Changes in the ADA leadership likely to change oral cancer awareness program

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….

Can we regenerate radiation damaged salivary glands? Stem cells may be the answer.

salivary_glands

A recent study conducted in Groningen, The Netherlands, may prove to be the Holy Grail for cancer survivors, since the vast majority are living with significantly compromised salivary function. Radiation treatments often have much of the major salivary glands within the field of radiation. This is deadly to the delicate glands. What follows is an abstract of some very promising work that may improve the quality of life for these survivors.

Head and neck cancer is the fifth most common malignancy and accounts for 3% (not a U.S. statistic) of all new cancer cases each year. Despite relatively high survival rates, the quality of life of these patients is severely compromised because of radiation-induced impairment of salivary gland function and consequential xerostomia (dry mouth syndrome).

In this study, a clinically applicable method for the restoration of radiation-impaired salivary gland function using salivary gland stem cell transplantation was developed. Salivary gland cells were isolated from murine submandibular glands and cultured in vitro as salispheres, which contained cells expressing the stem cell markers Sca-1, c-Kit and Musashi-1. In vitro, the cells differentiated into salivary gland duct cells and mucin and amylase producing acinar cells. Stem cell enrichment was performed by flow cytrometric selection using c-Kit as a marker. In vitro, the cells differentiated into amylase producing acinar cells.

In vivo, intra-glandular transplantation of a small number of c-Kit(+) cells resulted in long-term restoration of salivary gland morphology and function. Moreover, donor-derived stem cells could be isolated from primary recipients, cultured as secondary spheres and after re-transplantation ameliorate radiation damage. Our approach is the first proof for the potential use of stem cell transplantation to functionally rescue salivary gland deficiency.

Authors:
IM Lombaert, JF Brunsting, PK Wierenga, H Faber, MA Stokman, T Kok, WH Visser, HH Kampinga, G de Haan, and RP Coppes

HPV Poised to Become a Leading Cause of Oral Cancer in Men

gardasil

The sexually transmitted virus that causes cervical cancer in women is poised to become one of the leading causes of oral cancer in men, according to a new study. The HPV16 virus now causes as many cancers of the upper throat as tobacco and alcohol, probably due both to an increase in oral sex and the decline in smoking, (the historically dominant risk factor) researchers say.

The only available vaccine against HPV, made by Merck & Co. Inc., is currently given only to girls and young women. But Merck plans this year to ask government permission to offer the shot to boys. Experts say a primary reason for male vaccinations would be to prevent men from spreading the virus and help reduce the nearly 12,000 cases of cervical cancer diagnosed in U.S. women each year. I might add that by not doing gender based vaccination, we will reduce the overall reservoir of the virus in the US which is currently ubiquitous in the population. But the new study should add to the argument that there may be a direct benefit for men, too. The study was published February 1, 2008, in the Journal of Clinical Oncology.

“We need to start having a discussion about those cancers other than cervical cancer that may be affected in a positive way by the vaccine,” said study co-author Dr. Maura Gillison of Johns Hopkins University. Of course she is referring the the rapidly rising numbers or oropharyngeal, base of tongue, and tonsillar cancers we are seeing in both males and females.

Human papillomavirus, or HPV, is the leading cause of cervical cancer in women. It also can cause genital warts, penile and anal cancer, and oral cancers — risks for males that generally don’t get the same attention and press as cervical cancer. Previous research by Gillison and others established HPV as a primary cause of the estimated 5,600 cancers that occur each year in the tonsils, base of tongue and upper throat. It’s also been known that the virus’ role in such cancers has been rising. It is in fact, the primary cause of cancers in these anatomical sites.

The new study looked at more than 30 years of National Cancer Institute data on oral cancers. Researchers categorized about 46,000 cases, using a formula to divide them into those caused by HPV and those not connected to the virus. They concluded the incidence rates for HPV-related oral cancers rose steadily in men from 1973 to 2004, becoming about as common as those from tobacco and alcohol.

The good news is that survival rates for the cancer (when caused by a viral etiology) are also increasing. That’s because tumors caused by HPV respond better to chemotherapy and radiation, Gillison said. “If current trends continue, within the next 10 years there may be more oral cancers in the United States caused by HPV than tobacco or alcohol,” Gillison said.

Studies suggest oral sex is associated with HPV-related oral cancers, but a cause-effect relationship has not been proven as the only viral transfer mechanism for these cancers. Other researchers have suggested that even unwashed hands can spread it to the mouth as well. Gillison however pointed toward sex as an explanation for the increase in male upper throat cancers, and her previously published work documents this in the New England journal of Medicine. In women HPV-related upper throat cancers declined significantly from 1973 to 2004.

Merck’s vaccine, approved for girls in 2006, is a three-dose series priced at about $360. It is designed to protect against four types of HPV, including one associated with oral cancer. Merck has been testing the vaccine in an international study, but it is focused on anal and penile cancer and genital warts, not oral cancers, said Kelley Dougherty, a Merck spokeswoman. “We are continuing to consider additional areas of study that focus on both female and male HPV diseases and cancers,” Dougherty said. Merck officials praised Gillison’s research, saying it will elevate the importance of HPV-related oral cancers. As I have posted here before, I believe that Gillison’s work should be mandatory reading for all those that have the opportunistic ability to discover early these very deadly posterior mouth cancers (Dentists, oral hygienists, and members of the ENT profession.)

In a typically guarded observation, Government officials and the American Cancer Society say they don’t know yet whether Merck’s vaccine will be successful at preventing disease in men. No data from the company’s study are available yet. Indeed, it’s not clear yet that the vaccine even prevents the HPV infection in males, let alone cancer or any other illness, said Debbie Saslow of the American Cancer Society. However in speaking with experts in the virus research community, I believe that if Merck’s current trials show that it can prevent persistent HPV 16 infections, that the logical extension of that fact would indicate that without the persistent infection, there would also be no mechanism for the disease process to take place. Keep in mind that tobacco will still be a major player in the incidence of oral cancers, and we are looking at a subset population of people with oral cancer when speaking of HPV16.

Merck plans to seek U.S. Food and Drug Administration approval for the vaccine in men later this year, meaning a government decision would be likely in 2009.

ADA Oral Cancer Awareness Program’s Message Misses The Mark

Tongue lesion

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….

Who should get experimental drugs?

pills.jpg

When I started writing this site, I was sure that it was something that would remain non-political, but in this post I break that choice.

This week I had the opportunity to talk to a family that has recently lost their son to oral cancer. A man in his early thirties, a non smoker, athlete, and a father of two daughters. There are many aspects to this tragedy that I could explore here. The lack of early detection screenings in his dental appointments, his ignoring some hoarseness that persisted for several months, the treatments that were conducted initially by a small, local city hospital with minor cancer capabilities – which did not bring to bear all the potentially beneficial medical assets soon enough, and much more. But this particular entry is about the recent ruling by the high courts related to who in our population may have access to drugs which are not yet approved, but have shown potential in the trials to date and may even save a life. The current state of the situation is that there has been a ban on their use, regardless of the willingness of a patient to fully accept the risks associated with that use. Most of the patients who have petitioned for this ability have been in terminal disease states with no other hopes. Certainly the drug manufacturers have been quiet about much of this as they are regulated by the FDA’s rulings, but you have to believe that they too would be interested to see if a particular drug had impact or not, if only from a scientific perspective and not a compassionate one.

I can think of no greater means by which this administration, under the leadership of President Bush (and those that support his power base) has debilitated our country, for decades into the future, than his appointments to the judiciary and specifically to the supreme court. US Court of Appeals judge Thomas Griffith has ruled this week that “there is no right, deeply rooted in this nation’s history and tradition, of access of experimental drugs to the terminally ill.” It must be noted that Griffith, recently appointed by Bush, is a relatively young man. As such he has the potential to be making inane comments like this for decades to come. It is no surprise that Bush’s newly conservative weighted Supreme Court supported this ruling, and refused to hear the case themselves.

This is yet another instance, Iraq comes to mind immediately, in which “compassionate conservatives ” are willing to kill people in order to protect them. This distinction is not just academic, it is much more. What conservatives on the courts refuse to comprehend, is that the Bill of Rights is a list of rights that the citizens of this country grant to the government, NOT vice versa. The ruling should have been that the government has no fundamental right to deny potentially life saving or life extending drugs and treatments to dying patients… particularly when all parties concerned are cognizant of the inherent risks, willing to accept the consequences of their decisions, and no others are harmed through the process in any manner.

There were options and opportunities, granted with significant inherent risks for this young man with oral cancer. We will never know if those options would have given him a few more months with his family to communicate that which is now forever unsaid, or even to have defeated this disease and lived on. Thank you judge Thomas Griffith – I wonder how you would feel, were this you in a life and death battle, and how that might impact your decision making process. One only has to remember the reversal of opinion from other compassionate conservatives, like Ronald Regan and his wife, when they found themselves on the other side of a horrible disease issue that they failed to champion when the chance was theirs. Lastly, I note the recent statements made by John McCain, the current conservative front runner for the white house. There are many things to like about this man, but his recent statement that we might still be in Iraq a hundred years from now made my jaw drop… which was then followed by a statement to appease the conservative base, that he would appoint more conservative judges to the supreme courts were he elected. Remember that 6 of the nine judges will be 70 or older next year. I do not favor a liberal court, but one that has balance, and whose opinions are not based in ideological agendas. Our next president can take us to more of the same in judicial conservatism, or to balance. Any thinking person should consider this as one of the core issues when they cast their next ballot.

Stealth Viral Marketing of Tobacco on the Web

It’s bad enough what tobacco has done to health in the world, and even with the huge settlements from lawsuits against big tobacco, it isn’t about to go away or be less of a corporate profit center. What we need to never forget is that those lawsuits revealed that the tobacco companies have consistently lied to EVERYONE, not just to the addicted consumers, but to the government as well. They have NO track record of any honesty, and have only tried to deceive people in their pursuit of corporate greed. I think that one of the most insidious forms of this, which most people are not aware of, is the way that they are using buzz marketing or “word of mouth” techniques, straw men posters and bloggers, and video which appears to be consumer produced, to stealth market their products. When you know a tobacco company is behind something, it sets you to a certain path in your thinking (pro or con). If it appears an average person is saying it, you may believe them or not, but you may be completely unaware that they are paid to post a positive viewpoint, blog, or produce YouTube videos promoting or glamorizing tobacco by these firms. This is worse than outright advertising in my book. Stealth marketing of products is a growing trend in the world. It’s not just in tobacco, but this posting focuses on that. As new products like Snus attempt to gain marketshare in the US to replace the tobacco companies diminishing ranks of addict customers, we should be aware of how they are selling to us under other guises. In particular we should be thinking of how our youth may not be aware of this technique, and the impact that it may have on their decision making. This is certainly a vehicle to initiation of tobacco use that needs to be monitored, and controlled. Of course with our own White House planting stories in the media, employing fake reporters, and having public forums that are only attended by those in favor of the viewpoint being expressed (and not telling anyone about this attendee screening process) there isn’t much hope in this administration for control or change. Nice example to set W.

A fascinating study (very important link)  by Australian researchers [4] investigates the prevalence of smoking-related videos on YouTube. One of the study’s authors and a global authority on tobacco marketing, Professor Simon Chapman of the School of Public Health at Sydney University [2,3,4,5], has been quoted in the media as accusing tobacco manufacturers of hijacking YouTube by flooding it with videos of glamorous, smoking teens. YouTube and other popular social sites like Facebook and MySpace are running riot with pro-smoking messages which appear to have the fingerprints of tobacco companies all over them. In November 2006, when the authors conducted the research for their study, the use of the search term “smoking” returned 29,325 videos. For an Australian blogger’s reaction, see Melissa’s Blog.

Chapman says that tobacco companies are probably responsible for some of the most sophisticated online video promotions, with clips ranging from pro-smoking propaganda to images of celebrity smokers and seductive women smoking cigarettes. Smoking fetish videos are strangely popular. A video mentioned in the study depicts two women blowing smoke into each other’s mouths. It had 221,033 views and 142 comments. The majority of feedback was positive (e.g., “Smokin’ HOT HOT HOT. Loved it”). Others were less impressed (e.g., “Lung cancer becomes a STD. Nice.”) My attempt to follow the link provided by the authors led to a dead end. Some of the smoking fetish videos are restricted to those over the age of 18, and require registration. Interested readers can go to www.smoking-models.com for abundant examples of the genre.

The invasion of YouTube would be in line with the increasing use of “below the line” forms of viral cigarette marketing, such as promotions at dance parties, disguising market research as sampling promotions, and themed nights in bars and at music festivals. Just as tobacco-company marketers have a presence on youth-friendly venues, it is quite conceivable that they also have a presence on youth-friendly websites. Here is another quote from Simon Chapman: “If I was a tobacco marketer I’d be saying, ‘It’s not illegal; it’s an international market and it’s unregulated,’ and it goes right to the heart of what I believe will be the future of tobacco marketing.”

Although it is devilishly difficult to prove, it seems clear that young people are being encouraged to take up smoking through pro-tobacco stealth marketing on YouTube. According to the Word of Mouth Marketing Association (WOMMA), stealth marketing is any practice designed to deceive people about the involvement of marketers in a communication. Of course, from the tobacco biz there are only denials and claims that they are clear about their responsibilities to society and their obligations under the tobacco control laws of the countries in which they operate. They admit to the use of buzz marketing techniques, which are to be distinguished from stealth marketing by being, well, less stealthy.

The tobacco companies could never be criticized for slack performance [1]. Despite overall decreases in youth smoking, thousands of children under the age of 18 still start smoking every day, especially in developing countries. To increase demand among these groups, new, more targeted marketing strategies are being developed. Flavoured cigarettes, with alluring names like Dark Mint, Cool Myst, Midnight Berry and Mocha Taboo, have been successfully flogged in the United States. Complemented by stylish and colourful packaging, these candied cancer sticks contain invisible flavour delivery pellets inside their filters. Fortunately, many states have agreed on an outright ban of such confections, and the American Lung Association is advocating a total ban. As far as I know, they are not permitted in Canada. Whatever happens, the hawkers of halitosis will continue to take advantage of any opportunities, including Web 2.0 innovations, to bring lips to butts.

The good news is that YouTube and the like are obvious vehicles for the dissemination of anti-smoking messages. Health Canada has placed their latest anti-smoking ad on YouTube, and some of the brilliant thetruth.com ads can also be found on the site. Particularly striking is a Marlboro Man spoof entitled You don’t always die from tobacco.

The authors conclude their article with some suggestions:

1. YouTube could be lobbied to broaden its definitions of unacceptable material to include those that depict smoking.

2. YouTube could be urged to adopt a rating system for smoking in videos.

3. YouTube is an obvious vehicle for the dissemination of anti-smoking messages. Smoking cessation organizations will need to avoid the corporate marketing pitfall of hiring actors and being deceitful about the origins of the video content. Working with real people who are actually quitting smoking and producing inexpensive video blogs is another possible way for tobacco control to maximize this new form of media.
While the world wide web is being used extensively to sell cigarettes, its largely unregulated status holds much potential as a vehicle for the promotion of both smoking and non-smoking. The web has become a battleground for the lungs of our adolescents, says Professor Chapman.

Is Big Tobacco Stealth Marketing to YouTubers? By usmedstudent (Added to YouTube: 10 May 2007) A Harvard medical student discusses the implications of the study by Chapman and Freeman.

“I was stunned to learn that YouTube videos containing smoking imagery may be paid for by tobacco companies. Some of these videos with smoking imagery include anywhere from vlogs to movie clips. It’s sad, but in hindsight, given the tobacco industry’s track record, I shouldn’t have been surprised…”

Other videos on buzz marketing and stealth marketing:

Tobacco’s stealth marketing

http://www.youtube.com/watch?v=jevfwAwgAc4

Youtube Members In Stealth Marketing Scam

http://www.youtube.com/watch?v=tCQ5XPUkRl0

As One Gatherings : The Future Of Stealth Marketing

http://www.youtube.com/watch?v=qltsWjnVY6I

Allan Brandt – Health Research and the Tobacco Industry

http://video.aol.com/video-detail/allan-brandt-health-research-and-the-tobacco-industry/4101659155

Complete video at: http://fora.tv/fora/showthread.php?t=810
Medical historian Allan Brandt discusses the history of conflict between health researchers and the American tobacco industry. Allan Brandt researched “The Cigarette Century: The Rise, Fall, and Deadly Persistence of the Product That Defined America,” and after doing so for twenty years, he has become one of the top expert witnesses for tobacco-related state and federal cases. In 2004 Brandt took the stand as an expert witness for two full days of cross-examination in the case of U.S. vs. Phillip Morris. The judge’s opinion referenced Brandt’s testimony nearly 200 times and for the first time ever tobacco companies were found to be in violation of Federal racketeering statutes. Now, in “The Cigarette Century,” Brandt presents the definitive history of the cigarette, both as the ultimate cultural icon and as the produce that shaped US agriculture, big business, medicine, and regulatory policies in the 20th century. Making extensive use of previously secret corporate documents which became available in the last decade as a result of litigation, Brandt offers critical analysis of the cigarette controversy and how the industry used sophisticated public relations to invent a modern “disinformation” campaign. — Allan Brandt is the Amalie Moses Kass Professor of the History of Medicine at Harvard Medical School, and holds a joint appointment in the Department of the History of Science at Harvard University.

References:

1. Brandt AM. The cigarette century: the rise, fall, and deadly persistence of the product that defined America. Basic Books; 2006.

2. Chapman S. Falling smoking prevalence: how low can we go? Tobacco Control 2007;16:145-7.
Large public awareness campaigns to inform and motivate millions of smokers about quitting seem destined to remain a feature of everyday life in wealthier nations. However, very few poorer nations can afford to even get to the starting line with such campaigns and try in vain to inform their communities via valiant, low-budget efforts at publicity on World No Tobacco Day. A sustained international initiative to fund major public awareness campaigns in nations that could never afford to run such campaigns would make a huge difference to nations in which such awareness remains rudimentary. The profligacy of some areas of tobacco control expenditure in some industrialised nations is embarrassing when there are now many more smokers and deaths caused by smoking in less developed nations.

3. Chapman S. Public health advocacy and tobacco control: making smoking history. Wiley-Blackwell; 2007.
A major new book on advocacy and smoking prevention from the editor of Tobacco Control.

4. Freeman B, Chapman S. Is YouTube telling or selling you something? Tobacco content on the YouTube video sharing website. Tobacco Control 2007;16:207-10
Smoking imagery is prolific and accessible on YouTube. The effectiveness of overt tobacco advertising and sponsorship bans is well established. The industry has responded to these bans by implementing “buzz” or “viral” marketing techniques, such as nightclub and dance party promotions. This paper analyses possible tobacco industry content on the burgeoning consumer-generated media website, YouTube. Tobacco control efforts need to embrace this new medium, in order to counter pro-smoking messages and maximize media advocacy opportunities.

5. Gartner CE, Hall WD, Chapman S, Freeman B. Should the health community promote smokeless tobacco (snus) as a harm reduction measure? PLoS Medicine 2007;4(7)e185 doi:10.1371/journal.pmed.0040185 [you can listen here to a Radio 6PR Perth interview of Coral Gartner (11.12mins & 10.2mb) & Simon Chapman (11.06mins & 10.1mb) discussing this paper]
Smokeless tobacco [low nitrosamine oral snuff, or Swedish "snus"] has low appeal for the overwhelming majority of the world’s smokers. There are profound risks in letting tobacco industry tigers off their leash to use snus to subvert the hard-won provisions of the Framework Convention on Tobacco Control—provisions that include a ban on all tobacco advertising. Such a ban has already been achieved in some nations, but not in the US, from where much of the enthusiasm for snus now comes.

The American Dental Association’s Failure to Look at the Data Critically on Oral Cancer and Brush Biopsy

ADA_ad_07

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.

Researcher Maura Gillison: Completely Changing the Playing Field of Oral Cancer Screening

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Since her article on the relationship between HPV and oral cancers, published in 2000 in the Journal of The National Cancer Institute, the work done and published by Dr. Maura Gillison and her colleagues at Johns Hopkins has redefined the demographics of the oral cancer world in the US. While I have read many researcher’s work, I am really impressed by the series of publications from Dr. Gillison that have elucidated the oral cancer – HPV relationship in ways which are not just interesting, but which have direct applications in reducing the death rate from the disease today. What I am referring to is early detection.

The first rule in solving a problem is defining reality, that is, “what is the situation right now”? If professionals are to be effective in finding disease at the earliest possible stages when outcomes are the best, we have to understand WHO is at risk, and by doing so, who needs to be screened as a matter of routine. Her work has revealed a sub population of young, non-smoking individuals that no one was considering to be at risk, and by doing so changed everything. Being a non-smoker is no longer enough to allow you to dodge this disease. A virus is increasingly becoming a major factor in young people who develop oral cancer. Dr. Gillison’s epiphanies turned into proof of principal studies, and finally peer reviewed published articles that reveal how, with little control over the circumstances related to exposure available to us, we can do little to ensure that we are not at risk for developing this cancer. HPV is a ubiquitous virus, plentiful in the world around us, and easily contracted. For that matter, the CDC says that likely 80% of the US population will have at least one of the more than a hundred versions of HPV at some point in their lifetime. What we do not know is how many will get an oncogenic version of it, and of those, how many will go on to develop cancers.

Determining who was at risk used to be easy in the world of dentistry (doctors of general medicine have never been educated well in finding early stage oral disease). There were historical models that dentists were taught in school about the “typical” oral cancer patient. They were in their sixth and seventh decade of life, they had been tobacco users for at least a decade of their lives, used alcohol, were more frequently men, and more frequently black. But for the last several decades major treatment centers all around the US have anecdotally reported that they were seeing more and more young, non-smoking, white, under 50 year old patients with oral cancer. These people didn’t fit the historical demographic. Of course for the most part, with the exception of dentists working inside the cancer treatment centers, this information was not on the radar of most dental professionals. When they did screen, they thought of the older smokers. Notice that I said, when they did screen. Articles published by Horowitz et. al. from the NIH/NIDCR clearly showed that dentists have not been doing a very good job of engaging in actively screening their patients and finding disease at early stages. While there has been some improvement, things in the dental screening world are just starting to turn around in regard to screenings being done with any regularity. The quality of the screenings still remains to be evaluated. Medicine is even further behind the curve in all this.

Along comes Gillison and her articles. This really throws a wrench in what dentistry has considered the typical patient. Now they have to screen just about everyone that comes into their practice; because HPV16 has been shown through these articles to be a significant and unique (from tobacco and alcohol) pathway to oral cancer. She has defined the anatomical locations in the mouth it has a preference for (no excuses about where to look), she has defined in additional articles that it is easily transferred through oral and conventional sex, and she is telling us who the new demographic is – that is completely unlike the historical stereotype.

My question is – why is dentistry so far behind the curve over the last 7 years as this data has been revealed? Actually, I am being kind to the profession here, since their lack of interest in OC screening and early detection goes back decades, as does that of their professional society, the ADA. One excuse would be that these articles have been published in medical and oncology journals, and the general population of dentists seldom read these. But it is time that the work of this researcher becomes mandatory reading for the dental professional population. She has changed the understanding of the etiology of OC, and with it, who must be screened. My guess is that we will see HPV become THE dominant cause in young oral cancer patients, and the old 75% from tobacco cause is grossly out of date when considering this group.

Read the New England Journal of Medicine article that broke through the usual “research isn’t big news” apathy of major media because oral sex was part of the description… gillison_nejom_2007.pdf.

Actress Colleen Zenk Pinter becomes an Oral Cancer Advocate

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The Oral Cancer Foundation has partnered with yet another celebrity to help get the word out about oral cancer. They clearly understand the power that TV and movie personalities bring to raising public awareness, the first essential component to bringing the death rate down. Ms. Pinter is in good company with other OCF partners – three-time Emmy winner Jack Klugman, and two-time Emmy winner and Tony winner Blythe Danner (Gwyneth Paltrow’s mom for those who do not follow these kinds of things). Anyone reading my postings to date and looking at my links, can tell that I am a fan of OCF’s work. The only thing I do not get, is why they do not capitalize on these celebrities to help them raise funds. Clearly as a small non-profit charity they can’t be bringing in the kind of donations that the big guns like the American Cancer Society and the breast cancer folks do. Someone who is in a financial realm which I do not personally inhabit needs to look at these guys. They get more done for less than anyone else out there. What could they do if they had some financial support? Anyway, what follows is their press release on this relationship.

Actress Colleen Zenk Pinter Partners with the Oral Cancer Foundation to Raise Public Awareness

Two time Emmy nominated actress Colleen Zenk Pinter, best known for her long running role as Barbara Ryan on CBS’s As the World Turns, has teamed up with the Oral Cancer Foundation to share the story of her battle against oral cancer, and raise public awareness of a disease which kills more Americans each year than more commonly known cancers.

Zenk Pinter’s first stop was CBS’s The Early Show. In an interview with co-anchor Hannah Storm, Zenk Pinter revealed how a seemingly stubborn canker sore turned out to be a stage-two malignant oral cancer, requiring several surgeries to reconstruct her tongue, and months of radiation treatments. Zenk Pinter explained to Storm that she believes that her cancer was caused by the human papillomavirus. “I had absolutely none of the historic risk factors for this cancer, I never used tobacco and only drank socially,” she said, referring to the two other common causes of the disease.

“In fact, young Americans who have none of the historic risk factors are the fastest growing segment of oral cancer patients in the country,” Brian Hill, executive director of the Oral Cancer Foundation says, “and we believe the culprit behind the surge in cases is HPV16, the same virus that causes cervical cancer.”

Dr. Mark Lingen, Professor of Pathology at the University of Chicago School of Medicine says, “Colleen was very typical of most Americans in their lack of knowledge of oral cancer. Awareness and routine screening is particularly important, since early discovery is directly correlated to positive outcomes from treatment. HPV is the most common sexually transmitted disease in the United States. At least 50 percent of American adults will acquire the virus at some point in their lives. HPV16, one of the most destructive strains of the virus, was definitively linked to oral cancer in 2001. Research has also established that the virus, which can easily be transferred, may even be a more significant risk factor than tobacco in the younger portion of the population.”

“Colleen is an amazing woman”, said Hill. “Even BEFORE she had begun her treatments for the cancer, she contacted me and wanted to become an advocate for early detection and increased awareness. She was clearly taken by surprise to have developed this cancer. Most people at that point in the process are only thinking of themselves, and getting through the really tough treatments successfully. Her willingness to talk publicly about her very personal and painful battle with oral cancer is certainly courageous, and the desire to help others is palpable when you speak with her. Her story and high profile celebrity as a well-known TV actress will have enormous impact educating the public about this deadly and disfiguring disease. This is one of the purest examples of altruistic, celebrity power being used to better other people’s lives. We are lucky to have this partnership with Colleen.”

Now cancer-free, Zenk Pinter urged viewers of The Early Show to get regular oral cancer screenings. “Your dentist should be doing an oral cancer exam at every visit,” Zenk Pinter said. “It’s a simple 5 minute, painless exam that may save your life.”

The Early Show was only the first of what is on the public awareness schedule for Zenk Pinter. A recent interview with Soap Opera Digest is already on the newsstands, and interviews with other magazines have been scheduled. In December she will film a TV Public Service Announcement on the need for early detection through annual screenings. OCF will distribute the PSA to TV stations across the country at the beginning of 2008.

About Colleen Zenk Pinter
Ms. Zenk Pinter has worked professionally since the age of nine as an actress. Besides her long time association with As the World Turns, in which she has appeared in over 2,000 episodes, Colleen made her Broadway debut in Bring Back Birdie. Her film debut was in John Huston’s adaptation of Annie. Her benevolent and philanthropic association with health causes is not new, and for decades she has donated time to work with the Easter Seals, the March of Dimes, the Cystic Fibrosis Foundation and Bread to Roses, one of the first AIDS hospice programs. For more information about Colleen’s background, go to http://www.astheworldturns.net

The Oral Cancer Foundation, founded in 2000, is a national non-profit charity based in California. The foundation advocates for better public understanding of the disease and engages the medical and dental communities to be more involved in early detection. The foundation maintains a Web site with information for patients, the public, and health care providers at www.oralcancerfoundation.org. It is supported through tax-deductible public donations which can be made at http://www.oralcancerfoundation.org/membership/membership.htm

Berries May Supress Oral Cancers, VERY Early Study Results.

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What follows are some interesting works involving berries and cancer. Please note that while some of this is very interesting, it is a long way from being something that can be applied usefully today. These are very preliminary looks at things, and I put thm up on the blog to let people know some of the novel trains of thought people are pursuing. While it won’t hurt you to eat a ton of berries, and it certainly would be healthy, the evidence does not support a proven idea that you should suff yourself with these tasty fruits to do more than eat a nutritious food for your body. At this point in time whether there is any efficacy for them in relationship to cancer in humans is still a quuestion. But it’s, berry, berry interesting….. ( I can’t believe that I just typed that lame play on words.)

Dark fruits like blueberries, blackberries as well as papaya could be used to stop mouth cancer cells spreading through the rest of the body. They could also reduce the risk of mouth cancer, according to research published in the Journal of Cancer Research.

The study, carried out at the University of Hong Kong, found that as well as suppressing the spread of cancer, a substance called lupeol found in blueberries and other “super fruit” also reduced the size of the tumour three times faster than conventional drugs. When the two were used together they were even more successful. The compound works by blocking a natural protein called NFkB which helps to grow and repair all cells – even cancerous ones. Tests on mice also suggested that, unlike conventional drugs, lupeol would not cause the patient to lose weight.

Dr Nigel Carter, chief executive of the British Dental Health Foundation, said, “We already knew a healthy diet, including at least five portions of fruit and vegetables each day, could reduce a person’s risk of developing mouth cancer. “However the news that certain fruits might help to combat mouth cancer in people who have already developed the condition is a real revelation. “It is true that this research is still in its early stages. However, the suggestion is the lupeol compound could be more effective than traditional drugs in preventing the growth of mouth cancer cells.”

In anothger study, Ohio State University researchers found black raspberries may protect against esophageal cancer by reducing the oxidative stress that results from Barrett’s esophagus, a precancerous condition usually caused by gastroesophageal reflux disease. Reflux disease causes stomach acid to continually splash back up into the esophagus.

“Specifically in the case of Barrett’s patients, reflux of the stomach and bile acid contribute to ongoing oxidative damage. Thus, our hypothesis is that feeding a food that is high in potential protective constituents, such as antioxidants, vitamins, minerals and other phytochemicals, may help restore the oxidative balance,” lead researcher Laura Kresty said. People with Barrett’s esophagus typically are 30 to 40 times more likely to develop esophageal cancer, which has a poor five-year survival rate of 15 percent.

The team gave 32 grams to 45 grams of black raspberries daily for six months to 20 patients with Barrett’s esophagus. They analyzed changes in blood, urine and tissue before, during and after the treatment, and found lower levels of some of the chemical markers of oxidative stress in both urine and tissue samples. Black raspberries previously have been shown to reduce the risk of oral, esophageal and colon cancer in animal models, according to the researchers, who called for further study in humans.

Ohio has another take on berries as well. Gary Stoner, PhD, a scientist at the OSU Comprehensive Cancer Center – James (OSU CCC-James) who has spent years conducting food-based cancer-prevention studies, says one serving should involve black raspberries, blackberries or strawberries. Stoner and colleagues have found that all three exhibit anticancer properties in rodents, but their more extensive studies have involved black raspberries. “Black raspberries have high levels of anthocyanin pigments that give the berries their color and act as antioxidants to reduce cellular DNA damage caused by oxygen radicals and carcinogens in the body,” says Stoner. “The more antioxidant activity, the more a berry can inhibit cancer.”

Stoner’s studies began in the 1980s when he examined ellagic acid, a compound that inhibits carcinogen-induced cancer in animals. Seeking natural sources of this compound, his team examined many fruits and found it most abundant in berries. They then began testing the berries’ ability to inhibit chemically induced esophageal and colon cancer in rodents. Collaborating with the OSU College of Food, Agricultural and Environmental Sciences, Stoner’s team found that freeze-dried strawberries, black raspberries and blackberries, when added to the diets of rodents, prevented carcinogen-induced esophageal cancer by 60 percent compared with rodents on normal diets. They found that black raspberries inhibited carcinogen-induced adenocarcinoma in the colon of rodents by up to 80 percent.

At first they thought ellagic acid was principally responsible, but Stoner says they realize the inhibitory activity cannot be attributed to just one substance. “We think other components, such as anthocyanins and other polyphenols, and the vitamins and minerals in berries, are also responsible,” he says. “Now we are trying to find out what natural compounds are the most effective cancer fighters.”

In July 2003, he received a $2.7 million, five-year grant from the NCI to examine mechanisms by which freeze-dried black raspberries prevent cancer in rodent esophagus. “The goals,” Stoner says, “are to better understand how berries block and suppress cancer activity and to develop a ‘cocktail’ of chemopreventive agents for preventing human esophageal squamous cell carcinoma.”

The berry findings were presented at the International Conference on Frontiers in Cancer Prevention Research, being held in Philadelphia, Pennsylvania.The National Cancer Institute-funded trial included 30 participants, 20 of whom had identifiable precancerous lesions, and 10 normal controls. Each of the participants was instructed to gently dry the lesion sites (or a pre-selected control site for the normal participants) and rub the gel into the area four times a day, once after each meal and at bedtime.

After six weeks, about 35 percent of the trial participants’ lesions showed an improvement in their microscopic diagnosis, while another 45 percent showed that their lesions had stabilized. About 20 percent showed an increase in their lesional microscopic diagnoses. Importantly, none of the participants experienced any side effects from the gel. “The trial was designed to test the safety of the gel and detect any possible toxicity, but the next obvious step is a multicenter, double-blind, placebo-controlled Phase II study,” Mallery said. “Such a study would enable us to determine that the black raspberries are the active factor and not just the gel base or the act of drying and rubbing the lesions.”
The researchers also collected cell samples from the lesion sites of each participant before and after treatment in order to study the genetics and biology of the lesions. The majority of patients with precancerous lesions at the start of the trial showed elevated levels of COX-2 and iNOS, two proteins closely correlated with inflammation and malignant progression. Following treatment, Mallery says, levels of those proteins in the treated lesional epithelial cells decreased dramatically.

Mallery and her colleagues also examined samples for three tumor suppressor genes in order to determine what researchers call “loss of heterozygosity,” whether or not a cancer cell has lost one of its two copies of the gene. Such loss greatly increases a cell’s chances of losing the benefit of the tumor suppressor genes due to a second mutation or gene silencing event. Following the trial, the researchers noted that many lesions returned to normal, retaining both copies of each tumor suppressor gene. “We speculate that the chemopreventive compounds in black raspberries assist in modulating cell growth by promoting programmed cell death or terminal differentiation, two mechanisms that help “reeducate” precancerous cells,” Mallery said. “Oral cancer is a debilitating disease and there is a desperate need for early detection and management of precancerous lesions,” Mallery said. “While screening can help detect the disease early — and survival rates are definitely improved the earlier the disease is caught — many of these precancerous lesions recur despite complete surgical removal. There are currently no effective chemopreventive treatments which could conceivably serve as either adjunctive or alternative approaches to surgery.”

According to Mallery, the development of black raspberries as potential cancer-fighters is the result of decades of research into identification of naturally derived chemopreventive compounds by Ohio State researcher Gary D. Stoner, Ph.D., an emeritus professor at Ohio State University’s College of Medicine and Public Health. Clinical studies stemming from his research are currently underway for oral, esophageal and colorectal cancer.
The gel looks deceptively like black raspberry jam, but it certainly does not taste like something you would want to spread on toast, Mallery says. The bioadhesive gel, which contains 10 percent freeze dried black raspberries, is devoid of many of the tasty sugars found in native berries.
The black raspberry gel was manufactured by the University of Kentucky’s Good Manufacturing Production (GMP) facility. NanoMed Pharmaceuticals is partnering with OSU investigators Mallery, Stoner and Peter E. Larsen D.D.S. and Russell J. Mumper, Ph.D., of the University of North Carolina, in product development.