Drug Industry Critic Joins the FDA – Dr. Sydney Wolfe

According to this article in the Wall Street Journal, he is the Ralph Nader of the Pharmaceutical business and now steps in to even a bigger role. This probably is going right along with the desire for transparency I might guess.

Right now, the FDA, like all of us, is having the same issues as everyone else, too much information, but by today’s standards, we cant afford to over look any details at the FDA, as the drug business is a far cry from where it was 10 years ago too. The FDA with their new computer systems might be able to filter and analyze faster than what had been possible in the past too. If that is the case and everything is clean and on the table, then Dr. Wolfe may not be as big of a critic as he has been in the past. He also spoke out about silicone breast implants and stated saline was still safer in one of his campaigns, although after 14 years they were re-approved by the FDA.

It’s the way the world operates today, if there’s information available, we want it, and to this I might add the algorithms needed today to analyze applications for approval from both the drug and device side are also going to get a bit more complicated, which brings me right back to a post I made a while back. I never thought this post would carry any weight but with many recent posts, I keep finding myself referring back as it seems to fit. BD

The 2 New Hot Words in Healthcare: Algorithms and Whistleblowers

The pharmaceutical industry has a recurring nightmare: Drug-safety crusader Sidney Wolfe becomes a player at the Food and Drug Administration.

Dr. Wolfe also has a nightmare: One of his children goes to work for a drug maker.

Of the two, the doctor is sleeping more soundly.

Over three decades, Dr. Wolfe, head of the health group at advocacy organization Public Citizen that Ralph Nader founded, has helped push 16 drugs off the market and slap restrictions on several multibillion-dollar products. He has been so hostile to the FDA under President George W. Bush that he decried its 100th-anniversary celebration in 2006 as a "propaganda campaign" to hide its "unprecedented assault on the American public."