“At least 17 incidences of viral contamination in biologics have been reported, but industry insiders say that many more go unreported. Rather than risk negative publicity and lawsuits, companies have largely chosen to keep the details of contamination, and even their occurrence, secret — even, at times, from government regulators. Genzyme’s experience, which legally had to be made public because it caused a significant drug shortage, may have only deepened industry’s fears of going public.”
This has triggered a few thoughts about the future of biotech. I guess I’m primed by the “Windup Girl” book I read recently. Yet, if this were as prevalent and dark as the article suggests, we would have heard more on this. I can’t think that Genzyme is the only one who had to fess up about contamination of an existing product (though there might be contaminated products in biotech pipelines).
