Whitening Toothbrush Maker Responds to Criticism

J&J to Modify Some Toothbrush Whitening Claims

September 9, 2011 -- The National Advertising Division (NAD) of the Council of Better Business Bureaus has recommended that Johnson & Johnson Healthcare Products modify certain claims for its Reach Total Care + Whitening toothbrush to clarify that the brush whitens teeth through the abrasive action rather than through bleaching.

As part of its routine monitoring program, NAD -- the advertising industry's self-regulatory forum -- requested substantiation for express claims that included the following:

• "Ordinary toothbrushes clean teeth. Reach whitens them."
• "At the core of this revolutionary toothbrush Reach has engineered a unique row of bristles infused with calcium carbonate microwhitening technology. That means each time you brush, you're whitening teeth and removing stains.*" (*in lab tests)

NAD also examined the implied claim that the Reach Total Care + Whitening toothbrush has been proven to actually whiten teeth when used in the same manner as an ordinary toothbrush.

According to Johnson & Johnson, the toothbrush, launched in 2010, was designed with bristles embedded with calcium carbonate, recognized by the U.S. Food and Drug Administration as an abrasive used in fluoride toothpastes.

In support of its claims, Johnson & Johnson provided NAD with evidence that demonstrated that bristles infused with calcium carbonate do, in fact, provide statistically significantly better stain removal than brushes with ordinary bristles. The company also provided testing to demonstrate that its advertised toothbrush provided significantly better plaque removal than the other two ordinary toothbrushes tested. In addition, Johnson & Johnson's evidence demonstrated that the difference in whitening and stain removal was meaningful to consumers, according to NAD.

Following its review of evidence, NAD determined that Johnson & Johnson could support the claim that "[o]rdinary toothbrushes clean teeth. Reach whitens them."

However, NAD recommended that the company modify the claims "whitens and removes stains" and "each time you brush you're whitening and removing stains" to ensure that consumers are aware that stain removal is accomplished extrinsically, through the stain-removing abrasive action of the bristles, not intrinsically through bleaching.

According to NAD, Johnson & Johnson said it is disappointed with the NAD recommendation, "given the industry practice of making unqualified whitening claims based on data showing extrinsic whitening only. Nevertheless, we understand NAD's recommendations and will take them into consideration in future advertising."

      - Dr. Green's sidenote


Patients often ask me for product recommendations (the best toothpaste, toothbrush, etc.) that they can use at home.   We evaluate 100s of products every year to make these recommendations.  Johnson & Johnson is one of the leading manufacturers of these at-home products and to be fair, I will say that the vast majority of their products are excellent and safe.  By posting this article I am in no way suggesting to my readers that they should ban J&J products from their household.  The objective of this post is to educate my readers on the potential dangers of store-bought whitening products.
When I recommend any product to my patients, I always consider it's method of action (how it does what the manufacturer claims it does).  With whitening toothpaste or toothbrushes the method of action usually involves the removal of surface staining rather than through the whitening of the tooth enamel (which is how whitening solutions and gels work).  This is accomplished through the use of coarse abrasives, not whitening solutions.

The best analogy I can use would be to compare toothbrushing to sanding a piece of wood.  In order to take raw wood from being splintery and rough to a smooth surface that's ready to stain, a carpenter will start with a fairly coarse grit of sandpaper and use progressively finer grits until the board is smooth.  When you brush your teeth you are basically doing the same thing-you use a toothbrush and toothpaste containing a minty abrasive to remove the plaque and food debris from your teeth.  I always recommend the use of a soft or ultra-soft bristled toothbrush and a traditional toothpaste (non-whitening and non-tartar control) for my patients.  This will do more than enough to clean your teeth on a daily basis - without damaging or removing the protective enamel.  If you have issues with stain accumulation related to heavy coffee consumption, smoking or drinking colas or red wines, that's where we come in.

Regular visits to a dental hygienist are always essential to maintaining optimum dental health, especially if you accumulate stain easily! 

Limitations Suggested for Osteoporosis Medications

FDA advisers consider time limit for bone drugs

By Reuters Health

September 9, 2011 -- ADELPHI, Md. (Reuters) - U.S. health advisers are considering a time limit for taking a class of drugs used by millions of women to prevent bone fractures, due to concerns over unusual fractures linked to the medicines and possible higher cancer rates.

Two U.S. Food and Drug Administration advisory panels were jointly meeting on Friday over whether to recommend a "drug holiday" or otherwise clarify how long people should take a class of osteoporosis drugs known as bisphosphonates.

These drugs include Merck & Co's Fosamax, Warner Chilcott's Actonel, Roche's Boniva, and Novartis' Reclast.

Widely taken by women after menopause to prevent osteoporosis, drugmakers told the advisers that a sweeping imposition of an interruption in treatment may leave patients vulnerable to more fractures.

FDA staff said rare femur fractures appear to be associated with use of the drugs, and the risk of jaw bone death may increase the longer people take them orally. But they said the evidence for an increased cancer risk was inconsistent.

No advantage exists in staying on the drug beyond five years, FDA researchers said.

"In light of the risk-benefit challenges, the available data suggest that therapy can be safely discontinued without the loss of efficacy," said Dr. Marcea Whitaker, an FDA medical officer from the reproductive and urologic drugs division. "However, additional data are needed to further define an appropriate duration of drug cessation."

Some 4.5 million Americans over the age of 55 filled prescriptions for bisphosphonates in 2009. The medicines are commonly taken for osteoporosis, a progressive bone-thinning condition that typically causes bone fractures in the hip, wrist, or spine.

Boniva is available as either an injection or a tablet, Reclast is an injection, and the other drugs are taken orally.

Since Merck's Fosamax became the first bisphosphonate to get approval for osteoporosis in 1995, the labels for the drugs of this class have undergone multiple reviews and changes.

In 2005, a warning of higher risk of osteonecrosis of the jaw was added to labels, and in 2009, a caution about adverse gastrointestinal reactions. Earlier this year, the labels added a warning of atypical femur fractures and Reclast's label was changed to highlight a higher risk of kidney failure.

Just last month, a federal judge threw out part of a bellwether lawsuit against Merck, but said the plaintiff could pursue her claim that Merck's Fosamax had a design defect and caused her jawbone tissue to die.

Still, bisphosphonates remain a widely-used treatment option for women facing a risk of bone fractures.

"I have to tell my patients that we have no magic bullet, that our drugs decrease the risk of fracture but we have nothing that eliminates fracture," said Dr. Robert Adler, an invited speaker at the advisory meeting and endocrinology professor at the Virginia Commonwealth University.

"Despite rare side effects, those patients who take bisphosphonates have fewer fractures and lower mortality, and these findings need to be shared with our patients," he said.

Makers of the drugs emphasized that studies have not directly linked or explained the connection between their medicines and adverse side effects. They voiced concerns about the lack of data on what happens to patients who go off treatment and suggested "drug holiday" decisions are best done for each patient individually.

"A drug holiday may be appropriate for some patients, but that decision should be based on an individual risk-benefit basis, and a physician is in the best position to make that decision overall," said Joseph Kohles, international medical leader for Boniva at Roche.

Whitening - How to Reduce Sensitivity & Damage to Your Teeth

Can Remineralizing Agents Mitigate Whitening Side Effects?

September 14, 2011 -- Teeth whitening is one of the most popular cosmetic procedures today, but it can have negative side effects. For example, some studies have reported that whitening agents containing carbamide peroxide or peroxide may soften dental hard tissues.

But a new study has found that adding a remineralizing agent such as casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) to the bleaching agent could mitigate this effect (Operative Dentistry, August 5, 2011).

"I decided to conduct this research since there is still a debate over whether carbamide peroxide- or peroxide-containing agents can soften dental hard tissues," said lead study author Boniek Castillo Dutra Borges, DDS, an assistant professor at the school of dentistry at Potiguar University, in a DrBicuspid.com interview. "We were surprised to find that the use of a CPP-ACP paste (MI Paste, GC America) with carbamide peroxide bleaching agents increased the bleached enamel's microhardness and did not have an influence on whitening efficacy."

“CPP-ACP-containing paste with carbamide peroxides could protect enamel against the demineralization. ...”
— Boniek Borges, DDS

Although a large body of scientific evidence demonstrates that CPP-ACP could promote the remineralization of even enamel subsurface caries lesions, this study is the first to analyze the effect of MI Paste in conjunction with carbamide peroxides on bleached enamel microhardness, the study authors noted.

To evaluate the efficacy of an at-home bleaching technique using 10% or 16% carbamide peroxide modified by CPP-ACP and its influence on the microhardness of bleached enamel, the researchers studied 40 bovine incisors that were stained using a mixture of red wine and tea.

The samples were divided into four groups of 10 each and stored in artificial saliva for a 14-day bleaching regimen. The four groups were bleached using the following:

• 10% carbamide peroxide only
• A blend of 10% carbamide peroxide and a CPP-ACP paste
• 16% carbamide peroxide only
• A blend of 16% carbamide peroxide and a CPP-ACP paste

For two of the 10% and 16% peroxide groups, the peroxides were mixed with MI Paste by combining 1 mL of the bleaching gels with 1 mL of MI Paste until a homogeneous paste was obtained, which was then inserted into a 5-mL syringe. In addition, the peroxides alone were put into 5-mL syringes.

The researchers assessed the microhardness and color of the teeth at baseline and immediately after the 14-day bleaching regimen using a microhardness tester and a spectrophotometer. The degree of color change was determined by the Commission Internationale de l'Eclariage (CIE) L*a*b* system and Vita shade guide parameters.

Among the study's findings:

• The teeth that were bleached with a blend of peroxide (10% or 16%) and the CPP-ACP paste presented increased microhardness values after the bleaching regimen compared with the baseline measurements, whereas the samples that were bleached with peroxide only did not show any differences in their microhardness values.
• All the bleaching agents were effective at whitening the teeth and did not show a statistically significant difference using the CIE L*a*b* system or the Vita shade guide parameters.

Even though the concentration of carbamide peroxides was reduced to half after mixing them with MI Paste, this was not sufficient to affect color change after a 14-day bleaching regimen, the authors wrote.

"The use of a casein phosphopeptide-amorphous calcium phosphate (CPP-ACP)-containing paste with carbamide peroxides could protect enamel against the demineralization caused by these bleaching agents," Dr. Borges said. "This improves safety and might even reduce in vivo tooth sensitivity during the bleaching process."

The authors did note, however, that more studies are needed to evaluate how long this microhardness increase could last. Other bleaching peroxides should be tested in association with the CPP-ACP paste because the results of this study are not applicable to all types of bleaching systems, they added.