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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

      20150529 - May. 29, 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

        20150522 - May. 22, 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

          20150515 - May. 15, 2015