Welcome back to Five Minutes, the podcast series where we speak to the most interesting people in the world of malaria.
This interview follows breaking news released earlier this week that the malaria drug Tafenoquine had been endorsed by the FDA. The drug treats relapsing P. vivax malaria and removes the malaria parasite from the liver.
Some have hailed the drug’s approval as ‘good news’, notably the Bill and Melinda Gates Foundation, but many have been quick to criticize the FDA. Tafenoquine can have harmful side effects, some of which are neuropsychiatric and can have fatal consequences.
Dr Remington Nevin is, I guess, the leader of the opposition. He runs an organisation lobbying against certain antimalarial drugs, such as Tafenoquine, and he joins me now.
Due to time restrictions on this podcast, some parts of the interview have been omitted. You can read a full transcript of the entire interview by clicking here.
This is Five Minutes with Dr Remington Nevin.
When it was announced that Tafenoquine had been approved by the FDA, what was your initial reaction?
This was not at all surprising. Every drug that is eventually banned in the US, or that receives a strong boxed warning, was once deemed safe and effective by the FDA and its advisory committees. Mefloquine is a good example of this. Thirty years ago, the advisory committee reviewing the New Drug Application for Mefloquine was not even made aware that mefloquine prophylaxis could have psychiatric adverse effects.
I expect that in due course, the advisory committee and FDA will reconsider its conclusions. I expect that for tafenoquine, the time to recognition of its dangers will be measured in months or years, not decades.
It’s fair to say that you are very vocal about your concern for drugs like Tafenoquine, and Mefloquine which you mentioned there. What sort of message do you hope to share?
As someone who has extensive training in tropical and preventive medicine, I recognize the critical importance of antimalarial drugs. My work and that of our foundation are focused on the unique safety risks of the quinoline antimalarial drugs. This is a class of drug with inherent CNS toxicity, whose use is very likely contributing significantly to the global burden of mental illness and neuropsychiatric disability. We believe that if drugs of the quinoline class are to continue to be used in global malaria control efforts, greater consideration must be given by the malaria community to identifying and understanding these effects.
Right, but I one thing that stood out to me about your message is that you have said in the past that the main reason for why drugs companies are producing tafenoquine is because of financial gain. Could you expand on what you mean by this?
It should come as no surprise to the malaria community that drug companies are primarily motivated by profit and their fiduciary responsibility to their shareholders and this fact is demonstrated clearly in the development of tafenoquine. This drug had languished in the U.S. military’s drug development program for decades and had been nearly abandoned prior to FDA’s introduction of the Priority Review Voucher (PRV) incentive in the late 2000s. 60 Degrees was formed by ex-U.S.-military-affiliated personnel who had strong personal and professional connections to the military’s drug development community, and monetization of a PRV appears to have been a large part of the company’s business plan. The CEO of 60 Degrees had all but bragged that earning a PRV for tafenoquine’s approval could earn his newly-formed company up to $350 million.
Similarly, for GSK, the economics of bringing Tafenoquine to market in the U.S. do not make much sense outside of the PRV incentive. The favourable media attention GSK earns from its development of tafenoquine, which reflects well on its other profit-making activities, is also likely a strong related consideration.
You run a foundation called The Quinisim Foundation. Could you give us some information behind the name?
Our foundation has repurposed the once-obsolete term quinism, which had previously been synonymous with cinchonism, to define the more general family of medical disorders caused by quinoline poisoning. Quinine, from which both quinoline and quinism take their names, is of course, the prototypical drug of the class. Our foundation’s logo emphasizes the fundamental importance of the quinoline core in the toxicity of all antimalarial drugs of this class.
And what do you hope to achieve?
We promote and support education and research on the family of medical disorders caused by quinoline poisoning, but in practice, at the moment our work is focused on neuropsychiatric quinism.
That was Dr Remington Nevin