It has been a decade since Merck’s “super-aspirin” Vioxx was withdrawn from the market after a study showed it doubled the risk of heart attacks and strokes. Heavily advertised by celebrity athletes like Dorothy Hamill and Bruce Jenner and used by approximately 20 million patients, estimates of the heart attacks caused by Vioxx range from 27,000 to up to 140,000. The Vioxx scandal made Merck the poster child for deceptive marketing because the cardiovascular risk data was deliberately withheld from the FDA, medical journals and the drug-taking public and their doctors according to news reports. In 2010, Merck compensated 20,591 heart attack and 12,447 stroke plaintiffs out of a $4.85 billion settlement fund.
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 animals 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.
Merck is not the only Big Pharma company asking “forgiveness rather than permission” when it gets caught playing fast and loose with the truth for a quick buck. In 2009, Pﬁzer, AstraZeneca and Eli Lilly went before the FDA to request permission to market the extreme behavioral drugs Geodon, Seroquel, and Zyprexa to children, though a Pfizer whistleblower said Geodon was already off-label marketed to children and Lilly had pleaded guilty to off-label promotion of Zyprexa to children, three months earlier. Like Merck, they were largely successful in getting approval for what they were doing anyway.
Almost all major drugs companies have agreed to huge settlements related to off-label marketing, hiding safety information and inducements and outright bribing of doctors. These settlements are widely seen to be merely written into Pharma’s costs of doing business and to have no deterrent effect. What would have an effect? Banning a drug company from the government programs which are its lifeline–Medicare, VA etc–and frog-marching CEOS off to jail. That might work. That has yet to happen.
Since 2006, public records show that Harrison has pursued justice for the Vioxx injuries he claims, serving as his own lawyer (pro se) and encountering huge setbacks. Sick and disabled, he endured two 30 hour bus rides to New Orleans, one each way, where the MDL was based, only to be told his bone injuries would not be included in the MDL because they were “other” than stroke and heart injuries. This meant no formal, pre-trial “discovery” would be conducted on Vioxx’s bone effects (compulsory disclosure of pertinent documents to an opposing party in a lawsuit), documents reveal, which was a win for Merck: Harrison’s personal case would not be represented in the MDL and new lawyers would not be inclined to pursue bone cases since they would have to conduct their own discovery which is expensive and time consuming.
Since approximately 20 million people took Vioxx and 2 percent of the population breaks bones or has orthopedic operations, says Harrison, 400,000 people could have been affected by the impaired bone healing, if one does simple math. Lacking documentation from discovery, interested lawyers, awareness and warnings on the Vioxx label (which only mildly warned about the risk of “wrist fracture”) many likely attributed non-healing bones to other causes.
A Second Day in Court
Multidistrict litigation serves to obtain the maximal justice for the most plaintiffs in the most efficient manner with big cases (like the BP oil spill). But it has its downsides say detractors including the tendency of nonlead lawyers to receive money for little work, take-it-or-leave-it terms in which plaintiffs have no recourse but to accept compensation that is offered them and neglect of outlier cases like Harrison’s.
But Harrison and Duggan are optimistic about their “day in court” and have come to refer to Merck as “the gang that couldn’t shoot straight” for the haphazard and sloppy way it has tried to deflect the bone charges.
As part of its summary judgment, Merck lawyers included testimony from orthopedic surgeon Nicholas Blavatsky, serving as an expert witness, who actually cited research authored by a convicted fraudulent researcher to prove Vioxx’s safety. Objection! Scott S. Reuben is known as the Bernie Madoff of medicine because his widely quoted and published research was often found to be completely fabricated–with no studies conducted and no trial subjects ever recruited. Once Professor of Anesthesiology and Pain Medicine at Tufts in Boston, he was marched off to prison as a convicted felon.
A “pain researcher for hire,” Reuben got around. In addition to finding “positive results” for Vioxx, he reporting positive results for Pfizer’s Bextra (withdrawn for Vioxx-like risks) Celebrex, Lyrica and the antidepressant Effexor XR. Several of his studies confirmed the value of Vioxx after spinal fusion surgery, the exact use of Vioxx Harrison claims disabled him. Reuben even wrote to the FDA urging less restrictions on the painkillers he studied, says the Wall Street Journal, citing his own data as proof of their safety and effectiveness. When Reuben’s fraud surfaced, his papers were retracted–but the retractions apparently escaped Merck’s expert witness.
Harrison is one of a handful of plaintiffs remaining in the Vioxx personal injury case and remains pro se. Since he was prescribed Vioxx for RA when it was not approved, it is a fraud case says Duggan and “it is hard for me to even imagine how Merck can claim its innocence to a crime that it has settled charges for, essentially pleading guilty.” Further, “The jury will see that statistically Dennis had a 97.2 chance of success after his spinal fusion and just 44 percent because he was on Vioxx, a drug that left virtually no possibility of bone-healing,” says Duggan.
In a rare instance of courts holding drug companies’ feet to the fire, the legal document suggesting Merck return to court rejected Merck’s claim that “there is no scientific evidence that Vioxx interferes with bone healing in humans.” The document even adds “there does not appear to be any significant justification for further burdening Mr. Harrison with the costs and frustrations of proceeding within this MDL.”