The German manufacturer of a drug which has left six trial patients fighting for their lives in a London hospital has apologized to them and their families, but defended its conduct, saying it conformed to best practice.
The medication triggered severe symptoms in six of the patients at Northwick Park Hospital
The German pharmaceutical firm TeGenero AG, which developed the drug to treat chronic inflammatory conditions and leukaemia, apologized to the patients and their families after the clinical trial of the drug went horribly wrong.
Eight men had signed up to take part in the first human testing of the TGN1412 drug. The trials were run by an American company, Parexel, at the Northwick Park Hospital in London.
Shortly after receiving the first dose of the treatment on Monday, six of the men began complaining of severe side effects. British press reports described how the men, all volunteers paid 3300 euros ($4000) by Parexel, started fainting, vomiting and writhing in intense pain. They suffered inflammation which affected their internal organs.
The other two men in the trial had been given a placebo, and watched in shock as the symptoms worsened. They said it was several hours before hospital staff realized the severity of the situation and rushed the men to intensive care.
Thomas Hanke, chief scientific officer of TeGenero, said in a statement that the new drug had shown no safety problems in laboratory tests. He said his firm was "shocked" by the developments, and when asked by reporters whether the company had apologized, he replied "yes."
Reactions were unforeseen
US drug research company Parexel said it had operated within regulatory guidelines and that the reactions were totally unforeseen.
"An initial review at the site to date has shown that best practices were followed and all of the appropriate policies and procedures were adhered to," said Herman Scholtz, head of clinical pharmacology at Parexel. "This type of reaction is extremely rare, and is a very unusual event."
Parexel was "encouraged" that the condition of four of the victims had improved, Scholtz said, adding: "Our thoughts are with the patients and their families."
Experts are worried the botched trial will hinder drug trials in future
The six men have been in intensive care since Monday -- two are said to be in critical condition and suffering from severe bloating.
The girlfriend of one of the patients said her boyfriend's head and neck had swelled to three times its normal size.
Doctors are trying to ease symptoms, and have given the victims several blood transfusions in an attempt to rid their bodies of the toxins.
International efforts are underway to determine exactly what went wrong and what can be done to reverse the effects.
Britain's medicines watchdog, the Medicines and Healthcare products Regulatory Agency, immediately withdrew permission for the trial to continue and has sent out a warning to other testing laboratories worldwide.
Scotland Yard has begun an investigation and is talking to all those involved.
And on Friday, German prosecutors said they were considering launching a formal investigation into TeGenero.
"We are investigating whether we need to start preliminary proceedings," a spokesman for prosecutors in Würzburg, where the company has its headquarters, told Reuters.