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.

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.

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.

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.

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.

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.

U.S. Health Care -counterpoint to Krugman and Moore from Cato

If you read Paul Krugman and look at what Michael Moore has to offer concerning the relative merits of various countries health care systems (or in our case "non-system") you might begin pricing air fare offers to Croatia.

Before you pack your bags, take the time to read the analysis offered by the Cato Institutes's Michael Tanner and you might conclude things are relatively not as bad as you may conclude from Krugman's writings and the medical grass in rest of the world may be less green than depicted by Mr. Moore.

The author begins by pointing out the obvious-yes, the U.S.spends more on health care but that is not necessarily bad. If fact, some would say it is good and a sign we are an affluent country and are able to spend more on folk's health care than many less money challenged countries. His discussion on the vagaries and tricks and technical considerations in regard to using life expectancy and infant mortality will show that use of the those indicators has been misleading in some the widely quoted comparison studies in which the U.S. is relegated to implausibly low ordinal rankings. In view of his arguments, the assertion that the U.S. spends more and yet still has lower life expectancy looses credibility. Life expectancy varies significantly between certain states in this country even though both have the same "system". If one takes into account homicides and fatal car crashes ( areas where the U.S. unfortunately does lead the pack) the U.S. life expectancy is close to the top of the list.

If there is one simple message from Tanner's article ( there are actually a number) it is there is no free lunch. The medical utopia of which Moore talks about doesn't exist anywhere. Many countries are finding that some system of co-payments and deductibles need to be in place to mitigate the escalating costs that are occurring everywhere-rising costs are not unique to the U.S. Many are shifting to some degree of market mechanism cost control (aka- another form of rationing) while in this country the major rhetorical thrusts seem to advocate the opposite ( universal mandatory coverage and government boards to determine what is necessary care).

Physicians (or just folks with MD degrees) and product promotion

The Jarvik-Lipitor ads have disappeared from TV but the larger issue of physicians promoting certain products or services has attracted the interest-among others-of two straight-talking medical bloggers.

Dr, Howard Brody,director of the University of Texas Medical Branch (Galveston) Institute for the Medical Humanities makes his views clear and is quoted in an article in the March 24, 2008 issue of American Medical News. His blog is here.

What is a doctor doing putting money in his or her pocket,shilling for a product?..There is no positive reason for doing such a thing.

Dr. Roy Poses of the blog Health Care Renewal is also makes his views very clear when he states:

I wouldn't do it.

He argues that an endorsement could induce bias in in favor of a product when it is not in the best interest of the patient.

Arthur L. Caplan of the University of Pennsylvania Bioethics Center offers a more morally relativistic position: I might urge someone to think twice about it, but I can understand they may choose to do it.


The AMA "ethical guidelines" offers another tepid general statement saying that physicians are free to promote their services in what form they see fit but do not mislead or deceive.

I can remember a quaint era when physicians did not advertise at all and I seem to have a foggy memory of a time when internists also did not offer cosmetic procedures in their offices,sell vitamins or skin care products, actually attended their sick patients in the hospital after attending them as an outpatient, spent more time treating their patients than treating their chart in an effort to squeeze the best payment by performing the most clever coding and placating the latest pseudo-quality, documentation initiative and did not relegate their patient's care to "mid-level" practitioners or their call to triage nurses or a telephone answering machine and the default strategy of sending everyone to the ER.

Dr.Rich has spoken of a decline in the pride and ethics of physicians and I have echoed that notion. There is much to suggest a loss of pride and ethics but with the continuing straight talk that call our attention to matters that are wrong and things about which we should express outrage from physicians such as Dr. Poses and Dr. Brody you have to be hopeful that if you keep fighting the good fight there is at least a chance of winning.

More concern re: oral phosphate solutions and kidney damage

The PEG solutions that have been widely used for colon cleansing for colonoscopy are very effective but are also widely unpopular with patients. The times I have used it I began gagging a bit long before the giant bottle was emptied. The oral phosphate compounds seemed to offer an improvement as the volume burden was less and the taste arguably a little bit better.

However reports surfaced on renal damage for some using the oral phosphates and accordingly the FDA issued a warning with particular concern expressed regarding those patients who were using certain blood pressure pills, namely the ACEi and the ARBs.

Now we have a recent retrospective report from the Scott and White Clinic in Texas which tends to reinforce the concern. The authors conclude:

Oral sodium phosphate solution preparation is associated with decline in GFR in elderly patients with creatinine levels in the normal range. Its routine use for elective and screening procedures should be discouraged in the elderly population.

I agree- the PEG solutions are safer.

Dr. Rob -Health Care is not a system-so how will the medical home work?

The latest entry by Dr. Rob puts forth the notion that various advocates for medical care change ( single payer advocates or let the market have at it) tend to talk about a system and there is no system. There are multiple independent or variably dependent entities typically working in ignorance or purposeful disregard of the other's actions and influences and do their various jobs in often what is a myopic, self contained sphere of activity that sometimes only incidentally benefits either the patient of the health care provider ( forgive me for the designation) and too often does little good for either.He gives us a revealing thumb nail sketch of many of the players ( primary care docs, ERs, specialist, medical insurers, etc) that hits many nails on the heads. Whatever you can say about health care in the this county you cannot say it is coordinated.

All of this seems so obvious that I continue to fail to see how the increasingly hyped ACP version of the "Medical Home" would work wherein somehow the primary care doc (an internist if you go along with the ACP-United Health Care version of this latest dressed up P4P) would somehow accept responsibility for the comprehensive care of the patient. As long as the patient has the freedom to see whomever for whatever ( e.g. a orthopedist for his swollen knee who then sends him off for a MRI and PT outside of the watchful,comprehensive caring eye of the homie) the medical home doc cannot control the situation and therefore cannot reap the benefits of controlling cost, in the absence of which United HealthGroup would not be a player to begin with. It is looking more and more like a HMO-oid situation with a touch of P4P thrown in , significant restrictions on what the patients- and the doc - can do, plus a dollop of electronic records and a giant heaping of guidelines which will be more toothy than guidelines and a lovely icing of "continuous quality improvement" verbiage to suck in the corporate employer clients.

It does seem to be getting some traction as discussed in this latest press release from ACP which brags about recent grants received from Pfizer and others to study and implement the medical home plan.

The UHF and Pfizer grants, in addition to a grant awarded to ACP by the Commonwealth Fund in late 2007, will help ACP continue the design and implementation of practice-based resources for internists and their office teams. ACP Executive Vice President and Chief Executive Officer John Tooker, FACP, said the grants are an indication of how the model of care could be here to stay. “The patient-centered medical home, in coordination with the other components of the health care delivery system, is the future of health care,” he said.

Spiriva and Stroke-FDA's warning may be too much (or too soon) information

As best I could tell, wading through the big-pharma disseminated information and infomercials and what also sounded reasonable, and with a desire to try and make COPD patients breath a little better, Spriva (tiopropium) seemed a worthwhile improvement over the then available other medication in that category for the treatment of COPD. Once a day is better than twice a day if only for the fact that folks are more likely to use the medications as intended. Its anticholinergic ancestor, ipratropium or Atrovent was taken twice a day.

Now we are warned about possible an increase risk of stroke in Spiriva users. Dr. Matthew Mintz in his blog give us a good perspective of this breaking news and gives a good explanation of what sort of data the FDA looked at and what information is likely to come down the pike in a reasonably short length of time that might mitigate the worry generated by what might be described "as too much information" or at least maybe "too soon information". Data from a 4 year study called "Uplift" is said to be available in June.

A pet ranting topic of mine has been the issue of the small relative risk which I talked about here.

Could the FDA have waited until June to sound the alarms if they needed to at all.With their recent history of Avandia and Vioxx they probably can't win and will get flak whatever course they take. Being an expert is not easy anymore and epidemiology is not for sissies.

Health Care Renewal's take on the good life of some academics

The blog Health Care Renewal discusses the good times had by officials of Southwestern Medical School with funds donated to the school presumably for expressed reasons other than providing the good life for the bosses of the school. He points out the large, gaping disconnect between the mission statement of the school and such activities.

Thomas Sowell has provided his readers many insights as to how things work. He has said that when one wants to understand what is going on with a entity ( governmental agency,academic institution,business) do not expect to be informed by their mission or vision statement but rather by considering the incentives and constraints under which it operates and the feedback it receives.

If the leaders of the medical school received grants that consider to be unrestricted one might expect little in the way of constraints. In this instance the major mechanism of control of conduct may well be the feedback. If you get caught with your hand in the cash register and the local TV station lets folks know about it may be the behavior gets toned down a bit. Hats off to channel 11 in Dallas and to Dr. Poses of HCR for what we can only hope to be some behavior changing light shinning.

More on Health Care Vouchers

Definitely worth reading today is the latest entry by DrRich, who graciously took up my invitation to comment on ( and explain to me) exactly what the deal is with the proposal by Dr. Fuchs and Dr. Emanuel to fix the current health care mess with a voucher system.

In his first of a promised two part series DrRich begins to dissect the concepts underlying the Emanuel-Fuchs proposal. As usual insight-filled stuff.

As a physician and occasionally as a patient I have seen both sides of the "there-really is-a free lunch" thought process. There is no end to profligate spending if you are spending or even think you are spending "some one else's money".

Retired surgeon suggests why the days of the "giants" have passed

I normally do not publish long direct quotes from other bloggers but this one is so nail-on- the -head that I have to. It is from Dr. Sid Schwab of Surgeonsblog as he talks about the change in how medicine is practiced (including the medical and now surgical hospitalists) and the change in its culture with talk of work-life balance, etc.

... I don't doubt there will always be surgeons and primary care docs willing to sacrifice their personal lives in the name of their practices. But the days of the iron men and women are over, and it's happened in the blink of an eye, in a quarter of a generation. I reject that it's because this is the first generation to value life outside of work, or that they're just selfish. The explanation, I think, lies in the changes that have gone before and around them. The profession is under stress in many areas. To maintain income -- at whatever level -- in the face of steadily decreasing reimbursement, docs must work ever harder. They're increasingly bogged down in paperwork and bureaucratic demands, many of which are predicated -- so it feels -- on the notion that a physician is an thoughtless, careless, and incompetent screwup. (Comments on some of my related posts would seem to confirm that apprehension.) Not a week goes by without a notice from the hospital, the insurers, the malpractice carriers announcing the latest requirements for form-filling, order-justification, chart-polishing. Why, the new generation is asking, knock yourself out in such an environment? "Calling" isn't a word you hear much any more. Other than calling for help.

The notion that you were responsible for your patients made more sense when your decisions were respected and not second guessed by a clerk in Ohio with a check list or a pharmacist assistant in Massachusetts. It made more sense when you were not considered guilty of ( fill in the blank- ignorance,wasteful spending,not following whoever's guidelines, or being "disruptive") and had to prove your innocence. And it made more sense, putting it as bluntly as possible,when you made more money. It made more sense when there was a clear cut sense of your job being a profession, one that was very high in the societal pecking order, than it does when a hoard of watch birds are watching you to make sure you do everything to conform with whatever procedures and practices will maximize the profits of the third party payers or the hospital, not to mention the flagrant hypocrisy of dressing it up as quality measures. As prestige tanks so do pride and ethics and it makes more and more sense to go home after your shift and watch your daughter play lacrosse.

I quoted earlier from another blogger (EM Physician-Back Stage Pass) as he talked about the life of a hospitalist. He said in part :

I guess we're finally coming to realization as a group that medicine isn't worth your happiness and sanity. That it's hardly admirable to subject yourself to abuse (by CMS, by DHA, by joint commissions,by society by medicine) and be absent in the lives of your loved one. Maybe when doctors were respected,autonomous and paid well...but now,not as much.

For many physicians,younger and older ones, for the reasons cited above and more
medicine as a calling is " now, not as much".

The randomized trial-more on its limitations-this time from quality movement advocates

Several authors who have spoken out against the move to make certain forms of "alternative" medicine acceptable have recognized that the notion that the randomized trial trumps all other forms of evidence simply does not work in regard to therapeutic systems that are scientifically implausible. Recent articles can be found here and here, When something like homeopathy or Reiki flys in the face of basic scientific principles ,a RCT is not only unnecessary but actually has the potential for mischief as ultimately a false positive will find its way into the literature and being used to justify pure smoke.

In the March 12,2008 issue of JAMA there is a commentary asserting that the randomized trial also may be not the verification mechanism of choice to analyze and verify or falsify complex system changes such as those that are part of the quality movement.

The author, Dr. D M Berwick, CEO and President of the Institute of Healthcare Improvement, has written on this topic before. In this earlier article he relates a brief history of the framework
that has come to be known as evidence based medicine (EBM,) gives appropriate praise for its stellar accomplishments and then asserts that in some regards we may have gone too far.

We have transformed the commitment to "evidence-based medicine" of a particular sort into an intellectual hegemony that can cost us dearly if we do not take stock and modify it. And because peer reviewed publication is the sine qua non of scientific discovery, it is arguably true that hegemony is exercised by the filter imposed by the publication process.

He is saying that the "normative framework for judging the value of evidence " has become so dominant that any evidence adduced outside of the framework may be dismissed out of hand and never see the light of day in publication. For his perspective if a quality project is not validated by a RCT counts for nothing and this he believes is wrong.

Quoting now from the Berwick 's JAMA article;

Many assessment techniques developed in engineering and used in quality improvement-statistical analysis, simulations, and factorial experiments-have more power to inform about mechanisms and contexts than do RCTS, as do ethnography, anthropology, and other qualitative methods.

Some of the authors who have lead the crusade against non-scientific medical treatments (known now as woo) have recognized that the RCT need not be the trump card some believe it to be in the context of therapies that are clearly not scientifically possible. Here the RCT can really only be a false positive. At least some of the quality movements movers and shakers are arguing that in the context of complex quality improvement system changes that reliance on he RCT there will likely lead to false negatives.

While I can agree with a reasonably high degree of confidence that the former position makes sense (i.e. lets don't do any more homeopathy RCTs ) I have no operatinal knowledge about the value or reliability or weaknesses of the other assessment techniques that Berwick advocates. However, I can buy ( and have tried to sell) the notion that the RCT should not trump everything forever and always in assessing evidence in health care matters.Basic science implausibility may trump it at times-as in the woo arena. At others times, basic scientific principles and much everyday experience and common sense should prevail-as in the now overdone example of the parachute trial.

Patients value "thoroughness" in their docs

An article in WebMD discusses a survey from the UK which was published in the Annals of Family Medicine which indicated that the trait that patients value most in their physicians is thoroughness.

This characteristic was more important that friendliness or the doc being on time. It requires time on the physicians part to be considered thorough and to actually be thorough. As medicine continues to be transformed into something increasingly not under the physician's control , less time is spent with the patient.

In my non-scientific analysis of a patient satisfaction questionnaire that was used for a time in my practice I found that the most frequent comment made was in regard to how thorough my examination was. This was not recent and was still in an era in which I could spend time with patients. Interestingly, when I saw my new internist this year ( actually a former partner ) I came away with a much less satisfied feeling that I had the previous year when my former internist (also a former partner) did his exam which I perceived to be much more "thorough".

I remember an article a number of years ago (I cannot find the reference now even with Google) which deconstructed the physical exam "proving" that most aspects of it were a waste of time because each item per se has such a low yield of positive results. Maybe so,but we patients seem to really like the attention or some aspect of it when the doc seems to be thorough. That aspect may be that the physcian seems to care about enough about our problem to take the time to be thorough. The IOM and folks at the ACP like to talk about electronic medical records and team approach to medical care . I may have missed it but I cannot recall either group stressing the importance of taking time with the patient and how the current third party payer hegemony under which most doctors practice make this extremely difficult if not impossible. The retainer practice model in which time may be available looks like a good option for me ( as a patient) and if I still practiced, as a physician.

New ACS colon cancer guidelines-moves CT screening up

The American Cancer society (ACS) has published its latest colon cancer screening guidelines. which can found here.

These are their current testing options:

Flex Sig
Double-contrast barium enema (DC BE)
Colonoscopy
Ct colonography

DC BE appears to be a dying art, the review mentions that as time goes by even fewer and fewer radiologists will be proficient in the procedure. There is little to recommend it ,in my view. The pre procedure purging is a bad as colonoscopy and if a shadow is seen that could be a polyp or mass, colonoscopy has to be done anyway. In the last 7 or 8 years, I have not heard of anyone screened by this procedure except one of my class mates who is a radiologist.

Flex Sig if done to the splenic flexure ( or about the 40 cm. level)at best may be 60 to 70% as sensitive as colonoscopy. However, older patients and Afro-American patients are said to have a higher prevalence of proximal lesions so that in those groups even more cases of colon cancer will be missed. Plus you don't get any Versid.

CT colonography apparently has improved to the point that the ACS panelists have elevated it to prime time. Again as with the DC BE, the prep is as bad as the colonoscopy prep and if there is a positive finding the patient needs a colonoscopy as well.

My view is the bottom line (yeah, I know) is if you want to be screened optimally for colon cancer go with the colonoscopy. I have a bit of a family history of colon cancer and am getting that procedure every five years. The GI folks have tried various preps but the liquid diet for 1-2 days and then Golytely or Nulytely (both contain PEG 3350 and electrolytes) may be best. There is some risk of renal damage from some of the oral sodium phosphate solutions or tablets that were tried for a while in a effort to provide a less onerous bowel cleansing prep and you want to be sure that the endoscopy goes by the one- needle, one- syringe, one- vial one- patient rule which according to a recent report can have disastrous results if ignored.

The above reference from the ACS is very comprehensive and probably will tell you everything you wanted to know about this subject and more.

Bad news,bad news fill medical blogs but ....

In Bob Dylan's "Percy's Song" he writes about bad news coming down. The bad news one reads about in numerous medical blogs might be enough to stimulate SSRI sales ( oh wait, more bad news there too, they may not work but do not worry anti-psychotics may become the next SSRI if The Last Psychiatrist is correct in his predictions.

Here are just some of the items found in major med blogs over the last few days.

Roy Poses give us an extremely disturbing picture of the Chinese heparin debacle. I have always felt that the supply of drugs in this country was if anything safe. Now we learn, maybe not

In some regards, a more frightening piece of news is the revelation that thousands of patients have been exposed to blood borne pathogens by a endoscopy center reusing syringes and vials. This , if the reports are anywhere near correct, is about as bad as it gets-way past simple negligence.

Numerous reports of bogus CAM (aka Woo) growing in its presence and influence in mainstream medical schools have appeared in essays by ORAC and Dr. RW as well as others. RW now give us a look inside of a medical student retreat from the University of Florida which to someone educated in the pre-Woo,pre-social justice, pre-work-life balance (not that there is anything wrong with that) era is simply mind boggling. I can only say "are you kidding me?"

The Happy Hospitalist educates us about a growing government plan to hire higher outside contractors who will be paid based on how much fraud and waste they find with the way that docs do their work.This is known as the Recovery Audit Contractor Administration Program.

Dr. Carlat gives us even more information on the degree to which drug companies can manipulate and control what passes loosely as CME quoting from recent article in JAMA and the BMJ.

President Bush has proposed legislation that includes "quality" ranking of physicians and even better P4P.

But, beyond the bad news there may be theme of good news ( my five or six regular readers will be surprised at anything that seems like optimism from me).The underlying good news is that there are articulate, thoughtful bloggers who also happen to be physicians, who are thinking and writing about the problems, providing opportunities for more people to become aware and sometimes even suggesting solutions and the web is there to give a forum to their observations and thoughts which just a few years ago would have gone no farther than the doctor's coffee lounge.

Statins and tendon problems-a signal or just background noise

A recent Medscape article discusses the possible connection between tendon problems (tendonitis and rupture) and the use of statins, side effects which apparently have not been reported in any of the very large "landmark" trials. Of course, RCTs are not the best way to detect somewhat uncommon side effects (see here for my earlier comments on that issue) but there has been a very large clinical experience with these drugs without that particular adverse effect being recognized or at least reported on.However, so far the post marketing data also fails to make mention of this problem.

The report is from France and mentions that the achilles tendon is most commonly involved and that the tendonitis is more likely to occur in patients also taking fluroquinolones or steroids, both of which have been incriminated with tendon problems even though steroids are used to acutely treat tendinitis but long term steroid use may increase risk of rupture. See here for comments regarding fluroquinolones in this regard.

Both statin use and tendonitis or other tendon "problems" are common and the two are bound to occur in the same person now and again just by chance although I do not exclude the possibility that there is a causal linkage. However, the advice of the authors that persons entering into a strenuous exercise program should discontinue the statin seems way over the top. OK, to be fair they only say that discontinuation should be considered but they mention marathon training in particular in that regard. Tens of thousands of folks are running marathon these days and many are taking statins, stopping the medication for those people while they train does not seem to me to be good advice.Folks who regularly run marathons would never get to take the drugs as they are almost always training. Also exactly where would we draw the line about what is a strenuous exercise program?

JAMA article: The "Shared Responsibility" for paying for health care is a myth

Who pays for health care? The authors of a current JAMA commentary maintain that the notion that employers ,government and individuals all share in the payment of health care is a myth and a harmful one because the false notion that they are spending someone else's money reduces the incentive for cost control. The authors are Ezekiel J. Emanuel,director of clinical bioethics at the NIH, and Victor R. Fuchs , an economist from Stanford with a long track record of publications regarding financing of health care.

They argue that the employers who provide health insurance do not pay the cost or as they put it "bear the ultimate cost" Health insurance is part of the employee compensation package i.e. wages in another form. What you get in health insurance you don't get in your pay check. They quote another economist who concluded that "the cost of health insurance are fully shifted to wages." This seems to make sense and yet we are also told ( by the same authors in this 2005 reference) that large companies , such as notably GM, have a very large burden of health care costs and that is a major reason for their economic woes. So which is it?

Similarly the "burden of government provided health coverage falls on the average citizen". This is , they argue, because the government get its money through taxation, or borrowing from future taxpayers of reducing other state services. They fail to mention financing through the printing press creation of inflation.

Victor Fuchs and Ezekial Emanuel advocate a "Universal Health Care voucher" system financed by a value-added tax and eliminating employer insurance. Dr. Fuchs views on health care financing can be found in this article in the Annals of Internal Medicine and here is a brief NPR video interview of Dr. Emanuel in which he describes his voucher program.

I would agree that in the aggregate whatever the government does is paid for by taxpayers one way or another. However, everyone in the country does not pay-as some folks pay no taxes. Further, what an individual receives in terms of health care may be significantly greater than that person paid out to the government. For some, health care is actually paid for by using "some one else's money".There is certainly some cost shifting going on and for others there may well be a illusion that health care is paid for by others.

The Fuchs-Emanuel voucher proposal has been talked about for several years now and it should be distinguished from a single payer plan which it is not and which they believe would not work well in the U.S. Although the "universal" part should appeal to Democrats and the "voucher" part should appeal to Republicans, I have not seen that either has enthusiastically embraced it. In fact, Clinton talks about shared responsibility with all the players contributing the common goal. So why has not this proposal received more support and I am not sure that it should. I am having trouble implementing my "follow-the-money" rule to explain the opposition and wonder what take DrRich at Covert Rationing Blog has on this.

We throw the rascals out but then a funny thing happens

As election time draws closer even medical bloggers feel compelled to make political comments. Some are to the left, others the right and still others libertarian. Politician's vacuous slogans dart around suggesting empty choices and the frustrating sometimes scary world we live in is offered a glimpse of salvation made human in the form of politicians.

When things are going badly according to some observers the obvious solution is to thrown the rascals out. Many times the perceived rascals have been rejected and yet things change little and at the end of the term of their replacements the refrain repeats . If we replace those who are variously described as incompetent, dishonest or evil with folks who denounce all or much of what when on before why does the wheel keep turning?

Thomas Sowell has something to say about that. Throwing the rascals out does not work because we are replacing them with humans who will face the same incentives, constraints and feedback ( or lack of it) that their predecessors faced. It is the defining characteristic of the institutions in which they work that do not change. The same army of lobbyists will descend on the newly elected senator as they did on his predecessor. The same pork selling and trading will take place
with the pre election rhetoric of eliminating the special interests fading away. The incentives do not fade away.

Sowell, of course, said it much better:

Much discussion of the pros and cons of various issues overlook the crucial fact that the most basic decision is who makes the decision, under what constraints, and subject to what feedback mechanism. This is fundamentally different from the approach which seeks better decisions by replacing the bad guys with the good guys-that is by relying on differential rectitude and differential ingenuity rather than a structure of incentives geared to the normal range of human propensities.

When we hear how government programs will fix this or that and provide this or that it is worthwhile to listen to Sowell. He explains that government is not "society" or the embodiment and machinery of "the public interest" and it is not a single decision making unit but rather;

..an overlapping montage of autonomous branches, agencies and power cliques-each of these responsive to outside coalitions of interest groups or ideologists.

With that in mind it is not surprising that the lofty promises for a fix for this or that (including the health care situation) are never fulfilled.

Vitamin D is the new E, hype wise at least

A claim that vitamin D can increase longevity reminds me of the enthusiasm some folks had concerning the marvelous powers of vitamin E.

There is a very favorable ( almost glowing) report in Internal Medicine News (Feb 13,2008) (ww.internalmedicinenews.com) that outlines some of the more favorable evidence regarding D.

A meta-analysis from AIRC analyzing 18 RCTS with over 57,000 subjects indicated a 8% mortality reductions in those subjects in trials that lasted 3 or more years.

A telomere length analysis in 2,160 female twin pairs found that those with the higher Vitamin D levels versus those with the lowest Vitamin D had longer white blood cell telomere lengths. This difference was said to be the "equivalent" of five years of aging. Telemeres are the ends of chromosomes ( likened to the little plastic tips on shoe laces) that are known to shorten with each cell division and have gained some reputation as a type of surrogate maker for aging. Here is a good explanation of how that shortening occurs.

Dr. Robert Vogel of University of Maryland spoke highly of the potential benefits of Vitamin D and made the point that from the results of the Harvard Alumni Study being thin as you age and have a moderately vigorous exercise program as you get older seemed to increase longevity by about 6 months each. Well, taking a pill or two a day is easier than that, right.

Claims of anything being a fountain of youth pill deserve a very high level of scrutiny but I'll bet sales of D are going up. I'll admit I was surprised and then later accepting of the studies that demonstrated fewer falls in the elderly on D supplementation which seem to work by increasing strength. To say that you can increase your life by five years is over the top and too enthusiastic an extrapolation but I'll have to say that I have increased my Vit D dose from the previously generally recommended 400 u to 1000.

Congress investigates Jarvic TV ad but ignores danger of killer robots

Congress is looking into the TV ads starring Dr. Robert Jarvik, artificial heart valve innovator and researcher, apparently because he never was licensed to practice medicine and alarmingly the ad producers used a body double for the rowing scenes.The legislators apparently are concerned that the ads are "misleading". While protecting the public from misleading ads ( who would have thought ads could be misleading ) is a high priority there may be greater dangers.

I am not talking about the risk of receiving very bad heparin or dying in the hospital at night because all the staff are asleep or something I am talking about humanity in danger from killer robots.

Never can know enough

One sentence from a recent typically well written and insightful contribution by Intueri particularly resonated with me.

We [physicians] find ourselves pulled into the belief that we are squandering our skills and potential if we are not tending to our patients (through direct patient care, reading, studying, etc.) as much as we can.

I've written before ( now three years ago) about the transformation of a layperson into a physician. Much about that transformation is captured in that sentence.

That sentence describes how I felt beginning sometime in medical school and ending gradually sometime after I retired. Always the nagging fears of not knowing enough and not being alert enough and not working hard enough were there.Now since nothing I read will be translated into any real action for or to a patient( except myself and spouse) although I still read and think about medical matters a lot it as Osler said "“He who studies medicine without books sails an uncharted sea, but he who studies medicine without patients does not go to sea at all.”

Now when I read about the latest study on ventilating patient with ARDS it is with interest but it is not with the same limbic valence as reading about something that you know "will be on the test" or that you may will really need that information as you go to sea. As much as anything that is a major part of the "transformation" back. Without that motivation to try and know enough to do the right thing for your patient and to know that you will not be regularly asked what to do by your patients really does make the transformation nearly complete. Fully complete may entail not letting that bother you so much.

The problems of Evidence-based medicine widely accepted hierarchy of evidence

The generally (or maybe just widely) accepted formulation of the hierarchy of medical evidence that is a major construct in what has come to be known as evidence-based medicine (EBM) considers the randomized clinical trial (RCT) and the meta-analysis (MA) as the premium types of evidence capable of trumping other forms of evidence listed below them on the evidentiary ranking system. Observational studies, case reports,personal experience and notably physiologic considerations fall on the lower rungs of the ladder. According to a widely accepted and practiced version of this scheme, higher levels of evidence trump lower lower levels.

For some time I have been perplexed about this hierarchy .
This first thing that bothered me was if meta-analysis deserved such a lofty position. Two things made me decide that they definitely did not.

The important Annals of Internal Medicine Articles and editorial by Dr. Steve Goodman of Johns Hopkins made it clear to me that MAs were basically themselves observational studies in which the studies themselves were subjects. He discussed two major MAs on the value of mammograms, one which concluded they were effective and valuable and the other concluded the opposite.The major difference between the studies was their choice of studies to include and to exclude. Both sets of authors maintained their criteria for exclusion were valid and yet they were quite different and resulted in opposite conclusions. Quoting Goodman:

... this controversy shows that the justification for why studies are included or excluded from the evidence base can rest on competing claims of methodologic authority that look little different from the traditional claims of medical authority that proponents of evidence-based medicine have criticized.

Secondly, not only is the choice of inclusion rules important but so are the various statistical techniques used to analyze the data. A widely quoted MA on the use of large doses of Vitamin E published in the Annals Internal Medicine made it clear to me the importance of methodology and how impenetrable the bickering between statistical experts could be as they debate the merits of their technique of choice. In this case, the authors of the article found a tiny increase ( relative risk of 1.03) in overall deaths from the vitamin E. A flurry of letters to the editors claimed their technique was wrong and that when the "correct" method was used there was in fact no statistically significant difference. Since so much seems to depend on the investigator's choice of what studies to include and the method used to analyze the data and those actions basically takes place at least to the usual physician reader behind the thick methodological-statistical curtain that faith in the authors become very prominent.So accepting that type of evidence involves more than a little faith .

It seemed clear to me that the MA did not belong in the top of the evidence ladder and I wrote about it here.

Sometime later after I became aware of a more fundamental problem in this evidence ranking and trumping system in an 2001 article by Dr. M.R. Tonelli and after wrestling with that article for while I began to think that the construct of a hierarchy itself was in error. Tonelli said in part:

Proponents of evidence-based medicine have made a conceptual error by grouping knowledge from clinical experience and physiologic rationale under the heading of evidence and then compounded the error by developing hierarchies of evidence that relegate these forms of medical knowledge to the lowest rungs. Empirical evidence, when it exists,is viewed as the "best"evidence on which to make a clinical decision, superseding clinical experience and physiologic rationale.

More recently several articulate and thoughtful bloggers have discussed what one called the "elephant in the [EMB} room". Orac had this to say in a recent posting.

As I've come to realize, the elephant in the room when it comes to EBM is that it relegates basic science and estimates of prior probability based on that science to one of the lowest forms of evidence, to be totally trumped by clinical evidence. This may be appropriate when the clinical evidence is very compelling and shows a very large effect; in such cases we may legitimately question whether the basic science is wrong. But such is not the case for homeopathy, where the basic science evidence is exceedingly strong against it and the clinical evidence, even from the "positive" studies, generally shows small effects. EBM, however, tells us that this weak clinical evidence must trump the very strong basic science, the problem most likely being that the originators of the EBM movement never saw CAM coming and simply assumed that supporters of EBM wouldn't waste their time investigating therapeutic modalities with an infinitesimally small prior probability of working.

It seems that the elephant's cloak of invisibility was torn away when a number of small clinical trials allegedly found that such things as homeopathy and reiki ( the most improbably absurd of the improbable methods of CAM) seemed to work or at a minimum the claim was made that larger trials were needed. Perhaps worse still ,some meta-analysis of those trials by folks highly regarded in EBM circles (such as the Cochrane Collaboration)suggested there was some evidence of their efficacy , such analysis of the trials notable by the absence of any mentioning about how these techniques fly in the face of current concepts of chemistry, physics and physiology let alone contrary prior experience. The message of "trials trump basic science" seemed to have taken to heart by the folks at Cochrane.

Dr. RW had this to say

... treatments must pass not only the evidentiary test but also the test of scientific plausibility. Because EBM devalues the latter it is inadequate for the evaluation of implausible claims even though it may perform well in evaluating plausible ones. This fundamental error is built into EBM’s system of analysis as illustrated by its evidence hierarchy, which places physiologic rationale and scientific principles at the bottom of the heap...

Essential reading on this general topic must include posting by Dr. Kimball Atwood IV and the articles by Dr. Steve Goodman explicating meta-analysis and the topic of prior probability in the form of Bayesian analysis.

Goodman said "data alone cannot prove the hypothesis". It is essential to take into account biological plausibility and prior evidence.The astounding example of how sincere disciples of the extreme empiricism form of EBM "analyzed" homeopathy should be all we need to listen closely to what Goodman and Tonelli have been saying. Was is naive to think that a calculus had been devised that enabled us to make decisions simply by using a ranking system in which types of evidence higher on the pole invariably trumped those lower. To quote Goodman yet again.

Judgment determines what evidence is admissible and how strongly to weigh different forms of admissible evidence. When there is consensus on these judgments and the data are
strong, an illusion is created that the evidence is speakingfor itself and that the methods are objective. But this episode[ the mammogram controversy mentioned above] should raise awareness that judgment cannot be excised from the process of evidence synthesis and that the variation of this judgment among experts generates uncertainty just as real as the probabilistic uncertainty of statistical calculations.

I cannot help but think the EBM ranking- trumping system became for some a means to avoid the judgment that Dr. Goodman writes about, though it may have not been so intended by the founders of the movement. If medical students grow up to believe that clinical trials always trump basic science the incredible growth of CAM in main line medical schools (see here and here for how bad this is getting) will only continue to get worse and worse. Everything I have said here has been said better by the folks I quoted but I think it is important to keep the fires of protest burning.

Complex trials for complex condition can be ..well complex

The history of ARDS ( acute respiratory distress syndrome) is a relatively short narrative in contrast to some other diseases and their treatments. I remember writing a review of a book about the topic as a fellow in pulmonary disease circa the early 1970s at that time very little was written about that topic, the condition having been recognized somewhere around 40 years ago.

We now talk about ALI (acute lung injury) as well as ARDS, the former being a sort of "ARDS- lite"with less severe oxgenation issues than full blown ARDS and it considered a precursor to ARDS. The "A" in ARDS first stood for "adult" and now is taken to mean " acute". Specific definitions of ALS and ARDS appeared in 1994 based on oxygenation levels defined by the ratio of arterial oxygen tension and the fraction of inspired oxygen.

Ventilatory support of these patients can be lifesaving but the optimal techniques or "settings of the ventilator" continue to be a source of controversy.Too high a tidal volume or a pressure and we risk various forms of barotrauma and too little of either seems to be associated with atelectasis ,blood shunting and another form of ventilator induced lung damage from forces related to opening and closing of gas exchange units.

Recent published clinical trials involving various techniques to ventilate these patients report in- hospital mortality rates for the treatment and the control arms in the range of 30 to 40% while a 2005 observational trial of 467 patients reported a 60% mortality rate which may well more accurately reflect real world outcomes,the old efficacy-effectiveness gap issue.

Two large clinical trials were published in the Feb. 13,2008 issue of JAMA as were as two editorials on the subject. I believe this brings to three the total of clinical trials that investigated the use of "high"er versus "low"er levels of PEEP and all found no statistically significant difference in terms of mortality although some less final measures tended to favor the higher levels. There were fewer days on ventilator support in one trial and fewer deaths from progressive hypoxemia in another.

Also favoring the higher levels are current theoretical considerations regarding what seems to be a major pathophysiological factor in ARDS. There appears to be considerable non-cardiac pulmonary edema in ARDS and the suggestion that these wet alveloi are capable of being ventilated (recruitable alveolar units) and since PEEP should enable lung unit expansion the subset of ARDS patients with more edema might significantly benefit from PEEP while other patients with less edema might not. With the now commonplace use of low tidal volumes one would expect more micro-atelectasis and it seems reasonable that higher PEEP might be needed to mitigate that tendency.

Accordingly, one editorialist suggested trials in the future might well use some measure of edema to stratify patients.The thought here is that those patients with more edema might benefit more from higher PEEP.Interestingly, in some patients PEEP seems to cause harmful overdistention without eliminating the atelectasis.

Clinical trials in complex patients pose a number of problems not seen in simpler randomized clinical trials such as those in which two medications are compared in more stable patients.

One of the editorials discusses some of the problems seen in trials such as those reported in ARDS including the necessary lack of blinding and the difficulty and traps involving in the crucial definition of exactly what the control group will be.This involves in part how much discretion are the treating docs given in the control group. Further,"inferences in causality can only be drawn about the entire intervention and not about any specific piece."

Interesting (and somewhat disconcerting to me) even though we now have three major clinical trials that all failed to demonstrate a mortality benefit to higher versus lower PEEP, all of the authors of these latest two article and one of the editorials agree that because of the compelling theoretical arguments favoring adding high PEEP to the current low tidal volume standard of care and the favorable morbidity measures that higher PEEP should be part of the de facto standard of care. If I were still twiddling the dials of the ventilators in ICU in patients with ARDS I would probably opt for higher PEEP as it seems to being about (at least in some patients) higher oxygen levels and lung docs always seem pleased with higher values and feel that we have accomplished something.

Well Point,rat-out-patients,and capitation

A number of medical blogs, including Health Care Renewal which contributed this essay have commented on the recent revelation of the dear doctor letter from Well Point requesting information from physicians regarding pre-existing conditions and their patients.

In a world where so often nothing seems to make much sense we tend to leap upon and devour ravenously a narrative that makes sense to us and explains what otherwise is a mystery.

The otherwise mystery arises in this story from the revelation that apparently such letters had been sent in large numbers and for some time and only now does a physician make public a indignant complaint.No one is surprised that a physician would complain.It seems to be a dog bites man type story.But why not before? Dr. Rich offers an explanation that resonates in our "that makes sense" gyrus located in some obscure site in the frontal lobe.

The docs who didn't complain after receiving these letters apparently were in a capitation payment system. The less illness they take care per patient the more money they get to keep. Read Dr.Rich's full entry to see how all of this seems to fit with the grand scheme of covet rationing. The story as it is unfolding looks like a "drop a dime, earn a dime situation".

More crumbling dogma ? -this time lower and lower blood sugar is better

How many evening diner,CMEoid sessions included the chant, "treat to goal,treat to goal" in regard to blood sugar. As with LDl cholesterol-the goal just kept getting lower and lower.

The DPPT study seemed to provide very good evidence that the microvascular complications of type 1 diabetes could be significantly mitigated by "good"control of blood sugar.Later a follow up report from that landmark trial also provided some reasonable evidence that perhaps macrovascular disease could also be decreased.

There has been the hope that we could accomplish the same thing with the complications of type 2 diabetes by a similar surge of intensive treatment aimed at bringing about near normoglycemia. Would that life and disease and managing disease were so simple.

The UKPDS trial was-and to date is the only large trial with more or less the medications that are now used-that tried to examine whether tighter control of blood glucose would do for the type 2 diabetic patients what the DPPT trial showed that it did for type 1 patients.

The DPPT was a fairly simple trial. There were patients with a disease that seemed fairly homogenous and has relatively straightforward pathophysiology , i.e insulin lack from the get go and the treatment intervention was simply more insulin. On the other hand, the UKPDS trial involved several treatment arms and greater heterogeneity of comorbid conditions in the subjects as well as more variation in the the tempo of the various pathophysiological disturbances and the pathophysiology of type 2 is much more complex than in type 1.

With trials with more complicated conditions and multiple treatment arms there is greater likelihood of chance and confounding and various biases clouding the results. Clouded results or not the UKPDS became a major element in the argument to treat to lower blood glucose value in type 2 diabetes. The results of the UKPDS were not earth moving but were encouraging. There was some decrease in blood vessel disease on retinal exam and some decrease in the rate of progression of urinary protein leak but no change in renal failure or blindness or clinical manifestations of macrovascular disease. The benefit in terms of reduction of retinal microvascular and perhaps renal disease was arguably balanced by an almost four fold increase in serious hypoglycemia episodes ( 0.6% per year versus 2.3%). The former effect was emphasized and the later effect was not in the 2002 position paper from the American diabetes Association from which a lot of the enthusiasm for tight control arose. A somewhat less optimistic assessment of the UKPDS trial is offered here by Dr. Roy Poses and fits more with my ever increasingly cynical nature.

Now fast forward to the ACCORD trial . Here is the announcement of the cancellation of the intensive treatment arm of this large randomized trial. This was supposed to be the trial that would answer-among other questions- the question "can we decrease the macrovascular events associated with type 2 diabetes with intensive blood glucose control ?" Here the treatment goal was a HbA1C of less than 6 %, i.e. basically normal.

However,there were more overall deaths in the intensive treatment arm than in the standard treatment arm. Of those intensively treated about 1/2 had hemoglobin A1C values of less than 6.4 while in the standard treatment arm 1/2 had value less than 7.5. The mortality increase was certainly not what the investigators likely expected.The overall death rate was reported as 20% higher but there were actually fewer heart attacks in the intensive treatment arm but of those there was a higher mortality. So what is happening to cause increase mortality? The NIH announced their analysis so far has not determined what factor(s) are to blame.

Is this simply a matter of getting the glucose too low? Maybe, but an early report from the trial claimed that the excess mortality was not related to hypoglycemia although there were expectedly more hypoglycemia episodes in the intensive treatment group. Also the NIH reports the analysis so indicates no link to the use of any particular medication ,e.g. rosiglitazone.

Dr RW suggested that excessive insulin use may really be the culprit though not necessarily by precipitating hypoglycemia episodes but by fueling weight gain and the metabolic syndrome and insulin resistance. Other suggestions have been made,see here for references, including the stress placed on patients to achieve a difficult therapeutic goal and the theory that too rapid decrease in blood glucose might have played a role.

Dr. Steven Pinker has written extensively and eloquently about the human mind's mysterious and marvelous workings and has discussed how the human mind can see events in different frames. I'll bet that we be seeing the results of this trial (so far we have only a snippet of the results) spun this way and that. But deaths are not a surrogate measure and the major observation of more deaths with intensive treatment may well shift the momentum of diabetic treatment from "lower is better" to "well maybe not too low" and maybe " not necessarily the same target for everyone". A number of doctor bribe programs (A.K.A. pay for performance ) are keyed to hemoglobin A1C levels .Will we see those third party payers whose interests are claimed to be in improving quality of care quickly revise their guidelines?

Physicians want better treatments for their patients and they want results of promising treatments to be true. That desire to do good for their patients coupled with big pharma funded hype often aided by a shinny veneer pasted on by academic and other thought leaders can really energize therapeutic exuberance that may have a much less robust evidentiary base that we were lead to believe.Treating to a goal or treating the numbers can make clinical life seem simpler, sometimes too simple.

First, we find out that maybe we were giving to much EPO, and then maybe lower LDL per se is not better and now more insulin may be too much of a good thing (haven't we known that for a long time?). It is a good thing we quasi- codified all or some of those things into guidelines and pay-for-compliance programs otherwise we might not have had a chance to use them before we decided there weren't really a great idea after all. I remember as house officers we used to talk about the patient dying but the electrolytes were in balance.

Three years of blogging-a look back and a happy blog birthday to me

Some of things I have learned about and written about in my blog over the past three years I would have never imagined three years ago let alone forty years ago when I was handed a MD diploma. Here are some of them.

1.Alternative medicine, AKA integrative medicine, AKA woo . This is many ways may be the most mind boggling. Whatever you want to call it, Dr RW called is quackademics, "it" has moved into the medical school curriculum, research activities and the accepting mind sets of many medical students. We see large numbers of government funded research grants and for many of the projects all you can say is "you've got to be kidding me".

2.The role of the AMA in damaging primary care through its development and continuing support of an advisory group that virtually sets fees from CMS and does so in such a way as to denigrate primary care and elevate procedure based medical specialists.Three years ago I had not even heard about the RUC ( Relative value scale update committee) and paid too little attention to the RBRVS (Resource Based Relative Value Scale ). With friends like the AMA...

3. Three years ago I had not heard of DrRich's thoughts regarding "covert rationing". Now that I have I cannot think of medical practice in the same way. His thoughts can be found at his web site and more completely in his book docs and I believe medical students and physicians alike should read what he is saying before they do anything else. On the insight scale this would be a ten.

4.The downward spiral of primary care. No. 2 above plays a role here but a major culprit is the price controls that are part of the Medicare system which I ranted about here.

5.Pay for performance (P4P) as absurd and wrong on so many levels as seems to be to me it continues to thrive and I believe make matters even worse in primary care. Physicians accepting bribes to do their job is just another example of the continuing loss of pride and ethical demise.

How to apply group data to individual patients, the potential pitfalls and traps and tricks of evidence based medicine (EBM) and how some can pervert the sound principles of EMB to their own ends are some of the thoughts that have recurred in my mind and in my blog. Thanks to those who have commented on my comments, some of which were laudatory and a few of which were not and the occasional one who missed the point or whose mind set is imbued with a different vision. I know I have learned more from other blogs than they have from mine but it has been and I hope will continue to be a blast.

we all love a good story but it is not the way of science

Here is a great posting by Steve Novella entitled "Role of Anecdotes in Science-Based Medicine".

Understanding the world through stories was a good strategy in the environment of our evolutionary history but is far too flawed to deal with the complex world we live in today. In fact, the discipline of science developed as a tool to go beyond the efficient but flawed techniques we evolved .

Generalization and quick and dirty induction may well have been part of the survival package that our ancestors used to good advantage as they tried to avoid predators and gather together to hunt and gather but in dealing with the complex and nuanced world we now try to describe and unravel we need other tools and to be aware of the pitfalls and traps to which some of our mental apparatus makes us prone.

Novella gives a good briefing on why is it that anecdotes do not form the basis for sound conclusions . He give us the top 9 (or 8 depending on how you count) reasons for one to be skeptical about anecdotes including:

The phenomenon of regression to the mean, confirmation bias, and reporting bias-to name a few.

If medical students ( or docs for that matter) understood what Dr. Novella is saying we would not have med students writing nonsense about- for example-reike referenced on Jan. 30,2008 here by Dr. RW.

Dr. Robert Centor has recently been writing about the medical school and pre-med curriculum and what it should include. I was pleased to see this sentence in his latest effort along those lines.

I would add a cognition course throughout the first year. This course would teach logic, evidence based medicine and principles of cognition (as Jerome Groopman champions.) The course would stress thinking.

I agree completely.If medical students were made aware of the mental foibles that lead some presumably educated people to believe in such utter non-sense as reiki maybe we would not continue to see the acceptance and sad defenses of that and other versions of quackery in medical student organization's publications . As things stand now,I'm afraid that more medical students than medical educators would like to admit would not appreciate the on-target satire of altie medicine and post modernism found here