A small, private drugmaker in Massachusetts wants to bring a controversial arthritis drug back on the market after it was recalled in 2004 for leading to roughly 60,000 deaths, according to STAT.
Merck's drug, Vioxx, was recalled because studies found it almost doubled patients' risk of heart attack and stroke. The studies led to a congressional investigation, allegations of lapses at the FDA and a $5 billion settlement from Merck.
Now, Tremeau Pharmaceuticals is developing a generic version of Vioxx as a treatment for severe joint pain in patients with hemophilia. The drugmaker has said it plans to begin a trial in 2020 and apply for FDA approval if the resulting data is positive.
Although Vioxx became known as a "symbol of pharmaceutical danger," some medical experts argue the drug should return to the market. Before Vioxx's recall, it was the drug of choice to treat hemophilic arthropathy, according to STAT. There still aren't many effective treatments for hemophilia today.
Ellis Neufeld, clinical director of hematology at Memphis, Tenn.-based St. Jude Children's Research Hospital, told STAT that the recall of Vioxx "robbed patients with hemophilia of an important treatment."
Some argue that because Vioxx's risks are now well-understood, physicians can ensure high-risk patients aren't prescribed the drug and closely monitor patients who take the drug.
However, because there are only about 20,000 people in the U.S. with hemophilia and many other drugmakers are in the process of developing new hemophilia drugs, the return of Vioxx is not guaranteed. Additionally, Tremeau has only raised $5.2 million of the $25 million it needs to start its trial and has not yet enrolled any patients, according to STAT.
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