Issue 29 - Jul. 22, 2016
  • Health Centers Limit Reach of Texas Law Allowing Guns on University Campuses

    This may not be the sort of targeted therapy Texas healthcare institutions wish to be known for, but starting Aug. 1, visitors to designated areas at MD Anderson Cancer Center, UT Southwestern, and UT Health Science Center at San Antonio will be able to carry their guns.

    Texas Senate Bill 11, colloquially known as “campus carry,” decrees that “concealed handgun license holders can from now on carry handguns in a concealed fashion at institutions of higher education.”

    Controversy in Texas is fueled by belief of some that gun-carrying, law-abiding citizens are owed the opportunity to defend themselves.

    On the other side of this debate are doctors who—if an MD Anderson survey is an indication—don’t welcome the opportunity to pack heat, and believe that guns would, in fact, make them less safe in the workplace.

  • Conversation with The Cancer Letter

    Weber: We Cannot Completely Ban Guns From MD Anderson’s Campus

    In response to Texas concealed carry laws, MD Anderson proposed a plan that would allow guns only in designated buildings—the rest, specifically areas of worship and hospital facilities, are gun-exclusion zones.

    The UT System Board of Regents approved the cancer center’s recommendations on campus carry July 15.

    “We cannot invoke a policy that explicitly or implicitly bans guns from campus, so the primary message was we are going to follow Texas law,” said Max Weber, associate vice president and deputy chief compliance officer at University of Texas MD Anderson Cancer Center. “I think we sort of fell into this law incidentally…

    “We are a comprehensive cancer center. We are in the business of healing and curing cancer. We’re not a traditional school or university.”

  • Speaking of Guns

    MD Anderson Faculty, Staff Responses to Gun Survey

    MD Anderson surveyed 450 faculty, trainees and staff Sept. 29 through Nov. 10, 2015, to gather their opinions on campus-carry gun laws. Here’s what they said:

    “The American Medical Association has identified gun use and gun violence as a major medical problem in the US. Therefore, it is incumbent upon us as a health care institution to reflect the medical priorities and the values of those of us who have taken oaths to care for the health of others.”

  • BSA and NCAB Approve Three Concepts

    At a June 21 joint meeting, the NCI Board of Scientific Advisors and the National Cancer Advisory Board approved three concepts and deferred one.

  • In Brief

    • UC Santa Cruz receives $2.5 million grant from St. Baldrick’s for Treehouse initiative
    • Susan Pitt receives young investigator award from UW Carbone Cancer Center
    • Charles Simone II named medical director at Maryland Proton Treatment Center
    • Abishek Aphale named assistant professor of dermatology at Fox Chase
    • Rajeswari Nagarathinam joins Fox Chase department of pathology
    • Vy Dinh and Mariana Khawand-Azoulai join Miami Cancer Institute
    • NIH to work with Wondros communications firm for Precision Medicine Initiative
    • Merck to build new campus in Burlington, Mass.
  • Drugs and Targets

    • Health Canada approves Imbruvica in untreated CLL
    • CHMP issues positive opinion for Kisplyx in renal cell carcinoma
    • GlaxoSmithKline and University of Leicester to form collaboration
Issue 28 - Jul. 15, 2016
  • New NCI Clinical Trials Program Will Automate Matching Through Third-Party Data Software

    NCI is developing an open-source application intended to make it easier for patients and physicians to get information on clinical trials supported by the institute.

    Vice President Joe Biden endorsed the initiative June 29 at the National Cancer Moonshot Summit in Washington, D.C., saying it will “strengthen participation in cancer research studies to help accelerate medical discoveries and treatments for cancer.”

    When the institute’s application programming interface—a set of routine definitions, protocols, and tools for building software—is completed, data companies and programmers will be able to incorporate information on NCI-sponsored trials into their bioinformatics software. This enables physicians to search NCI’s clinical trials database via a more targeted and intuitive process eventually provided by any third-party software that uses the API.

  • Conversation with The Cancer Letter

    Kibbe: Anyone Can Build Search Interface With Open-Source NCI Clinical Trials API

    Vice President Joe Biden announced a new NCI application programming interface June 29 that will enable third-party developers to connect their bioinformatics software to NCI’s clinical trials database.

    When completed, the API is expected to improve access to the data available from NCI on cancer clinical trials that are supported by the institute.

  • Capitol Hill

    House Committee Approves Spending Bill Cutting Funding for CDC Anti-Smoking Programs

    The House Appropriations Committee approved a bill that would fund the Department of Health and Human Services through 2017, including the NIH, NCI and other related agencies.

    Released last week, the bill includes $161.6 billion in discretionary funding—a $569 million reduction below levels enacted for the 2016 fiscal year. However, the bill increases funding for the NIH by $1.25 billion and the NCI by $264 million.

    The bill contains several provisions to defund implementation of the Affordable Care Act, and prohibits the use of new discretionary funding for the president’s signature health care law. The committee considered more than 30 amendments over two days before approving the bill in a 31-19 vote July 14.

  • Capitol Hill

    Bill Introduced to Mandate Pediatric Clinical Trials

  • Obituary

    Alfred Knudson, Author of Two-Hit Hypothesis, Dies at 93

    Alfred G. Knudson Jr., the creator of the “two-hit hypothesis,” and a director of the Institute for Cancer Research at Fox Chase Cancer Center, died July 10. He was 93.

    The two-hit hypothesis postulates that cancer is produced by accumulated mutations in a cell’s DNA. The hypothesis explains the relationship between the hereditary and non-hereditary forms of cancer, and predicted the existence of tumor-suppressor genes that can suppress cancer cell growth.

  • In Brief

    • NCI announces 13 winners of its Cancer Clinical Investigator Team Leadership Award winners
    • Jeff Boyd receives ovarian cancer research award from the Ovarian Cancer Research Fund Alliance
    • Daniel Shasha joins Northside Radiation Oncology Consultants
    • Michelle Russell-Einhorn joins Schulman IRB
    • Regeneron Pharmaceuticals names three winners of its Regeneron Prize for Creative Innovation
    • American Society for Radiation Oncology elects five officers to board of directors
    • Bonnie J. Addario Lung Cancer Foundation and Van Auken Private Foundation announces team award winners
    • USC Norris and Trovagene to collaborate on liquid biopsy testing
  • Drugs and Targets

    • FDA approves Roche cobas HPV test with BD SurePath specimen vial
    • Health Canada approves Tagrisso in non-small cell lung cancer
    • FDA grants Rare Pediatric Disease Designation to ABT-414
    • FDA grants Orphan Drug Designation to TK216
    • FDA approves premarket supplement application for Novocure’s second-generation Optune system
    • U.K.’s NICE recommends use of Firmagon in prostate cancer
    • Guardant Health and OncoMed Pharmaceuticals to collaborate on custom blood test
    • Eli Lilly and Boehringer Ingelheim to collaborate in metastatic breast cancer
Issue 27 - Jul. 8, 2016
CL42-27
  • Conversation with The Cancer Letter

    Stanford Cancer Institute Earns NCI Comprehensive Center Designation

    Stanford Cancer Institute earned the NCI Comprehensive Cancer Center designation, becoming the eighth institution in California to earn this highest level of recognition.

    Nationwide, the number of comprehensive cancer centers now climbs to 47. Earlier this summer, the University of Maryland also received the comprehensive designation.

  • Slamming the Door

    Part XIV: How Al Got It Right 

    Gilman’s resignation enabled him to retain the most precious of all privileges: the ability to look at himself in the mirror.

    By slamming the door loudly and publicly—and by triggering an impossible-to-ignore resignations of scientists who conducted peer review at the Cancer Prevention and Research Institute of Texas—he made it clear that the institute’s scientific review was in danger of being subverted, and that its funds were at risk of being raided by politicians.

    “I built something I am proud of, and now it’s being taken apart,” Gilman said to me at the time. “I can’t work for people who are pushing their own interests at the expense of the interests of cancer patients.

    “A wise and experienced friend said to me: ‘This is always the way it works when you put a large amount of public money on the table. The vultures and the hyenas lie low for two or three years to see how the system really works. And then they come in for their feast.’”

  • Capitol Hill

    House Appropriators Propose $1.25 Billion Budget Increase for NIH in FY 2017

    The House Appropriations Subcommittee on Labor-HHS marked up a bipartisan spending bill July 6 that gives NIH a $1.25 billion increase in the 2017 fiscal year.

    NCI is to receive a $264 million increase over FY 2016.

    The measure boosts the NIH budget to $33.3 billion and now moves to consideration by the full House appropriations committee.

    The Senate Committee on Appropriations June 9 marked up a spending bill, which would provide a $2 billion funding increase for NIH and $216 million increase for NCI in FY 2017.

  • In Brief

    • Mark Socinski named executive medical director of the Florida Hospital Cancer Institute
    • ASTRO names 2016 class of fellows
    • University of Michigan to collaborate with Trovagene Inc.
  • Drugs and Targets

    • European Commission approves Kyprolis in mulitple myeloma
    • FDA grants Fast Track Designation to seribantumab (MM-121) in NSCLC
    • FDA grants 510(k) clearance to HARMONIC HD 1000i surgical device
Issue 26 - Jul. 1, 2016
CL42-26
  • News Analysis

    Biden’s Moonshot Goals are Flexible Enough to be Realistic

    After a year of trying to understand the biology and politics of cancer, Vice President Joe Biden admits that he has a stronger grasp on the nuts and bolts of Washington than the evolutionary mysteries known collectively as cancer.

    Hosting the National Cancer Moonshot Summit at Howard University on June 29, Biden delivered a wide-ranging speech, even as his main initiatives remain what they have been from the start of his cancer odyssey:

  • Biden Announces FDA Center of Excellence

    Vice President Joe Biden announced the formation of the FDA Oncology Center of Excellence, which is intended to consolidate the agency’s cancer portfolio and streamline regulatory pathways for cancer-related drugs, biologics, and devices.

    Richard Pazdur, currently the director of the Office of Hematology and Oncology Products, will serve as acting director of the agency’s new cancer center.

    Biden’s June 29 announcement at the National Cancer Moonshot Summit in Washington, D.C. follows months of lobbying by oncology professional societies, advocacy and patient groups.

  • Conversation with The Cancer Letter

    Pazdur Named Acting Director of FDA’s New Cancer Center

    Richard Pazdur, currently the director of the FDA Office of Hematology and Oncology Products, will serve as acting director of the newly formed FDA Oncology Center of Excellence.

    The exact structure, budget and staffing for the program will be determined in an ongoing process, Pazdur said to The Cancer Letter.

    “Because I will be working to develop the structure of the OCE with input across all centers, it would be premature to speculate about what the ultimate structure of the OCE will be,” Pazdur said. “The framework of the OCE will evolve over time, so as not to disrupt the ongoing work in each center.”

  • Biden: What I Learned About Cancer

    A transcript of Biden’s speech at the National Cancer Moonshot Summit at Howard University.

  • In Brief

    • Haakon Ragde named 2016 Honorary Member of ASTRO
    • Steven Paul elected chairman of Foundation for the NIH
    • Stephen Burley named leader of cancer pharmacology research at Rutgers Cancer Institute of New Jersey
    • Firas Eladoumikdachi named program director at Rutgers Cancer Institute of New Jersey at Hamilton
    • Joel Katz received Spirit of Life Award from City of Hope
    • American Cancer Society plans to double research budget in five years
    • Research!American launches 2016 election blog
    • Mount Sinai and Valley Health System to form partnership
    • IBM Research to collaborate with Melanoma Institute Australia
    • Wistar Institute enters agreement with Christiana Care Graham Cancer Center
  • Drugs and Targets

    • FDA approves Epclusa for chronic hepatitis C
    • FDA grants fourth breakthrough designation to Imbruvica
    • FDA grants fast track designation to TK216 in Ewing sarcoma
    • Hetero launches generic bevacizumab in India
    • Novartis enters into agreement with Xencor
    • OmniSeq receives New York State CLEP approval
Slamming the Door - Jul. 1, 2016
  • Slamming the Door

    How Al Gilman Taught Texas a Lesson in Science 

     This series re-examines the concurrent controversies at the Cancer Prevention and Research Institute of Texas and MD Anderson Cancer Center. This examination is possible in part because of new insight provided by Alfred Gilman, the Nobel laureate who served as the first scientific director of the state institution that distributes $300 million a year. Gilman died on Dec. 23, 2015.

     

    Alfred Gilman’s approach to distributing public funds wasn’t particularly difficult to understand: he wanted to pay for the best science available. Period.

    The pot of money entrusted to Gilman was vast. In 2007, Texas voters approved the largest investment in cancer research outside the federal government: $3 billion, to be spent over 10 years. By way of comparison, NCI grants going to Texas researchers and institutions added up to $240 million a year. CPRIT more than doubled that money. Only Texans were eligible to apply.

  • Part II: Cancer’s Butt

    CPRIT’s review process appeared to have become a major annoyance to those who wanted to redraft the criteria for dispensing the princely sum of $300 million a year. Texas geography and Texas politics did matter—a lot.

    The cross-state competition between MD Anderson Cancer Center and UT Southwestern Medical Center proved to be especially important.

  • Part III: 18,000 Bosses

    Between the fall of 2011 and the spring of 2012, I watched MD Anderson from afar, and I didn’t think about CPRIT at all.

    Friends who attended early meetings with Ronald DePinho soon after he became MD Anderson’s president said that he was literally grading presentations made to him by faculty members and administrators.

    “This was a C-,” he would say.

    It was difficult to get a B.

  • Part IV: Nobel Laureate in Crosshairs

    In early 2012, Gilman was under the impression that CPRIT was functioning smoothly.

    Then, to his surprise, the first of a series of controversies surfaced.

    CPRIT’s peer reviewers had evaluated 40 applications for Multi-Investigator Research Applications, the largest CPRIT grants designed to fund team science, recommending that seven of these project receive funding. This was no small undertaking. The applications described multiple projects and core facilities.

    Proposals for these projects—abbreviated as MIRAs—take a long time to write and a long time to review. The CPRIT committees worked hard to complete the review, but committee members were enthusiastic. There was a lot of good science on the table. In fact, one of the grants received the best score ever for an application of that type.

  • Part V: Gilman’s Resignation

    Gilman’s letter of resignation, dated May 8, 2012, concludes with a hard slam:

    “The purpose of this letter is to indicate my intention to resign from CPRIT, effective (with your permission) on October 12, 2012. At that time I will have worked for CPRIT for over three years—I believe longer than originally anticipated.

    “During that time we have launched strong programs because funding decisions have been based on high-level competitions, where the judges have been some of the best cancer researchers and physicians in the country—free of conflicts of interest and all coming from outside of Texas.

  • Part VI: The Provost’s Choice

    After my conversation with Gilman, I called MD Anderson and asked to talk with somebody about the $18 million grant for a biotech incubator.

    First, folks at the press shop told me that they view the controversy arising from the application as CPRIT’s problem.

    Let’s see: the wife of president of MD Anderson gets a grant seemingly out of turn, causing a political disaster, and this is not an MD Anderson problem?

    DePinho was initially silent on the controversy, but after the Houston Chronicle published a hard-hitting editorial that laid out a series of questions about the grant, he responded with a letter that portrayed the central question in the controversy as a “difference of opinions.”

  • Part VII – DePinho’s Stock Tip Revisited

    On May 25, 2012, I received an email from Len Zwelling:

    Paul: It can’t get worse than having our President pushing his own stock on TV. Len

    I clicked on the provided link to CNBC. What I saw was indeed difficult to process: a video of Ron DePinho, extolling the virtues of the stock of AVEO Pharmaceuticals Inc., a company he co-founded.

    On the CNBC program “Closing Bell with Maria Bartiromo” May 18, DePinho brought up AVEO in the context of the upcoming meeting of the American Society of Clinical Oncology.

  • Part VIII – A Conversation with DePinho

    The $18 million never made it from Austin to Houston.

    MD Anderson’s initial stance was to deflect all CPRIT-related questions to CPRIT, but this didn’t make the controversy go away. So, the cancer center suggested that the grant undergo scientific review, as well as commercial.

    Recently, I asked Dan Fontaine, MD Anderson’s executive chief of staff why the money never changed hands.

  • Part IX – “Furnituregate”

    I first heard something about a red sofa that cost an impressive amount of money soon after I started to cover the controversy at the Cancer Prevention and Research Institute of Texas.

    The sofa, I was told, was to be purchased with MD Anderson funds for the office of Lynda Chin. I wanted to look into it, but I want to look into many things, and some take precedence over others. This seemed to be fun, but it was undeniably trivial.

    The sofa in question was intended for the same entity CPRIT was being asked to fund. Had I been able to get it through my thick skull that the furniture was a part of the same story that was causing the ungluing of CPRIT, I would have filed my freedom of information requests sooner.

    When it finally appeared, my friends referred to this story as “furnituregate.”

  • Part X – Silencing Faculty Voice

    In the fall of 2012, just before Al Gilman’s departure, MD Anderson officials cracked down on internal critics.

    On Sept. 26, 2012, Raphael Pollock, head of MD Anderson’s Division of Surgery, was summoned to the office of Thomas Burke, then the executive vice president and physician-in-chief, and was relieved of his duties.

    Pollock, who is Jewish, was fired on Yom Kippur, the Day of Atonement.

  • Part XI: Gilman’s Teachable Moment

    During our first conversation in the spring of 2012, Gilman said that he would go public unless he received assurances that CPRIT would retain its integrity after his departure.

    He wanted guarantees that the structure he built would not be turned into a political pigsty. With guarantees being hard to come by, it was obvious that he would end up slamming the door hard. Publicly.

  • Part XII: Scientists Vote with Their Feet

    In their op-ed piece, Gilman and Sharp stated what it would take to fix CPRIT’s problems. That was the polite version of the Gilman Plan.

    The spoken version was more blunt: get rid of the “assholes” on the oversight board, jettison the administrators, then—maybe—CPRIT’s credibility would be restored.

    Maybe the place will become functional someday, but only the oversight committee is sent packing and after the Gogolesque characters are kicked out of CPRIT’s offices in Austin. Until that occurred, an effort to rebuild would require CPRIT to turn to the scientific establishment on some other planet.

  • Chair of CPRIT Oversight Committee: “Better to Get Them All Out of the Way Now”

    What were Texas politicians and CPRIT officials thinking as they were pounded by blistering letters of resignation?

    Condemnation seemed to be rolling off their backs as they marched toward what they thought was their great triumph.

    Jimmy Mansour, chairman of CPRIT’s oversight committee, mistakenly hit Reply All, sending an especially contemptuous email to a scientist who was announcing his resignation from CPRIT. In the email that came into public view because of his sloppiness, Mansour, a telecommunications entrepreneur, belittles scientists and the peer review process.

    The email is also remarkable because it illustrates the reluctance on the part of CPRIT officials to recognize that the institute that distributes $300 million a year in state funds is, in fact, in the midst of a crisis.

  • Slamming the Door

    Part XIV: How Al Got It Right 

    Gilman’s resignation enabled him to retain the most precious of all privileges: the ability to look at himself in the mirror.

    By slamming the door loudly and publicly—and by triggering an impossible-to-ignore resignations of scientists who conducted peer review at the Cancer Prevention and Research Institute of Texas—he made it clear that the institute’s scientific review was in danger of being subverted, and that its funds were at risk of being raided by politicians.

    “I built something I am proud of, and now it’s being taken apart,” Gilman said to me at the time. “I can’t work for people who are pushing their own interests at the expense of the interests of cancer patients.

    “A wise and experienced friend said to me: ‘This is always the way it works when you put a large amount of public money on the table. The vultures and the hyenas lie low for two or three years to see how the system really works. And then they come in for their feast.’”

Issue 25 - Jun. 24, 2016
CL42-25
  • Stanford, Intermountain and Providence Use Syapse Platform to Integrate Their Data

    Three health systems—Stanford Cancer Institute, Intermountain Healthcare and Providence Health and Services—have agreed to eliminate the electronic barriers between their medical records, tumor registries and genomics databases.

    The three entities said they have started to use a common IT platform to achieve interoperability and guide clinical decision-making.

    That platform is Syapse, a startup that is emerging as an important player in the ongoing conversation on bioinformatics and data sharing in oncology, led by Vice President Joe Biden and the National Cancer Moonshot Initiative.

    • Related Coverage of the Cancer Moonshot

  • Conversation with The Cancer Letter

    Hirsch: I Dropped Out of Stanford to Start Syapse

    Jonathan Hirsch was studying neuroscience at Stanford University when he wandered into two oncology classes and saw an opportunity to change the way health systems handle genomic data.

    “I started getting really immersed in molecular oncology, and the challenges in implementing molecularly guided treatment started coming together with the challenges in utilizing complex data,” Hirsch said to The Cancer Letter.

  • Joint BSA-NCAB Meeting

    The Moonshot’s Metric for Success: Avoiding a Single, Tangible Endpoint

    How will the success of the moonshot be measured? NCI Acting Director Doug Lowy touched on the subject during the joint meeting of the institute’s Board of Scientific Advisors and the National Cancer Advisory Board June 21.

    The moonshots of the 1960s were essentially engineering problems that had tangible goals. Cancer is an evolutionary problem, and the stated goal of the moonshot in cancer research, led by Vice President Joe Biden, is perhaps deliberately vague: to achieve a decade’s worth of progress in just five years.

    “Has there been any discussion of an endpoint that you can point to—like planting the flag on the moon, or sequencing the three-billionth base pair of the genome project?” asked BSA member Lincoln Stein, director of the Informatics and BioComputing Platform at the Ontario Institute for Cancer Research, during the meeting. “Something that looks like an achievable endpoint?”

  • Funding Opportunity

    SU2C, Merck Taking Proposals for Keytruda

    Stand Up To Cancer announced a request for proposals under SU2C Catalyst, a program supporting clinical trials and translational research.

  • In Brief

    • NCI Surgery Branch resumes enrollment in immunotherapy trials
    • Rajesh Garg named president and CEO of Cancer Treatment Centers of America
    • Prostate Cancer Foundation names 24 Young Investigator Award winners
    • Shuanzeng “Sam” Wei and Phillip Pancari join Fox Chase
    • MIT’s Tyler Jacks, Susan Hockfield, and Phillip Sharp publish report on convergence
    • Pancreatic Cancer Action Network lobbies Congress for research funding
    • Leukemia and Lymphoma Society and the American Society of Hematology to collaborate on promoting AML treatment research
Issue 24 - Jun. 17, 2016
  • Moonshot May Play Role in $400 Million Annual Contract to Run NCI’s Frederick Lab

    The contract for operations and technical support at the Frederick National Laboratory for Cancer Research could be accepting proposals as early as next month—but NCI advisors said they are hoping to slow the recompetition process to reform the laboratory’s mission.

    Moreover, NCI should consider how the laboratory could contribute to Vice President Joe Biden’s National Cancer Moonshot Initiative, members of the Frederick National Laboratory Advisory Committee said at a recent meeting.

  • Task Force Adds Tests to Colon Screening Guideline

    The final version of guidelines for colorectal cancer screening by the U.S. Preventive Services Task Force differ substantively from the group’s draft version published last October.

    The final version—unlike the draft—lists CT colonography and FIT-DNA as screening methods that are equal to others.

    It’s unclear whether political pressure had any role in prompting the panel to broaden its list of detection strategies from three to seven in the past six months.

  • Conversation with The Cancer Letter

    Guideline Edits Rooted in Science, Former USPSTF Member Says

    “I don’t see this recommendation as differing in any substantial way from some others that we’ve made, where we suggested that patients talk with their clinicians, and the important messages here is that colorectal cancer screening works, that colorectal cancer screening reduces deaths from colorectal cancer,” said Douglas Owens, a who has rotated off the U.S. Preventive Services Task Force, and was involved in developing the colorectal cancer screening guideline published earlier this week.

  • In Brief

    • President Obama names six appointees to the NCAB
    • Stand Up to Cancer to host fifth-biennial televised fundraiser
    • Kety Duron joins City of Hope as chief human resources officer
    • Miami Cancer Institute takes delivery of 220-ton proton therapy cyclotron
    • Takeda and M2Gen to collaborate on ORIEN genomic data
    • Mayo Clinic and Kiyatec to collaborate on ovarian cancer care
    • St. Jude receives pathology accreditation through College of American Pathologists
  • Drugs and Targets

    • Canadian review agency delivers positive opinion for Opdivo in NSCLC
    • Genomic Health launches Oncotype SEQ Liquid Select biopsy test
20160610 - Jun. 10, 2016
ISSUE 23 – June 10, 2016 PDF



Biden Designates NCI’s Genomic Data Commons as Foundation of Moonshot 

CHICAGO—Vice President Joe Biden June 6 announced the NCI Genomic Data Commons as part of the National Cancer Moonshot Initiative.

The GDC, a $20 million portal that consolidates NCI’s diverse datasets, contains genomic sequences and analyses of tumors, as well as clinical data on enrollment and treatment.

Biden’s announcement—made hours before his address at the 2016 annual meeting of the American Society of Clinical Oncology—establishes NCI as the leader in a high-stakes debate over who gets to set standards for how health records data should be aggregated and organized.

• Related Coverage of the Cancer Moonshot

ASCO 2016

Biden: “I’d Like to Issue A Challenge to You”

Vice President Joe Biden challenged individual organizations and leading initiatives in oncology bioinformatics to interoperate and share data.

Speaking at the annual meeting of the American Society of Clinical Oncology in Chicago, Biden announced the NCI’s Genomic Data Commons as part of the National Cancer Moonshot Initiative, and urged others to collaborate with NCI.

Cancer Groups, Congress Push for
Dedicated Cancer Center at FDA

The FDA Oncology Center of Excellence—first proposed in the National Moonshot Cancer Initiative—is gaining support from oncology groups as well as in both chambers of Congress.

Earlier this week, 28 oncology professional societies and advocacy organizations sent a letter to FDA Commissioner Robert Califf, describing the organizational structure they’d like to see in the proposed center.

Capitol Hill

Senate Appropriators Propose $2 Billion
Increase for NIH

The Senate Committee on Appropriations marked up a bipartisan spending bill June 9 that gives NIH a $2 billion increase in the 2017 fiscal year.

NCI is to receive a $216 million increase over FY 2016.

Passed on a 29-1 vote, the measure boosts the NIH budget to $34 billion and now moves to consideration by full Senate. Funding for the Centers for Disease Control and Prevention will remain flat.

ASCO 2016

Vose: “Are We Ready To Care For These Patients?

Julie Vose, president of the American Society of Clinical Oncology, addressed the opening session of the society’s annual meeting in Chicago, discussing the themes of her year in office, the coming changes in federal cancer research and Medicare reimbursement, and the progress made over the society’s past 52 years.

Safety Bills on Morcellators,
Essure Introduced in House

Two House measures introduced earlier this week aim to strengthen federal requirements for reporting adverse outcomes caused by medical devices and to increase access to legal recourse for patients harmed by Class III high-risk devices.

• Related Coverage of Power Morcellation

In Brief

  • Former NCI Director Samuel Broder to retire from Intrexon Corp.
  • Yoshinori Ohsumi wins Janssen research prize from Johnson & Johnson

  • Five Pew-Stewart cancer research scholars announced

  • Susan G. Komen names 16 new Komen Scholars

  • American Hospital Dubai joins Mayo Clinic Care Network

  • University of Kentucky joins TriNetX

  • Roswell Park forms for-profit biotechnology company

  • CDC publishes Youth Risk Behavior Survey showing historic low smoking rates

 

20160606 - Jun. 6, 2016
JUNE 6, 2016  

Biden Designates NCI’s Genomic Data Commons As “Foundational Element” of Cancer Moonshot

Vice President Joe Biden June 6 announced the NCI Genomic Data Commons as part of the National Cancer Moonshot Initiative.

The GDC, a $20 million portal that consolidates NCI’s diverse datasets, contains genomic sequences and analyses of tumors, as well as clinical data on enrollment and treatment.

Biden’s announcement—hours before his address at the 2016 annual meeting of the American Society of Clinical Oncology in Chicago—establishes NCI as the leader in a high-stakes debate over who gets to set standards for how health records data should be aggregated and organized.

• Related Coverage of the Cancer Moonshot

    20160603 - Jun. 3, 2016
    ISSUE 22 – June 3, 2016 PDF



    Obama and Congress Inadvertently
    Created Obstacles to Data Sharing, Biden Acknowledges—Now What?

    Seven years ago, when Congress sought to jumpstart the U.S. economy, few imagined that one aspect of the $800 billion stimulus program would turn electronic health records into the Tower of Babel.

    Speaking at Memorial Sloan Kettering Cancer Center last week, Vice President Joe Biden took full responsibility for the major bioinformatics snafu triggered by the American Reinvestment and Recovery Act of 2009.

    True, ARRA forced the U.S. medical establishment to digitize records in a hurry. Alas, today, fax machines and legions of data entry technicians are often required to transfer patient records from one hospital to another.

    Biden said the Obama administration didn’t foresee the consequences of mandating the switch to EHRs without developing a standard infrastructure for aggregating data.

    Biden: “You’re All Doing the Same Thing!”

    At a roundtable discussion at Memorial Sloan Kettering Cancer Center, Vice President Joe Biden urged greater efforts to aggregate cancer data.

    “I know MSK is part of Project GENIE and part of data sharing coalitions,” Biden said at the meeting May 26. “But I’ve met also with ORIEN, I’ve met with CancerLinQ.”

    “You’re all doing the same thing! I find it curious. I don’t know if that’s the only way it that can be done.”

        University of Maryland Cancer Center
        Earns NCI Comprehensive Designation

        The University of Maryland Marlene and Stewart Greenebaum Cancer Center has earned a designation as an NCI-designated Comprehensive Cancer Center. The center announced the NCI designation May 31.

        On Aug. 1, when the designation goes in effect, Maryland will become one of the 46 Comprehensive Cancer Centers in the U.S.

        ASCO Updates Value Framework

        The American Society of Clinical Oncology published an updated framework for assessing the relative value of cancer therapies that have been compared in clinical trials.

        The framework defines value as a combination of clinical benefit, side effects, and improvement in patient symptoms or quality of life in the context of cost. The updated framework will be the basis for a software tool that doctors can use to assist shared decision-making with their patients. The update was published in the Journal of Clinical Oncology.

        Study: 70 Cancer Treatments Launched Over 5 Years Pushes Oncology Market to $107 Billion

        A study reviewing trends in oncology found that more than 20 tumor types are being treated with one or more of the 70 cancer treatments that have been launched in the past five years.

        The surge in new therapies drove the global oncology market to $107 billion in 2015, an 11.5 percent increase over the previous year in constant dollars.

         

        Funding Opportunity

        CDMRP Taking Pre-Applications
        For Lung Cancer Concept Award

        Only 40 percent of Americans have a positive overall impression of clinical trials, according to a national survey conducted for Memorial Sloan Kettering Cancer Center.

        The survey, which polled over 2,100 people including nearly 600 physicians, found that 28 percent of doctors considered clinical trials as treatments of last resort.

        Letter to the Editor

        Progress Against Cancer:
        It Comes in Waves and Ripples

        By Silvia Paddock

        In 1916, Albert Einstein predicted the existence of gravitational waves. It took almost 100 years and the construction of the Laser Interferometer Gravitational-Wave Observatory (LIGO) to show that he was right. In 2015, a brilliant team of researchers detected gravitational ripples that had been generated by the collision of two black holes about 1.3 billion years ago.

        In Brief

        • Ralph De Vere White to step down as director of UC Davis Cancer Center
        • FDA publishes two guidances on compassionate use

        • ACCC launches Metastatic Breast Cancer Project

        Drugs and Targets

        • FDA approves cobas EGFR companion blood test for Tarceva

        • FDA approves NETSPOT for neuroendocrine tumors

        • European Commission approves Afinitor, Imbruvica
        • FDA grants orphan designations to Debio 1143 and SUBA-Itraconazole Capsules

        • Mylan launches generic version of Vidaza Injection

        • FDA grants Priority Review of telotristat etiprate in carcinoid syndrome