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In the year 1999 of May Vioxx was created and released to the public approved by the

FDA. Vioxx is a nonsteroidal anti-inflammatory drug that targets COX-2 (NSAID). Vioxx is a
prescription medication use to treat arthritis, acute pain in adults, and painful menstrual cycles.
Monsanto produced Vioxx, which Merck co-marketed. It quickly rose to prominence as one of
the most effective treatments for the painful and bothersome symptoms of various types of
arthritis. It was widely prescribed, used by millions of people worldwide, and brought Merck
billions of dollars in profits.
Rofecoxib is used to treat osteoarthritis, rheumatoid arthritis, acute pain in adults,
primary dysmenorrhea, and acute migraine attacks with or without auras. This compound is
classified as a stilbene. These are organic compounds that contain a moiety of 1,2-
diphenylethylene. Rofecoxib has a half-life of 17 hours and a mean oral bioavailability of 93% at
therapeutically recommended doses of 125, 25, and 50 mg. Rofecoxib targets proteins such as
elastin and prostaglandin G/H synthase 2. Rofecoxib is known to be metabolized by Cytochrome
P450 1A2, Cytochrome P450 3A4, Cytochrome P450 2C9, Cytochrome P450 2C8, and
Prostaglandin G/H synthase 1. The side effects of Vioxx includes respiratory infections,
headache, dizziness, diarrhea, nausea, vomiting and upset stomach, heartburn, stomach pain,
swelling of the legs and/or feet.
Merck's manipulation of the science surrounding Vioxx included ghostwriting of
scientific articles. According to internal documents, a Merck employee was initially listed as the
lead author of the first draft in 16 of 20 papers reporting on Vioxx clinical trials; on the published
versions, an outside academic was listed as the primary author. Merck officials listed the lead
author only as "External author?" in one draft of a Vioxx research study that did not yet have a
prominent outside name attached. "A Merck scientist was also discovered to have removed
evidence of three heart attacks among patients in a dataset from the results presented.
Tragically, Merck's data manipulation and the FDA's subsequent approval of Vioxx in
1999 resulted in thousands of unnecessary premature deaths and 100,000 heart attacks. Dr. David
Graham, Associate Director for Science and Medicine in the FDA's Office of Drug Safety,
testified before the Senate Finance Committee in 2004 that the FDA's failure to recall Vioxx
earlier had resulted in up to 55,000 premature deaths from heart attacks and strokes, comparing it
to allowing "two to four jumbo jetliners" to crash every week for five years. Patients who have
taken Vioxx continue to experience complications even years after discontinuing use.
Merck & Co. announced a voluntary worldwide withdrawal of Rofecoxib (Vioxx) on
September 30, 2004, following a study that found patients taking the drug long-term face twice
the risk of a heart attack compared to patients receiving placebo.

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