Drugs giant Roche accused of sitting on trial data for flu treatment
Doubts remain about efficacy and safety of Tamiflu, stockpiled for use in pandemics
JEREMY LAURANCE WEDNESDAY 31 OCTOBER 2012
The pharmaceutical giant Roche is being accused of irresponsibly withholding key trial data about a vital flu drug on which governments around the world have spent billions of pounds.
The anti-flu drug Tamiflu has been stockpiled by countries against the outbreak of a flu pandemic since 2004. The UK alone has spent £500m.
Yesterday, the British Medical Journal launched a campaign to persuade Roche to give doctors and patients the full data on Tamiflu, three years after doubts about its safety and efficacy emerged.
In 2009, researchers from the Cochrane Collaboration found that results of eight out of 10 key trials of Tamiflu were never fully published and concluded there was "insufficient data" to show it reduced complications – a vital factor in a pandemic which could save lives.
Roche promised to release the full data, but then reneged on its promise, according to the BMJ. The journal’s editor, Fiona Godlee, published an open letter to Sir John Bell, the Regius Professor of Medicine at Oxford University and a board member of Roche, in which she appeals to him to use his influence to persuade the company to release the data "for independent scrutiny".
The two trials that have been published, she says, "were funded by Roche and authored by Roche employees and Roche-paid external experts" and "could not be relied on".
There have now been 123 trials of Tamiflu but 60 per cent of the patient data "remains unpublished", she says. "I am appealing to you as an internationally respected scientist and clinician and a leader of clinical research in the UK to bring your influence to bear," she writes.
"In refusing to release these data of enormous public interest, you [the company's directors] put Roche outside the circle of responsible pharmaceutical companies. Billions of pounds of public money have been spent on [Tamiflu] and yet the evidence on its effectiveness and safety remains hidden from appropriate and necessary independent scrutiny."
The European Medicines Agency announced last week that it was investigating Roche’s alleged failure to report side-effects of some of its drugs in as many as 80,000 patients, following a review by the UK Medicines and Health Products Regulatory Agency. If found guilty, the company could be fined up to 5 per cent of its sales in the EU – which amounted to 8.2bn Swiss francs (£5.4bn) in 2011.
In the Commons, the Conservative MP Sarah Wollaston, a GP, called last week for drug companies to publish all clinical trial results, saying it was "vitally important for patient safety" and would give a "completely different evidence base for medicine."
The UK was among the first countries to place bulk orders for Tamiflu (and smaller amounts of Relenza, a rival drug made by GlaxoSmithKline) for stockpiling when fears about a possible avian flu pandemic emerged in 2003 and 2004.
The stockpile was used during the swine flu outbreak of 2009, but because the illness was mild in most people demand remained low.
Dr Godlee said yesterday: "Tamiflu was licensed over 10 years ago and has been in widespread use since. Once a drug is licensed it becomes a drug on which public money is spent and lives may be put at risk. Inevitably if there is information we are not allowed to see we wonder what is in there. There is a legitimate scientific question [about its safety and efficacy] which can only be answered by looking at the data. It is just shocking."
A spokesman for Roche said: "Roche provided the Cochrane group with access to 3,200 pages of very detailed information, enabling their questions to be answered. Roche stands behind the robustness and integrity of our data supporting the efficacy and safety of Tamiflu."
Sir John Bell was not available for comment yesterday.
Statistics: Posted by yoda — Wed Oct 31, 2012 12:14 am
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Pedophile Priests in Germany
‘Zero-Tolerance’ Bishop Accused of Leniency
By Anna Loll
Two years ago, Germany’s Catholic Church was rocked by reports of widespread child abuse. But Stephan Ackermann, the bishop subsequently made the German Bishops’ Conference’s spokesman on such issues, has rattled many in his own diocese by refusing to actively pursue investigations or impose harsh penalties.
A man with piercing blue eyes is putting flowers in the planters on the balcony of a retirement home. Father V. sits up and carefully pulls off his dirt-covered plastic gloves. "Many see me as the gardener here," he says.
In 1994, he was convicted on 28 counts of sexual abuse of minors in the Trier diocese and given a two-year suspended sentence. Despite the conviction, he remained a priest and, in 1996, he was simply transferred to a congregation in Ukraine. There, he says, he abused more minors.
V. is now 72. "I can only compare it to alcoholism," he says quietly with his arms folded over his chest and shaking hands. "It’s like an addiction," he adds, "a sort of schizophrenia in which you switch off entire parts of your consciousness."
Nevertheless, he once again has access to minors since children regularly visit his places of work, a retirement home and a clinic in the Trier diocese. V. says he is abstinent. But when asked whether he is cured, he takes a deep breath and says, "No. It remains part of one’s personality," adding that he shouldn’t have accepted his new position.
Not Practicing What Is Preached
With this insight, the offender is further along than his superior, Stephan Ackermann, the bishop of the Trier diocese, in southwestern Germany near the border with France. Ackermann has been the spokesman on abuse issues for the German Bishops’ Conference for more than two years. He promised "unrestrained investigation" of abuse scandals. Ackermann, who preaches a "culture of attentiveness" and a "zero-tolerance policy" toward offenders, wants to be the church’s trustworthy point of contact for abused souls.
However, it would seem that this zero-tolerance policy doesn’t apply in his own diocese. In January, Ackermann had to issue a public apology after failing to immediately suspend a suspected pedophile priest in 2011. Now SPIEGEL has obtained information about seven other cases of priests in the bishop’s diocese who are suspected of having abused minors.
One priest, a teacher at a boarding school on the Saar River, allegedly had sexual relations with one of his students for years and is now a parish priest in the Trier diocese. Two of his fellow priests were convicted of possession of child pornography and now work as religious officials in hospitals. Another priest was allowed to return to celebrating Mass at the end of last year, even though he had just been suspended in March 2011. He is also accused of several cases of abuse for which the statute of limitations has already expired.
The treatment of problematic ministers is similar in many cases: The presumed offenders are reported to the authorities for suspected sexual assault or are encouraged to turn themselves in. Then, they are given a suspended sentence. After that, they are permitted to return to service within the Church. They are often assigned to hospitals or retirement homes as well as permitted to assist in the surrounding communities.
Father M., for example, is a hospital pastor and can also work as a so-called "facilitator" — or assistant parish priest — in the churches of a small city in the southwestern state of Saarland. In 1995, he was convicted on 40 counts of sexual assault. But now he is once again responsible for celebrating Mass as well as for presiding over baptisms, weddings and funerals. "Yes, of course there are also children and adolescents at such events," says his superior, the dean. But, he adds, Father M. is not assigned to work with children and youth.
Choosing the Lenient Route
The Church has many ways to protect priests convicted of abuse while still taking the fears of believers seriously. It can remove offenders from their positions or send them to monasteries, or it can put them to work in Catholic libraries or in administrative positions.
But the Trier diocese prefers to take a more lenient route. Father W. is a case in point. Several years ago, the priest, now 48, assaulted several minors. "We picked up our children after a prayer weekend," says the father of one child. "They were supposed to be preparing for communion at the mission house." His 9-year-old son was distraught, but, after some hesitation, he told his father that he had been forced to take his pants off. The father says the priest told his son and the other boys to "pull everything down!" Then, according to the boy, the priest put the boys over his knee one by one and spanked them on their naked behinds. "The children’s feelings of anger and shame are immense," says the boy’s father.
W. was ordered to pay a fine, but he was allowed to continue working in another congregation. "It was not sexual abuse," he insists. He was told not to work with children and young people, but he apparently ignored the instruction. "He was very much involved with the altar boys and girls," says a priest from the local church administration. "That, of course, was contrary to the agreements."
Today, W. is a pastor at a hospital in Saarland, where children are both patients and visitors. "You’re powerless against the Church’s determination to cover things up," says the father of the boy who was abused by Father W. with resignation.
Criticizing Double Standards
Alarmed by the many signs of abuse within the diocese, Thomas Schnitzler, a historian who had been abused as a child, contacted other victims. Then, last year, he set up a research network with Claudia Adams and Hermann Schell.
The trio began their research where the diocese had stopped. They searched for witnesses in congregations, spent many hours in archives, compared data, and spoke with victims and their relatives. They publish their results on two websites, "MissBiT" and "Schafsbrief." "Nothing more than pseudo-investigations are conducted in Trier," Adams concludes. Secular teachers or social workers can expect to be barred from their professions if they are convicted of abuse, says Schnitzler, "but Ackermann allows former and potential offenders to continue working as priests." The risks to which he exposes children, Schnitzler adds, are "absolutely unjustifiable."
When Germany was rocked by revelations of a growing number of abuse cases more than two years ago, Ackermann, the bishop of Trier, was seen as the ideal man to re-establish confidence in the clergy. As one of the youngest members of the German Bishops’ Conference, he was viewed as someone who represented the Church’s desire to look into and resolve the abuse scandals.
But now he faces a firestorm of criticism. At a recent and emotionally charged event in Trier, even Church employees turned against their bishop. Jutta Lehnert, the spiritual director of Trier’s Catholic Students’ Association, told Ackermann in no uncertain terms: "The power structures in the Church must be carefully scrutinized," adding that they amount to "an open barn door for sexual predators."
Ursula Kaspar, a hospital chaplain from Saarbrücken, is sharply critical of the double standards applied to priests. She points out that, while people who were divorced and then remarried lose their right to be employed within the Church, pedophile priests with a criminal record apparently have no trouble retaining the right to continued employment. "This is indefensible," she says. Kaspar herself is one of more than 40 full-time and volunteer employees of the Catholic Church in the Trier diocese who have formed the "Saarbrücken Initiative," which aims to get local religious bodies to devote more attention to abuse issues.
Ackermann has defended himself by saying that he didn’t know what to do with the offenders and by pointing out that there couldn’t be a "Guantanamo for Church offenders." Their "limited deployment under certain conditions is possible," the diocese has now stated, although it is unwilling to say how many people could be affected by the policy.
Feeling Abandoned by the Church
However, the bishop recently proved to be particularly indulgent in the part of his diocese located in the nearby state of Saarland. In January 2011, the police informed his office that a pastor from Saarbrücken, the state capital, had allegedly abused minors.
According to the guidelines of the German Bishops’ Conference, prompt action must be taken in such suspected cases, and the priest in question can be suspended until the accusations have been cleared up. But, despite these guidelines, and despite his status as the Church’s spokesman on abuse issues, Ackermann allowed the suspected pedophile to remain in office. The priest continued to celebrate Mass and even held a dedication ceremony for a Catholic kindergarten in the summer. In the fall, another ceremony was held to mark his 70th birthday.
"We were appalled by the case," says Heiner Buchen, a pastoral assistant in Saarbrücken. "Why didn’t the diocese management intervene immediately?" The diocese didn’t even notify the alleged abuser’s immediate supervisor, he notes. After experiencing an initial "state of shock," Buchen says he organized a meeting attended by 35 despondent Church employees. They wrote the bishop a letter about their "deep emotional and pastoral irritation, as well as anger, shame and dismay" over the handling of abuse cases in the diocese.
Instead of taking up the case, the central office of Ackermann’s diocese initially reprimanded the critics and stated that they were to refrain from taking such actions in future. As a result, many victims and parishioners — and even the priests in question — feel abandoned by the Church.
Ignoring Victims’ Interests
In conversation, Father V. repeatedly pauses for longer periods of time as he stares at the flowers he has planted in front of the retirement home. "This proclivity is something that is destroying me, down to the deepest depths of my soul," he suddenly says. "I just want to shout, even to God: Why did you allow this?" In his view, there is only one solution for pedophiles like him: radical separation from children. Unfortunately, he adds, it took him a very long time to realize this.
He says his superiors meant well when they tried to transfer him to a German-language congregation abroad. In the end, however, their efforts were self-serving. "Their perspective was one-sided," he says, "and directed not toward the interests of the victims, but toward those of the Church."
Translated from the German by Christopher Sultan
Statistics: Posted by yoda — Thu Mar 22, 2012 1:30 pm
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