The Oral Cancer Advocate

Major changes have taken place at the American Dental Association. Recently the board decided to terminate the employment of the two top individuals at the organization rather abruptly. While there no doubt were accumulative reasons for which this action was taken, I think there is little doubt that their position to allow a commercial company’s marketing rhetoric to become the face of the ADA oral cancer awareness program played a part in all this. Undoubtedly this will trigger a rethinking of the relationship with Oral CDx, and if that continues, it will likely take a very different form. This would be a good thing in my mind. It is hard to imagine that (now involved as they should have been in the beginning), the ADA’s Science Council – which has a fair sampling of oral surgeons and oral pathology individuals on it – will rubber stamp the CDx brush biopsy rhetoric which has played to date.

Those who have read previous postings here, may remember my observations on what happened at the American Medical Association when their hired leadership decided to become intimate with the Sunbeam corporation, adopting Sunbeam’s sales and promotional materials, and flying those corporate colors under the AMA banner…. the trustees showed them the door very soon thereafter. My observation that similar fates could be avoided by anyone who was paying attention at the ADA, proved out. Money for these professional societies is a powerful draw, and at the core of the ADA/CDx relationship it was there, more than 9 million dollars over three years. CDx had it, the ADA wanted it, and in the end the organization proved that their logo and identity could be bought. I do not find this unusual, or for that matter new when you look at the last couple decades of the ADA’s behavior. There is little doubt that the money generated from their ADA seal of approval program generated significant revenues for the association.

The public must remember that their charter is to serve the needs of their constituents, dentists. They should not think that any created illusion, for instance that the public interest is the ADA’s prime focus, is actually little more than a distortion of reality. I wish to make it clear. This is as it should be. Their charter is to see to the needs of dentists, and as a private society with only dentists as members, this is completely appropriate and expected of this kind of organization. But the ADA would like to appear to the public as less of what is essentially a trade union, and more as a benevolent public service organization. They are not a public service organization. Efforts to create this organizational persona confuse the public, and I am in favor of more transparency, or at least the ADA visibly being what they actually are. It doesn’t detract from anything, or make them bad guys to be the protectors of the interests of dentists. And this does not mean that they do not have programs that the public benefits from, it just means that those are secondary to their primary function. Pushing Oral CDx’s marketing agenda for profit in a world in which they are viewed as what they really are isn’t problematic. However it does become so when they try to appear a champions of the public welfare, and at the same time put out a message that has a for profit motive associated with it, which distorts the reality of what a biopsy brush is and can do.

While I feel this major change needed to happen, they were getting at least part of the message right. A message that the public does not hear enough. Oral cancer is out there, and an annual screening – done opportunistically – for oral cancer will save lives. My hope now is that they will continue with an awareness program that puts DISCOVERY in first place, and any techniques for DIAGNOSIS in second. But I have little hope that CDx will wish to fund something other than their position that their brush cytology system “prevents oral cancer,” which I and others strongly disagree with.

One has to wonder why the ADA has not partnered up with non competitive public service entities like the Oral Cancer Foundation to work together towards what would seem symbiotic goals. With dentists being one of the primary mechanisms to engage in opportunistic screenings to reduce the death rate and treatment morbidity, I think they should use their strengths to work with OCF and others to get dentists up to speed on screening, to institute mandatory CE credits in oral cancer and early detection (I mean how many more CE credits do you need on bleaching, veneers, and Invisalign tooth straghtening?), so we can be sure that they know what to look for, how, and where, and help a non profit with fewer financial and infrastructure assests fulfill a needed mission that is in the public (and the ADA’s) interest.

For years the ADA has always been the 800 pound gorilla in any relationship. Their way or the highway. I hope that the new leadership (supported by trustees who get all this) will reach out to make real change in the world though these kinds of relationships. None of this compromises their ability to be the champions of dentist’s interests, and it might make both them and dentists real champions in the long run….

Tags: Oral Cancer News, Screening, The ADA by oc advocate
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Oral squamous cell carcinoma lesion

With money from a commercial enterprise, the ADA is beginning a three year campaign to raise oral cancer awareness. This is a good thing, but the problem is they are using that company’s marketing rhetoric instead of good science to sell the message. The message of the new ads is “We can prevent oral cancer,” taken right from Oral CDx’s marketing literature.

Under that tongue (picture above) is a squamous cell carcinoma, oral cancer. (The whitish lesion, not the dark spot which is just vascularization near the surface of the tissue). If your dentist or hygienist does a brush biopsy / brush cytology of that spot, I guarantee you that it will still be oral cancer. They have not “PREVENTED” anything by doing this. It is what it is. The ADA has made a huge mistake here in their new awareness program by allowing the marketing rhetoric of a commercial company, in this case Oral CDx, to dictate what the awareness program is all about. When the ADA adopts this stance they weaken their stature and look like an organization that only is interested in raising awareness of oral cancer and its early detection when someone else is willing to pick up the tab. Worse, it is the triumph of marketing over science.

This is the second time they have done so with this commercial company, the first was in 2001 when CDx gave them 2.5 million dollars to run a billboard campaign that no one remembers. Hey, I’m a big believer that when the tide comes in all boats rise, and because of that, at least part of this program is a good thing. The words oral cancer and early detection are getting out there in the same sentence to an American populace that hasn’t even heard of the disease for the most part, let alone the need for early detection of it. But oral cancers are NOT like colon cancer that requires a polyp to exist before it can become full-blown cancer. Or cervical cancer that requires a persistent HPV infection prior to the development of a malignancy. To compare using brush cytology in the mouth, of visible lesions, to either of those is wrong. There is no “mandatory” oral precancerous lesion that always appears before manifestation of this disease. Many times even the primary disease itself can be occult and not visible, only detectable early through the palpation and touching of the tissues – feeling for indurations or hard spots, or in some cases the primary lesion is completely occult right up until a metastasis of the disease is discovered as an enlarged lymph node in the neck, and the primary is never found. A brush biopsy DOES NOT prevent this disease.

Let’s say you have a leukoplakia under a tongue. It’s a huge thing – like half and inch long and three eights of an inch tall. Only about 25% of the time do these things go over to the dark side and become malignant. But they need dealing with (removal) or regular monitoring by a professional (less desirable in my opinion). With a brush biopsy you have to SCRUB the suspect tissue to the point of bleeding to get the proper collection of cells. Is a dentist going to do that over a lesion the size I just described? Hardly. And there is no way to tell where in that large lesion a group of cells that is going malignant might reside. Given this, you couldn’t just collect a few cells from the front or the back of it. Brush biopsy in this case is probably not the path to go down. You could have an oral surgeon laser off the whole thing, or you could watch it for changes (less desirable idea), because only a quarter of them actually become malignant.

The gold standard for diagnosis of cancer is a conventional punch or incisional biopsy. It gives you a core of tissue (if done with a small punch), and all the stratum of the different layers of cells intact. This is an important issue to a pathologist looking at that sample. Brush cytology gives you scrambled eggs… you don’t know where in the total thickness/layers of the tissue the cells scrapped off with the brush came from. Even Oral CDx literature (as required by the FDA) says that if you get a positive test result from them, you have to have it confirmed with a conventional biopsy anyway. If that is the case, generalists who are uncomfortable making the call should let the oral surgeon, oral medicine specialist, etc. make the call to biopsy or not when the patient is sent to them for a second opinion of any suspect tissue.

I get it that this idea is to keep dentists from watching and waiting while a potential malignancy develops in the mouth, because this has been a problem with things for some time. Actually that has been a smaller problem than the fact that not enough dentists are actually doing opportunistic screenings on their entire patient populations at all. This brush system has been around for years and it has not won a place in dentistry in all that time. The fact is, that a general dentist, when he finds suspect tissues, is better served by sending that patient for a second opinion to an oral surgeon, or especially to an oral medicine specialist (they are usually not in private practice but at institutions like dental schools),than messing around doing an indeterminate brush biopsy. Dentistry has a well established referral system, and with the potential of a cancer prospering un-referred on their watch, which is deadly for the patient, and exposes the dentist to significant legal liability, this makes the most sense.

As a patient I have learned that several sets of eyes, and differently trained minds with different types of clinical experience, yield the best end result when deciding what something is, or what should be done.

It is disappointing that the only time the ADA wants to get into the fray and try to do something in the oral cancer arena, it requires someone else to pick up the tab to get them interested. The oral cancer insert in their magazine JADA several years ago was paid for (in spades) by outside organizations like NYU, OCF, the NIDCR and others, the last billboard awareness campaign in 2001 with an equally off the mark marketing tone from CDx which stated “Don’t let it grow up to be cancer” was paid for by someone with a product to push, and now this. Of course their charter is not necessarily to help the public. They are a professional association to serve the interests of dentists, not the public.

As a side note, how is it that the Oral CDx brush bears the ADA seal of approval as a product, yet in the ad using it as the means to change the world, the ADA says they do not endorse the product? Someone didn’t think this through very well. Perhaps if someone like CDx was offering me 9+ million dollars to do something (as they have with the ADA), I might rush into it as well….

Tags: Adjunctive Screening Devices, Screening, The ADA by oc advocate
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2007 ADA ad compares brush test to others. (They got it half right….)

You would think that an organization that is made up of doctors would get things right. Let’s start with the misrepresentations in their current advertising campaign about early detection of oral cancer using a brush biopsy system, more commonly known as brush cytology. In my previous postings I have stated that one of the main features of their awareness campaign that is wrong, is that it bypasses the initial requirement of discovery. But now that some of the really knowledgeable people (from the world of science and research) have looked at this, more has come to light.

First, in the ads it shows a specificity and sensitivity in the 90 percentile, with the initials NCI next to it. The numbers did not come from the NCI, nor have they evaluated this system according to calls made to them. (Shall we call this a misprint…or should we just say it is fraudulent advertising? Perhaps this really doesn’t stand for The National Cancer Institute, but actually means not correct information…) The numbers actually come from a study funded by Oral CDx in Germany by Christian Scheifele et.al. How the ADA or anyone else who put this ad together ties that article, which was published in an Elsevier journal, to the National Cancer Institute is very unclear, and perhaps even deceiving. (Note: I have cut off the bottom portion of the ad that shows this copy from the ad above to fit the picture in the alloted space.)

To restate the obvious, since its use began in the 1920′s brush cytology, or if you want to use the branded term “brush biopsy” from many companies, and now from CDx, has had specificities and selectivity numbers in the 50-60 percentile range. I guess you would have to ask yourself how something, that in numerous studies showing this, would suddenly leap into the 90 percentile level. Actually, it just a matter of poor study design. When CDx did their studies, as a prelude to their marketing campaign, they included in them both class I and class II lesions.

If you are not familiar with what this means, in the simplest of terms, a class I lesion is advanced to the state that your suspicion that it is cancer is high. It is an open ulceration, it is bleeding, it is cratered, etc. it has characteristics that send lights and bells going off in your head when you look at it. In short your paperboy could look at it in your mouth and guess that it was something dangerous and likely malignant. The CDx system is NOT designed to be used on class I lesions, they say so themselves, and were it used in that manner, the person doing so would be doing the patient a disservice as well. Anything that obvious needs to be biopsied using a gold standard technique, not a brush. Class II lesions are small, and early developments that it would be hard for anyone to visually determine that they were something benign, or dangerous. This is what the Oral CDx brush is designed to evaluate.

But if you look at the company sponsored studies carefully, you see that they include in the lesions evaluated, a significant number of class I lesions. It would be one thing if these were used as a “control” but they are not. They are lumped in with the class II lesions. What happens to the numbers if you take the class I lesions (which without testing visually scream “I’m dangerous”) out? The specificity and sensitivity of the CDx system goes right back to where you would expect to find it… in the mid 50% range. Right where brush cytology has always been.

The ADA is counting on the fact that the public does not understand all this, and for that matter, I bet the bulk of the general dental professional population does not either. That the ADA has rushed into all this without looking carefully at the data, (after all, this is not their first dance with Oral CDx, they did a similar billboard campaign in 2001 with the company)without consulting recognized experts in the field, has put their logo on what is nothing more than a misleading advertisement from a product manufacturer; because they are either too lazy, or lacking the ability to design their own program, or unwilling to spend their own money on it, is really pathetic. The more I look at this the more it stinks. Yes, oral cancer and detection are getting out there in the media, but the message is wrong. I wonder when the dental community is going to pay attention to this and ask their professional association to discontinue this money-motivated ruse, or to at least quit rubber stamping the commercial company’s marketing program, and put out ads that state this in a scientifically correct manner. At least this current ad that I saw didn’t say “We can prevent oral cancer.”

I have said it before and I say it again. You wish to bring the death rate down from oral cancer it is through early discovery…. This program is based on diagnosis, and talks little about the most important component, opportunistic screening of dentist’s entire patient populations where early discovery will take place. No opportunistic screening = No early discovery = Nothing to biopsy with the brush or anything else. The message is FIRST about getting screened guys; eyeballs, fingers, ancillary devices, by a non complacent group of professionals. THEN it is about diagnosis.

As for the ADA, who clearly has not paid attention to debacles that have impacted other organizations in their league, I only have one final comment – Think of the AMA and the Sunbeam company. History is a hellava teacher if you pay attention.

Tags: Adjunctive Screening Devices, Screening, The ADA by oc advocate
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Does what we know about brush biopsy in cervical cancer screening have any meaning when using brush biopsy screening in a different location? The Papanicolaou (Pap) smear (brush biopsy) is commonly used to screen for cervical cancer, and since its introduction in organized screening programs in resource-rich countries it has been successful in dramatically reducing the incidence of cervical cancer. However, the sensitivity of the Pap smear is low, and so testing for DNA of the causal agent of cervical cancer, the human papilloma virus (HPV), either as an alternative or in conjunction with a Pap smear, is being recommended by the CDC.

Mayrand et al. reported the results of the first screening round of the Canadian Cervical Cancer Screening Trial, in which over 10,000 women aged 30 to 69 years were randomly assigned to receive either a Pap smear or an HPV DNA test approved by the US Food and Drug Administration to screen for high-grade cervical intraepithelial neoplasia. Women with positive test results underwent colposcopy and biopsy, as did a random sample of women who tested negative. The sensitivity of HPV testing was 94.6%, whereas that of Pap testing was 55.4%. The specificity was 94.1% for HPV testing and 96.8% for Pap smears. In a second study reported in the New England Journal of Medicine, over 12,000 women aged 32 to 38 years were randomly assigned to receive either an HPV test plus a Pap smear or, as a control, a Pap test alone. The results of this trial found also that the HPV testing was significantly more effective. A shift from cellular to viral tests, coupled with education and vaccination, will clearly contribute to more efficient control of cervical cancer.

Having this information available to us now, the ADA program on oral cancer early detection with what is essentially the same kind of brush cytology, seems misguided. The brush collection of cells is the same regardless of the type of tissue that you are collecting them from. When considering the cervix, it is a very small area and a general brushing of the area is possible. The mouth does not lend itself to such a generalized collection process because of its size, and therefore the sampling of something visible that is evident to the screener is necessary. What the ADA program needs to talk about is early DISCOVERY – without that, there is nothing to put a biopsy brush on anyway. The ADA program is all about DIAGNOSIS, which of course cannot take place until DISCOVERY happens first. They seem to have put the cart before the horse, and the emphasis in the wrong place.

One argument from the manufacturer is that the shape of the bristles on their brush are different than conventional cytology brushes, and that when rubbed against the tissue hard, (until blood appears) that they are collecting cells from ALL layers, and therefore to compare the two is inaccurate. I have spoken with several oral pathologists at two local dental teaching institutions and they are not big believers in the technique. (Granted, a very small sample.) A conventional incisional or punch biopsy still has to be sent to them if this brush system finds a positive.

Bottom line in all this is that the selectivity and specificity of the Oral CDx system seems an academic point. We do not have in the US a dental profession that is compliant in doing OPPORTUNISTIC screenings of their entire patient populations on a regular and systematic basis.

If a general practitioner of dentistry, otolaryngology, or medicine finds tissue which appears to them to be abnormal, and the patient has told them that it has existed over a period of 14 days or longer, or they recall the patient in that period and find that it still exists, I believe the appropriate thing to accomplish at that point is to obtain a definitive diagnosis of what it is. This cannot be accomplished with a brush cytology system. A positive result from this system still requires surgical biopsy. The more appropriate action would be to either do a punch or incisional biopsy should they feel competent, or better yet, to use the well established referral system to obtain a second opinion, biopsy and diagnosis. This may be to an oral medicine specialist, an oral surgeon, or otolaryngologist with additional training in head and neck surgery, who is familiar with oral malignancies and other pathologies. This not only serves the patient well by obtaining another informed opinion as to what the malady is, but it also (for those not completely conversant in oral pathologies), it ensures that any tendency to “watch and wait” will not be engaged in. This is the worst thing that can be done, and invariably leads to delayed diagnosis, and poorer outcomes for those who do have a malignancy.

This whole system only works if we have compliant screeners, something which do not exist in abundance in the US today.

Tags: Adjunctive Screening Devices, HPV, Oral Cancer News, Screening, The ADA by oc advocate
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