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First New Mesothelioma Therapy Approved by FDA in Over 15 Years

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The first new mesothelioma therapy approved by the FDA is based on a trial. In this single-arm STELLAR trial, the median overall survival rate was 18.2 months with patients with unresectable, locally advanced or metastatic malignant pleural mesothelioma who received TTF plus chemotherapy. This combination of treatments comprises the NovoTTF-100L System along with pemetrexed and platinum-based chemotherapy for front-line treatment.

History of new mesothelioma therapy

Bill Doyle, executive chairman of Novocure, the developer of NovoTTF-100L stated, “Since 2000, we have been developing and commercializing Tumor Treating Fields (TTF) to extend survivals in some of the most aggressive forms of cancer. FDA approval of NovoTTF-100L provides patients with the first FDA-approved treatment for MPM in more than 15 years and, as our first FDA-approved torso cancer indication, marks a major milestone for Novocure. We are thankful for the patients, caregivers and health care providers who partnered with us to make this possible.”

What is malignant pleural mesothelioma (MPM)?

Strongly linked to asbestos exposure, MPM is a rare malignancy. Approximately 3,000 people are diagnosed with MPM each year in the US. This new therapy is welcome news as there was only one FDA-approved therapy prior to the NovoTTF-100L approval. That treatment consisted of pemetrexed plus cisplatin.

In addition to extending life, this new mesothelioma therapy approved by the FDA, is noninvasive, delivering TTF directly to the region of the tumor. No increase in serious systemic wide effects were noted with this new therapy.

Results showed patient overall survival at:
• 21.2 months for epithelioid malignant pleural mesothelioma (53 patients)
• 12.1 month for non-epithelioid malignant pleural mesothelioma (21 patients)
• 62% of those in the STELLAR study were alive at one year.
• Disease control when at least one CT scan was given as a follow-up was 97% (72 patients).

Mary Hesdorffer, NP, executive director of the Mesothelioma Applied Research Foundation, said “MPM is a devastating disease, with only 10 to 20 percent of patients being candidates for surgery to remove the tumor. Typically, mesothelioma patients who cannot have surgery receive palliative care to mitigate their symptoms. NovoTTF-100L provides unresectable MPM patients with a treatment option that may improve survival. We are encouraged by the FDA approval and hope it is just the beginning of innovation in the treatment of this aggressive disease.”

Asbestos Stopped the Clock

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Asbestos in LSU clock tower
LSU Clock Tower

After almost a hundred years of service, the Louisiana State University (LSU) Memorial Tower in Baton Rouge was ready for restoration, but asbestos stopped the clock tower project when the potentially deadly mineral was found in the interior.

History

The tower was built in the early 1920s in memory of 1,447 Louisiana soldiers who died in World War I. The interior of the tower houses a military museum.

The Memorial Tower clock holds a special place in the heart of students and the community for its chimes. The bells ring every quarter hour until 10 pm and at noon they ring the tune of the university’s alma mater song. On Valentine’s Day, tradition states that receiving a kiss under the tower at the ringing of the chimes at midnight – the only night they ring past 10 pm – confirms a student is now an “official” LSU student.

The 175’ tall building was designed in the Italian Renaissance style and is a landmark in the city.

From its history, it is evident the tower is an important part of Louisiana’s past – from its construction in 1923, to today, and into the future. The restoration will ensure the building and its traditions carry on for future generations of students.

The restoration

Finding asbestos was not completely unexpected, as many buildings in the United States were built using the mineral from the 1920s until the late 1970s. Until renovations began, the asbestos was undisturbed and therefore not a danger. But once substances containing asbestos are handled, fibers can become airborne and inhaled by workers or others who are in the affected area.

When found in the tower, work on the interior was stopped and tests are currently underway. Most other buildings on the LSU campus were also constructed during this time period, meaning that as they are restored, they may also need testing and possibly abatement.

Because the asbestos was discovered at the beginning of the restoration, the university states there is no threat to students or faculty members. As a precaution, remodeling or renovations performed on any commercial buildings, schools, or residences during the time period asbestos was commonly used in construction, may require testing on possible asbestos-laden products before initiating a project.

Exposure to asbestos is a known cause of cancers, such as lung cancer and mesothelioma. At this time, mesothelioma remains a fatal disease. Mesothelioma can go undetected for decades – even 50 years – which makes it a silent killer. Early detection is critical.

Asbestos stopped the clock, but it will chime again

Exterior renovations continue and the entire $6.8 million project should be completed by the 2020 Fall semester. Baton Rouge, especially LSU students and alumni, look forward to enjoying their celebrated clock tower once again.

Photo by: Kkmurray – Own work, CC BY-SA 3.0, https://commons.wikimedia.org/w/index.php?curid=2666826

 

Is the EPA Making Asbestos Great Again?

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Is the EPA allowing asbestos again? Maybe. But there’s still time to act. The proposed EPA rule that is at the center of this firestorm is available for public comment until August 10.

Before we get to the current controversy, let’s review how we got here.

There’s Never Been an Asbestos Ban?

The undisputed recognition of asbestos as a killer lead OSHA to regulate asbestos in 1972. Millions of American lives were at stake. OSHA regulation made a real impact and saved lives by limiting asbestos exposure in the work place. In turn, many asbestos containing products could no longer be used in a way that complied with OSHA regulations. So, a steep decline in the manufacture of asbestos products ensued.

In 1989, the EPA followed up with what was to be the final blow – a complete ban on asbestos under the Toxic Substances Control Act (TSCA). Weaknesses in TSCA, however, led to an appellate court overturning the ban. So, while Europe banned asbestos in the mid 1990s, there’s never been an outright ban on the use of asbestos in the United States. We’ve had restrictions on the deadly fiber, but no complete ban.

A New Hope

Finally, in 2016, a bipartisan effort in Congress led to a reformed TSCA giving the EPA new tools to review thousands of chemicals. Asbestos, the EPA announced in the closing days of the Obama administration, was one of the first ten chemicals to be reviewed under the new TSCA. Just two years ago, the scientific community widely believed an asbestos ban in the United States was finally in sight.

EPA Under Trump Administration

TSCA, however, requires a three year review period. Thus, the majority of the TSCA asbestos review is now happening under President Trump’s EPA. And that’s where things have taken an unexpected turn. The EPA’s approach involves a three-fold problem.

First, on June 1st, the EPA announced a “Significant New Use Rule” (SNUR) – a proposed framework that will create opportunities for “new uses” of asbestos. The EPA insists it took unprecedented action by requiring EPA approval before manufacturers can import or use asbestos in the manufacture of products. But when there is no safe level of exposure to asbestos, why create a system in which the EPA can now approve new uses of this deadly fiber? Banning asbestos would be unprecedented action – not creating a system to actually approve of new asbestos use.

Second, in May 2018, the EPA published a “Problem Formulation of the Risk Evaluation for Asbestos.” The document lays out the EPA’s planned approach for evaluating new uses of asbestos and what to consider as part of the three year TSCA asbestos review. The problem with the Problem Formulation: the EPA won’t consider pre-existing information on the health consequences of legacy uses of asbestos, such as building materials that remain in place across America. Instead, the agency will focus on “new uses for manufacture, processing or distribution is intended, known to be occurring, or reasonably foreseen.”

This will severely limit the types of exposures the EPA will include in formulating the risk of new asbestos uses. As a result – the EPA most likely will find lower levels of risk and will likely impose fewer restrictions.

Finally, the EPA recently proposed a “scientific transparency” rule which sounds great, but would prohibit the agency from considering most large scale, peer-reviewed medical research concerning the health consequences of the substances we breathe, eat and drink.

Combine all of these issues and it’s clear the EPA under the Trump administration has no plans to ban asbestos. In fact, if the SNUR rule takes effect, the EPA will have a framework to approve new asbestos uses. Existing OSHA regulations and the specter of asbestos legal liabilities will probably prevent very many new uses of asbestos from becoming a reality, but there shouldn’t be any.

The EPA’s mission is to protect human health and the environment. The proposed asbestos SNUR does neither. A U.S. ban on asbestos would.

An even broader question: if the EPA is taking such tepid measures with an undisputed human carcinogen like asbestos, what will the agency do with the thousands of lesser known chemicals still to be reviewed?

New Orleans Workers at the W.R. Grace Vermiculite Exfoliation Plant Were Exposed to Asbestos

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New Orleans workers at the W.R. Grace vermiculite exfoliation plant were exposed to asbestos from 1965 to 1989. The facility is located in Jefferson Parish on River Road. During this time, the plant received 148,000 tons of asbestos-contaminated vermiculite from the Libby, Montana mine, also owned by W.R. Grace.

Libby, Montana

The vermiculite mine in Libby operated from the early 1920s until 1990, producing over 70% of vermiculite sold in the U.S. Though vermiculite is a naturally occurring mineral – in appearance, much like mica with multiple shiny layers – it was contaminated with asbestos in the Libby mine. W.R. Grace both mined and processed the ore and then shipped to locations all over the United States, including Louisiana.

The dangers of asbestos contaminated vermiculite

Inhalation is the primary means of exposure to asbestos. As tons of vermiculite were shipped to a location, processed, and shipped out to other locations, the ore released asbestos fibers into the air. These could also be released during the mining, milling, and exfoliation operations. Though workers were the most susceptible to exposure, people in nearby offices and residences could also be exposure, as well as their family members. In the case of W.R. Grace in New Orleans, there is a residential area a few hundred feet northeast of the site.

A report from the U.S. Department of Health and Human Services states, “Some studies suggest that populations who live near asbestos mines and mills have experienced excess asbestos-related diseases, specifically mesothelioma.”

Workers at the W.R. Grace vermiculite exfoliation plant were exposed to asbestos

The W.R. Grace plant was an exfoliation facility. That process required vermiculite to be heated to high temperatures. The water contained in the mineral converted to steam and then separated the mineral into its layers, expanding the vermiculite into small worm-shaped pieces. By doing this, its bulk volume was expanded, or “popped,” and the mineral became a commercially valuable product – primarily for attic insulation, concrete aggregate, masonry insulation, horticultural soil conditioner, and a spray-applied fireproofing. But, in this process, asbestos was released and made available for human exposure.

There was a population of 5,047 within one mile of the facility in 1989, the time production ceased. Jefferson Parish still ranks 19th among all U.S. counties in deaths from mesothelioma.

W.R. Grace reported that at the time operations ceased, a remediation was conducted at the site including vacuum and water rinse of equipment, walls, and floors, and removal of equipment.

What to do if you think you were exposed

Diseases from asbestos exposure, such as mesothelioma, can take up to 50 years before symptoms appear. It has only been 30 years since Libby vermiculite processing ceased. If you think you were exposed, the first precaution would be to stop smoking as that can aggravate any potential lung disease. It would also be prudent to let your doctor know the timeframe and degree of exposure you experienced and have regular checkups.

Exposure from working with a product containing asbestos, such as Libby vermiculite, dramatically increases the risk of disease. The sad truth is that those exposed to vermiculite had no idea they were inhaling fibers that would potentially shorten their lives.

The First Step to Revive the Cabana Motor Hotel: Asbestos Abatement

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revive the cabana motor hotelThe sixties-styled building along Stemmons Freeway has a long and varied history, but the first step to revive the Cabana Motor Hotel was demolition and that meant asbestos abatement for this 1960s structure.

The beginning

Designed by Melvin Grossman, construction began in 1961 and opened in 1963. The hotel had a modern design new to Dallas and the interior projected an ancient Roman theme throughout. A replica of Michelangel’s David as well as Venus de Milo and Winged Victory adorned the lobby. Intricate tiles and marble added to the luxurious furnishings for the time period. The hotel was 10 stories tall with a grand staircase and a wide array of amenities.

The developer was Jay Samo who had previously build two other Cabana Hotels, but the Dallas one was his most opulent. He went on to develop Caesar’s Palace and Circus Circus in Las Vegas.

Marty Melcher, Doris Day’s husband at the time, invested her money in the project. The Teamsters were also investors under the direction of Jimmy Hoffa.

Glory years: The Beatles and the Cabana

For long-time Dallasites, the Cabana Hotel was known as the “hotel where the Beatle stayed” in September of 1964. It was a place for celebrities in its early years including, Jimi Hendrix, Led Zeppelin, and Jimmy Hoffa. Raquel Welch was employed there as a waitress in the lounge. As a waitress, she would have been called a “goddess” and worn a short toga. Many top names in show business performed at the hotel in rooms such as the Bon Vivant Club and Nero’s Nook cocktail lounge.

The dream soon ends

Just six years after opening, the hotel was sold to the Hyatt House and renamed the Hyatt House Hotel. Then seven years later, Hyatt sold it to Holders Capital Corporation and it was renamed DuPont Plaza. The most shocking development came in 1984 – just over 20 years from its opening as a grand hotel –when it was purchased by Dallas County and turned into a minimum security jail.

Almost thirty years later it was sold again; this time to Lincoln Properties with plans to demolish the building and replace it with a data center. That never happened and it was on the market again in 2016 and purchased by Circa Capital Corporation. Finally, the hotel was once again valued for its unique design and history, but was passed again to Centurion American Development Group – a firm that recently completed restoration of the Dallas downtown Statler Hilton.

Demolition began with removal of asbestos throughout the building. Asbestos was used extensively for construction in the 1960s, but is a dangerous, and sometimes fatal, health problem when disturbed. When fibers are released into the air, they are easily inhaled and can cause lung cancer, asbestosis, and mesothelioma – a fatal disease.

The company is retaining historic elements that remain, but as the CEO of Centurion American, Mehrdad Moayedi said, “We are demoing stuff that is not historic. There were holding tanks and bars between the balconies and rooms.” The lobby and ballroom were converted from the original two-story design to separate floors during the prison phase. The pool was filled in and interior finishes were removed. The final plan calls for converting the hotel to 262 new rooms plus restaurants. In addition, the plan includes a 140,000 square foot apartment tower on top of the hotel’s garage.

Next steps to revive the Cabana Motor Hotel

At present, a historic plan from the developer is in Austin to be approved. In 2015, Preservation Dallas named the building as endangered to assist in saving the old hotel with its mid-century architecture. These historic designations are important for acquiring special financing for historic structures.

If all plans proceed as expected, construction will begin in 2019.

Photo from the Texas History Collection, provided by Dallas Heritage Village to the Portal to Texas History