It’s easy to see how complicated decisions and confusing actions feed into a narrative that to a previously unaware public can look like a conspiracy or a continuation of privilege to certain individuals. Let’s update the Ebola story.
Knowing the risks, very conscientious American healthcare workers placed their lives at risk to serve those in need in the midst of the largest Ebola outbreak in history, one that has affected more individuals than all other outbreaks combined (there have been 1700 infections and approximately 1000 deaths to date). Two individuals contracted the disease through first-hand contact, despite efforts to employ routine safety measures (or because of inappropriate utilization of routine safety measures). Statistically this amounted to a death sentence, as Ebola virus has up to a 90% mortality rate, and no approved treatment or vaccine for the illness exists.
The workers were given an experimental treatment that works to boost our immune system’s efforts to fight off the virus. This treatment is made from antibodies (the “fighting” part of one’s immune system) produced by lab animals exposed to parts of the virus. Apparently the treatment had been tested in monkeys but had never been tested on humans. This treatment was administered in Liberia, and by the time the first patient arrived back on US soil, he was well enough to walk into the hospital (under isolation precautions) for additional treatment.
Subsequently, the U.S. Food and Drug Administration (FDA) has eased safety restrictions on an experimental drug to treat Ebola. It is of note that this was done in the absence of this drug being proved safe and effective in humans – one success story does not constitute a sufficient amount of evidence for widespread treatment. It is also of note that this is a different drug than the one successfully used in Liberia. By the way, the FDA serves to grant approval for distribution of new drugs and permission for use of experimental treatments within the U.S. but does not have such authority over use in other countries, which is why you often see Americans going elsewhere for experimental treatment. This explains why the individuals could have “conveniently” had access to a “secret medicine.” All medicines everywhere aren’t under the control of the U.S. government.
This has to be confusing for the average citizen.
- If protocols exist, why were they broken? Does that mean the protocols were inappropriate? If so, how many have died because of the presence of bad protocols?
- If exceptions to protocols exist, why were they applied to the healthcare workers and not the thousands of individuals in need?
- What risks were involved in bringing the individuals back to the U.S. for additional treatment?
- Was the easing of restrictions on these experimental drugs wise? Was it politically based?
Be reminded the U.S. FDA and Centers for Disease Control and Prevention (CDC) doesn’t govern activity outside of the U.S. or its citizenry. The World Health Organization performs this function, admittedly under a large measure of influence from U.S. agencies. As such the U.S. CDC wouldn’t have been the entity tasked with providing experiment treatment to thousands of Africans. In the face of our own history (see this link to the Tuskegee experiment), it is inconceivable that we would have chosen to provide a treatment that had never been tested in humans to a continent of people. The decision of an individual American, particularly an American physician educated and very aware of the risks and benefits of a new medicine while at death’s doorstep, to receive an experimental medicine is a different matter. As a public health professional and a physician, I’m not especially concerned with this decision because I know appropriate checks and balances would need to be involved in the decision, including the use of ethics committees (had it been done in a hospital setting).
Another decision that has caused quite a bit of consternation is the decision to transport the patient back to U.S. soil for treatment. My initial thoughts focused on whether the patient was healthy enough for transport. That appeared to be the case. Many others were more concerned about delivering the contagion onto U.S. soil. Firstly, it’s naïve to think it wasn’t already here; if for no other reason, that’s how various levels of research has been conducted. Secondly, that fear ignores the logic of how the disease is transmitted. Folks, this isn’t a Godzilla movie. Ebola is a reasonably simple disease to contain and is transmitted in specific ways – not through air, not through causal exposure and not by living in the same city as someone infected. The mode of transmission of Ebola virus was discussed in detail in this Straight, No Chaser post. In short, the decision to transport the patient back to the U.S. appears to be justified, even before treatment and especially after the response to the experimental treatment.
This would have been the case even without the above considerations. If you were an American citizen and were ill in another country wouldn’t you want to return to the U.S. for treatment? Wouldn’t you feel like you had the right to do so if it could be done safely? Additionally, if you were dying in another country due to service rendered, wouldn’t you want to come home to be with your family if safe and possible? Honestly, that’s all that occurred in this case.
We have to come to terms with the notion that these decisions aren’t going to be made by mass public agreement or as a result of mass public hysteria. This is why protocols and safety regulations are in place and have been reviewed by career experts and professionals. These issues are the basis of public health and have been thought out far in advance of outbreaks of Ebola and many other diseases with which you’re unfamiliar. Just because you learned about Ebola a week ago from a sensationalized news report or internet feed doesn’t mean your thoughts on such issues will match public policy, and it doesn’t prove some massive conspiracy is in play.
On the other hand, what is legitimately concerning is the subsequent decision to suspend normal protocol to ease restrictions on experimental drugs. The U.S. FDA has often been criticized for its slowness in approval medications, but this has served the U.S. population well. Drug safety is a legitimate concern. Nothing about the current African outbreak seems to warrant a suspension of normal protocol in a way that would require emergency use of medicines or vaccines currently under study here in the U.S.
In fact the medicine being fast-tracked isn’t even the same one successfully used in Africa. To be clear, the current delay in advancing this particular treatment involves concerns about a type of drug reaction that can cause nausea, chills, low blood pressure and shortness of breath in small doses when tested in healthy adults. Simply put, no licensed drugs or vaccines have currently met the U.S. FDA’s traditional vigorous standard for testing; in fact, no successful tests have been completed on humans (and it would be illegal for such to occur without public knowledge). Coupled with the lack of any realistic threat to U.S. citizens on U.S. soil, this response seems like an overreaction that may not serve the public’s interest. Hopefully the decision to “make the drug available” will not be the same as a decision to approve the drug for widespread use prior to completion of necessary testing.
Stay tuned for additional updates.
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