34 Years Later, Monsanto's Mysterious Mouse Tumor Study Resurfaces
By Carey Gillam
Call it the case of the mysterious mouse tumor.
It's been 34 years since Monsanto Co. presented U.S. regulators with a seemingly routine study analyzing the effects the company's best-selling herbicide might have on rodents. Now, that study is once again under the microscope, emerging as a potentially pivotal piece of evidence in litigation brought by hundreds of people who claim Monsanto's weed killer gave them cancer.
This week, tissue slides from long-dead mice in that long-ago research study are being scrutinized by fresh eyes as an expert pathologist employed by lawyers for cancer victims looks for evidence the lawyers hope will help prove a cover-up of the dangers of the weed killer called glyphosate.
Glyphosate, which is the active ingredient in Monsanto's branded Roundup products, is the most widely used herbicide in the world, and is applied broadly in the production of more than 100 food crops, including wheat, corn and soy, as well as on residential lawns, golf courses and school yards.
Roundup Revealed: #Glyphosate in Our Food System https://t.co/yYSwvze8Kz @AsYouSow @nongmoreport @NonGMOProject @monsantotribun @ewg— EcoWatch (@EcoWatch)1496872551.0
Residues have been detected in food and human urine, and many scientists around the world have warned that exposure through diet as well as through application can potentially lead to health problems. The World Health Organization's International Agency for Research on Cancer (IARC) declared glyphosate a probable human carcinogen in 2015 based on a review of scientific literature, triggering the wave of lawsuits against Monsanto, and pushing California regulators to announce they would add glyphosate to a list of known carcinogens.
Rewind to 1983
Monsanto, as well as many other scientists and regulatory bodies, have defended glyphosate's safety. They say research showing a cancer connection is flawed and hundreds of studies support its safety.
And yet—rewind to July 1983 and a study titled "A Chronic Feeding Study of Glyphosate (Roundup Technical) in Mice." Following the document trail that surrounds the study offers an illuminating look into how science is not always clear-cut, and the lengths Monsanto has had to go to in order to convince regulators to accept scientific interpretations that support the company's products.
The two-year study ran from 1980-1982 and involved 400 mice divided into groups of 50 males and 50 females that were administered three different doses of the weed killer or received no glyphosate at all for observation as a control group. The study was conducted for Monsanto to submit to regulators. But unfortunately for Monsanto, some mice exposed to glyphosate developed tumors at statistically significant rates, with no tumors at all in non-dosed mice.
A February 1984 memo from EPA toxicologist William Dykstra stated the findings definitively: "Review of the mouse oncogenicity study indicates that glyphosate is oncogenic, producing renal tubule adenomas, a rare tumor, in a dose-related manner." Researchers found these increased incidences of the kidney tumors in mice exposed to glyphosate worrisome because while adenomas are generally benign, they have the potential to become malignant, and even in noncancerous stages they have the potential to be harmful to other organs. Monsanto discounted the findings, arguing that the tumors were "unrelated to treatment" and showing false positives, and the company provided additional data to try to convince the EPA to discount the tumors.
But EPA toxicology experts were unconvinced. EPA statistician and toxicology branch member Herbert Lacayo authored a February 1985 memo outlining disagreement with Monsanto's position. A "prudent person would reject the Monsanto assumption that Glyphosate dosing has no effect on kidney tumor production," Lacayo wrote. "Glyphosate is suspect. Monsanto's argument is unacceptable."
Eight members of the EPA's toxicology branch, including Lacayo and Dykstra, were worried enough by the kidney tumors in mice that they signed a consensus review of glyphosate in March 1985 stating they were classifying glyphosate as a Category C oncogen, a substance "possibly carcinogenic to humans."
That finding did not sit well with Monsanto, and the company worked to reverse the kidney tumor concerns. On April 3, 1985, George Levinskas, Monsanto's manager for environmental assessment and toxicology, noted in an internal memorandum to another company scientist that the company had arranged for Dr. Marvin Kuschner, a noted pathologist and founding dean of the medical school at the State University of New York at Stony Brook, to review the kidney tissue slides.
Kushner had not yet even accessed the slides but Levinskas implied in his memo that a favorable outcome was assured: "Kuschner will review kidney sections and present his evaluation of them to EPA in an effort to persuade the agency that the observed tumors are not related to glyphosate," Levinskas wrote. Notably, Levinskas, who died in 2005, was also involved in efforts in the 1970s to downplay damaging findings from a study that found rats exposed to Monsanto's PCBs developed tumors, documents filed in PCB litigation revealed.
Kuschner's subsequent re-examination did—as Monsanto stated it would—determine the tumors were not due to glyphosate. Looking over slides of the mouse tissue from the 1983 study, Kuschner identified a small kidney tumor in the control group of the mice—those that had not received glyphosate. No one had noted such a tumor in the original report. The finding was highly significant because it provided a scientific basis for a conclusion that the tumors seen in the mice exposed to glyphosate were not noteworthy after all.
Additionally, Monsanto provided the EPA with an October 1985 report from a "pathology working group" that also rebutted the finding of the connection between glyphosate and the kidney tumors seen in the 1983 study. The pathology working group said "spontaneous chronic renal disease" was "commonly seen in aged mice." Monsanto provided the report to the EPA stamped as a "trade secret" to be kept from the prying eyes of the public.
The EPA's own scientists still did not agree, however. An EPA pathologist wrote in a December 1985 memo that additional examination of the tissue slides did not "definitively" reveal a tumor in the control group. Still, the reports by the outside pathologists brought into the debate by Monsanto helped push the EPA to launch a reexamination of the research.
And by February 1986 an EPA scientific advisory panel had dubbed the tumor findings equivocal; saying that given the tumor identified in the control group by some pathologists, the overall incidences of tumors in the animals given glyphosate were not statistically significant enough to warrant the cancer linkage.
The panel did say there may be reason for concern and noted that the tumor incidences seen in the mice given glyphosate were "unusual."
The advisory panel told the EPA the studies should be repeated in hopes of more definitive findings, and that glyphosate be classified into what the agency at that time called Group D—"not classifiable as to human carcinogenicity." The EPA asked Monsanto for a repeat of the mouse oncogenicity study but Monsanto refused to do so.
The company argued "there is no relevant scientific or regulatory justification for repeating the glyphosate mouse oncogenicity study." Instead, the company provided EPA officials with historical control data that it argued supported its attempt to further downplay the tumor incidences seen in the worrisome 1983 study.
The company said the tumors in mice appear "with some regularity" and were probably attributable to "genetic or environmental" factors. "It is the judgement of Monsanto scientists that the weight-of-evidence strongly supports a conclusion that glyphosate is not oncogenic in the mouse." Monsanto said repeating the mouse study would "require the expenditure of significant resources ... and tie-up valuable laboratory space."
The discussions between Monsanto and the EPA dragged on until the two sides met in November 1988 to discuss the agency's request for a second mouse study and Monsanto's reluctance to do so. Members of the EPA's toxicology branch continued to express doubts about the validity of Monsanto's data, but by June of 1989, EPA officials conceded, stating that they would drop the requirement for a repeated mouse study.
By the time an EPA review committee met on June 26, 1991, to again discuss and evaluate glyphosate research, the mouse study was so discounted that the group decided that there was a "lack of convincing carcinogenicity evidence" in relevant animal studies. The group concluded that the herbicide should be classified far more lightly than the initial 1985 classification or even the 1986 classification proposed by the advisory panel.
This time, the EPA scientists dubbed the herbicide a Group E chemical, a classification that meant "evidence of non-carcinogenicity for humans." At least two members of the EPA committee refused to sign the report, stating that they did not concur with the findings. In a memo explaining the decision, agency officials offered a caveat. They wrote that the classification "should not be interpreted as a definitive conclusion that the agent will not be a carcinogen under any circumstances."
Despite the EPA's ultimate conclusion, the mouse study was among those cited by IARC for classifying glyphosate as a probable human carcinogen. Indeed, many other animal studies have similarly had questionable results, including a 1981 rat study that showed an increase in incidences of tumors in the testes of male rats and possible thyroid carcinomas in female rats exposed to glyphosate and 1990 study that showed pancreatic tumors in exposed rats. But none have swayed the EPA from its backing of glyphosate safety.
Christopher Portier, who was an invited specialist to the IARC review of glyphosate and is former director of the National Center for Environmental Health and Agency for Toxic Substances and Disease Registry at the U.S. Centers for Disease Control and Prevention, believes the evaluations applied to glyphosate data by regulators are "scientifically flawed" and putting public health at risk.
"The data in these studies strongly supports the ability of glyphosate to cause cancer in humans and animals; there is no reason to believe that all of these positive studies arose simply by chance," Portier said.
Monsanto fought the plaintiffs' request to view the mouse tissue slides, calling it a "fishing expedition," but was overruled by U.S. District Judge Vince Chhabria who is overseeing the roughly 60 combined lawsuits under his purvey. Monsanto has confirmed that roughly 900 additional plaintiffs have cases pending in other jurisdictions. All make similar claims—that Monsanto manipulated the science, regulators and the public in ways that hid or minimized the danger posed by its herbicide.
"The importance of the original kidney slides and the re-cut kidney slides is immense to the question of general causation and played a critical role in the EPA's decision to re-categorize glyphosate …" the plaintiffs' attorneys stated in a court filing.
Plaintiffs' attorney Aimee Wagstaff reiterated that in a recent court hearing, telling Judge Chhabria that the events surrounding the 1983 mouse study "sort of dominoed," and potentially are "extremely relevant" to the cancer litigation.
Carey Gillam is the research director at U.S. Right to Know and a journalist specializing in food, agriculture and environmental issues. Reposted with permission from our media associate Environmental Health News.
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EcoWatch Daily Newsletter
By Laura Beil
Consumers have long turned to vitamins and herbs to try to protect themselves from disease. This pandemic is no different — especially with headlines that scream "This supplement could save you from coronavirus."
Vitamin D<p><strong>What it is: </strong>Called "the sunshine vitamin" because the body makes it naturally in the presence of ultraviolet light, <a href="https://www.sciencenews.org/article/vitamin-d-supplements-lose-luster" target="_blank">Vitamin D is one of the most heavily studied</a> supplements (<em>SN: 1/27/19</em>). <a href="https://health.gov/our-work/food-nutrition/2015-2020-dietary-guidelines/guidelines/appendix-12/" target="_blank">Certain foods</a>, including fish and fortified milk products, are also high in the vitamin.</p><p><strong>Why it might help: </strong>Vitamin D is a hormone building block that helps strengthen the immune system.</p><p><strong>How it works for other infections:</strong> In 2017, the <em>British Medical Journal</em> published a meta-analysis that suggested a daily vitamin D supplement <a href="https://www.bmj.com/content/356/bmj.i6583" target="_blank">might help prevent respiratory infections</a>, particularly in people who are deficient in the vitamin.</p><p>But one key word here is <em>deficient. </em>That risk is highest during dark winters at high latitudes and among people with more color in their skin (melanin, a pigment that's higher in darker skin, inhibits the production of vitamin D).</p><p>"If you have enough vitamin D in your body, the evidence doesn't stack up to say that giving you more will make a real difference," says Susan Lanham-New, head of the Nutritional Sciences Department at the University of Surrey in England.</p><p>And taking too much can create new health problems, stressing certain internal organs and leading to a dangerously high calcium buildup in the blood. The recommended daily allowance for adults is 600 to 800 International Units per day, and the upper limit is considered to be 4,000 IUs per day.</p><p><strong>What we know about Vitamin D and COVID-19:</strong> Few studies have looked directly at whether vitamin D makes a difference in COVID.</p>
Zinc<p><strong>What it is: </strong>Zinc, a mineral found in cells all over the body, is found naturally in certain meats, beans and oysters.</p><p><strong>Why it might help: </strong>It plays several supportive roles in the immune system, which is why zinc lozenges are always hot sellers in cold and flu season. Zinc also helps with cell division and growth.</p><p><strong>How it works for other infections: </strong><a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6457799/" target="_blank" rel="noopener noreferrer">Studies of using zinc for colds</a> — which are frequently caused by coronaviruses — suggest that using a supplement right after symptoms start might make them go away quicker. That said, a clinical trial from researchers in Finland and the United Kingdom, published in January in <em>BMJ Open</em> <a href="https://bmjopen.bmj.com/content/10/1/e031662" target="_blank" rel="noopener noreferrer">did not find any value for zinc lozenges</a> for the treatment of colds. Some researchers have theorized that inconsistencies in data for colds may be explained by varying amounts of zinc released in different lozenges.</p><p><strong>What we know about zinc and COVID-19:</strong> The mineral is promising enough that it was added to some early studies of hydroxychloroquine, a drug tested early in the pandemic. (Studies have since shown that <a href="https://www.sciencenews.org/article/covid-19-coronavirus-hydroxychloroquine-no-evidence-treatment" target="_blank">hydroxychloroquine can't prevent or treat COVID-19</a> (<em>SN: 8/2/20</em>).)</p>
Vitamin C<p><strong>What it is: </strong>Also called L-ascorbic acid, vitamin C has a long list of roles in the body. It's found naturally in fruits and vegetables, especially citrus, peppers and tomatoes.</p><p><strong>Why it might help:</strong> It's a potent antioxidant that's important for a healthy immune system and preventing inflammation.</p><p><strong>How it works for other infections: </strong>Thomas cautions that the data on vitamin C are often contradictory. One review from Chinese researchers, published in February in the <em>Journal of Medical Virolog</em>y, looked at <a href="https://onlinelibrary.wiley.com/doi/full/10.1002/jmv.25707" target="_blank">what is already known about vitamin C</a> and other supplements that might have a role in COVID-19 treatment. Among other encouraging signs, human studies find a lower incidence of pneumonia among people taking vitamin C, "suggesting that vitamin C might prevent the susceptibility to lower respiratory tract infections under certain conditions."</p><p>But for preventing colds, a 2013 Cochrane review of 29 studies <a href="https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD000980.pub4/full" target="_blank" rel="noopener noreferrer">didn't support the idea</a> that vitamin C supplements could help in the general population. However, the authors wrote, given that vitamin C is cheap and safe, "it may be worthwhile for common cold patients to test on an individual basis whether therapeutic vitamin C is beneficial."</p><p><strong>What we know about Vitamin C and COVID-19: </strong>About a dozen studies are under way or planned to examine whether vitamin C added to coronavirus treatment helps with symptoms or survival, including Thomas' study at the Cleveland Clinic.</p><p>In a review published online in July in <em>Nutrition</em>, researchers from KU Leuven in Belgium concluded that the <a href="https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD000980.pub4/full" target="_blank" rel="noopener noreferrer">vitamin may help prevent infection</a> and tamp down the dangerous inflammatory reaction that can cause severe symptoms, based on what is known about how the nutrient works in the body.</p><p>Melissa Badowski, a pharmacist who specializes in viral infections at the University of Illinois at Chicago College of Pharmacy and colleague Sarah Michienzi published an extensive look at all supplements that might be useful in the coronavirus epidemic. There's <a href="https://www.drugsincontext.com/can-vitamins-and-or-supplements-provide-hope-against-coronavirus/" target="_blank" rel="noopener noreferrer">still not enough evidence to know whether they are helpful</a>, the pair concluded in July in <em>Drugs in Context</em>. "It's not really clear if it's going to benefit patients," Badowski says.</p><p>And while supplements are generally safe, she adds that nothing is risk free. The best way to avoid infection, she says, is still to follow the advice of epidemiologists and public health experts: "Wash your hands, wear a mask, stay six feet apart."</p>
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By Elliot Douglas
In early October, Britain's Prince William teamed up with conservationist David Attenborough to launch the Earthshot Prize, a new award for environmentalist innovation. The Earthshot brands itself the "most prestigious global environment prize in history."
The world-famous wildlife broadcaster and his royal sidekick appear to have played an active role in the prize's inception, and media coverage has focused largely on them as the faces of the campaign.
“Rather than a Moonshot 🌕, we need Earthshots 🌍 for this decade.” Watch Prince William’s @Tedtalks talk in full:… https://t.co/m5NCj6TQzH— The Duke and Duchess of Cambridge (@The Duke and Duchess of Cambridge)1602408749.0
But the pair are only the frontmen of a much larger movement which has been in development for several years. In addition to a panel of experts who will decide on the winners, the prize's formation took advice from the World Wildlife Fund, Greenpeace and the Jack Ma Foundation.
With more and more global attention on the climate crisis, celebrity endorsement of environmental causes has become more common. But why do environmental causes recruit famous faces for their campaigns? And what difference can it make?
'Count Me In'
"We need celebrities to reach those people who we cannot reach ourselves," says Sarah Marchildon from the United Nations Climate Change secretariat (UNFCCC) in Bonn, Germany.
Marchildon is a proponent of the use of celebrities to raise awareness of environmental causes. In addition to promoting a selection of climate ambassadors who represent the UN on sustainability issues, Marchildon's team has produced videos with well-known narrators from the entertainment world: among them, Morgan Freeman and Mark Ruffalo.
"We choose celebrities who have a lifestyle where they are already talking about these issues," Marchildon explains.
"Sometimes they reach out to us themselves, as David Attenborough did recently. And then they can promote the videos on their own social channels which reach more people than we do — for example, if they have 20 million followers and we have 750,000."
Environmental groups focused on their own domestic markets are also taking this approach. One Germany-based organization that uses celebrities in campaigns is the German Zero NGO. Set up in 2019, it advocates for a climate-neutral Germany by 2035.
German Zero produced a video in March 2020 introducing the campaign with "66 celebrities" that supported the campaign, among them Deutschland 83 actor Jonas Nay and former professional footballer Andre Schürrle. They solicit support as well as financial contributions from viewers.
"Count me in," they say, pointing toward the camera. "You too?"
"We are incredibly grateful for the VIPs in our videos," says German Zero spokeswoman Eva-Maria McCormack.
Assessing Success Is Complex
But quantifying the effectiveness of celebrity endorsement of campaigns is not a straightforward process.
"In order to measure effectiveness, first of all you need to define what is meant by success," says Alegria Olmedo, a researcher at the Zoology Department at the University of Oxford.
Olmedo is the author of a study looking at a range of campaigns concerning pangolin consumption, fronted by local and Western celebrities, in Vietnam and China. But she says her biggest stumbling block was knowing how to measure a campaign's success.
"You need a clear theory of change," explains Olmedo. "Have the celebrities actually helped in achieving the campaign's goals? And how do you quantify these goals? Maybe it is increased donations or higher engagement with a cause."
A popular campaign in China in recent years saw famous chefs Zhao Danian and Shu Yi pledge to abstain from cooking endangered wildlife. While the pledge achieved widespread recognition, both Olmedo and Marchildon say it's difficult to know whether it made any difference to people's actions.
"In life we see a thousand messages every day, and it is very hard to pinpoint whether one campaign has actually made a difference in people's behavior," she explains.
Awareness Is Not Enough
Many campaigns that feature celebrities focus on raising awareness rather than on concrete action — which, for researcher Olmedo, raises a further problem in identifying effectiveness.
"Reach should never be a success outcome," she says. "Many campaigns say they reached a certain number of people on social media. But there has been a lot of research that shows that simply giving people information does not mean they are actually going to remember it or act upon it."
But anecdotal evidence from campaigns may suggest reach can make an active difference.
"Our VIP video is by far the most watched on our social media channels," McCormack from German Zero says. "People respond to it very directly. A lot of volunteers of all ages heard about us through that video."
However, some marketing studies have shown that celebrity endorsement of a cause or product can distract from the issue itself, as people only remember the person, not the content of what they were saying.
Choosing the Right Celebrity
Celebrity choice is also very important. Campaigns that use famous faces are often aiming to appeal to members of the public who do not necessarily follow green issues.
For certain campaigns with clear target audiences, choosing a climate scientist or well-known environmentalist rather than a celebrity could be more appealing — Attenborough is a classic example. For others, images and videos involving cute animals may be more likely to get a message heard than attaching a famous face.
"We choose celebrities who have a lifestyle where they are already talking about these issues," says Marchildon from the UN. "You need figures with credibility."
McCormack cites the example of Katharine Hayhoe, an environmental scientist who is also an evangelical Christian. In the southern United States, Hayhoe has become a celebrity in her own right, appealing to an audience that might not normally be interested in the messages of climate scientists.
But as soon as you get a celebrity involved, campaigns also put themselves at risk of the whims of that celebrity. Prince William and younger members of the royal family have come under fire in recent years for alleged hypocrisy for their backing of environmental campaigns while simultaneously using private jets to fly around the world.
But Does It Really Work?
While environmental campaigns hope that endorsement from well-known figures can boost a campaign, there is little research to back this up.
"The biggest finding [from my study] was that we were unable to produce any evidence that shows that celebrity endorsement of environmental causes makes any difference," says Olmedo.
This will come as a blow to many campaigns that have invested time and effort into relationships with celebrity ambassadors. But for many, the personal message that many celebrities offer in videos like that produced by German Zero and campaigns like the Earthshot Prize are what counts.
The research may not prove this conclusively — but if the public believes a person they respect deeply personally cares about an important issue, they are perhaps more likely to care too.
"I personally believe in the power this can have," says Marchildon. "And if having a celebrity involved can get a single 16-year-old future leader thinking about environmentalist issues — that is enough."
Reposted with permission from DW.
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