Open Architecture Electronic Medical Record (EMR)

“In an open architecture, components have well-defined, published interfaces that allow interconnection and use in ways other than as originally implemented or intended. They allow interested parties to expand the functionality of the system without modifying existing components.”[1]

This plea could apply to the use of an off the shelf database system customized for patient records and bio-medical information. A relational database can extract correlations between the two, offering a differential diagnosis. Each specialty or student can modify the posting forms and the reporting forms to meet their own need.

Arguably, today’s practice places far too much emphasis on treatment, best evidence, and far too little on diagnosis. Many if not most diagnoses prove wrong. Correcting the record or even learning of the insufficiency remains difficult. Reasons for these discrepancies include: insurance clerk posting the most reimbursable diagnosis, making a snap diagnosis without exploring underlying or concurrent problems, failure to consider all the possibilities, lack of environmental and epidemiological information, expense and inaccessibility of current biomedical information.

A prodigious number of records accumulate over the life of a practice, more than in most clinical studies. Data mining will reveal statistically significant correlations peculiar to local population and trends. The diagnosis will evolve over time. With time, the physician can apply statistical probability to the differential diagnosis. Intriguingly, it becomes possible to correlate the patient’s genome with clinical condition and outcome. Every patient becomes a well-documented study of every event from treatment to genomics.

The practitioner may link-up with a medical school or research center for support, billing and education. Linkage provides a continuing real-time updating of medical information, diagnostic criteria and best evidence. The institution receives a significant contribution to an anonymous database that correlates genomics with clinical experience and provides a horizontal cohort study of everything else on every patient. Informed consent is no longer an issue.

In progress

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[1] Deborah  Estrin and Ida Sim Open mHealth Architecture Science vol 330 5 November 2010 p759

Translational Medicine & the Health Care Debate

Translational Medicine may never see the light of day with our health-care-by-committee solution. None of the solutions put forth in the current healthcare debate take into account the rapid advances in basic medical knowledge or the need to translate this revolutionary new knowledge into hands-on clinical practice.

Researchers and medical educators coined the term Translational Medicine to encourage bio-medical research leading more directly to clinical application. Clinical practice changes slowly. New ideas engender caution if not suspicion, and for good reason. Many new ideas prove wrong a decade later. The rapidly evolving evolution in the basic science of medicine creates the need for trusted research in clinical applications and a credible translation of new knowledge into practical clinical tools. We need accelerated medical education to keep pace with the pace of bio-medical discovery. There has always been a gap between medical research and clinical medicine. Translational Medicine is a much-needed strategy to fill that gap.

The rapid advances in basic science affects as great a change in thinking as occurred when our fundamental knowledge leapt from an understanding of the anatomical structures of the human body to understanding what these organs actually did. Today’s medical science takes a quantum leap, from a traditional understanding at the cellular level, to an explosion of knowledge at the molecular level. This tsunami of information pouring out of research institutions presents a new dimension in genetics, microscopy and the science of medicine. This new world on the nano scale, unleashes a vastly expanded view of these molecular interactions. We now visualize the DNA and protein molecules directly with high-energy photon microscopes, some even capable of high-speed video imaging of actual multi-step chemical reactions.1

For example, researchers at the Cardiovascular Research Center at Massachusetts General and others, report growing ventricular heart muscle from mouse progenitor cells.2 Injecting stem cells into a damaged or weakened heart might potentially develop into life-saving and cost-reducing treatments for heart disease.

You cannot pick up a peer-reviewed bioscience journal without finding reference to basic research with the potential for wildly imaginative clinical applications. This research is not limited to just a few industrial nations but rather accelerates worldwide. Diagnostic assays and genetic probes promise bedside diagnosis in the near future.3 The immediate bioassay of the patient’s condition could have lifesaving value and economic value as well.

With this burgeoning of knowledge comes opportunity to identify solutions to heretofore-insoluble medical problems. The benefit to patients from new knowledge, however, depends on a new generation of bioengineering, clinical trials, diversity and most importantly education. Industrial age solutions will not work in this new world of technology. Medicine is not a market economy and never was. I fear that forcing industrial age free market solutions onto a scientific, academic and humanitarian infrastructure will continue to produce the lagging inequitable health care problems that we have at present --- good for big business but not for patients. Copy right, patents, and privatization of education restricts new knowledge, shared research, and graduate medical education at every turn.

Graduate education must play a major role in transmitting new knowledge to clinicians on the front line of medicine. This mission requires a high level medical institutions, education, mentoring, trust and motivation of clinicians. Both motivation and mentoring involve close two-way communication implying regional if not local involvement.

Duke University and the University of Pennsylvania medical schools each sponsor an Institute of Translational Medicine. Two new peer reviewed scientific journals trace the progress of translational medicine.4 These efforts are desperately needed. There are many obstacles. Europe is ahead of us in much of this research and in the collection of necessary bio-medical databases. 5

Conflicting Problems
Pending legislation seeks increased coverage and greater access to health care, while decreasing costs, but does not address these issues of new science or the required education to apply that knowledge clinically.
To improve quality, the stimulus package earmarks 19.6 billion for healthcare information technology (IT), 17.6 billion to promote electronic healthcare records and 2 billion for a National Coordinator for Health Information Technology.6 Whoever controls that database will control the future of medicine, including the economics, the quality and patient privacy. One of the drug companies is already offering doctors free IT for their office. The same company provides the software application for viewing and transmitting CAT scans.7 A drug company controlling protocols within patient records might not be the best idea. However, a central Office of the National Coordinator for Health Information Technology might be cumbersome as well if not tied to a broad base of academic medicine and research.

The algorithms of evidence-based medicine might be awkward when considering rapid scientific advances and regional biodiversity of the population. The NICE evidence based UK National Institute for Clinical Excellence while highly regarded may not change physician behavior as effectively as education.8 Quality improvement suggestions thus far boil down to: a medical information system, a pay for performance strategy, and public reporting of provider performance.

Obviously, planners place great faith in information systems. These strategies require fixed criteria and an analysis of the resulting medical information database. Pay for performance requires measuring performance against some fixed criteria. In a Rand analysis, the authors suggest, “Providing (public) performance information on physicians is not sufficient to change their behavior: rather a combination of education strategies might be more effective.”9

Guidelines established in Washington could, among other things, delay changes in the area of adaptation to environmental factors, the tailoring of care to the unique needs of individual patients and the implementation of new knowledge into patient care strategies.

Standards influenced by insurance companies might tend to ration care. The influence of drug companies might direct treatment toward self-serving high profit alternatives. Both will continue to exert influence on criteria by way of sponsored publications and lobbying. Among the vast plethora of medical publications, there is more miss-information out there, than there is good science --- much of it intentionally miss-leading. “There are 2.3 health care lobbyists in Washington for every member of Congress.”10 Even NIH might fail to keep pace with "best evidence" and smother the very advances in medical science they attempt to promote. Health care and its reform may be too big a challenge for central control. Vast regional differences in medical need and in patients themselves defy central control.

Treatment guidelines developed by medical schools and a few impartial multi discipline groups are enormously helpful. They are unbiased but expensive. The clinician can access vast amounts of data on a pocket PDA.11 For these or any other guidelines to be effective, however, one must have the right diagnosis.

I am concerned that we place far too much emphasis on treatment and not enough on diagnosis, differential diagnosis and interrelated problems. Although it breaks my heart, I would almost agree with the trial lawyers’ claim that far too much serious illness goes un-recognized or miss-diagnosed.

Currently the diagnosis on the insurance claim provides the basis for judging whether the doctor followed the appropriate treatment. The insurance diagnosis, however, is unreliable. Clinics often report diagnosis on insurance claims completed by an insurance clerk, often more interested in a diagnosis that justifies the level of service than what is actually on the patient record.

Rapidly evolving medical terminology not reflected in the ICDA codes, further distorts the accurate reporting of diagnosis. Even under the best of circumstances, the diagnosis is often obscure and subject to much debate at surgical, morbidity or clinical pathology conferences.

Thus, poor statistical correlation exists between reported diagnosis and the actual medical problem. This discordance works against any measurement of compliance to guidelines from a distant central location. Pay for performance begs the question, by what criteria and by whose judgment. Rationally, the best judge of good performance comes from the chiefs of service in a clinic setting. If we judge performance by data and compliance, one runs the risk of clinicians treating the guidelines not the patient. As long as pay for service and pay for diagnosis dominate the system, there is likely to be distortion of both the service and the diagnosis.

Many if not most young doctors, especially primary care, would prefer to be on salary. Many argue that salary promotes quality over quantity while fee for service favors quantity. The reporting of claims and the administrative burden alone now overshadows the advantage of fee for service to the provider. Salaries take away that administrative burden. The question is who pays the salary and who supports the institution. Surgical specialties and administrators profiting highly from the present confusion will object. These surgical specialties function well in teaching centers and medical schools where patient care remains the first priority.

Solution
An academic based public option might fund medical schools with the challenge of providing the uninsured with low cost quality medical care. Such is the history of teaching institutions until recently when with funding cuts the teaching centers behave more like private hospitals. Teaching centers have both an academic advantage and a personnel advantage, utilizing highly motivated trainees in the care of patients. Medical education and an academic approach to research and clinical care may offer the most promising solution to our healthcare dilemma.

If you were to ask, what is the best thing about American medicine? The reply would have to be our medical schools. While we might be 16th behind most of the Western World by public health criteria, we probably still rank number one in medical education. We have an impressive number of teaching instructions, widely dispersed; missing only two or three less populated states. Even those are well served by adjacent medical centers. The point being, our system of teaching institutions already serves most of the country and constitutes the best that we have. With proper funding, these institutions can take care for all that do not afford health insurance.

The cost of funding these teaching centers should be far less than the insurance solutions thus far proposed. Much of the basic research already takes place in these centers, as does graduate medical education.
This medical center option requires satellite clinics. Most medical schools provide them now. Combining Veterans medical care, covering Workman’s Compensation, and Medicaid could mean substantial savings for both the taxpayer and for employers. The economics of basing the public option on an existing infrastructure is obvious.

Solving our health care problem with a more scientific approach would generate a biomedical database of the patient population, facilitating both the research and the translation of discovery into clinical practice.
Multiple regional medical centers will better accommodate the vast regional differences in medical problems and population. Multiple regional initiatives will foster a variety of economic strategies. Multiple initiatives will likewise both: spread the risk of unworkable solutions, and increase the probability of the desirable results. Responsibility would fall to the highest levels of scientific medical leadership. This academic strategy would be a nationwide effort.

Salaried or a combination of base salary with incentive pay could better focus providers on patient care rather than quantity. State medical school employment could offer a degree of shelter from frivolous lawsuits.
Politically such public option should prove to be non-polarizing and attractive to both sides. Funding the teaching centers to cover the uninsured brings back a two-tiered system, but this time the second tier provides the better care. The disagreements on other grounds are intense, but upon medical education and the science, both sides might agree.

There are other advantages. With time, the tension between the academic and the private sector will lead to a merging of the science if not the method and a broader translation of the science into the private sector. Greed should once again give way to humanity.

Do what you can to curtail the abuses of drug12 and insurance companies, and leave the private sector in place. An expanded medical education and graduate education program will go a long way towards improving the shortcomings of our traditional insurance and fee for service system, both by way of education and competition.

The taxpayers’ money can generate a far greater return in human health by supporting research, education, and local clinics run as part of the education and translational process.

Summary
· Public option based on state medical education/hospital systems already in place.
· Accommodate the rapid changes in basic medical science.
· Correct the abuses in the present Insurance system, but leave private medicine and insurance in place.

Our people are our most vital asset. Health is an issue for our economy and our security. If we do not fix the present problems, we are both less productive and less secure. The proposed legislation goes a long way towards fixing current insurance problems and extending coverage. The current fix does not address the science of medicine nor does it provide an environment wherein the science can evolve. Translational medicine is a tool for the USA to reclaim the technology, but the science has to advance within a highly diverse academic setting. Quality must emerge from education and guidance from trusted respected mentors. Whatever healthcare solution we seek must accommodate the rapidly changing science of medicine by funding both medical research and a close connection between that research and our front line clinicians.
2,342

[1] A micrometer is 1/1,000 of a millimeter. A nanometer is 1/1,000 of a micrometer. 1 nanometer =1 x 10-6 millimeter
[2] Science vol. 326 16 Oct ’09 p426
[3] Nature, 462, 26 November 2009 p 461-462
[4] Science vol 326, 9 Oct ‘09, p205
[5] Nature vol 461, 24 Sep ’09 p448
[6] Technology Review MIT vol 112, number 3 June 2009 p47
[7] McKesson Corp SIC: 5122 Wholesale-Drugs, etc.
[8] Nature 462, 5 Nov 2009, p35 and 461, p336-339
[9] Rand Supplement: Complete Checkup, Ridgely, Adamson, Vaiana Summer 2009
[10] Alaska Journal of Commerce, Nov. 22 2009, p4 Health Care Tim Bradner
[11] The Medical Letter: Treatment Guidelines
[12] The Medical Letter vol. 51, 1324, p87: Tadalafil and Sildenafil for pulmonary hypertension cost the patient $1,060 and $1,360 respectively for a 30-day supply.

Quantum Entanglement, a conjecture

Elisabetta Collini et al[1] write of experiments with marine cryptophytes algae. These tiny deep ocean algae display quantum coherence between molecules as an adaptive mechanism for increased efficiency in capturing photons and transmitting energy for photosynthesis.

“Intriguingly, recent work has demonstrated that light absorbing molecules in some photosynthetic proteins capture and transfer energy according to quantum-mechanical probability laws instead of classical laws at temperatures up to 180 K.”[2]

This paper and a most readable summary,[3] suggest a completely new level of biological mechanisms on a whole new level of reality – a quantum leap, if you will, into a yet smaller world of particle physics.

“There are more things in Heaven and Earth Horatio than are dreamt of in your philosophy.”[4]

There seems a growing suspicion that quantum-mechanical mischief plays a role in many if not all living things. These features, however, are on so small a scale and so poorly understood that the quantum phenomena do not yet met the eye.

Medicine today struggles with translating a new found physiology on the molecular scale. The breakthrough comes from the advances in genetics and from microscopy at the atomic level. Quantum mechanics, on the other hand, may be present on a larger scale, but becomes evident only at the particle level -- where particle behavior becomes strange indeed.

Entanglement for instance, involves particles behaving identically at a distance. Efforts are under way to develop computer applications based on this phenomena of quantum entanglement. Einstein called the theory “spooky behavior at a distance” and was skeptical because it defied the laws of relativity. Experimental evidence today, however, makes entanglement a proven reality. Quantum mechanics is not yet reconciled with classical physics, nor is it yet a consideration in bio-medicine.

As a analogy, one might imagine a party of 7 girls who in the course of the evening before school is out become entangled in a metaphysical sense. In the morning, they leave school traveling home to many parts of the country. In the course of a subsequent evening one of the girls experiences an ecstatic moment. Simultaneously and instantaneously, the others experience the same – spooky indeed. However, the analogy is more complicated. Each girl might find herself spinning around in one direction or the other, but always in the same direction. Observing these girls might determine their location or their direction but not both at the same time. (About sums up my experience with the opposite sex) In observing which foot the girl was standing on, it would only be possible to offer a statistical probability. However, this is only an analogy. Entanglement occurs among electrons and protons. (Never mind Shrödinger’s cat.[5])

What intrigues me with this phenomena, is the conjecture that quantum-entanglement may play a role in the infinity of things that we do not yet and perhaps never will understand about our own biology.
Probing what we know, despite its considerable substance, hardly scratches the surface of the vast dark depth of the unknown. Bio medicine has yet to explain sleep. We cannot explain scanning logic, intuition or even the metaphor that over shadows our stilted attempts at artificial intelligence.

The Golden Plover chicks find their way from Alaska to the Fiji Islands weeks after their parents leave for the long flight south. How do hundreds of shore birds all turn instantaneously in perfect formation? One might consider this spooky behavior at a distance.

I think that the next frontier in medicine will be a quantum leap deeper into the infinitesimal -- exploring quantum entanglement at the particle level as a part of our physiology.

[1] Collini, Wong, Wilk, Curmi, Brumer and Scholes – Dep. Of Chem. Inst. for Optical Sci. and Center for Quantum Information, Univ. of Toronto, Physics and Med. Research U. of South Wales, Dep. Science and Chemistry U. of Padova, Italy
[2] Nature 463, p644, 4 Feb. 2010
[3] Photosynthesis, p614 by Grondelle and Novoderezhkin, same issue
[4] Shakespeare, “Hamlet” act I scene V
[5] Schrödinger http://en.wikipedia.org/wiki/Schr%C3%B6dinger's_cat

Life Expectancy

https://www.cia.gov/library/publications/the-world-factbook/rankorder/2091rank.html
http://www.cdc.gov/nchs/data/nvsr/nvsr59/nvsr59_02.pdf

The Center for Disease Control today released statistics showing a drop in life expectancy for the first time since 1993. Clearly, the US has the best medical schools, the best-trained doctors and the most advanced technology, but something is obviously missing. The public health statistics tell the story, but not why. Life expectancy in 2008 dropped from 77.9 to 77.8

CDC presented 2008 as compared with 2007 counting 99% of the demographics and medical files. Six of the 15 leading causes of death actually decreased in number (Heart disease; Neoplasm; Cerebral Vascular Accident; Accidents; Diabetes and Assault)

Six others increased in number (COPD & Lower lung disease; Alzheimer’s; Influenza & Pneumonia; Nephritis, Nephrotic Syndrome, Nephrosis; Suicide; Hypertension and Renal Hypertension)

The report further reports on infant mortality, an improvement, yet a further embarrassment. 2007 rate was 6.75 deaths per 1,000 live births. In 2008 it improved by 2.4% down to 6.59. Black mortality rate is 2.3 times higher.

These figures, reflecting the health of a nation, attract the CIA’s concern as a security issue. The CIA reports that out of 224 countries, the US ranks 46^th with 178 under developed countries with higher mortality rates. Life expectancy by country, also from the CIA, shows the US in 37^th place, right after Cuba. Japanese can expect to live to an average of 82.6 years of age.

The CIA’s Infant mortality statistics, 2010, differ from the CDC’s,  2008, in deaths per 1,000 live births; CIA shows averages of: Angola 178, World 44, Mexico 17.84, Russia 10.32, US 6.14, Cuba 5.72,  the EU 5.61, Canada 4.99, Germany 3.95, Ireland 3.89, France 3.31 and Sweden 2.74.

Electronic Health Record (EHR) II draft

It is easier for a doctor, not connected with a major institution, to obtain government secrets than to access current medical information. The funding for electronic health records (EHR) affords an opportunity to advance education and channel that, difficult to obtain medical information, to the medical student, the practicing doctor and the point of patient care.

Translational medicine makes an issue of researching and implementing new knowledge into clinically applicable substance. That substance has little merit until it becomes a part of clinical practice. The flood of new bio-medical information overwhelms the process of translating and delivering relevant advances to the clinician. Many EMR proposals contain substantial decision support capabilities, but neglect to feed current and changing medical information.

Vender centric programs meet the economic needs of the client and the vender. Government centric strategies stress avoiding errors, reducing cost, meeting fixed quality criteria[1] and quantifying the benefit. Drug centric solutions attempt to aid in selection of medical treatment and prevent adverse drug reactions. Hospital centric EHRs must deal with pooled data with other institutions, confidentiality, their own institutional review boards (IRB) and somehow collate data from divergent sources.[2] Hospitals and insurance companies seek control of the data as an administrative and economic strategy. Drug companies have a similar motive.

Make patient needs the first priority by centering the EMR in the computer of the individual provider while linking that database with a secure cloud database. Supply the provider with total access to total medical information. Include the decision and support capabilities. Generate a continuous differential diagnosis. Include a self-correcting statistical element. Compare and analyze the relationship between patient data and outcome.

Impediments in developing meaningful EMRs

·         Battle over final ownership of the data

·         Divergent priorities in function and goal of the EMR

·         Colossal challenge in meeting every bodies demands

Proposing that these electronic patient records (EPR) belong jointly to the patient and the primary care provider resolves a number of the impediments and problems.

·         Eliminates incompatible database problems among various institutions

·         Individual providers work with off the shelf database linked to major database provider.

·         Clinician can modify the reports and add criteria at will without upsetting the core software schema.

·         Medical school and institutional researchers can access accumulated patient data anonymously.

·         Patient genetic data correlates with clinical pathology in real-time

·         Enhances medical student education by learning the database in clinical years

·         Gains acceptance among private practice physicians by its sponsorship in the medical school and by its use among graduating physicians

·         Puts the medical school in control of the patient database

·         Puts a regional and environmental spin on the relevance of medical information

·         Promotes competition between medical schools in developing the best medical information database and operating system

·         Frees the decision support function and diagnosis from the distortion created by arbitrary regulation and economic motivation

·         Maintains political neutrality

·         Data accessible:

o   1. because in standard and widely used database program  

o   2. Because all information recorded as specific data entries and thus retrievable  

·         Informed consent no longer an issue for cohort studies

·         Use and cooperation become ubiquitous – spreads voluntarily

·         Free use provides an unwitting contract to use the information wisely

·         Errors and misdirection become immediately transparent to the medical school and a pointed direction for CME

·         Gives medical students much more of a vision of the totality of medical knowledge and a more organized way to store it.

Requirements

·         Open source and free to all providers

·         All patents and copyright in the  public domain

·         A database purchase from Major database provider, probably Oracle or IBM, unlimited users

·         Medical information in database form provided by medical school, free of copyright and cost! As an educational and CME function

·         Enough federal and state financial support

·         Initial programming of the database schema and the statistical relational rules

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[1] J Am Med Inform Assoc. 2009 Sep–Oct; 16(5): 637–644 Decision Support Capabilities

[2] J Am Med Inform Assoc. 2009 Sep–Oct; 16(5): 624–630 The Shared Health Research Information Network (SHRINE)

Bio Medical Database

I need to tell you what I am excited about. It involves the patient record, the human genome, medical information, statistics and a database program.

Scope “In April, the Department of Health and Human Services awarded a second round of grants totaling $267 million to create 28 new centers to assist health-care providers in implementing health information technology. The funds were part of the $20 billion allocated in the American Recovery and Reinvestment Act of 2009 to help doctors and hospitals make the switch from paper to electronic records.”

This is an opportunity to channel biomedical information into the hands of students and graduates and correlate that information with the patient record. 

From MIT’s Technology Review, “Electronic medical records provide vast amounts of medical information that can be combed automatically and used to ask questions…

...Scientists and physicians are now scouring the growing number of electronic medical records and genomic databases to figure out how to use this vast medical resource…”

More to the point of medical education, students and graduates alike experience a continuing need to reference current medical information. Current information is not easy to come by. It is expensive, closely held and often inaccessible. U of Michigan took a great stride in recording the lectures for students to review on their computers. Bravo, but the data is not indexed and it’s slow to access for a specific reference. In addition, there remain the student’s patient contacts and a need to correlate patient information with medical knowledge to develop a differential diagnosis.

Lists are hard to remember, but a modern user-friendly database program can retrieve a relevant list. The database’s – pardon the analogy -- left-brain contains the patient information, recorded as data points, whilst the database’s right-brain contains all available medical knowledge also as data points. The relational features of the database can easily match patient variables with diagnostic criteria, providing a differential diagnosis or list. Filing information in a database obviously compresses the data in that it eliminates repetition.

Other electronic medical records (EMR) applications stress “best evidence” treatments. While including up to date treatment options, this proposal stresses differential diagnosis.

Furthermore, a built in statistical application offers probabilities for the differential. Intriguingly, a more developed statistical attachment will correct itself in real-time based on outcome; this is the important aspect of the matter.

Everything I have read suggests great difficulty in analyzing the data -- data mining -- and that may be so on a central server, but on the student’s computer with a current state of the art database, the real-time statistical analysis should give an accurate picture of the outcome in relation to the clinical data, including the genomic information if available. As this data accumulates in the medical school server, over the professional life of the student, analysis should be much easier.  

I had some operational experience with an old Borland database while I was in practice. I got some of this schema done, but at that time, it was slow and limited. Today the computers are fast and there is virtually no limit to scalability.

It will take a couple of high-level database persons, a couple of statisticians and a couple of medical people who can pull together the full range of medical information in a database format, genetic data included. Students should be able to write the data fields for the patient record.

The resulting product should be open source and available to all clinicians willing to link to the medical school server. Both patient and medical information would flow both ways. Researchers can extract patient data anonymously. New bio-medical information can flow back the other way providing the clinician with continuous access and update of biomedical information.

 The educational advantages speak for themselves. Health and Human Services has the money. I believe that Medical Schools represent the only trusted vehicle for such a program.

Differential Diagnosis

“This Week,” an editorial feature in Nature[1], The editor asks what the BBC, IPCC and the CIA have in common. As an example The CIA in Mar 1951, warned of a “serious possibility” that Russia would invade Yugoslavia. Kent, the intelligence analyst was dismayed that nobody seemed to agree on just what that meant. Correcting the problem, the CIA dropped the term possible, replacing it with almost certain and almost certainly not. The article goes on to examine the problems that the Intergovernmental Panel on Climate Change (IPCC) has with its estimates of global warming.

The same problem exists with medical diagnosis. Serious retrospective studies indicate an alarming error rate in initial diagnosis. There are a number of causes: Reimbursement for lab studies requires a relevant diagnosis. Reimbursement for the visit requires a definitive diagnosis, a so-called 5-digit code as opposed to a broader category of 3 or 4 digits. -- It’s an ugly system. Discounted reimbursement, often more than 50% encourages snap diagnosis. Additionally, many encounters hide conditions that are not on the clinician’s list of commonly encountered diseases, problems that require research and head scratching with studies that may or may not be revealing. After all, what good is a test if you already know the answer? Moreover, what good is a diagnosis if you don’t consider the possibilities? Differential diagnosis has become a lost art. Some form of quantitative measurement needs to accompany a medical diagnosis along with the other possibilities. Intriguingly, statistics may be a better answer

When a doctor attends a clinical pathological conference (CPC), he or she hears from a number of persons associated with the case, the clinician, the radiologist, the pathologist, any number of consultants and often a visiting expert. They seldom agree and this takes place after the autopsy.

How then should we state a diagnosis? Fuzzy at best, should we say, “almost certain” or “almost certainly not?” Statistics serves a better quantitative role. If we compare a thousand instances of a diagnosis with the final-outcome, we can equate the degree of fuzziness in quantitative statistical terms.

Furthermore, in real-time, we can offer these statistics --- taken in relation to the signs, symptoms, physical findings and tests --- to the clinician as a differential diagnosis with numeric probabilities. The doctor, nonetheless, must choose based on the individual. In doing so, the diagnosis will have some validity.

Statistics can provide enough documentation to overcome the denials from a third party provider, allowing for reasonable studies and testing before jumping to conclusions.

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[1] 21 October 2010 Vol 467 p883

Out of Order

The preceeding posts are older and transfered from my other blog where everything is mixed together. Only todays date shows. Furthermore, they are in reverse chronological order. From here forward postings will be in real-time.

Health Care Reform/Re-reform

It is no surprise that the AHA, American Hospital Association turned their back on the presidents plans for health care reform, and they will not be alone. The insurance companies defeated Secretary Clinton when she spearheaded President Clinton’s attempt at health care reform. I am afraid there is so much knowledge in DC that they miss what goes on in the world of hospitals, doctors, insurance, and drug companies. The extortion goes on at such a high level, involves so much money and has gone on for so long that the criminality is as invisible as it was with the credit default swaps. Old line New England Insurance companies with reputations above reproach find it difficult to resist this wind-fall and unfortunately allow themselves to participate. The AHA is in fact an organization of hospital administrators with a special interest agenda not of patient care but of personal gain through an expanded administrative role. Money percolates to the top.

Insurance is a wonderful thing in mitigating risk, but when it is no longer an option, when it is substituted for a basic humanitarian necessity it leads to abuse, and indeed it has. The criminal extreme of this system resembles a protection racket, and some aspects of health insurance come close. For example excluding prior conditions, cancelation of coverage and increasing rates as a result of diagnosis come close to extortion while seemingly logical to those not suffering from some of the outrageously expensive medical and surgical conditions. Of far greater significance, the subtle endorsement by insurance companies of rising costs, charges by hospitals and providers; it leads to an endless spiral of rising cost that serve only to increase the revenue of the insurance companies without affecting their margins. The end result is a massive fleecing of the American consumer/patient with no end in sight.

The percentage game makes it even worse. Pay, say, 74% of usual and customary charges to a provider with an 80% overhead and – guess what?—the charge suddenly increases 26% or more. This upward spiral applies to drugs, hospitals, laboratories, and providers. It is an ugly game and all are corrupted by it.

Facts: Insurance is the problem. Insurance will not go away. Hospitals are the problem. Hospitals will not go away. Drug companies are the problem. Drug companies will not go away. What is left? Well, it turns out there is a great deal left and that is the science and the care of academic medicine. We have centers of excellence, and medical schools that are the envy of the world despite our pathetic ranking in almost every other metric of health care.

Propose: A completely separate public health care system, run by the states and their medical schools and those centers of excellence that choose to participate: no insurance, free to anyone (or very low fee), providers paid by the state (fewer law suits) and utilizing only medical school connected teaching hospitals. Now here is the catch. The present insurance structure remains in place, encouraged and to whatever extent possible optimized as: a private sector, private practice, competitive system. (I’m not making this up; it’s what happened in Europe quietly and without fan fare.)

The private sector must be fairly treated and, indeed, private medicine may return to its humanitarian traditions. The hospitals, the insurance companies the drug companies and the doctors preferring traditional fee for service can thrive under this system unmolested and thus not inclined to fight against the absolutely essential reform that is going to happen one way or another. Who knows, the private sector may turn out to do a better job in the short run, but in the long run I doubt it.

At first the public clinics will be decried by all of the above and may get off to a slow start. Time however is on their side, and a slow start means an affordable program. Let the two systems compete, In fact let the states compete. The diversity is the very science of medicine and the best patient care formula will percolate to the top, control by academics and education, not by regulation, insurance or money. Include Medicare, Medicaid and Workman’s’ Compensation under this proposed public health care system and businesses will back the program as well. Politics is the art of the possible and this scheme is possible while – I suspect – reform under a mandatory insurance program is not.

Women Small Business Health Care

The Great Debate » Debate Archive » Women small business owners really need healthcare reform The Great Debate

Brain Drain on US Health Care

I received this in the mail last night. The email may be phishing but even so may foreshadow events to come. More and more Americans are choosing overseas hospitals for major surgical solutions rather than risking bankruptcy here in the US. This is not an overstatement. Between the lines in this schema lies a promise of a brain drain with US doctors and nurses migrating to Europe or where ever for salaried positions in a more relaxed and scientific atmosphere --- without so much of a threat of being sued.
None of the present health-care proposed solutions takes into account the complete paradigm change in our understanding of disease --- developing in the genetics and bio-medical laboratories. The translation of this new information to clinical medicine requires mass population screening in order to equate the genetic tags with disease. We now know much but there is far more to learn. Europe is way ahead of us in these screening projects with multi-national databases. We lag far behind in these screening efforts.
CERN, in Switzerland attracts many US physicists. European medicine may soon do the same for US doctors and nurses -- especially if the patients follow. Ah -- globalization.

FW: Global Heath Care Network -- Opportunity From: Robert Davis MD - MedRe Partners [mail to:rdavis@transactors.com]
Sent: Sunday, October 18, 2009 6:32 PM
To: clancy@hughesair.com
Subject: Global Heath Care Network -- Opportunity
:
The company is looking for between $5MM and $10MM.
We have an exciting opportunity with a employer-sponsored, consumer-choice global healthcarenetwork. The network provides individuals, employers, and payers with world-class health care. The company provides the world's first global health care network specifically designed to deliver high quality health care services, share the tremendous cost savings with plan sponsors and their employees and coordinate all medical and travel services for individuals who need care. Typically the costs for a major surgical procedure will be 40-80% less than that of the US, with the same or better quality doctors, and no deductible to the patient. The company's program offers a 100% medical benefit.Patients are not going to have any financial difficulties as a result of requiring an expensive surgical procedure.
The company has assembled a network of Joint Commission International (JCI) accreditedInternational Hospitals with departments designed to cater to U.S. patients, staffed by U.S./U.K. or equivalently trained and board certified physicians and nursing staff that are English speaking. The network hospitals are "the best of the best." The company has implemented a U.S. payer style contracts with all their international providers. They have contractually obligated all of our providers to participate in ongoing quality audits, monitoring, credentialing and quarterly reporting. Their contracts recognize the US payers' regulatory obligations. Their agreements have industry leading pay-for-performance provisions as well as the requirement that all health care personnel that touch our patients speak English. Among their many contract innovations, the pricing of the surgical procedure is bundled (all inclusive - hospital, physician, ancillaries) and negotiated as a fixed price case rate. They in turn provide a single bill to the payer , which is in US Dollars and is for the total expense including their fixed price case rate, all travel and hotel costs, their mark-up for overhead and profit, and a Personal Accident Insurance Policy for each patient.
The company has recruited a management team with over 120 years of leadership experience in health care services. Additionally, the company has established a leading group of advisers for our various Boards with over 275 years of successful health services entrepreneurship, medical management, patient care, benefits, health plan leadership, government and public policy leadership.
Please call me on my mobile at: 702-416-8678 or send me an e-mail at: rdavismd@medrepartners.com
Robert Davis MD, Managing Partner
MedRe Partners
rdavismd@medrepartners.com
www.medrepartners.com
702-436-3435 (office)
DISCLAIMER: Sender is not a United States Securities Dealer nor Broker nor US Investment Adviser. Sender is a Consultant and in some instances a Private Investor. This E-mail letter and the attached related documents are never to be considered a solicitation for any purpose in any form or content. Upon receipt of these documents you, as the Recipients, hereby acknowledges this warning and disclaimer. If acknowledgment is not accepted, Recipients must return the document copies, in their original receipt condition, to Sender via postal services immediately.

Translational Medicine (old)

None of the solutions put forth in the current healthcare debate take into account the rapid advances in basic medical knowledge or the need to translate this revolutionary new knowledge into hands on clinical practice. The disagreements on other grounds are intense, but upon the science, both sides might agree.

The term translational medicine refers to a newly created bio-medical specialty that attempts to develop practical clinical tools out of the genetic and molecular discoveries now flooding the scientific literature.

Duke University and the U of Pennsylvania medical schools now sponsor an Institute of Translational Medicine. Two new peer reviewed scientific journals trace the progress of translational medicine.[1] Translating new knowledge into clinical advances challenges the ability for researchers to communicate practical applications to clinicians. These efforts clearly fill a widely recognized practical and critical need. Europe is ahead of us in this research and in the collection of necessary bio-medical databases. [2]

The legislative solutions proposed on all sides contain a dangerous element of standardization, which would tend to delay change, adaptation to environmental factors, individual patients and the implementation of new knowledge. Standards of care set by insurance companies, influenced by drug companies, or even central planners such as NIH would tend to smother the very innovation it attempts to communicate. The task is too big for central control. There are vast individual and regional differences in patient need and in patients themselves.

Medical education and an academic approach to research and clinical care offer the only viable solution to our healthcare dilemma. The government should fund medical schools with the challenge of providing the uninsured with low cost medical care. This option will require satellite clinics; many medical schools provide them now. Combining VA clinics and covering Workman’s Comp. could mean savings for the taxpayer and for employers. The system is in place. The economics of basing the public option on an existing infrastructure is obvious. An academic based public system will generate a biomedical database of the patient population, which would facilitate both the research and the translation of discovery into clinical tools and education for the participating providers. Diversity between regional medical centers will better accommodate the vast regional differences in medical problems and population. Multiple regional initiatives will foster a variety of economic strategies. Multiple initiatives will likewise both: spread the risk of unworkable solutions, and increase the probability of desirable results. Responsibility would fall to the highest levels of scientific medical leadership; it would be a nationwide effort. Salaried or semi salaried providers could better focus on quality more than quantity. There might be some shelter from frivolous lawsuits as medical school / state employees. Politically this public option could prove to be non-political -- attractive to both sides.

Do what you can to curtail the abuses of drug and insurance companies. However, an educational and medical school centered public option will better serve the future of US medicine. Health is an issue of national security. If we do not fix the problems, we risk loosing both patients and medical doctors to a more advanced and humanitarian medical delivery system. Patients are going to Europe and Asia now for lower cost surgical care. Medicine is just one more sphere of US technological leadership we risk loosing due to selfish laissez-faire short-term choices when long-term choices in the national interest are required. Translational medicine is the tool for the US to maintain a leading role in the science of medicine and the care of patients – our vital human resource.

Whatever healthcare solution we seek, must accommodate the rapidly changing science of medicine ---funding both medical research and a close connection between that research and our front line clinicians. This translational medicine strategy must prevail.
633
[1] Science vol 326, 9 Oct ‘09, p205
[2] Nature vol 461, 24 Sep ’09 p448

Mother & Child Cohort Study

SpringerLink - Journal Article

Cohort Profile

Cohort Profile: The Guangzhou Biobank Cohort Study, a Guangzhou-Hong Kong-Birmingham collaboration -- Jiang et al. 35 (4): 844 -- International Journal of Epidemiology

P³G Observatory - LifeLines Cohort Study & Biobank

P³G Observatory - LifeLines Cohort Study & Biobank

Guidelines for health professionals about DNA / Biobanking in Europe

Guidelines for health professionals about DNA / Biobanking in Europe

PHG Foundation Biobank large-scale recruiting underway in Manchester

PHG Foundation Biobank large-scale recruiting underway in Manchester

eMJA: Biobank: who’d bank on it?

eMJA: Biobank: who’d bank on it?

GenomicsPopulation Research

GenomicsPopulation Research

GenomicsHuGENet

GenomicsHuGENet

Encouraging words on the Senate version of Health Care

But even these encouraging words treat the insurance industry as an immutable fixture about which everything else revolves.

Translational Medicine

Translational Medicine is the strategy of focusing on new medical research that can be rapidly translated into useful clinical tools, lower costs and improved patient care.

A Tsunami of new bio-medical knowledge promises to change nearly everything about the way we diagnose and treat disease.

The White Elephant in the room is the insurance companies. Others: drug companies and administrative entities including many hospitals feed deeply from the trough of the over bloated health care economy.

Reforming the system will be a near impossible uphill battle against entities with enormous market power, perhaps more market power than the government. The widely quoted mantra is that we have the best medical care in the world. This claim is only true for the congressmen who claim it, and others fortunate enough to have comprehensive insurance and proximity to the very top echelon of medical providers. Public health statistics undeniably ranks our overall health care well behind most of the Western World. Mal-distribution of service, access difficulties and outrageous cost cause most of the problems. Many with known chronic disease hide the fact for fear of loosing what insurance they have. Any major event involving diabetes, cancer, heart disease or major surgery results in almost certain bankruptcy for all but the wealthy uninsured elderly. If the insurance company gets wind of one of these high-risk conditions, the patient will most certainly be uninsured.

The reform legislation pending – you can argue all you want – remains a near necessity. We cannot sustain the current costs. A large segment of our population receives substandard care or no care at all. The proposals may provide insurance for the uninsured and stem some of the insurance abuses. The costs and quality of care may remain another matter. One might expect the reform to be gamed and gutted by subsequent administrations.

In my view, only an academic and educational approach moving away from pay for service can contain cost and bring us back to scientific medicine. Furthermore, our regional differences and unique problems will respond poorly to central administrative guidelines.

State sponsored university medical schools already amount to a public option. Strengthening this option with federally funded subsidy as an administrative fiat would avoid the wrangling and gridlock that blocks our present struggle for a complete solution. This incremental approach and the state sponsored nature of medical schools should be acceptable to conservative elements from both sides, and it has the advantage of being an accomplished fact.

If asked, how American medicine is the best in the world, one would have to reply, its teaching centers. Only these medical schools and teaching hospitals can direct a scientific solution to local problems and facilitate translation of new bio-medical research onto the front lines of clinical medicine. A great deal of postgraduate education will need to accompany new clinical approaches.

A scientific academic approach to the health care problem may compete with the private sector improving performance and reducing cost as a competitive necessity. Such diverse state-by-state planning is in keeping with the scientific method. Competing research and development with open source will float the best solutions to the top. Such a research based academic solution should return our profession to its past humanity, a better distribution of care, an alternative to the unaffordable and a translation of new science to the front lines of clinical care.

Drugs and Scallywags

When I left medical practice after 30 years, I was tired and cynical, but also disgusted by the shabby mess into which the medical practice environment had evolved. That is how I came to move north and take up my secondary passion of flying. I thought long and hard about how to fix the system, but gave up and just concentrated on the air taxi business. I hardly mentioned that I was a doctor. Today, I think about the problems again, but the health care environment seems even worse.

I do investments, which keeps us afloat since retiring from flying. One cannot go far in investing without attracting all kinds of investment newsletters and promotions for investment advice – for a price. I always thought that if these promoters were so good and their advice so valuable, why would they waste their time soliciting subscriptions. Anyway, I got this newsletter in the mail today and was drawn to the title `Junior Pharma.`

Most people in the health care business but few consumers realize that pharmaceutical companies re-engineer their high priced drug before the patent expires in order to re-patent the same product and maintain the high price.

Etc. etc. The newsletter goes on promoting a company that will serve the interests of Big Pharma in this `evergreening` strategy -- positioning itself as a probable buyout candidate.

Monopoly, privatization of research, deregulation all brings us to this dingy manipulation of patent laws. Deregulating the post office and the railways didn't do so well either. The airlines are not far behind and then there are the banks. It’s a balance isn't it. Too far in either direction, over regulation or no regulation, leads to disaster. What is so hard to understand about balance?

In Nature Magazine this week[2], an Australian private insurance company, NIB, offers discounted genetic testing. The fine print reads, “You may be required to disclose genetic test results --- to life insurance providers.” Guess who doesn't get insured?"

2] Nature vol463 Feb 2010, p854 News Briefs referencing “The Age”

Who do You Trust

From a USA Today survey: who do you trust to fix health-care.
Doctors, 77%
Hospitals, 64%
University professors or researchers who study health care policy, , 61%
Obama, 49%
Democratic leaders in Congress, 37%
Republicans leaders in Congress, 32%
Pharmaceutical companies, 30%
Health insurance companies, 26%

Well I'm not so sure about doctors, less so hospitals, both play the escalation game with insurance companies. I would trust even less the legislators and would give 0% for Pharmaceutical and Insurance companies -- both major problems. A fix would require a Warren Buffet or Bill Gates --half morphed int an Alexander Haig -- at NIH and there is no such person.

My proposal, for what little it is worth: let the states tackle the problem utilizing their medical schools. You would have 50 different solutions. One or more of them would work. It's the scientific method for a solution to what basically amounts to a scientific problem -- that is, once you chase the clarion vulchers out of the system.

The tsunami of new bio-medical discoveries presently unfolding in research laboratories demands both an educational component and collegial management by leaders in medical science. (Translational Medicine)

The Patient Protection and Affordable Care Act

They got it done, but at what cost. There is no doubt that things could not stay the way they were. Something had to give. US health care by public health standards trails most of the developed world. Emergency rooms bear the burden of our uninsured who seek help only when forced to do so by an illness they cannot afford. The cost shifts to those who can pay, and the government regulations designed to contain cost actually drive costs higher in an unending spiral. It is a paper chase wherein the dollar has become the goal rather than patient care. Most doctors agree. Many have quit.

The fix is complicated. There will be some good and some bad with the new law. The backlash comes as somewhat of a surprise to me. I assumed the vast majority of the population was as cynical about the system that we have as I was as a clinical doctor. This was not the case. Demonstrations spawned by radio talk shows grew ugly. President Obama tried public education then public campaigning with limited results. I think the problem is with youth who have good health and little financial responsibility and with the marginally employed or gainfully unemployed who would rather continue to live outside of the system – both for pragmatic and financial reasons.

My grand daughter, commenting on her lack of automobile liability insurance said, “It is cheaper to pay the fine if and when they catch me, rather than pay for the insurance.” I think the same thing will play out with mandatory health insurance. It will be a question of what percentage of people will opt out on that basis. State’s attorney generals are already filing lawsuits, claiming that mandates on individuals and on the states are unconstitutional. Is the Supreme Court political?

The new public law, 111-148 is as complex as the problem. I tried to download the 406,887-word document, and my computer locked up. I was able to order an official copy from the Government Printing Office bookstore, however, for $29 with free shipping, all 906 pages of it, delivered by May 5. I actually intend to read it.

I am hopping that there is a mechanism to fix what does not work and leave room for innovation. I am concerned that a law, this inclusive, may be inflexible. If so, it is a shame. I am also fearful that the solution may lack sufficient provision for rapid scientific medical advances and challenges. There needs to be a provision for provider education. Our entire Public Health System needs strengthening. The authority for `criteria of diagnosis,` provision for `differential diagnosis` and `evidence-based` recommendations for treatment should be distributed to regional research and teaching centers. It is no exaggeration to say that any published guidelines are obsoletes the day they are published. The science is moving that fast. The authority should go to the scientific leadership of regional teaching institutions not to a central medical bureaucracy.

Perhaps it will become opportune for the Administration to play the Republican `States-Rights` Card and move the Health Care authority from Washington to centers of medical science, distributed among the states. Time will tell. It is a certainty that this law is a first step, hopefully the first constructive step of many to follow.

Our teaching institutions are indeed the best in the world; however, we have a way to go in regaining our once renowned leadership in public health and a healthy public. More after the long read. I will look for all of the above considerations.

"Therefore, consideration of the dynamics of clock function across temporally distinct phases of the day/night cycle, and within different tissues as the cycle progresses, may also explain obesity and metabolic pathologies that emerge in states of circadian disruption including shift work and night eating." Nature 29 July 466 p630.

I've had a lot to say about depression and daylight saving time. In the far north the phenomena is accentuated. Disruption of circadian rhythms causing Jet Lag; few would doubt. Prolonged disruption, as in daylight savings time, may also be a not so subtle contributor to obesity, metabolic syndrome and diabetes. The problem of obesity has been with us for a long time; however, the rapid increase in incidence seems to coincide with the initiation of expanded daylight saving time from early spring to late fall. (Pure conjecture)

One has to ask just how much daylight savings helps with the energy crisis or the war, and is it worth interfering with the biological clock? Is DST a contributor to the world wide epidemic of obesity and diabetes? We need studies.

Where I live, we are already an hour out of our natural time zone, sun time, and the addition of daylight saving time makes it two hours. Indeed there is a local prevalence of obesity and diabetes. Studies are needed, but how long should we wait, considering the risk and the human cost of a work schedule out of sync with our internal clock.

In the meantime take your vitamine D.