Addressing threats to health care's core values, especially those stemming from concentration and abuse of power - and now larger threats to the democracy needed to advance health and welfare. Advocating for accountability, integrity, transparency, honesty and ethics in leadership and governance of health care.
Pages
▼
Monday, May 14, 2007
BLOGSCAN - Truthfulness in Biotech
David Williams in the Health Business Blog has another commentary on the need for unvarnished truthfulness in biotechnology. The examples he uses are germane to the debate about generic biotech drugs. In particular, biotech firms contend that different manufacturing processes produce different molecules, so that generic biotech drugs should undergo full-scale clinical trials. So then why do biotech firms only do limited bioequivalence studies when they switch their manufacturing processes? And since these firms often find batch-to-batch variation in their own products, should each batch undergo separate clinical trials?
I would certainly support your argument that "what's good for the goose, is good for the gander."
ReplyDeleteI'm still waiting for rDNA insulin to be classified as a biotech drug--and to see how eager Eli Lilly et al are to run bioequivalency trials. I imagine this segment--representing the first entrant into the field of biotech--might have to disclose some extremely interesting results.