I am concerned about the ethics of providing ZMAPP to Ebola patients before it is tested in animals (invivo) and human beings (clinical trials). My main concern is about the safety profile, dosage and efficacy of ZMAPP in human beings in the absence of both pre-clinical and clinical data. What are your views on this?
Since ZMAPP is not my field, I´ve just an unprofessional "meaning". So far I´m informed, ZMAPP was applied by wish and with explicite admission by the patients. And WHO allowed the application because of the very high mortality risk without this antibody coctail. I think the patients don´t have another chance.
On many occaisions, a drug company will release an experimental drug to a patient under "Compassionate Use" provisions (which include fully informed consent as to the experimental nature of the drug or product).
ZMapp apparently is owned by tobacoo company raynold's...
It is not the ideal drug for massive outbreaks. I am also very surprised that other drugs have not received similar media attention such as favipravir, which is already available in the Japanese market! and is safe, can be produced in large numbers, and available as tablet as opposed to injections...
As a military doctor, we have been implicated in my unit to be able to take care of confirmed cases. We were surprised by the choices of the WHO, namely presenting the convalescent plasma in first position, considering the siRNA which has so far never been tested in humans and as previously evocked, considering the favipiravir as "uncertain risk/benefit profile".
The convalescent plasma is not ideal because the antibodies obtained are not very efficient to neutralize the viruses. Moreover it should be used carefully particularly because of the risk of co-infection.
The others options Zmapp and favipiravir should of course be considered because we really are lacking knowledge and therapeutic options. But we have to bear in mind that so far, the patients are treated in low-income countries with few if not no health systems. So it is very probable that once in developped medical facilities, mortality of the Ebola infected patients would be similarly to the one of the septic shock, meaning 20-25%...
The latest news I read, was an infected medical doctor who knew his illness and continued to work and play social life for days before he died. I think, we need a lot of persuading efforts in the populations and, very astonishing, also between the medical personal. I hope they find a way especially in the behaviour. The medicines need to much time!!
I think it is ethically sound to offer an untested drug to a patient who will inevitably die under the circumstances, if it has even a remote chance of increasing your chance of survival. I think it would be unethical to not offer one if available, or to not offer alternative cures if the practitioner is aware of any. Ultimately, if the patient is fully informed about the risks involved in taking an untested drug, such as that it may not work, or that it may worsen the situation, or that it may have long term effects, then I don't see anything wrong with it. It is their informed choice. Just like we can choose to take an alternative medication that studies show inconclusive results.
Using untested drugs or biologicals for patients with Ebola Virus Disease in my opinion is ethically justifiable since there is no proven therapy and the case fatality is between 55-90%. Of course, it absolutely necessary to inform the patients that these are experimental drugs with unknown risks and let them decide to take it or otherwise. This approach of course should be only a part of multi-faceted strategies used in the battle against the EBV disease
I am very grateful to you Mark, Hanno, James, Mohamad-Ali, Clement, Elena and Joseph for your thought-provoking discussions about provision of Zmapp to Ebola patients. I have been enlightened by your contributions and I totally agree with you that it is ethical to provide Zmapp to Ebola patients in this emergency situation. However, I am aware that it is not common practice in most resource limited settings to obtain informed consent from patients before administering treatment. Therefore, I would urge the Clinicians who are administering Zmapp to Ebola patients to obtain informed consent from the patients before administration of Zmapp, which is being used to treat the patients on "compassionate use" provisions. Thank you!
Hi, just got this on the Lancet ID:
http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(14)70924-7/fulltext
It is not normal to trial experimental treatments on humans without more safety and other efficacy data. The EBOLA crisis however has allowed this to happen and provided official permission for this large scale Experiment on Africans by the major Pharmaceutical companies who have unofficially in the past run these types of human experiments in AFRICA.
The Ethics are very questionable especially since most Africans will never be able to afford these products which are being developed for sale to western countries.
These are some low cost safe Pharmaceuticals which could be used which have been pushed aside to allow these human experiments. WHO and MSF have been offered safe alternatives but have not opted to use them. The financial ties of WHO and MSF to major Pharmaceutical companies raises significant questions.
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