Wednesday, January 28, 2009

Concentrated benefits and diffuse costs-no need for docs to fight each other over the pie

Alex de Tocqueville is quoted as saying:

The American republic will endure until the day congress discovers it can bribe the public with public's money.

Well, he was partly right. He implies that day will not be a good thing and that discovery would lead to much mischief and worse but he greatly underestimated how long a country could slog along with the congress doing that very thing as a major-perhaps the major- activity.He underestimated the economic power of a free country.

The notion of concentrated benefits and diffuse cost was given much academic credibility and stature by the works of Nobel prize winner, James Buchanan,who developed what has become known as Public Choice theory.

Here from an interview in Canada is the way Buchanan explained the concept.

We have a system of taxation that is fairly general, so the cost of something is borne by everybody. On the other side of the budget account, concentrated spending benefits go to particularized groups. Through trading among these groups, coalitions are built up to benefit from that spending but the costs are spread out through taxation. That spending is very concentrated and brings pressure to bear on your political leaders, who are pressured to pass special interest, sometime called "pork barrel" legislation. You can get a coalition of senators from particular states in my country, for example, who want to construct highways or dams or ports which may well be very inefficient. The taxes would be paid by the people over the whole country, but the benefits would go to the few people in those particular locations,

We talk about special interest groups, the founding fathers talked about factions.James Madison worried a lot about the matter of factions.

The economic stimulus-recovery package proposes some 20 billion dollars to provide electronic medical records to "most" American in the next five years. A feeding frenzy is likely underway to share in this opportunity.Maybe the benefits will accrue to the patient and things will be much easier for the physicians and quality will soar and costs will plummet or maybe the major beneficiaries will be the vendors of the systems to provide the EMRs, who needless to say are ramping up their lobbying efforts as I write.

With a economic stimulus package that supplies only 7% of the stimulus to be spent by the end of 2009 and only 110 of the 355 billion by the end of 2010 ( GBO figures) we will see the hoped-for stimulation after many economists believe the recession will be over anyway. So what is this about anyway? See this interpretation from the blog, Austrian Economists by Steve Horwitz) which argues that much of what is said to be a stimulus are usual suspects,i.e. the off- the- shelf ideas that were waiting for a crisis to get passed and not have any arguable stimulatory effect at all and certainly not in the relevant time frame.

Thomas Sowell describes the current plan this way:

Out of $355 billion newly appropriated, the Congressional Budget Office estimates that only $26 billion will be spent this fiscal year and only $110 billion by the end of 2010. Using long, drawn-out processes to put money into circulation to meet an emergency is like mailing a letter to the fire department to tell them that your house is on fire.

(Warning :"Irony and sarcasm alert")
Everyone who knows how things work in Washington and have the means to do so are scrabbling around to get their piece of the pie that is alleged to be a stimulus. For some recipients it will be a stimulus or at least a nice windfall. With that in mind, I have to think that this suggestion by a primary care doctor to increase primary care payments by taking money away from others in the health care business is not only doomed to failure but primary care docs' efforts would be better spent by doing what everyone else is doing in Washington, i.e. elbowing for the pie.It is a time honored technique.

Monday, January 26, 2009

Universal health care-a religion or a bureaucracy

There are a number of conscientious, well meaning physicians who strongly believe that the problems of the current U.S. health care system can be solved by having a universal payer (aka the government) or at a minimum that such a system would improve things significantly. There are other conscientious, well meaning physicians who have also spend much time thinking and writing about the alternatives who believe exactly the opposite. Those in the second camp might think those in the former group are members of the church of universal health advocacy, a view expressed in this posting from Cato's blog.

I have quoted Thomas Sowell before. In this entry I wrote about his exposition of two very different visions and the explanatory power of that formulation.

Sowell's "Visions" are world views- or simply put- the way folks see how things work and how things are largely because people are the way they are. Sowell speaks of two such views-the constrained or Tragic view versus the unconstrained or Utopian view.

The Cato blogger would seem to fit into the first category and at least some of the advocates of a single governmental health care payer into the second.

For those who view the world through the Tragic view lenses, humans are basically limited creatures with those limitations involving their knowledge, virtue and wisdom and therefore social arrangements must take these inherent limitations in mind. The Utopians think differently believing that these limitations are due to the flaws of society and its arrangements and they can be overcome and that they should be overcome by better plans and putting better people in charge,often the same people who advocate for those putatively beneficial changes.


In the Utopian view, social inequalities such poverty,uninsured patients,drug addiction, not owing a home, racial or gender imbalances are seen as resulting from faults in society and therefore demand that social targets be developed and plans be made to rectify the social problems. The tragic Visionist would be concerned with the self interested motives of the people who are tasked with carrying out the programs and also with the unforeseen and unintended consequences that such projects seem to routinely bring about. The self interest and unintended consequences have been amply discussed and documented by the Public Choice school of thought authors. Utopian view physicians would celebrate the introduction and insertion of the concept of social justice into the new medical professionalism.

In the Tragic view, man is constrained by his moral limitations and his egocentricity. The social challenge is how to work with those limitations rather than engage in energy wasting and ultimately futile efforts to change human nature.In this view, one deals with trade-offs and not solutions. Benefits to society derive from actions largely unintended but emerging from market actions which derive from the pressures of the incentives for individual gain which include the monetary and the psychic.

If the tragic vision folks might see the Utopians as being faith based in their advocacy of a single payer I wonder if the reverse is also true. That is, do the utopians view the tragic world view's advocacy of individual freedom and market solutions also as a faith based initiative.

As Sowell has suggested advocates of both views typically frame their arguments by cherry picking facts that seem to conform with their vision and and the two camps rarely actually discuss or debate issue but rather talk past each other and cannot often even agree on what the terms of the discourse really are.

Friday, January 23, 2009

Forces gathering to blame the patient

There seems to be much blame to go around for the health care "crisis"-the physician,the hospitals,the insurance companies,the managed care companies, the pharmacy management companies, the Medicare payment system and most recently the patient.

Several factors, influences,movements, and lines of thought leading to the blame-the- patient notion include.

1)Basic human emotions-These tended to boil up in many of us as house officers, when fatigue and frustrations peak and we thought why are we wasting our time (and possibly sleep time) on someone who basically has brought the illness or its severity on themselves. Charges against the patient included; alcohol excess, or negligence, not wearing a seat belt or eating too much and not exercising or smoking or using illicit drugs.

A variation of this theme appears from time to time in comments and blog entries by emergency room docs who lament their interactions with citizens of unsavory character who often populate the ERs.

2.The P4P movement in which physicians are rewarded or not based on group outcomes. Their report card may look bad and their compensation may decrease based on numbers of their patients having the audacity to ignore advice or stubbornly refuse to live according to the healthy life style of the day and thereby arguably not meet their goal for HbA1C, blood pressure or something. If the physician's rating or income suffers from missed appointments or a patient's failure to have a given procedure so may the attitude of the physician towards the patient.

Drs JF Whatan and Daniel Salmasy writing in a JAMA Commentary entitled "Improving the Quality of Health Care.Who is responsible for what" (2009;301(2),215-217 (subscription required for full text of the article) point out the obvious but increasingly ignored fact that physicians have a obligation at an individual patient level but are increasingly judged by group or population level data. They quote Aristole who captured this issue

The doctor does not treat ‘man’ except accidentally; he treats Callius or Socrates or someone else described in this way, who is accidentally ‘man’. So, if someone has grasped the principles of the subject without having any experience, and thus knows the universal without knowing the individuals contained in it, he will often fail in his treatment; for it is the individual who has to be treated.

3.The collectivist-utilitarian mind set that says if the government (or society- even though the two are not the same) is going to pay for your heath care then you should loose your seat at the public trough if you do not comply with the rules it makes to keep you health.

This view has been expressed by several commentators.This one by an internist ( Dr. Chris Rangel on his bloghttp://www.rangelmd.com/index.php/2009/01/10/holding-patients-accountable-with-government-health-care/) explains it this way.

..the state has a practical interest in keeping the workforce healthy and reducing the economic burdens from people who become sick and disabled as a result of unhealthy or risky lifestyles (the reason seat belt and helmet laws). This is a utilitarian principle. Such policies benefit all citizens.

In counterpoint to all of forces blaming the patient or assigning societal obligations to her, I remember the comments of Dr. Lawrence J. Hergott in a JAMA article (JAMA Feb7,2007,vol.297,#5,p 477)

May I never see in the patients anything but a fellow creature in pain.

Not as someone who deserves his dyspnea because of cigarette use defying years of advice to quit, not as someone whose ascites is his just due from profligate use of alcohol, not as someone who should not be in this country at all, not as someone who would not be having the myocardial infarction at all if he had done what his doctors told him to do and not as someone who is taking "scarce medical resources" from someone who deserves them more or for whom the treatment could be more cost effective but as a fellow human whose is in need of what physicians spent so many years of their lives preparing themselves to be able to offer.

Thursday, January 22, 2009

Proposal to spend 1.1 billion to save money and lives

There is a bill before the House of Representatives that would fund a project to study comparative effectiveness of new medications and medical devices. I believe this is House Bill S-3408 offered in 2008.

Advocates claim not only would money be saved but so would lives. Interestingly, the governmental Congressional Budget Office has apparently said that this type plan will not really save much ( see here for a 2007 GBO report on the issue of costs and benefits from a comparative effective research center) and I wonder how would such a program save lives.

The British agency ( called NICE) that is in charge of approving or limiting certain treatments for certain conditions in Great Britain arguably has cost lives by disallowing certain treatments. See here for a 2008 NEJM article touching on some of the pros and cons of this British agency including certain of the denials of care that attracted more than a little press coverage.

I believe the argument for its life-saving function might run like this: By limiting certain treatments that are not cost effective we can shift the money to other treatments which will save more lives, i.e. more lives saved for the buck., a utilitarian claim of the greatest good for the greatest number. In the NEJM article we find this quote from the chair of NICE which captures that line of thinking fairly well: If we spend a lot of money on a few patients, we have less money to spend on everyone else. We are not trying to be unkind or cruel. We are trying to look after everybody."

Looking out for everybody is a tough job but cost effectiveness analysts claim they are up to the task as apparently did Dr. David Eddy in a series of articles in JAMA over ten years ago that proposed that type of planning and control within the context of health care entities such as HMOs, a topic I wrote about here expressing my opposition to Eddy's philosophy.

See here for a op-ed expressing concern about the current House bill by Dr. Scott Gottlieb.

The NEJM author summed it up this way " .. such an institute could help to improve quality and slow escalating costs only if it were able to make tough calls and remain independent of political and financial interests."

When big bucks are involved remaining independent seems very unlikely.

Abnormal cardiac function. limits exercise-you've got to be kidding me

The blog, "ACP Internist" has an occasional feature called "Medical News of the Obvious". A recent news item in the AMA morning E mailed report stated " Study Indicates abnormal heart function may impeded ability to exercise"seems to break new ground in that regard but actually what the referenced article demonstrated was significant and not what we really knew all alone. Just a somewhat sloppy headline by the reporter.

The article entitled "Left Ventricular Function and Exercise Capacity" involving over 2800 patients studied at Mayo Clinic (see here for abstract, subscription needed for full text) has this paragraph for a conclusion:

In this large cross-sectional study of those referred for exercise echocardiography and not limited by ischemia, abnormalities of left ventricular diastolic ( my bold) function were independently associated with exercise capacity.


Diastolic function , until fairly recently, has not been regularly measured and this article gives strong data indicating that patients with diastolic dysfunction (such as many of the elderly and hypertensive patients with normal ejection fractions and smallish, poorly compliant left ventricles) may well have exercise limitation on a cardiac basis. This would seem a bit obvious simply from a consideration of the physiology of cardiac function but this study does provide much data documenting the relationship between exercise capacity and diastolic dysfunction. In evaluating a complaint of exertional dyspnea a cardiac cause is not excluded by a normal ejection fraction.

Wednesday, January 21, 2009

Why would the Med-Fed board be immune to "regulatory capture" and undue influence

Tom Daschle is promoting the idea of a Federal Health Board that would in his words:

" set standards for benefits and quality for federal program and insurance." he continues:

Just as the Federal Reserve ensures certain standards, transparency and performance for our banking industry, the Fed Health would ensure harmonization across public programs of health-care protocols, benefits, and transparency. Ultimately, the Fed Health would offer a public framework within which a private health-care system could operate more effectively and efficiently.


See here for some more of his comments on the virtues of his plan.

If I were arguing for such a board, this last analogy I would want to make is reference the agency that was said to ensure standards and transparency and performance of the banking section. If the proposed Fed-Med lived up to the Federal Reserve's performance in regard to credit and loans, no one would be able to get medical care even though the government had just thrown billions into the health care industry to "shore it up'"

Thanks goodness, we had the Federal Reserve Bank and the FDIC and the SEC as well as several banking regulatory agencies or we would have a had a frightening financial meltdown.

While there are many folks and organizations that rightfully share the blame for recent financial meltdown there is a strong case that can be made by a major element being regulatory failure. See here for a discussion of that.

One of the reasons that can lead to regulatory failure ( but not the only one) is the phenomenon of regulatory capture.

Wikipedia explains the term "regulatory capture" this way:

Regulatory capture
is a term used to refer to situations in which a government regulatory agency created to act in the public interest instead acts in favor of the commercial or special interests that dominate in the industry or sector it is charged with regulating.

A national board with the power and influence that a Med-Fed would have will attract what economists called rent-seekers like flies to honey or some similar Dan Rather simile.(Basically we are talking about the efforts to cut one's self a bigger piece of the pie)
Medical equipment manufacturers, drug companies, rehab centers, managed care companies might all see the opportunity to score big.Medical Associations, hospital organizations etc etc- just about anyone and anything that wanted a bigger piece.

The Interstate Commerce Commission is often highlighted as the poster child for a regulatory agent that did more favors for the alleged regulated entity than acting in some nebulous public interest. However, the history of the FDA strikes closer to medical home. See here for the most recent expose of how that agency failed to monitor potential conflicts of interests in investigators who contributed to research used to support the approval of medications. Further, it is hard to forget their track record in the matter of telithromycin. OK some of that is more properly the typical bureaucratic way of doing things and not actual capture. It took the FDA about a year to re-analyze the Vytorin data and conclude that folks on that med and doing ok need not stop and that lower cholesterol is really better.Wow,only a year and somehow a federally mandated organization will- according to Daschle- be able "harmonize benefits and health care protocols" presumably for everything.

The health care protocol idea is being promoted by David Snow, CEO of Medco. Medco is the same organization that,as explained in this Sept 30, 2003 NYT report,that was accused by the federal government of destroying medical prescriptions,not filling prescription bottles with the ordered number of pills,lying about contacting physicians,coercing pharmacists and paying bribes to get contracts. DrRich has commented on Mr Snow's recommendations suggesting that an additional benefit would be solving the country's shortage in primary care physicians.(Warning for readers offended by frontal irony and sarcasm).

Tuesday, January 20, 2009

Clearly there is no end to the postive benefits for statins-the list goes on and on

I have written several times before expressing my amazement at the ever growing list of positive medical benefits that the statin group of drugs are said to bestow.

Here is a reference to a review that concluded there can be a significant reduction in the onset of atrial fibrillation with statin use. Here is reference to another review that analyzed the course of over 30,000 patients and found a 43% reduction in death following heart surgery for those given pre-op statins. And it seems good not just to prevent death, here is reference to an article from Canada that found a reduction in post-op delirium of almost fifty percent from statin use.

Of course, there are always doubters. Intrigued by observational reports that statin users were at lower risk from sepsis and were less likely to die from sepsis if they developed it, a group from Canada did their own investigation and failed to confirm a mortality benefit and offered the argument that, at least, in some of the observations studies that concluded a benefit in disease X, Y or Z from statin use that we were seeing our old friend , the healthy user effect.

With case controls studies and observational data analyses, all sorts of correlations will emerge, some of which will suggest negative effects of a medication. You have to wonder how many data dredging exercises with negative results never see the light of a published page . However,some have been reported in regard to statins. For example, a study from France raised the possibility of tendon damage from statin use. See here for earlier comments on that.There was also concern expressed about a possible association with statin use and risk of Parkinson Disease.

There is at least one disease in which statins may not be beneficial.This report suggest adding statins to inhaled steroids for asthma did not seem to help.

Sometimes, the magnitudes of the reported benefit are neuron boggling such as this report of a case control study that demonstrated an 83% reduction in death from COPD in statin users. The sicker COPD patients have lower and often quite low LDL levels and would be very unlikely candidates to have been treated with a statin in the first place and the healthier patients with airways obstruction were more likely to be treated to lower their LDL. We may have here not only a "healthy user " effect but an "unhealthy nonuser effect" which is one of the problems of working with "coarse grained data". When something seems to good to be true...

I like to call observational studies coarse-grained instruments with bias and confounding being the basis for the coarseness as well as often a dearth of patient specific data These hidden variables may lead to an association that is not real. We can only be confident that the calculated confidence interval takes only random variation in the data into account . It does not fix everything. Various types of bias and confounding are beyond its command,a point rarely made in the press blurbs about various benefits and harms of medical interventions.

Monday, January 19, 2009

Case study.How price controls in Medicine has worked out

Legislation was passed in 1991 and put into place in 1992 that effectively imposed on a major component of medical practice in the U.S. controls on physicians charges. Controls had already (1984) been placed on hospital charges for Medicare patients in the form of a Prospective Payment System. There were three major elements in the legislative action regarding Medicare fees for physicians.

1.The billing known as "CPR", or customary,prevailing and reasonable was replaced with a relative value formula for determining the maximal prices that could be charged for Medicare patients.

2.The billing practice known as balanced billing was abolished

3.To control growth in Medicare spending a system called Medicare Volume Performance standard was enacted which reduced reimbursement to physicians based on the degree to which total Medicare services increased. So if more surgery, x-rays and other procedures were done, the total amount spent on Medicare doctors fees was reduced to try and keep the global budget from growing.

The predictable effects of these price controls have been seen. Demand for services has increased, quality has decreased.We have seen gaming of the system and politicalization of health care. The type of medical practice that has come to be known as primary care has particularly felt the impact. FP and IM physicians have found it increasingly difficult to deal with the reduced fees . Primary care docs-whose fees were smaller to begin with-have tended to attempt to increase their output by seeing more patients to try and compensate for the decreased compensation per patient encounter by either spending less time per patient encounter and/or employing mid-level health care workers to see patients.The now only recently talked about role of the RUC played a key role in shaping the payment system controls so that primary care docs were the major losers and the procedure heavy specialist did relatively better.

What other profession has its charges limited by federal government enforced price controls? Of course, not all of medical fees are controlled. Private insurers ,however, tend to follow the fee setting of Medicare. While cosmetic plastic surgeons and cosmetic dermatologists and concierge docs can operate outside of this system and pediatricians may play in different ballpark, the effect of the price controls is determinative of much of what is wrong and worsening in American medicine.

The "Medical Home" suggested by the American College of Physicians will be operating in the same environment of price controls and is either naive or is a "wink-wink--nudge-nudge" suggestion that even they do not believe. P4P will only make things worse.

I wonder how many college students would seriously consider medicine as a career if they knew government price controls had been in place since 1992 and there was little if any hope of the situation changing.

Although price controls can be blamed for much of the perfect storm that is causing havoc in American medicine, at least two other factors are at work: 1)the phenomenon of spending other people money 2)the mind boggling developments in technology and therapeutics of the last several decades. Both of these have amplified the increased demand for medical services and it is not surprising that the "other people" ( government and other third party payers) have moved to enact measures to control costs which most notably are managed care and now P4P. The "measurement and forced compliance" managerial paradigm has been transplanted into medical care as the corporate and government players move to control medical costs in part by controlling medical practice in accordance with the current management fad of the day.

So, how have price controls in medicine worked out over the last 15 years? Exactly like you would expect : increased demand, shortages in primary care physicians and more recently general surgeons and decreased quality and ever increasing dissatisfaction among physicians and many patients.

The economic stiumlus package for electronic medical records-We are from the government and we are here to help

The following comments by Arnold Kling as quoted in the blog EclectEcon might be worth thinking about as we read about the amount of money ( 20 billion) that is planned for providing the means for most U.S. citizens to have an electronic medical record by 2014 according to the stimulus or recovery plan of the new administration.

It is true that markets have been overwhelmed by today's information problems, and consequently resources are unemployed. However, the ultimate solution of where resources belong is not known by government officials any more than it is known by private investors. A large "fiscal stimulus" is, ultimately, a major transfer of power away from the trial-and-error process of entrepreneurial markets and instead toward the bureaucratic planning process. It is not clear to me that technocrats have suddenly acquired the wisdom that would justify such a transfer. In fact, while they may have an air of certitude, they may know even less than usual about the best future direction for economic resources.



Here is the entire lecture by Dr. Kling.

Friday, January 16, 2009

doctor-nurses versus doctor-doctors-The AMA makes it clear where it stands

We already have doctors, folks who survive four years of medical school and then from three to six years in residencies and fellowships and pass a daunting battery of tests along the way.

We already have folks who complete a defined educational program in nursing and we have some nurses who then go past that level of education and take extra training to become advanced practice nurses. State laws vary in how much autonomy such folks have but the very name "mid-level " providers informs us that they are not at the same level as physicians.

So one wonders what would be the reason for existence of a new professional one that is a doctorate level nurse. Here we are talking about a clinical doctorate- not the PhD s that some nurses obtain in nursing educations. There is a so-far-fairly small- movement in the land which proposes that this new category of clinical practitioner is what the health crisis needs . The argument goes that there are not enough primary care physicians and too many nurses leave nursing for more rewarding careers and this doctor-nurse position will fill that need and we are told by the apparently self appointed spokesperson for that movement that:

A nurse practitioner with a DNP has achieved many of the competencies [of physicians]but through nursing education they will have the same skills in identifying a disease state and treating it but it is a different hybrid of care.


Apparently this doctor-nurse position will be rewarding and attractive to nurses even though the argument that primary care is becoming less and less attractive .


Dr. Mary Mundinger is the Dean of the Columbia University School of Nursing and holds a doctorate in Public Health (not the DNP degree she is proposing) and in this era of increasing awareness of real and perceived conflicts of interests, one has to notice that she is a director for United Health Group holding -as of Dec.11,2007- 32,000 shares.

The AMA has taken spoken out in opposition to this new clinical professional. In this era of increasing awareness of real and perceived conflicts of interests, one has to notice that the DNP would be competition for physicians.

So what is behind this doctor-nurse movement? Is it ,as Dr. Mundinger suggests,, the paucity of primary care docs and the purported exodus of RNs from nursing or can we see what is really going on if we follow the cynical but venerable follow-the-money rule. Here is DrRich's take from his June 17,2008 blog entry.

Having taken such careful pains to make primary care medicine so exquisitely unattractive to present and future physicians as to assure that the growing “PCP shortage” will become the next real medical crisis, the healthcare system is now grooming its solution to this manufactured crisis, namely, the doctor-nurses. These doctor-nurses will fulfill all the criteria the healthcare system desires for its practitioners of primary care medicine (no matter what healthcare reforms we may end up with). They will be “doctors” who are duly “certified” in primary care medicine by respected testing organizations, who have just enough training to diagnose and treat the average patient (i.e., the ones with high blood, low blood, fat blood and sugar), and who will cheerfully, unquestioningly (and with far better compliance than MDs - what with their traditions, attitudes, etc. - can ever hope to offer), follow whatever guidelines are handed down to them by the experts. And they will do it all for less pay and with less lip than the now-obsolete physician PCPs. These new practitioners of primary care medicine will be a perfect fit.

If you accept this analysis you can appreciated that Dr. Mundinger could have a conflict of interest as she is a board member of a organization that could profit from the care and feeding of this new breed of health care professional,namely (at least for a while) they will work cheaper.

Reports of potentially serious error in VA's computerized health records

The electronic medical record system at the VA system has for the most part received very high marks from various observers and users. However, problems with that system have recently hit the news after this report by a congressional committee.

Systems have problems and that should be no surprise but two particularly troublesome aspects have also come to light. One, there is the suggestion that this problem may have been keep secret (i.e. were not disclosed to the patients involved) and two the comments of a VA spokesman suggest that the patient should help the staff keep up with the treatment, etc. He is quoted as saying:

"VA believes that veterans are active partners in their health care, and encourages patients to always follow up with their health care teams to ensure that their treatment options meet their understanding and their health care needs."

Next time you are in the hospital semi- delirious with sepsis or a stroke be sure that dose of heparin or antibiotic is correct and conforms with what your physician ordered and that your needs are being meet.

Thursday, January 15, 2009

Lilly pays big settlement in Zyprexa case

For marketing an off label use of Zyprexa, Lilly has agreed to to pay 1,42 billion .
The medication has FDA approval for treatment of schizophrenia and bipolar disease but it is alleged that Lilly vigorously promoted its use to control agitation in the demented elderly as well as in children with certain behavior disorders.A number of physicians, academic and otherwise, took part in various of these promotional activities.One promotional campaign was cutely named "Viva Zyprexa".

In 2007,sales for Zyprexa reached 4.8 billion with total Lilly drug sales of 18.6 billion.

As interns, we carried around black bags that were given to us on graduation from medical school.Lilly gave out those bags and they came with our names on the bag and I think a reflex hammer and tuning fork inside.Big pharma was known as the "ethical drug industry" back then.How the adjective became part of their designation I don't know. It seemed similar to the House Ways and Means Committee always being referred to as the Powerful Ways and Means.The later adjective still applies, not so much for the former one.

I have written about the Zyprexa saga before and in that blog quoted Dr. Patricia Illingworth:

"some commonly accepted principles of business ethics are fundamentally incompatible with medical ethics"

I believe that is true but what ethics precept could Lilly have possibly adhered to in regard to the Zyprexa promotional activities.

Organized Medicine jumps into the "lets Jump start" the economy bandwagon

Dr. Nancy H. Nielsen, president of the AMA, said at a recent press conference

" Health care reform is a key component to jump starting our national economy.....quality,affordable health care is..good for business."

For some reason, I am reminded of the old quote that "what's good for general Motors is good for the country" That quote , of course, has taken on new meaning in the bailout or bridge loan requested by GM. Now we have what's good for health care is good for the economy.

With the degree of direness indicted by the media regarding the financial mess some have suggested that health care issue might have to be put on the back burner for a while.The recent ad campaign by AMA and others ( PhRMa, Blue Cross- to name two) might appear to be an effort to put it back up front, to exactly what ends is not made clear. What is that big pharma and the AMA suggest that will reform health care and somehow also jump-start things? Stay tuned, the ads to come may clarify their goals.

If vague generalities can help jump-start the economy we are off to a good start.Everyone is lining up in Washington for their share of the "recovery" package. We should not be surprised that the AMA does not want to be left out .

Wednesday, January 14, 2009

Randomized Trial comparing lung scan and CT angio

In the tradition of many,worthwhile and very well done clinical trials from Canada investigating various aspects of thromboembolic disease, we now have a head to head comparison between the venerable ventilation/perfusion (v/q) lung scan and the upstart CT pulmonary angio (CTPA). See here for an abstract from JAMA.

Out patients with a Wells Score of 4.5 or higher were randomized to either undergoing the CT angio or a v/q lung scan. There were 700 plus in each group and there was a three month followup.

After reading the article a few thoughts come to mind:

One can with good confidence rule out PE if both the CTPA and lower extremity ultra sound are normal.

It still seems to be true than a normal v/q rules out PE .In this study, 35% of of the patients had a normal study. The majority of v/q scans are non-diagnostic (54 % in this study) and in those patients there is a strong tendency for clinicians to order a CTPA.

More instances of PE are diagnosed by CTPA than v/q but the significant of peripheral defects remains a work in progress,particularly those in sub-segmental arteries. In this study 7% of the positive CTPAs involved the sub-segmental arteries alone.

The earlier concerns about published data indicating low sensitivity of the CTPA seems to have been only the case for the older technique as the new and now in general use multidetector CT has excellent (some might argue too much so) sensitivity.

Both tests have value but the clinical momentum (i.e. beliefs and tendencies of clinical docs) is to favor the CTPA, in part, because so many v/q s are non-diagnostic clinicians reason that it is better to go to the CTPA first. Also as pointed out by Dr. RW the v/q interpretive skills of the radiologists may be on the decline and their skills with angiographic interpretation are on the ascendancy. Even back in the day of flurry of interest in and lucrative nature of nuclear medicine the house officers called it "unclear medicine".

Tuesday, January 13, 2009

Rebroadcast of" Not your father's medical ethics any more"

With the beginning of a new year and the promised changes offered by a new administration in Washington and new players on the scene whose seem to be tasked to "reform"medical care, I brazenly am re-posting an offering discussing the changes that have occurred/are occurring in medical ethics. I have added some and deleted some from the original in an effort to make the thoughts more clear.


__________________

Can the traditional, medical-ethical prime directive of placing the individual patient's interest first survive in a financial environment in which physician autonomy is greatly diminished and income for most physicians is controlled by third party payers?

More broadly put, Dr. Edmund D. Pellegrino asked in 1995 (JAMA,May 24/31,1995,Vol 273,no 20,)

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

In 1988, Hall and Berenson writing in the Annals of Internal Medicine said that "the traditional [ethical ] ideal" was no longer compatible with the changed practice reality that "existing insurance contracts and manged care arrangements define for physicians."

We propose that devotion to the best interests of each individual be replaced with an ethic of devotion to the best interests of the group for which the physician is personally responsible.

Incredibly, the authors claimed that this shift in ethical focus would actually increase patient trust, an attribute that even in the late 80's was in decline as patients tried to live (sometimes literally) with the HMO's restrictions to medical care. Incredibly, they claimed that by not having the patient's interest as the prime directive there would be increased trust in their physician.

The expected wave of letters to the Annals editors expressed the belief that advocacy for the individual patient was the prime directive and what it was all about and to replace it was to effectively do away with medical ethics as it had been known and practiced for a very long time. This is what would be expected from an audience of internists who had grown up medically inculcated with an ethic which was the polar opposite of what the authors proposed. Practicing internists at that time were reared to believe that the physician was completely and ultimately responsible for their patients and that their primary duty was to the patient.

The average practicing internist if they read the article at all may have thought this was the contrived advocacy of someone who was attempting to make manged care appear ethical. All that was required was to turn medical ethics on its head.When I read that article I thought "you've gotta to be kidding me".

A few years later ,I saw no one was kidding as the ACP, ABIM and the European Federation of Internal Medicine joined forces to formulate what was called the New Professionalism in which physicians were admonished to do more than maximize the health of all the patients in their HMO, which was as far as the Annals authors went. Now, physicians were told that they had an ethical obligation to strive for Social Justice. This joint effort by several medical organizations was said to be necessary as the "old ethic" needed to be revised to align itself with the new economic environment in which physicians now lived and "medicine's commitment to the patient was being challenged by external forces of change within our society".

While the 1988 article's authors stopped short of suggesting physicians should conserve resources for others in society at large and not just concern themselves with their own HMO's population, the new ethics or professionalism as it was now called, headlined social justice raising it to the level of the big three ethical precepts-patient welfare, patient autonomy and social justice.More than one observer has asked does precept three conflict with precept one?

The era from 1963 to about 1990 has been termed the time of "retail medical care". Physicians and patients enjoyed the situation in which a patient's insurance followed the patient so that he could choose any physician and the physicians' fees were not set by the insurer but largely were set by what the physician considered and the payer agreed to be "reasonable,customary,and prevailing".

Things were good for physicians in those days as not only was physician autonomy largely unchallenged,but also Medicare had brought about a large influx of money to be spent largely at the discretion of the doctor and their patients and exciting new diagnostic and therapeutic tools were available. More could be done for your patients and more patients could afford medical care. Referrals could be based on the physician's knowledge of the area consultants and prescriptions were written without concern for some third party's list of permissible choices. But soon things were to change as the era of "wholesale medicine" replaced the old ways with the HMO now being a middleman-a very powerful middleman- and Medicare imposed wage and price controls on medical services.

A series of articles was published in 1995 in JAMA authored by Dr. David Eddy that discussed the metrics and merits of decision analysis which he hailed to be a mechanism that could perform magic. The magic was to increase quality of medical care while reducing cost. But it was all merely playing with words and defining words to suit the argument. Eddy defined quality as the greatest medical good for the greatest number within the eco-medical collective (aka HMO). It did not go unnoticed to the skeptical reader that Dr. Eddy listed his affiliation as "Kaiser Permanente of Southern California")

Pellegrino in 1995 also asked ...can physicians change the ethics of the profession at will ( as proposed by Berenson and Hall) or is there a more fundamental and universal foundation for the ethics of medicine in the special nature of the physician-patient relationship?

Pellegrino's quotes are found in an article entitled "Guarding the Integrity of Medical Ethics-Some Lessons from Soviet Russia" . The subversion of medical ethics in Russia suggested to Pellegrino two lessons. 1) corruption will afflict any health system not designed with care of the patient as the its primary driving force. 2) medical ethics must be independent of political exigency. "... a morally responsive profession is an indispensable safeguard for the sick against the statistical morality of utilitarian politics, even in democracies."

The statistical morality of utilitarian analysis seems to be increasingly unopposed as the group outcome derived data plays an increasingly large role in the decisions regarding the individual patient exhibited in part as guidelines executed by mid level practitioners as well as physicians. In this new day, the physician has more to worry about that just her patient, she must be concerned for everyone (as allegiance to social justice would demand) but at least she has been removed from the impossible role of being responsible for every aspect of his patient's well being as she is now (merely) a member of a team or perhaps the host of a medical home and part of a system of health care. It takes a village now to treat a patient.
______________
With increasing pressure for a single payer health care system and talk about a federal health board to determine what should/shall be done, the statistical morality of utilitarianism seems more and more on the ascendancy. As much as I do not want to believe it, more and more I am afraid that the old medical ethics may well have been and is now the "artifact of economics" about which Pelligrino speculated.

Monday, January 12, 2009

If you discuss health care reform you cannot ignore RUS

If you profess to analyze health care financing-with or without offering a fix to whatever problem(s) you believe to be present-you cannot leave out consideration of the role of the mysterious and powerful RUS. (The RUS is the RBRVC Update Committee .Here is a link to the AMA description of that entity.)

Yet,this seem to be exactly what one of the most widely quoted health care economists has done. Dr. Roy Poses discusses this interesting omission in another of one of his home run blog entries.

The economist is Professor Uwe Reinhardt of Princeton and the discussion at issue can be found here. Reinhardt places at least some of the blame for the high cost of medical care on the fee for service system.Interestingly, he does not mention that the current fee-for -service system has- since 1990- become one that is characterized by wage and price controls -at least as for as payments for Medicare is concerned.

Dr Poses says that there are strong positive incentive for procedures and strong negative incentives for cognitive services ( this includes much of what primary care consists of) and there are many interested "stakeholders" favoring the growth of procedures. These incentives in large measure can be traced back to the mysterious and only recently talked about RUC. that advises Medicare what to pay for various medical services. They provide a major input to Medicare in that regard.

If we regress further back in the causative chain, we note that the RUS is a child ( born in 1991) of the changes that took about 1990 in Medicare payments from what was called customary, reasonable and prevailing payments for medical services to a Medicare determined price control system. With such a price control system there was a need for a mechanism to set the prices and somehow the AMA was able to insert a committee into the system that would enjoy a powerful position that is virtually invisible to scrutiny.

Poses raises the question as to why Reinhardt would apparently omit the effect of the RUS on medical costs and I would additionally ask why he ignores the effect of wage and price controls on medical care. He then presents some interesting associations of Professor Reinhardt including the fact that he is on the board of an insurance company and a medical device company.

So, are we just playing around with an ad hominem fallacy.The fact that Reinhardt is on the board of and holds stocks in these companies does not necessarily mean that his analysis would be biased in favor of a conclusion beneficial to those entities even though he owes them fiduciary duty.One should evaluate his analysis without considering how those relationships might bias his conclusions. Fair enough. I challenge his conclusion based on his not explicitly taking into account wage and price controls and the power of the RUC and that the use of the term " fee for service" is misleading as the fees are basically set by the federal government for Medicare and for practical purposes (other than retainer medicine practices) adopted by the other third party payers.

What is not an ad hominem argument but a question regarding transparency is Poses's exposition of how those relationship do not appear in his Reinhardt's Princeton website CV nor in his disclosures in a Princeton Bioethics Forum ( give me a break- in an ethics forum he does not disclose possible conflicts of interests) nor when he discussed health care finance on NPR. Interestingly, Reinhardt is also on the editorial board of JAMA. (My web search efforts to locate the listing of possible conflicts of interests for those folks was unsuccessful.If anyone has that link,please let me know.)

To discuss the problems with medical care and medical care financing without substantively considering the role of price controls and the pivotal role of the RUC is not limited to Reinhardt's commentary. A NEJM round table discussion that purported to talk about redesigning primary care did the same thing. If you want to know what is happening with medical care, Roy Poses's discussion of that NEJM article is required reading.

Friday, January 09, 2009

Hospitalists,nocturnalists,admitologists,anyone rember personal physicians

A recent perceptive,poignant, essay has attracted the attention of two of my favorite medical bloggers. Dr. RW and DB have both blogged about this entry by Dr. Cherie Glazner.

At least the patient described in the narrative saw a physician. While jogging last week I was listening to a local call-the-doc talk show. The first caller's narrative was that he was recently seen by a cardiologist (actually he was not seen by a cardiologist but by his PA). He was told that his aortic aneurysm has grown from 3.5 to 4.5cm in diameter over the last year and if it grew to 5.0 cm he would need to have surgery. The caller did not indicate displeasure at not being able to discuss this with his doctor but was calling for more information about what would need to be done if the growth continued.

The second caller was also asking for information. He had a heart scan as part of a "wellness" evaluation and had a score of 600. He "saw" a cardiologist at a local heart center (actually had appointments at the doctor's office, he never saw him).An isotope stress test was done and he was told by the nurse that he had "no significant blockages" and he
should return in a year or so for followup.

Yesterday, I saw my dentist and following the hygienist poking about and cleaning, he poked about a bit and we briefly discussed a bridge issue. He then talked at some length about how he really didn't like the situation with his allergist with whom he had appointments but never was seen by anyone other than his NP. He pointed out that he always "sees" his patients.

My urologist is a dinosaur.I saw him last month.Yes,I actually saw him and talked to him and he actually examined me. When in practice i frequently referred him patients. Back then he would schedule both the patient and his wife for the last visit of the day so there would be time to describe exactly what the treatment options and complications for prostate cancer would be. He said he still does that. His economic situation was such that he and his 3 partners merged with 3 other practices and partnered in some way I did not understand with a therapeutic radiologist in the hope that their practice would still be viable.

My brother-in-law has coronary angiography following an episode of chest pain and an EKG that "showed some problem." After the cath, he was seen by someone in a white coat that he had not seen before . The white coated,scrub suited man explained the procedure very briefly ( there were " no significant blockages"),gave him several prescriptions and told him to call the office for a followup visit in 6 weeks. My sister said that somehow he didn't seem like a doctor.I told her he wasn't, he was a PA ( I looked him up on the state board's web site).He was later seen by the PA for the office visit.

I was having lunch yesterday with another retired doc.We talked about things like the above and he said "it is amazing, isn't it? It is really all about economics.When we began practice (35 plus years ago) we could afford to be generalists and take time to talk to patients and not delegate to NP and PAs (where they even around then?) but now we couldn't." He said "you just don't get paid enough to do what we used to do.The image in your head of the type physician you think you were trained to be cannot realistically exist under the current economic situation."

Thursday, January 08, 2009

SNIP associated with statin related myopathy

The August 21,2008 issue of the NEJM published an interesting paper entitled " SLCO1B1 and statin-induced myopathy" by the Search Collaborative Group.

They found a SNIP (Single nucleotide polymorphism) that is "strongly associated with an increased risk of statin-induced myopathy" .They used 300,000 markers -a genome wide scan- and ferreted out a SNIP on chromosome 12 that is related to the liver uptake of statins (I am not sure if this is all or just some statins) and a certain allele was associated with a odds ratio of an impressive 16.9.

This beats the heck out of the relative risk in the range of 1 to 2 that from time to time stirs up inappropriate concern and sophomoric media attention derived from a quick and dirty case control study.

The primary data source was from the SEARCH trial of over 12,000 participants from the UK who had a history of myocardial infarction and received either 80 mg or 20 mg of simvastatin daily. Definite myopathy (CK greater than 10 times the upper limit of normal plus muscle pain occurred in 49 of the 6031 subjects receiving the 80 mg dose, with 2 occurring in the 20 mg dose group. The odds ratio was 16.9 for those who were homozygous for the C allele. 60 % of the simvastatin associated myopathy cases were attributed to the gene variation. For the other 40% other cause or causes remain undetected. In those patients with myopathy using a high throughput technique about half a million genetic markers were screened. The results were replicated when applied to subjects from the Heart Protection trial with myopathy and an elevated but less impressive relative risk of 2.6 was demonstrated.

Note that presence of this particular mutation does not mean the patient will necessarily develop a myopathy and a number of patients without the SNIP will develop myopathy. So why is that? The physicist John Wheeler is quoted as saying:

"As the island of knowledge grows so does the shore of our ignorance."

but at least we seem to be making progress and the occurrence of myopathy related to statin use is now a bit less random and a bit more deterministic but we still have not squeezed all the randomness out.

In this age of the mega randomized trials and the chanting of treat- to- goal based on group data we might want to sit back sit back and remember the ecologic fallacy , what seems true for the group may not be true for any given individual.

Wednesday, January 07, 2009

COPD-Should we consider it one disease ?

Dr. J.J. Reilly authored a thought provoking editorial in the October 9,2008 issue of the NEJM,entitled " COPD and Declining FEV1-Time to Divide and Conquer?"

The editorial was a commentary in part on the publication of the results of the large,multi- center, UPLIFT trial which examined the effects of tiotropium on several outcomes in patients with COPD whose FEV1 values were 70% or less of predicted. Involving some 5993 subjects, the trial authors concluded that there were tiotropium related improvements in lung function and quality of life and fewer exacerbations. However, as has been the case with other trials investigating the effect of pharmacological interventions, there was no reduction in the rate of decline of FEV1., which seems to have become the golden grail of COPD clinical trials.Only smoking cessation and oxygen therapy and -in highly selected patients- lung volume reduction surgery have been shown to conclusively reduce mortality.

Dr. Reilly wonders in we have perhaps over simplified and COPD with a inclusive definition that recognizes only the FEV1. Are there important subtypes and clinical phenotypes lost in the movement to lump all patients with reduction in FEV1 into one category?

Whatever happened to the pink puffers and blue bloaters as described by Fletcher and Peto in the 1970s and taught to students and pulmonary fellows in that era? We thought of non-asthmatic, obstructive chronic lung disease as a spectrum with the prototypical blue bloater at one extreme and the pink puffer at the other with the plurality of patients falling in between having some feature of both.

The PP was thought of as having mainly pan-acinar emphysema with loss of the alveolar-capillary surface area as reflected by a decreased diffusing capacity test and overinflated lungs on x-ray with lung fields bereft of normal arterial lung markings while maintaining nearly normal arterial oxygen levels allegedly at the price of dyspnea.The BB patient typically had a radiograph with "dirty lungs", more sputum production and centrilobular emphysema and was more likely to be hypercapneic and develop right sided heart failure.

Reading the recent large clinical trials you cannot determine if there were subgroups, i.e. maybe those more like the BB patients, who did better.It was always difficult to conceive that any inhaled therapy would improve the PP patients since they had less airway disease and more air space destruction.

The editorial's main point is that thinking about COPD as a singular entity is misleading. There are likely a number of subgroups whose response to therapy may well vary as may their natural history. Perhaps, such groups can be defined on the basis of combinations of clinical,x-ray, physiological and even genetic factors. Post hoc subgroups analysis may be helpful to hypothesis generate. We may be under estimating the value of certain therapies by too much lumping.

Tuesday, January 06, 2009

Duration of anticogulation after PE, a work still in progress

The first lecture I ever gave to medical students was in my first year of a pulmonary disease fellowship and the topic was DVT and PE. The ventilation perfusion scan had recently become available and the two anticoagulants, heparin and coumadin, were used and remained unchallenged in that category until relatively recently.Duration of therapy was not part of my lecture as I probably did not know what to say.

Much effort and research has been devoted to venous thromboembolic disease since then and through the efforts of the American College of Chest Physicians guidelines on virtually every aspect of DVT and PE appear with some regularity and are widely quoted. Here is a link to a brief review of some of the highlights of the latest (8 th) version by the ACCP.

Information continues to accumulate and a recent paper concerning the issue of duration of therapy has been published from Canada (as much the literature on this topic has been) and this editorial from the CMAJ discusses their findings.

While the authors could discern no pattern of risk factors that predicted likelihood of recurrence in men their data suggested that could be the case in women. Younger, thin women with no elevation of d-dimer and no clinical signs of post phlebitis syndrome were thought to at a low enough risk to possibly justify stopping earlier rather than later the anticoagulant.They generated a so-called clinical decision rule which the authors emphasize is not ready for prime time.It is a post hoc rule and the age and body weight risk factors they identified have not been usually implicated.

How long to treat a patient with a unprovoked DVT or PE continues to be a perplexing clinical problem. The longer you treat the greater the likelihood of a serious bleeding complication, the shorter the period of anticoagulation, the greater the risk of thrombotic events. Six months for an unprovoked DVT seems like the usual recommendation and shorter for a provoked event.

The September 2, 2008 issue of the Annals of Internal Medicine has a useful section regarding DVTs (their "In the Clinic" section entitled "Deep Venus thrombosis" and if you want a single reference to read on the topic that looks like a good place to start.

To my way of thinking, if the D-dimer remains elevated it may be too soon to stop the coumadin.



Monday, January 05, 2009

Is medical literature not to be trusted at all?

Are medical publications so corrupted and biased by special interests ( i.e. drug and medical device companies to name just two) that physicians no longer can rely on the medical literature to learn how to manage patients and prescribe medications? That seems to be the conclusion reached by Dr. Marci Angell in her commentary in JAMA. ( subscription required for all but the extract) Here is a no-punches- pulled summary in her words:

Looking at this picture altogether, it would be naive to conclude that bias is only a matter of a few isolated instances. It permeates the entire system. Physicians can no longer rely on the medical literature for valid and reliable information. This is the conclusion I reluctantly reached toward the end of my 2 decades as an editor of the New England Journal of Medicine, and it has been reinforced in subsequent years. Clinicians just do not know anymore how safe and effective prescription drugs really are, but these products are probably nowhere near as good as the published literature indicates.

This are not the words of an- over- the hill, bitter, retired doctor who has been accused of being biased against academics, and of longing for the good old days when docs did whatever the hell they wanted and has protested against the misuse of evidence based medicine to further the aims of big pharma and fellow travelers.Rather they are those of someone who has spend twenty years of editing one of the (if not the-most prestigious) medical journal in the country.

All journal articles do not have to be biased or misleading or down right fraudulent to taint the entire endeavor so that the end result may be a marked diminution is the reliability of medical journal articles in general.

As bleak as Dr. Angell's analysis was, Dr. Roy Poses, of Health Care Renewal, wonders if she might not have been too optimistic. I am afraid what was too optimistic in her paper was her suggestion that there be an independent body (perhaps an institute in the NIH) to administer all clinical trials with drugs.

Why would not the same influences and pressures that, according to her analysis, have corrupted some (much?) of academic medicine not have the same effect in a governmental body ? I cannot believe that medical ( or at least drug ) research overseen by the government would be immune to the biases and incentives that government agencies generally are subject to.

For example, the FDA has been subject to increasing criticism regarding actions seemingly orchestrated-or at least influenced to a large degree-by both the drug companies they are alleged to regulate and well as bending to political pressure to make decisions that mix well with certain philosophical stances taken by the executive branch. There is a rather large and I think convincing body of evidence that demonstrates the degree to which governmental regulatory agencies often act more as facilitators for those they purport to regulate than as policemen .

Dr. Poses would prefer a non-governmental, independent body to a governmental one. I would also have problem with that notion including:

Considering the big bucks involved in medical care-how could independence be maintained?

How could an independent body have the necessary power to function and control research without being in effect " government".

And, perhaps most importantly would not this panel ( governmental or non-governmental) have to deal with the same suspect body of medical literature whose reputation is impugned by Dr. Angell's analysis.

Such a body, a Med-Fed sort of thing, is gaining traction as it is apparently part of Senator Baucus's medical reform plan.My cynicism is that regard may be misplaced and as suggested by DB in his blog this type of explicit rationing may well be better than the current state of covert rationing as described by DrRich in his blog and in his book.

Does the pretest probablity of a condition really determine which test you should do?

The December 25, 2008 issue of NEJM has a excellent article on "Acute Pulmonary Embolism."

It seems that standard practice has become to use (or at least to say that one should use,I am not sure how often that really happens)) one of the clinical prediction rules or "CPRs" ( in this case the Wells or the Geneva criteria) to make an assessment of how likely is the diagnosis of PE .

Of historical note, the early studies on how best to diagnose PE included a global assessment by the physician and the clinical prediction rules came on the scene later in part, it was said, to aid the less experienced physician.

In one version of this game plan, one determines if there is high,intermediate or low pretest probability of PE. Then the test you order depends on into which risk category the patient is placed. In the first two instances, one then proceeds to obtain a highly sensitive D-dimer test ( e.g.,enzyme-linked immunosorbent assay).If this test is less than some cut-off value (usually 0.5m/liter) the diagnosis is said to be effectively ruled out.However, if there is a high pretest probability of PE then one should not order the D-dimer but proceed directly to a multidetector chest CT .(This is basically the recommendations made by the PIOPED ii investigators in their 2007 summary article.)

This is said to be the case because-according to the NEJM review- clinical data have indicated that in patients with a high pretest likelihood of PE the negative predictive value of the D-dimer is too low to be safely determinative. Interestingly, when one reviews the quoted reference in the Archives of Internal Medicine for that advice it turns out the study involved only 13 instances of high probability PE cases all of whom had a elevated d-dimer. To my perhaps antiquated way of thinking this is a bit strange that we can determine the predictive value of a negative test from data that seems to contain no negative tests.There may well be other studies which I have not yet found that, in fact, provide enough data to conclude the negative predictive value is too low.

Ignoring that anomaly for the time being, what about the advice for those patients in the intermediate risk category. There are some data indicating that about 5% of such patients have false negative D-dimer tests.See the Wikipedia article for that reference.

I think a better reason not to rely on the D-dimer a high probability case is , is concern that a potentially fatal condition may be missed because of one erroneous negative biological lab test considering all the many ways lab tests can get screwed up.Plus you have to feel more confident that clots are in the pulmonary arteries when you can point to the their images plugging up segmental or larger vessels (seeing sub-segmental occlusions may be a bit more iffy).

In any event, I have some lingering trouble in getting my brain around the notion for that for a given condition there is not one most accurate and reliable test but that the test of choice varies with the pretest likelihood. My unease is not made better by the fact that one of the more heavily weighted Wells criteria (a value of 3) is credited to the patient's risk score when PE is thought to be "more likely" that an alternative diagnosis,such determination being made by undefined criteria and can not be standardized. ( O.K., the Geneva criteria seem to fixed that problem.)

Nevertheless, the above discussed game plan seems to work most of the time. The importance of not allowing the D-dimer's negativity to exclude PE is emphasized in this 2008 article from Holland in the journal CHEST.The authors reported data that indicated that almost 10% (9.3%) of patients with a likely diagnosis (they used a version of the Wells criteria that had only two categories, "likely" or "unlikely") and a negative D-dimer had evidence of thrombotic disease in the subsequent 3 months.

I have written about the D-dimer and Pulmonary embolism prediction rules before in a discussion about an earlier larger study from Holland which is generally considered to validate the rule of thumb that says "low likelihood Wells score plus negative high sensitivity D-dimer test equals no PE." As thumb rules go this one does seem pretty good but as an example of brazen self absorption let me quote a paragraph from an earlier posting.

" I wonder if the "dichotomized"version of the Wells decision rule is too simple.All patients in the "unlikely" category are not equally unlikely to have PE. I have a problem with reducing a physician's assessment of how likely the diagnosis may be to a mechanistic rule and apparently excluding any and all other elements that a physician may call upon to decide the likelihood of a diagnosis, for example a decreased 02 saturation. A clinician's "global assessment"( i.e. considering the overall clinical picture not just the check list from Wells) should trump the decision rule.If you believe PE or DVT is a reasonable diagnosis to pursue,testing should be done even if the Wells rule suggests low risk or unlikely and the d-dimer is negative.(show me a blood test that can't be wrong)."

Friday, January 02, 2009

What type Universal Health Care for U.S. is on the way?

DrRich applies his usual insight, keen analytic skills and puckish literary charm to the issue of Universal Health Care (UHC) in this post and believes that it will happen and the only questions involve the details. The major issue is will people be "allowed to pay" for services not covered by the government plan. Will it be like Canada or like Great Britain? DrRich is pessimistic and believes we will go the way of the Canadians

That question should not have to be asked in a country based on individual freedom but as DrRich points our, things could well go the way of Canada,even as there are indications that the Canadians are trying to retrench in that regard. See here for some developments regarding our northern neighbors.

Those who favor a no-opt-out system seem to put much importance to there being no "two-tiered system". The proximity of the U.S. health care facilities has made a quasi two tiered system in Canada a reality much to the vexation of those who find solace in the equality of deprivation.

Physicians may well differ in regard to UHC, some being so fed up with the current wage controls imposed by Medicare and insurance company hegemony that they now favor it (like Medicare for all will be better) but there should be nothing but opposition to a Canada like prohibition of private off-the-grid care.

The current renewal of free-market bashing may well bring along with it a renewed belief in the government as solution to whatever problem(s) flash on the volatile public consciousness.

What is there to suggest the U.S. will follow Canada?

1.There are rumblings, e.g. in the state of Maryland, that concierge medicine might be made illegal.
2.The libertarian prop 101 was defeated in Arizona.(You might want to follow the money there to see who funded the opposition.So why was a Realtors association a big donor to the fight against prop 101? see here for a reference.)
3.Hilliary care contained a provision to penalize docs who dared to treat patients off the grid.

But on the other hand.

1.Obama care , at least as promoted during the election, does not explicitly mention outlawing off the grid care.
2.Obama care seems to propose a subsidy for private insurance as well as an option to sign up for some Medicare-like public plan. And Medicare itself does not exactly preclude patients making private arrangements with physicians.
3.The British NHS coexists with a private insurance medical care system. Further we may look to France.Their health care system is a mixture of private and public elements and citizens can elect to buy a little more care and there seems to be a bit of choice.This might be a more viable role model now that we seem to be emulating the French approach to buying into industries and businesses that have problems, remember Renault.

Thursday, January 01, 2009

Medical Home the abstact ideal meets the bureacratic reality?

I had doubts about the concept of a Medical Home as a solution to the primary care crisis from the first time I read about it and you would have thought my spleen was fully vented in this verbose posting but...When I learned that the RUC would be making the payments rules my doubt titer went off the chart . Now when I read about how one such program is being introduced I can only say "you have got to be kidding me". Thanks to Kevin for the reference.

Dr. Douglas Farrago of Placebo Journal fame tells us about a plan in his home state that is recruiting docs for a program that cannot disclose how you will be paid or on what criteria you will be judged but there a lot of forms to fill out. That is an offer you do not want to pass up.