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Beware, you're at risk
This may not be the chill pill you were hoping for: medicines used to treat most diseases - high blood sugar, blood pressure, thyroid, obesity, even common cold and cough - are causing adverse reactions among patients across the world. But bizarrely enough, India has not officially reported even one unfavourable response to any drug so far.
In more advanced countries, even seemingly innocuous medicines have begun facing intense scrutiny from drug authorities. Safety alerts on new and old therapeutic drugs are regularly issued in the West. India, however, is content to do nothing more than to react to bans imposed abroad. We have an abysmal record of reporting or monitoring the side effects of drugs, with everyone concerned - physicians, patients, and even hospitals - turning a blind eye to the situation.Consider this scary statistic: One out of five new drugs poses serious side effects within the first five years of being put on retail shelves, according to medical experts. Most of these adverse drug reactions (ADR) have been reported in developed countries. Drug regulation is serious business in advanced countries and rules are not just stringently framed, but also imposed efficiently. Public opinion on the subject is also informed and vigilant. (Though of late, the US drug regulator, the Food and Drug Administration (FDA), has been facing flak on account of delays in handling high profile and controversial drug issues).
Significantly, adverse drug reactions are not discovered at the time when drugs are being tested in clinical trials as the number of patients on whom the drug is tested is too small to detect side effects. Usually Phase I-III testing involves only around 5, 000 subjects. Adverse drug reactions that occur in 1 in 1, 000 or more cases cannot be detected prior to marketing. For instance, the effect of the compounds used in a medicine on the heart or arteries may take at least five or more years to manifest itself.
There is another lacuna in early pharma testing. Subjects recruited in the trials are healthy and do not suffer from kidney, heart, or liver ailments. This means that some side effects are discovered only when a large number of subjects, both healthy and sick, are treated with the new drug, say doctors.
Also, "drugs may have different effects or even have different side effects on various ethnic groups. For example a particular blood pressure lowering drug, Hydralazine, works better in African populations than others. These distinctive effects and side effects could be explained on the basis of genetic and metabolic differences, " says Dr Anoop Misra, director and head, diabetes, of Fortis Hospital, New Delhi.
This means that multi-country, multi-ethnic group trials are necessary to cover a wide variety of genetic pools. Says Dr SK Gupta, director general and dean, Institute of Clinical Research and former head of pharmacology at the All India Institute of Medical Sciences: "We have recently seen that calcium, which is widely used for the prevention and treatment of osteoporosis and for bone density improvement in the elderly, has been shown to cause cardiovascular diseases, whereas Indian scientists do not agree with these studies. " To make matters worse, here in India, most drug companies do not have a system for post-marketing surveillance. Though a national pharmacovigilance programme (relating to detection, assessment, and prevention of adverse effects of medicines) has been in existence for some years now, it is yet to report any toxic drug side effects.
Detecting toxic side effects is a challenging task. "Unfortunately, doctors here fear that they may be held responsible for the adverse drug reaction and do not report them. In certain cases, they may not even be aware of the pharmacovigilance system. This is why it should be made mandatory to include pharmacovigilance in the medical graduate curriculum, " says Dr Gupta.
Some drugs that are banned in the developed world continue to be sold in India and other developing nations. Since the law does not insist that drug companies report adverse events, many side effects go undetected till after thousands have suffered. Says a Mumbai-based doctor: "We need strict regulatory control in India, on the lines of the US FDA, and Europe's EMEA. There should be an independent body for monitoring post-marketing studies in India, one that is distinct from the agency which approved the sale of the drug in the first place. "
Doctors point out that a vigilance programme involving all physicians is necessary. A centralised computerised programme that can imbibe a large amount of such data, and recognises 'signals' of possible adverse drug events, needs to be established. (An example is the ADR monitoring programme in Uppsala, Sweden). Further, the system should ensure education about newly recognised adverse drugs among physicians and pharmacists.
Today, the flow of information is quick and far-reaching and the news of a drug ban or a newly discovered side effect travels fast. The pharma sector cannot sit on negative information for too long. The sale of a globally discarded drug will die a natural death sooner or later, say experts. Prescribers will simply switch to non-controversial alternatives.
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