Let’s Get Ethical: Giving Untested Experimental Drugs to Ebola Patients

West Africa is in the throes of the worst Ebola outbreak to date. Ebola virus disease, the hemorrhagic fever caused by the Ebola virus, has been seen in small but often deadly outbreaks in tropical sub-saharan Africa since its discovery in 1976. Though researchers are fairly certainly that it is transmitted through bush meat, and fruit bats are suspected, no animal species has been confirmed as a reservoir. Combined with the fact that the virus is highly contagious and so often deadly (usually because there is little to no medical infrastructure in areas where outbreaks occur), it is the source of international fascination and fear. It is the perfect plot device for outbreak movies and sensational media reports – a mysterious ailment from the heart of darkness that could rear its ugly head in our packed population centers at any moment.

Although it’s not quite as scary as movies like “Outbreak” would have you believe, the havoc that it is currently wreaking in West Africa is most definitely real. The most recent update from WHO puts the death count at 932 and the number of cases (both suspected and confirmed) at over 1,700. Guinea, Liberia, and Sierra Leone have been battling the virus since the spring, and last week it made its way to Nigeria and there was even a suspected death in Saudi Arabia. We all know that international air travel means that these types of illnesses are only a plane ride, which raises the question of why we haven’t made more progress in developing a vaccine or treatment for such a devastating disease.

Frankly, most global health and development professionals know the answer – if the only market for potential drugs is among the poor in central Africa, commercial drug companies won’t exactly be lining up to put money into the research:

The factor preventing such trials in humans, though, has been cost, said Dr. Daniel Bausch, an associate professor of tropical medicine at the Tulane University School of Public Health who is currently stationed at the U.S. Naval Medical Research Unit 6 in Lima, Peru.

That’s because, while the National Institutes of Health and the U.S. government often fund the early animal safety and efficacy testing of a vaccine, pharmaceutical companies typically fund the human clinical trials to take a drug or vaccine to market.

“When you have a population or situation with Ebola where it only sporadically occurs, and it occurs really in the world’s poorest populations, it’s not exactly an attractive candidate for the pharmaceutical industry on the economic side,” Bausch said.

That all changed, however, when two American aid workers who were treating Ebola patients in Liberia fell ill with the virus themselves. Dr. Kent Brantly, a doctor working with Samaritan’s Purse, and Nancy Writebol, a nurse employed by Service in Mission, are now all over U.S. and global headlines as the first Westerners to contract the virus – and, because of their privileged status, as the first people to receive an experimental treatment in the early stages of development before being flown back to Emory for medical care (despite objections from Donald Trump and Ann Coulter).

Though several people have raised objections to bringing Americans back stateside for treatment (particularly at what it probably cost), Emory is probably the safest and best-equipped facility to treat and contain the patients. Samaritan’s Purse is footing the bill for transporting them, so no government funds are being used. Bringing them back to the states for treatment is not so much of an issue, in my opinion – but using an experimental drug which is untested in humans is another matter.

At first glance, an outbreak of a disease with a high fatality rate (usually 40-70%) and no cure seems like the perfect situation to bypass the standard drug testing and approval process, which can take several years. However, it is the recklessness generated by precisely this type of desperate situation that raises ethical dilemmas. Does informed consent really count when patients are panicked at the prospect of imminent death? What if the drug is administered to the afflicted on a large scale and turns out to be toxic, or causes long-term disability? Who determines which patients to prioritize and how to protect those most vulnerable – such as children or pregnant women – who may react very differently to the drug?

Additionally, the fact that the drug has only been given to the two Westerners raises a very different, but equally important, problem. The international community has struggled for years to bring critical medicines to populations with the greatest need, who are simultaneously the least able to afford them. The fact that this experimental treatment was given to two aid workers – who, unlike their patients, have the support of large and wealthy organizations and will be more able to access the needed high-quality supportive care than their own patients – raises some disturbing questions.

The WHO has announced that it will convene a panel of medical ethicists to discuss and provide guidance on the issue. The pharmaceutical companies that develop and manufacture the drug are, naturally, chomping at the bit to get a large production run funded in order to provide ZMapp, the experimental serum, to a large number of Ebola patients. It is unclear how the global health community will move forward. But perhaps it can serve as a lesson to the pharmaceutical industry to take a more active interest in developing therapies for diseases that may not seem lucrative at first glance. Perhaps then we’ll be prepared for an unexpected multi-country outbreak – instead of having to scale up an untested drug developed by a tiny biopharmaceutical.

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