Tuesday, April 29, 2008

"Free" pizzza may be gone for students and house staff but speaker's bureaus may be another matter

Go here to read the NYT article on the recent statement made by the Association of Medical Colleges.

The Association seems adamant when it states ""drug and medical device companies should be banned from offering free food, gifts, travel and ghost-writing services to doctors, staff and students."

However, in regard to the sometimes lucrative and sometimes very lucrative speaker's bureaus a somewhat weaker statement emerges;

...medical schools should 'strongly discourage participation by their faculty in industry-sponsored speakers’ bureaus,' in which doctors are paid to promote the benefits of drugs and devices."

On the one hand, banning on the other discouragement.

Dr. Robert Alpern, Yale's Medical School dean, is quoted by the NYT as saying :

“I don’t have a problem with doctors making $3,000 or $5,000 a year on the side, but it’s a totally different thing when it’s $80,000,” he said. Even more distasteful, Dr. Alpern said, is that the slides used in many of these presentations are created by drug makers, not the speakers."

Is he really saying it is ok to be a "ghost speaker" (Alpern's term) if you don't get paid too much?
(We have already determined what you are, Madam, we are just negotiating the price now.)

Dr.Carlat believes we are entering a new era which he labels "post deceptive" Dr. Wes is less impressed.

Dr. Howard Brody who has had much to say about this general issue makes these comments.

My non-insider take is that there will be a flurry of high profile (within the institutions at least) announcements of "no more free lunches" and much self congratulation and talk of professionalism but somehow I doubt the faculty will give up the lucrative lecture gigs although a veneer of word smithed propriety and oversight will be grafted onto it.

Monday, April 28, 2008

The FDA and "Regulatory Capture"

Dr. Howard Brody in his bog, Hooked: Ethics,Medicine and Pharma, hits another home run.

As explained in HOOKED, this shows the ambivalent relationship that is set up by the phenomenon of "regulatory capture" of a Federal agency by the industry it is supposed to regulate. The drug companies are walking a very fine line. They want the FDA to be rendered sufficiently toothless as to be unable to take any actions that cause any inconvenience or lowered profits for them. But at the same time they want the FDA to appear powerful and threatening enough so that they can turn around and blame the FDA oversight process whenever a scandal arises like tainted Chinese-made heparin. Ditto for the present efforts of the industry to support FDA rules changes that would allow companies to market drugs off-label by circulating reprints from medical journals (based on the assumption that the FDA stringently regulates this process so that no false information could ever get through), and to convince the U.S. Supreme Court that they should be shielded from any legal liability in relation to any drug that has been FDA approved (again assuming that the FDA approval process is so stringent that the public needs no additional safeguards).

The term "regulatory capture" refers to the phenomenon in which a governmental agency ostensibly tasked with acting in the public interest to regulate an industry becomes controlled or dominated by the interests of that industry.This is not so much like authorizing the fox to oversee hen house safety but more like the game warden helping the poachers poach while posturing that they are doing just the opposite. Note- finding a different fox believed to be more concerned with the hen's interests is not likely to change the situation in any meaningful way nor will a more dedicated game warden.

Nobel laureate and Chicago School economist George Stigler is credited with this concept in his Economic Theory of Regulation.

Regulatory capture is one of the mechanisms by which interest groups will use government power and coercion to benefit themselves.

I might quibble with Dr. Brody's characterization stating there is an ambivalent relationship between the drug companies and the FDA. Pharma will act in its interest and will control- to the extent it can manage to do so- the FDA's actions, nothing very ambivalent about that as that is the tendency for all such "regulated" industries.

There have been suggestions as to ways to "strengthen" the FDA and at least move to escape from this capture but I am pessimistic.

Thomas Sowell has suggested when you try and understand why a government agency acts the way it does, do not bother with their mission statement but rather consider the incentives and constraints within which it operatives and the feedback it receives. Combine that with the "follow the money rule" and you will likely come up with some useful insights.

Tuesday, April 22, 2008

Who will sing for me?

The WSJ 's medical health blog talks about general surgeon being the primary care docs for surgery and echoes the thoughts of several bloggers ( see here ) for one who inform us that the ranks of the general surgeon is decreasing much as the primary care docs are seeing refuge elsewhere and for much the same reasons.

Back in day when I was an internist in training we thought about the general surgeon as the other group of "real docs",we internists were the really real docs, all jokes about surgeons notwithstanding.OK, we should have included peds but I think we meant that when someone was "really sick" you would need an internist or a surgeon or both. They would take care of the horrible surgical abdomen patients regardless of what the cause.Perforated bowel, leaking aneurysm,gall bladder, ruptured appendix-all were within their area of expertise. In the strange now forgotten "system" under which we trained the first year medical resident was called to evaluate patients in the area of the hospital that was sort of an ER and sort of a triage out patient area. From time to time there would be a dispute as to whether the patients was "surgical" or "medical". In some of that encounters I would find myself completely out manned facing off with a senior surgery resident who had by that time endured some 4 or 5 years of post MD degree rigorous surgical training. I still admire the skill , confidence and medical expertise of those folks and what they went through to obtain that experience and expertise as I did in practice when I called a general surgeon at 2:00 am .

Fewer freshly minted internists go on to do primary care as more and more become sub-specialists or hospitalists and fewer rookie surgeons go on to do general surgery as more and more do sub-specialty fellowships. Money,control of one's practice and "life style" concerns appear to be the major culprit drivers in this shift as third party payers continue to squeeze the purses and tighten the controls and drain the joy out of being a physician.

I think back attending sick patients and calling in a general surgeon to help sort it out (and sometimes fix it and often follow the patient with me though an often complicated and challenging course in the hospital) and wonder who will be available to play those roles should I be on the other end of the stethoscope and knife. Emmylou Harris's song comes to mind.

Monday, April 21, 2008

Latest we-won't-pay proposal from CMS-Silly is too weak a word

The latest proposal from CMS to not pay for treatment of certain conditions appears to demonstrate evidence of such an outstanding ignorance of medicine that it is difficult to find words strong enough to characterize them. These conditions are referred to as " hospital acquired conditions" that are "reasonably preventable through the applications of evidence based guidelines" This are beyond absurd. The actions taken by hospitals to live with this rule (if it is finally approved and becomes a rule) will elevate the concept of unintended consequences to new heights.

Here is press release and here you can find comments by Dr. Roy Poses.

DVT/PE ( deep vein thrombosis/pulmonary embolism) is one such condition. There is no prophylaxis that lowers the attack rate to zero or close to zero. The heparins and warfarin and other non pharmacological preventive measures have not been shown to regularly achieve reductions to less than 10-20%% incidence and in a number of studies studies the treatment arm of a number of randomized trials with various anticoagulants may be as high as 25% to 40%. (for example the 1996 study from several institutions in Canada by J.R. Leclerc reported an incidence of DVT in 36.9% of knee replacement patients receiving fixed dose enoxaparin.See here for details.) If you do hip surgery, knee replacements, spine surgery, or neurosurgery you will have patients with DVTs in spite of the best preventive measure known to man.

Delirium is another event CMS seems to believe that can be totally prevented in hospitalized patients. Dr. Poses discusses the lack of evidence for any really effective preventive measure for this common complication of the elderly who become ill whether or not they are in a hospital.

Ventilator acquired pneumonia is another candidate condition. Again zero incidence is beyond what current knowledge and techniques can achieve.

What is going on when a government agency demands the impossible? What is going on when well meaning professionals attempt to do it? And you know they will. How long was the list of hospitals that refused to play along with the four-hour pneumonia rule?

Is it possible that a government agency charged with payment for medical services for millions of people could be so ignorant of fairly simple medical facts? Are there no folks there who know enough to say "wait, these things cannot be entirely prevented"? At least two medical bloggers suggest what is really going on with this absurd recommendation. Their comments can be found here and here. If it is about quality, we are in trouble with outrageous non-reality based proposals. If it really about saving money and rationing care while pretending to do something else it is another frightening chapter in the play book of covert rationing as explicated by DrRich.

Monday, April 14, 2008

When a measurement becomes a target, it is no longer a valid measurment

The title of this essay is one version of an insightful observation made by various people in a variety of settings .

The first time I became aware of that general thought was when I read about the Westinghouse Effect which is that the observation of an event is influenced by the act of observation.

Two eponymous designations refer to formulations that expand that concept and give it more useful meaning; Goodhart's Law and the Lucas critique. These have important implications in this era of hyperplastic medical guidelines, pay for performance, quality measures which pretend to measure the unmeasurable and the cookbookization of primary care medicine.

Charles Goodhart was an economist in Great Britain who expressed the following thought:

Once a measure is made a target for the purpose of conducting policy, it will loose the information content that would qualify it to play such a role.

A medical example is the four-hour pneumonia rule. There are data indicating that those pneumonia patients who received antibiotics within some several hour time frame did better that those whose antibiotics were delayed. This even conforms with common medical sense-a patient with a serious infection requiring antibiotics should do better getting the medication sooner rather than later. So promptness of delivery antibiotics was considered to be a measure of quality and then became a target. Once a target, ER personnel seemed to have treated towards this target and later we learned that one unintended consequence was some not insignificant number of patients were given antibiotics within the magic time frame but did not have pneumonia at all.

This line of thought was developed further by another economist and Nobel prize laureate, Robert Lucas.

Lucas said it was naive to think one could predict the effect of a policy purely based on aggregated historical data. An example might be the data suggesting promptness of treatment influenced pneumonia outcomes.To predict the outcome of a policy change one has to consider how individuals are likely to behave given the change.

To predict the effect of a policy change (rewarding 4 hr treatment for example) you need to consider the constraints the players operate under and basic human nature.Outcomes may change ( even if those outcomes are not measured) when policy ( or rules of the game) is changed.The effort to meet some deadline that folks are graded on may well take away efforts to provide necessary timely care for other patients not currently covered by some quality rule and target.In the era before the imposition of the four hour rule, promptness of antibiotic administration may have been one of a number of indicators of a good general care. Once it became a target it lost its value as an indicator of quality even though now it was considered to be an official indicator of quality.

This general theme was discussed recently by the Management editor of The Guardian.See here.

He offers this example also from the medical world having introduced a concept analogous to Gresham's Law, bad measurements drive out good ones.

What happens when bad measures drive out good is strikingly described in an article in the current Economic Journal. Investigating the effects of competition in the NHS, Carol Propper and her colleagues made an extraordinary discovery. Under competition, hospitals improved their patient waiting times. At the same time, the death-rate following emergency heart-attack admissions substantially increased. Why? As targets, waiting times were and are measured (and what gets measured gets managed, right?). Emergency heart-attack deaths were not tracked and therefore not managed. Even though no one would argue that the trade-off - shorter waiting times but more deaths - was anything but a travesty of NHS purpose, that's what the choice of measure produced.

At the risk of underlining something too much-the point is that measurements loose their value as measurements once they become targets and that does not depend on the original validity of the measure. It can be a great measure, but it is ruined when it become a target. So the answer is not to get better measures much as the answer to bad government is not to replace the officials with better ones.

Goodhart and others made this observation some time ago but fortunately we in medicine were- for quite a while- spared the pain of seeing it first hand in our practices.

Tuesday, April 08, 2008

Are hospitalists to be the change agents for universal medical coverage?

Some would argue that various economic forces coalesced to animate and catalyze the hospitalist movement. This report from the national hospitalist meeting would indicate that Dr. Berwick,of safety fame has lofty goals for the nation's hospitalists whatever the "follow-the-money" reasons may have been for their birth.

Delivering the first keynote address at the meeting of the Society of Hospital Medicine (SHM)Dr. Berwick speaks of the need for a financial management system, public health initiative and universal access to medical care. He would have hospitalists as the integrators of this new system focusing their boundless energy on what he call the triple aims which are:

1)the experience of care (safety and quality)
2)the per capita cost of care,
3)population health

I would hope that my hospitalist will provide good care ( o.k., call it high quality and we certainly hope it is safe-remember first do no harm.) And I hope the second aim won't trump the first. I wonder when she will have time to also fix- or at least improve- population health.

I imagine that many internists choose the hospitalist role because it provided an opportunity to spend much of their professional time doing what they were mainly trained to do-take care of complex,complicated, very sick patients-while having regular hours,no call and relative to what internists incomes have become a fairly good income. Dr. Berwick would like to task them to do much more than "simply" take the best care they know how for each individual patient and to act primarily in the interest of the patient; he wants hospitalists working for the common good. Will the number 2 and number 3 goals above conflict with the primary fiduciary duty of the physician to his patient?

Pleas and exhortations to work for the greater good and eschew one's own interests for a greater interests somehow never really change human nature or reality. The reality is that after you put in your shift at the hospital and devote as much time as many do in their off hours to trying to keep up with the medical literature there may be little time or energy left to rebuilt the system in Dr. Berwick's or anyone else's vision.

Tuesday, April 01, 2008

Survey indicates majority of physicians favor universal coverage-but what kind?

A recent survey claims that more than 50% of physicians (over 80% of psychiatrists for some reason) indicated they favor universal medical coverage. The research is in the April Issue of the Annals of Internal Medicine-subscription required

I believe-with no survey to support the claim-that many would say they would opt for
universal coverage because they believe or hope that almost anything would be better than the morass of increasingly impossible to deal with nonsense with the the third party payers.

However, a key point ignored in the survey is what is meant by universal coverage.
Such programs can vary on a number on dimensions but the most important in may opinion is will the patients be allowed to seek care outside of the system or seek more care than the basic coverage of the system provides. If not, we would have a system much like that in Canada or if such freedom would not be crushed then perhaps a system more like Great Britain or France.

How many physicians would favor a universal coverage system of the Canadian type?

DrRich discusses this important issue here.

He makes the important distinction between equality of access and equality of outcomes-choosing between autonomy and equality of outcomes.

...universal healthcare does not necessarily preclude individuals from supplementing publicly-funded services with their own resources. To achieve equal access to all healthcare services (and not just the services that are publicly-funded), we would have to actively restrict individuals from exercising their rights of individual autonomy.

[With the Canadian type system] we would be denying individuals the right to spend their own money on their own health....

...it is beyond disturbing that we seem ready to abandon our foundational principle, especially since it will be for no good reason. We would be empowering our government to abridge our personal liberties, all in a vain attempt to achieve something that our founders recognized could never be achieved and should not be sought - an equality of outcomes .

Yes,way beyond disturbing.