Hygienist’s BIONJ reminds us how drug marketing sometimes fails

May 1, 2012
I have not yet experienced a patient with symptoms or a diagnosis of bisphosphonate-induced osteonecrosis of the jaws ...

I have not yet experienced a patient with symptoms or a diagnosis of bisphosphonate-induced osteonecrosis of the jaws (formerly called BON/BRONJ/BIONJ and now referred to as ARONJ) so it came as quite a surprise to find the following letter from a Massachusetts dental hygienist in my inbox a couple of weeks ago:

Dear Ms. Slim,

I just received the most recent edition of RDH magazine and read your article on BIONJ. I had to write to you in response to this article and I am hoping that you receive this email and in return are able to respond to me.

Last year, I had two surgeries on my palate due to taking Fosomax for nine years. Yes, nine years! I was never diagnosed with osteoporosis but with osteopenia shortly after menopause. It was very slight, but my gynecologist recommended that I start the regime of 70 mg once a week. I tolerated the medicine very well with no apparent side effects until last spring.

At that time, I burned the roof of my mouth. Fortunately, the burn was located on my torus palatinus. It took a long time to heal, and a few months later when I put my tongue to the roof of my mouth, I was horrified to feel a lesion that turned out to be osteonecrosis. The oral surgeon removed a good portion of my torus, but it returned in another area a few months later. Another surgery removed most of the torus. I guess the good news is that only the torus was affected; otherwise, I would have had very serious long-term consequences with my palate and sinuses.

I would love to hear back from you so that I can discuss my case in more detail.

Thank you for your time!

Michelle Rosen, RDH

At age 59, Michelle had her entire world rocked when she felt something very odd as her tongue explored around her palate (circumference of her torus palatinus). In describing what she noticed, she said it felt like sand dunes around the edges of the torus with a soft indentation like a donut hole in the center. Feelings of panic set in and she immediately sought consultation from her dentist/employer. She walked into her employer’s private office, shut the door and announced with a trembling voice that there was something very strange and scary on the roof of her mouth. Michelle’s greatest fear was that the lesion could be cancer.

Her conscientious employer tried hard to calm her down and assured her it was probably related to Fosamax. He referred her to an oral surgeon.

Blood work and a sinus scan were completed to determine borders of the osteonecrosis and its depth. Surgery was performed to remove the necrotic bone without removing the entire torus. Biopsy confirmed the diagnosis of bisphosphonate-induced osteonecrosis of the torus palatinus. A few months after surgery, another area of necrotic bone appeared and the remainder of the torus was removed.

According to Dr. Robert Marx, professor of surgery and chief of the division of oral and maxillofacial surgery at Miller School of Medicine, University of Miami, the Merck drug Fosamax (alendronate), 70 mg orally once weekly, is the most toxic oral preparation and produces the bulk of oral BIONJ. It has also been noted to cause spontaneous femur fractures — the very entity it was developed to prevent — with long-term use.1

I recently read an excellent story on National Public Radio (NPR), “All Things Considered,” about how Fosamax gets into the medicine cabinets of millions of women across America (including Michelle Rosen) who have not been diagnosed with osteoporosis. As it turns out, the marketing of these pills is changing the definition of the disease and has created a large group of vulnerable women in a whole new category needing treatment.

What happens to a lot of women over 50, like Michelle, is a suggestion from their gynecologists that it’s time to take a bone density test. A letter might arrive in the mail several days after the bone density scan with a message that indicates a diagnosis of osteopenia. As it turns out, osteopenia is a slight thinning of the bones that occurs naturally as a woman ages and typically doesn’t result in bone fractures. There is uncertainty about which patients with osteopenia should be medicated. So why are so many of these postmenopausal women taking Fosamax?

NPR in “All Things Considered” weighed in on this discussion back in 2009.2 Apparently, Merck & Co. wasn’t selling a lot of Fosamax so they hired a marketing executive to figure out a way to increase awareness of the efficacy of the drug. At the time, bone density machines were rare, and the available units were costing too much per test. So Merck decided to find a way to place machines in doctors’ offices all over America and bring down the price of the tests.

According to NPR, Merck established a nonprofit called the Bone Measurement Institute and worked hard to find a way to boost bone scan machine sales, and smaller, cheaper options were found. You can read all the details of this story by visiting the link in the second reference below.

I want to end this column by mentioning two things:

  • I’m incredibly relieved to hear that Michelle lost only her torus and not half of her jaw.
  • Read the quote below from the NPR story that emphasizes the downside of blockbuster drugs such as Fosamax and questions the ethics surrounding Merck’s profitability model.

“The paradox of our health care system is that both of these men are probably right. That is, drug companies produce incredible drugs that can greatly relieve suffering. But one way they profit from those drugs is to extend their use to as many people as possible, which frequently means that medications are used in populations with milder and milder versions of a disease, so that the risks of medicating can come to outweigh the benefits.” — NPR.org, Dec. 21, 2009.


1. Marx RE. (2011) Oral and Intravenous Bisphosphonate-Induced Osteonecrosis of the Jaws (2nd.ed.). Quintessence Publishing Co, Inc.
2. www.npr.org/2009/12/21/121609815/how-a-bone-disease-grew-to-fit-the-prescription.

Lynne Slim, RDH, BSDH, MSDH, is an award-winning writer who has published extensively in dental/dental hygiene journals. Lynne is the CEO of Perio C Dent, a dental practice management company that specializes in the incorporation of conservative periodontal therapy into the hygiene department of dental practices. Lynne is also the owner and moderator of the periotherapist yahoo group: www.yahoogroups.com/group/periotherapist. Lynne speaks on the topic of conservative periodontal therapy and other dental hygiene-related topics. She can be reached at [email protected] or www. periocdent.com.

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