Tuesday, July 29, 2008

ViziLite Cancer Screening Test Comes Under Fire by Boston Globe

The Monday, July 28, 2008 Boston Globe featured an article about the new ViziLite oral cancer test. The main thrust of the article is that it's a waste of time and money.

You can read the full article here.

There is always someone who is willing to take the other side in a story in order to have their five minutes in the spotlight. It is not surprising the Globe did not have to look far to find a dentist not supporting a screening test that could save a life or prevent disfiguring surgery -- especially when you have many dentists who still think amalgam fillings are ok.

Oral cancer is rising due to the link to HPV. When oral cancer is detected early it can save your life. At this point there are only two oral cancer screening tests, ViziLite Plus and VELscope, which can detect malignant cells. The research shows that the tests do aid in early detection.

The ViziLite Plus test, which is what I use, is not a harmful test; the patient only needs to rinse with a vinegar tasting liquid and open their mouths. What other cancer screening test is that simple and pain free?

The Globe also goes on about the cost of the test, and quotes one dentist who charges $80 -- which, the Globe notes, insurance doesn't cover.

I charge $70 dollars and offer the test to high risk patients and those who want it. Each kit costs about $40 dollars, so $30 dollars is not a huge profit, as any dentist will tell you. I do not do the screening to make money.

Doctors are now saying that women don't need yearly mammograms, yet a woman I know was recently treated for breast cancer -- cancer which was found during her annual exam. Where would she be today if she had had to wait an additional year for her exam?

The dentists opposed to the oral cancer screening test lower themselves to the status of tooth plumbers instead of mouth physicians. It is my job as a dentist to educate people on maintaining their oral health -- which leads to whole body health -- not simply scrape plaque off their teeth.


Sharon Golubchik said...

Dr. Smith,

Your fight against oral cancer is admirable, and we should all work to eliminate it!

As you seem to be a dentist who cares tremendously about the facts, I wanted to respond to a point you made: "At this point there are only two oral cancer screening tests, ViziLite Plus and Velscope..."

1) According to the FDA, neither ViziLite nor VELscope are allowed to use the word "test" in regards to their products. They have no published false positive or false negative rate for dysplasia.

2) There is ONE screening TEST that finds both pre-cancerous and cancerous cells - the OralCDx BrushTest.

If you are interested in finding out more facts, I would be happy to get you in touch with an OralCDx clinical educator. Please e-mail me at gsharon@cdxlabs.com.

Thank you for joining us in the fight against oral cancer.

Sharon Golubchik

Helaine Smith, DMD said...


Thank you for your comment. However, I must clarify a few issues:

One, I refer to ViziLite as a test -- that is how I use it -- to test or screen for cancer. It doesn't matter to me how manufacturers must refer to it.

Two, you are incorrect about data concerning ViziLite.

The research to which I was referring in my post includes two JADA manuscripts for inclusion in their retrospective analysis, and those two clearly state that the the sensitivity of the ViziLite examination is 100%.

You may also want to refer to this article that refutes your claim that the CDx is the only method for finding dysplasia and cancer:

Three, it is very difficult for a dentist to "brush" what may be missed by visual inspection alone, thus the importance of the highly sensitive ViziLite Plus test.

I belive that the CDx brush biospy tests for cancer too late. You are taking cells of a lesion you can *see.*

ViziLite, on the other hand, is spotting malignant cells before they rise into lesion that the naked eye can see.

According to the ADA, oral cancer claims more lives than cervical and melanoma cancers combined.

Unfortunately, 70% of oral cancers are diagnosed in the late stages, III and IV, leading to a five-year survival rate of 57%.

This is why I stand firmly behind the ViziLite test.

Sharon Golubchik said...

It seems that you may have been misinformed.

OralCDx is a clinical laboratory that provides actual test results. In other words, the BrushTest tells you with great accuracy whether “what you are looking at” is dysplastic or not. There are only two tests for oral dysplasia and cancer, the scalpel biopsy and the BrushTest. No matter how you go about finding areas of suspicion to test, a laboratory test at the cellular level needs to be performed to determine whether a patient has dysplasia or not.

If you'd like more information, I would be happy to put you in touch with a clinical educator.

Helaine Smith, DMD said...

I am not misinformed nor do I want to continue this conversation which misses the initial point of my blog.

OralCDx is a 'biopsy' and of course those results are accurate.

I have no problem with your product. I am discussing deeper issues in the dental profession, the media, and dentists who think it is bad to make money even though they might be saving a life.

With ViziLite we are able to screen the public for oral cancer as ViziLite can detect cancer cells before they are visible to the human eye.

Anonymous said...

I agree with Dr. Smith.

Early detection is KEY, if you need to use brush biopsy is TOO late.
I guess the brush biopsy people didn't have much to say after that...

Anonymous said...

Both Drs. are admirable in their efforts to be pro-active; however, what do you do when you patient can go online and find our that their oral cancer test that for which they just paid $75-80 is not proven to be any better than a careful exam done by a trained professional? At least the patient should assume their dentist of choice is trained; why else would they go to them?

Anonymous said...

I usually don't respond to anything online, but quite honestly, this thread seems to reflect the same misinformation that permeates the trade magazines and online forums. There seems to be a great deal of confusion with regards to the term "too late". I am an oral surgeon. I use a brush biopsy on areas of the mouth to see if dysplastic (precancerous cell) are present to confirm that I actual need to cut. These can be seen without any device.

The notion that there are some magic aids that can see something going on "below" the surface just makes dentists second guess themselves - putting into their heads that they can't do it without an aid. Hooey! From my experience and every book I've read on oral pathology, I can tell you that something visible appears on the surface of the mouth when unhealthy cells are present, and long before they turn into cancer and present themselves as a scary-looking lesion.

Since the brush biopsy is detecting precancerous cells, how can it be "too late"? If a dentist uses one of the aids, they are looking for cancer, right? The device may claim to be used for "early" detection, but it's still cancer that they are looking for. So, if dentists are looking via a comprehensive oral exam, and they do a brush biopsy (or BrushTest for any patients reading), which is designed to detect "precancer", how is that too late? "Pre" means before. So it's actually finding things earlier than the Vizilite or other aids claim to.

Patients should expect, and even demand a thorough oral cancer exam from their dentists. And if something is seen (with or without an aid), it should be followed up by a biopsy, brush or scalpel. Each of these biopsies provides real pathology and piece of mind to the patient, with very high sensitivity. There is no doubt that the scalpel is the standard of care, but even as a surgeon, sometimes I like to be sure I'm cutting tissue that warrants it - this is especially true when it comes to oral dysplasia.

So let's stop arguing symantics or propagating mistruths for the sake of selling products. The truly scary thing about articles, blogs,and ads like this is that they convince dentists, who truly want to do what's best for their patients, that these magical aids are diagnostic. And, they aren't.

Helaine Smith, DMD said...

I think all companies need to differentiate themselves and state their product is better, more innovative, and will achieve superior results. This is marketing 101 -- and all the oral cancer detection companies claim this.

My point and goal is to raise awareness that oral cancer is serious and we as dentists need to join the fight and help the public realize that more occurs during a "cleaning" appointment than shining your teeth.

Let's not fight among ourselves and tear each down. The public does a good enough job of this. We need to unite and recognize that we all have the same mission despite what tool we use- protect and educate our patients about oral cancer. Thank you for your time and response to the details of the different tests.