So, you want to be a bias-buster? Gird yourself, because it’s not an easy task. In order to establish the presence of commercial bias, you have to demonstrate two things: first, that the activity is funded by industry; and second, that the content of the program is unreasonably slanted toward the sponsor’s product.
Establish the funding source. Generally, this is a no-brainer, since the funding is listed in small type somewhere in the first couple of pages. Typically, the statement is a variation on “supported by an unrestricted educational grant from …” While the term “unrestricted” implies that the company had no strings attached to its money, the reality is that any physician or MECC that receives drug company funding knows that their lecture or article will be closely perused by those with the cash, and that future “gigs” will be dependent on whether the company feels their product is shown in a favorable light.
A particularly well-hidden source of industry funding is in the form of journal “supplements.” Those published by the Journal of Clinical Psychiatry (JCP) are the most well-known examples, but increasingly other journals and magazines are getting into the act. To give you some idea of the scope of these supplements, in 2004 JCP published 18 supplements and one “monograph,” most of which were accredited for Category 1 CME credit. These substantially outnumbered their regular monthly issues (of which there are 12 per year). Each supplement was entirely funded by a pharmaceutical company, and the articles were typically derived from special events, which were also funded by the company. These events were meetings and teleconferences of various sorts, with a dizzying array of official-sounding names such as “planning roundtables,” “roundtable meetings,” “expert roundtables,” “symposia,” “national summit meetings,” and the like.
While we are not privy to the specifics of the planning of these meetings-transformed-into-supplements, opinion leaders typically are funded to attend such meetings and are given honoraria (usually between $1000 and $5000, depending on the prominence of the expert). The articles derived from the meetings may or may not be written by the listed author. Often, a medical ghost-writing company is hired to take care of the writing, and the expert need only review the article and agree to affix his or her name. While this practice may astonish some readers, the fact that it occurs is widely known, and was well-documented in court documents related to Parke-Davis’s illegal promotion of Neurontin for off-label uses (see Boston Globe, May 19, 2002).
Is the content actually biased? Sure, a lot of pharmaceutical money flows into the production of our medical education. But unless the final product is clearly biased in favor of the sponsor’s drug, there’s no problem.
Unfortunately, there are no clear answers here, because bias can be very subtle. Lacking a laboratory test for the presence of bias, each psychiatrist is left to his or her own judgment in reviewing articles and talks.
Nonetheless, three particularly common techniques used to slant presentations are listed below.
1. Define the CME topic in a way that is disadvantageous to the competitors. If you can’t beat your competitors on efficacy, you might be able to beat them on side effects. This is a favorite technique used in the marketing of both Geodon and Abilify. For example, recent JCP supplements funded by Pfizer and BMS have focused on the metabolic and weight gain liabilities of their competitors, rather than focusing on any efficacy differences (of which there are none). Thus, JCP supplement 18 is funded by BMS, and rather than organizing the issue around improving schizophrenia, the title is: “Metabolic Issues in Patients with Psychiatric Disorders.”
2. Make your product stand out in the text (otherwise known as the “neon light effect”). For example, in the JCP supplement mentioned above, the article entitled “Dyslypidemia and Atypical Antipsychotic Drugs” reviews data on metabolic problems with atypicals. Under the capitalized heading “ASSOCIATION OF SECOND GENERATION ATYPICAL ANTIPSYCHOTIC DRUGS AND DYSLYPIDEMIA” the author reviews clozapine, Risperdal, Zyprexa, Seroquel, and Geodon. Then, a new capitalized heading occurs: “THIRD GENERATION ATYPICAL ANTIPSYCHOTIC DRUGS AND DYSLYPIDEMIA.” Abilify, of course, is the only drug discussed in this section. In addition, the only figure in the entire paper to mention a specific drug occurs in this section (figure 2), and it showcases Abilify’s favorable metabolic profile.
3. Find case studies in which your product shines. Recently, two “Case- Based Medicine” Category 1 CME handbooks were sent as freebies in a package with an issue of CNS LongTermCare. One was supported by AstraZeneca, the other by Janssen. In the AstraZeneca-funded version, seven cases were presented in which antipsychotics were prescribed; in five of these seven, Seroquel succeeded as the rescue medication when its competitors were either ineffective or not tolerated. In the Janssen-supported version, on the other hand, of five cases involving the use of antipsychotics, Risperdal was the rescue medication in four; in the remaining case, two of Risperdal’s competitors (Zyprexa and Seroquel) were discontinued with diminishment in side effects, and no new antipsychotic was prescribed.
TCR VERDICT: Bias or paranoia? You decide!