May/June 2018

Providers Can Guide Patients' Use of Products Promoted on TV
By James Siberski, MS, CMC; Dan Kimbrough, MS; and Carol Siberski, MS, CRmT, C-GCM
Today's Geriatric Medicine
Vol. 11 No. 3 P. 22

Patients may be confused by television and online advertising for supplements that promise impressive inflated results when no evidence exists of their legitimacy.

Nugenix, Prevagen, Super Beta Prostate, Ageless Male, SuperBeets—and the list goes on. How can providers offer guidance on the efficacy of products with which TV ads bombard patients? It's a difficult landscape for patients to navigate.

What is a dietary supplement? As defined by Congress in the Dietary Supplement Health and Education Act that became law in 1994, "a dietary supplement is a product (other than tobacco) that is intended to supplement the diet; contains one or more dietary ingredients (including vitamins, minerals, herbs or other botanicals, amino acids, and other substances) or their constituents; is intended to be taken by mouth as a pill, capsule, tablet, or liquid; and is labeled on the front panel as being a dietary supplement." Unlike prescription medications, there is no requirement to list possible side effects, drug-to-drug interactions, or other potential contraindications.

One needs only to turn on a television to see numerous commercials for prescription medications and nonprescription supplements. In this direct-to-consumer advertising, a patient's need or problem is presented along with an offer to solve it via a product with benefits that are just too valuable to pass up. It's claimed that the product has been clinically tested or proven, and the hype includes persuasive testimonials to support the claims. However, it's unlikely that all of the viewing consumers fully understand the medical terminology used in the commercials. Consequently, many patients question their providers about these products.

Unless a patient informs a provider that he or she is consuming dietary supplements, the provider remains oblivious. Commercials promoting dietary supplements, including but not limited to those noted above, are not required to list side effects, and there is no guarantee of safety and effectiveness. An article by the FDA states, "Dietary Supplements can be beneficial to your health—but taking supplements can also involve health risks. The U.S. Food and Drug Administration (FDA) does not have the authority to review dietary supplement products for safety and effectiveness before they are marketed."1 The article goes on to note that "the manufacturers and distributors of dietary supplements are responsible for making sure their products are safe BEFORE they go to market." If a dietary supplement contains a new ingredient, manufacturers must notify the FDA about that ingredient prior to marketing. However, the notification will be only reviewed by the FDA (not approved) and only for safety but not effectiveness. Individuals viewing these commercials are unaware of the above limitations, and the clever wording of commercials may lead patients to believe that the FDA has approved the supplement. When appropriate, providers should make patients aware of the risks encountered in consuming supplements pitched to them in commercials.

Helping Patients Understand and Assess Medical Advertising
Encourage patients to evaluate the advisability of product use by employing the following:

• Understand propaganda and advertising techniques. Commonly used techniques include the "magic ingredient." The suggestion that some nearly miraculous discovery makes a product exceptionally effective gives the impression that a particular product owes its "effectiveness" to a magic ingredient. In clinical trials, the magic ingredient has been linked to the desired result. Another misleading practice is the testimonial. A famous personality who uses a product endorses it, touting the subsequent results as amazing. "Weasel words" are used to suggest a positive meaning without actually making any guarantee: "If product X works for me, it will surely work for you." Consumers often fall victim to "simple solutions." For example, a random doctor says that product X can help with an unwanted problem, avoiding complexities and attacking many problems with a single solution. It's suggested that buying a product will lead to the desired result, and even this and that in addition.

• Question the claims being made. How does product X do what is promised? If an ad offers solutions without a specific process, this should raise a red flag. What knowledge do the celebrity promoters have in the area of medical science and what else did they do to obtain the desired response? Often the celebrity is or was in peak physical condition. Can the same be said for the targeted consumer? Also, celebrities typically have no problem with affording specialized meals. How much did a celebrity promoter train and what was his or her diet? Who is the physician who promotes a product? What are his or her credentials and is he or she currently practicing? In the age of the internet, it should be possible to look up individuals offering testimonials and see their actual credentials. More importantly, if there are legitimate credentials, they should be cited in the ad. What is possibly being left out? Does an ad leave the viewer with more questions than answers? Although it appears to offer a great solution, what are the real risks and what information is not included?

• Evaluate the ad. Advertisements are, of course, meant to sell products. There's no guarantee that a product will deliver unless it's backed by the FDA. While all consumers are looking for a silver bullet, it's important for them to remember that they rarely exist, and if they did, they would have the full backing of the medical community and individuals' providers.

Consider Prevagen, for example. Prevagen (apoaequorin) is, according to its official webpage, clinically shown to help with mild memory problems, safe, and uniquely supportive of brain function. The website heralds a computer-assisted, double-blind, placebo-controlled clinical study (although it sounds impressive, it is cursory and lacks a proper citation). Prevagen improved certain aspects of cognitive function over a 90-day period; taking Prevagen to improve memory will yield full results in 90 days—these statements have not been evaluated by the FDA but are on display on the Prevagen website at www.prevagenoutlet.com.

While it is not intended to diagnose, treat, cure, or prevent any disease and offers no properly cited data to support it, a 90-day supply of this product, according to data available online, is more than $100 and, depending upon advertised strength, can exceed $250.

Gayle Nicholas Scott, PharmD, an assistant professor at Eastern Virginia Medical School in Norfolk, Virginia, evaluated Prevagen and in an article titled "Does Prevagen Help Memory Loss?" states that "apoaequorin, a protein originating within glowing jellyfish, is most commonly found within this supplement."

WebMD says apoaequorin is intended "to improve mental function, memory, and sleep quality."

According to Scott, "It is said to help with the regulation of the mineral calcium, which can help prevent natural age-related decline. WebMD postings note that there is a lack of quality studies to ensure there are no side effects and adds that the following have been seen in some users: anxiety, nausea, dizziness, headache, sleep disorders, and heart complications." The site postings admit that it's impossible to verify that apoaequorin caused the above side effects, but that it should be better studied to ensure what it can truly do. Studies are lacking from any third parties not affiliated with the creators of Prevagen.

Consider Nugenix Free Testosterone Booster. The ingredients include vitamin B6, vitamin B12, zinc, L-citruline malate, testofen fenugreek seed extract, and tribulus. WebMD suggests that consumers should "forget the supplements" claiming to increase free testosterone as "you aren't likely to find any that will do much good." Instead, focus on getting enough sleep, maintaining a healthy weight, staying active, controlling stress, and watching any medications that could potentially reduce testosterone levels. When purchased directly through the manufacturer the cost for a one-time order of 90 capsules (a one-month supply) is priced at $69.99 plus $4.99 shipping and handling. A 14-day trial is available, for which a consumer would pay only the shipping and handling fee to receive a 30-day supply of Nugenix. After the trial has expired, consumers will be billed $69.99 for the full price of the product and enrolled in the company's auto-ship program, meaning they'll continue receiving a new order of Nugenix once per month and billed $69.99 plus $4.99 shipping and handling each time. (See www.highya.com/nugenix-reviews.)

Proactive Guidance
What can providers do when older patients come in for their appointments? Initially ask, "Are you taking any supplements you learned about or are advertised on television?" That question can be included on the annual medical update form providers require many patients to complete. If the answer is yes, providers can counsel patients regarding the significant shortcomings of these products, the lack of quality research to support claims, the side effects, and any drug-to-drug interactions, and indicate that patients may be throwing their money away on an unproven product. Additionally, refer patients to a reliable website such as www.nia.nih.gov/health/dietary-supplements. Providers could also ask patients where Nugenix spokesperson Frank Thomas received his medical training. He's the retired, somewhat famous professional baseball player who inquires in press materials, "What guy over 45 hasn't noticed how much harder it is to get back in shape than it used to be? I used to think I just wasn't giving it enough effort, but Nugenix helped me understand it's not my fault, and I can do something about it." Focus patients' attention on spokespersons' lack of medical expertise.

Providers should also explain that not all dietary supplements are a waste of money, possibly dangerous, or ineffective. Dietary supplements such as multivitamins, calcium, omegas, and B12 have positive benefits. Patients should seek a medical professional such as a pharmacist, dietitian, or registered nurse, among others, for advice if they themselves lack the medical literacy to assess supplements. Providers can also mention that there are situations in which these supplements might not be helpful. When a patient is scheduled for surgery, including dental/oral surgery such as a root canal, a supplement might thin the blood, causing complications following the surgery.

Providers are patient educators. Without information supplied by providers, many elderly patients may be unaware of the damage they can do to their livers, kidneys, and other organs by taking supplements. An additional and less time-consuming strategy would be to place Age Page in the patient waiting area. Age Page discusses dietary supplements, herbal supplements, their safety, and other topics important to a patient's well-being. They are easy to read, and Age Page offers other references for additional information. Providers can also order free print materials/publications on healthy aging, health conditions related to aging, and dietary supplements for patients at https://order.nia.nih.gov.

Conclusion
The National Institutes of Health notes, "The majority of adults in the United States take one or more dietary supplements either every day or occasionally. Today's dietary supplements include vitamins, minerals, herbals and botanicals, amino acids, enzymes, and many other products. Dietary supplements come in a variety of forms: traditional tablets, capsules, and powders, as well as drinks and energy bars." This certainly creates a dilemma for providers conducting informed consent discussions with patients to weigh the benefits and risks of taking medications with potential interaction with supplements about whose use providers may be unaware. In attempting to address this problem, the authors recommend questioning patients on the annual medical update form about consumption of dietary supplements and placing educational materials in the waiting area. If the current treatment and medications are not improving or eliminating a patient's condition(s), providers should ask directly about the use of dietary supplements. Providers should seek to verify whether patients are in fact consuming supplements. Finally, providers can advocate for better rules (perhaps even laws) and purity regulations that would benefit patients and the public by protecting them from the modern day snake oil sales tactics.

— James Siberski, MS, CMC, is an assistant professor of gerontology and the director of the geriatric care management graduate certificate program at Misericordia University in Dallas, Pennsylvania. He is also an adjunct faculty member at University of Scranton in Pennsylvania.

— Dan Kimbrough, MS, is an award-winning media producer, consultant, and online brand manager, and is an assistant professor of mass communication and design at Misericordia University.

— Carol Siberski, MS, CRmT, C-GCM, is a geriatric care manager in private practice and participates in research in geriatrics and intellectual disabilities in Pennsylvania.

Reference
1. Dietary supplements: what you need to know. US Food and Drug Administration website. https://www.fda.gov/Food/ResourcesForYou/Consumers/ucm109760.htm. Updated November 29, 2017.

HELPING PATIENTS EVALUATE MEDICAL ADVERTISING
1. Understand propaganda and advertising techniques. Commonly used techniques include the following:

• Magic Ingredients. The suggestion that some nearly miraculous discovery makes the product exceptionally effective.

• Testimonial. A famous personality is used to endorse the product.

• Weasel Words. Claims are made to suggest a positive meaning without actually making any guarantee.

• Simple Solutions. These claims avoid complexities and attack several problems related to a single solution.

2. Question the claims being made.

• How does a particular product achieve what is promised? If the ad offers solutions without a specific process, this is a red flag.

• What knowledge does the celebrity have in the area of medical science and what else did they do to obtain the desired result?

• Who is the recommending doctor? What credentials do they possess? Are they currently practicing?

• What is being left out? Does the ad leave more questions than answers? While it seems to offer a great solution, what are the real risks and what isn't being mentioned?

3. Evaluate the ad.

• Advertisements are meant to sell products. Without backing by the FDA, there's no guarantee that a product will deliver.

— JS, DK, and CS

ENCOURAGE PATIENTS TO BE WARY
For patients looking at online advertising compared with traditional or legacy media, the biggest concern is medical literacy and being able to spot fake articles and news. Where the online world differs is that the ad is often disguised as an article. Many of the same hallmarks exist, such as the following:

• no clear definition on how a product works;
• lack of specifics on who a recommending doctor is; and
• offering a simple and too-good-to-be-true solution.

The difference is the dissemination of the information. Online promoters can create a website ("www.productx.com") that extols the virtue of the product but offers very few details. It might have the same doctors and promises and could even include testimonials and other media elements playing into its legitimate look.

Another source of misleading ads is social media. Consumers will likely see a sponsored post, article, or blog post that is shared from "livingwithdisorderx.com" on a social media feed or when searching for nonprescription and natural alternatives. The first site encountered may be legitimate and feature an article, such as "New and Effective Solution to Disease X Found" with the intent of helping this particular community. But the article itself is simply an ad focused on sending consumers to "www.productx.com."

Anyone can create a website and sell a product. With the proper disclaimer that a product isn't guaranteed to cure anything and isn't approved by the FDA and acknowledgment that it's a supplement rather than medicine, no law has been broken. And anyone can pay for ad placement on Google, Bing, or Yahoo, meaning that if someone starts three blogs with different web addresses about "disorder X" and fills them with content, the individual can pay to have the websites show up in the top 10 search results. Those blogs can all have information that leads back to "www.productx.com" even though that's not the website that's promoted. That's how the hook works.

First, patients find the product on a trusted site (eg, "livingwithdisorderx.com") or see it shared by someone believed to be internet savvy. Second, when researching it, patients find numerous articles about the product with what appear to be credible testimonials. Lastly, all searching leads back to the same website, which is "www.productx.com." The patients feel confident in completing the due diligence and having found a miracle cure. In reality, they have followed a trail of breadcrumbs that were meticulously laid out.

Anytime patients search online and the results are always associated with an ad or sponsored content, someone is paying top dollar for consumers' attention. Providers must be aware of patients' vulnerability to advertising that falsely suggests medical solutions where none credibly exist.

— JS, DK, and CS