Merck witness has chink in armor
During the past five months, Merck researcher Alise Reicin has stood toe-to-toe with some of the nation's best trial lawyers.
Described by her bosses at the New Jersey pharmaceutical company as a "tenacious defender of the Vioxx franchise," she has been Merck's most reliable witness in the three trials so far involving the once-popular painkiller.
Now, she's on trial as much as the drug itself.
That's because of a bombshell last month from the editors of the New England Journal of Medicine. They accused the authors of a key study on Vioxx of fudging the data, and making the drug look safer than it was. Reicin was a co-author of the Vioxx study, and plaintiffs attorneys say the editorial undercuts her testimony that Merck acted responsibly.
"The essence of the problem is when you have a witness who has a halo over her head, and crystalline credibility, any ding in that can shatter the entire aura and cast her as a profits-before-science marketing adjunct," said Sam Davis, a Teaneck attorney who is representing hundreds of Vioxx plaintiffs.
Reicin, a 45-year-old scientist, who lives in Englewood, helped design the clinical trials that led to the drug's regulatory approval in 1999. And she has consistently provided the scientific underpinning to Merck's claim it acted in good faith before pulling the drug from the market in September 2004, after a study linked it to an elevated risk of heart attack and stroke.
More importantly, she has shown the ability to win over a jury. After the first New Jersey case in Atlantic City last fall, jurors said they found her to be particularly credible. Merck won that case, after losing weeks earlier in a case in Texas. Later, a federal lawsuit in Houston ended in a mistrial. Merck faces more than 9,000 lawsuits around the country.
"Clearly, Dr. Reicin is a star witness for Merck," said plaintiff attorney Andy Birchfield, who nonetheless said he is looking forward to raising the New England Journal's concerns in his retrial of the first federal Vioxx case, which begins Feb. 6 in New Orleans.
LOOKING FOR INCONSISTENCIES After the editorial appeared, plaintiff attorneys immediately began combing Reicin's testimony for discrepancies. Four weeks later, no blatant contradictions have emerged.
Texas attorney Mark Lanier, who won a multimillion-dollar verdict against Merck last summer in the first Vioxx trial, has backed away from comments that he planned to pass information along to law enforcement officials. In an e-mail last week, he said he is saving inconsistencies he has found for a Vioxx case he is trying in New Jersey at the end of February.
Chris Seeger, one of the plaintiff attorneys who lost the first Vioxx case in New Jersey last fall, has said he wanted to add the New England Journal revelations to his motion for a new trial.
Seeger had not done so as of Friday, but it is possible the information could be included in time for a hearing before Superior Court Judge Carol Higbee later this month. Seeger did not return calls seeking comment.
Merck, meanwhile, insists it is keeping Reicin in its lineup of witnesses. Company lawyers pored over her testimony in the three trials, and found nothing of concern, said Ted Mayer, an outside counsel for Merck.
"What she testified to was entirely truthful and straightforward," Mayer said.
GOOD WITH THE JURY It's not surprising Merck will continue to rely on Reicin, even if the risks have gotten higher. In court, she is imperturbable under questioning. During breaks in testimony in Atlantic City in October, she routinely turned to the jury and smiled -- at one point, mouthing the words "It's cold in here," according to Davis, who was attending the trial.
"She comes across to the jury as knowledgeable, authoritative and articulate," said Daniel Keller, a New York plaintiff attorney who sat in on her testimony in the first Vioxx trial in Texas last summer. "She did a pretty good job presenting alternate views of some of Merck's most damning documents."
The medical journal's editors claim the authors of a Vioxx study named Vigor, published in 2000, failed to mention three heart attacks among those given the painkiller and also deleted other relevant safety information. The heart attacks were significant, the editors say, because they occurred in patients at a low risk of cardiovascular problems.
The authors of the study have said the three heart attacks occurred after a firm cut-off point for data, and are preparing a formal response to the New England Journal.
Reicin, who declined to be interviewed while litigation continues, did offer a brief written statement on the controversy.
"Ensuring the integrity of scientific data is of utmost concern to me as a doctor and scientist, and I would never do anything to compromise that principle," she said. "I have been honest and consistent in my testimony regarding the availability of the Vigor data and its disclosure to the New England Journal of Medicine and the Food & Drug Administration."
Keller, a former defense lawyer for pharmaceutical companies who now represents Vioxx plaintiffs, said Reicin will have to spend part of her testimony defending herself, instead of Merck.
"Its pretty simple: it dilutes her testimony," he said. "She'll be prepared to deal with it, but the facts are the facts."
'INTENSE AND SERIOUS' Reicin, who took Vioxx herself before it was withdrawn, is married to a managing director of Morgan Stanley, and has three children ranging in age from 9 to 15. Her father helped run a unit of a family business, M. Putterman & Co., that makes gym floor covers, industrial containment systems and other products. In testimony in Atlantic City, Reicin said her parents stressed the importance of education, and giving back to society.
"I developed an interest in science, an aptitude for science, and so it was kind of natural to decide to pursue a career in medicine, where I could combine science with the ability to help people," she said during the Atlantic City trial in October.
Reicin graduated summa cum laude from Barnard and went on to Harvard Medical School. She did her residency at Columbia-Presbyterian Medical Center, and conducted research on the HIV virus at Columbia.
"AIDs was the epidemic of my generation," she said.
Her mentor at the university, Stephen Goff, called her a terrific researcher who did well at "very hard-core, basic science."
"She's incredibly intense," Goff said. "She's very serious about science."
Reicin moved to Merck because she believed she could have a greater impact on patients' lives.
Despite her responsibilities on litigation, Mayer said Reicin continues to work on clinical research. He declined to say what projects they are.
"That continues to be her primary role," she said.
Described by her bosses at the New Jersey pharmaceutical company as a "tenacious defender of the Vioxx franchise," she has been Merck's most reliable witness in the three trials so far involving the once-popular painkiller.
Now, she's on trial as much as the drug itself.
That's because of a bombshell last month from the editors of the New England Journal of Medicine. They accused the authors of a key study on Vioxx of fudging the data, and making the drug look safer than it was. Reicin was a co-author of the Vioxx study, and plaintiffs attorneys say the editorial undercuts her testimony that Merck acted responsibly.
"The essence of the problem is when you have a witness who has a halo over her head, and crystalline credibility, any ding in that can shatter the entire aura and cast her as a profits-before-science marketing adjunct," said Sam Davis, a Teaneck attorney who is representing hundreds of Vioxx plaintiffs.
Reicin, a 45-year-old scientist, who lives in Englewood, helped design the clinical trials that led to the drug's regulatory approval in 1999. And she has consistently provided the scientific underpinning to Merck's claim it acted in good faith before pulling the drug from the market in September 2004, after a study linked it to an elevated risk of heart attack and stroke.
More importantly, she has shown the ability to win over a jury. After the first New Jersey case in Atlantic City last fall, jurors said they found her to be particularly credible. Merck won that case, after losing weeks earlier in a case in Texas. Later, a federal lawsuit in Houston ended in a mistrial. Merck faces more than 9,000 lawsuits around the country.
"Clearly, Dr. Reicin is a star witness for Merck," said plaintiff attorney Andy Birchfield, who nonetheless said he is looking forward to raising the New England Journal's concerns in his retrial of the first federal Vioxx case, which begins Feb. 6 in New Orleans.
LOOKING FOR INCONSISTENCIES After the editorial appeared, plaintiff attorneys immediately began combing Reicin's testimony for discrepancies. Four weeks later, no blatant contradictions have emerged.
Texas attorney Mark Lanier, who won a multimillion-dollar verdict against Merck last summer in the first Vioxx trial, has backed away from comments that he planned to pass information along to law enforcement officials. In an e-mail last week, he said he is saving inconsistencies he has found for a Vioxx case he is trying in New Jersey at the end of February.
Chris Seeger, one of the plaintiff attorneys who lost the first Vioxx case in New Jersey last fall, has said he wanted to add the New England Journal revelations to his motion for a new trial.
Seeger had not done so as of Friday, but it is possible the information could be included in time for a hearing before Superior Court Judge Carol Higbee later this month. Seeger did not return calls seeking comment.
Merck, meanwhile, insists it is keeping Reicin in its lineup of witnesses. Company lawyers pored over her testimony in the three trials, and found nothing of concern, said Ted Mayer, an outside counsel for Merck.
"What she testified to was entirely truthful and straightforward," Mayer said.
GOOD WITH THE JURY It's not surprising Merck will continue to rely on Reicin, even if the risks have gotten higher. In court, she is imperturbable under questioning. During breaks in testimony in Atlantic City in October, she routinely turned to the jury and smiled -- at one point, mouthing the words "It's cold in here," according to Davis, who was attending the trial.
"She comes across to the jury as knowledgeable, authoritative and articulate," said Daniel Keller, a New York plaintiff attorney who sat in on her testimony in the first Vioxx trial in Texas last summer. "She did a pretty good job presenting alternate views of some of Merck's most damning documents."
The medical journal's editors claim the authors of a Vioxx study named Vigor, published in 2000, failed to mention three heart attacks among those given the painkiller and also deleted other relevant safety information. The heart attacks were significant, the editors say, because they occurred in patients at a low risk of cardiovascular problems.
The authors of the study have said the three heart attacks occurred after a firm cut-off point for data, and are preparing a formal response to the New England Journal.
Reicin, who declined to be interviewed while litigation continues, did offer a brief written statement on the controversy.
"Ensuring the integrity of scientific data is of utmost concern to me as a doctor and scientist, and I would never do anything to compromise that principle," she said. "I have been honest and consistent in my testimony regarding the availability of the Vigor data and its disclosure to the New England Journal of Medicine and the Food & Drug Administration."
Keller, a former defense lawyer for pharmaceutical companies who now represents Vioxx plaintiffs, said Reicin will have to spend part of her testimony defending herself, instead of Merck.
"Its pretty simple: it dilutes her testimony," he said. "She'll be prepared to deal with it, but the facts are the facts."
'INTENSE AND SERIOUS' Reicin, who took Vioxx herself before it was withdrawn, is married to a managing director of Morgan Stanley, and has three children ranging in age from 9 to 15. Her father helped run a unit of a family business, M. Putterman & Co., that makes gym floor covers, industrial containment systems and other products. In testimony in Atlantic City, Reicin said her parents stressed the importance of education, and giving back to society.
"I developed an interest in science, an aptitude for science, and so it was kind of natural to decide to pursue a career in medicine, where I could combine science with the ability to help people," she said during the Atlantic City trial in October.
Reicin graduated summa cum laude from Barnard and went on to Harvard Medical School. She did her residency at Columbia-Presbyterian Medical Center, and conducted research on the HIV virus at Columbia.
"AIDs was the epidemic of my generation," she said.
Her mentor at the university, Stephen Goff, called her a terrific researcher who did well at "very hard-core, basic science."
"She's incredibly intense," Goff said. "She's very serious about science."
Reicin moved to Merck because she believed she could have a greater impact on patients' lives.
Despite her responsibilities on litigation, Mayer said Reicin continues to work on clinical research. He declined to say what projects they are.
"That continues to be her primary role," she said.
posted by Chris Placitella at 6:21 AM
0 Comments:
Post a Comment
<< Home