Medical Genetics in the Clinical Practice of ORL

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The presumed benefits of having clinicians control genomic information may be further impeded if, as we have suggested in our previous work, patients are more knowledgeable about genomics than their health care providers, which may diminish the confidence patients have in the advice of clinicians regarding genomic risk management [2]. Our findings suggest that clinicians find the DTP marketing model appealing because it offers a new way to enhance relationships with patients and to tap information they would not otherwise have in providing preventive care.

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But the benefits of the DTP marketing model nonetheless seem weighted toward laboratories. The strategy provides a steady stream of new users to generate profit, and it evades some of the regulatory scrutiny of the DTC model [1] by channeling the information through clinicians as more traditional laboratory tests.

The danger here is that this clinician-laboratory partnership model, in which expertise may be interactional, potentially compromises the integrity of clinical judgment. This is not to discredit the strengths that clinicians may bring to genomic counseling, from professional experience and caution to potential concerns about professional liability.

Rather, our goal is to draw attention to the potential for conflicts of interest that emerge when commercial laboratories with a profit motive market their tests to clinicians, and then counsel clinicians on how results should be interpreted and conveyed. Most of our interviewees seemed to lack critical reflection on genomic tests and results, and those that did take a more critical stance typically pointed to the prematurity of integrating genomic science into the clinical encounter rather than with the DTP marketing and service delivery model.

It appeared as though participants found it unproblematic to be receiving tests and advise on how to order and interpret test results from the same commercial source.


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However, these clinicians seemed even less critical of commercial genomic risk assessment platforms than early DTC consumers that we interviewed for an earlier study [2] , This is concerning because customers of DTC genomic profiling were cautioned to be watchful consumers, but critical reflection is assumed among those holding titles as clinical professionals and was not what we found among early adopting clinicians. Even if clinicians desire genomic knowledge, the DTP model of commercial marketing and test dissemination is unlikely to foster autonomous substantive expertise among clinicians.

Simply routing commercially-generated genomic risk information to patients through physicians will not meet the complex challenges posed by burgeoning markets in consumer and clinical genomics. To increase competent clinical judgment in genomics requires a more nuanced understanding of the dynamics of private clinical practice, how clinicians learn about new testing modalities, and the values that undergird clinical integration of genomic testing. Rather than emphasizing the need for expert interpretation of genomic test results, the mode of delivery itself requires further interrogation and regulatory oversight.

Regardless of the technological platform, further deliberation and guidelines from professional societies and federal oversight of commercial laboratory services is needed to demonstrate the analytic and clinical validity and clinical utility of genomic tests. The dependencies inherent in their interactions with clinicians pose risks to the integrity of clinical judgment and patient care.

Careers in Individualized Medicine: Genetic Nurse

Left unattended, these risks will only increase as genomics is further integrated into clinical care. Permissions: Written permission has been obtained from all persons named in the acknowledgment. Conceived and designed the experiments: MM JF. Performed the experiments: ML. Browse Subject Areas? Click through the PLOS taxonomy to find articles in your field. Methods and Findings We conducted qualitative in-depth interviews with 18 clinicians providing genomic risk assessment services to their patients in partnership with DNA Direct and Navigenics.

Conclusions DTP service delivery model cannot guarantee that providers will have adequate expertise or sound clinical judgment. Introduction As the cost of genomic analysis has plummeted over the last decade, genomic risk profiling has become increasingly available in consumer and clinical settings. Methods The study was designed to assess how early clinical users of genomic risk assessment understood genomics and used their knowledge of genomics to inform clinical decisions. Results We conducted a total of 18 interviews with clinicians affiliated with 16 clinical sites in the United States and 1 clinical site in Canada.

An internist affiliated with a network of concierge medicine providers explained that Navigenics approached his practice: to see if we would be interested in sending, having our patients genomically tested. Provider The training was a couple of one-hour PowerPoint presentations. Provider Participants were generally uncritical of and grateful for the training and information that they received from the commercial laboratories.

Discussion Our study suggests that many early-adopting clinical providers of SNP-based genomic testing were enthusiastic about the potential for these tests to enhance the personalized, preventive and wellness orientations of their clinical practices. Supporting Information.

Appendix S1. References 1. Journal of Community Genetics 1: — View Article Google Scholar 2. New Genetics and Society — View Article Google Scholar 3. JAMA — View Article Google Scholar 4. Howard H, Borry P Is there a doctor in the house? Journal of Community Genetics 3: — View Article Google Scholar 5. Journal of Genetic Counseling: 1— Pandey A Preparing for the 21st-century patient.

View Article Google Scholar 7. Public Health Genomics 22— View Article Google Scholar 9. Personalized Medicine 9: — View Article Google Scholar European Journal of Human Genetics — Genetic Testing and Molecular Biomarkers — Journal of Community Genetics 4: — Genetics in Medicine — Journal of Human Genetics — Journal of Genetic Counseling — Pollack A Consumers slow to embrace the age of genomics. The New York Times. Accessed June 11, Dorfman R Falling prices and unfair competition in consumer genomics. Nature Biotechnology — The American Journal of Bioethics 8: 18— Allison M Direct-to-consumer genomics reinvents itself.

Annals of Internal Medicine. Program Director Division of Genomic Medicine.

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Nicole C. Lockhart, Ph. Simona Volpi, Ph. Sylvia Garvey, M. Program Specialist Division of Genomic Medicine.

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