Thursday, September 30, 2010

Dr. Don Berwick addresses leaders of ACP, Tells them top-down government mandates won't work

Some would find that headline hard to believe. I do.While I believe the message I am surprised by the messenger.

It is hard to believe that the head of large government entity (CMS), which is noted for its top down mandates would express such a view. It is hard to believe that someone who heaped praise on the British National Health Service,also well known for its well known history of mandates, would hold such a view.

It is hard to believe that someone who has said that a health care system must,he emphasized the word "must", involve redistribution would say that. To achieve redistribution there must,now I emphasize the word "must", involve government mandates.

Berwick's address to the American College of Physicians Board of Governors was discussed in a blog entry by Bob Doherty,ACP's man in Washington, in his blog "The ACP Advocate Blog" See here for that entry.

There is much in Dr. Berwick's writings that strongly suggests his high regard for "rules with authority" and low opinion for the traditional doctor-patient relationship . The following is a quote from the book,"New Rules" which he co-authored with Dr. Troyen Brennan.

"Today, this isolated relationship is no longer tenable or possible… Traditional medical ethics, based on the doctor-patient dyad must be reformulated to fit the new mold of the delivery of health care...Regulation must evolve. Regulating for improved medical care involves designing appropriate rules with authority...Health care is being rationalized through critical pathways and guidelines. The
primary function of regulation in health care, especially as it affects the quality of medical care, is to constrain decentralized individualized decision making.”

He advocates regulation,rules with authority, constraint of individualized decision making and reformulating medical ethics. Clinical decisions, in this view, should not be in the hands of the patient and his physician. These views are clearly those of someone who believes in authoritative control over those clinical decisions, so if he believes that government top down rules won't work then he must envision some other,non-governmental system of controls.

Indeed, he has talked about vertically integrated medical systems which can seek out cost effective treatments and coordinate care referring to such things as accountable care organizations,and medical homes.So could he possibly think that they will be the source of the mandates rather than the federal government? The promotion of such organizations was a major theme of a recent article in the Annals of Internal Medicine by three member of the current White House staff which I blogged about here.

With the passage of the health care remake bill and the birth of scores of federal entities with the power to issue mandates and the unprecedented power given to the secretary of HHS to make mandates what else could possible happen but that medicine as it will be practiced will be medicine by federal mandate?

Mr. Doherty's interpretation of what Dr. Berwick has written is that Berwick believes that change must come from the bottom up. It is true that Dr. Berwick has earned an excellent reputation for working towards and catalyzing grass roots innovations to improve patient care and much of his rhetoric is consistent with that effort and promotion of that idea.

However, he is not leading a organization devoted to grass roots solutions but rather one whose history and thrust and machinery has and will continue to issue and enforce orders from the top.

Have we heard from Dr. Berwick any plans to dismantle the current CMS system of command and control?What will be the relationship of these vertical organizations to the central control systems of CMS and those created by the health care bill? Will they be the administrative arms of the central controllers?

Whatever vertically integrated entities emerge and regardless of the relationship of the accountable care-type organizations to the government particularly troubling to me is that the "bottom" of Berwick's bottom up solutions is not all the way down, namely to the level of the individual patient and the individual doctor as he has made it clear that the traditional doctor-patient relationship needs to be replaced."This relationship is no longer tenable or possible".

It is hard to say it better and simpler than the following questions posed by Dr. Edmund D. Pellegrino (JAMA,May 24/31/1995,Vol. 272,no 20)

" Is medical ethics a social, historical, or economic artifact? Or are there some universal , enduring principles?

Was the traditional physician-patient relationship with the strong and controlling fiduciary duty to the patient's welfare merely an artifact of an earlier economic time which was largely free of the third party payer hegemony? Fee-for-service and the traditional physician fiduciary duty are the two major enemies to centralized (private or public) control over medical care.

Monday, September 27, 2010

Avandia just barely hanging on and now Actos accused of increasing risk of bladder cancer

The TDZ's seem always to be in the news,the bad news. First, Rezulin was taken off the market because of liver toxicity.Next, the issue of Avandia increasing the risk of heart attack arose and arose and arose and seemingly the issue will never be settled. Now Actos is being accused of increasing the risk of bladder cancer.

Most recently the FDA has taken action to strictly limit its use and make it fairly difficult for a new patient to be prescribed that drug. In Europe, apparently it will be taken off the market and folks currently taking that medication will have to be switched to something else.

An interesting action taken by the FDA is to require GSK to commission an independent "re-adjudication" of the RECORD study. This was the clinical trial with 4447 patients in which rosiglitazone (Avandia) was compared with the combination of metformin and a sulfonylurea and concluded that results was inconclusive in regard to what everyone was interested, namely cardiovascular outcomes. Somehow the FDA expects more analysts looking at the data will turn the inconclusiveness into some conclusions. More likely it won't but then maybe everyone can move on and worry about some other adverse effect of something else.

FDA's reasoning seems to be that if these new adjudicators can get an answer then the TIDE trial ( still another trial that the optimists think will settle the issue) will not have to be taken off of hold. The FDA put TIDE on full clinical hold.

Several years ago when one attended the infomercials with food ( AKA drug company sponsored CME -dinners) several speakers could talk about little else but the PPAR receptors and after much time and money was aimed at doing something really good therapeutically with those receptors little was accomplished. See here for some comments by a research insider about the PPAR story.

Early on in the Avandia kerfuffle I went on and on about the issue of "small"increases in relative risk and how is relatively easy to tell a big thing from a little thing but how difficult it is for epidemiology to tell a little thing from nothing at all. The original Nissen and Wolski paper talks about a relative risk of 1.43. With risks of 3 and 4 there is typically little to argue about. With RRs less than 2 it seems we go round and round for a long time before the combatants run out of stream.

Thursday, September 23, 2010

What is fate of physician-patient relationship in a Don Berwick designed health care system ?

The following quote from the book Dr. Berwick authored with Dr. Troyen A. Brennan,which is frighteningly entitled , "New Rules" answers the headline question. (see here for a review of that book published in the NEJM)

H/T to the blog " Black Ribbon Project"

“Today, this isolated relationship is no longer tenable or possible… Traditional medical ethics, based on the doctor-patient dyad must be reformulated to fit the new mold of the delivery of health care...Regulation must evolve. Regulating for improved medical care involves designing appropriate rules with authority...Health care is being rationalized through critical pathways and guidelines. The primary function of regulation in health care, especially as it affects the quality of medical care, is to constrain decentralized, individualized decision making.”

I have expressed my concern abut Dr. Berwick views before and one such commentary was re-e-published by Kevin,M.D. with my permission. One of the replies to that entry on his web site accused me of taking his remarks " out of context". While it is true that remarks and words and phrases can be cherry picked to give an impression contrary to the speaker's intentions I offer a friendly, rhetorical challenge to anyone who can propose a context in which Berwick's words could be said and not mean anything other than their obvious meaning. OK, I can think of one and it is trivial. The author precedes that paragraph with the words "I do not believe the following".

Berwick's and Brennan's views dovetail with the ground work constructed by the "New Professionalism" (see here for the details of that project ) which implores physicians to somehow balance their duty the patient with some nebulous responsibility of stewardship to take proper care of society's limited medical resources and strive for social justice. Dr. Troyen Brennan was the chair of the Professionalism project. In fact Dr. Brennan name crops up more than once in a narrative of the transformation of medicine in which medical care is taken from the hands of individual physician and into the control of various organizations.

In 2002, Dr. Brennan's new Professionalism was revealed to the world in the Annals of Internal Medicine ( see the above link). (OK, it wasn't just Brennan's,others played a role.)Physicians were admonished to work for the good of society and not just be concerned with the parochial concern for their own patients.

In 2006 Brennan and Berwick published the book, "New Rules". The operative word is "rules".

In an Article in 2007 (JAMA,Vol 208,#6,p 670) Drs J. Cohen, ,S. Cruess, and C. Davidson report their " discovery " that individual docs basically could not resolve the ethical dilemma posed by balancing their efforts for the patient's welfare with their duty to work for the good of the herd. ( see here for my comments on that article) What was needed was a "Medical Societal alliance" which could be made manifest through large vertically integrated organization such as something called an "Accountable care organization (ACO). Note, the old medical ethics had no major, crisis -level conflicts it was the New Ethics that posed the problem that the author purport to remedy with their nebulous alliance between collective abstractions.

Another article in JAMA in 2007 carried this theme further. The article was written by the then President of the American College of Physicians, Dr. Christine K. Cassel and the then executive vice-president of Aetna Insurance, Dr. Brennan. (JAMA ,June 13, 2007, Vol 297, no. 22, p. 2518, "Managing Medical resources.Return to the Commons")

They speak of an abstract hypothetical " medical commons" and how the current emphasis by the physician on the welfare of the individual patient will spoil the commons much as the farmer who selfishly grazes his cattle on public land without regard for depleting the resource will destroy the resource.Physicians are implored to "reconstitute the medical commons" and think in terms of resource conservation and allocation so at the end the greatest medical good can be done for the greatest number of patients.They admit there is not currently such a commons. There never has been so I am unsure how a return is possible.

The medical commons figure of speech seems bizarre and lame.While a grassy knoll for the villager's sheep can be defined by a specific surveyor description, the "medical commons" is a extremely large amorphous array,the elements of which defy enumeration, and is every changing, with some elements growing ,others contracting and innovations cropping up constantly. Various entities own various elements of this array-society owns none.The skills,and knowledge of thousands of physicians are aggregated and then allocated as if somehow society own them.There is no easily defined entity called "medical resources". Rather,it is an amorphous abstraction.Further, to speak of allocation means some one or some elite group will be the "allocator in chief ". Decisions will not be made by thousands of individual physician-patient pairs, since those individual physician-patient pairs plans to spend money are the worse nightmare an officer of a health care insurance company could have. Is anyone surprised that an officer on a large medical insurance company would propose a plan to eliminate the pesky problem of physician-patient "dyads" scheming to spend the insurance company's money simply because the two agreed such expenditure would be in the patient's interest?

The old follow-the-money strategy continues to have explanatory power. but why would the leadership of the ACP take part in that philosophical sham?

Friday, September 10, 2010

Is more primary care really not the answer to all that ails U.S. medicine after all?

A recent WSJ article reports a Dartmouth Atlas study (DA study) that seems to cast at least a little doubt on the thesis that the key to good health care is lots of primary care docs. See here. See here for a more detailed discussion from the blog ACP Internist about the findings of the DA article.

So ,why are the indicators of good care used by the Dartmouth folks not better in an area where more primary doctors are available? The authors make several suggestions? I offer another. Maybe use of aggregate data often makes things less rather than more clear. A similar argument has been raised by some economists in their criticism of the major role of aggregate demand in Keynesian economics namely that the aggregation obscures more than it clarifies.

OR maybe the indicators purported to be of quality care are little more than something chosen because it was easy to measure and the data were available.

I think the real bottom line in regard to this Dartmouth publication is found in the authors' hypothesis that perhaps primary care is really the answer to much of what ails medicine only if that primary care is integrated into a larger system of other health care providers. This is the it-takes-a-village-to- provide -health- care type thinking. Can you say Accountable Care Organization (ACO)?

For the centrally managed health care that Obamacare portends to succeed at least one obstacle has to be overcome. That obstacle is the thousands of individual primary care docs out there practicing outside of the control of an organization such as an HMO,giant clinic or ACO. The Dartmouth publication could be part of a emerging argument similar to that put forth in a recent article in the Annals of Internal Medicine written by members of the administration urging physicians to get on board with the [Obamacare] program. See Dr. Rich's recent commentary about that article and what the message of that was.

What follows is a quote from the White House authored Annals Internal Medicine Study followed by a quote from one of the authors of the DA study.

"These reforms will unleash forces that favor integration across the continuum of care. Some organizing function will need to be developed to track quality measures, account for and manage shared financial incentives, and oversee care coordination…"

"Our findings suggest that the nation's primary care deficit won't be solved by simply increasing access to primary care, either by boosting the number of primary care physicians in an area or by ensuring that most patients have better insurance coverage," said David C. Goodman, MD, MS, lead author and co-principal investigator for the Dartmouth Atlas Project. "Policy should also focus on improving the actual services primary care clinicians provide and making sure their efforts are coordinated with those of other providers, including specialists, nurses and hospitals."

So, an "organizing function" is needed and someone/ something needs to make sure efforts are coordinated.

The message is that medical care is too important,too complicated, too whatever to be left to the individual patient and his physician.

Here is an earlier quote from the DA folks from there website.

"The availability of excellent primary care is central to high performing health care and favorable patient outcomes. Unfortunately in many regions of the country, residents cannot find the care they want and need."

Attorneys like to find expert witnesses making apparent contradictory statements so they can ask the old classic: Were you wrong then or are you wrong now?

Wednesday, September 08, 2010

Annals Internal Medicine publishes Obamacare advocacy commentary -I am shocked,shocked

The Annals of Internal Medicine published an article ( see here for full text) authored by three current or former members of the Obama administration .It is difficult to consider it anything other than advocacy for the health care law ( The bill is now generally known as ACA or Affordable Care Act.) The article, first appearing on line, lead to a flurry of negative comments from readers See here.

The authors are: Dr.Ezekial Emanuel,brother of Rahm Emanuel who is President Obama's chief of staff,Nancy-Ann Deparle ,Counselor to the President, and Dr. Robert Kocher. Kocher who recently resigned from the President's Council of Economic Advisers to return to the McKenzie group, was the lead author.

The article begin with this incredible statement, " It guarantees access to health care to all Americans."

However, it is well recognized "all" will not be covered. There is a group of people too prosperous for Medicaid but who are not required to buy insurance because their income is too low to trigger the mandatory insurance purchase mandate.This has been well covered even in the mainstream press so it is difficult to imagine that Dr. Kocher and his co-authors were not aware of that fact.The Congressional Budget Office estimates 17 million Americans would remain uninsured.

Dr. Kocher joined (and is now departed from) the President's National Economic Council after having lead a team from the business consultant company, the Mckensey Group, to study health care systems in various countries.See here for the publication co- authored by Kocher.

The attribution section of the Annals article ( the part that explained which author did what in the preparation of the article) makes it clear that the principle author was Dr. Kocher., who since the Mckensey article, is considered an "expert" in health care cost and cost controls.

A recent town hall meeting between voters and Senator Max Baucus lead to an exchange in which the senator told the audience that he had not read the health care bill and that was left to the experts.

Said Baucus: "I don't think you want me to waste my time to read every page of the health care bill. You know why? It's statutory language. We hire experts."

From the glaring factual error in the Annals article it seems that at least one expert hasn't read the bill either.