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Diet drug Qnexa: Don’t get too carried away by new study

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4 Star

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Diet drug Qnexa: Don’t get too carried away by new study

Our Review Summary

We applaud the degree and clarity of the context and explanations provided by this story – about how this is not new info, how the FDA had problems with this kind of data when it reviewed it earlier, and how there were financial ties between the study authors and the drug maker.

 

Why This Matters

This is the kind of explanatory journalism we appreciate:  seeing through the headlines and the trumpeting of benefits that may come through even in journal articles and their news releases.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Applicable

Not applicable.  There was no discussion of costs, but the entire story was about the troubled path of a drug that was denied FDA approval last Fall.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

This story didn’t quantify the benefits reported in the latest published study as well as the competing CNN.com story did. The story did make it clear that the journal article and accompanying news release “touted” benefits – but that “In its assessment of those improvements in a June 17 memorandum last year, the FDA’s scientists were not quite as breathless.”

But by not giving the actual numbers seen in the study, the story deprives readers of the chance to assess the value of the combo pill for themselves.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

No discussion of potential harms.

Does the story seem to grasp the quality of the evidence?

Satisfactory

Excellent job.  Readers should have no question after reading:

  • “Don’t get too carried away by new study”
  • “this study is not so new — and its findings may be less weighty than might be concluded with its publication in this respected medical journal.”
  • “the authors offer a comparison that is certainly not apples to apples but which may give Qnexa some competitive edge”

 

Does the story commit disease-mongering?

Satisfactory

No disease mongering in this story.

Does the story use independent sources and identify conflicts of interest?

Satisfactory

Good job on this.  The story stated clearly: “The study described in the Lancet was funded by Vivus. Three of its seven authors are employees of Vivus, a fourth was an employee of the contract research organization that coordinated the study for Vivus. The lead author has served as a consultant to Vivus, and the second author acknowledged receiving donations, honoraria, consulting fees or grants from Vivus (as well as several other pharmaceutical firms with interests in weight-loss drugs).”

Does the story compare the new approach with existing alternatives?

Satisfactory

There was an adequate analysis of the drugs that were the focus of the latest published study.  The story stated:

  • “When the FDA’s staff scientists combined the results of this study with a second study (both funded by Vivus, of Mountain View, Calif.) — they concluded that the weight-loss difference between those taking Qnexa and those taking a placebo was “of nominal statistical significance.”
  • The Lancet study does have some additional data not reviewed by the FDA – -and not entirely typical for such an article: comparisons between Qnexa’s effectiveness for weight loss and that of two other drugs vying for the potentially vast U.S. market for weight-loss drugs. These other weight-loss-drug candidates, commercially known as Lorcaserin and Contrave, haven’t won FDA approval either, but both remain under consideration. In a box labeled “research in context,” the authors offer a comparison that is certainly not apples to apples but which may give Qnexa some competitive edge: In studies performed by other researchers using different populations of subjects under different circumstances, the authors of the Lancet study note, Qnexa promoted greater weight-loss than Contrave, Lorcaserin or Orlistat (a fat-blocking drug long on the market).”

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

This story was clear that the drug Qnexa was “investigational” and had been denied FDA approval last October.

Does the story establish the true novelty of the approach?

Satisfactory

The story does a good job painting the picture of the landscape of Qnexa and two other drugs that have not won FDA approval.

More importantly, while some other news organizations reported, for example, on the “significant promise” in “the new report,” this story emphasized:  “this study is not so new — and its findings may be less weighty than might be concluded with its publication in this respected medical journal.”

Does the story appear to rely solely or largely on a news release?

Satisfactory

It’s clear that this story did not rely on a news release.  In fact, it countered some of the claims in a news release.

Total Score: 7 of 9 Satisfactory

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