Habitual readers of the printed version of the journal, whose ranks may be dwindling in this era of electronic downloading, might have noticed a rise in the number of pages devoted to advertisements. Our statistics show a doubling of such pages over the last 5 years. The change reflects both the availability of more commercial products for patients afflicted with liver disease and the various health care choices faced by their providers. With the focus on newer therapies comes an additional editorial responsibility to oversee advertisements. During our tenure, a number of controversial examples have come to light, serving to underscore our thoughts and concerns.
In the first instance, a drug company heavily advertised its product for correcting severe coagulopathy. While the drug received FDA approval for the treatment of hemophilia, liver disease was not included in the indication. The advertisement appearing in the journal avoided this restriction by stating the benefits of the drug for the treatment of hemophilia. Because of the high cost of the product and the anecdotal nature of the evidence supporting its use in liver failure, I contacted the company's management, requesting a moratorium on such advertisements until results from large-scale studies in patients with liver disease were forthcoming. The company accepted the approach. Off-label drug use might be a widely accepted practice, but it should not be encouraged in the absence of data. In fact, a cautionary approach might also benefit pharmaceutical companies, as evidenced by a recent lawsuit attacking off-label drug use.1
In the second case, an advertisement promoting the benefits of drug A (produced by the company) over those of drug B (its competitor in the field of immunosuppression) was submitted to HEPATOLOGY. Several graphs illustrated the benefits of drug A when compared to drug B. This “competitive advertisement” mirrored the negative advertising found in the general media. While this strategy is likely to be effective, as well as recognizing that the public might benefit from an increased awareness of options,2 such advertisements are misplaced in a scientific journal such as HEPATOLOGY. The journal maintains high standards for the quality of the data printed in its pages, including the rebuttal of alternative findings. Advertisements should not contradict this principle. Given this commitment, we did not condone its publication.
Our advertising pages, as well as those of many gastroenterology- and hepatology-oriented journals, have seen the promotion of an industry-sponsored clinical study aimed at comparing the effectiveness of two products, including one from the sponsor—for the treatment of hepatitis C—calling for recruitment of patients into the trial. The publication of the advertisement resulted in several complaints from readers whose criticism of trial design would render meaningless future conclusions of such a study. The editors lack the power to analyze the qualities of trial design in a one-page advertisement. We rely on the fact that such trials go through regulatory approval. Yet we cannot escape the fact that publishing the advertisement in HEPATOLOGY might provide legitimacy to trials whose main impetus lies in responding to market forces. In such studies, considerable efforts and resources are expended to demonstrate a competitive advantage over a similar product. Because of the potential for the perception of conflict with the mission of the journal, we will carefully scrutinize such advertisements in the future.
More than a decade ago, it was concluded that 44% of advertisements in 10 leading medical journals would lead to improper prescribing if a physician had no other source of information.3 Since then, much has changed. Ten years ago in our field, therapeutic options for patients with liver disease were quite limited. More options exist today, and many more are expected in the next years, as the efforts of laboratory and clinical work come to fruition. The pharmaceutical industry plays an important role in this expansion, providing ideas, resources, and infrastructure for critical studies. Advertising is a legitimate tool to highlight the benefits of a product. At the same time, the principles of rigor applied to prove the benefits of the product should be extended to the quality of advertisements in our pages.