Vioxx All Over Again?
The withdrawal of Merck’s "super aspirin," the COX-2 specific inhibitor Vioxx from the market may be as distant as the 2004 Bush-Kerry presidential election in the public’s memory.
But it’s not distant for Whitehouse Station, NJ-based Merck.
This week the drug giant’s profits plummeted 90 percent from dedicating $950 million to resolve a government criminal investigation into Vioxx research and marketing, says the Philadelphia Inquirer.
Merck, accused by the New England Journal of Medicine of concealing "critical data on an array of adverse cardiovascular events" caused by Vioxx, already paid $4.85 billion in 2007 to settle thousands of Vioxx product-liability lawsuits.
Nor is it over for the 27,785 patients who suffered heart attacks and sudden cardiac deaths according to the Wall Street Journal.
Merck used Olympic gold medalist ice skater Dorothy Hamill to sell Vioxx — I skate "five days a week for up to three hours," despite osteoarthritis she says in one ad — and pushed it for everyday minor pain like menstrual cramps.
Merck sold Vioxx as safer and more effective than simpler aspirin and other over-the-counter pain relievers (and some suspect was behind warnings about the safety of Advil and Aleve, publicized soon after Vioxx hit the hot seat.)
Not that Merck was the only company selling COX-2specific inhibitors.
Pfizer withdrew Bextra, a similar drug, in 2005 and last year agreed to pay $2.3 billion for fraudulent marketing of Bextra, Lyrica and two other drugs which was the largest criminal fine ever imposed in the US. Patients taking Bextra after heart surgery were 2.19 times more likely to suffer a stroke or heart attack said American Heart Association information.
Only five years earlier, Pfizer, a repeat offender, agreed to pay $430 million for abuses pertaining to seizure drug Neurontin and seven years before that, agreed to pay $49 million to settle charges it defrauded Medicaid by overcharging for cholesterol drug Lipitor.
Pfizer still manufacturers the COX-2 specific inhibitor Celebrex though it is also linked to life-threatening side effects included the case of Timothy Moorley, an outspoken patient in a class action suit against Pfizer in Canada, which is receiving wide publicity.
Though Vioxx and Bextra are gone and Celebrex is under a darkening cloud, the practice of prescribing unsafe drugs for simple pain that can just as easily be treated with older and over-the-counter drugs is alive and well.
FDA linked Lyrica and other seizure drugs to suicide in 2008 and mandated warnings, but Lyrica is widely prescribed off label in civilian and military contexts for pain and migraine — no doubt from the marketing abuses Pfizer acknowledges in last year’s settlement.
When Lyrica was first faced with a black box suicide warning, Pfizer sent FDA a 92-page appeal calling suicide statistics "an exaggeration of risk" that could "overwarn" patients and prescribers and make them "underestimate the risks of declining treatment." Especially revenue risks.
Lyrica, so similar to the deadly drug Neurontin it is called Son of Neurontin, is linked to memory loss, mental confusion, extreme weight gain, hair loss, impaired driving, disorientation, twitching and at least two deaths on the drug rating site askapatient.
Another dangerous drug now pushed for simple pain is Lilly’s Cymbalta.
Many remember Cymbalta as the drug 19-year-old healthy clinical volunteer Traci Johnson killed herself on during trials on the Lilly campus in 2004 — soon after FDA investigations into suicide/antidepressant links.
Johnson had no depression history said Rev. Joel Barnaby, a spokesman for the Johnson family, who called Lilly’s decision to proceed with Cymbalta’s launch as scheduled "offensive" posturing. Five others suicides occurred during Cymbalta clinical trials, said the FDA and twice the rate of suicide attempts were seen in women prescribed the drug for stress urinary incontinence — also patients with no depression to blame.
Others remember Cymbalta as the drug Carol Anne Gotbaum, daughter-in-law of New York City Public Advocate Betsy Gotbaum, was taking during her macabre death in police custody at the Phoenix’s Sky Harbor airport in 2007. There are 63 published news reports linking Cymbalta to depression, suicide and violence including the suicide of Ohio 15-year-old Megan Ficker three weeks ago.
This week, FDA approved Cymbalta for chronic musculoskeletal pain, "including discomfort from osteoarthritis and chronic lower back pain."
Cymbalta is the nation’s fourth-most-advertised prescription drug and Lilly’s second-best-selling product according to Indianapolis Star’s John Russell, who has called it the Swiss Army knife of Lilly drugs. Last year it made a cool $3.1 billion.
Approved for depression, anxiety, fibromyalgia and diabetic nerve pain, the new osteoarthritis and chronic lower back pain indications should double Lilly’s take. Already the front page of WebMD, the pharma mouthpiece web site whose original partner was Lilly, sports three Cymbalta ads — one for depression and two for pain. Maybe Dorothy Hamill is available.
MARTHA ROSENBERG can be reached at: firstname.lastname@example.org