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Month: October 2017

FDA Flags Mesothelioma Drugs

FDA Flags Some Mesothelioma Drugs On Quarterly Adverse Events Report

Mesothelioma patients have limited treatment options, and often times these come with some known side effects. While these side effects, such as pain, nausea and fatigue, can be treated by your medical team, there are some “adverse affects” that may require the U.S. Food and Drug Administration to take a second look at the drug. In the FDA’s latest quarterly watch list, it has identified seven cancer treatments, three of which are used in mesothelioma care, as having possible serious risks.

In “Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS): April – June 2017” issued Oct. 6, the FDA listed 19 drugs from its FDA’s Adverse Event Reporting System (FAERS). FAERS, according to the FDA, is a database that contains adverse event reports, medication error reports and product quality complaints resulting in adverse events that are submitted to the FDA. It is used as a tool by the agency to look for new safety concerns that might be related to a marketed product.

Although the FDA issues these reports, the agency warns that  the information does not give the complete story. The data, according to the FDA, is not an indicator of the safety profile of the drug or biologic, and the report does not establish “causation.” In fact, the FDA reports that “there is no certainty that a suspected drug caused the reaction.”

In the report, however, the FDA does indicate action it will take when looking into the data that caused a drug to end up on the report.

Identified Drugs and Related Mesothelioma Information

  • Keytruda (pembrolizumab): Complications of allogeneic hematopoietic stem cell transplantation (FDA is evaluating the need for regulatory action), and Stevens-Johnson syndrome and toxic epidermal necrolysis (the “Warning and Precautions” section of the labeling for Keytruda was updated to include Stevens-Johnson syndrome and toxic epidermal necrolysis.)
  • Opdivo (nivolumab): Complications of allogeneic hematopoietic stem cell transplantation (FDA is evaluating the need for regulatory action.)
  • Taxotere (docetaxel): Docetaxel and neutropenic enterocolitis (FDA is evaluating the need for regulatory action.)

Both Keytruda and Opdivo work by blocking the PD-L1 protein and activating the immune system, leading it to attack and kill cancer cells. These drugs are immunotherapy treatments and involve allogeneic hematopoietic stem cell transplantation, which translates to donor blood stem cell transplants. Opdivo clinical trials are ongoing for mesothelioma patients and they have shown “significant benefits” for patients.

Keytruda is approved for use in lung cancer and melanoma, and in an unprecedented move, in May the FDA approved the use of Keytruda for any cancer having a biomarker referred to as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), regardless of cancer type.

In the approval of Keytruda, the FDA noted potential complications or death related to allogeneic hematopoietic stem cell transplantation after using Keytruda. Stevens-Johnson syndrome is a rare, serious and potentially deadly disorder of the skin and mucous membranes that leads to a painful red or purplish rash that spreads and blisters.

Keytruda has brought hope to the mesothelioma community with mesothelioma warriors showing excellent results from use of the drug. Mavis Nye of England, an eight-year mesothelioma survivor, can now claim remission from her pleural mesothelioma after participating in a two-year clinical trial of Keytruda.

Docetaxel is a chemotherapy drug often combined with gemcitabine as a second-line treatment of lung cancer and mesothelioma. Neutropenic enterocolitisis, as triggered with docetaxel, is  a rare yet severe complication of chemotherapy signaled by extreme abdominal pain. If not treated properly, it can lead to death.

This report can be considered as another source of information when determining to use a drug for treatment, and is not an indication that you should halt treatment or use of a drug. Any questions you may have should be directed to your doctor.

Mesothelioma, an asbestos-caused cancer, is both incurable and deadly. Close to 3,000 Americans are diagnosed with the disease each year.

Talk with your doctor to find out which treatment is best for you.

Mesothelioma Medical Team Is On Your Side

Your Mesothelioma Medical Team Is On Your Side

People can play different roles in your life, and those roles can change dramatically based on the circumstances. The same goes for your doctors and medical team. While my father battled pleural mesothelioma, these amazing people went from strangers to confidants to friends.

When Dad was first diagnosed, we were complete strangers to all of the team. I remember in our first meeting with Dr. Harvey Pass, he entered the room and I immediately felt at ease. Hearing from someone who was optimistic and believed that he could really help was a welcome breath of fresh air. We had come off of the worst news of our lives and were given little hope until he entered the picture.

Once surgery was completed, we continued on with more and more practitioners who specialized in an area of need. They each treated us like real people, and counseled us on what steps were necessary moving forward, and joined in celebrations when the scans were clear.

I will always remember the office of my father’s primary care physician. The morning after he passed away, we were still working on notifying everyone when we got a call from them. They asked me if they could speak to my Dad; when I had to tell them that he was gone, the woman on the other end of the phone broke down in tears, saying, “Honey, I’m so sorry.  I really liked your Dad,” then quickly hung up without saying goodbye. Moments later, the doctor called, asking what had happened and offering the most sincere condolences. The staff later joined us at the viewing and funeral, and still check in with us today.

Always remember that your medical team is on your side. They will be with you through your entire struggle and can even become friends. I appreciate all those who treated my father, and also me and my family, although it was in a different way.  We thank you from the bottoms of our hearts.

Dr. Marjorie G. Zauderer - Medical Oncologist Specializing in Lung Cancer and Mesothelioma

Marjorie Zauderer of Meso Foundation Receives DoD Grant

A member of the Mesothelioma Applied Research Foundation’s Science Advisory Board and oncologist at Memorial Sloan Kettering Cancer Center has received a grant from the Department of Defense to help further her mesothelioma research.

Dr. Marjorie G. Zauderer is a medical oncologist specializing in lung cancer and mesothelioma. As the recipient of the DOD’s Career Development Award, she will be provided funding for her research into the role of the BAP1 gene in mesothelioma. Previous research has shown that mutations in BAP1 predisposes people to mesothelioma.

“A better understanding of this gene could mean a better understanding of mesothelioma and how it develops in patients,” said Zauderer in a press release.

http://www.prweb.com/recentnews/

BAP1 was first linked to mesothelioma through research done by Drs. Joseph R. Testa of the Fox Chase Cancer Center in Philadelphia and Michele Carbone of the University of Hawaii. A 2011 study led by Testa and Carbone and published in the journal Nature followed two families that carried inherited BAP1 mutations and had multiple mesothelioma cases. Family members also developed cancers of the eye, skin, breast, ovaries and kidneys, suggesting that BAP1 mutations underlie multiple cancer types.

More recently, Testa and colleagues found that mice with BAP1 mutations were predisposed to mesothelioma. Their results, published in Cancer Research, also showed that exposure to asbestos—currently the only known cause of mesothelioma—is a more important mesothelioma risk factor than genetics, as mice without BAP1 mutations still developed tumors.

Zauderer has been looking at the role of BAP1 in mesothelioma patients for three years. The DOD grant will provide her project funding for three more years. Her current work is focused on gathering a sufficiently large collection of genetic samples from people with BAP1 abnormalities in order to conduct a detailed analysis. She hopes to have a drug that is ready to begin or has already completed phase 1 clinical testing in the next 3 to 5 years.

The DOD is interested in mesothelioma research because the disease disproportionately afflicts people who served in the Navy or worked in shipyards. Comprising just 8 percent of the U.S. population, veterans represent around 30 percent of all mesothelioma deaths that have occurred in this country.

Mesothelioma typically develops 15 to 40 years or more following initial exposure to asbestos. The Navy and other branches of the military for decades specified asbestos for a wide range of products, including boilers, turbines, pipes, valves, electrical components, and much more. Even veterans who did not directly handle asbestos-containing products are at risk of developing mesothelioma via secondhand exposure.

If you or a loved one served in the Navy and has been diagnosed with mesothelioma, please contact Belluck & Fox, LLP to learn how we can help you.

Comprehensive MESO Center Established at West LA

Comprehensive MESO Center Established at West LA

The Comprehensive Mesothelioma Center (CMC) at the West Los Angeles Veterans Administration Medical Center (VAMC) provides veterans stricken with asbestos cancer access to specialized services and an unprecedented high standard of care. There’s just one problem: most veterans have never heard of the Center.

There is no mention of the Center on the VA website and even many doctors in the VA system aren’t aware that the Center exists.

https://www.fightmesofoundation.com

The Comprehensive Meso Center in West Los Angeles specializes in the treatment of malignant pleural mesothelioma (MPM), an aggressive and incurable cancer of the pleura (the lining of the lungs) caused by exposure to asbestos. Approximately one-third of the 3,500 Americans diagnosed each year with mesothelioma are former military members, and yet the US Government has never fully funded a medical program dedicated to veterans with asbestos cancer.

Advocates of the Comprehensive Meso Center in West LA are hoping to obtain $5 million in annual funding to expand the Center through a petition aimed at VA Secretary Robert A. McDonald. Supporters ask that it be called the “Elmo Zumwalt Comprehensive Mesothelioma Treatment & Research Center” in honor of Admiral Elmo A. Zumwalt, Jr., the youngest-ever chief of Naval Operations, who died of mesothelioma in 2000.

Son of Veteran Killed by Meso Says VA Has Failed to Publicize Specialty Center

One of the most outspoken advocates of VA-funding for the Center is Michael Johnson. Michael lost his father, Marine Corps veteran John Johnson, to mesothelioma in 2012. John received treatment at VA hospitals in North Las Vegas and Long Beach, but by the time his family learned of the Comprehensive Mesothelioma Program in West Los Angeles, his cancer was beyond treatment.

Michael says that his goal is to prevent something similar from happening to another veteran. He believes that his father would be alive today if John had access to mesothelioma specialists and has been lobbying the VA to provide better information about the services available at the West LA Center through letters. He’s also been getting the word out to the public through his website.

“Despite multiple requests and promises, the VA has yet to perform the simple administrative task of updating its website about the existence of the [mesothelioma] program,” Johnson said in a recent video. “There is no effort to educate our war heroes stricken with this cancer. There is no effort to publicize or build the program. That’s negligent, and that’s wrong.”

How Veterans With Mesothelioma Can Receive Treatment at the CMC

Veterans who have been diagnosed with mesothelioma should seek treatment at a mesothelioma center. A list of such centers is available on the website of www.mesotheliomahelp.org.

If you are treating with the VA health system, the team of doctors and nurses at the West LA VA Medical Center have extensive experience diagnosing and treating MPM and are available to care for all veterans stricken with mesothelioma—not merely those residing in the Los Angeles area. In fact, if you are able to secure a referral to the West LA VAMC, the VA will pay for all of your travel expenses.

In order to receive the best available mesothelioma care, veterans treating in the VA health system who have been diagnosed with mesothelioma should take the following actions:

  1. Let your doctor know about the specialty mesothelioma services offered at the West LA VAMC.
  2. Ask for an “inter-facility” consult through the VA’s “TeleHealth” program.
  3. Undergo a “virtual consult”.

If deemed eligible, you may be referred to the West LA VAMC for treatment.

House Votes to Cut VA Workplace Protections - Veterans suffering from asbestos disease

House Votes to Cut VA Workplace Protections

The House voted this week to make it easier to fire ineffective Department of Veterans Affairs (VA) employees, a measure that White House officials threatened to veto. Meanwhile, a plan to reallocate funds from the Veterans Choice program to fund a VA budget gap moved closer to fruition with an amendment tucked inside a highway spending bill.

It’s been a tough year for the Department of Veteran Affairs. Congress passed a $16.3 billion reform law last summer to shore up a scandal over long patient wait times and a VA cover-up of them, but problems persist. A June report indicated that, compared to a year ago, wait times for appointments longer than 30 days are up 50 percent. The department has fired practically no one despite receiving Congressional authority to more easily let go underperforming VA workers. And just weeks before the fiscal year ends, the VA announced that they have a $2.6 billion budget shortfall.

VA Secretary McDonald says that the shortfall is the result of increased demand for VA services, including expensive hepatitis C treatments. To close the gap, he wants to move funds from the Veterans Choice program, which provides funding for vets to see a private doctor if they cannot secure a VA appointment within 30 days or live more than 40 miles from a VA facility. The VA claims that hospital closures could occur if the funding gap is not closed.

House Veterans Affairs committee chair Jeff Miller reluctantly agrees with McDonald’s plan and sponsored an amendment to divert $3.35 billion from the Choice Program, according to ABC News. But as he explained, some veterans could suffer as a result.

https://abcnews.go.com/Politics/wireStory/emergency-bill-fund-veterans-affairs-department-32742493

“This is going to negatively impact the longevity of the Choice Program that we worked so hard last year to pass and have the president sign into law, that gives the veterans the opportunity to choose where they get their health care and when they get their healthcare,” said Miller.

The Choice Program is slated to run through august 2017 or until its $10 billion is used up.

The same legislation that created the Choice Program also made it easier to fire senior VA executives linked to scandals or found to be underperforming. Only a handful of administrators, however, have been fired. Around 190 lower-level workers associated with the scandal of last summer have faced disciplinary action, but only a few have been fired.

Critics, according to the Military Times, allege that the department is disinclined to fire workers due to complex federal labor rules. In response, House Republicans passed rules this week that shorten fired or demoted workers’ appeals process and limit paid worker suspensions.

https://www.militarytimes.com/story/military/capitol-hill/2015/07/29/house-new-va-reforms/30845137/

Rep. Jeff Miller, who sponsored the VA Accountability Act of 2015, said that, “Bad employees mean bad customer service. If we truly want our veterans to have the very best care and services, status quo is no longer acceptable.”

Rep. Donna Miller (D-MD) called the bill an attempt at “union busting,” while White House officials publicly threatened a veto, saying that the bill could “have a significant impact on VA’s ability to retain and recruit qualified professionals and may result in a loss of qualified and capable staff to other government agencies or the private sector.”

Senate Republicans are expected to take up the measure after their August recess.

Veterans suffering from asbestos disease who have questions about VA compensation or legal questions related to their illness should contact Belluck & Fox, LLP for a free consultation.

Vets can also use our veterans benefits tool to find out whether they qualify for VA financial assistance.

Free Mesothelioma Patient & Treatment Guide

We’d like to offer you our in-depth guide, “A Patient’s Guide to Mesothelioma,” absolutely free of charge.

It contains a wealth of information and resources to help you better understand the condition, choose (and afford) appropriate treatment, and exercise your legal right to compensation.

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