By: Allan M. Siegel
In the era of Edward Snowden, the general public is acutely aware of whistleblowers. Many of us have come to respect and appreciate the laws which protect the people who come forward to expose wrongdoing. So while watching the Dallas Buyers Club, which is up for an Oscar this coming Sunday, it was difficult not to wonder where the potential whistleblowers were. Without giving away too much of the plot, the AIDS drug AZT is being offered to patients who are selected to participate in its drug trials. Some researchers doubted its effectiveness and also speculated about its toxicity levels, but their voices went unheard. This predicament leaves many patients out in the cold without treatment, and in steps Matthew Mcconaughey. But why did the researchers voices go unheard. Did anyone ever step forward to blow the whistle on AZT? It turns out that Dr. Jonathan Fishbein, the former Head of the NIH's AIDS Division, is one of the highest ranking whistleblowers in history, and he blew the whistle on a study regarding AZT and a second AIDS drug, Nevirapine. He was one of the first doctors to step forward in this type of situation, and his case helped set a precedent which protects doctors from retaliation against whistleblowers.
Dr. Fishbein called into question a 1998 study in Kampala, Uganda following expectant mothers, who were placed on either AZT or Nevirapine, to prevent the transmission of HIV from mother to child. This study was fraught with issues from poorly trained technicians to improper record keeping. The study even failed to use a control group, placing the patients on either AZT or Nervirapine without the use of a placebo group. Dr. Fishbein noted that one of major flaws was the presence of adverse conditions in the patients. These adverse conditions, which lead to the death of thirty eight babies, should have been investigated and properly documented. However, the researchers chalked the issue up to Malaria, and therefore they did not bother to record any issues related to the deaths. Based on these issues, Dr. Fishbein found that the study's results were virtually meaningless. Two weeks after Dr. Fishbein filed an official complaint regarding the study he was demoted and subsequently fired. While fighting in his whistleblower case he said that in the Division of AIDS he was confronted with "a management system guided more by politics than sound science," and "and atmosphere of intimidation" which prevented the reform needed to correct both the study and the department's management system. After two years, Dr. Fishbein was reinstated at the NIH following the successful conclusion of his case, but he was not permitted to return to the AIDS division.
So it seems that doctors and researchers did not have the resources or protection to step forward in the days of the Dallas Buyers Club during the early stages of AIDS research. The few that probably did question the research findings were likely fired or too scared of the possible effects to their careers. Our pharmaceutical system is far from perfect, but is encouraging to know that progress is being made and protection against retaliation is now available for whistleblowers.