Subscribe to RSS feedFDA embraces YouTube, but falls flat
For the past six years, the Food and Drug Administration (FDA) has put out a short video segment called “Patient Safety News,” which FDA says is:
“a televised series for health care personnel, carried on satellite broadcast networks aimed at hospitals and other medical facilities across the country. It features information on new drugs, biologics and medical devices, on FDA safety notifications and product recalls, and on ways to protect patients when using medical products.”
About a year ago, FDA started posting these video snippets on YouTube.
One can assume that FDA is posting these so that they reach a broader audience, and not just health professionals. Since they’re aimed at health care personnel, it’s not surprising that the language in them is not all that consumer friendly. But the videos end up sound like little more than the announcers reading text from a drug’s FDA label. Do, for instance, doctors and nurses catching these short snippets in, say, a hospital staff lounge or cafeteria, really stop and listen to the droning text of a drug’s label? Even if they do, does the content penetrate and get retained in the probably busy and distracting environments in which they’re shown?
The FDA might be better off not simply reciting label text in these videos, but rather summarizing the warnings/label changes/what-have-you in a more consumer-friendly fashion. If the purpose behind posting these videos on YouTube is to reach consumers, then the the FDA is failing miserably on that front, as the language used in impenetrable and inaccessible. It’s safe to assume that consumers watching these videos have no idea after they’ve watched them whether it was good news, bad news or no news about the drug in question.
Take, for instance, this Patient Safety News segment with the riveting title of “New Data on Thromboembolic Events with Ortho Evra Contracept“:
It says things like “these findings support an earlier study that also concluded that women in this group were at higher risk for venous thromboembolism. Another earlier study found that women using the patch did not have a greater risk, but the results from the two positive studies support the concerns that the patch could increase the risk of blood clots in some women.”
And then it concludes that women with concerns should talk to their health care providers. But the overall message is completely unclear — is there a risk? is there not a risk? How much of a risk? This is likely confusing not just to consumers but to prescribers as well.
The FDA did much better in a segment it did on Over-the-Counter cough and cold remedies for kids, Caution Giving Children Cough and Cold Medicines. It had clear recommendations, and the visuals reinforced the message, even if the language was a bit unnecessarily complicated (how many consumers know what an “active ingredient” is?):
It would also be useful if FDA were to do versions of these videos in other languages, particularly Spanish.
The production values of the series are a bit low-tech, which is to be expected, I suppose. Perhaps the FDA needs to take a cue from the very Direct-to-Consumer Advertisements it regulates?
To see all of the videos FDA has posted on YouTube, go here.
You can also view the videos on the FDA website here.
August 26th, 2008 at 2:00 PM
Thia is why I use a website called iGuard.org
iGuard.org emails me alerts about my medications in a language I can understand.
September 2nd, 2008 at 8:49 AM
I’m glad the FDA is trying to reach as many parents as they can about the children’s cough medicine issue. As a dad and a doctor, I find this a very scary topic. I used to think that as long as my patient’s or I dosed the children’s cold & cough medications right, then everything would be OK. But when I researched this further, it turns out that children have died from “over dose” of ALL THE MAJOR CHILDRENS COLD AND COUGH MEDICINES even when given the correct dose (http://pediatrics.aappublications.org/cgi/reprint/108/3/e52?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=cough+medications&andorexactfulltext=and&searchid=1&FIRSTINDEX=0&sortspec=relevance&resourcetype=HWCIT).
Here are a few interesting facts:
1. Last October 2008, the drug companies promised the FDA that they would change all their labeling to say “do not use” for children under the age of 2, but I was just in the store last week, and a number of packages still had the old labeling!
2. The FDA reviewed safety and effectiveness data this last fall and its expert panel said that “right now the current cold & cough medications should not be given to children under 6.” Here is a link to the FDA’s minutes, “http://www.fda.gov/ohrms/dockets/ac/07/minutes/2007-4323m1-Final.pdf”, see page 6. The FDA made a public advisory in January 2008 about never using it for children under 2, because the Drug companies are fighting them on the panels ruling to never use cold and cough medications on children 2 to 6. Since these drugs were previously allowed by the FDA, the FDA is forced to go though “due process” before they are willing to make an official public statement about never giving these medications to children 2 to 6.
3. The number of infant deaths attributed to cold and cough medicines is dramatically underreported. New research published in the Journal of the American Academy of Pediatrics demonstrated that there were at least “10 unexpected infant deaths that were associated with cold-medication” in 2006 alone in the state of Arizona. Extrapolated over the US and Canadian population, that would be over 500 deaths a year associated with cold-medication! (http://pediatrics.aappublications.org/cgi/content/abstract/122/2/e318)
The thing that the drug companies don’t want anyone to know is that these medications never underwent the rigorous safety and effectiveness studies modern medications have to go though, they we grandfathered in the early 1970’s because at that time experts felt like they seemed to work, and they seemed safe enough.
Interestingly, some researchers from Penn State have shown that Buckwheat honey is better then the OTC drugs for children’s cough. There is a web site that talks about this, and gives lots of research to help parents be better informed about how to help their kids. Check out http://www.honeydontcough.com/
-Daddydoctor