BiDil, clinical trials and the popular press: an exploration of newspaper coverage.

• Author: Harry, Simrat

1. INTRODUCTION

   News about biotechnology is everywhere - on the web, in magazines, on TV and in newspapers. (1) But, in many ways, the popular press coverage of biotechnology has been less than ideal. (2) Studies examining the quality of pharmaceutical coverage, for example, have found "substantial shortcomings in journalistic practices". (3) Coverage is often overly positive, superficial, and omits relevant information on such things as side effects and the limitations of the relevant study. (4) This positive spin may result in the "hyping" of new technologies and drugs, (5) thus potentially misleading both the public and the health care community.

   BiDil, a combination heart failure medication, offers a fascinating case study in which to assess the quality of media coverage. Often considered the first "race-based" drug approved by the Food and Drug Administration (FDA), it generated a great deal of press coverage in both the scientific and lay media. In this paper, we build on our previous analysis of how the press covered the issue of race (6) by exploring the degree to which the articles provided a balanced view of the efficacy and success of the relevant clinical trials. Specifically, we look at the degree to which the popular press provided information about both the strengths and weaknesses of the drug. Were both positive and negative attributes enumerated?

2. METHODS

   Sample newspaper articles were collected using a search in the US news, major newspapers category of the Lexis-Nexis database. The search term "BiDil" yielded 167 articles in total, of which 105 were accepted for inclusion. The accepted articles were from 28 major American newspapers, ranging in date from 05/03/2001 to 05/23/2007. A coding frame was developed based on a review of the relevant literature and a preliminary review of articles. The coding frame consisted of a series of questions with standardized categorical responses. The questions were on topics such as listed benefits of the drug, side effects and contraindications, as well as strengths and weaknesses of the clinical trials. One coder independently coded all the articles. A selection consisting of 10% of the articles was randomly selected to assess inter-coder reliability and was completed by a second coder. Inter-coder reliability was calculated using Cohen's Kappa, with scores ranging from good to excellent.

3. RESULTS

   The clinical trials and controversy

   What did we find? For example, how did the media handle the controversy that emerged around the BiDil clinical trials? As background, it is important to note that many believe that the research surrounding BiDil has been less than ideal. The results of the first clinical trial, called the Vasodilator Heart Failure Trial (V-HeFT I), were deemed unconvincing by the relevant regulatory body, the US Food and Drug Administration's (FDA) Cardiovascular and Renal Drug Advisory Committee. (7) In response to the rejection, the researchers reexamined the data from V-HeFT I, finding some evidence the drug was effective in an African-American subgroup. (8) As a result, another set of trials (called A-HeFT) was undertaken to assess the drug efficacy in 1,050 self-reported African-American subjects. This trial found that BiDil significantly decreased mortality and hospitalization. (9)

   While the A-HeFT clinical trial appeared to be a success--indeed, it led to the 2005 FDA approval of BiDil as a drug for a specific racially defined population (10)--many commentators felt there were serious weaknesses with the research. (11) While critics accept BiDil is effective in treating heart failure, they contend the results of the research do not support the claim that the drug is only or more effective in African Americans. (12) Jonathan Kahn, for example, suggests that...