Healthy Skepticism Library item: 881

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Vioxx Withdrawal
ABC RN AM 2004 Oct 2

Full text:

Reporter: Annie Guest
HAMISH ROBERTSON: As Australia faces one of its biggest ever drug recalls, a doctor who raised concerns about the medication four years ago says it was inadequately tested before being released onto the market.

The American company, Merck, has issued a worldwide recall of its anti-arthritis drug, Vioxx, after tests revealed prolonged use could lead to increased risk of heart attacks and strokes. Vioxx is used by between 250,000 to 300,000 Australians.

The company has defended its actions, says it’s committed to patient safety, and it carries out rigorous clinical trials. But with one law firm already working on a class action, the problems are just beginning for Merck, as Annie Guest now reports.

ANNIE GUEST: The international pharmaceutical watchdog, Healthy Scepticism, warned against using the drug four years ago, saying not enough was known about it.

The director of the 130-member group, Doctor Peter Mansfield, says he’s not surprised by the recall.

PETER MANSFIELD: This is an extremely serious problem for those people that have had heart attacks or strokes who may not have had them at all, or had them later had they not taken these medications.

ANNIE GUEST: Now, you warned four years ago that you were concerned about this drug, but for different reasons?

PETER MANSFIELD: Our main concern at that time was that the advertising was misleading. It was using ambiguity to give the impression that these drugs were much safer and better known than they were.

ANNIE GUEST: Well, should there be longer term trials of drugs before they’re allowed on the market?

PETER MANSFIELD: I believe that there should be.

ANNIE GUEST: However, the head of the musculoskeletal unit at the Menzies Research Centre’s , Rheumatologist Doctor Graeme Jones has defended the drug. But he also acknowledges the incident is a major concern.

GRAEME JONES: This has to rank among the most serious drug recalls in Australia – certainly the largest in terms of the number of people on it.

ANNIE GUEST: How concerned should those 250,000 to 300,000 patients in Australia that are on this drug be, that they could be at greater risk of heart attack or stroke?

GRAEME JONES: I think somewhat concerned, but there’s certainly no need to panic here. The risk associated with this agent is small, and only seen with long term use. And it also reverses… the effect reverses promptly on stopping this medication.

ANNIE GUEST: Meanwhile, Merck’s share price has suffered in the wake of the news, and the Queensland law firm, Shine, Roche, McGowan, says its already preparing a class action against the company.

The managing director of Merck’s Australian operations, Wil Delaat, was unavailable for an interview, but yesterday he said the company is committed to patient safety.

HAMISH ROBERTSON: Annie Guest reporting