Quigley to tap into OTC market
DOYLESTOWN, Pa. Quigley plans to focus on product developments in the over-the-counter arena, as opposed to developing prescription drug products, the company announced Thursday.
Though Quigley will continue to pursue the prescription-only development of QR333, a medicine for the symptomatic relief of diabetic peripheral neuropathy; QR440, a remedy for relief of inflammation and joint pain; and QR448, an anti-infective against infectious bronchitis in poultry.
Ted Karkus, Quigley chairman and CEO, suggested that Quigley would be placing the lion’s share of its investment behind brand development of Cold-Eeze. “We are particularly interested in leveraging our distribution network in mass, pharmacy and grocery retail by acquiring or developing additional personal care and OTC products,” he said. “We are aggressively searching for product acquisitions and researching line extensions of our Cold-Eeze and Kids-Eeze brands to accomplish these goals, diversify our product offerings and to set the stage for future growth of our company.”
Study: Breast-feeding may lower women’s risk of developing metabolic syndrome
OAKLAND, Calif. Breast-feeding a child may lower a woman’s risk of developing metabolic syndrome, a condition linked to heart disease and diabetes in women, according to a Kaiser Permanente study that was published Thursday online, ahead of print, and will appear in the February issue of Diabetes, a journal of the American Diabetes Association.
The protective association was even stronger for women who had gestational diabetes during pregnancy, according to the study’s lead author, Erica Gunderson, an epidemiologist and research scientist at Kaiser Permanente’s Division of Research. Breastfeeding a child lowers risk by 39% to 56% (depending on the duration of breastfeeding) for women without gestational diabetes, and 44% to 86% (depending on the duration of breastfeeding) for women with gestational diabetes, researchers said. Investigators looked at durations that included up to one month of lactation up to greater than nine months of lactation.
Previous research has shown that lactating women have more favorable blood levels of glucose and lipids within several weeks after delivery than women who were not lactating. Other studies have reported much weaker protective associations of breastfeeding with the presence of Metabolic Syndrome and diabetes in middle-aged and older women.
Funded by the U.S. National Institutes of Health, this 20-year prospective study is the first to measure all components of metabolic syndrome both before pregnancy and after weaning in women of childbearing age, enabling researchers to examine breastfeeding in relation to new onset of metabolic syndrome, Gunderson said.
“The findings indicate that breast-feeding a child may have lasting favorable effects on a woman’s risk factors for later developing diabetes or heart disease,” she said, explaining that the benefits don’t appear to be due to differences in weight gain, physical activity, or other health behaviors. However, in this study, less belly fat and higher levels of good cholesterol (HDL-C) were characteristic of women who did not develop metabolic syndrome, Gunderson said.
Among the 704 women, who were ages 18 to 30 years at enrollment, had never previously given birth and were free of metabolic syndrome before all their pregnancies, there were 120 new cases of metabolic syndrome after pregnancies during 20 years of follow-up.
“Because the metabolic syndrome affects about 18% to 37% of U.S. women between ages 20-59, the childbearing years may be a vulnerable period for its development,” Gunderson said. “Postpartum screening of risk factors for diabetes and heart disease may offer an important opportunity for primary prevention.”
USADA develops ‘Supplement Safety Now’ initiative
COLORADO SPRINGS, Colo. A little more than two months following a Senate hearing on steroids in supplements, just about every professional sports organization in the United States and the U.S. Olympic Committee have partnered under the umbrella of the United States Anti-Doping Agency to challenge rogue companies masquerading steroids as supplements, the USADA announced Wednesday.
However, the USADA joint effort is not altogether industry friendly, as the new effort, called “Supplement Safety Now,” will be pushing for more regulation — most notably regulation that would require retailers of dietary supplements to help police the supplement industry.
“Most Americans are unaware that dangerous drugs are intentionally being sold as dietary supplements in retail and Internet stores across America, and that current laws allow for these products to get into the hands of our children too easily,” stated USADA CEO Travis Tygart.
“These unscrupulous supplement manufacturers intentionally exploit loopholes in the federal regulations by selling products containing drugs and marketing them as ‘safe’ and ‘legal.’ Congress needs to act now to close these loopholes,” added Robert Manfred, Jr., EVP labor relations at MLB.
“[The Council for Responsible Nutrition] believes that the current regulatory framework is more than adequate to support the objectives of ensuring consumers’ access to safe supplement products — if the laws are enforced,” stated Steve Mister, CRN president and CEO, in response to the announcement. There are enhancements to the current laws being recommended by Supplement Safety Now that CRN supports, Mister noted, such as clarification around the New Dietary Ingredient notification process from the Food and Drug Administration, which regulates supplements. CRN also supports enforcement actions taken against any companies that do not submit with NDI notifications. “These actions, along with rigorous inspections of manufacturing facilities under existing Good Manufacturing Practices, would help ensure that all new ingredients entering the market are safe, if used correctly,” Mister said.
“[However], some of the recommendations made under ‘Supplement Safety Now’ — which are well-intended — may not be very effective,” Mister cautioned. Instead, both FDA and the Drug Enforcement Agency should be afforded greater resources to enforce the laws that are already on the books, Mister suggested.
Specifically, Supplement Safety Now is advocating the following:
- All dietary supplement companies should be required to register as “dietary supplement companies” so that the FDA can identify them;
- Dietary supplement companies should provide a 75-day pre-market notice to the FDA not only for New Dietary Ingredients, but for all products containing steroids (including hormones, pro-hormones and hormone analogues) and must establish that the product is safe under its intended use;
- Dietary supplement companies should be required to maintain a substantiation file that is available on request to the FDA;
- Distributors and retailers of dietary supplements should obtain evidence of compliance from the manufacturers and licensors that all pre-market requirements have been complied with or bear responsibility for the products they sell as if they were the manufacturer;
- Supplement companies should be required to report all adverse events not just “serious adverse events” requiring hospitalization, surgery or death;
- The FDA should be given the power to unilaterally prohibit sales and initiate immediate recall of any product that has not followed all pre-market requirements or when the FDA determines that there is a reasonable probability that the product poses a safety risk or contains an ingredient that will ultimately be scheduled as a controlled substance;
- The DEA should be given emergency scheduling power for steroids and the criteria for scheduling steroids under Schedule III of the Controlled Substances Act should be modified to better address the current reality of designer steroids;
- As was done in 2004, Congress should immediately amend Section 102 of the CSA to schedule the 20 or more designer steroids that have been identified but not yet scheduled as controlled substances;
- Dietary supplement companies should be prohibited from advertising that any product performs like a steroid, is named similarly to a steroid, affects the structure of the body or touts the fact that a product may soon be declared illegal.
The professional sports leagues that have joined USADA include the NFL, MLB, NBA and NHL.