NPA challenges findings on vitamins C, E and cardio health
WASHINGTON In response to new findings to be published Tuesday in The Journal of the American Medical Association on whether long-term vitamin E or vitamin C supplementation decreases the risk of major cardiovascular events among men, the Natural Products Association Monday evening challenged the findings.
“On the second page of the study, it references nine pooled studies that when using 700 milligrams per day of vitamin C showed a 25-percent reduction in the occurrence of cardiovascular disease; yet this study only used 500 milligrams per day. Why wasn’t the 700 milligrams per day amount used when that has been correlated with a reduction in occurrence in prior studies?” asked Daniel Fabricant, vice president of scientific and regulatory affairs at NPA.
“Additionally, while the study did control for multivitamin intake to prevent overlap, intake of vitamin C and E from food was not controlled. With a population of health care professionals at an increased risk for CVD, these subjects most likely know the benefits of a diet rich in fruits and vegetables, and thus rich in vitamins C and E, and may adjust their intake accordingly. This would most certainly confound the study,” he said. “It is essentially a drug study but one without a positive control, which is necessary to ensure the experimental design can produce a positive result even if the intervention was unable to.”
The Council for Responsible Nutrition was less critical. “Although the results did not demonstrate an overall benefit, the results also do not discount the earlier epidemiological data showing that people with high intakes of vitamins E and C may have a lower risk of cardiovascular disease,” stated Andrew Shao, vice president, scientific and regulatory affairs, CRN. “Nutrition research is extremely complex, and doesn’t always provide clear cut answers. This study raises an interesting set of scientific challenges as to why the benefits found in observational studies have not been confirmed in this kind of trial,” he said. “The truth is, we don’t have conclusive scientific evidence in the form of randomized, controlled trials that demonstrate exactly how to prevent cardiovascular disease. We do know there are some well known practical approaches—like not smoking, maintaining a healthy weight, consuming a diet with a variety of foods, regular exercise, seeing your physician, and responsible use of vitamin supplements.”
Robitussin Cough & Chest Congestion DM Max added Wyeth’s cough-cold offerings
MADISON, N.J. Wyeth Consumer Healthcare recently added Robitussin Cough & Chest Congestion DM Max to its stable of cough-cold offerings. The new medication features twice as much guaifenesin—200 mg—as is in its Robitussin Cough & Chest Congestion DM SKU, as well as 10 mg of dextromethorphan, a cough suppressant.
Sun subsidiary extends tender offer to buy remaining shares of Taro
MUMBAI, India A subsidiary of Sun Pharmaceutical Industries has extended the expiration date of the tender offer to purchase all outstanding ordinary shares of Taro Pharmaceutical Industries.
Alkaloida Chemical Company Exclusive Group said the offer would expire Dec. 19 at 5 p.m. Alkaloida extended the tender offer to comply with a continuing order issued by the Supreme Court of Israel that temporarily prohibited closing the offer until the court issued a decision on the appeal of litigation against Alkaloida by Taro.
The court will hear arguments regarding the appeal on Dec. 8. If the temporary order remains in effect on Dec. 19, Sun will further extended the offer.
India-based Sun announced its offer to buy Israel-based Taro on June 30.