20140801 - Aug 1, 2014
ISSUE 31 – AUG. 1, 2014PDF



J&J Withdraws Power Morcellators, Citing Risk of Disseminating Cancer

Ethicon, the Johnson & Johnson subsidiary that manufactures nearly three-quarters of laparoscopic power morcellators on the market, has requested a withdrawal of the controversial devices.

“Immediately review inventory to determine if you have any Ethicon Morcellation Devices which are the subject of this market withdrawal,” the company wrote in a letter to hospitals worldwide.

“If you have provided Ethicon Morcellation Devices to any hospital within your system, you are responsible for notifying the appropriate parties immediately,” said the letter dated July 31.

FDA Moves to Regulate Lab-Developed Tests

FDA announced two plans to resolve a cluster of problems that have emerged as impediments to personalized cancer care:

• Targeted drugs will need to be approved simultaneously with companion diagnostics that would determine who should—and shouldn’t—get the drug. 

• At the same time, the agency will begin phasing in oversight of an essentially unregulated terrain: “laboratory-developed tests.” 

Tests that are intended to select therapy for deadly diseases including cancer would be among the first to be subjected to regulation. 

Surgeon General Issues Call To Reduce Skin Cancer Rates

The surgeon general issued a call to action this week, addressing the rising epidemic of skin cancer in the U.S. and around the world. 

Skin cancer is the most commonly diagnosed cancer in the U.S., but is also easily preventable. Billions can be saved on treatment if we adopt new standards and strategies, argued acting Surgeon General Boris Lushniak.

PCORI Approves $54.8 Million For Clinical Effectiveness Research

The Patient-Centered Outcomes Research Institute approved $54.8 million for 33 clinical effectiveness projects.

The projects, approved by the institute’s board of governors July 29, will study ways to improve outcomes for patients with cancer and other diseases, including diabetes, nervous system disorders, cardiovascular diseases, mental health conditions and kidney diseases.

Anonymous $100 Million Gift Moves OHSU Within $82 Million Of Reaching $1 Billion Goal

The Oregon Health & Science University Knight Cancer Institute moved one step closer to meeting a spectacular fundraising goal.

The institution said it received a $100 million gift from an anonymous donor, leaving the institution 17 months to raise the remaining $82 million needed to match the $500 million challenge set by Nike co-founder Phil Knight and his wife, Penny.

photoLetter to the Editor
Expanding the Horizons Of Proton Beam Therapy

By Minesh P. Mehta, Katja Langen and William F. Regine

The Cancer Letter recently published information regarding proton therapy facilities in the U.S., highlighting a contention that 85 percent of patients treated with protons have prostate cancer, the logical implication of which would be that this important resource is utilized minimally for other cancers. In this response, we wish to correct this erroneous impression and also wish to highlight the direction that this technology is moving in.

photoIn Brief

  • IOM Cancer Policy Forum names six at-large members

  • Allyson Kinzel named chief compliance officer at MD Anderson

  • Michael Sapienza receives award from American Society of Colon and Rectal Surgeons

  • Joel Helmke named oncology VP of WellStar Health System

  • W. Michael Alberts receives title of master fellow from American College of Chest Physicians

  • NCI consolidates central communications functions into one office

  • Study: Diagnosing breast cancer is more expensive in the U.S. than Europe

photoFDA News

  • Zydelig approved in three B-cell blood cancers

  • FDA approves Imbruvica in chronic lymphocytic leukemia

  • Avastin granted Priority Review in metastatic cervical cancer

  • FDA issues drug safety communication for docetaxel

  • European committee delivers positive opinion for Imbruvica in two blood cancers

20140725 - Jul 25, 2014
ISSUE 30 – JULY 25, 2014PDF



FDA Advisors Debate Ban, Black Box

And Status Quo of Power Morcellators

In a heated two-day hearing, several members of an FDA advisory panel on medical devices expressed low confidence in power morcellation as a treatment for uterine fibroids, and focused on alternative methods for performing hysterectomies and fibroid removal.

There was no formal consensus on either an outright ban on power morcellators or issuance of a “black box” warning label.

Photo: Families harmed by power morcellation pose on FDA’s White Oak campus July 11, following a two-day hearing on the controversial surgical procedure

The Numbers
GYN Group: Open Surgery Would Cost More Lives than Morcellation

More women would die from open surgery each year if the FDA decides to ban power morcellation, said Jubilee Brown, an associate professor at MD Anderson Cancer Center and a spokesperson of the American Association of Gynecologic Laparoscopists.

Capitol Hill
Sen. Harkin Introduces NIH Funding Bill That Boosts Budget to $46.2 Billion by 2021

Sen. Tom Harkin introduced a bill that would set NIH on a path to recoup the purchasing power it has lost since 2003, and make funding biomedical research a national priority.

The bill is not an appropriations bill, and does not authorize spending any money. It would, however, raise the limits set in place for NIH by the 2011 Budget Control Act and sequestration, allowing Congress to appropriate $46.2 billion by 2021—a level near where NIH funding would be, had it kept pace with inflation. 

photoAppropriations
Senate Committee Approves 4.5 Percent Cut to Defense Department Cancer Research Funding

The Department of Defense appropriations measure for the fiscal year 2015, approved by the Senate Appropriations Committee July 17, decreased overall funding for peer-reviewed cancer research programs by 4.5 percent. 

photoIn Brief

  • V. Craig Jordan to join MD Anderson Cancer Center

  • Georgetown’s Kevin FitzGerald named to Pontifical Council for Culture

  • John Birkmeyer named executive VP for enterprise support systems at Dartmouth-Hitchcock health system.

  • Ellen Miller Sonet named chief strategy and alliance officer of CancerCare

  • Rep. Henry Waxman receives lifetime achievement award from 340B Coalition

20140718 - Jul 18, 2014
ISSUE 29 – JULY 18, 2014PDF



DePinho’s Handling of MD Anderson Tenure Dispute Triggers Formal Investigation by AAUP

The American Association of University Professors has authorized a formal investigation of MD Anderson Cancer Center, a move that could result in censure.

The investigation was triggered by refusal on the part of MD Anderson’s administration to provide justification for denying tenure renewals to two faculty members.

The faculty members in question—Kapil Mehta and Zhengxin Wang—received unanimous votes in favor of renewal from the Faculty Senate Promotions & Tenure Committee, but the institution’s president, Ronald DePinho, ultimately decided not to extend their tenure. 

Memorial Sloan Kettering Seizes Top Cancer Hospital Prize from MD Anderson in U.S. News & World Report Rankings

MD Anderson Cancer Center’s uninterrupted seven-year stretch as the top cancer hospital in the U.S. News & World Report rankings has come to an end.

Memorial Sloan Kettering Cancer Center has broken the spell of being the perpetual runner-up and moved to the lead.

The result is as close as cancer care can come to a photo finish:

• MSKCC: 100 percent.

• MD Anderson: 99.9 percent.

photoCapitol Hill 
Advocates Lobby Congress To Close Medicare Loophole For Colonoscopy Coverage

A coalition of advocacy groups focused on colorectal cancer asked Congress to fix the loophole in Medicare coverage of colonoscopies.

The group, organized by Fight CRC and the American Cancer Society Cancer Action Network, met July 16 to lobby for proposed legislation that would ensure cost is not a barrier to colon cancer screenings.

photoIn Brief

  • University of Arizona forms plan with Banner Health to build statewide health system

  • Roswell Park Cancer Institute granted approval for genome trials by New York State Department of Health

  • Medical College of Wisconsin receives $2.6 million grant from NCI

  • Dana-Farber Cancer Institute forms three-year immuno-oncology lung cancer collaboration with Johnson & Johnson and Janssen Biotech

  • Eli Lilly and Company and Immunocore Limited form collaboration

  • The Ohio State University and the University of Michigan sign agreement with Venture Therapeutics Inc.