Integrity in CME: Understanding the Problem of Bias

July 23, 2010
Sidney Weissman, MD
Volume 27, Issue 10

The varied proponents of models for the regulation of CME programs for physicians would all agree that the primary charge of these programs is to provide physicians with scientifically unbiased information on issues or knowledge that affects medical practice.

The varied proponents of models for the regulation of CME programs for physicians would all agree that the primary charge of these programs is to provide physicians with scientifically unbiased information on issues or knowledge that affects medical practice. After agreement on this principle, however, further agreement ceases. Rather than logical reviews of how to provide and fund CME and how to ensure that it meets its primary mission to enhance medical practice, we frequently have presentations of varied models to fund CME argued with religious fervor.

A review of what is involved in constructing and funding educational programs that meet the core principles will reveal that the task is complex. What constitutes bias in a presentation is frequently not clear. Further, few participants in CME programs care to admit that they may not always be able to recognize bias. Even when participants report bias in a presentation, they will often fervently argue that it will not have an impact on their decision-making. It should be noted that the multibillion-dollar advertising industry is founded on the idea that it can influence our behavior in ways of which we are frequently unaware.

Let us begin by agreeing on the definitions of some of the terms used in CME:

CME
This should include all activities that provide information that is communicated to a practitioner in a number of formats and that is intended to inform how they practice. It includes CME accredited by the Accreditation Council for Continuing Medical Education (ACCME); CME, which may or may not follow the ACCME guidelines; promotional activities regarding drugs that are regulated by the Food and Drug Administration (FDA) and that contain relevant information on use of the medication as well as its promotion and marketing; and information that is mandated to be communicated to physicians by drug companies and device manufacturers by the FDA concerning the use of a medication or device.

Accredited CME
This refers to CME activity accredited by the ACCME.

FDA
This is the federal government agency responsible for regulating the pharmaceutical and medical device industries.

FDA Requirements
The FDA has specific regulatory requirements that instruct Pharmaceutical and Device Manufacturers to communicate certain information to physicians. For complex reasons, the ACCME does not consider information mandated by the FDA as meeting accredited CME standards set by the ACCME. Although mandated by the government and clearly educational and informational, these programs are considered promotional by some because they are not accredited by the ACCME and because they are created by the drug or device manufacturer. This FDA regulatory requirement is separate from the FDA regulation of drug marketing and advertising.

Promotional Activities
These activities are funded by an organization with a clear link between the activity and the organization funding the program. The program’s sponsor may use the activity to promote a product as well as to provide education. Promotional activities are not accredited by the ACCME.

Bias
This refers to programs constructed in a manner to highlight certain information and in which other relevant information is either not provided or done so in a limited fashion. The material may be presented in a manner so that the individual does not recognize that he or she is being directed to act in a particular fashion. Bias is not always immediately observable and may be missed.

At one time bias was easy to observe. A presenter would give the brand name of the drug made by the sponsoring company and the generic names of drugs manufactured by other companies. The audience might not recognize the generic drug names. Today, that approach is seen as primitive and it is seldom used-even in what are clearly promotional presentations.

Today bias is harder to observe. Required transparency of presenters or authors can enable the consumer of an educational program to potentially “know” the presenter.  But bias can potentially be present nonetheless. Consulting for a number of manufacturers of similar items could mask but not remove bias in presentations.

Examples of Bias in Accredited CME
In written material, disclosure of interest statements can be printed in a type noticeably smaller that the educational material and presented in a difficult-to-find format.

An expert who has worked as a consultant for a number of drug manufacturers of a specific class of drugs all under patent may give a talk regarding the therapeutic use of drugs in this class. The talk will not single out any one as better than another. However the presenter may not discuss drugs in another class that are all available in generic form and that may be as effective as the drug reported upon.

Conflict of Interest
These are situations where a presenter or author of a CME program has a secondary set of interests that potentially may interfere with the primary educational responsibility of the program.

Potentials for Conflicts of Interest
These usually arise when a presenter at a CME event has been paid by a pharmaceutical company or device maker who has a product related to the presentation. The concern is that because of the history of payments, the speaker will present information to highlight a given company’s products and will not discuss other products adequately. Having worked as a consultant for a company does not mean that the individual will or has acted inappropriately in a presentation-only that there is a potential for doing so.

The potential for conflicts of interest can exist in other circumstances. Often not considered is when a medical school professor presents-without any funding from nonmedical school sources-at an accredited CME program sponsored by his or her school. If the program highlights activities in the sponsoring medical school department that may compete with other hospitals for patients, a potential secondary role of promoting the department’s clinical activity could interfere with the program’s primary educational role. Generating referrals to the school’s clinical enterprise or presenting a diagnostic or therapeutic procedure for which the medical school may own a patent may be a clear secondary or possibly (at times) primary interest. 

In large urban areas it is possible on a daily basis to hear and see advertisements for each of their academic medial centers promoting their expertise in varied areas.  Income from clinical activities is essential to the funding of medical schools and for the salaries of the faculty and staff. Additionally, in 2009, 7 universities were among the top 300 producers of US patents.1 (http://talk.collegeconfidential.com/college-search-selection/934080-top-university-patent-pr). Not unlike their pharmaceutical company research colleagues those on medical school faculties also run the risk that their secondary interest in patents owned by their university will affect their presentations. In many ways, major academic medical centers are run in much the same fashion as pharmaceutical companies and device makers. Possibly the same conflict of interest polices should apply to them. The only difference for some may be that profits are called surpluses.

While it is possible to find potential conflicts of interest hidden in programs, it is also possible to see and attempt to prevent conflicts where there are none. Indeed, some of our rules may interfere with the exchange of knowledge.  If a scientist forms his or her own company and develops a new drug, device, or procedure that represents a major advance, he could not present elements of his work in certain accredited CME programs because he is now part of a commercial enterprise. Additionally, members of some professional societies could not participate in the development of practice guidelines in their area, even though they are clearly the most expert.

Rules must be flexible enough to allow the most knowledgeable individuals to present at accredited CME programs or to develop Practice Guidelines independent of where and how they are employed and their potential financial or personal interests. Audiences can be made aware of the potential for conflicts. A secondary interest may lead to a conflict of interest but it does not always do so.

These are but a few ideas on potential conflicts in CME and bias.