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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 ...

Friday, July 30, 2010

Donald Berwick and Great Britain's Prime Minister talk about different NHS s

While Dr. Don Berwick, Obama's recess appointee to head CMS, speaks of Britain's NHS in glowing if not poetic and outlandishly laudatory terms,Britain's Prime Minister who has actually studied a report about NHS failings presents a different portrait . See here for the white paper on the NHS.

Here is one except from that report:

...
the NHS has achieved relatively poor outcomes in some areas. For example, rates of mortality amenable to healthcare, rates of mortality from some respiratory diseases and some cancers, and some measures of stroke have been amongst the worst in the developed world.


"Worst in the developed world" Berwick began his remarks celebrating the 60th anniversary of the NHS with this:

"I am romantic about the NHS; I love it. All I need to do to rediscover the romance is to look at health care in my own country."

His expressed infatuation for the single payer,centrally planned health system of Great Britain is obvious.What is less obvious is how he (or anyone) could reconcile those views with his self admitted radical views of patients primacy.

Dr.RW takes on this daunting task in his recent blog posting (see here) and using in part material from a 2007 IHI publication (see here) he provides insight into Berwick's thinking about reconciling conflicting aims.

Everyone ,physicians,patients,anyone who might become a patient should read about the "goals" that Berwick's organization advocates for a health care system.Then consider on what planet or in what alternative reality those aims could be actually accomplished by governmental central planning.It makes Will Roger's quote " Boil the oceans" ( to get rid of German U-boats ) seem practical.

Dr RW says this about their formulation:

'Grandiose, nebulous and intrusive are adjectives that come to mind." I think he is too kind.

Saturday, July 24, 2010

Wall Chart of PPACA is so complex that no one who supported the bill could have possibly known what they supported

Go here to see the labyrinth of provisions, regulations, deadlines,subsides and cross subsidies from the hundreds of thousands of words from PPACA that will transform American medicine. Read through it and try and see who gains and who loses. I suggest the countless details defy a comprehensive analysis. It will be years before the the unintended consequences can begin to be sorted out.Did the advocates for Obama care from AMA and ACP and other medical organizations who claim a victory for "social justice" have a clue about what the bill really contained? I suggest they understood even less that some of legislators who admitted they had not even read the bill.Further, many of the operational particulars have not yet been defined.That is a work in progress by the numerous governmental agencies who are now beset upon by the various lobbying interests(known euphemistically as stakeholders ).

Perusing the chart makes me wonder why there is so so much detail,why so many elements and provisions are there ,why laws are crafted to be so long and so opaque and why are so many agencies and governmental entities are necessary to carry out any stated goal.

Angelo Codevilla's essay on the ruling class provides one answer:

"[O]ur ruling class’s standard approach to any and all matters, its solution to any and all problems, is to increase the power of the government – meaning of those who run it, meaning themselves, to profit those who pay with political support for privileged jobs, contracts, etc."

Simply put, it has to be long and detailed and governmental agencies have to empowered to make many discriminatory decisions so that the folks in power can ensure who is that profits and who it is that picks up the tab. A statute's mind-boggling length and opacity serves to obscure what is happening.

Senator Baucus apparently really knew what the health care bill was all about even though he likely could not detail exactly what all the provisions were when he said in his exuberant candor after the bill was passed:

"Too often, much of late, the last couple three years, the mal-distribution of income in America is gone up way too much, the wealthy are getting way, way too wealthy and the middle income class is left behind," he said. "Wages have not kept up with increased income of the highest income in America. This legislation will have the effect of addressing that mal-distribution of income in America."

Right, it was all about redistribution of wealth which it just so happens is Dr. Don Berwick's desire as well as regards health care in America expressed in this quote from Berwick:

"...and that any health care funding plan that is just, equitable, civilized, and humane must – must – redistribute wealth from the richer among us to the poorer and less fortunate.


H/T to the Blog We Stand Firm

Monday, July 19, 2010

So did AMA and ACP have a seat at the medical legislative table or were they on the menu?

An essay that is receiving much attention as it should is available here .The author is Angelo M. Codevilla, a professor emeritus from Boston University. His characterizations of the" Ruling Class" and the "Country Class" is in the least thought provoking. I quote from the section labeled " Dependence Economics" with my bolding added:

"By taxing and parceling out more than a third of what Americans produce, through regulations that reach deep into American life, our ruling class is making itself the arbiter of wealth and poverty. While the economic value of anything depends on sellers and buyers agreeing on that value as civil equals in the absence of force, modern government is about nothing if not tampering with civil equality. By endowing some in society with power to force others to sell cheaper than they would, and forcing others yet to buy at higher prices -- even to buy in the first place -- modern government makes valuable some things that are not, and devalues others that are. Thus if you are not among the favored guests at the table where officials make detailed lists of who is to receive what at whose expense, you are on the menu.
Eventually, pretending forcibly that valueless things have value dilutes the currency's value for all. Laws and regulations nowadays are longer than ever because length is needed to specify how people will be treated unequally. For example, the health care bill of 2010 takes more than 2,700 pages to make sure not just that some states will be treated differently from others because their senators offered key political support, but more importantly to codify bargains between the government and various parts of the health care industry, state governments, and large employers about who would receive what benefits (e.g., public employee unions and auto workers) and who would pass what indirect taxes onto the general public."

Treating people differently seems to be the essence of "social justice" for which supporters of Obamacare claim a victory.

While the leaders of AMA and ACP ( and other medical organizations as well) announced proudly they had a seat at the adults' table with the Obama administration in planning health care reform , for most of the medical profession, I think the designation of "on the menu" is more appropriate as it is for many citizens who were "happy with their doctors and health care plans". Maybe sometimes folks just thought they had a seat at the table or , even worse, maybe they got what they wanted.

Thursday, July 15, 2010

More medical blogs express concern about Donald Berwick's suitability for CMS head

For a while it seemed only a few medical blogs were expressing concern about Dr. Donald Berwick's suitability to be the head of CMS. See here for one of Dr. RW Donnell's posting on that topic and here for one by Dr. Doug Perednia of the new blog Road to Hellth. Now others are joining it.

The prolific and widely read Dr. David Gorski has submitted a detailed discussion about Dr. Berwick expressing in part concern about Berwick's apparent support for unscientific alternative medicine .See here for the commentary. Additionally, Gorski makes the case, based on quotes from Berwick, that in some regards his views appear to be naive and out of touch with real world physician-patient encounters and relationships. Quoting Gorski:

Berwick strikes me as a very well-meaning person with some good ideas about how to make our health care system less rigid and more responsive to patients’ needs, both medical and nonmedical. Unfortunately, he also appears to be naive to the point of my wondering whether he has any clue what it’s like to practice medicine in the real world or even in the idealized world of academics.

I agree.A number of Berwick's comments appear very naive,unrealistic, and something more expected from someone not actually caring for patients than a physician with any recent background in patient care.As best I can tell he had not been practices medicine for a while.

There is a major disconnect between Berwick's expressed adulation of the NHS and his statement that rationing must be done with his views of patient centerness which he self describes as radical.

Dr. Kimball Atwood,a tireless opponent of non-scientific alternative medicine expressed similar views to Gorski in his essay on the blog Health Care Renewal. See here. Quoting Atwood:

"In February of 2009, Dr. Berwick gave a 'keynote' address at the IOM and Bravewell Collaborative-sponsored Summit on Integrative Medicine and the Health of the Public. He shared the podium with Mehmet Oz, Dean Ornish, Senator Tom Harkin, and other advocates of pseudoscientific health claims. I wrote about the conference at the time, mainly to call attention to its misleading use of the term "integrative medicine": literature emanating from the Summit characterized it as "preventive" and "patient-centered," whereas the only characteristic that distinguishes it from modern medicine is an inclusion of various forms of pseudomedicine. I noticed that Dr. Berwick was on the speaker roster, which I found disappointing: I imagined that he had either gone over to the Dark Side or, perhaps, was sufficiently naive about the topic to have been duped; or, more likely, that he had cynically accepted the offer to further his ambitions."

Monday, July 12, 2010

Dr. Donald Berwick's medical utopia - a top down, technocratic, authoritarian pipe dream

Apart from some apparently radically contradictory expressed views on patient "centerness " and patients being in control ( see here for a discussion of some of his inconsistency) the newly appointed head of CMS, Dr. Donald Berwick, has made it clear what sort of medical system he would have for the United States.

What he wants is well explained in this commentary from National Review Online as is the authors' reasoning of why that sort of authoritarian central planing never seems to work. The following is from that article:

Ideologues on the left favor a single-payer system for, well, ideological reasons of material egalitarianism. But for technocrats like Berwick, who shape the liberal policy consensus, the single-payer system is the most
efficient way to manage health care. Top-down control, in their minds, ensures that every participant in the system serves the broader public good: hospitals and doctors only perform the tests and procedures they need to; private companies make enough money to get by, without excessive profits; and “integrators” mandate best practices for all parties based on the best available evidence.

From Berwick's extensive writing and speeches we see that he favors a system in which data is dispassionately collected,adroitly and in an unbiased manner analyzed and in the most scientifically validated method a cost benefit analysis is performed so that the proper testing, procedures and medications are dispensed in a fair, equitable, humane and compassionate manner. Mandated best practices would impose order on the chaotic unplanned, helter-skelter mess we have today. By the same token someone should impose order on the chaotic, unplanned mess that is our "grocery delivery"system. Getting food is even more important that health care. By that I mean the thousands of groceries across the country in which most of us find, most of the time, everything we want. and if we don't, we go to the store down the street.Contrast that with the iconic empty grocery shelves of the USSR which fixed the chaotic market with best practice central planning.

It is difficult to imagine that someone still thinks central planning is more efficient that market mechanisms.Most anti-markets theorists decry what they believe to be the lack of morality of markets while agreeing that markets are most efficient.

So what could be wrong with this technocratic approach? The NRO essay suggests the following for starters:

Even if you believe that technocrats could better organize our health-care system, Berwick’s approach only works if the narrow interests of Congressmen, labor unions, general hospitals, the AARP, etc., have no influence on the writing of law. No one who watched Democrats make the Obamacare sausage can harbor any illusions on this score.

In other words,it would work only if we change human nature and the folks in government ( both the legislative and the executive branches) miraculously are no longer vulnerable to the incentives and pressures and biases and,yes even self interest, that is the plight of the rest of humanity. Technocratic administration in theory and technocratic administration in practice could not be more different.

A second point from NRO's critique:

Technocrats may believe they can marshal statistics and analysis to optimize the health-care system, but they are not omniscient. Their analyses rely on too many assumptions and on unreliable data. This is why government programs always result in colossal amounts of waste, fraud, and abuse.

So, how well did the central planning work out in the USSR? Hint: There is no USSR anymore.Starvation and near starvation characterized both the Russian and Chinese central planning of farming.

Berwick longs for a situation in which "leaders with plans" can roll up their sleeves and get this chaotic,leaderless medical system on the right road. I can think of little worse that putting self anointed leaders with plans in charge of medical care or,for that matter, grocery distribution.

Saturday, July 10, 2010

Who Funds Don Berwick's foundation?And why did he not give that info to Senate Democrats?

H/T to Keithhennessey.com for calling attention to the fact that Dr. Donald Berwick did not reply to Senate Democrats questions regarding who funded his foundation, the Institute for Healthcare Improvement (IHI).See here.

The mainstream medical organizations seem to have nothing but praise both for Dr. Berwick's work and his institute.

If you visit the IHI website you will not learn about who funds the organization.You will learn that the IHI has quite a few vice-presidents for what that is worth.

I have no reason to believe that their activities are anything but those representing a sincere effort to improve medical care although I freely admit that I have not spent much time analyzing or learning about exactly what they have done. But the question remains- why are the donors' name(s) not made public.

This commentary, from the American Spectator (AS) appears to have answered some of the questions regarding funding and raises the issue of the dread conflict of interest (COI) in regard to Berwick and the IHI.

I was impressed with how lucrative it is have Berwick's job at the IHI and how well a number of their vice-presidents are compensated. If the facts are as they are claimed to be in the AS article, it seems like we have once again validated the Mafia rule of "follow the money" because managed care organizations and insurance companies contribute to the IHI. Could it be they may well profit from research on quality which just happens to find that less care is better and/or that there is much overuse and misuse in medical care.

Here is a quote from the NHS speech Dr. Berwick delivered:

In the United States, these hundreds of insurance companies have a strong interest in not selling health insurance to people who are likely to need health care. Our insurance companies try to predict who will need care, and then to find ways to exclude them from coverage through underwriting and selective marketing. That increases their profits. Here, you know that that is not just crazy; it is immoral.

There is a interesting contrast here.Very critical remarks about the U.S.health insurance industry are made by someone who, according to the American Spectator Article, received 2.36 million annually since 2008 in compensation from an institute which is to a significant amount funded by health insurance companies.

Why are these companies paying someone so well to travel the world and bad mouth them?

All of this is really the dogs barking while the caravan moves on.Obama has in place a staunch single payer advocate. A single payer is becoming more will likely to happen sooner rather than later if the debacle with Masscare is a precursor of what will happen to the insurance industry with Obamacare.

Thursday, July 08, 2010

New Head of CMS,Donald Berwick-friend of central planning and redistribution of wealth ?

President Obama has appointed Dr. Donald Berwick as head of CMS during Congress's recess .If you like central planning and the notion of redistribution of wealth, you should love Dr. Berwick at least if you believe he was sincere in his speech praising the National Health Service in Great Britain.But is there another side to his philosophy?

He said that we need "leaders with plans" to design and reform the U.S. health care system. He said that"excellent health care is by definition redistribution". See here for a portion of speech praising the British NHS for in which the "redistribution " quote appears.

He has expressed his "love" for the NHS which is well known for its particular form of rationing medical care. This poses an interesting and puzzling contrast with the following statement from his paper from Health Affairs (vol.28,no.4):

Evidence-based medicine sometimes must take a back seat. First, leaving choice ultimately up to the patient and family means that evidence-based medicine may sometimes take a back seat. One e-mail correspondent asked me, "Should patient ‘wants’ override professional judgment about whether an MRI is needed?" My answer is, basically, "Yes." On the whole, I prefer that we take the risk of overuse along with the burden of giving real meaning to the phrase "a fully informed patient." I contemplate in this a mature dialogue, in which an informed professional engages in a full conversation about why he or she—the professional—disagrees with a patient’s choice. If, over time, a pattern emerges of scientifically unwise or unsubstantiated choices—like lots and lots of patients’ choosing scientifically needless MRIs—then we should seek to improve our messages, instructions, educational processes, and dialogue to understand and seek to remedy the mismatch. For the same reason, I wish we would abandon the word "noncompliance." In failing to abide by our advice or the technical evidence, the patient is telling us something that we need to hear and learn from. Honestly, how many of us have ever faithfully taken a full ten-day course of a prescribed antibiotic or never consciously skipped a statin dose? Are we fools who did that? Or did we choose that because of some sensible, local considerations of balance, convenience, or even symptom information that the doctor never had?

I would have liked to have heard his attempt to reconcile those views some of which sound like advocacy for ground up versus a top down control mechanisms with his affinity for the rationing activities of the NHS and his preference for leaders with plans to design the health care system but the recess appointment eliminates the need for Senate confirmation and the hearings that precede it.So we may never hear that.

Does Berwick believe the patient should call the shots or should the "leaders with plans" be the decision makers? It is hard to believe that in his beloved NHS a patient can get an MRI if she wants one or for that matter get certain cancer treatments? Perhaps he can miraculously merge those views which appear to be contradictory and the result of his leadership at CMS in the era of Obama care will be health care that is " generous, hopeful, confident, joyous and just " which are the words he used to characterize the NHS. What does it even mean to describe a health care system with as many problems as have been documented in the NHS as hopeful and joyous?

Sunday, July 04, 2010

Another virtue of Obamacare-massive job stimulus for lobbyists

There is benefit to make a law ambiguous-at least to the bureaucrats whose rule making will give that law operational meaning. There is benefit to a law which delegates to federal agencies the power to flesh out what a exhaustingly long and dense morass of legalese really means-at least to the lobbyists who represent the special interests who will benefit from the"proper interpretation" and implementation of the statute.

Such it is with PPACA aka Obamacare. Hat Tip to the The blog "Thinkmarkets .

" these reams of regulation are an epitome of vagueness...In the murk and the wide-open discretion given to bureaucrats lie gems for lobbyists. The White House and Congressional Democrats-even as they chided business lobbies-maximized the bill's scope and vagueness, laying the groundwork for massive growth in the crony system that intermingles government with private interests".

"Void for vagueness" is a legal concept that seems to particularly apply to criminal law and perhaps only to criminal law. In non criminal law vagueness seems to have become a virtue so that both sides in regard to particular legislation might think they have passed what they wanted and after passage the real meaning of the law is authored by various regulatory agencies and then the regulations themselves are often couched in another layer of vagueness allowing much interpretive leeway to those agencies.



Thursday, July 01, 2010

A possible job for Retired Doc

Ever since I retired I have had my eyes open for a suitable job opportunity. This might work. Thanks to the Carpe Diem blog for the reference. An older white guy might be even better as a candidate .

Monday, June 28, 2010

The best name yet for Obamacare-TNRKMA (turkey ma)

High fives to the endlessly insightful blog of John Goodman for what I believe is the best designation yet for PPACA which is also known as Obamacare.

I quote his introduction to the new name,TNRKMA.(The Thing that Nobody Really Knows Much About.)

'...what should we actually call this thing? That is, the Thing that Nobody Really Knows Much About (TNRKMA). At this blog, we have followed the convention of calling it “ObamaCare,” but that could be considered derisive. There is always “health reform,” but this bill will almost certainly be reformed many, many times, even before all of the original provisions are enacted.

On balance, I’m inclined to go with the acronym, TNRKMA — which is pronounced “Turkey Ma” (mother of all turkeys), with the N silent, or simply “Turkey,” for short.'


I tend to prefer the simpler designation, "turkey".Read his entire blog here.

Sunday, June 27, 2010

Business Roundtable suffers buyer's remorse with Obama care, will AMA, ACP, etc. be next ?

This article, from the WSJ, tells a precautionary tale that has been told many times in the past.It is a narrative with apparent deal-making,double cross ,doing what seemed expedient and the regrets of buying a pig in a poke.

The prominent business organization, the Business Roundtable, provided valuable support to the Obama administration in regard to the health care bill. Their support, according to this article, was based on the fear that the Obama administration would push forward with a tax on US corporations who have overseas operations. Now Mr. Orszag tells the group that the administration will go ahead with the tax anyway but by the way thanks for your help with the health care bill.

The folks at BR are now realizing what they "gained" from their earlier support .

"Roundtable President John Castellani, ... We stuck with that majority "through trying circumstances," even "alienating many of our traditional colleagues," and what did we get? They keep "vilifying" the private sector! And taxing it, and empowering unions, and ignoring trade. "The time has come for a new course," declared Mr. Castellani, a mere 18 months after Democrats announced plans to tax companies, empower unions and ignore trade."

Several professional medical organizations, including the AMA and the ACP, also supported the health care bill. Both have been rightly critical of the tardiness exhibited by Congress to fix the SGR but ,so far, I have heard no denunciation of the many provisions of Obama care that delegated unprecedented power to the HHS and other government entities and will exert increasing hegemony over the practice of medicine. Rather we have heard self congratulatory comments about furthering social justice which along with having a "seat at the table" may have been all organized medicine received for their support.

h/t to Wolf Files:12% Pure Hope for the link to the WSJ article.See here for his comments which close with this:

"It was the perfect execution of manipulative divide and conquer by a power-hungry government that sees the private sector as its adversary. And the proverbial man who sat idly by as the king ran over all others because it didn't affect him directly is now left without friends to defend him as the king comes knocking on his door."

Tuesday, June 08, 2010

Laymen find notion that more care and more expensive care can be worse as counter intuitive

A recent publication in the publication "Health Affairs" has evoked comments and some concern from advocates of comparative effectiveness research and admirers of the Dartmouth Atlas. See here for full text (pdf). A survey of "consumers" found a level of skepticism that is alarming to those folks who are in the business of claiming to know what aspects of medical care should be offered.

The idea that more care and more costly care gives inferior results to less care and less expensive care seem to be inconsistent with one's experience in a variety of areas. Many would relate to the experience of having a fly by night craftsman using cheaper materials doing a shoddy job at painting the house or doing household repairs. Few people believe that a cheaper car is better than an expensive luxury car. Think of a Mercedes versus those jokes made in Russia sold as cars. Most dental patients accept the notion that a root canal treatment followed by a crown is better than a dental extraction though the latter is much cheaper.

In the sixties what passed for treatment of acute myocardial infarction was cheaper than the much more effective and life saving treatment available now. In that instance more is better.

Until hip replacements became available patients with severe degenerative arthritis of the hip could look forward to years of limited mobility and pain. Now their lives are clearly improved but at a monetary cost considerably greater than the pain pills. In that instance more is better.

HIV-AIDS has been transformed from a rapidly debilitating and fatal illness to a chronic controlled illness with often very good quality of live.In that instance more is better.

I could easily generate a number of instances in which certain tests or procedures or medication use was/is not reasonably indicated and in the cases more is not better and I would agree that sometimes it is worse.

Surely, sometimes more is better and sometimes it is not. It is a more a matter of case law than the application of a universal general principle that cheaper is better. It is an empirical question regarding the particular intervention and the particular outcomes of interest. Sometime it may be but often the opposite seems to be the case. Many people seem to believe the lay adage that you get what you pay for even if that is not always right.

It is interesting that much of verbiage saying that more is not better comes from the progressive side of the spectrum of ideas and they will have their work cut out for them to disabuse the less informed of the naive notion that less is often not better.

An interesting parallel to this current day notion of there being too much spent on medical care ( not care for too many but too much care for some) is the economic nonsense that was spun out by the early Roosevelt administration. Their early theory as to why there was a recession/depression was that there was an overproduction of goods. Therefore,farmers had to cut back on production as did manufacturers. Interesting argument that the government tried to sell-people going hungry and the claim that farmers had to grow less.

Dr RW gives his take on this topic here and DB gives his here

I quote Dr.RW:

The Dartmouth Atlas was spun far beyond what the evidence supported, for political ends. That’s where the problem lies, not with the project itself. The data need to be viewed within the limitations of the methods. The findings are relevant. The sheer enormity of the variation in cost says deviation from best practice is widespread. Many questions remain unanswered. One is why? What external factors drive the variation? Another is in what direction? The popular assumption is that the error is in the direction of over utilization but it could just as easily be the other way around. After all, that’s what the best quality data we have and a sampling of public opinion say.

DB's headline got it right: "Sometimes money buy better care"

To avoid confusion let me say that I am not against comparative effectiveness research.There are many instances of it being done now and previously without a governmental agency being put in charge of it.I am quite concerned with the power that a governmental CER agency will have and afraid that the well known phenomenon of regulatory capture will happen there.On the basis of the article it looks like a number of "medical consumers" also have some concerns.

Sunday, June 06, 2010

Is refusal to accept government price controls "price fixing"

According to this article in the Christian Science Monitor, the Justice Department says it is -at least in regard to as physicians.

This governmental action seems to go past earlier efforts by the Federal Trade Commission who previously considered effort by groups of physicians to band together to try and increase their bargaining position with third parties as violating antitrust laws. See here for my 2007 commentary on one such case. Now physicians seem to have another governmental entity with even bigger teeth ( potential criminal penalties), the Justice Department, to content with as they deal with third party payers in and out of government.


Here is a quote from the CSM article describing the nature of the teeth"

"This is another reason why the DOJ’s presence in a physician case is more disturbing than the normal FTC case. The DOJ has a number of “tools” the FTC does not, including the self-granted power to award amnesties from criminal prosecutions to the first “conspirator” to step forward and provide evidence against one’s competitors.

A doctor that feared prosecution could seek amnesty — and provide the Justice Department a blank check to rummage through his files and private communications. And if that doesn’t work, the DOJ can always seek wiretaps of physicians’ phones and computers, a power awarded the DOJ during a 2006 renewal of the PATRIOT Act. The potential exposure of your physician’s confidential records — including your medical records — is limitless ."


As long as insurers set the prices for medical services and the FTC and now the Justice Department prohibits physician groups from fairly negotiating for fees, efforts by physicians to support and take part in P4P programs in the hope that the downward spiral of fees for primary care will be halted will be less effective than rearranging deck chairs on a sinking ship.More and more "going Gault" seems to be the way to go.My take on medical going Gault is to have a retainer practice and do not deal with insurers in and out of government.Unfortunately this seems feasible only for primary care docs.I don't see that arrangement viable for surgeons and procedurists.


H/T to Medical Pastiche.See here. See also here for a discussion of this recent development in limiting the ability of physicians to negotiate with third party payers from the blog " Road to Hellth"

Tuesday, June 01, 2010

Composite endpoints in clinical trials can be very misleading

The blog commentary by Dr. David Rind discusses the issue of composite end points in clinical trials and in particular the CREST trial which compared carotid endarterectomy with carotid stenting. See here.

The end points in Crest were periprocedural stroke,myocardial infarction,death or ipsilateral stroke occurring within four years after the procedure. Since both procedures are really done to decrease the risk of stroke in a patient with carotid stenosis, why not just compare the rate of stroke occurring in the two treatment groups over a several year period following the procedure? That would appear to be the key outcome of interest. Well, the more invasive endarterectomy procedure might be more likely to cause operative or post op problems than the catheter based treatment so some measure of that needs to be included in the accounting.

Basically end composite outcomes are done because the difference between two competing therapies is thought to be so small that a very large number of patients would be needed to provide a clinical trial that has sufficient ability or power to detect a difference between the two treatments. This has been particularly evident in regard to the treatment of acute myocardial infarction as treatments have continued to decrease the mortality of acute MI and incremental changes in benefit become smaller as therapies improve.

So what could be wrong with the composite approach?

CREST illustrates what could be wrong. Here the stinting group had fewer myocardial infarction with more strokes. So the trade offs appears to be more strokes with stints and more MIs with surgery. This could be interpreted to mean that the two techniques are quite equivalent but they differ in the adverse effects but are the two adverse effect equivalent? Most folks would say no since surviving a stroke can be much more devastating and life altering that a survived heart attack.

Rind put it this way:

Composites can quickly get you into trouble, though, if you combine events of very different importance to patients. Sometimes this appears to have been done with the intention of obscuring the real outcome of a trial or to make a therapy look far better than it really is
.

A recent commentary in JAMA also discussed the composite outcome issue and warned readers to beware of a" bait-and-switch" type phenomenon. See here. The following is the authors' final paragraph.

Readers of randomized trial reports must understand both the reasons for and pitfalls of choosing to combine clinical outcomes. Examination of the relative importance, frequency, and consistency of effect size across the components of a composite outcome are important steps in the interpretation of information derived from trials. But it is equally important to be aware of a potential bait and switch strategy. In some cases, readers and authors of reports of randomized trials may wish to weight each of the outcomes by an importance factor, similar to the way quality of life is measured.10 In other cases, they may wish to point out that even though a randomized trial was designed to detect a difference in the composite outcome (because the vast majority of the effect is on one component, typically the least severe), the trial has mainly showed the effect on surrogate outcomes and not definitive ones.

Monday, May 24, 2010

P4P(Pay for performance) harmful effects may impact surgeons as well-I am shocked,shocked

This paper (see here) regarding P4P and its impact on surgery or the lack of it for the obese patient has received at least two appropriate commentaries in the medical blog world. DrRick (see here) and Robert Centor (see here)have highlighted the article pointing out yet another example of the unintended consequences of P4P.

The main point is that if surgeons or the institutions in which they practice are penalized for certain surgical complications or length of stay in the hospitals it is likely that when possible surgeons just might tend to avoid elective surgery in patients who are in a group likely to have a higher than average complications rate.Such a group is the obese.

Goodhart's Law which indicates that when a measure become a target it looses the characteristics that made it a valid measure is a valuable insight capable of explaining a lot of behavior. One of my favorite examples is the ill fated " four hour pneumonia rule.See here and here. Teaching to the test and treating the chart are phenomena in same general category.These things are so common and predictable that maybe we should not call the consequences unintentional. The planners ( at least some of them ) must have it figured out by now but just do not care.

Physicians have been criticizing the P4P nonsense for years now but the caravan moves on.Here are some comments I made in 2008 with reference to an excellent essay on the subject by the prolific Dr. Roy Poses.

Thursday, May 20, 2010

Medicare and Price controls -one more time

I harp on the theme of the effect of the price controls on physician's fees in regard to Medicare several times. It is good to see someone else playing that song. See here.

Price controls equals less and poorer quality medical care and PPACA , in part, through the agencies and panels it establishes will only make worse.

For another glimpse back into Economics 101, read this commentary by yet another articulate, thoughtful, EP cardiologist-blogger who talks about the decreasing supply of primary care docs and the soon to be ( well, by 2014) increase in demand for medical services plus the additional factor of more docs likely to be on salary and the likely incentives that will bring.Further, the increasing shortage of medical providers is not just in primary care.See here.

Tuesday, May 18, 2010

More on freedom to purchase one's own health care

See here for a interesting review of aspects of the history of health care insurance in the U.S. from Peter Zavislak at the blog Medical Pastiche. Note carefully what almost happened with Hillary Care .More detail on one important development in the history of US health insurance,namely the RBRVS, can be found on Doug Perednia's blog, The Road To Hellth, See here.

This is what Thomas Sowell had to say about what was being planned for America's health care by Hillary and friends in the update to his 1980 masterpiece, Knowledge and Decisions.

....[the]1993 attempt to have the government take over the entire medical sector of the country-an attempt spearheaded by people with neither medical training, hospital management experience,nor expertise in pharmaceutical research or even in the running of a drugstore.


Note what was contained in the Hillary care plan. Here are Zavislak's words on that:

Clinton Era – Attempted passage of Universal Health Insurance Plan Fails. IF it had passed, it would have been illegal to use one’s own private funds to pay for services NOT covered by this plan!!

This was a close call apparently largely averted by in fighting among Democratic party factions but this time we have a home run for those who believe that medical care is too important to be left to the individual physician and the individual patient that was made to happen by some folks with the same qualifications as described above by Sowell as well as some folks who actually went to medical school.

No, PPACA does not contain words that explicitly prohibit private transactions between physicians and patients ( as Hillary wanted) but see here for Dr. Richard Fogoros's presentation of his concerns about that possibility arising out of the recently passed health care reconstruction.

Sunday, May 16, 2010

Will Obama care lead companies to drop their health care plan?

An analysis published in Fortune ( see here ) makes a strong case for many employers to do just that."If you like your health care plan you can keep it"). Note to the leaders at AMA and ACP -can you say unintended consequences? On one of the other hands,could it be that the plan was to do that all along?

It seems to be a matter of doing the math. For example, the article says ATT now spends about 2.4 billion per year in health care costs and if they drop coverage and pay the penalties they will pay out 600 million.So if companies go that route, who pays for at least some of the cost of the shift to the exchanges.The government does in the form of subsidies which will invalidate the accuracy of the alleged savings from PPACA which has already been shown to be a bogus projection.

Did the brilliant planners in the administration and congress not see this coming or maybe that was the plan all along.Was the plan really to get employers out of the health care insurance business and move everyone over to the exchanges wherein insurance companies can be made to fail by the government setting the rates too low and and coverages too broad and then coming to the rescue with a single payer which is what Obama said he wanted all

Dr. Paul Hsieh makes the case here for a scenario in which the health care insurers tank and the government rides in and saves the day.

Friday, May 14, 2010

When you see how IPAB will cut costs, you will want to thank AMA and ACP for their roles in support of PPACA

Yes, the tittle is sarcastic. Go here to read a clear explanation of how exactly the Independent Payment Advisory Board (IPAB) will limit Medicare costs. In a nutshell, Medicare will reimburse physicians and other providers less. The bill is structured so that is about all it can do.

With more stringent price controls that IPAB will generate we will see an even more critical shortage of primary care physicians and a further decrease in quality of primary care. Did anyone at AMA or ACP read that part of the bill?

Another well recognized effect of wage-price controls is the development of a black market which we have not seen so far in health care but see here for how that might play out.

It gets even worse because the IPAB will also through administrative actions of the HHS secretary act to control the rise of private medical costs not just those controlled by CMS.See here.

H/T to John Goodman's blog ( see here ) which is a seemingly inexhaustible source of important information regarding health care economics and the effects we can expect from Obamacare.

Tuesday, May 04, 2010

Important series of blog posts on Individual prerogative to purchase health care

Earlier I had cited the first in a series of posts by DrRich of the Covert Rationing Blog concerning the issue of
of the future of the right of an individual to purchase his own health care. See here for the fourth and final post from which one can link to the first three.

In light of the numerous reassurances that PPACA is not a government take over and that one's access to medical care will not be limited it is enlightening to think back to 1965 and the Medicare law which clearly stated :

....that nothing in the new law “shall be construed to preclude [an individual] from purchasing or otherwise securing protection against the cost of any health services.”

DrRich then describes in detail the limitations contained with the Medicare system that already restrict private arrangements between Medicare patients and physicians who participate in Medicare.Understand this mean limitations on the individual to purchase certain medical test or treatments or procedures. I quote


... amendment to the Balanced Budget Act of 1997 - Section 4507 - which prohibited any self-pay contracts whatsoever between Medicare patients and their doctors for medical services which are covered under Medicare. Under Section 4507, which is still the law today, if a doctor provides even one self-pay medical service to a single Medicare patient, that doctor is punished by complete banishment from the Medicare program for at least two years.

The entire four part series is important and I urge followers of this blog to read it and take part in the discussion.