Seven doctors and pharmacists went on trial in France last week over the death of at least 110 people who became infected with Creutzfeldt-Jakob disease after being given tainted human growth hormone when they were children.
The United States, Britain, and other countries halted the distribution of growth hormone in 1985, after it was discovered that three people had died after being given the product. Growth hormone at that time was extracted from pituitary glands removed from corpses. The cause of some subsequent deaths was Creutzfeldt-Jakob disease.
Doctors in France, however, continued to use the hormone for several years, treating thousands of children, before turning to a synthetic substitute in 1988 (BMJ 1997;314:165).
After the first death in France was recorded in 1991 the family took to court the company responsible for collecting the pituitary glands, France-Hypophyse, along with the Pasteur Institute, which prepared the treatment, and the Pharmacie Centrale des Hôpitaux de Paris, which distributed the treatment.
Some 250 people have taken out lawsuits, and the hearing is expected to last until 31 May. The defendants are charged with “involuntary homicide” and “aggravated deception.” Six of them risk up to four years in prison and fines of up to €150 000 (£112 000; $218 000), while the seventh, Fernand Dray, formerly of the Pasteur Institute, also faces charges of corruption and up to 10 years in prison.
Nearly 60% of the deaths worldwide caused by the treatment were in France.
“Among the cumulative factors of this health catastrophe,” said an article in Le Monde, “we find French hyper-centralisation, which obliged the children to follow a treatment provided by France Hypophyse, while during the same period three industrial firms produced and sold the medicine throughout the world—and none of those had cases of Creutzfeldt-Jakob” (www.lemonde.fr, 6 Feb, “Hormone de croissance: le process d’un scandale sanitaire”).
France Hypophyse was run by Jean-Claude Job, one of the defendants, who is now 85 years old. Dr Dray, also 85 years old, is accused of profiting from the collection of pituitary glands, which were removed not only in France but also in Bulgaria, through a contact in Belgium. Collection was done through a network of non-medical staff who took the pituitary glands from corpses in morgues for cash payments of a few francs per gland. The glands were often removed with crude instruments, such as coat hangers, through the nostrils of the corpse. As a result contaminated brain tissue was sometimes also taken with the gland and was present in the extracted growth hormone.
Despite written warnings as early as 1980 by Luc Montagnier, one of the discoverers of HIV, the process continued.
“I indicated in a letter sent in January 1980 to Fernand Dray, who asked me my opinion, that they would have to watch out,” Dr Montagnier said in an interview in the Parisien newspaper (www.leparisien.fr, 6 Feb, “Dès 1980, j’avais lance l’alerte, en vain”). “The technique described for purifying the growth hormone contained no step to deactivate even a virus of average resistance.” He warned, in particular, about the Creutzfeldt-Jakob disease.
The defendants, using the same arguments employed by doctors who were sued by haemophiliac people who had contracted HIV from contaminated factor VIII, argue that such medical procedures always carry risks and that there was general ignorance of the problem at that time.