In this study of 213 educational programs organized through an academic provider of CME, the vast majority of CME activities were perceived to be free of commercial bias. Extent of commercial support, a variety of other event characteristics, and a summative risk index were not associated with the level of perceived bias or the perceived overall quality of CME activities. Stated otherwise, rates of perceived commercial bias were consistently low regardless of the presence or absence of risk factors for commercial bias.
There is a paucity of other research that has directly evaluated the impact of commercial support on the content of CME.6
However, other studies of bias in CME and on relationships between industry and medicine can shed light on potential explanations for our findings. The most direct interpretation of our results is that CME activities in general are free of commercial bias. Under rules of the Accreditation Council for Continuing Medical Education (ACCME), all accredited providers of CME must abide by the Council’s Standards of Commercial Support. These standards require accredited activities to be balanced and that conflicts of interest be disclosed and managed.8,9
However, these regulations cannot prevent all forms of commercial influence, and experts in drug industry promotion have identified widespread opportunities for commercial influence in CME and have documented industry marketing strategies that rely heavily on clinician education to boost drug sales.10–20
Other reports have documented that many physicians believe that industry-supported CME is biased.13,21,22
Finally, many commentators have noted that it is unlikely that industry would expend $1.2 billion per year to support CME if it did not help companies’ bottom line.1–3,11,23,24
Thus, although one interpretation of our findings is that industry support does not lead to bias in CME, other interpretations are possible as well.
One such alternate explanation is that the screening process instituted by the UCSF Office of CME successfully rejected activities with commercial bias that might have been permitted by other CME providers. This screening process is substantially more rigorous than prescribed in the ACCME’s Standards of Commercial Support, for example rejecting proposals with a single industry supporter or those with no cost to the participant. This screening process may have weeded out CME activities at higher risk of commercial bias, leaving only activities where commercial bias was more subtle or entirely absent. Furthermore, activities that were allowed to proceed but flagged as having intermediate or higher risk of bias were subject to mitigation procedures prior to and/or during the activity.
Finally, our findings of low rates of perceived bias may in part be explained by insensitivity of the simple “yes/no” question used to assess learners’ perceptions of bias. Given that commercial influence is often subtle, a single binary question may fail to fully capture the range of learner perceptions of commercial influence.25
Moreover, learner perceptions of bias may not precisely correspond to actual bias in CME activities. It is possible that some suspicious observers may have perceived bias where in fact there was none. However, a wealth of literature in the medical and social sciences suggests that physicians (and people in general) often fail to perceive bias, particularly when these biases are subtle.26–28
Prior work investigating mechanisms of bias in CME has highlighted the importance of subtle, often subconscious and unintentional forms of bias that may be difficult for screening processes to identify and for learners to perceive.1,15,29
Course organizers may focus course curricula more on drug or device-based therapies and less on lifestyle-based treatments, or devote special attention to one aspect of disease management for which a supporter’s drug (or class of drugs) may be commonly used.30
In addition, the medical literature from which evidence-based recommendations are made is subject to commercial influence, as noted in studies which have shown strong and consistent associations between industry support of clinical trials and the outcomes and interpretation of those trials.31,32
Speakers may also play an important role in introducing subtle biases, for example through their choice of topics and presentation of course material.
In each of these cases, bias is introduced not through a direct quid-pro-quo but through subconscious attitudes and feelings of reciprocity that can arise when a speaker or course director has benefitted from industry, for example through funding of an educational or research grant, service on a speakers’ bureau, or receipt of personal educational materials, food, or samples for one’s clinic. Because attitudes and feelings of reciprocity largely occur on a subconscious level, physicians often fail to recognize the ways in which they might be influenced and overestimate their ability to resist commercial influence.23,26
Of note, in 2007 only 20% of speakers at UCSF CME activities reported conflicts of interest such as grant funding or speakers bureau honoraria relevant to their talks; however, this number may be substantially higher elsewhere.
To the extent that influence on the content of CME can often be subtle and occur without the conscious knowledge of course organizers and speakers, bias in CME can be difficult to detect even for the watchful observer.23,33
In addition, in many cases it can be challenging, if not impossible, to determine whether a speaker is emphasizing a certain topic or recommending a certain treatment strategy because of subtle commercial influence on that speaker or because that speaker has a truly independent, scientifically-valid opinion that reaches the same conclusion.22
Paradoxically, CME activities where commercial influence is subtle are likely to be more effective than activities with overt influence, since physicians are more receptive to information that appears objective and may reject information they perceive to be promotional.30
Given the difficulty of disentangling unvarnished educational goals and scientific opinion from subtle forms of commercial bias, there have been increasing calls to fundamentally change the relationship between the healthcare industry and CME providers. In a seminal article, Brennan et al. recommended eliminating industry support of individual CME activities at academic medical centers, and instead suggested a mechanism in which industry donations would be pooled into a central account that would be used to help fund individual CME activities without industry input.29
Several universities have adopted this model, with a handful forsaking all industry funding of their CME programs.34
A recent conference commissioned by the Josiah Macy Foundation went a step farther, recommending the complete elimination of industry support of accredited CME.16
Not surprisingly, these recommendations are controversial, in part because many CME providers are financially dependent on industry, and because physicians are concerned about increases in course registration fees if industry support was substantially reduced or withdrawn.4,13,21,35
Our results could be interpreted as either supporting or contradicting these recommendations. On the one hand, one might conclude that the safeguards offered by the UCSF Office of CME’s screening practices resulted in a series of CME programs with little if any bias. On the other hand, our results are consistent with the observation that commercial bias is difficult to detect, both by organizers and recipients of CME, and that the only way to safely guard against industry influence is to eliminate or limit industry involvement in CME. To resolve this and other questions, more research is needed to systematically investigate the presence and impact of bias in CME, including in-depth explorations of course content and learner perceptions of bias. Of note, definitive research will likely require large sample sizes and sophisticated measures, making it unlikely that a substantial body of new research will be available in the near future. Until then, policy-makers will need to carefully interpret existing data and apply lessons learned from research on other types of interactions between physicians and industry to help inform their judgments.
Our study has several limitations. As noted earlier, our sample of CME activities were organized by a single institution with a distinct set of criteria for vetting proposed activities. It is thus unclear to what extent our findings would be generalizable to other academic and non-academic providers of CME with less stringent review criteria and a different set of administrative procedures and institutional culture. In addition, as noted above the question that we used to determine perceptions of bias was limited to a binary yes/no response, preventing us from capturing subtlety in participant responses. Third, our study evaluated only activities which had passed an initial screening process in which proposals deemed to have an unacceptably high risk of commercial influence were rejected (whereas such activities might be approved by other accredited providers of CME). As a result, our study design prevents us from assessing perceived bias in activities believed to carry the highest risk of industry influence. Finally, our study evaluated a moderate but limited number of CME activities. Nonetheless, it is unlikely that a larger sample of activities would have changed our conclusions, as even if the observed differences in perceived bias between lower vs. higher-risk activities were statistically significant they would not be meaningfully different.
In summary, in this study of 213 CME activities rates of perceived commercial bias were very low, with no differences in perceived bias between activities with and without potential risk factors for commercial influence. These findings suggest that rigorous review criteria effectively screened out activities with explicit commercial bias. Further research will be needed to evaluate the presence of subtle forms of commercial bias and risk factors to predict these biases in CME.
Box: Items evaluated in UCSF Office of CME Risk Score
Items derived from ACCME Essential elements - Planning 2.1
- First time activity
- First time activity chair
- First-time event planner for UCSF event
- Third-party event planner
- Initial contact with UCSF Office of CME made by non-UCSF faculty or staff
- Co-sponsored activity
- Registration not provided by UCSF
Items derived from ACCME Essential elements - Needs Assessment 2.2
- Content not evidence-based, or other (as determined by Governing Board Accreditation Review Committee or Associate Dean)
Items derived from ACCME Essential elements - Disclosure Standards 3.3
- Activity Chair with ties to industry (requiring disclosure)
- Faculty includes representatives from industry
- More than one non-UCSF faculty
Items derived from ACCME Essential elements - Commercial Support Standards 3.3
- Commercial support greater than 20% of course budget
- Only one or two commercial supporters
- Registration fees below market value (<$25 per hour of event)
- Honoraria or Chairman’s fee is high (mean honorarium <$750 except in prescribed circumstances)
- Projected surplus greater than 20% of expenses
- Projected loss greater than 10% of expenses
Scoring of risk index:
Each item receives one point. The points are summed and scored as follows:
- 0–2 points - lowest risk
- 3–5 points - intermediate risk
- ≥ 6 points - highest risk
In addition, events co-sponsored with a non-accredited organization, society, or institution are automatically considered “highest risk”