Recent Articles in Members-Only Content

Mar 25, 2016

ISSUE 12 - MARCH 25, 2016

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Clifford Hudis Named CEO of ASCO

Clifford Hudis was named CEO of the American Society of Clinical Oncology.

Hudis, who served as ASCO president in 2013 and 2014, is chief of Breast Medicine Service as well as vice president for government relations and chief advocacy officer at Memorial Sloan Kettering Cancer Center.

Hudis, 56, will start the job at the society’s headquarters in Alexandria, Va., June 27. He will succeed Allen Lichter, who is retiring after having held that job for ten years.

 

	NEJM Editors: There Will Be No Clarification For Disputed Power Morcellation Story The New England Journal of Medicine said it stands by the story that has triggered investigations of a potential breach of patient confidentiality. In a paper that criticized FDA's regulatory actions that effectively ended power morcellation in gynecology, Lisa Rosenbaum, an NEJM national correspondent, made a statement that some readers interpreted as suggesting that she had access to confidential patient information (The Cancer Letter, March 18). Rosenbaum is a cardiologist at Brigham & Women’s Hospital, the institution where Amy Reed—a patient who brought national attention to the harm associated with the procedure—underwent her ill-fated hysterectomy.  Related Coverage of Power Morcellation
	Slamming the Door 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.
	NCCN Launches Evidence Blocks as Part of its Guidelines The National Comprehensive Cancer Network launched its value tool, NCCN Evidence Blocks, which will be presented at its annual conference, March 31 to April 2. NCCN has published two additional resources since its 2015 meeting: the NCCN Framework and the NCCN Quick Guide Series for patients.
	In Brief Maha Hussain joins Northwestern University Lurie Cancer Center Jean-Yves Douillard appointed chief medical officer of ESMO Karmanos promotes five scientific staff members Jennifer Pietenpol receives award from T.J. Martell Foundation Pediatric Oncologist Dennis Hughes pleads guilty to collecting child pornography American Cancer Society receives $1.58 million grant from The Merck Foundation MD Anderson submits plan to comply with Texas "Campus Carry" gun law  The Cancer Letter's coverage of power morcellation named a finalist in the 2015 Best in Business Awards for Outstanding Business Journalism
	Drugs and Targets FDA Approves Roche Hepatits C RNA Test UPenn and Genisphere form photodynamic therapy collaboration

 

Mar 18, 2016

ISSUE 11 - MARCH 18, 2016

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Brigham Doc’s NEJM Paper Decries Morcellation’s Demise—Did She Get Confidential Patient Information?

Clearly, Lisa Rosenbaum wanted to trigger a heated discussion—but not of the sort she ended up with.

Rosenbaum, a national correspondent at the New England Journal of Medicine, focused on the demise of power morcellation, a once widely used gynecological procedure, which in some cases ended up disseminating undetected uterine sarcomas.

In a paper published in the March 10 issue of the journal and titled “N-of-1 Policymaking—Tragedy, Trade-offs, and the Demise of Morcellation,” Rosenbaum alleges that Amy Reed, a high-profile opponent of power morcellation, had stage IV cancer before her hysterectomy.

• Related Coverage of Power Morcellation

	Capitol Hill Senate Bill Gives FDA More Control Over Its Hiring, Salaries and Structure The FDA and NIH Workforce Authorities Modernization Act was introduced in the Senate by Republican and Democratic leaders of the health committee. The bill aims to help FDA and NIH “attract top talent during this exciting time in science.” The bill, introduced by Sens. Lamar Alexander (R-Tenn.) and Patty Murray (D-Wash.), looks to improve coordination within and between FDA medical product centers and allow the FDA to update its structure, as well as make it easier for the agency to hire; improve access to scientific meetings for federal employees; and streamline processes for NIH research information collection.
	Slamming the Door 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.
	Bunn Wins ASCO Karnofsky Award; Kaelin to Receive Science of Oncology Award The American Society of Clinical Oncology announced the winners of its highest honors, the Special Awards, to be presented during the 2016 ASCO Annual Meeting in June. “The exceptional accomplishments of each of our awardees reflect their exemplary dedication to furthering cancer research and serving as a beacon of hope to the cancer community,” said Peter Paul Yu, immediate past president of ASCO and chair of the Special Awards Selection Committee. “It is our honor to recognize their enduring contributions with ASCO’s most prestigious awards.”
	Obituaries UNMC Radiologist Glenn Dalrymple, 81; and MSKCC Researcher Robert Golbey, 93 Glenn Dalrymple, a radiology professor at the University of Nebraska Medical Center from 1990 to 1996, died March 9 in Omaha after a long battle with colon cancer. He was 81.
	In Brief Itai Yanai to Lead New Institute at NYU Langone Debra Patt named Editor-in-Chief of JCO Clinical Cancer Informatics  Jennie Crews elected president of Association of Community Cancer Centers Charles Serhan receives Ross Prize from Feinstein Institute for Medical Research American Society of Clinical Oncology publishes State of Cancer Care 2016 V Foundation and WWE announce research funding partnership  Providence Health & Services and Institute for Systems Biology
	Drugs and Targets Gilead Halts 6 Zydelig Trials As FDA, EMA Warn of Deaths From Respiratory Infections FDA Grants Orphan Designation to VAL-083 FDA Grants Priority Review to Atezolizumab

 

Mar 11, 2016

ISSUE 10 - MARCH 11, 2016

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CMS Experiment Targets Incentive To Use the Most Expensive Drug

Is Average Sales Price plus 6 percent the right amount to pay doctors under the Medicare Part B program?

Would a smaller margin diminish what may be an incentive for doctors to prescribe the most expensive drugs on the market? With clinical performance being equal, or close enough to equal, is it not better for the doctor’s wallet to bill 6 percent of the highest possible ASP available?

In a move that immediately set off an explosion in the cancer field, the Centers for Medicare and Medicaid Services announced a proposed rule to test new models to improve Part B payment for prescription drugs.

 

	Slamming the Door 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.
	National Academy of Medicine Calls for Integrated FDA-CMS Pathway for Biomarker Tests The National Academy of Medicine listed 10 goals for advancing the appropriate use of biomarker tests in precision medicine. “How do we ensure patients have timely access to appropriate tests that may accurately direct targeted therapies, while at the same time protecting them from potential harm due to the adoption of poorly validated tests or inappropriately used tests?” the report asked, saying that broader implementation was being held back by a lack of consensus over evidentiary standards, inefficient and inconsistent regulatory and reimbursement approaches, the need for a framework for collecting patient data, and translating that data into improved patient outcomes.
	Companies, Health Systems Commit to Data Interoperability Companies that provide 90 percent of electronic health records used by U.S. health care organizations have agreed to improve the flow of health information for consumers and health care providers, HHS officials said.
	Study: California Hospitals with Low Volumes of Surgeries Associated with Higher Risks In California, nearly 75 percent of the state’s hospitals performed only one or two surgeries when treating one of 11 selected cancer types in 2014, according to a report from the California Health Care Foundation. The report linked the low hospital surgery volumes with higher rates of mortality and complications, while evaluating cancers of the bladder, brain, breast, colon, esophagus, liver, lung, pancreas, prostate, rectum and stomach.
	Obituary UNMC Scientist Michael Brattain Dies Unexpectedly at Age 68 Michael Brattain, University of Nebraska Medical Center Eppley Institute professor and associate director for basic research in the Fred & Pamela Buffett Cancer Center, died unexpectedly in his sleep March 5. He was 68. “Mike was a brilliant scientist who had a prolific scientific career,” said Kenneth Cowan, director of the Eppley Institute and the Buffett Cancer Center. “Mike’s experience and input was extremely valuable to me in many areas within the Buffett Cancer Center.
	In Brief Sadik Esener to lead OHSU Center for Early Detection Research Jorge Lopez Jr. Named MSKCC General Counsel Aron Parekh receives research grant from American Cancer Society Robin Mjelle receives grant from Addario Foundation and International Association for the Study of Lung Cancer William Grady receives grant from DeGregario Family Foundation and the Price Family Foundation Baylor College of Medicine and Baylor Scott & White Health enter collaboration Tufts Medical Center and New England Cancer Specialists form affiliation UC San Francisco and Berkeley Lights Inc. form collaboration
	Drugs and Targets FDA Approves Xalkori in NSCLC with ROS-1 mutations FDA Approves American College of Radiology Digital Mammography QC Manual Regulatory Authorities in Six Countries approve Yondelis China Food and Drug Administration Approves CINtec PLUS Cytology Test Veritas Genetics introduces whole genome platform for under $1,000

 

Mar 8, 2016

BREAKING NEWS - MARCH 8, 2016

In an Experiment, CMS Will Vary Part B Drug Payments by Providers’ ZIP Codes

Is Average Sales Price plus 6 percent the right amount to pay doctors under the Medicare Part B program?

Would a smaller margin diminish what may be an incentive to prescribe the most expensive drugs on the market? With clinical performance being equal, or close enough to equal, is it not better for the doctor’s wallet to bill 6 percent of the highest possible ASP available?

In a move that immediately set off an explosion in the cancer field, the Centers for Medicare and Medicaid Services is on the verge of announcing a Part B Drug Payment Demo, a project where ASP add-ons would vary based on zip codes.

Mar 4, 2016

ISSUE 9 - MARCH 4, 2016

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NCI Developing Mouse Models To Succeed NCI-60 Cell Lines

The NCI-60, a panel of 60 cancer cell lines that have become the Rosetta Stone for the development of anticancer drugs, may be entering its twilight years as NCI develops new, and more expansive, patient-derived xenografts, or PDX models.

For over 25 years, the NCI-60, a set of about a dozen tissue types—leukemia, non-small cell lung, small cell lung, colon, CNS, melanoma, ovarian, renal, and breast—have been used to perform initial screens on over 100,000 compounds.

 

	Conversation with The Cancer Letter Doroshow: Evidence Suggests PDX Models Come Closer to Simulating Human Cancer NCI is developing patient-derived xenograft mouse models as a potential substitute for the NCI-60 cell lines, a standard screen which experts say can no longer keep up with advances in cancer research and targeted molecular therapy. “The goal is to try to understand whether these new models will be more successful in providing a better reflection of the underlying biology in the context of the clinical history and treatment history of patients from whence the tissues came,” said James Doroshow, director of the NCI Division of Cancer Treatment and Diagnosis and deputy director for clinical and translational research.
	Slamming the Door 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?
	National Academy of Medicine Publishes Report on Categorizing Different Ovarian Cancers Ovarian cancer should not be categorized as a single disease, but as many different cancers involving the ovary, according to a report published by the National Academy of Medicine. Questions remain on how and where various ovarian cancers arise, said the report that also presents research opportunities for reducing the number of women who are diagnosed with or die from ovarian cancers. Roughly two-thirds of women are diagnosed at an advanced stage when the cancer has already spread beyond the ovary, of which less than 30 percent survive past five years. The report was also sponsored by the Centers for Disease Control and Prevention.
	Funding Opportunity FDA Providing $2 Million for Natural History Studies in Rare Diseases FDA will provide $2 million in two to five research grants for the study of the natural history of rare diseases. The objective of the grants is to expedite the development of products for these conditions. The Feb. 29 announcement marks the first time FDA will provide funding through its Orphan Products Grants to collect data on the progression of specific rare diseases in individuals over time.
	In Brief Joan Massagué wins Pezcoller-AACR International Cancer Research Award David Weiner named executive vice president at The Wistar Institute Douglas Levine named director of gynecologic oncology at NYU Perlmutter Cancer Center Lauren Streicher joins Northwestern Medical Group as medical director Michael Bukosky appointed chief operating officer of USMD Holdings Inc. International Cancer Genome Consortium authorizes 1,000th user IBM and New York Genome Center to collaborate using Watson technology Vantage Oncology LLC acquired by McKesson Specialty Health
	Drugs and Targets Imbruvica granted approval for first-line CLL patients Health Canada approves Opdivo for metastatic NSCLC FDA grants orphan drug designation to SELLAS's WT1 cancer vaccine EMA grants orphan drug designation to venetoclax FDA and EMA grant orphan designations to FLAG-003 for glioma Merck KGaA, Pfizer and Verastem enter into avelumab research agreement NanoString Technologies and Merck to collaborate on Keytruda assay

 

Feb 29, 2016

February 2016

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	Leukemia Phase III Blincyto Study Stopped Early After Meeting OS Primary Endpoint A phase III study of Blincyto met its primary endpoint of overall survival in patients with acute lymphoblastic leukemia following a prespecified interim analysis. The study was stopped early. The randomized, open-label TOWER study evaluated the efficacy of Blincyto (blinatumomab) versus the standard of care in adult patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Patients were randomized in a 2:1 ratio to receive Blincyto or treatment with investigator choice of one of four protocol defined SOC chemotherapy regimens.
	Soft Tissue Sarcoma Halaven Study Improves Overall Survival In Liposarcomas and Leiomyosarcomas Full results from a phase III study showed improved median overall survival in unresectable locally advanced liposarcomas and leiomyosarcomas in patients receiving Halaven (eribulin), compared to dacarbazine. The clinical trial, study 309, included data from 452 adults, and was published in The Lancet, which also published an editorial discussing the study results. The study compared patients treated with eribulin mesilate (1.4 mg/msquared intravenously on days 1 and 8) and those treated with dacarbazine (850 mg/msquared, 1000 mg/msquared, or 1200 mg/msquared [dose dependent on center and clinician] intravenously on day 1). Additional endpoints included progression-free survival and quality of life.
	Breast Cancer OBI-822/821 Phase II/III Study Does Not Meet PFS Endpoint, But Shows Positive Results In Patients with Immune Response OBI Pharma Inc., announced topline results from a phase II/III study of OBI-822/821 (formerly OPT822/OPT821), which evaluated the clinical benefit and immunogenicity in patients with metastatic breast cancer. The study did not meet the primary efficacy endpoint of progression-free survival. However, patients who demonstrated an immune response showed highly significant improvement in progression-free survival and the secondary endpoint of overall survival is trending towards statistical significance. OBI-822/821 was generally well tolerated with no major safety concerns. Full results will be presented at an upcoming international scientific conference.
	Pancreatic Cancer Two Studies Evaluate 2nd Line Treatments Following Abraxane
	Non-Small Cell Lung Cancer Gilotrif Improves PFS Compared to Iressa in Phase IIb Trial
	Thyroid Cancer Study: Afirma Genomic Test Can Reduce Unnecessary Fine Needle Aspiration Biopsies
	NCI CTEP-Approved Trials for the Month of February
	Drugs and Targets Gazyva Combination Approved In Follicular Lymphoma FDA approves Afinitor for GI and lung NETs Venetoclax receives third FDA Breakthrough Designation FDA grants breakthrough designation to PKC412 (midostaurin) FDA grants orphan drug designation to tazemetostat for malignant rhabdoid tumors FDA grants orphan drug designation to CD101 IV for candidema

Feb 19, 2016

ISSUE 7 - FEB. 19, 2016

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Should ODAC Vote? Yes? No? Undecided?

At its most recent meeting, in July 2015, the FDA Oncologic Drugs Advisory Committee voted…

No, it didn’t vote!

Breaking with a long-standing tradition, the agency asked ODAC members to “discuss” the key questions of risk vs. benefit of an experimental therapy instead of reducing their answers to a yea-or-nay vote. Agency officials are mum on the subject of whether not voting has become a thing.

	News Analysis Rejected Therapy Reveals Inconsistency of FDA Procedures for Drugs, Immunotherapies Reform of the FDA oncology program is emerging as the immediately tangible element of the Obama administration’s moonshot program. With a modest $75 million commitment, the administration may be able to standardize the manner in which elements of modern cancer care are reviewed and approved by the regulatory agency (The Cancer Letter, Feb. 12). As it stands, immunological and cellular cancer therapies as well as diagnostics don’t go through the same review procedures as cancer drugs and biologics.
	Slamming the Door 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.
	Report: Medicare Pays 340B Hospitals Less Part B Drug Reimbursement A group advocating for the 340B Drug Discount Program examined the widely held belief that health care organizations enrolled in the controversial federal program receive significantly higher reimbursement for drugs than institutions that do not take part in the program. Previously, a July 2015 study by the Government Accountability Office found that, per beneficiary, Medicare Part B drug spending was indeed higher at 340B hospitals than at non-340B hospitals.
	In Brief Arnold Foundation gives $7.2 million to drug pricing programs Joan Schiller named deputy director at Inova Cancer Institute Jeannie Lee receives 2016 Lurie Prize Canadian Cancer Society names four excellence award winnerse Marcia McNutt named president of National Academy of Sciences Medical Oncology & Hematology Associates of Northern Virginia joins Inova Medical Group

 

Feb 12, 2016

ISSUE 6 - FEB. 12, 2016

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Obama's $4.1 Trillion Budget Proposes Mandatory Funds for $1 Billion Moonshot

President Barack Obama Feb. 8 unveiled his budget proposal for the 2017 fiscal year—a $4.1 trillion spending blueprint that is unlikely to be passed by a Republican-controlled Congress.

The administration’s proposal appears to cut the NIH existing budget by $1 billion in discretionary funding and makes up the difference with mandatory funding.

In a joint snub, the House and Senate budget committees declined to hold a hearing for Shaun Donovan, the director of the Office of Management and Budget. The move marks the first time in 41 years that Congress has refused to review a president’s budget.

	Conversation with The Cancer Letter Sigal: FDA Should Consolidate Cancer Portfolio President Barack Obama’s Feb. 8 budget request for fiscal year 2017 slates $75 million in additional funding for FDA for the creation of a virtual Oncology Center of Excellence. The proposal is arguably the most tangible component of Vice President Joe Biden’s National Cancer Moonshot program, which aims to double progress in cancer research and drug development over the next five years.
	Slamming the Door - How Al Gilman Taught Texas a Lesson in Science 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.
	In Brief Miami Cancer Institute joins MSK Cancer Alliance Ramalingam named deputy director of Winship Cancer Institute David McConkey appointed director of Johns Hopkins Bladder Institute Sylvester Comprehensive Cancer Center creates two endowed chairs Pat Keel appointed CFO of St. Jude Paul Vanveldhuisen named COO of The Emmes Corporation American Urological Association, Urology Care Foundation and Chesapeake Urology Associates form partnership Bonnie J. Addario Foundation launches second phase of crowdsourcing challenge ESPN's Jimmy V Week for Cancer Research raises $3.2 million
	Drugs and Targets FDA grants orphan designation to tazemetostat PDS Biotechnology signs CRADA with NCI FDA grants orphan designation to antifungal drug candidate CD101 IV

 

Slamming the Door: How Al Gilman Taught Texas a Lesson in Science
Feb 5, 2016

A SERIES BY THE CANCER LETTER

 

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, a 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.

Part I is free to the public.