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June, 2012

Inventive Medicine

By Michael J. Katin, MD

Plus ca change, plus c'est la meme chose.      
Jean-Baptiste Alphonse Karr, 1849      

Here we a go-go again.     
Johnny Rivers , 1964      

The United States Preventative Task Force caused no end of turmoil in October when it reported a preliminary conclusion.full that screening men with an annual PSA test should not be recommended as an effective technique and could even be harmful. Those of us in clinical practice spent hours discussing with our patients and with staff members and support personnel that the PSA was still necessary for monitoring disease and important in detection as long as it was used in context. It was more difficult to convince people that the annual PSA test was harmful not because blood could be taken with pre-used needles or by having it done by someone who can't draw blood , but, rather, because the test result could lead to having men undergo procedures they otherwise could have avoided. Of course, in the individual case, this could be determined only in retrospect , if at all.

There was considerable backlash from many organizations, even to the point that the legislature of the State of New Jersey passed a resolution, signed by Governor Christie on January 17, opposing the recommendation. Eventually, the furor died down and things went back to normal. Not being content with the trauma that it had already provoked, however, on May 21 the United States Preventative Services Task Force again reared its ugly head by announcing that its final recommendation was in agreement with the draft resolution from October. The discussions started all over again and have not ceased.

One unintended consequence is that this column has once again been diverted from its goal to deal in greater depth with topics such as translational omics, diagnostic advances, and clinical guidelines. Instead we now have to spend time not on proteomic or genomic discoveries, but a different omic, to revisit the amorphous entity of socioeconomic medicine.

It is not comical, however, to observe that the March 15, 2012, issue of The New England Journal of Medicine contained an article by Fritz Schroder et al which concluded that the European Randomized Study of Prostate Cancer Screening had demonstrated that a program of PSA-based screening for men aged 55 to 69 after 11 years showed a 21% reduction in risk of death from prostate cancer. One criticism was that the study was not powered to demonstrate the effect of screening on overall mortality. This would indicate that men are destined to die regardless of what is done, although, in this case, fewer as a result of prostate cancer. Is this a Final Destination? Does this mean that any test or treatment that does not confer immortality does not deserve to be performed? Wait a minute . . . . .

TO ANYONE READING THIS WHO IS IN ANY WAY AFFILIATED WITH THE UNITED STATES PREVENTATIVE TASK FORCE, THE FEDERAL DEPARTMENT OF HEALTH AND HUMAN SERVICES, OR OF THE SENATE COMMITTEE ON HEALTH, EDUCATION, LABOR & PENSIONS, PLEASE NOTE THAT THIS IS THE END OF THIS MONTH'S COLUMN. ANY FURTHER TEXT ON THIS PAGE IS DESIGNED TO TEST THE FORMATTING SYSTEM FOR THIS WEBSITE AND DOES NOT IN ANY WAY REPRESENT A CONTINUATION OF THIS MONTH'S COLUMN. THERE IS NOT NEED WHATEVER TO READ ANY FURTHER. All work and no play makes Jack a dull boy. All work and no play makes Jack a dull boy. All work and no play makes Jack a dull boy. All work and no play makes Jack a dull boy. All work and no play makes Jack a dull boy. All work and no play makes Jack a dull boy.

Are they gone? Now that it's safe, let's continue. It doesn't take a genius to suspect that recommendations for less aggressive PSA, mammogram , and PAP smear testing may be part of a vast cost-containment conspiracy intending to have everyone present with an advanced form of disease that would indicate the need for supportive care rather than active treatment. The most expensive patient is one who can be cured, since it's less straightforward to disallow treatment recommendations. In addition, persons who can be treated aggressively enough to stabilize their diseases are also a burden on the system. Wait until they realize that the best way to reduce the cost of medical care is to not treat anyone!

This past year there was controversy in the state of Florida since a very large number of students in grades 3 through 11 who took the Florida Comprehensive Assessment Test (FCAT) were not doing well enough After reviewing the options (changing the curricula, more stringently assessing teaching skills, or addressing the basic philosophy of the educational system) the most logical solution was reached: the passing score was lowered to 3 out of 6 rather than 4 out of 6. The brilliance of this approach is breathtaking. There is a significant risk that medical policy staffers may learn about this and apply this approach to healthcare. Most laboratory tests reflect a 95% reference interval , but if one doesn't want to be too strict on grading the reference interval could be increased to 99.9%. This would result in the vast majority of sick people having "normal" values for PSA, CEA, alkaline phosphate, LDH, WBC, platelet count, and all the other parameters that determine whether anything needs to be done. In fact, this could be extended to other values such as blood glucose and serum creatinine, to name but a few, that could significantly reduce the expenditures required to manage diabetes mellitus, renal failure, and other conditions. And why is it necessary that an elevation of the ST segment of 2 millimeters has to be significant? A more generous measurement would be at least 5 millimeters. That's still hardly anything . What if they decide to be more liberal ? There are probably plenty of other adjustments that can be made to get people out of the emergency rooms and back out into the real world where they belong. Deaths from " natural causes " would skyrocket , but expenditures on medical care would plunge .

Most physicians would be out of business , but wasn't that the intention of the Affordable Care Act, anyway? Would the regulators be willing to accept these new ranges? Why not? After all, the government doesn't seem to care about maintaining restrictions anywhere else , does it?