Zyprexa and the Unanswered Question: Is it Safe?

Indianapolis, INIf the
Zyprexa web site is any indication, perhaps Eli Lilly has finally heard the message from consumers, lawmakers and the courts: downplaying serious risks and side effects is dishonest and reprehensible. The fact remains, however that for all the advantages Zyprexa carries for patients with symptoms of schizophrenia and bipolar disorder, a veritable parade of side effects offers little to assure even the most casual observer that Zyprexa is safe.

It depends on your definition of safe.

A quick check of the Zyprexa web site reveals that Eli Lilly appears to have made improvements on the disclosure front. Unlike the sites of other drug manufactures, many of which focus almost exclusively on business performance and product promotion and glossing over safety data, Eli Lilly presents a web presence for Zyprexa that is quite easy to navigate. Rather than having to hunt for data, Lilly links all necessary information right from the Zyprexa home page, allowing the consumer to access important information on side effects, a Q&A on Zyprexa, and other important data.

Of course, the first thing you see is the smiling and relieved countenance of a woman, presumably a representation of a patient for which Zyprexa has been approved and prescribed, together with a few lines of text trumpeting, however briefly, Zyprexa's virtues.

That's normal. Make sure what the consumer first sees, is a positive. Marketing 101.
But to Eli Lilly's credit, it doesn't overkill on the smiling faces and the cheerleading, and instead cuts to the chase with quick links to the data consumers want, and need to know.

However, it wasn't always this way with Eli Lilly, which has a checkered past not only through Zyprexa, but Evista and the infamous Prozac before that. Adverse incidents have been hushed and side effects downplayed, together with a pattern of off-label marketing that is definitely a no-no for pharmaceuticals. While doctors have the legal capacity and qualification to prescribe drugs off-label, drug manufacturers do not have the right to market, or promote those off-label uses that fall expressly within the jurisdiction of a practicing medical professional.

As well, it's hard to present a positive face to a drug that carries so many known adverse affects. And there is a litany of them—from increased blood sugar levels and risk for diabetes, to drowsiness, tremors, weight gain, seizures, low blood pressure, and the rare but potentially fatal Neuroleptic malignant syndrome (NMS).

Among others.

Yes, they're all on the web site. They're not hidden; you don't have to go on a treasure hunt looking for them. And Lilly appears to call a spade a spade, answering each question in the prescribed Q&A page in a seemingly forthright fashion.

Every question, except one...

In the 'Frequently Asked Questions' category, to the question 'is Zyprexa safe for me to use?' the answer amounts to a carefully worded dodge.

In answering the question, Lilly defers to the prescribing physician. Provided the patient has been prescribed Zyprexa by a qualified professional, "you can confidently take it, based on your doctor's sound medical judgment..."

So there's the rub. Is it safe? No one is prepared to say. It can be assumed that Zyprexa is helpful to those who suffer from bipolar disorder and schizophrenia. Mental illness is not easy to treat.

However, the balance between benefit and risk is hard to achieve. Which end of the scale outweighs the other depends on an individual's symptoms, risk tolerance, and the advice and recommendation of the patient's medical advisor.

Eli Lilly includes a portal on its Zyprexa web site for medical professionals, posting in-depth data that pulls no punches. Even so, there is still the temptation on the part of the manufacturer for a little spin, as it reminds doctors that schizophrenia patients and those suffering from bipolar disorder have a tough time of it—and it's important that the doctor not give up on them.

Of course, few if any would ever give up on a patient. Even if it means prescribing a drug that carries the potential for harm in so many different areas. One can imagine it takes the Wisdom of Solomon to know which way to go.

With 20 million people prescribed Zyprexa in 84 different countries, it's obvious which way the Wisdom of Solomon is going.

In the meantime the manufacture's legal team continues to languish in the courts, having so far settled with over 26,000 plaintiffs at a cost of over $1 billion--a drop in the bucket compared with the $30 billion Zyprexa has earned for the company since it first came on the market twelve years ago.

Which makes the following, literally, billion-dollar questions:

Does it help those for whom Zyprexa was approved, and prescribed?

Sure.

It it safe?

Don't go there...