FDA Regulation "Hurts" - Worse than Depression

It was supposed to replace Prozac profits when the patent expired in 2001 and cash in on the national love affair with antidepressants.

But Eli Lilly & Co.'s Cymbalta (duloxetine) seemed cursed from the start.

The first antidepressant to be introduced since FDA investigations into suicide/antidepressant links, Cymbalta itself was marred with suicides before it was approved.

Five occurred during Cymbalta clinical trials including previously healthy volunteer Traci Johnson who hung herself in Lilly's Indiana University Medical School lab in 2004.

"Their posturing was offensive," said the Rev. Joel Barnaby, spokesman for Traci Johnson's family upon hearing Lilly would not delay the drug's planned introduction. "They were saying that this little death certainly should not defame our study or, God forbid, make us miss a deadline for FDA approval."

Nor was Traci, "in a depressed state of mind or had a spirit wounded so much that she gave up on life," Mr. Barnaby said.

Despite $208 million in sales in its first eight months of marketing thanks to auto suggestive "Depression Hurts" television ads and do- you-have-this-disease? symptom checklists on its web site, Cymbalta's bad buzz didn't go away.

A year after Cymbalta hit drug store shelves it was indicted for causing more than twice the rate of suicide attempts in women prescribed the drug for stress urinary incontinence--a use not approved in the US--according to the FDA.

Last May, the FDA ordered Lilly to add a black box to Cymbalta warning about suicides and antidepressants in young adults.

And in October Lilly was told to "immediately cease" its Cymbalta campaign for diabetic nerve pain--an approve use--which promises "significantly less pain interference with overall functioning." In a letter, the FDA says the claim "has not been demonstrated by substantial evidence or ... clinical experience" nor do the Cymbalta marketing pieces give precautions about liver toxicity or reveal risks for patients with certain conditions.

(Lilly spokesman Charlie McAtee said Lilly will take action once it has "more clarity" on FDA objections. Which part of "immediately cease" does he not understand?)

Even Lilly's own reps are trashing the drug on the pharma chat room cafepharma.com.

"My territory includes a high percent of blue collar beer guzzlers that drive home from work with a six pack on their lap," wrote one anonymous poster. "The Docs around here won't touch Cymbalta."

"This product should have never been approved by the FDA. The benefits do not outweigh the risks," wrote another. "That is why there are very few insurance companies that will cover this product. This is the dirtiest product in the anti-depressant class."

"Cymbalta will be pulled from the market within the next 2 years due to its major liver damage," predicted another poster.

Things wouldn't be so bad for Lilly if its number one drug-- Zyprexa (olanzapine) --wasn't also in trouble.

In the last year, doctors learned that side effects of the atypical antipsychotic, taken by 20 million people since 1996, "include diabetes, stroke and death," according to the New York Times.

Lilly's own published data shows morbid patient weight gain--30 percent of patients taking Zyprexa gained 22 pounds or more, 16 percent, 66 pounds or more and some gained over 100 pounds--and blood sugar levels that keep increasing with use says the Times-- information it hid from doctors and regulators.

("Olanzapine-associated weight gain and possible hyperglycemia is a major threat to the long-term success of this critically important molecule," wrote Lilly Chief Medical Officer Dr. Alan Breier in an 1999 email to employees; "Unless we come clean on this, it could get much more serious than we might anticipate," concurred a group of diabetes doctors Lilly hired to assess the drug's safety in 2000.)

Worse, Lilly was caught playing off label roulette with Zyprexa; marketing it for any condition that would stick to the wall instead of the schizophrenia and bipolar disorder for which it was approved.

Its Viva Zyprexa campaign marketed unabashedly to older patients with symptoms of dementia--though the drug increases the risk of death in older patients with dementia-related psychosis according to its own label-- earning Lilly 49,000 new prescriptions valued at $300 a month after only three months.

(The elderly people might have had undiagnosed schizophrenia offered Lilly's vice president for corporate affairs, Anne Nobles, as a weak excuse.)

The campaign then evolved to Zyprexa Limitless and began targeting the set of all people diagnosed as depressed who don't know they are really bipolar yet.

At a 2001 sales meeting, Michael Brandick, Zyprexa brand manager, called the new prescriptions, "a pretty sweet incentive," for sales representatives and olanzapine, "the molecule that keeps on giving."

Lilly is now paying for its over the top marketing having spent $2 billion since 2004 to settle lawsuits from 28,500 people who blamed diabetes or heart problems on the drug with 1,200 more lawsuits to be resolved.

No wonder Lilly "voluntarily" strengthened Zyprexa's warning label in October with tougher language about weight gain and elevated blood sugar after "reviewing more data from internal tests and major outside studies."

Of course creating diabetes with one pill and treating it with another may look like self dealing. But Lilly is also interested in other diseases. Like fibromyalgia which afflicts so many US women and no doubt hurts too.

Martha Rosenberg is staff cartoonist for the Evanston Roundtable.

© Scoop Media