Fourteen years ago, the feminist research identifying the manslaughter of children by the arrogant claims that France's pituitary growth hormone was safe
Dumble, Lynette J. and Klein, Renate. The lethal legacy of the human pituitary hormone programme. Search 1993; 24: 270-273.
2008; 371:637(February 23, 2008)
French doctors on trial for manslaughter
The families of those who died and their lawyers outside the justice court in Paris (Getty Images)
After 16 years of legal wrangling, seven health professionals have gone on trial in France, accused of causing the deaths of over 100 people from Creutzfeldt-Jakob disease. Patients were infected after receiving contaminated growth hormone extracted from corpses. Sam King reports.
A trial is underway in France over the use of contaminated human growth hormones that led to the deaths of more than a hundred children from Creutzfeldt-Jakob disease (CJD).
Seven health officials have been accused of manslaughter after ignoring basic hygiene practices and failing to warn patients of the risks of the hormone treatment. The prosecution claims hygiene standards were ignored as pituitary glands were removed from corpses in the 1980s to extract growth hormone. The corpses themselves included patients treated for neurological or infectious diseases or dementia.
The glands were pooled, increasing the chance of cross-infection and prohibiting any possibility they could be traced should any infection occur. The laboratory at the Pasteur Institute where the hormone was extracted has been described as a “back kitchen”.
The extraction of hormones from the pituitary glands of corpses began in the 1950s and was introduced in France in the 1970s. In 1973, a monopolyFrance-Hypophysewas created to collect the glands. The Pasteur Institute was responsible for the purification and extraction of the hormone, while the Central Pharmacy for Hospitals (PCH) packaged it for injection and distributed it to patients.
A report by the French health sector watchdogGeneral Inspectorate for Social Affairsclaims that France-Hypophyse started cutting corners from 1983 to meet a growing demand, and became less selective about where the glands came from. The Inspectorate also warned that sanitation procedures were inadequate and pointed to a “serious dysfunction” in the production and distribution of the hormone as well as the “manifestly insufficient precautions” taken during the removal of glands.
In June, 1985, France introduced new purification methods to counter the risk of CJD contamination but did not ban the use of the human growth hormone, although the synthetic version was now available. Even after 14 countries had stopped using the human-extract hormone because of the risk of CJD, France continued. Furthermore, the PCH made no moves to recall some 20 000 doses already distributed. Instead, they were used to treat children over a 7-month period without their parents being warned of the risks.
The investigating magistrate, Marie-Odile Bertella-Geffroy, has submitted a report saying contamination in France was “only possible because of the multiple errors at each stage of the French organisation of the human growth hormone. If regulations existed in theory, it proved quite different in practice. Serious errors of recklessness and negligence have been uncovered with an accumulative effect and of greater intensity during the course of the period from January 1983 to July 1985.”
In 1991, 15-year-old Yliassyl Benziane died of human variant CJD. He had been taking growth hormones since 1983. His parents filed a complaint, setting in motion the legal process which has resulted in the current trial. The state has already paid compensation of £168 000 to each of the victims' families, but they say money is not enoughthey want to see justice done.
The defendants are Jean-Claude Job, former head of France-Hypophyse; Fernand Dray, former head of the Pasteur Institute laboratory dealing with the pituitary glands; Elisabeth Mugnier, who oversaw the collection of glands from morgues; Jacques Dangoumau, former director of pharmacy and medicine at the health ministry; Marc Mollet, scientific director of the PCH; Henri Cerceau, director of the PCH; and Micheline Gourmelen, a prescribing doctor at a Paris hospital.
All are charged with involuntary manslaughter and all, except Gourmelen, with aggravated deception or abetting aggravated deception. Dray also faces corruption charges over the import and export of medicines. The medics deny all charges. Their defence rests mainly on the question of exactly how much was known and when. Guy-Charles Humbert, lawyer for Mugnier, said: “I, and no doubt others, will seek to show that we are going back 25 years at least and that medical and research knowledge at the time was not what they are today.” The trial is expected to last until the end of May.