How U.S. Army officials got played by GlaxoSmithKline into subjecting 1,540 Australian peacekeeping troops to tafenoquine drug trials for commercial purposes

Walter Reed Army Institute of Research, Silver Spring MD

CONTRADICTING recent claims by Australian Defense Force (ADF) Surgeon General Air Vice Marshal Tracy Smart that a malaria outbreak during the early stages of the East Timor deployment in 1999-2000 necessitated the use of the experimental drug tafenoquine, a former WRAIR director has stated that the U.S. military was looking for large numbers of allied troops able to participate in clinical trials as part of its commercial arrangements with GlaxoSmithKline (GSK).

We essentially said: ‘We have developed [tafenoquine] to the point at which we cannot develop it any further. We need an industrial partner. You [GSK] develop it and make it available to us.’

We were completely naive, because we were desperate.

We were very mission driven, very altruistic, really babes in the woods when it came to business and such, and it showed, right? We routinely got taken advantage of, and didn’t understand the operating environment.”

FORMER WRAIR DIRECTOR, 2018

A 1998 Australian Army Malaria Institute (AMI) clinical trial in Bougainville had previously found another GSK drug, Malarone (from another drug class), to be as effective against malaria (less P. vivax eradication) and better tolerated than the existing ADF first line drug doxycycline. AMI recommended against the adoption of Malarone due to cost, less than the cost of a cup of coffee per day. Regardless, Malarone replaced mefloquine as the ADF’s second line antimalarial in 2006, when the latter drug was relegated to “drug of last resort” due to the risk of neuropsychiatric side effects. Malarone is now regarded as so safe that it is sold over the counter (without prescription) in many countries.

AVM Smart’s claim that the P. Vivax malaria outbreak most likely resulted from “drug resistance”, or “poor compliance” with the standard primaquine post exposure prophylaxis (PEP) regimen, has also been largely debunked in some of the world’s leading medical-scientific journals. Throughout the history of the use of primaquine, a significant proportion of individuals have contracted P. vivax malaria despite compliance with the recommended dose regimen. Drug failures have typically been mis-attributed to “poor compliance” or assumed “drug resistance” in the malaria parasite. However there has never been any direct scientific evidence of P. vivax resistance to primaquine. This has only ever been an assumption.

In recent years, leading malaria research scientists have discovered that the 8-aminoquinolines (including primaquine and tafenoquine) are largely ineffective because they need to be metabolised by an enzyme known as CYP2D6. Up to one quarter of the population carry a genetic deficiency which means they remain at risk of contracting malaria even if they are fully compliant with the prescribed drug regimen. In allowing the U.S. military to subject 1,540 of their soldiers to these drug trials, senior ADF officials switched from a largely ineffective but relatively safe and registered drug, to very high doses of an equally ineffective but unregistered drug which is also known to be neurotoxic.

Some time around 2010, coinciding with the publication of AMI Study 033 (the 1 RAR tafenoquine prophylaxis trial in East Timor), GSK discontinued it’s involvement in developing tafenoquine for malaria prophylaxis, ostensibly due to safety concerns for G6PD-deficient individuals. The GSK drug indicated for the treatment of P. vivax malaria, based on a single 300 mg dose sometimes called “radical cure” is known as Krintafel® in the U.S. or Kozenis® in Australia. Regulatory approval of Krintafel® by the U.S. Food and Drug Administration in 2018 entitled GSK to the award of a “priority review voucher”, a saleable product valued at up to USD$350 million, even if a single tablet of this drug is never sold.

Further background is available here and here.

Curtin University (Perth, Australia) response to query regarding possible involvement in the Linear Clinical Research tafenoquine long-term safety study

LAST week, after a tip-off from a reader in Australia who had been raising safety concerns with universities in Perth regarding the tafenoquine study currently being undertaken by Linear Clinical Research, I sent a query to the Curtin University research office.

This is the response from a Curtin University spokesperson, in full:

Curtin University has absolutely no involvement in the clinical trial, called Long-Term Safety Study of Tafenoquine, being run by Linear Clinical Research and 60 Degrees Pharmaceuticals. Curtin is not currently undertaking any clinical trials related to tafenoquine.

The Curtin staff member you contacted has had no involvement at all in the development of tafenoquine.

ENDS

Curtin University, Perth, Australia