Sunday, December 26, 2010

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.
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[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.

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