VIOXX:Safe enough for children

It’s been discovered that the discredited painkiller Vioxx had been approved for use by children just days before the manufacturer removed it from the market.
The drug, one of the new generation of painkillers known as COX-2 inhibitors, almost doubles the risk of heart attack and stroke in patients who had taken the drug for 18 months. America’s drug watchdog, the Food and Drug Administration, reckons that Vioxx may have caused more than 27,000 heart attacks in the four years it has been on the market, of which 7,000 have been fatal.
So it’s especially surprising that it was the FDA that approved the drug for pediatric use, a decision taken after studying a three-month trial carried out by the manufacturer on a group of children. An FDA spokesman told a newspaper that the decision was the correct one based on the information available at the time. Paradoxically, he added that it was also the correct decision of the manufacturer to withdraw the drug.
It’s an odd statement to make bearing in mind the enormous amount of information that was already pointing to the drug’s dangers. It was even taken up by one of the FDA’s own officials, who found even more evidence of a link to cardiovascular disorders. The agency chose to ignore his findings as they did not meet the ‘gold standard’ of research, presumably meaning it was not derived from the double-blind placebo study beloved of medical researchers.
Even so, there were still plenty of ‘gold standard’ studies that might have given the FDA pause. Back in February, 2000 What Doctors Don’t Tell You was telling its readers that common adverse reactions included abdominal pains, dizziness, fluid retention, and hypertension, and three years later was able to confirm that Vioxx patients were twice as likely to suffer a cardiovascular problem than those taking a NSAID (non steroidal, anti-inflammatory drug), one of the older generation of painkillers.
Last week the European Medicines Evaluation Agency finally entered the fray, and ordered a safety review of the COX-2 family.
The COX-2 saga raises a number of questions about drug safety and regulation. How did this drug get approval in the first place? And why didn’t the drug regulators act sooner when they knew full well that there were serious problems with the drugs? And how could the FDA approve the drug for use among children with the information at its disposal?
Of course Vioxx is not an isolated case. There are many drugs still on the market that should be withdrawn, and it’s something our watchdogs – ostensibly there for our protection – know all about.