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Read Original Story

A new reason to frown

Rating

2 Star

A new reason to frown

Our Review Summary

This was a story raising safety concerns about botulinum toxin – most notably known for its cosmetic use.  It reported on the results of a recent study using animal models.  It did not put the new observations in the context of what other studies have found beyond stating that the potential harms observed have previously either not been seen or perhaps appreciated. 

The study on which the story is based is interesting in that it describes a phenomenon that previously had not been observed.  It remains to be seen if the results can be reproduced and what – if any – relationship exists between the findings in an animal model and in humans.

The last paragraph of the story is clever and appealing.  Unfortunately it provides little insight.  The risks and benefits of these products are not altered by this piece of information. 

Criteria

Does the story adequately discuss the costs of the intervention?

Not Applicable

No costs of treatment were mentioned but that’s understandable in the context of this story about potential harms.

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

Not Satisfactory

The story focused on the cosmetic uses of this product, which is approved for use to treat a variety of conditions (neurological, urological, ocular).  While the story did mention this product is also used for lots of so-called ‘off-label’ applications, it did not shed much light on its benefits. The findings are interesting and should lead to additional research in this area.  While the toxicity of these drugs may be related in some fashion to this spread, there are no data to support any definable toxicity in humans.  Without placing this information in context (ie the benefit of these drugs), the reader is left with a imbalanced view on the topic.

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

Not Satisfactory

The story provided a clear report on the potential harm to rats receiving Botox injection into whisker muscle. But the story went beyond a reasonable argument to suggest a link between the study results and harms to patients.   While the implication of the study is that there is the potential of systemic effects following local treatment with botulism toxin, the story didn’t really make clear what this meant.

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

Not Satisfactory

The story mentioned of the some of the findings reported in a recently published study that used mice and rats to examine the localization of botulism toxin when delivered to several different types of tissue (brain, eye, and whisker muscle).  The story focused on the concerns about what the results of this study could mean to people who are treated with this compound.  It mentioned that the results of this most recent study differed from those which had been previously published.  While it is perfectly reasonable to discount the support voiced by the manufacturer of the product, there does appear to be a body of literature which has found the compound to be relatively safe.  (A 2008 review in Laryngoscope estimated that 1.3% of patients experienced morbidity; these were reported to consist of "minor side effects.")

Technically, the investigators did not demonstrate that botulinum toxin migrated but rather the pharmacologic effect did.  While the outcome may be the same, the mechanism is important.  It is also unclear how the author compared dosing in this animal model to the doses used in humans.  Thus the implication of a dose/toxicity relationship in this animal model to humans is erroneous.

Does the story commit disease-mongering?

Not Satisfactory

This story is an example of disease mongering.  It is perhaps unnerving to learn that the injection of botulinum toxin into muscle may not be as completely localized, at least in rats, as had been previously thought.   Implying, however, that the adverse events and deaths are somehow related to the evidence presented in this study is incorrect and misleading.  While it makes the story more compelling to the average reader, it is factually incorrect and an unfortunate example of fear mongering.

Though the story included an estimate of the number of adverse events (1,437) that have been reported following the use of this product, in order to understand whether adverse events are frequent or not, it is necessary to know the total number of treatments with this product.  

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

Not Satisfactory

The story included interview material with the author of the rodent study and an excerpt from a comment made by a company spokesperson.  It should have included comments from independent experts about medical use of botulinum toxin in peple to provide insight into what the compound does, how it works, and the concerns about its use. 

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story really did not provide much insight into the uses of this compound other than its use with wrinkles. It did not include any information about treatment options for wrinkle management or treatment options for the other conditions which botulinum toxin is used to treat.

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

Satisfactory

The story states that Botox reached the market in 1989.

Does the story establish the true novelty of the approach?

Not Satisfactory

The story did not provide a clear picture of how long botulinum toxin has been used and why.  It was first approved by the FDA in 1989 for the treatment of two ocular conditions.  It has subsequently been approved for a variety of uses, though the story mentioned only its cosmetic uses.  

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

Satisfactory

Does not appear to rely on a press release. 

Total Score: 2 of 9 Satisfactory

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