BOSTON-NEW YORK, – The increased heart risk from Merck & Co.’s withdrawn arthritis drug Vioxx appears to begin earlier and last longer than previously believed, according to experts who reviewed new data presented to U.S. health regulators by the drug maker.
Health experts were also concerned by data that showed patients appeared to be at increased risk of suffering a stroke even a year after they have stopped taking Vioxx. The new data showed seven Vioxx users had strokes and two had mini-strokes in a year-long follow-up period after they had stopped taking the drug compared with no strokes in the placebo group.
“These data raise some very important questions because for a while we assumed Vioxx caused temporary problems, and here it is more than that. It could be causing permanent damage,” Dr. Curt Furberg, a member of the FDA Drug Safety and Risk Management Advisory Committee, said in an interview after reviewing the data.
Merck pulled Vioxx from the market in September 2004 after a study showed it doubled the risk of heart attacks and strokes in patients who took it for more than 18 months.
But new data from a one-year follow-up review of patients in the study that led to the withdrawal and presented to the U.S. Food and Drug Administration last week suggests to some health experts that the dangers are not limited to long-term users as Merck has contended.
“For patients the implications are that you can be injured by the drug from the moment you start taking it, and the risk persists,” Furberg, a professor at Wake Forest University School of Medicine, said.
Merck denied the risk began earlier than 18 months. It said that 26 patients on Vioxx who suffered a cardiovascular event in the first 18 months differed only slightly from the 21 patients who suffered heart attack or stroke in the placebo group. The gap widened significantly after 18 months, the company said.
The new data also showed that 28 patients had a heart attack or stroke in the year after discontinuing therapy compared to 16 who took a placebo. That difference was not deemed statistically significant, but cardiologists and other health experts believe the actual numbers tell the story and find the trend to be disturbing.
David Graham, the FDA whistle-blower who warned about Vioxx’s heart risks, said Merck’s analysis tries to hide behind statistics and the study’s small size.
“Their argument is based on a false and misleading interpretation of their own study results,” said Graham, a scientist still with the FDA.
Merck spokesman Michael Heinley said the company “has not misrepresented the data in any way.”
Merck is facing more than 11,500 lawsuits from people who claim to have been harmed by Vioxx.
David Moskowitz, an analyst at Friedman, Billings, Ramsey, said that while the data may not be statistically significant, juries may find it to be numerically significant.
“My personal feeling is that juries understand that and it’s damaging. I think juries are pretty easily convinced that Vioxx is dangerous at almost any time interval,” he said.
Attorneys believe they will now be able to make a stronger case for clients who took the drug for less than 18 months.
“They have done masterful job of spinning that 18 months as the magical date for having any effect,” said Jere Beasley, whose Birmingham, Alabama, law firm has filed about 400 Vioxx product liability lawsuits and is reviewing more than 7,000 more potential cases.
“It’s like a house of cards. One thing falls and the next thing falls and pretty soon they’re in deep trouble,” he added.
Chicago attorney Kenneth Moll, who is involved in 950 Vioxx product liability cases, believes the new data could help push Merck into settlement talks, and that any settlement will now have to include short-term Vioxx users.
“Every little study like this helps,” he said. “It’s significant if Merck is looking at a global settlement because they can’t exclude under 18 months users.”
Merck has insisted it will fight each Vioxx lawsuit case by case and was not considering settlement.