If you haven’t been hiding under a rock in the past few years, you’ve probably heard about Zyprexa (olanzapine). It’s an atypical antipsychotic psychiatric medication used first to treat schizophrenia, then extended to include the treatment of different types of bipolar disorder. There’s nothing extraordinary about the drug, other than it’s a fairly typical example of this new class of medications that was supposed to have fewer — and less serious — side effects.
Time, of course, tells a different story, as it so often does with these kinds of medications. Research that was at first promising and sold the U.S. Food and Drug Administration on the drug’s approval doesn’t study a drug’s real-world use. The fact is, virtually nobody is prescribed any psychiatric medication for as little as 6 to 8 weeks (the typical time of 90%+ of FDA drug approval studies). This means that while drugs can gain approval with little display of side effects initially, researchers simply don’t spend much time looking at the side effects longer-term. At least not early on.
Later, as the drug “catches on” with docs, more studies are typically done, and some may even span into additional months of treatment. But since the FDA hasn’t required such studies in the past (companies are now required to do a little more followup early on), companies were content with letting the short-term data speak for itself. Meanwhile, people start taking the drug and staying on it not just for 6 to 8 weeks, but for 6 to 8 months (and then for 2 to 4 years, especially for serious, chronic conditions like schizophrenia and bipolar disorder).
And that’s when you start seeing the real side effects of a medication.
In this case, Zyprexa’s side effects (some of which were actually noted in the original clinical FDA studies) included weight gain and higher risk of diabetes. Properly managed, such side effects might be okay for some people. But early on, the drug company who made Zyprexa — Eli Lilly — downplayed the significance of these side effects and their association with Zyprexa.
They also marketed the drug for uses and populations that the company never sought formal approval for — a big no-no in the U.S.
Ultimately, the chickens came home to roost in the form of dozens of lawsuits filed against the company by U.S. states. They settled many of the lawsuits for $1.42 billion (yes, that’s with a “B”), but may be on the hook for another $4 billion in settlements related to the drug in years to come.
One of the people who “broke” the scandal over Zyprexa and what the company knew and when it knew it was Philip Dawdy over at Furious Seasons. He brings us his take on this Rolling Stone account of the Zyprexa story. Philip was interviewed extensively for the article, but never quoted or referred to, which is just unconscionable given his was the first site to make the leaked Zyprexa documents widely and easily available to the public. He also has provided an enormous amount of analysis into those documents, and has stuck with the story for years now.
We continue to acknowledge and applaud Philip’s work over at Furious Seasons, which provides a valuable public service. And while we don’t always agree with everything he writes, we feel his contributions remain worthy of your notice.
Grohol, J. (2009). Zyprexa Redux. Psych Central. Retrieved on October 9, 2015, from http://psychcentral.com/blog/archives/2009/02/12/zyprexa-redux/