Uncertain Health in an Insecure World – 28

“Ebola – So Over It”

Beatrice Yardolo, Liberia’s last active Ebola case was released from hospital on March 5, 2015. Liberia’s deputy health minister, Tolbert Nyenswah, declared “victory” in their fight against Ebola.  This was no doubt a pyrrhic victory for Ms. Yardolo (in yellow) – 3 of her children died from Ebola!

The U.S. Ebola emergency began when Thomas Eric Duncan was diagnosed in Dallas on September 30, 2014 – Mr. Duncan died on October 8, 2014. The subsequent infection of a Dallas hospital healthcare work who contacted Mr. Duncan, and the return of a medical doctor to New York City from Guinea, raised U.S. public health and political concerns to a fever pitch.

In 5 short months, the Ebola crisis has gone from 800 new cases a day to zero! Previously affected countries of Nigeria, Senegal, Mali, Spain, the U.S. and U.K. are currently free of active Ebola virus disease (EVD). Sierra Leone remains an EVD ‘hot zone’, with one patient and ten exposed health workers now returning to the U.S. for treatment at specially equipped hospitals.

According to U.S. CDC and WHO counts, the current death toll from the 2014-15 West African EVD epidemic stands at 10,096, or 41% mortality among those infected. Ill-prepared small economy West African countries saw the greatest mortality, using only isolation & quarantine techniques to contain the outbreaks and “supportive care” to treat the infected.

Until recently, active treatment protocols using ZMapp and anecdotal infusions of survivors’ blood serum were relegated to small numbers of infected foreign aid workers, and were often administered once they had returned for care in their home countries. In late February 2015, San Diego’s Mapp Biopharmaceutical began ZMapp versus supportive care clinical trial in Liberia. 

The fall 2014 scramble by leading anti-viral Pharma companies and government regulatory agencies to generate clinical effectiveness data through West African clinical trials has generated some progress. A Japan Fujifilm antiviral, favipiravir, was administered to 60 Ebola patients treated at MSF centers in Guinea in December, 2014 using historical controls – results are pending. Two public-private partnerships involving the NIH & GlaxoSmithKline and the Canadian government & Merck produced vaccine versus placebo trials in 18,000 Liberian health and emergency workers in February 2015.

Were western drug approval rules promulgated by the U.S. FDA and NIH being brought to bear on Ebola research a version of “unfair trade”? Is it realistic to expect that the FDA’s typical clinical trial requirements for proving drug efficacy & safety involving hundreds to thousands of patients be applied to such remote acute infectious outbreaks?

In the fall of 2014, this academic debate raged among “experts” on the pages of high-impact medical journals such as Lancet and the New England Journal of Medicine.

Epidemiologists understand bio-statistics. As international health experts in tropical diseases, they know that the bloom of acute infectious disease cases is terribly transient. Whether treating those acutely infected or vaccinating those at greatest risk, there may be insufficient big data generated to draw scientifically robust conclusions.

Clinical trialists and Pharma understand randomized placebo-controlled trials. Traditional clinical trials of new drugs for the chronic diseases impacting the global health of millions are safety-first by FDA design. The WHO, Wellcome Trust and MSF medical ethicists have pushed for fast-tracked drug studies without a placebo control study arm.

So who is right?

Senior WHO officials have decried the low number of Ebola cases now available for study, and the related opportunities missed to test potential therapies and vaccines. Chimerix Inc.’s clinical trial of an antiviral drug, brincidofovir, at MSF-run medical centers was recently cancelled due to the lack of new Ebola cases.

The global health panic that was “Fear-Bola” is over.

But there is still a crying need for rapid response times and alternative clinical trial designs for deadly infectious diseases like Ebola with a 41% acute mortality rate.

Absent such bold innovations, for its victims, Ebola is over in three short weeks!

Observing from afar, we in the Square think that WHO is right.