When the American pharmaceutical firm, Merck, developed an arthritis relief drug which lacked the usual side-effects of regular painkillers, it was the sort of breakthrough that drug companies pray for. Within five years of Vioxx's appearance on the market it was being taken by 20 million patients around the world and generating some $2.5bn (£1.4bn) in revenue for Merck annually. The new drug accounted for a tenth of the firm's sales. But now that drug has the potential to destroy the very company that created it.
Vioxx was swiftly taken off the market in September last year after a clinical trial linked it to an increased risk of heart attacks and strokes in those taking it for prolonged periods. And now the first in a series of lawsuits being brought against Merck has gone against the drug manufacturer. Last weekend, a court in Texas found Merck negligent for the death of a 59-year-old man and ordered it to pay out substantial damages. This ruling could prompt 4,200 similar lawsuits around the world. There are at least 150 potential claimants here in Britain. Merck has promised to fight all of the cases. But it is estimated that the scandal could cost Merck $1bn a year over the next decade.
No one disputes that Vioxx is unsafe. The central issue is at what point did Merck know this for sure. Merck claims it investigated safety concerns about the drug as soon as they arose and took it off sale the minute it was confirmed to be a danger. But this is disputed by the families of those who died. The court in Texas heard that Merck had, in fact, played down safety fears about Vioxx for a decade. A number of internal company e-mails and documents came to light during the trial that suggest the company knew the drug had safety problems but ignored them to maintain profits. A report by the House of Commons Health Select Committee in March claimed Merck had suppressed the results of drug trials in the US, and that it may well have done the same in the UK. It also criticised the excessive promotion of Vioxx to doctors.
The public has a right to expect that pharmaceutical firms will put patient safety before profit. And there seems to be evidence that the lure of hefty profits skewed Merck's ethics. For that, it must be made accountable. But we should not overlook the fact that many forms of treatment involve a balance between benefit and risk. And we must bear in mind that it serves no one's interests if drug companies shy away in future from developing new drugs.
We are learning the risks associated with a new generation of anti-depressants. But if these were withdrawn overnight it would have the potential to do great harm to millions who rely on them. This is the complexity underlying the issue of drug safety. The goal must be to ensure confidence that potential health dangers from drugs are made public without delay. The problem is that the findings from many clinical trials never reach the public domain. There are some valid reasons for this, such as the desire of drug companies to prevent rivals learning too much about their new products. But there are invalid ones too, such as the desire of companies to prevent negative results undermining a valuable product.
The only solution is to establish a comprehensive and compulsory database of all clinical trials undertaken by pharmaceutical companies. All drug firms should be bound by this, creating a level commercial playing field. This would also mean that no company would find itself open to the charge that it had suppressed commercially sensitive trials. The only way for the pharmaceutical industry to avoid more scandals like Vioxx is to open itself to a greater degree of outside scrutiny.Reuse content