Now, in an improbable chain of events, Merck is returning to court against its will to face charges that Vioxx also caused devastating non-healing of spine/bone after surgical procedures, a charge supported by scientific studies. The suit is brought by Dennis Harrison one of few plaintiffs remaining from the 70,000-case multidistrict litigation (MDL) that led to Merck's 2007 settlement. Unlike patients prescribed Vioxx for its FDA-approved uses of osteoarthritis, menstrual pain and acute pain, Harrison was prescribed Vioxx for the unapproved use of rheumatoid arthritis (RA). In 2011, Merck also settled charges that it "misbranded" Vioxx by promoting it for RA, illegal marketing that made RA the fifth most common reason for Vioxx use.
Because RA was an unapproved Vioxx use and Merck is not shielded by FDA approval, the suit claims outright fraud. "It is no different than if Merck sold the drug on a street corner," Jim Duggan who has been providing legal support to Harrison, told me in a phone interview. A summary judgment filed by Merck (a legal move that says the case is without merit and does not need to be tried) was denied in May and Merck must go to court in New York.
Harrison, 61, a former product planner and business strategist with ATT/Lucent Technologies, sustained permanent spinal damage from years of high doses of Vioxx, according to court filings, when his body failed to form bone after a 2001 spinal fusion operation. He spent months in a nursing home unable to walk, endured sepsis and other life-threatening conditions and is largely bed-ridden to this day. Nearly all of his doctors attended Merck-funded seminars to build confidence in Vioxx, claims Harrison, and were not told about its serious bone effects. "Merck knew and the doctors and public didn't," says Harrison.
There is no denying the scientific evidence of Vioxx's bone effects. Vioxx reduces pain by inhibiting COX-2, an enzyme responsible for inflammation and pain. The problem is, inflammation, notably the actions of prostaglandin, is also necessary for bone repair! Scientific journals, practicing surgeons and physicians have observed how the inhibition of COX 2 delays and impairs bone healing. Over-the-counter painkillers like Motrin and Aleve (called Nonsteroidal Anti-inflammatory Drugs or NSAIDs) also suppress COX-2 but most of their action is suppressing the body's COX-1 which is not involved in bone healing.
There is also no denying that Merck knew about the negative bone effects and hoped to avoid admitting them to the FDA, doctors and patients. As early as 1997, Merck memos reflect concern that blocking COX-2 may alter bone metabolism and in 1998, memos show that the FDA has similar concerns. (Handwritten notes between Merck scientists ask whether non-healing bone in animal studies has "implications" for people.) A year before Vioxx was withdrawn, Merck executives wrote to each other that they were not "interested in additional animal studies" and that they therefore needed to "provide the rationale for our lack of interest in the animal model." Merck, like all drug companies, conducts animal studies to "prove" a drug's safety yet dismisses the studies as not "applicable to humans" when safety questions surface. Hello?
After Merck received an FDA warning letter in 2001 for its illegal but successful marketing of Vioxx for the non-approved indication of rheumatoid arthritis, Merck sought to get Vioxx approved for RA. Who can say "after the fact"? It submitted a study that actually showed 40 percent of RA patients had impaired bone healing on Vioxx! Oops. Chastened by the FDA, Merck proceeded to resubmit a study, lowering the Vioxx dose from 50 milligrams to 12.5 which no longer revealed the bone effects, says Harrison's legal "team" which is just volunteers. The maneuver earned Merck RA approval for Vioxx--shortly before the drug was withdrawn from the market altogether. Meanwhile Merck continued to recommend 50 milligrams of Vioxx in users despite what it knew from the first study. Harrison himself was on 50 milligrams of Vioxx for years.