FDA denies trying to block Vioxx results

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FDA denies trying to block Vioxx results

Last Updated: 2004-10-08 12:14:36 -0400 (Reuters Health)

WASHINGTON (Reuters) - The U.S. Food and Drug Administration denied charges

it tried to suppress a safety official's findings that painkiller Vioxx,

which was pulled from the market last week, raised heart attack risks.

Dr. Graham's study on the Merck & Co Inc. arthritis drug was sent

through the " standard review process " before being made public in August,

the FDA said in a statement released late Thursday.

Graham told Senate Finance Committee Chairman Grassley on Thursday

that FDA officials pressured him to keep quiet or water down his conclusions

about Vioxx, according to Grassley.

Conversations between Graham and his supervisor were part of the " open

discussion and frank exchange about scientific and medical issues " that are

part of the process for reviewing staff research presentations, the FDA

said.

" After that discussion, it was Dr. Graham's decision to revise the

abstract, " or a summary of his findings, the FDA said.

Graham, associate director for science in the FDA's Office of Drug Safety,

concluded that patients taking Vioxx were more likely to suffer heart

attacks than others who took rival medicine Celebrex, made by Pfizer Inc.

Graham's findings were presented at a medical conference in France on Aug.

25.

Grassley, an Iowa Republican, is investigating how the FDA handles safety

concerns about medicines.