Friday, August 8, 2008

How To Prevent Commercial Exploitation Of Bypass Operation & Angioplasty.

A Joint Task Force has been set up by the American College of Cardiology, American Heart Association and European Society of Cardiology (ACC/AHA/ESC), to frame guidelines for carrying out various treatments, procedures and surgeries related to heart. This expert committee has studied the published research data from world over to formulate these guidelines. Purpose of this is not only to help doctors to reach at correct conclusions while working out the best possible approach for the given patient but also to exercise restraint on commercial exploitation of certain types of treatment modalities especially Bypass Operation and Angioplasty with Stent. These guidelines are upgraded from time to time, in keeping with the newer research data coming in.
Depending upon the strength of available scientific evidence (class A, B, C or D), various severities of each disease have been classified into Class I, Class II (a & b) and Class III of indications. Detailed descriptions have been given as to the various parameters pertaining to Clinical Examination (severity of Angina, severity of breathlessness etc), lab test reports, echocardiography report and Coronary Angiography findings and accordingly all patients are meant to be clubbed in to various classes of indications. In case the level of indication is Class I, immediate Bypass Operation or Angioplasty must be performed without any delay. But in case the level of Indication is II (a) or II (b), at least three months trial must be given to the patient with conservative (non-surgical & non-invasive) treatments, whichever are available at the time. After three months, the patient is meant to be re-evaluated and in case improvement is observed in his condition, the same line of treatment is recommended to be carried on. But in case no improvement is observed or in case further deterioration is noted, then the classification of indication automatically gets upgraded to “Class I”. In case the class of indication works out to be “Class III”, then the given treatment or surgery is “Contraindicated” i.e. forbidden, unless performed under exceptional circumstances, which the treating physician/ cardiologist / cardiac surgeon has to specify.
In USA, Canada and Europe, it is an obligatory/mandatory requirement that before a patient can be taken up for Bypass Operation or for Angioplasty, the treating Cardiologist must issue a “Class I Indication” certificate. In our country, such a legal stipulation has not come into force as yet, for whatever reason/s but conscientious physicians and cardiologists and alert public can take advantage of these guidelines to put brakes on misuse of these two commercially lucrative kinds of treatments.
Even lay people can make a rough evaluation based upon these guidelines: for a patient who has been detected to be having severe blockages in his angiogram (70% or more at one or more places), he should fulfill the following criteria to be classified as “Class I” indication for Bypass or Angioplasty:
1. His/her angina should be so severe that it interferes with his daily routine. Which means that an office worker on a desk job gets an attack of angina only when he runs up a hill or a flight of stairs but otherwise throughout the day he does not experience angina is NOT a “Class I” candidate (remember: every chest pain is not angina. A pain gets labeled as “Angina” only when specific abnormalities have been demonstrated in ECG, which can be a resting ECG, transtelephonic ECG or a continuous monitored ECG for 24 hours which is called “Holter ECG Monitor”). Various severities of Angina have been classified into Class I, Class II, Class III and Class IV, as described by the New York Heart Association (NYHA) and this classification is accepted world-over.
2. Similarly goes the severity of his breathlessness vis-à-vis the nature of his occupation/ life style. Breathlessness (called “dyspnoea” in medical parlance) too has been divided into four classes by the NYHA.
3. Echocardiography should reveal “Left Ventricular Ejection Fraction” (LVEF) to be equal to or less than 50% [II (b)] or less than 35% [II (a)] (normal LVEF is between 50% and 70%).
4. Coronary Angiography should reveal any of the following three:
a. Left Main Coronary Artery (LMCA) disease, measuring more than 50%.
b. Left Main Equivalent (LME) disease (both the branches of Left Main trunk i.e. LAD and LCx are involved to an extent of 70% or more and that too only where the “proximal segment” i.e. the segment before their first branch is given off, is involved.
c. Triple Vessel Disease (TVD), where LAD, LCx and RCA all three are involved and that too only the “proximal segments”. Mid segment or terminal segment lesions (blockages), even when showing up as 70% or more end up as Class II (a) or (b) or as Class III.
In nutshell, just because an Angiogrpahy shows blockages, it does not mean that a Bypass Operation or Angioplasty is a must. The process leading to blockage formation is not a disease process at all. It is nature’s protective mechanism wherein the lining of our arteries (called “endothelium”) has been equipped to pick up toxic particles, including “oxidized LDL” particles of cholesterol to render then harmless. If this protective mechanism were not there, our life spans would have been drastically cut down! The process of this blockage formation starts right at birth (even before birth, in fact!) and it takes many decades for the blockages to show up on angiography. As the blockages keep forming, new arteries keep growing in us all the time (called “Angiogenesis”) leading to formation of “Collateral Circulation”. Therefore, essentially blockage formation is not a curse: it is in fact a blessing! By the time severe blockage showing up as 70% or more on angiography develop, a lot of Collateral Circulation is deemed to have developed which neutralizes the strangulating effect of them. But as the age advances, angiogenesis and collateral channel development keep slowing down and the process of blockage formation keeps speeding up as risk factors keep adding up over the years: risk factors like high blood pressure, diabetes, cholesterol, obesity, smoking, pollution etc. It is only when the blood supply to the heart starts getting choked and symptoms in the form angina and breathlessness start appearing and only when pumping action of the heart starts becoming weak (shown by weakness of movement on echocardiography called “hypokinesia” and reduced “ejection fraction”) that Bypass Operation or Angioplasty are called for, not as such.
Alternatives to bypass surgery or angioplasty with modern drugs and other management techniques have changed the natural history of coronary artery disease. Like so many other diseases of the past that were considered lethal and are now considered benign because we have effective treatments, it is time to downgrade coronary artery disease from the lethal disease it once was, to a relatively benign disorder which, like arthritis, which might bother you once in a while, but should not shorten your life or significantly change it’s quality.
All those people whose angiography shows blockages at one or more places, which are 70% or more, should not rush headlong into Bypass Operation or Angioplasty. They should insist on being evaluated on the touchstone of the Joint Task Force (JTF) of AHA/ACC/ESC, which have been painstakingly formulated for your benefit by people who are treated like demigods in the field of Cardiology all over the world. If advised Bypass or Angioplasty, they should do self evaluation as per details given above or should at least insist on demanding a certificate from their Cardiologist to the effect that they fit in with the “Class I” level of indication as per the JTF guidelines. Wording of the suggested certificate is given as under:

One might ask: if all this were true, it should have been talk-of-the-town by now but nobody, not even most of the doctors seem to be knowing about it! Reason is corporatization/ commercialization of the medical profession. Nowadays, the healthcare industry looks upon you all as ‘clients’ rather than as ‘patients’ and tries to fulfill your ‘felt needs’ or ‘perceived needs’ rather than professionally assessed ‘altruistic/true needs’. Visible blockages on Angiography create fear/panic in you and the industry tries to help you by removing or bypassing these blockages. The fact that blockages are dangerous not because of their physical bulk, but because of their propensity to burst/rupture is quitely ignored. In the absence of scientific knowledge, people tend to get scared of shadows and real threats lurking in the background are glossed over. One ploy the industry uses to keep the people quiet and not babble about inconvenient things like JTF and “Indication Class” and such like things is to create very large and posh buildings which are very impressive looking. The aim is to subdue you into bovine submission and discourage you from asking inconvenient questions. Healthcare industry has created such an environment that words like “Angioplasty” or “Bypass Surgery” are spoken with slick ease even by illiterate people. Normally such words should be like tongue twisters and quite a mouthful for lay people; esp. non-english speaking population. Why can’t the same people pronounce “Joint Task Force”, “American College of Cardiology”, “American Heart Association”, “Left Ventricular Ejection Fraction”, “hypokinesia”, “Angiogenesis” and “Collateral Circulation” with the same consummate ease? Least we can do is to try-it is never too late, not even more than half a century after having gained freedom (or is it just “so called freedom”?).

BLOCKAGES IN ARTERIES ARE BETTER LEFT ALONE! No need to bypass them or to open them up.

Whenever an angiography report reveals blockages in heart’s arteries, people are told to get them opened up with the help of balloon angioplasty or to get them bypassed surgically. Most patients never ask why. A few who do raise this question are told that they are under an imminent threat of a heart attack and death. It is a well-known fact now that heart attacks are caused when the blockages burst (plaque rupture). Conversely, as long as they don’t rupture, they are harmless. A lesser known but more interesting fact is that smaller, harmless looking blockages, which are many a times not even visible on angiograms and mostly less than 60% in size, are the ones which are most likely to rupture. Therefore, in most cases angiograms give misleading information: either it does not show up the dangerous blockage, or it shows a dangerous blockage to be rather safe because it is less than 60%. Blockages which are more than 60% in size are considered as dangerous enough to warrant some serious intervention such as bypass operation or balloon angioplasty. But the fact is that it takes many decades for a blockage to reach that size (60% or more) and in that much time a lot of calcium has got deposited in the fatty material and a lot of fibrous tissue has grown into it, making it a “stable lesion” not likely to rupture and therefore, comparatively safe. Few decades ago when we were not armed with the presently available powerful research data, angiography-angioplasty-bypass nexus made some sense. But it is amazing that it is still not only carrying on, but is flourishing and thriving. A close and hard look at this anomalous phenomenon is called for: very interesting results are assured.
Only a few research studies have shown a survival benefit with bypass surgery and angioplasty, and these were done in the seventies before the availability of modern medications. Even these few studies are suspect as to their reliability because the differences shown by them in morbidity and mortality data as compared to management of heart disease with conservative approach (medicines + dietary modifications+ life-style modifications + exercise; collectively called “Medical Management”), is not “statistically significant” i.e. the difference is not clear cut. Most talked about such research study is CASS (Coronary Artery Surgery Study), conducted between 1975 and 1979. It showed marginally better 5-year survival benefit, but the results were not “Statistically Significant” There is not a single research study available to-date, which shows a clear-cut advantage over medical management. A noteworthy point is that in the 70’s, we did not have powerful medications which we have today, i.e. ACE-I’s, ARB’s, selective & highly selective Beta-Blockers, Statins, Ezetimibe, Fenofibrate, Nicotinamide, Antiplatelet Aggregation agents, Antioxidants and much more effective medications for treating Diabetes Mellitus. In addition, since 1995, we have access to another USFDA approved non-invasive treatment modality called “External Counter Pulsation” (ECP), which, when combined with diligent “Medical Management” significantly improves the outcomes. In the list of indications for bypass surgery, there is only ONE clear-cut/ absolute indication given by the American Heart Association, Canadian Heart Association and other such respected bodies: significant and symptomatic Left Main Disease. All other indications are subject to “failure of medical management” or “refractory to medical management”. The implied meaning is that it is NOT proper/appropriate to suggest Bypass Surgery till such time that all non-surgical options have been exhausted. But ground reality is unfortunately very different: moment blockages are detected, patients are threatened, "You can have a massive heart attack and die at anytime unless you undergo immediate surgery!" Some people have started calling it “Medical Terrorism”.
The truth of the matter is that the most recent studies, involving now more than 41,000 patients, and population studies involving more than two million people, have shown that an alternative or alternatives to bypass surgery are associated with far lower morbidity and mortality. In other words, alternative treatment with modern pharmaceutical agents as well as other alternatives are highly effective, provided the cardiologist you are dealing with knows how to use medication, takes it seriously and carries it out diligently. Sad to say, most do not and prescribe an inadequate number of drugs or too low a dosage. It should also be pointed out that not only do angioplasty and bypass surgery NOT slow down the progression of the disease and its consequences, but actually accelerates it’s progression, by causing injury to endothelial membrane.
Finally, many cardiologists and surgeons will casually dismiss an alternative or alternatives to bypass surgery/ angioplasty with modern drugs and other management techniques because these alternatives are unable to eliminate or unclog the obstructed coronary artery. That is true. It is not possible to restore the obstructed coronary artery back to normal by any form of treatment. But we don't have to and nor do bypass/ Angioplasty achieve that, though somehow, it is made out to be that. What modern drug treatment does is to restore blood flow to the heart muscle in that part of the heart where blood flow is reduced. This is accomplished by dilating other blood vessels in the same area that are not blocked. At the same time other drugs reduce the workload of the heart so that the heart muscle requires less blood. This is like finding another source of income and reducing expenses if you lose your job. Once income to the heart muscle (blood flow) is adequate for the expenses (work load) of the heart, chest pains will disappear. There are other drugs, which stabilize the vulnerable plaques, minimizing the chances of their rupture, and accordingly the chances of a heart attack or death. This gives sufficient time to heart to grow new channels, using body's natural adaptive responses leading to formation of new blood vessels through angiogenesis (angio = blood vessels, genesis = birth of). The result is the formation of a vast network of small vessels that develop around the obstructed artery allowing blood to flow around the obstructed artery without resistance. In other words, the heart has put in its own bypasses with the help of medical therapy with modern drugs that is an alternative to bypass surgery. Unfortunately, such collateral vessels, as they are called, are not visible on an angiogram because they are too small to be seen by this primitive imaging technique. However, other imaging studies such as an echocardiogram or nuclear imaging will clearly show the heart muscle is functioning and contracting in a perfectly normal manner, even though the artery going to that area of the heart is partially or completely obstructed. How can that be? Obviously, blood is getting through to that heart muscle, even though this can't be seen on the angiogram---an imaging procedure that has been around since 1958 and has obvious limitations and has far outlived it’s utility. Finally, modern drug therapy is more than just an alternative to bypass surgery and angioplasty. We now recognize that certain drugs such as beta blockers, Ace inhibitors and Statins actually slow down and even stop the progression of coronary artery disease, and may even reverse some of the changes that have occurred. Neither bypass surgery nor angioplasty are capable of doing this.
In summary, an alternative or alternatives to bypass surgery or angioplasty with modern drugs and other management techniques has changed the natural history of coronary artery disease. Like so many other diseases of the past that were lethal and are now considered benign because we have effective treatment, it is time to downgrade coronary artery disease from the lethal disease it once was, to a relatively benign disorder which, like arthritis, might bother you once in a while, but should not shorten your life or significantly change it’s quality.
A study published in 1999 in the New England Journal of Medicine continues to produce controversy and infighting amongst cardiologists. The Atorvastatin VErsus Revascularization Treatment (AVERT) trial compared aggressive cholesterol -lowering (with the statin atorvastatin) to angioplasty in patients with mild to moderate coronary artery disease. The AVERT study reported that patients randomized to statin therapy had a lower incidence of later problems (including the need for later angioplasty procedures, coronary-artery bypass operations, and hospitalizations for worsening angina) than did the patients who had received angioplasties. These results stunned the cardiology community. Now slowly, a consensus seems to be emerging: a coronary artery blockage is not like Mt. Everest, needing to be dilated, bypassed or cleared, “because it’s there.” So if anyone is confronted with an advice to go for Bypass Surgery or Angioplasty, he should not think twice, but should think thrice at least. Here is a compendium of 37 research studies, which I have compiled from the published literature; conducted between late 80’s and 2001 in: New England Journal of Medicine, Journal of American College of Cardiology, Journal of American Medical Association, Archives of Internal Medicine, European Heart journal, The Lancet, Circulation and British Medical Journal. All these studies compared the quality of life and survival benefits (morbidity and mortality data) between Angioplasty and/ or Bypass Surgery on one hand and “Medical Management” on the other hand. In all of them, “Medical Management” was a clear winner, with the results being “Statistically significant”. (Full-text/ abstract available on request):
1. Non-Q-wave Myocardial Infarction Following Thrombolytic Therapy: A Comparison of Outcomes in Patients Randomized to Invasive or Conservative Post-Infarct Assessment Strategies in the Veterans Affairs Non-Q-Wave Infarction Strategies In-Hospital (VANQWISH) Trial.. Wexler,LF, Blaustein, AS, Philip W. Lavori, PW, et al. Journal of the American College of Cardiology. ; 2001; 37: 19-25.
2. Percutaneous Transluminal Angioplasty Versus Medical Treatment For Non-Acute Coronary Heart Disease: Meta-Analysis of Randomized Controlled Trials. Bucher, HC, Hengstler, P, Schindler, C, Gordon, H, Guyatt, GH. British Medical Journal. 2000; 321: 73-77.
3. Intensive Medical Therapy Versus Coronary Angioplasty for Suppression of Myocardial Ischemia in Survivors of an Acute Myocardial Infarction. Dakik HA, Kleiman NS, Farmer, JA et al. Circulation, 1998; 98: 2017-2023.
4. Outcome In Patients with Acute Non-Q Wave Myocardial Infarction Randomly Assigned to An Invasive As Compared with a Conservative Management Strategy. Boden WE, O'Rourke RA, Crawford MH, et al. New Engl J. Medicine. 1998; 338: 1785-1792.
5. Twenty-two Year Follow-up in the VA Cooperative Study of Coronary artery bypass surgery for Stable Angina. Peduzzi, P, Kamina A, Detrie, K, American Journal of Cardiology. 1998; 81; 1393-1399.
6. A Prospective Randomized Trial of Triage Angiography in Acute Coronary Syndromes Ineligible for Trombolytic Therapy. Results of the Medicine Versus Angiography in Thrombolytic Exclusion (MATE) Trial. McCullough PA, O'Neill WW, Graham M, et al. Journal of the American College of Cardiology. 1998; 32: 596-605.
7. Danish Multicenter Randomized Study of Invasive Versus Conservative Treatment In Patients With Inducible Ischemia After Thrombolysis In Acute Myocardial Infarction. DANAMI) Madsen JK, Grande P, Saunamaki K, et al. Circulation. 1997; 96: 748-755.
8. Coronary Angioplasty Versus Medical Therapy For Angina: The Second Randomized Intervention Treatment of Angina (RITA-2) Trial. RITA-2 Trial Participants. Lancet. 1997; 350: 461-468.
9. One Year Results of the Thrombolysis in Myocardial Infarction (TIMI) IIIB Clinical Trial. A randomized Comparison of Tissue-Type Plasminogen Activator Versus Placebo and Early Invasive Versus Early Conservative Strategies in Unstable Angina and Non-Q Wave Myocardial Infarction. Anderson HV, Cannon CP, Stone PH, et al. Journal of The American College of Cardiology. 1995; 26: 1643-1650.
10. The Medicine, Angioplasty or Surgery Study (MASS): A Prospective Randomized Trial of Medical Therapy, Balloon Angioplasty or Bypass Surgery for Single Proximal Left Anterior Descending Artery Stenosis. Hueb WA, Bellotti G, Oliveira SA et al. Journal of the American College of Cardiology. 1995; 26: 1600-1605.
11. Two and Three Year Results of the Thrombolysis in Myocardial Infarction (TIMI) Phase II Clinical Trial. Terrin ML, Williams DO, Kleiman, NS et al. Journal of the American College of Cardiology. 1993;22; 1763-1772.
12. Randomized Trial of Late Angioplasty Versus Conservative Management For Patients with Residual Stenosis After Thrombolytic Treatment of Myocardial Infarction. Ellis, SG, Mooney, MR. George, BS, et al. Circulation. 1992: 86; 1400-1406.
13. A Comparison of Angioplasty With Medical Therapy in the Treatment of Single Vessel Coronary Artery Disease. Parisi AF, Folland ED, Hartigan P. New Engl J Med. 1992; 326: 10-16.
14. SWIFT Trial of Delayed Elective Intervention v. Conservative Treatment After Thrombolysis With Anistreplase in Acute Myocardial Infarction. Should We Intervene Following Thrombolysis? SWIFT Study Group Trial Study Group. British Medical Journal. 1991: 302: 555-560.
15. Comparison of Immediate Invasive, Delayed Invasive and Conservative Strategies After Tissue-Type Plasminogen Activator. Rogers, WJ, Baim, DS, Gore, JM et al. Circulation. 1990: 81; 1457-1476.
16. Randomized Controlled Trial of Late In-Hospital Angiography and Angioplasty Versus Conservative Management After Treatment With Recombinant Tissue-Type Plasminogen Activator in Acute Myocardial Infarction. Barbash GI, Roth A, Hanoch H., et al. American Journal of Cardiology. 1990; 66: 538-545.
17. Comparison of Invasive and Conservative Strategies After Treatment With Intravenous Tissue Plasminogen Activator in Acute Myocardial Infarction. The TIMI study Group. N. Engl J Med 1989; 320: 618-627.
18. Thrombolysis With Tissue Plasminogen Activator in Acute Myocardial Infarction: No Additional Benefit From Immediate Percutaneous Coronary Angioplasty. Simoons, ML, Betriu, A, Collateral, J et al. The Lancet. January 30, 1988; 197-203.
19. Comparison of Medical and Surgical Treatment forh Unstable Angina Pectoris. Luchi, RJ, Scott SM, Deupree RH, et al. N. Engl. J. Medicine 1987; 316: 977-984.
20. Racial Differences in the Use of Invasive Cardiac Procedures and 1 Year Clinical Outcomes for Non-Q-Wave Myocardial Infarction Patients Randomized to Invasive vs. Conservative Management. Samar H, Heggunje PS, Deedwania PC et al. Journal of the American College Cardiology, Supplement, 2001; 37: 15A
21. A Comparison of the Impact of Practice Patterns on Outcome of Patients With Acute Coronary Syndromes in the USA and Canada: Post Hoc Analysis of ESSENCE and TIMI IIB. Batchelor, WB, Radley D, Cohen M, et al. Journal of the American College Cardiology, Supplement, 2001; 37: 359A
22. Outcome Study of Two Large Populations With Different Rates of Cardiac Interventions. Mahrer, PR. Cardiovascular Reviews and Reports, December 2000 638-651
23. Piegas, IS, Flather, M, Pogue J. et al. for the OASIS Registry Investigators. The Organization to Access Strategies for Ischemic Syndromes (OASIS) registry in patients with Unstable Angina. Am J. of Cardiology. 1999; 84(suppl): 7M-12M.
24. Comparison of Medical Care and Survival of Hospitalized Patients with Acute Myocardial Infarction in Poland and the United States. Rosamond W, Broda G, Kawalec E, et al. American J. Cardiology 1999; 83: 1180-1185.
25. Use of Coronary Angiography and Revascularization Procedures Following Acute Myocardial Infarction: A European perspective. Woods, KL, Ketley D, Agusti, A, et al European Heart Journal. 1998; 19; 1348-1354.
26. Use of Cardiac Procedures and Outcomes in Elderly Patients with Myocardial Infarction in the United States and Canada Tu JV, Pashos CL, Naylor Color Doppler, et al. N Engl J Med 1997; 336: 1500-1505.
27. Variation in the Use of Cardiac Procedures After Acute Myocardial Infarction. Guadagnoli E, Hauptman BJ, Ayanian JZ, et al. N Engl J Med 1995; 333: 573-578.
28. A Comparison of Management Patterns After Acute Myocardial Infarction in Canada and in the United States Rouleau JL, Moye LA, Pfeffer, MA et al. N Engl J Med 1993;328: 779-784.
29. Differences in the Treatment of Myocardial Infarction in the United States and Canada. A Comparison of Two University Hospitals. Pilote L, Racine N, Hlatky MA. Arch Intern Medication 1994; 154: 1090-1096.
30. Comparison of Medical Care and One and 12 Month Mortality of Hospitalized patients with Acute Myocardial Infarction in Minneapolis-St. Paul, Minnesota, United States of America and Goteborg, Sweden. McGovern OG, Herlitz J, Pankow JS, et al. Am. J Cardiol. 1997; 80: 557-562
31. Longitudinal Assessment of Neurocognitive Function After Coronary Artery Bypass Surgery. Newman MF, Kirchner JL, Phillips-Bute B, et al. N Engl J Medication 2001; 344: 395-402.
32. Coronary Stenting or Percutaneous Transluminal Coronary Angioplasty Prior to Noncardiac Surgery Increases Adverse Events: The Evidence is Mounting, Van Norman GA, and Posner, K. Journal of the American College of Cardiology. 2000; 36: 2351
33. Catastrophic Outcomes of Noncardiac Surgery Soon After Coronary Stenting. Kaluza GL, Joseph J, Lee JR, et al. Journal of the American College of Cardiology. 2000; 35: 1288-1294.
34. Results of a Second-Opinion Trial Among Patients Recommended For Coronary Angiography. Graboys TB, Biegelsen B, Lampert S, Blatt CM, Lown B. JAMA; 1992: 268 2537-2540.
35. Two to Eight Year Survival Rates in Patients Who Refused Coronary Artery Bypass Grafting. Hueb W, Bellotti G. Ramired J, et al. American Journal Cardiology. 1989;63: 155-159.
36. Prognosis of Medically Treated Patients with Coronary Artery Disease With Profound ST-Segment Depression During Exercise Testing. Podrif, PD, Graboys, TB, Lown, B. N Engl J Med. 1981; 305:1111-1116.
37. Exercise Performance-Based Outcomes of Medically Treated Patients with Coronary Artery Disease and Profound ST Segment Depression. Thompson, CA, Jabbour S, Goldberg, RJ, et al. Journal of the American College of Cardiology. 2000; 36: 2140-2145. From Harvard Medical School, the Lown Cardiovascular Research Foundation, and the University of Massachusetts Medical School

Health Insurance & Medical Profession:

(Following is the text of a speech I had prepared, under invitation, for making at a seminar on common problems faced by the Health Insurance Industry and the Healthcare Industry. It was not accepted, for reasons best known to the organizers. Ostensible reason given was inability to spare a time slot)
Revenue generation capacity and accordingly, prosperity of medical profession (esp. in the private sector) is directly proportionate to incidence & prevalence of sickness and inversely proportionate to that of health, whereas that of the Health Insurance industry is other way round. Therefore, aims and goals of the two are opposite to each other and accordingly, apparently and logically, we are adversaries.
But in this seminar, we are trying to come together as if our goals are common. There is some lacuna somewhere. Either our goals are actually common, the apparent disparity being an illusion, or there is some fault in our understanding of each other. World Health Organization (WHO) defines “Health” as: “Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity”. If, and it is a big IF, this utopian dream comes true, hospital centric and sickness orientated medical profession, as it is being practiced today, shall be in a serious trouble, but insurance industry shall have all the reason to celebrate. But this celebration shall be only temporary, as health insurance premiums shall start tumbling, and the disease/ sickness centric so called health insurance industry, as it is functioning today shall also collapse. This proves that we both are in the same boat, having a symbiotic relationship. Medical profession, with its focus on only commercially viable diagnostic & therapeutic services, drives the costs high and makes the medical services inaccessible to the common man. Health Insurance steps in to the rescue of the beleaguered common man, bringing down the costs (only slightly) for him. This technique is often used in interrogation chambers: two interrogators work as a team- one menacingly scares and the other tenderly cares. Ultimate goal is to break the subject into submissiveness and co-operation. Some hunting animals too use the same technique-one tires & exhausts the prey and the other goes for the kill. On the surface they seem to be adversaries, competing for the common prey. Do you find a similarity in the coming together of our two professions? I do. It creates a win-win situation for both of us, but a lose-lose situation for the patients and the public. If we keep ourselves (the two comrades with common goals) on one side and patients/ public (our clients) on the other, then it is win-lose situation.
Marketing and business experts often say that only those business enterprises; where the businessman and the client share a win-win situation; survive & thrive. Those businesses where it is a win-lose situation loaded against the user/ consumer, do not succeed, in the long run at least. If we consider the situation in the context of Healthcare-Insurance Industry combine as the service providers vis-à-vis the consumers, it surely is a win-lose one. True to the aforementioned principles of business, both of us, healthcare as well as insurance industries are in trouble. Unfortunately, this is just the beginning of the end, unless we do some soul searching. Can the two of us come together and join hands as service providers in such a way that we offer to the public a win-win situation? I take this opportunity to make a couple of humble suggestions to this august gathering.
Our first step has to be a change in the mindset. We have to become ‘Healthcare’ providers in true sense of the word, and abandon our fixation on ‘Sickness- care’. In this direction, the initiative has to be taken by the insurance industry. At present, you are approaching us to seek therapeutic intervention to treat/ cure established diseases. My profession is doing a commendable job of it; I am proud and happy to say. But we are doing that and just that-no more & no less. We have lot more to offer; probably the insurance industry does not know this. We can predict diseases and we can prevent them well in time. Our capabilities & competencies in this field are much more refined than curative therapies, esp. for modern day diseases/ disorders. There is an enormous amount of research data available (wastefully unutilized) as to how much hypertension causes how much damage to the ‘end organs’ like kidneys, eyes, brain and heart in how much time and how to effectively prevent it. The same goes for Diabetes Mellitus and for Rheumatoid Arthritis and so many more medical conditions. But we are NOT doing it, because no one seeks this service from us. Almost none of us is monitoring and treating Diabetes Mellitus as per the recommendations of the expert committee, which deliberated upon the findings of a research study called ‘UKPDS clinical trial’, published in 1996. Almost none of us is following the recommendations & guidelines of JNC-VII committee on detection and treatment of hypertension. I can unabashedly state that almost none of us is monitoring lipids as per recommendations made by the NCEP-ATP III. But medical professionals cannot be blamed for the foregoing. We can offer only that which is sought from us. In our professional capacity, we cannot be expected to go around thrusting clinical research findings upon an unwilling public/ insurance companies. We are aware (this is one of the basics taught to us in medical schools) that when we break the news of a diagnosis to a patient and his family, they go through five stages before coming to terms with the ground reality: Denial, Anger, Blame, Dejection and finally Reconciliation. To take the patient and his family though this quagmire needs enormous amount of resources in the form of clinicians’ time and time & efforts of paramedical counseling staff. In addition building, furniture and communications equipments are required. Also required is software of various types (recorded dramas, skits and messages from leading expert authorities in respective fields) prepared by professionals, to effectively communicate the message. But who will pay for these resources? After all, there ain’t no free lunch, as Americans say. At present, no one is paying, neither attention nor money, to this vital service we are crying ourselves hoarse to offer to a needy but unaware public. Neither the Governments, nor the Insurance companies and of course nor the public. Now, the public cannot be faulted, because they shall do whatever the leadership decides is good for them. And Governments in democracies cannot be expected to take the initiative because in a popular democracy, the public is not lead by leaders but by vote seeking petty politicians, whose vision beyond the tips of their noses extends only to as far as the outer limits of their cherished vote banks. That leaves only the two of us in the field, to take up this challenge. At least a hundred times more revenue generation is assured. Are you a game? If yes, we are ready to play ball, most enthusiastically. *******************************************************************

New Technology called “External Counter Pulsation” (ECP) comes to rescue of heart patients.

These are the words; on ECP; of the President of India and an eminent scientist, Dr APJ Abdul Kalam, in his address to the 2nd world congress on interventional cardiology at mumbai, held on 25 Feb. 2005: “We have all witnessed the treatment of cardiovascular disease moving from very invasive to less invasive methods. In the seventies bypass surgery was the big news, in the eighties it was balloon angioplasty and in the nineties it was the stent. Now, moving a step further is a totally non-invasive treatment - EXTERNAL COUNTER PULSATION (ECP), a truly non-operative, non-pharmaceutical, safe and effective treatment, which has made big news in the west. ECP is FDA (USA) approved and finds reference in medical and cardiology textbooks. Many favorable articles have been published in the Journal of the American College of Cardiology, Cardiovascular Reviews Reports, Cardiology, Mayo Clinical Proc., Clinical Cardiology, Journal of Critical Illness, Journal of External Counter Pulsation, etc. The success of ECP can be judged from the fact that in USA the insurance sector reported that the reimbursement for ECP has gone up by 6 % whereas that of other procedure like angioplasty, bypass surgery, etc. has come down by 7%. Now the treatment is available in most of the leading hospitals of the world. It is well known that following bypass surgery - only 75% patients are symptom free for 5 years or more and only 50% after 10 years or more. The number of patients having recurrence after bypass, ballooning and stenting is increasing and for them ECP is the only FDA approved treatment available which is documented to increases blood supply to the heart by 20-42%, to the brain by 22-26% and to the kidneys by 19%. ECP also increases heart's output. More patients now prefer non-invasive treatments. With improved cerebral circulation patients may notice improved memory, etc. This 2nd World Congress may like to study this technique of ECP EXTERNAL COUNTER PULSATION for providing non-invasive cardiac care.”
Analysis of accumulated research data over the past more than three decades has revealed some very disturbing findings: when the outcomes of the people who underwent bypass operations and those who underwent angioplasty were compared with those of the people who refused to undergo any of these invasive/ surgical procedures, there was found to be hardly any difference. Almost the same number of people had suffered heart attacks and almost the same number of people died over the next ten years or more between the two groups. Clearly, patients are not benefiting from CABG and PTCA. But bypass operations and Angioplasties are continuing to be performed with great flourish and in great numbers. Surely, at least some people must be benefiting? Yes, some indeed are benefited, but rarely they are patients and usually they are the hospitals and the doctors.
Extensive research has been conducted over the past few years to understand the reason behind this puzzling phenomenon-after all when blockages have been cleared away or bypssed and effective blood supply has been restored, why should heart attacks and deaths continue to take place more or less at the same rate as before? An answer came from the dead people-those who had died of heart attacks. Post Mortem examination of their hearts revealed that more than 85% of the deaths had taken place NOT because of physical obstruction caused by deposits, but they had been caused by “Plaque Rupture”, that is, bursting of the covering membrane of the fatty mass leading to triggering of massive blood clotting locally. Another interesting finding to emerge from Post Mortem examinations was that it was discovered that blockages are not a localized phenomena. They are generalized, affecting the entire length of coronary arterial tree; less at some places and more at some places. If all the branches of coronary artery are arranged end-to-end, the resultant conduit will stretch for more than ten kilometers. Therefore, a bypass here and an Angioplasty (with a stent or two may be) there; will be a very truncated solution to a very complex problem. After these very disturbing findings surfaced, a crying need for some solution, which could tackle the problem across its daunting length & breadth, rather than
When all these exciting things like CABG (Bypass), PTCA (Angioplasty) and “Stents” and “Drug Eluting Stents” were taking place, another development was going on quietly, in the field of “External Counter Pulsation”. Research in this field started way back in 1953 and by mid seventies, the technique had been refined to such an extent that it had started showing promising results. But around the same time, the euphoria & hype created by Bypass and Angioplasty; due to their “glamour” and “quick fix” nature (and of course, very attractive scope for commercial exploitation); overshadowed this promising new technology. But over the years, the sky high hopes raised by CABG and PTCA were belied and further refinements in the ECP technology raised new hopes. Finally, External Counter Pulsation got approval of USFDA in 1995 for treatment of Angina Pectoris and subsequently for the treatment of Acute Myocardial Infarction (Heart Attack). Recently, it has even been approved for the treatment of Congestive Heart Failure (in CHF, pumping action of the heart becomes so weak that fluid starts accumulating upstream, in various organs).
This noninvasive technique provides augmentation of diastolic blood flow and coronary blood flow similar to the intra-aortic balloon pump, utilizing the serial inflation of three sets of cuffs which wrap around the calves, thighs and buttocks. Inflation and deflation are timed to the patient's ECG; which is fed into a computer and the arterial pressure waveform thus created is monitored noninvasively, by applying an electronic monitor either on an ear lobe or on one of the fingertips. The overall effect on blood circulatory status is such that it provides augmentation of diastolic blood pressure (during the heart’s resting phase). This leads to increase in coronary perfusion pressure. There is unloading of systolic (systole: heart’s beating/ contracting phase) cardiac workload also and therefore decrease in myocardial (myocardium: heart muscle) oxygen demand. Venous return increases and as a result, cardiac output (volume of blood pumped out by the heart in one minute) improves.


History of research in ECP is very interesting. It is a remarkably simple but smart idea. Researchers realized that heart gets its own blood supply during its resting phase, after supplying blood to the whole body during it’s contracting phase. Accordingly, search started for a mechanism to increase pressure of blood column at root of the Aorta (the main artery carrying blood from the heart to supply the whole body). One such was “Intra Aortic Balloon Pump”, wherein; a balloon was positioned at the root of the Aorta, by threading a catheter in through leg arteries, under x-ray monitoring. This balloon is then sequentially inflated and deflated through an external “Pulsator”, which operates on the basis of ECG input from the patient and fires an inflation at the beginning of Diastolic phase and fires a deflation at the end of the diastolic phase. This rhythmical inflation-deflation provides support to a week and failing heart. Taking a cue from IABP, two brilliant scientists, Soroff and Birtwell first described how the application of a positive pressure pulse to the lower extremities during diastole could raise diastolic pressures by 40 to 50% and lower systolic pressures by up to 30%. Herein, lower limbs are looked upon as if they are fluid filled bags, filled with at least one & a half liters of blood at any given time. Lower limb and abdominal arteries are used as conduits or pipes to transmit pressure to root of the Aorta (When nature has given built in tubes to us in the form of arteries, why insert tubes from outside in the form of catheters?) Inflatable cuffs when made to inflate in a sequential manner as already described above, lead to ‘milking’ action on the blood column, resulting in formation of pressure wave traveling in retrograde fashion towards the heart. State University of New York at Stony Brooks has conducted independent research and confirmed the efficacy and safety of ECP. Further boost to ECP has been given by the Multi-center Study of Enhanced External Counterpulsation (MUST-EECP) (Enhanced External Counter Pulsation-EECP is a brand name) research study. Results of this study were presented at the annual scientific meeting of the American Heart Association in November of 1997 and published. Seven centers enrolled into this study: University of California, San Francisco Moffitt-Long Hospitals; Columbia Presbyterian Medical Center; Yale New Haven Medical Center; and Beth Isreal Deaconess Hospitals of Harvard Medical School; University of Pittsburgh Medical Center; and Grant/Riverside Methodist Hospitals of Columbus, Ohio.
Scientific research always leads from complexity to simplicity and from bigger to smaller and from more difficult to easier e.g. Radio, television, computer and all such things. Similarly the ease of use and simplicity of ECP is a marvel of scientific research and technology. In the coming day, ECP is predicted to emerge as the treatment of choice for Coronary Artery Disease (Blocked heart arteries). Often people ask, “Why did it not occur to any one before?” But no idea ever surfaces before its time. The time of this smart new idea has now come.

A Fresh Look At The Role Of Insulin.

Insulin is a hormone, which is produced by a part of the Pancreas gland, situated just below the stomach. For more than a century it was believed and this is what we were taught in medical college that principal function of this hormone is to push glucose into the body’s cells, where it is used as fuel for producing energy, which in turn is used for muscular activity and metabolic needs. By & large, this view continues to be held by most of the people concerned though unfortunately this is NOT true. Principal role ordained by nature to Insulin is storage of excess glucose in the form of glycogen and fat and NOT pushing glucose into cells for their metabolic needs. If you cross check for factual correctness with the published literature (references available, on request), you will come across the following hard facts:
1. Principal glucose using tissues in human body are:
a. Central & Peripheral Nervous System (consisting of the brain, spinal cord, and nerves).
b. Contracting muscles.
Mind you: contracting muscles and NOT relaxing muscles. Accordingly, brain and other parts of the nervous system are not dependent upon Insulin to transport glucose inside their cells. Their cell walls are, in a way or so to say, porous/ permeable to glucose and depending upon the cell’s needs, glucose just slips in from the blood stream, independent of Insulin. Similarly, contracting muscles use only glucose (glycogen, to be precise, which is a storage form of glucose) for their energy requirements. The mechanisms involved in releasing energy from fats are just too slow to meet with the need of sudden bursts of energy required for muscular activity. Therefore, during exercise or physical activity, muscles require almost no Insulin or very little Insulin is enough to push glucose into muscle cells. In other words, muscles become freely permeable to glucose during physical activity, even as gentle a physical activity as walking. (therefore lesson No 1: walk, whenever and wherever and howmuchsoever you can: each step counts and the benefits are enormous.)
2. Rest all the tissues in the body, including relaxing muscles; though preferentially use Free Fatty Acids for their metabolic requirements but are capable of using various other substrates also quite freely and are adept at switching between various modes of energy production. Exception to the foregoing is heart, which can use ONLY Free Fatty Acids for its energy needs. Heart muscle is incapable of metabolizing glucose (though it can metabolize Lactic Acid, which is a byproduct of glucose and fat metabolism). All energy requirements of this nature have been clubbed together in the term “Basal Metabolic Rate”, which has been measured quantitatively and works out to be around 1400 Cal. Per day. These 1400 Cals are meant to come from 150 gm of fat, and come from fat they will: whether you consume 150 gm of fat per day, or convert 300 gm of glucose into fat with the help of Insulin (there are evolutionary reasons for this, which are beyond the scope of this article). Don’t you think that this second option is like going from Delhi to Agra via Mumbai? (Therefore, lesson No. 2: consume at least 100 gm of visible fat per day, which should mostly be in the form of monounsaturated fats like Soya-bean, mustard or groundnut oil, with one third coming from milk fat in any form; another 50 gm of invisible form of fat will be there in other food stuffs. This approach will automatically curb carbohydrate consumption by suppressing hunger).
From the foregoing, it is clear that glucose dependent tissues are not dependent upon Insulin for availability of glucose. Then why has nature created Insulin? As Albert Einstein said “God does not play dice”. In nature, nothing happens for nothing. Every little thing has a role and a meaning. Careful scrutiny reveals that the most significant role of Insulin is to push excess (excess, yes!) glucose into fat cells, which store fat. These cells are mainly located in subcutaneous tissue, below the skin. They mop up not only fats from blood for storage but also convert glucose into fat. For this purpose, glucose has to be pushed into these cells by Insulin. Once inside, glucose gets converted into fat and gets stored. Storage capacity of these cells is unlimited, unlike storage capacity for glucose of muscles and liver. Muscles and liver also store excess glucose under the influence of Insulin in the form of glycogen, but the quantum of this storage is limited to between one & two percent by weight for muscles and between two & four percent by weight for liver, amounting to a total of approximately one kg glucose stored in this form. Now, if one is consuming 100 gm carbohydrate in excess of glucose expenditure for energy production, liver and muscles will get saturated with glycogen in just ten days’ time, and progressively larger amounts of Insulin shall be required to push glucose into these storage sites, leading to Insulin resistance, persistently excess circulating Insulin and a plethora of problems collectively called “Dysmetabolic Syndrome”.
The aforementioned simple observations have enormous scope for clinical applications. We can logically conclude that Insulin is not essential. Our bodies need very little Insulin for metabolic requirements. Insulin was precious for primitive man thousands of years ago, when food scarcity was common and excess intake of food ; when available; had to be stored for use during starvation period (so called “alternative feasting & fasting” pattern of food habits, first propounded a few years ago by the “Thrifty Gene Hypothesis”). But nowadays when abundance is problematic rather than scarcity, Insulin is literally an excess baggage from the past. What was an asset once upon a time is turning out to be a curse now. Therefore, it can be logically concluded that we should consume only that much carbohydrates which is absolutely necessary (which works out to be between 100 and 150 grams per day) and avoid overloading ourselves with starch and sugar. For diabetic patients, there is a lesson in this: control your blood sugar by carbohydrate-intake restriction, and not by excessive dependence upon Insulin (external or internal) for, through the latter route, though blood sugar will come down, but weight will start increasing, consequences of which are no less deadly than those of persistently raised blood sugar. In fact it prompts us to consider changing the very definition of Diabetes Mellitus, which today goes like this: “Diabetes Mellitus is a metabolic disorder, resulting in hyperglycemia due to inadequate secretion or impaired sensitivity or both of Insulin” You see, here the focus of attention is Insulin. A more rational definition should be, to my mind, “Diabetes Mellitus is a metabolic disorder, resulting in hyperglycemia due to excess dietary consumption or inadequate metabolic utilization or both of carbohydrates”. Herein, the focus of attention has shifted to carbohydrates, which is more rational and clinically useful.
The foregoing prompts a logical thought that probably, theoretically at least, it should be possible to live a healthy life with normal blood sugar levels, even in the face of total absence of Insulin or with very little Insulin. Yes, personally I am convinced that this is possible, if carbohydrate intake is totally and completely eliminated or minimized to less than 100 gm per day, with bulk of Calorie requirement coming from fats and proteins. Apprehensions that total absence of or very low content of carbohydrates in diet may lead to hypoglycemia (when blood sugar drops too low) are misplaced, as there is a mechanism called “Gluconeogenesis”, which gets activated in liver when blood sugar goes too low. Gluconeogenesis leads to breakdown of proteins and converts them into glucose. The difference is that earlier; in the face of excess carbohydrate intake; the system was struggling to keep blood glucose low by secreting excessive amounts of Insulin, but now it is struggling to raise blood sugar to keep it above a minimum level. Fears that increased fat intake may lead to excess cholesterol buildup have already been quelled, I hope, with my previous article “Cholesterol Conundrum: A Reality Check” in the same publication dated------------. But to sustain such a diet for prolonged periods, it is very difficult as such diets are rather expensive and a lot of work in the fields of cuisine & culinary refinement needs to be done to bring down costs and to increase palatability & acceptability in accordance with cultural aspects. Our wheat, rice and sugar centric food habits have to be substituted with the ones orientated towards dairy products, edible oils, pulses, vegetables and fruits & nuts, with poultry & fish thrown in for non-vegetarians. Purified proteins (protein hydrolysates) should enter into our cuisines in a big way- economy of scale will bring down the prices, which are very high today. As per available statistics, consumption of Pulses (Dals) in our country is only 32 gm/person/day and that of fats (vegetable oils + milk fat) is only 24 gm/person/day, whereas both should be five times this figure. The reason is poverty- to some extent financial, but largely intellectual. Sugar has to be totally eliminated, substituting it with Aspartame or Stevia as sweeteners which are calorie free and proven food grade substances of plant origin, unlike Saccharine, which is a chemical substance. (Often people say that they feel uncomfortable with protein hydrolysates, Aspartame, Stevia etc. These things are not natural, they say. I would like to remind them that mankind gave up the natural way of living many thousand years ago, when fire and wheel were invented, and since then we have come a very long way. Need of the hour is not to go back to nature but it is to handle our unnatural existence more intelligently and scientifically. With a little imagination, incredibly tasty but healthy (protein rich, moderately fat rich and low on carbohydrates) fare can be dished out, at a very low cost. But who will take up this challenge? Who will fund the research in this field and who will market the products so developed? I have no answer. Any suggestions? In Europe and North America, such diets have spawned a multibillion-dollar industry. Is there someone who is enterprising enough to take up the initiative and create an Indian equivalent, thereby generating health and wealth in one stroke? Wholehearted & unstinted support from my side is assured.


Range of blood sugar levels for diagnosing Diabetes Mellitus is: Fasting-126 mg per deciliter and Post Prandial (PP) (After meal)-200 mg per deciliter (100 ml). Normal range of blood sugar is: 100 mg per deciliter for fasting sample and 140 mg per deciliter for an after meal sample. The readings falling in-between the aforementioned values i.e. between 100 & 126 fasting and between 140 and 200 after meal denote a grey area called “Pre Diabetes” or “Impaired Glucose Tolerance” (IGT). People having IGT are at a greater risk of not only developing Diabetes in the future, but are also at a higher risk of developing heart disease. More about it later.
As long as blood sugar levels remain below 250 mg %, (say, 150 mg % fasting and 250 mg% PP), the patient is NOT likely to feel any symptoms of Diabetes Mellitus, which are: increased urine output, increased thirst, slow healing or non healing of wounds, progressive weight loss in the face of ravenous appetite & excessive eating, persistent feeling of weakness etc. Under these circumstances, Diabetes becomes a “silent killer” insidiously continuing to cause damage inside the body, with all outward appearances being normal.
Often, it is symptoms of Diabetes which bring a patient to a doctor and invariably, blood sugar levels of symptomatic patients are above 200 mg % fasting. With the help of medical intervention, in a few days blood sugar level comes down to the aforementioned “silent killer” range and symptoms by & large disappear. Patient feels quite happy and is lost to follow-up, ignoring the medical advice to further bring down blood sugar levels to at least ‘near normal’. An unfortunate fact is that this so called ‘mild diabetes’ damages small arteries throughout the body (microangiopathy), progressively cutting off blood supply to various organs, leading to permanent, irreversible damage leading to total destruction of these organs. Brunt of this damage is borne by such organs of the body which have an extraordinarily rich blood supply- i.e. heart, eyes, kidneys and brain (so called ‘target organs’) and the resulting damage is called ‘target organ damage’, (TOD), (as if rest of the body is not getting affected at all-fact is that entire body undergoes this damage, leading to acceleration of the ageing process). I repeat for effect: TOD is not reversible with any available treatment and no such treatment is likely in the coming many decades. As if this was not bad enough, another disturbing fact has been revealed by research findings: - microangiopathic damage does not bear a linear relationship with severity of Diabetes. Therefore, whether your diabetes is severe or mild, damage to small arteries continues more or less at the same rate. So much so, that this expression “mild diabetes” is an anathema to medical professionals, to the extent that if a medical student happens to mention it during his viva-voce examination, God only can help him!
By mid 80’s, another observation was made by experts: that even if blood sugar levels are consistently maintained within normal range, Target Organ Damage still takes place at a significantly higher level than in normal population. Further investigation revealed that in such patients, though blood sugar test reports were all normal, but Glycosylated Hemoglobin (HbA1c) was invariably higher than normal. HbA1c is a blood test, which reveals average blood sugar over the past four months. The inference is obvious: normally done blood sugar test reveals blood sugar level at a given point of time. But blood sugar fluctuates within a wide range throughout the day. Accordingly, in these patients, blood sugar was deemed to have remained above normal range for a major part of the day. HbA1c is expressed as a percentage and its normal range is between 4% and 6.2%. To find out the correlation of HbA1c with Target Organ Damage, a research study called UKPDS (United Kingdom Prospective Diabetes Study) which is by now quite famous was organized in England. In this study, more than 10,000 diabetics were enrolled in 1986 and they were treated and observed for ten years. The results, which came out in 1996, were very surprising: It was found that if HbA1c is more than 7%, TOD incidence rises very sharply. In the form of an arm of UKPDS research trial, an attempt was made to bring down HbA1c even below 7%, but it resulted in an unacceptably high incidence of hypoglycemia (when blood sugar level goes too low). Therefore it was decided by experts that practitioners should strike a balance by aiming to bring HbA1c level down to 7% and no further down, in the bargain risking some TOD in the long run, but keeping hypoglycemia at bay. Certain amount of TOD is still expected to take place, but it was considered unavoidable.
Since 1996, newer forms of medications have become available with the help of which; if the treating physician and the patient are determined and are ready to put in hard work and adequate resources; it is possible to bring down HbA1c even below 6%, eliminating the possibility of TOD altogether. The first & foremost requirement for achieving this miracle is a strong desire; firstly in the mind of the patient and secondly in the mind of the treating physician; to achieve this goal.
Now coming back to IGT; which was mentioned in the first paragraph above. Leave aside ‘mild’ Diabetes, TOD starts taking place during IGT itself. It is on record that 42% of TOD takes place before IGT becomes frank Diabetes, which generally takes five years or so. Maximum TOD during IGT takes place in the heart. Second, in order of frequency, sufferers are the kidneys. Diabetes induced kidney failure is not unknown during IGT. Experts are recommending that full fledged treatment of Diabetes Mellitus should be started in all earnestness at IGT stage itself. By now it should be quite clear to you as to why ‘mild’ Diabetes is more deadly than ‘severe’ Diabetes. To drive the point home more forcefully, I would like to mention here that ‘severe’ Diabetes is like an enemy who strikes openly, giving you a chance to defend yourself, whereas ‘mild’ Diabetes is like a guerilla fighter or like white-ants or termites, which cause total destruction silently. If you want proof (there is abundant proof available in medical literature; but nothing is like seeing for yourself), go to any Dialysis unit (Dialysis is done for kidney failure, as a temporary arrangement while the patient waits for kidney transplant operation) of any hospital and speak to patients there. You will find that more than two thirds of them shall be diabetics and a majority of them shall have been on treatment for diabetes for many years, with a fairly good control of blood sugar, but diabetes still destroyed their kidneys. But there will not be a single such patient whose blood sugar was being monitored using HbA1c as a parameter. Tragically most of them even do not know that Diabetes was the culprit! They think that kidney failure is another affliction which struck them, in addition to diabetes and a few other unrelated things like heart disease and hypertension etc. That; in most cases, all these are different manifestations of a common root cause is something they find really difficult to come to terms with, when informed!
Unfortunately, even in developed countries; forget about developing countries like ours; the aforementioned eye-opening and path-breaking research findings are not being put to good use. Even in USA, the percentage of Diabetics, whose HbA1c is being monitored; forget about achieving the targets; is abysmally low. Why? Even I do not have a clear answer, but I guess the reason is something like this: traditionally down the centuries, medical profession has been orientated towards relief from symptoms arising from various diseases and towards curing the diseases which produced those symptoms. Accordingly, physicians are identified as ‘healers’. But how can you heal a person of a disease which has not arisen as yet? After all, so called ‘mild’ Diabetes is not a disease in traditional sense of the word, as it is not giving the patient any symptoms. It is a clinical condition which can only be detected with the help of a blood test. It takes the form of a disease when TOD has taken place and due to that the patient starts getting symptoms; list of which is too huge to enumerate here; depending upon the organ involved. Therefore, sensitizing a diabetic to the possibility of TOD is an enormously difficult task. In rich western societies, they have many more resources than us; in the form of formally trained paramedical staff like Diabetes Counselors, Dieticians, and Exercise Instructors etc, all supported by adequate infrastructure and educational tools like audio-visual aids etc. (though end results still are dismal, sadly). But here in our country, your friendly neighborhood physician/ family physician is the all-in-one in most of the cases. Super-specialist doctors, in the field of Diabetes are too few, and their work load is so high and paramedical support so little, that they cannot spare enough time to enter into a detailed discussion on the subject with the patient and convince him regarding hidden dangers. A solution to the problem is that rather than we doctors chasing people to achieve HbA1c level of below 6%, the equation should be turned other way round, i.e. patients should specifically demand the end goal from us (for phonetic convenience of vernacularly orientated tongues, it is okay to call it GULUCOSE HB). For this they have to be ready to work hard to achieve the goal and their dedication to the cause should be complete. We, the medical professionals, shall be too happy to deliver.

Is It Healthcare Or Sickness Care?

Medical profession is often described as ‘Healthcare Industry’. But today’s hospital centric, commercially orientated medical profession is more like a ‘Sickness Care Industry’. World Health Organization (WHO) defines “Health” as: “Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity”. Let me try to explain it in simpler language. If you happen to get surgery done for a Gall Bladder or a kidney stone in any hospital, be it a government hospital or a private one, you are likely to get excellent quality medical care till the stage when your stitches are removed. All this is “Sickness care”. But unfortunately, no attention is likely to be paid to the reason for stone formation in the first place; other likely attendant medical conditions and towards preventive strategies/ interventions to ensure that it doesn’t happen again. Had the foregoing been done, it would truly have been “Healthcare”. But this exercise is almost never undertaken. Why? Because nobody asks for it. Whatever you get in life, the least you are required to do is to ask for it. How can something; which you have not even desired; be thrust upon you in a civilized society? Let us go back to the previous two examples given above: Gall bladder stones and kidney stones. Do you know that the basic processes that lead to stone formation may be such that stone formation itself may only be a tip of the iceberg, i.e. there may be many more likely complications due to the basic underlying defect/ malfunction; stone formation being only one amongst many? For example, people with gall bladder stones are more likely to have heart disease and diabetes in the future, if not having the same already. Similarly, there are some underlying disorders related to bones, to calcium absorption & metabolism and to phosphorus absorption & metabolism, wherein calcium rich or phosphorous rich kidney stones are formed. If these underlying conditions; which are not giving rise to any symptoms on their own at present; are not attended to properly, then not only will the stones come up again in the future, but many more troubles will erupt. When medical technology and knowledge is used to detect these ‘silent’ disorders, and proper treatment plan is instituted well in time, this is called “Secondary Prevention” (“Primary Prevention” is what the lay public can do on its own, without active participation of medical profession). But you do not see it being done anywhere, not only in our country but also almost nowhere in the world. Reason is that medical profession today is not controlled by doctors, but it is being controlled by big businessmen & industrialists, who also control other related, lucrative activities like diagnostic industry and pharmaceutical industry. A basic principle of business or commerce is that the client is supreme and his wish is a command for you. You give him precisely what he wants, only then can you hope to succeed in pulling the bucks out of his pocket. In ‘healthcare’ profession, the big business was quick to realize that people shell out money only when in trouble and big money lies in hospital admissions, lab tests and surgical operations. So they started pumping big money into setting up large, sophisticated and posh hospitals and diagnostic centres. Public was mesmerized & awed by the glamour & glitz. Gradually the good old family physician was relegated to the background; who could give sound & timely advice based upon a wealth of professional knowledge & experience and robust common sense. In the backdrop of a ‘quick-fix’ culture, in which the patient wants the stone out as quickly as pulling out a thorn and is least interested in finding out or bothering about it’s causation & prevention, and a pliant & compliant commercial healthcare provider ready to serve the ‘valued client’ eagerly; you have a fertile ground ready to spawn “sickness care industry”. But is it just a case of wrong nomenclature? What’s in a name after all, one may say. No, a lot more is involved. Huge amount of research based medical intervention in the form of “Secondary Prevention” is being wasted, most of it knowledge based. Is there any practical method of making the medical profession to apply this “Secondary Prevention” vigorously? Appeals to ethics, morality & conscience are woefully inadequate and application of administrative mechanisms is not practicable. One solution is to allow individual medical professionals to offer Health Insurance. Competition will take care of the premium rates and fear of claims will keep the doctors on their toes to ensure application of the best of “Secondary Prevention”. Role of Health Insurance companies should be restricted to offering “Indemnity Insurance” to doctors. As the financial burden for lab tests and hospital admissions shall shift to the medical professionals; use of commonsense, medical knowledge & clinical acumen amongst clinicians will automatically be encouraged and shall obviate unnecessary lab tests and hospital admissions. Accordingly, overall expenditure on healthcare will drastically come down, while improving the health status of society. Moreover, it will redefine the relationship between the public and healthcare providers; wherein peoples’ health will become directly proportionate to the prosperity level of the latter. At present, this relationship is rather awkward & embarrassing: peoples’ sickness is directly proportionate to the level of prosperity of healthcare providers i.e. sicker the people, happier & richer the healthcare providers and vice-versa.

Cholesterol Conundrum: A reality check.

Most people think that Cholesterol is a fat, which; strictly speaking; it is not. This myth took root because Cholesterol, being a highly fat-soluble substance and being insoluble in water, is found in fatty tissues of animals. The fact however, is that cholesterol is a form of alcohol. There are many types of alcohols and cholesterol is a very large and complex alcohol molecule, modified and tampered in certain ways. As you know, all alcohols are made from sugars and starch-rich substrates, so is cholesterol. It is made in liver, from Acetyl Co-enzyme A, which ultimately uses glucose, amongst others, as a substrate. Glucose is the simplest carbohydrate. All other forms of carbohydrates ultimately get broken down to glucose in the digestive system. Therefore, the real culprit in causing excess cholesterol build up in our system is carbohydrate overload through excessive consumption of sweet and starchy foodstuffs and NOT excessive fat intake. Fats derived from animal sources do contain certain amount of cholesterol, but the quantities involved are so small that overall, it does not matter. Further, due to a process called “Feed Back Inhibition”, the cholesterol content of foodstuffs by-and-large becomes irrelevant. Paradoxically, approximately 100 grams of fat intake per day; in the form of butter or ghee; leads to lowering of cholesterol level. This runs contrary to the oft-repeated medical advice that fats are not heart friendly due to their cholesterol content. Well, this is what we all thought initially, but in the light of new research based facts emerging, this concept has been discarded. Only noteworthy caution in this matter however is that fried fats still are considered unhealthy, because the process of deep frying causes changes in molecular structure of fats, leading to formation of Trans-Fatty Acids, which are harmful.
Vegetable oils and Vanaspati ghee do not contain cholesterol at all, for the simple reason that cholesterol is found only in the animal world. In the plant world, it is non-existent. Therefore, only eggs, meats, milk & milk products and all such foods coming from animals only can contain cholesterol. Any food; including fats; sourced from plants is free from cholesterol. Based upon this concept vegetable oils and vanapati ghee were considered safer compared to butter & butter oil (ghee). But new research findings have turned this belief upside down. Now, as we know that cholesterol content of natural ghee is just a bogey, and we know that vanaspati ghee contains Trans Fatty Acids (even in un-fried form), therefore natural ghee is safer; inspite of it’s cholesterol content; than vanaspati ghee, despite it being free of cholesterol.
Do you know that cholesterol-free polyunsaturated fats such as in sunflower oil are actually more harmful than natural ghee, because of their exceedingly low content of Omega-3-fats and exceedingly high content of Omega-6-fats? The ratio between these two special types of fats in healthy diet (fat component of diet) should be 1:4. In sunflower oil it is 1:50. But in natural ghee, it is a healthy 1:6. An unhealthy ratio increases the clotting tendency in blood, which, in turn, is one causative factor amongst many (yes! There are many, cholesterol is not the only one) for heart disease and heart attack.
The other day, a patient promised to me; upon my advice; that he will exercise regularly; then onwards. Then he added, “I realize that exercise will not only keep me fit, it will also burn my cholesterol away”. No, exercise does not burn cholesterol. But it helps in bringing cholesterol level down through reducing carbohydrate load in the body. This leads to reduced levels of free glucose intracellularly (within body cells, esp. liver cells), and it also increases Insulin sensitivity, leading to lower level of Insulin hormone in circulation. It has been known to medical scientists for a couple of decades that high blood levels of Insulin hormone somehow increase cholesterol formation and low levels of the same have the opposite effect. How exactly this happens is still under investigation and is not clearly known. Point to be stressed here is that cholesterol reduction as a result of exercise is neither due to burning of cholesterol, nor due to burning of fat, but it is due to burning of glucose. Principal fuel utilized by our muscles during exercise, is glucose, because it yields energy very quickly. The process, through which fats yield their energy inside our bodies, is very slow. Therefore, through evolution, our metabolic processes have been designed in such a way that during resting state, the principal fuel for energy requirements is fat and glucose is conserved to provide a source of instant energy during physical activity/ exercise. Therefore, even as mild an exercise as simply walking does wonders for cholesterol reduction, as each step you take burns between five and ten milligrams of glucose.
It will not be out of place here to mention that the pattern of diet which we were recommending till now (Carbohydrates 80%, Fats 10% and Proteins 10%) has turned out to be disastrous, as shown by experience and scientific scrutiny. Actually it is suited for people who undertake hard labour as a way of life, burning 4000 or more Calories per day, wherein fat intake will work out to be between 100 and 150 grams per day. But the lifestyle for the past few decades has been such that even farm labour is no more hard labour, due to mechanization, and average daily Calorie requirement has come down to less than 2000 Calories per day. Here the point to remember is that the reduction in Calorie requirement; between the old and the new order; has been in the realm of glucose burning Calories (muscular activity). The proportion of fat burning Calories (resting state energy requirement), if at all, has increased. Therefore, mindlessly applying the old formula for today’s sedentary population and cutting down the fat intake to no more than 20 grams per day; for misplaced fear of cholesterol, was a big mistake, resulting in the epidemic of Diabetes and Heart Disease today. The recommended proportion of Calorie content of diet for today’s lifestyle is Fats: 60%, Carbohydrates: 30% and Proteins: 10%, which is a slight modification of famous and popular “Atkins’ Diet”. This will translate to between 100 and 150 grams of visible (added from outside as free fat, as opposed to invisible fat, which is incorporated in all foodstuffs) fat intake per day. As a ready reckoner, add 25 to 30 grams of butter or ghee to each of your three meals, use soybean, mustard, groundnut or olive oil (no sunflower oil) for cooking; avoid fried foods and knockout sugar, rice and white bread (and all other preparations containing maida) from your diet, take as many chapattis as you feel like (you’ll not feel like having many with so much visible fat added because satiety value of fat is four times that of Carbohydrates, though the calorie content is a little more than double. Therefore, fat intake makes you feel full with small quantities). With this kind of a diet; which is rather fat rich and more palatable; you’ll be keeping your cholesterol levels surprisingly low. But even a bigger and pleasant surprise will be the weight loss contrary to your apprehensions of weight gain, believe me.