Earlier this month the manufacturer of Zyprexa agreed with a recommendation by the U.S. Food and Drug Administration (FDA) to strengthen the label warnings on its product to include a reference to side effects including weight gain and high cholesterol, among other issues.
For the first time, Lilly is required to admit on its product labelling that Zyprexa carries a greater risk for increased levels of blood sugar than some other competing atypical antipsychotics. This can lead to the onset of diabetes, and there have been 23 deaths amongst users of Zyprexa - known generically as olanzapine - arising from complications from diabetes.
The risk factors and side effects associated with Zyprexa have long been known - as far back as a dozen years, when a large clinical trial undertaken by the manufacturer revealed that Zyprexa carried issues concerning weight gain, elevated blood sugar levels and other metabolic factors. Even so, Zyprexa was approved as a safe product for the treatment and control of schizophrenia and bipolar disorders, a year later.Concern has been building about the product ever since, even though it has grown to become a huge generator of revenue for Eli Lilly, and its most robust performer.
And now, Eli Lilly wants an even bigger slice of the pie, by lobbying for approval of Zyprexa for use among adolescents.
This, in spite of clinical trials which determine that weight gain and other metabolic problems can be more severe in teens, than those encountered by adults.
The weight gain alone is a huge issue. Once claiming that weight gain would plateau after only a few months after starting treatment on Zyprexa, Eli Lilly was forced to admit (and include on its labelling) that weight gain could continue unabated for as long as two years after the onset of Zyprexa therapy, with one-in-six gaining, on average, 33 pounds over the course of two years.
The thought of such weight gain - only worse - in an adolescent already dealing with the often-complicated issues of growing up, suggests a well-worn path to the therapy couch. With America's youth, and indeed the entire American population already patently obese, the introduction of Zyprexa to the adolescent market would only serve to exacerbate the problem.
There is no word concerning the FDA's position on Zyprexa use in adolescents.
The new breed of antipsychotic drugs, of which Zyprexa is one, continues to be the fastest-growing class of drugs in the industry. Overall sales for the sector are projected to be $13 billion dollars this year.
It's a staggering figure. Little wonder, then, that Eli Lilly and other competitors in the class are attempting to line up new markets in an effort to push that figure even higher.
For its part the FDA has never indicated any position as to whether or not Zyprexa is likely to cause diabetes in greater or lesser proportion than other competing drugs - although the American Diabetes Association is on record as saying in 2004 that Zyprexa was more likely to cause diabetes than other commonly-prescribed antipsychotic medicines.
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In 2003, the FDA required that all makers of atypical antisychotics include warnings for hyperglycaemia.
Still, one wonders as to the timing of this latest label change, given the many years that concern has existed for Zyprexa. Last December, the New York Times published internal documents from Eli Lilly, indicating that the company knew of risk factors as far back as the late 1990s, but played down those risks.
There's nothing like public scrutiny to force change. And given the fact the company is seeking FDA approval of Zyprexa for use with adolescents, a little well-placed contrition on Eli Lilly's part may have been in order.