Hi! Resident PhD Candidate here!
I'm back again to try and shed some light on the current situation with the Ebola vaccine.
We now know that three doses of ZMapp have been administered. The two Americans that received it are recovering at Emory in conjunction with the Centers for Disease Control in Atlanta. The 3rd dose went to a Spanish priest who later died.
Since we pharmaceutical scientists are the makers of drugs, I thought I'd share some thoughts on the situation.
This drug is a monoclonal antibody cocktail. Let me explain what that is and how you get it.
To make a monoclonal antibody you must first combine two different types of cells: myeloma cells and spleen cells of a mouse that has been immunized with the desired antigen. The antigen is the toxin or Ebola in this case. As I understand it, they expose mice to three different fragments of the Ebola virus. One mouse gets exposed to one fragment each. They then take the spleen cells of each mouse and fuse them with myeloma cells to create a hybridoma. Three separate hybridomas are needed, one for each fragment.
The important parts of this are:
1. The ability to create the antibody from the spleen cells that were exposed to Ebola
2. The indefinite growth characteristic from myeloma cancer cells to continuously reproduce this antibody
Together, you have cells that make antibodies and will never stop growing as long as they are provided the right growth environment to live in. What is that environment?
Science can either artificially create an environment to grow cells via cell culture or the hybridomas can be injected into the bellies of mice and grown inside the mouse.
Next, the antibody has to be extracted and purified. Regardless of how it was produced, it has to be cleaned. This is no small task. Think of it like this: You want to get the pinch of salt you added to muffin batter back after you baked them into muffins.
Difficult? Most certainly.
Yield? Very low.
As you can imagine this means that there must be massive numbers of hybidomas grown and maintained to get enough antibody to treat one person, much less a population. Additionally, for this Ebola treatment you need three different hybridomas to grow enough antibodies to combine them together. This kind of scale up doesn't happen overnight.
Even in my small experiments, I sometimes have to wait a week or two just to have enough cells to study and I'm studying the WHOLE cell or the whole muffin if you will. If you're trying to get antibodies, you only want the salt out of an already baked muffin. There isn't a whole lot of salt in the muffin AND its going to be hard to get.
Scale up will take months. No drug company has on hand the amount of drug needed to stop an epidemic if the drug is still experimental. Think about it like this: Would you make 5000 cupcakes with a new spice or would you make 12 cupcakes? You would make 12 to see if you even liked the spice. The same philosophy applies in science. We make enough to test until we know the treatment works. Once a treatment is FDA approved, we then purchase the infrastructure to make larger quantities. They couldn't make population sized doses if they wanted to AND the doses wouldn't be ready for months.
NO FDA Approval = no mass production of any drug
Hypothetically, this company has about 12 doses. This is not an accurate number but I'm continuing the cupcake analogy. They have given out 3. That leaves 9 left.
Even if the company had known this was going to happen way back in May, they would still only have about 20 doses because:
1. The drug isn't FDA approved
2. They don't have the means to scale up production so they could produce more but only incrementally
3. The drug takes months to make
Please read the following statement carefully.
The US Government DOES NOT OWN ZMapp. The US can't give it to anyone. They don't own it. They don't have any of the drug. They can't get the drug. What the FDA did was allow it to be given to American citizens. All the FDA of the US Government did was give permission for this company to experiment on two people.
No other country should say the US refused to give them something we don't have. Had we been asked for the flu vaccine, the US Government could have given it because we own the vaccine. Essentially, African nations are asking another nation for something that doesn't belong to them. It would be like Nigeria asking the US to give them Mexico. Yes we have access to Mexico, but we do not own it. Mexico is a sovereign nation. The makers of ZMapp are like a sovereign nation. No one can take their land or their product from them. Aside from the fact that there isn't much of the drug to give anyway, the US Government cannot compel a private company to give anything to anyone.
The US Government has no power over ZMapp distribution because they have no ownership of the drug AND there is very little to give anyhow.
Additionally, the Americans' recovering in Atlanta CAN NOT attribute their recovery to this drug. At this point, there is no way of knowing why they are recovering. In scientific studies, success is measured long term. Recovery and treatment are a long game. Research is the definition of delayed gratification.
The Americans' recovery could be due to the intense supportive care they receiving at Emory and have zero to do with the drug. At this point we know next to nothing about how this drug actually functions in the human body. If this drug causes kidney failure in 6 months this drug will have been a categorical failure.
There is no way of knowing if this drug is helping anyone at all and these Americans are still guinea pigs. They have entered into a life long experiment. The admissions ticket for this experiment was purchased with their lives. If the Americans live, they will be studied for the rest of their lives. What exactly does that mean?
These two Americans will be followed by the CDC. They will be required to give blood, urine, and any other specimens scientists desire for analysis. They now belong to science. Treatment with ZMapp is experimentation on humans. Humans!
Lastly, if the company gave the last 9 doses to an African country, which one would it be? Liberia? Nigeria?
Would the drug go to the highest bidding nation?
From there, to whom would they administer the remaining 9 doses?
Is there an application process?
Should they go to the young who have stronger immune systems or the most educated persons who get sick?
Should the drug then go to the highest bidder or the hospital best equipped for supportive care?
How will you determine who gets the treatment?
This is a very ethically slippery slope.
1. We are now experimenting on humans affected by Ebola.
2. The last experiment carried out on humans in America was the Tuskegee experiment, carried out on brown bodies, and remains the greatest failing of the American scientific community. When you know better, you do better.
3. The recipients of ZMapp have not been selected by the US Government but by the company.
4. ZMapp could kill people 5 months after administration and at this point we don't know. This drug isn't a cure.
5. There isn't a way to get more ZMapp quickly.
Rock….meet hard place!
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