Trials of a drug that was expected to save millions of people from heart attacks and stroke, ushering in a new era of protective heart medicines, have been abruptly halted after it became clear that it increased the risk of patients dying.
Pfizer, the world’s biggest drug manufacturer, announced it was stopping an $800-million trial of the pill, known as torcetrapib, for which it had intended to submit a licence application next year.
An independent group of scientists monitoring the trial results recommended pulling the plug after they discovered that 82 people taking torcetrapib together with Pfizer’s best-selling statin, Lipitor, had died, compared with 51 in the comparison group who were on Lipitor alone.
The blow is profound for New York-based Pfizer, which was relying on the blockbuster potential of the pill to make good the income it will shortly lose as its monopoly on a number of bestsellers expires. Torcetrapib was forecast to earn the company as much as $9-billion a year.
The company’s shares tumbled on Monday on the New York exchange, ending more than 10% down at $24,90.
The reverberations are also serious for the new class of drug of which torcetrapib was the advance guard. Statins have been a runaway success, lowering levels of “bad” cholesterol in the blood which can clog up arteries.
Scientists believe that they could bring down heart deaths even more dramatically by raising the other type of cholesterol in the blood — “good” or HDL cholesterol.
This was what torcetrapib appeared to do well in early trials. Pfizer, in a move criticised by some heart specialists, intended to combine it in a single pill with its statin Lipitor — the world’s bestselling drug, but one that will be off-patent in 2010, allowing the manufacture of cheap generic copies that will decimate Pfizer’s earnings from it. The two drugs together were expected to be a dream ticket.
The dream was in tatters on Monday as Pfizer contacted clinicians in trial sites on three continents to tell them to take their patients off the new drug. All work on torcetrapib has ceased.
“This is such a surprise,” said Peter Weissberg, medical director of the British Heart Foundation. “It will set things back quite considerably.” He added: “It does raise HDL cholesterol, but doesn’t save lives — in fact, it may do the reverse.”
Pfizer’s chief executive, Jeffrey Kindler, said the bad news from the data safety monitoring body, received on Friday, was “surprising and disappointing”.
The chairperson of the steering committee for the study, Dr Philip Barter, director of the Heart Research Institute in Australia, said: “We believed that the study was coming along as expected, and this new information was totally unexpected and disappointing, given the potential benefits of this drug.”
There was speculation that the deaths could be linked to raised blood pressure, which was reported earlier on in some patients but which Pfizer had discounted.
Weissberg said other companies would have similar drugs on their books. “It doesn’t necessarily mean that because the Pfizer product has had a problem the others will, but it is unfortunate because other companies might pull out.” – Guardian Unlimited Â