In March 2006, one of the biggest drug experiment failures happened in the U.K. Tegenero, a German drug company engaged Parexel to conduct a drug trial. What have we learned since then? Are drug trials still dangerous?
Back in 2006, six young men signed up and participated in a human drug test for a novel drug called TGN1412. The men were told of some possible side effects but nothing like what they experienced. Once injected with the medicine, the symptoms grew out of control. Symptoms included vomiting, severe headache, back pain, intense cold, and intense heat, shaking, extremely low blood pressure, and more.
It was an emergency. The men were taken to the intensive care unit at Northwick Park Hospital in London. Surprisingly, the trial was privately run at a research facility at Northwick Park but the hospital was not aware of the drug trial. The men were experiencing multiple organ failures and were not sure if they would make it out alive. Fortunately, they were able to be transported to the hospital.
In the end, their lives were saved. But one man lost his fingers and toes. All the men were told they would be likely to develop cancers or auto-immune diseases as a result of their exposure to the drug. The experience for all of these young men was horrific.
The MHRA [Medicines and Health products Regulatory Agency] in the U.K. now ensures that committees look at pre-clinical data to decide whether the first dose given to humans is the right dose and has rules for stopping if things don’t go as planned.
MHRA discovered the following regarding the drug trial:
Failure to complete the full medical background of a trial subject in writing, and the medical history of one volunteer was not updated.
There was no contract in place between TeGenero and Parexel at the start of the trial, and only a draft contract between Parexel and a private laboratory that was involved
Two volunteers were allowed to leave the trial before it was confirmed that they had received the placebo
Parexel failed to review TeGenero’s insurance policy to ensure there were no exclusions in it that would impact the volunteers. Exclusions were subsequently found.
One of the doctors involved in the trial did not have adequate training or experience
There was no 24-hour medical cover
Many believe this kind of trial could not happen again. What about drug companies that are in a hurry to get approval? There are laws in place all over the world regarding drug trials, especially in humans. The disaster in the U.K. brought to the spotlight the many things that can go wrong. If you plan to participate in a drug trial, pay close attention to the contract. Even if you need the money, it’s important to pay attention to the details and possible side effects.
That is a nightmare