20141205 - Dec 5, 2014
ISSUE 45 – DEC. 5, 2014PDF

Urgent FDA Action Turns Power Morcellation Into Rarely Used Gynecological Procedure

The power morcellator should no longer be used for hysterectomies or fibroid removal in the vast majority of women getting these procedures, FDA declared in a highly anticipated guidance document Nov. 24.

Using a new authority that bypasses public comment, the agency stopped short of imposing an outright ban on the device, but severely restricted its use.

Top NCI Officials Pledge No Further Consolidation of Clinical Trials System

Top NCI officials made an unusual assurance that the reorganization of clinical trials cooperative groups isn’t a “prelude to reducing the commitment of the NCI to clinical trials-based research.”

The document, published as a letter to the editor of the Journal of Clinical Oncology on Dec. 1, follows up on a meeting Sept. 23, where group chairs and directors of statistical centers asked NCI to assure them that no new cuts are in the works.

Brigham & Women’s Suspends Controversial Morcellation Study As Apparent “Difference of Opinion” with FDA Comes to Light

The Brigham & Women’s Hospital has halted a controversial study that combined power morcellators with “containment bags” intended to capture tissue during minimally invasive gynecological surgery.

Launched earlier this summer, the study was designed to enroll 400 women to test dye leakage in several commercially available bags that have not been cleared by FDA for use with power morcellators.

Varmus’s 2016 Bypass Budget Seeks “Modest” Increase of $823 Million

NCI has published the bypass budget for the fiscal year 2016, asking for $5.754 billion, an $823 million increase over the estimated budget of $4.931 billion.

NYC Doctor Pays $2.35 Million To Settle False Claims Act Suit Over Radiosurgery Reimbursements

A New York City radiation oncologist who specializes in fractionated stereotactic radiosurgery and stereotactic body radiation therapy agreed to pay $2.35 million to resolve a 10-year-old Medicare fraud lawsuit.

 

Drugs and Targets

  • Blincyto granted accelerated approval in R/R ALL
  • Broad Institute, Harvard University, MIT and Editas Medicine form collaboration
  • FDA grants clearance to IQQA-BodyImaging
  • CMS issues final payment decision for Cologuard screening test
photoIn Brief

  • David Chambers named deputy director for implementation science at NCI DCCPS

  • Linda Weiss announces intention to retire from NCI Office of Cancer Centers

  • 2014 John Scott Award winners announced

  • Nicholas Petrelli receives clinical research award from the Association of Community Cancer Centers

  • Anjen Chenn named VP of clinical operations at Metamark

20141121 - Nov 21, 2014
ISSUE 44 – NOV. 21, 2014PDF

As FDA Weighs its Options on Morcellation, Debate Erupts Over Harvard Device Study

Here is what we know: A surgical device used to perform about 100,000 hysterectomies and myomectomies every year in the U.S. has been shown to spread cells from undetected or missed uterine cancers—rapidly upstaging the disease.

And here is what we don’t know: What will FDA do about it?

The agency is under pressure to respond to the growing outcry from patient advocates, who want a ban on the device.

Conversation with The Cancer Letter

Demetri: Morcellation Worsens Outcomes In Patients with Undiagnosed Cancers

As an oncologist who treats sarcoma, George Demetri has seen the adverse consequences of power morcellation, the surgical technique widely used to perform laparoscopic hysterectomies and remove putative fibroids.

In a small minority of cases, these fibroids instead represent unsuspected malignancies—including rare and aggressive leiomyosarcomas—which were impossible to detect prior to the morcellation procedure.

The Cancer Letter is taking a Thanksgiving Break.

The next issue will be published on Dec. 5.

CPRIT Awards 32 Grants

The Cancer Prevention and Research Institute of Texas awarded 20 grants through its product development program, five grants through its prevention program, and seven recruitment grants through its research program, totaling more than $65 million.

ASCO Proposes Principles For Future Debate on Medicaid

The American Society of Clinical Oncology has proposed a set of principles for shaping future debate of the role of Medicaid.

Obituary

Connie Curran, 67, C-Change Executive Director

Connie Curran, 67, the first executive director of C-Change, died Nov. 10.

C-Change brings together leaders in cancer from the public, private, and not-for-profit sectors. 

Curran was born in Berlin, Wis. She held degrees from the University of Wisconsin, DePaul University, and Northern Illinois University. She also is a graduate of Harvard University Business School’s Owner/President Management program.

FDA News

photoIn Brief

  • D. Gary Gilliland Named President and Director of Fred Hutchinson Cancer Research Center

  • Mark Gilbert named chief of Neuro-Oncology Branch at NIH

  • Bert Vogelstein awarded Warren Triennial Prize by Massachusetts General Hospital

  • Susan Mayne appointed director of FDA Center for Food Safety and Applied Nutrition

  • Merck KGaA and Pfizer Inc. to co-develop anti-PD-LI antibody

  • NYU Langone Medical Center and Lutheran Medical Center to create integrated healthcare network

  • Dana-Farber Cancer Institute and Astellas Pharma Inc. announce three-year collaboration

  • Tapimmune Inc. and Vaccine & Gene Therapy Institute of Florida form partnership

  • St. Jude Children’s Research Hospital opens Marlo Thomas Center

  • Karmanos Cancer Institute honored by Michigan Cancer Consortium

20141114 - Nov 14, 2014
ISSUE 43 – NOV. 14, 2014PDF

CMS Inserts Unprecedented Conditions Into Medicare Coverage of Lung Screening

CT screening of the lungs of current and former heavy smokers is about to become a Medicare benefit.

A proposed decision published Nov. 10 has inserted some unprecedented conditions into its decision to cover screening:

Beneficiaries would have to go through counseling, and health professionals would be required to provide documentation that “shared decision-making” took place. The Centers for Medicare and Medicaid Services has never mandated shared decision-making as a gateway to paying for a service.

Guest Editorial

Brawley: CMS Got it Right in Lung Cancer Screening Decision

This week the Centers for Medicare & Medicaid Services issued a proposed rule stating that the scientific evidence was sufficient to support reimbursement for counseling on the risks and benefits of lung cancer screening as well as lung cancer screening with low dose computed tomography in high risk individuals and once per year. CMS will pay for such services when provided to beneficiaries at high risk for lung cancer and when provided by physicians and centers with specific qualifications.

FDA News

CPRIT Sets Funding Priorities For Rare and Pediatric Cancers

The Cancer Prevention & Research Institute of Texas is adding rare cancers and childhood cancers to its list of funding priorities, according to a draft program report.

The Texas legislature requires the oversight committee of the $300 million state-funded program to establish funding priorities on an annual basis. This is the first time these priorities are articulated and vetted in a public setting, officials say.

CDC: About 8 Million Women Skipped Cervical Cancer Screening in the Past 5 Years

About eight million women ages 21 to 65 years have not been screened for cervical cancer in the past five years, according to the Centers for Disease Control and Prevention. More than half of new cervical cancer cases occur among women who have never or rarely been screened.

2015 Breakthrough Prize Winners Announced at Gala

The Breakthrough Prize Foundation announced the recipients of its prizes in life sciences and fundamental physics, who will receive awards of $3 million.

photoIn Brief

  • Susan O’Brien to move to UC Irvine Health

  • Rosemarie Henson named senior vice president for prevention and early detection of the American Cancer Society

  • Michael Bishop to receive award from the Van Andel Research Institute

  • Antje Hoering named CEO of Cancer Research and Biostatistics

  • Nancy Hesse named chief nursing officer of Cancer Treatment Centers of America

  • Kathleen Green appointed associate director of basic sciences research at Northwestern University’s Robert H. Lurie Comprehensive Cancer Center

  • Nancy Weigel named editor-in-chief of the journal Hormones and Cancer

  • American Society of Clinical Oncology forms new clinical affairs department

  • Community Oncology Alliance publishes report on closings of cancer clinics

  • Harrington Discovery Institute and University of Oxford form affiliation

  • Dana-Farber Cancer Institute and Astellas Pharma Inc. announce three-year collaboration

  • AstraZeneca, Pharmacyclics Inc., and Janssen Research & Development LLC to collaborate on MEDI4736 and Imbruvica trials