Data for Merck's new painkiller called flawed

WASHINGTON -- Merck & Co., which stopped selling its blockbuster Vioxx drug due to heart problems caused by the painkiller, manipulated the design of a key study for a new painkiller to minimize its cardiovascular risks and increase chances of approval, a federal whistle-blower says.

If Merck had compared the new drug, Arcoxia, with naproxen -- a painkiller that poses fewer heart risks -- Arcoxia would look as unsafe as Vioxx, and its approval by the Food and Drug Administration ``might be difficult," wrote Dr. David J. Graham in an editorial posted yesterday on the Journal of the American Medical Association's website, which can be found at http://jama.ama-assn.org.

Instead, Merck stacked ``the deck in favor" of Arcoxia, a potential successor to Vioxx, by comparing it to diclofenac , another painkiller with heart attack risks, wrote Graham, an FDA drug safety officer who is pushing for changes at the FDA and a separate drug safety office.

Merck denied the allegations Graham made in his editorial, which accompanied two papers that describe cardiovascular risks posed by painkillers.

The company said diclofenac ``was carefully chosen" when its study began in 2002. Diclofenac is used by three times more people than naproxen, Merck said.

The FDA has already said it is willing to approve Arcoxia.

``Dr. Graham's views expressed in the accompanying editorial are his own, and do not reflect the official positions of the FDA," the agency said. Because it has not given full approval, the FDA said it would be ``highly inappropriate for the agency to opine on the available data" supporting Arcoxia's approval.

The papers posted on the association's website were written by two groups of researchers, including a team led by Brigham and Women's Hospital scientists, who culled through hundreds of clinical trials for newer and older painkillers.

They found that taking Vioxx increases the chances of suffering serious heart problems, regardless of the dose or whether patients took it for just a few weeks. The Brigham researchers found that Vioxx, which Merck withdrew from the market almost two years ago, was the worst in a now-tarnished class of newer painkillers because it ``uniquely increased " kidney and heart risks.

Australian researchers found that taking Vioxx doses higher than 25 milligrams doubled heart risks, with risks rising ``during the first month of treatment." Merck says that Vioxx heart risks occur after long-term use.

The FDA said it has made sweeping changes to labels for dozens of painkillers to reflect heart risks, and has no plans for regulatory action in response to the papers.

Diedtra Henderson can be reached at dhenderson@globe.com.