PARIS--Few criminal investigations go on so long that one of the accused dies of old age, and fewer draw upon the opinions of someone soon to win a Nobel Prize, but a court case in which both happened ended here today. Three French judges rejected charges of involuntary homicide and aggravated fraud against six doctors and pharmacists, which may end a stunningly prolonged investigation centering on the distribution of human growth hormone apparently contaminated with deadly prions.
The hormone had been isolated from cadavers, and much of the trial centered on whether appropriate purification standards were used, an issue that resulted in several prominent scientists being called to the witness stand. The Pasteur Institute, located here, which was involved in purifying the hormone, had already been fined by a civil court that held it responsible for the contamination, but whether someone had done anything criminal remained an open matter.
The defendants' acquittals today come more than 25 years after high-risk batches of the hormone were administered to 968 children in France and 18 years after the criminal investigation began. (Science's original stories from the early 1990s are available here and here.) So far, 117 of the youngsters have died from Creutzfeldt-Jakob disease (CJD), the human form of mad cow disease, and three more have recently shown symptoms.
For virologist Luc Montagnier, a witness in the trial and a winner
of this year's Nobel Prize in physiology or medicine, the ruling
arouses concern. "I fear we may have not learned any lessons from this
case and will face other and bigger public health scandals in the
absence of adequate scientific and medical caution over the effects of
new treatments on young people and future generations," he says.
In 1980, Montagnier recommended a series of precautions to be taken in the gathering and processing of the pituitary gland but was ignored. He says that the authorities should have halted the use of cadaver-derived human growth hormone when the first case of CJD was linked to the substance and detected in the United States.
"This disaster could have been partly avoided," Montagnier told Science.
Montagnier said he was "surprised and saddened" by the court's failure to attribute responsibility, and is also critical of the fact that since the scandal, there has been little research into technology that could detect early signs of CJD.
But the French scientific community is split on whether today's ruling was just. "No one committed a real fault or negligence," says another witness, neurologist Yves Agid, who was formerly in charge of monitoring CJD cases in France and is scientific director at the Institute of Brain and Spinal Cord Disorders here. "At the time, no one could imagine that patients would contract CJD from human growth hormone."
The public prosecutor had demanded 4-year suspended sentences for the two main protagonists, pediatrician-endocrinologist Jean-Claude Job, who headed the defunct association in charge of collecting the hormone-containing pituitary glands from cadavers and who died after the trial ended, and Fernand Dray, who was in charge of purifying the material at the Pasteur Institute. Dray was also accused of corruption over purchases of human growth hormone from abroad, but the charges were dropped under the statute of limitations.
The criminal court case had proceeded despite a dismissive 2005 report from the French National Institute for Health and Medical Research (INSERM) that had concluded: "It is not reasonable to expect the players involved in the production of growth hormone to have guessed there was a possible risk of CJD from a treatment used since the 1960s" without a single incidence of disease. That report was prepared by an international group of experts including Stanley Prusiner, who won the Nobel Prize for his discovery of prions, and another prion expert, Paul Brown, formerly of the U.S. National Institutes of Health in Bethesda, Maryland.
In contrast to the INSERM report, in 2003 a French civil appeal court upheld an earlier court ruling that the Pasteur Institute was responsible for the 2001 death of 30-year-old Pascale Fachin from CJD contracted from contaminated human growth hormone administered in 1985 and imposed a fine of €322,000.
The prosecutor of the criminal case that just ended has 10 days to appeal the ruling. The families of victims have no right of appeal, but they hope to meet Justice Minister Rachida Dati to elicit her support, according to Bernard Fau, a victims' lawyer. The court did award civil damages to the families who hadn't already accepted an indemnity from the state.