Tysabri returns

I'm about to head out of town for most of the day, so I'll just quickly note that an FDA advisory panel, as expected, has recommended that natalizumab, brand name Tysabri, which I wrote about a few days ago, again be allowed on the market.

This is a case in which MS patient activists wanted the drug, in spite of the risks, and there is a lot to be said for allowing people to make such choices, in consultation with their physicians. Indeed, one of the main reasons why the FDA has been less diligent in protecting the public in recent years is because HIV activists demanded an expedited approval process. The problem is that drug company influence resulted in the quicker approval process being hijacked for drugs that are not intended for life threatening or seriously disabling conditions, or for which good alternatives already existed. We need a system that better distinguishes between the amount of risk it makes sense to accept in different situations, and the only way to define "acceptable" risk is to ask the people whose risk is at issue, in other words, potential consumers of medications.

Right now, us folks don't have a real voice in the drug approval process -- it's pretty much a dialogue between drug manufacturers and government experts. There are a lot of other problems with the system of drug regulation, but that seems to be one of them. Yes, members of the public and disease advocacy organizations such as the American Cancer Society can offer comments -- although the ACS doesn't precisely represent people affected by cancer, it has a lot of industry funding -- but I'm talking about something more structured and proactive in reaching out to people affected by medical conditions and getting their input on how to balance risks and benefits. This idea is still a bit vague, but the bottom line is, a more democratic and inclusive process would better serve the public interest.