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| Farber | A DAIDS project officer close to the HIVNET study closed the door when she had her first meeting with Fishbein. She had also crossed over from the private sector, and so she and Fishbein shared a disillusionment over how much shoddier and more chaotic the research culture was within the government, compared with industry. “I'm really frightened about the stuff that goes on here,” she told him. “We really need somebody.” This project officer, who for her own protection cannot be named, told Fishbein that the division's flagship study in Africa—HIVNET 012—had been wracked with problems and completely lacking in regulatory standards. She told Fishbein that the trial investigators were “out of control,” and that there was no oversight of them, and nobody with either the inclination or the authority to make them adhere to safety standards. What Fishbein subsequently learned entangled him in a story with eerie echoes of John Le Carre's Constant Gardener. |
| Gallo | Farber uses innuendo and rumours, from the perspective of Jonathan Fishbein, to cast aspersions on HIVNET 012, particularly on the honesty of its investigators. No concrete evidence is supplied. Surely this is not acceptable journalism in a magazine of Harpers' quality. In actual fact, problems with HIVNET 012 were identified and made public by NIAID long before Fishbein made an issue of them37 . The NIAID took steps to address these problems. The problems turned out to have no bearing on the scientific findings of HIVNET 012. Book-keeping errors should not be automatically equated with a lack of ethics or any problems of a more serious and significant nature. To maintain clinical records in some developing countries (especially very poor ones such as Uganda) is not as simple as doing so in a leading industrialised country clinical research centre for a variety of reasons including financial ones and the shortage of fully trained clinical staff. This does not mean that clinical trials should not be conducted in developing countries or that trials in such countries are necessarily flawed, but there does need to be some understanding of the circumstances that can apply. |
| RA | Jonathan Fishbein was hired by Director of the Office for Policy in Clinical Research Operations in the Division of AIDS within the National Institute of Health’s NIAID (National Institute for Allergy and Infectious Diseases). There is no justification for calling his opinions “innuendo and rumours”. Fishbein’s resume can be found at http://www.honestdoctor.org/resume.html. Furthermore, Farber was talking about a meeting that Fishbein had with another NIH employee. For an independent view of the dysfunctional workings of this department, consult the deposition of Mary Ann Luzar at http://wid.ap.org/documents/nih/luzar_deposition.pdf. This describes not only serious problems with clinical trials, but also sexual harassment by some senior male managers. Luzar has a medical microbiology research PhD and was Branch Chief of a Regulatory Affairs branch within NIH, responsible for “all of the regulatory aspects of the human clinical trials that are conducted by the Division [NIAID] and funded by the Institute [NIH]”. |