Looking for Inspiration

Running on treadmillby Mary Hesdorffer, NP, Executive Director of the Meso Foundation

I found myself on the treadmill looking for inspiration to go the extra mile. Two miles into it and I am running out of steam. I am not an ESPN fan, which means that I have to take inspiration from another source. Into my mind pops up the image of Joe Friedberg, MD.

Of course, I wonder, who else would channel Joe Friedberg while on a treadmill? Am I losing it?

As you know, Joe is a champion in the field of mesothelioma, toughing it out in the operating room with a grueling procedure, which has recently reported some promising results. I recalled a conversation with Joe when he suggested that to complete a pleurectomy decortication, one has to be totally committed to going the extra mile (as these operations last up to 8 hours) and one has to be willing to persevere through fatigue, and physical and mental challenges.

There has been much debate about surgery – extrapleural pneumonectomy (EPP) vs. pleurectomy decortication (PD) vs. those who believe that surgery should not be offered to patients with mesothelioma, and advocate for palliative care only.

I think about Joe in these debates, and his honesty and lack of bravado when he simply states that “we don’t know what is the best surgical option to offer patients and that all surgery in this disease is experimental.” Though the uncertainty is unsettling, the honesty is refreshing.

Recently, Dr. Friedberg and his team at UPENN have launched a new clinical trial that will randomize patients to either a pleurectomy decortication or a pleurectomy decortication coupled with photodynamic therapy. Joe has spent many years championing photodynamic therapy as an adjuvant therapy to his pleurectomy decortication surgery, making this clinical trial a one-of-a-kind move to get closer to the truth.

Doing 3 miles on a treadmill no longer seems daunting.

Here is why Joe’s courage is so important and why I hope others follow in his footsteps. It is well-known among researchers that most surgical studies have an inherent bias to them. In other words, a surgeon’s excellent numbers may be produced not only by their skill, but also by choosing to operate on patients who have the best chance to tolerate the surgery and do well after. The fact is, surgery often results in a surgical remission, but unfortunately, in mesothelioma, the cancer generally returns after a certain period of time. To extend the remission, surgeons use specific adjuvant therapies to lengthen the time to progression and, of course, create the best case scenario to prevent the return of disease. This is the crux of the discussion about what will kill the cells that are waiting like seeds in a garden ready to sprout into recurrent disease.

I am appalled to hear so many surgeons in this disease state quite frankly that their approach works and there is no need to do a randomized trial which will eliminate bias from their results. Worse yet are those surgeons who boast that their patients do better in their hands, with their procedure yet when I scour the literature there are no published reports in scientific journals. In academic medicine there is a phrase “If it isn’t published, it never happened.” In other words it is expected that you submit your results to a peer reviewed journal to demonstrate that your outcomes are accepted by your peers and your data has been analyzed by, and scrutinized by unbiased reviewers who are experts in the field of surgery. There is no room for arrogance when we are losing patients in these procedures. We need to know what is the true statistical difference. The gold standard is to compare a new hypothesis and test it against the standard to see if this really is a significant improvement.

Dr. Friedberg has reported some impressive results with his combination of pleurectomy decortication combined with photodynamic therapy, and now he’s willing to take a step further to understand if there is a difference between patients undergoing pleurectomy decortication alone from those getting both the surgery and the adjuvant therapy.

This is what the mesothelioma community needs – “proof of the pudding.” We truly do not know what is better so we need to strip back the notion of “my treatment works, and I don’t need to prove it.” Randomized clinical trials can help us find a gold standard of treatment for mesothelioma.

I guess, what that means is that I, too, should be going the extra mile on this treadmill. Mile 4, here I come.

Meso Foundation Updates its Peer-Review for Research Grant Funding

ResearchAs the only non-government funder of peer-reviewed mesothelioma research, the Meso Foundation has announced an update to its peer-review process for evaluating research grant proposals, so as to once again match the process by the National Institutes of Health (NIH).

The Foundation has always modeled its peer-review process after the NIH, so when the NIH made changes in 2013, the Foundation followed suit.

The change involves streamlining the reviews by eliminating the two-step process and replacing it with one step only. Instead of sending a project through two separate rounds of review, which would usually result in a total of 3-4 number of reviewers looking at each project, now all 3-4 reviewers evaluate the project in the one and only round. This ensures a quicker review turnaround and a more efficient process.

To learn more about the Meso Foundation’s research grant program, visit curemeso.org.

A Look at the Advancing Breakthrough Therapies for Patients Act

Dr. Mary Hesdorffer, NP, Executive Director, Mesothelioma Applied Research Foundation takes a look at the Advancing Breakthrough Therapies for Patients Act.by Mary Hesdorffer, NP, Executive Director, Mesothelioma Applied Research Foundation

The Advancing Breakthrough Therapies for Patients Act was first introduced in the Senate by Senators Bennet ( D-CO), Hatch (R-UT) and Burr (R-NC). Two months later, Congresswoman DeGette (D-CO) and Congressman Bilbray (R-CA) introduced the act in the House of Representatives. The bills, which received bipartisan support, were included as an amendment to the Food and Drug Administration’s Safety and Innovation Act (FDASIA), the latest iteration of the Prescription Drug User Fee bill, and in July of 2012, the breakthrough therapy designation was signed into law.

As a result of this law, a new drug may be designated as a breakthrough therapy if it is intended to treat a serious or life-threatening disease, and if preliminary clinical evidence suggests it provides a substantial improvement over existing therapies. Once a breakthrough therapy designation is granted, the FDA and drug sponsor work together to determine the most efficient path forward. In just two years, 178 requests for breakthrough designation have been submitted, 44 designations have been granted, and 6 drugs have been approved within the program.

On May 6 of this year, Mary Hesdorffer, the executive director of the Meso Foundation, and Melinda Kotzian, its chief executive officer, attended the congressional briefing titled Friends of Cancer Research, which focused on evaluating the progress of this program.

The panel agreed that the next task will be to streamline the process. This will eliminate applications that absolutely do not meet the criteria for breakthrough designation.

Janet Woodcock, MD, director, of the Center for Drug Evaluation and Research within Food and Drug Administration, stated that they “are not planning on moving drugs through this process that offer only incremental progress, but those that demonstrate a substantial benefit.”

Two representatives of the pharmaceutical industry shared their companies’ experience in gaining the first designation under this act. They noted that the time and commitment of all parties involved made this process work.

Dr. Woodcock cautioned that sequestration had an impact on the financing of this program. It will take more funding to continue operating the Breakthrough Therapies program at the present level, but she hopes that streamlining the process will allow for a more drugs to reach the patients in need.

Hypnosis Therapy may Decrease Fatigue in Mesothelioma Patients

RelaxationIt was recently reported that a clinical trial that randomized patients to receive hypnosis and cognitive therapy had a statistically significant reduction in their fatigue levels as compared to 79 percent of patients who did not have this intervention. The sudy was led by Guy Montgomery, PhD, Director of the Integrative Behavioral Medicine Program at Mount Sinai Hospital in New York.

Two hundred breast cancer patients who were undergoing radiation therapy were eligible to participate in this study. It was unusual to find that six months after the completion of radiation therapy, the intervention group reported less fatigue than 95% of the control group (patients who did not receive hypnosis and cognitive therapy). Mesothelioma patients often receive radiation therapy following the completion of an extrapleural pneumonectomy (EPP) or a Pleurectomy Decortication (PD). Though there are no studies currently underway in mesothelioma, it seems reasonable that patients who will be undergoing surgery plus radiation should be put in touch with integrative medicine to ascertain what services might be available to them.

A few years back, we invited a hypnotherapist to conduct a workshop at the Meso Foundation’s Symposium to aid the community in banishing negative thoughts usually implanted during the initial diagnosis when they were informed of the disease and prematurely provided with a prognosis from a doctor unfamiliar with mesothelioma. A positive outlook certainly does not cure the disease, but patients who are positive tend to eat better, engage with others, and less often fall victim to depression, which could impact their ability to function.

The study, recently published in the Journal of Clinical Oncology (2014; doi:10.1200/JCO.2013.49.3437

Mesothelioma Researcher Receives Pioneer Award

Dr. Michele Carbone

Dr. Michele Carbone spoke at the Meso Foundation’s 2013 International Symposium on Malignant Mesothelioma

The Mesothelioma Applied Research Foundation announced today that the 2014 recipient of its Pioneer Award is Michele Carbone, MD, PhD, for his remarkable achievements in mesothelioma research.

Michele Carbone, MD, PhD is a Professor of Pathology and the Director of the University of Hawaii Cancer Center, a National Cancer Institute designated Consortium Cancer Center affiliated with the University of Hawaii – Manoa. He has published over 150 peer-reviewed papers, most in the area of the pathogenesis of mesothelioma.

In addition to his impressive publication record, Dr. Carbone is known in the mesothelioma community for his tireless work in the Turkish region of Cappadocia, where mesothelioma causes 50% of all deaths. Dr. Carbone discovered that a combination of environmental exposures and genetic predisposition were the reason for such a high incidence of mesothelioma among the villagers. Taking his role as a scientist a step further, alongside famed Turkish professor Izzettin Baris, Dr. Carbone demonstrated his compassion by convincing the Turkish government to move and rebuild the affected villages, thus removing them from the environmental exposures.

Dr. Carbone’s studies in Turkey led him to a life-long quest to identify genes implicated in mesothelioma. In 2001, he published in “The Lancet” that predisposition to developing mesothelioma was transmitted as an in an autosomal dominant character in certain Turkish families.

Subsequently, back in the United States, Dr. Carbone and Joseph Testa, PhD led their research team, which included Drs. Giovanni Gaudino, Harvey Pass, Jianming Pei, Mitchell Cheung, and Haining Yang, to study US families with a high incidence of mesothelioma, and through this collaboration discovered the “BAP1 cancer syndrome.” They found this “syndrome” to be caused by germline mutations of the BAP1 gene, which is characterized clinically by a very high risk of developing mesothelioma, melanoma, and other cancers.

Dr. Carbone is known in his field as a generous mentor, and has helped several prolific scientists enter the field of mesothelioma research. Dr. Haining Yang, is one researcher whose work with Dr. Carbone resulted in a peer-reviewed grant award of $100,000 from the Mesothelioma Applied Research Foundation which helped her to develop the data that allowed her two years later to win her NCI-RO1 and DOD grants to study mesothelioma.

“I have worked closely with Dr. Carbone over the years and have been impressed by his kindness and availability,” said Mary Hesdorffer, NP, Meso Foundation’s executive director. “He has been a leader in the field of mesothelioma research, and every one of his many contributions brings us that many steps closer to life-saving treatments for mesothelioma patients.”

The Pioneer Award honors individuals “pioneering” scientific advances in the field of mesothelioma, with the goal of eradicating the life-ending and vicious effects of mesothelioma. The award will be presented during the Awards Dinner, at the International Symposium on Malignant Mesothelioma in Alexandria, VA, on March 5-7.

Mesothelioma is a malignant tumor of the lining of the lung, abdomen, or heart known to be caused by exposure to asbestos. Medical experts consider it one of the most aggressive and deadly of all cancers. Approximately 3,500 Americans are diagnosed with mesothelioma every year and an estimated one-third were exposed while serving in the Navy or working in Navy shipyards.

ABOUT THE MESOTHELIOMA APPLIED RESEARCH FOUNDATION
The Meso Foundation is the only 501(c)3 non-profit organization dedicated to eradicating mesothelioma and easing the suffering caused by it. The Meso Foundation actively seeks philanthropic support to fund peer-reviewed mesothelioma research; provide patient support services and education; and advocate Congress for increased federal funding for mesothelioma research. The Meso Foundation is the only non-government funder of peer reviewed scientific research to establish more effective treatments for mesothelioma and, ultimately, a cure for this extremely aggressive cancer. To date, the Foundation has awarded over $8.7 million to research.

More information is available at http://www.curemeso.org.