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Promising New Mesothelioma Treatments

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New treatment discussion

Three promising new mesothelioma treatments have recently been approved by the FDA or are in clinical trials. Approximately 2,500 Americans are diagnosed with mesothelioma each year. Mesothelioma is almost always caused by exposure to asbestos. Common exposures occurred in mines, construction, ships, industrial settings, refineries and chemical plants.  Household exposures, hobbies and even home remodeling can also be sufficient exposures to cause mesothelioma.  There is currently no cure for the disease.

An FDA-approved treatment was last approved in 2004. Now, however, there are some newly approved and others in clinical trials. The following shows three treatments that are extending lives.

Optune Lua

No new treatments were available for almost 16 years until Optune Lua was approved by the FDA in 2019. (FDA approval under the Humanitarian Device Exemption [HDE] pathway.) Optune Lua was developed by Novocure.

Since this was approved as a humanitarian device, it is only authorized by Federal Law for treatment of adult patients 22 years of age or older. They must need it for unresectable, locally advanced or metastatic, malignant pleural mesothelioma. It must be used in tandem with pemetrexed and platinum-based chemotherapy.

The device is worn on the body and produces electric fields – tumor treatment fields. These fields interrupt the division of cancer cells. The therapy is worn where the cancer resides.

Nivolumab and ipilimumab

These two drugs are also known as Opdivo and Yervoy. This combination is now approved by the FDA as a first-line treatment of adults with malignant pleural mesothelioma unable to be removed by surgery. These are monoclonal antibodies which decrease the growth of tumors by enhancing T-cell function. In a randomized trial with patients, those who received the antibodies lived a median of 18.1 months versus the patients who had the standard chemotherapy and lived 4 months less. This is a beginning for improved overall survival rates and the first FDA approved treatment since 2004.

Atezolizumab plus bevacizumab

This combination of atezolizumab (Tecentriq) and bevacizumab (Avastin) have garnered interest as they have shown marked responses in patients with advanced malignant peritoneal mesothelioma. Study author, Kanwal P.S. Raghav, MBBS, MD from the University of Texas MD Anderson Cancer Center wrote, “This study establishes a promising treatment option for our patients who suffer from this morbid cancer and represents an unprecedented effort to bridge the gap of dedicated research in this orphan disease.”

Raghav also said that this combination had an objective response rate of 40% in patients though they were resistant to previous chemotherapy of platinum-pemetrexed. “There is absolutely no other therapy approved for use in this setting. The only treatments we use are cytotoxic chemotherapies . . . all of which have response rates of less than 10%.”

Good news

After almost 16 years without an FDA approved treatment for mesothelioma, progress is being made. Researchers throughout the world work to bring new, creative ways to irradicate the world of this horrible disease. For too long, a diagnosis of mesothelioma has been a death sentence. We are moving forward and one day, hopefully soon, that sentence will be lifted and victims of this disease will return to health.

Johnson & Johnson Talc Spinoff Files for Bankruptcy Protection

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baby powder may contain asbestos
Asbestos talc in baby powder

Johnson & Johnson, while not filing for bankruptcy protection itself, may still avoid asbestos talc liabilities. This is done by spinning liabilities off to a newly created subsidiary.

Late last week, Johnson & Johnson (J&J) created a new subsidiary named LTL Management. Company officials confirmed the parent company then moved $2 billion in asbestos talc lawsuit funds over to LTL Management. In turn, LTL Management then filed for bankruptcy protection on October 14th. 

This bankruptcy technique saw increasing use by large corporations in recent years seeking to avoid responsibility from product liability and class action claims. 

Since last summer, lawyers representing cancer victims unsuccessfully asked multiple judges to prevent J&J from completing a spin-off of its liabilities.

Bankruptcy protection restricts recovery for thousands

Recent lawsuits, as well as a Reuters investigation in 2018, revealed that asbestos contaminated talcum powder existed in baby powder for years. Thousands of cancer lawsuits were pending against Johnson & Johnson at the time of the LTL Management bankruptcy filing.  Now the recovery options for those individuals are significantly restricted by this bankruptcy protection maneuver.

Linda Lipsen, of the American Association for Justice, called Johnson & Johnson’s move “an unconscionable abuse of the legal system. Congress must act to ensure that no other ill-intentioned corporation can ever do the same by passing the Nondebtor Release Prohibition Act of 2021 as soon as possible.”

Need to examine reform measures

Congress is examining how to reform the bankruptcy code to limit corporations’ ability to avoid legal responsibility.  “Bankruptcy is there to help companies in trouble, but over time rich people in giant corporations have figured out how to game the system.  Johnson & Johnson has decided to join in on the abuse of our bankruptcy system to shield its assets and evade liability for the harm it has caused people across the country.  We can’t keep letting this happen and our Nondebtor Release Prohibition Act would enact criminal reforms to stop it,” said U.S. Senator Elizabeth Warren.  

Immunocompromised Conditions Added by FDA and CDC to Receive Third Dose Booster Shots

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Some immunocompromising medical conditions were approved by the Food and Drug Administration (FDA) on August 12th to receive third dose booster shots. This is an amendment to the emergency use authorization (EUA) for the Pfizer and Moderna vaccines.

Acting FDA Commissioner Dr. Janet Woodcock said, “Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19. As we’ve previously stated, other individuals who are fully vaccinated are adequately protected and do not need an additional dose of COVID-19 vaccine at this time.”

This action by the FDA starts the process for Center for Disease Control (CDC) recommendations for a third shot. That came on August 13, 2021. “The CDC’s Advisory Committee on Immunization Practices’ (ACIP) signed the recommendation that endorsed the use of an additional dose of COVID-19 vaccine for people with moderately to severely compromised immune systems after an initial two-dose vaccine series.”

Who would be approved for a booster shot?

Approximately 2.7 percent of American adults are immunocompromised in some way. These are people whose immune response lacks the strength to fight off most infections. A number of conditions can influence immunity, such as HIV, organ transplants, and some cancers. While two vaccine doses give some immunity, the antibodies don’t last as long as in healthy individuals with strong immune systems.

Israeli study of vaccines for cancer patients leads to third shots in Israel

A study in Israel’s Rabin Medical Center in Petah Tikva observed 87 percent of cancer patients still had high antibody levels after four months. But in healthy people, the antibodies remained at 100 percent. While a good response for the cancer patients, the observed drop in levels over time reveals compromised protection. It is thought booster shots will add immunity strength and also the length of time antibodies stay active in protecting the body.

There is also a benefit to the overall population as reducing infections in this compromised group should reduce the threat of additional variants. It is thought new variants likely begin in immunocompromised individuals.

Does the booster shot apply to you?

The CDC provides a list of qualified immunity challenges, however, the best answer is to discuss your situation with your medical provider.

Johnson & Johnson Considering Plan to Cap Asbestos Talc Liabilities

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baby powder may contain asbestos

Reuters reports Johnson & Johnson (J&J) is considering a plan to cap asbestos talc liabilities from widespread Baby Powder and other talc lawsuits.

More than 30,000 plaintiffs alleged J&J’s talc products were unsafe. These women suffered from ovarian cancer, mesothelioma, and other cancers they assert were brought on by asbestos contained in J&J Baby Powder and other talc products. Asbestos exposure is known to be a carcinogen and unsafe at any level.

In 2018 a Missouri jury found in favor of talc victims awarding $4.7 billion damages to the women.  An appellate court reduced the award to $2 billion.  Last month, the US Supreme court denied J&J’s last attempt at an appeal by denying certiorari and leaving in place the Missouri verdict. 

A plan to cap asbestos talc liabilities

With anticipated legal action from tens of thousands additional victims, J&J is contemplating alternative legal remedies. Rueters is reporting the company is considering creating a new business entity. This new business would contain all the J&J talc liabilities, then subsequently file for bankruptcy. This “divisive merger” law is known as the Texas Two-Step and leaves victims unable to bring their claims to a jury. Instead,  their only remedy would be filing claims against the new bankrupt entity. 

While this is one plan to cap asbestos talc liabilities apparently under consideration, the Texas Two-Step is controversial and there remain challenges to its permissibility under US bankruptcy laws.

Did J&J know?

Talc and asbestos are often found in close proximity when mining. This brings about the need for extreme caution when using talc in products. In 2018, Reuters shared findings from their investigation into the possibility of asbestos contamination in J&J talc products. “Facing thousands of lawsuits alleging that its talc caused cancer, J&J insists on the safety and purity of its iconic product. But internal documents examined by Reuters show that the company’s powder was sometimes tainted with carcinogenic asbestos and that J&J kept that information from regulators and the public.”

Through many documents and testimonies, Reuter’s examination showed at “least 1971 to the early 2000s, the company’s raw talc and finished powders sometimes tested positive for small amounts of asbestos, and that company executives, mine managers, scientists, doctors and lawyers fretted over the problem and how to address it while failing to disclose it to regulators or the public.”

J&J removed its Baby Powder from the US and Canadian markets in May 2020.

Will there be justice?

If J&J uses this dubious plan to cap asbestos liabilities, victims who have not settled their cases would find themselves in long and slow bankruptcy proceedings with a significantly reduced chance for compensation and the victims’ pursuit of full and unimpeded justice.

Over 100 Firefighters Possibly Exposed to Asbestos

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possible asbestos exposure

More than 100 firefighters and civilians were possibly exposed to asbestos in Austin, Texas. The potential exposure came while fighting a 3-alarm fire in a city-owned abandoned warehouse.  Through a survey contracted by the Building Services Department in 2013, asbestos was discovered in three buildings on the property. It was found in drywall, ceilings, flooring and floor adhesive in all three buildings, including the warehouse that burned. Preparation to demolish all these buildings was underway before the fire.

Firefighters were not aware they were possibly exposed to asbestos

Until the third alarm unit arrived on the scene, the firefighters and civilians were unaware of the possibility of asbestos. The incident report stated, “Although best precautions were taken to avoid exposure after notification, the fire was very significant and the smoke produced from the fire swirled throughout the fireground with multiple shifts in the wind while units were on scene. All firefighters and civilians on the fireground could have a possible exposure to asbestos.” 

Dangers of asbestos exposure

Asbestos is a highly carcinogenic mineral. Its microscopic fibers can embed in lungs when inhaled. This can lead to lung cancer, asbestosis, and mesothelioma. All three diseases are harmful, but mesothelioma has no cure at this time and is fatal. It can take many decades after exposure before a victim is diagnosed.

Buildings, commercial and residential, often contained asbestos. It was a common building material until the early 1980s. It was in shingles, insulation, ceiling tiles, tile mastic and many other materials. If asbestos remains undisturbed, the fibers are not released. However, with remodeling or an accident, such as this fire, airborne fibers may lead to a possible exposure to asbestos. Removing asbestos requires abatement professionals. There is no safe level of exposure.

Firefighters deserve respect

Asbestos is not the only danger firefighters’ encounter. From falling structural pieces, to unknown chemicals or other hazardous materials stored inside, to environmental factors such as wind and storms, they remain focused. The president of the Firefighters Cancer Support Network, Bryan Frieders, said “firefighters are in danger and can be exposed to up to 200 cancer causing chemicals when they go into a burning building. Yet we still see firefighters on a daily basis going into these known-dangerous situations to try to save lives.”

Frieder said, “A lot of retirees two, three, four or five years after they retire are being diagnosed [or decades in the case of asbestos]. That’s a significant problem for us. They took an oath to serve the city they are serving. There is an expectation that the city they are serving is going to take care of them — and their families.”

The firefighters exposed in this fire were given chest X-rays as a baseline in case they develop lung problems in the future.

Cause unknown

A film crew had recently vacated the building. Employees of Building Services inspected the building three hours before the fire started. At the time of the fire, officials didn’t know exactly what, if anything, was stored in the building. Currently, the cause of the fire is unknown.