Title: Usmle
Step 1 MCQ's # 10
Subject: Behavioral Science
Q NO 10: 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 Ill 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 in author when the
results re published it 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
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
OH. Refer the
patient to the study but decline the administrative fee offered
Explanation:
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 otter 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.
Bribing the patient
to accept a presented treatment option (choice D) is not appropriate either.
True, the physician does not benefit, so the money does not cloud his or her
judgment. The problem is that it may cloud the patient’s judgment when
rendering consent.
The administrative
fee is tainted money. Laundering it by donating it to a scholarship fund
(choice F) does not prevent it from influencing the physician’s judgment. In
the worst-case scenario, a medical school might pressure faculty to institute
this procedure as away to fund the medical school. Just say,” No!” to the
money.
Choice 0 is wrong on
three counts. The patient is not told about the fee. The physician accepts the
fee. The patient is referred, but is not given the chance to understand the
circumstances and consent.
Choice H is
incorrect. The referral and the decline of the fee are appropriate. However,
the physician must also explain all the circumstances to the patient so that
the patient can make a fully informed decision.
No comments:
Post a Comment