Flashback: Zyprexa 2008, WSJ Alaska Settlement Article

By 
• AVERY JOHNSON

Eli Lilly & Co. struck a $15 million settlement with the State of Alaska that closes the book on a potentially costly trial over the antipsychotic medicine Zyprexa.

Zyprexa, which notched $4.8 billion in sales last year, is approved by the Food & Drug Administration to treat schizophrenia and bipolar disorder. Thousands of product-liability suits have been filed against Lilly, alleging the company didn't adequately disclose information about Zyprexa's links to weight gain and diabetes. Other suits claim Lilly pushed the drug for unapproved purposes, causing state Medicaid programs and third-party payers to bear unwarranted costs.

Lilly already has reached a $1.2 billion settlement with 31,000 plaintiffs. It still faces nine cases filed by other state attorneys general, 1,600 by individual plaintiffs, and others by shareholders and third-party payers such as insurers.

In addition, Lilly is in talks with the U.S. attorney for the eastern district of Pennsylvania to resolve a probe into the Indianapolis drug maker's marketing practices.

The central issue in Alaska's suit, which sought $5,000 for each of the roughly 200,000 Zyprexa prescriptions written for state residents, was whether Alaska's consumers were deceived because Lilly failed to adequately warn about a link to diabetes.

Before Tuesday night's settlement ended the three-week trial, closing arguments had been set to begin as early as Friday.

Lilly didn't admit any wrongdoing and said it settled to avoid having the trial drag on. "This represented, from the company's perspective, a very good way to resolve this matter and get back to business," said Nina Gussack of Pepper Hamilton LLP, a law firm representing Lilly.

Alaska Assistant Attorney General Ed Sniffen said the state took the deal because damages would be difficult to prove and the certainty that Lilly would appeal an unfavorable verdict made a final outcome uncertain. He said $200 million would have been the "best-case scenario," but added that, "at the end of the day, our original estimates kept getting refined, and as the trial went on it became clear that we could take some money now or risk more later."

Anchorage Superior Court Judge Mark Rindner bolstered the state's position last week when he said the FDA has proven incapable of policing drug regulation, according to an Associated Press report.

But both Lilly and the state also were anticipating a U.S. Supreme Court ruling this fall on whether FDA approval pre-empts state claims regarding drug defects. A decision in favor of pre-emption could have made moot any judgment in Alaska's favor.

While the $15 million is a fraction of the penalties the state sought, it is a substantial sum relative to Alaska's population of 670,000. The attorneys general for other states that have sued -- as well as those for the roughly 30 states with Zyprexa probes under way -- could use their larger populations to multiply any claims based on the Alaska settlement, says Edward Sherman, a specialist in complex litigation at Tulane University Law School in New Orleans.

A clause built into Tuesday's deal requires the company to pay Alaska more per capita if any other state gets a better deal.

Ms. Gussack said Lilly would consider each claim separately and that $15 million wouldn't be a benchmark. She said "the reason the number is so small is because Lilly's defense was so good," not because Alaska's population is small.

Connecticut Attorney General Richard Blumenthal, who filed suit against Lilly March 11, said he was "highly encouraged" by the Alaska settlement.

Write to Avery Johnson at avery.johnson@WSJ.com

A Bitter Pill to Swallow:Zyprexa: (Un)Informed Consent

Stay Puft, indeed. Thanks, Zyprexa.

I’ve written before about my growing frustration at my failure to lose weight in the many months after being hospitalized and treated for my anxiety, depression, OCD, and most of all, chronic insomnia, with a “drug cocktail” containing  the atypical anti-psychotic Olanzapine (Zyprexa).  

By the time I finally weened myself off of Zyprexa (more than a year ago), I'd socked on 80 pounds of ugly Syndrome-X type fat, and have stubbornly maintained this ponderous girth – the heaviest weight I’ve been.

I’ve been heavy and slim before through various phases of my life, but now that my weight homeostasis has been reset at an alarming, elephantine level -- I can’t lose much -- and have been unable to keep even any modest temporary weight losses off.

My guess is it has to do with a change in body chemistry/function due to the drug -- perhaps due to insulin resistance or other unidentified hormone-like dysregulation.

I originally balked at taking this atypical antipsychotic for an “off-label” use – due mainly to fear over the horrible movement disorder tarditive dyskensia. 

In order to allay my fears, and convince me to take my medicine, the nurses provided "informed consent" printouts (required by law) for each psych med I was prescribed.

I saved my original “informed consent” printout from the CareNotes System from Texas Health Resources (dated 11-28-10) and pulled it out of files the other day.

On the second page of all the dire warnings for:

Olanzipine (by mouth).

Treats psychotic mental disorders, such as schizophrenia or bipolar disorder (manic-depressive illness)

We find:

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

Allergic reaction; Itching or hives, swelling in your hands,, swelling or tingling in your mouth or throat, chest tightness, trouble breathing.

Blurred or other changes in vision.

Change in how much or how often you urinate.

Fast or uneven heartbeat.

Fever, sweating, confusion, or muscle stiffness

Increased restlessness or excessive movements.

Jerky muscle movement you cannot control (often in your face, tongue, or jaw).

Lightheadedness or fainting.

Numbness or weakness in your arm or leg, or on one side of your body.

Severe sleepiness, slurred speech, or trouble with breathing.

Shakiness, problems with balance or walking.

Swelling in your hands, ankles or feet.

Swollen breasts, or liquid discharge from your nipples (men or women).

Trouble swallowing.

Then:

If you notice these less serious side effects, talk with your doctor:

Back pain.

Constipation, upset stomach.

Dry mouth, increased thirst, or watering of the mouth.

Increased appetite.

Missed menstral period.

Redness or swelling in your eye.

Sleepiness or unusal drowsiness.

Stuffy or runny nose.

Trouble with sleeping.

Weakness.

…And finally, at the very, very bottom of all these warnings, only then do we find my bete noire:

Weight gain.

As I now know from OCD-powered research on various internet and magazine exposes, serious big-time weight gain is a very common problem with Zyprexa, and this side-effect was suppressed by its Big Pharma manufacturer, Eli Lilly.

The side effects of long-term use are reportedly so significant that class-action lawsuits against the manufacturer of the medication are ongoing. Problems associated with use of this drug include development of blood sugar disorders, movement disorder and weight gain. For those that suffer the slings and arrows of our fat-prejudiced society every day (even leaving aside the serious health problems of diabetes) it’s in no way a “less serious side effect.”

 The bottom-of the list “weight gain” side effect warning could be more accurately relabeled “May lead to near-permanent, impossible to shed insulin-resistant weight gain.”

 See my other blog posts about Zyprexa for more on all that.  

With the well-known food labeling, the ingredients are listed in descending order by weight. I would/should think that “informed consent” forms would/should similarly list adverse drug side effects in descending order from most common to least common. Are they? Clearly, no. Using such a common-sense standard, “weight gain” would land at the top of any list, not the bottom.

And statistically -- is the weight gain really “near-permanent weight gain?” In my case, the weight did not budge after I stopped the medication. I’d politic for some serious, public studies done on this alarming reality.

Anecdotally, many of the bipolar folks I’ve met in my group therapy sessions have ballooned up due to their meds, and many have had to resort to bariatric surgery to shed the weight. I’d hate to see it come to that for us uninformed “off-label” atypical antipsychotic users.

So much for the “informed consent.” Thank you, too g*d- d#mned much, Eli Lilly. Perhaps the time to contact a lawyer and join in on the class-action lawsuits is here.

In any case, other “off-label” patients need to be forewarned.

Jonah Lehrer's Imagine: The Pulled Book

I continue to enjoy reading the now-tragically ironic Imagine: How Creativity Works by Jonah Lehrer. I guess he just created his quotes! I'm about halfway through it. I found this rather harsh passage on Wikipedia,

"A review of Imagine: How Creativity Works in The Washington Post said, 'Lehrer practices what he preaches, showing an appetite for learning, a determined effort to cross fields and disciplines, and a delight in exploring new possibilities.'

By contrast, The New Republic, called the book 'inaccurate,' 'simplistic,' and 'glib,' and concluded, 'Like Malcolm Gladwell and David Brooks, Lehrer writes self-help for people who would be embarrassed to be seen reading it.'

The New York Times published two reviews of Imagine. The first called Lehrer 'adept' at 'teasing out the social and economic implications of scientific theories while commuting easily among the realms of science, business and art. He deconstructs the creative process behind a Bob Dylan song with the same verve he brings to the story of how Procter & Gamble created the Swiffer, its New Age mop.'

But the second, in The New York Times Book Review, criticized Imagine for its 'many elementary errors' and 'formulaic' approach, as well as for 'Lehrer's failure to grasp some fundamental principles of scientific thinking.'

Before it was pulled from the shelves by the publisher, Houghton Mifflin Harcourt, Imagine was on the Los Angeles Times' hardcover nonfiction bestseller list for many weeks.^"

So, what's so embarrasing about reading self-help books, anyway? Personally, I rather enjoy some of them. I enjoyed reading Galdwell and Brooks' book as well. I personally think Jonah Lehrer should write another book, about this fall from grace and what he's learned from it!