For starters, this is not a problem for most of us.   Because most of us don’t live in Liberia, Guinea, Sierra Leone, or even Nigeria.  Which is exactly where the Ebola virus is a problem now.  Yes, if folks do come to “here”, wherever your “here” is, it is a potential issue.

Ebola is a (viral) hemorrhagic fever with other symptoms including headaches, vomiting, diarrhea, and internal bleeding.  But, contracting Ebola requires close contact- really close contact.  Which is why isolation of the cases found is such a critical response- to keep ‘them’ away from others, so they won’t become infected.

Ebola is not new.  It was first isolated in 1976 or so, in Zaire and Sudan.  And, it hasn’t taken over the world, even though we know of no cure.  (Maybe.)  And, it kills at least ½ of those who develop the disease, but the mortality rate is often closer to 90%.

So, there is tremendous cause for alarm when a case of Ebola is found. And, right now there are about 700 known cases is Sierra Leone (296 deaths), 495 in Guinea (363 deaths), and 520 in Liberia (292 deaths).  Don’t take those low death numbers as gospel, though, since the incidence rate in Sierra Leone was only about 250 and 100 in Liberia just forty-five (45) days ago.

Scientists have been seeking a cure- or a viable treatment- for about a ¼ century now.  The current ‘therapy’ is to hope we can help the immune system stay viable and then have it fight off the virus.  So, we provide fluids (because the patients become dehydrated), aspirin and similars (to lower the elevated temperature that ensues, as well as the aches), antibiotics (for the other infections that arise as the patients become debilitated), oxygen (as the respiratory system becomes compromised), blood transfusions (since the patients often lose blood) and blood pressure medication (due to blood loss and the infection itself which attacks the kidneys).  Without such “therapy”, the death rate approaches 100%.  The faster and more complete this “therapy”, the better.

But, there seems to be a new hope- ZMapp.  Mapp Biopharmaceuticals (San Diego), in concert with Defyrus (Toronto), are using 3 monoclonal antibodies combined in an experimental therapy.  There’s also Kentucky BioProcessing (Owensboro, Kentucky) who has been able to produce the drugs, using biologically modified tobacco plants, from there harvesting the drug.  And, for those of you who have been in research for a while, you won’t be surprised that Department of Defense is involved- providing a $ 10 million, 3 year contract to develop such a therapy.

The firms were expecting to begin clinical trials next year. So, right now, they’ve just been testing it in animals.  And, like would be true for such testing protocols, only a small amount of drugs are available now.

But the ZMapp group lucked out- maybe.  Because two missionaries (Nancy Writebol and Kent Brantley) operating in Western Africa contracted the virus.  And, being outside of the US, were not subject to the rules of the FDA, which has a long-established protocol for drug approvals. And these two missionaries were treated with ZMapp. (It is not clear this test passed the muster- or even the attention- of the local national authorities.)  An unproven drug, still in trials.

Which means there are all sorts of debates.  Like is this an ethical choice?  Why were only these two folks given the drugs?  What does this mean for the rest of Africa?

I wish I had all the answers.  But, I can say a few things, having developed more than a few drugs and devices, shepherded them and others through the FDA protocols, and worked with manifold companies who operated in this market space.

First of all, given the mortality rate for Ebola, why shouldn’t we let folks take a drug that shows great promise- but has not quite passed the safety protocols of the FDA? (In case you don’t know, the first rule for a new drug or device is to do no harm to those who are treated or proffered the treatment.  Only then will the drug be tested for its efficacy.) If you contracted Ebola, knowing your chances of survival were abysmal at best, wouldn’t you opt for an unproven but promising therapy?

Now that assumes the “do no harm” rule applies for this drug.  Right now, that looks correct, but it’s a little too early to verify. But, even so, these two folks opted for the treatment- and, I am guessing, so would have I.  And, the FDA has been known to approve such treatments when the choices are so stark, despite their normally lengthy test and approval protocols.

Now the real question is can Mapp ramp up production – and can get approval from the four African nations- to treat the epidemic in Africa?   (My guess is that since the two missionaries were White and were treated [it now seems successfully], there will be few qualms that this is a therapy being foisted upon “the others”.  This “test the natives” concept has been a long problem in Africa.)

(By the way, this is not the only choice for Africa and the rest of the world.  Sarepta (Massachussets) has a potential drug- one it developed when a government researcher pricked herself with a needle- a needle that was infected with Ebola.  It might have beaten ZMapp to the punch, but our Congress, in its inimical wisdom (sic), terminated the funding of the program to “save money”.  (Lives don’t count, unless those lives are from those who donate money to the politicians, it seems.  Oh- and this was not part of a DOD [Department of Defense] study.)

Because this whole issue now also looks like dialysis therapy was in the early 70’s.  When there was limited production of devices and no funding for the treatment.  A true death panel concept ensued then.  The “death panel” was responsible for  determining (to the best of their ability) who should live and who should die.  A choice normally best left to the Supreme Being.

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