Roundup Non-Hodgkin’s Lymphoma Risk

Exposure to the chemical glyphosate, contained in Roundup has been linked to cancer or other serious illnesses.

RoundUp® Weed Killer

The product Roundup® is a broad spectrum herbicide that contains an isopropylamine salt of glyphosate as its active ingredient. In 1974, this product was first sold to farmers for commercial use. Since the late 1970s, the use of this herbicide has grown over 100 fold. This was especially true after Monsanto (the original developer) released Roundup® Ready Crops. These crops were resistant to Roundup® and allowed farmers to grow their crops without the fear of damage by blanket application of Roundup® for the control weeds in their fields.

Many researchers also believe that this increase in use was due to the widespread emergence of glyphosate-resistant weeds. By the year 2007, Roundup was the leading product used in commercial agriculture and the second-most popular for home, gardens, schools, government properties, industrial sites, and other commercial applications.

Interestingly, Roundup® was developed to replace other herbicides that were causing well-documented problems. The problems included damage to crops, decreased efficacy of the products, and risks to human health. It was initially tested for industry standards including toxicity. Early reports found that glyphosate-based herbicides (GBHs) posed a relatively low threat to non-target species, including mammals. Because of this, leading worldwide regulatory agencies set high acceptable exposure limits.

Glyphosate Exposure

The current U.S. Environmental Protection Agency (EPA) Acceptable Daily Intake (defined as the Chronic Reference Dose) is 2.0 mg of glyphosate per kilogram body weight per day (mg/kg/day). In contrast, the current European Union (28 countries) Acceptable Daily Intake is more than 5 times lower at 0.3 mg/kg/day (a level adopted in 2002). The data upon which these exposure thresholds are based was supplied by the manufacturers during the registration process (in 1986) and are considered proprietary. These reports are typically not available for any type of independent review.

Concerns about the carcinogenic properties of glyphosate-based herbicides increased after the World Health Organization’s International Agency for Research on Cancer (IARC) re-classified glyphosate as “probably carcinogenic to humans” in 2015. This decision was based on epidemiological studies that looked at occupational exposure and rodent studies which showed an association between glyphosate and renal tubule carcinoma, hemangiosarcoma, pancreatic islet cell adenoma, and/or skin tumors.

The IARC evaluation was based on the systematic selection and review of all publicly available and pertinent studies. The review of this information was conducted by independent experts that were free of any vested interests. They followed strict scientific criteria that are recognized throughout the world.

To reach these conclusions that they drew from their research, the IARC reviewed approximately 1000 studies. Some of these studies evaluated people that were exposed through employment, such as farmers. Others were experimental research related to cancer and cancer-related effects.

On April 30, 2018, the EPA closed the 60-day comment period for their Draft Human Health and Ecological Risk Assessments for Glyphosate paper that was released December 18, 2017. At the closing of this comment period, they stated that the “EPA is now evaluating the comments received and will consider any potential risk management options for this herbicide”. To date, no additional information has been released.

Researchers from the University of Washington have evaluated existing studies to look at the risk factors of exposure to the glyphosate-based herbicides including Roundup®. Their study results were recently published in the journal Mutation Research/Reviews in Mutation Research on February 10, 2019. These scientists concluded that this exposure significantly increases the risk of non-Hodgkin lymphoma (NHL), a cancer of the immune system.

Lawsuits against Bayer

The first high-profile case that was filed against Monsanto in the U.S. District Courts, California Northern District, San Francisco. This case (Docket number 3:16-cv-01244) was filed by DeWayne Johnson a former school groundskeeper who was diagnosed with terminal non-Hodgkin lymphoma in 2014. As a groundskeeper for the school, he applied Roundup® 20 – 30 times per year. He also recalled two incidents in which he accidentally was soaked with the product.

The case was filed as a “Personal Injury-Product Liability” lawsuit and alleged that chronic exposure to the glyphosate-based herbicide Roundup® caused the cancer that the plaintiff was diagnosed with and that the manufacturer of the product (Monsanto) did not sufficiently warn consumers of this risk.

The case was filed in March 2016. After the evidence was presented to the court and jury with just three days of deliberation, in August 2018 the jury found in favor of Mr. Johnson. They found that the weed killer Roundup® was directly responsible for the non-Hodgkin lymphoma that Mr. Johnson was dying from. The jury awarded DeWayne Johnson $250 million in punitive damages and about $39 million in compensatory damages.

After the verdict, Monsanto issued a statement saying it stands by the studies that suggest Roundup® does not cause cancer. The Monsanto Vice president stated, “We will appeal this decision and continue to vigorously defend this product, which has a 40-year history of safe use and continues to be a vital, effective and safe tool for farmers and others”.

One month later, Monsanto filed an appeal for a new trial and in October 2018, a judge from the San Francisco Superior Court denied a request for a new trial by Bayer-Monsanto but reduced the total damages from $289 million to $78.5 million.

In June 2108, Bayer announced that their acquisition of Monsanto was complete. With this, they not only acquired all of the rights to the product Roundup® but also all of the lawsuits associated with this product. At the beginning of 2019, it was estimated that the number of lawsuits that had been filed against Bayer had exceeded 9000. In the wake of these lawsuits and to cut costs following the acquisition, this German drug giant has announced that they would sell some of their brands and cut 12,000 jobs worldwide.

References:

http://npic.orst.edu/factsheets/glyphogen.html

https://www3.epa.gov/pesticides/chem_search/reg_actions/reregistration/fs_PC-417300_1-Sep-93.pdf

https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)70134-8/fulltext

https://www.epa.gov/pesticides/epa-releases-draft-risk-assessments-glyphosate

https://www.epa.gov/ingredients-used-pesticide-products/draft-human-health-and-ecological-risk-assessments-glyphosate

https://www.sciencedirect.com/science/article/pii/S1383574218300887https://www.courtlistener.com/?type=r&q=docket_id%3A4182663

https://www.cnn.com/2018/08/10/health/monsanto-johnson-trial-verdict/index.html

http://www.pharmtech.com/bayer-completes-monsanto-acquisition-63-billion-0

https://non-gmoreport.com/as-roundup-lawsuits-mount-bayer-cuts-12000-jobs-considers-settling-lawsuits/

Tracy R Everhart, MSN, MS CAM

For more than 20 years I've had the opportunity to work in numerous rolls within the medical field, including the last 7 years as a professional medical writer. With an undergraduate degree in biology/microbiology, postgraduate education in allopathic and complementary alternative medicine, my education has afforded me career opportunities with direct patient care, medical research and clinical oversight of statewide projects to improve the health of patients of all ages. I have a broad and deep knowledge of illnesses and conditions that can affect the human body. Even more important is that I have learned traditional treatment methodologies combined with alternative forms, to make the most informed decision about options that may be available.

Johnson & Johnson Talcum Powder Complications

Talcum Powder Ovarian Cancer Risk

What you need to know if you or a loved one used this product.

Written by Tracy R Everhart, MSN, MS CAM

What is talcum powder?

You will hear this product referred to as talcum powder, talcum or just talc. Talcum powder is made from a mineral called talc. It has been included in many different products and was initially marketed in the 1800s along with other feminine hygiene products. This mineral has historically been added to baby products and cosmetics because of its ability to absorb moisture and reduce friction. Because of this property, talc prevents rashes from moisture and allows cosmetics to be applied smoothly.

Talc is the softest known mineral and because of its properties, it is used for many other purposes. In 2011, about 26% of the talc consumed in the United States was used in the manufacturing of plastics because of its heat resistance and its ability to stiffen and prevent shrinkage of products such as polypropylene, vinyl, polyethylene, nylon, and polyester.

Unfortunately, talc and asbestos may occur naturally in close proximity to each other in some metamorphic rocks. Studies published as early as the 1960s and 1970s identified health concerns about the use of talc that contains asbestos in some cosmetic products. According to the FDA, those studies did not conclusively demonstrate such a link, or if such a link existed, what risk factors might be involved.

Health Risks of Using Talcum Powder

The Cosmetic, Toiletry, and Fragrances Association (CTFA) is the agency that regulates the cosmetics and personal products industries and in 1976 they issued voluntary guidelines for the use of talc. These guidelines stated that it should be standard that all cosmetics produced with talc should be free of any detectable amount of asbestos.

Talcum Powder and Ovarian Cancer

In 1982, a case-control study of ovarian cancer that collected information on talc use reported an increased risk with perineal dusting. Subsequently, cosmetic grade talc was nominated to the National Toxicology Program’s (NTP) 10th Report on Carcinogens, but the decision was deferred. By 2006, the International Agency for Research on Cancer listed cosmetic (perineal) talc application as possibly carcinogenic to humans.

In the above case study, Dr. Cramer from Harvard University hypothesized that there was an association between talc and ovarian cancer. This was because of the similarity of ovarian cancer to mesotheliomas and the chemical relationship of talc to asbestos, a known cause of mesotheliomas. His research concluded that there was an association between talc and ovarian cancer. Despite these findings, manufacturers like Johnson & Johnson continued (and do to this day) to market and sell products that contain talc.

Exposure to Asbestos

Of all of the studies conducted over the years, the issue has been whether or not the talcum powder that was used for nearly a century, contained detectable amounts of asbestos. According to the National Cancer Institute, asbestos has been classified as a known human carcinogen by the U.S. Department of Health and Human Services (HHS) and the U.S. Environmental Protection Agency (EPA). Exposure to asbestos has been shown through significant research to be the primary cause of mesothelioma and that there is sufficient evidence that it also causes cancer of the lung, larynx, and ovaries (International Agency for Research on Cancer).

What are the experts saying?

The International Agency for Research on Cancer (IARC) classifies talc that contains asbestos as “carcinogenic to humans.” The also found, based on limited human study evidence, that the perineal (genital) use of talc-based body powder as “possibly carcinogenic to humans.”
The US National Toxicology Program (NTP) has not thoroughly evaluated talc (with or without asbestos) as a possible carcinogen.
The Centers for Disease Control and Prevention (CDC) released the results of a study that was conducted in 1972. “Fiber exposure during use of baby powders, report No. IWS-36-6” has stated that during the testing of nine commercial baby powers, seven were found to contain asbestos fibers (known to be carcinogenic) that could be inhaled on a regular basis, several times each day with each diaper changes and over time it could amount to a significant number of exposures. From this information, they determined that baby powder (talcum powder) that contains asbestos could be potentially harmful if inhaled.
The US Food and Drug Administration (FDA) conducted a survey in 2009-2010. They identified 9 manufactures to explore and asked for their participation in the study, Only four of those manufactures agreed. The FDA does not have the equipment necessary to conduct the research that they wanted to do, so they contracted with an outside testing laboratory to complete these studies. They collected 24 talc-containing cosmetic products (including baby powder) from retailers in the Washington, D.C. metropolitan area and found that none of them contained asbestos. They admitted that while the information gathered was informative, it was also limited. They will continue to monitor as new information is reported.

Lawsuits related to talcum powder and ovarian cancer

11/22/13 Deane Berg

This was the first lawsuit brought against Johnson & Johnson. Deane filed her lawsuit after being diagnosed with ovarian cancer. A federal jury sided with Berg but determined that no damages were to be awarded. They believed that there wasn’t enough evidence connecting her diagnosis to the use of talcum powder. The jury did state that they felt that Johnson & Johnson was negligent, and women should have been warned about the potential risks associated with the use of talcum powder.

2/22/16 Jackie Fox

Ms. Fox was diagnosed with terminal cancer and passed away in 2015 before a determination could be made. Her case stated that she was diagnosed with ovarian cancer after using Johnson & Johnson baby powder for years. Her family was awarded $72 million dollars. The courts determined that her attorneys had proven that Johnson & Johnson knew about studies linking its products to ovarian cancer. Furthermore, they failed to warn customers about the possible dangers associated with its use.

5/2/16 Gloria Ristesund

This case presented the fact that Gloria used Johnson & Johnson powders that contained talc for decades before she was diagnosed with ovarian cancer. A jury in the Missouri state court found Johnson & Johnson liable for failing to warn consumers about the risk of ovarian cancer when exposed to talc-containing powders.

10/27/16 Deborah Giannecchini

Deborah used Johnson & Johnson’s baby powder as part of her feminine hygiene routine for over forty years. She filed a lawsuit against Johnson & Johnson in the state court in St. Louis, Missouri after she was diagnosed with ovarian cancer. The jury in her case found that Johnson & Johnson was negligent for failing to warn women about the risk of ovarian cancer related to talcum powder. The court awarded Deborah a $70 million settlement.

5/4/17 Lois Slemp

A state court jury also in St. Louis, Missouri awarded Ms. Slemp $110 million. This was the result of Johnson & Johnson failing to warn her about the risk of ovarian cancer caused by talcum powder.

8/21/17 Eva Echeverria

A state court jury in Los Angeles, California granted an award to Eva in the amount of $417 million. The jury felt that Johnson & Johnson failing to provide a warning to her about the risk of ovarian cancer with the use of talcum powder. The verdict included $347 million in punitive damages. This large award was designed to send a loud and clear message to this manufacturer.

7/12/18 22 Female Plaintiffs

This case was also filed in the state court of St Louis, Missouri. The case involved 22 women that proceeded as a joint Plaintiff against Johnson & Johnson. The jury reached a unanimous verdict in a products liability case with a verdict that is one of the largest products liability cases in the U.S. The members of the jury agreed on an award of $25 million for each of the 22 women for compensatory damages and, in addition, they awarded an additional $4.14 billion in punitive damages. This award totaled $4.69 billion.

This lawsuit included women from across the US. They were varying ages and races, but all were former users of Johnson & Johnson talcum powder that developed ovarian cancer. Since that case was settled, six of these plaintiffs have died. It is estimated that more than 9000 former talcum powder customers have filed lawsuits against Johnson & Johnson. Most of these claims have been filed for damages for ovarian cancer, but some allege that using this talcum powder led to the development of mesothelioma.

References:

https://geology.com/minerals/talc.shtml

https://www.sciencedirect.com/science/article/pii/0013935167900084

https://obgyn.onlinelibrary.wiley.com/doi/abs/10.1111/j.1471-0528.1971.tb00267.x

https://onlinelibrary.wiley.com/doi/abs/10.1002/1097-0142(19820715)50:2%3C372::AID-CNCR2820500235%3E3.0.CO;2S

ftp://ftp.cdc.gov/pub/Documents/OEL/02.%20Kuempel/References/IARC_2010-Vol%2093.pdfhttps://ntp.niehs.nih.gov/testing/status/agents/ts-10167-p.html

https://www.cdc.gov/niosh/nioshtic-2/00106056.html

https://www.fda.gov/cosmetics/productsingredients/ingredients/ucm293184.htm

https://monographs.iarc.fr/wp-content/uploads/2018/06/mono100C.pdf

https://www.washingtonpost.com/news/morning-mix/wp/2016/02/24/johnson-johnson-ordered-to-pay-72m-in-suit-linking-talcum-powder-to-ovarian-cancer/?noredirect=on&utm_term=.c167f342707d

https://cvn.com/proceedings/gloria-ristesund-v-johnson-johnson-trial-2016-04-11

https://www.cnn.com/2018/04/11/health/talc-ovarian-cancer-cases/index.html

https://www.bna.com/jj-face-nonmissouri-n73014472672/

https://images.law.com/contrib/content/uploads/documents/403/18584/Talc-appeal-7-18.pdf

https://www.npr.org/2018/07/13/628684038/jury-awards-4-7-billion-to-women-in-johnson-johnson-talcum-powder-suit

Tracy R Everhart, MSN, MS CAM

Valsartan Recall

The reason this blood pressure medication has been recalled, and the complications associated with it.

Written by Tracy R Everhart, MSN, MS CAM

Valsartan®

This medication is prescribed to individuals that have been diagnosed with high blood pressure (hypertension) and congestive heart failure. Valsartan® is part of a class of medication that are called Angiotensin II receptor blocker (ARB) and is available in several different forms. These include:

Valsartan® tablets (40, 80, 160 and 320mg)
Valsartan® and hydrochlorothiazide (HCTZ) tablets (80mg/12.5 mg, 160mg/12.5 mg, 160mg/25 mg, 320mg/12.5 mg, and 320mg/25 mg)
Amlodipine and valsartan tablets (5mg/160mg, 5mg/320mg, 10mg/160mg and 10mg/320mg)
Amlodipine, valsartan and hydrochlorothiazide tablets (5mg/160mg/12.5 mg, 5mg/160mg/25mg, 10mg/160mg/12.5mg, 10mg/160mg/25mg, and 10mg/320mg/25mg

Why has this drug been recalled?

In July 2018, the U.S. Food and Drug Administration (FDA) announced a voluntary recall of several medications that contained the active ingredient valsartan. The companies listed in this original release included Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries, Inc. The FDA made it very clear at the time, that not all valsartan-containing medication sold in the U.S. were part of the recalled.

These products contained valsartan that was supplied to these manufacturers by Zhejiang Huahai Pharmaceuticals (Linhai, China) and were found to contain an impurity known as N-nitrosodimethylamine (NDMA). Patients were advised to contact their physician or pharmacy if they had any questions about the brand of Valsartan® that they were taking.

Based on laboratory studies, NDMA is classified as a likely human carcinogen (a substance that could cause cancer) and the Environmental Protection Agency (EPA) classifies NDMA as a probable human carcinogen and that exposure to high levels of NDMA may cause liver damage.

By the end of 2018, another carcinogen was found in samples that were recalled (N-Nitrosodiethylamine (NDEA)) and the number of recalled medications containing Valsartan® had increased so significantly that the FDA set up a webpage containing a list of those drugs. This list includes the manufacturer’s name, the drug, the dose, the lot numbers, and the expiration dates.

Carcinogenic effects of N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA)

Numerous studies conducted in the early 1990s indicated the carcinogenic effects of NDMA. During this time nitrates and nitrites were routinely used as food additives in processed meats such as ham, bacon, sausages, and hot dogs. These were added to prevent spoilage and preserve the appearance and flavor of these meat products. High consumption of processed meats has been shown to be linked to an increase in gastric cancer risk, and many researchers consider nitrates/nitrites as the main cause.

Nitrosamines are produced by chemical reactions of nitrates, nitrites and other proteins and (NDMA) is one of the most frequently occurring nitrosamines found in foods. NDMA is known to be a potent carcinogen. It is capable of inducing malignant tumors in different laboratory animal species. The cancer induced in these laboratory animals was seen in a variety of tissues, including liver, lung, and stomach.

Nitrosodiethylamine (NDEA) is classified by the Environmental Protection Agency (EPA) as a probable human carcinogen and has primarily been used in research studies of laboratory rats when it is necessary to induce liver cancer. The EPA fact sheet for NDEA states that chronic (long-term) exposure may cause liver damage and low platelet counts. They go on to say that animal studies suggest that chronic ingestion may cause liver tumors or other tumors, but the data of the carcinogenic effects of NDEA in humans are limited.

Impact on patients taking Valsartan®

Since the discovery of NDMA and NDEA impurities in valsartan, the FDA recommended that those patients who were taking one of the affected drugs continue taking the medication until their physician or pharmacist provided an alternative medication or replaced it with a different brand. They continue to make this recommendation based on the fact that the risk of stopping the medication outweighs the risk of continued use.

It is unknown how the exposer to the different levels of these two carcinogens will affect the patients that took the various versions of this drug. However, the first case was filed in New York against manufacturers of these drugs and the pharmacies that dispensed them. The case, Duffy vs Prinston Pharmaceutical, Inc., Solco Healthcare U.S., L.L.C., Throggs Neck Pharmacy and Walgreen Co. (Walgreens) was filed on August 16, 2018, and on October 11, 2018, it was transferred to the United States District Court for the District of New Jersey.

This case (1:18-cv-07460-RJS) has been filed as a class action lawsuit, sighting that the manufacturers of the recalled drugs produced and distributed a generic version of valsartan that contained carcinogenic impurities and that these impurities went undetected for six years. The filing states that this case seeks equitable relief and to recover damages and restitution for:

Breach of express warranty,
Breach of the implied warranty of merchantability,
Violation of New York’s General Business Law §§ 349, 350 (Consumer Protection From Deceptive Acts and Practices),
Unjust enrichment,
Fraudulent concealment,
Fraud,
Conversion,
Strict products liability
Gross negligence,
Negligence, and
Battery

The plaintiffs, in this case, were prescribed valsartan for an extended period of time and each time that they refilled their prescriptions, they received information about the medication, including “representations and warranties that the medication was properly manufactured and free from contaminants and defects”. They also received notification via U.S. Mail advising him that the valsartan-containing medication that they were taking was affected by the recall. It is unknown at this time how many manufacturers have produced contaminated valsartan as the list continues to grow. It is also unknown how many individuals will be affected by these carcinogenic impurities.