Probe nails scientists in GM crop scandal

Tuesday, 18 December 2012 13:36

1.Indian research council in GM crop scandal
2.Probe nails scientists in GM cotton scandal
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1.Indian research council in GM crop scandal
Farming News (UK), 17 December 2012
http://www.farming.co.uk/news/article/7685

A committee set up to investigate a scandal surrounding India's first public-sector GM crop (a genetically modified cotton plant), have indicted scientists involved for deliberately misleading regulators.

BN-Bt cotton

The crop in question is Bikaneri Narma-Bt cotton, known as BN-Bt cotton. The plant was designed to kill insect pests by releasing Bt toxins and released for sale in 2009. It was developed by a number of research organisations working with the Indian Council of Agricultural Research (ICAR). Developers claimed to have used a novel gene sequence created 'in-house,' however, the cotton seeds were withdrawn from sale in December 2011, after they were found to contain a gene patented in the United States by agribusiness Monsanto.

The committee investigating the scandal was set up by ICAR itself. In its report, published last week, the committee accused ICAR and two research institutions involved in producing the crop of "scientific, institutional and ethical failure". The committee euphemistically said scientists at the institutions in New Delhi, Nagpur and Dharwad had 'contaminated' the seeds with Monsanto's MON-531 gene and claimed to have created a new gene, BNLA106.

Although evidence of another gene in one of the early samples of BN-Bt was present, the panel of investigators said they could not prove that this was BNLA106 and requested further tests be carried out.

The panel also discovered evidence of a cover-up, suggesting the cotton's developers were aware of the 'contamination'. It also indicted two scientists for conflict of interest, as they had been involved in both developing the GM seed and later approving its commercial release.

The seeds had been released to compete against GM seeds sold by agribusinesses; the publicly-developed BN-Bt seeds were available at a fraction of the price and seed from the crops could be saved and reused, which major agribusinesses do not allow. However, seed company Mahyco, a partner of Monsanto in India, complained that the BN-Bt contained a gene developed by Monsanto.

However, the gene in question is used widely in GM crops sold in India as the 1985 patent on MON-531 has expired.

The scandal raises questions about the regulation of GM crops and biosecurity in one of the world's major agricultural producers, where the technology is still highly controversial.

Strong voices oppose GM crops in India and maintain that patent laws should not be applied to seeds. Delhi-based sustainable food expert Dr Vandana Shiva has said that current trends in industrial agriculture, including patenting seeds present a "serious risk to the future of the world's seed and food security," as they limit growers' access to seeds, either by copyrighting genetically modified seeds as new organisms or protecting a certain breeding method, which prevents the saving and exchange of seeds.

She maintains that, in addition to the food security implications, locally adapted and culturally important crop varieties are suffering as a result of the use of patent laws.

In the UK, sustainable farming advocates have reacted strongly to the unequivocal support for GM shown by Environment minister Owen Paterson during an interview last week. Several interest groups have warned of a potential industry-backed push to introduce GM crops into the UK; although EU regulations covering GM remain strict and the devolved governments of Wales and Scotland oppose the technology, the Westminster government is a supporter of GM within Europe.

Soil Association Scotland director Laura Stewart responded to Mr Paterson's assertions that the introduction of GM crops would benefit the UK, and that concerns over the technology are "humbug." She said, "Studies have demonstrated that GM crops do not offer a sustainable solution. Instead, they lock farmers into depending on costly inputs from a handful of powerful chemical companies and, undoubtedly, bring the production of food further under corporate control."

Summarising a number of reservations held over GM crops, Stewart added, "Instead of reducing pesticide use, data from the US suggests that more potent chemicals are used on these crops than on non-GM alternatives… Once GM crops are out in the environment, they cannot be contained, so they deny that choice. Meanwhile, regulators don't undertake good enough safety checks or even ask whether new technologies are in the public interest."
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2.Probe nails scientists in GM cotton scandal
JAIDEEP HARDIKAR
The Telegraph, December 17 2012
http://www.telegraphindia.com/1121217/jsp/nation/story_16327224.jsp

Nagpur, Dec. 16: An expert committee probing a scandal relating to India’s first public sector-developed genetically modified (GM) cotton has indicted the scientists involved for foul play.

The Indian Council of Agricultural Research, which oversaw the project, admitted last year that the Bikaneri Narma-Bt (BN-Bt) cotton contained not an “indigenously” created gene sequence as claimed but a gene patented by US firm Monsanto.

The committee has also indicted the ICAR for scientific, institutional and ethical failure.

Indirectly, the probe report raises doubts on the efficacy of India’s bio-safety regulatory mechanism, considering the ease with which it was fooled about the GM cotton’s genetic composition, although the bio-safety clearance itself is not under question.

The five-member probe panel was set up by the ICAR itself and was headed by Sudhir Sopory, JNU vice-chancellor and plant biologist. It handed in its 129-page report in August but the ICAR made it public only yesterday,

On February 6 this year, The Telegraph had reported how BN-Bt was released commercially in mid-2009 and planted extensively. The seeds were not only far cheaper than other available GM cotton seeds but, unlike the rest, didn’t need to be bought every year — they could be reused from the previous year’s plants.

But in December 2009, the ICAR suddenly withdrew the seeds. In December 2011, it acknowledged that the gene sequence in the BN-Bt had not been developed in-house. The gene used was Mon-531, available in 2,000-odd cotton seed varieties sold in the Indian market (because Monsanto’s 1985 patent on it has expired).

With private sector Bt cotton seeds flooding the market, BN-Bt was developed as a collaborative public sector effort by the National Research Centre on Plant Biotechnology (NRCPB), New Delhi; University of Agricultural Sciences, Dharwad; and the Central Institute for Cotton Research, Nagpur.

The results were published by the principal scientists in Current Science in 2007. According to this paper, the Dharwad university developed BN-Bt using an in-house gene sequence, BNLA106, developed from the cry1Ac gene-construct provided by the Delhi institute.

The Nagpur institute carried out the bio-safety and field trials and later sold the seeds to farmers after the regulator, the Genetic Engineering Approval Committee (GEAC), approved their commercialisation.

That the seeds contained Mon-531 and not BNLA106 came to light after two scientists from the Dharwad institution filed an RTI query.

The Sopory panel has confirmed that the “contamination” — which appears to be a euphemism for foul play — by Mon-531 happened before the commercialisation but went undetected by the GEAC.

It said the only Bt gene found in the BN-Bt samples from the fields was Mon-531, but a “purified” sample provided by the Dharwad institute — when the scandal first broke — had a gene sequence other than Mon-531. The panel said it could not verify if this was BNLA106 and suggested third-party verification.

It cited another anomaly. The cry1Ac gene was developed by Illimar Altosaar of the University of Ottawa and obtained by R.P. Sharma, former director of the Delhi institute, by signing a material transfer agreement (MTA) that allows only educational use. In 2006, Sharma tried to negotiate a freedom-to-operate agreement — which would have allowed other uses — with Altosaar but failed for reasons that remain unclear.

But in 2006, the ICAR decided that Sharma had signed the MTA in his “personal capacity”, that a freedom-to-operate agreement was not necessary, and that the gene construct would be referred to as an “NRCPB construct”.

The committee said, “It was a violation of the MTA and, to say the least, unethical.”

GMO pig study scientists reply to Monsanto

Friday, 14 June 2013 22:04

NOTE: Monsanto has released a few comments on the Carman et al study, which showed increased severe stomach inflammation and uterine abnormality in pigs fed GM feed.
http://www.organic-systems.org/journal/81/8106.pdf

Carman and colleagues have answered the Monsanto critique (below). More answers to critics can be read at: gmojudycarman.org
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A specific reply to Monsanto
Dr Judy Carman and co-authors
GMOJudyCarman.org, 13 June 2013
http://gmojudycarman.org/a-specific-reply-to-monsanto/

Monsanto (M):  Some of the factors reported as different between the test and control groups appear to be in the normal range of observation for both.

Answer Summary:  Monsanto provided no proof for this statement.  Carman et al used adequate sample sizes, appropriate statistical tests and generated reliable findings.

Detailed Answer:  Monsanto do not back up their assertion with any data.  That is, they do not provide an officially-endorsed normal range for uterus weights for pigs, nor do they provide an officially-endorsed normal level of stomach inflammation in pigs.  In fact, they provide no data at all.

It is important to understand that Monsanto are saying that the level of severe stomach inflammation seen in pigs fed the GM diet is normal in piggeries – ie that it's normal for a third of pigs to experience severe stomach inflammation in piggeries.  This is a worrying animal welfare allegation about conditions in commercial piggeries and Monsanto needs to provide proof for their allegations.

It is also important to understand that the level of severe stomach inflammation in the GM-fed pigs was many times higher than in the non-GM fed pigs.  Overall, GM-fed pigs had 2.6 times the level of stomach inflammation, with female pigs experiencing 2.2 times the rate and male pigs experiencing 4 times the rate.  This is not “normal”.

M: The author’s speculation about differing uterine weights might be the result of pigs in estrus (heat) which would be complicated by the use of a pen design that had only 1 or 2 pens per treatment.

Answer Summary:  Randomisation and proximate housing ensured estrus was not a confounding factor.

Detailed Answer:  Two to six pens were actually used per dietary group, depending on the age of the pigs, not 1 or 2 as Monsanto says.

The weights of the uterus cannot be due to differing rates of estrus (heat) in the pigs, as pigs were thoroughly randomised before they began their diets. And then all the pens were placed very close to each other, so that pigs could touch snouts between pens.  So, if estrus in one pig stimulated estrus in another pig in this study, then all the pigs in both dietary groups should have been in estrus together. Which means that estrus cannot be causing the differences that were seen between the GM-fed and the non-GM-fed groups.

By Monsanto suggesting that the rate of estrus was different between the GM-fed and non-GM-fed pigs, then, because of the way the study was conducted, with everything except for the GM aspect of the diet “randomised out” from having an effect on the results, Monsanto is actually suggesting that the GM diet caused a difference in the rates of estrus in pigs. This is a hypothesis that is both interesting and worrying for health and should be followed-up.

M:  The results are due to poor animal husbandry practices, as shown by the fact that pigs died, even in the control group.

Answer Summary:  The pigs in both groups were treated equally, humanely and within commercial piggery standards. Any assumption otherwise would be contesting the standards of the U.S. government and should be directed as a complaint to U.S. legislators.

Detailed answer:  Pigs were housed under conditions that apply in commercial piggeries in the US.  If Monsanto is suggesting that these pigs were subjected to inhumanely poor conditions, then they are also suggesting more widely that pigs in commercial piggeries in the US are subjected to those conditions as well.  Pigs in commercial piggeries are housed in groups. They can and do get infectious diseases and there are indeed a number of infectious diseases that tend to occur in US commercial piggeries.  Furthermore, pigs fight, bite, and harass each other.  As a result, some pigs, particularly runts, can, and do, die.  Piggery owners expect some pigs to die and they factor this into their financial returns.  Indeed, if no pigs had died in this study, many US piggery owners would have found the results of the study rather incredible.

The number of pigs that died was essentially the same between the GM-fed and non-GM-fed pigs. All pigs that died underwent autopsies.  In all cases, death was found to be due to things such as infectious diseases, ie things that were piggery-related.  At no time did any pig handler or veterinarian note, or autopsy indicate, that there was anything treatment-related associated with any pig’s death, including intestinal or stomach problems.  Moreover, the number of deaths were the same between groups, which adds weight to the evidence that there was no treatment-related aspect to these deaths.

All pigs, regardless of dietary group, were fed and treated the same way by experienced pig handlers that were blinded as to the dietary group of the pig so that any differences between the two dietary groups can only reasonably be due to the effect of the GM component of the diet.

A Silent Forest

Monday, 12 April 2010 10:00

The Growing Threat of Genetically Engineered Trees. This award winning documentary film explores the growing global threat of genetically engineered trees to our environment and to human health. The film features renowned geneticist and host of PBS' The Nature of Things David Suzuki, who explores the unknown and possibly disastrous consequences of improperly tested GE methods.(Total time 46:16)

Watch video

Appeals Court backs whistleblower in GM virus case

Tuesday, 18 December 2012 13:33

NOTE: from SynBioWatch: Microbiologist Becky McClain, infected by a genetically engineered virus in a Pfizer lab, became the first whistleblower in the nation to try to shed light on the threats of biotechnology to workers and the public. Now, the U.S. Second Circuit Court of Appeals in New York, has validated her claims that Pfizer "acted willfully, maliciously, or with reckless indifference" concerning allegations that her free-speech rights had been violated and she had faced retaliation for raising safety concerns.
http://www.synbiowatch.org/2012/12/appeals-court-backs-scientist-in-pfizer-retaliation-case/
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Appeals court backs scientist in Pfizer retaliation case
Lee Howard
The Day, December 17 2012
http://www.theday.com/article/20121214/BIZ02/121219791/1047/NWS04

Pfizer Inc. whistleblower Becky McClain’s legal battle to draw public attention to worker-safety issues came to an end Friday as an appeals court refused to overturn a $2.3 million verdict in favor of the former Groton-based scientist.

Pfizer said it is “evaluating its options” on whether to appeal the verdict to the U.S. Supreme Court. But McClain’s attorneys said no constitutional claim was associated with the case.

“Justice prevailed,” said attorney Bruce E. Newman, who represented McClain along with attorney Stephen J. Fitzgerald.

“We disagree with the court’s conclusion but respect its decision,” Pfizer said in a statement.

McClain, according to a three-judge panel of the U.S. Second Circuit Court of Appeals in New York, proved her claims that Pfizer “acted willfully, maliciously, or with reckless indifference” concerning allegations that her free-speech rights had been violated and she had faced retaliation for raising safety concerns.

One of McClain’s main concerns — that Pfizer had exposed her to an unsafe laboratory in Groton, leading to an illness from a novel virus that left her dangerously ill — never got a hearing in the courts. And McClain said she is unsure whether her message about needing to shore up regulations regarding the nation’s largely unregulated biotech labs is getting through, but she is glad to have the financial security to pursue better medical care.

“We’re happy,” McClain said in a phone interview. “But whistleblowers need swifter, quicker protections. Ten years is a long time to make it through something like this.”

McClain became ill in 2004, was fired by Pfizer in 2005 and filed her lawsuit the following year. In March 2010, an eight-person jury at U.S. District Court in Hartford decided that Pfizer should pay McClain $1.37 million, an amount that was increased by Judge Warren W. Eginton when he added in attorneys’ fees and punitive damages.

The New York-based court panel, which included retired U.S. Supreme Court Justice Sandra Day O’Connor, heard Pfizer’s appeal in October. McClain’s attorneys plan to file an additional claim against Pfizer to cover interest charges on the initial court award.

Pfizer claimed that the former Deep River resident, now living in Albuquerque, N.M., was fired after abandoning her job.

“Pfizer holds the health and safety of its colleagues and contractors among its highest priorities thereby reaffirming the earlier federal court decision that Ms. McClain’s allegations of work safety issues were completely without merit,” Pfizer said in its statement.

Pfizer referred to a judge’s decision to disallow a legal claim related to McClain’s concerns about being exposed to a dangerous virus. The judge who made the decision later disqualified herself from pursuing the case because of a conflict of interest.

McClain, a longtime molecular biologist at Pfizer’s Groton laboratories, claimed that Pfizer refused to hand over records showing the type of virus to which she was exposed. Pfizer said McClain was never exposed to a hazard, and therefore there were no records to hand over.

McClain filed a complaint with the U.S. Occupational Safety and Health Administration, which investigated the claim but could not substantiate the safety problems. McClain said OSHA didn’t have the staff expertise to determine hazards on a molecular level. McClain was subsequently fired after taking a leave from work to fight her illness, which caused periodic paralysis, she said.

McClain said she still doesn’t understand why Pfizer didn’t address her safety concerns instead of trying to sweep them under the rug. She said her actions could have saved Pfizer money in the long run, in addition to protecting the public health and safety.

“Why would you retaliate against someone like that?” she said.

McClain, who has become a spokesman for worker safety groups nationwide, said she feels businesses such as Pfizer are becoming too influential in the academic community. The result, she said, is that academics are feeling constrained in speaking out about matters that might put lucrative partnerships with industry at risk.

Newman, McClain’s attorney, added that the case highlighted the work that still needs to be done nationwide to ensure that workers and the public are protected from biological hazards at laboratories.

“That is still an area that needs to be addressed by OSHA,” he said.