Leading article: A worrying possibility

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In the aftermath of this week's drugs trial disaster, it is important to note, first of all, that it is incredibly rare for such trials to go wrong. Thousands of similar experiments pass off without incident every year. This case also shows why human drugs trials are necessary. The consequences of such a product as TGN 1412 being released on to the market without first being tested on humans are unthinkable. But, despite these minor consolations, there can be no disguising how potentially dangerous this development is for the future of medical research.

The Medical and Healthcare Products Regulatory Agency has launched an investigation into what went wrong. The most important thing to establish is whether there was any human error or malpractice by the two companies involved in the testing process. If the medication these men took was contaminated, the manufacturer of the drug, TeGenero, would most probably be liable. If the testing guidelines were not followed, Parexel, the company conducting the trial, would have to assume responsibility. The investigation must also get to the bottom of what tests had been carried out on animals, and what they showed.

The question of negligence is crucial. This information will tell us whether the regulations governing human drugs trials need to be tightened up, or other types of control introduced. It seems possible, at this early stage, that the dose administered was too high. This is because there are very few substances that can have such a rapid and violent effect on the human body as occurred in this case. This would indicate the requirement for much stricter dosage controls. And some senior doctors have reportedly expressed concern that all six patients were given the same dose of the experimental drug at the same time, when the Textbook of Pharmaceutical Medicine warns that such practices can be very difficult to manage. Enforced staging of the administration of drugs in trials would seem to be another likely conclusion.

But we should be mindful of a more worrying possibility. What if it turns out that all the correct procedures were scrupulously followed, no danger signs were registered at the animal testing stage, and yet the drug still had this effect on humans? This has the potential to destroy the human testing industry. Not many people are likely to volunteer for drugs trials in future if they believe they could be playing a game of biological Russian roulette. This would, in turn, have profound implications for modern medicine. New vaccines and treatments cannot be released without human trials. It could be more than the lives of six unfortunate volunteers hanging in the balance while this investigation takes place.

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