I'm a PhD candidate in Pharmaceutical Science. In December, I'll be a PhD. Now….what is a pharmaceutical scientist?
We makes drugs.
I make breast cancer drugs. People getting the degree I'm getting are the people that actually study chemicals and compounds that make the drugs that you pick up from your local pharmacy. We study everything about them from the cell level to the animal level. We study whats in it, how much is in it, where to transport it, how to transport it, how to avoid sending it places we don't want it to go. I know more about my research than anything else I've ever studied. Researchers want to know everything.
Now, I'm not your average graduate student. I'm a National Science Foundation Graduate Research Fellow. This means I was funded for 3 years of study and specifically educated in how to teach students and communicate with the public at large. That means talking to you, tax paying citizen who funds my research, was actually a part of my training. Most graduate students aren't American which means they have no vested interest in talking to the public about science and they aren't trained to do so. This is my first foray into talking to the public in this medium. So…here we go.
That's breast cancer.
This is actual data from my actual dissertation. In this picture I saw normal looking cancer cells. The microscope was set up to detect a normal amount of fluorescence or light being emitted from the fluorphores or dyes I added to the cells.
I then changed the computer software I was using to detect a more than usual amount of light and discovered this. Footprints. Those cells you see now at the top, that you didn't see before, aren't actually there. They are footprints of cells that use to be there. The cells that were there are gone. They aren't in a different plane meaning above or below the level of the cells at the bottom. They are just not there. Dead actually because these are adherent cells meaning if they are alive the attach themselves to the plate. No attachment = no life.
So the cells for the first picture are overexposed in the second showing yellow and the footprints are now visible. At this point, this graduate student needed more proof.
I then returned the setting of the microscope to normal and imaged another section of cells. As you can see in the black cube, there was very little red light. The clear box on the right shows these clear things that are in fact cells BUT they aren't doing well. This is demonstrated by the lack of red in the black box and other parameters you can't see from this iPhone shot. One of them is the fact that the cells look to be bubbling up meaning they are becoming unattached to the plate. That's all I'm giving you though…. gotta save something from my publication :-)
Nonetheless, we now have
1. Footprints of cancer cells and loss of the actual cells
2. Cells that don't light up indicating that they are dying
The face of a graduate student that
CURED CANCER!!!!!
Yup…little ol' me took some drugs, treated some cancer, and killed it. That's why I'm crying. Well technically I'm crying because I know this data is going to make my publication look really good AND wrap up my dissertation nicely but also…. CANCER GO BYE BYE!!!!!!!
Now….what I've done is really cool right. But its a dissertation... in cells. Yes the cells are human derived but they're cells. They are cells in a tissue culture dish. I keep them sterile but they have no immune system.
What's the importance of them having or not having an immune system. You have an immune system. If I sneezed on you, you'd be mad but you'd be fine. I could also kill these cells by sneezing on them.
That glass is protecting the cancer cells from me, not me from them. There is also air blowing through the vent below my arm, between the glove and my lab coat, to keep outside room air out. The hoods use UV light to sterilize them and I spray alcohol on my gloves before I put my hands inside the hood each and EVERY time. The cells can't fight any germs. They'll die if they get exposed to anything. They are are the basic unit of life, but they aren't able to exist outside of strict settings.
These cells aren't animals. Killing something in a tissue culture dish, while impressive and the start of something that could be great, does not a human treatment make! There is no way of knowing if this treatment will kill mice, rats, dogs, or monkeys if administered to them and ALL of those other animals will have this drug tested on them before we even consider testing it on humans. That kind of testing takes money and time.
Lots of both.
A drug like mine takes 15 years to go from what I saw that night in the basement of the hospital to a patient's IV in a room within the hospital. That's how long it takes for a drug to get through all the hurdles the FDA requires because the FDA is charged with keeping us safe.
A blip in a study that shows that 1 in 1,000 people get sick/die from something looks a whole lot different when the population of people taking drug goes from 1,000 to 10,000,000. For the sake of the mathematical exercise….a drug that hurts 1 in 1,000 people will hurt 10,000 people if administered to 10 million people. That's a whole lot of people. The American population is approximately 314 million. This is why the FDA doesn't mess around. The FDA can't allow a drug that kills people to be approved even if it saves some people. Lives are at stake.
And you know what other precaution we take? When we test new chemotherapy drugs on humans, it will be on people who are in late stages of cancer meaning they have little hope of recovery anyway. Why?
Because testing on humans is TESTING ON HUMANS! We don't experiment on our fellow man until we know something is completely safe in other animals. We also don't want to risk people's lives if other treatments, that are already FDA approved for effective treatment, could eradicate the disease. New cancer drugs have to prove that they handle the most dire of situations before they start being used in place of drugs we know preserve life.
So we start human testing on people who are already dying. They know they're dying. We scientists know they're dying BUT they are will to the the human guinea pigs because often times this is their last chance at getting a few extra months of life AND they recognize that they can help people in the future by participating in a clinical trial.
Now….about this Ebola. This drug is years from being available. It's supposed to start being tested in humans in Phase I clinical trails in January 2015. (Generally there are 3 phases and each phase takes about a year.) That's a long time from now in research time. Between now and January, there could have been a monkey study of the drug that failed and the drug never would have touched human skin AND no one would have known about it. This happens to drugs all the time. Even when we take all the necessary steps to insure safety a drug can still be deadly. I know of a drug that was being tested and in its first clinical trial it kills all the people that received it. Every person in the trial died. That is a risk associated with testing drugs.
Because of this situation with the Americans, Samaritan's Purse was able to get the FDA to agree to compassionate release of the drug.
Compassionate release of a drug means that the drug is experimental and the patient is at the end of their rope and willing to agree to be a guinea pig. The patient won't be able to sue if the drug kills them and scientists will be able to study the patient while they are getting it and collect data from their treatment. It also means the patient is giving informed consent to be experimented on. The patient knows exactly what they are doing. They understand the risks involved in being given a drug the FDA can't guarantee won't kill or maim them.
Remember when I said we have less than a tablespoon of the drug I used to kill cancer in a tissue culture dish? That's because scale up is expensive. Very expensive. Scale up is the process by which a drug goes from being made in small batches to population sized batches. Even if we wanted to do that with this Ebola drug it is a monoclonal antibody cocktail. Basically they grow it in mice.
Mice.
Small white mice.
And it takes 3 different mice growing three different parts of the cocktail and I'm not even sure how many mice are required to make a single cocktail dose.
My lab does research on mice. The mouse house, which houses our mice and takes care of their day to day needs, sends us bills in the tens of thousands of dollars. A $25,000 mouse house bill is normal. And we are still doing very small studies. Less than 100 mice.
Consider the fact that this drug is being grown in mice.
Firstly, it takes a long time to grow something in mice.
Secondly, you can't get that much of it out of a mouse.
And thirdly, you'd need a whole HEAP of mice to do so.
And I'd like to remind you that we still don't know if this drug is actually safe in humans. It appears to be but what if this drug kills 1 in 10 people. We'd still need to administer it to 8 more people to find just 1 death. Population size data samples are very different from two isolated cases of a drug working. If this drug ends up killing 1 in 17 people in the Phase I trial, it will only ever have been administered to the trial participants and these two Americans because killing 1 in 17 or even 1 in 1,000 is not safe. Drugs approved by the FDA are approved for the population. These drugs have to be safe for the masses.
Last but not least, consider this.
An experimental American drug, that hasn't been tested in humans, is able to be scaled up and sent to Africa. What if that drug kills people? What if that drug maims people? If we administered this drug en mass, we would be conducting a population sized experiment on African people. That is unacceptable.
We do not experiment on humans.
No one in the scientific community has forgotten the Tuskegee experiment.
That was a huge population of Brown bodies that scientists experimented on. I realize that experiment was following the course of an untreated disease given to the people by the scientists themselves but there is a uniting principle: population sized experiments on brown bodies.
The Tuskegee experiment is the single greatest failing of the American scientific community.
We WILL NOT repeat such a crime against humanity against the African people. And yes, its a crime against humanity to experiment on them using a drug meant to cure a disease because it could very well do tremendous harm. We have no way of knowing.
We won't be experimenting on Brown bodies.
We haven't forgotten. We know better. We do better.
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