HEALTH

Research says 500 deaths of children annually tied to cough-cold medicines

BY Michael Johnsen

ELK GROVE, Ill. Research published Thursday in the American Academy of Pediatrics official journal Pediatrics determined that there is an estimated 500 pediatric deaths a year associated with children’s cold and cough medicine.

“Up until this new research, officials assumed that there were only 3 or 4 deaths a year from these medications,” said Jeffery Chamberlain, co-founder of Honey Don’t Cough, who performed the mathematical extrapolation. “Deaths have been drastically underreported because when a child gets sick and dies, doctors assume that the death was solely related to the illness itself. Typically, no one thinks to check for toxic medications that could have contributed to the death.”

“We have suggested that our state Medicaid program initiate a public education campaign regarding the risks associated with use of OTC cough and cold medicines since poor, publicly insured families may be more likely to give these products to their infants,” said Mary Ellen Rimsza, lead author of the article “Unexpected Infant Deaths Associated With the Use of Cough and Cold Medications,” and chair of the Arizona Child Fatality Review Program.

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Bausch & Lomb announce new corporate VP

BY Michael Johnsen

ROCHESTER, N.Y. Bausch & Lomb on Wednesday named Susan Roberts as a corporate vice president, the company announced. She is the company’s chief compliance officer, having been named to this post in 2006, and heads the global pharmacovigilance and safety surveillance groups.

Roberts joined Bausch & Lomb in 1995 after several years in private practice as a trial lawyer at Harter, Secrest & Emery. She then held positions of increasing responsibility in the Bausch & Lomb law department, including serving as vice president and assistant general counsel.

Roberts holds a J.D. cum laude from the Albany Law School of Union University and a Bachelor’s degree from Binghamton University.

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NFL warns players about unidentified ingredients in dietary supplements

BY Michael Johnsen

NEW YORK As what may be a damning testament as to the common misperception that dietary supplements are unregulated, the National Football League on Tuesday suspended six players without pay for four games for violating the NFL’s Policy on Anabolic Steroids and Related Substances, stating that consumer a dietary supplement that may contain unidentified ingredients unbeknownst to the player is not an adequate defense.

“A positive test will not be excused because it results from the use of a dietary supplement that unknowingly contained a banned substance,” the league stated in its release. “Supplements are not regulated or monitored by the government and players have been warned about the risks of supplement use.”

“The overwhelming majority of dietary supplements, and certainly sports nutrition products, are well-made and safe and not adulterated,” charged Andrew Shao, vice president of scientific and regulatory affairs for the Council for Responsible Nutrition, after reviewing the NFL’s press release. “It’s these rare … obscure cases that, of course, get lots of media attention. That can skew things in some people’s minds,” he said.

In highlighting the few rogue companies that sell adulterated products, news stories like this can color legitimate supplement makers with the same brush. “The [vast majority] of products on the shelf are used by lots of people, including professional athletes [and] weekend warriors all over the country … without any problems. Let’s not lose sight of that,” Shao said.

It’s not a new challenge facing the dietary supplement industry—Donald Fehr, executive director of the Major League Baseball Players Association, in January charged that the dietary supplement sports nutrition end of the business may be juicing its products with performance enhancement ingredients and making them available to the general public at retail. “It’s a red herring,” Steve Mister, president and chief executive officer of the Council for Responsible Nutrition, told Drug Store News for that Feb. 11 story. During CRN’s annual meeting in October, Mister outlined the number of initiatives that CRN is pursuing in an effort to dispel the myth that supplement makers are unregulated, or worse, unscrupulous in marketing supplements to the American consumer—including a self-regulation initiative in partnership with the National Advertising Division of the Council of Better Business Bureaus in vetting supplement claims.

As part of its press statement issued Tuesday, the league published the specific rule governing use of dietary supplements (emphasis not added): “You and you alone are responsible for what goes into your body. … Claiming that you used only legally available nutritional supplements will not help you in an appeal. … Even if they are bought over-the-counter from a known establishment, there is currently no way to be sure that they contain the ingredients listed on the packaging or have not been tainted with prohibited substances. … If you take these products, you do so AT YOUR OWN RISK! For your own health and success in the league, we strongly encourage you to avoid the use of supplements altogether, or at the very least to be extremely careful about what you choose to take.”

According to the NFL, in addition to advising players to avoid the use of supplements, the league specifically warned players against using Nikki Haskell’s StarCaps, the weight loss product that three of the suspended players claimed contained a banned prescription diuretic that led to a positive drug test, having added Balanced Health Products, which makes StarCaps, to its list of prohibited dietary supplement companies on Dec. 19, 2006.

According to the NFL, in addition to advising players to avoid the use of supplements, the league specifically warned players against using Nikki Haskell’s StarCaps, the weight loss product that three of the suspended players claimed contained a banned prescription diuretic that led to a positive drug test, having added Balanced Health Products, which makes StarCaps, to its list of prohibited dietary supplement companies on Dec. 19, 2006.

According to the NFL, in addition to advising players to avoid the use of supplements, the league specifically warned players against using Nikki Haskell’s StarCaps, the weight loss product that three of the suspended players claimed contained a banned prescription diuretic that led to a positive drug test, having added Balanced Health Products, which makes StarCaps, to its list of prohibited dietary supplement companies on Dec. 19, 2006.

According to the NFL, in addition to advising players to avoid the use of supplements, the league specifically warned players against using Nikki Haskell’s StarCaps, the weight loss product that three of the suspended players claimed contained a banned prescription diuretic that led to a positive drug test, having added Balanced Health Products, which makes StarCaps, to its list of prohibited dietary supplement companies on Dec. 19, 2006.

According to the NFL, in addition to advising players to avoid the use of supplements, the league specifically warned players against using Nikki Haskell’s StarCaps, the weight loss product that three of the suspended players claimed contained a banned prescription diuretic that led to a positive drug test, having added Balanced Health Products, which makes StarCaps, to its list of prohibited dietary supplement companies on Dec. 19, 2006.

According to the NFL, in addition to advising players to avoid the use of supplements, the league specifically warned players against using Nikki Haskell’s StarCaps, the weight loss product that three of the suspended players claimed contained a banned prescription diuretic that led to a positive drug test, having added Balanced Health Products, which makes StarCaps, to its list of prohibited dietary supplement companies on Dec. 19, 2006.

In a statement on its Web site, the NFL Players Association stated, “We strongly disagree with the decisions issued by the League in the StarCaps cases.  The evidence showed that the doctors in charge of the steroids program had previously tested the product and knew that it contained a banned substance, but nevertheless failed to inform the players or the union of that fact.”

And according to an ESPN report, attorney Peter Ginsberg, who represented Minnesota Vikings player Kevin Williams in the appeal process, suggested that Adolpho Birch, vice president of law and labor policy at the NFL, passed along the league’s findings that the dietary supplement StarCaps contained a prescription drug ingredient to the Food and Drug Administration. “Birch, in fact, personally informed the FDA that scientific studies showed that [StarCaps] contained bumetanide,” Ginsberg told ESPN.

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