After a rather scathing report in the New York Times, it looks like the pharmaceutical giant Eli Lilly is in hot water yet again.

Lilly’s own published data, which it told its sales representatives to play down in conversations with doctors, has shown that 30 percent of patients taking Zyprexa gain 22 pounds or more after a year on the drug, and some patients have reported gaining 100 pounds or more. But Lilly was concerned that Zyprexa’s sales would be hurt if the company was more forthright about the fact that the drug might cause unmanageable weight gain or diabetes, according to the documents, which cover the period 1995 to 2004.

The article suggests that Lilly spent the early years telling reps to downplay or not even mention the risks, but then ultimately had to face the side-effects head on:

By mid-2003, Lilly began to change its stance somewhat, publicly acknowledging that Zyprexa can cause severe obesity. Marketing documents make clear that by then Lilly believed it had no choice. On June 23, 2003, an internal committee reported that Zyprexa sales were “below plan� and that doctors were “switching/avoiding Zyprexa.�

Since then, Lilly has acknowledged Zyprexa’s effect on weight but has argued that it does not necessarily correlate to diabetes. But Zyprexa’s share of antipsychotic drug prescriptions is falling, and some psychiatrists say they no longer believe the information Lilly offers.

Bear with me (pun not intended) a minute but I feel I have to point out that Eli Lilly has historically been a big backer of the Bush family campaigns, and you may recall that they were found fiddling with Homeland Security for profit:

Everyone in D.C., it seems, is utterly baffled as to how an ugly little provision shielding pharmaceutical behemoth Eli Lilly from billions in lawsuits filed by the parents of autistic children made its way, in the 12th hour, into, of all things, the 475-page Homeland Security bill.

“It’s a mystery to us,” shrugged Eli Lilly spokesman Rob Smith.

It’s a mystery to us, too, echoed spokesmen for the White House, the Department of Health and Human Services, and physician-turned-senator-turned-drug-company-shill Bill Frist, who had originally penned the Lilly-friendly provision for a different bill.

[…]

But in a town where knowledge is power, and where there is no shortage of people willing to take credit for even the most minute accomplishment, there has been a sudden outbreak of people playing dumb. Official Washington is observing a code of omerta that makes the Sopranos look like the loose-lipped gals on “The View.” In other words: nobody’s seen nothin’.

Huffington has such a way with words, and those guys running today’s GOP sure hate being exposed to litigation by little people. Zyprexa litigation related to diabetes is not really new, but the firm’s reaction so far for this incident has been to issue a five-point statement on the PR Newswire. I found an interesting fourth point:

…leaked documents are a tiny fraction of the more than 11 million pages of documents provided by Lilly as part of the litigation process. They do not accurately portray Lilly’s conduct.

I suppose you could also say that tens or even hundreds of patients dying from side-effects do not accurately portray the conduct of all the other patients, but those lives are still important. While the leaked documents might not be representative of the whole, the point seems to back-fire when you think about what it implies.

I did notice, incidentally, that the Zyprexa safety information page lists diabetes as one of the side effects:

Serious side effects reported by patients treated with ZYPREXA include:

[…]

# High blood sugar or diabetes. Patients who already have diabetes should have their blood sugar checked regularly during treatment with ZYPREXA. Patients at risk for diabetes (for example, those who are overweight or have a family history of diabetes) who are starting treatment with ZYPREXA should undergo blood sugar testing on an empty stomach at the beginning of treatment and regularly during treatment. Any patient treated with ZYPREXA should be monitored for signs of high blood sugar, including being thirsty, going to the bathroom often, eating a lot, and feeling weak. Patients who develop signs of high blood sugar during treatment with ZYPREXA should undergo blood sugar testing on an empty stomach. In some cases, high blood sugar has gone away when ZYPREXA was stopped; however, some patients had to keep taking medicine for diabetes even though they stopped taking ZYPREXA

Is that a tiny fraction of the information? Does it accurately portray the side effects? See what I mean about point four in their statement?

Oh, and by the way, that statement from Lilly was posted by Forbes who also had this to say last year:

Eli Lilly Shares ‘Highly Attractive’ For Long Term

[…]

Credit Suisse First Boston maintained an “outperform” rating on Eli Lilly and said the drugmaker’s growth pipeline remains underappreciated by investors.

“Diabetes and cardiovascular projects are high potential late-stage pipeline opportunities for Lilly,” said CSFB.

Hey, I’m not making this stuff up. If Lilly’s “underappreciated…pipeline opportunity” is diabetes, then a story about their top-selling drug causing diabetes really does start to make things a bit dark and convoluted. Wonder what Huffington would say.

EDITED TO ADD (18 Dec 2006): A blog called Pure Pedantry offers a touch of medical student analysis:

“In summary, there is no scientific evidence establishing that Zyprexa causes diabetes,” the company said. (Emphasis mine.)

I have a one word response to that: horseshit.

[…]

Zyprexa causing weight gain and diabetes isn’t rare. It is a side effect so common for the drug that they make you memorize in medical school pharmacology courses. That is the definition of common as I understand it.

The author goes on to say that Lilly would have been far better off admitting the side-effects earlier because it would have avoided the controversy. Hindsight is 20-20, of course, so the tougher question is whether Lilly will make the same mistake again, or perhaps if they are making it right now with another drug.