The buck stops here

It’s a second-opinion consultation for a patient who has traveled over an hour to see you. She is an aspiring actress who was told that she must improve her smile if she wants to excel in her career. Two other orthodontists have advised her that she is not a candidate for correction via removable appliances, but one told her he could complete full appliance therapy in 10 months without surgical procedures. He suggested a new technology called the “Powerwand,” which he claims “stimulates the teeth,” leading to accelerated tooth movement. The technique, he said, is newly developed but worked in a patient he finished treating just last month. “Will it work for me?” she asks. You tell her you have not read any research studies about the technique, but you will contact a friend who serves as a faculty member to find out. Later that night, your Internet search yields only advertisements for the device, with no refereed literature support.

There is no question that technology in medicine and dentistry can elevate the level of patient care. In industry’s zeal to market a product, however, commercially motivated promotion rather than investigational evidence can often prematurely drive the availability of a product or service. Sometimes that product or service might need a bit more research and development before it is placed into routine clinical practice. Many of us will recall the initial marketing of ceramic brackets in the late 1980s. Although the anterior teeth had been bonded with metallic and semitransparent plastic brackets before that time, both systems had esthetic drawbacks. Lingual orthodontics had been introduced several years before, but the specialty was eager to find a cosmetic bracket that could be utilized with traditional concepts of mechanotherapy. When ceramic brackets were introduced, our specialty was delighted. The difficulty proved not to be the application and use of the brackets but, rather, their removal. There were numerous reports of enamel fractures and significant discomfort at debanding.

Such overzealous marketing is not unique to dentistry. Zetia and Vytorin, 2 relatively new cholesterol-inhibiting medications, reached a sales level of $1.8 billion in 2007 before they were withdrawn from the market. Clinical evidence later showed that these products were ineffective as cholesterol-lowering agents. Closer to dentistry, the COX-2 analgesic Vioxx was recalled in 2003 after worldwide marketing campaigns because clinical trials indicated that it increased the incidence of strokes and heart attacks. These issues indicate that physicians are also inclined to use new products before thorough investigation of their risk-benefit ratios.

In their efforts to expedite or facilitate treatment, orthodontists and other health care professionals might be too eager to use new technologies in patient care. Although endorsements by individuals or organizations, including faculty members, can be used in an attempt to authenticate the safety or efficacy of a new treatment product or technique, an intelligent skepticism is essential even after clinical research is used to assess the innovation. A recent study indicated that 39% of a 2944-patient sample “mistakenly believed that the FDA approves only ‘extremely effective’ drugs and 25% mistakenly believed that the FDA approves only drugs without serious side effects.” This confirms the public’s vulnerability, especially with regard to product endorsement.

Who has the ultimate responsibility regarding our patients’ exposure to new products and services? It is incumbent on us, as doctors, to determine whether a product has been sufficiently investigated before we advocate its use for our patients. If one is not certain of a product’s efficacy or safety, there are usually time-tested alternatives that can be used until such confirmation is received. In the enduring words of President Harry S. Truman, “The buck stops here.”

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Apr 8, 2017 | Posted by in Orthodontics | Comments Off on The buck stops here

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