Report: Union, Mo., passes new PSE legislation
NEW YORK There is a big danger here, and it’s a danger that has less to do with the neighborhood meth addict in search of pseudoephedrine, and more to do with appropriate access to medicines and who gets to be the gatekeeper to that access. Because not only will a prescription-only PSE restrict consumer access to a legitimate nonprescription cough-cold ingredient, but if successfully mandated by the local government, it also has the potential to limit legitimate access to just about any cost-saving OTC medicine and for just about any reason.
And that’s because you’ve just usurped the ability to switch or reverse-switch a drug from the scientists employed by the Food and Drug Administration, scientists who vet each decision through clinical trials, and placed that ability into the hands of a local politician, who’s sole clinical experience with any given drug may be that he used it one afternoon because he felt under the weather. Or that his niece experienced an adverse event from overdosing on an OTC cough-cold medicine that she shouldn’t have had access to in the first place.
There are some areas that are appropriately left to local municipalities to govern. This isn’t one of those areas, especially since the industry has offered to supplement the cost of a measure that would both cut down on the use of store-bought PSE in the manufacture of meth while at the same time maintaining access of the decongestant to legitimate users.
Study finds aspirin may reduce colorectal polyps recurrence
NEW YORK Although aspirin has been found to reduce the recurrence of tumors in the digestive system, the question of why has yet to be determined, a study found.
The study, reported in the Journal of the National Cancer Institute, tested the hypothesis aspirin affects colorectal polyps, which can lead to cancer in the digestive tract, by affecting inflammation markers.
Researchers at Albert Einstein College of Medicine in New York, led by Gloria Ho, found changes of five inflammation markers are not associated with adenoma recurrence. Adenomas are benign tumors that over time may progress to become malignant.
The researchers looked at inflammation marker changes in 884 subjects divided into three aspirin groups — including an aspirin placebo group and two folic acid groups including a folic acid placebo group. Dietary folic acid — a B vitamin — has also been linked with less colorectal cancers.
“Our data suggest that low-dose aspirin has modest effects on stabilizing C-reactive protein, which may be abrogated by a high level of folate,” the study authors say in a statement. “However, such beneficial effects do not appear to confer protection against colorectal neoplasia. Inflammation markers do not mediate the previously observed effects of aspirin and folic acid on colorectal adenomas.”
FDA warns, then withdraws letter over combining vitamin C and Vicks cough-cold formulations
ROCKVILLE, Md. The Food and Drug Administration on Wednesday initially issued a warning letter to Procter & Gamble for combining the dietary supplement vitamin C with its Vicks NyQuil and Vicks DayQuil cough-cold formulations, according to published reports, and then withdrew that letter from its Web site Thursday citing that the posting was made in error.
The letter initially read: “Because the vitamin C in these products is an active drug ingredient, it is therefore both false and misleading to state that it is an inactive ingredient in these drug products.”
P&G on Wednesday claimed that its marketing of the combination product was appropriate. “P&G has clearly differentiated benefits by the NyQuil or DayQuil active ingredients versus the dietary supplement vitamin C,” stated spokeswoman Crystal Harrell.
Bayer fell under similar criticism last year with its Bayer Aspirin with Heart Advantage (since removed from the market), which contained low-dose aspirin and phytosterols. The Council for Responsible Nutrition, in a statement issued soon after that initial Bayer warning letter, stated: “CRN continues to believe that combination dietary supplement-OTC drug products have a useful and important role to play in integrated healthcare and wellness. … Our hope is that FDA will assist companies attempting to maneuver the regulatory challenges of developing products that combine these ingredients and meet the labeling and formulation requirements of both drugs and dietary supplements, as required by the law.”
CRN noted then that FDA in 1994 stated in the Federal Register that “FDA does not believe that it would be appropriate to preclude such claims [health claims and OTC drug labeling] under all circumstances. Such claims may be permissible if a firm can demonstrate that dual claims can be made in a manner that will neither misbrand the product nor create a safety problem.” Since that 1994 publishing, FDA has issued a few warning letters addressing specific combinations of supplement and OTC drug ingredients, but has never publicly reversed its view that combination products with dual labeling can be developed that would satisfy the agency’s appropriate concerns for safety.