'It should be noted that these data come from voluntary reports submitted to the FDA which have been estimated to represent approximately 10% of the actual occurrences.'

The headline up top is from yesterday's "Death by Botox" post.

It got me thinking about how to extrapolate from reported events to total occurrences.

This has always been a vexing problem to me ever since, back when I was younger, I mentioned in passing to a friend that I'd just seen an ant racing across my kitchen counter.

He responded, "There's never one ant."

That's the best I've ever heard this kind of thing expressed, and I've said it to myself many times in many places, among them the OR, where just one PVC (premature ventricular contraction) rarely occurs.

Rather, you see one on the EKG monitor screen and then when you keep looking, you see more.

Anyway.

The real incidence of things is always a mystery, even to those who know the most about such things, for the simple reason that no one can be everywhere all the time.

So lots of things go unremarked, or are taken to be one thing when in actuality they're another.

The estimate of 10% of actual occurrences being reported to the FDA is, I think (based on my experience as a clinical investigator and practitioner for many years), probably much too high.

I can appreciate the fact that Public Citizen, which used that percentage, chooses to be conservative, in that they'll be accused of all sorts of agenda-driven things anyway, so why simply add fuel to its critics' fire?

I'd estimate the true ratio of reported adverse events to actual occurrences to be closer to 1%.

Consider that it's not in the interest of those involved in an adverse event — even if reporting same is legally required — to do so.

If word gets out a lawsuit is sure to follow, with accompanying bad publicity and potentially devastating financial repercussions.

The overriding tendency by both Big Pharma and the involved hospital is to circle the wagons and try to tamp down the news.

More often than not, it's successful.

What finally gets to the FDA is but a smoking gun, which seldom results in walking back the cat to the point where the real magnitude of a problem is recognized.

So when I read reports such as that by Public Citizen on Botox and Myobloc, I tend to believe they're on to something.