Medication monitoring and drug testing ethics project.
In 2012, Duke University initiated a research project, funded by an unrestricted research grant from Millennium Laboratories, a drug testing company. The project focused on assessing the frequency and nature of questionable, unethical, and illegal business practices in the clinical drug testing industry and assessing the potential for establishing a business code of ethics. Laboratory leaders, clinicians, industry attorneys, ethicists, and consultants participated in the survey, were interviewed, and attended two face-to-face meetings to discuss a way forward. The study demonstrated broad acknowledgment of variations in the legal and regulatory environment, resulting in inconsistent enforcement of industry practices. Study participants expressed agreement that overtly illegal practices sometimes exist, particularly when laboratory representatives and clinicians discuss reimbursement, extent of testing, and potential business incentives with medical practitioners. Most respondents reported directly observing probable violations involving marketing materials, contracts, or, in the case of some individuals, directly soliciting people with offers of clinical supplies and other "freebies." While many study respondents were skeptical that voluntary standards alone would eliminate questionable business practices, most viewed ethics codes and credentialing as an important first step that could potentially mitigate uneven enforcement, while improving quality of care and facilitating preferred payment options for credentialed parties. Many were willing to participate in future discussions and industry-wide initiatives to improve the environment.
Professor of Medicine and Divinity, Duke Divinity School, Duke University, Durham, North Carolina.
Richard
R
Payne
Executive in Residence, Fuqua School of Business, Duke University, Durham, North Carolina.
Jeffrey L
JL
Moe
Project Director, Fuqua School of Business, Duke University, Durham, North Carolina.
Catherine Harvey
CH
Sevier
Project Director, Fuqua School of Business, Duke University, Durham, North Carolina.
David
D
Sevier
Catawba Consulting, Floyd, Virginia.
Michael
M
Waitzkin
D000068:Accreditation; D002568:Certification; D003132:Commerce / Q000941:ethics; D016265:Conflict of Interest; D016903:Drug Monitoring / Q000941:ethics* / Q000592:standards; D005607:Fraud / Q000941:ethics / Q000517:prevention & control; D033161:Government Regulation; D019983:Guideline Adherence; D017408:Guidelines as Topic; D019538:Health Care Surveys; D006801:Humans; D007753:Laboratories / Q000941:ethics* / Q000331:legislation & jurisprudence / Q000592:standards; D008389:Marketing of Health Services / Q000941:ethics; D055118:Medication Adherence; D009657:North Carolina; D011237:Predictive Value of Tests; D016730:Program Development; D015397:Program Evaluation; D015203:Reproducibility of Results; D015813:Substance Abuse Detection / Q000941:ethics* / Q000592:standards; D019966:Substance-Related Disorders / Q000175:diagnosis* / Q000517:prevention & control; D011795:Surveys and Questionnaires