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.

I almost forgot to post my reaction to the “Bicycle Helmets Put You at Risk” article from last weekend:

For years, cyclists who ride on city streets have cherished an unusual superstition: if they wear a helmet, they are more likely to get hit by a car. “I belong to an e-mail list for cyclists, and they complain about this all the time,� says Ian Walker, a psychologist at the University of Bath who rides his bike to work every day. But could this actually be true?

Walker decided to find out — putting his own neck on the line. He rigged his bicycle with an ultrasonic sensor that could detect how close each car was that passed him. Then he hit the roads, alternately riding with a helmet and without for two months, until he had been passed by 2,500 cars. Examining the data, he found that when he wore his helmet, motorists passed by 8.5 centimeters (3.35 inches) closer than when his head was bare. He had increased his risk of an accident by donning safety gear.

Several issues jumped right out at me:

1. Risk is related to the countermeasure to vulnerabilites and assets, not just threats (e.g. likelihood of being hit by a car). Your head is, in fact, more protected from a proper helmet than without. Having survived many crashes myself, I can attest to this fact personally. So whether or not the likelihood of an incident decreases, your brain is far more likely to survive an actual incident in a helmet.
2. “Risk of an accident” is misleading. What percentage of all bicycle accidents are related to being hit by a car? I found some really old data that suggests only 17.5% of all bicycle accidents involve an automobile. Of course it depends, right? If you ride desolate dirt mountain trails, would you remove your helmet to reduce the chance of being hit by an automobile? So the study should clearly exclude the 80% or whatever number of bicyclists are not at risk from autos, even if a threat reduction were possible.
3. If the theory is that “helmets change the behavior of drivers”, then why should the answer be to remove helmets (significantly increasing risk related to vulnerability — see #1) instead of mandating helmets for everyone and reducing the chance of special treatment from drivers? If everybody wears them, then after a settling period helmets could not be accused of changing behavior.
4. Did the study control for other factors like time of day and road, type of clothing and bike, and/or gestures from the bicyclist to the motorist? The study could just as well prove that wearing hot pink socks or a “one less car” jersey makes drivers more likely to side-swipe you than putting on protective gear.

I know I’ve completely destroyed (foam cracked all the way through or seriously dented) at least two, maybe three, bicycle helmets but I have yet to make contact with a car. Perhaps that colors my perspective. Anyway, might be worth a read to see if/how the more complete risk picture is addressed.

I just ran into the findings recently reported in a LiveScience article:

…a new study finds teens spend more time weighing risk than adults and in fact often overestimate the odds of a bad outcome. But the desire for acceptance among peers wins out in the decision-making process of a young mind.

Cornell University researcher Valerie Reyna and Frank Farley of Temple University conducted a review of scientific studies on the topics.

Compared to adults, teens take about 170 milliseconds more weighing the pros and cons of engaging in high-risk behavior, the researchers conclude. Adults scarcely think about risk, perhaps because they think they recognize risk intuitively. Teens, on the other hand, take time to mull the risk vs. benefit equation.

My guess is that the difference is relative to experience. I suspect that if you measure the risk aptitude of someone who has been through a number of experiences directly related to that risk, then you will find they spend less time thinking about it than someone new and more “open” to persuasion. I see that as different from “scarcely thinking about risk”, but rather becoming a proficient (perhaps even intuitive) thinker. In other words, when comparing white-belts to black-belts in martial arts, does it help us to say white-belts think more and black-belts less? Are white-belts more susceptible to “pressure”, particularly in groups, about how to react to risks? Of course, but can someone find an inverse law that says how susceptible we are to influence relative to wisdom or some other form of experience? Maybe that’s the conclusion of the actual study. Hard to tell from the article alone.