FDA and ASA

My initial assignment this morning was about family flu shots (see my blog entry from yesterday). Interviews were all set up, and I was about to leave the station.

Then, just after noon, I received an email from the FDA (http://www.fda.gov/consumer/updates/bayer102808.html) about its warning letters to Bayer concerning the combination over-the-counter products, Bayer Heart Advantage (aspirin with phytosterols to "lower cholesterol") and Bayer Women's (aspirin with calcium to "fight osteoporosis").

• These products have not been FDA approved.
• The labeling is confusing about length of use, and touts claims for which there was no FDA review.
• While the aspirin and the dietary supplements are all available over-the-counter, the combination is problematic. Calcium supplementation isn't all there is to fighting osteoporosis, and phytosterols are not sufficient for people who really need to lower their cholesterol. The label implies these components are for chronic use. But the pills also contain aspirin. Chronic aspirin use should be monitored by a doctor, due to the risk of bleeding in the digestive tract.

This was the preferred story by the powers that be. So I had to quickly and completely switch gears. On top of that, I was to be in the 4:00 show.

But bonus -- being in the 4:00, I was the first in the market to report it -- a badge of honor in this business. Another bonus -- my husband, who rarely gets to see my work, caught my report on the TV in the doctors' lounge at the hospital...and he said I looked nice in my stand-up :).

In the short amount of time I had, I was pleased to have been able to get interviews with a pharmacist and a doctor. The pharmacist at the community drug store actually didn't carry the products in question. He sent his assistant to Giant Eagle to purchase the medicines, so we could shoot video of the packaging. My illustrious executive producer was able to procure a statement from Bayer and fashion a full screen graphic to round out the piece.

I remember seeing the asa/phytosterol product on shelves in the grocery store. I wondered, how could this be, this OTC cholesterol lowering medicine? If I had had more time today, that's what I would have liked to have explored more. Neither the doctor nor the pharmacist I spoke to had the inside scoop on how the products circumvented the FDA to make it onto drug shelves everywhere. Maybe some of my medical journalism colleagues who work in longer formats can pick up on this.

What now becomes of Cheerios and oatmeal and their ad campaigns saying these breakfast foods can lower cholesterol?