|
Some of the world's largest drug manufacturers are braced for a tense week as European and US regulators gear up to examine the safety risks associated with a widely used class of anti-inflammatory drugs.
The European Medicines Agency reconvenes deliberations behind closed doors on the so-called cox-2 inhibitors, and the US Food and Drug Administration (FDA) safety panel meets.
Both are soon likely to deliver verdicts that could have a significant impact on the pharmaceuticals industry, for those launching or considering cox-2s, and for others closely watching the evolving attitude of regulators.
"The meetings are likely to provide insights on how the FDA will consider drug safety going forward," said Tony Butler, analyst at Lehman Brothers.
He forecast the FDA would be "unlikely" to recommend removing cox-2 inhibitors from the market, but could ask for warnings on labels. But a potentially bigger result, he added, would be how regulators in the US react to current pressure for tougher safety standards.
The cox-2 review underlines the debate over how to weigh a drug's relative benefit to many people, over its risks on serious side-effects. The question of what level of risk can be tolerated for a wider benefit to patients nags both regulators and drugmakers alike.
Legislators, consumer health watchdogs and other critics have blasted regulators, particularly in the US, for being too cosy with drugmakers. They argue FDA needs to be restructured to improve its safety vigilance.
Meanwhile, drugmakers have been criticised for heavily promoting drugs, pushing them on a wider-than-necessary population and exposing them to risks.
The drug industry counters that all drugs have some risk, and the very nature of pharmaceuticals is the trade-off between benefits and risk from introducing a chemical into the body. It also argues that the public has become intolerant of any risk.
Garrett FitzGerald, researcher at the University of Pennsylvania and a cox-2 expert who proposed years ago that the drug class might cause heart problems, said the drugs should be used, but more sparingly, to help those arthritis patients susceptible to stomach bleeding caused by older medicines.
"I would still like to see us conserve the value of the class and manage the risk," he said.
But he added that the only cox-2s that have proved better for the stomach versus older drugs such as ibuprofen or naproxen are not available -- Vioxx, now withdrawn, and Novartis's Prexige, not yet approved. Prexige and Merck's Arcoxia are waiting US approval.
Any new cox-2 drug should probably face study on long-term use of the drug in people with low heart risk, experts said.
"If that is the case, it is logical this would be a hurdle currently approved drugs would also have to clear to retain approval," Dr FitzGerald said.
Such a scenario would disappoint drugmakers, who are already sensitive to the high costs of developing drugs. It would add to the growing fall-out after Vioxx, which has given the industry a black eye.
The withdrawal of Vioxx eliminated estimated annual sales of $2.4bn for the next several years. It left Merck's profits in decline and spurred significant litigation, for which it has reserved $675m for legal fees.
While challenging Pfizer's assertions that only Merck's drugs are unsafe, Merck also is trying to obtain US approval for Arcoxia. But analysts who once thought Arcoxia would reach $1.3bn in 2009 have now scaled that down to $353m.
Pfizer initially benefited from an upsurge in sales after the Vioxx withdrawal. But while it has remained defiant, it too is under pressure. Analysts expect last year's combined Celebrex and Bextra sales of $4.6bn to halve this year.
Despite the gloom, some in the industry remain confident that the cox-2 crisis will pass. GlaxoSmithKIine, the UK-based group, said that it had no intention of dropping the development of its own new cox-2, currently known by its working name 381, which is still in the pipeline.
Jean-Pierre Garnier, GSK's chief executive, claimed his drug had demonstrated greater efficacy and safety than Celebrex, and that the company remained on schedule for an FDA submission in 2006.
|