Global Evolutions

Harvard Health Letter Inaccurately Slams Heart Supplements

<p>The Harvard Health Letter&#8217;s August 2014 edition says supplements don&#8217;t benefit people with heart disease and may even pose health risks, however the article contains inaccuracies and unsupported statements.</p>

The Harvard Health Letter’s August 2014 edition says supplements don’t benefit people with heart disease and may even pose health risks.

The article, “Dietary supplements: Sorting out the science," contains good advice to consumers, such as talk with doctors about supplement use and look for third-party certifications, but it’s also filled with inaccuracies and unsupported statements.

Issue 1: Efficacy and Safety

The article states, “Unlike pharmaceuticals, which undergo extensive testing to prove they're effective and safe before they can be sold, dietary supplements can be sold without proof of effectiveness or safety. Moreover, supplement makers can claim their products enhance health, despite a dearth of evidence in most cases."

While supplements are not approved prior to entering the market like drugs, supplement brands are required by law to have claims substantiation, according to Dan Fabricant, CEO and executive director, Natural Products Association (NPA), and former director of FDA’s division of dietary supplements. “Whatever they claim needs to be truthful and not misleading," Fabricant said. “By law, you have to have substantiation of claims, and if a brand claims to enhance health, it should have studies that show how the product is enhancing health."

Regarding safety, Fabricant noted any article of food—including supplements—needs to have a reasonable expectation of safety to enter the market. That expectation can come from history of use or, if it’s a new dietary ingredient (NDI), brands are required to show FDA safety information prior to selling the product. “If it’s something that’s never been in the diet, they have to have acute and subacute toxicity studies, and studies on tolerated doses; that’s required by the law for NDIs," Fabricant said. In addition, Fabricant noted post-market surveillance monitors supplement safety. “Folks should use the post-market and adverse event report (AER) data to learn more about their products and take corrective action, if necessary."

Andrea Wong, vice president of scientific and regulatory affairs, the Council for Responsible Nutrition (CRN) also noted the many safety measures in place for supplements including GMPs (good manufacturing practices) and adverse event procedures as required by law. “Dietary supplement products have a strong safety record," she said.

Issue 2: Multivitamin Efficacy

The article claims, “One of the most popular dietary supplements taken by people trying to prevent heart disease—a daily multivitamin—does not lower the risk of heart disease."

Wong said this is a pharmaceutical mindset, but supplements are a category of food, so their effects are different from those of drugs. “Supplements are not alternatives to conventional medicines, as implied in this article," she said.  “Supplements produce modest effects over time, and they are not intended to have the same immediate or dramatic effects that you would expect from pharmaceuticals."

Specifically on multis, Wong noted, they fill nutrient gaps, “So that alone is reason enough to take them because we know so many Americans fall short of several important nutrients, but we need to manage expectations. Supplements in isolation should not be expected to prevent chronic diseases such as cardiovascular disease."

Issue 3: Scientific Support

The article says most supplements have limited evidence of health benefits.

As the editor of INSIDER, I know the thousands of studies that demonstrate the health benefits of dietary ingredients. But again, supplements are not drugs and they don’t act the same way in the body.

The article says a handful of supplements are possibly effective for treating high blood pressure and high cholesterol, and that studies show garlic supplements can reduce blood pressure by 8 percent. That’s a lot, and I wouldn’t call that limited evidence, especially for the consumers who are helping their hearts without the unwanted side effects of pharmaceuticals.

“If you have a numbness in your arm and a lot of pain in your chest, you should seek medical attention right away," Fabricant noted. The answer is not to take a supplement. However, “There’s a lot of science behind ingredients, and people should follow the research instead of the ‘nothing works’ language." Fabricant pointed to the body of science on ingredients like fish oil and beta glucans that help with cardiovascular health. Fish oil was again approved by FDA as a drug just this week (AstraZeneca’s Epanova). “While it’s a higher concentration, it’s effectively the same fish oil you get as a supplement," Fabricant said.

Issue 4: Interactions Without Notification

From the Harvard Health Letter: “Just like conventional medicines, however, garlic supplements may interact with a variety of different drugs—including those taken by people with heart disease, such as warfarin (Coumadin). But you won't typically see that information on a supplement label."

Supplements are components of foods, and foods also don’t label which drugs they may affect. The most well-cited example is grapefruit, which can interact with dozens of drugs and supplements.

Fabricant noted that while some supplement firms voluntarily include possible interactions on their labels, drugs carry the warnings. “The warning is on the drug as it should be, so people should be are of them."

Fabricant and Wong both stressed the importance of consumers talking with doctors to ensure their medications don’t adversely interact with supplements, other drugs or foods. 

Issue 5: Contamination

In one study, notes the Harvard health Letter, one-third of red yeast rice supplements were contaminated with a kidney toxin called citrinin, and they said, “such contamination isn't rare."

Fabricant said citrinin is a contaminate, but questioned the validity of the research Harvard used for the statistic. “I know Consumerlab said they found citrinin, but consumerlab isn’t peer reviewed," Fabricant said, “so I can’t speak on how useful that data is, or if it has scientific validity to it."

Responsible firms that are making red yeast rice supplements under GMPs are testing for citrinin, so controls are in place to make sure the contaminate is not found in finished products.

Issue 6: Use Only Single-Ingredient Supplements

“With a multi-ingredient supplement, it's impossible to tease out which substance is having an effect—either good or bad," the article said. “Also, combination products are more likely to be adulterated with banned drugs."

Wong said, “I’m not sure where that information came from." The article doesn’t site a source here, so it’s hard to tell where they came up with that nugget.

Wong continued, “Companies that follow the law won’t have banned substances regardless if they are single or multi ingredients." Also, she noted some nutrients can work in a synergistic fashion, so often the strongest benefits are seen when they are consumed in combination. “Teasing out individual effects may not be relevant," she said.

Fabricant added, “Those products are not supplements, they are drugs. It’s fraud. It’s a horrible thing, and we’d like to see more enforcement on that area."

Positive1: Talk to Your Doctor

Despite all the issues noted, the Harvard Health Letter contained some good advice for consumers. “Tell your doctor about any supplement you take, so he or she can double check if a particular ingredient interacts with any of the medicines you're on," the authors wrote.

You won’t find any responsible supplement company arguing with that advice.

Positive 2: Look for Third-Party Certifications

The article called out the United States Pharmacopeia (USP) and NSF International as solid verification programs, but they aren’t the only ones. Supplement brands who want to demonstrate their products are safe and effective can work with a third-party to get audited, products tested and methods verified. This shows consumers that their products are safe and meet label claims.

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