Wednesday, October 27, 2010

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.