HEALTH

Weight loss rather than adverse effects driving patient satisfaction with alli

BY Michael Johnsen

NEW ORLEANS Data presented at the 2007 Annual Scientific Meeting of NAASO, the Obesity Society, found that patient satisfaction with alli, the only FDA- approved, over-the-counter weight loss product, was connected to the product’s effectiveness in helping them lose weight, and not to potential gastrointestinal treatment effects.

Treatment effects are characterized by predictable GI side effects when alli is taken with meals with too much fat.

This is important because these data show that the weight loss achieved with alli strongly motivates subjects to continue treatment regardless if they are experiencing treatment effects.

“Since having my first child, I have been carrying around extra weight and now I’m a mother of three,” stated Jaime Clear, a 28-year-old alli First Team member from Henderson, Nev. “I committed to losing the weight with alli and have lost 20 pounds in 10 weeks. The treatment effects have been manageable and have kept me honest about my diet.” The alli First Team is a group of 406 men and women that was formed after alli was approved by the FDA, and given the opportunity to use alli at no cost before it was available in stores.

In the study, less than 5 percent of subjects stopped taking alli because of treatment effects and were able to maximize their weight loss.

The analysis of controlled studies shows that during the first week of treatment with alli, the overall incidence of most treatment effects was generally low—between 3 percent and 8 percent. The overall rate was 33 percent lower when compared to those taking Xenical (which has 120 mg of orlistat, the active ingredient, as compared to the 60 mg dose found in alli). Researchers determined that when alli was used for three months without physician supervision in a non-controlled setting, the overall incidence of treatment effects was 20 percent lower compared to controlled studies.

“The alli data we’re reviewing show that treatment effects are not a major issue for most patients taking alli because they are highly motivated by the weight loss achieved,” stated Vidhu Bansal-Dev, GlaxoSmithKline Consumer Healthcare director of medical affairs. “In addition, many alli users have repeatedly told us that they view treatment effects as a positive tool to help make them aware of hidden fats in foods.”

In addition to the cumulative data analysis released at NAASO, recently collected consumer data show overall satisfaction with the alli weight loss program was ranked at 85 percent among alli First Team members. Moreover, a new consumer survey conducted by Nielsen and funded by GlaxoSmithKline Consumer Healthcare showed nearly 70 percent of people reported losing weight after starting the alli program.

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FDA committees vote against cough-cold products for children under six

BY Michael Johnsen

SILVER SPRING, Md. Purveyors of cough and cold medicines were today dealt a significant blow immediately before the cough and cold illness season.

A pair of advisory committees for the Food and Drug Administration Friday afternoon voted against recommending any cough or cold products to any child under the age of six.

Specifically, the committees, representing both the Nonprescription Drugs Advisory Committee as well as the Pediatric Advisory Committee, voted almost unanimously that cold medicines should not be used for children under the age of two; and voted 13 to 9 in favor of not advising cold medicine use on children under the age of six. However, the committees leaned the other direction with regard to children between the ages of six and less than 12—seven committee members recommended that cold medicines not be used in this population and 15 members suggested that cough and cold medicine use in children of this age group was appropriate.

The Consumer Healthcare Products Association earlier this month announced that its member companies have voluntarily recalled all products marketed toward infants and babies, or children under the age of two.

Part of the concern in taking any of these medicines off the market expressed by several committee members is one of unintended consequences. What will parents do if these cold products are not made available to them?

Hopefully consult their pharmacist, or another healthcare professional on alternative remedies or the practice of not administering any remedies, commented Winnie Landis, president of the American Pharmacists Association. If these products are removed from the market, Landis expressed a concern that parents will make a go at treating their children without consulting a healthcare professional. APhA was on hand before the committee to recommend that use of medicines should not be recommended for children under the age of two, in accordance with the CHPA position, and that line extensions within the same brand name of products should be limited as these line extensions tend to add to the confusion in shopping the OTC cough/cold aisle.

On the other side of the argument, several committee members expressed concern that there appears to be no evidence proving efficacy of cold medicines in children. Consequently, it would be irresponsible to recommend the use of these products given known serious adverse events, however rare those events might be. “The discussion I’ve heard regarding efficacy is that there is none demonstrated,” commented Robert Daum, professor of pediatrics at the University of Chicago Medical Center and member of the Pediatrics Advisory Committee. However, Mary Tinetti, chairman of the Nonprescription Drug Advisory Committee and professor of medicine, epidemiology and public health at the Yale University School of Medicine, countered that lack of evidence of efficacy does not necessarily mean lack of efficacy.

“I do not believe that these” products should be removed from the market, commented Amy Celento, a temporary voting member for this committee representing patients and families. “There are many, many adults who will … administer adult products to children” if products specifically marketed toward children are removed from the market.

The Food and Drug Administration will be unable to implement any hard and fast regulatory changes in the immediate future, however, suggested that the advisory committee recommendations may be a prompt for the agency to consult with industry on more immediate action. “That doesn’t prevent us from having a meeting with industry and say ‘Look, you need to go down this path because this is where we’re heading,’” commented Charles Ganley, director of FDA’s office of nonprescription products.

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Report calls into question marketing of OTC cold medicines for children

BY Michael Johnsen

BOSTON The Prescription Project on Thursday released a report showing that companies producing over-the-counter cough and cold medicines spent more than $50 million marketing these products for children under the age of 6 despite evidence of risks and lack of effectiveness in treating children.

The report, titled Risk With No Benefit: The Marketing of Over-the-Counter Cough and Cold Medications for Children, was released to coincide with today’s Food and Drug Administration’s Nonprescription Drug Advisory Committee hearing on the potential dangers of these products for children under the age of 6.

The Prescription Project report, which analyzed FDA, industry, and epidemiological documents on OTC remedies, found a lack of efficacy data but a significant number of reported injuries and deaths associated with overdosing of these products. “Especially when it comes to over-the-counter drugs, physicians and patients rely on the FDA to ‘calculate’ the benefits versus risks and communicate this to the public,” stated John Santa, a consultant to the Prescription Project and former medical director of the Drug Effectiveness Review Project. “In this case, it appears the benefits are close to zero while the risks are significant.”

The Consumer Healthcare Products Association contends that OTC cough and cold medicines administered to children over the age of two, when used as directed, is safe and effective. Overdosing and misuse, such as using an antihistamine to sedate a child, are legitimate concerns, the Association has noted, that should be addressed through increased education. 

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