Friday, August 31, 2007

Consequences of Medicare's new don't pay for certain problems policy

Dr. RW discusses some of the problems associated with Medicare's latest ploy to decrease costs. You can bet there will be predictable consequences and some others we might not be smart enough to predict.

In my consultative foray into certain limited aspects of occupational medicine, I had the opportunity to see some consequences of a OSHA program which on the face on it was designed to improve workplace safety. Employer are supposed to record on a form (at the time the OSHA 200 form) certain injuries at work. Plant managers looked at the statistics and the safety officers were either given high marks or trouble depending on the numbers. If the safety officer were imaginative enough he could turn a real injury into one that did not require recording but the event still occurred. If an employee twisted his ankle on a slick walkway it would not be recorded if he could accompany the employee to the ER and convince, cajole the ER doc to treat the worker without using a prescription medication as that would trigger a recording. Basically the record was treated and more time was spent playing the game than working to improve workplace safety ( at least in some instances).

You can be certain that hospitals will be as least as devious and clever as some workplace safety officers and will devise ways to treat the record or spin the facts or something to minimize the "occurrence" of those complications the treatment of which will be no longer paid for by CMS. Hospitals will find ways to cheat and it is very unlikely that those ways will improve patient care.

Monday, August 27, 2007

If we required evidence before initiating quality projects, there would be many fewer such projects

This thoughtful and -I think-spot-on commentary in the NEJM is worth reading.I always like to read things that make me say, "I wish I had said that", things that fit my current set of biases and beliefs.

The authors' main message is that in the rush to do the "right things" regarding improving medical quality and improving safety in health care, sometimes ( probably many times) the rules of evidence have been suspended. We are not demanding the same evidence we would to use adopt a new therapy. Quality measures are put into place without proof of efficacy and safety and often after they are in place no systematic evaluation of their value is done and to suggest that they should be is likely to evoke accusations of not being a team player or even worse being disruptive. It seems as if the skeptical analysis of the scientific approach has been pushed aside by blind belief in and allegiance to the paradigm of continuous improvement and other management buzz words of the month.

The authors list and refute a number of pseudo reasons used to justify programs that lack evidence of their effectiveness . Here are some of them.

Argument 1: We cannot wait.

Argument 2: Anything we do to improve something must be better than what we have now (my paraphrase)

Argument 3: Company X did it and it was great.

I can particularly relate to number 3. I had the occasion to do consultative work for 2 large corporations over the years and had the opportunity to be a bemused fly on the wall on some of the quality projects . Since it widely believed you have to quantify something to show how much you have improved, a early session with the highly paid outside consultant quality experts involved a mini course in how to draw a x-y graph. The pupils in the class I sat in on were from the company research center and were in fact senior scientists there most of whom had a PhD
in some hard science area. They were all made to do a "quality" project and then everyone had to agree how helpful it was. Later the company claimed how valuable their quality project was.

Some of the baseless medical quality efforts may not be as blatantly hypocritical as this one but the nurses and doctors who often get caught up in these programs feel the same type pressure to be a team player and not "disrupt" the effort with thoughtful criticism or healthy skepticism.

Twenty years ago when I began to do some consultative work with the corporate world,I felt rather smug that my field (medicine) was immune to the Dilbert like silliness that seemed to pervade the corporate culture. However,medicine has become more and more corporate and the business school belief that one does not need know a business to run it is increasingly applied to medical practice . The business-speak jargon now echoes through the hospitals and clinics and we talk about vision statements and leveraging this and that and the suits with MBAs are no longer minor distractions but are in control. What the Dilbert cartoons depict are as applicable to much of medicine as they are to the bureaucratic world of big business.

Friday, August 24, 2007

UnitedHealth Group's "Medical Home" -Old wine new bottle?

DrRich in his latest commentary in The Covert Rationing Blog delves into the Medical Home as it is being put into motion by Unitedhealth Group. I am glad to see someone else expressing concern about this latest effort to control costs using a different rhetorical smokescreen. I had had my say about that here.

Dr. Rich says it well:

Whether you call it medical home, pay for performance, or just plain managed care, as long as the big insurers (and the feds) are the ones who determine the doctor’s viability as a practitioner, and as long as patients are the individuals who cause doctors to risk their viability as practitioners, the genuine practice of medicine - and the fabled doctor-patient relationship - must remain fond dreams.

I continue to be puzzled about the role of ACP in all of this.Is the leadership naive or is this nudge,nudge wink, wink or do they want to be the power position of making the rules that the rank and file physicians will play by? The family docs might be asking similar questions about their self appointed leaders. Is refusing to participate in all plans and Medicare the only way to maintain the doctor-patient relationship that some of us remember ?

Friday, August 17, 2007

United Health Care Teams with internist,peds, and FP groups for medical home-for whose benefit

Health Care Renewal raises important concerns and asks pertinent questions regarding the recently announced alliance of Unitedhealth Group and ACP( and AFP,AAP and AOA) here and I will not repeat all of Dr. Poses's points but wish to add a few concerns of my own.

The press release talks about how the physician in the medical home will be responsible for the patient's total health picture. How does that work if/when the patient goes to see another physician for a medical condition outside of the internist's area of competence? This pesky problem of freedom has always vexed planners of medical care systems.Will the patients have to sign some sort of exclusivity care arrangement.?

When I first read about the concept of medical home, I thought it was just another lame attempt by ACP to try and do something to salvage the dwindling away of internists ( I remembered their slogan of internists as "doctors for adults) but although available details (while quality platitudes are plentiful) are still sketchy we can get some sense of what operationally this medical home concept might be-at least in the version involving a major health insurance company. My early assessment is that we will see more of a third party's attempt to save money on health care and exert more control over physicians using a new rhetorical cover .

Let's look at what the press release says about the role that United Health Care will play.

UHC will support it by integrating its extensive quality improvement and care management programs into the practices's infrastructure. I imagine this will include practice guidelines and algorithms and flow charts designed by UHC by some process that mere private practitioners could never generate the mental juice to conceive which will be more efficient (translate save more money) and of course, improve quality.

In regard to the payoff we learn the following:

Unitedhealth Group will pay participating practices a monthly management fee based on projected savings for all patients that select a medical home...the company will share any excess saving (excess saving is an interesting concept) that accrue from the pilot program and by way of premium reductions with employers.

This looks like a combination of capitation and reward for being a compliant doc. Does this sound like an HMO? Is this an early effort to set up the "integrated delivery systems" that I have ranted about before and have been hyped by leaders of ACP and the medical insurance industry.

Apparently some medical groups have agree to go with this. I cannot conceive of agreeing to a set of practice guidelines approved of by a major third party payer and to compensated in part by how well I complied with these guidelines, most if not all of which are not likely to be made known before the agreement and the basis and origin of which are probably proprietary . Talk about selling your soul to the devil and probably for not much of a good price. All this with the blessing and cooperation and encouragement of the ACP and the other professional groups.With friends like the ACP, practicing internists......

I suppose the same could be said for pediatricians and family docs because
the leadership of pediatric and family practices organizations seem to be fellow travelers in this journey to what sounds something that makes regular managed care a pretty good deal.

Dr. David Dale, President of the American College of Physicians offers reassuring words:

Primary care practices should exemplify ...dedication

to team care,...clinical information systems, ...coordination of care ,and (we should never forget) continuous performance assessment and improvement.

Thursday, August 16, 2007

Multi "generational" agreement -it is all about time (and money)

Health Care Renewal called my attention to a Over My Med Body posting suggesting another force pushing in the direction of fewer docs going into primary care, time spent with the patient during the clinical rotations in medical school. He points out that in the teaching clinics the primary care patient are zipped through in 15 minutes-never mind they might have 5 different illnesses and 10 different meds and three new complaints-while at the specialty clinics 30 minutes is allowed.The student has more time to understand what is going on and naturally feels better about the encounter there than in the primary care clinics which may well influence his choice of career path.

Dr. Robert Centor in his blog, DB'S Medical Rants, has repeatedly emphasized the importance of having adequate time as have I. So, we have medical students, physicians in practice and even retired physicians all agreeing about the importance of time.Yet third party payers and managed care have pushed to allow less time(more throughput) per patient encounter and it is the practicing and retired physicians who have allowed this to happen.

Of course, the even bigger driver in the demise of primary care physician and the underlying reason for the time crunch is the paying-with-someone else's-money- reimbursement issue which is discussed brilliantly by Dr. Roy Poses here.

Friday, August 10, 2007

The FDA's deliberations on Avandia-worthwhile insights

Dr. Clifford Rosen speaks candidly in the NEJM about the multi-faceted situation regarding the issue of cardiovascular risk of Avandia and how hard it is to pluck out the "truth" from often conflicting and incomplete data.

His full text comments are available here from the NEJM.

One of the important points he makes is that is more than just very hard to discern small increases in risk between groups when the disease or event of interest is fairly common such as myocardial infarction. I have written before about how statistics works well to find big difference but struggles to differentiate between small things and nothing at all.

Dr.Rosen provides a good overview of the various data sets that were analyzed in the FDA panel's effort to reach a decision about what to do with Avandia. I believe at the end of the day public sentiment and physician assessments of the risk has for the most part lead to the end of the road for Avandia.

He also speaks of several guiding principles to apply in regard to drug approval.
Two of which are :
the pathogenesis must be "fully understood"
treatment options should be clarified through an evidence based system.

Worthy aspirations to be sure, but I doubt we can wait for the pathogenesis to be "fully understood" to make judgments. What diseases can you think of in which we fully understand their pathogenesis, certainly not hypertension, heart failure,diabetes, depression for which many drugs have received FDA approval.

The Avandia saga and the panel's deliberations illustrate how difficult it can be and usually is to discern the truth from conflicting and incomplete data. At the end of the day someone has to decide something. It is commonly said of trials and court decisions that they do not produce justice so much as they settle the issue and the participants can move on. FDA's decisions are sort of like that.

Quality can be hazardous to your health

"No man's life,liberty or property are safe when the legislature is in session".

This thought has been attributed to various sources but according to this website, it originated in a court decision in the 19 th century. Having read about the harmful and probably unintended consequences of some quality rules ( the word guideline has become a euphemism) I believe you could as well say : " When the quality rule makers are at work, no patient's well being is safe".

The four hour pneumonia antibiotic treatment rule has lead to patients without pneumonia getting antibiotics within four hours of arrival in the E.R. A recent posting by Dr. RW pointed out the weak evidence supporting rigid blood sugar control in sick hospitalized patients is poorly suited to mandate such an approach to all sick hospitalized patients yet guidelines mandating just that seem to be being prepared if not already proposed.Peri-operative use of beta blockers became a guideline but now there is more than a little doubt about the utility universal application.

The evidentiary best of the quality rules are supported to varying degrees by randomized clinical trials but even here one should proceed slowly as the reality of the well known efficacy-effectiveness gap tolerates simplistic approaches poorly. RCTs are often small and fail to capture the rich and perplexing diversity of relevant pathophysiological variables (known and unknown) that coexist in complex, hospitalized patients. It is in the sickest patients that rules formulated by committees based on what-ever that the most harm can be done and in whom the pathophysiological diversity is likely to overwhelm premature generalizations and an overly eager rush to mandate treatment rules.

The hubris,arrogance and naivete that I believe characterize those who make rules for how to treat individuals based solely on group data ignoring the input of the physicians on the scene is even worse that the folks who simplistically sprout out coarse grain outcome data quality indicators such as percentages of patients with HbA1c less than 7 %. In the later they are just counting beans in the former they are making rules about treatment decisions that might be determinative of the outcome. It all seems to be part of the notion that medicine is too important to be left to the individual physicians and patients.

The mandatory and quasi mandatory nature of guidelines or quality indicators as wielded by the CMS mandarins become even more dangerous with the spreading use of the "disruptive physician" doctrine. Not only must you go by the rules you can't complain about them without incurring the wrath of the hospital's disruptive physician committee.

In a recent post Dr. Robert Centor , of DM's Medical Rants quotes from a thoughtful article that correctly states that black and white answers are rare in clinical research and those that may seem clear cut today may not be as more data are accumulated. Committee derived quality indicators mandate that the grey be magically transformed into black and white and CMS and other third party payers give powerful financial valence to the process .

Thursday, August 09, 2007

Crisis in medical professionalism or 'professionalism" highjacked for social policy agenda

A commentary in the August 8,2007 issue of JAMA by an international group of authors (U.S.,England,Canada) presents the notion that the professional responsibilities that physicians are "honor bound" to fulfill are beyond the control of individual physicians and will require a "medical societal alliance". Only an extract can be found on line here. ("Alliance Between Society and Medicine",The Public's stake in medical professionalism", Cohen,J, Cruess, S and Davidson,C. JAMA vol. 208, no.6,p 670)

On first reading you have to wonder what the authors are taking about because when the basic ethical precepts of a physician come to mind no alliance of anyone to anyone else seems to be required or even makes sense. The physician is the one solely responsible for not harming the patient, placing the patient welfare first, honoring the patients autonomy and the confidentiality of the patient information.etc. So what are they talking about?

However, it is not the old but the new tenets of professionalism that the authors believe to be unworkable by physicians solely by their own efforts. You may ask when did we get new ethics and what was wrong with the old ones

The new ethical precepts were written in a joint effort several groups of internists (ACP,ABIM, and the European Federation of Internal Medicine) and was revealed to the world in 2002 in the Annals of Internal Medicine and spoke of three ethical principles:

Primacy of patient welfare.
Principle of patient autonomy
Principle of social justice, "to promote justice in health care including the fair distribution of health care resources"

The professional responsibilities that physicians cannot achieve by themselves in living up to the third principle are enumerated in the JAMA article and include the following all of which the authors say cannot be done without this alliance. (some have been paraphrased for brevity)

ensure that all have access to basic health care
provide an infrastructure to improve quality and safety
construct a medical liability system that encourages dissemination of lessons learned from medical error.
align payments with professional values and performance
provide medical education and research funding

The authors leave undefined the nature of this alliance but we are told it must "interrelate .. with the country's policy and decision making apparatus" ( I think this means government) and the primacy of public welfare,public accountability and social justice must prevail.

I have written before about the serious conceptual and ethical problems of inclusion of the concept of social justice into medical ethics before.

The JAMA article is basically the work of the same folks who gave us the new professionalism rules as it arose out of a meeting with the European internists and ABIM and ACP. Some of the same players (Dr. Casell of ABIM and Dr. Brennan of Aetna) wrote an earlier article in JAMA that may give us some hint about one road this alliance could take to make real many of its goals. That article,that I have written about before, speaks of large vertically integrated health systems that would be responsible for the health of groups-the so-called "accountable care organizations" or "integrated delivery systems". What better than a giant HMOoid organization could provide quality,cost effective, just, efficient,professionalism-promoting, conflict of interest free, patient centered, evidence based compassionate care and thus prevent the "public health crisis" that is brewing if we do not stop the erosion of medical ethics?

I cannot help but notice that is took five years for the folks who brought us the new ethics to realize ("on close reading'") that the precepts that this international consortium devised were in fact something that was beyond the control of physicians in the first place. Could the positioning of the concept of social justice into medical ethics serve to highjack medical ethics into promoting a social agenda and will the insurance companies not be in the wings ?

Wednesday, August 08, 2007

Physician fiduciary duty-a thing of the past?

Has the increasing hegemony of third party payers over physicians lead to a change in medical ethics, one that is compatible with and may even serve to justify a collective approach to medicine.

Until it was deleted in 2003 by the ACGME, Resident Review Committee (RRC) for Internal Medicine, the following statement was a touchstone of IM training and future practice ;

"Physicians...must recognize their obligation to patients are not discharged at any given hour or any particular day of the week.In no case should the resident go off-duty until the proper care and welfare of the patient is ensured".

It has been suggested that the most significant change in post graduate medical education occurred in 2003 when the ACGME instituted rules limiting house office duty hours. I suggest at least in regard to internal medicine the above omission signaled a more significant change.

However, I believe a broader change occurred with the publication of the "New Professionalism" In this, physicians are charged with more than care of their patients they are somehow to serve as stewards for the collective medical resources.

The New Professionalism speaks of three fundamental principles

Primacy of patient welfare. Here they got off to a very good start and one that apears to be without conflict with the (unstated) "old Professionalism".

Principle of Patient Autonomy

Principle of Social Justice. Here physicians are urged to promote " justice in health care including the fair distribution of health care resources".

In the first two principles the issue is simply ( simple in theory not in practice) to do the best thing for the patient. The locus of concern is the patient. Fidelity to his/her welfare , to act in the interest of the patient are the goals of the physician. In the third- problems arise, however.

"Justice" is a term with multiple meanings and interpretations but the authors of the new professionalism seem to specify a certain type of justice, namely "social justice". However, even the term social justice is not without different meanings and interpretations. Libertarians would argue that social justice in one of its more common interpretations violates the principle of "non-aggression". Social justice advocates commonly argue for equality of results versus the libertarian view of equality of opportunity and equality under the law and for legislative actions to bring about those allegedly fair outcomes.

Similarly what one considers as fair is determined in part by what concept of justice one has.

The arguments and related philosophical considerations could take up volumes but my point here is simply that the terms social justice and fairness do not mean the same to everyone and there is no reason that a small of physicians ( the authors of the "New Professionalism") should preemptly settle those arguments and disagreements by declaring what philosophical stance is appropriate for the physician as she practices medicine.

Critics of the new professionalism argue that the first and third principles stand in contradiction to each other. Proponents counter simply that there is no contradiction. This is much like the arguments that goes "health care is a right" "- No it is not." Debate will not settle polar opposite views .

I believe that principle number three justifies a collectivist approach to medicine and if one follows the "follow the money rule of thumb" the new professionalism could serve well as a philosophical cover for the "movement" that claims that the solution to all of American medicine's problems are medical collectives in which the greater health good can be achieved. Physicians who are locked into the fiduciary model would not be eager participants in this new world and the philosophical trial balloons for a utilitarian alternative have been floating for some time.

Tuesday, August 07, 2007

Fewer internists passing re-certification exam

According to an ABIM website in 2001 the first year of the current re-certification test for internists 92% passed, in 2004, 86 %passed the re-certification exam ( now called maintenance of certification or MOC) while in 2005 84% passed, now we are told the pass rate is down to 75%.

Is the test harder or less relevant to what internists do and need to know or is the knowledge base of the internists falling in proportion to the test scores? Are younger internists not as sharp as the older docs, a position 180 degrees from the views expressed a while back in an Annals of Internal Medicine editorial by Dr. Christine Cassel in which she defended and accepted an unusually poorly done article- see here for some comments regarding that issue- that claimed as physicians aged so did the quality of their care.

Dr. Cassel, President and CEO of the American Board of Internal Medicine (ABIM) defends the test and opines that perhaps the current cohort of internists are less competitive,whatever that means.She also wonders if those who take the test early (certification has a ten year cycle and some docs may take the test early and she thinks those may be less prepared because they will have another chance before they are defrocked.)

I have a theory that could actually be tested by surveys of the test takers. Could the decrement be due to more general internists limiting their practice to office patient encounters? If you never treat seriously ill patients in an in-patient setting how current do you feel you should be in regard to a wide variety of medical conditions? Your practice is more involved in seeing if your patient is at goal for this or that and have they had their bone density and flu shot than the choice of antibiotics for a seriously ill patient with pneumonia or sepsis or how to manage emergent upper GI bleeding. It would be interesting to know if internists who practice as hospitalists do better than those whose office day is closer to that of the typical family practice physician.

Hospitalist-A deal with the Devil or why bother to learn all that ICU stuff?

D. Rob has a thoughtful piece concerning his group's (IM-PED) experience with the new world of the hospitalist. Dr. Rob is a meds ped physician and in the era pre hospitalist he spent considerable time caring for sick IM patients in the hospital and taking call which on weekend was often a time of no stop work.

Enter the hospitalist. Now his office is more available to patients ( longer hours), his pay per time spent is better, and there is more sleep and family time. This , in a many ways, could be portrayed as a win-win situation for the office based physician who does not do hospital work.

But ,as he explains, everything did not get better. His patients ( the folks he sees now only as outpatients) have their care fragmented and all are not pleased by having a stranger as their doctor at a time when they are sickest and most vulnerable to stress and fear. He laments that typically there is a major informational disconnect between the in and the out patient care.

So it is a trade off. If you follow the money you have to conclude that there is little chance that the hospitalist movement will be reversed. Both the hospitals and the office based physician seem to benefit financially.

If a residency trained internist becomes a "officist" you have to wonder what was the point of the ICU, CCU sick-patient training in the hospital that he endured and that in fact took up the bulk of his training. I suppose you could say he will be more able to recognize who needs to go be temporarily managed by the hospitalist and arguably better at zebra spotting which could be offered as one feature distinguishing the office internist from the FP physician which may well be a distinction without a difference in the eyes of the patient . As best I can tell and as much as I hate to say it in regard the average 10 minute encounter with a blur of a white coat there is little or no difference if the coat is worn by a FP or IM doctor except the former probably does a better job with derm and office type ortho problems.

Thursday, August 02, 2007

Air quality in airplane cabins and TB

I have held for a long time an erroneous idea of the risk of disease transmission aboard airplanes.I envisioned the passenger cabin as some sort of 3-d Petri disk crammed full of various viruses and other pathogens just waiting for a new host.

An excellent article in the July 2007 issue of Mayo Clinic Proceedings corrected my misconceptions. The editorial " Dealing with threat of Drug-resistant Tuberculosis" written by Dr. Priya Sampathkumar is an excellent review of the basics of drug resistant TB and the quality of air in a plane from a medical point of view and can be found free, full text here.

He tells us that the recommended rate of air exchanges in a hospital isolation room used for TB patients is 6-12 exchanges per hour while modern passenger aircraft have 20-30 exchanges per hour. Further,there are high efficiency particulate air filters that remove 99.9% of particles that are between 0.1 and 0.3 micra. The TB bacteria is about 0.5 to 1.0 micra. More reassurance comes from the fact that air enters and leaves the cabin at the same seat row there being little flow from the front to the back of the plane. Of course, all of this assumes everything is working as it should and as always anything that can work can break down. The cases of TB that have been linked to in-flight exposure apparently all occurred in persons who were seated within 2 or 3 rows of the patient.

White Matter Lesion (WMLs) link hypertension to frontal lobe dementia

A good deal of evidence links leukoaraiosis (white matter lesions or WML) to decline in executive function and there is much evidence linking WML to hypertension.

Here is a recent paper linking non-amnestic mild cognitive impairment(MCI) to hypertension.
A number of cross-sectional studies linked hypertension with WML, here is one prospective study showing the same findings increasing the weight of the evidence of the association.

The periventircular WMLs seem to correlative with frontal lobe dysfunction ( such as diminution in executive function) and also with abnormalities of gait. In fact, a paper from the Bronx Aging study published in NEJM showed a clear relationship between the development of a "frontal lobe" type gait and the subsequent appearance of a vascular type dementia with relatively good retention of verbal memory skills but much difficulty in executive function. The widely used Mini-Mental status is not a great tool for detection of the "hypo-frontal" patient. Watching the patient walk can give valuable information about the elderly patient whose mental status has become an issue.

Oscar the cat,confirmation bias and NEJM editorial judgement

All of the above topics were touched upon in an excellent posting by Dr. Steven Novella. You would expect the President of the New England Skeptical Society to be skeptical and he is as he discusses the matter of a nursing home cat whose visits to residents of a certain nursing home are claimed to portend imminent death. An article in the NEJM called national attention to this claim.

One thing to consider in regard to this and similar claims, this would include the famous seizure dogs and weird things happening when the moon is full, is the phenomenon of confirmation bias. A related thought is expressed in the concept of "numerator based"statistics. In Oscar's case the article in the NEJM failed to give us the denominator of interests , i.e. the number of visits made by Oscar to patients' rooms and beds.

Should the NEJM publish stuff like this? It may well have been intended to be a cute (although nursing homes deaths might not be considered the stuff of cuteness) rather whimsical piece of writing and nothing more, but the editors might want to consider how much impact their publication has and that rightly or wrongly folks tend to believe what the NEJM writes.

Wednesday, August 01, 2007

You can tell a big thing from a little thing but a litle thing from nothing at all is really hard

I have obsessed about the issue of small relative risks before and quoted some folks who know a lot more about it that I do. One of those folks' quote is paraphrased in the title to this piece. Michale Thun,VP of epidemiology and Surveillance at the American Cancer Society said:

With epidemiology you can tell a little thing from a big thing.What's very hard to do it to tell a little thing from nothing at all.

If you don't think it is hard, plow through the material presented to the FDA panel and their considerations in regard to the issue of Avandia cardiovascular safety.

Robert Temple ( of the FDA-at least at the time he was quoted) said in regard to the topic of "small" relative risks,

My basic rule is if the relative risk isn't at least 3 or 4 , forget it.

The relative risk in the Avandia, NEJM Nissen article was 1.43. That was not ignored and not forgotten. So is this purported increase risk in cardiovascular events that is attributed to Avandia something or nothing at all ? The experts at the recent FDA hearing couldn't really agree on that. Some thought the evidence indicated an increased risk really exists while others believed that the data was not sufficient to reach that conclusion.

The fact that something is a close call does not mean we can suspend action. Even if something is close sometimes someone has to make the call. In the course of human events this happens all the time. Human brains seemed to have evolved to make decisions with inadequate data. Issues cannot be debated ad infinitum, at some point a call is made and we move on. The panel made a call: add a warning label about c-v risk and do not remove it from the market. The action of many individual docs and many individual patients will likely to a large degree remove it anyway. I can think of no reason for a physician to add Avandia to a diabetic patient's treatment program in light of recent events even though we may never know with apodictic certainty if there is an increased risk of heart attack or not. I wouldn't prescribe it because people are worried about it and there is a drug in the same family that could be used not because I know that the Peto method-used by Nissen-was the statistically correct thing to do and his analysis lead to the "correct" answer. ( Heck, I have no clue as to what the Peto method really is.)

The Nissen relative risk may not have been "big" in the sense of a big RR such as 7 or 8 designating the risk of cigarette smoking and lung cancer and we may never be able to determine what the risk situation really is but it was big enough to kick off a argumentative storm that likely will lead to the demise of Avandia with the statistical arguments put forth by the statistical team at Glaxo falling on the deaf ears of many doctors and patients.