Saturday, July 31, 2010

Colchicine

Colchicine is an old drug. Extracted from meadow saffron, it was described in De Materia Medica by Pedanius Dioscorides, published in the year 1. I mean, 1 CE (or AD, depending on the nomenclature). I first learned of this drug in biology as it binds tubulin and serves as a classic test question on microtubules and other proteins. But from a medical standpoint, it's not a pleasant drug. Occasionally used for gout (and the very rare familial Mediterranean fever), it causes pretty severe diarrhea. The doses at which it's useful are pretty much the doses at which it's toxic; I once heard, almost jokingly, that you titrate the dose of the drug up until the patient complains about the diarrhea more than the gout (an unpleasant image I know, but what can I say - you're reading a medical blog).

In any case, the story of colchicine is quite interesting. It's been around for centuries and that's why it was dirt cheap at 9 cents a pill. We have known for decades that it is efficacious for treating flares of gout. Colchicine has been used for so long that it existed before the Food and Drug Administration was around. Recently though, the FDA determined that even medications that existed before the FDA should be FDA-approved. Thus, one company came up with a lucrative and ridiculous idea. They ran a clinical study to show something we already know - that colchicine is useful for gout - and then applied for exclusive marketing rights for their version of the drug (which is the same active ingredient as all the generic versions). The FDA decided to approve that company for the exclusive production of colchicine, and as a result, they immediately raised the cost from $0.09/pill by markup of 54 times to $4.85/pill. Furthermore, they sued to get the generics off the market, even though we've been using the generics for decades without problems. How absurd is that? The cost for state Medicaid programs is estimated to increase from $1 million to $50 million without any discernible increase in the quality of health care delivered. This is why our country is in trouble.

Image of colchicine biosynthesis is from Wikipedia, shown under Creative Commons Attribution Share-Alike License.

1 comment:

Eric said...

I'm glad to see you comment on this story, it truly is an incredible one that shows how little our healthcare system makes sense. Unfortunately I don't see it getting much better under PPACA.

I think the government should fund drug studies through grants just like other types of scientific research, and a condition of the grant should be that the drug belongs to the people who funded (the people of the United States)...skip this whole Brand/generic thing altogether. It seems like for biologic drugs, it'd be the only way to go over "biosimilars."