Author Archives: alison abbott

Italian scientists protest proposed animal law

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Protesters in Rome

{credit}Pro-Test Italia{/credit}

Hundreds of scientists demonstrated in Rome today against a proposed law on the protection of animals for scientific purposes, which they fear threatens biomedical research in Italy.

The law — which was approved by Parliament on 31 July and is awaiting government rubber-stamping — is intended to implement a 2010 European Union (EU) directive covering research animals.

That directive is considered to provide among the strictest regulations in the world. But the Italian law introduces further restrictions which critics say go beyond the directive’s intentions, and may even be illegal under EU rules. It would, for example, stop the use of dogs, cats and non-human primates for research in Italy (except in mandatory drug testing or when directly related to translational medicine), and require anaesthetic for any procedure causing mild pain in animals (such as giving injections).

The rally was organized by Pro-Test Italia, a science lobby group.

Several international scientific societies have publicly voiced their support. The American Physiological Society, the Federation of American Societies for Experimental Biology (FASEB) and the Illinois-based International Society for Stem Cell Research (ISSCR) provided statements that declare their own commitments to responsible and humane use of animals in research. The FASEB wrote: “We commend Pro-test Italia in championing life-saving animal research and opposing restrictive regulations that will slow scientific progress.”

The ISSCR declared that it was most concerned about a proposed ban on xenotransplantation (in which cells and tissues are transplanted between species) “which would have a profoundly negative impact on the ability of scientists to conduct stem cell research in Italy.”

Advisers declare Italian stem-cell therapy ‘unscientific’

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A scientific advisory committee in Italy yesterday (11 September) gave a decided thumbs down to a controversial stem-cell treatment slated for a €3-million (US$4-million), government-sponsored clinical trial.

The committee had been appointed by the health minister to evaluate the clinical protocol proposed by the Brescia-based Stamina Foundation, which developed the therapy.

The government had agreed in May to support the trial, after lobby groups of patients protested that they were being denied their only hope for cure. The Italian Medicines Agency had closed the Brescia facility on safety grounds after a site inspection in May 2012.

The therapy involves extracting stem cells from the bone marrow of patients, manipulating them in a dish, and re-infusing them into the same patients. Scientists argue that the treatment — which has already been administered to more than a hundred very sick adults and children — is unlikely to be effective, and could be dangerous. They called for the trial to be halted after revelations in July that Stamina chief Davide Vannoni and his colleagues had presented flawed data in patent applications describing the method.

After missing several deadlines, Vannoni finally submitted his clinical protocol for the trial to the committee on 1 August. At a press conference the scientific advisory committee declared it to be “unscientific”.

Health minister Beatrice Lorenzin must now decide whether to abort the trial.

Academies expose plight of jailed Turkish scientists

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A human-rights mission to Turkey to investigate the cases of eight scientists, engineers and medical doctors detained under vague but broad-ranging crimes such as ‘attempting to overthrow the government’ has concluded that prosecutors have not provided convincing evidence of their guilt and called for all eight to be released.

Nonetheless, one is serving a 13-year sentence, and prosecutors have requested life imprisonment for the others. Their verdicts will be read out on Monday.

The mission’s report was prepared on behalf of the Committee on Human Rights of the US National Academy of Sciences, the National Academy of Engineering and the Institute of Medicine and the human-rights committee of the Leopoldina, Germany’s national academy.

Three representatives of the committees visited the prisons where the accused have been kept, in some cases for several years, pending verdict. Their report describes the complex political context of the cases; hundreds of others who are not academics face the same fate.

The authors call on the Turkish government to seriously consider the report’s findings, and to improve its human-rights record in general.

Italian parliament approves sweeping restrictions to use of research animals

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The Italian parliament has voted in favour of introducing extreme restrictions on the use of animals in research — which some scientists say would halt important biomedical research in the country.

But some experts say that this may contravene European Union (EU) legislation — leaving the Italian government with the uncomfortable choice of either upsetting its democratically elected parliament or upsetting the European Commission.

The dilemma arose as the government began earlier this year to prepare legislation required to adopt into national law an EU directive covering the protection of animals for scientific purposes.

The directive, which was approved in 2010 after a long battle, strikes a delicate balance between animal welfare and the needs of biomedical research. It is considered to be among the strictest in the world.

Earlier last month the senate approved a series of amendments that further tighten the directive, and these were rubber-stamped yesterday by the Chamber of Deputies.

The amendments would, for example, forbid the use of nonhuman primates, dogs and cats in research, except in mandatory drug testing or when directly related to translational medicine. They would also forbid procedures that impose mild pain — such as injections — without anaesthesia.

The legislation further prohibits the use of animals in some research areas — such as xenotransplantation, in which cells and tissues are transplanted between species, and addiction. “It’s terrible,” says  Gaetano Di Chiara, a pharmacologist at the University of Cagliari, Sardinia. “Drug addiction is a major health issue, and it requires research with animals.”

But Roberto Caminiti, a physiologist at the University of Rome La Sapienza, who chairs the Committee on Animals in Research for the Federation of European Neuroscience Societies, points out that the second article of the EU directive explicitly bars EU member states from ‘gold-plating’ the directive by adding restrictions.

“If the government does actually implement these changes, we will call on the EU to open a procedure against Italy — that’s for sure,” Caminiti says.

The final legislation must be in place by the end of this year.

German cardiologist’s stem-cell papers attacked

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The copious publications of high-profile German cardiologist Bodo-Eckehard Strauer — who has long claimed that stem cells derived from bone-marrow cells can repair damage in diseased hearts — have come under new attack.

Strauer, who retired from the University of Düsseldorf in 2009, has been a controversial figure in Germany since he first claimed clinical success with the approach in 2001. Many stem-cell scientists have been openly sceptical of his claims, which have been reported enthusiastically in the media.

An article published this week in the International Journal of Cardiology dissects 48 of the papers from his group and exposes a series of problems, including arithmetic errors in the presentation of statistics and identical results in papers presenting different numbers of patients. The authors also searched systematically in all of the papers for discrepant information — pairs of statements that could not both be true.

They document hundreds of errors. For example, in some papers patient groups are said to be randomized, whereas in others patients with identical outcomes are reported as being non-randomized to treatment and control groups.  “And when we ran the statistical tests on the control groups, we found many amazing P values of up to 10–60 and 10–108,” Darrel Francis, a cardiologist at Imperial College London and one of the study’s co-authors, told Nature.

In a press release, Francis says:

Looking deeper, the seemingly comprehensive and decisive proof of efficacy gradually unravelled … the more we thought about it, the less we could understand.

In the end we couldn’t even work out whether some of these studies were randomised or not, or how many patients had really been studied. This is an unusual situation for studies which report being able to make the difference between life and death.

In response to a request for comment on the allegations, Ruben Engel, Strauer’s lawyer, wrote in an e-mail to Nature:

In manuscripts of the working group of our client have appeared, unfortunately, arithmetic errors, what can never be excluded completely. Our client apologizes for this to the publishers resp. has already corrected these errors [sic].

In one case, one picture in a publication — of approx. 20 (!) pictures in the whole study — was mistaken. This picture showed one of a huge number of parameters of the documented investigation results. No advantage of the published results was reached by the use of the picture: Even if the picture had been left out, the statement of the study would remain completely unchanged.

The University of Düsseldorf began an investigation into some of Strauer’s  published papers last December.

‘Liberated’ mice from Italian lab now housed in poor conditions

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Mice removed by protestors from a Milan lab arw

Mice removed by protestors from a Milan lab appear to be housed in cramped cages.

Two months after animal-rights activists broke into an animal facility at the University of Milan and removed hundreds of animals, photographs of many of the mice have appeared on the Facebook page of one of the protestors’ supporters who uses the pen name Jooleea Carleenee.

The raid took place on 20 April. Researchers at the university said that they lost years of their work along with the animals, most of which were genetically modified mice serving as models for disease. They said that they did not expect mutants that were particularly delicate, or immunosuppressed ‘nude’ mice, to survive outside controlled laboratory conditions.

Carleenee says that she posted the pictures to show that the animals were still alive. But the images of the overcrowded and uncontrolled conditions in which the mice appear to have been kept in her home have fuelled a new row, with scientists posting angry comments, complaining of cruelty.

Daria Giovannoni, president of the pro-science lobby group Pro-Test Italia, says: “If these photos show the actual conditions of the stolen mice, we’re seriously concerned about their well-being and health: we don’t think that these animals are faring better now than when they were in the laboratory.”

The raid on 20 April spurred the nascent Pro-Test Italia — modelled on UK and US Pro-Test organizations — to action. It arranged a series of demonstrations by scientists in defence of their work on animals.

UPDATE: 28 June, 2013 We have been contacted by Jooleea Carleenee who requests that we report that the mice are now being kept in humane conditions and that the pictures showed only a temporary situation when the mice arrived with her.

New brain-banking network for children

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Autism is a neurodevelopmental disorder, so it is important for researchers to have access to developing human brains. But acquiring donations of brains from young children is painfully hard.

Two foundations in the United States which fund autism research have now announced the launch of Autism BrainNet, a network of sites which will acquire donated brains from children who have died, and will process, store and distribute the tissue to researchers.

The Simons Foundation will donate US$5 million and Autism Speaks will donate $2.5 million to the project in its first five years. They made the announcement today at the International Meeting for Autism Research in San Sebastian, Spain.

The first four partners are the Autism Tissue Programme in Boston, Mount Sinai School of Medicine in New York, the MIND Institute of the University of California, Davis,  and the University of Texas South-western Medical School in Dallas.

Each of the participating institutions will collect tissue in its own region, but applications for tissue from researchers will be reviewed centrally. Requests directly related to autism will have priority. Researchers who receive tissue will be required to return all data they generate, which will be made available freely through the Autism BrainNet portal.

Autism researcher David Amaral from the MIND Institute will be the first director.

Autism BrainNet will engage in active outreach activity to explain the importance of brain banks for neurodevelopmental diseases.

Nobel Laureate Rita Levi-Montalcini dies at 103

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Rita Levi-Montalcini{credit}ANSA/Corbis{/credit}

Yesterday the world lost one of its most extraordinary scientists when Rita Levi-Montalcini died at her home in Rome at the age of 103.

Tiny in stature but outsize in personality, Levi-Montalcini survived fascist Italy, where Jews were barred from working at universities, converting her bedroom into a makeshift lab to continue her studies on how nerves grow. Never losing her ruthless obsession with the topic, she went on to discover the molecule nerve growth factor, which won her a share of the 1986 Nobel Prize in Physiology or Medicine. Most of that work was carried out in the United States.

She spent her last decades back in Italy, where she became a national heroine and was appointed Senator for Life. In parliament she made sparks by blocking legislation that might have been unfriendly towards research. She also created a foundation to support scientific education for women in Africa and a Rome-based research institute called the European Brain Research Institute Rita Levi-Montalcini. That institute was opened to great fanfare in 2005, but inappropriate management meant that it did not develop into the vibrant legacy she had hoped to leave behind. It now struggles to keep going on a shoestring budget.

Her 100th birthday was marked with national celebrations (see this Nature profile feature, ‘One hundred years of Rita‘); today she lies in state at the Italian Senate. Her funeral will take place according to Jewish rites in her home city of Turin on 2 January 2013.

Bulgarian scientists’ corruption protest slams PM’s mobile phone

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More than 100 young Bulgarian scientists staged a second protest in Sofia yesterday, demanding that a competition for 14.8 million Lev (US$9.8 million) from the Bulgarian National Science Fund (BNSF) be scrapped. They claim that the winners were selected corruptly. They also demanded the resignation of research minister Sergei Ignatov, who has not addressed their concerns about corruption.

{credit}Atanasov{/credit}

The protest won unprecedented press coverage because physicist Victor Atanasov from the University of Sofia acquired, and broadcast, the mobile phone number of prime minister Boyko Borisov. The protesters blasted so many SMS text messages announcing their demands that Borisov had to switch his phone off.

The scientists’ first protest, on 5 December, had not drawn much response. Some of the participating scientists say that their e-mail accounts became blocked after the protest, and others were notified that state inspectors would turn up in their labs to spot-check their purchases of equipment. Members of Parliament voted down a proposal to establish a formal investigation into the affair.

This time around, says Atanasov, “we had the prime minister’s attention — and our e-mail accounts are unblocked.”

Atanasov says that the SMS campaign was a cry for help to the prime minister because “we feel we have been subject to enormous injustice and we need his protection”.

The scientists also charge that BNSF chief Rangel Gjurov, a geologist with an eccentric view on earthquake prediction, is not qualified for the position. They have sent a formal request to the Supreme Administrative Court to determine whether Gjurov is legally a professor. “If we win this it would invalidate the competition, even without a formal investigation into how it was carried out,” says Atanasov.

 

German funding agency rules on long-running misconduct case

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Germany’s main funding agency, the DFG, has imposed sanctions on Silvia Bulfone-Paus, an immunologist from the Research Centre Borstel who was at the centre of a data-manipulation scandal two years ago. An investigation committee commissioned by the centre found that two lab members had manipulated data in four papers involving DFG-funded research on which they were first authors and lab chief Bulfone-Paus was last author. In total, 13 of her papers were retracted during 2011.

In a statement, the DFG said:

Bulfone-Paus had committed ‘gross negligence of her supervisory duty’ in her function as the leader of the working group and was therefore guilty of scientific misconduct as stipulated in the DFG procedures. On the basis of this result, the Joint Committee of the DFG decided to issue Bulfone-Paus with a written reprimand, to prohibit her from submitting proposals for three years, and to exclude her from statutory bodies at the DFG and not to appoint her as a reviewer for three years. However, since Bulfone-Paus had voluntarily suggested at the start of the proceedings that she withdraw from her appointments, not be appointed as a reviewer, nor be included in statutory bodies, the Joint Committee decided that this period should count towards the measures taken, leaving only the issue of the written reprimand to continue in effect.

The DFG also named Elena Bulanova as one of those primarily responsible for falsifying the data in these publications and banned her from applying for DFG research grants for five years.