20150702 - Jul 2, 2015
ISSUE 26 – JULY 3, 2015PDF

How NCI Will Spend New Money (If it Comes)

 

Is new money on the way to NCI? It’s certainly been promised in President Obama’s budget proposal and in the appropriations bills gestating in the House and Senate.

Those who seek logic in history will read much into timing:

After a decade of flat funding, decreases and inflationary erosion, the purchasing power of the NIH budget is where it was the year the doubling began in 1999.

Yet, a cycle this is not. The institute’s 1999 message was “Give us the money and we will use it wisely, because we are the best.”
In 2015, a leaner, more focused NCI is delivering the more compelling message: “Give us the money and we will give you the cutting edge of precision medicine.”

 

Lowy’s First Director’s Report to Advisory Panel

The following is a transcript of NCI Acting Director Douglas Lowy’s remarks to the joint meeting of the National Cancer Advisory Board and the NCI Board of Scientific Advisors, June 24:

I’m coming to the close of my third month as acting director, and I’d like to give you a status report. It has been really interesting and exciting for me and I can’t thank all of you enough for your incredible support—both my colleagues in NCI, and so many of you extramural colleagues.

    Senate Appropriators Approve $2 Billion for NIH

    The Senate Committee on Appropriations June 25 approved the fiscal 2016 Labor, Health and Human Services, and Education Appropriations Bill, which would boost NIH’s budget to $32 billion—an increase of $2 billion above fiscal 2015.

    The $153.2 billion measure would provide the largest increase NIH has received since the doubling of its budget was completed in 2003.

    BSA Approves Three Concepts at Joint Meeting with NCAB

    The NCI Board of Scientific Advisors approved the following concepts at a meeting June 24:

    • The Non-Communicable Disease Regional Infrastructure Core Planning Grants program seeks to support activities for the planning and designing of sustainable, regional research infrastructure core, established to build, strengthen, and coordinate research and training of non-communicable diseases in low and middle-income countries or regions.

      The Cancer Letter’s Coverage of Power Morcellation Wins Three Journalism Awards

      The Cancer Letter won a first place 2015 National Press Club Award in the NPC’s annual journalism competition June 26.

      The award recognizes Matthew Ong’s series “Power Morcellation: A Hazardous Practice” as the winner in the Newsletter Journalism category.

        In Brief

        • Raphael Pollock named surgeon-in-chief for OSU Health System

        • Jonathan Licht named director of UF Cancer Center

        • George Wilding named vice provost at MD Anderson Cancer Center 

        • LIVESTRONG Foundation appoints Donna Palmer and Katie Merrell to leadership team

        • Cyrus Ghajar receives $4.1 million award from the Department of Defense

        Drugs and Targets

        • EMA grants accelerated approval to Opdivo in metastatic melanoma

        • Leukemia & Lymphoma Society accelerates payment to Celator Pharmaceuticals

        • Mevion Medical Systems delivers proton accelerator to UH Seidman Cancer Center
        • Proton Partners International Ltd. acquires site for proton beam therapy center in Wales

        20150626 - Jun 26, 2015
        ISSUE 25 – JUNE 26, 2015PDF

        NIH Receives Glimmer of Hope as AHRQ Inches Closer to Elimination

         

        The House and Senate appropriations committees earlier this week passed parallel spending bills that would boost NIH budgets while eliminating the Agency for Healthcare Research Quality, a $465 million agency that plays a central role in the implementation of President Barack Obama’s health care law.

        After more than a decade of flat funding and budget cuts, both bills provided aggressive increases for NIH:

        • The House appropriations committee approved a proposed $1.1 billion increase on June 24.

        • Senate subcommittee appropriators went even further, proposing a $2 billion increase during markup June 23.

         

        ASCO Publishes Drug Value Assessment Tool

        The American Society of Clinical Oncology earlier this week published a proposed framework for assessing the value of new cancer treatments.

        The paper, published in the Journal of Clinical Oncology June 22, quantifies clinical benefit, side effects and cost as components of value.

        ASCO’s objective is to build a standardized tool that can be used as the basis of shared decision-making by oncologists and their patients.

        OHSU Reaches $1 Billion Goal, Begins Recruiting Scientists and Researchers

        Oregon Health & Science University met the challenge posed by Nike co-founder Phil Knight and his wife Penny by raising $500 million in less than two years, earning the Knights’ matching gift and setting a $1 billion fundraising record. The announcement was made June 25.

        The $1 billion will support the first large-scale program dedicated to early detection of lethal cancers. OHSU Knight Cancer Institute will now begin rapid recruitment of about 25 of top-tier researchers.

        Appropriations Bill Seeks to Preempt FDA Efforts to Broaden Tobacco Regulation

        A $20.65 billion agriculture appropriations bill, which cleared a House subcommittee June 18, seeks to limit FDA’s ability to review electronic cigarettes, cigars and other tobacco products already on the market.

        The legislation—which was approved by the House Appropriations Subcommittee on Rural Development, Food and Drug Administration and Related Agencies—would prevent the FDA Center for Tobacco Products from requiring products already on the market to go through the Premarket Tobacco Review application process under the Federal Food, Drug and Cosmetic Act.

          Study: Widespread Overtreatment Of Benign Lung Nodules in Community Oncology Practices

          Thousands of U.S. patients may be undergoing unnecessary lung biopsies and surgeries annually due to overtreatment of benign lung nodules, according to a study published in the journal CHEST.

          The study—funded by Integrated Diagnostics, or Indi—examined how community pulmonologists treated and managed the care of 377 patients with indeterminate (medium-sized) lung nodules. The paper is titled “Management of Pulmonary Nodules by Community Pulmonologists: A Multicenter Observational Study.”

            Funding Opportunity

            AACR Launches Grant Program For Young Investigators

            The American Association for Cancer Research has launched the AACR NextGen Grants for Transformative Cancer Research, a funding initiative to stimulate innovative research from young investigators.

            The grant mechanism is intended to promote and support creative, paradigm-shifting cancer research that, because of its very nature, may not otherwise be funded through existing channels.

              In Brief

              • Five new members appointed to NCAB

              • Five members rotate off the NCI Board of Scientific Advisors

              • AHRQ to fund three centers of excellence with $52 million over five years

              • Maurizio D’Incalci receives award from European Association of Cancer Research, AACR, and Italian Cancer Society

              • Conquer Cancer Foundation honors six oncology practices with Clinical Trials Participation Awards

              • Broad Institute to collaborate with Google Genomics

              • Guardant Health partners with SWOG for NSCLC study
              • Karmanos Cancer Institute and Detroit Tigers to host “Pink Out the Park”

               Drugs and Targets

              • FDA grants priority review to MM-398

              • Soligenix to recruit patients for phase III study

              • Advaxis submits special protocol assessment to FDA
              • Amgen and Roche to collaborate on phase Ib study

              • Cigna publishes positive coverage decision for VeriStrat

              20150619 - Jun 19, 2015
              ISSUE 24 – JUNE 19, 2015PDF

              Are Cancer Drugs Worth the Money?
              MSKCC Tool Tests Pricing Rationale

              A health services researcher at Memorial Sloan-Kettering Cancer Center has proposed a method for assessing whether cancer drugs are rationally priced.

              Peter Bach, director of the MSKCC Center for Health Policy and Outcomes, constructed DrugAbacus, a tool for analyzing the value of the new generation of cancer drugs.

              Also:

              Appropriations

              House Spending Bill to Eliminate AHRQ While Adding $1.1 Billion to NIH Budget

              A $153 billion spending bill that cleared a House subcommittee June 17 seeks to abolish the Agency for Healthcare Research and Quality, the federal entity that funds patient-centered outcomes research and monitors the manner in which medicine is practiced in the U.S.

              At the same time, the bill proposes increasing the NIH budget to $31.2 billion, a $1.1 billion above this year’s level and $100 million more than the White House requested.

              AAUP Censures MD Anderson

              MD Anderson Cancer Center has been censured by the American Association of University Professors, an organization that defends academic freedom and shared governance.

              The decision was made at AAUP’s annual meeting, which concluded June 13 in Washington, D.C. Founded in 1915, AAUP has 47,000 individual members and 300 chapters.

              Congress Reintroduces Bill to Limit Out-of-Pocket Costs for Oral Anticancer Drugs

              House and Senate sponsors have reintroduced the Cancer Treatment Parity Act, a bill that would require insurers to provide coverage for oral anticancer drugs on terms no less favorable than coverage for intravenous chemotherapy.

              Previously introduced in 2011 and 2013, the 2015 version would reduce out-of-pocket costs for oral chemotherapy, but would not mandate coverage of oral medications.

                CPRIT Reaches Milestone in Providing 2 Million Cancer Prevention Services to Texans

                The Cancer Prevention and Research Institute of Texas has provided more than 2 million cancer prevention services to Texans across all 254 counties in the state, the institute announced June 16.

                Prevention measures funded by CPRIT grants include tobacco cessation programs, vaccinations, screening for breast, cervical, and colorectal cancers, genetic testing and counseling, and survivor care.

                  In Brief

                  • John Sampson named chair of Duke Department of Neurosurgery

                  • John Zaia named director of City of Hope’s Center for Gene Therapy

                  • AHRQ to fund three centers of excellence with $52 million over five years

                  • Eli Lilly & Co. announces collaborations with Dana-Farber and Sarah Cannon Research Institute

                   Drugs and Targets

                  • Gardasil 9 receives marketing authorization from European Commission

                  • FDA approves Ventana ALK (D5F3) CDx companion diagnostic assay for Xalkori

                  20150613 - Jun 13, 2015
                  SPECIAL REPORT – JUNE 13, 2015 

                  AAUP Places MD Anderson on Censure List

                  MD Anderson Cancer Center has been censured by the American Association of University Professors, an organization that defends academic freedom and shared governance.

                  The decision was made at AAUP’s Annual Meeting, which concluded June 13 in Washington, D.C. Founded in 1915, AAUP has 47,000 individual members and 300 chapters.

                  Several hundred AAUP members unanimously voted to censure Ronald DePinho’s administration, said Gregory Scholtz, AAUP associate secretary and director of the Department of Academic Freedom.

                  “There was no debate,” Scholtz said to The Cancer Letter.

                  20150612 - Jun 12, 2015
                  ISSUE 23 – JUNE 12, 2015PDF

                  NCI Frederick Laboratory’s $400 Million Per Year Contract Up for Re-Competition

                  NCI is opening up its contract for operations and technical support at the Frederick National Laboratory for Cancer Research for re-competition—a process that officials said will take up to two years.

                  The institute is broadening the statement of work for the contract to maximize new opportunities in cancer research, which involves fostering interactions with academia. Bidders can include universities, consortia of universities, other nonprofit institutions and for-profit companies.

                  The contract, which was awarded in 2008, is scheduled to end in September 2018. Leidos Biomedical Research Inc. received $400.2 million to run the lab in fiscal 2014. It is not publicly known how much NCI is budgeting for the 2018 contract.

                    21st Century Cures Heads for House Floor Vote

                    The 21st Century Cures Act cleared the House Committee on Energy & Commerce and is heading for floor vote.

                    The legislation, H.R. 6, is designed to expedite drug development, modernize clinical trials, and accelerate approval of drugs and medical devices. Capitol Hill insiders say the floor vote may occur within two weeks.

                    Guest Commentary

                    Obamacare was Undermined from the Outset

                    By Leonard Zwelling

                    Could the Supreme Court functionally end Obamacare before the end of June?

                    It could if the court determines that subsidies paid to those individuals eligible for the payments who gained health insurance on the federal exchanges are inconsistent with the Affordable Care Act as written.

                    Pediatrician Charged With Child Porn Possession Resigns From MD Anderson

                    A pediatric oncologist at MD Anderson Cancer Center is facing federal charges of one count of receiving and possessing child pornography.

                    Dennis Hughes, an associate professor of pediatrics, was arrested at his home June 5 after the Federal Bureau of Investigation found a thumb drive containing 8,200 downloaded files, the majority of which appeared to contain child pornography.

                      In Brief

                      • Karen Knudsen named director of Sidney Kimmel Cancer Center at Thomas Jefferson University

                      • Roberto Pili joins IU Melvin and Bren Simon Cancer Center

                      • Mary Beckerle appointed to board of Johnson & Johnson

                      • Pew Charitable Trusts name 27 biomedical research scholars

                      • The Cancer Genome Atlas Research Network publishes study on molecular classification of diffuse gliomas

                      • AACR and Bayer partner to expand research fellowship program

                      • Scripps Mercy O’Toole Breast Care Center opens in San Diego

                      • ASCO Publishes Practical Tips for Oncology Practice 

                      • Chris4Life Colon Cancer Foundation and Smart Patients launch DATABLUE

                      • The Cancer Letter receives first place award from the Society of Professional Journalists for its coverage of power morcellation

                       Drugs and Targets

                      • Lenvatinib launches in U.K. for advanced thyroid cancer

                      • Keytruda authorized for sale by Health Canada

                      • FDA grants orphan designation to APTO-253

                      • Janssen initiates rolling submission for daratumumab in multiple myeloma

                      • MD Anderson and Nektar Therapeutics announce collaboration

                      20150605 - Jun 5, 2015
                      ISSUE 22 – JUNE 5, 2015PDF

                      NCI-MATCH to Bring in Public, Private Funds, Giving NCI New Urgent Scientific Agenda

                      ECOG-ACRIN Cancer Research Group is starting enrollment in NCI-MATCH, the most ambitious of NCI’s new generation of clinical trials.

                      In addition to being the centerpiece of the institute’s recently formed National Clinical Trials Network, NCI-MATCH—the name is an acronym for Molecular Analysis for Therapy Choice—provides a strong case for garnering Congressional support for the White House precision medicine initiative.

                      The $215 million program proposed by Obama as part of appropriations for fiscal 2016 hasn’t translated into congressional appropriations. The PMI budget request includes $70 million for NCI to scale up efforts to identify genomic drivers in cancer and apply that knowledge to develop more effective approaches to cancer treatment. Similarly, the new-generation trials would boost the NCI case in pursuit of a share of another potential windfall: the 21st Century Cures.

                      See also:

                      Conversation with The Cancer Letter

                      Doroshow: NCI-MATCH is an Example of What Smart Public-Private Partnerships Can Do

                      The NCI-MATCH phase II study is intended to allow the institute and its clinical trials groups catapult to the premier role in cancer research.

                      In a conversation with The Cancer Letter, James Doroshow, director of the NCI Division of Cancer Treatment and Diagnosis, said NCI-MATCH established the institute as a trusted party in a complex, multi-agent trial intended to produce leads for government-funded investigators and pharma companies would be able to follow.

                      ASCO CEO Lichter to Step Down in June 2016

                      Allen Lichter, CEO of the American Society of Clinical Oncology and the Conquer Cancer Foundation of ASCO, announced June 1 that he would step down June 30, 2016.

                      Lichter has led ASCO since 2006.

                      Melanoma Drugs Could be Used to Treat Lung, Liver, Head-Neck and Colorectal Cancers

                      Three immunotherapy drugs approved for the treatment of melanoma may be used to treat advanced lung, liver, head and neck, and colorectal cancers, according to clinical trial results presented at the 2015 American Society of Clinical Oncology annual meeting in Chicago.

                      These drugs—Keytruda (pembrolizumab) by Merck, and Opdivo (nivolumab) and Yervoy (ipilimumab) by Bristol-Myers Squibb—are called checkpoint inhibitors because they release the molecular checkpoints that keep the immune system from attacking tumors.

                        ESMO Scale Stratifies Magnitude of Benefit of Cancer Drugs

                        The European Society for Medical Oncology May 30 published the ESMO Magnitude of Clinical Benefit Scale, a tool to assist oncology clinicians in evaluating the most effective anti-cancer medicines for their patients.

                        According to the society, the ESMO-MCBS offers a “rational, structured and consistent approach to stratify a drug’s clinically meaningful benefit”—a scale that can be used in public policy decision-making, to develop or improve clinical guidelines, in day-to-day clinical situations.

                          Canadian Judge Orders Tobacco Companies to Pay $12 Billion to About One Million Quebec Citizens

                          A Quebec court ordered three major tobacco companies to pay US$12 billion, over 15 billion Canadian dollars, in damages in a landmark class action lawsuit.

                          On June 1, Quebec Superior Court Judge Brian Riordan instructed Canadian tobacco companies JTI-Macdonald, Imperial Tobacco, and Rothmans, Benson & Hedges to pay punitive and moral damages to two groups of Quebecois plaintiffs. The lawsuit was filed in fall 1998, and legal proceedings began in 2012.

                            ASCO President Peter Paul Yu’s 2015 Presidential Address

                            A transcript of ASCO President Peter Paul Yu’s address at the 2015 ASCO Annual Meeting.

                              Amgen Seeks to Depose Reporter, TCL Invokes First Amendment Shield

                              Amgen Inc. is seeking to depose The Cancer Letter editor and publisher Paul Goldberg in connection with a shareholders suit stemming from his 2007 story about the results of a Danish trial of Aranesp.

                              The Cancer Letter is contesting the subpoena, asserting first amendment protection and its rights to protect confidentiality of sources.

                                Obituary

                                Wally Sampson, 85, Challenged Alternative Remedies

                                Wallace Ira Sampson, a longtime “quackbuster,” emeritus clinical professor of medicine at Stanford University, and former director of oncology at the Santa Clara Valley Medical Center, died May 25 following a three-month hospital stay for complications following cardiac surgery. He was 85.

                                Sampson was one of a group of scientists and physicians who focused on the growing influence of alternative medicine, said Stephen Barrett, a fellow quackbuster.

                                  In Brief

                                  • Nicole Robinson named VP of Industry Relations at Fred Hutch

                                  • The Department of Defense appropriations bill includes an additional $12 million for lung cancer research

                                  • The Community Oncology Alliance announces nine practices received oncology medical home designation

                                  20150529 - May 29, 2015
                                  ISSUE 21 – MAY 29, 2015PDF

                                  Neupogen’s New Indication:

                                  Nuke Mishaps and Terrorism

                                  Neupogen, a drug widely used in oncology, recently received an FDA approval for boosting survival in people acutely exposed to myelosuppressive doses of radiation, also known as hematopoietic syndrome or acute radiation syndrome.

                                  Neupogen (filgrastim)—a myeloid growth factor, a class of drugs that includes GM-CSF and Neulasta—as well as other similar drugs have been used to treat victims of radiation and nuclear accidents since Chernobyl.

                                  “Based on my experience treating victims of many nuclear and radiation accidents worldwide, I think drugs like G- and GM-CSF may be useful in accelerating bone marrow recovery in persons exposed to moderate doses of ionizing radiations in whom sufficient numbers of undamaged bone marrow cells remain to respond and who have no irreversible damage to other tissues and organs such as the skin and lungs,” said Robert Peter Gale, an American physician who was the first physician to use these drugs in the aftermath of a nuclear accident.

                                  Two Chernobyl Doctors were the First Humans to Get GM-CSF

                                  By Robert Peter Gale

                                  By 1986, there were substantial data in animals that molecularly-clone human haematopoietic growth factors, such as granulocyte-macrophage colony stimulating factor (GM-CSF), could accelerate bone marrow recovery and increase survival after exposure to high-dose ionizing radiations given under controlled experimental conditions.

                                  On April 26, 1986, my Soviet colleagues and I were suddenly faced with treating about 200 firefighters, emergency personnel and technicians exposed to very high doses of ionizing radiations from an accident at the Chernobyl nuclear power facility in Ukraine. The most severely affected persons receiving >2 Gray (Gy; for reference the average dose of the A-bomb survivors was 10 times less and there were no survivors of doses >1 Gy) were flown to Moscow where we set up operations at Clinical Hospital 6, a high security facility attached to the Institute of Biophysics.

                                  FBI Probes Who Knew What and When in Power Morcellation Imbroglio

                                  The Federal Bureau of Investigation is reportedly trying to establish whether Johnson & Johnson—one of the largest manufacturers of power morcellators—knew as early as nine years ago that the gynecological device can disseminate uterine cancers.

                                  According to the Wall Street Journal, the FBI’s Newark, N.J. office interviewed three people, including Robert Lamparter, a retired pathologist who alerted Ethicon, a J&J subsidiary, about potential problems with morcellators in 2006.

                                  Federal Appeals Court Instructs Tobacco Companies to Issue “Corrective Statements”

                                  The U.S. Court of Appeals for the D.C. Circuit Court upheld on May 22 a lower court’s order requiring nine tobacco companies to publish “corrective statements” about the dangers of tobacco and its practices of marketing to children.

                                  The ruling stems from a case the federal government brought against a group of the largest tobacco companies in 1999 under anti-racketeering law.

                                    ASCO Conquer Cancer Foundation Names 2015 Winners of Young Investigator, Career Development, and Clinical Research Awards

                                    The Conquer Cancer Foundation of the American Society of Clinical Oncology announced the recipients of the 2015 Young Investigator Awards, Career Development Awards, Advanced Clinical Research Award in Breast Cancer, and the Comparative Effectiveness Research Professorship in Breast Cancer.

                                    The recipients will be recognized during the 2015 ASCO Annual Meeting taking place May 29 – June 2 in Chicago.

                                      In Brief

                                      • Shohreh Shahabi named chief of gynecologic oncology at Northwestern University

                                      • Varian Medical Systems and Flatiron Health to collaborate on EMR software

                                      • AbbVie completes its acquisition of Pharmacyclics Inc.

                                      Drugs and Targets

                                      • EU Approves Aloxi for CINV in pediatric patients

                                      • CHMP issues positive opinion for change in Imbruvica label

                                      • Halozyme Therapeutics and Ventana Medical Systems to collaborate on PEGPH20 assay

                                      20150522 - May 22, 2015
                                      ISSUE 20 – MAY 22, 2015PDF

                                      The Price of Deception: How a Duke Patient was Harmed In Potti’s Fraudulent Trials

                                      Joyce Shoffner would never have predicted that Duke University, an institution she revered and at one time worked for, would put her in a breast cancer clinical trial testing a fraudulent technology.

                                      “They advertised publicly that this science offered an 80 percent cure rate,” Shoffner said. “To have the type of cancer I had, I was just going to do that, there was nobody that was going to stop me, because this was what I was told and this was what I believed was going to happen.”

                                      In July 2008, Shoffner became patient No. 1 in the trial that promised to choose the best therapy for the unique characteristics of her disease. Alas, the groundbreaking genomic predictors pioneered by Anil Potti and his mentor Joseph Nevins, which the trials were testing, would turn out to be fraudulent.

                                      FDA Notifies 300 Medical Practices that they May Have Purchased Unapproved Prescription Drugs

                                      FDA notified more than 300 medical practices that they may have purchased unapproved prescription drugs or injectable devices from a foreign supplier, Gallant Pharmaceutical International.

                                      “Gallant and twelve individuals, including a doctor and an office manager, have been convicted for their roles in distributing drugs and devices that have not been approved or cleared by FDA in the U.S.,” the agency’s letter to the practices said. “The unapproved drugs and unapproved/uncleared devices sold by Gallant were obtained from foreign sources and shipped and stored outside of the regulated supply chain.”

                                      The drugs sold include Avastin, Erbitux, Herceptin, Rituxan, and Velcade.

                                      Four Cancer Charities Charged with Fraud in Raising $187 Million

                                      The Federal Trade Commission charged four cancer charities with fraudulently raising $187 million between 2008 and 2012.

                                      The federal complaint names Cancer Fund of America Inc., Cancer Support Services Inc., their president, James Reynolds, Sr., and their chief financial officer and CSS’s former president, Kyle Effler; Children’s Cancer Fund of America Inc. and its president and executive director, Rose Perkins; and The Breast Cancer Society Inc. and its executive director and former president, James Reynolds II.

                                      CPRIT Awards 41 Grants, Totaling Over $89 Million

                                      The Cancer Prevention and Research Institute of Texas awarded 28 grants through its academic research program, 11 grants through its prevention program and two grants through its product development research program.

                                      Totaling over $89 million, the grants include nearly $31 million for six Core Facilities Support Awards. Additional research grants help support the recruitment of cancer scientists to academic institutions in Texas.

                                        In Brief

                                        • PCORI Approves $120 million in research grants

                                        • Catherine Brown named president of John Wayne Cancer Foundation

                                        • Community Oncology Alliance and Community Oncology Pharmacy Association appoints advisory board

                                        • Meridian Health and Hackensack University Health Network sign definitive merger agreement
                                        Drugs and Targets

                                        • FDA grants fast track designation to AG-120

                                        • Palmetto GBA issues draft LCD for Oncotype DX prostate cancer test

                                        • Baylor Research Institute and TGen extend collaboration

                                        20150515 - May 15, 2015
                                        ISSUE 19 – MAY 15, 2015PDF

                                        Fisher Discusses Turnaround at Fox Chase

                                        A year ago, Fox Chase Cancer Center lost money: $17 million.

                                        In 2015, the losses have stopped and an $8 million operating profit is projected. Fox Chase is part of the Temple University Health System, which is rebuilding its cancer services around the venerable center.

                                        “We’re in an interesting time at Fox Chase—because as I look ahead to the future of health care and accountable care coming, I think it’s unlikely if many, if any, of the freestanding cancer centers will be able to stand by themselves in that kind of arrangement,” Fisher said to The Cancer Letter. “So right now, we’re a fascinating model that’s going to be looked at by our colleagues to see how it works.”

                                        21st Century Cures Passes House Subcommittee

                                        The 21st Century Cures bill—a bipartisan initiative aimed at streamlining development of drugs and medical devices—received unanimous approval May 14 from the Health Subcommittee of the House Energy and Commerce Committee.

                                        Congressional leaders expect a full committee markup next week, and a floor vote in June.

                                        Guest Editorial

                                        AACR: 21st Century Cures a “Model for an Open and Honest Conversation”

                                        By José Baselga and William S. Dalton

                                        Almost one year ago (on April 30, 2014), House Energy and Commerce Committee Chairman Fred Upton (R-Mich.), along with Oversight and Investigations Subcommittee Ranking Member Diana DeGette (D-Colo.) announced the launch of 21st Century Cures, an initiative aimed at accelerating the pace of cures and medical breakthroughs in the United States by ensuring that our laws are keeping pace with innovation.

                                           

                                          ASCO Annual Meeting 2015

                                          Highlights of Selected Studies

                                          The American Society of Clinical Oncology announced results from four major studies May 13, which will be presented at the society’s 51st Annual Meeting, May 29 to June 2, in Chicago.

                                           

                                          Study: Discrepancy in Definition of “Value” in Cancer Care

                                          The “value” of cancer care may be interpreted differently among health care stakeholders, according to a study by the Cancer Support Community, an international nonprofit.

                                          The study, “Defining Value in Oncology: Perspectives from Patients with Metastatic Breast Cancer,” asked 769 patients to define value, based on their cancer experience.

                                           

                                          Report: Global Cancer Spending Reaches $100 Billion Mark

                                          Global spending on oncology drugs in 2014 reached $100 billion, up 10.3 percent over 2013 and up from $75 billion in 2010, according to the 2015 Global Oncology Trend Report, published by the IMS Institute for Healthcare Informatics. The annual compound growth rate increased to 6.5 percent over the past five years.

                                          The study, “Developments in Cancer Treatments, Market Dynamics, Patient Access and Value,” found that the U.S. and the five largest European nations continue to spend the most in oncology, making up two-thirds of the total international market.

                                          In Brief

                                          • Sotomayor named first director of GW Cancer Center

                                          • Lisa Kachnic named chair of department of radiation oncology at Vanderbilt-Ingram Cancer Center

                                          • MD Anderson makes several changes in executive leadership

                                          • Michael Simon wins award from Blue Cross Blue Shield of Michigan Foundation 
                                          • Eric Liu to join Rocky Mountain Cancer Centers
                                          • Maryland Proton Therapy Center completes funding
                                          Drugs and Targets

                                          • FDA grants fast track designation to evofosfamide

                                          • Eli Lilly and Company and BioNTech AG launch research collaboration

                                          • FDA approves cobas KRAS mutation test

                                          20150508 - May 8, 2015
                                          ISSUE 18 – MAY 8, 2015PDF

                                          Nascent Group Points to a Way To Validate, Pay for Genomic Tests

                                          How is this for a plan:

                                          Replace the U.S. system for validation and payment for cancer genomic tests with something that actually makes sense.

                                          Dane Dickson, a doctor in Idaho, who until recently had the distinction of being the only oncologist working under the roof of Centers for Medicare and Medicaid Services, would like to do just that—and some important players in cancer research are betting on his success.

                                          Conversation with The Cancer Letter

                                          A Doctor’s Quest to Save Personalized Medicine

                                          Dane Dickson would like to change the U.S. system for validation and coverage of molecular tests, thereby opening the road to development of complex tests and comprehensive genomic assays.

                                          Recently, Dickson formed a nonprofit public-private partnership, called MED-C and published a white paper, which is posted here.

                                          In an interview with Paul Goldberg, editor and publisher of The Cancer Letter, Dickson described his rationale for trying a new approach to solving this fundamental problem in personalized medicine.

                                          Duke Settles with Potti’s Patients; Misconduct Probe Now in Fifth Year

                                          Duke University has settled the suits filed by patients who were enrolled in clinical trials that were testing the technology developed by Anil Potti and his mentor Joseph Nevins.

                                          By settling, Duke avoided having to confront embarrassing revelations about how much the university’s deans knew about the problems in the genomic research organization.

                                           

                                          Conversation with The Cancer Letter

                                          Gunsalus: Duke’s 4.5 Years is at Extreme End of Spectrum for a Misconduct Probe

                                          The Cancer Letter invited C. K. Gunsalus, an expert on scientific misconduct, to discuss the settlement of the lawsuits against Duke.

                                          Gunsalus is the director of the National Center for Professional and Research Ethics, research professor, Coordinated Science Laboratory, professor emerita, College of Business at the University of Illinois at Urbana-Champaign. She runs a consulting company and is the author of The Young Professional’s Survival Guide (Harvard University Press, 2012) and The College Administrator’s Survival Guide (Harvard University Press, 2006).

                                          In Brief

                                          • Dan Theodorescu and Seth Lerner named editors-in-chief of Bladder Cancer

                                          • UW Health, ProHealth Care, and Aurora Health Care agree to co-manage cancer center

                                          • GW Cancer Institute launches online patient navigation training

                                          • NIH raises nearly $700,000 for The Children’s Inn
                                          • Proton Partners selects companies to help supply U.K. proton beam centers
                                          • Moffitt Cancer Center and Aetna form oncology medical home model
                                          • Swedish Cancer Institute adopts Syapse software for its precision medicine program
                                          Drugs and Targets

                                          • FDA grants breakthrough designation to Venetoclax

                                          • DanDrit Biotech USA forms collaboration with GISCAD Foundation

                                          • PhRMA report says member companies invested $51.2 billion in R&D