20140404 - Apr 4, 2014
ISSUE 14 – APRIL 4, 2014PDF


Group Chairs: Research in “Crisis”

 

The chairs of the adult clinical trials groups that make up the NCI National Clinical Trials Network said in a letter that recent budget cuts have triggered a “crisis” in clinical research.

Simultaneously, a statement by the president of the American Society of Clinical Oncology, Clifford Hudis, amplified the concerns of the group chairs, and pointed to a separate problem in NCI’s transition to the new structure of clinical research: a three-month gap in funding for community oncology clinics engaged in institute-funded research.

photoAACR, ASCO Publish Reports Criticizing Current State of U.S. Cancer Care

Cancer research remains underfunded, and the U.S. cancer care system as a whole may be unprepared to handle an aging population, according to two separate reports from the American Association for Cancer Research and the American Society of Clinical Oncology.

photoOncologists Tell Congress Community Practices Are Not Adequately Reimbursed

Current Medicare policies do not adequately reimburse cancer care provided in the community setting, the Community Oncology Alliance and the U.S. Oncology Network said in a joint, open letter to members of Congress.

photoAACR Academy Names 2014 Class of Fellows

The American Association for Cancer Research named its 2014 class of elected fellows of the AACR Academy. The fellows will be inducted at the association’s annual meeting in San Diego, April 5-9.

photoIn Brief

  • PCORI Forms Clinical Trials Advisory Panel

  • Samuel Broder named executive VP at Intrexon Corporation

  • Marion Couch named chair of IU Head and Neck Surgery

  • John Powderly II honored by ACCC

  • Two foundations offer $300,000 for neuroendocrine tumor lines

  • Fred Hutch honors thirteen graduate students

  • Community Oncology Alliance publishes IV Fluid Shortage Survey

  • NCCN Updates colorectal assessment guidelines

20140328 - Mar 28, 2014
ISSUE 13 – MARCH 28, 2014PDF


FDA Advisory Panel Unanimously Favors New Stool DNA Colorectal Screening Test

 

The FDA Molecular and Clinical Genetics Panel voted 10-0 to recommend approval of Cologuard—a noninvasive, multitarget stool DNA screening test for colorectal cancer.

Sponsored by Exact Sciences Corp., Cologuard outperformed a standard fecal immunochemical test in a study published March 19 in the New England Journal of Medicine.

photoRising Costs at NCI Threaten to Overtake
Slim Increases In Budget Appropriations

Sometimes a funding increase can be no increase at all.

NCI’s budget was increased by 2.8 percent for the current 2014 fiscal year, or about $134 million, restoring about 53 percent of previous cuts made by sequestration. The institute’s total budget stands at $4.9 billion.

photoIn Brief

  • Caplan Receives NSB Public Service Award

  • Fazio and Kantarjian Receive Lifetime Achievement Awards

  • Pienta named director of Johns Hopkins Prostate Cancer Program

  • American Society of Hematology awards 15 bridge grants

  • Stewart named incoming president of Patient Advocate Foundation

  • Ohio State signs agreement with MedVax Technologies Inc.

  • UC San Francisco signs agreement with Advaxis Inc.

  • Georgia Regents receives CEO Gold Standard accreditation

  • The winners of the Research!America Advocacy Awards

  • European Commission approves MabThera SC

  • Japan approves LonSurf combination tablet

20140321 - Mar 21, 2014
ISSUE 12 – MARCH 21, 2014PDF


Does a B from USPSTF Guarantee Coverage? Lung Screening will Define Medicare Stance

 

The Centers for Medicare and Medicaid Services is facing the formidable challenge of deciding what kinds of patients should be screened for lung cancer. 

The agency’s Medicare Evidence Development & Coverage Advisory Committee will meet April 30 to decide how the positive findings of a large randomized trial and the recommendation the U.S. Preventive Services Task Force should be translated into policy.

The controversy over screening for lung cancer will demonstrate how scientific findings influence the standard of care in the new healthcare system. Under the Affordable Care Act, USPSTF grades translate into coverage mandates for private insurers.

photoConversation with The Cancer Letter
Kazerooni: The Case for Broad Coverage

The Cancer Letter asked Ella Kazerooni, a professor of radiology at the University of Michigan, chair of the American College of Radiology Committee on Lung Screening, and vice chair of the lung screening panel of the National Comprehensive Cancer Network, to lay out the rationale for a proposal for broad coverage for lung screening.

photoIn Brief

  • Alan Ashford named center director at UCSF

  • Edith Perez receives Claude Jacquillat Award

  • NCI announces 2013 Cancer Center Clinical Investigator Team Leadership Awards

  • Chad Ellis named associate director at UNC Lineberger

  • Tripathy joins MD Anderson as breast medical oncology chair

  • Thayer named chief of surgical oncology at University of Nebraska

  • Bayer Pharma and Ventana enter agreement

  • MD Anderson signs three-year agreement with MedImmune

20140314 - Mar 14, 2014
ISSUE 11 – MARCH 14, 2014PDF


NCI Rethinks Cancer Center Grants

 

NCI is moving toward adopting a formula that will fundamentally restructure the manner in which cancer centers are funded.

The new approach, developed by a working group of the National Cancer Advisory Board, seeks to eliminate the advantage that comes with a center’s longevity in the program.

As it stands, just being in the centers program for many cycles can build up an institution’s funding base. This favors older centers. 

photoRobert Cook-Deegan’s Viewers’ Guide To the Super Bowl of Gene Patent Cases

Patent litigation is a blood sport if you see corporations as people and count spilled ink or loss of money as hemorrhage. 

One of the most closely watched cases in recent years centers on genetic testing for BRCA1 and BRCA2 genes. 

On March 10, Judge Robert Shelby from the Federal District Court for Utah denied Myriad Genetics’ motion for a preliminary injunction against its competitors that had entered the market starting June 13, 2013, when the Supreme Court handed down its ruling in Association of Molecular Pathology v. Myriad Genetics.

20140307 - Mar 7, 2014
ISSUE 10 – MARCH 7, 2014PDF


NIH to Review Intramural Program

NCI’s Intramural Spending is 17 Percent, Higher than 11.1 Percent NIH-Wide Level


NIH has launched a systematic examination of its intramural program, which accounts for 11.1 percent of its $30 billion budget.

The program was last examined in 1993, pursuant to a mandate from the House Appropriations Committee.

That examination was written by a panel co-chaired by Paul Marks, then president of Memorial Sloan-Kettering Cancer Center and Gail Cassell, then chair of the University of Alabama Department Microbiology.

photoPresident Requests Extra $200 Mil for NIH

President Barack Obama’s $3.9-trillion budget proposal for the 2015 fiscal year would bump NIH funding up to $30.2 billion—a $200 million increase over fiscal 2014—and would include an additional $8 million for NCI, totaling $4.931 billion for the institute.

photoHPV Vaccines Should be Priority, says President’s Cancer Panel

Human papillomavirus vaccines are underused in the U.S. and need to be made a national public health priority, according to a report from the President’s Cancer Panel.
In a presentation to the National Cancer Advisory Board Feb. 27, panel chair Barbara Rimer outlined three goals to accelerate uptake of HPV vaccines, including having providers strongly encourage HPV vaccination to adolescents when other vaccines are being administered.

photoNCI Publishes Report on Pancreatic Cancer

NCI has issued a report detailing a “scientific framework” for advancing research on pancreatic ductal adenocarcinoma, indicating potential new funding opportunities for genomic studies for early detection of pancreatic cancer.

The institute’s report is the result of the Recalcitrant Cancer Research Act, a bill proposed by the Pancreatic Cancer Action Network, and passed Jan. 2, 2013.

photoIn Brief

  • Pasche named center director at Wake Forest Baptist Medical Center
  • Jiali Han named Rachel Cecile Efroymson Professor in Cancer Research at the Indiana University Simon Cancer Center
  • Carol Bier-Laning will lead CTCA Head and Neck Cancer Program
  • Curie-Cancer renews partnership with DNA Therapeutics
  • A correction
20140228 - Feb 28, 2014
ISSUE 9 – FEB. 28, 2014PDF

Groups Have No Budgets as NCTN Begins Work March 1

Two years ago, NCI officials made a promise to increase the budget of the cooperative groups program by $25.6 million.

The boost, which was approved by the NCI Board of Scientific Advisors, was part of an effort to revamp the groups inspired by a report from the Institute of Medicine.

On March 1, as the cooperative group program officially becomes the NCI National Clinical Trials Network, new money will not be a part of the transformation. 

photoNCI National Lab’s Budget to Grow Over Its $299.2 Million FY2013 Level

The contractor running the Frederick National Laboratory for Cancer Research received nearly $300 million from NCI in the 2013 fiscal year, and is slated for an increase, officials said at a recent advisory committee meeting.

photoIn Brief

  • Van Andel Research Institute to build epigenetics hub

  • Jennifer Doudna named winner of the Foundation for the NIH’s Lurie Prize

  • GRU Cancer Center receives $6 million committment

  • Twenty-six public health organizations call for retailers to stop selling tobacco products

  • ION Solutions selects Foundation Medicine for genomic profiling services

  • Mylan launches first Herceptin biosimilar

  • NeoGenomics launches profiling tests covering 22 cancer categories

  • Clarient adds BRAF diagnostic to its service offerings

20140221 - Feb 21, 2014
ISSUE 8 – FEB. 21, 2014PDF

NCI Launches M-PACT Next-Generation Trial As Group System Nears March 1 Transition

NCI has launched a pilot study to assess whether assigning cancer patients treatment based on the genetic characteristics of their disease can improve outcomes for patients with advanced metastatic solid tumors.

The Molecular Profiling based Assignment of Cancer Therapeutics, or M-PACT, trial is one of the first to use a randomized trial design to assign treatment based on specific mutations.

photoNCI Clinical Trials Enrollment Drops to 17,500

Enrollment in NCI-sponsored National Clinical Trials Network clinical trials will drop to about 17,500 this fiscal year, the network groups have been told by NCI officials. 

This enrollment figure includes 3,600 pediatric patients, so the total adult enrollment will add up to about 14,000, insiders at cooperative groups say.

photoGAO: FDA Data on Drug Shortages Inadequate

FDA needs to improve its access to data if it is to manage drug shortages more effectively, the Government Accountability Office concluded.

The FDA’s management of drug shortage data is “inconsistent with federal internal control standards,” the GAO report states.

photoDuke’s Dzau Named IOM President

Victor Dzau, chancellor of health affairs at Duke University and president and CEO of the Duke University Health System, was named president of the Institute of Medicine.

Dzau will succeed current IOM president Harvey Fineberg effective July 1.

photoIn Brief

  • NCI’s John Czajkowski to take executive dean position at Harvard Medical School

  • Issam Markhoul named distinguished chair for hematology and oncology at University of Arkansas for Medical Sciences

  • Margaret Dimond named president of Karmanos Cancer Hospital

  • North Shore-LIJ Cancer Institute opens $47 million radiation facility

  • Duke-NUS Graduate Medical School Singapore partners with ImaginAb Inc.

  • St. Jude Thanks and Giving campaign rasies over $97 million

  • Roswell Park Cancer Institute to collaborate with GenomOncology

  • Roche Servicios S.A. and Cancer Genetics Inc. enter agreement

  • Novartis acquires CoStim Pharmaceuticals Inc.

20140214 - Feb 14, 2014
ISSUE 7 – FEB. 14, 2014PDF

A meeting of the FDA Oncologic Drugs Advisory Committee has become a rare occurrence.

Why?

Because cancer drugs are getting better, as are applications for their approval, said Richard Pazdur, director of the FDA Office of Hematology and Oncology Products. 

“Drug development is much more focused, and decisions are being made on the basis of understanding the molecular basis of the disease rather than the number of responses observed in an early phase study,” Pazdur said.

photoGuest Editorial 
Once Again, Hype Overshadows Data
In Breast Cancer Screening Debate

By Otis W. Brawley

Studies assessing the merits of cancer screening tend to get a lot of play in the news media. It seems every six months or so a new study makes a big splash.

photoDrasga and Einhorn Respond to Single Payer Proposal Rebuttal

In a recent article published in the Journal of Oncology Practice, oncologists Ray Drasga and Lawrence Einhorn called on their colleagues to support “an improved Medicare for all” program.

The provisions of the Affordable Care Act are insufficient to solve the crises facing American cancer patients, they wrote in the journal published by the American Society for Clinical Oncology.

photoIn Brief

  • Waun Ki Hong will retire as head of MD Anderson Cancer Center’s Division of Cancer Medicine

  • Fraser Symmans named director of CALGB Alliance Translational Research Program

  • American Cancer Society adds five officers to redesigned volunteer board of directors, with Pamela Meyerhoffer as chair

  • John Walter, president and CEO of The Leukemia & Lymphoma Society, steps down

  • MD Anderson’s Jim Allison awarded Szent-Györgyi Prize

  • AVEO Oncology and Astellas Pharma Inc. to End Tivozanib Agreement 

20140207 - Feb 7, 2014
ISSUE 6 – FEB. 7, 2014PDF

“Confidential and Proprietary” Document Proposes Plan for National Network

You might think of this as an event isolated to Columbus or central Ohio: 

On Feb. 7, OhioHealth, a health system that operates not-for-profit, faith-based hospitals in central Ohio and competes with Ohio State University, said it would join the outreach network of MD Anderson Cancer Center, located almost 1,200 miles away.

photoConversation with The Cancer Letter 
McKinsey Charge: Create Plan 
To Expand MD Anderson’s Reach

Responding to questions from The Cancer Letter, Jim Newman, director of external communications at MD Anderson, confirmed that the presentation obtained by The Cancer Letter was prepared under a contract by McKinsey & Company.

photoCVS to Stop Tobacco Sales at Pharmacies

CVS Caremark plans to stop selling cigarettes and other tobacco products at more than 7,600 CVS/pharmacy stores by Oct. 1.

The country’s largest drug store chain in overall sales estimated that it will forego approximately $2 billion—about 17 cents per share—in revenues on an annual basis from snuffing out Big T.

photoDrug Development
Tivozanib Trial Discontinued Due to Insufficient Enrollment

AVEO Oncology and Astellas Pharma Inc. discontinued a phase II study of tivozanib in locally recurrent or metastatic triple-negative breast cancer due to insufficient enrollment.

photoIn Brief

  • Wendy Selig elected president Of NCCR board of directors

  • Dana-Farber Receives $900,000 for ovarian cancer research

  • Richard Folkers named director of communications for the Foundation for the NIH

  • Sarah Cannon to integrate cancer programs with HealthONE hospitals

  • Amgen and Merck to collaborate on oncolytic immunotherapy

  • Univ. of Pittsburgh selects GenomAnalytics platform for TGCA data

  • Health Canada approves Aptima HPV assay

  • Definiens and Clarient sign agreement over image analysis software

20140131 - Jan 31, 2014
ISSUE 5 – JAN. 31, 2014PDF

Congress Mandates NIH Cut PR Costs, Coordinate Spending on Communications

Congressional appropriators instructed NIH to cut spending on communications activities and coordinate the broad range of activities that fall under the category of public relations.

The mandate is a part of the report that accompanied the recently passed appropriations bill.

photoIPRI’s Peter Boyle on Closing the Gap In Global Cancer Treatment and Outcomes

The International Prevention Research Institute has published “The State of Oncology 2013,” a report that highlights disparate cancer outcomes between higher- and lower-resource countries and proposes long-term recommendations. 

photoPresident Calls For Reversing Cuts to Basic Research Budget

In his state of the union address to Congress Jan. 28, President Barack Obama called for reversing the cuts made to basic research in the federal budget.

photoDrasga, Einhorn Make Appeal For Single-Payer Healthcare

In a feature article published in the Journal of Oncology Practice, oncologists Ray Drasga and Lawrence Einhorn called for their colleagues to endorse single-payer healthcare.

The journal is published by the American Society for Clinical Oncology.

photoACS, SU2C Commit $20 Million For Lung Cancer Dream Team

The American Cancer Society and Stand Up To Cancer announced a collaboration to fund translational research and advocacy programs.

photoIn Brief

  • Indiana University cancer center receives $15 million pledge from Vera Bradley Foundation

  • Hope Funds for Cancer Research announce James D. Watson Award 

  • Dept. of Defense offers $580 million in medical research funding

  • Justin Klamerus named chief quality officer at Karmanos Cancer Institute

  • Angela Davies named chief medical officer of Champions Oncology

  • UCSF and Quest Diagnostics form collaboration

  • John Porter to receive Public Welfare Medal from the National Academy of Sciences

photoFDA News

  • FDA lifts clinical hold on tosedostat

  • U.K. National Institute for Health and Care Excellence issues final opinion on Pixuvri