Before a medical drug makes its way into the market it has to go through various stages
of testing.
This starts with a laboratory investigation which might begin with lab-grown human cells
and computer models.
If the drug passes that test, then scientists move on to animal testing.
If the drug gets the green light again we bring in the humans.
The drugs are tested on people in what we call clinical trials, or drug studies.
These trials might include healthy people or sick people.
They can test a drug’s effectiveness, side-effects, or how the body absorbs it (bioavailability).
The drugs should already be safe, but there have been times that things went horribly
wrong.
That’s what we’ll talk about today, in this episode of the Infographics Show, Medical
drug trials that turned in living nightmares.
Before we get to the horror, let’s first paint a picture of what a medical trial might
look like.
They don’t always create “Elephant Men”, our last and most disturbing tale on this
list.
Let’s say you’re testing for bioavailability.
Generally, you will apply to do the test and then be asked to come in for an interview
and some checks.
If you pass you’re given a date and location where the study will take place.
You will likely be asked to fast just before you come in, not take drugs (including alcohol)
and possibly even grapefruit juice.
All trials are different, but one man told us when he did trials in Montreal, Canada
that he would turn-up to a center and then was told he would be a number as well as a
name.
He fondly remembers being number 17 during one trial.
He said the center had a pool table, rooms with bunk beds, TVs, and games consoles.
There were also books and magazines to read.
Everyone had to eat the same food and finish the meal; all participants ate according to
their number and that’s why everyone wanted to be number one.
After awhile he said everyone is peeing and pooing almost in line with their numbers.
You can leave the study, but you won’t usually get paid.
He said being confined with other snoring, not always nice men, can be challenging and
on his trials at least one day involved having 20+ blood draws.
If you don’t have a catheter this can turn your arms black and blue.
“Many of the people were jobless and desperate, some were musicians or writers and others
were actually medical students from Montreal’s universities,” he said.
He got about $200 a day and the longest trial he did was two separate runs of 5 days, so
it’s not a bad paycheck for doing nothing but playing games and reading.
No one in his trial had a bad reaction to the drugs, although he said there were heated
arguments at times over the TV channel or someone’s loud snoring, and some people
fainted during blood draws.
Ok, you get the picture.
We’ll start with some lighter stories and finish with 2006’s horror trial that shook
the world.
All these are fairly recent cases, but going back into the past we could certainly dig-up
some shocking tales such as the testing of the drug Thalidomide.
If it kills monkeys…
This recent trial that went wrong took place in France in 2016.
It was so bad that the European Union decided it was time to create new laws that protected
volunteers.
The trial was said to have been bungled, and it led to the death of one man and brain damage
of four more.
A company called Biotrial was testing a compound called BIA 10-2474 that was being tested to
cure a number of diseases.
The volunteers at the trial at first did not suffer any serious side-effects.
But when their dose was increased “volunteer 2508” said his vision went blurry and he
had headaches.
“We expected to see him come back,” said one of the staff, so the trial continued.
The man, a 49-year old artist, was declared brain dead the next day.
As for three of the four others that were sick, a doctor later said, “that even in
the best situation there will be an irreversible handicap.”
The payment was around $2200 for two weeks.
An investigation later revealed that several monkeys had died during pre-human testing,
but this information was not in the study protocol report.
Drug Blindness This story involves women taking part in a
drug trial to improve eyesight.
What happened was exactly the opposite, they lost their sight.
The Independent in the UK called the 2017 drug trial “botched.”
It certainly was.
The U.S. patients even had to pay $5,000 to take part.
They were testing stem cell treatments to improve their eyesight as the aged women suffered
from something called “macular degeneration” that can make some objects look blurry.
“They are now totally blind and unlikely to recover,” an associate professor of clinical
ophthalmology at the University of Miami told The Independent.
Reports suggest the study was a kind of wild west trial, with some experts saying it wasn’t
even founded on scientific evidence.
The Independent writes, “The treatment involved combining fat tissue removed from the patients’
abdomens with enzymes to obtain ‘adipose-derived’ stem cells.”
That was mixed with blood and injected into the women’s eyes.
But the drug was injected into both eyes at once, which is a very fundamental mistake.
They might have only lost one eye’s sight had the test been done right.
In all, the study was a kind of Dr. Frankenstein experiment according to experts, and the women
now see nothing at all.
Enlarged Brains This terrible tale happened in 2016 when five
people died after testing a medicine called chimeric antigen receptor (CAR-T) in the USA.
The treatment was seen as possibly a miracle cure, which consisted of adding an extra disease-fighting
protein to a person’s immune cells.
All the people in the trial had leukemia and were hoping to be cured.
The treatment was seen as a great breakthrough in medicine and even won prizes.
But things went wrong during one trial.
The company doing the trial admitted that an internal investigation revealed the patients
had died due to severe cerebral edema.
The worst thing is, the trial continued as they thought they knew what had caused this
brain swelling.
And then in a subsequent trial more people died.
CAR-T therapy is still seen as a possible cure for cancer, although in 2017 during a
French trial we were told, “One patient died from multiple organ failure probably
triggered by neutropenic sepsis at day 15.”
We should add here that hundreds of people die each year in drug trials in the U.S. and
UK (thousands in India), but many of those people are already on death’s door.
That’s certainly not always the case, though, as you will see.
Pocket Money 19-year old student Nicole Wan was a healthy
young girl who took part in a medical trial in 1996 to earn a bit of extra cash to pay
the bills and have some fun.
She would have got $150 for taking part in a trial at the University of Rochester Medical
Center in New York state.
The New York Times wrote that the researchers had violated their own guidelines by giving
the girl an increased amount of the anesthetic, Lidocaine.
The test was to see what effect pollution had on her respiratory system, and that involved
having a tube inserted into her lungs.
For that you must have a local anesthetic as without one it would be mightily uncomfortable.
The Times wrote at the time, “She never told her parents, a restaurant worker and
a seamstress who are immigrants from Hong Kong and live in Queens.”
Because she was given so much anesthetic, after the study the young woman started to
feel weak and had a lot of pain.
Two days later her heart stopped, and she died.
“She was coughing and having difficulty,” a doctor told the Times.
“So, they kept spritzing more Lidocaine down her throat,” he said.
Reports also state the girl had not known exactly the kind of test she would be going
through.
The Elephant Man Trial Finally, we come to perhaps scariest story
in drug study history, what we know about anyway.
It happened in the UK in 2006 at London’s Northwick Park Hospital.
Eight very healthy young men would be given an experimental immune system drug called
TGN1412, for the treatment of leukemia.
After taking the drug things turned very dark for six of them (two lucky others took the
placeboes).
The story sounds like something from a horror movie.
“It was all manic, everything was happening all at once, they were vomiting, they were
screaming in pain, people fainting,” said one BBC documentary on the disaster.
As the men’s organs failed and their temperatures rocketed, their bodies also swelled in the
extreme.
Some reports say their heads almost doubled in size – hence Elephant Man trial.
No one knew what had happened.
“This was a mystery, we had no way of predicting how severe it was going to get.
There was no rule book for how to deal with this,” one doctor later said.
One man told The Guardian, “I started shouting, 'Doctor, this pain is killing me, do something.'”
He recalled the placebo takers were happily reading books, although some reports say they
were later horrified by what they saw.
The Guardian writes that one man, “suffered heart, liver and kidney failure, pneumonia,
septicemia and frostbite-like symptoms that resulted in his toes and sections of his feet
being amputated and several fingertips falling off.”
They were all rushed to intensive care and the trial was declared by police a crime scene.
Amazingly, they all survived, but what happened to them may mean they don’t live long lives.
They are still alive today, though.
We imagine they got their $2,500 for the trial, and at least one of them claimed millions
in compensation.
Although, one medical website writes, “The long-term effects on their immune systems
remain unknown, though on discharge some were warned they may suffer an increased risk of
cancers and autoimmune diseases.”
A bit of advice, if you’re going to do a drug trial, be sure to do your research.
Is the drug new?
Are you the first to test it?
That’s a matter of importance.
After hearing this, would you take part in a medical drug trial?
Have you already done one?
What was it like?
Tell us in the comments.
Also, be sure to check out our other video A Day in the Life of North Korean Dictator
Kim Jong Un.
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See you next time.