Supplemental Reading

Council on Ethical and Judicial Affairs, American Medical Association. Gifts to physicians from industry. JAMA 1991;265:501. Updated June 1996 and June 1998. Available online at http://www.ama-assn.org (E-8.061 Gifts to Physicians from Industry.)

Davidson R. Source of funding and outcome of clinical trials. J Gen Intern Med 1986:1:155-158.

Emanuel E, Wendler D, and Grady C. What Makes Clinical Research Ethical? JAMA 2000;283(20):2701-2711.

Executive Committee of the Pharmaceutical Research and Manufacturers of American (PhRMA), PhRMA Code on Interactions with Healthcare Professionals, July 1,2002. Available online at http://www.phrma.org

Fletcher J et al. Introduction to Clinical Ethics (2nd ed.). Frederick, MD: University Publishing, 1997.

Kessler DA. Drug promotion and scientific exchanges: The role of the clinical investigator. N Engl J Med 1991;325:201-203.

Levine RJ. Some recent developments in the international guidelines on the ethics of research involving human subjects. Annu N Y Acad Sci 2000;918:10-8.

Svensson C. Ethical considerations in the conduct of clinical pharmacokinetic studies. Clin Pharmacokinet 1989;17:217-222.

Wazana A. Physicians and the Pharmaceutical Industry: Is A Gift Ever Just a Gift? JAMA 2000;283(3):373-380.

Wolfe SM. Why do American drug companies spend more than $12 billion a year pushing drugs? J Gen Intern Med 1996;11:637-639.

^ Case Study Dr. Drew and the Hypertensi

Lee Drew, MD, has been invited by Modern Pharmaceutical Company to participate in a new drug trial for hypertension. For every patient Dr. Drew recruits through his small private practice, he will receive $1,000 to help defray the costs of quarterly blood draws and the additional paperwork required by the study. In addition, Modern Pharmaceuticals will replace Dr. Drew's computer system to enable better patient tracking. Given the declining reimbursement rates from third-party payers, Dr. Drew could really use the financial support but wonders what benefits this drug offers to patients. Is it simply a me-too or copycat drug, designed primarily to make money for the drug company? And, if so, can Dr. Drew be justified in asking patients to enroll in the study? Still, Dr. Drew finds the financial incentives tempting and knows the risk to patients is low. How should Dr. Drew resolve the ethical dilemma?

Answer: Dr. Drew faces many ethical questions in deciding whether or not to participate in the drug trial for hypertension sponsored by the Modern Pharmaceutical Company. In analyzing whether to participate, Dr. Drew should focus on the primacy of the role of physician, with the attendant duty to protect patients from harm, and recognize that the role of investigator must remain secondary. Having established the priority of Dr. Drew's obligations to provide good patient care and protect patients from harm, Dr. Drew should assess the study's value. Assessing value entails analyzing whether the data generated will change the course of patient care or otherwise provide a valuable scientific benefit, over and above profit for the pharmaceutical company.

Drug Trial

Further, Dr. Drew should examine the scientific validity of the study and assess whether the study is well designed and positioned to answer the question at hand while minimizing risks and maximizing benefits to subjects. Dr. Drew should consider whether subjects will be selected fairly, and whether subjects will be well informed. Dr. Drew should consider the quality of the ethical and scientific review that the protocol has undergone by the Institutional Review Board, and see if the protocol raises ethical issues that have not been addressed. Finally, Dr. Drew should consider whether the payment offered is commensurate with the time, effort, and actual expenditures to enroll patients and implement the trial. The offer of a computer system to enable better patient tracking is especially troubling, since it is debatable whether such a system really serves the needs of patients or primarily serves the needs of the drug company. In any case, PhRMA guidelines recommend that physicians not accept gifts over $100 in value even if they offer benefit to patients, so Dr. Drew should not accept the computer system even if its absence makes it impossible to participate in the study. Finally, if Dr. Drew feels that the study is valuable, well designed, and meets ethical standards, before enrolling any patient Dr. Drew should consider whether that patient is doing well on current therapy. Enrollment is most easily justifiable for a patient who is not doing well on standard therapy and most ethically problematic for patients whose current therapy is effective. These issues, although complex, must be considered and resolved before Dr. Drew can determine the ethical justifiability of participating.

Blood Pressure Health

Blood Pressure Health

Your heart pumps blood throughout your body using a network of tubing called arteries and capillaries which return the blood back to your heart via your veins. Blood pressure is the force of the blood pushing against the walls of your arteries as your heart beats.Learn more...

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