THE US Food and Drug Administration reasserted the principles of benefit and risk in the drugs industry yesterday as a panel of experts voted to allow Merck to keep Vioxx, its controversial painkiller, on the market.
Earlier a panel of leading scientists, including a number of doctors who have criticised the class of painkiller to which the drug belongs, unanimously declared that the medicine could trigger heart problems in some patients.
But in a decision that will reinforce the principles of drug development, the panel voted by 17 to 15 to leave the medicine on the market, arguing that its benefits outweighed the risks.
Speculation mounted that Merck would consider relaunching the drug, which belongs to a family of painkillers called Cox-2 inhibitors.
The company said that it would consider the implications of data that had recently come to light and that it had heard “numerous reports” from patients with debilitating conditions that “Vioxx was the only treatment to relieve their pain”.
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The panel also gave Pfizer the green light to keep its Cox-2 drugs on the market, voting by 31 to 1 to uphold Celebrex’s approval and by a closer margin, 17 to 13 (with two abstentions), to confirm Bextra’s licence.
The panel sits in an advisory capacity, but while the decision must still be ratified by the FDA, it is rare for the regulator to ignore its advice.
Shares in Merck rose 13 per cent after the decision, closing at $32.61 as hopes circled Wall Street that some of the 600 class action lawsuits now hanging over the company might be dropped. Analysts suggested that the ruling would strengthen Merck’s defence that it did not act negligently by keeping the drug on shelves. It could also help to revive Merck’s next-generation Cox-2 medicine, Arcoxia. Pfizer shares also rose 6 per cent on the news.
The ruling will be welcomed by drugs companies, which have expressed concerns that the public is losing sight of the fact that powerful drugs can cause side-effects.
Sir Tom McKillop, chief executive of AstraZeneca and J-P Garnier, his counterpart at GlaxoSmithKline, have cautioned that overly risk-averse regulation would impede the development of life-enhancing treatments.
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The FDA summoned the panel to review the status of all Cox-2 inhibitors amid gathering evidence that these drugscould exacerbate heart problems. The crisis was prompted by Merck’s sudden withdrawal of Vioxx from the market. Merck cited a clinical study that appeared to link the treatment to increased risk of heart problems. Similar data has since been published on Celebrex and Bextra, Pfizer’s Cox-2s.