Vioxx was a very popular drug for a few years and then turned out to have some terrible side affects. The story is printed here as a caution about early adopting of the flatest new miracle drug. Or running of to a foreign country for surgery like the rush for balloon angioplasty for m.s. invented by Dr. Zamboni.
How did Vioxx debacle happen?
By Rita Rubin, USA TODAY
As drugmakers scramble to grab Vioxx's multi-billion-dollar share of the arthritis and pain-relief market, patients might find themselves wondering whether the competing medications are much safer.
The fact that no one can answer that question conclusively, and the fact that Vioxx remained on the market as long as it did, point to serious deficiencies in how the Food and Drug Administration regulates prescription drugs, critics say.
Merck yanked Vioxx on Sept. 30, 2004 because a new study had found a higher rate of heart attacks and strokes in patients taking the drug than in those on a placebo.
The move was a stunning denouement for a blockbuster drug that had been marketed in more than 80 countries with worldwide sales totaling $2.5 billion in 2003.
Vioxx, hawked by the likes of Olympic gold medalists Dorothy Hamill and Bruce Jenner, had been sold in the USA for more than five years.
But the new Vioxx study was not the first to raise concerns about heart attack and stroke risk.
"We have been concerned and aware of the potential for cardiovascular effects for the last few years," Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, said the day Merck announced the withdrawal.
"This is not a total surprise."
In fact, in April 2000 the FDA required Merck to add labeling information about a possible link to such problems.
Yet 2 million Americans were taking Vioxx when it was pulled.
Critics describe the rise and fall of Vioxx as a cautionary tale of masterful public relations, aggressive marketing and ineffective regulation.
"The FDA didn't do anything," says Eric Topol, chief of cardiovascular medicine at the Cleveland Clinic. "They were passive here."
Sen. Chuck Grassley, R-Iowa, says the FDA was worse than passive.
Investigators for the Senate Finance Committee, which Grassley chairs, met Thursday with FDA researcher David Graham, lead scientist on a study presented in August at a medical meeting in France.
.....................................
Vioxx timeline
May 1999: FDA approves Vioxx.
March 2000: Merck reveals that a new study found Vioxx patients had double the rate of serious cardiovascular problems than those on naproxen, an older nonsteroidal anti-inflammatory drug, or NSAID.
November 2000: The New
England Journal of Medicine publishes the study, called VIGOR.
February 2001: An advisory panel recommends the FDA require a label warning of the possible link to cardiovascular problems.
September 2001: The FDA warns Merck to stop misleading doctors about Vioxx's effect on the cardiovascular system.
April 2002: The FDA tells Merck to add information about cardiovascular risk to Vioxx's label.
Aug. 25, 2004: An FDA researcher presents results of a database analysis of 1.4 million patients; it concludes that Vioxx users are more likely to suffer a heart attack or sudden cardiac death than those taking Celebrex or an older NSAID.
Sept. 23, 2004: Merck says it learned this day that patients taking Vioxx in a study were twice as likely to suffer a heart attack or stroke as those on placebo.
Sept. 30, 2004: Merck withdraws Vioxx from the U.S. and the more than 80 other countries in which it was marketed.
...............................................................................................
The study, an analysis of a database of 1.4 million Kaiser Permanente members, found that those who took Vioxx were more likely to suffer a heart attack or sudden cardiac death than those who took Celebrex, Vioxx's main rival.
Based on their findings, Graham and his collaborators
linked Vioxx to more than 27,000 heart attacks or sudden cardiac deaths
nationwide from the time it came on the market in 1999 through 2003.
Graham told the finance committee investigators that the FDA was trying to block publication of his findings, Grassley said in a statement.
"Dr. Graham described an environment where he was 'ostracized,' 'subjected to veiled threats' and 'intimidation,' " Grassley said. Graham gave Grassley copies of e-mail that appear to support his claims that his superiors suggested watering down his conclusions.
"In light of Merck's withdrawal of Vioxx ... and other recent news stories examining FDA's review of the safety and efficacy of antidepressant drug use by children, I am concerned whether FDA has been sufficiently aggressive in monitoring drug safety," Davis wrote.
Topol, in a column posted last week on The New England Journal of Medicine's Web site, called for a congressional review of the Vioxx "catastrophe."
"The senior executives at Merck and the leadership at the FDA share responsibility for not having taken appropriate action and not recognizing that they are accountable for the public health."
Source:
USATODAY.com - How did Vioxx debacle happen?
http://www.usatoday.com/news/health/2004-10-12-vioxx-cover_x.htm
How did Vioxx debacle happen?
By Rita Rubin, USA TODAY
As drugmakers scramble to grab Vioxx's multi-billion-dollar share of the arthritis and pain-relief market, patients might find themselves wondering whether the competing medications are much safer.
The fact that no one can answer that question conclusively, and the fact that Vioxx remained on the market as long as it did, point to serious deficiencies in how the Food and Drug Administration regulates prescription drugs, critics say.
Merck yanked Vioxx on Sept. 30, 2004 because a new study had found a higher rate of heart attacks and strokes in patients taking the drug than in those on a placebo.
The move was a stunning denouement for a blockbuster drug that had been marketed in more than 80 countries with worldwide sales totaling $2.5 billion in 2003.
Vioxx, hawked by the likes of Olympic gold medalists Dorothy Hamill and Bruce Jenner, had been sold in the USA for more than five years.
But the new Vioxx study was not the first to raise concerns about heart attack and stroke risk.
"We have been concerned and aware of the potential for cardiovascular effects for the last few years," Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, said the day Merck announced the withdrawal.
"This is not a total surprise."
In fact, in April 2000 the FDA required Merck to add labeling information about a possible link to such problems.
Yet 2 million Americans were taking Vioxx when it was pulled.
Critics describe the rise and fall of Vioxx as a cautionary tale of masterful public relations, aggressive marketing and ineffective regulation.
"The FDA didn't do anything," says Eric Topol, chief of cardiovascular medicine at the Cleveland Clinic. "They were passive here."
Sen. Chuck Grassley, R-Iowa, says the FDA was worse than passive.
Investigators for the Senate Finance Committee, which Grassley chairs, met Thursday with FDA researcher David Graham, lead scientist on a study presented in August at a medical meeting in France.
.....................................
Vioxx timeline
May 1999: FDA approves Vioxx.
March 2000: Merck reveals that a new study found Vioxx patients had double the rate of serious cardiovascular problems than those on naproxen, an older nonsteroidal anti-inflammatory drug, or NSAID.
November 2000: The New
England Journal of Medicine publishes the study, called VIGOR.
February 2001: An advisory panel recommends the FDA require a label warning of the possible link to cardiovascular problems.
September 2001: The FDA warns Merck to stop misleading doctors about Vioxx's effect on the cardiovascular system.
April 2002: The FDA tells Merck to add information about cardiovascular risk to Vioxx's label.
Aug. 25, 2004: An FDA researcher presents results of a database analysis of 1.4 million patients; it concludes that Vioxx users are more likely to suffer a heart attack or sudden cardiac death than those taking Celebrex or an older NSAID.
Sept. 23, 2004: Merck says it learned this day that patients taking Vioxx in a study were twice as likely to suffer a heart attack or stroke as those on placebo.
Sept. 30, 2004: Merck withdraws Vioxx from the U.S. and the more than 80 other countries in which it was marketed.
...............................................................................................
The study, an analysis of a database of 1.4 million Kaiser Permanente members, found that those who took Vioxx were more likely to suffer a heart attack or sudden cardiac death than those who took Celebrex, Vioxx's main rival.
Based on their findings, Graham and his collaborators
linked Vioxx to more than 27,000 heart attacks or sudden cardiac deaths
nationwide from the time it came on the market in 1999 through 2003.
Graham told the finance committee investigators that the FDA was trying to block publication of his findings, Grassley said in a statement.
"Dr. Graham described an environment where he was 'ostracized,' 'subjected to veiled threats' and 'intimidation,' " Grassley said. Graham gave Grassley copies of e-mail that appear to support his claims that his superiors suggested watering down his conclusions.
"In light of Merck's withdrawal of Vioxx ... and other recent news stories examining FDA's review of the safety and efficacy of antidepressant drug use by children, I am concerned whether FDA has been sufficiently aggressive in monitoring drug safety," Davis wrote.
Topol, in a column posted last week on The New England Journal of Medicine's Web site, called for a congressional review of the Vioxx "catastrophe."
"The senior executives at Merck and the leadership at the FDA share responsibility for not having taken appropriate action and not recognizing that they are accountable for the public health."
Source:
USATODAY.com - How did Vioxx debacle happen?
http://www.usatoday.com/news/health/2004-10-12-vioxx-cover_x.htm
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