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Biology’s Holy Grail

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By Dr. B. M. Hegde, India [ Published Date: May 8, 2011 ]

Has biology, the mother of modern medicine, found its Holy Grail, leave alone drinking from it? As a medical student at the Stanley Medical College, Madras, I got the impression that what I was taught was the whole truth and nothing but the truth. That was long time ago, in fact, in the last century, to be precise in 1956 AD. Since then a lot of water has flowed down the Cooam Bridge on the Marina Beach. Unfortunately, nothing much has changed in our thinking in the medical field in the last half a century although lots of new technology that I did not even hear about during my student days have come into the picture and some of them have been since abandoned as they produced more suffering in their wake compared to the relief that they gave. Lot more new drugs have come and gone and are making media news almost everyday of a breakthrough or of a life saving drug.

Shaken to my bones by some of the events in my medical life since then, I have tried to unlearn what I had learnt as an examination going student, almost for a decade from the time I entered the medical school, only to relearn the realities in the field sans the claptrap. It has not been an easy task, an uphill task at that, at great risk to my career even. But now after more than half a century I feel it has been time well spent. I deem it my duty to share my arduous journey with the newer breed of doctors, trained in the present five-star, hi-tech atmosphere under the glare of an array of scopes and scanners and breathtaking heroic (the hapless patient as the hero) surgical feats.  I would like to share my joys and sorrows with them lest they should also go through the same process that I went through and waste their time.

Medical literature today is like a thick jungle, what with 7.5 % new information pouring into biology through, well over forty thousand bio-medical journals all over the world, every month, the novice would find it difficult to separate the wheat from the chaff. In fact, that is the job of an ideal teacher to guide the novice in this thick jungle of mostly dead wood to the real useful rose wood or the teak for his/her benefit. Otherwise, the novice would not reach the real stuff and might get lost in the jungle for ever. I wish to share that with the readers through these columns. David Eddy, a former professor of cardiovascular surgery at the Stanford, changed his profession after having gone deep into the realities (or otherwise) of medical science and trained to be a mathematics teacher at the Dukes University after his Ph.D in mathematics! I did not do that as I found it difficult to study advanced mathematics. I tried to swim along and see how we could change things if we can or bear with things that need no change and also to have the wisdom to know the difference. I do not know if I have reached my goal and that is why I consider myself a medical student even today.

Human body does not follow the linear rules of conventional mathematics and time evolution in man depends on the whole man (his genes, phenotype as well as his consciousness) and not on a few parameters of the phenotype. This is where our predicting man’s (patient’s) future rarely comes true.  We have been predicting the unpredictable and intervening unnecessarily in apparently healthy people. This is precisely the reason for death and disability rates to plummet in Israel recently when doctors struck work for three months. Similar experience was reported from Saskatchewan in Canada twenty years ago and from Los Angeles country ten years ago when doctors went on strike. There has been hardly any difference in the per capita deaths due to chronic myeloid leukemia at the Christy’s Hospital, Manchester, during the two time slots, 1900-1940 and 1950-1990, although there were sea changes in our approach during the latter period.

The basic tenet to understand is that our body cells, of which there are about one hundred thousand billion in all, love one another so much that they would like to work as one whole. Even the cells of all sentient beings do the same. But for evolution (nature) developing the most powerful immune system all living things (humans included) would have been one large mass of a cell syncitium. Thank God for that. With that background in view, our organ based specialties and therapeutic measures would have to have problems on a long term basis. While modern medical quick fixes could be useful in an emergency, they would come to grief on long term use.

Another bane of modern medical thinking is the definition of normality. In a bell shaped Gaussian graph of any measure in the human system, normal human beings are those who fall within the mean+- two SD (standard deviations). This automatically brings in the issue of false positives. In every parameter thus measured, 5% of normal population would, per force, be declared abnormal (false positives). This five per cent suffers the long term consequences of our interventions, anyway. Be that as it may, now with the new Total Body Scanner, threatening to invade India in a big way in the near future, one shudders to think of the future of Indians. Total body scanners would measure five-hundred body parameters in one sitting. Now think of the mind boggling 5% of the five hundred measures making a total of 2500 false positive measures for every one hundred people that go for a routine screening! Any one that sees the doctor for a check up when apparently healthy, after the TBS, would have, on an average, 2.5 abnormal reports. There will be no NORMAL HUMAN BEING AT ALL. Although it is a very good business proposition, it is bad for mankind. Even at the present day it takes one thousand healthy women to be screened for cervical smear for forty long years to save one woman from cancer cervix!     A sizeable per cent of those women would have lost their organs for no fault of theirs, as nearly 75 women in this group would have had abnormal smears with normal cervix and so on. Similar is the story of prostate, breast and many other cancers. The MRC study of mild-moderate hypertension showed that it takes 850 innocent normal people to be drugged for a period of five years to, probably, save one stroke.

So read on to know the other hidden face of the moon (medical science) bereft of all the dressings and frills in medical science, and, in the bargain, get a glimpse of the new science in the horizon of holism (in place of reductionism), CHAOS and fractals, without any heavy dose of mathematics that we doctors generally are not good at (I am talking for myself). Happy reading folks!

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James Fernandes/Barkur/India, USA :
“Skeptics will always be there”. Dr. B. M. Hegde;
Reminds of Jesus Christ, “The poor you will always have with you.” Mathew 26:11.
In Bombay (Goregoan/Malad) in the early sixties, I learned while working part time, some pathological techniques like counting RBC, WBC by using Haemocytometer, differential counts, Urine analysis including Blood Sugar detection using Folin Wu method (mouth pipetting), filaria, sperm counts etc. (Today we have sophisticated instruments, (play boy magazines to collect sperms) and yet we complain how difficult to use these instruments…..… besides the point.)
Some physicians used to prescribe Routine blood counts, Complete blood chemistries, Urine analysis, etc, irrespective ……, practically on a pre-printed check-list form! Some poor patients used to grumble, “If the test results are normal, why the tests were prescribed?” “Paise Ke vaasthe, Kyaa?” (Most of the patients used to approach the doctor to obtain a sick certificate, anyway, … another besides the point issue.)
Needless to say, during Diwali, I had to deliver gift packets/Sweets to these physicians on behalf of the laboratory.
It’s not the West kissing skeptics, who question (your) Dr. Hegde’s St. John the Baptist spirit; what he complains is an universal phenomena….
Doc, the bed bugs are still around, the dandelions are still around, nepotism is still around, age old profession is still around, insulting ignorance and poverty is still around, however; for most of us;
“It’s not who/what is right, or who/what is wrong, but ‘staying alive’ is the primary goal of the day for most of us who are under respected.”
Can we get along?
Drona, India :
The dysplastic cells in the pap smear have very little predictability and so many women have lost their uteruses for no fault of theirs and suffer the consequences.-Prof Hegde

Can it be combined with HPV test as well? That would definitely place the woman at very high risk to develop cervix cancer.

Again, conisation does not mean hysterectomy and no woman needs to lose the uterus when this is done. However, closer follow up will be indicated.

Pap smear and self examination of breast are two tools which are widely used in current medical practice by most of the gynecologists who advocate it for their clients.Mammogram may or may not have its buyers.The desire to live as well as possible and as long as possible drives the early detection programs.

I would look forward to Prof Hegde's articles on Diabetes Mellitus, a malady which affects most of the Indian population.
BM Hegde, India :
Cervical cancer screening is much more dangerous than all other screenings.
The dysplastic cells in the pap smear have very little predictability and so many women have lost their uteruses for no fault of theirs and suffer the consequences.
Anyway, I do not have to get more scientific data to convince the naysayers as it is a waste of time. Once any one makes his mind to reject an idea he/she will do it anyway. Every one has full rights on his/her opinion in my opinion.
Drona, India :
Thanks Prof Hegde for quoting the article to provide further substantiation of your article. The points are well made and I have no problem in understanding the points. I don't think the Americans and people with American mindset understand these articles. There is a trans-Atlantic divide in thinking as you very well know. The Americans create the problem and then find a solution/sell a solution whereas the others look for solutions when the problems present. The unnecessary routing scanning has made the people nervous wrecks there. The statistics get perverted by screening mammograms which jack up the non invasive breast abnormalities which may never progress to cancer. I do think however that screening for cervix cancer is worth it as the cure rate for even stage IB is around 90% which means 10% will have recurrence and eventually dies of the disease. Conisation for in situ changes can save lives and is relatively inexpensive. To that extent I agree with Ram from UK.

The late Jacquelyn Kennedy/Onassis was dignified when she requested discharge from her clinic and went home to die from her non Hodgkin's lymphoma. I wish more Americans follow suit and accept that human beings and even Americans are not immortal.
BM Hegde, India :
See the latest on what happens when you screen. Every one becomes a patient.

From BMJ

BMJ 2011; 342:d2548 doi: 10.1136/bmj.d2548 (Published 3 May 2011)
Cite this as: BMJ 2011; 342:d2548

* Feature

* Medicalisation

A new deal on disease definition

1. Ray Moynihan, author, journalist, and conjoint lecturer

+ Author Affiliations

1University of Newcastle, Australia


How do we replace the old panels of conflicted experts? Ray Moynihan investigates

As this still-fresh century rolls forth, medicine’s imperial project looks on the whole to be in remarkably good health, despite the odd failed campaign. With our new found fondness for preventing disease and premature death we’re redefining more and more of the healthy as sick, and then prescribing our new patients lifelong pharmaceutical solutions to reduce their risks. One recent analysis suggests that the definitions of common conditions have broadened so much that virtually the entire older adult population is now classified as having at least one chronic disease.1

Yet a growing scrutiny of the seemingly well meaning march of medicalisation suggests we may sometimes be pushing boundaries too wide, and setting treatment thresholds so low, that people with mild problems or modest risks are exposed to the harms and costs of treatment with little or no benefit.2 It has also become clear that many of the people on the panels that are widening the patient pool have direct financial ties to the companies benefiting from that expansion. Concerns are mounting that doctors are collectively overdiagnosing millions of what were until very recently considered healthy people, and leading voices are asking whether it is time society at large took a more direct role in deciding who really warrants a medical label.3 Some are now calling for a major renovation of the way in which we define disease.

Next Section
Conflicted panels widen diseases, lower treatment thresholds

Among the 12 members of the panel that created the controversial diagnostic category “pre-hypertension” in 2003, 11 received money from drug companies, and half of those people declared extensive ties to more than 10 companies each.4 Critics have rejected “pre-hypertension” as a dangerous pseudo-syndrome that could increase drug company markets,5 while others point out that it gives a diagnostic label to nearly 60% of the adult population of the United States.1 Similarly, 11 of the 12 authors of a 2009 statement on type 2 diabetes were heavily conflicted, with authors working as consultants, speakers, or researchers for an average of nine companies each.6 That panel advocated a contentiously low blood sugar target, and explicitly defended the use of rosiglitazone, a drug since suspended from the European market because of its hazards to human health. Within the field of sexual dysfunction, conflicts of interest have reached new heights of absurdity, with drug company employees joining their paid consultants to design diagnostic tools to identify and then medicate millions of women with a disorder of low desire that may not even exist. 7 8

One of the best known examples of conflicted panels widening disease definitions comes from the Diagnostic and Statistical Manual of Mental Disorders. An examination of those who produced its fourth edition found 56% of panel members had financial ties to drug companies, although for some panels, including that for mood disorders, the figure was 100%.9 Despite a new American Psychiatric Association policy aimed at reducing conflicts, an analysis of the forthcoming fifth edition found that of those panel members who’d made disclosure statements, exactly 56% had financial relationships with pharmaceutical companies.10

“We’ve got to take this away from the American Psychiatric Association,” said Allen Frances, the psychiatrist who chaired the taskforce for the fourth edition, the DSM-IV. He now believes that that edition unwittingly contributed to an explosion of unnecessary diagnoses in the areas of attention deficit, autism, and bipolar disorder. Frances argued that it was not just financial ties that were important, but intellectual conflicts too, where researchers pushed for greater recognition of their own pet conditions. To emphasise this point, he said that he did not believe a drug industry push was behind even those decisions that would most benefit the industry. Today he warns that the forthcoming DSM-V could unleash multiple new “false positive epidemics,” where common experiences including binge eating and temper problems are mistaken for the “symptoms” of new disorders.11 “Experts tend to loathe the idea of missing a potential patient, and they lack the ability to assess the risks and benefits of creating new conditions or widening old ones,” he explained to the BMJ. “This sort of work should no longer be done by any professional association. A new way to define disease is needed.”
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New panels, free of conflicts of interest

One of the strongest arguments for maintaining conflicted individuals on influential panels is that most leading medical experts do paid work for drug or device companies, and it is almost impossible to find respected individuals who do not. But a recent policy change at the US Food and Drug Administration has made that argument look extremely shaky. Since 2008, tough new guidelines have strongly discouraged doctors with major financial conflicts from taking part in the powerful panels advising on which new drugs should be approved.12 “It’s just laziness, because it’s much easier to find a conflicted expert,” said Sidney Wolfe, a member of one of the newly constituted panels, and director of the health research group at the Washington, DC based organisation Public Citizen, which has long pushed for such a clean up. Importantly, the Institute of Medicine’s landmark report in 2009 also recommended that committees that write clinical practice guidelines should exclude individuals with conflicts of interest.13 Wolfe argues that the same rules should apply to the panels that define disease, and create the cut-offs for treatment.

“The stakes are very great in terms of public health,” Wolfe told the BMJ, because the old panels are “constantly broadening the numbers of people defined as ill and recruiting millions of people to drug treatments that may not benefit them.” The youthful 73 year old physician cites the example of cholesterol, where people like him in good health have lipid levels defined as “above-optimal,” which can lead some doctors to prescribe unneeded cholesterol lowering drugs. Others have observed that treatment thresholds have now become so low that in some cases hundreds of people at low risk of future illness need to take medications for a year, in order for one of them to benefit by having a bad event prevented.14

Just a short metro ride from downtown Washington, DC is the sprawling campus of the US National Institutes of Health. The epicentre of the global biomedical project, it also boasts the world’s toughest policies on conflicts of interest for panels that draw the lines between health and sickness. “We don’t manage conflicts of interest on those panels,” says Barry Kramer, until recently a senior manager at the National Institutes of Health, “we simply avoid them.” Not only are experts with financial ties prohibited from sitting on the National Institutes of Health state-of-the-science and consensus panels, if a researcher has a declared view on a question being considered, he or she too will be excluded. “Intellectual conflicts of interest can be equally potent,” Kramer told the BMJ.

A recent example of this model in action was the 2009 state-of-the-science conference on the diagnosis and management of ductal carcinoma in situ of the breast, a condition often treated aggressively.15 The 14 member panel—which included representatives from nursing, social work, and population health alongside surgeons, radiologists, and oncologists—made the dramatic recommendation to change the very name of the condition. The panel wanted to remove the “anxiety producing term carcinoma” because of the “non-invasive nature” of ductal carcinoma in situ coupled with its “favourable prognosis.” The group also highlighted the need to better identify women for whom tissue abnormalities would not progress to breast cancer, in order to prevent them having to risk the side effects of unneeded treatments including tamoxifen and radiotherapy—“both of which are proven to cause cancer,” says Kramer, currently a contractor to the National Cancer Institute, and editor of the cancer journal JNCI. “I view it as the high court of medicine,” he says, referring to the panels that strictly excluded the conflicted, “and the judges are picked for their respect in the field and their ability to assess evidence.”

This tough model is endorsed across the other side of the Atlantic by Sir Michael Rawlins, chair of the UK National Institute for Health and Clinical Excellence (NICE). As to the broader question about the risks of over-medicalisation, Rawlins told the BMJ that he didn’t believe the boundaries of disease were being inappropriately widened, but he agreed that panels writing definitions or setting treatment thresholds should be as free as possible of conflicts, both financial and reputational.
Previous SectionNext Section
Panels with broad representation, evidence based

The National Institutes of Health model also calls for panels to be more broadly representative than just those within a particular subspecialty. It specifies that as a general rule, along with practising clinicians and researchers, panels should include biostatisticians, epidemiologists, non-health professionals, and people representing the wider public interest.16 The addition of a health economist is also critically important, to assess the cost effectiveness of changing diagnostic categories.

Given the growing evidence on the social and environmental determinants of health and disease,17 perhaps the membership of newly renovated panels might be broadened even further. For example, might it be possible that the myriad panels that focus in a fragmented way on treating surrogate end points like blood pressure or lipids be subsumed into a broad new panel addressing multiple measures to fight cardiovascular disease in a more holistic way, which would include representatives from the worlds of transport, building design, and food regulation, along with doctors and others? Fran Baum, public health professor at Flinders University in Australia and a member of the World Health Organization’s Commission on the Social Determinants of Health, says that the idea of panels combining a clinical and social approach is feasible. “It would be good to have the conversation,” she told the BMJ cautiously, “but it would need to happen in the context of government policy less dominated by clinical medicine and more interested in addressing social determinants.”

Whatever the make-up of new more independent and broadly representative panels, everyone agrees on the need to inform decisions with the best evidence, such as that currently produced by systematic reviews, including those from the international Cochrane Collaboration. Yet groups like Cochrane have so far focused their reviews far more on interventions, rather than assessing the different forms of evidence used to make decisions about disease definition or diagnosis. As a result the claims about the nature or extent of medical conditions are rarely exposed to the same rigorous systematic scrutiny as the studies of treatments for them.

Jeremy Grimshaw, co-chair of the Cochrane Collaboration Steering Group, says a key problem is the lack of a gold standard “against which to judge different claims around how to define disease.” Further complicating matters, the judgments about what constitutes sufficient distress or risk to warrant a definition of “case-ness,” and what might best be considered normal life, are “highly subjective decisions.” Despite the complexities, Grimshaw sees some merit in the idea of new citizens’ panels making these judgments, empowered and informed by the evidence from systematic reviews by groups including the Cochrane Collaboration.

Perhaps one of the most contentious questions is whether the process of disease definition is deemed so important that it warrants more regulatory oversight, rather than the loose self regulating system that currently exists. While the US National Institutes of Health consensus panels may have a strict model, many of the groups around the world deciding who is normal and who is not are simply self interested professional societies, whose panels are riddled with conflicts. “New diagnoses are as dangerous as new drugs,” said Allen Frances. “We have remarkably casual procedures for defining the nature of conditions, yet they can lead to tens of millions being treated with drugs they may not need, and that may harm them.” Frances wonders whether regulatory agencies should play more of a role in overseeing new panels, and is developing proposals as part of a forthcoming book.
Previous SectionNext Section
Medicalisation and its discontents

Meanwhile medicalisation and its discontents continue, with one of the latest controversies being gestational diabetes, a condition of raised blood glucose in pregnant women. A 2010 revision of the definition by an international panel of professional societies has just dramatically lowered the threshold for diagnosis, more than doubling the number of women classified as having the condition, to almost 20% of the entire pregnant population.18 While the new definition is already being adopted in a number of jurisdictions, serious concerns are being expressed in the medical literature that the proposed screening test has poor reproducibility for mild cases, the evidence of benefit for the newly diagnosed pool of pregnant women is weak, and the magnitude of that benefit modest at best.19 The international panel’s report argues that the widened definitions will reduce health problems, including babies being “large for gestational age,” but it concedes that some recommendations are based on opinion because good evidence is not yet available, and that the new expanded definition “will substantially increase the frequency of hyperglycaemic disorders in pregnancy.”18 According to the critics, another case study of over-medicalisation is in the making, with the risk that millions of women will receive an unneeded label, and vast resources will be wasted. Perhaps those planning to conceive a new deal in defining disease should find a hotel room, and quick.
Summary points


Many existing panels that define and expand diseases are heavily tied to drug companies

Some voices are calling for fresh new ways to define disease, with new panels

New panels could be independent of industry and entirely free of conflicts of interest

The constitution of new panels could be broadened, more representative, with more citizens’ voices

The best evidence should inform decisions, including evidence on social determinants

Previous SectionNext Section

Cite this as: BMJ 2011;342:d2548
Previous SectionNext Section


Competing interests: All authors have completed the Unified Competing Interest form at (available on request from the corresponding author) and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

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BM Hegde, India :
and this

2) Stewart-Brown S and Farmer A. Screening could seriously damage your health. BMJ 1997; 314 : 53
Drona, India :
Dr Hegde's rebuttal is based on the publications in The BMJ of 2003. I tend to agree with most of the views expressed in those articles which do not encourage screening. Screening usually means looking for the evidence of presence of very early disease which may be dealt with curatively. Theoretically very sound. However in practice, pit falls do exist. Unreliable radiology reports is one of the pIt falls we know too well. Unreliable cytology is another area. Solution? Large volume centres with staff trained to deal with this particular issue. End result? Probably not much better before it all began. So, what next? Avoid unreliable unnecessary investigations. Use your clinical skills aided by investigations to confirm as needed.
BM Hegde, India :
Cancer screening is the biggest myth and is dangerous in many situations., cervical screening in particular.
I am sorry that people quote one or two vested interest funded research.
I have been at it for four decades and have voluminous evidence to show that our War on Cancer is anything but won!
Please read more. To start with read this editorial in the BMJ - The Screening Industry.
James Fernandes/Barkur, USA :
Hi Ram: Edison tested 6000 (six thousand) plant (or other) materials to find ONE suitable element which is being used in the light bulb today. Was he greedy? Was Columbus greedy? Were Wright brothers greedy?
So be it. For every three pointer in basket ball game, how many thousands of balls have not made it? How many millions of swimming sperms are ejected to produce one statistically significant viable life?
Drona, India :
I have enjoyed this article very much. It is important to do no harm to the clients. Unfortunately, this world is full of money making people who bring the profession into disrepute.
Ram, UK:
Dear Dr Hegde

Many thanks for this thought provoking article. I am, however, a bit wary about some of the statistics/logic that you have put forward.

For example your remark about usefulness/uselessness of cervical cancer screening. You have mentioned that 1000 healthy women have to be screened for 40 yrs to save 1 life. I think actual usefulness of this screening is far better than this.

Please have a read on this website:

Also please have a look at this article:

Peto, J. et al. The cervical cancer epidemic that screening has prevented in the UK. Lancet 364, 249-256 (2004)

3.37 million women were screened in a year and 4,500 lives were saved. 4,500/3,370,000 is 0.0013( theoritically life saved per person per screen). If you multipy this figure by 1000 you get the number of lives saved by screening 1000 women on one occasion.

This is how I have understood above information !

Correct me if I am wrong.

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