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

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.

20140715 - Jul 15, 2014
SPECIAL REPORT – JULY 15, 2014


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

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.

20140711 - Jul 11, 2014
ISSUE 28 – JULY 11, 2014PDF



NCI to Implement More Transparent Formula
For Calculating Cancer Center Support Grants

NCI took another step toward adopting a new formula for determining the size of cancer center support grants, with the National Cancer Advisory Board accepting a report from a working group that has been working on the problem since the fall of 2012. 

The schema proposed by the working group was accepted by the advisory board at its meeting June 23. It recommends broad organizing principles rather than specific numbers. 

After the Plenary
Don Berry: In NeoALTTO & ALTTO Trials, Neoadjuvant Response Predicts Adjuvant

An article in the June 6 issue of The Cancer Letter described plenary presentations at ASCO 2014. One presentation was the adjuvant breast cancer clinical trial ALTTO in HER2-positive disease, which “was chosen [for the plenary session] because it addressed the reliability of pathological complete response as a surrogate for patient benefit.”  

photoCounterpoint
George Sledge Responds To Berry’s Letter: Neoadjuvant Doesn’t Predict Adjuvant In Breast Cancer

As always, I both enjoyed and learned something interesting from Dr. Don Berry, one of the great biostatisticians of our era. I find, reading his analysis of ALTTO and NeoALTTO, much that I agree with. I am certainly no statistician, and must bow to his statistical analysis of ALTTO and NeoALTTO. And yet at the same time I think it misses the point. So I will beg to differ.

Also: Don Berry’s Rejoinder

photoAACR Changes Its Logo— For the Fifth Time Since 2000

The American Association for Cancer Research ushered in the year 2000 with a round logo that combined the lamp of knowledge with a map of the Americas and an aspirational slogan in Latin.

The 26-year-old logo gave way to one that looked more corporate. However, AACR didn’t stop at just one redesign. It changed the logo four more times. 

photoNIH Funding Opportunity
Outstanding Investigator Award In Cancer Research Available

The NIH has published a funding opportunity announcement for the Outstanding Investigator Award in any area of cancer research.

photoIn Brief

  • Three appointed to leadership positions at St. Jude

  • Duke’s Amy Abernethy named chief medical officer at Flatiron Health

  • William Hogan joins University of Florida as director of bioinformatics

  • J. Alan Diehl named associate director of basic sciences at MUSC

  • Vincent O’Neill named chief medical officer of Exosome Diagnostics

  • Joseph Haywood named president of FASEB

  • Thomas Jefferson University receives $110 million gift

  • Stand Up to Cancer Canada launched

  • Bristol-Myers Squibb announces collaboration with Duke University

  • Pew Charitable Trusts announce class of cancer research scholars

  • Steven Bangert named CEO of the Year by the American Cancer Society

photoDrug Development

  • Breakthrough Therapy designation granted to CTL019 in ALL

  • European Commission approves Halaven for metastatic breast cancer

  • Breakthrough Therapy designation granted to blinatumomab in Ph- ALL

  • Mylan launches generic Carboplatin Injection in multi-dose vials

20140704 - Jul 3, 2014
ISSUE 27 – JULY 4, 2014PDF



Harvard Physician, Whose Cancer Was Spread Through Morcellation, Seeks to Revamp FDA Regulation of Medical Devices

On Oct. 17, 2013, a surgical instrument called a power morcellator tore into the uterus of Amy Reed, an anesthesiologist at Beth Israel Deaconess Medical Center, pulverizing what were believed to be benign fibroids.

Reed’s “minimally invasive” hysterectomy, a routine procedure, was performed at the Brigham and Women’s Hospital, a teaching hospital of Harvard Medical School.

Alas, Reed’s uterus contained an occult sarcoma, which the morcellator proceeded to spread through her abdominal pelvic cavity. Over ensuing months, as Reed battled to stay alive, her husband, Hooman Noorchashm, a cardiothoracic surgeon and, at the time, a lecturer at Harvard, waged a national campaign to put an end to the practice of power morcellation.

Conversation with The Cancer Letter
Challoner: We Recommended FDA Replace 510(k) Clearance

The Cancer Letter asked David Challoner, emeritus vice president for health affairs at the University of Florida, to discuss FDA’s 510(k) medical device clearance process.

The process has come under scrutiny after laparoscopic power morcellation procedures were found to spread previously undetected sarcomas inside benign fibroids.

Challoner chaired an Institute of Medicine committee tasked by FDA and Congress in 2009 to review the 510(k) approval process. 

photoBertagnolli: Why Brigham Stopped Making Morcellation Available Outside of a Registry Trial

“We know that this improves patient care,” Bertagnolli said in an interview with Matthew Bin Han Ong, a reporter with The Cancer Letter.

“In a case such as this one, close communication between the oncology and general gynecology communities is a key requirement for reducing morbidity and deaths due to uterine sarcomas.”

photoBSA Approves Trial of Carbon Ion Therapy, Extends EDRN and Provocative Questions

Question: What’s more expensive than proton beam radiation therapy?

Answer: Carbon ion radiation therapy.

With CIRT centers costing about $300 million to construct—about twice as much as proton beam centers—the potential adoption of this technology threatens to further inflate health spending worldwide.

photoIn Brief

  • Li Ma and Jeffrey Tyner receive Wachter Award from AAAS

  • John Cleveland named associate director of basic science at Moffitt Cancer Center

  • The Community Oncology Alliance appoints new officers

  • Roswell Park Cancer Institute receives “outstanding” distinction from NCI

  • The American Society for Radiation Oncology names 30 new fellows

20140627 - Jun 27, 2014
ISSUE 26 – JUNE 27, 2014PDF



ODAC Clarifies Standards for Maintenance In Ovarian Cancer;
Nixes Olaparib in 11-2 Vote

Some of the questions that landed the AstraZeneca drug Olaparib (lynparza) before the FDA Oncologic Drugs Advisory Committee were classic:

• How much progression-free survival is enough?

• Can you make use of post-hoc analysis to identify a cohort in which the drug appears to be most effective?

Two big questions in their own right, but in the case of Olaparib, these questions were even more important because of the setting. Olaparib is intended as maintenance for relapsed ovarian cancer, where the standard of care is no cancer drugs at all.

Joint NCAB-BSA Meeting
NCI Prepares for Intramural Program Review

NCI has received some relief from sequestration, and the budget cuts will be adjusted proportionally, Director Harold Varmus said at the joint meeting of the National Cancer Advisory Board and the Board of Scientific Advisors June 23.

“The FY 14 budget is not very dissimilar from last year’s budget,” Varmus said. “We had relief from sequestration. We have correspondingly reduced the level of cuts we have imposed on both competitive and non-competitive awards. We expect to be awarding roughly the same number of RPGs, research project grants, as we did in FY 13.”

photoGroups Urge FDA to Take More Action Against Tobacco Products

On the fifth anniversary of the landmark 2009 law granting the FDA authority over tobacco products, 10 leading public health and medical organizations called on the FDA and the Obama Administration to prioritize three actions to reduce tobacco use.

photoIn Brief

  • James Downing named CEO of St. Jude Children’s Research Hospital

  • Lynda Chin receives fellowship at MD Anderson Cancer Center

  • Thomas Hansen, CEO of Seattle Children’s, to retire in 2015

  • Cornelia Ulrich and Bruce Edgar to join Huntsman Cancer Institute

photoFDA News

  • Lymphoseek label updated to include head and neck SCC

  • Aloxi injection approved to prevent chemotherapy-related nausea and vomiting in children as young as one month old

  • Fast Track status granted to DNX-2401 in glioblastoma

  • Orphan Drug status granted to mocetinostat for myelodysplastic syndrome

20140620 - Jun 20, 2014
ISSUE 25 – JUNE 20, 2014PDF



Partnership Points to New Path Forward For Drug Approval and Clinical Research

SWOG earlier this week started to accrue patients to Lung-MAP, a clinical trial for second-line treatment of non-small cell lung cancer.

The trial, also called Lung Cancer Master Protocol or SWOG S1400, uses the patients’ tumor characteristics to select one of five targeted therapies, comparing them with active control in each arm. 

Lung-MAP is funded by a public-private partnership, which combines NCI’s limited funds with those of commercial sponsors, pointing to a new way of pooling resources to conduct faster, more efficient registration trials. 

Conversation with The Cancer Letter
What $34,000 per Patient Buys in Lung-MAP

The Cancer Letter asked David Wholley, director of research partnerships for the Foundation for the National Institutes of Health, to explain the novel scientific and administrative structure of Lung-MAP.

“For the first five drugs that are going into the trial, NCI is putting in about $24 million, and companies are putting in about $55 million. This would cover the costs for all of the drugs to complete testing through phase III,” he said.

photo90-Ton Cyclotron Delivered To University of Maryland, Touching Off D.C.-Area Proton Radiation Competition

BALTIMORE—Constructed in Germany, shipped to the port of Baltimore, and driven through downtown during the night, the 90-ton cyclotron arrived at the University of Maryland’s Proton Treatment Center.

photo340B Drug Discount Program
HRSA Defends Orphan Drug Rule

Cancer survivors face higher medical costs and productivity losses when compared to people without a cancer history, according to a CDC study published June 13. 

photoIn Brief

  • Patricia LoRusso named associate director of innovative medicine at Yale Cancer Center

  • Corrine Augelli-Szafran named director of chemistry at Southern Research Institute

  • Sandeep Reddy named chief medical officer of Caris Life Sciences

  • Hiromitsu Ota receives award from Wistar Institute

  • Yeshiva University and Montefiore Health System agree on new management structure for Albert Einstein College of Medicine

  • Dana-Farber Cancer Institute and Trovagene Inc. begin collaboration

  • Eli Lilly and Qiagen announce plan to co-develop assay panels

  • Bayer Pharma AG and arGEN-X collaborate to develop therapeutic antibodies

20140613 - Jun 13, 2014
ISSUE 24 – JUNE 13, 2014PDF



Judge’s Order Likely to Derail Federal Rule Clarifying 340B Drug Discount Program

Many people love the 340B Drug Pricing Program. 

Hospitals, clinics and cancer centers rely on it to buy drugs at discounts as deep as 50 percent—and then collect reimbursements that don’t reflect the discount. 

Many others hate 340B, arguing that the federal program gives qualified providers an unfair advantage, and making it even more difficult for office-based oncology practices to survive. 

Guest Editorial
OHSU’s Brian Druker on Accelerating the Pace of Scientific Progress

We are facing a disturbing paradox in science. We have unprecedented potential for advancements spurred by current technologies. But at the same time we are confronting flat to declining funding. 

This climate provides a unique opportunity to examine and improve how we fund research. 

photoGroups Organize Capitol Hill Push for Lung Cancer Screening

The Centers for Medicare and Medicaid Services have another six months to decide whether to cover low-dose computed tomography screening. Yet, proponents of screening seem unwilling to take the chance that Medicare coverage would be restrictive.

To tilt the scale in their favor, they have launched two congressional sign-on letters to CMS.

photoCancer Survivors Face Greater Economic Burdens, Study Says

Cancer survivors face higher medical costs and productivity losses when compared to people without a cancer history, according to a CDC study published June 13. 

photoAs Cigars Gain Popularity Among High School Boys, Legacy Urges FDA Regulation

The number of high school boys who smoke cigars—16.5 percent—is now on par with cigarette use, said the Centers for Disease Control and Prevention.

photoIn Brief

  • Kraft named director of University of Arizona Cancer Center

  • St. Jude redesignated as an NCI Comprehensive Cancer Center

  • AstraZeneca CAMCAR, S.A. partners with Cancer Genetics Inc.

  • Memorial Sloan Kettering forms collaboration with Quest Diagnostics

  • Merck signs agreement with Sysmex Inostics GmbH

  • ASCO publishes suvivorship compendium

  • International health organizations publish guidelines for establishing cancer registries

  • Association of Clinical Research Professionals coordinator designation recognized by ANCC Magnet program

  • The Cancer Letter receives the 2014 Dateline Award for Excellence from the Society of Professional Journalists