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Shocking 'lack of evidence' - Medics sentenced to death in Libya
 
 
  Health workers accused of deliberate HIV infection found guilty.
 
Declan Butler
Nature.com
 

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Valya Chervenyashka, one of five Bulgarian nurses on death row in Libya. Fred Abrahams/Human Rights Watch 2005
 
A Libyan court today condemned to death six foreign health professionals accused of infecting over 400 children with HIV in 1998. The court refused to take into account a swathe of independent scientific evidence indicating that the outbreak had begun several years before the accused began working there and was caused by poor hygiene at the hospital.
 
The defence say they intend to appeal to the Supreme Court, which would be the last chance that the medics would have of being acquitted. Emmanuel Altit, the head of the international defence team, says the international community can help by insisting that scientific evidence be taken into account.
 
Behind-the-scenes discussions are also ongoing between the European Union, Bulgaria, the United States and Libya to find a diplomatic solution (under Islamic law, victims' relatives may withdraw death sentences in return for compensation) but so far this has proved elusive.
 
The verdict has prompted widespread international condemnation. "We are appalled by the decision of the Libyan court to sentence the five Bulgarian nurses and the Palestinian doctor to death," says a statement from The World Medical Association and the International Council of Nurses. They emphasize that the denial of health problems that can promote the accidental spread of HIV, such as the use of dirty needles, is an ongoing, dangerous situation in Libya. "How many children will go on dying in Libyan hospitals while the Government ignores the root of the problem?"
 
Denial of evidence
 
This is not the first time that the five Bulgarian nurses and Palestinian doctor have faced the firing squad. The group were previously condemned to death in May 2004 after an earlier trial in the same court. But the Supreme Court overturned the verdict on 25 December 2005 and ordered a retrial. The retrial began in May this year, and ended on 4 November.
 
In the retrial, the court denied requests by the defence to hear evidence from international experts. It did hear the opinions of five Libyan physicians, who testified that they stood by the conclusions of their 2003 report, which had been commissioned by the court's earlier trial. Their report claimed that HIV and hospital hygiene were not a problem in Libya (the prosecution describes the Al-Fateh Hospital as a "model" facility), and that the outbreak was so large that deliberate, malicious infection of HIV could not be excluded.
 
In October, Nature asked international AIDS experts to review this Libyan report. They concluded that it contained no scientific evidence, and was nothing but conjecture and supposition (see 'A shocking lack of evidence below'). The following month, 114 Nobel Laureates wrote to Libya's leader Colonel Gaddafi urging the appropriate authorities to hear independent science-based evidence, and reaffirming the need for a fair trial.
 
In a paper published online in Nature last week1, an international team led by researchers from Oxford, Edinburgh and Rome showed that the strain of HIV with which the children had been infected was already present and spreading locally in the mid-1990s, long before the medics arrived in Libya in 1998 (see 'Molecular HIV evidence backs medics' text below).
 
Study support
 
Over the past few days, Libyan state-controlled media has printed and broadcast statements in support of the medics' guilt, and called for opposition against all those who argued that the six were innocent.
 
"Skeptics say medical negligence was the cause, but evidence shows that the Bulgarian medics are involved in this crime," reads the website for Libya's main news provider, Jamahiriya Broadcasting corporation, citing the confessions of the medics. Amnesty International and many other groups have reported credible allegations that these confessions were extracted by torture.
 
Mohammed Daw, one of the authors of the 2003 Libyan expert report saying that deliberate infection could not be ruled out, also held press conferences over the weekend in Geneva and London defending the report's conclusions.
 
The timing of the appeal and any future re-trial remains uncertain.
 
"The only just outcome of this trial would be the immediate release of the nurses and physician," says Physicians for Human Rights deputy director Susannah Sirkin.
 
'A shocking lack of evidence'
 
Special report
Nature
Published online: 25 October 2006
 
The trial in Libya of six medics accused of infecting children with HIV ends next week. With the defendants facing possible execution, Declan Butler asked AIDS experts to assess the case against them.
 
A scientific report being used in the case against six foreign medical workers facing the death penalty in Libya is nothing but conjecture and supposition, say international experts. The evidence, commissioned from Libyan medics, has bolstered the charge that the six knowingly infected more than 400 children with HIV at the Al-Fateh Hospital in Benghazi in 1998.
 
The court has denied requests by defence lawyers to hear evidence from international experts. Instead, five Libyan physicians testified in August that they stand by the conclusions of their 2003 report, commissioned by the court in an earlier trial, and on 29 August the prosecution called for the medics to be given the death penalty. The trial is due to end on 31 October (see 'Countdown to a verdict').
 
With a guilty verdict looking likely, Nature obtained an English translation of the Libyan report, which has been key to the prosecution's case, and asked leading international experts to assess it.
 
"I don't see any evidence in it," says Janine Jagger, an epidemiologist and MacArthur fellow who heads the International Health Care Worker Safety Center at the University of Virginia in Charlottesville. "It wouldn't meet the lowest standards of epidemiological evidence for establishing any causal relationship."
 
In 2003, the court also ordered a report from Luc Montagnier, who discovered the AIDS virus and is president of the World Foundation for AIDS Research and Prevention, and Vittorio Colizzi, an AIDS researcher at Rome's Tor Vergata University. They concluded that the infections were caused by poor hospital hygiene, and started before the medics arrived in Libya (see "Montagnier and Colizzi's conclusions"). But the court threw out this report, on the grounds that the Libyan panel had reached the opposite conclusion. The panel had dismissed the external report as "hypothetical" and "lacking precision".
 
'That's tosh'
 
"The [Libyan] report refutes the Montagnier and Colizzi report on the grounds that there is no written record of the reuse of injecting equipment, and a blank denial that indwelling catheters were ever used," says Robin Weiss, an AIDS virologist at University College London. "It wrongly turns lack of evidence into evidence of absence."
 
The report argues that HIV and hospital hygiene were not a problem in Libya (the prosecution describes the Al-Fateh Hospital as a "model") and that the outbreak is so large that deliberate, malicious infection of HIV cannot be excluded. "I don't agree with that statement," says Weiss. "And even if I did, it does not amount to sufficient evidence to incriminate the accused medical staff."
 
The Libyan report also suggests that because the genetic sequence of the Benghazi HIV strain is different from any lodged in public databases, there are grounds for suspecting foul play. "That's tosh," says Weiss. Montagnier agrees, pointing out that the virus was a new natural recombinant of a highly infectious strain common in Central and West Africa, which has replaced most other strains in the region over the past few years.
 
In contrast, Weiss describes Montagnier andColizzi's report as excellent. "Colizzi has done a really superb job in difficult circumstances," he says. After studying both reports, Weiss concludes: "There are no grounds for suspicion of deliberate infection by any staff, and strong evidence of hospital-acquired infection before the arrival, and after the departure, of the Palestinian physician and the Bulgarian nurses."
 
There are no grounds for suspicion of deliberate infection, and strong evidence of hospital-acquired infection.
 
'Completely inadequate'
 
Jagger, an expert in occupational exposures to blood-borne pathogens, says she is astonished that the medics were even arrested, given the flimsiness of the prosecution's scientific evidence. In this sort of case, she says the minimum standard should be a thorough field study that tracks all medical procedures carried out during the outbreak, and calculates attack rates, epidemic curves and other standard epidemiology measures for inferring cause. She describes the Libyan data as "completely inadequate".
 
To firmly establish any cause, a case-control study should also have been done, Jagger adds, comparing risk factors and medical procedures used between the HIV-infected patients and a similar uninfected group to try and explain transmission. "Inexcusably, there has been no attempt by Libyan officials to conduct an epidemiological study that could establish a causal link between the infected patients and individual care givers."
 
Luc Perrin, a clinical virologist at Geneva University Hospital in Switzerland, who has treated many of the infected children, describes the Libyan report as "a lot of generalities that are not always correct". The report also fails to provide any evidence for its assertion that HIV infection has not been seen in children at other Libyan hospitals, he says.
 
Perrin is an expert on primary HIV infection. He has analysed samples from 148 of the infected children, collected in September 1998, and has obtained further data on 37 of them and 46 of their parents, when they were treated in Switzerland. Perrin says his genetic data support Colizzi's analysis, and that many of the 1998 samples have protein profiles corresponding to infections well over a year old: "I can tell for sure that the HIV infection cases occurred before September 1997 and the first cases most likely before 1996." The accused medics first arrived in Libya in March 1998.
 
The Libyan report is also silent on the prevalence of hepatitis at Al-Fateh Hospital and other Libyan hospitals, notes Perrin \ who found that half of the HIV-infected children were also infected with hepatitis B or C. He says these high levels "clearly indicate" that the children were exposed to infection via contaminated blood or other medical material. Moreover, many of the children were infected with several subtypes of hepatitis, suggesting they were exposed to hospital contamination on multiple occasions, possibly when receiving vaccination injections. "If a single source of contaminated blood had caused the HIV outbreak, all the children would be infected by the same hepatitis C subtype," says Perrin. "What we observed can [instead] be explained by the reuse of syringes or poor sterilization procedures."
 
Perrin believes the most likely scenario is that a child who was infected with HIV in Al-Fateh in 1997 or earlier, returned to the hospital in 1998. "The child now is highly infectious, so poor medical procedures or sterilization procedures will rapidly translate into a number of new HIV infections."
 
'Sinister legacy'
 
Perrin was commissioned to write reports for the Libyan government in 2000 and 2001, and for President Muammar Gaddafi in 2004, but says that they received no response. "It is strange that I was asked by the World Health Organization representative of Libya to investigate, and received a grant for that, that I sent the reports accordingly and finally the report is not considered," he says. Testimony he submitted to the court was also rejected, he adds.
 
The purported 'smoking gun' in the Libyan report is the detection of HIV antibodies in vials allegedly found at one of the nurses' homes during a raid in 1999, but not tested until 2003. Both Montagnier and Colizzi have seen the results of a western blot, a test to detect proteins: they are "indeterminate", says Montagnier. "They say nothing," adds Colizzi. In 2002 Libya promised that they could test the samples independently, but neither has ever been given access.
 
Even a positive test could detect only antibodies to HIV. It would not show that the vials had contained the virus, points out Massimo Amicosante, a biologist also at Tor Vergata. "This is one of the main weak and controversial points of the Libyan report," he says. Finding the virus would require testing for HIV RNA, which has not been done.
 
After reviewing the evidence, experts are in no doubt as to the consequences of a guilty verdict. "If the accused are found guilty, it will be a travesty of justice," says Weiss. "Moreover, it would be foolhardy for any expatriate healthcare worker, whether from the Arab world or elsewhere, to work in Libya."
 
Jagger's conclusions are similar: "There is a shocking lack of evidence in this case," she says. "The Libyan government stands to carry out an act that would not be forgotten by the international healthcare community. Such a horrific humanitarian tragedy would stand for ever as a sinister legacy of the Libyan government."
 
Molecular HIV evidence backs accused medics
 
DNA analysis indicates health workers were not to blame for infections.

 
Declan Butler
Nature, 6 December 2006
 
International experts in DNA forensics say that a paper published online by Nature this week provides a firm alibi for the six medical workers facing the death penalty in Libya. The workers have been charged with deliberately infecting more than 400 children with HIV in 1998.
 
In the study, an international team led by researchers from Oxford and Rome used the genetic sequences of the viruses isolated from the patients to reconstruct the exact phylogeny, or 'family tree', of the outbreak. Analysing the mutations that accumulated over time allowed the researchers to work out when different outbreaks occurred. They showed that the strain of HIV with which the children had been infected was already present and spreading locally in the mid-1990s, long before the medics arrived in Libya in 1998.
 
The trial of the six medical workers ended in Tripoli on 4 November, and a verdict is expected on 19 December. Despite mounting international pressure to free them, defence lawyers are pessimistic about the outcome, and Nature has fast-tracked publication to make this new evidence available before the verdict (see Nature 444, 2006).
 
There was already a body of scientific evidence indicating that the outbreak was caused not by deliberate transmission, but by poor hygiene at the Al-Fateh hospital in Benghazi, where the outbreak took place (see Nature 443, 888-889; 2006). Analysis of hospital records suggested that the outbreak began before the medics arrived. And almost half of the HIV-infected children were also infected with hepatitis B or C, pointing to poor hospital practices as the cause.
 
The new results provide independent genetic confirmation of these findings. As well as showing that the outbreaks predated the medics' arrival, the study suggests that the HIV strain is related most closely to strains from West Africa, suggesting a natural introduction, probably via the many migrant workers in Libya, says co-author Tulio de Oliveira of the University of Oxford, UK.
 
Other phylogenetic analyses of HIV have been used in court cases involving allegations of HIV infection. The first was in 1991, when a Florida dentist was shown to have contaminated his patients. The technique has since been accepted as evidence in dozens of cases involving rape, hospital infection transmissions and people with HIV knowingly exposing others in Sweden, France and elsewhere.
 
Thomas Leitner of Los Alamos National Laboratory in New Mexico has provided forensic HIV evidence in more than 30 such cases over the past 15 years. He describes the de Oliveira paper as "compelling evidence that the outbreak had started before the accused could have started it", a view shared by every expert that Nature contacted (see 'Expert opinion').
 
Leitner points out that calculating evolutionary timescales is tricky, but that because HIV has such a fast mutation rate, even recent events can be pinpointed quite accurately. "De Oliveira et al. have tested and evaluated the clock and its uncertainty using several methods," he says. "I find their analysis well done and timely, and hope it will affect the judgement in the Libyan court."
 
 
 
 
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