Consumers Union, publisher of Consumer Reports, and a frequent critic of DTC advertising practices is seeking to add to safety requirements for television ads. A citizens’ petition to FDA is being circulated that would require a website and phone number for reporting adverse events.

Consumers Union believes that television drug ads gloss over side effects while hyping the benefits. They cite data that show reporting of side effects is under reported, saying that in 2005 only 465,000 side effects were reported but there were millions unreported. Consumers Union’s Liz Foley says consumers spend 100 minutes watching drug ads for every minute spent with a doctor. Therefore, they feel a specific phone number and website should be included in ads to increase side effect reporting.

While I have no problem encouraging side effect reporting, it is dangerous to encourage or promote it in ads after the litany of side effects is read by actors or voice over announcers. All of us know the power of suggestion and how many side effects are imagined once disclosed. Most consumers will report serious side effects to their doctors and only after a full discussion with the physician can it be determined if the drug is the cause.

Imagine the flood of calls received by a call center or reported on a website if side effect reporting is encouraged in ads. Most will be minor and many will be imagined. FDA will be investigating many more side effect incidents, and so will drug companies. Serious side effects should be reported promptly and consumers, I believe, already know where to go to report them. Making a new channel for reporting side effects will not make us safer but just clog the already overburdened safety system.

If FDA wants to encourage additional side effect reporting, they will need vastly increased internal resources to investigate and analyze the reports. I doubt they will be given such resources, so the additional requirement will create a bureaucratic burden, with no increase in safety. I clearly support the goal of catching serious side effect patterns sooner in a new drug’s life cycle, but there is no evidence encouraging mass reporting will catch those life threatening effects sooner. In fact, over burdening the system with minor complaints may slow down investigation of serious side effects.

This entry was posted on Friday, February 15th, 2008 at 7:07 am and is filed under Uncategorized. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.