publication date: May. 13, 2016

In Brief

Brigham Does Not Contest Plaintiffs’ Offers of Proof as Morcellation Cases Proceed

 

BRIGHAM & WOMEN’S HOSPITAL chose not to contest the plaintiffs’ offers of proof in two medical malpractice lawsuits against the Boston hospital at a Massachusetts tribunal May 13.

The two lawsuits related to power morcellation will now be allowed to proceed. The suits were filed by Richard Kaitz and Hooman Noorchashm, whose wives, Erica Kaitz and Amy Reed, had the controversial minimally invasive surgery at Brigham in 2012 and 2013, respectively.

The procedure, which until recently was performed in an estimated 100,000 women annually in the U.S., is the focal point of a two-year debate that has divided the surgical field. When a previously undiagnosed malignant tumor—usually a sarcoma—is present, the procedure spreads the cancerous tissue, upstaging the disease (The Cancer Letter, How Medical Devices Do Harm).

Erica died Dec. 7, 2013 from metastatic leiomyosarcoma, and Reed, formerly an anesthesiologist at Beth Israel Deaconess Medical Center, is undergoing treatment for stage IV disease.

“It’s a rare case that the defendant does not contest the plaintiff’s offer of proof at the tribunal stage,” said Tom Greene, the attorney representing Kaitz and Noorchashm’s families. Brigham did not respond to an email from The Cancer Letter by deadline.

Massachusetts law requires that a tribunal—consisting of a judge, an attorney, and a physician—review medical malpractice cases to screen out lawsuits that are not supported by clinical evidence or fact. The process determines whether there is sufficient evidence for the case to proceed.

According to the Massachusetts Medical Society, tribunals screen out approximately 16 percent of all medical malpractice cases in the state.

 

THE AMERICAN UROLOGICAL ASSOCIATION honored its 2016 award recipients during its 111th Annual Meeting in San Diego.

William Marston Linehan received the Ramon Guiteras Award for his contributions to the art and science of urology, most notably in the identification of genes associated with different types of kidney cancers and developing new strategies for their management.

Margaret Sue Pearle was presented with the Hugh Hampton Young Award for contributions to the science of nephrolithiasis by providing the evidence base that has shaped paradigms for the medical prevention and surgical therapy of stone disease, and for exemplary service in AUA Education and Guidelines.

Benjamin Canales received the Gold Cystoscope Award for his research initiatives in the pathogenesis of nephrolithiasis, which include the development of new animal models and the exploration for novel therapeutic approaches. The Gold Cystoscope Award is presented to a urologist within 10 years of completing residency training.

James Montie received the Lifetime Achievement Award his leadership in the field of urologic oncology and a lifelong commitment in helping advance urological education.

Peter Albertsen received the Eugene Fuller Triennial Prostate Award for his contributions to the understanding of prostate cancer, most notably in epidemiology and statistical analysis. This award is presented once every three years for contribution to the study of the prostate gland and its associated diseases.

W. Hardy Hendren III received the Victor A. Politano Award for his contributions in developing surgical techniques of reconstruction of urogenital anomalies and undiversion in children. This award is for research and work in the field of incontinence and for enhancing the treatment of incontinent patients and improving quality of life.

William Parry was presented with the William P. Didusch Art and History Award for his work in preserving the art and history of urology, naming the William P. Didusch Urology History Museum and creating four award winning urology exhibits. This award recognizes contributions to urological art, including, but not limited to, illustrations, sculpture, still photography, motion pictures and television productions.

Paul Lange received the Gold Cane Award for his career of academic leadership, mentorship and innovative contributions to the fields of urological oncology and endourology.

Medivation Inc. received the Health Science Award for support of physician and patient education in prostate cancer.

The Distinguished Contribution Awards are presented to individuals who have made contributions to the science and practice of urology, including, but not limited to, contributions made in a sub-specialty area, for military career service or for humanitarian efforts. The following individuals were recognized with this award:

Gopal Badlani, for leadership as secretary of the American Urological Association as well as decades of urological education and humanitarian service.

Allen Morey, for contributions to the science and education of civilian and military urologists in the performance of urological reconstructive surgery as well as 18 years of philanthropic missions to Honduras.

Peter Schlegel, for years of research, discovery and treatment of male infertility as well as urological education and dedication to students, residents and fellows.

The Distinguished Service Awards are presented to individuals who have made contributions to the goals of the AUA. The following individuals received this award:

Martin Dineen, for more than two decades of leadership in health policy as well as humanitarian service in Haiti to eliminate urogenital elephantiasis.

Roger Dmochowski, for leadership in the specialty of Female Pelvic Medicine and Reconstruction, and for development of AUA Guidelines.

Raju Thomas, for leadership as the chair of urology at Tulane University, particularly after the devastation of Hurricane Katrina, as well as for humanitarian service in providing minimally invasive surgery to less-privileged areas of the world.

Presidential Citations are presented to individuals deemed to have significantly promoted the cause of urology during a specific period of time. Each recipient is chosen by the AUA president. Presidential Citations were bestowed upon the following individuals:

Arnold Belker, for years of leadership in andrology and reproductive medicine and for innovation and teaching in microsurgery.

Peter Bretan, for leadership in disaster relief and humanitarian work both in the U.S. and abroad; and for teaching urological skills in developing nations.

Anthony Casale, for years of leadership in pediatric urology, for the treatment of complex urogenital anomalies in children and resident teaching.

Col. Paul Friedrichs, for outstanding leadership in the United States Air Force Medical Corps, for support of combat operations in Iraq, and for leadership in the AMA House of Delegates.

J. William McRoberts, for many years of leadership as chair of urology at the University of Kentucky and for service as the AUA Southeastern Section secretary and president.

Drogo Montague, for innovation and teaching in prosthetic surgery and penile reconstruction and for leadership in creating AUA Guidelines.

 

TOM ANDRUS was named chief digital officer and executive vice president of the Prostate Cancer Foundation.

Most recently, Andrus was general manager and senior vice president of AXS.com, a division of AEG, building a new ticketing company. Previously, he was senior vice president of product at MySpace, where he led the product, design, mobile, and search businesses.

Prior to joining MySpace, Andrus spent eight years at EarthLink where he created the company’s product management team, led business development, and established new divisions, launching the wireless, voice, cable and value-added services business units. He also led the Utilities product team at Symantec/Norton, and was one of the founding employees of Fitnesoft, a health management software company.

 

STAND UP TO CANCER published a series of Certification for Nursing Education training modules, with the Boston College William F. Connell School of Nursing, focused on immunotherapy.

The first web-based CNE modules will be available in July. In its first round, the program will seek to train 25 nurses working in immunotherapy. The program was announced as part of National Nurses Week, May 6-12.

The program will address providing care for cancer patients receiving immunotherapy, including education on immunology and related pathophysiology, symptom management, and nursing interventions to reduce symptom distress and promote wellness. The modules will meet CNE standards and each module will provide 3.5 to 5 contact hours from the Boston College William F. Connell School of Nursing.

 

CANCERCARE published a report illustrating the physical, emotional, financial, practical and informational needs cancer patients experience during and after clinical treatment.

The 2016 Patient Access and Engagement Report analyzed more than 3,000 patients in ethnicity, income, education, geography, age, insurance, cancer type and treatment stage—and evaluated their understanding of their diagnosis and access to care, participation in treatment planning, communication and engagement with providers, insurance and financial issues, the impact of cancer on quality of life, and issues related to survivorship. The project was made possible by AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Genentech, Helsinn Therapeutics, Gilead Sciences, Incyte Corporation, Janssen Oncology, Lilly, Merck, PhRMA, and Pfizer.

The report found that people in all stages of cancer say they don’t have enough information about their illness, treatment options, benefits and risks, clinical trials, insurance coverage, and how to find emotional, financial and practical support.

One-quarter of respondents ages 25 to 54 disagreed with some of their doctors’ recommendations for diagnostic testing and did not follow them, with the majority citing cost as the reason. Fewer than half of respondents discussed the cost of follow-up testing with their physician. Patients ages 25 to 54 had nearly twice as many post-diagnosis conversations about their cancer with nurses, religious leaders, social workers, physician assistants, or nurse practitioners as patients 55 and older.

The report is available on the CancerCare website. www.cancercare.org/accessengagementreport

 

CANCER SUPPORT COMMUNITY BENJAMIN CENTER presented its annual Gilda Award Gala in Los Angeles. The organization honored actress Frances Fisher with the Gilda Award; CSC advocate Joyce Green with the Wellness Award; and City of Hope’s Matthew Loscalzo with the Harold H. Benjamin Innovation Award.

The event was hosted by John Sencio, a national television host, producer and cancer survivor.

Loscalzo is the Liliane Elkins Professor in Supportive Care Programs, professor in the Department of Population Sciences, executive director of the Department of Supportive Care Medicine, and the administrative director of the Sheri & Les Biller Patient and Family Resource Center at the City of Hope-National Medical Center.

Fisher has starred in over 30 theatrical productions and was honored for promoting wellness and generosity. Green served as director of development for Cancer Support Community Benjamin Center.

 

CITY OF HOPE received a $2.3 million R01 research project grant from NCI to fund studies associated with a phase I/II clinical trial in relapsed/refractory adult acute myeloid leukemia. The research team will be led by Steven Rosen, City of Hope’s provost and chief scientific officer.

The phase II clinical trial will test 8-chloro-adenosine in AML patients whose disease has failed to respond to initial chemotherapy. The research will also detail the drug’s mechanism of action, and further characterize the cytotoxic effect of the drug on leukemia stem cells. In addition, researchers will conduct genomic profiling of AML cells to generate gene expression signatures that may help identify patients who may particularly benefit from 8-chloro-adenosine treatment.

The Rising Tide Foundation will fund the clinical trial testing the drug’s safety and efficacy, while the NCI grant will fund correlative studies in genomic profiling and the drug’s mechanism of action in patients.

 

BIODELIVERY SCIENCES INTERNATIONAL Inc. and Collegium Pharmaceutical Inc. signed a licensing agreement in which BDSI grants exclusive rights to develop and commercialize Onsolis (fentanyl buccal soluble film) in the U.S. to Collegium.

Onsolis is an opioid agonist indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.

Under terms of the agreement, Collegium will be responsible for the manufacturing, distribution, marketing and sales of Onsolis in the U.S. Both companies will collaborate on the ongoing transfer of manufacturing, which includes submission of a Prior Approval Supplement to FDA. Upon approval of the supplement, the New Drug Application and manufacturing responsibility will be transferred to Collegium.

Financial terms of the agreement include: $2.5 million upfront non-refundable payment, payable to BDSI within 30 days; reimbursement for a pre-determined amount of the remaining expenses associated with the ongoing transfer of manufacturing of Onsolis; $4 million upon first commercial sale of Onsolis in the U.S.; and up to $17 million in potential payments based on achievement of performance and sales milestones.

 

THOMAS JEFFERSON UNIVERSITY joined the TriNetX network for clinical trial design and to support Jefferson’s clinical research programs.

Pharmaceutical researchers will be able to access Jefferson’s de-identified clinical data through TriNetX’s network of healthcare institutions to support clinical study and protocol design, site selection, and patient recruitment across a range of therapeutic areas and development stages.

 

The UCLA Department of Pathology and Laboratory Medicine and Leica Biosystems will collaborate in digital pathology.

Product testing will be conducted with UCLA to validate digital pathology in a high-volume setting. This joint effort builds upon the existing relationship between UCLA and Leica Biosystems that was established in 2011.

The pathology team at UCLA will be working with Leica Biosystems Aperio ePathology and will test and provide quantitative feedback on current and next-generation products from bench research to full clinical adoption.

 

ST. JUDE CHILDREN’S RESEARCH HOSPITAL, with Univision Local Media, raised $4 million during this year’s Promesa y Esperanza (Promise and Hope) radio event held in 17 media markets in the U.S. and Puerto Rico April 7-8.

St. Jude content included more than 30 hours of radio programming and featured several patient family stories, broadcasted coast to coast via Univision’s radio network, television affiliates, network programs, websites and social media. Since the partnership began in 2006, the St. Jude/Univision national radio event has raised more than $56 million.

 

PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA’s member companies invested an estimated $58.8 billion in research and development in 2015, up 10.3 percent from 2014, based on the 2016 PhRMA annual member survey published in the 2016 Biopharmaceutical Research Industry Profile.

According to PhRMA, the biopharmaceutical industry is the most research-intensive sector of the U.S. economy, investing on average six times more in R&D as a percentage of sales than all other manufacturing industries.

The sector also accounted for an estimated 17 percent of all U.S. business R&D spending, the largest share of R&D spending by U.S. businesses. From 2000 to 2015, more than 550 new medicines were approved by FDA, including a record 56 new medicines in 2015.

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