The Proposed RECA Amendments 2023October 7, 2023
Exposure and Causation Presumptions under EEOICPAOctober 7, 2023
Roundup is a glyphosate-based herbicide widely used by large-scale farmers worldwide. Glyphosate is a chemical used in herbicides to kill weeds and grass. It works by blocking the production of a protein or enzyme that supports plant growth. In 2015, the International Agency for Research on Cancer (IARC) committees of scientists evaluated several studies and determined that glyphosate is probably carcinogenic. Exposure to glyphosate has been associated with different types of cancer, primarily multiple myeloma and non-Hodgkin’s lymphoma. The link between glyphosate and multiple myeloma and non-Hodgkin’s lymphoma in humans has been highly contested by researchers, with some studies giving contradictory results. EPA glyphosate interim decision registration review (ID) still maintains that the product is “unlikely to be a human carcinogen” when used per the label instructions.
What is Multiple myeloma (MM)?
MM is a cancer that affects white blood cells called plasma cells. These cells are formed in the bone marrow, and they create antibodies that help the body fight infections. For someone with multiple myeloma, the plasma cells multiply fast, suppressing the growth of other blood cells formed in the bone marrow, including platelets, white blood cells, and red blood cells. This condition results in other complications related to blood shortage, such as anemia, excessive bleeding, and increased infections. Over time, the excess plasma cells form multiple bone lesions that weaken bones, causing fractures.
While healthy plasma cells produce good antibodies, myeloma cells produce defective antibodies known as M protein, monoclonal protein, or monoclonal immunoglobulin. These proteins build up in blood and urine, reducing immunity and damaging kidneys.
Myeloma cells can form masses or tumors in single (Solitary plasmacytoma) or multiple sites (Extramedullary plasmacytoma), mainly in the bones. Myeloma can also start in other body organs outside the bone marrow, such as the lymph glands, sinuses, nose, throat, liver, and digestive tract.
The disease occurs mainly in people over 60 years old. Persons exposed to radiation and some chemicals, such as benzene, asbestos, and some pesticides, are at an increased risk of developing the disease.
Signs of multiple myeloma include:
- Anemia, which occurs from suppressed production of red blood cells
- Fatigue, often resulting from anemia and abnormal cytokine production
- Bone pains; resulting from bone thinning, damage, and fracture
- Pain and numbness; where the cancer has spread to the spinal cord causing bones to collapse and compress nerves coming out of the spinal cord
- Kidney damage; resulting from excess M protein can be diagnosed early through urine and blood tests. Late stages of kidney failure will result in itching, fatigue, weakness, shortness of breath, loss of appetite, muscle cramps, nausea, urination problems, and swollen legs.
- Hypercalcemia- the breaking down of bones, can result in high calcium levels in the blood, which may cause kidney damage, drowsiness, and constipation.
- Increased infections and fever; may result from suppressed immunity.
- Blood problems, such as hyperviscosity, from thickened blood. This condition can result in bruising, nose bleeding, bleeding gums, and cloudy vision.
- Other symptoms may include weight loss, increased thirst, and mental confusion.
There is no cure for multiple myeloma; however, the disease can be managed for years through treatment such as chemotherapy, proteasome inhibitors, immune-modifying medications, and stem cell transplantation.
What is non-Hodgkin’s lymphoma (NHL)?
NHL is a cancer that affects lymphocytes or white blood cells responsible for immunity. The cancer causes the cells to grow abnormally and form tumors throughout the body. There are different types of NHL, including large B-cell lymphoma and follicular lymphoma.
NHL is associated with many causes. Some risk factors include exposure to certain chemicals such as benzene and pesticides, drugs used to treat rheumatoid arthritis (RA), such as methotrexate and tumor necrosis factor (TNF) inhibitors, and chemotherapy. A weakened immune system may also create a favorable environment for the growth of NHL cancer cells. Certain viral infections can alter the DNA of lymphocytes, making them cancerous.
NHL symptoms include:
- Swollen lymph nodes in the neck, armpits, or groin
- Abdominal swelling or pain
- Trouble breathing, chest pain, coughing
- Persistent fatigue
- Sweating at night
- Unexplained weight loss
Treatment for non-Hodgkin lymphoma may involve chemotherapy, immunotherapy, targeted drug therapy for non-Hodgkin lymphoma, radiation therapy, high-dose chemotherapy, and stem cell Transplant and surgery.
Studies on Glyphosate and multiple myeloma and non-Hodgkin’s lymphoma
In 2015, the International Agency for Research on Cancer (IARC) published a report indicating that glyphosate and GBFs are probably carcinogenic to humans. The IARC assessment established strong evidence that GBFs and glyphosate have two human carcinogenic qualities: they are genotoxic and induce oxidative stress in cells. As a result, the agency categorized glyphosate under group 2A due to the limited evidence of human carcinogenicity, as the findings were based on animal experiments.
The IARC report resulted in opposing industry-sponsored articles and reviews on the subject. However, some studies continue to establish a link between glyphosate and various cancers.
Various mechanistic studies established that glyphosate and GBFs could alter or damage human lymphocyte DNA, which are normal cells forming NHL. Animal and cell models with lower glyphosate doses show genotoxicity and other biological effects.
Various glyphosate NHL mechanistic studies demonstrate the chemical upregulation of the B-cell genome mutator enzyme activation-induced cytidine deaminase (AID), compelling evidence that glyphosate and GFBs cause NHL in humans.
Animal studies also show that surfactants added to glyphosate herbicides to help with penetration in plants, such as polyethoxylated tallow-amine (POEA), are highly toxic. Some earlier studies found an increase in toxicity of the Roundup formulation compared with pure glyphosate. According to Peluso et al. 1998, Roundup increases DNA adducts in mice, whereas glyphosate alone did not show these effects. Another study involving chronic glyphosate feeding to mice showed no evidence of a carcinogenic effect.
Glyphosate induces benign monoclonal gammopathy and promotes multiple myeloma progression in mice
In a study conducted by Chinese researchers at Lerner Research Institute at the Cleveland Clinic in Cleveland, Ohio, Glyphosate induced benign monoclonal gammopathy and promoted multiple myeloma progression in mice. The study methodology involved Vk*MYC mouse, a highly preferred MM animal model. In this study, the Vk*MYC mice and the wild type were treated with drinking water with 1000mg of glyphosate per liter and observed after 72 weeks.
The Vk*MYC mice treated with glyphosate developed progressive hematological abnormalities and plasma cell neoplasms, including anemia, splenomegaly, and high serum IgG. These mice also showed signs of multiple organ dysfunction, such as lytic bone lesions and renal damage.
The wild-type mice exposed to glyphosate developed benign monoclonal gammopathy with increased serum IgG and anemia. They also showed plasma cell presence in the spleen and bone marrow.
The researchers observed that glyphosate upregulated activation-induced cytidine deaminase (AID) in the spleen and bone marrow of both mice exposed to glyphosate. AID can potentially cause changes in DNA by altering the base pairs forming the DNA double-helix ladder stair steps.
This study explains why glyphosate is associated explicitly with MM and NHL. The researchers concluded that glyphosate increased the risk of developing multiple myeloma and non-Hodgkin’s lymphoma, specifically through B-cell mutation.
Pesticide regulatory authorities, including the European Food Safety Authority and the US Environmental Protection Agency (EPA), reviewed this study and concluded that glyphosate is not likely to be carcinogenic to humans. These divergent opinions have been attributed to bias, different data sets, and methodological differences.
Reviews associating glyphosate and multiple myeloma and non-Hodgkin’s lymphoma
Numerous earlier studies have established that human lymphocytes exposed to glyphosate in vitro showed increased sister chromatid exchanges, chromosomal aberrations, and indicators of oxidative stress. Case–control studies (McDuffie et al. 2001, Hardell et al. 2002, Hardell and Eriksson 1999 and De Roos et al. 2003b) suggested an association between glyphosate use and the risk of non-Hodgkin lymphoma (NHL).
A review funded by the National Cancer Institute of the National Institutes of Health found an association between glyphosate and follicular lymphoma. In the analyses of NHL subtypes, the association between glyphosate use and follicular lymphoma was stronger when lagged by ten years, which was more potent with a shorter duration, contrary to the research’s general hypothesis.
These results were consistent with those reported in a recent case-control study conducted in Italy from 2011 to 2017, which concluded a shorter duration of glyphosate use (≤16 years in that study) for all NHL, B-cell lymphoma, and follicular lymphoma.
A Chinese Review and Update with Perspective of Evidence that Glyphosate (Roundup) is a Cause of Non-Hodgkin Lymphoma, published in September 2021, showed a link between glyphosate exposure and NHL. The review examined more recent scientific literature linking GBFs and glyphosate exposure to NHL. These epidemiological studies provided sufficient evidence that the chemicals increased the risk of NHL. Animal studies involving mice indicate that glyphosate is carcinogenic and can cause NHL.
A meta-analysis of the exposure to glyphosate and risk of non-Hodgkin lymphoma and multiple myeloma by Francesca Donato, Enrico Pira, Catalina Ciocan, and Paolo Boffetta shows an increased risk of non-Hodgkin lymphoma and multiple myeloma for persons exposed to high levels of glyphosate. According to the researchers, the slight risk of diffuse large B cell lymphoma (DLBCL), the most common lymphoma, was worth noting. The researchers conducted a systematic review and meta-analysis of ten relevant non-overlapping epidemiologic studies to determine the link between occupational glyphosate exposure and the risk of MM and NHL.
A 2013 systematic review and meta-analysis of glyphosate exposure and risk of lymphohematopoietic cancers report marginally significant positive meta-RRs for the association between glyphosate use and risk of NHL and MM. The review identified a statistically significant positive meta-RR for B-cell lymphoma. However, the research was funded by Monsanto Company, the original producer and marketer of glyphosate formulations.
Contact us for help filing a glyphosate lawsuit
Herbicide-producing companies fund most glyphosate and multiple myeloma and non-Hodgkin’s lymphoma studies. As a result, the aspect of bias has been an underlying factor. However, many lawsuits against glyphosate herbicide producers have been ruled in favor of plaintiffs. If you or you loved one suffered from non-Hodgkin lymphoma or multiple myeloma after using glyphosate herbicides, you could be eligible for compensation. Reach out to Hugh Stephens at Stephens and Stephens LLP, and he will review your case and advise on the next course of action.