20140516 - May 16, 2014
ISSUE 20 – MAY 16, 2014PDF

Over $20 Million Carved Out
From Statistical, Operations Centers

The budgets of operations and statistical centers of adult clinical trials groups were cut by about $20.4 million, group chairs say.

The cuts make it difficult for the groups to continue to support ongoing trials and raise questions about the prospects for starting a new generation of trials. 

NCI officials say that, overall, the budget for the groups is staying flat, in part because some of the money is being channeled into 30 sites that received the Lead Academic Participating Site designation. 

LAPS, which are run by cancer centers, will be allowed to charge more for putting patients on studies. 

So where are the cuts? 

photoNo Justification Provided
AAUP Demands Reinstatement of Faculty Denied Tenure Renewal at MD Anderson

The American Association of University Professors sent a letter to Ronald DePinho, president of MD Anderson Cancer Center, urging the reinstatement of two faculty members who were denied tenure renewal without stated reasons.

The letter is a part of AAUP’s response to a request for an investigation, which was triggered by the administration’s refusal to provide justification for denying tenure renewals to faculty who received unanimous votes for renewal from the Faculty Senate Promotions & Tenure Committee. 

photoReport: Rising Treatment Costs Due to 340B Discounts

The 340B drug discount program is causing a rise in the costs of treating cancer patients, according to a new report.

Published by the IMS Institute for Healthcare Informatics, the report, “Innovations in Cancer Care and Implications for Health Systems,” showed that marketplace behaviors, triggered by a lack of eligibility integrity, are a major reason for increasing costs of cancer care, said the Alliance for Integrity and Reform of 340B in a statement.

photoTGen and George Mason Form Precision Medicine Alliance

The Translational Genomics Research Institute and George Mason University announced a strategic research alliance May 6.
Called the TGen-George Mason Molecular Medicine Alliance, the effort is designed to recommend medications and treatments to clinicians based on each patient’s molecular profile.

photoIn Brief

  • Oncology Nursing Society names board of directors

  • American College of Radiology names new officers

  • Bristol-Myers Squibb and Celldex Therapeutics Inc. enter agreement

  • Moffitt Cancer Center collaborates with Vermillion Inc.

  • Children’s Oncology Drug Alliance helps form international collaborative

20140509 - May 9, 2014
ISSUE 19 – MAY 9, 2014PDF

Oregon Center Launching $1 Billion Program To Identify Lethal Cancers Before They Kill

Brian Druker has some awesome jobs to fill.

As many as 30 scientists and their teams will get to focus on cancer research without having to worry about applying for grants.

“It’s about bringing 20 to 30 people together, giving them sufficient funding—almost like [Howard Hughes Medical Institute] level funding,” Druker said to The Cancer Letter. “If you have 20 to 30 people who are focused on science, working as a team to solve a problem, judged on progress toward the goal, as opposed to how many grants and publications do you have, we think we can make a more rapid contribution in this area.

photoCMS Advisors Express Low Confidence In Low-Dose CT Screening for Lung Cancer

An advisory panel for the Centers for Medicare and Medicaid Services expressed low confidence in low-dose computed tomography as a method for screening for lung cancer in the Medicare population.

Evidence is inadequate to ensure that benefits of the procedure would outweigh harms, the Medicare Evidence Development & Coverage Advisory Committee said at the hearing April 30.

photoBach: LCA Center Certification Untrustworthy; CISNET Models Don’t Match

When it appeared that CT screening for lung cancer was a shoo-in for Medicare coverage, the Lung Cancer Alliance, an advocacy group, started to certify “screening centers of excellence.”

Centers all over the country received this designation from LCA and were listed on the group’s website.

However, as he prepared for a recent Medicare advisory committee meeting, Peter Bach, a pulmonologist and health systems researcher at the Memorial Sloan-Kettering Cancer Center, checked the list of LCA-certified centers.

photoSteven Woolf: Why CMS Should Not Cover LDCT

National coverage for low-dose computed tomography may result in more harm than benefit to the Medicare population at this time, said Steven Woolf, a member of the Medicare Evidence Development & Coverage Advisory Committee.

Speaking at the April 30 MEDCAC hearing, Woolf said coverage would run into many implementation challenges and adherence problems—it would be unlikely that all practices would observe the strict criteria set by the U.S. Preventive Services Task Force and the National Lung Screening Trial, he said.

photoGrowth of the Cost of Drugs Slows to 5.4 Percent per Year; 21 Therapies Launched in 2 Years

The growth of global spending on oncology medicines has slowed over the past five years, according to a report by the IMS Institute for Healthcare Informatics.

Spending on cancer drugs, including those used for supportive care, increased at a compound annual growth rate of 5.4 percent during the past five years, reaching $91 billion in 2013, compared with 14.2 percent from 2003 to 2008. 

photoWomen’s Health Initiative Trial Produced $37.1 Billion in Returns

The overall economic return from the Women’s Health Initiative estrogen plus progestin trial indicates that the changes in practice it produced provided a net economic return of $37.1 billion over 10 years.

photoFDA Oncology Unit Fastest in Approvals Despite Having Highest Workload

A study by a conservative think tank found large differences in performance of the FDA divisions, with oncology demonstrating the agency’s fastest time from application submission to approval.

Paradoxically, the Manhattan Institute found that the oncology division’s staff members had the agency’s highest workload—measured in INDs per staff member at the division.

photoIn Brief

  • David Cole named president of The Medical University of South Carolina

  • Peter Bach’s account of his wife’s death from breast cancer

  • MD Anderson honors 16 junior faculty members

  • US Oncology and Community Oncology Alliance speak to Congress

  • Athena Breast Health Network adopts ASCO’s HL7 Guide for EMRs

  • Eli Lilly & Co. sign agreement with Prasco Laboratories

  • Johns Hopkins receives $10 million from Under Armour 

  • Melanoma Research Alliance and L’Oreal Paris begin campaign

  • Kristin Darby named chief information officer of Cancer Treatment Centers of America

Drug Approvals

  • Zykadia granted accelerated approval for ALK+ NSCLC

  • ADXS-HPV grated orphan drug designation

20140502 - May 2, 2014
ISSUE 18 – MAY 2, 2014PDF

NCI Officials Open to Fine-tuning Group Budgets
As Advocates Chip Away at NCTN’s Façade

NCI officials said they plan to hold a series of meetings with clinical trials group chairs and group financial officers in order to fine-tune the new National Clinical Trials Network.

“We are in the midst of one-on-one meetings with the group chairs and their financial people and their statistical leadership, [meeting] group-by-group [to] look at the numbers as they exist, and try to understand from both sides what that research budget will support and what it won’t support,” said James Doroshow, director of the NCI Division of Cancer Treatment and Diagnosis. 

“Without seeing, from the group perspective, what the resources can and can’t support, it’s hard to know from a system-wide perspective how we will move forward.”

In a telephone conference the institute convened to respond to concern from advocates, Doroshow said, in effect, that the budgets sent to the groups recently didn’t represent fait accompli, and that flexibility was an option.

photoOn Biomedical Malthusianism
Varmus, et al. Propose a Strategy For Saving Biomedical Research

The assumption that growth in research funding would be sustained indefinitely has created an “unsustainable hypercompetitive system” heading toward “long-term decline,” a group of scientists, including NCI Director Harold Varmus, wrote in a paper published in the April 22 edition of the Proceedings of the National Academy of Sciences. 

photoIn Brief

  • CFO Dwain Morris to leave MD Anderson Cancer Center

  • National Academy of Sciences elects new members

  • Dept. of Defense taking applications for $25 million in research grants

20140425 - Apr 25, 2014
ISSUE 17 – APRIL 25, 2014PDF

No Justification Provided
DePinho’s Nixing of Tenure Renewals
May Bring Censure to MD Anderson

A year before Kapil Mehta’s tenure term expired last August, the 11-member Promotions and Tenure Committee at MD Anderson Cancer Center had unanimously recommended renewal.

“I’ve done everything I’m supposed to do during my tenure,” Mehta said to The Cancer Letter. “I’ve done publications, organized international meetings, service, teaching—everything.” 

Mehta’s application was personally rejected by MD Anderson President Ronald DePinho, who overruled the PTC recommendation in May 2012.

Mehta appealed, and a second committee—the Faculty Appeals Panel—endorsed the PTC’s recommendation to renew Mehta’s tenure. However, the administration wasn’t swayed. DePinho’s decision stood.

photoItri Pays Fine, Agrees Not to Serve As Company Officer for Five Years

The Securities and Exchange Commission earlier this week said it has settled insider-trading charges against a prominent cancer researcher who was also an executive of a now-defunct company. 

photoASCO Releases Three Guidelines For Survivorship Care

The American Society of Clinical Oncology published three clinical practice guidelines for the prevention and management of neuropathy, fatigue, depression, and anxiety. 

photoIn Brief

  • Gareth Morgan named director of UAMS myeloma institute

  • Michael Gordon named medical director of Virginia G. Piper Cancer Center Clinical Trials

  • Clinical Research Forum names its Top Ten achievement awards

  • Conquer Cancer Foundation names 2014 Merit Award winners

photoFDA Approvals

  • Cobas HPV Test approved for primary cervical cancer screening

  • Arzerra sBLA approved for previously untreated CLL

  • Cyramza approved for advanced stomach cancer

20140418_1 - Apr 18, 2014
ISSUE 16 – APRIL 18, 2014PDF


The Walgreens Connection
ACS Calls on Drug Stores to Stop Tobacco Sales


Last week, a blistering opinion piece on The New York Times editorial page focused on the coziness of the relationship between the American Cancer Society and Walgreens.

The piece initially triggered criticism by ACS officials, but then—with no fanfare whatsoever—the society’s CEO called on the drug store chain, as well as others, to stop selling tobacco products.


photoConversation with The Cancer Letter
Youle: ACS Stance on Tobacco Sales is Clear

The American Cancer Society prefers to avoid public confrontation with corporate donors, even those who make money by selling tobacco products.

“We have come to the conclusion that in the case of Walgreens, CVS, and other business partners, the best strategy is to work with them rather than against them,” said Robert Youle, vice chair of the board of the American Cancer Society and an attorney with the Denver firm Sherman & Howard.

photoIn a Change of Heart, LCA Endorses NLST

Almost one decade ago, Laurie Fenton-Ambrose, president and CEO of the Lung Cancer Alliance, described the National Lung Screening Trial as “failed” and “outdated.”

photoFunding Opportunity
Defense Department Offering $30.5 Mil In Lung, Ovarian Cancer Research Grants

The Department of Defense announced the availability of several grants through its Ovarian Cancer Research Program and its Lung Cancer Research Program.

20140411 - Apr 11, 2014
ISSUE 15 – APRIL 11, 2014PDF

Varmus Pledges No Funding Gap for NCORP, Blames Snafu on “Unclear Communication”

Following an explosion of criticism, NCI said funding for community oncology clinics would not be interrupted.

In “an open letter to the cancer community” April 10, NCI Director Harold Varmus assured researchers that funding for the NCI Community Clinical Oncology Program sites would continue as it morphs into the NCI Community Oncology Research Program.

photoWhat the Physician Pay Report Won’t Tell You

For a good time, go to the Medicare database and key in the name of your physician friend, foe, or whatever, and presto!—you will see how much that person had billed Medicare in 2012.

This will make for hours of guilty pleasure, especially if you are willing to set aside concerns about—not just privacy—but accuracy.

photoPresident Obama Signs Law Authorizing $126 Million for Pediatric Research over the Next 10 Years

President Obama signed a bill authorizing $126 million for pediatric medical research over the next 10 years, following a rare showing of bipartisanship on Capitol Hill.

photoAACR Presents Awards, Arteaga Becomes President at Annual Meeting

The American Association for Cancer Research presented its 2014 awards at its annual meeting, held April 5-9 in San Diego. The AACR also inaugurated its officers for the next year during its annual business meeting. Carlos Arteaga was named president of the organization. 

photoIn Brief

  • Patricia Goldsmith named CEO of CancerCare

  • Becky DeKay named president of the Association of Community Cancer Centers

  • MD Anderson Cancer Center partners with GlaxoSmithKline

  • AACR taking applications for SU2C-Cancer Research UK Fellowship

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.