Study Linking Supplements, Mortality Sparks Questions On Safety, Oversight
This article was originally published in The Tan Sheet
|
A study linking higher mortality with common dietary supplements triggers criticism about the products’ safety and how they are regulated. The Archives of Internal Medicine study found women who took multivitamins, B6, folic acid, iron and other common supplements daily had a 3% to 18% increased risk of death compared to nonusers (Also see "Groups Defend Supplement Safety After Study Shows Higher Mortality Risk" - Pink Sheet, 17 Oct, 2011.). It also found daily supplement use by subjects in the Iowa Women’s Health Study, from which the researchers analyzed data, increased substantially from 62.7% in 1986, when the data was first collected, to 85.1% in 2004. The sharp increase in use combined with the potential long-term risks some supplements may pose prompted researchers to conclude there is “little justification for the general widespread use of dietary supplements.” “Although we cannot rule out benefits of supplements, such as improved quality of life, our study raises a concern regarding their long-term safety,” they add. A related editor’s note and invited commentary published in the journal go one step further and recommend consumers forgo supplements in favor of more fruits and vegetables. They also link current regulations to the significant, and potentially dangerous, increased use of supplements. The significant increase in supplement use is due to the “permissive approach” to regulation laid out in the Dietary Supplement Health and Education Act, according to the editor’s note. DSHEA “puts the onus on [FDA] to show that supplements are unsafe before it can take action. Manufacturers are not required to disclose” safety or efficacy data to support claims, Rita Redberg, a physician, says in the editor’s note. The act “has encouraged” more than $20 billion in annual sales of supplements, but “consumers are getting little value for this expenditure,” and could be at increased risk of mortality, Redberg writes. “A better investment in health would be eating more fruits and vegetables,” she adds. Physicians Call For Regulatory Change In the commentary published with the study, physicians at Copenhagen University Hospital in Denmark agree that “consumption of a varied, healthful diet seems to be a prudent preventive strategy,” especially considering “supplements do not replace or add to the benefits of eating fruits and vegetables and may cause unwanted health consequences.” The physicians – Goran Bjelakovic and Christian Gluud – say the increased risk of mortality found in the study should prompt a change in supplement regulation. “We believe that politicians and regulatory authorities should wake up to their responsibility to allow only safe products on the market,” they write. Council for Responsible Nutrition President and CEO Steve Mister defended regulatory oversight of supplement manufacturers and marketers. He argued that regulating supplements like drugs would increase their cost and reduce access without necessarily increasing safety. “Although drugs undergo rigorous RCT testing, many safety issues for drugs still exist,” Mister said. Accusatons Of Bias Mister also criticized the journal as biased against supplements, and says it inappropriately combines “political agendas with what should be pure science.” He complained the publication invited commentary from Bjelakovic, “whose opinion on supplements and their potential role in good health is already well-known, and whose own work has been the subject of controversy in scientific circles.” “In the spirit of true scientific discourse, wouldn’t it have been more appropriate to invite a commentary from a researcher who might have looked at the data in its entirety, with sufficient lead time, and provided a different perspective?” “It’s time scientific journals acknowledge they have some biases,” Mister added. |