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Quick shot replacing nip, tuck

Rating

1 Star

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Quick shot replacing nip, tuck

Our Review Summary

This story about the rise in the use of injectable products spent most of its space on the product called laViv.  The story does not even name the company – or tell readers where they might get the product. The experts quoted are debating whether laViv is “as good as other injectables” but nobody is asking – what is the evidence that it is safe or what do skeptics say about it?

 

 

Why This Matters

People spend money on vanity and cosmetic dermatology, making it a big business. Approval of a product requires testing and attention to safety. Readers deserve the same reporting standards about this sort of product as any other. Although laViv and the other drugs used as fillers appear to be benign, they are drugs that require the same level of scrutiny as any other drug approved by the FDA. They have the potential for side effects as any other drug does.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The story does not give an actual cost for the therapy but suggests the regimen will be more expensive than available approaches. We are left unsure of any detail for the reader to understand how much they will pay for a typical treatment with laViv.

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

Not Satisfactory

The story does not give readers enough description of potential benefits of laViv or other fillers. The FDA approved it on the basis of a 6-month study in several hundred patients. Just over 50 percent reported improvement in the nasolabialfolds (as compared to 30 percent who received placebo injections.)

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

Not Satisfactory

The story does not quantify harms. There is no mention of harm. One expert indicates FDA approval means the product is “safe and can work.” What the story does not say is that the FDA advisory board had significant issues about the safety of the product and the FDA required the manufacturer to conduct a post marketing study to determine the safety of the product.

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

Not Satisfactory

There is no evidence offered in the story for the effectiveness of the newly approved laViv. The sole skeptic voice quoted in the story is Thomas Mustoe, a professor of surgery at Northwestern Memorial Hospital. His skepticism is limited to not being sure that laViv will work “as well as other nonsurgical options.” No one in the story questions whether laViv or other cosmetic therapy is safe. “What is unknown is whether it is going to turn out to better than other fillers,” Mustoe states in the story.

Does the story commit disease-mongering?

Not Satisfactory

The story engages in disease mongering, suggesting that a widow could not come “out of her shell” because the “aging process was taking hold.” The story assumes that all Americans desire to use cosmetic surgical or injection procedures to try to erase natural aging.

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

Not Satisfactory

The sources are dermatologists who may market this therapeutic in their practices. No expert – from outside the cosmetic industry – is asked for an opinion.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story does talk about Botox, which is one existing alternative for cosmetic enhancement. It does not use any metric to compare effectiveness of laViv with other therapies.

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

Not Satisfactory

The story suggests that LaViv is available at the present time. In a few minutes online, we were able to find a company statement saying “we hope to make it available soon” and that was dated June 2011. According to other news accounts, the company is Fibrocell Science of Exton, Pa., and several published reports say it has very little money to promote its new therapy, which may be available to only about 1,000 patients nationwide in this first year and only in “major metropolitan” centers.

Does the story establish the true novelty of the approach?

Satisfactory

The story provides a bare minimum of information about the novelty of laViv compared to other FDA approved cosmetic fillers.

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

Satisfactory

It does not appear to rely on a news release. However, there is an apparently word-for-word identical blogpost by the same author at
a link called “cosmeticenhancementonline” and no reference there to the newspaper story.
http://cosmeticenhancementonline.blogspot.com/

Total Score: 2 of 10 Satisfactory

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