Vitamin and Mineral Research: Reading between the Headlines

Is the media accurately reporting the results of the latest dietary supplement research? If not, what should the industry do? If so, what can the industry do? Manufacturers have been grappling with these questions for the past several years and may be closer to finding some answers.

The latest reports have undoubtedly hurt the reputations of several popular supplement ingredients. In 2005, an article in the Journal of the American Medical Association (JAMA) questioned vitamin E’s influence on heart disease, and in 2006, two major clinical trials cast doubts on the ability of B vitamins to do the same. Another major trial in 2006 found that calcium and vitamin D only had a modest effect on preventing fractures and had no protective effects against colorectal cancer.

Media coverage of the trial results often has been harsh, causing a steady drumbeat of negative publicity that has left some consumers wary. But many industry experts are now asking questions, not only about the interpretation of the data, but also about the designs of the studies themselves. Recently, trade groups and manufacturers have stepped up their efforts to anticipate negative study announcements and inject their own voices into the debate. Is the strategy working? Many companies involved hope so.

QUICK SOUND BITES

There are a number of reasons why the media continue to publish negative articles on vitamins and minerals. Sometimes the clinical trial results actually show that an ingredient doesn’t work. Other times the clinical trial results are ambiguous, lending themselves to interpretation-positive or negative. But there can be other factors as well. Many reporters don’t have a background in science or nutrition. Others are under pressure to meet deadlines and often need to compress a complicated issue into a single newspaper or magazine column, when in reality, an entire series would be required. Another explanation is that reporters tend to ignore other studies that may conflict with or explain the current study findings.

“The media often seek a quick sound bite from study experts for a story,” says David Madsen, PhD, director of scientific affairs at Pharmavite (Northridge, CA). “This leads to reports on medical and science issues that fail to put a current study in context-that is, how it fits with all the previous evidence on the subject. It is rare that one sees a story on science that does not portray the latest study as the final and definitive word on the subject.” Smith notes that while the majority of health and medical reporters are not medical experts, most are well intentioned and some seem to be knowledgeable about the issues.

Judy Blatman, vice president of communications at the Council for Responsible Nutrition (CRN; Washington, DC), agrees. “In any industry, there are people who are good at their jobs and people who aren’t,” she says. “Journalism is not an exception to that rule. Given that newspaper reporters are generally on tight deadlines and are sometimes covering a field with which they have very little familiarity, I’m often impressed with their ability to get as much of it right as the good ones do.”

Blatman adds that problems happen when reporters cover new studies out of context, as if previous studies didn’t exist. “That leads to an overall flip-flop on advice and general confusion for consumers,” Blatman says. “But there are reasons why reporters report that way. Consumers aren’t interested in the details. They’re more interested in the bottom line: Do I take vitamin E or not? Additionally, media outlets need to sell papers or drum up ratings, and it’s the black-and-white, sensational story that appears to be more likely to achieve that goal.”

WHEN THINGS GO AWRY

What things can go wrong in an article that covers nutrition research? Inexperienced reporters tend to make four general types of errors, according to Brian Wansink, PhD, director of Cornell University’s (Ithaca, NY) Food and Brand Lab. Wansink gives the media good marks overall but notes that some media outlets, particularly small newspapers, use general assignment reporters rather than medical reporters. “That’s often where things go horribly awry,” he says.

One mistake is reporting correlation as causation. For example, say a study shows that children who watch a lot of television tend to be obese. Inexperienced reporters who cover the story might interpret the results to mean that TV makes people obese. “That study will get a reasonable amount of fanfare,” notes Wansink, who is also the author of the books Marketing Nutrition and Mindless Eating. “But the causation isn’t part of the study.”

Another error is exaggerating the size of an effect. Wansink notes that in large studies involving thousands of people, small differences detected among groups of people can be magnified and overinterpreted. “Something can be statistically significant and still be meaningless,” Wansink says. “The size of an effect is very important. Often that’s very easy to skip over.”

A third mistake is using a single link in a chain of events to make predictions, Wansink says. For example, say researchers gave volunteers something hot and spicy to eat, and it increased their feelings of satiety. Some people might reason that if people feel satiety, they eat less, and if they eat less, they won’t become overweight. The conclusion that eating spicy foods will lead to less obesity, however, isn’t necessarily proven by the experiment.

A fourth problem is generalizing the study results to a broader population that isn’t part of the study. As an example, Wansink points to studies that have shown that red wine may help reduce cholesterol. But he adds that few of those studies included women in the study populations. “The fact is, most scientists aren’t going to do studies on wine and include women in the population for fear that if a woman is unexpectedly pregnant and anything happens, they could be sued,” Wansink says. A neophyte reporter could wrongly read the study’s conclusions and generalize them, thinking that they refer to the entire population.

STUDY DESIGN PROBLEMS

Many of the latest articles on vitamins appear to fall into the fourth category. Two trials that made headlines earlier this year, the Heart Outcomes Prevention Trial (HOPE-2) and the Norwegian Vitamins Trial (NORVIT), were based at least in part on data from people with heart disease. Media reports, however, typically didn’t mention the health of the study populations and implied that the results applied to everyone. Similarly, a study reported last March in JAMA on vitamin E’s effects on cancer used data from patients with diabetes and vascular disease.

“While these studies contribute importantly to the research base, they have a limited application for the general population,” according to Annette Dickinson, PhD, past president of CRN. “These studies did not test whether B vitamins used by healthy people can keep them healthy. Instead, they looked at whether B vitamins can treat or reverse heart disease in people who already have it. Vitamins should not be expected to perform like drugs-their greatest promise is in prevention.”

So why aren’t researchers testing the effects of vitamins on healthy populations? The most likely reason is cost. “Chronic diseases take many years, even decades, to develop and manifest themselves,” explains Andrew Shao, PhD, vice president of scientific and regulatory affairs at CRN. “It’s easier to study people who already have disease to see if a substance can have a secondary effect, rather than spending the time and money to study people who are healthy to determine if something can prevent them from getting seriously ill. Another thing to consider is that presumably, those with existing disease will derive the most benefit in the shortest amount of time from an intervention or substance, and those results, if positive, would be good not only for the population studied, but also for the researchers because fewer subjects and a shorter amount of time are needed to conduct the study. That translates into spending significantly less money than you would if you were testing in a healthy population.”

To run similar studies in healthy populations, the number of subjects and study durations would need to be increased by orders of magnitude to be able to detect statistically significant effects, Shao adds. “These types of studies are done, but are rare in comparison with studies in diseased populations because they are simply cost prohibitive. For example, the Women’s Health Initiative was conducted in a healthy population and included 160,000 women, lasting more than seven years and costing more than $700 million.”

Vitamin E Demand Expected to Recover

While negative media coverage of letter vitamins has hurt demand for vitamin E, the long-term picture seems positive. “I think we can expect to see renewed interest in vitamin E, but it will take time,” says Rob Bailey, marketing manager at Cognis Nutrition & Health (LaGrange, IL). 'Internationally renowned researchers are refuting findings of recent studies exploited by the media, and their viewpoints are being heard. We’ve seen some positive research about studies emerge.”

Bailey notes that consumers continue to be confused about the conflicting headlines. “We have our work cut out for us,” he says. “Education is key, and Cognis will continue to work with its customers in reminding consumers about the powerful health benefits of vitamin E.”

One positive sign is that Cognis recently won a production differentiation and innovation award from Frost & Sullivan (Palo Alto, CA) for its line of vitamin E ingredients, which includes products that are generally recognized as safe and that aren’t genetically modified (non-GM). Cognis was selected in part because of its non-GM vitamin E ingredients, which were developed quickly in response to changes in European legislation.

“Today’s business environment is extremely complex,” says Bailey. “Local government regulations can make or break the successes of a product. Cognis’s global team of experts anticipated these rulings and worked diligently to create new products so our customers would have the products they needed once the legislation passed.”

Supplements may also be more difficult to study in a clinical setting because of the way they interact with other factors, such as exercise and overall nutrition. “When research is done, the goal is usually to show improvement by introducing a new variable,” says Katie Ferren, marketing director for TR Nutritionals (Alpharetta, GA). “If the starting point is illness and the subject improves by taking a supplement versus a placebo, it is easy to point to the supplement as the cause for the improvement. But if the person is already healthy, that’s a lot harder to do. Maybe the person just continued to stay healthy because he or she eats a balanced diet or exercises three times a week. It’s much harder to isolate that supplements are the cause of the improvement.”

Another point to consider, experts say, is that most clinical trials are highly qualified examinations of specific questions. “The study populations are very narrowly selected-for example, people in a narrow age range with serious preexisting disease who are often on multiple medications-and often involve an insufficient number of subjects or too short a treatment duration to allow detection of an effect of treatment,” says Pharmavite’s Madsen.

“Perhaps the most egregious flaw in much research,” Madsen adds, “is unrealistic expectations of nutrients, such as trying to show that very sick people, getting the full complement of treatment available, can be improved by a vitamin-when no drug exists to do the same thing.”

A FINE LINE

In theory, vitamin supplements are supposed to be used in combination with healthy lifestyle changes as part of an overall strategy of prevention. In practice, however, supplements often are marketed as treatments for specific conditions. Therefore, it’s possible that some researchers select study populations on the basis of a supplement’s perceived use. Some researchers, for instance, say that the dosages used in their clinical trials are based on the dosages indicated on product labels.

However, the distinction between treatment and prevention is often murky. The high number of treatment trials is ironic, according to CRN’s Shao, given the Food and Drug Administration’s (FDA; Rockville, MD) regulations regarding product claims.

“When the industry talks about prevention, what we usually mean is reduction of risk,” Shao says. “From a legal and regulatory standpoint, manufacturers cannot claim, either on the label or in advertising, that their dietary supplement product treats any disease. That’s a drug claim. And manufacturers may only claim prevention for a specific disease if a specific claim has first been approved by FDA.”

Studies such as the Glucosamine/ Chondroitin Arthritis Intervention Trial (GAIT) actually pose a challenge for manufacturers that would like to publicize the results, forcing them to walk a fine line in their educational efforts, Shao says. “That is just one reason why CRN has urged and will continue to urge government agencies like the National Center for Complementary and Alternative Medicine to conduct more research on reduction of disease risk in healthy populations,” he adds.

Consumers, meanwhile, tend to gravitate toward treatment on their own. “They are basically oblivious to the regulatory framework that we operate in,” Shao says. “It doesn’t matter to them if it is a food, supplement, or drug. If it helps and it’s safe, they’ll take it.”

STRENGTH IN NUMBERS

The industry is no longer waiting to react to studies as they are reported. Its latest strategy revolves around organizing active campaigns to get its point of view into the reporting cycle before the articles receive widespread distribution. “One of the things CRN has developed a strong reputation for in this industry is our ability to respond to studies in time to get us into the first-day media stories,” says Blatman. “Our response to the NORVIT and HOPE-2 studies being published online in the New England Journal of Medicine is one example, but in February we were also out in front of three studies published literally three weeks in a row. In all three cases, we were able to help ensure that either the study limitations, or positive news from the studies, were included in stories from outlets such as the New York Times, Washington Post, and CNN.”

Such efforts rely on the efforts of industry as well as advocacy groups. CRN, for instance, works closely with its member companies to provide information that the companies can use to educate themselves and their customers. “We often work with our members in task force mode to accomplish these priorities, and sometimes we work with outside public relations agencies, depending on the scope of the study and our anticipation of how much media coverage will be involved,” Blatman says. “This is an area where trade associations are so important, so companies should belong to a trade association, whether it’s CRN or another group.”

Pharmavite’s Madsen, for instance, notes that his company responded to the NORVIT and HOPE-2 trials by first consulting with experts to clarify the proper role of vitamins. The company then worked in conjunction with others to caution against making judgments about applying the study findings to healthy populations. “In partnership with CRN and prominent nutrition experts, we outreached to print and broadcast media to emphasize the importance of vitamins and supplements,” Madsen says. “We fostered a balanced view, countered negative comments about supplement intake, and assured consumers of the benefits of supplements.”

While many in the industry may have been content in the past to react to the news as it happens, the ability to engage the public in a discussion about the limits of new research is becoming increasingly important. The industry’s latest cooperative attempt to help shape the discussion about letter vitamins is a case in point. “It’s true that there is strength in numbers, whether it’s extra bodies to do media outreach or extra funding to send out news releases,” Blatman says. “Our members have gotten this process down to a science.”