The Morning Drill: May 10, 2012

Dr. Bruce Fisher - charges dropped

Good Thursday morning!

On to today's dentistry and health headlines:

Charges against Lewes dentist dropped

Delaware Department of Justice has dropped its offensive touching case against Lewes dentist Dr. Bruce Fisher in Sussex County Family Court.

Jason Miller, spokesman for the Department of Justice, said the charges were dropped because of insufficient evidence before trial. He said the department had no further comment at this time.

Fisher, 44, was arrested March 9 after he allegedly covered the mouth of an 8-year old and told him to shut up. Police said the child was at Fisher’s First State Oral Surgery for a medical procedure and began screaming after the procedure was finished. A family member was in the room and reported Fisher to Delaware State Police.

Cavity-fighting measure sinks along with civil unions

A bill aimed at thwarting cavities in babies became collateral damage in the fight over civil unions in Colorado late Tuesday night.

Senate Bill 12-108 had sailed through earlier hearings and was expected to pass in the House on Tuesday night, then be up for final approval today.

But the bill died along with nearly three dozen other measures that were held hostage during the civil unions standoff.

SB 108 would have provided funding for dental benefits for pregnant moms on Medicaid. Research has shown that mothers who have tooth decay and untreated cavities can pass bacteria to their babies, thus infecting their teeth and causing some babies and toddlers to lose all their baby teeth before age 3. Poor dental health of mothers also has been associated with premature birth, another highly expensive health problem.

Numerous dental experts from Children’s Hospital Colorado and the Colorado Dental Association had worked with advocates for low-income patients and members of the legislature’s Joint Budget Committee to find funding to help pregnant mothers take better care of their teeth.

“We are disappointed,” said Dr. Ulrich Klein, a doctor of dentistry at Children’s Hospital and chair of the pediatric dentistry at the University of Colorado School of Dental Medicine. “We have been fighting this battle for so long.”

New Cautions About Long-Term Use of Bone Drugs

In an unusual move that may prompt millions of women to rethink their use of popular bone-building drugs, the Food and Drug Administration published an analysis that suggested caution about long-term use of the drugs, but fell short of issuing specific recommendations.

The F.D.A. review, published in The New England Journal of Medicine online on Wednesday, was prompted by a growing debate over how long women should continue using the drugs, known as bisphosphonates, which are sold as generic versions of brands like Fosamax and Boniva, as well as Novartis’s Reclast.

The concern is that after years of use, the drugs may in rare cases actually lead to weaker bones in certain women, contributing to “rare but serious adverse events,” including unusual femur fractures, esophageal cancer and osteonecrosis of the jaw, a painful and disfiguring crumbling of the jaw bone.

Although the concerns about the long-term safety of bone drugs are not new, the F.D.A. performed its own systematic review of the effectiveness of bisphosphonates after years of use. The agency’s analysis, which found little if any benefit from the drugs after three to five years of use, may prompt doctors around the country to rethink how they prescribe them.

Scientists Identify Neurotranmitters That Lead to Forgetting

While we often think of memory as a way of preserving the essential idea of who we are, little thought is given to the importance of forgetting to our wellbeing, whether what we forget belongs in the "horrible memories department" or just reflects the minutia of day-to-day living.

Despite the fact that forgetting is normal, exactly how we forget -- the molecular, cellular, and brain circuit mechanisms underlying the process -- is poorly understood.

Now, in a study that appears in the May 10, 2012 issue of the journal Neuron, scientists from the Florida campus of The Scripps Research Institute have pinpointed a mechanism that is essential for forming memories in the first place and, as it turns out, is equally essential for eliminating them after memories have formed.

"This study focuses on the molecular biology of active forgetting," said Ron Davis, chair of the Scripps Research Department of Neuroscience who led the project. "Until now, the basic thought has been that forgetting is mostly a passive process. Our findings make clear that forgetting is an active process that is probably regulated."

Enjoy your morning!

Merck Wins Another Fosamax Lawsuit

Osteonecrosis of the Jaw (ONJ)

This particular lawsuit was about the use of Fosamax, an oral bisphosphonate drug, and osteonecrosis of the jaw (ONJ).

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today said a federal court jury in New York found in its favor in the Secrest v. Merck case, rejecting the claim of a Florida woman who blamed her dental and jaw-related problems on her FOSAMAX use.

"We believe the company acted properly," said Chilton Varner of King & Spalding LLP, outside counsel for Merck. "Unfortunately, the plaintiff had medical problems that cause people to develop the jaw and dental problems that the plaintiff has, regardless of whether they were taking FOSAMAX. She has a long history of invasive dental procedures and suffers from medical conditions that inhibit the body's ability to heal."

Today's verdict marks the fourth time a jury has found in Merck's favor on a plaintiff's product liability claim in the litigation regarding FOSAMAX. The plaintiff in this case alleged she used FOSAMAX and suffered various jaw problems and complications following multiple tooth extractions and failed dental implants.

At trial, Merck presented evidence that it acted responsibly in researching and developing FOSAMAX and in monitoring the medicine since it has been on the market, and that FOSAMAX is a safe and effective medication as described in the product labeling that was properly designed and did not cause the plaintiff's dental and jaw problems. The company's clinical trials, conducted both before and following approval, have involved more than 28,000 patients, including more than 17,000 treated with FOSAMAX.

"Merck is pleased with the jury's verdict," said Bruce N. Kuhlik, executive vice president and general counsel of Merck. "We have now won four of the first five cases that have been tried to verdict. We continue to believe that FOSAMAX is a safe and effective medication and the company provided appropriate and timely information about FOSAMAX to consumers and to the medical, scientific and regulatory communities."

U. S. District Judge John F. Keenan presided over the trial. Merck is represented by Chilton Varner of King & Spalding LLP in Atlanta, Andrew Goldman of Goldman Ismail Tomaselli Brennan & Baum LLP in Chicago and Stephen Marshall of Venable LLP in Baltimore.

This suit was all about this particular woman and her pre-existing dental condition and if Fosamax was the proximte cause of her injuries. The jury said no.

But, there is an awarenenss of ONJ occurring with patients that take oral bisphosphonates and I recommend to all dental patients to please consult with your physician and dentist, if you are taking the medication and must have teeth extractions or other surgical dental procedures.

What is the state of the many lawsuits against Merck?

This is the fifth case regarding FOSAMAX® (alendronate sodium) to go to trial. Merck won three of the first four. The first three trials were conducted as part of the federal multidistrict litigation proceedings before Judge Keenan. The first case to be tried to a verdict, Maley v. Merck, resulted in a defense verdict for Merck in May 2010. The second case to be tried to a verdict, Boles v. Merck, initially resulted in a mistrial in September 2009 after the jury was unable to reach a unanimous verdict. A retrial of that case in June 2010 resulted in a plaintiff verdict, which was later reduced by Judge Keenan and which Merck intends to appeal after the damages portion of the case is retried. The third case to be tried to a verdict, Graves v. Merck, resulted in a defense verdict for Merck in November 2010. The fourth case to go to trial, Rosenberg v. Merck, which was tried in the Superior Court for Atlantic County, New Jersey, resulted in a defense verdict for Merck in February 2011.

As of June 30, 2011, approximately 1,650 cases, which include approximately 2,050 plaintiff groups, had been filed and were pending against Merck in either federal or state court.

The Morning Drill: September 27, 2011

A collection of dentistry and health related links/comments for your day.

Bisphosphonates Cut Risk for Bone Metastasis

The use of bisphosphonates prior to a diagnosis of breast cancer appears to help prevent the development of bone metastases, which can result from the disease, according to research presented here at the American Society for Bone and Mineral Research 2011 Annual Meeting.

Bisphosphonates, used widely for the treatment of osteoporosis, have antibone resorption effects that make them valuable in the treatment of osteolytic bone disease and osteolytic lesions of metastatic breast cancer, in particular.

Pamidronate, an aminobisphosphonate, has been approved for the treatment of metastatic breast cancer to bone since 1996, and the bisphosphonate clodronate has been shown in research to be effective in preventing skeletal metastasis in high-risk cancer patients when given immediately after tumor removal.

"Bisphosphonates can be useful in osteolytic bone disease, particularly in patients with breast cancer," said lead author Richard Kremer, MD, PhD, associate professor in the division of endocrinology, McGill University, Montreal, Quebec, Canada. "However, that benefit in the context of prevention has not been well established in clinical studies.

EU MOVE TO LIMIT TOOTH WHITENING

MOVES to regulate the use of over-the-counter teeth whitening products was hailed by dentists here yesterday.

The Irish Dental Association has backed the decision to limit the use of hydrogen peroxide.

A directive by the European Council bans toothwhitening products containing more than 6% of the chemical.

It also advises that the process should only be carried out under the supervision of a dentist.

Tom Feeney of the Council of European Dentists said: "Patient safety is the No1 priority.

"The new regulations ensure properly-qualified dentists are carrying it out, that safe products are being used and the treatment is restricted to those over 18."

For women, risk of depression falls as coffee intake rises

A few cups of coffee a day may help keep the blues at bay. According to a large new study, women who drink caffeinated coffee are less likely to become depressed -- and the more they drink, the more their risk of depression goes down.

The study, which was published today in the Archives of Internal Medicine, included more than 50,000 women between the ages of 30 and 55 who periodically filled out surveys about their coffee consumption and health. None of the women had depression symptoms (or a history of depression) at the start of the study, but during the next 10 years roughly 5% received a depression diagnosis or began taking antidepressant medication.

Compared with women who drank little or no caffeinated coffee, those who averaged two to three cups per day were 15% less likely to develop depression, even after the researchers took into account a wide range of potentially mitigating factors including marital status, church or community participation, and various health measures. Drinking four cups a day was associated with a 20% lower risk of depression.

The study doesn't prove cause and effect, so there's no reason to believe that drinking cup after cup will actually prevent depression, the researchers say.

"There's no need to start drinking coffee," says study co-author Alberto Ascherio, M.D., a professor of epidemiology and nutrition at the Harvard School of Public Health, in Boston. "The message is that coffee is safe to drink, with no adverse effects. That's really all that can be said."

More Aggressive Whooping Cough Vaccine Use Advised

The American Academy of Pediatrics and the US Centers for Disease Control and Prevention have revised their recommendations on the whooping cough vaccine to call for the administration of 1 vaccine at particular ages and with minimal intervals between vaccinations, according to a new policy statement published online September 26 in Pediatrics.

"There are a lot of places where we have opportunities to have a positive impact, and if we don't take advantage of all of them, we're not likely to be successful," said Michael Brady, MD, from Nationwide Children's Hospital in Columbus, Ohio, and chair of the American Academy of Pediatrics' infectious diseases committee. "We're finding that 7- to 10-year-olds are underimmunized, and that older adolescents, if immunized at age 11, by the time they get to age 17 or 20, they're probably not protected. Also, we're giving the vaccine to mothers during pregnancy, rather than after delivery, because that will protect the mothers, and the mothers will develop the antibodies that they will give to their babies."

The 2 groups removed their previous minimum interval between administering a tetanus or diphtheria vaccine and the tetanus toxoid, reduced-content diphtheria toxoid, and acellular pertussis vaccine (Tdap) based on a committee's review of clinical trials and other studies that cited no excess adverse reaction when Tdap is given shortly after tetanus and diphtheria toxoid vaccine (Td). To help to prevent pertussis, the 2 groups recommend a single dose of Tdap for children aged 7 to 10 years who may have been underimmunized with Tdap or whose immunization history is incomplete. Previously the preferred ages were 11 through 18 years.

At this time, the standard schedule for whooping cough vaccines lists shots at ages 2, 4, 6, and 15 to 18 months, as well as at ages 4 to 6 years and 11 to 12 years. Tdap is one of a group of pertussis vaccines used and was the first approved for ages 7 years and older.

The groups recommend extending the age for administering Tdap to people aged 65 years and older and to healthcare workers of all ages — anyone who may come in contact with infants too young for vaccination — because research has shown that grandparents are often caregivers for infants. The groups also recommend vaccination of adolescents, including pregnant adolescents, and pregnant women, whereas previously the recommendation was to wait until after pregnancy.

Enjoy your morning!

FDA to Look at Fosamax and Other Bisphosphonate Drug Side Effects

According to this press release.

A panel of outside advisers to the FDA are scheduled to meet and review questions about the side effects of Fosamax and other osteoporosis drugs, which may increase the risk of bone fractures and severe jaw problems after long-term use.

The FDA advisory committee will meet on September 9 to evaluate the risks associated with long-term use of Fosamax, Actonel, Boniva and Reclast.

All of the osteoporosis drugs belong to a class known as bisphosphonates, which are designed to strengthen bones, particularly in women, and prevent or treat the onset of osteoporosis.

Long-term use of oral bisphosphonates has been linked to an increased risk of serious and debilitating jaw problems, known as osteonecrosis of the jaw. The condition causes the jaw bone to decay and rot, often resulting in the need for surgery to remove portions of the jaw.

Hundreds of Fosamax lawsuits over jaw problems have been filed against the drug’s maker, Merck. At least one case has resulted in a jury awarding $8 million last year, after finding that Merck failed to adequately research the potential Fosamax side effects or warn about the risk of jaw necrosis.

More recently, use of the medications, particularly Fosamax, has been linked to a growing number of reports involving spontaneous femur fractures, which often occur with little or no trauma at all. A growing number of Fosamax bone fracture lawsuits are now being filed against Merck, alleging that the drug maker also failed to adequately warn about this risk.

In October 2010, the FDA required the manufacturers of all oral bisphosphonates to add warnings about the risk of bone fractures, placing new information on the label that informs consumers to seek immediate medical attention if they experience new groin pain or thigh pain while taking the drug, which can occur weeks or months before a complete fracture of the femur on Fosamax occurs.

The findings of this committee will not be binding but will probably recommend protocols for the duration of use. I have seen some recommend a five year usage followed by a five year holiday of not using these drugs.

The Morning Drill: July 8, 2011

A collection of dentistry and health related links/comments to start your day.

Mom's Antidepressant Use Linked to Autism Risk in Children

Use of selective serotonin reuptake inhibitors (SSRIs) by pregnant women may increase the risk for autism spectrum disorder (ASD) in their offspring, new research suggests.

In a study of more than 1800 children, investigators found an adjusted 2-fold increased risk for ASD among mothers who used an SSRI during the year before delivery and a 3-fold increased risk when SSRIs were ingested during the first trimester.

"The potential association between use of antidepressants during pregnancy and risk of [ASDs] has never been investigated before," lead author Lisa A. Croen, PhD, senior research scientist and director of the Autism Research Program at Kaiser Permanente Northern California (KPNC) in Oakland, told Medscape Medical News.

However, she noted that the results "should be interpreted with extreme caution" and that further studies are needed to determine if this association represents a causal connection.

"At this point, we do not recommend that women make any changes to their treatment approach for depression and/or anxiety," said Dr. Croen.

Instead, she recommends that those prescribed SSRIs during pregnancy discuss the issue with their doctors.

"We know that there are real risks to the woman and their children if mental health disorders in mom go untreated, and there are real benefits to appropriate treatment.  So the potential risk of autism must be balanced with the real benefit of treatment," she said.

The study was published online July 4 in the Archives of General Psychiatry.

Dental implants seem safe for people taking low-dose oral bisphosphonates

Mainly, two groups of people take bisphosphonates to strengthen their bones: people who have osteoporosis and those who have bone cancer.  People with osteoporosis usually take a low dose of the medication by mouth (as a pill, for example).  By contrast, people who have cancer receive bisphosphonates in high doses intravenously (directly into the bloodstream).

We know that people who take bisphosphonates, either by mouth or intravenously, are at risk of developing a condition called osteonecrosis of the jaws, or ONJ.  People who develop ONJ suffer severe loss of the jawbone. The authors wondered whether people who took bisphosphonates were more likely to develop ONJ if they got dental implants than other people taking bisphosphonates.  They also wondered whether implants were more likely to come loose in patients who took bisphosphonates than in other patients.

They found three studies that involved 217 people who took bisposphonates by mouth for up to four years before they got dental implants.  Overall, the group had 840 implants.  All of the studies recorded how many implants stayed in place for up to four years after placement.  They found no studies that involved people taking high doses of bisphosphonates intravenously. Since the authors could not find any research articles about people taking bisphosphonates intravenously, they looked at six published expert opinions and treatment guidelines.

Authors' findings
None of the people who took bisphosphonates by mouth developed ONJ after implant placement, and for the first four years after placement, the implants remained functional. For people taking bisphosphonates intravenously, most of the guidelines said they should not have dental implants placed.

Conclusions
People who take low doses or bisphosphonates by mouth can consider having dental implants put in place without increased worry about developing ONJ or concern about the stability of the implant. Dental implants, however, are not recommended for people taking high doses of bisphosphonates intravenously. Talk to your dentist about your options and the best course of treatment for you.

Source: Madrid C, Sanz M. Clinical Oral Implants Research. 2009;20 Suppl 4():87-95

Why did my dentist ask me about my swimming pool?

It may seem odd that when a patient sits in my dental chair I might ask about their swimming habits.  This summer thousands of folks will be splashing away in their backyard pools.  Some of these people may be putting their dental health at risk.

Why?  Pool water can become very acidic if the chemistry is not monitored and adjusted regularly. Simply put, a poorly maintained swimming pool can erode away a lot of dental enamel. This loss of enamel can make teeth weak, discolored and prone to sensitivity and decay. The centers for disease control  (CDC) has reported numerous cases of individuals with compromised teeth related to extended exposure to acidic swimming pool water.  A recent report by the NY College of dentistry highlights the rapid erosion and dental problems associated with poorly maintained pools.

Mutations in One Gene Cause Craniosynostosis, Delayed Tooth Eruption and Supernumerary Teeth

Researchers have described a new, recessively inherited human syndrome featuring craniosynostosis, maxillary hyperplasia, delayed tooth eruption and extra teeth. They also identified causative mutations in a gene IL11RA.

In craniosynostosis, the sutures between skull bones become ossified prematurely, affecting skull shape and limiting space for the growth of the brain. It is observed in 1:2500 and often requires operative surgery. Supernumerary teeth are more common, and in most cases they also require dental surgery.

A combination of these anomalies was observed in four children of a Pakistani family living in Denmark. Extra teeth developed in positions suggesting that they may represent a third set of teeth, the formation of which is normally prevented in humans.

The parents of the family were first cousins, which made it possible to localize the gene in the genome (so called homozygosity mapping) and identify the mutation, causing a change of a single amino acid, in a gene for interleukin 11 receptor alpha (IL11RA). This is a protein on cell surface that binds the extracellular interleukin 11 and makes possible for the cells to sense the presence of this factor. When tested in cultured cell lines, the mutation inactivated the function of the receptor.

The researchers also found four other mutations in IL11RA in patients from Pakistan, England and The Netherlands.

"This is a quite novel discovery as IL11 -- or the signaling pathway it belongs to -- has not previously been associated with any inherited human disorders," says Dr. Pekka Nieminen, the leader of the study (University of Helsinki). "The results show that IL11 signaling is essential for the normal development of craniofacial bones and teeth, and that its function is to restrict suture fusion and tooth number."

Enjoy your morning!

The Saturday Drill: June 4, 2011

A collection of dentistry and health related links/comments for your day.

Hormone-blocking drug, Aromasin, reduces breast cancer risk

Millions of women at higher-than-usual risk of breast cancer have a new option for preventing the disease. Pfizer Inc.'s Aromasin cut the risk of developing breast cancer by more than half, without the side effects that have curbed enthusiasm for other prevention drugs, a major study found.

It was the first test in healthy women of newer hormone-blocking pills called aromatase inhibitors, sold as Arimidex, Femara and Aromasin, and in generic form. They're used now to prevent recurrences in breast cancer patients who are past menopause, and doctors have long suspected they may help prevent initial cases, too.

Prevention drugs aren't advised for women at average risk of breast cancer. Those at higher risk because of gene mutations or other reasons already have two choices for prevention tamoxifen and raloxifene. But these drugs are unpopular because they carry small risks of uterine cancer, blood clots and other problems.
"Here's a third breast cancer prevention drug that may in fact be safer," said Dr. Allen Lichter, chief executive of the American Society of Clinical Oncology.

Training new dental health providers in the United States

Abstract

Objectives: Introduction of dental therapists in the United States involves a wide range of issues including permissive governmental policymaking; determinations of their education, supervision, and deployment; their acceptance by dentists and the public; financing of their services; and, most fundamentally, their training. This contribution re-releases and updates the executive summary of an extensive report comparing therapists' training across five industrialized countries and comparing therapists' training to that of conventional U.S. dental providers.

Methods: Literature reviews, web searches, key informant interviews, and program document reviews.

Results: Internationally, three-year training programs that dually qualify trainees as hygienists and therapists dominate. There are marked differences between non-US and US-based therapist training programs and between US-based programs. Reported goals of establishing dental therapists include expanding the availability of basic dental services to underserved disadvantaged subpopulations; potentially reducing costs of basic care; and enhancing the roles of dentists in providing the most sophisticated care, serving the most complex patients, and managing an expanded dental team. Criteria for establishing training programs include program length, supervisory arrangements, recruitment and incentives, deployment, educational costs, curriculum, oversight, and accreditation.

Conclusion: International experiences can well inform US policy on training of dental therapists.

Minnesota Graduates First Class of Dental Therapists

Christy Fogarty will always remember the man whose wedding she saved. "His front teeth were so decayed he literally couldn't smile," she told Medscape Medical News. Fogarty restored all 6 of the man's front teeth and sent him beaming to his bride. It is the kind of happy ending that many dentists like to reminisce about, but with one key difference: Fogarty is not a dentist.

A dental hygienist in practice as an independent contractor for 7 years, Fogarty, 41, is about to obtain her master of science in oral health care practitioner through a controversial program at Metropolitan State University in Minneapolis, Minnesota. Her class of 7 will graduate June 23, adding a new category of dental practitioner to the state, with duties falling between those of a dentist and those of a hygienist.

The program, enacted into law in 2009 despite continuing opposition from the Minnesota Dental Association (MDA), is only the second in the United States that licenses such dental therapists. Compared with the dental health aide therapist program in indigenous Alaska communities, the Minnesota therapists, who are also being trained at the University of Minnesota, will have more education and more limited capacities.

They will be able to prepare teeth and place all types of direct restoration, as well as stainless steel crowns; do pulpotomies; make prostheses; and extract primary teeth. They will do this work only under the indirect supervision of a dentist, meaning that the dentist must be on the premises but not necessarily in the operatory when the work is done.

With 2000 more hours of clinical practice, and after passing an examination that is as yet to be devised, these dental therapists can become advanced dental therapists, who will also be able to extract mobile permanent teeth and work under a dentist's general supervision meaning the dentist could be miles away from the therapist when the work is done.

Dental Tourism: How Far Would You Go for A Crown?

Have you heard of the term "medical tourism"? If you have, give me a second to explain what it is to everyone else -- essentially, medical tourism is combining a vacation abroad with a medical procedure/operation. The reasoning is, many procedures and operations can be done much cheaper in many other countries.

India is a country that is a popular medical tourism destination. And, from my "outsiders" perspective, with good reason -- in many areas, they have state-of-the-art medical facilities and world-renowned medical professionals.

I'm stating the above because I do not know enough about medical tourism to be a naysayer on the entire industry. But I do have an opinion on it when it comes to medical tourism and dentistry, particularly in the area of Mexico.

Maybe you've seen some ads or websites that state something like: Hey, how about a Mexican vacation, complete with sun, surf and tequila? And while you're here, why not get a dental implant or cheap crown?

Why not indeed... Allow Dr. Connelly to tell you why not.

Bone Drug Bisphosphonate Zometa May Prevent Return of Breast Cancer

A drug that battles bone loss may have added benefits for women with estrogen-sensitive breast cancers, significantly reducing the chance that their cancer will return or spread, a new study shows.

What's more, researchers say, the lowered risk of recurrence seems to last years after the treatment, a bisphosphonate drug called Zometa, is stopped.

"I find that very reassuring. It obviously demonstrates that we can impact on the long-term outcome of our patients with an early intervention. We do not have to give these drugs forever. I'm very enthusiastic about this," says study researcher Michael Gnant, MD, professor of surgery at the Medical University of Vienna in Austria.

For the study, which is published in TheLancet, 1,803 premenopausal women with early-stage, estrogen-driven breast cancers were given a drug which suppresses estrogen production by the ovaries. They were also treated with drugs, Arimidex or tamoxifen, that help prevent cancers from using estrogen to grow.

In addition to those treatments, half were randomly assigned to receive intravenous infusions of Zometa every six months for three years.

Two years after their treatments ended, women who got the bone drug continued to have a 32% reduced risk of cancer recurrence compared to those on estrogen suppression alone.

strogen suppression alone.

Overall, 92% in the Zometa group were cancer-free two years after treatment compared to 88% on estrogen suppression alone

Enjoy your Saturday drill!