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Tuesday, January 22, 2013

Study questions effectiveness of oral cancer detection devices

By Rabia Mughal, Contributing Editor

September 30, 2008 -- Clinicians should rely on oral exams, specialty referrals, and tissue biopsies to best diagnose premalignant and malignant oral lesions because there isn't enough data to prove that adjunctive cancer detection devices are effective in a general practice setting, according to a recent study in the Journal of the American Dental Association(JADA, July 2008, Vol. 138:7, pp. 896-905).

There is an ongoing debate in the dental community about the utility of these devices in the early detection of oral cancer. But the manufacturers of these products stand by them and contend that the JADA study is too limited in its scope.

In the JADA literature review, the authors searched for articles on PubMed, ISI Web of Science, and the Cochrane Library from January 1966 through February 2008 that evaluated the effectiveness of toluidine blue (TB), ViziLite Plus with TBlue, ViziLite, Microlux DL, Orascoptic DK, VELscope, and the OralCDx brush biopsy. Ultimately, they short-listed 23 studies that met their criteria.

In particular, they included studies that reported histologic confirmation of lesions identified by adjunctive techniques, or those that allowed calculation of the test's accuracy compared with tissue biopsy.

The researchers looked at study design, sampling, and characteristics of the study group; interventions and reported lesion diagnostic outcomes; information about the clinical setting (mucosal disease or cancer center clinic or a general practice); and subjects' presumed oral cancer risk.

"We gave each article a summary quality score by means of assessing a priori identified important attributes of the study that may have led to bias in interpretation of results," the authors wrote.

ViziLite Plus with TBlue

The authors looked at three studies that examined ViziLite and reported that its sensitivity was consistently at 100%. However, the authors noted, all three studies involved patients with previously visualized mucosal lesions. The specificity ranged from 0% to 14%. The positive predictive value (PPV) was 18% to 80%, and the negative predictive value (NPV) ranged from 0% to 100%.

No longer available as a standalone device, ViziLite is only available as a kit with blue phenothiazine dye (TBlue). Two studies assessed ViziLite Plus with TBlue.

"The investigators found that ViziLite enhanced visual lesion characteristics in approximately 60% of lesions, identified all lesions previously identified with standard light and identified no additional lesions," the authors wrote. "The addition of TB application to the chemiluminescence enhanced visual examination ... improved the specificity and PPV and increased the NPV to 100%."

Zila Pharmaceuticals, the company that manufactures and markets ViziLite, took exception to some of the study's findings, however. ViziLite's efficacy in identifying suspicious lesions that are missed during visual examination was not accurately reported in the article because the authors used only manuscripts reporting previously identified visual lesions, Mark Bride, D.D.S., Zila's vice president of medical and clinical affairs, told DrBicuspid.

"The ViziLite studies eliminated from consideration were conducted by mucosal disease specialists and thus, per their [the authors] criteria, considered lower quality studies," he noted. "This makes little sense in that the outcomes of those studies demonstrated an improvement in the net yield of lesions suspicious for precancer or cancer with the inclusion of chemiluminescent examination. The article determined that these results are not translatable to a general practitioner in a general screening population. This conclusion is disconcerting and should have no bearing on determining study quality."

Dr. Bride also pointed out that, since Zila's only product is ViziLite Plus with TBlue, reporting on the performance of individual components does not accurately represent the product.

"Unfortunately, by eliminating pertinent studies from the analysis for the purpose of comparing device outcomes to histologic (biopsy) outcomes, ViziLite Plus with TBlue was positioned as a diagnostic tool instead of a screening adjunct," he added.

VELscope

VELscope manufacturer LED Dental also said the study selection does not accurately represent its product.

The JADA study authors looked at two studies that assessed the VELscope. Both involved patients with known oral dysplasia or squamous cell carcinoma (SCCa) confirmed by biopsy.

"Compared with the sensitivity of histopathological examination in patients with identified high-grade dysplastic lesions and SCCa, the reported sensitivities of tissue autofluorescence with the VELscope technology as an adjunct to visual examination were 98% and 100%; specificity was 100% and 78%; PPVs were 100% and 66%; and NPVs were 86% and 100%, respectively," the authors wrote.

The VELscope is useful in assessing lesion margins in patients with oral premalignant and malignant lesions, the authors noted. No studies have been published on its effectiveness as a diagnostic adjunct in lower-risk populations or in patients seen by primary care providers.

"I believe it is a good exercise to see how the various oral cancer screening methods and technologies 'stack up' against this type of rigorous criteria," stated David Morgan, Ph.D., LED Dental's chief science officer, in an e-mail to DrBicuspid. "The bottom line is that none of them compare very well against this type of standard -- and this includes the conventional oral examination itself. Even biopsy with histopathological examination, the gold standard for diagnosis, has significant issues -- sampling problems and subjective rather than objective assessment criteria, which lead to less than ideal inter- and even intrapathologist variability."

Holding newer adjunctive techniques to this kind of standard -- prospective, randomized, controlled, community based multisite studies conducted by nonexpert clinicians on a general, low-risk population -- and recommending that clinicians not to use them because they don't measure up to this standard yet is misguided, he added. The VELscope is not a standalone diagnostic test, he stated.

"It is peculiar that there is concern about using technologies which, when used properly in combination with a conventional exam, help you see more things better, things you might have missed, sometimes things that might save somebody's life," Morgan noted.

OralCDx brush biopsy

The JADA study authors also looked at four studies involving the use of the OralCDx brush biopsy in detecting or diagnosing oral premalignant and malignant lesions. They concluded that, while the test has utility in detecting dysplastic changes in mucosal lesions, there is insufficient data to assess its utility in low-risk populations or clinically innocuous lesions.

Drore Eisen, M.D., D.D.S., medical director of OralCDx Laboratories, said that this finding is "clinically pointless."

"Using the same inclusion criteria that the authors applied to studies of OralCDx, the sensitivity of the scalpel biopsy for testing those nonsuspicious lesions, which are not subjected to scalpel biopsy, is certainly unknown," he said. "For the practicing general dentist, how suspicious an oral lesion may appear matters little, since all white and red tissue changes without a known cause require testing regardless of how suspicious they may appear, and OralCDx offers dentists the only noninvasive and accurate method of testing them."

The study authors stated that, based on the literature, the sensitivity of the OralCDx test varied from 71% to 100%, specificity varied from 27% to 94%, PPV ranged from 38% to 88%, and NPV ranged from 60% to 100%.

But in every comparative study in which the OralCDx brush and scalpel biopsy of a lesion are performed simultaneously and on the same tissue, a very high degree of agreement between these two biopsy techniques is always confirmed, Dr. Eisen said.

"In a recent study of 200 patients with oral leukoplakia, two scalpel biopsies taken of the same lesion agreed with each other only 56% of the time, and underdiagnosis from scalpel biopsy was noted in 29.5% of patients," he said. "Therefore, those studies quoted in the JADA paper, which reported some discrepancies between brush biopsy and scalpel biopsy results, are completely meaningless since in all of those studies the two biopsy samples were obtained by two different examiners and at widely different times."

The authors did not find any studies that met their criteria for the Microlux DL and Orascoptic DK systems.

The authors did not respond to repeated attempts to give them the opportunity to respond to the vendors' comments here.

Study: Dental care can reduce risk of preterm birth

By DrBicuspid Staff

October 1, 2008 -- Women who receive dental care before or during their pregnancy have a lower risk of giving birth to a preterm or low-birth-weight baby than pregnant women who don't seek dental care at all, according to a study by Aetna and the Columbia University College of Dental Medicine.

The study, conducted between January 1, 2003, and September 30, 2006, reviewed medical and dental insurance data for 29,000 pregnant women who each had medical and dental coverage with Aetna to determine if there was an association between dental treatment and the likelihood of experiencing either birth outcome.

"Further studies need to be done, but our findings show that dental treatment had a protective effect on adverse birth outcomes in women who sought dental treatment," said David Albert, D.D.S., M.P.H., director of the Division of Community Health at Columbia University College of Dental Medicine, in a press release.

When comparing the group who did not receive any dental treatment to the groups that received gum treatment and dental cleaning, the study found:

The preterm birth rate was 11% for those not receiving dental treatment and 6.4% for those receiving treatment.
The low birth weight rate was 5.4% for those not receiving dental treatment and 3.6% or lower among the groups receiving treatment.

"The results of this study send a strong message about the importance of dental care for women who want to start a family," said Dr. Mary Lee Conicella, D.M.D., F.A.G.D., national director of clinical operations for Aetna Dental. "We are seeing evidence that supports the role of routine preventive dental care in helping to protect the health of the newborn and the mother, and contributing to lower associated medical costs."

Mass. dental practices sued by state attorney general

By DrBicuspid Staff

October 1, 2008 -- Massachusetts Attorney General Martha Coakley is suing more than a dozen individuals and corporations -- including three dentists and their business managers -- for allegedly exploiting dental patients by performing unnecessary and overpriced procedures to obtain funds from finance companies and insurers.

According to the complaint, filed September 24, the defendants marketed free dental exams and low monthly payment plans to potential customers with "limited means and inadequate or no dental insurance." They then allegedly "baited" them with false and misleading marketing tactics about the defendants' dental practice, promising free exams and affordable monthly payment plans for "quality treatment."

Repeated attempts to contact the defendants and locate their attorneys were unsuccessful.

The complaint states the defendants set up a call center in order to control the alleged deceptive marketing scheme and instructed their employees to lure patients into the dental clinics by emphasizing the free exams. Once the patient was in the chair, the defendants allegedly "switched" them into expensive, hasty, and often incomplete or shoddy treatment, together with costly payment plans. Instead of low monthly payments, the loans carried interest rates as high as 22.98%, the complaint states, and the insurance companies of patients with dental insurance were given false and inflated claims.

"Over and over, the defendants collected thousands of dollars per patient by arranging loans for them from credit companies and billing for the entire proposed procedure up-front, and then left the patients with inadequate and incomplete treatment and costly debt from the credit companies," the complaint states.

When the patient complaints mounted and the scheme became apparent, the defendants allegedly abandoned the patients, their records, and the dental practices. Ultimately, hundreds of patients were left with dental problems and thousands of dollars in debt, according to the complaint.

The attorney general's office says it received more than 200 complaints from individuals claiming they had been injured and overcharged by the defendants, including one patient who was charged $16,126 for "root canals and bridges" that resulted in bruises, swelling, and pain ever since being treated. Another patient reported going into a clinic with a toothache and emerging four hours later with a tooth extraction, root canal, filed-down teeth, a temporary bridge, and a $5,000 credit line with annual interest at 27.99%.

"Many consumers thought they were going for a routine trip to the dentist and left these clinics in worse shape, both physically and financially, than when they walked in the door," Coakley said in a press release. "Our office filed this lawsuit to ensure that these defendants can never again exploit Massachusetts citizens in need of dental care, and we intend to seek relief for the many people already hurt by these unconscionable practices."

In addition to three dental practices -- Spectrum Dental, Coast Dental, and Sierra Dental -- the defendants named in the lawsuit include the following:

Gary Anusavice, D.D.S., who "took and maintained a leadership role in creating and operating the defendants' scheme," according to the press release
Michael Rinaldi, Joseph Robbio, Vincent O'Neill, and Heather Pavao, all finance advisors and business managers at the dental operations
Merhad Haghkerdar, a dentist that facilitated the defendants' scheme at Spectrum Dental
William Salisbury, a dentist doing business as Sierra Dental

A temporary restraining order has been issued that secures any assets the defendants may have, prohibits them from applying for or maintaining a license to practice dentistry in Massachusetts, and prohibits them from destroying or altering any records.

Both the attorney general's office and the Board of Registry in Dentistry have previously taken action against Dr. Anusavice and Dr. Salisbury, and both have lost their licenses to practice dentistry in Massachusetts.

Dr. Anusavice was previously accused of stealing thousands of dollars from patients by billing them for services they didn't receive at his Pawtucket, RI, business, Premier Dental. In 1997, he pleaded guilty to healthcare fraud after his DDS Dental Center in Worcester, MA, filed hundreds of thousands of dollars of fraudulent insurance claims and credit card charges, according to the attorney general. In 2005, Rhode Island suspended his license, accusing him of defrauding patients of tens of thousands of dollars through various billing and credit schemes.

Monday, January 21, 2013

Dentistry and depression: Part II -- How to cope

By Rochelle Sharpe, DrBicuspid.com contributing writer

August 21, 2008 -- Few of those who attended the spring meeting of the California Dental Association in Anaheim, CA, suspected anything unusual. But while most were in the convention center listening to lectures on topics such as crown lengthening and digital photography, John H. Newman Jr., D.D.S., was losing his battle with depression. On May 2, the opening day of the conference, he leapt to his death from the balcony of his 14th-floor room at the nearby Disneyland Hotel.

Dr. Newman's suicide came as a reminder of the devastating potential of depression -- and the need for dentists to take care of themselves as well as their patients.

"The most important asset in the dental office is the health of the dentist," said James Willey, director of the American Dental Association's Council on Dental Practice, which now sponsors biannual conferences on health and wellness issues.

It's no secret that dentistry can be a stressful profession. Performing technically complicated procedures on anxious patients in a small, confined space can take its toll. Add financial pressures, government regulations, and the threat of malpractice suits, and it's no wonder that dentists have the reputation of committing suicide at a higher rate than any other profession (see part I of this series).

A difficult job

"It's a difficult job that is very demanding -- and people don't appreciate [dentists]," said Dorothea Lack, Ph.D., a San Francisco psychologist who used to work as a dental hygienist. Dentistry is comparable to medical surgery, she said, yet medical surgeons are revered like gods, while dentists are often feared.

Dentists reporting stress
Work is stressful	80%
Work stress is moderate	69%
Work stress is extreme	11.7%
Sometimes have difficulty falling asleep	21.4%
Sometimes feel depressed	17.8%
Sometimes feel hopeless	10.3%
Dentists in counseling	6.8%

It is unclear how many dentists are suffering. But in the ADA's 2003 Dentist Well-Being Survey of 2,565 dentists, 80% said their work was stressful. (See chart for more survey results.)

While the pressures may not always be openly discussed, many dentists appear eager to vent about them, if given the opportunity. When Robert Rada, D.D.S., M.B.A, co-authored an article for the Journal of the American Dental Association (June 2004, Vol. 135:6; pp. 788-794) on stress, depression, and burnout, he got more feedback than he has on anything else he ever published. The clinical assistant professor at the University of Illinois at Chicago found himself commiserating with dentists and even trying to give a dentist's wife ideas on how to help her husband cope.

Some dentists get too absorbed by the profession, Dr. Rada said. "Practices that were once simple have gone out of control."

But typically, it's not just work that that drives dentists over the edge, psychologists say. Instead, it's a combination of professional and personal stresses.

To deal with his own stress, Dr. Rada, who maintains a general practice in La Grange, IL, decided to shorten his workweek -- first from six to five days a week, and eventually down to four days. "I cut my hours, kept making as much money, and enjoyed my practice more," he said. Not only did he learn to be more efficient, but he had fewer patients cancel appointments. They knew that his shortened workweek meant that appointments were harder to reschedule.

When dentists are in their offices, they can find plenty of ways to reduce stress, too, experts say. "People don't realize how easy it is to reduce stress simply by breathing," said Uche Odiatu, D.M.D., a Canadian dentist who is also certified as a nutrition specialist and fitness trainer.

When most people are stressed, they hold their breath or take shallow breaths, while depressed people often hunch over or look at the ground, Dr. Odiatu said. Unfortunately, dentists are forced to hunch over for most of the workday, a posture that is not optimal for their mental well-being, he noted.

But it can help to simply take deep breaths and pause to lift your head up, pretending to look out over the horizon, he said. "The brain gets fooled into feeling good."

Dr. Odiatu also advocates exercise, getting enough sleep, and staying hydrated, noting that physiological changes in the body begin when the body is just 1% dehydrated.

When to get help

Depression and suicide resources

ADA
The ADA offers a Web page on health and wellness with links to other resources.

National Suicide Hotlines USA
Offers a list of state hotlines. (National hotlines include 1-800-SUICIDE and 1-800-273-TALK.)

American Association of Suicidology
The organization is dedicated to the understanding and prevention of suicide by promoting research, public awareness, education, and training for professionals and volunteers.

Suicide Prevention Action Network USA
A nonprofit organization dedicated to the creation of an effective national suicide prevention strategy.

American Foundation for Suicide Prevention
An organization also dedicated to understanding suicide.

On his Web site, Mark Hillman, Ph.D., a New York psychotherapist, wrote that dentists can use progressive relaxation techniques whenever they feel stressed -- even in the office. By tensing then releasing the muscles, the technique allows muscles to deeply relax, he wrote, inducing a physiological state that is incompatible with anxiety.

Hillman also recommends thought-stopping: concentrating briefly on unwanted thoughts and then emptying your mind of them. By controlling negative thoughts, stress levels can be reduced, he said.

There are productive ways to deal with anger, too, said psychologist Marian Stuart, Ph.D., a professor at Robert Wood Johnson Medical School and author of The Fifteen Minute Hour: Practical Therapeutic Intervention in Primary Care, a book on incorporating psychology into healthcare practices.

Instead of dwelling on what is wrong, dentists should think about what it is they want and what they can do about it, she said. If nothing can be done, then they need to try to accept the situation or try to reframe the problem.

Certainly, dentists need to know the warning signs of depression and seek professional help if they are suffering from them. These signs include feelings of worthlessness, decreased ability to concentrate, diminished interest in pleasurable activities, and recurrent thoughts of death or suicide. "When people think about killing themselves, they want to do anything possible to stop the pain," Stuart said.

Her message to overwhelmed dentists: There are better ways out of the anguish.

Sirona stock drops on news of possible sell-off

By DrBicuspid Staff

August 21, 2008 -- Shares of Sirona Dental Systems fell $2.64, or 9%, to $25.85 on August 20 after a private equity firm that holds more than two-thirds of the company's stock said it may sell part or all of its stake in Sirona.

According to a shelf registration filing with the Securities and Exchange Commission, Sirona Holdings Luxco S.C.A. could sell its entire holding, nearly 37 million shares (67.5% of all available Sirona shares). The holding company, which comprises Madison Dearborn Partners, Beecken Petty O'Keefe, and members of Sirona's management, bought a controlling interest in the company in June 2005.

Upgrade available for older Waterlase lasers

By DrBicuspid Staff

August 21, 2008 -- Biolase Technology is offering a software upgrade designed to extend the capabilities and useful life of first-generation Waterlase hard- and soft-tissue dental lasers, the company announced in a press release.

The upgrade is intended to provide smoother cutting and increased patient comfort by giving the first-generation lasers variable pulse repetition rates (frequency) similar to the company's latest generation Waterlase MD and Waterlase C100 systems.

The software upgrade comes one month after the introduction of the Waterlase C100, which is due to begin shipping at the end of the current quarter.

The upgrade includes the Waterlase LB 3.0 Operating System, which provides five different repetition rates (from 10-30 Hz) in addition to the original 20 Hz, and a new CPU board.

The upgrade is being launched with the company's exclusive North American distribution partner Henry Schein Dental, and installations will start in Waterlase dentists' offices in September.

Sunday, January 20, 2013

Plaintiff wants FDA amalgam settlement overturned

June 24, 2008 -- Just when it looked as though the FDA had calmed critics of mercury fillings, the hornet's nest has been stirred up again. Two weeks after the FDA negotiated a settlement in a lawsuit filed by anti-amalgam activists, one of them has moved to reopen the case.

In the settlement, the agency changed the way it describes amalgam on its Web site -- to imply that some patients may be at risk from the substance -- and agreed to reclassify it by July 2009.

Now one of the plaintiffs, Karen Palmer, a former dental assistant, claims she was not notified of the settlement agreement and would not have accepted it if she had been, according to her new attorney, Jim Love, who also serves as counsel for the International Academy of Oral Medicine and Toxicology. She is asking to be removed from the settlement and for the court to consider earlier petitions that call for a complete ban of amalgam.

"There was a mediation scheduled by the court that was attended not by the plaintiffs but plaintiff's counsel, and there was no authority to settle the case on any particular terms," Love said in an interview with DrBicuspid.com.

Charles Brown, the attorney representing the 11 plaintiffs in the original lawsuit against the FDA, says he is shocked by Palmer's sudden opposition to the settlement. He claims she originally agreed to it "until some lawyers started talking to her."

"We didn't anticipate getting a settlement that day, but I was in a settlement room [with the FDA] and we ended up getting the thing we have never had before: an agreement to reclassify," Brown told DrBicuspid.com. "The goal of the case was to get a date to classify and we achieved that, and even more. The FDA has actually gone from praising mercury to advising of its risks. The plaintiffs had a contract to accept reasonable settlement offers, and they were very excited about this settlement agreement. She [Palmer] was very excited about it. I have e-mails from her saying how much she praised the settlement."

But Love maintains that Brown and the FDA had no right to negotiate the settlement agreement without the plaintiffs knowing the details beforehand.

"The settlement was reached by the attorneys for FDA and by Mr. Brown, but you can't limit a plaintiff's or party's right to control the settlement through a fee agreement," he said. "Whether the settlement agreement was reasonable or not isn't the point. The point is that he [Brown] didn't go to Ms. Palmer to get her authority. She was never contacted concerning the terms of the agreement."

In her motion, Palmer says that if she had received notice of the settlement before it was reached, she would not have agreed to its terms. In particular, she "would have agreed to no more than three months for the completion of the classification process," the motion states.

Love says he has already had assurances from FDA counsel that it will go along with the motion to overturn the settlement. FDA spokespeople could not be reached. But Brown is confident that the settlement agreement will move forward as is.

"We will file a motion and we will win that motion," he said. "That settlement will not be overturned because there is no basis for it."