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Persons who volunteer to test newly developed drugs may have second thoughts about getting involved when they learn the plight of six victims in a recent experiment in England.
Each of them suffered nearly immediate and severely adverse reactions to an injection of the drug known as TGN 1412. The reactions were so devastating that two of the six entered comas and were near death before beginning the long road to recovery.
Eight individuals were recruited and hired by the Parexel Clinical Pharmacology Research Unit of Boston. The drug to be tested was on humans, for the first time, was a drug known as TGN 1412. It was developed by the biopharmaceutical company TeGenero AG of Würzburg, Germany. The host facility for the testing was Northwick Park Hospital in London, England. Two other fortunate individuals were administered a placebo.
Individuals were informed that they would be receiving injections of the drug; an anti-inflammatory agent makers hoped would become a lucrative treatment for rheumatism, leukemia and multiple sclerosis. Researchers knew that earlier animal tests in monkeys had caused swollen glands and volunteers who were paid on the order of £150 a day for their services were also made aware of this.
This said, no one apparently could have predicted what occurred during the first human test. One eyewitness, who was one of the lucky placebo recipients, described the scene of chaos as one human guinea pig after another felt the effects and suffered reactions.
The test ward turned into a living hell minutes after the injections. The men went down like dominoes. First they began tearing their shirts off complaining of fever, and then some screamed out that their heads felt like they were about to explode. After that they started fainting, vomiting and writhing around in their beds. An Asian guy started screaming and his breathing went haywire, as though he was having a terrible panic attack. He started convulsing and shouting that he was getting shooting pains in his back. Most suffered organ shutdown and two went into a coma. Fortunately, none of the victims died.
The test firm did immediately stop the experiments and flew in expert medical people from Germany to assist. Transfusions were delivered hourly to remove toxins from the body and victims slowly recovered. Six weeks after the event, one of the victims will likely suffer the removal of portions of his fingers and toes in areas where no feeling has returned and the tissue of which is turning black and dying.
Dr. Benedikte Hatz, Chief Executive Officer of TeGenero AG commented in the official press release of Parexel International, “These events were completely unexpected and do not reflect the results we obtained from initial laboratory studies which enabled us to progress investigations into human volunteers. The clinical trial performed by Parexel adhered to standard clinical research guidelines.”
Still, the reactions did happen and the chance they will happen again in the future is likely as major pharmaceutical companies aim at greater profits by developing more and more drugs. Thinking twice before submitting to testing of this nature would be sage advice to anyone considering joining up as a volunteer participant.
Sources:http://www.mhra.gov.uk/home/idcplg%3FIdcService%3DGET_FILE%26dDocName%3DCON2023519%26RevisionSelectionMethod%3DLatestReleased+drug+test+Northwick+Park+Hospital+&hl=en&gl=us&ct=clnk&cd=151, http://www.parexel.com/news_and_events/press_releasesSingle.asp?id=233
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