FDA Black Box Warning
In 2013 the U.S. Food and Drug Administration (FDA) issued a “black box” warning regarding the safety of the anti-malarial drug mefloquine. This is the most serious warning issued by the FDA, which in this case followed a review of the published research on mefloquine neurotoxicity. The FDA updated the drug’s mandatory drug labelling to warn specifically that mefloquine’s neuropsychiatric side effects “may persist or become permanent”:
“FDA has revised the patient Medication Guide dispensed with each prescription and wallet card to include this information and the possibility that the neurologic side effects may persist or become permanent. The neurologic side effects can include dizziness, loss of balance, or ringing in the ears. The psychiatric side effects can include feeling anxious, mistrustful, depressed, or having hallucinations (For a more complete list of potential side effects, see Additional Information for Patients).”
In response to this updated safety warning from the U.S. national drug regulator, documents obtained under the U.S. Freedom of Information Act (FOIA) now show that senior officials from the U.S. Centers for Disease Control and Prevention (CDC) accused injured veterans with malingering, launched a taxpayer funded social media “duel” to promote continued use of this dangerous drug, and criticised academics as “crusaders” for publishing peer-reviewed research on the drug’s neurotoxic properties.
Injured Veterans as “Malingerers”
Among the most incriminating of the internal CDC emails is a comment relating to published case reports of U.S. veterans who had been diagnosed with vestibular disorders as a result of the known neurotoxicity of mefloquine. This drug is able to cause a permanent injury to parts of the brain including the vestibular system, which is involved in balance, hearing and mood – a serious condition with debilitating symptoms. Yet one of the emails from Dr Paul Arguin accused these veterans of “malingering”. Dr Arguin is the Chief of the Domestic Response Unit in CDC’s Malaria Branch and is an editor of Health Information for International Travel, also known as The Yellow Book.
Taxpayer-funded Social Media “Duel”
The internal CDC emails further reveal that Dr Arguin was contacted by the FDA as soon as the they had decided to issue the black box warning. In response to this Dr Arguin and his colleagues formulated a social media response by the CDC to support continued use of the drug, drafting Facebook posts and tweets to counter what they perceived as “anti-mefloquine crusaders”. Once these had been posted, Dr Arguin complained of the “miserably small numbers” of initial responses, then endeavoured to post the information on other CDC social media accounts with a greater number of followers. CDC staff then requested continual updates of social media monitoring to gauge the success of what one of the staff described as a “duel” with an academic who has published numerous peer-reviewed papers on mefloquine neurotoxicity. Dr Arguin describes this academic as “not my favourite person”.
Shameful Episode in Public Administration
The official documents revealed here constitute a shameful episode in public administration. In this case, officials from one government health department decided that their role was to promote the continued use of a neurotoxic drug and undermine the statutory processes of the national drug regulator. This resulted in the misuse of public resources for the conduct of a personal social media “duel” and the slandering of injured U.S. veterans as “malingerers”. What remains to be seen is whether Dr Arguin and his colleagues will be appropriately sanctioned for this gross abuse of their authority as public officials.
Some U.S. troops haunted by anti-malaria drug’s drastic side effects, CBS News, 23 December 2013.
Remington Nevin, Mefloquine: The Military’s Suicide Pill, Huffington Post, 25 November 2013.
Associated Press, Army units ordered to stop taking anti-malarial drug linked to brain damage, Fox News, 19 September 2013.
Maggie Fox, FDA strengthens warnings on malaria drug, NBC News, 29 July 2013.
Kelly Kennedy, Army scales back use of anti-malaria drug: Concerns centered on soldiers with brain injury, anxiety, Army Times, 24 May 2009.
Dan Olmsted, Military drops toxic-drug diagnosis, United Press International, 9 February 2005.
Dan Olmsted, Army suicide rate in Iraq plummets, United Press International, 28 January 2005.
Mark Benjamin and Dan Olmsted, Army surrenders to ‘coward’ GI, United Press International, 16 July 2004.