Since 2015 the Australian Army Malaria Institute (AMI) has been embroiled in a scandal over its testing of the neurotoxic anti-malarial drugs mefloquine and tafenoquine on military personnel deployed on peacekeeping operations in Bougainville and Timor Leste from 1999 to 2002. Many of these veterans have recently come forward to describe the devastating long-term impact of these drugs on their health and to explain that they were coerced into participating in the trials under the threat of being excluded from these deployments if they did not “volunteer” to become test subjects.
More than 100 veterans, family members and health professionals recently met with ADF Surgeon General Tracy Smart at a forum in Townsville to discuss these concerns. The Department of Defence has confirmed that it is conducting a high level inquiry “to determine whether any failures in military justice may have occurred”, but has thus far refused to implement an outreach program or provide research funding to help these veterans.
What has now been revealed is that the Government recently provided $10 million in “foreign aid” funding to a consortium involved in the development of tafenoquine with the aim of having it registered by the Therapeutic Goods Administration (TGA) and other national drug regulators, aided by pharmaceutical industry lobbyists and Australian Defence Force (ADF) officials.
In 2009 researchers from the U.S. Walter Reed Army Institute of Research (WRAIR) found that tafenoquine is “more neurotoxic than mefloquine“, which is able to cause a lasting or permanent brain injury in a sizeable minority of people who use it as an anti-malarial. Despite this, in 2013 the drug was granted a special “breakthrough therapy” status by the U.S. Food and Drug Administration (FDA), and is now in the final phase of pre-license clinical trials. This is being conducted as a joint venture by manufacturer GlaxoSmithKline (GSK) and the “product development partnership” Medicines for Malaria Venture (MMV).
The FDA states that Breakthrough Therapy designation “is intended to expedite the development and review of drugs for serious or life-threatening conditions”, and “conveys all of the fast track program features, more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and eligibility for rolling review and priority review.”
In March 2015 the Foreign Affairs Minister granted MMV $10 million in foreign aid funding “to support [MMV’s] work to discover, develop and deliver new antimalarial medicines. This follows a previous grant of AUD$2.5 million in 2013-14.”
MMV in turn directed this funding to Professor James McCarthy at the Queensland Institute of Medical Research, who has a long association with AMI. What has also been discovered is that the current AMI Director Professor G. Dennis Shanks is a member of the MMV “expert scientific advisory committee“. This conflict of interests appears not to have been publicly disclosed by the Department of Defence. Professor Shanks’ financial interests in the pharmaceutical industry are also yet to be disclosed.
Professor James McCarthy, Queensland Institute of Medical Research
Professor Shanks has long been involved in the testing of tafenoquine on vulnerable subjects, including military personnel and people in developing countries such as Kenya in 2001. Around one quarter of the 4,000 people he and other scientists have used to test tafenoquine were members of the ADF.
The current MMV Australia “External Relations Adviser” is Ms Rebecca James, a former staffer to Michael Wooldridge, who was Australia’s longest serving Health Minister. Wooldridge is now a pharmaceutical industry lobbyist. Ms James is a former CEO of Research Australia and is currently the “Consumer Representative” on the Government’s Medical Services Advisory Committee.
In September 2015 Ms James represented MMV as a witness to a Senate foreign affairs committee inquiry, extolling the “world class, ethical” practices of AMI:
Senator FAWCETT: I notice that you do a lot of trials and help facilitate the introduction of new drugs. Is that in both cure and preventative drugs?
Ms James : It is.
Senator FAWCETT: How do you approach the question of the ethics of informing the participants in trials, particularly in Third World countries, of risks, obligations et cetera?
Ms James : That is a fairly technical, scientific question, but we go through ethics approvals processes at every stage of our drug development process where it involves humans. We have very stringent governance frameworks and requirements that are set by the World Health Organization, and in the countries where we are trialling drugs we go through local ethics approvals processes.
Senator FAWCETT: Do you do any collaborative work with the Australian Army Malaria Institute?
Ms James : We certainly do; they are one of our collaborators here. We have been working with a gentleman whose name escapes me—I am sure you would know him; you are familiar with the area. But yes, we have had very strong links, particularly in relation to our collaborative work in Indonesia with the Indonesian Army through—
Senator FAWCETT: You would consider them a world-class, ethical organisation in terms of how they go about their work?
Ms James : Absolutely.
MMV’s written submission to the inquiry applauded the $10 million foreign aid grant for drug development:
In 2013-2014 the previous Australian government announced a $10million program support Product Development Partnerships, including $2.5 million to support MMV’s portfolio of drug development. MMV applauded the Australian government for taking this first step towards supporting MMV’s drug development portfolio in accordance with MMV determined priorities.
In March 2015 the Minister for Foreign Affairs and Trade announced a further $10 million over three years, so accelerating the government’s support for malaria. This funding demonstrates a valuable commitment to ensuring the development of tools and technologies for malaria, and complements regional strategies to build systems to eliminate malaria.
Ms James’ appearance at this inquiry coincided with the same Senate committee’s inquiry into ADF mental health, which in its final report recommended the implementation of an outreach program for veterans affected by the neurotoxicity of mefloquine and tafenoquine. The Government has thus far refused to provide this support, or any related research funding, claiming in part that this would cause “undue distress” to the participants of the AMI drug trials.
*The manufacturer of tafenoquine, GlaxoSmithKline, has requested those affected by the toxicity of the drug to contact them on 1800 033 109.*