designing appropriate rules with authority...Health care is being rationalized through critical pathways and guidelines. The primary function of regulation in health care, especially as it affects the quality of medical care, is to constrain decentralized individualized decision making.” (My bolding).
Yeah,that pesky decentralized decision making just gets in the wise of wise centralized decision making which history tells us worked out really well in the 20th century.
The best quality or guidelines rules are supported to varying degrees by randomized clinical trials but even here one should proceed slowly because the well known efficacy-effectiveness gap tolerates simplistic approaches poorly. RCTs are often small and have multiple exclusion rules and fail to capture the perplexing diversity of relevant pathophysiological variables (known and unknown) that coexist in complex, hospitalized patients. It is in the sickest patients that rules formulated by committees based on what-ever data or personal bias that the most harm can be done and in whom individual variation overwhelm premature generalizations and an eager rush to mandate treatment rules.No, all guideline writers do not always intend that their wisdom should be mandatory ( but some do) and write disclaimers at the end of the articles to that effect, but guidelines have a way of morphing from suggestions to dicta and rules the ignoring of which may have financial or other consequences for the rouge doctor.
The mandatory and quasi mandatory nature of guidelines or quality indicators as wielded by the CMS mandarins and other institutional elites become even more dangerous with the spreading use of the "disruptive physician" doctrine. Not only must you go by the rules you can't complain about them without incurring the wrath of the hospital's disruptive physician committee.This doctrine is a brilliant control mechanism.If you challenge the disruptive physician concept you are by definition disruptive.
I have blogged before about the dangerous tendency of guidelines tendency to cause unintended consequences and talked about the idiotic four hour pneumonia rule, one unintended consequence of which was the treatment of non-pneumonia patients for pneumonia within the four hour deadline.Well at least the treatment was started within 4 hours.
My longest screed about guidelines can be found here.
Guidelines can be considered part of the mind that says " medicine is too important and too complicated to be left to the individual physician and individual patient." This dangerous mind set was made explicit and championed by the former header of CMS, Dr. Don Berwick who said :
"Today, this isolated relationship [ed. the individual doctor-patient ] is no longer tenable or possible… Traditional medical ethics, based on the doctor-patient dyad must be reformulated to fit the new mold of the delivery of health care...Regulation must evolve. Regulating for improved medical care involves designing appropriate rules with authority...Health care is being rationalized through critical pathways and guidelines. The primary function of regulation in health care, especially as it affects the quality of medical care, is to constrain decentralized individualized decision making.” (My bolding).
Yeah,that pesky decentralized decision making just gets in the wise of wise centralized decision making which history tells us worked out really well in the 20th century.
The best quality or guidelines rules are supported to varying degrees by randomized clinical trials but even here one should proceed slowly because the well known efficacy-effectiveness gap tolerates simplistic approaches poorly. RCTs are often small and have multiple exclusion rules and fail to capture the perplexing diversity of relevant pathophysiological variables (known and unknown) that coexist in complex, hospitalized patients. It is in the sickest patients that rules formulated by committees based on what-ever data or personal bias that the most harm can be done and in whom individual variation overwhelm premature generalizations and an eager rush to mandate treatment rules.No, all guideline writers do not always intend that their wisdom should be mandatory ( but some do) and write disclaimers at the end of the articles to that effect, but guidelines have a way of morphing from suggestions to dicta and rules the ignoring of which may have financial or other consequences for the rouge doctor.
The mandatory and quasi mandatory nature of guidelines or quality indicators as wielded by the CMS mandarins and other institutional elites become even more dangerous with the spreading use of the "disruptive physician" doctrine. Not only must you go by the rules you can't complain about them without incurring the wrath of the hospital's disruptive physician committee.This doctrine is a brilliant control mechanism.If you challenge the disruptive physician concept you are by definition disruptive.
Monday, March 26, 2012
Cardiac stress test before endurance exercise might just make sense
The party line (I mean the consensus of reasoned expert opinion by panels of highly educated people) has been there should not be stress tests before a person begins training for or entering a marathon because of some combination of the following reasons: low incidence of cardiac events in endurance races and shorter fun runs,large numbers of false positives noted on treadmill stress testings,and the dominant theory that the major cause of cardiac events precipitated by exercise is acute plaque rupture rather than fixed coronary artery stenosis.
An extensive assessment of cardiac events during long distance runs might change the thinking in that regard.
JH Kim et al reached that conclusion following their analysis of cardiac arrests associated with marathon and half marathon races in the US from 2000 to 2010.See here for ref.
The authors' data including races involving 10.9 millions runners and 51 men had cardiac arrests. Hypertrophic cardiomyopathy and atherosclerotic coronary disease were the two most common causes.
The authors said:
"The absence of coronary plaque rupture in these persons was surprising because prior data and expert consensus documents have suggested that exercise induced acute coronary syndrome result from atherosclerotic plaque disruption and coronary thrombosis.
Their findings suggested that rather than plaque rupture that there was an imbalance between oxygen supply limited by stenotic coronary arteries and oxygen demand greatly increased by the exercise.
So exercise testing would be useful to the extent that the exercise related events were due to fixed obstruction. Of course both mechanisms could be present alone or in combination in various people. A resting ekg should be helpful in alerting to the possibility of hypertrophic cardiomyopathy. But, of course, there is that new directive by the progressive medical elite for parsimonious care to take under consideration.
An extensive assessment of cardiac events during long distance runs might change the thinking in that regard.
JH Kim et al reached that conclusion following their analysis of cardiac arrests associated with marathon and half marathon races in the US from 2000 to 2010.See here for ref.
The authors' data including races involving 10.9 millions runners and 51 men had cardiac arrests. Hypertrophic cardiomyopathy and atherosclerotic coronary disease were the two most common causes.
The authors said:
"The absence of coronary plaque rupture in these persons was surprising because prior data and expert consensus documents have suggested that exercise induced acute coronary syndrome result from atherosclerotic plaque disruption and coronary thrombosis.
Their findings suggested that rather than plaque rupture that there was an imbalance between oxygen supply limited by stenotic coronary arteries and oxygen demand greatly increased by the exercise.
So exercise testing would be useful to the extent that the exercise related events were due to fixed obstruction. Of course both mechanisms could be present alone or in combination in various people. A resting ekg should be helpful in alerting to the possibility of hypertrophic cardiomyopathy. But, of course, there is that new directive by the progressive medical elite for parsimonious care to take under consideration.
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