British journal argues against prenatal multis, CRN counters
LONDON – Prenatal multivitamins are an "unnecessary expense" according to a review published by BMJ earlier this week, which advised pregnant women to focus on supplementing with folic acid and vitamin D supplements while improving their overall diet.
"Good nourishment, both before and during pregnancy, is essential for the health of the mother and her unborn child," BMJ's Drug and Therapeutics Bulletin reported. "And deficiency in key nutrients has been linked to various complications of pregnancy and birth, including pre-eclampsia, restricted fetal growth, neural tube defects, skeletal deformities and low birthweight."
According to BMJ, prenatal supplements oftentimes contain more than 20 vitamins and minerals, such as vitamins B1, B2, B3, B6, B12, C, D, E, K, folic acid, iodine, magnesium, iron, copper, zinc and selenium, at a cost of almost $20 per month.
BMJ advocated supplementation of folic acid and vitamin D, but nothing else. They may have misssed supplements crucial to healthy fetal development, such as iodine and iron, argued an American trade association representing the dietary supplement industry.
"Reputable medical organizations, including the American Academy of Pediatrics, the Endocrine Society and the American Thyroid Association, recommend that pregnant women take a multivitamin as a way to assure they are getting adequate nutrients such as folic acid and iodine that are critical for the development and well-being of the fetus, as well as for their own health," countered Duffy MacKay, SVP scientific and regulatory affairs for the Council for Responsible Nutrition, a U.S. association representing the dietary supplement industry. "In fact, iodine is now recognized as a nutrient so critical to the cognitive development of the baby during pregnancy that CRN recently developed guidelines urging the dietary supplement industry to ensure that prenatal multivitamins contain at least 150 mcg of iodine daily," he said.
"The scientific evidence is clear — requirements for folic acid, calcium, iron, iodine, protein and other nutrients go up during pregnancy — and the consequences of not getting enough can be significant for both mother and child," MacKay added. "In addition, we know from the 2015-2020 Dietary Guidelines that most Americans fall short in key nutrients, and pregnancy is no exception, especially if you consider appetite changes and nausea that can accompany pregnancy."
BMJ reviewed current UK guidance for vitamin supplements recommended for pregnant women, and found that folic acid had the strongest evidence to support national UK guidance, which recommends that women take 400 micrograms of folic acid daily from before, until 12 weeks of, pregnancy. A daily dose of 5 mg is recommended for those women at higher risk of having a child with neural tube defects – those who have neural tube defects themselves, a family history of the condition or who have diabetes.
The evidence for vitamin D supplementation was less clear-cut, BMJ noted, with little of the trial data showing any impact on reducing the risk of complications of pregnancy or birth. Nevertheless, BMJ advised a daily dose of 10 micrograms is recommended throughout pregnancy and breastfeeding.
As to the other supplements, BMJ suggested there was no evidence of any obvious clinical benefit for most women who are well nourished, and high doses of vitamin A may harm the developing fetus. "We found no evidence to recommend that all pregnant women should take prenatal multi-nutrient supplements beyond the nationally advised folic acid and vitamin D supplements, generic versions of which can be purchased relatively inexpensively," BMJ stated. "For most women who are planning to become pregnant or who are pregnant, complex multivitamin and mineral preparations promoted for use during pregnancy are unlikely to be needed and are an unnecessary expense."
BMJ's arguments against supplementing a diet with a multivitamin may be misguided, CRN argued.
"It is unfortunate that, in addition to disregarding the immense value a multivitamin and its ingredients can provide pregnant women, the authors fail to acknowledge that conducting randomized controlled trials on a multivitamin in pregnant women would be unethical as you cannot deprive a pregnant woman of essential nutrients," noted MacKay. "When the totality of all available evidence is considered, the value of nutrient supplementation during pregnancy makes a clear case."
Jumpstart Foundry and GMDC partner on Health:Further – Retail Tomorrow event
NASHVILLE, Tenn., – Jumpstart Foundry and Global Market Development Center on Tuesday partnered to advance consumer health and wellness innovations through its Health:Further and Retail Tomorrow initiatives.
The partnership is expected to help fuel the growing movement from physician-centric to patient-centric care, where increasingly consumers are driving health care insurance choices, product purchases and wellness – a “health care = self care” model.
“We are excited about partnering with GMDC to explore new levels of health and wellness innovation and engagement for entrepreneurs,” stated Vic Gatto, CEO Jumpstart Foundry. “The industry is moving toward more patient-centric solutions and responsibility is being transferred from insurance companies and employers to consumers. There’s a migration of care out of the hospital and toward retailers, home settings and to patients.”
The first Health:Further – Retail Tomorrow partnership initiative will feature executives from Johnson & Johnson and Wakefern Food Corp. during the Health:Further 2016 conference Aug. 23-24 at the Music City Center in Nashville, Tenn.
Geoff Betrus, senior director of shopper solutions for Johnson & Johnson, and Chris Skyers, VP health and beauty care for Wakefern Food Corp. will reveal how the evolving health care landscape is driving consumer behavior – and how retailers are challenging manufacturers to think differently to impact a new shopping culture in the Affordable Care Act era.
“Now more than ever, the most important customer is the patient, who is empowered within the health care industry value chain. This shift is driving innovation downstream with the potential to generate immense and consistent sales and profit growth at the retail level,” commented Patrick Spear, president and CEO of GMDC. “With our new Jumpstart Foundry partnership, we will advance an innovative Health:Further – Retail Tomorrow culture, where health care is transforming into self care.”
GMDC is an official supporting organization of Health:Further and as a result, members receive a 35% discount to attend.
In an uncertain health care atmosphere and average consumer costs increasing 20% year-over-year, Health:Further recognizes a need for innovation that drives opportunity in the industry. The Nashville-based conference series seeks to bring established retailers and suppliers to the same table as innovators and investors to foster the conversations that are moving health care forward.
In its first year, Health:Further attracted more than 600 attendees for a sold out crowd at the OMNI Nashville Hotel. The program featured C-level speakers from major healthcare companies like HCA and Saint Thomas Health as well as pitches from some of the most innovative emerging health care companies. The 2016 Health:Further Summit will build on this success to fill the Music City Center with more than 1,000 attendees targeting health care industry executives, entrepreneurs, investors and Fortune 500 companies.
In addition to programming, Health:Further 2016 will feature new experiences, including investor matchmaking and mentor hours.
CHPA, FDA discussing user fee program for OTC drugs
WASHINGTON — Since the Food and Drug Administration’s March 25, 2014 Part 15 public hearing on the OTC Drug Monograph, the Consumer Healthcare Products Association has been in discussions with FDA and relevant committees in Congress to identify potential enhancements that would update and modernize this regulatory framework for most nonprescription medicines.
"CHPA strongly supports the OTC Monograph System, but we believe that policy reforms could make the system more flexible, responsive and accommodating to innovation," the association noted in a press release issued Tuesday. "We recognize that resource constraints would affect the ability of FDA to implement any potential monograph reforms, and we are open to discussing ways of adequately funding reforms, including consideration of a user fee program for OTC drugs."
Following the FDA Public Meeting on OTC Monograph User Fees on June 10, 2016, CHPA has entered the stage of discussion that will include detailed talks about the parameters of a potential user fee framework.
Any such framework would require Congressional action. The FDA will post public minutes of these meetings on its website.