3 posts tagged “U.S. Food and Drug Administration”

Why is dietary advice so all over the place? Nutrition experts explain

Posted September 18th, 2018 by

If you’re confused about what kind of milk to drink, what type of cooking oil is “healthiest” or whether the Mediterranean diet is the ticket to heart health, you’re not alone. Nutrition experts dig into the complexity of dietary research.

Digesting dietary advice

The constant churn of nutrition news, books and blog posts — combined with the growing number of food options at the grocery store — can feel contradictory and make your head spin when it comes to making healthy diet decisions.

“As a dietitian, even I get tripped up when new studies that come out that question my beliefs,” Washington Post writer Cara Rosenbloom admits in a recent article on “how to handle ever-changing nutrition science.” She interviewed Dariush Mozzafarian, the cardiologist and researcher behind this 2018 BMJ analysis of nutrition science.

They make the case that we have an issue with how we “digest” food advice:

  • We take it very personally. “If you learn in physics that there was new research about a black hole, you may say, ‘Oh, that’s interesting,’ but you don’t change your habits because the science has changed,” Mozaffarian says. But people these days tend to swiftly avoid or adopt foods (such as wheat/gluten or coconut oil) based on new information or faddish magazine reports that may not warrant dietary changes.
  • We cling to every new study. New nutrition research comes out weekly but people (and policymakers) would be wise not to focus on single studies, Mozaffarian argues. Understanding the relationship between foods, wellness and disease takes a long time.
  • We don’t have centralized government guidelines. The U.S. Department of Agriculture (USDA), the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) are just a few sources of government recommendations on nutrition. Mozaffarian says a cabinet-level position that centralizes or coordinates nutrition guidelines would help eliminate confusion.

Other issues + pointers

Other nutritionists point out that dietary science is still in its infancy (see this infographic), and most nutrition studies are observational (rather than randomized control trials, which offer more evidence about “X may cause Y or Z”).

Researchers behind a major study on the Mediterranean diet and heart health recently had to retract and re-analyze their work because it was flawed (although version 2.0 reached the same conclusion — the Mediterranean diet can be beneficial for those with cardiac risks).

Even if you’ve figured out your own eating plan or nutrition philosophy (like Michael Pollan’s famous one: “Eat food. Not too much. Mostly plants.”), articles about diet still make great clickbait. Look for pieces that ask questions and cite research and credentialed nutrition experts, rather than making blind declarations or heavily promoting certain products. And always check with your own doctor or care team before making dietary changes or even taking new vitamins or supplements.

Do you follow a certain eating plan or style? What do you struggle with most when it comes to eating (or understanding nutrition advice)? Join PatientsLikeMe or log in to connect with the community in this forum discussion. As a member, you can also add any supplements or diet types (such as Mediterranean or low-carb/high-protein) to your profile (under the “My Health” tab) to assess them and track a more complete picture of your health.

Share this post on Twitter and help spread the word.


Sally Okun explains the new research collaboration with the FDA

Posted June 16th, 2015 by

Yesterday, we announced a new research collaboration with the U.S. Food and Drug Administration (FDA) that will explore how patient-reported data can lead to new insights about drug safety. It’s the first time the FDA will analyze patient-generated data for pharmacovigilence (aka drug safety).

But we’re no strangers to drug safety. Check out some of the previous work the community has helped to drive:

To learn more about this new (and unprecedented) collaboration, we talked to our very own Sally Okun, Vice President of Advocacy, Policy and Patient Safety.

What will this collaboration do?
Patients’ lives and well-being often depend upon medical products approved and regulated by the FDA. But most of the information we see on safety labels comes from clinical trials, which aren’t typically representative of the actual populations of patients who will take the medication. Working with us, the FDA will be able to see the real-world impact of taking medications over time, which can help identify benefits and risks earlier. The FDA isn’t just talking about patient-centricity; they are partnering with us to work directly with patients, and give them a collective voice as part of the FDA’s surveillance system.

How does the FDA normally hear about side effects?
Right now the FDA uses a voluntary reporting system consisting of individual case safety reports, the majority of which are submitted by healthcare professionals and patients to drug product manufacturers, who then are required to report them to the FDA. Our data are different in that the information is generated by patients themselves, and provide real-time insights about what its like to use medical products over time, like tolerability of the drug and factors that may influence taking the drug as prescribed.

When did PatientsLikeMe’s start gathering information about side effects and adverse events?
We’ve actually been collecting information about patients’ experiences with treatments, including patient-attributed side effects, since we launched the website in 2006. In 2008 we took steps to formalize adverse event reporting by developing a customized version of the FDA’s MedWatch tool for use in a pilot project with our MS community. The pilot set us on a path to develop our future drug safety functionality. By 2009 we had created a fully integrated, standards-based drug safety platform, the first on social media. It enabled industry partners to meet their regulatory obligations.

What’s the future?
It’s pretty exciting! The patient experience can more deeply inform the way medications are regulated. And patient-reported data can ultimately have a greater impact on the way that drugs are developed. This collaboration can lead to all of that.

Share this post on Twitter and help spread the word.