Painful painkillers

Notwithstanding the nature of the verdicts emanating from both the European and US regulatory offices during the last week over the fate of Cox-2 inhibitors, drug manufacturers who have existing products or are likely to introduce variants in the same class, are putting up a stoical front. The advisory panels reviewing safety analysis on painkillers can recommend either restrictions on the use of this class of drugs or to add warnings. This is again not an easy situation considering the amount of influence the drug companies wield even today and the way forward for drug safety by regulators worldwide is on test. It is not only existing drugs like Pfizer’s Celebrex and Bextra, doubts are also now arising on naproxen. With UK’s MHRA ban on dextropropoxyphene, the Indian regulatory authorities are reported closely watching combos of this drug with paracetamol. Ever since Merck’s withdrawal of rofecoxib last september, critics, health activists and legislators have come down heavily on the FDA for being too accomodative of the drug industry. Pressures on it to restructure and enhance safety vigilance in favour of the consumer is definitely a painful experience for the drug industry in general. The drug industry’s attempts at providing improved or new generation drugs to the consumers is one side of the story. But increased marketing programmes and wooing of the medical community and defensive counter-claims by the industry, as revealed by documents now being unearthed in the vioxx case show that today there is a very thin divide between permissible promotion and the offering of inducements to doctors.

The Cox-2 reviews are at the centre of an intense debate between the manufacturers and regulators over the evaluation of risk-benefit profiles and the extent of risk that could be tolerated if a wider benefit accrues over existing drugs. It is another matter that most drugs are in the me-too category and that there is intense rivalries between companies, even going to the extent of being compared with the marketing war in the consumer goods segment. This is where one creates a demand and then pushes the product, but the drug industry cannot be doing that. The drug industry defence is that there is bound to be some amount of risk in all synthetic drugs and that people are making too much out of it. True, consumers have no choice but to contend with this philosophically. However, the industry’s attempts at concealing data and pushing a product solely on the hunches of marketing honchos and business managers, throwing the safety of consumers to the winds, is unbecoming of the industry. Yes, there is a chance that too much of villiany is being meted out to the Cox-2 drugs and that there are some Cox-2 experts who still advocate a cautious use of these drugs. Because, if the older anti-inflammatory drugs caused intestinal bleeding in chronic users like arthritic patients, a sparing use of Cox-2 drugs by them would definitely be of help. But where are the restraints exercised by the industry or the medical community? When the former act at the bidding of the latter and the hapless patient totally dependant on the doctors advise, sooner or later health activism will be on the rise and the regulators will have no choice but to act with alacrity.

—nvramamurthy@expressindia.com