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No beating about the bush.
Is the relationship between scientific method and medicine fragile?
Many years ago, I wrote an article titled “Evidence based or evidence burdened science” that attracted much criticism from the ‘great medical scientists’. Luckily, today, I chanced upon an article in the International Journal of Evidence Based Health Care 2006 (Volume 4: pp 180-186) wherein the authors, Dave Holmes, Stuart J Murray, Amélie Perron RN and Genevieve Rail, claim that evidence-based movement is not just a fraud but a dangerous game that the powerful people play to keep their industry moving. The abstract of their paper is reproduced below:
“Drawing on the work of the late French philosophers Deleuze and Guattari, the objective of this paper is to demonstrate that the evidence-based movement in the health sciences is outrageously exclusionary and dangerously normative with regards to scientific knowledge. As such, we assert that the evidence-based movement in health sciences constitutes a good example of micro fascism at play in the contemporary scientific arena.
“The philosophical work of Deleuze and Guattari proves to be useful in showing how health sciences are colonised (territorialised) by an all-encompassing scientific research paradigm—that of post-positivism—but also and foremost in showing the process by which a dominant ideology comes to exclude alternative forms of knowledge, therefore, acting as a fascist structure.
“The Cochrane Group, among others, has created a hierarchy that has been endorsed by many academic institutions, and that serves to (re)produce the exclusion of certain forms of research. Because ‘regimes of truth’, such as the evidence-based movement currently enjoy a privileged status, scholars have not only a scientific duty, but also an ethical obligation to deconstruct these regimes of power.”
The above abstract leads to the conclusion that medicine is NOT a science. The much-touted randomised controlled trials (RCTs) that are sold as hard evidence in medicine are making a mockery of science. In fact, medicine is not a science; but is not unscientific either. It is better called non-science enquiry. The doctor’s job is to make a diagnosis which is exclusively done by trial & error and more by past experience of having seen hundreds of cases. That is where experience plays a vital role. The diagnosis can be supported by some investigations; but the final proof of the pudding is in the response to the treatment. The pain-in-the-neck is the side-effects of various drugs. If one uses very powerful drugs, one might feel that the disease comes under control sooner. This is, often, only an illusion.
That is why adverse drug reactions (ADRs) have become a common cause of hospital admissions and death. Even simple antibiotics, like clarithromycin, can give rise to heart attacks in the ensuing months and years! In fact, a senior functionary of a well-known drug company said: “It is an open secret within the drugs industry that most of its products are ineffective on most patients.” Now, we also have strong evidence that the faith of the patient in the doctor is a vital part of the patient's response to treatment, even surgery! Therefore, medicine is less scientific but more humanistic.
Case histories and individualised outcomes work better in medicine than large-scale trials which look at a large group. RCTs will not be admitted as evidence in a law court but case histories may be admitted as evidence. Medicine can learn more from law rather than from the so-called hard sciences like physics and chemistry.
“The practice of medicine is largely observational and functions without the level of certainty essential to science. As the reign of ‘evidence-based medicine’ with its crippling flaws is replaced by evidence-informed individualised care, healthcare providers, physicians and surgeons will once again better appreciate the importance of and application of non-scientifically obtained evidence. Case reports and case series are examples fundamental to medical practice and education,” wrote Clifford Miller and Donald W Miller Jr in their article in the European Journal of Person Centred Healthcare (Volume 2, Issue 2, 2014, pp144-153).
Professor Dr BM Hegde, a Padma Bhushan awardee in 2010, is an MD, PhD, FRCP (London, Edinburgh, Glasgow & Dublin), FACC and FAMS.
Texas-based Applied Food Science is asked by the FTC to pay $3.5 million to settle misleading weight-loss claims complaint
Just because a company touts a “clinical study” that it says proves its product works doesn’t mean you should believe it. Especially when it comes to weight loss. Make that especially when it comes to weight loss and green coffee extract.
On Monday, the US Federal Trade Commission (FTC) settled allegations with Texas-based Applied Food Service Inc that it used a “hopelessly flawed” study to promote weight loss claims for its green coffee extract product. The study was also touted on The Dr. Oz Show.
(More on Oz and his miracle products here.) The company agreed to pay $3.5 million and have at least two adequate and well-controlled human clinical tests to support any future weight loss claims it makes.
The FTC said in its complaint that the company paid researchers in India to conduct a clinical trial but that the trial’s lead investigator repeatedly altered weights and other key measurements of the subjects, changed the trial length and misstated which subjects were taking placebos and which were taking the dietary supplement, Green Coffee Antioxidant, that contained the green coffee extract. The company used the study to claim that the product caused consumers to lose 17 pounds in 22 weeks, and these results were repeated by retailers marketing the products to consumers.
“Applied Food Sciences knew or should have known that this botched study didn’t prove anything,’’ said Jessica Rich, the FTC’s director of the bureau of consumer protection. “In publicizing the results it helped fuel the green coffee phenomenon.”
Cardiac procedures bring in billions of dollars in cash for doctors, hospitals and the instrument manufacturers, in addition to television interviews. Sadly, the procedures are done not to help patients but to benefit these few
“Rather fail with honour than succeed by fraud.”
In a book that is very well reviewed by the New York Times, an Indian born American doctor, Sandeep Jauhar “puts himself on the couch” pricked by his conscience. In his book “Doctored”, Sandeep examines the broken system of medical practice in the US. Thanks to the Indian Karma theory, this young cardiologist, who was the director of a teaching hospital in New Jersey, had to eventually leave his job as he refused to interfere where the patient did not need it. After being thrown out, he joined another practising cardiologist, where again he found that ethical practice was given a go by. His boss told him that he also tried ethical practice and found himself in debts. Now, he has joined the mainstream. Sandeep left that job also as he was asked to carry out all tests including angiography for all patients who came there!
This is exactly what we do in India now and even our politicians think that we have the best system in place. Our Union Health Minister wants AIIMS like hospitals in every state! In the west, there is a cry for closing down such hospitals, while we want to start more of them. No one seems to be bothered to audit the system to see what AIIMS achieved during the time it exists, and what is the benefit to the common man? Such a study would be most appropriate to scientifically find out what to do for the future. An audit of 14 industrialised countries from US to Japan showed that those countries with too many specialists and sub-specialists and very high doctor -patient ratio like the US fared so badly that the system had completely broken down with highest disease, death and disability rates, while Japan with the very small doctor- patient ratio with majority of doctors being family physicians ranked first with increased longevity, decreased death, disease and disability rates!
When doctors went on strike in many countries in the last 25 years-Saskatchewan, Bogota, Los Angeles County, Dublin and recently in Israel- death rates almost plummeted to the bottom with disability rate reduced significantly in every place only to return to the original levels when doctors came back to work. It is reported that in Israel morticians had to bribe the government to give doctors higher pay for them to get back to work as morticians’ coffin business had almost shut down! This prompted the British Medical Journal to comment in an article that “doctors going on strike will improve society’s health”. The French government started a Chinese medical hospital with one hundred beds in Paris while their western medical system had become prohibitively expensive. The new hospital had brought down the medical expense to the government very significantly. Nobel Laureate Professor Bernard Lown, one of world’s best cardiologists from Harvard felt in his research article in the JAMA that unless we ban coronary angiograms for diagnosis of coronary artery disease, patients will suffer unnecessarily. Professor Tom Treasure, a cardiac surgeon, pleaded with the British Government through The Lancet that they should drastically reduce cardiac surgical centres in Britain to stop wasting money on unnecessary tests.
Professor Harlan Krumholz, a Yale cardiologist, wrote an editorial in the (NEJM 1997; 336: 1523) about cardiac interventions: "cardiac procedures bring in billions of dollars in cash for doctors, hospitals and the instrument manufacturers, in addition to television interviews. The procedures are done mainly to get those benefits and not to help patients in the US.”
Let me conclude this by quoting a patient that I saw yesterday, who had a very sordid story. A very healthy 63-year-old man, who is also a good writer in Kannada, had mild elevation of his blood sugar for the last six months, which he had very well controlled with exercise and diet. On an average, he walks ten kilometres a day, including a steep incline up a hill to reach his temple. He was feeling fit as a fiddle.
His publisher and a dear friend, an Ayurvedic physician, who, for some unexplained reason, has a fascination for western medicine, almost forced him to have a “check-up” since he has been a “diabetic”! He took him in his own car to a “special centre” in an upcoming District headquarters nearby. The doctor had also told him to have enough money should he need any interventions. As soon as they went in, the patient was asked by the cardiologist to have his ECG done, which unfortunately turned out to be normal. But he was told that he needed an exercise test to see if there is any fault. Before that he had an echo test, which showed a normal heart with very good ejection fraction (good function). Still, the cardiologist insisted that he should have the TMT. No one had either talked to him or listened to him or even touched him, leave alone physically examine him. Doing TMT on a healthy man who walks daily ten kilometres up a hill with ease is a business. Scientifically TMT has no value as that test has its sensitivity and specificity less than 50%, which means whether it is positive or negative it means nothing. More over, the test results depend on the disease prevalence in society, which we do not know for India! Professor Perloff of Washington University had designed a Hyperbole, which should be used to plot the results to get a semblance of value for the test. The only value of TMT is the fall of blood pressure during exercise. This denotes a bad heart muscle. In this hospital BP was never recorded during the TMT!
However, TMT was declared to be positive and the patient was almost forced to have an angiogram in spite of his mild protests. Poor man still has a swollen left hand with blood leak outside the artery and inflammation from the catheter! He was then told that he needs either an angioplasty or bypass surgery ASAP. At this stage, he smelt a rat and paid their bill and walked out of the hospital. Interestingly, the discharge note has the following diagnosis for an apparently healthy man who NEVER ever had chest pain. Chronic Stable Angina with three vessel disease and diabetes Mellitus type II. The angiogram, in fact, showed some small peripheral blocks in the epicardial vessels.
The man came to see me walking slowly (he was asked not to walk till he has the interventions) and talking in whispers- a really sickly pathetic picture. It took me nearly an hour to make him a MAN again and send him back asking him to go back to get his eight tablets prescription also gradually reduced, lest he should bleed seriously from the gut or inside the brain for no fault of his. He was on two blood thinners, beta-blockers, ACE inhibitors, long acting nitrates (which get tachyphylaxis soon and become useless), and some other fancy drugs. All the man needed was, change of his mode of living with some minimal drugs for him to get off the high horse of the rat race that he was running, which put him in the fight-flight-freight mode always. Medication could be an added boost.
God save our hapless patients from this corporate monstrosity.
“There are three things in the world that deserve no mercy, hypocrisy, fraud, and tyranny.”
(Professor Dr BM Hegde, a Padma Bhushan awardee in 2010, is an MD, PhD, FRCP (London, Edinburgh, Glasgow & Dublin), FACC and FAMS. He is also Editor-in-Chief of the Journal of the Science of Healing Outcomes, chairman of the State Health Society's Expert Committee, Govt of Bihar, Patna. He is former Vice Chancellor of Manipal University at Mangalore and former professor for Cardiology of the Middlesex Hospital Medical School, University of London.)