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SMC Heads-Up: Pig cell trial, food packaging

Published: Fri 21 Feb 2014 03:32 PM
SMC Heads-Up: Pig cell trial on hold, controversial science and food packaging worries - PLUS Science Media SAVVY!
Issue 266 14-20 February 2014
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Cutting-edge Parkinson's trial on hold
An Auckland biotech company is putting its trial of an experimental Parkinson's disease treatment on hold following the withdrawal of previous animal research.
Living Cell Technologies (LCT) has suspended patient recruitment for a clinical trial testing thexenotransplantation of specially encapsulated pig-derived cells (NTCELL) as a treatment for Parkinson's disease.
Earlier research from the company had shown the implanted cells were effective in treating animal models of Parkinson's disease in rats and monkeys. However, following the discovery that the original data from the rat study was incomplete, LCT has retracted the study, published in the journal Regenerative Medicine.
"The publication is being withdrawn following an internal quality assurance audit which showed that the source data for the study held on file at LCT are incomplete and therefore the efficacy conclusions in the publication cannot be confirmed," the companysaid in a press release.
In the light of the retraction LCT, which is a listed company on the Australian stock exchange, announced its early stage human trial taking place at Auckland hospital would not be recruiting further patients. One patient is already taking part in the trial and will continue treatment as planned.
The company said this was a "precautionary measure" to "allow the company to work with the New Zealand medicines regulator (Medsafe) and the data safety monitoring board (DSMB) to fully understand the impact of the withdrawal of the rat efficacy data on the Phase I clinical trial."
A full record of the planned NTCELL trial can be found on the US clinical trials registry, clinicaltrials.gov.
The retraction was announced quietly just a week before Christmas last year and was briefly noted by the New Zealand Herald. A month later the retraction was highlighted by the websiteretractionwatch.com and this week was the focus of further coverage on ABC News, Radio New Zealand and the New Zealand Herald.
Following renewed interest in the trial, the Science Media Centre contacted experts for comment.
Professor Gareth Jones, Bioethics Centre, University of Otago, comments:
"In this instance the procedures are particularly complex, involving as they do xenotransplantation (from pigs), and therefore if the procedures are to be ethical there has to be no doubt that the porcine tissue transplants work in the first place in animal models. The slightest doubt about this should automatically exclude any use of the porcine tissue in human subjects. If additional caution isnot exercised in a case like this one, its ethical character has to be questioned."
Dr George Slim, chief executive officer of biotech industry group NZBio, comments:
"The most important issue this particular case highlights is the complete response of LCT. As soon as the issue was raised in an internal audit the company has taken a precautionary approach; suspending the clinical trial, having the paper retracted and more importantly taking care of the patient already enrolled in the trial. They have been prepared to communicate with investors and the media. I think this professional response to something that did not in fact raise safety issues is a lesson to companies world-wide, not just in New Zealand."
You can read further expert commentary on the Science Media Centre website.
Talking about controversial science
Scientists, sociologists and science communicators immersed themselves in the nitty gritty of communicating controversial science and technology this week, at an international meeting in Hamilton.
Held to cap off a programme of Marsden-funded research, the symposium covered everything from assisted reproductive technologies and predictive policing, to nanotechnology and climate change.
Abstracts and papers for many of the presentations are available online here.
A notable keynote during the symposium was delivered by Professor Shaun Hendy, who illustrated how scientists can make communication a central part of their career, to great effect.
For more on that, read SMC Manager Peter Griffin's blog postNaked Science: Why Scientists Need to Communicate.
Shaun Hendy expands on his views in this Sciblogs post Timing is Everything
On the science radar this week...
Contagious cavities, dishonest creativity, cannabisconcern, Gravity reality, and the sweet sound ofyour own voice.
Food packaging concerns criticised
Two environmental scientists are warning chemicals in food packaging could be an unrecognised health concern. However, independent criticism has challenged some of their wide-reaching claims.
The paper 'Food packaging and migration of food contact materials: will epidemiologists rise to the neotoxic challenge?' by Jane Muncke et al. was published in theJournal of Epidemiology and Community Health this week.
The authors argued that chemicals used in the packaging, storage, and processing of foodstuffs could leach into food and might be harmful to human health over the long term,
Despite the fact that some of these chemicals are regulated, people who eat packaged or processed foods are likely to be chronically exposed to low levels of these substances throughout their lives, say the authors.
International media jumped at the chance to report on this new hidden threat and headlines such like the UK Mirror's 'Cancer fear over plastic food and drinks packaging' were widespread.
Independent criticism
The UK and Australasian Science Media centre were quick to contact experts in epidemiology and food toxicology to check the claims of the authors:
Dr Oliver Jones, Lecturer in Analytical Chemistry and Co-director of the RMIT Centre for Environmental Sustainability and Remediation (EnSuRe), comments:
"While the topic of this paper is relatively interesting the title is needlessly alarmist, especially as the authors don't present any actual data (either their own or from other studies) to back up their statements... The overwhelming weight of scientific opinion (including that from Food Standards Australia and New Zealand) is that there is no health or safety issue from these chemicals at the levels people are exposed to."
Dr Ian Musgrave, Senior Lecturer in the Faculty of Medicine, University of Adelaide, comments:
"While we should not be dismissive of the potential for undesirable materials in packaging to migrate into food, the risks are exceptionally small... Epidemiology has many challenges, but epidemiology uninformed by biology risks exaggerating hazards and causing unwarranted concern."
A 'clear' conflict?
The Conversation website noted the authors' affiliation with theFood Packaging Forum Foundation, a Swiss-based charity that includes as donors, Vetropack, Bucher Emhart, Owens-Illinios and Consul - all packaging companies that specialise in glass packaging...
You can read extensive expert commentary on the research, collected by our UK and Australasian colleagues, on the Science Media Centre website.
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Quoted: The Press
"You'll be able to come here and walk around and you'll see rats running across the road, you'll see rats running through the forest in broad daylight, let alone in the evenings.
"Effectively they are going to cover the whole valley. They will chew the milking cups out of the dairy sheds, they will chew the electrics out of people's cars in their carports, they'll be trying to get into the houses and they will be doing all that and more in the bush."
DOC senior ranger Brad Edwards warns ofincreasing rat populations in the Lewis Pass.
Policy news and developments
Environment reporting: Environment Minister Amy Adams has introduced the Environmental Reporting Bill which wil provide for legally-mandated independent environmental reporting across five key domains. The Environment Commissioner has alsocommented on the bill.
eHealth ambassadors: The Ministry of Health has named a group of seven GPs who act a eHealth Ambassadors, leading the way in a national rollout of online patient information portals this year.
Tracing dairy: Primary Industries Minister Nathan Guy and Food Safety Minister Nikki Kaye today announced a working group set up to improve dairy traceability in the wake of the Fonterra whey contamination incident.
Psychoactive substances: The Ministry ofHealth has released a consultation paper on Regulations to the Psychoactive Substances Act 2013 seeking community, local government and industry views on the proposed regime.
New from the SMC
Experts Respond:
Parkinson's trial: Experts comment on the recent suspension of an Auckland clinical trial investigating a potential Parkinson's disease treatment.
Food packaging risks: Independent experts question the research behind a commentary article warning of drastic health risks associated with food packaging.
Depression Biomarker: Experts comment on research indicating increased cortisol levels and mild depression symptoms can be anearly signpost for major clinical depression in teenage boys.
In the News:
Marsden turns 20: Scientists and politicians this week celebrated the 20th Anniversary of the Marsden Fund.
Sciblogs highlights
Some of the highlights from this week's Sciblogs posts:
Could dads-to-be drinking cause foetal abnormalities? Animal research doesn't always stack up with human real-world situations, writes Siouxsie Wiles.
Infectious Thoughts
Marvelous measles media and menacing measles myths - Helen Petousis-Harris discusses the ongoing impact of measles vaccines myths that started over a decade ago.
Diplomatic Immunity
A load of rubbish - Waste heat: throw it into the 'landfill' or 'recycle' it and put it to good use? Marcus Wilson explores the parallels between trash and temperature.
Physics Stop
Research highlights
Some of the research papers making headlines this week.
Super-human muscles on the cheap: Researcher have developed artificial muscles from high-strength polymer fibers that can lift loads one hundred times heavier than human muscles of the same length and weight. Potential applications of the fibers range from robotic limbs to temperature sensitive clothing. But despite sounding high-tech the fibres are relatively inexpensive - they are made from tightly coiled ordinary fishing line and sewing thread! Images available.
Science
The rebirth of an island: Satellite imagery showing the rapid growth of a Pacific reef island offers the first evidence that island formation and expansion is possible despite sea level rise. In 1905 a devastating typhoon hit and destroyed Nadikdik Atoll in the southern Marshall Islands. Now a University of Auckland study draws on aerial photographs taken in 1945 and modern satellite imagery to provide a unique record of the reef island rebuilding to a fully vegetated and stable island over six decades.
Geomorphology
Rotorua gas poses no threat: Rotorua's "rotten egg" smelling gas does not pose a risk to residents' cognitive function, according to a study released today. Previous research has suggested exposure to the hydrogen sulfide gas from industrial processes, such as sewage treatment plants and oil and gas refineries can lead to impaired performance on cognitive tests . Fortunately, chronic exposure to low-levels of hydrogen sulfide, as experienced in and around Rotorua, was found to have no association with impairment of cognitive function.
Neurotoxicology and Teratology
Monkey see (different) monkey do: Brain-machine interfaces decode electrical signals from the brain and convert them to a digital signal, typically controlling a machine or computer cursor. Now researchers have used the real-time movement signal from one monkey's brain to accurately control the hand of another monkey, via the spinal nerves. According to the authors, the findings act as a proof of concept for the use of such systems in rehabilitation of injury after paralysis.
Nature Communications
Geoengineering caution: US researchers are warning governments not to be too hasty in the pursuit of some 'solutions' to global warming. They claim that one proposed geoengineering option - injection of sulfate particles into the atmosphere to reflect sunlight and curb the effects of global warming - could pose a severe threat if not maintained indefinitely and supported by strict reductions in greenhouse gas emissions.
Environmental Research Letters
Upcoming sci-tech events
For these and more upcoming events, and more details about them, visit the SMC's Events Calendar.
International Anaesthesia Congress - 21-25 February, Auckland.
Emergency Management and Resilience Summit -25-26 February, Wellington.
2nd International symposium on Minerals and Diary Products - 26-27 February, Auckland.
The Role of Statistics in Scientific Inquiry: how do we know our results are not random? Public lecture from Todd Pataky (Japan) - 26 February, Dunedin.
Why babies are born small - Public lecture Prof Marjo-Riitta Järvelin (UK) - 26 February, Auckland.
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