FRIDAY, Nov. 9 (HealthDay News) -- With Friday's announcement of almost $5 billion to be paid out to those people claiming they were hurt by the now-withdrawn painkiller Vioxx, the drug's maker, Merck & Co., may have hoped to end the glare of publicity on these types of drugs.
But, according to experts, the move has merely swung the focus back on the medications once again.
Cox-2 inhibitor drugs such as Vioxx, Bextra and Celebrex were initially hailed as a means of treating pain without causing gastrointestinal problems like bleeding, as can happen with related analgesics known as nonsteroidal anti-inflammatory drugs (NSAIDs).
NSAIDs include cox-2 inhibitors and common over-the-counter drugs, such as ibuprofen (Advil, Motrin), naproxen (Aleve), and aspirin.
However, cox-2-mediated stomach protection came at a price. In September 2004, Vioxx was pulled from the market after studies linked its long-term use to increased risk for heart attacks. In April 2005, Bextra was pulled because of similar fears, as well as evidence of increased risks for a rare but potentially fatal skin reaction. Celebrex remains the only cox-2 inhibitor sold in the United States, and its label carries a black-box warning detailing potential heart risks.
Dr. Eric J. Topol, director of the Scripps Translational Science Institute in La Jolla, Calif., and Scripps' chief academic officer, was one of the experts who first exposed the problems with Vioxx. He said he doesn't have a problem with cox-2 inhibitors, but he does take issue with Merck's response to emerging data about heart risks.
Topol claims Merck hid evidence about the risk for heart attack associated with Vioxx. "This whole field wouldn't be in the state it's in had it not been for the problems that occurred early on with Vioxx," he said. "They wouldn't have had to make a settlement if they hadn't concealed things."
In December 2005, the editors of the New England Journal of Medicine accused researchers and Merck of withholding key heart risk data that showed up in one of the first large trials of Vioxx; the findings from that trial were published in the journal. Specifically, the editors charged that the study published in November 2000 was submitted to the journal after information about three heart attacks among Vioxx trial participants was deleted by Merck, which funded the study.
In a statement quoted by the Associated Press, Merck said the additional heart attacks "did not materially change any of the conclusions of the article." Merck also said the additional heart attack data was not included in the study, because the heart attacks were reported after Merck's cut-off date for including study data.
Cox-2 inhibitors do work to ease pain, Topol said. "They work at least as well as NSAIDs and, in some patients, better," he said. "Unfortunately, this whole class of drugs has been hit by an outlier."
With the FDA slapping a strong "black box" warning on Celebrex's label, Topol believes the public and doctors are now well-informed about that drug, so they can make appropriate decisions about which patients should or should not receive the medicine.
"Celebrex is safe for most patients, so is Vioxx," Topol asserted. Celebrex, at higher doses, can increase the risk for blood clots, "but the risk never appeared to be as at the same level as Vioxx," he said.