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Author Topic: I know they lie. Why? They open their mouth.  (Read 829 times)

Omegafant

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I know they lie. Why? They open their mouth.
« on: September 25, 2016, 04:17:51 PM »

[*quote*]
Health Affairs 34(3) 438-446 (2015)
Mandatory Disclaimers On Dietary Supplements Do Not Reliably Communicate The Intended Issues

Aaron S. Kesselheim (1), John Connolly (2), James Rogers (3) and Jerry Avorn (4)

1 Aaron S. Kesselheim (akesselheim@partners.org) is an associate professor of medicine at Harvard Medical School, in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, in Boston, Massachusetts.
2 John Connolly is a research assistant in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital.
3 James Rogers is a research assistant in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital.
4 Jerry Avorn is a professor of medicine at Harvard Medical School and chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital.

Abstract

Some efforts by the government to regulate the promotional statements of pharmaceutical manufacturers have recently been found unconstitutional under the First Amendment, which has been interpreted to protect commercial as well as personal speech. As an alternative means of protecting patients from unreliable marketing claims, courts have proposed that the Food and Drug Administration could add disclaimers to promotional messages that discuss off-label, or unapproved, uses. We conducted a systematic review of studies of the disclaimers currently required for dietary supplements, to assess how well disclaimers inform consumers’ health choices. A few small studies reported a modest impact of disclaimers on consumers’ attitudes about dietary supplements, but larger and more rigorous studies generally revealed that many consumers were unaware of a disclaimer or reported that it did not affect their perceptions of a product. The available evidence indicates that replacing government restrictions on pharmaceutical marketing with potentially ineffective disclaimers will be an inadequate way of informing patients about the efficacy and safety of drugs, and it risks returning the United States to a previous era when inappropriate marketing claims about prescription drugs proliferated and contributed to the inappropriate use of those products.

http://content.healthaffairs.org/content/34/3/438.abstract

Excerpts (reference numbers deleted):

"The aforementioned five randomized studies were of consumers’ interpretation of the safety and efficacy of various dietary supplements when a DSHEA disclaimer was present (Exhibit 1). The two largest assigned participants to assess hypothetical dietary supplements labeled with the DSHEA disclaimer or not.

"In one...The authors then tested the effect of the standard DSHEA disclaimer on subjects’ interpretation of these messages. The authors found no effect of the presence or absence of the disclaimer on consumers’ belief that the product would have the effect it claimed to have, nor on their belief that the FDA had evaluated the manufacturer’s claims of effectiveness—despite the DSHEA disclaimer clearly stating that the FDA did not review the claims.

In the second study, Tonya Dodge and Annette Kaufman randomly assigned 266 undergraduates to assess a hypothetical dietary supplement intended to improve muscle mass and burn fat, with or without the standard DSHEA disclaimer. Participants answered seven questions about the product’s effectiveness and safety. Those assigned to the disclaimer group rated the product slightly less effective but rated the two products equally safe."

"Two other randomized studies by Marlys Mason and coauthors focused on dietary supplement users to assess whether the DSHEA disclaimer affected perceptions of two fictitious products. In the first study...They found no effect of the DSHEA disclaimer on safety ratings, overall product evaluations, or efficacy ratings by the respondents."

"In the second study, the same researchers presented a fictitious weight loss supplement to 199 undergraduates, of whom 61 were current or previous weight loss supplement users. The researchers found similar results."

"The remaining six studies used various qualitative metrics to address how consumers interpret and react to disclaimers...The largest study...was a phone survey of 3,500 adults that assessed their perceptions of dietary supplements. The investigators found that 48.8 percent of self-identified supplement users and 45.0 percent of nonusers agreed with the statement that over-the-counter 'appetite suppressants, herbal products, and weight loss supplements must be approved for efficacy, or effectiveness, by a government agency like the FDA before they can be sold to the public.' The DSHEA disclaimer notes clearly that the effectiveness claims made for the product have not been reviewed by the FDA."

"Marlys Mason and Debra Scammon confirmed these results in a qualitative face-to-face interview study of dietary supplement users. The authors found that users knew about the disclaimer, but many still believed that the FDA had tested the claims made by the manufacturer."

“We identified only a handful of studies that attempted a rigorous assessment of the impact of mandatory disclaimers attached to dietary supplements on consumers’ perceptions of the safety and effectiveness of the products or of their regulatory status. Nearly all of these studies found that consumers were generally unaware of the disclaimer or attached no weight to it in their perceptions of the product. Overall, the existing evidence base presents a disappointing picture of the effectiveness of disclaimers as a means of communicating the limitations of health claims that do not meet scientifically rigorous standards for validity.

“There are at least three reasons why disclaimers may have had such unimpressive effects. First, recipients of advertising messages may be overwhelmed by the totality and complexity of the marketing messages to which they are subjected.”

“Second, readers or viewers may be aware of the disclaimer but discount its importance. One survey found that a majority of Americans believed that advertising associated with health-related products was ‘generally true.’

“In the pharmaceutical marketplace, some studies have shown that physicians tend to trust marketing messages that they receive, even when contradictory scientific evidence is available.”

“Third, disclaimers also may not have had much impact because consumers who do not understand the role of the FDA in the marketplace may discount the relevance of a given disclaimer...consumers generally did not understand the limited role that the FDA plays in dietary supplement regulation, even when it is described verbatim in a disclaimer.”

“The limited effect of disclaimers is likely to be even more attenuated outside of the experimental setting. For instance, compliance with rules that require the use of disclaimers or mandate a certain positioning of them may be poor. One review of real-life implementation of printed disclaimers for bodybuilding dietary supplements showed that the disclaimers were typically not placed near the specific health-related claims and sometimes were even placed on different pages. When present in advertisements or television commercials, the DSHEA statement is often presented in a hard-to-find way, whether through tiny type or (on television) a fleeting appearance, if it is there at all. In addition, the advertisements ignored FDA requirements that disclaimer information be presented in a stand-alone paragraph in an appropriate contrasting typeface. One study of Internet-based dietary supplement advertising found that 52 percent of 292 website ads that contained a health claim omitted the required DSHEA disclaimer altogether.

“The impact of disclaimers on patients’ perceptions of medical product marketing claims is important because dubious claims about such products abound.”
[*/quote*]


The industry MUST be forced to tell the plain truth, and not to lie, not to bent the truth, not to twist. Disclaimers are a means to lie and to twist and to withhold true important facts.

What is ALL on the package must not deceit. If it does: lifetime jail for the whole upper management of the whole company! And for the shareholders.

And THEN let us see how fast their lies will collapse.
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