New Pain Uses For Cymbalta and Lyrica Are Vioxx All Over Again

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New Pain Uses For Cymbalta and Lyrica Are Vioxx All Over Again

By Martha Rosenberg 06/11/2010 19:58:00

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

every day minor pain like menstrual cramps.

Merck sold Vioxx as safer and more effective than simpler aspirin

and other over-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 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 killed herself on during trials

on the Lilly campus in 2004 -- soon after FDA

investigations into suicide/antidepressant links.

had no depression history said Rev. Barnaby, a

spokesman for the 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.

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 , who has called it the Swiss Army knife of

Lilly drugs. Last year it made a cool $3.1 billion.

Already approved for depression, anxiety, fibromyalgia and

diabetic nerve pain, the new osteoarthritis and chronic lower back

pain indications should double Lilly's take. Maybe Dorothy Hamill

is available.