Why is the US army funding antimalarial trials on Perth’s cash-strapped students with a drug found to be neurotoxic a decade ago? Stuart McCarthy reports.

Several months ago, I was contacted by an ex-Army friend from Perth whose nephew had been recruited to participate in a clinical trial for a new antimalarial drug at the Linear Clinical Research centre. Participants can earn up to $2880.  My friend asked if I knew anything about this drug. Indeed, if it might have been one of the same experimental drugs given to several thousand of us during the Army Malaria Institute’s (AMI) notorious antimalarial drug trials in Bougainville and East Timor at the turn of the century.

On sighting the patient information and consent form, I discovered this was not actually a “new” drug at all. It was, indeed, tafenoquine — a drug found to be neurotoxic a decade ago, having already destroyed the lives of many of the Army’s 1,540 test subjects from Bougainville and East Timor.

There is nothing overtly wrong with a placebo-controlled drug safety study like this one, involving up to 600 subjects spread across three locations: Perth (Australia),  Colorado Springs (Colorado, US) and McAllen (Texas, US). Linear has actually forged a solid reputation for sound, ethical research over its short history. However, what’s significant is that this trial is sponsored by 60 Degrees Pharmaceuticals (60P), a company founded in 2014 by former US Army employee Dr Geoff Dow and funded by the US Army. One of Dow’s former consultants told a Senate inquiry last year that 60P is “millions of dollars in debt,” despite receiving more than $US18 million in public funds over the last several years.

Even before we consider tafenoquine’s toxic effects, one point worth highlighting is that Linear’s target recruiting base is vulnerable to exploitation. As Cathy O’Leary explained in The West Australian two years ago, Perth’s post-mining boom economic downturn has made it a prime recruiting ground for trials like this one:

“Perth is becoming a mecca for students, backpackers and unemployed people who are earning thousands of dollars a year tax-free as volunteers on clinical drug trials. The economic downturn is being linked to more healthy men and women aged 18 to 60 signing up to take part in a range of drug trials for conditions such as diabetes, hepatitis, impotence, malaria and kidney disease.”

When we do consider this drug’s unusual development by US and Australian military scientists, including the cover-ups of harmful effects such as brain damage and suicide, there is cause for alarm. Tafenoquine is from the 8-aminoquinoline class of antimalarials, initially discovered in pre-WWII Germany and long since known for its neurotoxic properties.

During a post-WWII US government anti-malarial drug discovery program on par with the Manhattan Project in terms of scientific scale, malaria researchers seeking to find safer alternatives found that more than 85 of the 8-aminoquinolines were neurotoxic. Extensive studies on monkeys found these drugs caused permanent damage to regions of the brain linked to severe, chronic neuropsychiatric symptoms including psychosis, severe depression and anxiety, hearing and balance problems, and a raft of debilitating neurological disorders.

Aaron and Rae from QVFA on Vimeo.

Tragically, when tafenoquine was developed in the 1970s and 80s, scientists overlooked this earlier research in their haste to introduce what they perceived to be a new malaria “wonder drug.” Despite ready availability of safe alternatives, US and Australian scientists skipped neurotoxicity screening on primates and proceeded to test this drug on 1,540 Australian Defence Force (ADF) personnel serving on overseas peacekeeping deployments. As a result, it’s believed dozens of the trial subjects have died as from suicide or neurological disorders, while many hundreds have continued to suffer the debilitating symptoms of lasting or permanent brain damage.

So why is the US Army funding this study? When tafenoquine was approved by the US Food and Drug Administration last year, based primarily on the flawed results of the notorious “Study 033” involving 654 troops from the 1st Battalion Royal Australian Regiment (1 RAR) in East Timor two decades ago, FDA officials were sufficiently concerned about the drug’s side effects that they directed 60P to conduct another safety study.

What we don’t yet know is what effect this drug has had on the subjects enrolled in the Linear study. The company hasn’t responded to our questions.

What we do know is that the 24-page consent form does not inform them that tafenoquine was found by its developer to be neurotoxic a decade ago, or that it still has not undergone appropriate pre-clinical testing, or that the Therapeutic Goods Administration (TGA) holds dozens of adverse event reports from the ADF trial subjects including brain damage and suicide. See reports here: Tafenoquine TGA AE Document 1 AR (1)

This is only the tip of the tafenoquine iceberg. In 2015, while I was still serving in the Army and protected under the Public Interest Disclosure (‘whistleblower’) Act, I testified to a Senate committee that the ADF’s health system, including the AMI, had been “co-opted to do the dirty work of the pharmaceutical industry,” right under the noses of the ADF’s senior leadership.

What I’ve learned since then is that it’s not only the ADF health system which has been co-opted. So, too, has the TGA, the National Health & Medical Research Council, the Department of Veterans Affairs, several parliamentary oversight committees, and basically every public institution responsible for safeguarding our health and enforcing the law.

All this to pave the way for the registration of a “blockbuster” drug which in reality is redundant, dangerous and largely ineffective.

With the help of a small group of dedicated federal politicians, over the coming weeks I will expose the the cover-ups, dodgy research, grubby politics and the systematic abuse which lie at the heart of Australia’s current veteran suicide crisis, in the hope we might prevent the next one.

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