20140808 - Aug 8, 2014
ISSUE 32 – AUG. 8, 2014PDF



“Wild West” of Molecular Testing?

Caris Engaged in Aggressive Marketing, Improper Medicare Billing, Lawsuit Alleges

It’s possible that molecular testing is doing a lot of good, pinpointing cancer therapies that are most likely (or least likely) to work.

It’s also possible that Medicare is paying for molecular tests that are marketed aggressively despite being based on flimsy evidence.

The latter picture is painted in a suit filed by two former employees of Caris Life Sciences Inc., a company that markets the “Caris Molecular Intelligence” test, a panel of assays previously called “Target Now.”

The whistleblowers allege that their former employer violated the federal anti-kickback statute by routinely waiving some of its fees to induce referrals to federal healthcare programs.

Conversation with The Cancer Letter
Daniel Hayes Leads Tour of Caris Website

Tumor profiling information Caris Life Sciences provides in its reports isn’t backed by sufficient evidence to justify some clinical decisions, said Daniel Hayes, a breast cancer expert at the University of Michigan.

Hayes, the university’s Stuart B. Padnos Professor of Breast Cancer Research and a member of a recent Institute of Medicine committee that issued a report on omics, was clicking through the Caris website as he spoke with Paul Goldberg, editor and publisher of The Cancer Letter.

Caris Officials Respond To Questions Submitted By The Cancer Letter

The Cancer Letter submitted seven questions to Caris Life Sciences regarding their suite of molecular diagnostic tests. 

Questions focused on the costs of the tests, who pays for them, and how much of the information they provide is actionable. 

The Cancer Letter is taking a Summer Break

The next issue will be published Sept. 5.

NCI Launches NCORP with 53 Grants Totaling $465 Million

NCI awarded 53 five-year grants for multi-site clinical trials and care delivery research studies through the NCI Community Oncology Research Program. The program will provide $93 million each year.

photoObituary
Emmanuel Farber, Experimental Pathologist, Dies at Age 95

Emmanuel Farber, a pathologist who made contributions to the understanding of chemical carcinogenesis, died Sunday, Aug. 3. 

photoIn Brief

  • Peter Pisters named CEO of University Health Network in Toronto

  • MD Anderson and Hospital Israelita Albert Einstein form partnership

  • Richard Wahl named head of radiology at Washington University in St. Louis

  • David Espey steps down as acting director of CDC Division of Cancer Prevention and Control

  • Michael Bookman named medical director of US Oncology Research Gynecology Research Program

  • Richard David named professor of urology at UCLA

  • Jennifer Zeitzer named deputy director of FASEB public affairs office

  • Jeffrey Albers named CEO of Blueprint Medicines

  • Conquer Cancer Foundations names Raj Mantena and Aaron Sasson to board of directors

  • Dr. Susan Love Research Foundation receives NIH grant to develop low-cost, portable ultrasound

  • Massachusetts General Hospital receives award from American Hospital Association

  • Association of Community Cancer Centers launches online drug database

  • Bristol-Myers Squibb forms agreement with Leica Biosystems

  • AstraZeneca and Qiagen to collaborate on companion diagnostic

  • Optim Oncology and Urology Centers of Oklahoma join The US Oncology Network

  • FDA and EMA grant orphan designation to AbbVie’s ABT-414

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