Whose benefit?

It has taken almost three decades for India to realise that phenformin’s clinical benefits do not outweigh its risks. While the developed world banned it in the seventies, India has continued to debate and allow the antidiabetic to be marketed. By whatever logic it was allowed to be marketed, one fails to understand a sudden change of mind by the DTAB to consider its ban now. How much time is required for the DCGI or DTAB, or for that matter, anybody to realise that a drug needs to be withdrawn if its risk-benefit ratio is not to the benefit of patients? No doubt, phenformin is a potent drug. But there lies its problem too. Its greater half-life and circulation time increases lactic acidosis as it promotes “anaerobic glycolysis” whose end-product is lactic acid. The important physiological pH 7 is disturbed due to increased blood lactate levels leading to complications. This is one of the drugs whose good potency does no good because of inherent negatives. In fact, as a class, biguanides promote anaerobic glycolysis, but metformin in the same class, is a weaker drug, in that, it has lower potency, has a low half-life and is not metabolised, thereby no strain on the liver. It does not promote anaerobic glycolysis and because of its multiple mechanism of action is the preferred choice over phenformin. All this was known decades ago. .

It is indeed difficult to digest the fact that Indian scientists or researchers (on who the drug regulators depend on) cannot realise the import of positive decisions taken by other developed countries. Are such basic facts of science unfathomable? Surely not, but if decisions have to outweigh the benefits for manufacturers more than that of patients, every flimsy excuse generated, appears to hold forth in the Indian context. Take the case of another controversial drug nimesulide which is also under DTAB review after such a long time. In absence of safety data, it was imperative for a mandatory PMS to be in place to generate data. This was not done immediately, instead companies aggressively promoted the drug and created a large enough market for this drug. Give the companies an inch and they will grab a foot. Not only have they promoted paediatric nimesulide, they have now embarked on irrational combinations with it. That the drug controller’s office should remain unperturbed with such events may appear incomprehensible at first, till one gets used to a lax monitoring system. A common refrain of various Drug Controllers in the past has been ‘‘but the drug already has a large market share.’’ Why was it allowed to grow in the first place? Undoubtedly at the behest of pressure groups working on them. Indian companies lift medical information when it suits them but are reluctant to generate data as in case of nimesulide. Risk-benefit studies are for benefit of the consumer, unfortunately in such cases, the risk is shared by patients and benefits accrue to the drug companies. It is doubly unfortunate when regulatory authorities and the medical profession shirk their responsibilities.

—nvramamurthy@express2.indexp.co.in