VIOXX: A Pharmaceutical Giant And A Painkiller
With Problems
In May 1999, U.S. drugs giant Merck & Co. introduced a blockbuster new
drug: Vioxx. Merck touted Vioxx as a safer way to reduce acute pain
and pain from osteoarthritis, rheumatoid arthritis and menstruation.
Sales of Vioxx exploded, accounting for more than $2.5 billion in
sales for Merck.
But less than a year later, a study found
that people who take Vioxx have five times the risk of heart attack
than those who take other painkillers. Subsequent studies discovered
that Vioxx could double or triple the chance of a heart attack,
stroke, blood clots and cardiovascular injuries. In addition, the Wall
Street Journal revealed in a Nov. 1, 2004 article that as early as
February, 1997, internal Merck emails reflected evidence that patients
taking Vioxx developed more blood clots and that this could "kill the
drug."
The FDA was so concerned about problems
associated with Vioxx that it instigated its own study, which found
that Vioxx might have caused 27,785 heart attacks or deaths. Since
April 2002, the FDA has required that Vioxx's label warn consumers
about potential cardiovascular risk.
Yet despite all of this, Merck continued
to sell the drug in 80 different countries. It wasn't until Sept. 30,
2004, when Merck's own three-year study found that long-term use of
Vioxx could double the risk of heart attack, that the drug company
withdrew Vioxx from the market. Vioxx is now the subject of a number
of lawsuits.
February 1997: Internal Merck & Co.
email warns that a proposed trial known as VIGOR may show Vioxx
patients having more blood clots than those taking another medication,
and could "kill the drug," according to a Nov. 1, 2004 Wall Street
Journal article.
May 1999: The FDA approves Merck's
Vioxx drug for arthritis, acute pain and menstrual pain.
March 2000: Merck's VIGOR trial
shows that patients taking Vioxx have five times the risk of heart
attacks as those taking the naproxen Aleve. Merck publicly attributes
the results to naproxen's proven heart-healthy qualities rather than
to flaws in Vioxx, but the Journal reports that Merck's research chief
says in an internal email that Vioxx's cardiovascular problems are
"clearly there" and appear to be "mechanism based."
August 2001: A Cleveland Clinic
study of 8,000 people finds that those taking Vioxx have twice as much
risk of a heart attack as those taking other non-inflammatory drugs.
September 2001: The FDA sends Merck
a warning letter, accusing it of misleading the public about Vioxx's
cardiovascular safety.
April 2002: The FDA approves a
label change for Vioxx, showing data about potential cardiovascular
risk.
August 2004: An FDA study finds
that patients taking Vioxx have 1.5 to 3.7 times the risk of heart
attacks compared to those taking Celebrex. In November, the FDA
reports that the same study discovered that Vioxx could have caused
27,785 heart attacks or deaths since it was approved.
September 2004:
After receiving the results of an in-house study reporting that heart
attack risk is doubled in patients who take Vioxx for more than 18
months, Merck announces a worldwide withdrawal of Vioxx.
