Dr. Almas Kiran Shamim
A drug goes through many steps of clearance before being finally introduced into the commercial market. However, it is not surprising if, even after passing through rigorous trials, some drug ends up being banned due to newly reported adverse effects. After all, the human body is more complex than our imagination can permit us to believe. And it is only in our best interest that such pharmacovigilance exists lest there be absolutely no control over a drug once it is introduced into the market. There are innumerable instances of commercial drugs being banned, one of the most famous being the ban on thalidomide following birth defects in the babies whose mothers had consumed the teratogenic drug. Such instances, however scary, do reassure us in at least some ways- that harmful drugs won’t be allowed to pervade the market. However, there is a flip side to every drug ban which not many of us think about, especially if the drug had never concerned us in the first place.
The recent banning and unbanning of pioglitazone, the potent anti-diabetic drug, and the melodrama that accompanied both the steps is only the visible tip of the iceberg that is the real problem. While on one side there are many questions that remain -Why did the Govt. of India ban the drug without evidence strong enough to prove its relation to certain types of cancer? Is there a lobby that brought about the ban so that more expensive anti diabetic drugs like gliptins can be promoted? Or is there is a lobby promoting the sale of pioglitazone in spite of its potential adverse effects?- on the other side remains the not so talked about effects of the ban! The effects on the patients and their families!
Pioglitazone, a very effective and cheap drug used in the control of Diabetes Mellitus, was banned in India in the month of June 2013.
The market was emptied of the drug in days leaving the millions of Indians relying on this drug for their blood sugar control totally helpless. While those on pioglitazone alone or lower doses of other anti-diabetic drugs had more scope of gaining blood sugar control, those who were on multi drug regimens and already on high doses of other family drugs had a tough time. This is especially true in situations where there are not many experienced doctors available to manage diabetes well, or where the very availability of other drugs is a question. Another issue could be the expenses that the patient and his/her family would have to meet with, if the newer substitute drugs are more expensive than the previous drugs. Such problems can drastically reduce the compliance to treatment and cause a sharp increase in the incidence of complications. Diabetes is known to effect almost every organ adversely and can even lead to death through many pathways. One example of a complication that arose after the ban is of a female patient who went into diabetic ketoacidosis, an acute complication of uncontrolled diabetes, even as treating physicians were trying to fix a new regimen of drugs for her. This, in turn, led to an infection in the kidneys with a high fatality rate. The patient is still recovering and is now on insulin, while the ban has happily been lifted.
This only stresses on the need for the Govt. to function with more sensitivity to issues of public health importance. With each drug ban, there should be sufficient media coverage of notifications of the best available alternatives, notices to health professionals to adopt alternate means and steps to insure that the alternatives are made economically, socially and geographically accessible to all. A harmful drug in the market is a failure of pharmacovigilance. But, a ban that comes without new management guidelines is no success either!
Leave a Reply