Unapproved prescription drugs ... the backstory
People always ask me, "Where do you find the stories you produce?" And I tell them I find them everywhere -- sometimes in a something I read, sometimes from people I talk to and sometimes I find stories from my own life. This story
is one of those times when I turned life experience into a two-part investigation for "360."
A little over seven months ago, in the middle of winter, I gave birth to my second son. Being a second-time mom, I had a little more experience than I did the first time around, so when my newborn got sick with a hacking cough and cold, I called our pediatrician and asked him to prescribe the same cold medicine that I gave my first son as an infant three years ago. Much to my chagrin, my pediatrician told me that the cold medicine that he had formerly prescribed was no longer being given to kids under two. When I asked why? He said it wasn't advised.
Being a journalist and a mom is a unique mix. Not wanting my child to suffer (or for me to have another sleepless night) and a nagging feeling that something wasn't right, I started to do a little research to find out what had changed about the cold medicine. What I found out shocked me -- the drug that I had given my first son as a baby had been pulled off the market because it had not been tested in kids under two and there had been reports of adverse effects in some children. I was completely shocked. I had inadvertently given my first child drugs that could have made him sick.
How could my doctor have prescribed my son something that could have made him sick? Why didn't he know? Why didn't I know? I am in the media. I report the news everyday. I thought there was a system in place to prevent something like this from happening.
Let me preface these questions. Aside from the occasional tantrum and the refusal to kiss some particular relatives, my first son is perfectly fine. But what if he wasn't? How could my doctor not have known that this drug was unapproved? Well, it turns out he and I are not alone in our lack of knowledge. It turns out that 65 million prescriptions are written every year for drugs that are unapproved by the FDA and the FDA has known about it for decades.
This led me to ask more questions -- How does this happen? Who is responsible here? What other drugs are out there that are unapproved? Why don't doctors know which drugs are approved and which aren't?
I mentioned all this to Gary Tuchman, a CNN correspondent and regular on this blog, and my bosses here at "360." Everyone was as curious as I was, so they sent me off in search of answers. The pieces you will see on tonight's program and the text version you can read now on CNN.com
are the result of several months of digging and talking to people. The answers we got from the people in charge at the FDA, on Capitol Hill and from a manufacturer might surprise you. They did surprise me.
And for those of you now wondering about my infant son and his cold, well, he got over it with a lot of TLC and vaporizers. It took a lot longer than it did with the cold medicine, and I was a mess, but that's what being a parent is all about. As for my older son, I guess I can blame the tantrums on the cold medicine he got when he was an infant or more realistically, it's probably because he is now three-and-a-half years old.
-- By Audrey Gruber, CNN Producer