Wednesday, February 24, 2016

Bringing Evidence To The Debate Around Dietary Supplements

Blog_Supplements

We are inundated with health news, yet the quality and accuracy of the news is variable— the Healthnewsreview.org project reviewed more than 1,800 news stories on health care interventions and found that about two out of every three stories failed to adequately address costs and quantify harms and benefits to patients.

The effective and accurate communication of research findings and health information to the public is essential to improving the health care system, and this is the goal of the journalism grant program of the National Institute for Health Care Management (NIHCM) Foundation. This program, established in 2014, supports timely health care journalism examining emerging health issues and their implications for health care cost, quality, and access. Recognizing the evolving journalism landscape and the variety of ways Americans access news, we have a diverse portfolio of grantees including nonprofit investigative news organizations, documentary filmmakers, and consumer-friendly digital media. We also fund educational opportunities for reporters working at newspapers, magazines, TV and radio stations, and online media outlets across the country.

Equally important to communicating accurate information to the public is building the evidence base from which journalists can draw for stories, and NIHCM Foundation does this by supporting innovative investigator-initiated research.

We also support the collaboration of researchers and journalists through our grant programs. For example, we support the Health Matters webinar series (a project of the Center for Health Journalism at the University of Southern California Annenberg School for Communications and Journalism) which aims to improve journalists’ understanding of health policy and research, thus leading to better health journalism that informs and engages the public and policy makers.

An example of our support for investigative reporting that sheds light on research and policy about emerging issues affecting health and the health care system is a recent FRONTLINE documentary on the vitamin and supplement industry. In “Supplements and Safety,” FRONTLINE, the New York Times, and the Canadian Broadcasting Corporation use research and interviews with current and former policy officials, among others, to illuminate serious health problems associated with use of some vitamins and supplements and to explain the lack of federal oversight of the industry.

The documentary was broadcast nationwide on PBS in January and was supported by many large funders. NIHCM Foundation’s grant funding has helped to support the dissemination of this documentary.

Here are some key takeaways from the film.

In the United States, we spend $30 billion on supplements, yet we know little about their safety and health effects.

Vitamins and supplements are now a $30 billion industry in the United States, yet evidence continues to call into question the safety of many herbal supplements, as well as the validity of their health-related claims. The film reveals how a popular supplement, OxyElite Pro, caused acute liver failure/nonviral hepatitis in more than seventy patients before a Food and Drug Administration (FDA) warning to the manufacturer led to a voluntary recall of the product. The film also emphasizes the lack of scientific evidence on the health benefits of fish oil, pointing to a study in JAMA Internal Medicine that found no evidence that fish oil protects against cardiovascular disease.

The role and capacity of the FDA is limited.

The supplement industry is largely regulated under the Dietary Supplement Health and Education Act of 1994, which prohibits dietary manufacturers from making health claims about their products without scientific proof but does not go so far as to require FDA approval of the products. In an interview in the film, former FDA commissioner David Kessler explains, “What Congress did is basically said, ‘Industry, you go make the claims, and if FDA has a problem with it, FDA has to prove it’s false or misleading.’”

That’s what happened in 2015, when the FDA, along with the Department of Justice, the Federal Trade Commission, and the U.S. Postal Inspection Service brought criminal and civil charges against more than 100 manufacturers and/or distributors of dietary supplements. The FDA admits the industry’s growth has outpaced the agency’s ability to regulate it—there are an estimated 80,000 to 90,000 products on the market. In December, the FDA announced the creation of the Office of Dietary Supplement Programs to both “raise the profile of dietary supplements within the agency” and allow it to “better compete for government resources and capabilities to regulate this rapidly expanding industry.”

Scrutiny of the industry continues to increase.

The film describes how a 2013 New York Times article on labeling fraud in the supplement industry led to an investigation by the New York State attorney general’s office into the contents of supplements sold by four national retailers. In February 2015, that office sent cease and desist letters to GNC, Target, Walgreens, and Walmart, which asked them to halt sales of many store-brand herbal supplements that were found to contain contaminants not identified on ingredient labels or that could not be verified as to whether they contained the herbs listed on their labels.

In April 2015, thirteen state attorneys general joined New York to call for a congressional investigation into the herbal supplements industry and for stronger FDA oversight of the industry.

Recent research supports the need for additional oversight on the safety of supplements—a study in the New England Journal of Medicine estimated that supplements cause 23,005 emergency department visits every year, with 2,154 of these visits warranting hospitalizations.

NIHCM Foundation has been proud to support the work of FRONTLINE as it shed light on this important topic and spurred discussions about potential policy changes and the need for additional research on vitamin and supplement use and its impact on health and health care costs. We look forward to continuing our research and journalism grant making to build a strong evidence base and bring hard data to coverage of health care issues—all with the ultimate aim of improving our health care system.



from Health Affairs Blog http://ift.tt/1oHWLhz

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