39,000 Chinese Can't Be Wrong

Scripts (sort of)

After several weeks of hand wringing over the decision to get my 9 year-old vaccinated for h1n1, I have made up my mind. Roll up your sleeve, Princess.

You see, as a pharmacist, I'm a big fan of the clinical trial process. Prior to the Federal Food, Drug, and Cosmetic Act of 1938, drug manufacturers didn't have to prove their products were safe and effective before they were released for public use. The passage of the Act was prompted by 107 deaths due a toxic inactive ingredient in a liquid antibiotic that had been released in 1937.

The approval process for drugs has gotten more complicated, time-consuming and expensive (as in 100's of millions of dollars expensive) over the years. Big Pharma can grumble all it wants, but I find this reassuring. Every once in a while some new drug product, like h1n1 vaccine, will come along that will get "fast tracked" because of an urgent need. The idea of my one-and-only-light-of-my-life being injected with something that's been "fast tracked" makes me nervous.

What do I do when I'm nervous? I turn to Google, of course. For a couple of weeks now I've been searching the internet for results of clinical trials of h1n1 vaccine. I found that most of the trials that have ended had 25 people in the test group. 25??!! I don't care how many government agencies want to say that safety is expected to be the same or immune response should be the same as the seasonal flu vaccine that I get myself every year without a second thought. No flippin' way was my kid getting this shot without some cold, hard, big numbers.

Yesterday I decided to try again. I'm afraid to admit my enthnocentricity is showing, because it hadn't occurred to me to search for results from any countries other than the US and the UK, countries that don't have laws like the the Federal Food, Drug, Cosmetic Act of 1938. I stumbled across a report from Associated Press about the low incidence of adverse effects in China where 39,000 people have already been vaccinated for h1n1. My mind is now eased as far as my own immediate family is concerned, and I'll be getting my child vaccinated as soon as possible. Bribery will probably be involved. Bribery of my kid, that is, not someone at the Health Department.

But I have to wonder: How big were the test groups in China? How much choice did these 39,000 people get? Did they know they were being the Guinea pigs for the rest of us? I never thought I'd say this but...Thank Heavens for China and its speedy drug approval process.