The world's third largest drug manufacturer, Merck and Company pulled Vioxx from
the market September 30, 2004. The drug's withdrawal is possibly one of the largest
in history, and was not done without realization that serious problems exist
with the drug. Vioxx was approved in June 1999 as a new Non Steroidal Antiinflammatory
Agent (NSAID) which was effective in blocking the COX-II enzyme. This
enzyme plays a key role in inflammation and in pain, and Vioxx was used for it
anti-inflammatory, analgesic and anti-pyretic properties. The drug was available
as a 12.5, 25, and 50 mg tablet and as an oral suspension for the treatment
of pain from osteoarthritis, rheumatoid arthritis, dysmenorrhea and other conditions.
It was marketed as a safer NSAID than older less COX II specific inhibitor
medications such as Ibuprofen, Naproxen or Aspirin because it carried a lesser
risk profile for gastrointestinal bleeding.
Heavy Marketing Boosts Vioxx
Sales
Merck heavily promoted Vioxx to both physicians and potential consumers,
spending 160.8 million dollars for direct consumer marketing in 2000 alone.You
may be familiar with advertisements featuring Dorothy Hamill heavily endorsing
the product. Unsurprisingly, annual sales were breathtaking, with 91 million
prescriptions written for the drug in the United States alone and worldwide
sales last year totalling over 2.5 billion dollars.
Unfortunately, from
the beginning there were suggestions of significant risks associated with the
drug. "Red flags right from the beginning were ignored because of business issues,"
said Researcher Eric Topol of the Cleveland Clinic. Harvard University researcher
and physician Jerry Avorn feels " ... it's taken far too long for it to
be resolved. This information was out there waving in the breeze." Prior to its
approval, a study done at the University of Pennsylvania may have suggested that
Vioxx could increase the risk of heart attack. Subsequent studies also raised
the possibilty that patients taking Vioxx were at significantly higher risk
of suffering from heart attacks and other serious compications than were those
not taking Vioxx. On Sept. 17, 2001,an eight-page warning letter was sent by the
FDA to Merck Chief Executive Raymond Gilmartin. |
