The story of drug development in modern medicine is a saga of dangerous and concealed efforts to fool gullible patients. A chemical molecule is discovered in the laboratory and then is checked for its potency, toxicity and other dynamic features using an animal model and volunteers' studies. If all these are uneventful, a controlled study is mounted for a maximum of five years before the drug is let loose on the gullible public. Many of the unforeseen side-effects occur only after five years.
Sexed-up Studies
With research funds drying up from independent sources, more studies are conducted with industry sponsorship; these necessarily have strings attached. Positive reports have better chance of publication. For every positive study, there are at least over a dozen negative studies swept under the carpet. The sponsors indulge in data dredging and, occasionally, companies get doctors to 'create' diseases in order to sell drugs. Academic medicine seems to be on sale these days, with doctors and researchers being offered lavish gifts by companies. Even textbooks are written with drug company funds. The final blow comes from researchers trying to confuse doctors with complicated statistical modelling when the data are not convenient to their mentors.
The Present Scenario
Type-2 diabetes treatment has been a history of failures; when drugs lower the glucose levels, complications set in, sometimes more vigorously in the tightly-controlled sugar status. Professor Leif Groop, in a paper entitled "Treatment and Mistreatment of Type-2 diabetes" stated that no treatment thus far has been able to change the inevitable course of this disease; diabetes is far more heterogeneous than thought of. Therefore, treatment should be custom-built for the individual patient.
Rheumatoid arthritis (RA) drugs, present controversy notwithstanding, lower the pain, yet mortality and morbidity remain frightening. RA trials paint a rosy short-term picture, while patients' status deteriorates over the long term. While anti-hypertensive drugs lower blood pressures, survival and mortality rates worsen compared to those who do not take such drugs. A recent report of IOM (Institute of Medicine) in America showed that modern medicine is the third largest cause of death in the country and adverse drug reactions the fourth largest cause—put together they are numero uno. The French government plans to cut 50% of drugs used in hospitals, saving 10.5 billion Sterling Pounds. Statins are at the top of blacklisted drugs there.
For major issues like cancer, heart attack, hypertension, stroke, diabetes, arthritis and peptic ulcer, do we possess a decisively effective technology for cure or prevention? Thomas Lewis thinks that it does not look like the record of a completed job, or even of a job half done. In essence, it is a failure. Incidentally, the name 'painkiller' is very apt; while it removes the pain, it could kill the patient. An analysis of 10 trials showed that beta blockers are no better than sugar pills in blood pressure treatment. They are now known to increase heart attacks and strokes. Elderly people on anti-BP medicines are at a higher risk of hip fractures!
The Future
We seem to have built our modern medical edifice on quicksand using the bricks of reductionism and linear mathematics both of which do not have any relevance to our human dynamic system. The controlled studies, RCTs (randomised controlled trials) as they are called, 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, mend their ways and be more transparent for the common good of mankind. Medical science should learn from quantum physics and try to take the right road to success. Change is a part of life and change is science. Blind faith in our methods is akin to being unscientific.
Professor Dr BM Hegde, a Padma Bhushan awardee in 2010, is an MD, PhD, FRCP (London, Edinburgh, Glasgow & Dublin), FACC and FAMS
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