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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, 2015

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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, 2015

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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. A Timeline of the Duke Scandal The Cancer Letter’s Previous Coverage of the Duke Scandal
	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

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