In 1977, the US Food and Drug Administration issued a guideline that excluded women of "childbearing potential" from participating in clinical research studies, which was broadly applied to any "premenopausal female capable of becoming pregnant.” The guideline was the result of certain drugs–most notably thalidomide–that led to serious birth defects. This guideline single-handedly changed the course of clinical trials, leading to a world of research plagued with gender inequity.
In 1993, FDA explicitly reversed the 1977 recommendation that women with childbearing potential be excluded from early clinical studies when it published "Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs." The new guideline also called for data to be analyzed to assess gender effect.
While this relates to clinical research on pharmaceuticals, it has impacted all research and led to the shortcoming and biases we see today.
“The FDA aptly states participants in clinical trials should represent those who will use the products to reduce biases, promote social justice and health equity, and produce more innovative science. Yet, even though Caucasian males make up only 30% of the American population, a vast majority of all clinical trial participants are White men in metropolitan areas. Women, People of Color, and the elderly often are not adequately represented,” said Pelin Thorogood, co-founder & executive Chair, Radicle Science, a proof-as-a-service offering that allows dietary supplements to clinically prove their effects beyond placebo.
Since co-founding the AI-driven health technology B-corp in 2018, Thorogood has been on a mission to break the barriers in clinical trials that arise from conscious and unconscious biases experienced by women and minorities.
Change offers hope
At the end of 2022, the Federal Trade Commission issued its Health Products Compliance Guidance, which updated and replaced its long standing Dietary Supplements: An Advertising Guide for Industry that was issued in 1998.
While many aspects of the original remain in the new guidance, there are some key changes that articulate how marketers can go about making health-related claims. Thorogood sees this as an opportunity to disrupt the current system’s cumulative bias.
In the new guidance, Thorogood wants to bring attention to the mandate on diversity in clinical trials with respect to label claims and/or ads. Specifically, the section where the FTC states study populations should “reflect the characteristics of the population targeted by the ad”…and “advertisers shouldn’t rely on research based on a specific test population for claims targeting the general population.”
Specific population vs general population
“How’s an individual using a given health and wellness product expected to rely on its benefits or predict its side effects if no one in the product clinical trial resembles them?” Thorogood asked. “This is why I’m so encouraged by the new FTC guidelines that not only define ‘competent and reliable scientific evidence standard’ backing any health claims as double-blind, randomized, placebo controlled human clinical trials (RCTs), but also bring the focus on the often overlooked area of much needed study population diversity.”
Thorogood said given the increasingly skeptical, educated and label-literate customer-base, coupled with women serving as the chief operating officers of their household, it's going to take a lot more than feminine packaging to win hearts, minds, shelf-space and market share.
“Women are expecting transparency in marketing and evidence-based substantiation of claims. With the new FTC regulation, we are going to get that. The brands that are quick to adapt to this new truth and evidence-based marketing will win with consumers and retailers. The way I see it–and FTC seems to agree– anything less can be considered deceptive marketing,” Thorogood said.
Will the new guidelines move the needle?
Susan Hewlings, PhD, RD, vice president of research affairs at Radicle, said that while the new FTC guidelines do not directly address diversity in research, it may indirectly encourage it by requiring that claims be made for specific populations, whether direct or implied, be supported by randomized, double-blind, placebo-controlled studies in the exact population.
“This has a potential beneficial impact on women in that many ‘women's health’ products are vague about exactly which life stage they are targeting. The more specific guidance will hopefully increase the rigor of women's health studies and enhance the number of quality products for women to support their own health,” said Hewlings.
“It is still very surprising to me how few products there are in the dietary supplement space for women's health that are targeted to various life stages, especially considering the availability of market research that indicates that women make the majority of the purchase decisions in the household for natural health products. Furthermore, there is scientific knowledge that nutritional health needs change throughout the life stages. For example, protein needs increase as women transition into menopause. Where are the products targeting this need? Perhaps the guidelines will push such endeavors and assure they are backed by quality targeted studies,” Hewling said.
Dawna Salter-Farfan, PhD, RD, senior clinical research manager, PLT Health Solutions, said that overall, clinical studies done to support health products are difficult to design due to the fact that they must use healthy people.
“It can take a good amount of creative skill to elucidate clinical outcomes that translate into concrete benefit statements showing the ‘healthy people are now healthier,’ so to speak. Add in the constraints of time, funding, and risk-aversion, and you can start to see why studies might be pulled towards designs that are simpler, faster, cheaper, and with outcomes deemed more reliable. Any additional study variable, such as recruiting equal numbers of women and men, or increasing the subject number so that women and men are properly powered for separate analysis, are going to go up against those constraints of time, money, and risk,” noted Salter-Farfan.
“In the end, I honestly feel that the increasing power and expectations of the woman consumer is what is going to truly drive study population diversity forward. I believe women want products that have been shown–in gold standard clinical studies–to support benefits that are relevant to women in general, and to women who are in discrete life stages with unique need states, specifically. I’m hoping the updated guidance of the FTC will help weed out some of the lesser-supported benefit claims, but also that they will help educate the diverse consumer to use the power of their purse to support those products with benefits substantiated by appropriately conducted studies,” Salter-Farfan added.
“I think it’s good to see these goals set in writing, but it is, after all, just guidance,” said Susan Kleiner, PhD, RD, owner of High Performance Nutrition. “I think it will further support those brands that are already beginning to respond to consumer demand for more evidence based, population-specific data. Perhaps it’s another small motivator for those brands that are on the fence, wondering if there is any ROI for them to invest in research, or base their products on population-specific data. The more brands that get on board, the more likely we will have successful brands that are doing the research, and they will set an example for the business model that leads to successful change. Every little motivator helps.”
Kleiner added that she expects the most impactful changes in the industry to come from within, as the industry now has more diverse leadership and allies in leadership to listen to consumer demand, educate consumers and their brands, as well as implement the changes to research and product development.
Shut up and move
“The discussion on diversity in clinical trials has been going on for far too long with not enough forward movement,” asserted Thorogood. “The new guidelines clearly articulate what constitutes truth in labeling and advertising, and state anyone participating in deceptive marketing is potentially liable under FTC law. The good news is advances in clinical science and technology make it far easier and more affordable than ever to conduct the kind of rigorous and inclusive clinical trials we deserve So, it is time we all embrace and execute on this new mandate to elevate supplement industry marketing, improve science standards, but most importantly, promote health equity for all.”
