U.S. eyes label warning for Allergen devices

FDA pressure results in breast implants that cause rare cancer of the immune system being recalled

Allergen is recalling its textured breast implants worldwide that have been linked to anaplastic large-cell lymphoma, a rare cancer of the immune system.

The company has responded to belated pressure from the Federal Drug Administration.

According to a recent story by Denise Grady in The New York Times, however, the FDA reports that women who have the implants but no symptoms don't need to remove them.

Yet the article does note "the recall means that doctors and hospitals should not implant any more of the devices and should return any on their shelves to Allergen."

The disease is not breast cancer but developed in tissues around the implant. "In most cases," Grady's story says, "removing the implant and the scar tissue around it cures the cancer, but if it is not detected early it can spread and kill the patient."

The condition, it continues, "has occurred with implants placed for cosmetic breast enlargement and with those used for reconstruction after mastectomy for breast cancer."

Thirty-three deaths and 573 cases have been reported from implants, Grady's piece reports, with a dozen deaths and 481 of them attributed to Allergen Biocell, according to the FDA, which dragged its heels after first recognizing the link to breast implants in 2011.

The Times story, which notes that the devices were banned months ago in Europe, contends that the "Biocell textured implants carry a risk that is about six times that of other textured implants sold in the United States."

Dr. Binita Ashar

It also reports that Dr. Binita Ashar, director of the FDA's Office of Surgical and Infection Control Devices, said at a news briefing…about the recall" that "hundreds of thousands of women in the United States have Biocell implants." 

The article also quotes Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, as saying that "the data regarding deaths was particularly informative of our decisions."

Main symptoms of the disease "are usually swelling and fluid accumulation around the implant," Brady writes.

FDA officials reportedly are considering "adding a black-box warning [to the labeling of the breast implants] to draw attention to the risks, and requiring doctors and patients considering the surgery to go over as checklist to help women understand the benefits and risks of the devices."

More information about implants can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book that I, Woody Weingarten, aimed at male caregivers.

'Gaping hole' is found in U.S. health system

N.Y. Times article exposes major economic hardships that some cancer caregivers are facing

America's health system is badly flawed because it's making caregivers of patients with cancer and other diseases work much too hard to negotiate it — especially economically.

Aaron E. Carroll

That's the basic conclusion of a recent The New York Times article by Aaron E. Carroll, a professor at Indiana University School of Medicine.

In the piece, Carroll says his friend, international fraternity CEO Jim Fleischer's story about a rare cancer taught him about the problem in our health system.

Despite his friend having "great insurance" and "enough money" and getting "excellent care," he discovered the "impossibility and hardship faced by…friends and family members who are caregivers."

The situation, Carroll writes, is "hugely disrupting and expensive. There's no system for it. It's a gaping hole." 

The writer cites as an example that following his surgery and chemotherapy, his friend's wife, mother-in-law, friends and co-workers needed to take lots of time off to care for him and take him to appointments.

Carroll also suggests that "if it was this hard for [Jim], it's probably unbearable for many others with fewer resources. People can be financially ruined by illness — and health insurance won't fix that."

Last year, the Times piece notes, "it's estimated that more than 1.7 million people faced a cancer diagnosis. The year before, America spent more than $147 billion caring for people with cancer. But that doesn't include the costs outside of health care."

This year, the article continues, "the National Cancer Institute will spend more than $5.7 billion on cancer research. Almost none of that will investigate how to support the families of those who have the disease."

Researchers in the past have estimated the "economic burden for caregivers for patients with lung and colorectal cancer," Carroll says. "They reported that the average cost to a caregiver in the initial phase of treatment was more than $7,000," with an additional $20,000 spent after treatment on so-called continuing care.

Another study cited caregiving costs for breast cancer at $38,000, lung cancer at $72,000, for ovarian cancer $66,000, for lymphoma $59,000.

Carroll concludes that it's crucial to recognize "that the efforts of caregivers are probably just as important to health as the drugs and procedures the medical system provides."

More details about the issues that helpmates have can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book that I, Woody Weingarten, aimed at male caregivers.

'Seismic shift' about fragility hits food industry

Female chefs in San Francisco fight restaurant industry taboo, speak out about having breast cancer

Several female chefs have had to fight the macho atmosphere of Michelin-rated San Francisco Bay Area restaurants when they contracted breast cancer.

According to a story by Mary Ladd in the San Francisco Chronicle last week, those chefs had to break a long-standing taboo in the $800 billion industry against talking openly about the disease. 

"Stress, long hours and pressure have historically been constant" in the restaurant world, an environment in which "even taking time off for illness has been a no-no," the story notes.

Pim Techamuanvivit

That, Ladd explains, fuses with "the old macho chef mentality that you shouldn't talk about mental and physical health."

But the story details what may be a "seismic shift" in attitude happening.

It cites as an example Pim Techamuanvivit, a Michelin star-recipient who attended an award story in a wheelchair "because she was recovering from her third breast cancer surgery" — an event she wouldn't miss "even if she was…in pain."

Techamuanvivit found support from Kin Khao employees who changed shifts to be there when she couldn't. She reported, too, that "managers who had already left to help open other restaurants would come back to take over a few nights a week."

The Chronicle piece also quotes pastry chef/cancer patient Carolyn Nugent, who'd worked  in five three-star kitchens, as saying that she doesn't think there specifically "is a stigma of having cancer in the culinary world [but] there is a stigma of having any sort of weakness in the culinary world."

And she elaborates: "You learn to push through the pain. In the kitchen, anything that is not related to the job is a distraction — and when you lose your focus on the job, unpleasant things happen."

Dominique Crenn, the story indicates, posted photos on Instagram with her hair gone as a result of chemotherapy — and several of her co-workers at her three-star Michelan restaurant Atelier Crenn also "posted photos of their own shaved heads as a sign of support."

Much more information about attitudes regarding the disease can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book that I, Woody Weingarten, aimed at male caregivers.

Pair to get $87 million for Roundup lymphoma

An Alameda County judge blames Monsanto for cancer-causing agent despite cutting $2 billion award 

Even as a judge sliced an award against Monsanto from $2 billion, she reaffirmed the jury's conclusion that the company's weedkiller was "a substantial factor" in causing cancer.

Judge Winifred Smith

Alameda County Superior Court Judge Winifred Smith recently reduced the verdict to $87 million in the lawsuit brought by Alva and Alberta Pilliod after, having used Roundup for three decades, the couple contracted non-Hodgkin's lymphoma.

But the judge also asserted, according to an Associated Press story, that evidence "supported the finding that Monsanto knew the herbicide's active ingredient, glyphosate, could be dangerous and failed to warn the couple from Livermore, California."

It marked the third time a judge had reduced an award over the disputed chemical.

Smith cut the punitive damages from $1 billion each to $70 million for the pair, and awarded the Pilliods $17 million for future pain and suffering.

The lawyer for the couple, Brent Wisner, called the overall ruling "a major victory."

But Monsanto's corporate parent, the German pharmaceutical firm Bayer AG, intends to appeal.

The three California trials were the first involving an estimated 13,000 plaintiffs with pending suits again the agribusiness, the AP story indicates.

Monsanto will face its first non-California trial at a courthouse in St. Louis this month.

Information about other trials of manufacturers whose products cause disease can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book that I,
Woody Weingarten, aimed at male caregivers.

High-sugar foods can lead to obesity, then cancer

Daily glass of fruit juice or diet soda can boost disease risk, new French study of 100,000 adults shows

Even one daily glass of juice or soda can increase your risk of cancer. 

That conclusion, according to a recent story by Najja Parker in The Atlanta Journal-Constitution, stems from a new study of 100,000 French adults who were followed for nine years.

The study, published in the British Medical Journal, says that consuming sugary drinks each day — in amounts as small as 100 ml of 100% fruit juice or one-third of a typical can of an artificially sweetened diet beverage — is now "associated with an overall increase in cancer risk of 18% and breast cancer risk by 22%."

Earlier this year, the AJC article continues, "researchers from the Harvard T.H. Chan School of Public Health found sugary drinks were linked to higher risk of early death, especially for women."

Dr. Mathilde Touvier

But lead researcher Dr. Mathilde Touvier told The Guardian that "it's probably safe to drink soda or fruit juice on occasion," according to a story by Stephen Johnson on the Big Think website. "The recommendation from several public health agencies," she's quoted as saying, "is to consume less than one drink per day. If you consume from time to time a sugary drink it won't be a problem, but if you drink at least one glass a day it can raise the risk of several diseases — here, maybe cancer, but also with a high level of evidence, cardiometabolic diseases."  

A handful of U.S. cities — including Albany, Berkeley and San Francisco in California; Boulder, Colorado; Philadelphia; and Seattle — have levied taxes on the soda industry. "Those levies seem to decrease soda consumption," Johnson's piece says.

The Big Think article also notes that "although consuming large amounts of sugar has been linked to some forms of cancer, like esophageal cancer, there's no strong evidence showing that it causes the disease, according to the American institute for Cancer Research. But there is an indirect link: Eating high-sugar foods often leads to obesity, which, in turn, raises the risk of developing cancer."

Information on other cancer-causing agents can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book that I, Woody Weingarten, aimed at male caregivers.

Disease may cause loss of control of limbs, eyes

Rare autoimmune disease that attacks brain can be triggered by testicular cancer, new study says

Scientists using a novel diagnostic tool have discovered that testicular cancer can trigger a rare autoimmune disease.

That process stems from antibodies fighting the cancer going on to attack the brain, according to a recent story by Lois Zoppi in News Medical Life Sciences online.

The severe neurodegenerative disease that results (it's called "testicular cancer-associated paraneoplastic encephalitis"), the article says, "is often mis- or undiagnosed" — which means that appropriate treatment to limit its effects "often comes too late." 

The encephalitis causes men to lose control of their limbs, eye movement and, sometimes, their speech.

"Until now," the story continues, "scientists have been unable to identify which specific antibody was causing a staining pattern only seen in patients with testicular cancer. But the new study…showed a unique biomarker responsible for the disease."

A research team based at Chan Zuckerberg Biohub, the Mayo Clinic and the University of California at San Francisco made the discovery via "a variation of 'programmable phage display' technology, which simultaneously screens over 700,000 autoantibody targets across every human protein," the piece continues.

Dr. Sean Pittock

"By working together, our organizations have the potential to make biomarker discoveries much more rapidly," the News Medical Life Sciences piece quotes Dr. Sean Pittock, study co-author from the Mayor Clinic, as saying.

The story also quotes Joe DeRisi, who worked on the study, to the effect that their joint research "is the tip of the iceberg. We know there are more paraneoplastic autoimmune diseases waiting to be discovered and more people to help."

The study was published in "The New England Journal of Medicine."

More information about other studies of disease can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a  VitalityPress book that I, Woody Weingarten, aimed at male caregivers.

Jurist raps Bayer company for being uncaring

Judge expected to trim $80 million jury verdict against Monsanto for its cancer-causing Roundup

The judge in the first federal court suit against Monsanto intends to reduce a jury's $80 million damage award.

Bob Egelko

According to a story by Bob Egelko this week on the San Francisco Chronicle's website, although Judge Vince Chhabria plans to reconsider the Roundup weed-killer verdict in favor of Edwin Hardeman, he's not expected to totally eliminate punitive damages "for what he called the company's 'reprehensible' conduct."

The judge has already rebuked the agribusiness for ignoring a 2015 World Health Organization agency ruling that glyphosate, an active ingredient in the weed-killer, is a probable carcinogen — and for "showing no interest in conducting new studies or reconsidering their public assurances to regulators or consumers."

In short, he charged during last week's hearing, evidence at the trial showed the Bayer AG company "not caring whether its products cause cancer."

Hardeman, 70, had sprayed Roundup on his Sonoma County property for more than 26 years. He was diagnosed with non-Hodgkin's lymphoma in 2015. 

Jurors had awarded him $75 million in punitive damages as well as $3 million for past pain and suffering, another $2 million for emotional distress in the future, and $200,000 for economic losses. 

Monsanto had requested Chhabria overturn the verdict. The judge has showed no signs of doing that. 

He did, however, indicate he'd probably cut the punitive damages damages to comply with Supreme Court standards limiting awards, under normal circumstances, to nine times the amount of awarded compensation.

No date has been set for his latest decision.

More information on court verdicts regarding products that may cause disease can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book that I, Woody Weingarten, aimed at male caregivers.

Bayer/Monsanto trying to fix damaged image

Maker of Roundup herbicide planning to spend $5.6 billion on research to find a new weed-killer

Despite, or maybe because of, facing more than 5,000 lawsuits over its Roundup herbicide causing cancer, Bayer AG plans to spend $5.6 billion on researching a new weed-killer.

Bayer, parent company of agribusiness Monsanto, which recently lost three court cases that found the glyphosate-based weed-killer caused cancer, is desperately trying to wipe the tarnish from its image.

All three court cases are being appealed.

According to a recent story by Rachel Siegel in The Washington Post, though Bayer still insists that glyphosate is safe, it announced it's not only investing that $5.6 billion but it's pledging "to reduce the company's environmental footprint by 30 percent through 2030."

That promise, Siegel's story says, "signaled a change in tone for Bayer. On its website, along with a full-page ad in [the] Post, Bayer said, 'We listened. We learned.'"

The vow reportedly also added the following phrases: "As a new leader in agriculture, Bayer has a heightened responsibility and the unique potential to advance farming for the benefit of society and the planet. We are committed to living up to this responsibility."

Ken Cook

Siegel's piece, however, quoted Ken Cook, president and co-founder of the nonprofit Environmental Working Group, as saying that "if Bayer is serious about reforming its products, it has to commit to a fundamentally new paradigm for pesticides, which must start with a simple principal: This class of chemicals should not end up in people."

EWG last week published a report, the Post story asserts, that Roundup has "been detected in 21 oat-based cereals and snack products tested by the organization."

Siegel apparently believes Monsanto/Bayer "underestimated the reputational damage" that stemmed from the losing lawsuits "and how they damaged the company's public perception."

The Post also quotes Anthony Johndrow, an expert on how corporations manage crises, to the effect that Bayer is making its decisions more transparent and "is sincerely making a change."

Bayer, he indicates, knew what they were getting when they bought Monsanto last June: "This is their going forward, whether they like it or not."

When a jury recently awarded $2 billion to a Livermore couple who blamed Roundup for their non-Hodgkins lymphoma diagnoses, the verdict added to Bayer's steep stock descent to its lowest level in seven years, erasing more than 40 percent of its market value.

To read about more court cases involving manufacturers sued because their products caused disease, check out "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book that I, Woody Weingarten, aimed at male caregivers.