Untie the apron strings: FDA is no 'Nanny'

March 1, 2011

It took 40 years for me to see that the FDA is no "Nanny" and that, unfortunately, we are on our own as patients and squarely on the spot as pharmacists.

Four decades ago, I was a firm believer in the “Nanny Government” that is the United States of America. I felt that the authorities in charge were going to regulate industry so that your welfare and mine would always come first. Since I was a medical professional, I liked to point to FDA as a stellar example of the government doing the right thing.

In the early 1960s, Frances Kelsey was a new medical officer at FDA. She rejected a Wm. S. Merrell Co. application to bring a drug it called “Kevadon” to the U.S. market. At the time, it was widely prescribed in Europe and other countries for morning sickness. Thanks to her, Thalidomide - a drug that caused devastating birth defects to approximately 10,000 children around the world - was kept out of the United States. What more evidence could I want that regulatory agencies existed to protect you and me from danger or excess or greed?

Over time, reports about the negative consequences of taking drugs like Baycol, Avandia, Bextra, fen-phen, and Vioxx got my attention, but like most unexamined beliefs, my basic conviction was not shaken. I believed the FDA was our “Nanny.” She watched out for us.

That belief lasted until Darvon was pulled from the market in November 2010. This was the same drug the FDA had declined to ban in 1978 and again in 2006.

My faith in the FDA was thoroughly shaken when I read the following statement, made by the director of the FDA Advisory Committee: “It’s hard to praise the FDA when there have been 120 million more prescriptions for propoxyphene filled since 2005 and conservatively 1,000 to 2,000 more deaths.”

It took 40 years for me to see that the FDA is no “Nanny” and that, unfortunately, we are on our own as patients and squarely on the spot as pharmacists.

Jim Plagakis is a community pharmacist in Galvston, Texas. You can e-mail him at jpgakis@hotmail.com and visit his website, jimplagakis.com.