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Is the new professionalism and ACP's new ethics really just about following guidelines?

The Charter ( Medical Professionalism in the New Millennium.A Physician's Charter) did not deal with just the important relationship of ...

Thursday, April 28, 2011

The semi-secret RUC is getting less and less secret

The RUC (more formerly known as the AMA/Specialty Relative Value Update Committee) up until recently has been an obscure creature of the AMA about which little was known and even less was written about. Thanks to a number of physicians,including Dr. Roy Poses, more and more information of the composition of that group is being revealed. See here for Dr. Poses's latest revelations about the current members of the RUC and and some of their relationships which might represent conflicts of interest.

Not only are we treated to looking behind the curtains but there is an organized effort to opt out of the RUC influence. See here for information about the "Replace the RUC" effort.

Dr Poses raises several of the unanswered questions regarding the RUC. The one that interested me for some time is this. Why was there and is there so little outcry about the central governmental management of physician's fees, i.e. price controls.? (If there is anything Keynesians and non-Keynesians agree on it is that price controls lead to shortages and decreased quality) Could part of it be that the AMA whose brainchild we are talking about kept the whole process obscure and largely behind the scenes?

Tuesday, April 26, 2011

How bad is the Supreme's denial for expedited review of Obamacare?

According to David Catron the news is really bad for those of us who still hold out some hope that Obbamacare will be stopped by the Supreme Court. Here is his commentary in the American Spectator. While the issue(s) crawl though the courts, the "leaders with ideas" are cranking out rules and regulations for the statute's implementation.

Friday, April 22, 2011

Meta-analysis fails to show all-cause mortality benefits to statins in primary prevention

A 2010 meta-analysis by Dr. KK Ray et al ( see here for full text) in the Archives of Internal Medicine stirred a bit of interest and commentary as it failed to show an all-cause mortality benefit from statin use in the setting of primary prevention in patients with elevated risk factors for coronary artery disease.

A few context setting comments are in order. First, it is well established that statins are clearly beneficial in secondary prevention of coronary disease. In patients with proven coronary artery disease few would disagree with statin use.Its efficacy and safety have been demonstrated in several of the well known so-called landmark statin trials.

Second, the argument is strong for the conclusion that statin use in primary prevention results in a decrease in cardiovascular (CV) deaths. The authors of the Archives article make their position clear in that regard when they say in their comments sections "the benefits of statins in CV deaths are unequivocal based on primary prevention data from the CTT meta-analysis." The Cholesterol Treatment Trialist Collaboration or CTT was published in Lancet in 2005 ( see here ) .

So, the issue that Ray and his fellow authors addressed was not do statins reduce CV mortality in primary prevention but do statins reduce all cause mortality and their data analysis lead to the conclusion it does not.

Ray analyzed data from 11 randomized clinical trials of patients with what they considered to be high risk for coronary artery disease ( 244,000 patient years). Big numbers for patient years tends to give credence to findings but the key thing here is that in these trials the follow-up period was only 4-5 years as is typical of clinical trials. In patients with increased CV risk -as opposed to patients with proven CAD-the ratio of CV deaths to total deaths is relatively low particularly in a 4-5 year time frame. So that it is not surprising that all cause mortality may not be decreased, which is what Ray demonstrated.

Both the editorialist in the Archives and a subsequent commentator in a Update section in the April 5, 2011
Annals of Internal Medicine seem to conflate failure to show decrease in all cause mortality in a short observation period with overall lack of benefit. Ray and co-authors do not deny benefits in terms of decrease in C-V mortality.
.

Thursday, April 21, 2011

Major cuts in Medicare Advantage postponed until after election

Remember how we were told that if ACA ( Obamacare) were not passed the country would "go broke". Obamacare would reduce the deficit. One of the cost saving mechanisms contained in the bill was a major reduction in Medicare costs including significant reductions in Medicare Advantage (MA).This was supposed to bolster the long term solvency of the entire Medicare program. Now the Obama administration has decided to postpone saving the country from going broke until after the election and actually spend a little more money of the MA program.Why? To avoid a voter push back from looming cuts in Medicare Advantage seems the obvious answer . AARP can't be happy with that. See here for more on AARP.

See more about the Medicare Advantage ploy from Black Ribbon Project blog here. Also I commented on this egregious political play before.
Link
Another alleged cost saving proposal included in Obamacare was the Community Living Assistance and Support Act (CLASS).

Early on, opponents of the health care bill insisted that its provisions were not fiscally sound and were placed in the bill to give the illusion that Obamacare would cost less than the magic one trillion dollar price tag. The plan was to front load the plan with premiums without any benefit payments for a number of years. It was advertised as a mechanism to decrease the federal deficit by 86 billion over a ten year period. Now even with the deck as rigged as it was it will not work . The Secretary of HHS has admitted that.

More and more elements of the Obamacare monster bill seem to be either unraveling completely or postponed until after the 2012 election.

Monday, April 18, 2011

Still more data on adverse and beneficial effects of statins

Here is a recent article in the BMJ detailing the absence of numerous adverse effects of the statin class of drugs and the occurrence on a few beneficial effects. The article mentions cataract as a complication of statin therpay , an adverse effect that was of concern in very early animal work by Merck but about which I had stopped worrying until the BMJ article. In fact, there was this study from 2010 which claimed the opposite, i.e . a decrease in the risk of cataracts from statin use and this 2003 fairly large case-control article that found no effect in regard to cataract.


For a while those who read or skimmed medical literature were treated to an array of articles that claimed numerous effects of the statins that were not just further evidence of the pleotrophic effects of statins but were really just short of miraculous. I wrote about some of those claims here. Most of those claims did not pan out. Another claim,that of the statins causing an epidemic of heart failure made by Dr. Peter Langsjoen ( see here),does not appear verified by the BMJ article.Link

Tuesday, April 05, 2011

Federal Judge" Entitlements" are mandatory-people are trapped [in Medicare]

Regulations put into place during the administration of Bill Clinton prohibited folks from opting out of Medicare part A unless they agreed to forgo their social security payments ( and pay back whatever SS funds they had received).

It seemed to take a long time for someone to challenge this rule but someone finally did and the federal judge presiding over the case has now rejected the case with an appeal pending. Here is a link to the decision by the US District Court Judge Rosemary M. Collyer.


Her convoluted and self-contradictory reasoning (see here) concluded that this entitlement ( to Part A) is mandatory .To some the notion of a "mandatory entitlement" may seem Orwellian but at least the judge did offer some interesting comments in her written opinion that suggests lawyers even when they become judges might retain a sense of irony.

For example Judge Collyer said in her conclusion:

Plaintiffs are trapped in a government program intended for their benefit. They
disagree and wish to escape. The Court can find no loophole...

In her introduction she stated:

Medicare costs are skyrocketing and may bankrupt us all; nonetheless, participation in Medicare Part A (for hospital insurance) is statutorily mandated for retirees who are 65 years old or older and are receiving Social Security Retirement (so-called ‘old age’) benefits. Whether Congress intended this result in 1965 or whether it is good fiscal and public policy in 2011 cannot gainsay the language of the statute and the regulations

It seems to me she might have well said, the program is ridiculous but that is the law -get over it.

DrRich takes up this case (see here) in his blog and considers this case in the broader context of his lingering (or growing) concern about the possibility that down the road seniors and others may face a health care system which prohibits the patient from purchasing any health care not approved by the central authorities. See here for his earlier commentaries on the efforts to limit individual prerogatives in obtaining medical care. I share his concern.

Friday, April 01, 2011

Follow the money rule suggests reason for AARP support of Obmacare

The venerable follow the money rule continues to have explanatory power. This time, apply it to AARP's support for the health care overhaul-reconfiguration bill and presto we have a plausible explanation for AARP support for the bill . Simply put, AARP makes a hefty brokerage fee for selling Medicare supplemental policies and Obamacare dealt a blow to the Medicare Advantage programs so that it is likely many senors will migrate from MA plans to traditional Medicare and will likely purchase a supplemental policy the sale of which is a major income stream for AARP.

See here for details about how much money AARP might make as a result of changes brought about by the health care bill that they vigorously supported.

Meanwhile surveys suggest that most seniors believe Obamacare will diminish access to care for them (that they are the Peters robbed to pay Paul) and more entities are receiving waivers from some of the provisions of Obamacare. Things just get better and better.

Thursday, March 24, 2011

Earth Day again-time to look at the satellite view of Korea

Rather than encouraging school kids to guilt their parents into turning off the lights for a while to "celebrate" earth day ,my suggestion is for school teachers to assign an essay to their charges. The topic-why is North Korea dark and South Korea lighted as illustrated in this iconic image.

An alternative topic might be what would our lives be without electricity.

Here is an earlier earth day commentary offered as a counterpoint to the usual sanctimonious
earth day platitudes and indoctrination of youth with the secular religion of naive environmentalism with its rituals of turning off lights and mindless recycling.

Finally, here is an essay from the economist Steven E. Landsburg from his book "The Armchair Economist" in which he makes the distinction between the religion of environmentalism and the science of ecology and makes clear my choice of "mindless" to modify "recycling", putting forward the notion that recycling per se is not a moral issue and therefore always right (or wrong) but each case is an empirical one.

Wednesday, March 23, 2011

Still another argument against P4P

I have based my opposition to P4P in medicine on several lines of argument. These included :

1) It is unethical (see here for the comments of Drs. Edmund Blum and Faith Fitzgerald)

2 ) it often is a disingenuous method to control costs with feigning a desire to improve care

3)Goodhart's Law (see here).

Now the prolific Dr. Doug Perednia offers another reason to oppose P4P. Read about it here ( this is part 2, read Part 1 also). He offers a brief and very instructive introduction to a field of study known as Self-determination Theory (SDT) and relates that to the P4P issue.

SDT is based upon the idea that there are many things that people do not for the promise of external reward, but because of some sort of intrinsic, human desire for autonomy, competence and relatedness.

Including in that category of things people do not necessarily because of carrots and sticks is the practice of medicine.

The theoretical and empirical case against P4P has grown so strong that the only reason physicians and their organizations put up with it must be they just want to go along to get along.

Thursday, March 10, 2011

HHS gets more efficient , now giving an entire state an exemption from Obamacare

The task of giving exemptions to aspects of Obamacare company by company might have proved to be to time consuming for the Department of Health and Human services so they are issuing state by state. See here.

The state of Maine was given a waiver,good for three years,exempting health care insurers from the requirement that they spend at least 80% of premium fees on actual patient care. In Maine, at least for a while, 65% will suffice.

Earlier Maine's secretary of insurance has expressed concern that one company,Healthmarkets,Inc, would drop coverage for policyholders and leave the state.See here for some background on that company .

Friday, March 04, 2011

Class Act a fraud? Secretary HHS claims she will "reform" it

Financially unsound is the most generous way one can describe the part of Obamacare known as the CLASS Act ( The Community Living Assistance and Supports Act). see here.

Even the secretary of HHS admits to problems with this section of ACA but her answer is that she will use her discretionary powers to " reform it". What ever happened to the rule of law? A law is passed and if there are problems with it and an administrative arm of the executive branch will alter the law to fix it.It will be fixed by a politically appointed administrator who serves at the pleasure of the president.

Secretary Sebelius,at a congressional hearing, said that those provisions were "totally unsustainable" meaning it would not pay for itself and would require taxpayer money to make it fiscally viable.

Early on, opponents of ACA insisted that the provisions were not fiscally sound and were placed in the bill to give the illusion that Obamacare would cost less than the magic one trillion dollar price tag. The plan was to front load the plan with premiums without any benefit payments for a number of years. It was advertised as a mechanism to decrease the federal deficit by 86 billion over a ten year period. Now even the administration admits it will do no such thing.

Either the authors of the CLASS Act were aware of the lack of sustainability but proceeded on in a wink-wink-nod-nod manner or they did not know what they were doing. Ms. Sebelius testified that they (the folks at HHS) realized right way that was the case. Did the folks at HHS have no input to the crafting of the legislation?

Tuesday, March 01, 2011

One of the ways Obamacare was to "save money" was to cut Medicare Advantage but now..

But now HHS announces that , at least for the short term- that is until the 2012 elections, payments will increase for Medicare Advantage Programs. See here.

It was a decrease in the Medicare Advantage Payments ,along with cuts to hospitals and other providers, that was to provide about half of the funding for the expanded insurance coverage to low income folks. It was projected that some 137 billion would be saved from cuts to Medicare Advantage programs. The alleged savings was touted to also extend the solvency of the Medicare Part A Trust fund.

The actions of HHS in this regard is typical of what George Will references as the "administrative state" which the United States have (has?) morphed into. In the "administrative state", Congress passes "sentiments" not laws, and delegates to the administrative tentacles of the Executive Branch the authorship and administration of the various rules that make the Congressional sentiments operational.See here for Will's comments.

Woodrow Wilson envisioned a government that would be run by experts who would be unencumbered by the messy give and take of politicians who would stray from what was right and good for the people by the actions of various interest groups and their own selfish urges. Somehow the only PhD to occupy the White House did not realize that the experts of the various agencies might themselves posses human characteristics that steer them to act for political reasons. It is hard to consider the recent actions of HHS other than being politically motivated.

Tuesday, February 22, 2011

So how did that P4P thing work out in Great Britain?

If you want to know the answer to that headline question, go here to Dr. Doug Perednia masterful analysis of a large study of how P4p worked out in Britain's NHS. The bottom line was that P4P had no useful effect at all.None.

If the so-called thought leaders and powers that be in such organizations as AMA and ACP and others supported ( continue to support?) P4P because of a belief that patient care would improve they should now take a strong stand against such programs. P4P does not work.

Implicit in P4P program is the concept of target goals. Goodhart's Law stands the test of time and logic. When a measure ( as in a purported measure of "quality") becomes a target it looses its value as a measure.

Monday, February 21, 2011

Is lying for the greater good part of the New Medical Ethics

Dr. Paul Hsieh discusses the antics of alleged physicians in the current Wisconsin kerfuffle writing notes falsifying an illness to excuse absence from work while the recipients attended the rally.See here.

He suggests that this dishonest behavior ties in nicely with the New Medical Ethics as promulgated by the American college of Physicians in which the notion of Social Justice is elevated to a prominent position.

Well, one way or another someone is lying. If those claiming to be physicians are really not, they are obviously lying and if they are physicians they are lying about the purported sick time.

Dr. Scott Silverstein, writing on the blog "Health Care Renewal" discusses the sick-note incident in terms of the slippery-slope situation that arises when there is "physician dishonesty-on-an-agenda " which he describes as the face of postmodern medicine.

Wednesday, February 16, 2011

Overhauling America's Health Care - a must read book

Go here to read a lucid review of an excellent book by Dr. Douglas Perednia.Then go to Amazon to buy the book.It is entitled "Overhauling America's Healthcare Machine."

Dr. Perednia provides a brilliant and detailed description of what is wrong with the current system/non system and then offers his proposal to remedy the mess, a proposal very similar to that offered by Dr. Richard Fogoros in his book, "Fixing American Healthcare".

Wait- why read about plans to overhaul American healthcare, don't we already have a solution in the form of ACA? If you want to read a brief explanation of why ACA is not the answer, go and read Dr. John Goodman's latest comments on the incredible absurdity that Congress put together.

AND congratulation to DrRich At Covert Rationing Blog for his Weblog award for the category of Health Policy and Ethics.

Friday, February 11, 2011

Limited "coarse grain" data suggest following certain pneumonia guidelines can be bad for survival

While that headline sounds like a typo that is what a recent article in Lancet seemed to show.Further we are not talking about all pneumonia guidelines,as , for example the guidelines for the treatment of community acquired pneumonia (CAP) actually work out rather well. The focus in the above headlined article was on the ATS and IDSA guidelines for the treatment of hospital acquired pneumonia (HAP).

When I read about that finding my first thought was to look more closely at the guidelines and importantly what was the evidence underlying the recommendation. As has happened more than once, Dr.RW saved me the trouble. See here.

Dr RW's analysis suggests that the evidentiary basis of the recommendation of the IDSA and does not belong on the top of the classical,mythical evidence based medicine (EBM) evidence hierarchy in which randomized clinical trials and meta-analyses perch at the top.

My take on this article is that we might be cautious in accepting the findings on face value. After all this was a retrospective observational study replete with all the potential biases this type study might possess. This is what I call coarse grain data without the fine grain detail that might be provided by detailed patient level analysis. For example, the authors speculated that perhaps the side effect of the double gram negative antibiotic combination may have contributed to the increased mortality in the group treated in accord with the guidelines. Maybe so, but more detailed analysis might provide support or refute that speculation.

Wednesday, February 09, 2011

Runner has seizure at near the end of Houston Marathon

On an unusually warm and humid day in Houston ( Jan. 30,2010) the Houston marathon was held.According to this local TV report,a female runner had an apparent seizure near the finish line.She was treated on the scene , experienced two cardiac arrests and was successfully resuscitated,intubated and transported to a hospital.Further details are not available.

One of the first things that comes to mind is exercised associated hyponatremia (EAH).

EAH has attracted much attention in recent years. Dr. Tim Noakes,from Cape Town ,South Africa, attributes the apparent increase incidence of the condition to overemphasis of encouraging runners to drink liquids past the point of reasonable and safe short term replacement needs. Subsequently more physiologically reasonable recommendations regarding drinking during longer races have been issued. The New York Marathon's fluid replacement advice was 8 ounces every 20 minutes. The International Marathon Medical Directors Association (IMMA) recommended 400-800 ml per hour. Too often in the past the advice seemed to be drink as much as possible.This advice seemingly lead to some slower runners ingesting so much liquid that they actually gained weight during the event.

Acute EAH has been associated with cerebral edema and non-cardiac pulmonary edema. With acute lowering of the serum sodium and less than instant re-equilibration of cerebral intracellular solutes, water moves into brain cells. If untreated in severe forms, cerebral herniation can occur with brainstem compression. Judicious amounts of three percent saline I.V. has become the consensus treatment.

Here is an earlier blog entry on putative mechanisms in EAH.

An elite runner collapsed and died early on in the marathon trials in New York and at least early reports indicated no specific cause was determined. Exercise associated hyponatremia was not a likely cause in this case.See here for comments regarding causes of sudden death in athletes.

Marathons in hot weather can be a disaster ( the Houston weather was merely warm and humid) which is how some reporters described the ill fated 2007 Chicago Marathon. See here.

Tuesday, February 08, 2011

New Guidelines for treatment of carotid artery stenosis

The full text of the new guidelines for treatment of vertebral and carotid stenosis can be found here.

The guidelines apparently were a joint effort of the cardiologists and practically everybody else who had interest in the diagnosis,medical or surgical or catheter treatment of vascular construction to the brain.

The paper is gives a wealth of information and references and could easily take up many hours of study. Here is one snippet-

It is reasonable to prefer endarterectomy (CEA) over stenting in asymptomatic patients with greater than 70% stenosis.The panel had grade A evidence for that recommendation.

Although they do not recommend screening for carotid obstruction in asymptomatic patients, many folks will be getting ultrasound exams of their necks,abdomens and doppler exams for vascular disease of the lower extremities as roaming, proprietary groups are frequenting churches and other sites.So when your patient for whom you did not recommended screening shows up with a report suggesting significant blockage you have a good resource to consult.

Thursday, February 03, 2011

"High-value"health care achieves buzz word status-An ACP Committee defines "rationing"

In the 1 Feb 2011 issue of the Annals of Internal Medicine in the Clinical Guideline section, ACP's Clinical Guideline Committee authored an article entitled :

High-Value, Cost Conscious Health Care: Concepts for Clinicians to Evaluate the Benefits,Harms,
, and Costs of Medical Intervention". see here for full text.

Dr. Douglass K. Owens, author of numerous cost effectiveness studies, was the lead author.

The article begins with expression of the customary alarm about increasing health care costs and the need for cost control, an effort the authors believe should focus on the value of the health care interventions.

Their operational definition of value is " an assessment of the benefit of an intervention relative to expenditures".Value is determined by balancing benefit and costs.

This is consistent with Harvard Business School professor, M.E. Porter's definition which is:
Value =outcome/cost.

Simple enough we just figure out the benefits and the cost and ...but the devil is in the details as always.

The Annals authors then make what they believe to be critical distinction -the distinction between cost and value. A high cost item may or may not provide high value and low cost may have little benefit , therefore that intervention is of low value. So what we want is high-value health care.

(As best I can tell,the busswordification of" high-value health care" can be attributed at least in part to the efforts of Porter and Dr. Elizabeth Teisberg, although I don't wish to slight Dr. Don Berwick and physicians at the ACP.Whatever it origins and vectors of spread, medical authors and policy wonks talk about it now as if everyone knows what it is.)


The authors then redefine rationing (or in the authors words " more appropriately" define) to mean "restricting the use of effective, high-value care". So that if an intervention that is "determined" to be low value is restricted that would not be by the new definition considered rationing. This should provide comfort to those who worry about the rationing of health care. eliminating an intervention that is determined (By whom?) to be of low value is not rationing at all. One can see what power this puts in the hands of those determining what is high and low value.

The authors then discuss the importance of considering the downstream costs and benefits of an intervention.For example, one has to factor in the cost of maintaining a ICD not just the initial cost of assessment and placement of the device.

If a treatment is both better and cheaper than an alternative there is no problem in deciding between the two. More complexity emerges when an alternative provides more benefits but also costs more.

In this situation we are told we need comparative effectiveness analysis which is basically cost benefit analysis (CAB) that compares the various alternative interventions. Conceding this point, at least for the sake of argument, one now asks who will make that analysis

Owens et al provide the answer:

...we recommend assessing their value [competing interventions] to patients and society by using cost effectiveness analysis. Such analysis require specialized expertise and training,are often expensive, and thus are typically performed by investigators.

Note this type of assessment cannot be done by just anybody, only those with specialized expertise and note what they claim to provide-assessment of value not only to patients but to society.

Realizing that some may find that level of hubris unsettling, the real money quote of the article is :

"The choice of a cost effectiveness threshold is itself a value judgment and depends on several factors, including who the decision maker is.

That is the heart of the matter, after all of the gathering of various costs and developing estimates of the quality adjusted life years (QALY) and the aggregation of costs and aggregation of estimated benefits and using various analytic tools ( e.g. cost-effectiveness ratios), someone or some committee has to make a value judgment. Is the benefit worth the cost or not? At the end, it is a human value judgment- not the solving of some equation. Then the question is who will decide.


In the same issue of the Annals of Internal Medicine there is an Editorial by Michael Gusmano and Daniel Callahan of the Hasting Center offering cautionary counterpoints.

They emphasize Owen and co-authors' admission that effectiveness evidence is lacking and our ability to assess quality of life is inadequate. If the evidence is lacking and our ability to assess quality of life is inadequate even investigators with expertise and special training might be challenged. Gusmano and Callahan continue:



Perhaps the biggest problem with cost-utility analysis in that the expenditures on health care cannot be compared with other societal needs..the failure to consider opportunity costs may eliminate existing,but un-assessed health care technologies and services that are a better value than the "cost effective" technology included in these assessments.

Wednesday, February 02, 2011

More on the concept expressed by Goodhart's law

Calling it "teaching to the test" or ...

John Goodman asks the question "Does measuring quality actually decrease quality?". See here for his recent blog entry.

Charles Goodhart, a British economist put it this way in 1975:

Any observed statistical regularity will tend to collapse once pressure is placed upon it for control purposes

In other words, a measurement when used as a target looses its value as a measure.

This basic notion was expressed about the same time by a sociologist, Donald Campbell, who said :

"The more any quantitative social indicator is used for social decision-making, the more subject it will be to corruption pressures and the more apt it will be to distort and corrupt the social processes it is intended to monitor."

A poster child for this phenomenon in the context of quality measures in medicine is the absurd 4-hour pneumonia rule.I have blogged about that before.

When the incentive for ED staff was to get the antibiotics to pneumonia patients within 4 hours, because that was established as a quality measure, distortion and corruption emerged in the form of giving less prompt attention to non-pneumonia suspects and treating folks who really didn't have pneumonia with antibiotics.

From Goodman's post:

Quality measures also degrade quality by distorting behavior.

Dr. Douglas Perednia had a great discussion of this topic here.