Scientist 'worried' at Vioxx heart risk

A MERCK scientist involved in developing the drug Vioxx admitted the possibility of increased heart attacks was "of great concern".

A MERCK scientist involved in developing the company's anti-arthritis drug Vioxx admitted in an internal email two years before the drug was released that the possibility of increased heart attacks was "of great concern".

A 1997 email written by Alise Reicin, tendered to the Federal Court as part of a case against the US pharmaceutical giant, reveals she was worried about the increased cardiovascular risks of the new anti-inflammatory drug when designing a clinical trial of Vioxx.

"The possibility of increased CV (cardiovascular) events is of great concern - (I just can't wait to be the one to present these results to senior management!)," she writes in the email, dated February 25.

Ms Reicin goes on to suggest they "exclude" any patients with a history of heart problems so the difference between the two study groups "would not be evident".

Ms Reicin, the senior vice-president of Merck's research laboratories, was responding to suggestions made by her colleague, Briggs Morrison, that they include aspirin - which is known to reduce heart attacks but cause stomach problems - as part of the clinical trial.

Dr Morrison wrote to Ms Reicin a few hours earlier saying he recommended they put any participants in the Vioxx trial on aspirin, otherwise it would lead to more heart attacks and the death of Vioxx.

"Would allow low-dose aspirin - I know this has been discussed to death, but real world is everyone is on it so why exclude AND without COX-1 inhibition (that is in traditional anti-inflammatories) you will get more thrombotic events and kill drug," he wrote.

Ms Reicin emailed her colleague back, saying there was an increased risk to the success of Vioxx by using aspirin and they could solve the problem by not allowing any patients with a cardiovascular history to be involved.

"Low-dose aspirin - I HEAR YOU! This is a no-win situation!" she writes. "What about the idea of excluding high-risk CV patients ... This may decrease the CV event rate so that a difference between the two groups would not be evident. The only problem would be - would we be able to recruit any patients?"

Another colleague responded to Ms Reicin's suggestions, saying the trial would be "severely hurt" if the study showed a win in reducing gastric problems but a "loss" in cardiovascular events.

The trial - which was called GI Outcomes study - was not proceeded with by the company and replaced a few years later with another, known as the VIGOR study.

The results of the VIGOR study were released in 2000 and showed there was an increased risk of heart attacks for participants on Vioxx, compared with another anti-inflammatory drug.

The emails were tendered by the plaintiff in a class action for compensation against US company Merck & Co and its Australian subsidiary Merck, Sharpe and Dohme.

Lead plaintiff Graeme Peterson - along with more than 1000 other Australians - claims Vioxx caused him to have a heart attack in 2003 and is suing the company. He also alleges Merck knew of the cardiovascular risks of the drug but downplayed them before its recall in 2004.

Vioxx was launched in 1999, and at its height was used by 80million people worldwide because it did not cause stomach problems, as did other anti-inflammatory drugs. Merck has already settled thousands of lawsuits in the US over the effects of Vioxx for $US4.85 billion, but has made no admission of guilt. The company is fighting the class action in Australia.

The trial continues.