20141212 - Dec 12, 2014
ISSUE 46 – DEC. 12, 2014PDF

Is Everyone in Academic Medicine Unhappy?
Or is it Just MD Anderson?

Faculty members at MD Anderson Cancer Center are arguably the most intensely watched cohort in academic medicine. Their angst has been measured four times by three administrative entities over two years.

Now, the institution’s president, Ronald DePinho, is under a mandate from his bosses to improve faculty morale.

Are these folks an anomaly, or is everyone in academic medicine unhappy these days?

There is a place to obtain comparison data: the Faculty Forward Engagement Survey conducted by the Association of American Medical Colleges. 

Senate Debates $1.1 Trillion “Cromnibus” Bill That Includes a $150 Million Increase for NIH

Early Friday morning, President Barack Obama signed a two-day funding resolution averting a government shutdown and giving the Senate time to debate a $1.1 trillion funding package passed by the House of Representatives late Thursday night.

The year-long “cromnibus” bill—a Washington-speak portmanteau of continuing resolution and omnibus—passed by a 219-to-206 vote three hours before government funding expired.

Daniel Hayes Elected President of ASCO

Daniel Hayes was elected president of the American Society of Clinical Oncology. The three-year appointment begins with Hayes becoming president-elect on June 1, 2015. He will serve as president from June 1, 2016, to May 31, 2017, and will serve as immediate past-president for the year after. 

 

Varmus Discusses Grant Policy, Changes in Congress and Ebola

NCI Director Harold Varmus addressed a joint meeting of the NCI Board of Scientific Advisors and the National Cancer Advisory Board Dec. 2, updating them on his proposed bypass budget for the institute, changes in Congressional leadership, and NCI and NIH grant policy.

NCI’s Douglas Lowy and John Schiller Honored with National Medal

NCI’s Douglas Lowy and John Schiller were honored by President Barack Obama with a National Medal of Technology and Innovation, the nation’s highest honor for technological achievement, for their work in developing a vaccine for human papilloma virus.

 

Obituary

Lee Wattenberg, 92, “Father of Chemoprevention”

Lee Wattenberg, emeritus professor of laboratory medicine and pathology at the University of Minnesota Masonic Cancer Center, died Dec. 9 at the age of 92. 

His research established the discipline of chemoprevention. Wattenberg first recognized that some compounds could effectively block the development of carcinogens in animals. In 1966, he published a paper in the journal Cancer Research that reviewed 36 years of animal studies on the effects of certain compounds on carcinogenesis and laid the framework for our understanding of how these compounds work. It was in this paper that he introduced the term chemoprophylaxis. 

Regulatory Approvals

  • Gardasil 9 approved, which covers five additional HPV types
  • FDA grants Fast Track designation to DPX-Survivac cancer vaccine
  • FDA approves a new indication for Xgeva (denosumab)
  • FDA approves MP Diagnostics HTLV Blot 2.4 test
  • FDA grants clearance for SAVI SCOUT surgical guidance system
In Brief

  • Weldon Gage named CFO at MD Anderson Cancer Center

  • Marcelo Bento Soares named senior associate dean at University of Illinois College of Medicine at Peoria

  • Boris Kuvshinoff II named chief medical quality officer and interim chief medical officer at Roswell Park Cancer Institute

  • David Currow named director of palliative medicine and hospice care at Dartmouth-Hitchcock

  • Joanna Weiss appointed VP of revenue cycle management at Moffitt Cancer Center

  • American Cancer Society publishes second edition of The Cancer Atlas

  • Marlo Thomas receives Presidential Medal of Freedom

  • RxTrials and Clinical Oncology Research Excellence form collaboration

  • Yale University and Organovo Holdings Inc. partner to research 3D printed tissues

  • Pharmacyclics receives award for Imbruvica

  • The CrowdCare Foundation announces myeloma research crowdfunding initiative

  • Seattle Children’s launches Strong Against Cancer fundraiser

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