Glaxo’s Weight-Loss Petition Relied On “Deeply Flawed” Survey – AHPA

The American Herbal Products Association says GlaxoSmithKline used data from a flawed consumer survey when the firm asked FDA to reclassify weight loss claims as disease claims.

In an April citizen petition, GSK and three advocacy groups argued that FDA should limit weight-loss claims for supplements in part because the majority of consumers contacted in a survey said they thought weight-loss supplements were tested and proven safe before being sold.

AHPA argues the petition presents "invalid conclusions" from the GSK-sponsored survey that is "deeply flawed in both design and interpretation, and therefore provides little meaningful support."

GSK spokeswoman Malesia Dunn notes that the firm worked with The Center for Survey Research & Analysis at the University of Connecticut to organize, design and analyze the results, which were peer reviewed and published in the journal Obesity.

In the survey, conducted between Nov. 18, 2005 and Jan. 10, 2006, a majority of respondents said they thought FDA requires warnings of side effects on weight-loss supplement labels, the petition says.

AHPA argues the petitioners misinterpreted and misrepresented the survey data. The results are based on "poorly worded" key questions that make it unclear if respondents' answers refer to "OTC appetite suppressants," "herbal products" or "weight-loss supplements," AHPA says, noting that the products are regulated differently.

For example, AHPA says, the survey asks if it is true or false that "OTC appetite suppressants, herbal products and weight loss supplements must be approved for safety by a government agency like the FDA before they can be sold to the public."

AHPA says, "There is no way to intelligently answer" questions like this with a simple true/false because the survey does not differentiate between OTC products and supplements. Nor can investigators make clear conclusions about how consumers perceive the safety and efficacy of these products because, as the investigators acknowledged, they "do not know which of these specific products respondents used," according to the comments submitted Oct. 8.

The petitioners argue FDA should consider weight-loss claims as disease claims in part because a majority of consumers who buy weight-loss products believe overweight increases the risk of diseases (¹ (Also see "Petition Requests Pre-Market Approval For Supplement Weight-Loss Claims" - Pink Sheet, 28 Apr, 2008.), p. 3).

However, AHPA notes, the survey found only 5 percent of respondents identified avoiding serious health conditions as the benefit they most hoped for from weight loss, while 43 percent said they wanted to improve general health and health-related concerns by losing weight.

An additional 22 percent of respondents said they wanted to lose weight to look better, and 28 percent said they wanted to lose weight for minor health reasons, such as to "feel better," AHPA said.

Based on these data, AHPA argues the petition is "inaccurate to claim ... that consumers engage in weight loss primarily to reduce the risk of serious disease such as cancer, diabetes or heart disease; rather, the data indicate aesthetic reasons and minor health issues as the primary motivators."

Some supplement industry experts say that claiming to help people lose weight to improve their image and feel better in general is an appropriate FDA-approved structure/function claim.

Petition Threatens To Eliminate alli Competition

AHPA argues that the petition's request to require pre-market approval for supplements would "grant GSK's alli a monopoly in the weight-loss market."

GSK's alli (orlistat) is the only OTC weight-loss drug available in the U.S. The firm launched the product in 2007 with a package display panel featuring the phrase "FDA approved non-prescription weight loss aid" (² (Also see "Alli Marketing Stresses Education, With Emphasis On Minority Groups – GSK" - Pink Sheet, 28 May, 2007.), p. 4).

AHPA says the petition asks FDA to ignore the Dietary Supplement Health and Education Act's promotion of consumer choice. "Congress made clear its intent with regard to consumer empowerment and right of access to information relating to dietary supplements. ... The petition largely disregards these notions. ... [T]he very purpose of the petition is to limit consumer choice," AHPA says.

Petitioners Cite New Data?

AHPA agrees with comments previously submitted by the Council for Responsible Nutrition that FDA appropriately ruled in 2000 that being overweight is not a disease. The trade group also discounts the petition's argument that FDA should reconsider this decision based on "new" information not available when FDA published the final rule.

Information about the link between overweight and certain diseases existed years before the agency promulgated the final rule, AHPA says, noting the petitioners cited many studies published in the 1990s that make the connection.

GSK contends there is no evidence that FDA considered those studies and, Dunn noted, most of the studies conducted prior to 2000 involve risk associated with obesity rather than overweight.

AHPA adds the petitioners failed to discuss new data published in 2007 that contradicted their position. A study on the "obesity paradox," published in the Journal of the American Medical Association, found overweight was associated with fewer "excess deaths" than being underweight.

Dunn counters that "there is an overwhelming body of science about weight and risk that is enough for FDA to grant the position."

First Amendment Rights Threat

AHPA argues that if FDA grants the petitioners' request, it would violate the dietary supplement marketers' First Amendment right to make "commercial speech that is not false or misleading."

The government cannot restrict commercial speech unless it is false or misleading, which the petition claims but does not substantiate, AHPA says.

For example, "the petition offers no support for the notion that the presence of cellulite is necessarily related to being overweight, let alone that it is a risk factor for obesity." Nor does the petition show consumers perceive the claim that a dietary supplement "increases fat oxidation" as a claim regarding weight reduction, much less that this somehow relates to obesity, AHPA writes. Yet, the petition seeks to wipe out both types of claims.

Further, if FDA decides weight-loss claims are disease claims, the agency "would have to prohibit both dietary supplement and OTC drugs such as alli from making weight loss claims - otherwise, FDA would be arbitrarily treating these speakers differently in violation of the First Amendment," according to AHPA's comments.

- Elizabeth Crawford ([email protected])