Health News Review

In Our Forum: Reviewer Adds Comments On Hype, USNWR Acne Story
Created 6/09/08

After we published our review of the June 9, 2008 U.S. News & World Report story, "The Latest Advance Against Acne," we discovered some additional information about the product highlighted in the magazine article.

In our discussion forum, reviewer and medical editor Harold DeMonaco summarized what he found:

In the spirit of full disclosure I was the medical editor for this story.

This story is interesting in a number of ways. While new, the device in question hardly represents a breakthrough at least according to the Food and Drug Administration. The Isolaz device was approved under a so-called 510K approval process. The URL for the FDA approval letter is http://www.fda.gov/cdrh/pdf6/K062048.pdf . If you read the letter you will note that the FDA deemed the device to be "...substantially equivalent to the predicate devices." Or put another way, the Isolaz is similar to the following devices:
* Aesthera AIP Intense Pulsed Light System (K04 1554);
* Radiancy Acne System with ClearTouch Light Unit Assembly (KO5 1268);
* Radiancy Skin Station with Modified Light Unit Assembly for Psoriasis System
(K052442);
* Radiancy Clear Touch Lite Acne Clearance System (K06041 1);
* Palomar LuxV Pulsed Light Handpiece for StarLux Systems (K04008 1);
* Palomar StarLux Pulsed Light System (K041086);
* Novalis Clareon & Solarus Pulsed Light Systems w/ AR Handpiece (K0433 19)

The suggestion then that the device is a breakthrough is a bit of an exaggeration.

One of the investigators (Dr. Munavalli) quoted in the article is a member of the medical advisory board of the manufacturer of the device (Aesthera)as well as an investigator.

These facts do not necessarily take away from the value of the device or the validity of the claims made by the interviewees. However, the article is tainted at least in my view by its failure to disclose these facts.

Harold J. DeMonaco

Perhaps the time and space could have been better used by U.S. News & World Report - both when they first posted the story online last February and when it "repurposed" the story this week in print - if it had also explained to readers how medical devices in this country often don't even face the same level of scrutiny for approval as drugs do.

That may have been "news you can use."

If you have comments about this story, visit our discussion forum

Gary Schwitzer
Publisher