Saturday, April 15, 2006

Bausch & Lomb...

... has a pretty poor reputation right now. From what I had read in the press before yesterday, it seemed a virtual certainty that Renu had been linked with a fungal eye infection. According to this article the link is based on "reports" of 109 cases of Fusarium keratitis. The FDA has interviewed 30 of those patients, "However, of the 28 who wore soft contact lens, 26 reported using Bausch & Lomb’s ReNu brand contact lens solution or a generic type of solution also made by the Rochester, N.Y., company." I didn't spend a huge amount of time searching, but I couldn't really find a more detailed explanation than that. If someone has one, I'd be interested in reading it.

But about these reports, did they also report wearing a red shirt any time in the last 6 months? This is a very weak link. I'm not saying that we should ignore it, or even that Bausch & Lomb should have acted differently. However, there's not really much evidence of any link yet, so there's no reason to panic. I watched a girl in my class terrify herself into near hysteria because her eye started to itch, and she's "been using that brand in the news."

I have a buddy that works QA at B&L, so when I saw him last night I asked him about the whole affair. Apparently, he's been working very hard recently as the FDA has been investigating the QA process for the last 3 or 4 weeks. They're down to asking what kind of glue was used to put the box together. That doesn't sound to me like they've been able to find anything of any substance to link Renu to these fungal cases.

There is a valid reason to watch the story and to discontinue use of the product. B&L has acted very responsibly so far. But it is far from a certainty that B&L has anything to do with the problem. It's not even very probable at this point. From everything I know on the subject now, I doubt that B&L will be found to be actual source of the problem. Still, it's possible, and I'll be watching to find out if I'm right.

1 comment:

Anonymous said...

Here's the MMWR report on the matter. The clustering of cases of this rare infection is highly unusual--this is a disease that normally shows up in men with a history of eye trauma who live in tropical or sub-tropical areas. Now all of a sudden you get three cases in three months at the same New Jersey practice? More information is needed, clearly, but B&L did the right thing by pulling Renu. Perhaps the solution itself was not contaminated, but perhaps the no-rub method does not adequately cleanse a lens of Fusarium? I'll be watching the outcome with interest as well.