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EPA Bows to Industry in Delay of Glyphosate Cancer Review

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By Carey Gillam

The U.S. Environmental Protection Agency (EPA) was slated to hold four days of public meetings, Oct. 18-21, focused on essentially one question: Is glyphosate, the world's most widely used herbicide, safe?

However, the EPA Scientific Advisory Panel (SAP) meetings were "postponed," just four days before they were suppose to meet, after intense lobbying by the agrichemical industry, including Monsanto. The industry first fought to keep the meetings from being held at all, and argued that if they were held, several leading international experts should be excluded from participating, including "any person who has publicly expressed an opinion regarding the carcinogenicity of glyphosate."

As the meetings drew near, CropLife America, which represents the interests of Monsanto and other agribusinesses, specifically took issue with at least two scientists chosen for the panel, alleging the experts might be unfavorably biased against industry interests. On Oct. 12, the group sent a letter to the EPA calling for Dr. Kenneth Portier of the American Cancer Society to be more deeply scrutinized for any "pre-formed conclusions" about glyphosate. More notably, CropLife called for leading epidemiologist Dr. Peter Infante to be completely disqualified from panel participation.

"EPA should replace Dr. Infante with an epidemiologist without such patent bias," CropLife told the EPA. The chemical industry group said Infante was unlikely to give industry-sponsored research studies the credibility the industry believes they deserve. CropLife said Infante has testified in the past for plaintiffs in chemical exposure cases against Monsanto.

Croplife also argued that because Infante was the "only epidemiologist on the glyphosate SAP" he would have enhanced influence in the evaluation of epidemiological data about glyphosate and cancer. The CropLife letter was dated Oct. 12 and by Oct. 14, the EPA announced it was looking for additional epidemiology expertise to ensure "robust representation from that discipline." The EPA also said one panelist had voluntarily departed, though the agency refused to say who that panelist was.

Challenging Infante's role is a gutsy move. After all, Infante spent 24 years working for the Occupational Safety and Health Administration helping determine cancer risks to workers during the development of standards for toxic substances, including asbestos, arsenic and formaldehyde. His resume includes a stint at the National Institute for Occupational Safety and Health where he conducted epidemiological studies related to carcinogens, and he has served as an expert consultant in epidemiology for several world bodies, including the EPA and the World Trade Organization.

According to sources close to the situation, Infante remains a panelist as of this week, but there is no certainty when the meetings might be rescheduled, and what the panel membership might look like when they are rescheduled. The EPA has refused to discuss who remains on the panel, but some onlookers believe that the EPA was clearly bowing to agrichemical industry interests.

"This is outrageous. The industry wants to say that our own government scientists, the top ones in their fields, aren't good enough for these panels," said Michael Hansen, senior staff scientist at the Consumers Union. "If the EPA wants to add extra epidemiologists that is great but why didn't they do it before? They are doing this because of pressure from industry."

The industry clearly has much at stake, as does the public. Glyphosate is the key ingredient in Monsanto's branded Roundup herbicides as well as herbicides marketed by numerous agrichemical companies around the world. It is also the key to what has been 20 years of sales of genetically engineered glyphosate-tolerant crops developed by Monsanto. The future sales of both the chemical and the crops are being jeopardized by the mounting concerns that glyphosate can cause cancer and other illnesses or disease.

Scientists around the world have been raising red flags for years over worrisome research findings, and last year the International Agency of Research on Cancer, said glyphosate was a probable human carcinogen. More than three dozen lawsuits have been filed against Monsanto by people claiming Roundup gave them non-Hodgkin lymphoma, and both European and U.S. regulators are evaluating the chemical for continued use.

Since the International Agency of Research on Cancer classification, Monsanto has asked the EPA to back industry assurances that glyphosate is safe, and so far, the EPA has done exactly that, issuing a series of reports and memos that dovetail with Monsanto's position. Monsanto also has sought to bolster arguments for glyphosate's safety by pointing to supportive research papers published in late September in Critical Reviews in Toxicology. Monsanto hired the group that arranged for the panel, and most of the 16 scientists involved are former Monsanto employees or Monsanto consultants. At least one, Gary Williams, has also consulted for Monsanto on litigation matters involving glyphosate.

It seems more than a little hypocritical that those scientists are presented as credible by the industry, but scientists like Infante and Portier are said to be unfit to advise the EPA because of suspected bias. Like Infante, Portier has a long track record as an independent scientist. He is vice president of the Statistics & Evaluation Center at the American Cancer Society. He has participated in more than 60 other SAP meetings and has served on expert and advisory panels for the National Institutes of Health, National Institute of Environmental Health Sciences, the National Toxicology Program, and the World Health Organization Food and Agriculture Organization.

Portier also would not comment about the industry concerns about him, the postponement or changes to the makeup of the SAP, other than to say that as of today, he remains on the panel. EPA said it is "working to reschedule as soon as possible." But the delay and the maneuvering by industry to influence panel participation does little to bolster consumer confidence for the likelihood of an objective outcome.

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On Monday and Tuesday of the week that President Donald Trump held his first rally since March in Tulsa, Oklahoma, the county reported 76 and 96 new coronavirus cases respectively, according to POLITICO. This week, the county broke its new case record Monday with 261 cases and reported a further 206 cases on Tuesday. Now, Tulsa's top public health official thinks the rally and counterprotest "likely contributed" to the surge.

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Guillain-Barre syndrome occurs when the body's own immune system attacks and injures the nerves outside of the spinal cord or brain – the peripheral nervous system. Niq Steele / Getty Images

By Sherry H-Y. Chou, Aarti Sarwal and Neha S. Dangayach

The patient in the case report (let's call him Tom) was 54 and in good health. For two days in May, he felt unwell and was too weak to get out of bed. When his family finally brought him to the hospital, doctors found that he had a fever and signs of a severe infection, or sepsis. He tested positive for SARS-CoV-2, the virus that causes COVID-19 infection. In addition to symptoms of COVID-19, he was also too weak to move his legs.

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We are neurologists specializing in intensive care and leading studies related to neurological complications from COVID-19. Given the occurrence of Guillain-Barre Syndrome in prior pandemics with other corona viruses like SARS and MERS, we are investigating a possible link between Guillain-Barre Syndrome and COVID-19 and tracking published reports to see if there is any link between Guillain-Barre Syndrome and COVID-19.

Some patients may not seek timely medical care for neurological symptoms like prolonged headache, vision loss and new muscle weakness due to fear of getting exposed to virus in the emergency setting. People need to know that medical facilities have taken full precautions to protect patients. Seeking timely medical evaluation for neurological symptoms can help treat many of these diseases.

What Is Guillain-Barre Syndrome?

Guillain-Barre syndrome occurs when the body's own immune system attacks and injures the nerves outside of the spinal cord or brain – the peripheral nervous system. Most commonly, the injury involves the protective sheath, or myelin, that wraps nerves and is essential to nerve function.

Without the myelin sheath, signals that go through a nerve are slowed or lost, which causes the nerve to malfunction.

To diagnose Guillain-Barre Syndrome, neurologists perform a detailed neurological exam. Due to the nerve injury, patients often may have loss of reflexes on examination. Doctors often need to perform a lumbar puncture, otherwise known as spinal tap, to sample spinal fluid and look for signs of inflammation and abnormal antibodies.

Studies have shown that giving patients an infusion of antibodies derived from donated blood or plasma exchange – a process that cleans patients' blood of harmful antibodies - can speed up recovery. A very small subset of patients may need these therapies long-term.

The majority of Guillain-Barre Syndrome patients improve within a few weeks and eventually can make a full recovery. However, some patients with Guillain-Barre Syndrome have lingering symptoms including weakness and abnormal sensations in arms and/or legs; rarely patients may be bedridden or disabled long-term.

Guillain-Barre Syndrome and Pandemics

As the COVID-19 pandemic sweeps across the globe, many neurologic specialists have been on the lookout for potentially serious nervous system complications such as Guillain-Barre Syndrome.

Though Guillain-Barre Syndrome is rare, it is well known to emerge following bacterial infections, such as Campylobacter jejuni, a common cause of food poisoning, and a multitude of viral infections including the flu virus, Zika virus and other coronaviruses.

Studies showed an increase in Guillain-Barre Syndrome cases following the 2009 H1N1 flu pandemic, suggesting a possible connection. The presumed cause for this link is that the body's own immune response to fight the infection turns on itself and attacks the peripheral nerves. This is called an "autoimmune" condition. When a pandemic affects as many people as our current COVID-19 crisis, even a rare complication can become a significant public health problem. That is especially true for one that causes neurological dysfunction where the recovery takes a long time and may be incomplete.

The first reports of Guillain-Barre Syndrome in COVID-19 pandemic originated from Italy, Spain and China, where the pandemic surged before the U.S. crisis.

Though there is clear clinical suspicion that COVID-19 can lead to Guillain-Barre Syndrome, many important questions remain. What are the chances that someone gets Guillain-Barre Syndrome during or following a COVID-19 infection? Does Guillain-Barre Syndrome happen more often in those who have been infected with COVID-19 compared to other types of infections, such as the flu?

The only way to get answers is through a prospective study where doctors perform systematic surveillance and collect data on a large group of patients. There are ongoing large research consortia hard at work to figure out answers to these questions.

Understanding the Association Between COVID-19 and Guillain-Barre Syndrome

While large research studies are underway, overall it appears that Guillain-Barre Syndrome is a rare but serious phenomenon possibly linked to COVID-19. Given that more than 10.7 million cases have been reported for COVID-19, there have been 10 reported cases of COVID-19 patients with Guillain-Barre Syndrome so far – only two reported cases in the U.S., five in Italy, two cases in Iran and one from Wuhan, China.

It is certainly possible that there are other cases that have not been reported. The Global Consortium Study of Neurological Dysfunctions in COVID-19 is actively underway to find out how often neurological problems like Guillain-Barre Syndrome is seen in hospitalized COVID-19 patients. Also, just because Guillain-Barre Syndrome occurs in a patient diagnosed with COVID-19, that does not imply that it was caused by the virus; this still may be a coincident occurrence. More research is needed to understand how the two events are related.

Due to the pandemic and infection-containment considerations, diagnostic tests, such as a nerve conduction study that used to be routine for patients with suspected Guillain-Barre Syndrome, are more difficult to do. In both U.S. cases, the initial diagnosis and treatment were all based on clinical examination by a neurological experts rather than any tests. Both patients survived but with significant residual weakness at the time these case reports came out, but that is not uncommon for Guillain-Barre Syndrome patients. The road to recovery may sometimes be long, but many patients can make a full recovery with time.

Though the reported cases of Guillain-Barre Syndrome so far all have severe symptoms, this is not uncommon in a pandemic situation where the less sick patients may stay home and not present for medical care for fear of being exposed to the virus. This, plus the limited COVID-19 testing capability across the U.S., may skew our current detection of Guillain-Barre Syndrome cases toward the sicker patients who have to go to a hospital. In general, the majority of Guillain-Barre Syndrome patients do recover, given enough time. We do not yet know whether this is true for COVID-19-related cases at this stage of the pandemic. We and colleagues around the world are working around the clock to find answers to these critical questions.

Sherry H-Y. Chou is an Associate Professor of Critical Care Medicine, Neurology, and Neurosurgery, University of Pittsburgh.

Aarti Sarwal is an Associate Professor, Neurology, Wake Forest University.

Neha S. Dangayach is an Assistant Professor of Neurology and Neurosurgery, Icahn School of Medicine at Mount Sinai.

Disclosure statement: Sherry H-Y. Chou receives funding from The University of Pittsburgh Clinical Translational Science Institute (CTSI), the National Institute of Health, and the University of Pittsburgh School of Medicine Dean's Faculty Advancement Award. Sherry H-Y. Chou is a member of Board of Directors for the Neurocritical Care Society. Neha S. Dangayach receives funding from the Bee Foundation, the Friedman Brain Institute, the Neurocritical Care Society, InCHIP-UConn Center for mHealth and Social Media Seed Grant. She is faculty for emcrit.org and for AiSinai. Aarti Sarwal does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

Reposted with permission from The Conversation.


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Democratic presidential hopefuls Joe Biden and Senator Bernie Sanders greet each other with a safe elbow bump before the start of the Democratic Party 2020 presidential debate in a CNN Washington Bureau studio in Washington, DC on March 15, 2020. Mandel Ngan / AFP / Getty Images

By Jake Johnson

Unity Task Forces formed by presumptive Democratic presidential nominee Joe Biden and Sen. Bernie Sanders unveiled sweeping party platform recommendations Wednesday that—while falling short of progressive ambitions in a number of areas, from climate to healthcare—were applauded as important steps toward a bold and just policy agenda that matches the severity of the moment.

"We've moved the needle a lot, especially on environmental justice and upping Biden's ambition," said Sunrise Movement co-founder and executive director Varshini Prakash, a member of the Biden-Sanders Climate Task Force. "But there's still more work to do to push Democrats to act at the scale of the climate crisis."

The climate panel—co-chaired by Rep. Alexandria Ocasio-Cortez (D-N.Y.) and former Secretary of State John Kerry—recommended that the Democratic Party commit to "eliminating carbon pollution from power plants by 2035," massively expanding investments in clean energy sources, and "achieving net-zero greenhouse gas emissions for all new buildings by 2030."

In a series of tweets Wednesday night, Ocasio-Cortez—the lead sponsor of the House Green New Deal resolution—noted that the Climate Task Force "shaved 15 years off Biden's previous target for 100% clean energy."

"Of course, like in any collaborative effort, there are areas of negotiation and compromise," said the New York Democrat. "But I do believe that the Climate Task Force effort meaningfully and substantively improved Biden's positions."

 

The 110 pages of policy recommendations from the six eight-person Unity Task Forces on education, the economy, criminal justice, immigration, climate change, and healthcare are aimed at shaping negotiations over the 2020 Democratic platform at the party's convention next month.

Sanders said that while the "end result isn't what I or my supporters would've written alone, the task forces have created a good policy blueprint that will move this country in a much-needed progressive direction and substantially improve the lives of working families throughout our country."

"I look forward to working with Vice President Biden to help him win this campaign," the Vermont senator added, "and to move this country forward toward economic, racial, social, and environmental justice."

Biden, for his part, applauded the task forces "for helping build a bold, transformative platform for our party and for our country."

"I am deeply grateful to Bernie Sanders for working with us to unite our party and deliver real, lasting change for generations to come," said the former vice president.

On the life-or-death matter of reforming America's dysfunctional private health insurance system—a subject on which Sanders and Biden clashed repeatedly throughout the Democratic primary process—the Unity Task Force affirmed healthcare as "a right" but did not embrace Medicare for All, the signature policy plank of the Vermont senator's presidential bid.

Instead, the panel recommended building on the Affordable Care Act by establishing a public option, investing in community health centers, and lowering prescription drug costs by allowing the federal government to negotiate prices. The task force also endorsed making all Covid-19 testing, treatments, and potential vaccines free and expanding Medicaid for the duration of the pandemic.

"It has always been a crisis that tens of millions of Americans have no or inadequate health insurance—but in a pandemic, it's potentially catastrophic for public health," the task force wrote.

Dr. Abdul El-Sayed, a former Michigan gubernatorial candidate and Sanders-appointed member of the Healthcare Task Force, said that despite major disagreements, the panel "came to recommendations that will yield one of the most progressive Democratic campaign platforms in history—though we have further yet to go."

 

Observers and advocacy groups also applauded the Unity Task Forces for recommending the creation of a postal banking system, endorsing a ban on for-profit charter schools, ending the use of private prisons, and imposing a 100-day moratorium on deportations "while conducting a full-scale study on current practices to develop recommendations for transforming enforcement policies and practices at ICE and CBP."

Marisa Franco, director of immigrant rights group Mijente, said in a statement that "going into these task force negotiations, we knew we were going to have to push Biden past his comfort zone, both to reconcile with past offenses and to carve a new path forward."

"That is exactly what we did, unapologetically," said Franco, a member of the Immigration Task Force. "For years, Mijente, along with the broader immigrant rights movement, has fought to reshape the narrative around immigration towards racial justice and to focus these very demands. We expect Biden and the Democratic Party to implement them in their entirety."

"There is no going back," Franco added. "Not an inch, not a step. We must only move forward from here."

Reposted with permission from Common Dreams.