MODERN MEDICAL RESEARCH-TIME IS RIPE FOR ITS AUDIT.

“Two roads diverged in the woods and I-Took the one less traveled by,

And that has made all the difference.”



Robert Frost.





Modern medicine abounds in research, mostly repetitive. Original articles on research findings pour into the literature at a phenomenal speed of 7% per month. In addition, we have the web sites for free publication. In the peer reviewed journals, by and large, only positive research is published although there are a few exceptions. Publication bias is not totally eliminated. Consequently, all that is published is not necessarily true! One or two reputed journals require the authors to give the details of funding for research. It may be difficult to unravel the hidden agenda behind these studies, at times.



It is estimated that there are more than 30,000 biomedical journals as of now. Inducements for publishing the desired results have ranged from large sums of money to entertain at international conferences in five-star hotels to other perks while the work is in progress. (Looking the Gift horse in the mouth JAMA 1999 April) The researchers are looking primarily for p-values, confidence intervals, and statistical significance in the routine IMRDC presentation. A few complicated charts and diagrams make for the best presentation and would be acceptable to editors and reviewers. The status of the institution where the research work is done matters a lot, if not to the reviewers in the blinded review system, at least to the editorial team.



Conference presentation of data is in no way better. The speaker flashes slides with complicated statistical data and a lot of numbers on each slide, which remain, on the screen for a very short time because of time constraints. The audience gets hardly any time to grasp the data, leave alone critically evaluating the same. By the time the listener gets to see the data properly the slide has already changed. With all the social functions there is hardly any time left for question answer at the end of each presentation. There are other seasoned keynote speakers who are past masters in the trade of feeding dubious data in the most fashionable way with the help of modern gadgetry and funding from pharmaceutical giants.



Let us look at some of the recent publications. There was a report on zinc supplementation in childhood to reduce morbidity and mortality due to diarrhoeal diseases and pneumonia. In addition, zinc is supposed to help growth in the poor children on inadequate diet. The studies were done mainly in third world countries. The metaanalysis showed that zinc supplementation is very important. (BMJ 1999; 319: 1521) Sure enough the drug companies must be ready with zinc in various forms at exorbitant prices in the market!



One of these studies was done in a remote village in rural India, and the same investigator has now got a million dollars extra grant to repeat the study in Africa. The original researchers and the funding came from one of the very prestigious institutions in the West. Of course, we have enough of their collaborators here. Nearly one thousand very poor children, mostly from the slums, were picked up for the study. The following rules were strictly followed:



* The children or their parents did not know that they were participating in a drug trial.

* No attempt was ever made to either educate them on preventive measures or change their unhealthy environment.

* Their diet remained what it was before the study, except in one half zinc supplements were added.

* They continued to drink water from an open canal, which was stagnant most of the time with very little rainfall in that part of the country.

* This water is definitely unfit even for animals in the West.

* The mortality and morbidity were recorded scientifically most faithfully!



The special clinic set up during the study period meticulously did the work as per the protocol, unconcerned about the other medical needs of the community, only to close shop after the work got over. This is pure exploitation of the hapless human beings in the name of research! I wonder how many such inhuman and criminal acts are swept under the carpet to get research data! We have organizations to question animal experiments even in our country but, alas, there are no such organizations to question misusing hapless human beings. No wonder Britain has a Royal Society for Prevention of Cruelty to Animals but only a National Society for Children. Is it because man hates man that he has suddenly started loving animals? May be it is because animals do not have the power to protest, but these unfortunate ignorant villagers are being treated worse than dumb animals.



The reader would have by now got an idea of the impact of this study. The primary aim of the study was to prove the hypothesis that zinc, a micro-nutrient, added to food could make all the difference. During the study the hapless children continued to die or suffer the consequences of infective diarrhea and pneumonia in their own setting.



If the same million dollars were to be used to supply clean drinking water and also to educate the poor people in hygienic methods, diseases would have vanished without any zinc! One could have eradicated infective diarrhea in that part of the country and people would have enjoyed clean water supply forever. In addition, they could have been empowered with the knowledge to prevent diseases.



Reductionist science, looking at bits and pieces, has already done enough damage by way of wrong conclusions drawn from such studies that do not look at the organism as a whole in its environment. However reductionist science has been a very good business proposition. Would they dare do such studies in the West? Does this not amount to exploiting the poor people?



Let us look at some of the other happenings in this field. Recent studies in Britain once again reaffirmed my belief that poverty (may be even relative) is the basic problem in illness (BMJ 1999;314:1522). This is more glaring in the Indian scenario. The poor pay for their poverty with their lives.



Doctors are not taught that they are human and could make mistakes in their working life as in any other field. This has led to secrecy when mistakes occur. Over the years this secrecy has led to consumer court suits against doctors. Doctors who commanded so much love and respect from their patients do no longer enjoy that privilege. On the contrary, they are being viewed suspiciously.



In the United States alone there have been more than 1,00,000 mistakes by doctors ranging from minor faults to major accidents like amputating the wrong leg! Nearly 8000 mistakes, including many deaths, were due to wrong drug combinations. Majority of them was due to the bad handwriting of doctors and a few were, of course, the mistakes of pharmacists. One could imagine the gravity of the situation elsewhere. Time has come to be open about this and teach medical students that mistakes are inevitable and they should try to minimize them. When they occur it is better to take the patient and relatives into confidence and explain the human aspect of medicine. Secrecy leads to all the trouble later. (BMJ 1999;314:1519)



Crime is no stranger to medicine either. “Man whether in the palace or pad, castle or cottage is governed by the same emotions and passions,” wrote Shakespeare years ago. We have to humanize medicine a lot. With the advent of modern hi-tech gadgets doctors might get an idea that they are omnipotent and they could do any thing from conception to death. The truth is that man’s capacity to run this world with only free will has not been proven as yet. The twentieth century has definitely proved one important thing and that is the enormity of man’s ignorance. But there are doctors who still feel that they could do anything and get away with it. One pathologist in a childrens’ hospital in England has a collection of 2000 hearts and 800 other organs of children collected after postmortem examinations between 1988 and 1995, without the consent of either the parents or the authorities. The innocent parents were told that their dead babies were all intact and only bits of tissues were taken for further examination. A thorough enquiry has been ordered. (BMJ 199;314:1518)



Many times in the past I have written, and have been badly rebuked by my peers for that, that money and its effect on human mind could have deleterious effects on our patients in any corporate hospital set up! “Money” said John Kenneth Galbraith in his celebrated book The Age of Uncertainty “is a singular thing. It ranks with love as man’s greatest source of joy and with death as his greatest source of anxiety.” Now we have scientific research proof that patients who undergo kidney dialysis in a “hospital for profit” set up suffer more than in a teaching set up. In the USA on an average about 2,00,000 patients undergo dialysis per year and about 67% of them do so in the “hospital for profit” set up. These are the ones who have more complications and have less opportunity for transplants. The mind set of doctors in those set ups are that if patients continue to get dialyzed it is more profitable for them rather than their being sent for transplant. They also have more complications as the profit goes up with more interventions! (New England Jr. Medicine 1999; 341: 1653-1691).



In contrast, purely governmental set ups give their patients a raw deal. This was shown by the inferior quality of treatment given to cancer patients in NHS hospitals in the UK. ( BMJ 199;319:1521) The NHS is suffering from lack of funds very badly. That brings us to the dire need for doctors to be aware of the enormous strengths and also weaknesses of the complementary medicines, which could ease this malady to a great extent. This is now realized in the UK where students are given instructions in the above two aspects of complementary therapy. (BMJ 199;319:1561.) While I have been advocating that for more than two decades my friends have been labelling me a quack of the refined variety!



Modern medicine is not all that safe and effective as is made out. Every single advance in therapy with modern methods is fraught with the danger of unforeseen side effects. It is now known that the prohibitively expensive bone marrow transplants that are being advertised even in India are not safe in the long run. Long term survivors of bone marrow transplants have four times higher chance of getting other cancers as compared to their peers who did not have bone marrow transplants. (Ann. Intern. Med. 1999; 131: 1738) May be, they do not live long to experience this! Adverse Drug Reactions have been the fourth most important cause of death in America, the third being hospitals and doctors (JAMA 2000; 284: 483-485)



“Prediction is difficult, especially of the future.” Wrote Neils Bohr, a Nobel Laureate. Human beings are immeasurably more complex than any system in this Universe. It is impossible to predict who will contract which disease, or who will respond to which treatment? Both those are intrinsic and not necessarily due to either absence of any routine check up or other precautions. Time and again this was brought out by studies. Recent one is the routine screening for small vessel abnormality, called aneurysms, inside the brain that might bleed in those having a family history. This study showed that it is impossible to predict who would bleed even if screened. This is true of cancer of the prostate and many other (any other) illnesses. (BMJ 1999; 319:1512)



Happiness is living dangerously but sensibly. Ayurveda has the following advice. If you have good appetite, have regular bowel movements, and proper water works system, if you sleep well and have the enthusiasm to work you only have to keep your mind free of all negative feelings like hatred, jealousy and pride and fill the mind with universal love, you will live happily as long as you live. You will certainly not live here forever. What a beautiful advice given thousands of years ago? Live and let live by loving all creatures on the planet!



“I eat when I am hungry,

I drink when I am thirsty,

If heavens don’t fall down,

I shall certainly live till I die.”

Irish Couplet.

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