The General Medical Council (GMC) has detailed guidelines on handling conflicts of interest. These state that “You must not allow any interests you have to affect the way you prescribe for, treat, refer, or commission services for patients.” [1] But in many cases, doctors who fail to disclose a conflict of interest are not only breaching rules governing conflicts of interest; they are also breaching guidelines on consent.
When seeking consent from a patient, doctors must ensure that three criteria are met: the patient must be adequately informed and be competent to make a decision, and that decision must be voluntary. The GMC guidelines on consent state that “you must…share with patients the information they want or need in order to make decisions [and] maximise patients’ opportunities, and their ability, to make decisions for themselves” (principle 2). In addition, principle 3 states “For a relationship between doctor and patient to be effective, it should be a partnership based on openness, trust and good communication.” [2]
If a patient is not told that his doctor has a financial interest in a particular treatment or provider, then the patient has not been given enough information because the fact that the doctor could be biased by this conflict of interest has been withheld. Equally, if a doctor recommends a particular treatment as the best one for the patient in the circumstances but does not disclose the conflict, they may also be guilty of manipulating the patient, calling the voluntariness of the decision into question.
How can doctors disclose a conflict of interest in a way that does not derail the consent process? Disclosure of conflicts of interest, though aiming at increasing trust, might in some cases serve to diminish it. If a doctor discloses that he has received payments from the maker of a drug but wants to recommend it anyway, the patient may feel confused and possibly distrustful. This means that disclosing a conflict could itself generate conflict between the doctor and the patient: a conflict of informing. Just as the placebo effect could be lost if a doctor informs the patient that a pill is a placebo, so disclosing a conflict in order to bolster trust and respect the norms of informed consent could actually undermine both. [3] Furthermore, the possibility of generating tension in the patient interaction itself creates a conflict of interest that might tempt doctors not to disclose conflicts.
One potential solution that would allow doctors to disclose financial payments without interfering directly with the consent process is the Disclosure website, run by the ABPI. This allows doctors to disclose online without raising the issue directly with patients. This would solve the problem of awkwardness of disclosing directly to patients, but fails to address the main issue: patients would in most cases not have checked the website and would therefore continue to be given inadequate information. Indeed, relying on a website or register might actually make things worse in two ways: first, it could make doctors less likely to disclose directly to patients; second, if a patient is prescribed a treatment and later checks the website only to find out that her doctor has a financial stake in it that they did not disclose, this could destroy their doctor-patient relationship. In addition, doctors are not obliged to disclose on the new website due to UK data protection law (in contrast, US physicians have no opt-out). Many UK doctors have refused to disclose on the website; if they are unwilling to disclose indirectly online, it appears unlikely that they will have done so directly to patients – this in turn would mean that they are breaching GMC guidelines on both conflicts of interest and consent.
Ultimately, the onus must be on doctors to disclose directly to patients. If done delicately and sensitively, disclosure of conflicts directly to patients can take place without undermining the consent process, but training must be provided to doctors if the GMC’s high standards are to be met.
David Shaw is the senior research fellow, Institute for Biomedical Ethics, University of Basel, Switzerland.
Conflicts of interest: I have read and understood the BMJ Group policy on declaration of interests and declare the following interests: none. However, the fact that I have no financial conflicts of interest to declare might be seen as a conflict of interest by doctors who do.
References:
[1]. General Medical Council. Financial and commercial arrangements and conflicts of interest. Good Medical Practice (2013) http://www.gmc-uk.org/guidance/ethical_guidance/21161.asp]
[2]. General Medical Council Consent Guidance Part 1: Principles. [http://www.gmc-uk.org/guidance/ethical_guidance/consent_guidance_part1_principles.asp
[3]. Oakes JM, Whitham HK, Spaulding AB, Zentner LA, Beccard SR. How should doctors disclose conflicts of interest to patients? A focus group investigation. Minn Med. 2015 Jan;98(1):38-41