Merck exec denies pressuring doctor over Vioxx
A Merck executive denied today she tried to pressure one of the nation's top cardiologists into not publishing an article in a highly respected medical journal raising concerns that Vioxx could cause heart attacks and strokes.
Dr. Alise Reicin testified shortly before the defense rested that she was simply trying to give Dr. Eric Topol, chairman of the department of cardiovascular medicine at the Cleveland Clinic Foundation, Merck's position that the drug was safe when she visited him at his office.
That visit occurred four months before Topol and several associates published their August 2001 article in the Journal of the American Medical Association.
In it, Topol testified Saturday, the scientists said studies of Vioxx "raise a cautionary flag" about the risk of cardiovascular events in users.
Andy Birchfield, an attorney for a Florida woman suing Merck over the May 2001 death of her husband, confronted Reicin with not only the visit to Topol, but also with company e-mails showing she was part of a Merck team that sought to edit an early draft of his article.
Among those edits, shown to the jury on Saturday, were that Topol's conclusion should be "toned down"and that the article should be changed to reflect the "Merck perspective."
"Didn't you attempt dissuade him from publishing his article?" Birchfield asked tersely during the nation's first federal trial involving the drug.
"Absolutely not," snapped Reicin, vice president of clinical research at Merck. "It's not something I would do."
Also today, a local pathologist testified that a Florida man whose widow is suing the company died naturally of a common heart condition, countering earlier testimony that Vioxx caused his death.
With his testimony, attorneys for Merck rested their case.
Closing arguments are expected to begin Thursday.
Evelyn Irvin Plunkett contends Vioxx caused the blood clot that led to the May 2001 death of her husband, 53-year-old Richard "Dicky" Irvin, manager of a wholesale seafood shop in St. Augustine, Fla.
Plunkett also maintains Merck knew Vioxx could cause heart problems but sought to cover that up because the painkiller was a blockbuster drug that had roughly $2.5 billion in sales each year.
Much of the evidence in the nine-day trial has focused on a Merck study called VIGOR, which found in March 2000 that patients on Vioxx had five times as many heart attacks and strokes as those on an older painkiller, naproxen, sold under the brand name Aleve.
Merck officials said then and now that they believe the study showed naproxen prevents heart troubles, not that Vioxx causes them.
The first real signal of any link between adverse cardiac events and Vioxx didn't come until September 2004, three years after Irvin's death, when the company got early results of a study involving Vioxx in cancer patients, Merck officials have said.
That study, which prompted Merck to pull Vioxx from the market, found that patients who took the drug for 18 months or longer had twice the risk of heart attacks and strokes.
Also today, a local pathologist who reviewed Irvin's autopsy told the jury the blood clot that led to his death occurred naturally as the result of plaque buildup in his left artery.
Dr. Thomas Wheeler, interim chairman of Baylor College of Medicine, said that more than 300,000 people a year, many of them men in their 50s, die in the United States for the same reason Irvin did.
He said plaque in Irvin's artery likely had been building up over several years without any outward symptoms.
"In essence, Mr. Irvin was skating on thin ice," Wheeler said.
Using a microscope connected to a projector, Wheeler's highly technical testimony focused on what has become a key issue in the case — whether the cross sections of Irvin's artery show that the clot was caused by a plaque rupture.
If there was such a rupture in Irvin's artery, as Wheeler testified, the clot likely was not caused by Vioxx, Merck lawyers have said.
Last week, however, another pathologist testified for the plaintiff that he saw no sign of plaque rupture and concluded Vioxx caused the clot.
Dr. Alise Reicin testified shortly before the defense rested that she was simply trying to give Dr. Eric Topol, chairman of the department of cardiovascular medicine at the Cleveland Clinic Foundation, Merck's position that the drug was safe when she visited him at his office.
That visit occurred four months before Topol and several associates published their August 2001 article in the Journal of the American Medical Association.
In it, Topol testified Saturday, the scientists said studies of Vioxx "raise a cautionary flag" about the risk of cardiovascular events in users.
Andy Birchfield, an attorney for a Florida woman suing Merck over the May 2001 death of her husband, confronted Reicin with not only the visit to Topol, but also with company e-mails showing she was part of a Merck team that sought to edit an early draft of his article.
Among those edits, shown to the jury on Saturday, were that Topol's conclusion should be "toned down"and that the article should be changed to reflect the "Merck perspective."
"Didn't you attempt dissuade him from publishing his article?" Birchfield asked tersely during the nation's first federal trial involving the drug.
"Absolutely not," snapped Reicin, vice president of clinical research at Merck. "It's not something I would do."
Also today, a local pathologist testified that a Florida man whose widow is suing the company died naturally of a common heart condition, countering earlier testimony that Vioxx caused his death.
With his testimony, attorneys for Merck rested their case.
Closing arguments are expected to begin Thursday.
Evelyn Irvin Plunkett contends Vioxx caused the blood clot that led to the May 2001 death of her husband, 53-year-old Richard "Dicky" Irvin, manager of a wholesale seafood shop in St. Augustine, Fla.
Plunkett also maintains Merck knew Vioxx could cause heart problems but sought to cover that up because the painkiller was a blockbuster drug that had roughly $2.5 billion in sales each year.
Much of the evidence in the nine-day trial has focused on a Merck study called VIGOR, which found in March 2000 that patients on Vioxx had five times as many heart attacks and strokes as those on an older painkiller, naproxen, sold under the brand name Aleve.
Merck officials said then and now that they believe the study showed naproxen prevents heart troubles, not that Vioxx causes them.
The first real signal of any link between adverse cardiac events and Vioxx didn't come until September 2004, three years after Irvin's death, when the company got early results of a study involving Vioxx in cancer patients, Merck officials have said.
That study, which prompted Merck to pull Vioxx from the market, found that patients who took the drug for 18 months or longer had twice the risk of heart attacks and strokes.
Also today, a local pathologist who reviewed Irvin's autopsy told the jury the blood clot that led to his death occurred naturally as the result of plaque buildup in his left artery.
Dr. Thomas Wheeler, interim chairman of Baylor College of Medicine, said that more than 300,000 people a year, many of them men in their 50s, die in the United States for the same reason Irvin did.
He said plaque in Irvin's artery likely had been building up over several years without any outward symptoms.
"In essence, Mr. Irvin was skating on thin ice," Wheeler said.
Using a microscope connected to a projector, Wheeler's highly technical testimony focused on what has become a key issue in the case — whether the cross sections of Irvin's artery show that the clot was caused by a plaque rupture.
If there was such a rupture in Irvin's artery, as Wheeler testified, the clot likely was not caused by Vioxx, Merck lawyers have said.
Last week, however, another pathologist testified for the plaintiff that he saw no sign of plaque rupture and concluded Vioxx caused the clot.
posted by Chris Placitella at 6:03 AM
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