Healthy Skepticism Library item: 15758

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Publication type: news

Rout M.
Vioxx witness backtracks in court
The Australian 2009 Jun 10
http://www.theaustralian.news.com.au/story/0,25197,25613447-5013404,00.html

Full text:

PHARMACEUTICAL giant Merck & Co applied to patent a new product that combined its blockbuster anti-arthritis drug Vioxx and a heart protecting agent as concerns were being raised about the cardiovascular safety of Vioxx.

The Federal Court yesterday heard that staff from Merck – including the vice-president of research and a marketing employee – applied in 1999, 2000 and 2001 to patent a new drug that would include Vioxx and another agent that prevented blood clotting.

The class action against Merck & Co was told that one application for a patent was granted in October 2000. In the same year, a trial found Vioxx caused more heart attacks than another drug and concerns were growing that Vioxx caused more cardiovascular problems by increasing the risks of blood clotting in patients.

Lawyers for the plaintiff said the applications for the new Vioxx drug were submitted to the US patent and international patent office by Merck research head Ed Scolnick and Steven Nichtberger, from the company’s marketing department.

Vioxx was launched in 2000 and used by millions of people worldwide before being voluntarily withdrawn from the market in 2004 because of safety concerns.

Lead plaintiff Graeme Peterson – representing more than 1000 Australians who used Vioxx – is suing Merck, as well as its Australian subsidiary, Merck, Sharp and Dohme, for compensation. He blames Vioxx for causing his heart attack and alleges the pharmaceutical company played down the risks of the drug long before it withdrew it.

Merck is fighting the class action, saying there is no definitive scientific proof that Vioxx caused heart attacks.

Merck & Co senior research scientist Alise Reicin, who worked on clinical trials of Vioxx from 1997, told the Federal Court yesterday she did not know of any patent applications lodged by Merck from 1999 to 2001.

“I certainly wasn’t aware at the time,” she said.

Ms Reicin told the court she found out about the patents through the litigation process.

Flown from the US to testify in the case and considered to be a star witness for Merck, Ms Reicin said she had given evidence at scores of civil trials involving Vioxx. “I have lost count,” she said. “I think it is somewhere around 16.”

Under cross-examination from counsel acting for the plaintiff, Julian Burnside, Ms Reicin tried to back down from an email she wrote in 1997 to a Merck colleague saying the possibility of increased cardiovascular events with Vioxx was of “great concern” and that she “can’t wait to be the one to present those results to senior management”.

Yesterday Ms Reicin, who is now the vice-president of research at Merck, said her concerns were not about the safety of the drug. Rather, she was worried about the difficulty of interpreting Vioxx research results to senior management.

“I think it was an off-the-cuff comment,” she said.

The trial continues.