Hanging On/Cautionary Tales of Modern Medicine

By Ronald J. Glasser, MD
Reprinted with permission

This is an article based on a chapter in a soon to be published book "Hanging On/Cautionary Tales of Modern Medicine" written by Ronald J.Glasser, MD. To find other articles and books by Dr. Glasser visit www.ronaldjglasser.com

Never send to know for Whom The Bell Tolls, it Tolls for thee

John Donne

Within hours of the news that Tim Russert, the host of Meet the Press, had died of a heart attack I received over a dozen phone calls from middle-aged reporters, columnists, screen writers, editors, playwrights I'd known or worked with over the years, wondering-though clearly concerned for themselves- how a privileged and well connected 54 Year-old man under the care of a personal physician as well as a cardiologist, who had just passed a stress test, was most likely on one of the lipid lowering statins and probably an anti-hypertensive medication, exercising and dieting, could get up in the morning, go to work, sit down at his desk, have some coffee, cough once, stand up and die.

I was baffled by the phone calls. What had happened to Russert happens over 1.5 million times a year in America. These are not what the cardiologists called the usual "cardiac events", most of which are chest pain in the middle of the night, a 911 call, a quick ambulance trip to the ER and the placement of a stent into an occluded coronary artery by 4 am that same morning-these are the "cough once, sit up or roll over in bed and die events."

Everyone who called clearly had heard of or knew about the "risk factors" for coronary artery disease and that appeared to be the problem. There was obviously a deadly, if popular misunderstanding, of the whole issue of cardiac risks. Something is either wrong with how risks are determined, how they are used or more to the point how they have been presented in the medical literature as well as the popular press. As it turns out for those 1.5 million who die each year and the other few million who managed to make it to an emergency room and survive, it is all three.

The truth is that statistically sound and reproducible risk factors are fairly new to medicine. Just look how long it took to realize and then accept the risks of smoking or the harmful effects of estrogen replacement therapy.

It isn't as if physicians have ignore risks. As far back as the 14th Century, the medical community of Venice recommended that the citizens of Venice stay clear of the oppressive badly smelling swamps surrounding the city during the summer months to avoid "the summer fevers". Three centuries later, John Snow, a statistician, using a residential map of East London to chart the houses of those afflicted during the spread of the Cholera Epidemic of 1854, recommended the closing down of the Broad street Pump which, according to his maps, was the source of the spreading epidemic. It was all similar to The Old Testament's approbation to place latrines at least two hectors from a military campsite.

It is true of course, that the summer fevers of the 14th Century and cholera of the 19th as well as dysentery at the military camp sites of the Hebrew's were dramatic affairs with people sick at noon and dead by nightfall. It does not take much imagination to understand that with sudden, dramatic and deadly diseases, people will listen to issues of risks; at first willing to try something, and then as the illness continues to spread, desperate to do anything.

Unfortunately, heart disease is a silent killer until it kills you. There is usually nothing dramatic or very observable about heart attacks until "The Big One" hits. And when heart attacks do occur, for the most part, they happen in private with few people around to see the terrible results. And for this reason, risk factors for coronary artery disease have had a somewhat more checkered and confusing course than the risk factors for the infectious diseases, despite both being based on reliable statistics.

What is more worrisome is that even with the current understanding of cardiac risks, there is no cardiologist sitting in his office-talking to a patient about the results of their most recent stress test, coronary angiogram, gadolinium heart scan, EKG, lipid profile and blood pressure-who can say with absolute confidence that the patient will make it to their car alive, much less make it safely though the rest of the day.

Unlike bacterial and viral infections and even cancers that lead to fevers and high white counts, coughing, blood in the urine, weight loss, nausea and diarrhea, you can have serious heart disease and have no symptoms and worse no signs until the coronary artery ruptures dumping the surrounding fatty plaque into the center of the vessel where a blood clot rapidly forms, occluding the artery leading to a heart attack and that final fatal arrhythmia. There is something even more worrisome than not feeling you are ill until you die. The old Negro spiritual said it best: It isn't what you don't know that does you in…it is what you think is so, but ain't.

Everyone knows or has heard about cardiac risks and at least think their doctors understand them. But that clearly ain't so. The real confusion over cardiac risk factors is that those risks did not come out of mainstream medicine, but rather from the discipline of Public Health with its concerns for preventive medicine and population-based interventions. The two, the practitioners of private medicine and those who practice public health have always been at odds. Those involved with Public Health worried about the many in order to help the few, while those in the practice of medicine focus on the few to help the many. Two different Gods / Two different Mountain Tops…

It was World War II, with the need for the country to maintain the health and stamina of two great armies stretched across the globe that gave Public Health and the establishment of reliable population based medical studies, both government support and funding. It was the war that put the institutions of Public Health squarely in the center of the modern medical map. Plasma, the use of blood and blood products, portable water supplies, the prevention of malaria and the establishment of nutritional rations for troops fighting from the hedge groves of France to the jungles of the Philippines all came out of the Public Health labs of the Second World War.

Among the most famous of these government-supported institutions was the Laboratory of Physiological Hygiene in the School of Public Health at the University of Minnesota. The LPH under the direction of a senior scientist and PHD in Public Health, Ancel Keys, received a contract from the Army to conduct a study on starvation in conscientious objectors to discover the minimum diet which would sustain troops in the field while allowing them to move quickly without having to wait for logistical backup or long supply lines. All the studies were carried out under the University's Football Stadium, the only site on campus that could support the enormous weight of the huge water tank that was used to measure body surface areas as a reference point for the metabolic studies.

The study, named with understated simplicity, The Human Starvation Study was one of the first scientific study devoted solely to nutrition. Everything was measured; BMRS (Basic Metabolic Rates), amount of physical activity, percentage of body fat and blood tests including fats, lipids and protein levels. The famous "K rations" - K for Keys - that kept all our armies fed and on the move were developed from these studies. The Human Starvation Study remains among the ten most extensive and important works in nutritional science and is still referred to today by researchers and scientists in the field.

After the war, these different public health institutions remained in place and with additional federal funding focused more generally on issues of health, nutrition and disease in the general population. The abilities honed during the war for the military were now put to use in the public sector. In medicine, as in education, it is not what you teach that is important as much as what is emphasized. And following the war, public health institutions focused on the causes of disease rather then on interventions and treatments. Most of these basic physiologic laboratories were incorporated into state and federal institutions, as well as the nation's medical schools, where the first of a dozen different population studies were put into place.

The Laboratory for Physiologic Research continued its studies on nutrition with definitive studies of lipid metabolism including levels of cholesterol in both health and disease. It was these studies that laid the foundation for what were to become a number of hallmark, long-term population studies including the Framingham Study where 60% of the population of Framingham, Massachusetts were enrolled in the late 1940s and continued to be followed, including their children, with sequential clinic visits and blood tests for the next sixty years. These observational studies were the first to established the major risk factors for heart and vascular disease. It is, of course, one thing to identify risk factors and quite another to prove that modifying these factors will prevent disease. That would take some time and require the discovery of medications that specifically lowered each of the individual factors as well as a new statistical tool, the clinical medical trial.

An early by-product of these first observational studies was the redefining of high blood pressures as a pre-morbid condition or a "risk factor" for heart attacks and strokes. The validity of the risk factor analysis was dramatically documented for the first time with the publication of one of the first clinical trails, the Veteran's Administration Hypertension Study begun in the early 1960's to study the effects of lowering the blood pressures among VA patients. The study not only validated the risks discovered in the population studies like The Framingham Study, but dramatically had to be terminated half way through the study for ethical reasons, when the preliminary data showed that the group taking a placebo compared to those being treated with the anti-hypertensive drug available at the time would all be dead by the end of the study.

The core of the study had been the issue of risks. At the time, there was an argument about the risk of hypertension and whether high blood pressures should be treated or left alone and simply tolerated. One group of physicians argued that patients with the very high blood pressures-referred to as "Malignant Hypertension" because those patients had the same prognosis as patients with aggressive cancers-should not have their pressures lowered and that it was, in fact, misguided and outright dangerous to lower the blood pressures. These physicians thought that lowering pressures was sure to lead to the very heart attacks and strokes everyone was trying to eliminate. The high blood pressures were considered to be a positive adaptation to maintain adequate blood flow to the vital organs already damaged by significant vascular disease and were in fact "essential"in keeping the patient alive. In short this group of physicians felt that vascular disease lead to the high blood pressures.

The other group of physicians argued that the first group of physicians had it not only all wrong but backwards and that it was not vascular disease that caused the high blood pressures, but the high blood pressures that caused the vascular disease. They recommended that high blood pressures be lowered as quickly and as completely as possible. The VA study proved not only that lowering blood pressures did indeed save lives; but how little was known, even by the early 1970s, about risk factors in general and cardiac risks in particular.

It was the population study that prompted the newly established National Institute of Health to tackle the issue of medical interventions in heart disease by establishing clinical trials of medications to lower the cardiac risk factors other than hypertension. In the 1970s three landmark large-scale intervention trials; the Hypertension Detection and Follow Up Program with 10,940 participants; the LRC-Coronary Primary Prevention Trial (CPPT) 3806 participants and the Multiple Risk Factor Intervention Trial (MRFIT) study with 12866 participants were funded. These clinical trials were laying the foundation for what in the 80s and 90s would eventually be called "Evidence Based Medicine".

A great deal was learned from these studies. Some of what was discovered was to be expected from the original war and post-war population studies, while other results were both unexpected and terribly troubling. The Framingham study found that heart disease had become the major killer after the age of fifty, while the MRFIT follow ups showed that the systolic blood pressures-the higher reading of a blood pressure evaluation -were more predictive of heart and strokes than diastolic -or lower reading. Everyone in medicine had been wrong on that as they tried for over a hundred years to lower diastolic readings while treating the systolic readings as unimportant. Amazingly, that mistake still goes on today until the systolic readings become so high that no physician can ignore them.

Every early population study or clinical trial dealing with heart attacks or strokes showed that whatever the issue was under investigation that smoking was just about the worse thing you could do if you wanted to remain healthy and live much past 50. They also showed that being overweight-by itself-clearly led to ever higher cholesterol levels, increasingly high blood pressures and eventually to the diagnosis of diabetes and more than likely the development of the various cancers.

All of this made both nutritional and biochemical sense. The demographics of the average man in the early 1960s through the middle 80s were a bit frightening. He was a smoker of two to three packs of cigarettes a day, was 50 to 80 pounds overweight, did not exercise, had elevated blood pressures and high cholesterols, many levels of well over 400 with some already diabetic or pre-diabetic. It was to say the least, a menu for disaster.

The studies on high cholesterol levels that began with Ancel Key's work on high lipid levels in the general population was given greater credence when during the Korean War when autopsies of the eighteen and nineteen year-olds killed in the war showed startling and ominous results. In autopsy after autopsy, the pathologists discovered the coronary arteries of these young men filled with fatty atheroma and plaques that had previously only been seen in much older men dying of heart disease.

By the 1980s, the original observation data and clinical trials as well as additional nationwide autopsy studies were proving so persuasive and statistically sound that there was general agreement among the scientists and many in the medical community that patients had to be treated to lower their cholesterol levels, that both high systolic and diastolic blood pressures had to be treated and all patients had to be encouraged to alter their lifestyles by changing eating patterns, losing weight and increasing exercise.

Luckily by the late 1980s very effective and well-tolerated medications were becoming available to lower blood lipids and moderate blood pressures. Dieting too had become a national craze and smoking was finally on its way to being socially unacceptable. It is not an exaggeration to say that from the 1980s on we have learned more about what causes heart disease and strokes than any of the other chronic diseases, while having available an increasing number of well tolerated and effective drugs that effectively lower if not control all the most damaging risk factors, while increasing the heart healthy blood components. And yet, somehow the message appears not to have gotten out as the families of the 1.5 million patients dying from coronary artery disease found out this year and another 1.5 million will find out next year, not to mention the additional two million families each year who will call 911 at two in the morning, hoping they can get their loved one to the hospital in time to survive their heart attack or stroke. Something has gone terribly wrong either with the methods used to establish risks or the recommended interventions.

In times of confusion, it is always best to go back to the beginnings of things. For heart attacks and strokes and cardiac risk factors that means going back some thirty-seven years to July 1972 when a twenty-six year old, newly minted physician, Dr. Richard Grimm, fresh out of the University of Oklahoma medical school began his internal medicine internship in of all places, New York City's Metropolitan Hospital in East Harlem.

City Metropolitan in the 70s was not for faint of heart or the squeamish. It was a keep ‘em breathing; keep ‘em alive kind of hospital. The 1973 gritty movie "Hospital" starring George C. Scott dealing with the insanity of caring for the almost hopeless in a charity hospital was filmed not long after Grimm's arrival. At the Met, the supervising attending physicians volunteered their time, staying only for morning rounds before they left for their own offices. There was no real sense of owner by any of the attending or staff or specialists-as in "this patient" versus "my patient"- leaving the daily as well as the minute to minute and emergency care of the patients, who were mostly Puerto Rican, indigent, speaking little if any English and usually desperately ill, in the hands of the hundred or so interns and residents.

The house staff worked every other night, which meant being in the hospital 36 hours at a stretch. There were no weekends off. That kind of exhausting, hot-house work coupled to what was a very personal kind of responsibility was bound to lead some of the doctors to what were operationally important and practical questions; the most important being "is what we are doing to treat this patient really working, helping them live longer and at least making them feel better." There is little time when you are worn down to applaud ideas or treatments that don't work, make patients worse or forced you to come back and have to start all over again. It is not effort that is the mother of invention, but the need to be right and the pressure of time.

Many of the patients at Metropolitan were admitted with a diagnosis of liver and kidney failure from alcoholism, drug overdoses, or cancers that had been left unattended. But it was those patients in congestive heart failure and those admitted following heart attacks that were the most trying, most difficult to treat and most pathetic as they drifted off into pulmonary edema.

It all seemed a chaotic crapshoot to Grimm. Most of the heart failure patients who did not appear to be to all that ill on admission seemed to get better no matter what they did and most who were desperately ill got worse and eventually died despite any treatment. In some, the medications actually seemed to be making them worse. But Grimm was use to this. He had earned money as a medical student by working as an aid on the coronary care unit at the community hospital in Oklahoma. The patients weren't as difficult to deal with but the confusion and the results and the desperation was just as great as it was at Metropolitan. He slowly realized that nobody knew how to do this. It was all speculation or with some of the attending no more than a kind of established intuition. Getting lost, but now responsible Grimm decided to go back to the journals and medical textbooks to see if what they were being told to do was actually based on evidence or at least on some kind of medical science.

After several weeks of sitting in the library looking through the established medical literature, he experienced what could only be called a personal epiphany. Almost everything he was doing on the wards and in the emergency room had no scientific basis and was based solely on the personal opinions of the attending staff, based on what they called "established clinical judgments", even if what they were doing was clearly making the patients worse. It seemed to the young Dr. Grimm that much of what they were doing was just a kind of medical alchemy and clearly no more or no better than wishful thinking on the part of those he felt should have known better.

As a medical student in the coronary care unit in Oklahoma and on the wards in New York, Grimm had heard the arguments on whether or not malignant hypertension should or should not be treated. But the actual turning point for him was the use of digitalis for the patients following a heart attack. They were prescribing the medication for all kinds of heart failure, whatever the cause, from valve failure to a myocardopathy to a heart attack. There was some general agreement in the text books that digitalis did make normal heart muscle work more efficiently short term; but there was absolutely nothing in the literature that digitalis would also work on damaged muscle for longer periods, especially if the muscle was severely damaged following a severe heart attack.

In fact, there was absolutely nothing in the medical literature that showed digitalis was effective in treating heart failure from any cause. The ward patients clearly got better or worse with or without the drug and yet he and the other interns and residents were prescribing the medication for every cardiac patient in the hospital, and if the patients survived and made it to the outpatient clinics, for the rest of their lives.

Grimm voiced his concerns about how they were using digitalis, but no one listened. He was learning early how hard it was to convince physicians that they might be wrong. But what had become a young physician's quest in going back to the medical literature to see if reality supported the theory grew into a life long commitment to scientific facts of medicine, biometrics and real statistics. And it has taken a lifetime. Whatever else might be said about medical progress, it has moved forward more funeral by funeral than idea by idea.

With scientific evidence as the Holy Grail, Grimm began a four decade long interest in the causes, treatment and prevention of cardiovascular disease. He became a preventive cardiologist, a Robert Wood Johnson Clinical Scholar at Duke. Along the way he received a PhD in Physiologic Hygiene, a Master's degree in Statistics and eventually became a tenured full Professor of Cardiology and Epidemiology at the University of Minnesota's Medical school.

No more blind reliance of traditional treatments or simple wishful thinking. As Dr. Grimm would explain to a each new class of medical students, "The value of science is that it keeps us from fooling ourselves" and throughout the 1980s and 1990s there were still a great deal lot of fooling going on in what was now Professor Grimm's field of heart disease. Throughout those decades, medical school lectures still related coronary artery disease and cardiac deaths – if not totally, at least in large part – to stress, not sleeping, working to hard, genetics or simply bad luck.

Yet throughout those decades, ongoing and ever more sophisticated population studies and clinical trials continued to identify the major causes of cardiovascular disease as due to life style rather than stress or genetics, documenting that 45% of the adult populations in advanced nations would die of heart disease or stroke over the course of their lifetimes. In India and in China, among the growing middle classes – currently some 400 million people in India and another half a billion in China – the major cause of death was no longer found to be infectious diseases, but strokes and heart attacks.

High fat diets, obesity and increased smoking in these developing countries appear to be the largest contributing factor to these deaths and not the stresses of a hectic capitalistic life. The cardiac risk factors discovered through the Framingham, MRFIT, and The Seven Countries studies are exactly the same as those now prevalent in India and China: high cholesterols, weight gain, hypertension, lack of exercise and diabetes. Increasing life spans too, was clearly a contributing factor; but not so much the years added as the different types of damage acquired along the way.

Grimm and other medical statisticians were not surprised that the analysis of risk factors throughout an increasingly more affluent world mirrored the original studies in America. It was not that medicine was on to something that was important as much as on to something that was right. But getting a real handle on who is at risk and who isn't was more then a statistical game; it is at its core the beginning of a basic understanding of human disease. The knowledge of medical risk does in fact become the difference between living and dying…no small thing.

Still, it does little good to recognize risk factors, if all that is offered is to stay away from swamps during the summer months or the very difficult task of changing one's life styles. Luckily, the development of medications to lower the various cardiac risk factors took the recommendations to lower those risks out of the realm of suggestions and in some areas of shear fantasy into the area of actual treatment and cure. Study after study in the 80s, 90s and first decade of the 21st Century showed that these new medications not only effectively lowered each individual risk factor but reversed the pathological changes in all blood vessels including the fatty occlusions of coronary arteries that lead to heart attacks. If this wasn't yet the fountain of youth, it was definitely a better longer life through chemistry.

Aspirin itself was found to decrease the stickiness of blood that leads to the formation of clots – a second major cause of blockage of a fat filled coronary artery and the singularly most important physiologic event leading to sudden death-was part of the new effort at prevention. Indeed last month a Northwest Flight to California was diverted to Las Vegas because of a passenger clearly undergoing a heart attack. There were a number of physicians on board. A cardiologist collected all the aspirin he could from the other passengers and crushing the aspirins gave the medication to the heart attack victim. Within minutes the pain had subsided and the passenger made it off the plane and to the waiting ambulance alive. The cardiologist has done all that he could under the limited conditions of treating a heart attack on a plane traveling at 27,000 feet and it was enough. Whatever clots were being formed in the passenger's coronary arteries did not extend and whatever clots had been formed did not completely block the artery. Enough Aspirin can do that and a little Aspirin each day can stop the whole process from beginning.

The Beta Blocker medications introduced in the late 70s did slow abnormally fast and dangerous heart rates while taking the strain off damaged heart muscle. In short, the Beta Blockers let the heart make the most out of whatever heart muscle might be left after a significant myocardial infarct.

The introduction of powerful diuretics in the late 1960's to treat hypertension along with the development of several new classes of antihypertensive drugs developed over the next 30 years were all so well tolerated that they could be used in combinations to lower even the most resistant types of high blood pressure.

But it was the development of the statins – Lipitor and Zocor-in the middle 1980's that was the most important intervention in regards to vascular risks lowering the major risk factors for heart attacks -dropping cholesterol, triglycerides and low density lipoproteins- the fats most likely to cause heart blockage to astonishingly low levels-levels unable to be reached through diet alone.

By the end of the 20th Century, there were powerful and effective medications available to deal with risks. Finding out what put people's lives in danger from vascular disease had not been a meaningless or for that matter the anticipated frustratingly fruitless task. There were interventions available that worked even if the patients refused to change what they ate, what they drank and even if they smoked. The strengths and potency of the available medications had caught up with the substantial dangers of how we live. Yet, clearly something has gone dangerously wrong if the Tim Russerts of the world continue to die on a regular basis and so seemingly out of the blue.

Yet, every new observational study proved the data and the analyses to be correct while clinical trail after clinical trial proved that the medications actually worked to decrease the incidence of heart attacks and strokes. Give diabetic patients injections of insulin and they are effectively cured. Someone with thyroid disease can have normal thyroid function restored by simply taking the right dose of a synthetic thyroid medication. You can eliminate strep infections by taking four hundred units of penicillin every six hours for three days. Take a statin for three months and your cholesterol, triglycerides and lipoproteins will all decrease. Medicine is called medicine for a reason.

But with patients, even under the care of cardiologists, continuing to die at alarming rates, Grimm and a few other preventive cardiologists realized there had to be a structural flaw in the cardiac risk analysis themselves or how those risks were interpreted and presented. A fifty percent failure rate of what should have been reliable data could hardly be comforting to physicians taking care of patients and of no use to the baby boomer who wakes in the middle of the night with chest pain that he puts off to heart burn from the pizza he ate before he went to bed and reaches for an Alka-Seltzer or Zantac when he should call 911. Something had to be changed.

There was no doubt that the data on smoking, untreated hypertension, high cholesterols, high triglycerides and LDLs being risky was accurate. All those patients as well as the patients with elevated blood lipids were clearly at some risk of heart attacks. But what Grimm noticed in going back over all the data was that those at highest risk and in fact those that had heart attacks were found at the outer extremes of the data. But for the majority of patients, those with the lower numbers, the data was obviously not clear enough or presented accurately enough to pick out which were the ones most likely to have a heart attack. Somehow the less damaged but still diseased trees had been lost within in the whole forest.

Grimm finally realized that the fragmentation of the data was causing the basic data not only to be misinterpreted, but misapplied. It was a shock, but what Grimm finally understood was that this fragmentation clearly mimicked the fragmentation of medicine itself. What had gone wrong with the appropriate applying of the data on risk factors was what had gone wrong with medicine itself. Nobody was in charge of the whole patient anymore. Nobody was looking at the whole patient so nobody was willing to look at the totality of the individual data on risk factors. Each sub-specialty had staked out one of the risk factors as their own and that was the factor they focused on and pushed. What each specialist was saying to each one of their patients was not the whole story and that made what they were saying not only misleading, but also tragically wrong.

The nephrologists and internists focused on the high blood pressure risk since that was what they treated as part of their specialty. The endocrinologist feeling comfortable with both diagnosing and treating diabetes struggled to lower blood glucose attempting to control the diabetic aspects of vascular disease through glucose management. The cardiologist with their eyes fixed on the fat blockage of the coronary arteries took over the lowering blood lipids as part of their specialty, devising ever more complicated statin dosage schedules along with every more sophisticated blood tests to evaluate the results of treatments. Family practitioners picked up the slack from the nephrologists and endocrinologists by ardently and devotedly trying to get their patients to eat healthy, lose weight and exercise. These were issues they could and would talk about as part of their specialty.

But this fragmented way of dealing with risk factors allowed both the medical profession and the patients to ignore the obvious. Dealing with cardiac risks had become little more than a group of blind men trying to explain an elephant, each feeling different parts of the animal and then confidently giving an explanation of what the whole animal looked like based on the parts they were feeling.

But there was something more pernicious about this fragmentation of both the data and the patient than a myopic view of what was medical reality. Physicians are taught to think in terms of absolutes of all or nothing kinds of things. This categorical thought process is drilled into their brains over the four years of medical school and years of specialty training. It is how physicians think, how they are taught to think, how medical data is presented in a digital world of yes/no and what physicians are told their patients expect. After all, who wants a doctor who says that maybe you have cancer or maybe you don't…either you have herpes but it could be something else…this might just be a muscle strain or a torn ligament. More importantly this way of thinking is not just a convenience, it is how physicians used their own minds to organize disease. Those who practice medicine today do not like nor are they encouraged or expected to be vague. "Maybe" or a "most likely" or "probably" simply wouldn't work.

For decades a blood cholesterol of less than 350 was called "normal" but a cholesterol of 350 and higher were reported as "abnormal". A blood pressure of 120 over 80 was again "normal", while pressures at or above 140 over 90 are said to be in the hypertensive range. As for all the numbers in between, who knew? With the in-betweens, everyone-physicians and patients were kind of on their own.

Yet what Grimm saw when going through the old population data again and again was that the studies did not give all or nothing results. Looked at again, the risks played out like risks in the rest of the world whether you were analyzing car accidents or volcanic eruptions. Any why wouldn't they. Why sould cardiac risks be any different from the mathematics of any other kind of risk. All risks are continuous. Any engineer will tell you that much about risk analysis.

Carbon steel is the perfect example. The equivalent carbon content of alloy steel refers to a method of measuring the risk of the steel rupturing based on the chemical composition of the steel. The higher the total concentration of carbon along with other elements such as manganese, chromium, molybdenum, copper, vanadium and nickel, the greater the increase in hardness of the steel but the greater the decrease in the ability of the steel to flex under an increasing load and eventually to shatter.

An actual formula exists in which the percentage of carbon as well as the percentages of the other non-iron elements are all added together to give the engineers an absolute number that allows them to determine the actual risk of the steel breaking apart under ever increasing loads. The formula is the summation of carbon content along with the concentrations of all the other various elements. The real risk of the steel giving way is simply the addition of all the individual risks of each element with no lower limit to that cumulative risk. What engineers had to balance out is the desire for hardness versus the integrity of the steel to safely carry any future load.

In short, the propensity of a piece of alloy steel to crack is measured by the CE or Carbon-Equivalent formula:

CE(Risk of Fracture)=%C+%Mn/6+(%Cr+%M+%V)/5+(%Ni+%Cu)/15

The importance of the formula is not the different factors but the fact that the actual risk of the steel undergoing a catastrophic failure is the summation of all the smaller individual risks added together.

Grimm realized that cardiac risks too were clearly continuous and clearly additive. And when recalculated he found that the data also indicated no lower limit to the actual risk and more importantly each of the individual risks were clearly cumulative. The all or nothing approach to individual cardiac risks while clearly appealing and even comforting had little or nothing to do with reality.

Grimm's revised view on blood pressures proved the perfect example of the dangers of an all or nothing approach to risk data. If one was brave enough and willing to let go of the "all or none" theory of normal versus abnormal high blood pressures and looks again at the data, breaking the information down into smaller segments and looking at the accumulative risks of these smaller packets of data, you quickly find that if a so called "normal" blood pressure of a group increases in a linear and graded fashion over time, and even if the new and higher systolic and diastolic readings are still considered to be in the "normal range", the risk of a fatal heart attack within that group of patients doubles over that time period with the incidence of non-fatal events three times higher than the fatal attack. That kind of accumulating risk occurs when any of the major risk factors is looked at in this incremental way.

It is the old sixty-five mile an hour safe highway speed limit turned into an evaluation of heart disease. Drive a car more than 65 miles an hour and if you are pulled over by a highway patrol officer you will be given a ticket. Drive 64 miles an hour and not only will you not be pulled over, but everyone acts as if there is no risk of an accident under 65 miles per hour. It was not to stop accidents that the 65 mile an hour limit was put into effect; it was to stop the really horrendous accidents, those accidents where no one has a chance to survive. But everyone knows, or should know, that you clearly run the risk of some sort of injury the faster you drive and that the 65 miles an hour designation is an unreal yes/no limit on a future accident or injury. It is at best an arbitrary number. You run a risk of an accident the faster you drive at any speed, and slower if safer even down to forty or fifty miles an hour. Grimm saw something similar when he looked at the cumulative data on the various risk factors of heart disease whether it was age, blood pressure, glucose metabolism, weight, exercise, smoking or lipid levels.

Grimm found support for the view that there was no "normal" for cardiac risk factors from observation studies of those few humans living a hunter-gatherer lifestyle. The hunter-gatherers do not die of strokes or heart attacks and if they are not injured or acquire a life-threatening infection they can and do live vigorous lives well into their late 90s. These populations have cholesterols of less than 50, are not overweight, not hypertensive with systolic blood pressures considerably less than 100 that do not increase with age as blood pressures do in developed countries, and they clearly exercise just to stay alive. All our baselines are way too high. All our values are in a very fundamental way abnormal when compared to a hunter-gatherer society were there is no vascular disease.

As. Dr. Grimm has said more than once in his articles, scientific seminars and lectures, "Using risks as an all or nothing proposition flies in the face of what medical research and medical data tells us. All the risk factors of cardiovascular disease are graded and continuous." With our current life style there were no truly safe values for any of the measured risk factors.

Others have made the same observation. Dr. Craig Bowron, a physician and medical essayist, recent wrote in an article posted on his blog "Risk Factor versus Risks" that today we simply cannot predict who who will develop cardiovascular disease, "One of the major implications of a system that is built to respond to (single) risk factors and not to cumulative risk is that treatment and prevention are focused on the minority of people to be at the very highest risk for heart attack or stroke, and actually those who have already shown up in the ER with a "cardiovascular event".

In short, our medical system is set up only to catch those with the very highest risks. It is clear that under the current warning system those at measurable risk are not so much under the medical radar screen as ignored by the radar operators who refuse to see the mountain that the majority of patients are quickly approaching.

Grimm understood that what was needed to cut through the confusion and static of a half dozen decades long misreading of cardiac risk factors was a single composite number, specific for each patient that would give a quick and reliable estimate of that individual's risk of dying from cardiovascular disease over a defined period of time.

That number actually did drop out of Grimm's more sophisticated cumulative indexing. If you take each of the risk factors for any one patient and added them together in a sequential manner, the statistics give what Grimm called the "Absolute Risk" of that person having a cardiac event. The issue of having a heart attack or stroke is not risk factors that reach a certain explosive point, but the risk based on all the individual risks added together. Steel will collapse depending on its carbon-equivalent and the exposed load, while a patient will collapse depending on the combination of lipid values, blood pressures, serum glucose, the degree of obesity, smoking, lack of exercise and age.

The only argument against the use of an individual absolute risk profile is that with this number virtually everyone in America would be at risk. Still, there are decided advantages in knowing your own actual risk. At the very least you would be much less likely to misread that chest pain at night or the shortness of breath racking leaves or shoveling snow.

What has finally become clear is that the so called "abnormal" values at which we define hypertension or diabetes, high cholesterol levels, being overweight are arbitrary and based more on tradition than any evaluation of medical outcomes. Indeed as larger more statistically powered clinical trials are carried out, the established "normal" values for the major risk factors have been lowered over the last three decades and continue to drop, but according to the newest data clearly not yet to values that lead to little or no risk.

As Grimm has written "We could control all he abnormal risk factors as currently defined and just make a small dent in disease rates in the overall population because there are just not that many people who have high enough risk factors to get their doctor's attention." Yet the risks at any level are there and they are real. Real science does keep us from fooling ourselves. Increasing age, increasing weight, rising blood pressure, lipid and glucose levels above a draconian low level, any number of cigarettes, all band together and are all culprits in the causation and pathology of heart disease.

So what to do if virtually everyone tested for risk factors will have a risk-and in the majority of cases a substantial risk- of a heart attack or stroke and what do we do about that 50% of patients who are told by their physicians that they are doing just fine with maybe a little more weight loss or the taking of an aspirin once a day.

Grimm and a few others of his colleagues have reluctantly came to the conclusion that the only answer was to treat everyone-and that means everyone-with a combination pill containing all the medications known to lower each individual risk factor. His own calculations indicate that by treating everyone and driving risk factors below the current "normal" values, well over 80% of those who would surely have a "cardiac event " and most likely die or become severely disabled over the next two decades would be saved. In essence their disease would be cured.

Scientists in the UK agreeing with Grimm's new data while pursuing their own studies on absolute risk have gone so far as to recommend forgoing any testing or physician visits and simply offering such a combination pill to everyone over the age of 50. The World Health Organization too has recently adopted the idea of "Absolute Risk" and there are now at least three groups around the world testing the safety of a combination pill containing an aspirin, an antihypertensive medication, a diuretic and a lipid lowering statin.

An international study Pill-Pilot involving eight countries including the U.S. under the guidance of Dr. Grimm is testing the so called "Heart Pill". In India the combination pill is called the Polycap. The public health community in this country calls it generically the pollypill. Epidemiologists verifying Grimm's work estimate that within the United States at a minimum 60% of those who would die from a heart attack would be spared "The Big One". World wide the numbers would be in the hundreds of millions. Perhaps not surprisingly, Grimm, even in the face of the preliminary studies that have proven the safety of the Polypill and the fact that the National Heart, Lung and Blood Institute has expressed interest in the polypill, although there has been substantial hostility to the use of the Heart Pill within the United States.

The resistance within the United States-as one would expect watching the current debate about Health Care Reform- comes from the different special interest groups. The anti-immunization and lifestyle lobbies have gone nuclear about the medicalization of America. The medical community is against giving a medication – even if proven safe and effective – to anyone without first having a medical examination. The pharmaceutical industry is not happy with having a multiple pill made up totally of generic agents that are extremely inexpensive when each of the different medications is what Big Pharma calls one of their blockbuster drug- basically a medication that once prescribed will be prescribed for the rest of that patient's life. Even the insurance companies and health plans are resistant since a patient on the pollypill would pay only one pharmacy co-pay instead of four. And there remains the resistance that is intrinsic to basically conservative medicine when faced with anything that is new… and giving a multiple pill to everyone without seeing a doctor or doing any preceding blood work is indeed something that new.

Add to all this, a chaotic, dysfunctional health care system and action is virtually impossible. You can almost hear it now. "Who is going to supervise all this?" "Who is going to give the pill?" "Who is going to pay for the pill?" "Who gets called if something does go wrong?"

But if we are ever going to commit to evidence based medicine as a method to save lives while decreasing medical costs Heart Pill is it. Issues of access can be handled by simply giving the pill, as the British recommend, to everyone over 50. The costs can be handled by using generic drugs. A daily Heart Pill in America would be less than four dollars a month.

A little bit of his East Harlem experience has never left Dr. Grimm. The idea of taking care of those in distress, of relieving suffering and curing the ill is still a part of him as it is of so many who chosen or been forced to deal with the desperate and the suffering. In the face of a fragmented, enormously expensive, poorly functioning, indifferent and increasingly dysfunctional medical system, Grimm has decided simply to by pass the medical establishment and go directly to the patients… and that means directly or indirectly all of us.

Grimm with a statistical colleague had developed what he called (no pun intended) the "Grimm Meter", a circular slide disc shaped slide rule, that allows anyone who knows their age, systolic blood pressure, average HDL( the good cholesterol), their blood values of LDL or low density lipoprotein levels, as well as the number of cigarettes smoke per day and a yes/no on the history of type 2 diabetes. Add those values in a sequential manner by simply rotating the disc, the pointer giving a running index of the cumulative risks as the disc is moved through all the different established risk factors.

In less than a minute or two, you will have the your absolute risk of dying – not in some arcane and easily ignored statistical mumbo-jumbo, but in the more easily understandable real life number of whether you will be that one out of five of the people around you, the one out of six , the one out of ten or one out of fifty, who will be likely to die of a heart attack or have a stroke within the next five, ten and twenty years. Grimm has clearly decided that he and you and I can't wait for America to come around. This is something we are going to have to do for ourselves.

The meter has been designed to be user friendly for both health professionals and patients. But it would seem from the growing popularity of the Meter that lay people have picked up the concept of absolute risk a great deal quicker than the majority of physicians and health professionals, and not a moment to soon.

Since Tim Russert has died, other Hollywood celebrities have died unexpectedly from heart attacks. Christopher Hipp, a computer designer at age 47; Michael Martin, a graffiti artist, age 52; and last month Garrison Keller at age 67 had a nonfatal stroke. They would have all benefitted from the Gimm Meter.

In 1984 study of 1000 apparently healthy patients undergoing routine coronary angiography, only 8% had completely open un-obstructived coronary arteries. Coronary artery disease was already an epidemic back then (self induced but an epidemic non the less) with what would surely be be even lower numbers of opened arteries today. Those ambulances that you see pulling up to a neighbor's house are not there because someone has fallen down the basement stairs.

Every day hundreds of patients die where they stand, where they work or where they sleep, while those luckily enough to survive make it to an emergency room. The data to date clearly shows that a majority of these patients would have been spared by the use of the Heart Pill. That of course has been Grimm's hope from the very beginning and may now be a real possibility. That we have to do this on our own makes no difference. A cure in medicine is a cure wherever you find it. So until your own physician comes around, here is where and how you can get the Grimm Meter. Just go to the Web site:

GrimmMeter.com

If you are getting older and care about yourself, a loved one who is pushing fifty or beyond, then get the Meter and use it. Find out your real cardiac risks. And if you or a loved one are at an unacceptable risk, then demand that the Heart Pill be made available and if it isn't or wouldn't be, then make up your own Heart Pill by having your physician write you prescriptions for generic aspirin, a generic Beta Blocker, an anti-hypertensive medication and a generic statin. Just giving 80 milligram of a statin pre-operatively for a month to patients undergoing any type of vascular surgery improves post-operative outcomes including a significant decrease in post-operative cardiac deaths. Yet, there is organized pressure on the FDA not to even clinically test the Heart Pill for eventually national release. It appears that as far as heart attacks and strokes, we are all still pretty much on our own.