A drug trial run by an American research company for a German biotech has left six young men seriously ill in London, two of them fighting for their lives. The six were participants in a Phase 1 trial, the first humans to use an experimental leukaemia drug called TGN1412. Minutes after taking it, they became violently ill. One sobbing woman told the press that her swollen, discoloured and unconscious boyfriend looked like “the Elephant Man”.
The drug company, TeGenero, is one of a new breed of university spin-offs hunting for miracle cures. Its leading product, TGN1412, is a monoclonal antibody. This is a new and very promising type of drug, a genetically engineered “humanised” protein which binds to a targeted protein. TeGenero engaged Parexel to recruit volunteers and conduct the drug trials. TeGenero says that the calamitous result was “completely unexpected”. The UK’s Medicines and Healthcare Products Regulatory Authority is investigating what happened, along with Scotland Yard.
Much is still unclear: whether the drug was contaminated, whether the dosage was appropriate, whether proper procedures were followed. Apparently it was tested successfully on monkeys, although two of these had developed swollen glands, but it is far from certain that humanised monoclonal antibodies can be tested adequately with animal trials. A scientist told the London Times that “in animals binding may not occur because the antibody may not recognise any animal tissue at all, or binding may be weaker”. TeGenero insists that everything had been done by the book and that it was just an unpredictable and very regrettable incident.
The outcome prompted a flurry of commentary on the ethics of clinical research. Had the participants really given their informed consent even if they had signed a form detailing the risks? As the London Times pointed out, they were paid ?2,000 for their time and effort, but they were responding to an advertisement which promised free food… digital TV, pool table, video games, DVD player and now FREE internet access!” Some of the young men were cash-strapped students; one is said to have been a “serial guinea pig” who had earned ?60,000 from clinical trials over four years.
American bioethicist Arthur Caplan railed against greedy drug entrepreneurs: “The business of conducting medical research is profitable. Private companies running studies for pharmaceutical and device companies are now a $14 billion industry in the United States alone. The problem with the intense commercialization of research is that it’s not clear that contract research organizations… always put subject welfare first. There is plenty of room for conflicts of interest when the person recruiting volunteers for research is being paid to get subjects enrolled and data generated as quickly as possible.”
Baroness Julia Neuberger, a Liberal Democrat in the House of Lords who also teaches at Harvard Divinity School, suggested that more studies should be done on animals, especially primates, even if primate studies are viewed as morally wrong by animal welfare activists. (Which raises the question of whether Parexel found it easier to organise testing a dangerous drug on humans than on apes.)
A number of scientists declared that it was too early for human trials with a powerful monoclonal antibody. Apparently a similar drug had produced severe side effects in half of a group of cancer patients in the US. “They should have known they would get a meltdown,” Angus Dalgleish, professor of cancer at London University, told the Times. He was surprised that the regulatory agency had not consulted outside specialists before allowing the trial to proceed.
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