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.
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