Random Thoughts – Randocity!

Here’s a story about six men, in 2006, who endured the fight for their lives after a drug trial went horribly wrong. The above program runtime is 58m 15s. Let’s explore.

Method of Action

As soon as the method of action of this drug was revealed in this documentary, my first thought was, “Uh oh”. Trying to teach the immune system to do anything is somewhat akin to attempting to steer a flood away from a town. The immune system attacks foreign invaders. That they injected this drug not knowing exactly how many receptors it might bind to was a severe “UH OH” moment before I even watched this. I already know how unpredictable the immune system can be. To intentionally try to tame the immune system to solve a medical problem is essentially playing with fire.

Too Many Mistakes

There were a number of mistakes made during this trial as well.

• Not enough separation between patient injections
• When reactions began to occur, the trial should have been halted until determining each injections patient’s reaction extent. Isn’t the point to document the reactions?
• Waiting too long to determine the problem and attempt countermeasures.
• The trial doctor was horribly uninformed of reaction possibilities
  • Because doctor was uninformed of side effects, the facilities were ill prepared to handle what came after
  • Not enough drugs or equipment handy to handle medical complications

Trial Paradigm Failure?

The 10 minute separation between the patients was far too quick a succession, particularly when you’re screwing with the immune system, to fully understand how the drug might react. When the first patient began experiencing problems, the trial should have halted further injections to assess the already injected patients. This trial simply threw caution to the wind and endangered all of its trial participants even when they had huge red warning flags from patient 001.

That the doctor wasn’t self-informed on the possible reactions and had to spend valuable time to seek information later, “Wow”. If that’s not the very definition of uninformed, I don’t know what is. Before a single vial was injected, the doctor should read and understood each and every possible manufacturer side effect including having enough known remedies handy. You can’t know what you don’t know, but you can know what is written down by the manufacturer. Not reading and comprehending that literature fully before starting the trial is a huge mistake. If he had fully understood the ramifications of cytokine storm syndrome before injecting a single patient, he could have had started countermeasures much, much sooner in these patients.

If he wasn’t proficient in cytokine storm syndrome, he should have had a doctor on standby should the patients need another opinion.

The almost fatal mistake here was the attending doctor bought fully into the hype of the manufacturer that “nothing bad” would happen after injection. That’s called taking things for granted. Trial drugs are experimental for a reason and must be treated with all of the seriousness and respect they deserve.

Patient Trials

While it’s critically important to trial medicines in humans, it’s equally important to perform those trials in as safe a manner as humanly possible. This includes performing these trials in facilities capable of handling the load of every patient in the trial potentially crashing. If there’s not enough equipment in the hospital facility to handle that number of simultaneous crashes, then the trial needs to be moved to a hospital that can handle this patient load.

No trial clinic should be waiting for ambulances, equipment and medicines to arrive from around the city. All of this should be immediately on-hand, ready and waiting. To me, that’s a huge failing of the company that scheduled this trial. That company should definitely be held accountable for any problems that arise from being ill prepared at its clinic facilities.

Cytokine Storm Syndrome

One of the possible side effects after the doctor read the manufacturer’s literature of the trial drug TGN-1412 was a cytokine storm. He only read this after the trial had started and patients were already suffering. Cytokine storm is when the body’s immune system reacts systemically over the whole body. It can cause basically rapid shutdown of organs including fever, nausea, redness (heat) because the body’s immune system is attacking… well basically everything. That this reaction was fully documented in the drug’s literature is telling. It says that the manufacturer knew this was a possible complication, yet the trial doctor didn’t look at this literature until it was nearly too late.

Of course, by that time other doctors had been consulted in the midst of crashing patients, these other doctors felt the need throw their own wrenches into the works by claiming the drug itself may have been tainted or improperly stored, prepared or handled… possibly causing these patients to have an systemic infection. Throwing this wrench into the works was also reckless by those additional doctors who joined in on the action. Perhaps they needed to also ready the manufacturer’s literature before jumping to that conclusion.

It’s good that someone finally decided the correct course of action was to treat for cytokine storm as the manufacturer’s reactions suggest, but not before one of the trial patients had ended up with dry gangrene losing his fingertips and parts of his feet. A horrible ending to a drug trial that was ill prepared and improperly staffed for that kind of a drug reaction.

Hindsight

I know it’s easy to both see and say all of this in hindsight. But, I have worked at many companies where the all mighty buck is rules… basically, “Do it for as cheaply as possible”. The saying, “You get what you pay for” applies in every situation. I’ve worked for many organizations that blaze ahead with projects without fully evaluating all consequences of their actions. They do this simply because they want the product out the door fast for the least amount of money. They don’t care what problems might arise. Instead, they deal with the problems along the way. If that means throwing more money at it later, so be it. Just don’t spend it now.

To me, that’s reckless. Thankfully, I have never worked for a medical organization at all. I’ve chosen to stay away from that line of work for the simple reasons of what this level of recklessness can do when put into the hands of medical organizations. This trial should be considered the very definition of reckless and what can happen when the all mighty buck is more important than patient’s lives. Thankfully, the NHS stepped in on behalf of the patients and treated them as the sick patients they were, not guinea pig trial participants.

I encourage you to watch the program in full. Then please leave a comment below if you agree or disagree.

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