Commenter Kiwi Geoff kindly wrote a program that calculates LDL using the Friedewald equation and the equation from this paper, which may be more accurate for people with a total cholesterol over 250 and triglycerides under 100. For people whose triglycerides are over 100, the Friedewald equation should be relatively accurate. You can plug your total cholesterol, HDL and triglycerides into the program (in mg/dL), and it gives you both LDL values side-by side. Here it is:
LDL Cholesterol Calculator
Thanks, Geoff.
LDL Calculator
Commenter Kiwi Geoff kindly wrote a program that calculates LDL using the Friedewald equation and the equation from this paper, which may be more accurate for people with a total cholesterol over 250 and triglycerides under 100. For people whose triglycerides are over 100, the Friedewald equation should be relatively accurate. You can plug your total cholesterol, HDL and triglycerides into the program (in mg/dL), and it gives you both LDL values side-by side. Here it is:
LDL Cholesterol Calculator
Thanks, Geoff.
LDL Cholesterol Calculator
Thanks, Geoff.
UK's National Programme for IT in the NHS Known Doomed at Outset?
It would seem likely.
In May 2009 at "The Machinery Behind Healthcare Reform: How the HIT Lobby is Pushing Experimental and Unsafe Technology on Unconsented Patients and Clinicians" I wrote:
I (and many like minded colleagues) don't find healthcare information technology issues a laughing matter, however.
-- SS
In May 2009 at "The Machinery Behind Healthcare Reform: How the HIT Lobby is Pushing Experimental and Unsafe Technology on Unconsented Patients and Clinicians" I wrote:
... I can add that if this initiative [the U.S. multibillion dollar ARRA push towards national healthcare IT by 2014] blows up as it has in the UK, then the only triumph will be the financial triumph of the trade group and its apparatchiks. The losers will be the administration, patients, clinicians, and everyone else in the healthcare system.
The UK situation is much worse than I thought. The UK's NPfIT in the NHS was suspected to have been doomed from the start, but proceeded anyway; see "16 key points in Gateway Reviews on NHS IT scheme" and the secretive Gateway Reviews themselves upon which the preceding article was based, released under UK Freedom Of Information laws. From ComputerWeekly.com author Tony Collins on Gateway Reviews:
Highlights of the secretive health IT program reviews, now made public:
How many of these findings apply in the U.S. Health IT program in 2009?
Finally, about the aforementioned May 2009 post, Matthew Holt of the Healthcare Blog wrote that I had "gone loopy", i.e., crazy (see footnote to the above-linked May 2009 post). The Chairman of CCHIT Mark Leavitt wrote that concerns about health IT are expressed by "fearmongers" and should be "laughed off."
These cavalier attitudes are a major part of what has gone wrong in HIT, as well as our society more generally.
... Gateway reviews are mini-audits at critical stages in projects. The reports in question gave a red, amber or green status at each stage to help the project’s senior responsible owner decide whether to move to the next phase.
The government’s policy on Gateway reviews is to keep them confidential. All copies of a review are shredded, with the supporting material, to ensure only two reports remain – one for the Treasury’s Office of Government Commerce (OGC) and the other for the project’s senior responsible owner.
Highlights of the secretive health IT program reviews, now made public:
- the NPfIT was probably doomed from the start, in Spring 2002. As one Gateway Review put it, many dedicated people were working hard on building the components for a car that hadn't been designed. To some extent that's still true today.
- people didn't really know what they were doing in the first critical months in 2002
- the initial plan was for new IT - not for changes to the way people work. So the preoccupation was with IT and not patients. It was hoped that new IT would drive change. But that rarely if ever succeeds.
- that the costs and complexity were initially underestimated - by about £7bn - because nobody had an understanding of what was needed.
- that speed was unduly important. One gateway review suggested that key staff didn't have time to take action on recommendations or learn lessons.
- the programme as a whole, according to one Gateway Review, was not assessed against a list of Common Causes of Failure, as published by the National Audit Office. Only individual projects were assessed against the list.
How many of these findings apply in the U.S. Health IT program in 2009?
Finally, about the aforementioned May 2009 post, Matthew Holt of the Healthcare Blog wrote that I had "gone loopy", i.e., crazy (see footnote to the above-linked May 2009 post). The Chairman of CCHIT Mark Leavitt wrote that concerns about health IT are expressed by "fearmongers" and should be "laughed off."
These cavalier attitudes are a major part of what has gone wrong in HIT, as well as our society more generally.
Not to draw a specific comparison with these individuals, but our society is crumbling, and it's in no small part due to clowns in leadership roles, rather than as performers in Ringling Bros. and Barnum and Bailey's Greatest Show on Earth.
According to Matthew Holt and Mark Leavitt, Health IT concerns are a laughing matter, expressed by crazy people.
I (and many like minded colleagues) don't find healthcare information technology issues a laughing matter, however.
-- SS
Another Fatty Liver Reversal
Just to show it wasn't a fluke, reader "Steve" replicates the experiment:
The liver is a remarkable organ. Besides being your "metabolic grand central station", it's the only organ in the human body that can regenerate almost completely. It can be 75% obliterated, and it will grow back over time. Fatty liver and NASH are largely reversible.
I had a similar problem as what Sam described, and it just happened to coincide with my discovery of and commitment to a new eating plan (based on low/good carb, high in good fat and omega 3, and good protein--basically a mix of paleo, primal, low carb, whatever they call it). I consider myself lucky to have had great fortune in my timing of finding out about my fatty liver.And a later comment:
My ALT and AST [markers of liver damage] had been at 124 and 43 respectively, and then still at 80 and 30 in a follow up a few months later. I weighed in at about 205 (I'm 6'1.5" on a slimmish frame), which was my heaviest. I had been on a basic American (bad) diet. The whole thing shocked me, especially after a CT with contrast showed the fatty deposits on my liver (and prior to that, when the muddy ultrasound revealed a fatty liver and a possible pancreatic mass, later ruled out by the CT). Like Sam, though I was surely overweight, I was not fat or heavy. (Most people have noticed I look leaner, but are shocked when I disclose how much weight I have lost since they say "I cannot believe you had that much to lose.")
At about the same time I found out about my liver issue, I had been getting into reading about diet and health (something I had done once when I read the Zone stuff from Sears many years ago). I practically dove through Taubes, Eades, Cordain, and a bunch of blogs (including yours), and I made a commitment to fix my problem.
I started a pretty severe regimen at first, which included only protein and good fats with a minimal amount of non-starchy fruits and vegetables. Almost immediately, I started losing weight and body fat (as measured by an electrical impedance scale). I have always supplemented with fish oil, but I added krill oil and I also started eating grass-fed beef and pastured eggs and pastured pork as much as possible. I have added some coconut oil and pastured butter to my diet as well. I have dropped almost 40 pounds, I am down to about 10-11% body fat (from 24%), and my ALT/AST on my last test was 24/14 [normal]. I am getting another test soon, and I expect similar results.
I can add to the story that I first found out about the fatty liver on a routine new patient blood screening when I moved to a new town. I can also add that it took a bit of initiative on my part to get to the right diagnosis. The first doctor suspected hepatitis, but when blood work ruled that out, he ordered the imagining tests. Once I was referred to a GI specialist, it was a quick diagnosis. Still, I had to undertake myself to figure out the best diet. The GI recommended eliminating white bread, rice, pasta, starches, etc. but also recommended lowering fat intake. Having done some of my reading on diet and health, I knew to follow the former advice and to modify the latter to be "get plenty of fat, but make sure its the right kind."Steve took the initiative and fixed his damaged liver. He modified his GI doctor's advice based on what he had read about nutrition, with excellent results. I suspect his doctor will be all ears next time Steve comes into his office.
The liver is a remarkable organ. Besides being your "metabolic grand central station", it's the only organ in the human body that can regenerate almost completely. It can be 75% obliterated, and it will grow back over time. Fatty liver and NASH are largely reversible.
Another Fatty Liver Reversal
Just to show it wasn't a fluke, reader "Steve" replicates the experiment:
The liver is a remarkable organ. Besides being your "metabolic grand central station", it's the only organ in the human body that can regenerate almost completely. It can be 75% obliterated, and it will grow back over time. Fatty liver and NASH are largely reversible.
I had a similar problem as what Sam described, and it just happened to coincide with my discovery of and commitment to a new eating plan (based on low/good carb, high in good fat and omega 3, and good protein--basically a mix of paleo, primal, low carb, whatever they call it). I consider myself lucky to have had great fortune in my timing of finding out about my fatty liver.And a later comment:
My ALT and AST [markers of liver damage] had been at 124 and 43 respectively, and then still at 80 and 30 in a follow up a few months later. I weighed in at about 205 (I'm 6'1.5" on a slimmish frame), which was my heaviest. I had been on a basic American (bad) diet. The whole thing shocked me, especially after a CT with contrast showed the fatty deposits on my liver (and prior to that, when the muddy ultrasound revealed a fatty liver and a possible pancreatic mass, later ruled out by the CT). Like Sam, though I was surely overweight, I was not fat or heavy. (Most people have noticed I look leaner, but are shocked when I disclose how much weight I have lost since they say "I cannot believe you had that much to lose.")
At about the same time I found out about my liver issue, I had been getting into reading about diet and health (something I had done once when I read the Zone stuff from Sears many years ago). I practically dove through Taubes, Eades, Cordain, and a bunch of blogs (including yours), and I made a commitment to fix my problem.
I started a pretty severe regimen at first, which included only protein and good fats with a minimal amount of non-starchy fruits and vegetables. Almost immediately, I started losing weight and body fat (as measured by an electrical impedance scale). I have always supplemented with fish oil, but I added krill oil and I also started eating grass-fed beef and pastured eggs and pastured pork as much as possible. I have added some coconut oil and pastured butter to my diet as well. I have dropped almost 40 pounds, I am down to about 10-11% body fat (from 24%), and my ALT/AST on my last test was 24/14 [normal]. I am getting another test soon, and I expect similar results.
I can add to the story that I first found out about the fatty liver on a routine new patient blood screening when I moved to a new town. I can also add that it took a bit of initiative on my part to get to the right diagnosis. The first doctor suspected hepatitis, but when blood work ruled that out, he ordered the imagining tests. Once I was referred to a GI specialist, it was a quick diagnosis. Still, I had to undertake myself to figure out the best diet. The GI recommended eliminating white bread, rice, pasta, starches, etc. but also recommended lowering fat intake. Having done some of my reading on diet and health, I knew to follow the former advice and to modify the latter to be "get plenty of fat, but make sure its the right kind."Steve took the initiative and fixed his damaged liver. He modified his GI doctor's advice based on what he had read about nutrition, with excellent results. I suspect his doctor will be all ears next time Steve comes into his office.
The liver is a remarkable organ. Besides being your "metabolic grand central station", it's the only organ in the human body that can regenerate almost completely. It can be 75% obliterated, and it will grow back over time. Fatty liver and NASH are largely reversible.
When Friedewald Attacks
I don't get very excited about nitpicking blood lipids. That's not to say they're not useful. There's definitely an association between blood lipids and certain health outcomes such as cardiovascular disease. The thing that tires me is when people uncritically interpret those associations as evidence that lipids are actually causing the problem.
Low-density lipoprotein, or LDL, is the cholesterol fraction that typically gets the most attention. High LDL associates with heart attack risk in Americans and some other groups. Statins reduce LDL and reduce heart attack risk in a subset of the population, and this has been used to support the idea that elevated LDL causes heart attacks. This is despite the fact that lowering LDL via diet doesn't seem to reduce heart attack risk (typically by reducing total fat and/or saturated fat). Statins may in fact work because they're anti-inflammatory, rather than because they reduce LDL. But both explanations are speculative at this point.
The fact remains that if you want to know if Mr. Jones is going to have a heart attack in the next five years, measuring his LDL will give you more information than not measuring his LDL. This association doesn't seem to apply to all cultures or to Americans eating atypical diets. Then you can get into the fractions that associate more tightly with heart attack risk, such as low HDL, high triglycerides, small dense LDL, etc. Triglycerides vary with HDL (that is, when trigs go up, HDL generally goes down) and the ratio also happens to be a predictor of insulin sensitivity. Total cholesterol is virtually useless for predicting heart attack risk in the general population. This is something I'll discuss in more detail at another time.
When you walk into the doctor's office and ask him to measure your cholesterol, the numbers you get back will generally be total cholesterol, LDL, HDL and triglycerides. All of those except LDL are measured directly. LDL is calculated using the Friedewald equation, which is (in mg/dL):
I had a lipid panel done a while back, just for kicks. My LDL, calculated by the Friedewald equation, was 131 mg/dL. Over 130 is considered high. Pass the statins! But wait, my triglycerides were 48 mg/dL, which is quite low. I found a paper through Dr. Eades' post that contains an equation for accurately calculating LDL in people whose triglycerides are below 100 mg/dL*. Here it is (mg/dL):
*This equation was designed for individuals with a total cholesterol over 250 mg/dL.
Low-density lipoprotein, or LDL, is the cholesterol fraction that typically gets the most attention. High LDL associates with heart attack risk in Americans and some other groups. Statins reduce LDL and reduce heart attack risk in a subset of the population, and this has been used to support the idea that elevated LDL causes heart attacks. This is despite the fact that lowering LDL via diet doesn't seem to reduce heart attack risk (typically by reducing total fat and/or saturated fat). Statins may in fact work because they're anti-inflammatory, rather than because they reduce LDL. But both explanations are speculative at this point.
The fact remains that if you want to know if Mr. Jones is going to have a heart attack in the next five years, measuring his LDL will give you more information than not measuring his LDL. This association doesn't seem to apply to all cultures or to Americans eating atypical diets. Then you can get into the fractions that associate more tightly with heart attack risk, such as low HDL, high triglycerides, small dense LDL, etc. Triglycerides vary with HDL (that is, when trigs go up, HDL generally goes down) and the ratio also happens to be a predictor of insulin sensitivity. Total cholesterol is virtually useless for predicting heart attack risk in the general population. This is something I'll discuss in more detail at another time.
When you walk into the doctor's office and ask him to measure your cholesterol, the numbers you get back will generally be total cholesterol, LDL, HDL and triglycerides. All of those except LDL are measured directly. LDL is calculated using the Friedewald equation, which is (in mg/dL):
LDL = TC - HDL - (TG/5)Low-carb advocates have known for quite some time that this equation fails to accurately predict LDL concentration outside certain triglyceride ranges. Dr. Michael Eades put up a post about this recently, and Richard Nikoley has written about it before as well. The reason low-carb advocates know this is that reducing carbohydrate generally reduces triglycerides, often below 100 mg/dL. This is the range at which the Friedewald equation becomes unreliable, resulting in artificially inflated LDL numbers that make you have a heart attack just by reading them.
I had a lipid panel done a while back, just for kicks. My LDL, calculated by the Friedewald equation, was 131 mg/dL. Over 130 is considered high. Pass the statins! But wait, my triglycerides were 48 mg/dL, which is quite low. I found a paper through Dr. Eades' post that contains an equation for accurately calculating LDL in people whose triglycerides are below 100 mg/dL*. Here it is (mg/dL):
LDL = TC/1.19 + TG/1.9 - HDL/1.1 - 38I ran my numbers through this equation. My new, accurate calculated LDL? 98 mg/dL. Even the U.S. National Cholesterol Education Panel wouldn't put me on statins with an LDL like that. I managed to shave 33 mg/dL off my LDL in 2 minutes. Isn't math fun?
*This equation was designed for individuals with a total cholesterol over 250 mg/dL.
When Friedewald Attacks
I don't get very excited about nitpicking blood lipids. That's not to say they're not useful. There's definitely an association between blood lipids and certain health outcomes such as cardiovascular disease. The thing that tires me is when people uncritically interpret those associations as evidence that lipids are actually causing the problem.
Low-density lipoprotein, or LDL, is the cholesterol fraction that typically gets the most attention. High LDL associates with heart attack risk in Americans and some other groups. Statins reduce LDL and reduce heart attack risk in a subset of the population, and this has been used to support the idea that elevated LDL causes heart attacks. This is despite the fact that lowering LDL via diet doesn't seem to reduce heart attack risk (typically by reducing total fat and/or saturated fat). Statins may in fact work because they're anti-inflammatory, rather than because they reduce LDL. But both explanations are speculative at this point.
The fact remains that if you want to know if Mr. Jones is going to have a heart attack in the next five years, measuring his LDL will give you more information than not measuring his LDL. This association doesn't seem to apply to all cultures or to Americans eating atypical diets. Then you can get into the fractions that associate more tightly with heart attack risk, such as low HDL, high triglycerides, small dense LDL, etc. Triglycerides vary with HDL (that is, when trigs go up, HDL generally goes down) and the ratio also happens to be a predictor of insulin sensitivity. Total cholesterol is virtually useless for predicting heart attack risk in the general population. This is something I'll discuss in more detail at another time.
When you walk into the doctor's office and ask him to measure your cholesterol, the numbers you get back will generally be total cholesterol, LDL, HDL and triglycerides. All of those except LDL are measured directly. LDL is calculated using the Friedewald equation, which is (in mg/dL):
I had a lipid panel done a while back, just for kicks. My LDL, calculated by the Friedewald equation, was 131 mg/dL. Over 130 is considered high. Pass the statins! But wait, my triglycerides were 48 mg/dL, which is quite low. I found a paper through Dr. Eades' post that contains an equation for accurately calculating LDL in people whose triglycerides are below 100 mg/dL*. Here it is (mg/dL):
*This equation was designed for individuals with a total cholesterol over 250 mg/dL.
Low-density lipoprotein, or LDL, is the cholesterol fraction that typically gets the most attention. High LDL associates with heart attack risk in Americans and some other groups. Statins reduce LDL and reduce heart attack risk in a subset of the population, and this has been used to support the idea that elevated LDL causes heart attacks. This is despite the fact that lowering LDL via diet doesn't seem to reduce heart attack risk (typically by reducing total fat and/or saturated fat). Statins may in fact work because they're anti-inflammatory, rather than because they reduce LDL. But both explanations are speculative at this point.
The fact remains that if you want to know if Mr. Jones is going to have a heart attack in the next five years, measuring his LDL will give you more information than not measuring his LDL. This association doesn't seem to apply to all cultures or to Americans eating atypical diets. Then you can get into the fractions that associate more tightly with heart attack risk, such as low HDL, high triglycerides, small dense LDL, etc. Triglycerides vary with HDL (that is, when trigs go up, HDL generally goes down) and the ratio also happens to be a predictor of insulin sensitivity. Total cholesterol is virtually useless for predicting heart attack risk in the general population. This is something I'll discuss in more detail at another time.
When you walk into the doctor's office and ask him to measure your cholesterol, the numbers you get back will generally be total cholesterol, LDL, HDL and triglycerides. All of those except LDL are measured directly. LDL is calculated using the Friedewald equation, which is (in mg/dL):
LDL = TC - HDL - (TG/5)Low-carb advocates have known for quite some time that this equation fails to accurately predict LDL concentration outside certain triglyceride ranges. Dr. Michael Eades put up a post about this recently, and Richard Nikoley has written about it before as well. The reason low-carb advocates know this is that reducing carbohydrate generally reduces triglycerides, often below 100 mg/dL. This is the range at which the Friedewald equation becomes unreliable, resulting in artificially inflated LDL numbers that make you have a heart attack just by reading them.
I had a lipid panel done a while back, just for kicks. My LDL, calculated by the Friedewald equation, was 131 mg/dL. Over 130 is considered high. Pass the statins! But wait, my triglycerides were 48 mg/dL, which is quite low. I found a paper through Dr. Eades' post that contains an equation for accurately calculating LDL in people whose triglycerides are below 100 mg/dL*. Here it is (mg/dL):
LDL = TC/1.19 + TG/1.9 - HDL/1.1 - 38I ran my numbers through this equation. My new, accurate calculated LDL? 98 mg/dL. Even the U.S. National Cholesterol Education Panel wouldn't put me on statins with an LDL like that. I managed to shave 33 mg/dL off my LDL in 2 minutes. Isn't math fun?
*This equation was designed for individuals with a total cholesterol over 250 mg/dL.
Why Did US Physicians Give Up Their Ability to Enforce Their Own Professional Standards?
In his recent review of Dr Ezekiel Emanuel's book, (Healthcare, Guaranteed: A Simple, Secure Solution for America,) Dr Arnold Relman, Editor-Emeritus of the New England Journal of Medicine, discussed the history of the deprofessionalization of American physicians.
Writing about the decline of physicians' professionalism in 2007 [ Relman AS. Medical professionalism in a commercialized health care market. JAMA 2007; 298: 2668-2670. [link here) ], Dr Relman had briefly alluded to the effect of the 1975 Supreme Court decision, (see our post here):
It seems to me that Dr Relman has elucidated one of the "missing links" that help explain the current sorry state of physicians' core values, and the broader continuing health care crisis. I am amazed that this bit of history seems to have been so thoroughly forgotten. Dr Relman did write about it before 2007, but in publications that few physicians and other health care professionals were likely to see. Other than Dr Relman, almost no one writing in the medical and health care literature seems to have interest in this issue. (It has been discussed in the Journal of Health Politics, Policy and Law, and the Stanford Law Review by M. Gregg Bloche, but these unfortunately also could have easily been missed by nearly all physicians and health care professionals.) So we have another example of the anechoic effect.
Yet in my humble opinion, every physician and health care professional ought to know that the profession once foreswore the commercialization of medical practice, but gave up on its ability to police its own conflicts of interest after the US Supreme Court decided that professionals are subject to anti-trust law.
But knowing this important bit of history raises more questions than it answers:
Inquiring minds want to know.... And answering these questions might bring us back on the path of true medical professionalism.
Hat tip to Merrill Goozner in the GoozNews blog.
References (from Relman)
1. Goldfarb v. Virginia State Bar, 421 U.S. 773 (1975).
2. Kenneth J. Arrow, "Uncertainty and the Welfare Economics of Medical Care," The American Economic Review, Vol. 53, No. 5 (December 1963).
The behavior of US physicians has been changed by the commercialization of medical care, and this too has increased costs. US medical practice has traditionally relied on fee-for-service, which has always given it some of the attributes and incentives of a business. However, the American Medical Association (AMA) maintained for many years that medical practice was a profession, not a business. The AMA's ethical guidelines therefore advised physicians to limit their income to reasonable earnings from the care of patients, and to refrain from advertising and from entering financial arrangements with drug and device manufacturers. Those restrictions were lifted after the US Supreme Court decided in 1975 that lawyers, and by extension members of other professions, including physicians, are engaged in interstate commerce and therefore must be subject to antitrust law (from which they had largely been exempt).(1)
This decision had an enormous effect on the medical profession, but its consequences have received relatively little public attention. Although the courts did not initiate the commercialization of medicine, they certainly accelerated it and gave it legal justification. In 1980, after medical organizations lost some costly antitrust trials, in which they were accused of such offenses as limiting doctor fees or denying staff privileges, the AMA changed its ethical guidelines, declaring medicine to be both a business and a profession. This lowered the AMA's barriers to the commercialization of medical practice, allowing physicians to participate in any legal profit-making business arrangement that did not harm patients.
Nearly a half-century ago, Stanford economics professor Kenneth Arrow, later a Nobel laureate, convincingly argued that medical care cannot conform to market laws because patients are not ordinary consumers and doctors are not ordinary vendors. He said that sick or injured patients must rely on physicians in ways fundamentally different from the price-driven relation between buyers and sellers in an ordinary market. This argument implied that, contrary to the assumptions of antitrust law, market competition among physicians cannot be expected to lower medical prices. And since physicians influence decisions to use medical services far more than patients do, the volume and types of services provided to patients—and hence total health costs—need to be controlled by forces other than the market, such as professional standards and government regulation. But Arrow's argument was largely ignored in the rush to exploit health care for commercial purposes that ensued after the passage of Medicare and Medicaid in 1965.(2)
Writing about the decline of physicians' professionalism in 2007 [ Relman AS. Medical professionalism in a commercialized health care market. JAMA 2007; 298: 2668-2670. [link here) ], Dr Relman had briefly alluded to the effect of the 1975 Supreme Court decision, (see our post here):
The law also has played a major role in the decline of medical professionalism. The 1975 Supreme Court ruling that the professions were not protected from anti-trust law undermined the traditional restraint that medical professional societies had always placed on the commercial behavior of physicians, such as advertising and investing in the products they prescribe or facilities they recommend. Having lost some initial legal battles and fearing the financial costs of losing more, organized medicine now hesitates to require physicians to behave differently from business people. It asks only that physicians' business activities should be legal, disclosed to patients, and not inconsistent with patients' interests. Until forced by anti-trust concerns to change its ethical code in 1980, the American Medical Association had held that 'in the practice of medicine a physician should limit the source of his professional income to medical services actually rendered by him, or under his supervision, to his patients' and that 'the practice of medicine should not be commercialized, nor treated as a commodity in trade.' These sentiments reflecting the spirit of professionalism are now gone.
It seems to me that Dr Relman has elucidated one of the "missing links" that help explain the current sorry state of physicians' core values, and the broader continuing health care crisis. I am amazed that this bit of history seems to have been so thoroughly forgotten. Dr Relman did write about it before 2007, but in publications that few physicians and other health care professionals were likely to see. Other than Dr Relman, almost no one writing in the medical and health care literature seems to have interest in this issue. (It has been discussed in the Journal of Health Politics, Policy and Law, and the Stanford Law Review by M. Gregg Bloche, but these unfortunately also could have easily been missed by nearly all physicians and health care professionals.) So we have another example of the anechoic effect.
Yet in my humble opinion, every physician and health care professional ought to know that the profession once foreswore the commercialization of medical practice, but gave up on its ability to police its own conflicts of interest after the US Supreme Court decided that professionals are subject to anti-trust law.
But knowing this important bit of history raises more questions than it answers:
- The Supreme Court decision apparently involved interpretation of law, not the constitution. Therefore, why didn't organized medicine pursue a change in the law that would allow physicians to continue to enforce their traditional professional values?
- The Supreme Court decision was primarily directed at lawyers, not physicians. Since the decision, to my knowledge, the law profession has maintained strict rules about conflicts of interest. (For example, no legal CME is sponsored by corporations whose products they seek to have the attendees favor.) Why did the decision wreck physicians' but not lawyers' abilities to regulate their own conflicts of interest?
- The Supreme Court decision only affects US law. Why have physicians in other countries also abandoned their traditional values about commercial entanglements?
- Why did this application of US antitrust law have such significant effects during an era when antitrust enforcement in health care was generally declining? (Insurance companies and hospitals that dominate local markets have not feared antitrust enforcement.)
- Why did only Dr Relman and Prof Bloche seem to care about this up to now?
Inquiring minds want to know.... And answering these questions might bring us back on the path of true medical professionalism.
Hat tip to Merrill Goozner in the GoozNews blog.
References (from Relman)
1. Goldfarb v. Virginia State Bar, 421 U.S. 773 (1975).
2. Kenneth J. Arrow, "Uncertainty and the Welfare Economics of Medical Care," The American Economic Review, Vol. 53, No. 5 (December 1963).
The RUCkus Continues: Former Medicare Administrator Calls the "RUC Process" "Incredibly Flawed," and the AMA Chair Says He's "Inaccurate"
We have posted frequently about the role of the RBRVS Update Committee (RUC) in fixing the rates at which Medicare pays physicians. These payment rates have been much more generous for procedures than for "cognitive" services, (that is, services including interviewing and examining patients, making diagnoses, forecasting prognoses, recommending tests or treatments, and counseling patients.) Several authors have suggested that how the RUC fixes payment rates is a major cause of the decline of primary care. (See our previous posts on this here, here, here, here, here, here, and here and important articles by Bodenheimer et al,[1] and Goodson.[2])
An Interview with a former Medicare administrator
Health Affairs just published an interview(3) with Kerry Weems, a recent administrator of the US Center for Medicare and Medicaid Services (CMS) under the Bush administration, who had some remarkable criticism for the RUC.
There are a number of important points here.
First, a former CMS administrator charged that the RUC has a substantial role in the decline of primary care in the US. Such charges have been made by well-reputed academics who have analyzed the role of the RUC from the outside. But as we have said before, aspects of what the RUC does are obscure, especially because the proceedings of RUC meetings are not made public. But now someone more directly involved has made the same charges.
Second, a former CMS administrator has called the "RUC process ... incredibly flawed." Even the second Bush administration felt these flaws were sufficient to have "a number of discussions," but found "it's a hard nut to crack." Hence he said that although there is something fundamentally wrong with the "RUC process," the government could not easily fix it.
Yet RUC leadership has repeatedly said that the RUC is merely a private advisory committee which gives recommendations to CMS using its rights to free speech and to petition the government. (Note also that above, Inglehart first said that the RUC was formed as "an expert panel" to make "recommendations." But then he said the committee "determines ... how much doctors will earn.") If the RUC is simply an advisory committee, and CMS did not like the advice the RUC was giving, why couldn't CMS leaders simply ignore the RUC?
Weems' remarks do not make sense if the RUC is merely an outside private group providing advice. But they do make sense if the RUC is acting like a government agency.
So this interview once again raises the question: why does CMS rely exclusively on the RUC to update the RBRVS system, apparently making the RUC de facto a government agency, yet without any accountability to CMS, or the government at large?
A response by the Chair of the Board of the AMA
Within days of this interview, Dr Rebecca Patchin, the Chair of the Board of Trustees of the American Medical Association (AMA), wrote a response to the Weems interview. (Amazingly, the response appeared as a blog post on the Health Affairs Blog.)
First, she implied that a former CMS administrator did not know what he was talking about when it came to the RUC.
Now I feel like I am in good company. The leaders of the RUC have charged that I made inaccurate statements about the RUC as well (see post here).
However, Dr Patchin failed to identify any particular statements by Kerry Weems or his interviewer as inaccurate, much less provide any evidence to that effect. Note that while the RUC leaders also charged me with making inaccurate statements, they did not specify any particular statements as inaccurate, much less produce evidence in support of their contentions.
Next, Dr Patchin wrote:
This may be so, but it ignores an important issue. While the RUC may have made some recommendations to increase payments for cognitive services, it has made many more recommendations to increase payments for procedural services. Furthermore, while payments for individual procedures went up, and the volume of procedures also went up, the global budget for physicians' services, called the Sustainable Growth Rate (SGR), resulted in across the board cuts. Since raises for procedures were larger and more frequent than raises for cognitive services, the net effect was that payments for procedures increased relative to cognitive services.
Even more important, it begs that question: what has the RUC done at times when no one asked it "to review payments for E&M ... codes?" After all, the RUC leadership has argued again and again that it is only a private advisory committee (and see below for another such argument). As such, it should be able to choose how often it deals with payments for cognitive services. It should not have to wait to be asked to review them. So why wasn't the RUC reviewing these payments more frequently?
Then, Dr Patchin reiterated:
and again,
This, once more, begs the questions. Why didn't the RUC make more recommendations to improve payments for cognitive services? Why doesn't CMS get recommendations about payments to physicians from sources other than the RUC? Why doesn't CMS make the process for setting physicians' payments, and updating and revising the RBRVS system more broad-based and transparent? Why did the administrator of CMS feel unable to change or ignore the "RUC process?"
I don't have the capacity to find out the answers to these questions. Answering them might take some investigative reporting, or even a Congressional investigation. Given that physicians' payments are key incentives driving the health care system, and that payments favoring procedures are likely to be a major cause for rising volume and costs of procedures, which, in turn, is likely to be a major reason our health care system is so expensive, why do we know so little about how these payment rates are set?
References
1. Bodenheimer T, Berenson RA, Rudolf P. The primary care-specialty income gap: why it matters. Ann Intern Med 2007; 146: 301-306. Link here.
2. Goodson JD. Unintended consequences of Resource-Based Relative Value Scale reimbursement. JAMA 2007; 298(19):2308-2310. Link here.
3. Iglehart JK. Doing more with less: a conversation with Kerry Weems. Health Aff 2009; http://content.healthaffairs.org/cgi/content/full/hlthaff.28.4.w688/DC1
An Interview with a former Medicare administrator
Health Affairs just published an interview(3) with Kerry Weems, a recent administrator of the US Center for Medicare and Medicaid Services (CMS) under the Bush administration, who had some remarkable criticism for the RUC.
Iglehart: The last question I wanted to ask you relates to the Specialty Society Relative Value Scale Update Committee [RUC] of the American Medical Association. The AMA formed the RUC to act as an expert panel in developing relative value recommendations to CMS. The twenty-nine-member committee essentially determines, through the relative values it establishes for the codes that form the basis of Medicare payments, how much doctors will earn from providing services to beneficiaries. In recent years the RUC has come under criticism based on the view that its specialty- dominated composition undervalues primary care services and, in some instances, overvalues specialty services. I have two questions, Kerry, regarding the RUC. You have been in government for twenty-six years; have you ever heard of an administration that has seriously questioned the RUC process, and whether CMS ought to somehow internalize it or delegate it to another body?
Weems: I think there is a general consensus that the RUC has contributed to the poor state of primary care in the United States. In many ways the supposition behind the RUC process, behind the whole relative value scale, is incredibly flawed. It's an input measurement system, so it asks, What's the cost of my inputs, and that's how I'm going to price my outputs. It has no relationship to perhaps the market value of what you might buy. So because it's highly procedure based, it's prejudiced against just standard primary care evaluation and management [E&M] visits, because in an E&M visit it's hard to document what happens in the same way that it is when you remove a mole, or perform some other procedure.
So the process itself is flawed. I don't think that we can make a change without a statutory change giving us the ability to do that. But it's something that is drastically needed. You know, it's funny that we talk about better coordination of care and creating the medical home. Well, the place where this can occur is in an E&M visit, which has been highly undervalued by the RUC.
Iglehart: You say that the RUC process is seriously flawed and needs to be overhauled. Was there ever any discussion during the eight years of the George W. Bush administration about doing that?
Weems: There were a number of discussions, but it's a hard nut to crack. Those discussions never ripened to the point where we could say we've got something better.
Iglehart: But you'd anticipate under the Obama administration that those discussions will continue?
Weems: Sure. And, you know, you can even see the early attempts at trying to crack that. Representative [Pete] Stark [D-CA] introduced last year the so-called CHAMP [Children's Health and Medicare Protection Act] bill, in which he proposed to develop a new payment approach that would have provided more money to primary care physicians. He split it up into several different categories. This probably wasn't the right approach, but again, he was trying to work through the problem, trying to provide more money for primary care. His heart was in the right place.
There are a number of important points here.
First, a former CMS administrator charged that the RUC has a substantial role in the decline of primary care in the US. Such charges have been made by well-reputed academics who have analyzed the role of the RUC from the outside. But as we have said before, aspects of what the RUC does are obscure, especially because the proceedings of RUC meetings are not made public. But now someone more directly involved has made the same charges.
Second, a former CMS administrator has called the "RUC process ... incredibly flawed." Even the second Bush administration felt these flaws were sufficient to have "a number of discussions," but found "it's a hard nut to crack." Hence he said that although there is something fundamentally wrong with the "RUC process," the government could not easily fix it.
Yet RUC leadership has repeatedly said that the RUC is merely a private advisory committee which gives recommendations to CMS using its rights to free speech and to petition the government. (Note also that above, Inglehart first said that the RUC was formed as "an expert panel" to make "recommendations." But then he said the committee "determines ... how much doctors will earn.") If the RUC is simply an advisory committee, and CMS did not like the advice the RUC was giving, why couldn't CMS leaders simply ignore the RUC?
Weems' remarks do not make sense if the RUC is merely an outside private group providing advice. But they do make sense if the RUC is acting like a government agency.
So this interview once again raises the question: why does CMS rely exclusively on the RUC to update the RBRVS system, apparently making the RUC de facto a government agency, yet without any accountability to CMS, or the government at large?
A response by the Chair of the Board of the AMA
Within days of this interview, Dr Rebecca Patchin, the Chair of the Board of Trustees of the American Medical Association (AMA), wrote a response to the Weems interview. (Amazingly, the response appeared as a blog post on the Health Affairs Blog.)
First, she implied that a former CMS administrator did not know what he was talking about when it came to the RUC.
In the interview, inaccurate statements were made about the role of the AMA/Specialty Society RVS Update Committee (RUC), which advises CMS regarding the relative levels of reimbursement for different medical procedures performed by physicians.
Now I feel like I am in good company. The leaders of the RUC have charged that I made inaccurate statements about the RUC as well (see post here).
However, Dr Patchin failed to identify any particular statements by Kerry Weems or his interviewer as inaccurate, much less provide any evidence to that effect. Note that while the RUC leaders also charged me with making inaccurate statements, they did not specify any particular statements as inaccurate, much less produce evidence in support of their contentions.
Next, Dr Patchin wrote:
Every time the RUC has been asked to review payments for E&M (evaluation and management) codes, the RUC has sent CMS recommendations that would lead to higher payments.
This may be so, but it ignores an important issue. While the RUC may have made some recommendations to increase payments for cognitive services, it has made many more recommendations to increase payments for procedural services. Furthermore, while payments for individual procedures went up, and the volume of procedures also went up, the global budget for physicians' services, called the Sustainable Growth Rate (SGR), resulted in across the board cuts. Since raises for procedures were larger and more frequent than raises for cognitive services, the net effect was that payments for procedures increased relative to cognitive services.
Even more important, it begs that question: what has the RUC done at times when no one asked it "to review payments for E&M ... codes?" After all, the RUC leadership has argued again and again that it is only a private advisory committee (and see below for another such argument). As such, it should be able to choose how often it deals with payments for cognitive services. It should not have to wait to be asked to review them. So why wasn't the RUC reviewing these payments more frequently?
Then, Dr Patchin reiterated:
To clarify: The RUC makes recommendations to CMS, and then CMS makes its payment decisions.
and again,
Bottom line: the RUC makes recommendations, CMS makes payment decisions.
This, once more, begs the questions. Why didn't the RUC make more recommendations to improve payments for cognitive services? Why doesn't CMS get recommendations about payments to physicians from sources other than the RUC? Why doesn't CMS make the process for setting physicians' payments, and updating and revising the RBRVS system more broad-based and transparent? Why did the administrator of CMS feel unable to change or ignore the "RUC process?"
I don't have the capacity to find out the answers to these questions. Answering them might take some investigative reporting, or even a Congressional investigation. Given that physicians' payments are key incentives driving the health care system, and that payments favoring procedures are likely to be a major cause for rising volume and costs of procedures, which, in turn, is likely to be a major reason our health care system is so expensive, why do we know so little about how these payment rates are set?
References
1. Bodenheimer T, Berenson RA, Rudolf P. The primary care-specialty income gap: why it matters. Ann Intern Med 2007; 146: 301-306. Link here.
2. Goodson JD. Unintended consequences of Resource-Based Relative Value Scale reimbursement. JAMA 2007; 298(19):2308-2310. Link here.
3. Iglehart JK. Doing more with less: a conversation with Kerry Weems. Health Aff 2009; http://content.healthaffairs.org/cgi/content/full/hlthaff.28.4.w688/DC1
Letter to the Editor
I just got a letter to the editor published in the journal Obesity. It's a comment on an article published in October titled "Efficiency of Intermittent Exercise on Adiposity and Fatty Liver in Rats Fed With High-fat Diet."
In the study, they placed rats on a diet composed of "commercial rat chow plus peanuts, milk chocolate, and sweet biscuit in a proportion of 3:2:2:1," and then proceeded to simply call it a "high-fat diet" in the title and text body, with no reference to its actual composition outside the methods section. We can't tolerate this kind of fudging if we want real answers from nutrition science. Rats eating the "high-fat diet" developed abdominal obesity, fatty liver and hyperphagia, but this was attenuated by exercise.
As I like to say, the problem isn't usually in the data, it's in the interpretation of the data. The result is interesting and highly relevant. But you can't use terminology that tars and feathers all fat when your diet was in fact high in linoleic acid (omega-6), low in omega-3 and high in sugar and refined grains. Especially when butter and coconut oil don't cause the same pathology. I pointed out in the letter that we need to be more precise about how we define "high-fat diets". I also pointed out that the study is highly relevant to the modern U.S., because it supports the hypothesis that a junk food diet high in linoleic acid and sugar causes metabolic disturbances and fatty liver, and exercise may be protective.
In the study, they placed rats on a diet composed of "commercial rat chow plus peanuts, milk chocolate, and sweet biscuit in a proportion of 3:2:2:1," and then proceeded to simply call it a "high-fat diet" in the title and text body, with no reference to its actual composition outside the methods section. We can't tolerate this kind of fudging if we want real answers from nutrition science. Rats eating the "high-fat diet" developed abdominal obesity, fatty liver and hyperphagia, but this was attenuated by exercise.
As I like to say, the problem isn't usually in the data, it's in the interpretation of the data. The result is interesting and highly relevant. But you can't use terminology that tars and feathers all fat when your diet was in fact high in linoleic acid (omega-6), low in omega-3 and high in sugar and refined grains. Especially when butter and coconut oil don't cause the same pathology. I pointed out in the letter that we need to be more precise about how we define "high-fat diets". I also pointed out that the study is highly relevant to the modern U.S., because it supports the hypothesis that a junk food diet high in linoleic acid and sugar causes metabolic disturbances and fatty liver, and exercise may be protective.
Letter to the Editor
I just got a letter to the editor published in the journal Obesity. It's a comment on an article published in October titled "Efficiency of Intermittent Exercise on Adiposity and Fatty Liver in Rats Fed With High-fat Diet."
In the study, they placed rats on a diet composed of "commercial rat chow plus peanuts, milk chocolate, and sweet biscuit in a proportion of 3:2:2:1," and then proceeded to simply call it a "high-fat diet" in the title and text body, with no reference to its actual composition outside the methods section. We can't tolerate this kind of fudging if we want real answers from nutrition science. Rats eating the "high-fat diet" developed abdominal obesity, fatty liver and hyperphagia, but this was attenuated by exercise.
As I like to say, the problem isn't usually in the data, it's in the interpretation of the data. The result is interesting and highly relevant. But you can't use terminology that tars and feathers all fat when your diet was in fact high in linoleic acid (omega-6), low in omega-3 and high in sugar and refined grains. Especially when butter and coconut oil don't cause the same pathology. I pointed out in the letter that we need to be more precise about how we define "high-fat diets". I also pointed out that the study is highly relevant to the modern U.S., because it supports the hypothesis that a junk food diet high in linoleic acid and sugar causes metabolic disturbances and fatty liver, and exercise may be protective.
In the study, they placed rats on a diet composed of "commercial rat chow plus peanuts, milk chocolate, and sweet biscuit in a proportion of 3:2:2:1," and then proceeded to simply call it a "high-fat diet" in the title and text body, with no reference to its actual composition outside the methods section. We can't tolerate this kind of fudging if we want real answers from nutrition science. Rats eating the "high-fat diet" developed abdominal obesity, fatty liver and hyperphagia, but this was attenuated by exercise.
As I like to say, the problem isn't usually in the data, it's in the interpretation of the data. The result is interesting and highly relevant. But you can't use terminology that tars and feathers all fat when your diet was in fact high in linoleic acid (omega-6), low in omega-3 and high in sugar and refined grains. Especially when butter and coconut oil don't cause the same pathology. I pointed out in the letter that we need to be more precise about how we define "high-fat diets". I also pointed out that the study is highly relevant to the modern U.S., because it supports the hypothesis that a junk food diet high in linoleic acid and sugar causes metabolic disturbances and fatty liver, and exercise may be protective.
Practicing (Clinical Trials) Medicine Without a License
Another story of dubious clinical research, this time reported by the St Petersburg (Florida, US) Times:
A little Google searching turned up another example on ClinicalTrials.gov of a commercially funded clinical study for which the Alliance Medical Research Group enrolled patients. This was a Phase III study sponsored by Cephalon, an "Open-Label Study to Evaluate the Effect of Treatment With Fentanyl Buccal Tablets on Pain Anxiety Symptoms When Used for the Management of Breakthrough Pain." Note also that Sterling Institutional Review Board appears to be another example of a for-profit, commercial institutional review board.
Here we have another example of remarkably bad implementation of commercially sponsored and commercially supervised clinical trials.
We have posted a number of times about sloppy and mismanagement of commercially sponsored clinical research, often under the auspices of for-profit contract research organizations (CROs) and for-profit institutional review boards (IRBs). See this 2006 vintage post on the infamous study 3014 on Ketek, sponsored by Sanofi Aventis.
In my humble opinion, in the contemporary business world, many managers are driven mainly by quarterly profits. However, what works best to boost profits in the short run may not be what works to produce valid clinical research that maximizes the safety of and respect afforded human research subjects. When all the organizations involved in the research, the sponsor, the organization implementing the research, and the organization supervising research ethics are for-profit, the incentives to cut corners are multiplied. Cutting corners can jeopardize the validity of the studies, and the safety and respectful treatment of study subjects.
I again submit that making human experimental research into a commercial enterprise, mainly serving the marketing of drugs and devices, may not produce good science, and may not be good for patients. It might be a better idea to leave human research to not-for-profit organizations and health care professionals.
Hat tip to PharmaGossip.
Vladimir Martin called himself 'doctor' and ran 17 clinical trials of new drugs for major pharmaceutical companies before one patient noticed he didn't have a medical license.
The patient alerted the St. Petersburg Times, whose resulting story led to a state investigation. On Saturday, Martin, 43, was arrested on charges of practicing medicine without a license. He was later released from the Pinellas County Jail on $10,000 bail. The felony charge carries a maximum sentence of five years in prison and maximum fine of $5,000.
The Clearwater man, who changed his last name from Kossatchev after moving to Florida in 2003, went to medical school in the former Soviet Union and practiced in a hospital in his native Ukraine.
Ruth Weber, a 74-year-old Clearwater resident, told the Times in April 2008 that the man who called himself Dr. Martin enrolled her in a study for lower-back pain and adjusted the dosage of her medicine. Only licensed physicians are supposed to conduct such activities. Patients in the study were randomly selected to receive a new Johnson & Johnson painkiller called tapentadol, a placebo or the potent narcotic oxycodone.
Though Dr. Robert Lee Jackson, a Clearwater osteopath, was listed by the FDA as the physician conducting the study, Weber said she never saw Jackson. In weekly visits to Alliance Medical Research Group on Belcher Road, Weber said it was Martin who drew blood, doled out medication and, at one point, doubled her dosage.
Martin also conducted electrocardiograms on Weber, although his techniques were so rusty the electrodes kept slipping off, she said. Weber eventually dropped out of the study when she saw no improvement for her back pain.
A second woman, Ann Reed, told investigators she also responded to an ad for a drug study trial at Alliance Medical Research. Martin took her blood, listened to her heart and gave her medications, Reed said. Martin sometimes had to stick her four times to draw blood, she said.
Like Weber, Reed said she never saw Jackson during her trial, which involved 13 visits between May 2007 and March 2008.
Greg Panico, a spokesman for Johnson & Johnson, said the company audited Alliance Medical after the Times' story and submitted its findings to the FDA. He declined to discuss the nature of the report, but said the drug company is no longer working with Alliance Medical.
Panico also said data collected in the tapentadol study at that site was not submitted to the FDA.
The drugmaker said it reported its findings to the Sterling Institutional Review Board in Atlanta, which had been hired by Johnson & Johnson to oversee patient safety during the trial.
Despite losing the Johnson & Johnson trial, Martin told investigators in July that he was conducting four other drug studies.
A little Google searching turned up another example on ClinicalTrials.gov of a commercially funded clinical study for which the Alliance Medical Research Group enrolled patients. This was a Phase III study sponsored by Cephalon, an "Open-Label Study to Evaluate the Effect of Treatment With Fentanyl Buccal Tablets on Pain Anxiety Symptoms When Used for the Management of Breakthrough Pain." Note also that Sterling Institutional Review Board appears to be another example of a for-profit, commercial institutional review board.
Here we have another example of remarkably bad implementation of commercially sponsored and commercially supervised clinical trials.
We have posted a number of times about sloppy and mismanagement of commercially sponsored clinical research, often under the auspices of for-profit contract research organizations (CROs) and for-profit institutional review boards (IRBs). See this 2006 vintage post on the infamous study 3014 on Ketek, sponsored by Sanofi Aventis.
In my humble opinion, in the contemporary business world, many managers are driven mainly by quarterly profits. However, what works best to boost profits in the short run may not be what works to produce valid clinical research that maximizes the safety of and respect afforded human research subjects. When all the organizations involved in the research, the sponsor, the organization implementing the research, and the organization supervising research ethics are for-profit, the incentives to cut corners are multiplied. Cutting corners can jeopardize the validity of the studies, and the safety and respectful treatment of study subjects.
I again submit that making human experimental research into a commercial enterprise, mainly serving the marketing of drugs and devices, may not produce good science, and may not be good for patients. It might be a better idea to leave human research to not-for-profit organizations and health care professionals.
Hat tip to PharmaGossip.
Mark Leavitt, Head of CCHIT: Behind the Times and Uninformed on Health IT Realities?
Signs that a leader who alleges himself or herself to be objective and a scientist is, in fact, neither objective nor scientific include:
That is, Bah! to the apostates' narratives --
-- even though many of these narratives are in the peer-reviewed biomedical science and biomedical informatics literature ...
Bah!
I'm really tired of amateurish political rhetoric and marketing puffery masquerading as substantive debate on critical issues as above. However, being experienced with EHRs, their design, implementation and lifecycle, and concerned with widespread irrational exuberance over health IT (a facilitative tool that carries risk to patients and medical organizations if not done well) I am not at all "laughing these stories off", and will critique the above in a quite serious manner.
Indeed, "laughing off" stories from credible sources and personnel (e.g., many AMIA members) about potential harm from an experimental technology affecting patients seems the height of hubris, or blindness of a kind mediated by incomplete knowledge or conflicts of interest.
First, binary thinking. It seems those who critique health IT's drawbacks are "individuals with a deeper-seated anti-EHR bent." That is, they don't buy into the consensus of the industry "experts" and must therefore be biased and wrong.
- Resorting to ad hominem attacks when questioned or criticized.
- Deficient familiarity with the current literature.
- Opining that others' concerns expressed in that literature could be "laughed off."
- Years-behind view of the situation on the ground.
The head of CCHIT, Mark Leavitt, has penned the following at iHealthBeat (emphases and comments in red italic mine):
June 19, 2009 - Perspectives
Health IT Under ARRA: It's Not the Money, It's the Message
by Mark Leavitt
... Estimates by the Congressional Budget Office suggest the total incentive payout could reach $34 billion, although with expected savings the net cost is half that. Add to that another $2 billion that the Office of the National Coordinator for Health IT can use on various initiatives in support of the goal of having an EHR for every American by 2014.
[Note the catchy marketing slogan, which carries the implicit message "what manner of people would oppose Mother and Apple Pie?" - ed.]
But more important than the money itself is the message implicitly conveyed along with it. Will incentives be perceived as an intrusive, carrot-and-stick manipulation of health care providers' business decisions? Or will health care providers interpret ARRA as the correction of a reimbursement anomaly, welcoming the opportunity to modernize their information management and transform the care they deliver.
[Cybernetic Miracle™ Alert - note the grandiose term "transform", as opposed to "facilitate" or "improve" - ed.]
Some of the early signs have been worrisome. Before ARRA, most surveys concluded that cost was the No. 1 barrier to EHR adoption. But as soon as it appeared that the cost barrier might finally be overcome, individuals with a deeper-seated "anti-EHR" bent emerged. Their numbers are small, but their shocking claims -- that EHRs kill people, that massive privacy violations are taking place,
[As an information scientist, I'm almost embarrassed to post this link and this link, the results of just a few minutes' work with public resources. Thorough, robust searches in Dialog's suite of databases, Current Contents, Lexis Nexis, SciFinder etc. would show far more - ed.]
that shady conspiracies are operating --
[i.e., HIT industry lobbies - ed.]
make stimulating copy for the media. Those experienced with EHRs might laugh these stories off, but risk-averse newcomers to health IT, both health care providers and policymakers
[i.e., those who take due diligence and fiduciary responsibilities seriously - ed.]
are easily affected by fear mongering.
That is, Bah! to the apostates' narratives --
-- even though many of these narratives are in the peer-reviewed biomedical science and biomedical informatics literature ...
Bah!I'm really tired of amateurish political rhetoric and marketing puffery masquerading as substantive debate on critical issues as above. However, being experienced with EHRs, their design, implementation and lifecycle, and concerned with widespread irrational exuberance over health IT (a facilitative tool that carries risk to patients and medical organizations if not done well) I am not at all "laughing these stories off", and will critique the above in a quite serious manner.
Indeed, "laughing off" stories from credible sources and personnel (e.g., many AMIA members) about potential harm from an experimental technology affecting patients seems the height of hubris, or blindness of a kind mediated by incomplete knowledge or conflicts of interest.
First, binary thinking. It seems those who critique health IT's drawbacks are "individuals with a deeper-seated anti-EHR bent." That is, they don't buy into the consensus of the industry "experts" and must therefore be biased and wrong.
I, in fact, am a health IT proponent, but simply abhor poor HIT such as at my series here, or HIT sold to my organization in an unusable (but "Certified") state as in the Civil Complaint here (PDF). I believe the rush to national EHR by 2014 is premature, will waste massive amounts of money, and will cause disruption to an already strained healthcare system with resultant adverse effects. I believe far more research remains to be done before our social and technical understanding of "how to do clinical IT well" justifies mass government-mandated cybernetic re-engineering in healthcare. (See literature list below.)
Now that we're hopefully past the expected ad hominem, perhaps the real issues can be addressed.
As a final piece of advice to Dr. Leavitt, I can add that dismissing concerns of others, Dogbert-style, is not a way to win friends and influence people.
On the issue of ad hominem attacks against questions and critique, I documented those at Healthcare Renewal at "Open letter to Mark Leavitt, Chairman, Certification Commission for Healthcare Information Technology on Penalties For Use of Non-Certified HIT" at this link. Both I and another physician, David Kibbe, MD, MBA, Health IT Consultant at American Academy of Family Physicians, were subjected to "nonlinear" commentary.
It also seems Dr. Leavitt is unfamiliar with or deliberately downplaying a growing body of literature on health IT risks and failures. [Health IT failure never, ever puts patients at risk, as I wrote here, of course - ed.]
Examples of this growing body of "unknown" or "ignored" or "downplayed" literature include:
It also seems Dr. Leavitt is unfamiliar with or deliberately downplaying a growing body of literature on health IT risks and failures. [Health IT failure never, ever puts patients at risk, as I wrote here, of course - ed.]
Examples of this growing body of "unknown" or "ignored" or "downplayed" literature include:
1. The article "Health IT Project Success and Failure: Recommendations from Literature and an AMIA Workshop", Bonnie Kaplan and Kimberly D. Harris-Salamone, Journal of the American Medical Informatics Association 2009;16:291-299. DOI 10.1197/jamia.M2997 - and the references cited.
There are more than 70 references at the end of this article (See fulltext at link above), and my comments on the findings and recommendations of the multi-working group informatics workshop that created it are in the post "Health IT Project Success and Failure: Recommendations from Literature and an AMIA Workshop" at this link.
2. This corpus of literature below. These are just examples and not a comprehensive listing:
Joint Commission: Sentinel Events Alert on HIT, Dec. 2008.
National Research Council report. Current Approaches to U.S. Healthcare Information Technology are Insufficient. Computational Technology for Effective Health Care: Immediate Steps and Strategic Directions, Jan. 2009
The National Programme for IT in the NHS: Progress since 2006, Public Accounts Committee, January 2009. Summary points here.
Common Examples of Healthcare IT Difficulties (my own 10-year-old website). S. Silverstein, MD, Drexel University College of Information Science and Technology.
Health Care Information Technology Vendors' "Hold Harmless" Clause - Implications for Patients and Clinicians, Ross Koppel and David Kreda, Journal of the American Medical Association, 2009; 301(12):1276-1278
Finding a Cure: The Case for Regulation And Oversight of Electronic Health Records Systems, Hoffman and Podgurski, Harvard Journal of Law & Technology 2008 vol. 22, No. 1
Failure to Provide Clinicians Useful IT Systems: Opportunities to Leapfrog Current Technologies, Ball et al., Methods Inf Med 2008; 47: 4–7,
IT Vulnerabilities Highlighted by Errors, Malfunctions at Veterans’ Medical Centers, JAMA Mar. 4, 2009, p. 919-920.
Unexpected Increased Mortality After Implementation of a Commercially Sold Computerized Physician Order Entry System, Han et al., Pediatrics Vol. 116 No. 6 December 2005, pp. 1506-1512
Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors. Ross Koppel, PhD, et al, Journal of the American Medical Association, 2005;293:1197-1203
Hiding in Plain SIght: What Koppel et al. tell us about healthcare IT. Christopher Nemeth, Richard Cook. Journal of Biomedical Informatics. 38 (4): 262-3.
Workarounds to Barcode Medication Administration Systems: Their Occurrences, Causes and Threats to Patient Safety, Koppel, Wetterneck, Telles & Karsh, JAMIA 2008;15:408-423
The Computer Will See You Now, New York Times, Armstrong-Coben, March 5, 2009,
Bad Health Informatics Can Kill. Working Group for Assessment of Health Information Systems of the European Federation for Medical Informatics (EFMI).
Electronic Health Record Use and the Quality of Ambulatory Care in the United States. Arch Intern Med. 2007;167:1400-1405
Predicting the Adoption of Electronic Health Records by Physicians: When Will Health Care be Paperless? Ford et al., J Am Med Inform Assoc. 2006;13:106-112
Resistance Is Futile: But It Is Slowing the Pace of EHR Adoption Nonetheless, Ford et al., J Am Med Inform Assoc. 2009;16:274-281
High Rates of Adverse Drug Events in a Highly Computerized Hospital, Nebeker at al., Arch Intern Med. 2005;165:1111-1116.
"Dutch nationwide EHR postponed: Are they in good company?", ICMCC.org, Jan. 24, 2009
“Avoiding EMR meltdown.” About a third of practices that buy electronic medical records systems stop using them within a year, AMA News, Dec. 2006.
"The failure rates of EMR implementations are also consistently high at close to 50%", from Proceedings of the 11th International Symposium on Health Information Management Research – iSHIMR 2006
"Industry experts estimate that failure rates of Electronic Medical Record (EMR) implementations range from 50–80%.", from A Commonsense Approach to EMRs, July 2006
Adverse Effects of Information Technology in Healthcare. This knowledge center presents a collection of information on the adverse effects of information technology in its application to healthcare. It also references sources of information on information security, and related media reports.
Pessimism, Computer Failure, and Information Systems Development in the Public Sector. Shaun Goldfinch, University of Otago, New Zealand, Public Administration Review 67;5:917-929, Sept/Oct. 2007
The literature at my HIT website's "Other Resources" page (link)
The teachings of the field of Social Informatics about new Information and Communications Technologies (ICT's) and the unanticipated negative consequences they cause. An introductory essay entitled “Learning from Social Informatics” by R. Kling at the University of Indiana can be found at this link (MS-Word file). The book “Understanding And Communicating Social Informatics” by Kling, Rosenbaum & Sawyer, Information Today, 2005 (Amazon.com link here) was based on this essay.
3. The warnings of HIT dangers from the U.S. Joint Commission, the EFMI, as linked above, and others; doubts about cost savings from Wharton and Stanford professors (surely no amateurs).
In the June 20, 2009 Wall Street Journal article "The Myth of Prevention", Abraham Verghese, Professor and Senior Associate Chair for the Theory and Practice of Medicine at Stanford, echoed several Wharton professor's doubts about the cost savings and ultimate value of electronic medical records, touted as the cybernetic savior of healthcare:
... I have similar problems with the way President Obama hopes to pay for the huge and costly health reform package he has in mind that will cover all Americans; he is counting on the “savings” that will come as a result of investing in preventive care and investing in the electronic medical record among other things. It’s a dangerous and probably an incorrect projection.
There are also reports of problems from FDA-like agencies of other countries such as Sweden's, whose report entitled "The Medical Products Agency’s Working Group on Medical Information Systems: Project summary" (available in English translation at this link in PDF) stated:
It is becoming more common that electronic patient record systems and other systems are interconnected, for instance imaging systems or laboratory systems. It is obvious that such systems should not be regarded as “purely administrative”; instead they have the characteristic features that are typical for medical devices. They sort, compile and present information on patients’ treatments and should therefore be regarded as medical devices in accordance to the definition.
Since the electronic patient record system often replaces/constitutes the user interface of “traditional” medical device systems, the call for 100% accuracy of the presented information is increased. Patient record systems have crucial impact on patient safety, and this has been proven to be the case after a series of incidents [including deaths - ed.] that has been reported to the Swedish National Board of Health and Welfare.
On wonders if Dr. Leavitt would include the Swedish Medical Products Agency, who incidentally have a cooperation agreement with our own FDA, under the category of "fearmongers."
Finally, stories of HIT mayhem of which Dr. Leavitt seems blissfully unaware are making their way to appropriate political circles. The whistleblowers are afraid to speak out publicly due to fear of job loss or retaliation. However, when the case examples do come out, it may be Dr. Leavitt who will be found to be "fear mongering" about those who care more about patients and their rights than about information technology.
Finally, stories of HIT mayhem of which Dr. Leavitt seems blissfully unaware are making their way to appropriate political circles. The whistleblowers are afraid to speak out publicly due to fear of job loss or retaliation. However, when the case examples do come out, it may be Dr. Leavitt who will be found to be "fear mongering" about those who care more about patients and their rights than about information technology.
Health IT Under ARRA: It's Not the Money, It's the Message. Indeed.
And Dr. Leavitt's message about those who think critically about health IT seems quite ill informed and mean spirited.
Finally, to get past the ad hominem and other logical fallacy nonsense I believe will be coming my way, I'll just admit to any and all of it. I'm an SOB, I'm a disgruntled curmudgeon, I'm an HIT dilettante, my uncle was in the mafia, I kick little cygnet swans in the park to be mean to Chucky, the cob (father) , and Princess, the pen (mother). /sarc
:-)
:-)
The Mute Swan family of Towamencin Twp., PA. Click to enlarge. The cygnets have really grown this past month (major cuteness warning if you click this picture from June 1!)
Now that we're hopefully past the expected ad hominem, perhaps the real issues can be addressed.
As a final piece of advice to Dr. Leavitt, I can add that dismissing concerns of others, Dogbert-style, is not a way to win friends and influence people.
Humor and a little humility work much better.
-- SS
-- SS
Fatty Liver Reversal
On April 15th, I received an e-mail from a reader who I'll call Sam. Sam told me that he had elevated levels of the liver enzyme ALT (alanine transaminase) in his blood, which indicates liver damage. ALT is an enzyme contained in liver cells that's released into the bloodstream when they rupture. Sam also had fatty liver confirmed by biopsy.
Liver damage with fat accumulation is very common in the United States. According to the NHANES health and nutrition surveys, in the time period 1999-2002, 8.9% of Americans had elevated ALT. Just 10 years earlier (1988-1994), the number was 4.0%. Fatty liver is a growing epidemic that currently affects roughly a quarter of Americans. Sam told me he had been trying to reverse his fatty liver for nearly a decade without success, and asked if I had any thoughts. He was not overweight, and from what I could gather, his diet was already better than most. I believe Sam knew intuitively that the right diet would improve his condition. With the usual caveats that this is not advice and I'm not a doctor, here's what I told him:
The latest test was 52, just on the cusp of normal. That's nearly 50% lower than his next lowest result over the past 7 years, in less than one month of eating well. I suspect that his next ALT test will be well within the normal range, and the fat in his liver will gradually disappear, if he continues this diet. When I asked him how he was feeling, he said:
How to Fatten Your Liver
Excess Omega-6 Fat Damages Infants' Livers
Health is Multi-Factorial
Liver damage with fat accumulation is very common in the United States. According to the NHANES health and nutrition surveys, in the time period 1999-2002, 8.9% of Americans had elevated ALT. Just 10 years earlier (1988-1994), the number was 4.0%. Fatty liver is a growing epidemic that currently affects roughly a quarter of Americans. Sam told me he had been trying to reverse his fatty liver for nearly a decade without success, and asked if I had any thoughts. He was not overweight, and from what I could gather, his diet was already better than most. I believe Sam knew intuitively that the right diet would improve his condition. With the usual caveats that this is not advice and I'm not a doctor, here's what I told him:
The quality of fat you eat has a very large influence on health, and especially on the liver. Excess omega-6 is damaging to the liver. This type of fat is found primarily in refined seed oils such as corn oil, soybean oil, and safflower oil... Sugar is also a primary contributor to fatty liver. Reducing your sugar intake will go a long way toward reversing it. Omega-3 fats also help reverse fatty liver if an excess of omega-6 is present. There was a clinical trial using fish oil that was quite effective. You might try taking 1/2 teaspoon of fish oil per day.On May 11, I received another e-mail from him:
The day after your recommendations, less than a month ago, I started a regimen of 1200 mg/day of fish oil concentrate.In the same e-mail, he sent me his new ALT test results. He had been getting tested since 2002. The latest result, reflecting his progress since adopting the new diet, followed the previous test by less than a month. Here's a graph of his ALT levels. Below 50 is considered normal:
At the same time, I significantly reduced or even eliminated all forms of sugar from my diet. I did have a half glass of orange juice for breakfast every few days or so, and some fruits, and maybe a taste of dessert or a small candy bar here and there. I never exceeded the 30 g/day sugar limit you suggested.
I completely eliminated any and all fried foods and avoided most oils. I also avoided high glycemic index foods to some degree, e.g. white bread and potatoes. I did eat quite a bit more protein, including red meat, eggs, fish, chicken, and pork.
The balance of my diet and lifestyle was largely unchanged. I do drink a couple of beers every two to three weeks, but never more than three drinks in day. I have been doing more yard work, simply because of the season. Other than that, I don't get much more exercise than a typical inactive office worker.
The latest test was 52, just on the cusp of normal. That's nearly 50% lower than his next lowest result over the past 7 years, in less than one month of eating well. I suspect that his next ALT test will be well within the normal range, and the fat in his liver will gradually disappear, if he continues this diet. When I asked him how he was feeling, he said: I did feel different after adjusting my diet. It's hard to describe, but overall I just felt better. I wasn't as tired when I woke up in the morning and I became a little slimmer, not a lot, maybe 3-5 pounds [note: he was not overweight to begin with]. I figured it was a placebo effect, but I think the fish oil has made a real difference.Fatty liver is a serious problem that responds readily to diet. I believe the main culprits are excess omega-6 from industrial vegetable oils; insufficient omega-3 from seafood, leafy greens and pastured animal foods; and excess sugar. The liver is your "metabolic gatekeeper", so it pays to take care of it.
Yesterday I had a few potato chips, corn chips, and some others. I didn't like it at all. Today I had half of a brownie for an afternoon snack and I completely crashed after an hour or so. I had a hard time keeping my eyes open. I no longer have much of a craving for snack food, I prefer to eat a full meal with more protein, e.g. beans, meat etc.
How to Fatten Your Liver
Excess Omega-6 Fat Damages Infants' Livers
Health is Multi-Factorial
Fatty Liver Reversal
On April 15th, I received an e-mail from a reader who I'll call Sam. Sam told me that he had elevated levels of the liver enzyme ALT (alanine transaminase) in his blood, which indicates liver damage. ALT is an enzyme contained in liver cells that's released into the bloodstream when they rupture. Sam also had fatty liver confirmed by biopsy.
Liver damage with fat accumulation is very common in the United States. According to the NHANES health and nutrition surveys, in the time period 1999-2002, 8.9% of Americans had elevated ALT. Just 10 years earlier (1988-1994), the number was 4.0%. Fatty liver is a growing epidemic that currently affects roughly a quarter of Americans. Sam told me he had been trying to reverse his fatty liver for nearly a decade without success, and asked if I had any thoughts. He was not overweight, and from what I could gather, his diet was already better than most. I believe Sam knew intuitively that the right diet would improve his condition. With the usual caveats that this is not advice and I'm not a doctor, here's what I told him:The latest test was 52, just on the cusp of normal. That's nearly 50% lower than his next lowest result over the past 7 years, in less than one month of eating well. I suspect that his next ALT test will be well within the normal range, and the fat in his liver will gradually disappear, if he continues this diet. When I asked him how he was feeling, he said:
How to Fatten Your Liver
Excess Omega-6 Fat Damages Infants' Livers
Health is Multi-Factorial
Liver damage with fat accumulation is very common in the United States. According to the NHANES health and nutrition surveys, in the time period 1999-2002, 8.9% of Americans had elevated ALT. Just 10 years earlier (1988-1994), the number was 4.0%. Fatty liver is a growing epidemic that currently affects roughly a quarter of Americans. Sam told me he had been trying to reverse his fatty liver for nearly a decade without success, and asked if I had any thoughts. He was not overweight, and from what I could gather, his diet was already better than most. I believe Sam knew intuitively that the right diet would improve his condition. With the usual caveats that this is not advice and I'm not a doctor, here's what I told him:
The quality of fat you eat has a very large influence on health, and especially on the liver. Excess omega-6 is damaging to the liver. This type of fat is found primarily in refined seed oils such as corn oil, soybean oil, and safflower oil... Sugar is also a primary contributor to fatty liver. Reducing your sugar intake will go a long way toward reversing it. Omega-3 fats also help reverse fatty liver if an excess of omega-6 is present. There was a clinical trial using fish oil that was quite effective. You might try taking 1/2 teaspoon of fish oil per day.On May 11, I received another e-mail from him:
The day after your recommendations, less than a month ago, I started a regimen of 1200 mg/day of fish oil concentrate.In the same e-mail, he sent me his new ALT test results. He had been getting tested since 2002. The latest result, reflecting his progress since adopting the new diet, followed the previous test by less than a month. Here's a graph of his ALT levels. Below 50 is considered normal:
At the same time, I significantly reduced or even eliminated all forms of sugar from my diet. I did have a half glass of orange juice for breakfast every few days or so, and some fruits, and maybe a taste of dessert or a small candy bar here and there. I never exceeded the 30 g/day sugar limit you suggested.
I completely eliminated any and all fried foods and avoided most oils. I also avoided high glycemic index foods to some degree, e.g. white bread and potatoes. I did eat quite a bit more protein, including red meat, eggs, fish, chicken, and pork.
The balance of my diet and lifestyle was largely unchanged. I do drink a couple of beers every two to three weeks, but never more than three drinks in day. I have been doing more yard work, simply because of the season. Other than that, I don't get much more exercise than a typical inactive office worker.
The latest test was 52, just on the cusp of normal. That's nearly 50% lower than his next lowest result over the past 7 years, in less than one month of eating well. I suspect that his next ALT test will be well within the normal range, and the fat in his liver will gradually disappear, if he continues this diet. When I asked him how he was feeling, he said: I did feel different after adjusting my diet. It's hard to describe, but overall I just felt better. I wasn't as tired when I woke up in the morning and I became a little slimmer, not a lot, maybe 3-5 pounds [note: he was not overweight to begin with]. I figured it was a placebo effect, but I think the fish oil has made a real difference.Fatty liver is a serious problem that responds readily to diet. I believe the main culprits are excess omega-6 from industrial vegetable oils; insufficient omega-3 from seafood, leafy greens and pastured animal foods; and excess sugar. The liver is your "metabolic gatekeeper", so it pays to take care of it.
Yesterday I had a few potato chips, corn chips, and some others. I didn't like it at all. Today I had half of a brownie for an afternoon snack and I completely crashed after an hour or so. I had a hard time keeping my eyes open. I no longer have much of a craving for snack food, I prefer to eat a full meal with more protein, e.g. beans, meat etc.
How to Fatten Your Liver
Excess Omega-6 Fat Damages Infants' Livers
Health is Multi-Factorial
An Original Excuse
The Associated Press just published a story about another company which apparently failed to report adverse events associated with its product:
What is most striking is the company's rationale for not reporting:
That is an original excuse. Did the "company officials" really mean to imply that in the absence of a promise to protect against a specific microbiologic organism, patients and physicians should assume that the product could be contaminated with that organism? This completely ignores the company's basic responsibility to supply a product that is uncontaminated with any harmful organisms, and unadulterated with any harmful substances, and hence to be vigilant for any events that suggest that the product could have been contaminated or adulterated.
The "company officials'" bizarre excuse suggest a fundamental lack of comprehension of their responsibilities for the health and safety of the patients using their products. This is a particularly weird example of how little many leaders of health care organizations understand about health care.
Complaints about a contact lens solution linked to a 2007 outbreak of eye infections that blinded several people went unreported by the manufacturer for more than a year, government documents show.
The documents show Advanced Medical Optics received complaints about the solution more than a year before it was recalled, and failed to promptly report nine complaints as required by law.
The company pulled its Complete MoisturePlus off the market in May 2007 after the Centers for Disease Control and Prevention linked the fluid to dozens of cases of a serious infection called Acanthamoeba keratitis.
Lawyers for customers suing AMO obtained the documents, which stem from a previously undisclosed inspection by the Food and Drug Administration, through a Freedom of Information Act request. The papers were obtained by The Associated Press.
Of roughly 70 plaintiffs suing AMO and represented by the law firm Schmidt LLP, three had eyes removed, three others suffered blindness and about two dozen had at least one corneal transplant. The others suffered permanent vision damage.
Beginning in February 2006 and continuing through November, AMO received a series of complaints about users who were diagnosed with the Acanthamoeba infections. But those reports were not disclosed until June 2007, when FDA inspectors came to investigate the company's headquarters following its product recall.
What is most striking is the company's rationale for not reporting:
When questioned by FDA inspectors, company officials said they were not obligated to report the complaints because the product's labeling does not say it protects against Acanthamoeba, according to the FDA documents.
Kelly Morrison, a spokeswoman for Abbott Laboratories, which acquired AMO in February, said the company 'believed it was reporting customer complaints in compliance with FDA regulations.' She declined to elaborate. Abbott Laboratories is based in North Chicago.
That is an original excuse. Did the "company officials" really mean to imply that in the absence of a promise to protect against a specific microbiologic organism, patients and physicians should assume that the product could be contaminated with that organism? This completely ignores the company's basic responsibility to supply a product that is uncontaminated with any harmful organisms, and unadulterated with any harmful substances, and hence to be vigilant for any events that suggest that the product could have been contaminated or adulterated.
The "company officials'" bizarre excuse suggest a fundamental lack of comprehension of their responsibilities for the health and safety of the patients using their products. This is a particularly weird example of how little many leaders of health care organizations understand about health care.
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