Real-world data on Glyphosate

October 2014
picture of a pig looking through a wire fence
A healthy pig. CC photo by thornypup on Flickr.
When new antiviral drugs came on the markets, many governments thought it prudent to stock-pile them in case of any major new viral epidemic.

Accordingly, the UK government forked out £500 million and the US government $1.3 billion largely on the Roche version of antiviral sold as 'Tamiflu'.

The Cochrane Foundation, a global not-for-profit organisation whose aim is “to produce accessible health information free from commercial sponsorship and other commercial interest”, conducted their own review of 46 pharmaceutical company-sponsored Randomised Control Trials* on the effectiveness of Tamiflu. Such Trials are carried out routinely as part of the drug's licensing procedure. Its conclusion was that the benefits of this class of drug had been exaggerated. In short, the money paid to pharmaceutical companies for such flu-treatments had been largely wasted and could have been much better spent on other health measures.

*Randomised Control Trials are considered the gold standard for assessing drug efficacy. They involve a random selection of subjects half of whom are given the test drug and half of whom are given a placebo. Neither the subjects nor the researchers know who has been given what until the data on the drug's effects have been collected.

Roche, governments, health-workers and scientists swiftly responded that Tamiflu is effective in alleviating symptoms and saving lives.

A counter-review was then produced by Roche: this wasn't based on scientific investigation, but on observational evidence from 78 studies of patients admitted to hospital. The Company claims that these “real-world” data are more relevant to judging the efficacy of a drug than Randomised Control Trials.

So, what happens if you apply Roche's emphasis on real-world data to GM?

The biotech industry insists that “you need to be grounded in science” (Monsanto's chairman), but seems quick to dismiss scientific evidence of harm from GM on the grounds that the experimental conditions were too far from the real-world situation to be relevant. (For example, this was the fate of the first study indicating harm to America's iconic Monarch butterflies, and of the first experiment showing a link between glyphosate herbicide accumulated by many GM crops and birth defects.)

However, a recent example of what might emerge from real-world data on eating GM has come from a pig farmer in Denmark.

Ib Borup Pederson observed how 
“Deformities in the pigs used to be very rare and I used to be proud to send Siamese twins to schools for classes because it would only happen one in a million. But then they became too frequent”. 
The change seems to have coincided with GM crops becoming part of standard pig feed.

A change from GM to non-GM feed on his farm in 2011 led to a two-thirds saving on medicine for diarrhoea and increase of both litter size and piglet survival.

Alerted by several strands of evidence implicating glyphosate herbicide* in birth defects, he started to record what was happening on his farm.

*Glyphosate is the active ingredient of Roundup formula herbicide and is accumulated by many GM crops used as pig feed since the late 1990s.

Pederson listed all the deformities arising (See below). In partnership with scientists at the University of Leipzig, measurements were made of the glyphosate content of the feed and urine, and of the organs of deformed piglets, and the finding published.


Piglet deformities seen in the 'real-world':

(Don't read this if you're squeamish)

Farmer Pederson listed and photographed all 'clear deformities that cannot be missed'. Most of the piglets were born alive.
“One had a 180o bend in one of its vertebra. There were also deformities in the soft tissue, and one without an anus. One had kidney problems; another had its stomach outside the body. One had a cranial deformity, with no eyes and its brain outside the head; this is very typical. One had no cranium at all. Some are even messier. There was a piglet with only one eye, and one completely headless. There was a little nose, but it had no bones to grow on ... We also started counting deformities of the tail, which are never fatal but are actually spinal deformities.”


A major advantage of such 'real-world' data is the scale of the study. Unlike a laboratory or field station, Farmer Pederson's operations are long-term and on a commercial scale, involving 30,000 piglets born over two years.

When sows were fed 1/100 of the allowed level of glyphosate during the first few weeks of pregnancy, the study found a slight increased incidence of deformed piglets. But, once the glyphosate was raised to 1/10 of the allowed level, the numbers of deformed piglets got very high. This level of glyphosate-contamination was also associated with significantly fewer piglets born. All organs and tissues analysed contained glyphosate.
“In short, the differences we saw with having 5 times difference in glyphosate levels from 0.2 to 1 part per million (ppm) was a 5 times increase in cranial and spinal deformities at birth, as well as 5 times more abortions as well as 0.95 less piglets born per litter.”
Pederson also found his own urine tested positive for glyphosate after eating food from normal Danish shops. 'Normal' food now comes from livestock fed glyphosate-contaminated GM feed and from crops 'dried down' just before harvesting using glyphosate. He commented “Is this why in the Western world we have a very big problem with fertility?”

OUR COMMENT



Such a large scale collaborative study is much more robust than the health-care workers observations Roche was happy to use in preference to gold-standard science.

Bearing in mind that pig physiology is much more similar to humans than the rodents normally used in laboratory testing, these 'real-world' data have to be taken seriously.

Don't let it be air-brushed away as 'unscientific' observation.

SOURCES
  • Prof. Peter Saunders, Tamiflu: a Colossal Waste of Money, Science in Society 63, Autumn 2014
  • Changing from GMO to Non-GMO Natural Soy, Experiences from Denmark, Institute of Science in Society Report, 10.09.14

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