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Comment by mrbrowning | Hacker News Reader

I used to work in a pharmacological research lab, and while I'm frequently discomfited by the misalignment between commercial incentives and social good in the pharmacology industry, this statement isn't quite fair:

> Everyone has heard of "mission creep." In the pharmaceutical world, approval creep means getting the FDA to approve a drug for one thing and pushing a lot of other drug approvals through on the coattails of the first one.

This is more accurately referred to as "drug repurposing," and it's hardly the unalloyed evil that it's characterized as here. It's true that drug companies love to repurpose existing FDA-approved drugs, both because it saves them money and because it typically permits them to patent the compound again in a new context, but there are nonetheless real benefits to the public at large when a drug whose side effects are comparatively well-characterized over the long term is put into service to treat a different malady.

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The real problem isn't drug repurposing, but off-label promotion. If you want to take a drug through FDA approval for another set of indications, that's fine and dandy. What isn't cool is actively promoting the use of a drug without market approval - having reps drop subtle hints, funding third-party publication, paying doctors to speak at conferences about their off-label prescribing and so on.

Eli Lilly, Pfizer and AstraZeneca have collectively paid out more than $2.5bn in settlements over the off-label promotion of atypical antipsychotics. The drugs that they unlawfully promoted are now being used widely for the treatment of a variety of conditions for which there is little evidence of efficacy. Lilly were marketing Zyprexa for the treatment of dementia, in spite of having extensive unpublished research showing that it was ineffective.

Atypical antipsychotics are being used by far too many psychiatrists as a catch-all where other lines of treatment have failed - OCD, autism, PTSD, ADHD, anorexia, substance abuse, you name it. In most cases the evidence of efficacy is slim-to-none. That's not medicine, it's quackery. Frankly, I'd be happier if they were prescribing placebo; Nobody has ever died from the side effects of sugar pills.

But turning an off-label use into an on-label one to promote it has its own nasty consequences, even if the drug is proven to work for the new indication (or whatever).

Consider Lucentis vs Avastin. Ophthalmologists were using Avastin off-label for wet AMD. Genentech was making a huge multifaceted effort to discourage off-label use because they had sunk a bunch of effort/$ into the order-of-magnitude-more-expensive Lucentis for not much of an improvement. Similar situation and different ending with Lumigan (glaucoma/ocular hypertension eyedrops) vs Latisse (eyelash enhancer), where Latisse's patent (afaik) was thrown out because Allergan was trying to patent a known major side effect of Lumigan.

I'm not a fan of misleading promotions of off-label uses either, but I wish there was a middle ground still banning that that didn't also involve more patents and protection.

To take the atypical anti-psychotics as an example, it turns out they or at least some of them are good mood stabilizers, i.e. can be used to treat bipolar disorder (manic depression). And while they have their fair share of nasty side effects, there pretty much aren't any nasty side effect free mood stabilizers....

I was prescribed an atypical antipsychotic* originally for bipolar disorder in my late teens. At the time, it was an absolute lifesaver. I had almost completely lost my ability to function, and the treatment brought me back to an operating state sufficient to complete high school without completely sinking my GPA.

I had to stop using it because of unacceptable side effects (rapid weight gain and sexual dysfunction), and it took me a long time to find something else that worked as well. The medication that ended up working for me was originally developed as an anticonvulsant. My symptoms lessened over time in adulthood, but if I hadn't had the course correction provided by repurposed 'Big Pharma' medications I would be living a much harder life.

*: I'm not naming medications because I don't want to promote them. What worked for me isn't necessarily what will work for anyone else.

Back when my doctor and I didn't know if I had true bipolar disorder vs. what seems to be "depression of a bipolar nature" (with my never going manic unless I'm taking a drug that triggers it), I was prescribed the atypical antipsychotic Zyprexa at full dosage, initially by my previous doctor, and also found its infamous side effects to be unacceptable. Tried another with that previous doctor and got orthostatic hypotension, then with this doctor tried an anticonvulsant, which I had to stop because of bad skin side effects (still have little bright red flecks on my skin here and there). At that point, especially with the very slow ramp up of the anticonvulsant (meaning for a long while I didn't have a therapeutic dose), we crossed our fingers and stopped trying mood stabilizers, which lead to the change in diagnosis. (Elsewhere in this topic I mention how I later started taking a low dose of another antipsychotic to deal with anxiety in general, with very useful side effects for insomnia and allergies.)

I did name one drug name because if any other atypical anti-psychotic will do the trick it should perhaps be tried, Zyprexa is pretty infamous for weight gain among other things.

Sure, nobody denies that's a good thing. Viagra is a famous example of this.

But the article is clearly talking about its abuse.

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