The star of the hearing was FDA whistleblower, Dr David Graham, who told the panel that his superiors at the FDA tried to suppress the results of a recent study that determined that Vioxx at low doses was associated with a 50% increase in the risk; and doses of greater than 25 mg a day showed a 370% increase in the risk of heart attacks.
In reviewing the documents on the Vioxx-related studies, a strange coincidence appeared. As it turns out, the report for the above study, authored by Dr Graham, has the exact same date, September 30, 2004, that Merck supposedly "voluntarily" took Vioxx off the market and it says it was sent to Paul Seligman, MD, then acting director of the FDA's Office of Drug Safety.
"Disturbingly," Dr Graham wrote in the report, "while evidence of increased cardiovascular risk with rofecoxib continued to accrue following VIGOR in 2000, the only study to examine the gastrointestinal benefits of rofecoxib compared to celecoxib found that the risk of hospitalization for gastrointestinal bleeding was significantly increased in patients treated with rofecoxib."
"Additionally," he continued, "this reviewer was unable to identify articles demonstrating a substantial benefit with the high-dose strength of rofecoxib that would counter-balance the level of cardiovascular risk shown in VIGOR or any subsequent observational study, including this one," he wrote.
Dr Graham's report and testimony at the hearing led many doctors and scientists, at home and abroad, to conclude that the FDA was in large part responsible for the deaths of tens of thousands of Americans, because it allowed Vioxx to remain on the market for years while Merck made billions of dollars off the sale of the drug.
Critics liken the rise and fall of Vioxx to a masterful public relations coup of aggressive marketing and ineffective regulation. In the months following the hearing, Merck and the FDA, came under attack from experts all over the world. Two months after Vioxx was pulled off the market, Dr Richard Horton, editor in chief of the British medical journal Lancet, wrote: "With Vioxx, Merck and the F.D.A. acted out of ruthless, short-sighted, and irresponsible self-interest."
Other experts demanded an explanation. A team of scientists from the University of Berne, Switzerland, expressed distain in the December 2004 Lancet saying: "Our findings indicate that Vioxx should have been withdrawn several years earlier."
"The reasons why manufacturer and drug licensing authorities did not continuously monitor and summarize the accumulating evidence need to be clarified," they said.
In the weeks following the hearing, Dr Graham was interviewed on a series of TV news programs and was also featured in articles in USA Today, Newsweek, the Wall Street Journal, and the Washington Post, leaving a trail of ammunition for attorneys to use in court as far as Dr Graham's opinions.
However, federal judge Eldon Fallon dealt Merck a major blow in April 2006, when he ordered Dr Graham to testify in a deposition for the Vioxx multidistrict litigation proceedings in response to subpoena issued by attorneys for the plaintiffs.
In addition to Dr Graham, the equally forthright expert witness, Dr Gurkirpal Singh, MD, Adjunct Clinical Professor of Medicine at Stanford University School of Medicine also testified at the November 18, 2004, hearing through a video conference due to health problems.
Dr Singh is a rheumatologist by training with research expertise in drug safety and epidemiology. For the hearing, Dr Singh was asked to review internal company documents and emails between Merck scientists and executives that had been subpoenaed by Congress.
Dr Singh began his testimony by pointing out that as far back as 1996, Merck was already considering the possibility that a clinical trial of Vioxx versus a non-selective NSAID, would find that patients treated with Vioxx would have an increased risk of cardiovascular complications.
"We now know that by November of 1996," Dr Singh told the panel, "Merck scientists were seriously discussing a potential risk of Vioxx - association with heart attacks."
At that time, he said, it was not known that Vioxx could cause heart attacks, but the discussion focused on the issue that by inhibiting platelets, other painkillers may protect against heart attacks. Vioxx has no effect on platelets, and thus may seem to increase the risk of heart attacks in studies comparing it to other painkillers, he said.
"This was a serious concern because the entire reason for the development of Vioxx was safety," he explained. "If the improved stomach safety of the drug was negated by a risk of heart attacks," Dr Singh said, "patients may not be willing to make this trade-off."
In reviewing the documents on the Vioxx-related studies, a strange coincidence appeared. As it turns out, the report for the above study, authored by Dr Graham, has the exact same date, September 30, 2004, that Merck supposedly "voluntarily" took Vioxx off the market and it says it was sent to Paul Seligman, MD, then acting director of the FDA's Office of Drug Safety.
"Disturbingly," Dr Graham wrote in the report, "while evidence of increased cardiovascular risk with rofecoxib continued to accrue following VIGOR in 2000, the only study to examine the gastrointestinal benefits of rofecoxib compared to celecoxib found that the risk of hospitalization for gastrointestinal bleeding was significantly increased in patients treated with rofecoxib."
"Additionally," he continued, "this reviewer was unable to identify articles demonstrating a substantial benefit with the high-dose strength of rofecoxib that would counter-balance the level of cardiovascular risk shown in VIGOR or any subsequent observational study, including this one," he wrote.
Critics liken the rise and fall of Vioxx to a masterful public relations coup of aggressive marketing and ineffective regulation. In the months following the hearing, Merck and the FDA, came under attack from experts all over the world. Two months after Vioxx was pulled off the market, Dr Richard Horton, editor in chief of the British medical journal Lancet, wrote: "With Vioxx, Merck and the F.D.A. acted out of ruthless, short-sighted, and irresponsible self-interest."
Other experts demanded an explanation. A team of scientists from the University of Berne, Switzerland, expressed distain in the December 2004 Lancet saying: "Our findings indicate that Vioxx should have been withdrawn several years earlier."
"The reasons why manufacturer and drug licensing authorities did not continuously monitor and summarize the accumulating evidence need to be clarified," they said.
In the weeks following the hearing, Dr Graham was interviewed on a series of TV news programs and was also featured in articles in USA Today, Newsweek, the Wall Street Journal, and the Washington Post, leaving a trail of ammunition for attorneys to use in court as far as Dr Graham's opinions.
However, federal judge Eldon Fallon dealt Merck a major blow in April 2006, when he ordered Dr Graham to testify in a deposition for the Vioxx multidistrict litigation proceedings in response to subpoena issued by attorneys for the plaintiffs.
In addition to Dr Graham, the equally forthright expert witness, Dr Gurkirpal Singh, MD, Adjunct Clinical Professor of Medicine at Stanford University School of Medicine also testified at the November 18, 2004, hearing through a video conference due to health problems.
Dr Singh is a rheumatologist by training with research expertise in drug safety and epidemiology. For the hearing, Dr Singh was asked to review internal company documents and emails between Merck scientists and executives that had been subpoenaed by Congress.
Dr Singh began his testimony by pointing out that as far back as 1996, Merck was already considering the possibility that a clinical trial of Vioxx versus a non-selective NSAID, would find that patients treated with Vioxx would have an increased risk of cardiovascular complications.
"We now know that by November of 1996," Dr Singh told the panel, "Merck scientists were seriously discussing a potential risk of Vioxx - association with heart attacks."
At that time, he said, it was not known that Vioxx could cause heart attacks, but the discussion focused on the issue that by inhibiting platelets, other painkillers may protect against heart attacks. Vioxx has no effect on platelets, and thus may seem to increase the risk of heart attacks in studies comparing it to other painkillers, he said.
"This was a serious concern because the entire reason for the development of Vioxx was safety," he explained. "If the improved stomach safety of the drug was negated by a risk of heart attacks," Dr Singh said, "patients may not be willing to make this trade-off."
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