Welcome to English as a Second Language podcast number 1071, Waiting for Drug Approval.
This is English as a Second Language podcast episode 1071.
I'm your host, Dr Jeff McQuillan, coming to you from the Center for Educational Development in beautiful Los Angeles, California.
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This episode is a dialogue between Florence and Alexander about getting new drugs, especially new drugs that need to be approved by the government.
Let's get started.
A package came for you.
I think it's from overseas.
You're buying your medication from overseas?
I have no choice.
This drug isn't FDA-approved yet.
Isn't it dangerous to take a drug that isn't approved?
Not if it's been approved in other countries.
This drug is considered experimental here but has been used in other countries safely for years.
But shouldn't you wait?
How long could the process take anyway?
You have no idea.
That's hard to believe.
It's true.
First, it has to be tested on animals or in a lab.
And then it has to go through clinical trials.
Only then is it put through a rigorous review by the FDA, which alone can take years.
You're right.
I had no idea.
In the meantime, I'm suffering needlessly.
That's right. but I feel like I have to circumvent the law to get the medicine I need.
So, how does it feel to be an outlaw?
Healthy?
Florence begins our dialogue by saying to Alexander...
Florence says, I think it's from overseas.
In the United States, we use the term overseas, O-V-E-R-S-E-A-S, to refer to other countries.
Now, technically in the US, Mexico and Canada are not overseas because you don't have to go over an ocean.
Sea is another word for ocean, in order to get there.
But it's a general term we use to mean from a foreign country, from another country.
Specifically from Europe or Asia or Africa.
If you're in the United States, that is.
Alexander says, oh, those are my drugs.
Drugs are medications, medicine that you take because you are sick or for some other reason.
Some people take drugs even when they're not sick.
You'll sometimes hear the word drugs used to mean illegal drugs, drugs like cocaine, heroin and marijuana.
But it can also be used to refer to what we call prescription drugs drugs that you get from your doctor because you are sick.
Or simply drugs such as aspirin or other kinds of drugs you can buy without the approval of a doctor.
Florence says to Alexander, you're buying your medication from overseas.
Medication is just another word for drugs.
Things that you take online. to make you feel better or to get healthy.
Alexander says, I have no choice.
I have no option.
This drug isn't FDA approved yet.
To be approved means that someone or some organization says it's okay to use or to buy.
The FDA says, is the official government organization in the United States that approves of drugs.
FDA stands for Food and Drug Administration.
Florence says, isn't it dangerous to take a drug that isn't approved?
Alexander responds, not if it's been approved in other countries.
Florence is asking if He Alexander thinks it is dangerous to take a drug that has not been officially approved for use in the United States.
Alexander says The drug he continues is considered experimental here but has been used in other countries safely for years.
When we say a drug is experimental, we mean that we are still researching it.
We are still examining it.
We're not sure if it's safe yet.
It's not ready for everyone to use.
Experimental drugs usually are drugs that have not yet been approved for the average person to use.
They can only be used in experiments that are carried out or conducted by researchers and scientists.
Florence says, but shouldn't you just wait?
How long could the process take anyway?
Florence thinks that Alexander should wait until the FDA approves of the drug for use here in the United States.
Alexander has different ideas.
He tells Florence that in fact in the United States it can take many years, a very long time, for a drug to be approved.
He says, you have no idea, meaning you don't really understand the situation here.
It can take years for a drug to be approved here. especially those that aren't fast tracked.
The expression fast tracked T-R-A-C-K-E-D refers to something that is done more quickly than usual, something that would normally take a long time, especially the approval of some plan or idea.
That is instead approved very quickly.
Governments sometimes, if there is a serious illness or disease that is affecting people, fast track, approve something more quickly than they would normally otherwise do.
Florence says that's hard to believe.
Alexander says it's true.
First it has to be tested on animals or in a lab.
When we test drugs on animals, we give the drug to an animal and see if the animal dies.
For something to be tested in a lab means that Scientists and researchers look at the drug in a laboratory.
The word lab L-A-B is short for laboratory, which is a place where scientists conduct their experiments.
Alexander says, then it, meaning the drug, has to go through clinical trials.
Clinical C-L-I-N-I-C-A-L trials.
T-R-I-A-L-S are research studies that doctors do on a small group of humans, of people who are sick, to make sure that the drug is safe.
Clinical trials are required for most drugs that are approved by the FDA in the United States.
You have to test the drug on a group of people to make sure that it's safe for the average person.
Many times you can get paid to participate in these clinical trials.
The government or drug companies will give you money to participate in the experiment.
Alexander says, only then is it again the drug put through a rigorous review by the FDA, which alone can take years.
A rigorous R-I-G-O-R-O-U-S review.
R-E-V-I-E-W is a very thorough, detailed investigation of something.
When you look at something very closely to make sure that everything is okay.
Alexander says that the FDA's review alone can take years.
The word alone here means by itself, not including all of the other steps, all of the other things that have to happen in order for the drug to get approved.
If you say a person is alone, you mean that the person is by him or herself.
There are no other people with that person.
Here it refers to the fact that just this one thing, just this one part of the process can take many years, not including the time it would take for all the other things to occur.
Florence says, you're right.
I had no idea, meaning I wasn't aware of this.
I didn't know this before you told me.
Oh, Alexander, you're so smart.
I love you.
Oh, no, she doesn't say that.
Maybe Alexander is trying to impress Florence.
Maybe Alexander is interested romantically in Florence and he's just telling her all of these things so that Florence will fall in love with his intelligence.
You think?
Nah.
Anyway, back to our story.
Alexander says in the meantime, meaning while I am waiting for the FDA to approve of this drug, I'm suffering needlessly.
If something is done needlessly N-E-E-D-L-E-S-S-L-Y, it is being done without a good reason, without a good cause.
Alexander is saying that by waiting he would be suffering, he would be in pain, say more without any reason to, because he could get this drug from another country.
Florence however, reminds Alexander or asks him.
In any case, you can't legally import the drug for your own use, right?
To import, I-M-P-O-R-T, means to bring something into a country from another country.
In the United States.
Normally it's not legal for you to buy drugs in another country and bring them into the United States if those drugs are not legal already in the US.
Alexander says, that's right, that's correct.
I can't do that.
But, he says...
To circumvent, C-I-R-C-U-M-V-E-N-T, means to go around something.
Usually, it's used to mean to find a way to avoid rules and restrictions that you don't want to follow, to do something that isn't necessarily allowed by the rules but allows you to do what you want to do.
In the case of Alexander, he's circumventing the law.
He's really breaking the law, going against the law, by bringing these drugs in, but it is something that he thinks is helping him.
Florence says, so how does it feel to be an outlaw?
The word outlaw O-U-T-L-A-W is an older term for a someone who has done something illegal but has not yet been arrested or caught by the police.
Florence is asking Alexander how it feels to be an outlaw, to be a criminal in effect.
Alexander says, healthy, meaning he feels healthy, he feels better.
And he feels better because, in fact, he was able to bring these drugs illegally into the United States in order to make him feel better, in order to help cure him of whatever disease he has.
Now let's listen to the dialogue, this time at a normal speed.
A package came for you.
I think it's from overseas.
Oh, those are my drugs.
You're buying your medication from overseas?
I have no choice.
This drug isn't FDA approved yet.
Isn't it dangerous to take a drug that isn't approved?
Not if it's been approved in other countries.
This drug is considered experimental here, but has been used in other countries safely for years.
But shouldn't you just wait?
How long could the process take anyway?
You have no idea.
It can take years for a drug to be approved here, especially those that aren't fast-tracked.
That's hard to believe.
It's true.
First, it has to be tested on animals or in a lab, and then it has to go through clinical trials.
Only then is it put through a rigorous review by the FDA, which alone can take years.
You're right.
I had no idea.
In the meantime, I'm suffering needlessly.
You can't legally import the drug for your own use, right?
That's right.
But I feel like I have to circumvent the law to get the medicine I need.
So how does it feel to be an outlaw?
Uh, healthy?
There's no need for you to suffer needlessly in trying to improve your English.
The best drug for your condition is the writings of Dr. Lucy Say and her wonderful dialogues.
From Los Angeles, California, I'm Jeff McQuillan.
Thank you for listening.
Come back and listen to us again right here on ESL Podcast.
English as a Second Language podcast is written and produced by Dr Lucy Say, hosted by Dr Jeff McQuillan.
Copyright 2015 by the Center for Educational Development.
