Genus, which supplies pig and bull semen to farmers worldwide, said on Tuesday it had worked with the University of Missouri to develop pigs resistant to porcine reproductive and respiratory syndrome virus (PRRSv).

The condition, also known as blue-ear disease, can be fatal as it affects the animals’ immune system and costs farmers hundreds of millions of dollars a year. There is no cure.

By using precise gene editing, the team from the University of Missouri was able to breed pigs that do not produce a specific protein necessary for the virus to spread in the animals. Their research was published in journal Nature Biotechnology.

Early-stage studies showed the new PRRSv-resistant pigs, when exposed to the virus, did not get sick and continued to gain weight normally.

The development of these resistant pigs is further proof of the power of gene editing, which is taking the biotech industry by storm. Genus chief scientific officer Jonathan Lightner said it was “a potential game-changer for the pork industry”.

Editing the genes of living organisms holds out great promise for treating diseases and improving agricultural crops and animal species. But when applied to humans it could also be used to create “designer babies,” prompting critics to call for a global ban on genetic modification of human embryos.

The technology allows scientists to edit genes by using biological “scissors” that operate a bit like a word-processing programme that can find and replace selected stretches of DNA.

It has been put to work in laboratories around the world, even as the ethical and safety issues it raises are fiercely debated.

An international summit on human gene editing in Washington last week urged caution on human gene editing but said editing genes in human embryos was permissible for research purposes.

The work on Genus’s gene-edited pigs is still at an early stage and Lightner said there were several critical challenges ahead to fully develop and commercialise the technology.

Liberum analyst Sophie Jourdier said commercialisation would likely take five years or more but the new resistant pig line would add to Genus’s long-term growth prospects, given the economic importance of PRRSv.

PRRSv affects millions of pigs and costs the swine industry around US$700 million a year in the United States and 1.5 billion euros (US$1.6 billion) in Europe, according to a 2011 Iowa State University study cited by Genus.

— Ben Hirschler reports on the health and pharmaceutical sectors for Reuters from London.

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The H7N9 virus was found to be resistant to Roche’s widely used flu drug in three out of 14 patients who were studied in detail by doctors from Shanghai and Hong Kong.

Tamiflu, which is given as a pill, belongs to a group of medicines known as neuraminidase inhibitors that currently offer the only known treatment option for bird flu. GlaxoSmithKline’s inhaled medicine Relenza has the same mode of action.

In one patient, the gene mutation responsible for resistance appears to have arisen after infection took hold, probably as a result of treatment with Tamiflu, leading to concerns that medication may be the trigger for resistance to develop.

“The apparent ease with which antiviral resistance emerges in A/H7N9 viruses is concerning; it needs to be closely monitored and considered in future pandemic response plans,” the researchers wrote in an article published online by The Lancet medical journal on Tuesday.

Earlier genetic studies had raised worries about drug resistance but this is the first time that the problem has been documented in clinical cases.

For most of the 14 patients studied, Tamiflu successfully reduced the amount of virus found in throat swabs and helped speed clinical recovery. But it had no impact on the amount of virus found in swabs from three patients who became severely ill.

A spokeswoman for Swiss-based drugmaker Roche said rates of Tamiflu resistance remained low globally, but it took the issue of resistance “very seriously” and was collaborating with health authorities to monitor the situation.

The H7N9 virus is known to have infected 131 people in China since February, but no new cases have been detected since early May, according to the World Health Organization.

Experts from the United Nations agency said last week the bird flu outbreak in China had caused some US$6.5 billion in losses to the economy.

Scientific studies of the virus have established it is being transmitted from birds — probably mostly chickens — to people. But experts have yet to identify the source of the circulating virus — the so-called “reservoir” — that is leading to chickens contracting it and sporadically passing it on to humans.

— Ben Hirschler is a Reuters correspondent covering health, science and the pharmaceutical sector from London, England.

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The French government asked the country’s health watchdog to investigate the findings further, although a number of scientists questioned the study’s basic methods and Monsanto said it felt confident its products had been proven safe.

Gilles-Eric Seralini of the University of Caen and colleagues said rats fed on a diet containing NK603 — a seed variety made tolerant to Monsanto’s Roundup herbicide — or given water with Roundup at levels permitted in the United States, died earlier than those on a standard diet.

Experts not involved in the study were skeptical, with one accusing the French scientists of going on a "statistical fishing trip" and others describing its methods as well below standard.

The animals on the genetically modified (GM) diet suffered mammary tumours, as well as severe liver and kidney damage, according to the peer-reviewed study which was published in the journal Food and Chemical Toxicology and presented at a news conference in London.

The researchers said 50 per cent of male and 70 per cent of female rats died prematurely, compared with only 30 per cent and 20 per cent in the control group.

Monsanto spokesman Thomas Helscher said the company would review the study thoroughly. However, he added, "Numerous peer-reviewed scientific studies performed on biotech crops to date, including more than a hundred feeding studies, have continuously confirmed their safety, as reflected in the respective safety assessments by regulatory authorities around the world."

"Longevity continues"

Genetically modified organisms (GMOs) are deeply unpopular in Europe but dominate major crops in the U.S. after Monsanto introduced a soybean genetically altered to tolerate Roundup in 1996.

Experts asked by reporters to review the scientific paper advised caution in drawing conclusions from it.

Tom Sanders, head of the nutritional sciences research division at King’s College London, noted that Seralini’s team had not provided any data on how much the rats were given to eat, or what their growth rates were.

"This strain of rat is very prone to mammary tumours particularly when food intake is not restricted," he said. "The statistical methods are unconventional… and it would appear the authors have gone on a statistical fishing trip."

Mark Tester, a research professor at the Australian Centre for Plant Functional Genomics at the University of Adelaide, said the study’s findings raised the question of why no previous studies have flagged up similar concerns.

"If the effects are as big as purported, and if the work really is relevant to humans, why aren’t the North Americans dropping like flies? GM has been in the food chain for over a decade over there — and longevity continues to increase inexorably," he said in an emailed comment.

David Spiegelhalter of the University of Cambridge said the methods, statistics and reporting of results were all below standard. He added that the study’s untreated control arm comprised only 10 rats of each sex, most of which also got tumours.

"Statistical power"

While supporters of GM crops say previous studies have overwhelmingly pointed to their safety, critics argue there is still limited information about the long-term effects since the crops have only been around for just over 15 years.

In France, where opposition to GMOs has led to a ban on growing such crops, the government said it had asked its health and safety agency to assess the study and had also sent it to the European Union’s food safety agency (EFSA).

"Based on the conclusion… the government will ask the European authorities to take all necessary measures to protect human and animal health, measures that could go as far as an emergency suspension of imports of NK603 maize in the European Union," the French health, environment and farm ministries said in a joint statement.

Seralini, the scientist at the centre of the latest research, previously raised safety concerns based on a shorter rat study in 2009. His new study takes things a step further by tracking the animals throughout their two-year lifespan.

Michael Antoniou, a molecular biologist at King’s College London, who helped draft the paper, told reporters at a London briefing that its findings highlighted the "need to test all GM crops in two-year lifelong studies."

"I feel this data is strong enough to withdraw the marketing approval for this variety of GM maize temporarily, until this study is followed up and repeated with larger number of animals to get the full statistical power that we want," he said.

Seralini believes his latest lifetime rat tests give a more realistic and authoritative view of risks than the 90-day feeding trials that form the basis of GM crop approvals, since three months is only the equivalent of early adulthood in rats.

— Ben Hirschler is a senior Reuters correspondent on biotechnology issues in London. Kate Kelland is a health and science correspondent for Reuters in London.

Related stories:
‘Big Food’ girds for California GMO fight, Aug. 17, 2012
Standoff looms over U.S. plans to cut GMO oversight, July 17, 2012
U.S. court turfs organic growers’ suit against Monsanto, Feb. 27, 2012
Monsanto says to appeal French poisoning verdict, Feb. 15, 2012

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