New concerns that the Ebola outbreak in West Africa is much worse than reported are adding to the global pressure to find a solution – even if that means testing unproven drugs on desperate Africans.
But medical ethicists and others in the drug-testing business say the focus on miracle cures for Ebola is misplaced.
And, in any event, Western nations owe Africans a huge debt of gratitude for even considering being the ones to try these experimental medications.
Untested drugs and vaccines are now in the spotlight after reports that three Westerners received the experimental Canadian drug ZMapp, and about the Canadian government announcing it would donate up to 1,000 doses of a potential Ebola vaccine that is in the development stage.
Meanwhile, the death toll keeps rising rapidly.
As of Aug. 16, there had been at least 2,240 people infected, of which 1,229 had died, according to the World Health Organization. However, the WHO says its numbers "vastly underestimate the magnitude of the outbreak."
By comparison, the reported death toll of all previous Ebola outbreaks, dating back to 1976, totals about 1,600.
Miguel Pajares, a Spanish priest who was infected with the Ebola virus while working in Liberia, is transferred from a plane to an ambulance near Madrid on Aug. 7. He died Aug. 12. Spain's Health Ministry said it had obtained a course of the experimental drug ZMapp to treat the priest. (Spanish Defence Ministry/Associated Press)
Those outbreaks were contained through quarantine, patient isolation, case identification and tracing Ebola patients' contacts.
That's also the approach in West Africa today, but, perhaps because the virus has now reached large cities, health workers have been unable to bring it under control.
Another factor in the latest outbreak has been the distrust among the West African population of government and health professionals, both domestic and foreign, a distrust that may stem from past experience.
1996 drug experiment goes awry
For example, in Nigeria in 1996, when a meningitis epidemic was underway, the American pharmaceutical company Pfizer arrived in the hot zone in Kano. Its representatives immediately set up their clinic next to the makeshift tents of a hospital then staffed mostly by Doctors Without Borders.
Meningitis, an inflammation in a membrane surrounding the brain or spinal cord, affects mostly children, and without treatment, about half of those infected will die.
Fiddausi Abdullahi Madaki, a victim of Pfizer's 1996 test, sits at her home in Kano on Oct. 2, 2007. Nigeria's government and the northern Nigerian state of Kano were suing Pfizer for a combined $8.5 billion US in damages over Trovan, a new drug tested on children during a meningitis epidemic. (Mike Oboh/Reuters)
Pfizer had a new treatment that it wanted to test, so its doctors gave Trovan (floxacin) to about half the 200 children they treated, while the other half received an approved drug for meningitis.
About five per cent of the patients taking the experimental Trovan died, while some others were left blind, deaf and/or paralyzed.
In the aftermath, the U.S. Food and Drug Administration refused to approve Trovan, hundreds of Nigerian parents sued Pfizer and the company eventually settled in 2009. (Its position was that it was the disease that had caused the deaths and other conditions.)
Pfizer claimed to have permission from the local hospital to conduct its experiment, but the approval letter was said to be a forgery. Pfizer claimed it had informed consent from the patients' families but could not provide written proof.
Harriet Washington discusses the 1996 Trovan drug experiment in Nigeria in her book, Deadly Monopolies. (Random House of Canada)
Harriet Washington, who wrote about the Trovan case in her 2011 book Deadly Monopolies, told CBC News that in the absence of that consent, people in Kano "had no way of distinguishing the doctors who are giving approved drugs meant to work, from doctors right next to them who are giving them something experimental."
That experiment, along with others, informs public perception today in Ebola-ridden West Africa as well as the WHO policy on the use experimental drugs during the current outbreak, a policy that stresses the necessity of informed consent, according to Jim Lavery, who heads the ethical, social and cultural program for global health at St. Michael's Hospital in Toronto.
Why the focus on new drugs
But even with informed consent, is today's new focus on cures and vaccines overly optimistic?
"Our ability to draw any inferences whatsoever about the efficacy or safety of ZMapp in those three patients I think is fundamentally zero," Lavery says.
"We simply can't make credible claims at the scientific level that we know anything about the relationship between the administration of the drug and survival or mortality," he adds.
While the Ebola virus does kill most of the people it infects, many do survive, and Lavery points out that paradoxical effects often occur in drug testing.
A man's temperature taken using an infrared digital laser thermometer at the Nnamdi Azikiwe International Airport in Abuja, Nigeria, on Aug. 11, part of the cautions being exercised as with the Ebola death toll rising rapidly. (Afolabi Sotunde/Reuters)
"You could actually be increasing the overall mortality rate in the outbreak, and you'll never be able to detect it unless the research protocols are structured well enough.
"And, to be frank, I can't in my wildest dreams imagine how those protocols could be effective enough for us to derive the kind of information that will be necessary to improve the care of future patients in Ebola outbreaks."
Untested agent
Alison Thompson, who teaches bioethics and pharmacy at the University of Toronto, says drugs like ZMapp have barely scratched the surface of the requirements to make sure that drugs are safe and effective.
A scientist separates blood cells from plasma cells to isolate any Ebola RNA in order to test for the virus at the European Mobile Laboratory in Gueckedou on April 3. (Reuters)
"Even though there may be no safety signals in the animal models you've done, there can be very catastrophic effects in humans when you try these drugs," she says, noting that in the first phase of clinical trials, people often become very ill.
"The perception that you're withholding something valuable is not an accurate reflection of what you're doing."
It's better, she says, to view these new drugs as just an untested agent. "It's more like you're withholding hope than the actual benefit."
'The fundamental problem'
With the current Ebola outbreak, Lavery argues that the fundamental problem is not drug testing, but the lack of public health infrastructure in the infected areas of West Africa.
That infrastructure is what is really needed right now, and on that front, Lavery finds the international response woefully inadequate.
"If we're not reflecting, as a result of this Ebola outbreak, on our collective and global responsibilities to one another, then it's a completely missed opportunity."
Medical ethicist Harriet Washington says that while 'people often talk about the Africans as if they are only beneficiaries,' because of the huge risks from drug testing, they are 'actually delivering an enormous financial boon to the West.' (Gannett Co./Random House of Canada)
Washington argues another issue is being "seriously ignored" in the debate about potential anti-Ebola drugs. "People often talk about the Africans as if they are only beneficiaries," she says.
But because of the huge risks patients there undergo, "these people are actually delivering an enormous financial boon to the West."
She notes that the pharmaceutical industry conducts two out of five clinical trials in the developing world "because they can do higher quality trials more cheaply and more quickly there, and they save a great deal of money by testing drugs on these people."
Then, if and when the drugs get approved, those companies sell them at a price many people in the developing world cannot afford.
In the process, Washington says, "we owe them an immense debt and here's a chance to help pay them back."
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