All our drug studies have major flaws. Recent revelations about antidepressants causing more suicides in the recipients and the COX2 inhibitors causing heart problems are not isolated instances of drug dangers. If one looks at the history of modern drug development, one notices that firstly a chemical molecule is discovered in the laboratory and then this is checked for its potency, toxicity, and other dynamic features using an animal model. The animal data is then extrapolated to man and preliminary studies are done on volunteers. If all these are uneventful the final phase of drug development, the controlled study is mounted. In addition, all the controlled studies are done for not longer than five years before the drug is let lose on the gullible public, single drug at a time under ideal settings while in real life situation a single drug is rarely ever, if ever give and the ideal situation obtaining in controlled studies is rarely seen in patient care set up.. Occasionally, the last step is even given a go by before letting patients have the drug with disastrous consequences as had happened in the case of Milrinone. Many of the unforeseen side effects occur only after five years when the drug has been given to millions of people. Similar is the fate of surgical interventions and many other medical interventions. Swan-Ganz catheter, that used to be routinely used in the intensive care set up, was found to have resulted in at least 100,000 deaths in the American hospitals in one year!



Sexed-up Studies:



Research funds drying up from independent sources more and more studies are done with industry sponsorship. Most of them have strings attached. Positive reports have better chance of publication, the sponsors many times indulge in data dredging in addition, and occasionally companies get doctors to create diseases to sell drugs. It is a multibillion dollar business anyway and market forces influence research in this area very significantly. Academic medicine seems to be on sale these days with doctors and researchers being offered lavish gifts by the companies. Even the textbooks are written with drug company money! Final blow comes from researchers trying to confuse the doctors with complicated statistical methods when the data are not convenient to their mentors. One only has to read the editorial in the Lancet on the influence of drug company money in medical education in the US as also the one in the New England Journal same year 2000 entitled “Is Academic Medicine for Sale?” John Cleland systematically deciphers the long term effects of small dose aspirin in healthy people in the British Medical Journal in 2002, to show how the good effects sold to the public are the result of sexing up the real data.



The present scenario:



SSRIs, Cox2 inhibitiors are not the only culprits in making man miserable. Let us survey the other common diseases and their drugs. While Type 2 diabetes has been a history of failures, when the drugs lower the glucose levels complications set in, sometimes more vigourously in the tightly controlled sugar status. In a paper entitled-Treatment and Mistreatment of Type 2 diabetes- Prof. Leif Groop stated that no treatment thus far has been able to change the inevitable course of this disease; diabetes is far more heterogeneous than thus far thought of, therefore treatment should be custom built for the individual patient, a sagely advised followed for “time out of mind” in Indian Ayurveda. Unfortunately, in the reductionist science that we follow the individual patient does not exist. Only bits and pieces exist.



Rheumatoid arthritis drugs, present controversy notwithstanding, lower the pain, yet mortality and morbidity remain frightening. Pincus discusses this and says” RA trials paint a rosy short term picture, while patients’ status deteriorates over the long term. Anderson et. al have shown that while anti-hypertensive drugs lower blood pressures, yet survival and mortality rates worsen compared to non-hypertensives. Recent IOM report in America showed that modern medicine is the third cause of death in that country and adverse drug reactions the fourth cause. Most conventional medical treatments are not helping the majority of people taking them most of the time! Many Americans are seriously harmed by modern medicine while more than 200,000 die annually because of modern medical interventions, drugs and all.



Aaron Wildavsky in 1977 said: “Most of the bad things that happen to people are at present beyond the reach of medicine.” In the same book Lewis Thomas questioned concerning the major issues like cancer, heart attack, hypertension, stroke, diabetes, arthritis and peptic ulcer, the following: “For many of these illnesses, do we possess a decisively effective technology for cure or prevention, directed at a central agent or mechanism, comparable to the treatment, say, of pneumococcal lobar pneumonia with penicillin?” His answer was that “It does not look like the record of a completed job, or even of a job more than half begun, when you run through the list,” In essence a reflection of failure.

The story seems to be veering round to Heinemann’s thinking that drugs in large doses seem to cause diseases that they are supposed to control. Recent reports about one of the beta-blockers in the long run causing higher strokes in hypertensives, and pain killers causing heart failures comes close to this thinking. Incidentally, the name pain killer is very apt; while it removes the pain it could kill the patient.



The Future:

The moral of the story is that we seem to have built our modern medical buildings on quick sand using the bricks of reductionism and linear mathematics both of which do not have any relevance to human dynamic system. Our controlled studies are seriously flawed, to say the least. No one wants drug companies to close shop; on the contrary, the powerful drug companies could listen to sane advice and try and mend their ways and be more transparent for the common good of mankind. Medical science should learn from quantum physics and try and take the right road to success. Change is a part of life and change is science. Blind faith in our methods is close to being unscientific.