Don’t You Know That You’re Toxic?

Being Toxic’s been on my mind this week.  And no, not the pre-breakdown sparkle-Britney song that makes it way onto every “treadmill” playlist that I have (there, I admitted it) but the kind of toxic that sends stocks tail-spinning and media anchors hawking stories about deadly-drugs.

This week, a news report came out that two people had died of pancreatitis while taking the diabetes drug Byetta (sold by Eli Lilly and Amylin), and that there had been 36 reported cases of pancreatitis in patients taking Byetta.  The FDA said that they are going to require a new, stronger warning on the label.  On the surface, that doesn’t seem very good, does it?

I was curious about this, so I poked around for some information.  According to the Cleveland Clinic, the prevalence of acute pancreatitis in the US population is 17 in 100000.  Serious cases are 3.4 per 100000.  What’s the rate of Byetta patients? 5.1 per 100000 people.  I find it hard to believe that those numbers are meaningfully different.  Confound that data even more:  on one hand, pancreatitis is more common in diabetics (regardless of treatment) and but on the other, there is the possibility that the number of Byetta-related pancreatitis cases (mild ones) are under-reported.

So, where are you left as a consumer, citizen and potential patient?

Is Byetta causing pancreatitis in patients? – Probably not.

Could Byetta be trouble for people with a history of pancreatitis? – Maybe.

Will we know one way or another anytime soon?  Most assuredly not – toxicology is probably the most inexact science in the whole pharmaceutical business

Will the FDA and the companies involved be working overtime to cover themselves against any litigation and media onslaught? – You bet’cha.

I think I’m gonna go for a run.

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19 thoughts on “Don’t You Know That You’re Toxic?

  1. I totally agree. when I first read your post that there were 36 cases I thought that's it!!! Once again the media typhoon of ignorance makes itself known.

  2. My aunt sings the praises of Byetta because it is helping her lose weight. She says if she eats after taking it she gets sick or if she eats anything fried. I read they were considering using it for a weight lose drug. No thanks.

  3. …yeah… let's *NOT* compare the prevalence of this problem in this sub-group to the prevalence in the population of diabetics or the population overall. Gotta love the panic-stricken media! Such thorough and balanced reporting we get these days…
    …and uh, yeah, on that note, think I'll head out for some exercise too…

  4. sdede2— i think its dreadful that people will take numbers out of context, and that they will assume a causal relationship between drug and outcome. Let see, I took and advil and tripped on the stairs — advil impairs motor coordination!!

  5. Grandma-P — byetta has had really beneficial effects on weight. One of the things it does is delay the emptying of food from the stomach — which is really good from a controlling-glucose standpoint. It also has the effect of making people feel "overfull" and queasy — especially with fatty or fried foods.
    If I was diabetic, though, I'd take byetta.

  6. Carole — there's a real rush to judgement in society these days that is scary — and the need to BLAME somebody for everything. The darn thing is, what if the risk of developing pancreatitis ends up being 0.005% — an informed doctor-patient pair can make the call on whether to try it.

  7. Agree with your rush to judgment take and the causational relationship. I spend literally hours trying to explain this to the nurse managers where I work. Correlation does not prove Causation. It's mostly with patient lab values. They see a study that shows a Correlation between Albumin decreasing and Mortality. They think that means low Albumin CAUSES mortality. I have to laugh or I'd cry at the hours I've put in trying to explain that it's not so……sigh.

  8. people are always making correlations between things that probably don't really have much to do with each other. it's i have "toxic" in my head. thanks, steve. thanks.

  9. Zak — Lilly is large enough (and Byetta sales are small enough) that its stock only took a few percent hit. This is Amylin's bread-and-butter, and they're down > 20% since Friday. Ouch.
    Oh and the first lawsuit was filed today. 48 hours! Good turn around time.

  10. Oh gosh, I had no idea Pancreatitis was that uncommon. I guess I have no decent idea of how many people are actually on the planet. I've teated at least 6 cases of pancreatitis this month that I remember.

  11. I wonder at what point the pharm companies will just give up and quit offering any drugs to the public altogether for fear that lawsuits will put them out of business. One of these days, one will be big enough to accomplish that. And apparently there doesn't even have to be reason to believe that there is a relationship between the two.
    Despite the efforts to make drugs w/zero side effects that treat the problem but do nothing else, don't you kind of have to assume the risks involved with a drug when you make the decision to take it? No drug is 100% safe. That's why you get that big long disclaimer from the pharmacist. Grrr.

  12. Trust me, Mello — if I knew the drug discovery and development business was going to turn into *this* — I might have reconsidered my career choice. Of course, now I'm not good at anything else (other than blogging and making fun of people — neither of which I can get paid for…)
    And every drug from aspirin and tylenol to the latest new therapies ALL have a side-effect profile — doctor/patient education is key, but not enough folks seem to bother or think it applies to them

  13. Well, it's the typical American "I want everything handed to me with no risk/effort/consequence and if I don't get it I'll sue you" attitude.
    I think there are blogs out there that make fun of people where the writers get paid. You could be the next Perez Hilton!

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