Tuesday, July 26, 2011

TGN1412 - The Catastrophic Human Drug Trials

The drug trials of TGN1412, or also known as "CD28-SuperMAB" is something out of a science fiction movie. The name that sounds like a science-cy evil pathogen of doom doesn't help either.

On March, 13, 2006, a drug trial was conducted on eight young healthy volunteers and since the title of this post is "The Catastrophic Drug Trials", one could assume it didn't end well.

Before I discuss what happened on that faithful day, I'll tell you what "TGN1412" is.

TGN1412 was the working name for a immunomodulation drug that was later withdrawn after certain events occurred. The drug was developed by the German company, TeGenero Immuno Therepeutics, tested by Parexel and manufactured by Boehringer-Ingelheim.

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TGN1412 was the first drug that TeGenero developed, which was only comprised of 15 employees. A month after the catastrophic drug trials, they attempted to keep the test subjects quiet by offering them 5,000 euros ($7,235); (Probably) insulted, the volunteer's lawyers immediately rejected the offer. At that time, the company was only insured for about two million euros, which was far below the amount they were soon to lose.

About four months after the trials, TeGenero filed for insolvency, which meant that they were unable to pay back their debts, under the grounds that nobody wanted to invest in their company after the incident.

"It appears that almost murdering people isn't good for business."

The drug itself, was originally made to help people in treatment of immunological diseases with high un-met medical needs. Some examples of immunological diseases are multiple sclerosis, rheumatoid arthritis and certain cancers, although the drug would generally be used as a last resort when all else fails. Undoubtedly, it wasn't intended for daily over-the-counter use.

The drug was put into animal trials, which proved successful enough to move onto human trials. Eight volunteers were paid more then average payments from normal drug trials, at the price of 2,000 euros ($2894.20) to participate in the drug trials.

Swiftly after the drugs were injected, six volunteers were hospitalized. Witnesses at the scene reported that the men were dropping like dominoes, they began tearing their shirts off, complaining about fever, and screaming that their heads were going to explode. Not exactly the response they expected.

"There was 417% more pain and agony then expected."

One of the men were reported to become extremely bloated "like the elephant man". Another said that he felt a burning sensation that he has never felt before, right before he took off his shirt. After that, the other subjects  became ill, vomiting, and suffered severe pain.

The six men were reported to have catastrophic systemic organ failure, and were hospitalized into intensive care. (The others received the placebo, so were fine) According to the company, most of the men returned home in stable conditions within a month. Despite that, the Head of Pharmacology at the University College London, Trevor Smart has said that the men many never truly recover, and that they may suffer from long-term disruptions of their immune system. (After all, smart runs in the family. See what I did there? Hahahahahaha.)

The doses administered were reportedly, five hundred times less then the amount deemed safe during the animal testing. Despite of that, almost all the men suffered long-term effects such as cancer, multiple sclerosis, and chronic fatigue. They pretty much got the same things the drug was made to "cure", or treat. 

Originally, the first dose was suppose to be the start of a series of multiple doses, starting at 1/500th of the largest dose in the animal testings. The obvious failure caused the MHRA to quickly stop the other drug trials that were to carried out later in other countries.

What experiments?

When the multiple organizations were informed, they were so surprised, that the police were called to examine the area for evidence of foul play/crime. Nothing was found.

After examining the area, more suspicion was placed onto the TGN1412 itself. Some have suggested that TGN1412, triggered the T-cells to release a toxic flood of cytokines, or that TGN1412 caused the T-cells to attack the bodies own tissues, which would have resulted in multiple organ failure. The body basically attacked saw itself as a foreign body and attacked it.

Many have said that the outcome of the drug trials could not have been predicted, and it was a horrible unforeseen event that occurred. Others claimed that certain risk factors could have been avoided, such as drugs similar to TGN1412 has caused various other "negative" symptoms, and that the use of eight test subjects for the first human trials were both unnecessary, and silly.

"Sir, reports say that we've accidently engineered a biological super weapon." "Damn it, eighth time this year!"

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