Lack of Oversight in Clinical Trials

"In many ways, rats and mice get greater protection as research subjects in the United States than do humans," said Arthur Caplan, chairman of the department of medical ethics at the University of Pennsylvania.

That quote powerfully sums up the report discussed in an article on the lack of FDA oversight in clinical trials. The FDA has only 200 inspectors, some of whom are only part-time, to monitor around 350,000 test sites.

The article paints a poor picture of the FDA in general, and it is this sort of report that can definitely contribute to the lack of faith/understanding some people have in science and medicine to really help them. That isn't to say, of course, that such reports shouldn't be released - they're obviously very important. But successfully addressing these sorts of issues (and then reporting on the improvements) could probably help build the general public's confidence in the FDA and other government agencies to successfully protect their health and wellbeing.

Childhood Obesity Risk Factors

A note from RWJ about a special issue of the American Journal of Preventive Medicine (AJPM) on childhood obesity risk factors caught my eye. There are eleven studies in the issue, which cover a range of issues.

One of the things that I found most interesting was problems related to schools. One study found that 67% of middle schools and 83% of high schools had contracts with soft drink companies. Another pointed to the lack of physical education in schools, with only 20% of high school seniors attending schools with such requirements.

I wonder what the trend here will be… Obviously childhood obesity is a big problem that is only getting worse. But when studies report that social norms play a role in letting obesity spread through social networks, one has to wonder how likely it is that people will really do much about this. I’ve also seen (incomprehensible, to me) news coverage of some parents not wanting to hear doctors or other medical professionals tell them their kids are overweight. They’re the parents, they argue, so they know what’s best for their children.

The role of schools contributing to childhood obesity is hard to ignore, but I feel like it’ll take some very creative solutions to address some of these problems – the financial pressures on schools and pressure to prepare children for college make cutting ties to soft drink companies and focusing more on physical education unlikely… Hopefully some of the findings in that AJPM issue will lead to new, effective interventions.

Doctors' Knowledge of Supplements

I ran across this article about doctors flunking a quiz about nutritional supplements, and I couldn't make up my mind if this is surprising or not...

At one level, it's a little surprising with the prevalence of these supplements that so many doctors didn't know much about them. I'd have to think a lot of patients come in saying they're on glucosamine or creatine or insert-popular-supplement-here. Given that, it's surprising the issue seems not to have been on the radar for many of the surveyed doctors.

On the other hand, some of the things they didn't know (that they don't require FDA approval and don't need to be shown to really do anything) are so counter-intuitive that I can understand doctors not knowing the truth. What kind of sense does it make that these companies don't need to go through FDA approval or really establish any sort of benefit?

Anyway, I think regulation and advertising of supplements is an extremely interesting area, since (like the supplements themselves) they don't go through the same sort of FDA approval process that prescription pharmaceuticals go through.

New DTC Legislation?

Advertising Age has an article today about a new bill regulating direct-to-consumer (DTC) drug ads. Reading the first paragraph, one might expect this to be something the industry would not be excited about:

The House of Representatives today voted 405 to 7 to endorse new drug-approval procedures that allow the Food and Drug Administration for the first time to fine marketers for misleading direct-to-consumer drug ads.

The industry actually is excited about this, though, because more harsh versions of this legislation might have restricted advertising the first 2-3 years a new drug is on the market. Compared to that, this isn't too bad.

I think the whole debate surrounding DTCs is an interesting one, there are certainly plenty of arguments to be made on all sides of the issue. I'll be curious to see if or how DTC ads change as a result of this legislation.

Two Quickies

I wanted to post two quick notes/links before calling it a night as I sort through newsletters and other e-mails...

The first is a brief RWJ report on Burger King's plans for healthier kids meals. It'll be interesting to see how well-received its efforts are by parents and the kids eating these healthier kids meals.

Of more interest (at least to me), was the news regarding Arkansas' student BMI reporting program. Since 2003, schools in Arkansas have conducted yearly BMI assessments of students, which are then given to parents. It would appear from the 2006 data that there are fewer overweight students than there were in 2004. Then comes this gem:

Although the program had generally been well-received by parents and students, in 2006 some state legislators sought to eliminate the BMI-tracking effort, citing concern among some parents and lawmakers that the program could be damaging to children's self esteem. Ultimately, legislators agreed to decrease the frequency of collecting BMI data to once every two years, and also to make it easier for parents to remove their children from the program.

I've read and seen a number of stories discussing this point. The most bothersome comments (at least to me) are when doctors talk about some parents not wanting to hear what they have to say. What is more important - protecting students' self esteem or protecting their physical health?

It's hard to fully grasp how policymakers and parents would think it's a good idea to take overweight children out of this program, because the reports might hurt their feelings. Perhaps it would make more sense to learn from the reports and try to make changes to eating and exercise behavior that might actually address the problem?

Making Global Health Interesting

I don't know how many people would think of global health as an interesting or exciting topic... But I recently discovered at least one person who has done an amazing job making global health something that almost anyone can get excited about - Hans Gosling.

Gosling has two fantastic talks available through TED:

• Debunking Third World Myths
• New Insights on Poverty and Life Around the World

Beyond the material itself, it's just the style with which Gosling presents his topic that I find incredible. While the content of the talk might really only be appropriate for some sort of health communication-oriented class, the talk can serve as a great model of telling a good story for almost any class that involves presentations. (If you can make global health look this amazing, you can do it for anything.)

Anyway, these are two impressive talks by a man who is obviously (1) very bright and (2) very good at telling a compelling story.

Apple Fries at Burger King

There is a great article over at AdAge about Burger King offering fry-shaped apple slices with kids' meals. The move required some R&D, but should be helpful for their efforts to promote healthier meal options for kids:

"We think kids will flock to it," said Burger King spokesman Keva Silversmith. To devise the product, Burger King developed a proprietary cutting process that makes apple slices look like fries. Then they're washed in water with lemon, to keep from turning brown.

It'll be interesting to see how these catch on, along with other changes Burger King (and others) are making to try and improve the foods their offering to kids. This move is also more proof that making health-oriented decisions in food offerings can generate a lot of free PR - these new apple fries will generate a lot of news buzz. Perhaps shifting to healthier food offerings will be the fast food equivalent of car companies pledging to be more green? It could be a nice match when doing the right thing (in terms of health) also happens to be a great marketing advantage.

Reports of Adverse Drug Effects Up

This article over at WebMD, Reports of Adverse Drug Effects Up, caught my eye. The opening paragraph sums up the entire article nicely:

Reports of adverse drug effects reported to the U.S. Food and Drug Administration (FDA) more than doubled in the last decade, according to a new study. Deaths associated with the serious effects also more than doubled.

It includes a lot of other interesting information related to trends in adverse drug effects, some of the drugs most commonly associated with adverse effects, etc.

One of the things I don't see enough of in this particular article, though, is the role that effective patient education plays in such problems. How many patients leave the doctor really understanding everything that just transpired? I think this is a very under-studied aspect of these sorts of problems, the percentage that can be traced to patients taking medications incorrectly. And while some solutions to adverse drug effects are complicated, more effective patient education seems like a potential solution that is (hopefully) within reach.

Two Pandemic Items

First, RWJ has a nice little blurb about the U.S. Department of Health and Human Services (HHS) awarding $75 million dollars to help build capacity to respond to a major infectious disease outbreak.

Mostly, though, that release was a useful cue to post a link to this fantastic speech by David Brilliant about pandemics and how we can make sure the next pandemic doesn't happen. The TED summary states:

Accepting his 2006 TED Prize, Dr. Larry Brilliant talks about how smallpox was finally eradicated from the planet. In a conversational style that belies the deadly seriousness of his subject, he describes the dangers of pandemic disease, and offers a solution in his dramatic TED Prize wish, a plan to use the Internet to help prevent the next pandemic.

His views on the Internet as a tool to prevent pandemics is particularly interesting, I think. It's an impressive talk, definitely worth a look.

The Ads Kids See

Perhaps this doesn't come as a surprise, but a new study confirms vast majority of ads seen by kids promote foods high in sugar, fat or sodium. One of the highlights, from the RWJ write-up:

In the most comprehensive effort to date to assess the nutritional content of food advertisements viewed on television by children, researchers found that 97.8 percent and 89.4 percent of all food advertisements viewed by children ages 2 to 11 and adolescents ages 12 to 17, respectively, were for products high in sugar, fat or sodium.

While the results of that study are interesting, I'm also curious what the numbers would be for adults... When I tend to think of the ads that I see on TV, I'm thinking the vast majority are for products that are high in sugar, fat, or sodium. I'd guess the numbers wouldn't be as high, but still a lot higher than is probably ideal. That would certainly make for a great follow-up or companion study to this one.

PSA Central

I wanted to alert readers to a great resource for health communication researchers and teachers - PSA Central. From the intro on the website:

PSA Central makes it easy to browse and preview current PSA materials for Ad Council campaigns. Everything available for download or order on this site is provided free of charge. If this is your first visit, please register using the link in the login box.

For anyone that has a need for PSA-style advertisements, this site is fantastic. I'm teaching a health communication theory/practice course this semester, and the assortment of ads available on this website is a huge help when looking for materials to discuss in the classroom. The site lets users search by campaign and media (magazines, newspaper, radio, TV, Internet, etc.) to quickly find the things they're looking for.

PSA Central is definitely a useful website for anyone with an interest health communication campaigns, for teaching, research, or professional purposes. It seemed like a useful thing to point people toward.

Scientific American: Feast and Famine

For those who might not have seen it in stores, Scientific American has a special issue (Feast and Famine) out with issues related to food, diet, exercise, etc. It's a great edition of the magazine, with a number of interesting articles on a range of topics that are likely of interest to health communication researchers.

Advertising for Smoking Cessation Products

I feel like I saw or read something about related results a couple weeks ago, but a study just published in the Journal of Political Economy found that advertising for smoking cessation products encouraged smokers to quit. The abstract states:

We study the impact of smoking cessation product advertising. To measure potential exposure, we link survey data on magazine-reading habits and smoking behavior with an archive of print advertisements. We find that smokers who are exposed to more advertising are more likely to attempt to quit and to successfully quit. While some increased quitting involves product purchases, we find that product advertisements also prompt cold turkey quitting. Identifying the causal impact of advertising is difficult because advertisers target consumers. Although reverse causality could bias our estimates upward, our baseline results are not sensitive to a series of checks.

I think the big, interesting finding here is that some of the people decide to quit cold turkey. While that's certainly not what the advertisers are shooting for, it's a clear benefit for public health. There are plenty of arguments over the benefits/negatives of direct-to-consumer (DTC) pharmaceutical advertising, this (at least to me) is another clear point in favor of such ads. More fuel for the fire...