Complaints about cherry-picking of data and non-transparent processes ring hollow, writes Claire Robinson

We’re all too familiar with seeing individual scientists whose research uncovers risks from GM crops and foods being targeted with calls for the retraction of their studies.

But now Monsanto is demanding that the IARC, the cancer research arm of the World Health Organisation, retract its report declaring that glyphosate herbicides like Roundup probably cause cancer (item 1 below).

Monsanto says it is “outraged” by the IARC report (item 2). That should not surprise us, given that the company’s stock “was down sharply on the news” of the cancer link (item 3).

Who’s cherry-picking data?

The reasons Monsanto gives for its outrage are especially ludicrous. Monsanto’s chief technology officer Robb Fraley accuses the IARC of “cherry-picking” data in order to reach its conclusion and of doing so in a non-transparent process.

This is pure hokum, as is evident from a glance at the system for regulatory approval of every GMO and pesticide in the world.

Approvals are based solely on a set of safety data provided by the GMO or chemical company that manufactures the product and stands to profit from its approval. Independent studies — which are far more likely than industry studies to find risk — do not get a look in.

Epidemiological studies and other studies by independent scientists, which generally do not conform to the outdated protocols designed decades ago for industry toxicology studies, are excluded from the risk assessment as irrelevant and unreliable.

Industry’s own safety data on its pesticides are a commercial secret. Independent scientists and the public are not allowed to see them.

What’s more, when independent studies are carried out on GMOs and pesticides, they are necessarily done after the product has been on the market for years – as scientists cannot get access to a product prior to approval, when it’s still viewed as in development and a commercial secret. So independent scientists are always playing catch-up with the multitude of toxins that we’re exposed to.

Eventually, in the case of a few selected pesticides and chemicals, independent scientists manage to catch up and do genuine research using study designs sensitive enough to find harmful effects.

Then, as with a range of substances from Roundup to the plastics chemical bisphenol A, we are subjected to the unedifying spectacle of a massive pile of studies by independent scientists showing harm from a product, while industry and regulators insist it’s safe based on a few secret studies that we are not allowed to see.

If that’s not cherry-picking data in a non-transparent process, we don’t know what is.

In contrast, IARC based its verdict on published studies and publicly available government reports. This is how real science is done – when findings are published, other scientists are free to build on the work and refute or confirm it.

Monsanto should learn from the IARC review process and the studies that the IARC considered, and start to do some real scientific testing on its products prior to commercialisation. Apparently, however, it prefers bullying to science.

NOTE: A superb and clear scientific analysis of the IARC report, by Drs Maewan Ho and Nancy Swanson, has been published on the Science in Society website.

1. Monsanto seeks retraction for report linking herbicide to cancer
2. Monsanto is ‘outraged’ by WHO’s cancer assessment
3. World Health Organization: GM-crop herbicide a probable carcinogen

1. Monsanto seeks retraction for report linking herbicide to cancer

By Carey Gillam
Reuters, 25 March 2015

Monsanto Co, maker of the world's most widely used herbicide, Roundup, wants an international health organization to retract a report linking the chief ingredient in Roundup to cancer.

The company said on Tuesday that the report, issued on Friday by the World Health Organization's International Agency for Research on Cancer (IARC), was biased and contradicts regulatory findings that the ingredient, glyphosate, is safe when used as labeled.

A working group of the IARC, based in Lyon, France, said after reviewing scientific literature it was classifying glyphosate as "probably carcinogenic to humans."

"We question the quality of the assessment," Philip Miller, Monsanto vice president of global regulatory affairs, said on Tuesday in an interview. "The WHO has something to explain."

Monsanto officials have asked to meet with WHO and IARC members, and Miller said the company wants a retraction.

A representative of the IARC could not immediately be reached for comment on Tuesday.

Miller said the company provided scientific data to the IARC showing the safety of glyphosate, but that the agency largely ignored it.

Miller said the IARC report should not affect the safety review of glyphosate currently under way by the Environmental Protection Agency.

The EPA, which has the power to limit or ban use of glyphosate, said it would look at the WHO report as part of the review process.

Farmers have been using glyphosate in increasing quantities since Monsanto in the mid-1990s introduced crops genetically engineered to withstand being sprayed with Roundup herbicide.

"Roundup Ready" corn, soybeans and other crops are popular because of the ease with which farmers have been able to kill weeds. But weeds have developed resistance to glyphosate, leading farmers to use more herbicide.

The U.S. Geological Survey estimated agricultural use of glyphosate in 2012, the most recent year available, at more than 283 million pounds, up from 110 million pounds in 2002.

The United States and other international regulatory bodies have backed the safety of glyphosate when used as directed, but the IARC report cited studies that raised concerns about glyphosate and impacts on health.

Monsanto says such studies are invalid. But critics say they merit attention.

"There are a number of independent, published manuscripts that clearly indicate that glyphosate ... can promote cancer and tumor growth," said Dave Schubert, head of the cellular neurobiology laboratory at the Salk Institute for Biological Studies in La Jolla, California. "It should be banned."

(Reporting by Carey Gillam in Kansas City, Mo.; editing by Matthew Lewis)

2. Monsanto is ‘outraged’ by WHO’s cancer assessment

Jack Kaskey
Bloomberg, March 25, 2015!/article/monsanto-is-outraged-by-who-s-cancer-assessment-1.1836595

MONSANTO was “outraged” by the World Health Organisation’s (WHO) assessment that its Roundup weedkiller probably caused cancer, it said, the latest defence by the world’s biggest seed company of its best-selling product.

In an extended response to Friday’s WHO assessment of glyphosate, the active ingredient in Roundup, Monsanto chief technology officer Robb Fraley said on Monday that the WHO’s International Agency for Research on Cancer (IARC), reached its conclusions by “cherry picking” data.

Monsanto’s core business is closely tied to Roundup. It’s the world’s most used herbicide, and most of Monsanto’s sales come from crops genetically engineered to survive the weedkiller. Two other WHO programmes had determined that glyphosate was not carcinogenic, and regulators in the US and EU were among those concluding it was not a human health risk, Monsanto said.

“IARC’s process is not transparent, its decision is irresponsible and it has the potential to cause confusion about such an important issue as safety,” Fraley said.

IARC reached its conclusion as part of a review of five pesticides, including glyphosate, conducted from March 3 to 10. Regulators in the US and EU typically spend years reviewing such data.

Monsanto wrote to WHO director-general Margaret Chan on Friday to “request an urgent meeting” to find ways to “rectify this highly questionable review and conclusion”.

“It is our understanding that IARC participants purposefully chose to disregard dozens of studies and publicly available regulatory assessments that support the conclusion that glyphosate does not pose a human health risk,” Philip Miller, the Monsanto vice-president for global regulatory affairs, said.

The classification does not affect glyphosate’s registration or use, which in the US is the responsibility of the Environmental Protection Agency, which in 2013 found “glyphosate does not pose a cancer risk to humans”.

3. World Health Organization: GM-crop herbicide a probable carcinogen

Timothy A. Wise
Food Tank, 25 March 2015

The World Health Organization (WHO) apparently has not gotten the memo about the supposed consensus on GMOs being safe. On March 20, 2015 the WHO’s International Agency for Research on Cancer (IARC) released a new analysis of the evidence on five organophosphate pesticides, including glyphosate, the herbicide in Monsanto’s Roundup weed-killer. The international scientific body concluded that glyphosate is “probably carcinogenic to humans.”

The WHO analysis puts the lie to the supposed “scientific consensus” on the safety of GM crops, declared but not proven by National Geographic, the Gates Foundation, and the Cornell Center for Science, among others. (See my previous article, “The War on Genetically-Modified-Food Critics.”)

The WHO findings, summarized in an accessible two-page monograph and in The Lancet Oncology, raise alarms. Glyphosate is by far the most widely used herbicide because it is the weed-killer that genetically modified corn and soybeans are engineered to “tolerate.” With GM varieties now accounting for 90 percent or more of the U.S. market for corn and soybeans, glyphosate is being liberally sprayed over ever-more-vast tracts of farmland with farmers secure in the knowledge that their crops won’t be harmed by the herbicide.

Apparently humans may not be so tolerant, and animals in feeding trials certainly aren’t.

The WHO found, “For the herbicide glyphosate, there was limited evidence of carcinogenicity in humans for non-Hodgkin lymphoma.” By WHO protocols, “limited evidence” means some evidence but not conclusive evidence. The expert panel cited studies that glyphosate “caused DNA and chromosomal damage in human cells, although it gave negative results in tests using bacteria. One study in community residents reported increases in blood markers of chromosomal damage (micronuclei) after glyphosate formulations were sprayed nearby." Because there have been no long-term human feeding trials, the evidence is limited, mainly to studies of agricultural exposures.

Human feeding trials are considered unethical, so the gold standard for epidemiological research is the animal study. WHO found, in its year-long expert scientific review of the evidence from government and peer-reviewed studies, that “there is convincing evidence that glyphosate also can cause cancer in laboratory animals.”

That finding makes glyphosate a “probable carcinogen” for humans, according to accepted WHO standards.

That probably will not quiet the consensus campaigners, but it should. Will the Gates-funded Cornell Center for Science declare the members of WHO’s International Agency for Research on Cancer to be “science doubters” on GM food safety? Probably. That’s what the center is funded to do.

Et tu, National Geographic? How about a correction or a retraction of your assertion that such scientists are no more credible than creationists?

The first retractions came from investors: Monsanto stock was down sharply on the news.

Timothy A. Wise is researcher at Tufts University’s Global Development and Environment Institute.