q26 - raji_321

[ArchivalUser]

For the past 3 years, a physician has been treating a 55-year-old man for peripheral neuropathy of undetermined cause. Extensive tests have ruled out both diabetes and multiple sclerosis. The patient is in considerable pain that is only controlled by a multiple drug regimen that includes amitriptyline. The physician is approached by the local representative of a pharmaceutical company who is seeking subjects to be included in a Phase III clinical trial of a drug that treats peripheral neuropathy. The representative says that the company is willing to pay a $500 administrative fee for any referral to the study. In addition, the physician is offered the chance of becoming an author when the results are published if he refers 20 or more patients to the study.
Phase II results for this new drug have been very promising. The physician feels that this patient is an excellent candidate for the study, and that the clinical trial offers the best chance of the patient achieving real relief from his symptoms in the long term. Based on this belief, the physician's best course of action would be to do which of the following?

A. Allow the pharmaceutical representative to meet with the patient and explain the details of the clinical trial
B. Decline to enroll the patient to receive an untested treatment
C. Discuss the clinical trial with the patient and disclose fully the financial arrangement agreed to with the pharmaceutical company
D. Discuss the clinical trial with the patient and offer to rebate the administrative fee to him as an incentive to participate
E. Discuss the clinical trial with the patient, disclose the offer of an administrative fee, but tell the patient that the physician will decline the fee
F. Refer the patient to the clinical trial, accept the administrative fee, and donate it to the scholarship fund at a local medical school
G. Refer the patient to the study and accept the administrative fee as offered
H. Refer the patient to the study but decline the administrative fee offered

[ArchivalUser]

H?????

[ArchivalUser]

The correct answer is E.
Payment for referrals, even for a study, even when the referral is appropriate, even when the payment is disclosed, is a breach of ethics. Period. Professional judgment must not be clouded by other considerations including financial incentive. The clinical trial is right for the patient, so he should be referred, but the "administrative fee" is a disguised bribe and must be refused. In addition, the patient must be fully informed about the circumstances surrounding the referral, including the offer of the administrative fee.

The physician must deal directly with his or her own patient. Communication about the study must come from the physician and not be passed off to the pharmaceutical representative (choice A). Who knows what pressure the representative might place, however unwittingly, on the patient to consent to enroll in the clinical trial?

Choice B is incorrect. All of the indications are that this treatment may be the patient’s best hope. Remember that the treatment is not completely unknown. Phase II data are available and, although not definitive, certainly give an indication of this drug as a reasonable option.

Choice C is incorrect. Disclosure is not enough. The fee must be refused.

[ArchivalUser]

CCCC

[ArchivalUser]

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