Nanotechnology Targets Mesothelioma; FDA Keeps Watchful Eye on Developments

The latest emerging medical technology, nanotechnology, has heralded myriad breakthroughs in the development of novel therapies for orphan diseases and cancers. Mesothelioma researchers have started focusing on using nanotechnology to deliver cancer-fighting drugs directly to cancerous cells, thus, leaving healthy cells intact.

The infinitesimal size of nanoparticles – the size of one-billionth of a meter – allows payloads of drugs to home in on tumors while minimizing side effects from toxicity due to excess medicine that is currently needed to effectively attack cancer cells. Most often, capsules, referred to as “magic bullets,” are developed to deliver the medicines directly to the targeted cells.

In an article in FDAVoice, the U.S. Food and Drug Administration’s blog site, Celia Cruz, PhD, reports that “materials at the nanoscale can have different chemical, physical, or biological properties compared to their conventionally-scaled counterparts.” As a result, the safety and effectiveness of the drug can be affected, leading the FDA to study the issues and monitor developments with nanotechnology.

Primarily, the FDA set out to determine if the “current regulatory processes are adequate to identify any potential risks and reduce those risks.” The FDA’s Center for Drug Evaluation and Research Nanotechnology Risk Assessment Working Group (Nano Group) was used to conduct an extensive review of the emerging technology.

The Nano Group concluded that the FDA’s current processes are adequate for monitoring nanomaterials. However, the team also identified areas for improvement, such as increased nanotechnology regulatory science research and up-to-date training of the review staff who evaluate marketing applications for drug products developed using nanomaterials.

Nanotechnology Benefits Mesothelioma Researchers

Mesothelioma is a rare, aggressive cancer primarily caused by exposure to airborne asbestos fibers. Designated as an orphan disease in the U.S., a disease that affects fewer than 200,000 people, mesothelioma treatment is limited to managing symptoms and extending survival. Currently, there is no cure available, and the average survival time is less than 18 months. However, researchers are now looking to nanotechnology as a way to attack mesothelioma.

The NYU Langone Medical Center’s Cancer Institute recently purchased a NanoString Technologies nCounter Analysis System with funds donated by the New York mesothelioma lawyers of Belluck & Fox, LLP. Dr. Pass, Chief of Thoracic Oncology, NYU Cancer Center and Chief, Division of Thoracic Surgery, NYU Langone Medical Center, is a renowned mesothelioma specialist and is a past winner of the Pioneer Award from the Mesothelioma Applied Research Foundation for his dedication to mesothelioma research. This tool allows Dr. Pass and his colleagues to obtain faster results as they seek the clues to better treatments and, one day, a cure for mesothelioma.
In 2011, the University of Pennsylvania established the Penn Center for Orphan Disease Research and Therapy focused on discovering novel treatments for rare diseases. One of the primary goals of the Center is to focus on nano-scale systems for developing new ways to deliver drugs.
Researchers at the Institute of Bioengineering and Nanotechnology in Singapore developed a miniaturized biochip using nanotechnology that can assess the effectiveness of anti-cancer drugs on cancer stem cells. This is especially important for allowing oncologists to offer personalized medicine to mesothelioma patients.

“Nanotechnology is a new and exciting field that offers scientists the opportunity to control matter at very small dimensions, opening many possibilities for making all kinds of new products,” said Ms. Cruz.

Sources:

FDAVoice
http://blogs.fda.gov/fdavoice/index.php/2013/10/as-nanotechnology-is-being-used-to-develop-new-drugs-fda-is-working-to-ensure-quality-safety-and-effectiveness/
MIT News
http://newsoffice.mit.edu/2012/noninvasive-diagnostics-for-cancer-1216
University of Pennsylvania
US FDA Nanotechnology Fact Sheet
http://www.fda.gov/Food/GuidanceRegulation/default.htm
Bioengineering and Nanotechnology in Singapore
http://www.ibn.a-star.edu.sg/
University of Pennsylvania
http://www.uphs.upenn.edu/news/News_Releases/2011/07/orphan/

Mesothelioma Invades All Walks of Life

Once again, mesothelioma has shown that it is a disease that knows no bounds. Last week a famous Hollywood actor, Ed Lauter, and a Pennsylvania man in a local Bluegrass band, Don Smitley, both lost their lives to the rare, asbestos-caused disease. Although from very different backgrounds, the two men spent their last year fighting pleural mesothelioma, that more than likely developed decades after the men were first exposed to the toxic fibers.

Asbestos is a known carcinogen and is proven to cause mesothelioma, lung cancer, asbestosis and other respiratory diseases. Often called “asbestos cancer,” mesothelioma is highly aggressive and is resistant to many cancer treatments. The cancer has an extended latency period with diagnosis anywhere from 15 to 60 years after initial exposure to asbestos. Currently, there is no known cure for the disease, and the average survival time varies from 4 – 18 months after diagnosis.

Lauter, 74, was a character actor who starred in over 200 movies, including The Longest Yard, Cujo and recently, The Artist, during his nearly 50-year career. Lauter starred alongside Hollywood A-listers such as Clint Eastwood, Burt Reynolds, and Tom Cruise. According to his publicist, Edward Lozzi, Lauter became ill in May and died last Wednesday from mesothelioma.

Smitley, 57, whose life with mesothelioma was recounted through his daughter’s eyes in her Faces of Mesothelioma blog, was diagnosed with the cancer in January 2012. Since then he had surgery, chemotherapy and radiation in an effort to halt the growth of the cancer. Smitley enjoyed playing the guitar with his other band members in The Dunbar Boys, taking walks with his dog, Charley, and mostly he enjoyed spending time with his wife, Judy and daughter, Jennifer. Smitley passed away last Tuesday.

Recent Mesothelioma Deaths Break the Mold

According to Linda Reinstein, co-founder and President/CEO of the Asbestos Disease Awareness Organization, 30 Americans die every day from asbestos-related diseases. The primary demographic of mesothelioma patients is men aged 65 and older with a history of work in construction and general industry.

The U.S. Centers for Disease Control and Prevention reports that of the 18,068 deaths attributed to mesothelioma from 1999 – 2005, over four times more men than women died from the disease. Recently, however, mesothelioma has seemingly ignored the statistics and has taken the lives of young women as well.

In June, 37-year-old Janelle Bedel of Indiana, also known as “Wonder Woman,” died from mesothelioma after fighting the disease for six years. Janelle tirelessly worked to raise awareness of the cancer, and supported the Asbestos Disease Awareness Organization and the Mesothelioma Applied Research Foundation.

Also in June, Debbie “Muvmuv” Brewer, 54, of England, lost her battle to pleural mesothelioma. Debbie was also a stalwart advocate for the mesothelioma community, and during her seven-year battle with the disease fought to raise awareness of the dangers of asbestos. Debbie’s father died from an asbestos-related disease just three months before she was diagnosed in 2006.

The tragedy of mesothelioma is that the disease is entirely preventable by eliminating exposure to asbestos. In its report “Malignant Mesothelioma Mortality — United States, 1999–2005,” the CDC notes:

“Although asbestos has been eliminated in the manufacture of many products, it is still being imported (approximately 1,730 metric tons in 2007) and used in the United States in various construction and transportation products.

Ensuring a future decrease in mesothelioma mortality requires meticulous control of exposures to asbestos and other materials that might cause mesothelioma.”

Know more about mesothelioma and how you can deal with it.

Allied Health Professionals, Vital to Mesothelioma Care, Recognized

This week is National Allied Health Professionals Week. The week brings to light the number of health care professionals, that are distinct from doctors and nurses, who provide for the physical, emotional and spiritual needs of patients. They also provide support in the prevention, identification and treatment of diseases. Due to the rare and complex nature of mesothelioma, a large number of allied health professionals are needed to provide the appropriate level of support mesothelioma patients require.

Mesothelioma, a rare form of cancer typically affecting the lining of the lungs, is highly aggressive and is resistant to many standard cancer treatments, making it a difficult disease to treat effectively. Patients often undergo surgical procedures, chemotherapy and radiation, interacting with a variety of allied health professionals during each medical appointment.

Allied health professionals are either technicians (assistants) or therapists/technologists. Technicians are trained to perform procedures, but are required to work under the supervision of technologists or therapists. Typically, a technologist gets a certificate with two years or less of higher education, and includes professions such as physical therapy assistants, medical laboratory technicians, radiological technicians and respiratory therapy technicians.

Therapists or technologists are able to evaluate patients, diagnose conditions, develop treatment plans, and understand the rationale behind various treatments. Therapists or technologists learn to evaluate patients’ responses to therapy and to assist with decisions concerning continued treatment or modification of treatment plans.

Since mesothelioma is such a complex disease, it is important for patients to receive multidisciplinary care from a team of specialists that is not limited to physicians or nurses. Following is a short list of allied health professionals that may be involved in the care of a mesothelioma patient:

Respiratory Therapists. Evaluate, treat and care for patients with breathing or other cardiopulmonary disorders. Highly trained respiratory therapists may assume primary responsibility for all respiratory care, therapeutic treatments and diagnostic procedures.
Anesthesiologist Assistants. Under supervision of licensed anesthesiologists (doctors), they operate anesthesia equipment, monitor patients, and assist in providing patient care before, during and after anesthesia.
Cardiopulmonary Rehabilitation Specialist. Help patients understand and manage their heart or lung disease so they can live longer and do more, primarily by making sure the patient understands his condition and his medical regimen.
Clinical Laboratory Science professionals. While not directly involved in the care of the patient, a medical technologist can discover the presence or absence of a disease. They typically maintain vital data for identifying and treating mesothelioma and other health conditions.
Health Information Manager. These professionals manage and maintain all of the medical information vital to providing care to the patient. The health manager must capture each piece of information that is tracked every time a health care personnel treats the patient including medical history, results of examinations, results of X-rays and laboratory tests, diagnoses, and treatment plans.

According to ExploreHealthCareers.org there are 5 million allied health care providers in the U.S., who work in more than 80 different professions. Thank you to all Allied Health Professionals! For a list of Allied Health Professionals see ExploreHealthCareers.org .

Extended Stay America Offers Free Rooms to Mesothelioma Patients Undergoing Treatment

Many people diagnosed with mesothelioma choose to travel to larger cities where mesothelioma specialists are available to offer the latest treatments. The cost for this can be prohibitive, however, for some. Thanks to support from the American Cancer Society and Extended Stay America, patients and their families undergoing cancer treatment now have a place to stay for free.

In an Oct. 21 press release, the American Cancer Society announced that Extended Stay America will “provide 10,000 free nights and 10,000 discounted nights in its hotels to cancer patients who must travel to another city to receive treatment.” Beginning November 1, the rooms will be available in Atlanta, Boston, and Houston, and will be rolled out to other cities in early 2014. The 10,000 rooms at a discounted rate of $12 per night will be offered at 684 locations in the US.

“With cancer impacting everyone’s life in some way, we’re proud to partner with the American Cancer Society to provide the key to hope for patients battling cancer so they can focus on their fight,” said Jim Donald, chief executive officer at Extended Stay America.

Mesothelioma is a rare, incurable disease, not often seen by many oncologists. For optimal treatment, patients are encouraged to receive care from a mesothelioma specialist. A physician who specializes in treating mesothelioma patients has first-hand experience in treatment and diagnosis, as well as information on clinical trials and current studies in the field. More often than not, that specialist is in another city.

Boston and Houston both offer renowned mesothelioma centers. The University of Texas MD Anderson Cancer Center of Houston, which “cares for more patients with mesothelioma than almost any other center in the United States,” houses the Mesothelioma Program. The Program has over 30 experts representing the areas of thoracic surgery, thoracic medical oncology, radiation, pulmonary, and pathology – all with an expertise dedicated and focused on mesothelioma. Anne Tsao, M.D., associate professor in MD Anderson’s Department of Thoracic/Head and Neck Medical Oncology and director of its Mesothelioma Program is one of the leading authorities of mesothelioma in the United States.

Dr. David Sugarbaker, Chief, Division of Thoracic Surgery, founder and Director of the International Mesothelioma Program, Brigham and Women’s Hospital in Boston, is one of the world’s leading authorities on treating mesothelioma. Dr. Sugarbaker founded the International Mesothelioma Program at Brigham and has dedicated his career to treating malignant pleural mesothelioma and to improving mesothelioma patients’ survival rates.

The American Cancer Society already runs and manages the Hope Lodge that “offers cancer patients and their caregivers a free place to stay when their best hope for effective treatment may be in another city,” according to the ACS website. There are 31 Hope Lodge locations throughout the United States, including New York and 22 other states.

Jennifer Gelsickwrote a glowing review of the Hope Lodge in New York City where her father, Don Smitley, and her mother were able to stay during Smitley’s treatment for mesothelioma. Smitley traveled from Pennsylvania to NYC to receive treatment from Dr. Harvey Pass of NYU Langone Medical Center and Dr. Lee Krug of Memorial-Sloan Kettering Cancer Center.

“My family has benefitted greatly from the services offered by the Hope Lodge,” said Ms. Gelsick. “God bless all those involved in the Hope Lodge program, and thank you on behalf of all families and patients you’ve encountered!”

For more information about the Hope Lodge or Extended Stay America programs, call the American Cancer Society at 1-800-227-2345 or visit them on-line.

http://www.cancer.org/treatment/supportprogramsservices/hopelodge/index

Proposed Roadmap for Research on Asbestos

By Wade Rawlins

A draft report, prepared by the federal agency responsible for conducting research and making recommendations to protect worker health, summarizes the current state of scientific understanding of asbestos and other mineral fibers and offers a roadmap to explore unresolved questions.

The reappraisal of asbestos and other mineral fibers, written by the National Institute for Occupational Safety and Health, is intended to guide the development of specific research to reduce scientific uncertainties and provide a firm foundation for future policies.

Asbestos has been a prominent public health issue for more than three decades. During the mid- to late-20th century, scientists made advances in the understanding of the serious health effects of inhaling microscopic asbestos fibers.

Yet, questions remain, the report says. For example, due the complexity of asbestos minerals, the scientific literature contains inconsistencies about the definition of the term asbestos for health protection guidelines. And debate continues about whether to include certain non-asbestos mineral fibers under federal asbestos policies.

The results of new research can inform development of new exposure limits and policies for asbestos and other mineral fibers that are based on well-established risk estimates, NIOSH researchers say.

The report sets three goals:

Develop better sampling and analytical methods for asbestos fibers
Develop a clearer understanding of what determines the toxicity of elongated mineral particles
Develop information on workplace exposures to various elongated mineral particles and health risks associated with them.

In the 1970s, federal agencies developed regulatory standards for exposure to airborne asbestos fibers based on evidence of respiratory disease in workers. Since the standards took effect, the use of asbestos has declined substantially and mining of asbestos in the U.S. stopped in 2002. Still, many asbestos products remain in use and new products continue to be manufactured and imported.

Deaths from asbestosis, a chronic disease, increased almost 20-fold from the late 1960s, when NIOSH began tracking them, to the late 1990s, the report says. Since then, they have leveled off at about 1,500 per year in the U.S. and are expected to continue for several more decades.

Meanwhile, annual deaths from malignant mesothelioma, an aggressive cancer caused by exposure to asbestos and other mineral fibers, increased 7 percent between 1999, when the disease began being categorized separately on death certificates, and 2004, the most recent year of complete data. In 2004, 2,657 people died of mesothelioma. The disease usually appears 20 to 30 years after exposure to asbestos.

The report says that scientific studies of workers exposed to asbestos have clearly documented increased risk of respiratory diseases, including lung cancer, mesothelioma and non-malignant abnormalities involving the lining of the lung. In addition, researchers have determined that laryngeal cancer can be caused by asbestos exposure and there is evidence asbestos exposure may cause other diseases including stomach and colorectal cancers and immune disorders.

Despite the decline in use, an estimated 1.3 million employees in construction and general industry still face significant asbestos exposure on the job, the U.S. Occupational Safety and Health Administration estimates.

Over time, the nature of workplace exposures has changed. In earlier decades, workers were exposed to asbestos that was used in manufacturing processes such as in textile mills and cement pipe fabrication. Today, the primary exposure is during maintenance activities and de-contamination of buildings containing asbestos. Researchers and policymakers need better projections of the number of workers exposed to asbestos fibers now and in the future, the report says.

Initially, researchers concern and workplace safety standards focused on six commercially used forms of asbestos mineral: chrysotile asbestos; and five amphibole varieties: amosite, crocidolite, actinolite asbestos, anthophyllite asbestos and tremolite asbestos.

As researchers learned more about the link between the dimensions of asbestos fibers and their ability to cause respiratory disease and cancer, they became more interested in other elongated mineral fibers that could be inhaled.

In 1990, NIOSH broadened its definition of airborne asbestos fibers to encompass other elongated mineral fibers, in part because the common method to test for microscopic airborne fibers could not distinguish between the various fibers.

Still, much less is known about other mineral fibers in terms of health effects. More research is needed to determine the toxicity of the elongated mineral fibers, the draft report says.

Populations of special interest include the workers at taconite mines in Minnesota and the talc mines in upstate New York who are exposed to mineral fibers that are non-asbestos.

An ideal outcome of the draft roadmap, the researchers write, would be scientific studies that supported recommendations for exposure limits to elongated mineral fibers to protect workers’ health.

The report currently is being reviewed by The Institute of Medicine of the National Academies, the nation’s advisors on science, medicine and engineering. That is scheduled to be completed by the fall of 2009.

NIOSH Report

Author: Nancy Meredith