Guam Series: FDA Presence and Impact in Pacific Islands Pt. 3 of 5: Outreach, partnership building, and health fraud literacy campaigns

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Host John Zaccone: Welcome to a brand-new episode of On The Frontlines. I'm John Zaccone, your new host for this OII podcast, a forum where we share the experiences and viewpoints of FDA employees at all levels who work to protect your family's health. 

This is the third episode in our five-part series focusing on FDA's presence in the Pacific Islands. And my guests today are both OII personnel. Commander Shannon Aldrich is an officer in the United States Public Health Service, or USPHS, working as a regulatory officer in the Health Fraud Inspectorate Branch. And joining her is Lieutenant Claire Tipton, who's also an officer in the USPHS, and a consumer safety officer within the Office of Import Operations.

They're here to provide firsthand accounts of the efforts being made by FDA employees in Guam. So first, I want to thank both of you for sharing your experiences with us today.

Commander Shannon Aldrich: Thanks, John. Pleasure to be here.

Lieutenant Claire Tipton: Thanks, John.

Mr. Zaccone: And, Claire, I'd like to begin with you. We talked a bit before this podcast about how you went to Guam really motivated with clear objectives. So, what is it that inspired you to go there?

Lieutenant Tipton: Sure. It was exciting to hear about Guam from the others who had already been there. At that point, I'd been working at FDA for a few years. I was looking for a chance to get more experience in the field and grow my career. It was also exciting to hear I'd have a chance to represent the agency, help build positive working relationships, and make a positive public health impact on island.

So, when the opportunity arose for 70-day detail, I didn't hesitate. I saw it as a unique opportunity for me to leverage my strengths with communication and knowledge of import regulations to provide FDA’s expertise and guidance on the island. Prior to applying, I actually had the chance to ask some colleagues who had already been in Guam questions like, “Would I be a good fit?” and, “What are the needs on island?”

I learned that it was a great opportunity to provide hands-on education and training and to support regulatory oversight to help protect public health on Guam. So, I was hooked.

Mr. Zaccone: Now, Guam is considered a U.S. territory, and therefore those living there are U.S. citizens, correct?

Lieutenant Tipton: Absolutely. So, the people on Guam are proud U.S. citizens and they deserve all the same public health protections and infrastructure as those on the mainland. Guam's a diverse culture and people, I like to say. For example, they are the Chamorros, the native people of Guam, and the Guamanians, which include Chamorros and all those who call the island their home.

There's also thousands of U.S. military personnel and their families stationed on the island, as well as tourists from across the globe, mainly from the Asian countries such as South Korea and Japan. The amazing thing is too, Guamanians are some of the kindest people on earth. They will literally give you the shirt off their back and rally around to support each other and their community.

For example, shortly after my detail, a Category 4 typhoon hit Guam, Typhoon Mawar, and I was able to get involved in the response. Seeing the community, FDA, and our partners on island rally around each other and support each other during that response and recovery efforts, it's just amazing to see. So yeah, for me, this detail started as an opportunity to make an impact and grow my career. But it ended up also as a wonderful community building experience for me, for the FDA, and for Guam. It's an incredible community over there, John.

Mr. Zaccone: As a former investigator myself in the field, I know that FDA really does do a good job in training personnel to really prioritize relationships and community building, which obviously builds trust. So, let's focus on that for a minute. Tell us about FDA's presence in the Pacific Islands, how it's strengthened our relationships in Guam.

Lieutenant Tipton: Sure. Building relationships and connections through face-to-face interactions, I was told, is much more important to the people in Guam versus sending emails and having virtual meetings. So, when an agency is present on Island, we’re introducing ourselves, we’re shaking hands, we're listening and asking, “How can we help?” It means a lot. It shows respect. From my experience, it felt more like a diplomatic mission, which I thought was fascinating.

Mr. Zaccone: What a great message. Now, you obviously see the importance of meeting people where they are, and it sounds like you knew it before even going. So, can you speak to why it was so vital, in your opinion, to practice cultural sensitivity and be willing to listen?

Lieutenant Tipton: Absolutely. So, practicing cultural humility is always a must, no matter where you are in the world. Especially on Guam. For example, we worked with many different government agencies and community partners that touch public health across Guam at the federal, territorial, and local levels, such as the Guam Customs and Quarantine Agency, the Department of Public Health and Social Services, the Division of Environmental Health, and the Police Department.

We also spoke with the U.S. Attorney's Office, the U.S. Naval Hospital on Guam, and elementary schools and universities across the island. Bottom line is, everyone has different challenges and tasks that we are all working on, but we all have a shared goal to protect and promote public health in Guam. So, showing respect and appreciation, listening, seeing where our missions overlap, allowed FDA to help connect the dots by bringing groups together to discuss common issues while providing support through regulatory guidance, resources, and public health education.

Face-to-face interactions were key for these collaborations to work effectively.

Mr. Zaccone: That sounds like a lot of coordination, as you said, among many different strategic partners. So, what one aspect from your detail are you most proud of?

Lieutenant Tipton: I would say the most impactful mission I was able to participate in was helping get the island's interagency Opioid Taskforce back up and running. So, the goal of the taskforce was to bring together Guam agencies involved in public health, public safety, behavioral health, law enforcement—things like that—to share data, knowledge, and strategies to better understand the extent and combat opioid misuse and abuse in Guam.

Mr. Zaccone: It sounds like, unfortunately, even in the islands, they're experiencing the devastating effects of the opioid crisis. 

Now, can you tell me more about your role in working with the taskforce?

Lieutenant Tipton: Sure. So, I was tasked with reaching out and meeting with all the various parties who are involved, to introduce ourselves, pitch the restart of the taskforce and gather interest. As you can imagine, each group had different objectives—the police, the Behavioral Health Center, the U.S. Naval Hospital, the Department of Corrections, etc.. But each group also had different data, strategies, and ideas of what was going on.

Bringing them all together to share that data, to help build the security, infrastructure, and knowledge around opioid use and abuse on the island was needed to better understand and collaborate on ways to combat this crisis. Thanks to a lot of handshaking, building positive working relationships, educating on FDA's mission and projects, and sharing common public health goals, we were able to successfully get the Opioid Taskforce up and running again.

So, that was probably my biggest impact there.

Mr. Zaccone: And tell us more about the “how.” How did you get all those different groups to come together and focus on that one critical objective?

Lieutenant Tipton: Well, the main thing was to reach out to each of the groups to let them know the FDA was here on island, and that one of our goals was to help start a conversation about opioid misuse and abuse, and to learn more about their concerns island wide. Our goal was to work collaboratively, offering our subject matter expertise, coordination, education, and outreach resources to help get all these groups together and talking. To enable a collaborative environment to share the thoughts, knowledge, and information to protect the people in Guam.

Then it was a matter of explaining it had to be a community-wide effort. FDA, by no means, was an expert on the island. You know, we deeply valued and needed their opinion and insight. So, the goal was to share resources and expertise to better understand the scope of the opioid misuse on island and strategies to help combat it. We knew they had good information, and they knew a lot more about the situation—about the people, the culture, and needs on Guam—than the FDA did. So, by working alongside local, military, and federal agencies, they took charge and ownership of the taskforce. FDA personnel concentrated on offering our expertise in coordination and resources to help facilitate and bring it all together.

Mr. Zaccone: It sounds like the FDA was there to act more as a guide in these efforts.

Lieutenant Tipton: That's right. Our goal with the initiative was not for FDA to lead the charge, but to bring these groups together to promote collaboration and knowledge sharing. We sought to help coordinate and provide any sort of subject matter expertise that they needed. 

The other important aspect of working in Guam was remembering our focus on our stakeholders and the needs on the ground. After all, that's why we were there. We worked with them on investigations of FDA-regulated commodities, for example, that were imported onto the island. And we provided advice and expertise to our Guam counterparts on types of actions FDA would take on these violent products.

Mr. Zaccone: Facilitation and providing subject matter expertise are certainly within the FDA's wheelhouse. 

Now, Shannon, I want to turn to you. I know you were on detail as a subject matter expert in Guam, and your expertise, obviously, is in health fraud. Let's talk about the health fraud challenges that are going on now in Guam.

Commander Aldrich: Thanks, John, that's right. So, my introduction to the Pacific Island project was well before arriving there. You know, there were other consumer safety officers who were on detail, and they were reaching out to Health Fraud Branch about suspicious products, looking for support and feedback. So, I was able to, again, before you even getting there, offer some insight, tricks of the trade, a little bit of long-distance reassurance, if you will.

And I think a bonus of that was it helped me to early on, like, develop this picture of what maybe I would see if I had the opportunity to get out there. So, again, early on in the project, the CSOs, the consumer safety officers, were finding these products and testing them with this handheld device. And this device actually allows for, if you will, a real-time snapshot of what could be in a product that, you know, might not be labeled on there.

So, something potentially hidden, like a drug or an ingredient. And one of the things that we say is when something is found like that, we would consider that product, “tainted.” So, you know, after these products were tested on island, folks there were shipping them to the mainland. So, that was like for confirmatory FDA testing. And that was another place where my group, Health Fraud Branch, was inserted.

So, we would be made aware of these official results, you know, if something contained an unlabeled ingredient, and we would put out something called immediate public notification, sort of affectionately known as an IPNs. And these IPNs, they allow FDA to notify consumers of tainted products that, you know, could potentially cause serious issues if ingested or taken with other medications.

So, these notifications can be found on FDA’s website. Consumers can look at them, and frankly, I think other countries do, too. And I think it's as... it's funny, I had just recently remembered this because I know other people aren't as familiar. Those notifications are really critical because they not only serve, you know, the American public, but e-commerce giants, you know, like Amazon, eBay, Walmart—all the big ones—they have, like, software, essentially, that culls our lists, and it helps remove dangerous products from their marketplaces.

Mr. Zaccone: Wow. So, considering how much e-commerce goes on today, those notifications, you mentioned IPNs, those play a critical role in protecting public health. And it sounds like this is a significant partnership between the Guam project folks and OII’s Health Fraud Branch to really leverage information regarding tainted products. 

And can you explain why these products are so dangerous?

Commander Aldrich: Yeah John, so tainted products, you know, they can cause potentially serious side effects because they can interact with medications or supplements that someone is already taking. And we know from just experience that there are some main categories that these products fall into. And some of those include sexual enhancement, weight loss or bodybuilding, and pain products. And this was actually consistent with what we saw, as far as suspicious products, in Guam.

You know, the biggest thing that FDA wants to remind folks, and I tried to echo this while I was on island, is that, you know, wherever you are and these products come up and you take them and you have an event, an issue, we want consumers and health care professionals to report these events to the FDA. And there are a number of mechanisms to do this, and they're on our FDA website, you know, such as MedWatch. We also have a form, it's called reporting suspicious illegal products, and frankly, you can actually go right into Google and type that in and it will pop up.

Mr. Zaccone: So, does Guam have a system for reporting adverse events? Something like what we have here, stateside, as you said, MedWatch. And as a reminder for our listeners, that can be found on our website, www.FDA.gov.

Commander Aldrich: Yeah, it's a really good question. Unfortunately, there does not seem to be. I think there was little awareness, if any, around just general reporting of products like this. So, most of the reports that we were aware of were, or at least that the Department of Environmental Health was getting, appeared to be foodborne illness related. And I think the hope is that as this partnership grows, we can continue to encourage consumers, whether that's on the island or anywhere else, to utilize this existing infrastructure for suspicious products and/or, like we just said, adverse events, so that the FDA or island personnel can follow-up accordingly.

Mr. Zaccone: And I think that's important to underscore, and I appreciate you saying that. That regardless of where folks are, they can use www.FDA.gov to report any adverse events, even if they're not here in the U.S. 

So, Claire, I'd like to come back to you, now. We've touched on consumer notifications. Is there a health fraud literacy program as part of the Pacific Island activities?

Commander Aldrich: That's a good question. So, right now they're in a learning phase. Recently, FDA has increased our formalized training on Guam. For example, we’ve provided trainings and presentations to our counterparts, such as the Guam Customs Department and the Department of Public Health and Social Services, on topics such as health fraud of FDA-regulated products, FDA import processes, and what to look for when shipments come in.

This is just one key part of our knowledge building foundation on island. For example, I had the opportunity to present to Guam Customs on FDA-regulated products and what to look for when targeting suspect shipments trying to enter Guam through the island's ports of entry, such as the international airport and seaports.

Mr. Zaccone: That's a remarkable amount of information exchange, and I have to imagine that you'd agree that keeping that momentum going with these efforts is also important.

Commander Aldrich: Yeah, for sure. It's my understanding our partners really appreciate and have asked for more formalized training curriculums where the FDA can collaborate with our counterparts, such as the Department of Public Health and Social Services and the Guam Customs and Quarantine Agency to provide trainings to their frontline inspectors.

Mr. Zaccone: And Shannon, anything you'd like to add to that?

Commander Aldrich: John, I do have a health fraud plug for you. You know, just a benefit to our listeners and this conversation, and again, I tried to stress this on island. Tainted products can cause direct and indirect harm. And I think that, you know, the direct is very obvious, right? A consumer takes the product, it injures them in some way, some sort of severe reaction, contraindication, God forbid, even maybe loses their life over taking this product.

But I think meanwhile, there are these indirect harms and they're much less obvious. It may not do physical harm, but it sometimes keeps folks from seeking appropriate, timely, or essential medical treatment. And frankly, this class of products we're talking about, ones that claim to be a panacea or a cure-all quick fix. They play on people's hopes and their fears. And John, I think at the end of the day, we're all human, right? And when we're human, sometimes that leads us to things that are, unfortunately, too good to be true. So as a takeaway, I think it's really important to remember that just because it's sold in familiar stores, does not mean it's safe. 

And so, I think from my perspective, if we can continue this dialog back and forth with Guam's Customs and Quarantine offering timely information on health fraud basics, maybe even continuing to assist with hallmarks of labeling and what that would look like in suspicious products. It's really going to it's going to leverage, you know, the notifications that FDA puts out, consumer alerts, and other various warnings.

Mr. Zaccone: I appreciate you highlighting the indirect harms. 

So, continuing that training is essential in building that on island infrastructure.

Commander Aldrich: Yeah, it truly is. And I'm hopeful that as this relationship continues, we can leverage those preexisting trainings that we've already done, the relationships, and maybe even increase our message, possibly using social media. I know that not everybody's fond of like, you know, extra social media, right? Like it's more Facebook, more Instagram, but it's a great tool to reach people and people utilize it. So, I think the ultimate goal is a well-rounded, sustainable infrastructure that protects consumers.

Mr. Zaccone: And I think it's fair to say that, unfortunately, we are seeing that unsuspecting consumers are able to access fraudulent products almost anywhere. Would you agree?

Commander Aldrich: Oh, man. Yeah. Unfortunately, tainted products are anywhere and everywhere. You know, they're on online marketplaces, gas stations, convenience and grocery stores. Sometimes they're just sitting next to the energy beverages. And I don't want to be a broken record here, but you really, it can't be overstated that these products, just because they're on well-known retailer marketplaces or mom and pop shops, doesn't mean that they're safe or even legally marketed.

I want to give a couple examples for you. You know, when we were in Guam and we collected some samples there, products were found to contain non-steroidal anti-inflammatories. So, you know, those are NSAIDs—things like piroxicam and indomethacin. This is not your over-the-counter ibuprofen. These are, you know, legit prescription drugs. You would be in shock if you were a consumer to find out you've been taking some product that you thought was all-natural and all holistic. Come to find out it had large quantities of said NSAIDs, right? Like that Diclofenac perhaps. And maybe that person was already taking a prescription drug. 

You know, sometimes tainted products, particularly in the pain category, even have hidden corticosteroids. And those, you know, unfortunately, can cause different impairments, whether that's, you know, psychiatric problems or you can have issues fighting infections. And I think something a little less well known is that when you're discontinuing the use of corticosteroids, it can come with very severe symptoms of withdrawal. So, we just want to always let consumers know if this happens to them, it's really a process that needs to be under the care of a supervised provider, if you will, to attenuate the discontinuation of that.

Mr. Zaccone: Well, that's obviously very concerning, and a difficult reality that we're now all facing. 

Let me take a moment to switch to something more uplifting. Now, the Pacific Islands encompass, obviously, a lot of places. Did either of you travel to anywhere beyond Guam, in the region?

Commander Aldrich: I did. I was super fortunate. I had a chance to go to Saipan not only once, but twice.

Mr. Zaccone: So, tell us where Saipan is in relation to Guam. And of course, what did you do there?

Commander Aldrich: Saipan’s about 120 miles north of Guam and it's part of the Commonwealth of the Northern Mariana Islands. So, that's called CNMI. And it was beautiful and exciting and probably the most uplifting 30-minute plane ride I've ever experienced. It was truly unforgettable. 

On my first visit there, I met public officials. I participated in something called a joint agency taskforce operation, so a MASFO, that was attended by a number of different entities. I was also, I had the opportunity to provide some health fraud training on hidden ingredients. So, that was, you know, things like dietary supplements, foods, cosmetics, as well as doing a little bit of in-field shadowing with the inspectors there at local retail establishments.

Mr. Zaccone: And what was it like shadowing their inspectors in the field?

Commander Aldrich: It was awesome. Being in the field’s a completely ideal opportunity to enjoy, if you will, real-time discussion. So, you know, we'd be in a grocery store and would come across a face cream from whatever country, and it was a time to discuss an FDA alert that we often put out about contaminated creams that often contain mercury. 

Or, we came across pediatric cough syrups from other countries, and that allowed us to talk about an alert that the FDA and the World Health Organization had put out. These cough syrups at the time, they were coming from Indian and Indonesian manufacturers and, unfortunately, they had disturbing levels of ethylene glycol or diethylene glycol, too. And they were contaminants, obviously very fatal or toxic, if they were to be ingested. And essentially, you know, you would want to remove these from circulation if you found them. Ultimately, the products that we found in Saipan, you know, didn't match this alert, but it was this really great moment and sounding board to discuss suspicious products, you know, talk to the shopkeeper, and also just sort of describe how one would locate necessary alerts and information.

So, John, I kind of think at the end of the day, health fraud, it's really about people. You know, it's about spreading timely information, it’s about arming consumers with knowledge, you know, for themselves, for loved ones. And it's about being there for each other and extending this, you know, this deep sense of respect and care to all American consumers, wherever they are.

Mr. Zaccone: And that really dovetails perfectly with the FDA's overall mission of protecting public health. 

So, how did your second visit to Saipan compare with your first?

Commander Aldrich: Let me think. The second visit, similar. I met with staff. This time with, it was the only, it’s the only hospital on island. And I vividly recall the chief operating officer, what she said to me. I'm going to quote her, “We have the most limited resources yet, the best ability to maximize.” And I have to tell you, her comment, it really, it really made an impression on me. It was so clearly evidenced by, like, the creativity and passion in her and her staff and how they were providing this quality care. But frankly, with very few resources. For me, I had a very quick appreciation for the logistical challenges, you know, that would inherently exist being on a remote island. 

I also had the opportunity to speak to the chief of ancillary services at the hospital, and he told me a little bit about a potential surveillance study on herbal supplements where they were going to be testing for opioids, fentanyl, and other hidden ingredients. So, obviously, that totally spoke to me, given my wheelhouse. 

And so, yeah, I think, you know, as all this continues to take shape and FDA grows its roots a little bit more in the Pacific Islands, I think the sky's the limit as far as potential collaborations in Saipan.

Mr. Zaccone: Well, it sounds like the people there are extremely resourceful, as you mentioned. And that said, perhaps there's still a lot of opportunities to improve infrastructure and an understanding around the FDA, our regulations, for instance, and even the protections we offer consumers.

Commander Aldrich: Yeah, absolutely. And in fact, similar to Guam, you know, Saipan seemed to take a number of reports for the foodborne illness situations, but there wasn't necessarily a mechanism dedicated to reporting suspicious products or just general tips. So, it's like anything right, John? We don't know what we don't know.

Mr. Zaccone: Well, hopefully with the FDA's continued focus and assistance on the Pacific Island region, issues like those you've mentioned can be resolved. 

And with that, we're at the end of our time. But before we go, I do have one final question for both of you. And simply put, would you go back to Guam? Would you do it all again? And Shannon, your thoughts?

Commander Aldrich: Do I want to go back? Yes, I absolutely want to go back. I would love to go to Guam or Saipan or just anywhere in the Pacific Islands. To me, you know, it's about staying relevant. It's about staying connected. Fraudulent products are just, by their very nature, constantly changing, so that makes them elusive. It's sort of this game of underground systems and relabeling.

And you have to remember in the islands, there's a little bit of lag time between what happens on the mainland, tracking and trending, from what happens to the island, if that makes sense. So, deploying a multifaceted approach, hopefully staying ahead of some of these issues, and just actively monitoring, getting the tips, all the things that we've already discussed today.

In a nutshell, it would be such a gift to go back because of what I know now.

Mr. Zaccone: It's great to hear that you're obviously so inspired by the mission and want to go back. And what about you, Claire?

Lieutenant Tipton: Oh, absolutely. Like Commander Aldrich said, it really resonated with me. It's about protecting public health and Americans everywhere. And yeah, I've even talked about it with my family, and if an FDA opportunity opened up for one of those longer-term positions in Guam, I’d consider it. So, we'll see what happens, but I’d love to go back.

Mr. Zaccone: It's been really interesting hearing about both of your experiences in the Pacific Islands. You've clearly gotten an in-depth perspective, having lived and worked there. And the fact that you're willing to go back, I think, really speaks to the impact that the FDA's having in the region. And let me add, of course, that we all genuinely appreciate and respect the work that you've both done and can only imagine how hard it's been to be away from your homes and families for so long. Claire, you said 70 days. On behalf of the agency, I want to thank you for your efforts. 

Now, in this episode, we were provided an in-depth and personal look at the FDA's presence in the Pacific Islands, and the meaningful differences that agency personnel are having on public health. We also heard about the importance of outreach, partnership building, and health fraud literacy efforts on Guam.

If you'd like to hear more about FDA's impact in the Pacific Islands, you can visit our website at www.FDA.gov to access existing and upcoming episodes in this series. Once there, you can also learn more about this podcast, you can access our featured profiles, and subscribe to OII News and Stories. 

Once again, I'm John Zaccone. Your new host of On The Frontlines, An OII Podcast.

Until next time, be well.