The second day of the ODS Practicum proved to be just as busy as the first. Again, I had an early breakfast at the Tastee Diner. My hotel is about a ten minute walk to the NIH campus which is a nice way to start the day.

Today’s morning agenda was one that really caught my eye. We started off with Meghan Murphy, PhD discussing how a drug is brought to market. Then, Debrah Miller, PhD (and the Director of Nutrition for Hershey) talked about bringing a food to market. Finally, Anthony Lamada, MS spoke about bringing a supplement to market. Comparing and contrasting these three things was quite interesting and, honestly, confusing. There is a lot of gray. If a manufacturer does not like the rules of one type, they may be able to change to another. Stevia is a great example. They didn’t have the research initially to have it declared a food additive, but they could have it declared a nutritional supplement immediately! Since then, enough scientific evidence has been presented to have it labeled as a food additive. Given the variety of people attending the practicum, there was good discussion about, for example, using dried berries as a medical treatment – is it a food or a drug? This is just one example we discussed.

The last session was given by Bill Gurley, PhD who discussed interactions between supplements and drugs. He talked about several interactions I was aware of, but also quite a few I was not. Bill focuses on interactions between drugs and herbals. Again, lots of great information.

Over lunch we got another overview of the NIH and a preview of the campus tour scheduled for later in the day.

The afternoon sessions were not high on my list, but yet again, I learned a lot. We started with Lawrence Friedman, MD talking about efficacy and effectiveness and how to measure them in research settings. He was followed by Elizabeth Yetley, PhD who talked about safety. Finally, Joseph Betz, PhD spoke on identity and quality. Once again, the grouping of these topics proved to be an excellent design. Each laid a foundation and then built upon it and on the information provided previously. I learned that there are quite a few differences in designing studies to test efficacy vs. effectiveness. There was more information about safety and the facets of safety than I had considered. Finally, the lecture on identity and quality added on to the information provided earlier today and yesterday.

The highlight of the day was a tour of the NIH campus including the Clinical Center and the National Library of Medicine. The NIH campus in Bethesda has over 80 building on 322 acres and over 18,000 employees just on this campus. It is a beautiful campus. The Clinical Center is the hospital on the NIH campus and has 320 (I think) beds. In order to use the Clinical Center, patients have to be enrolled in NIH funded studies. There is also a “hotel” onsite and a facility similar to the Ronald McDonald House for children and their families. The building is beautiful. We visited several units including the metabolic unit. I have pictures I’ll post when I get home. We also got to see one section of labs used for bench research.

Next, we went to the National Library of Medicine. There are some great resources available. I’ll post more links when I return home and have more time. Here’s a link to “Turning the Pages” which lets you page through a high quality virtual copy of some of the seminal works of science and medicine. We also got to go into the computing area where they have four screens showing: number of people using the Library databases (PubMed/Medline for example) at one time, top 100 search terms, where the library is being accessed from, and I don’t remember the last one. It was interesting to see what people were researching. If you are in Bethesda, I’d highly recommend visiting. Yes, you can go to the National Library of Medicine. We also toured the exhibit called “Against the Odds” in the library which was subtitled “Making a Difference in Global Health.” It was an amazing exhibit and covered interventions all over the world to improve the health of people everywhere. It covered topics like food supply, rehydration, public health clinics, AIDS, landmines, etc. When you have a few minutes, I’d recommend taking a look at it.

Key learnings from today:

• Manufacturers can play around with what they want to call their product which changes how the product is regulated by the FDA.
• Again, the FDA’s hands are tied by the laws written and passed by the congress and signed by the president.
• I knew bringing a drug to market was time consuming and expensive, but I got reminded of just how time consuming and expensive it is.
• There is a lot of confusion about how to classify products – particularly between food and dietary supplement – among the attendees. If we’re confused, then the manufacturers and public are definitely confused.
• My understanding of efficacy, effectiveness and safety have been deepened. There are a lot of things to think about regarding these concepts, how they are researched and measured.
• Again, enforcement is so limited it is easy for manufacturers to do what they want with little chance of being fined. Even if they are fined, the fines are a slap on the wrist often only taking a tiny amount of the profits gained from sales of the product.

Tomorrow we head to DC to have a panel discussion with Senator Orrin Hatch who was key in the development and passing of DSHEA into law. The other panel member is from the Congressional Research Service. Then, we have a panel session with representatives from the dietary supplement industry followed by a panel from the consumer groups (including CSPI) and media. Tomorrow should be a highlight of the practicum!