Without undue influence

Advertised as the latest and greatest adhesive ever made, Security is hailed as an orthodontist’s dream come true. It provides effective strength in cementing orthodontic appliances, ranging from bands and bonds to fixed orthopedic appliances, with an unlimited array of possible applications. Adhering to enamel, cementum, dentin, and any restorative material, Security is reported to perform flawlessly in a wet or dry environment.

The corporation that developed Security has approached you with a research grant proposal that would bring your orthodontic department sufficient funds to update your clinic’s cone-beam computed tomography and digital scanning technology—and more. After meeting with the company’s representatives and securing clearance from your school’s administration, you begin investigation of the product’s strength via an in-vitro experimental protocol.

Several months into the study, you become concerned. Although your results indicate exceptional bond strength, your independent assessment of the intrapulpal temperature changes caused by Security during its setting phase suggests that pulpal vitality could be jeopardized. You approach the manufacturer with your concern, but you receive a disturbing response. The company spokesman says that assessment of intrapulpal temperature change is not an objective of your investigation, and your work should be confined to the specifications of the research grant. He threatens to discontinue your funding if the increase in pulpal temperature is publicized.

Now you have a conundrum. Do you withhold your findings and confine your investigation solely to bond strength, or do you expose the potential dangers of Security?

Dilemmas in privately funded research are especially pertinent in medico-dental applications because of our patients’ vulnerability. A landmark case involving such a dilemma occurred in the 1990s, when hematologist Nancy Oliveri determined that the chelating agent used to treat thalassemia, a rare blood condition hallmarked by low hemoglobin levels and an insufficient red blood cell count, was not only ineffective but linked to severe liver toxicity in children. Contrary to the manufacturer’s demands, she exposed the risks of the drug to protect the patients for whom it was intended. As a result of her disclosure, Dr Oliveri not only lost her corporate funding for the investigation but also was eventually dismissed by the university that employed her. She eventually received accolades—including several awards—for her overriding commitment to patients’ welfare, despite the profound personal and financial costs.

Privately funded research is prone to 2 forms of investigative bias. First, nondisclosure can occur if unexpected or unfavorable results emerge and publication of the results is prohibited by the funding entity. Second, if an investigation expands beyond the scope of its original research design and finds adverse information, the sponsor might insist that those results remain undisclosed. This is termed “narrowing the scope” of an investigation. Nondisclosure and limitation of scope under duress can impact an investigator’s independence by jeopardizing project funding and affecting the authenticity of the investigation. Of equal concern is that repeated influence by the funding entity might affect the integrity of future research by altering the behavior of research personnel. The investigator might adopt the perspective that control of the project by the funding source is the rule rather than the exception.

Because of the trend toward decreased public funding for research, private funding might provide a substantial share of future funding. The ethical challenge to the investigator to maintain veracity will rise proportionately, and readers of those investigations will need to be very discerning.

A difficult decision now awaits you. Do you jeopardize your funding with an authentic report of your results, or do you preserve your funding by limiting the scope of your findings? You must consider that your colleagues and their patients rely on your results to meet the ultimate challenge: optimal and safe patient care. From that perspective, the choice is simple.

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Apr 6, 2017 | Posted by in Orthodontics | Comments Off on Without undue influence
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