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The Cancer Letter Inc.
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Recent articles

(in: The Cancer Letter) Jan 30, 2015

ISSUE 4 - JAN. 30, 2015

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Guest Editorial
SWOG Chair Blanke to Climb Mt. Kilimanjaro to Draw Attention to Clinical Trials Funding

By Charles D. Blanke

Rising 19,341 feet above sea level, Mt. Kilimanjaro is the highest mountain in Africa and the tallest freestanding mountain in the world. It is a dormant but non-extinct volcano which last erupted some 150,000 years ago.

Next week I will climb Mt. Kilimanjaro to draw attention to the risks posed by financial cuts to publicly funded cancer clinical studies, to raise funds to help fill the gaps those cuts have left, and to pay homage to some 200,000 SWOG trial volunteers.

Draft Bill Seeks to Revamp FDA, NIH, CMS To Accommodate 21st Century Science

The House Committee on Energy and Commerce Jan. 27 released a draft version of a massive bill that seeks to streamline the pathways of innovation in medicine.

The 393-page “discussion document,” which sets forth the committee’s long-awaited 21st Century Cures initiatives, includes proposals reworking many important structures in funding medical research and the regulatory approval processes—from strengthening the authority of the NIH director and boosting the size of the NIH Common Fund, to including new incentives for makers of orphan and generic drugs to changing the manner in which FDA reviews drugs and devices.

	Duke Trial Delayed, But University to Turn Over More Documents The trial stemming from Duke University’s clinical trials of a fraudulent genomic technology has been delayed, most likely until September. The attorneys who represent the seven plaintiffs in Aiken vs. Duke initially sought the delay. Struck by the flu, the attorneys, including the lead counsel, were in no condition to deliver opening arguments Jan. 26. However, even as the principal case has been continued, the judge in Durham County Superior Court Jan. 29 heard an argument over discovery, ordering Duke to turn over additional materials to the plaintiffs. The Cancer Letter's Related Coverage of the Duke Scandal
	Duke’s Califf to take No. 2 Job at FDA Robert Califf was named FDA Deputy Commissioner for Medical Products and Tobacco, a de facto No. 2 post at the agency. Califf, 63, an expert in cardiology, clinical research, and medical economics, is leaving his job as vice chancellor of clinical and translational research at Duke University. He will join the agency in late February. Califf will oversee the FDA Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Tobacco Products. He will also oversee the Office of Special Medical Programs in the Office of the Commissioner.
	Desequestration? Obama, Congress Seek to Restore Federal Funding President Barack Obama and several members of Congress announced a slew of initiatives this week aimed at eliminating the effects of sequestration for the government, and for medical research by providing increases for NIH and other federal agencies. Two bills introduced in Congress would provide sustained increases by boosting funding through direct appropriation and by adjusting caps established in the Budget Control Act. The American Cures Act, introduced by Sen. Dick Durbin (D-Ill.), would adjust the budget caps to allow for 5 percent annual funding increases over 10 years for NIH, CDC, the Department of Defense Health Program, and the Veterans Medical & Prosthetics Research Program.
	Funding Opportunity SITC and Merck Offering Immunotherapy Fellowship The Society for Immunotherapy of Cancer, with support from Merck, is providing funding for cancer immunotherapy research through the SITC-Merck Cancer Immunotherapy Clinical Fellowship
	In Brief Scott Strong named chief of GI surgery at Northwestern Memorial Hospital James Orr named chair of Florida Board of Medicine Columbia University eliminates its mesothelioma center BBVA Foundation names winners of Frontiers of Knowledge Award in Biomedicine Cancer Treatment Centers of America partners with National Football League Alumni Association MD Anderson begins collaboration with AstraZeneca in gynecologic cancers UC San Diego and UC San Francisco to launch Cancer Cell Map Initiative
	Drugs and Targets FDA adds Waldenström’s macroglobulinemia to Imbruvica label FDA grants orphan drug designations to tarextumab in pancreatic cancer and small cell lung cancer Health Canada grants device approval to xTAG CYP2D6 Kit v3 Array BioPharma reaches agreement with Novartis PharmaAG Amgen and Onyx Pharmaceuticals submit applications for Kyprolis

(in: The Cancer Letter) Jan 23, 2015

ISSUE 3 - JAN. 23, 2015

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CMS Opens Door to Coverage of Comprehensive Genomic Sequencing

At first glance, it’s hard to imagine anything as obscure as a policy by a private contracting firm that runs the Medicare program in the Carolinas, Virginia and West Virginia.

But look closer: a “local coverage determination” by Palmetto GBA addresses an urgent, vexing problem of precision oncology: how advanced molecular testing can be used to determine treatment options for individual patients and what insurers will be willing to pay for.

The coverage determination, titled “Comprehensive Genomic Profiling for Non-Small Cell Lung Cancer” popped up on a government website well after close of business Jan. 22. There was no press release; no rollout whatsoever.

Nonetheless, the decision may introduce clarity into the informational pea-soup fog that engulfs molecular testing by spelling out the criteria for opening payment for complex tests and comprehensive genomic assays, which measure multiple markers.

As it stands, the vast majority of assays that cost thousands of dollars and are used to determine treatment for cancer patients are not reviewed by government agencies before they enter the marketplace.

The Cancer Letter's Previous Coverage of Lab-Developed Tests

Duke's Legal Stance: We Did No Harm

Attorneys defending Duke University are preparing to argue that no patients were harmed in the institution’s phase II clinical trials of genomic predictors that were later shown fraudulent.

The technology in question came from the laboratories of Duke stars Joseph Nevins and Anil Potti, and was based on findings that, from the outset, seemed too good to be true—and were ultimately discredited and retracted.

The suit claims negligence, breach of fiduciary duty, unjust enrichment, infliction of emotional distress, loss of chance, battery, deceptive trade practices, civil conspiracy and obstruction of justice.

The trial is scheduled to begin Jan. 26 at Durham County Superior Court. Altogether, 117 patients enrolled in the three clinical studies at Duke.

The essence of Duke’s argument—which forms the basis of a flurry of motions for a partial summary judgment—is that patients who entered the clinical studies were, for the most part, in late stages of disease and that the predictor models were used to assign them to existing therapies.

	News Analysis Misconduct Expert Dissects Duke Scandal By C. K. Gunsalus On Jan. 9, 2015, The Cancer Letter reported that Duke University received information in early 2008 that called into question the validity of the methodology and results published by the Anil Potti research group. Potti, along with his mentor and co-author Joseph Nevins, had galvanized the world of cancer research in 2006 and 2007 with their reports of successful gene expression tests for directing cancer therapy, the “holy grail” of cancer research. The 2008 information came in the form of a letter from a third-year medical student, Brad Perez, who was working in Potti’s lab. The letter, which does not seem to have been given any credence at the time, described with precision the problems that eventually resulted in the termination of clinical trials and the subsequent retractions, beginning in 2011, of at least ten (and counting) papers from major scientific journals. The Cancer Letter's Previous Coverage of the Duke Scandal
	Cancer Drug Prices Increased $8,500 Per Year Since 1995 The launch prices of anticancer drugs have increased substantially over time—even when adjusted for inflation and survival benefits—according to a study published by the National Bureau of Economic Research.
	State of the Union 2015 Obama Launches Precision Medicine Initiative President Barack Obama called for innovation in genetic medicine, through the launch of a new initiative, in his State of the Union address Jan. 20. “Twenty-first century businesses will rely on American science and technology; research and development,” Obama said. “I want the country that eliminated polio and mapped the human genome to lead a new era of medicine—one that delivers the right treatment at the right time. In some patients with cystic fibrosis, this approach has reversed a disease once thought unstoppable,” he said. “So tonight, I’m launching a new precision medicine initiative, to bring us closer to curing diseases like cancer and diabetes, and to give all of us access to the personalized information we need to keep ourselves and our families healthy.”
	ASCO Teams with SAP For CancerLinQ Project The American Society of Clinical Oncology announced Jan. 21 that its CancerLinQ health information technology project will use the SAP HANA platform. SAP HANA is a flexible, in-memory data management and application platform that provides predictive text analytics, spatial processing and data virtualization. SAP has teamed with medical organizations in Germany and Japan for cancer data analytics and genomic analysis.
	Letter to the Editor Is $100M in Stock Enough to Make MD Anderson Go Public with its Conflict-of-Interest Management Plan? By Leonard Zwelling Last week, it was reported in both The Cancer Letter and the Houston Chronicle that The University of Texas MD Anderson Cancer Center had closed a deal to sublicense intellectual property to two pharmaceutical firms, Intrexon and Ziopharm Oncology. There is nothing terribly unusual about that. The deals, however, were mostly in exchange for equity, $50 million in stock from each company plus $15-20 million per annum. The technology is chimeric antigen receptor T cells (CAR T) and The Cancer Letter article suggests that the clinical trials testing the technology’s efficacy will be done at MD Anderson, at least in part. This struck me as odd. MD Anderson's Response: Consider the Source and Venue
	Letter to the Editor LLS President Responds To "Bad Luck" Cancer Study By Louis J. DeGennaro A new study indicates that the risk of developing cancer in some types of tissue is based on the frequency of stem cell divisions, and therefore beyond individuals’ control to minimize their own risks. As the study stated, a majority of these cancers develop due to random mutations of noncancerous stem cells; in other words, it’s just “bad luck.”
	In Brief Moffitt's Johnathan Lancaster to join Myriad Genetics Sue Biggins receives prize from Genetics Society of America Pancreatic Cancer Action Network and NCI's Frederick National Lab award two fellowships Caris Life Sciences establishes Caris Centers of Excellence for Precision Medicine Network City of Hope and Trovagene Inc. enter into clinical collaboration WuXi PharmaTech acquires NextCODE Health Medical University of South Carolina location upgrades imaging systems Royal Phillips partners with Indica Labs Inc. Picador acquires world publishing rights to the debut novel by Paul Goldberg, editor and publisher of The Cancer Letter
	Drugs and Targets European Medicines Agency's CHMP issues positive opinion on Jakavi for Polycythemia Vera Palmetto GBA publishes CMS coverage policy for Decipher prostate cancer classifier Ventana Medical Systems submits ALK assay for FDA premarket approval

(in: The Cancer Letter) Jan 16, 2015

ISSUE 2 - JAN. 16, 2015

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Duke Scientist: I Hope NCI Doesn't Get Original Data

In May 2008, the Blue Devils of genomic medicine were facing a mortal threat.

An NCI biostatistician was demanding the data Duke University scientists used to derive the predictors of response in ovarian cancer.

This inquiry had the potential to sink Duke’s technology that was purported to analyze tumors and use genomic insight to identify the optimal treatment for each patient. According to Duke’s projections, cancer treatment decisions are made 700,000 times a year in the U.S. alone.

Multiply that by $3,000—the going rate for advanced tests at that time—and you have $2.1 billion.

	How the "Bad Luck" Cancer Paper Was Misread by the Press How much of the potential to develop cancer is due to plain “bad luck”? A paper published Jan. 1 in Science titled, “Variation in cancer risk among tissues can be explained by the number of cell divisions,” generated a mild controversy when the authors’ use of the term “bad luck” caught on in the press.
	Conversation with The Cancer Letter Kramer: Our Cancer Risk Is Not in the Stars The stochastic process of stem cell divisions should not be equated with bad luck, said Barnett Kramer, director of the NCI Division of Cancer Prevention, focusing on misinterpretations of the “Bad Luck” paper by Cristian Tomasetti and Bert Vogelstein, of Johns Hopkins University School of Medicine.
	AVEO Cuts Workforce by 66%, Ending Research Functions AVEO Oncology announced plans to cut its workforce by two-thirds, end its internal research functions, and vacate up to 80 percent of its facilities, including laboratory and vivarium locations. The biotechnology company was co-founded by Ronald DePinho, president of MD Anderson Cancer Center. The restructuring would leave about 20 full-time positions.
	FASEB Offers Recommendations To Improve Research Funding The Federation of American Societies for Experimental Biology called for a re-examination of the way research is funded in the U.S., in a report detailing the challenges facing researchers and the threats to continued progress in the field. The report, Sustaining Discovery in Biological and Medical Science: A Framework for Discussion, presents a series of recommendations to alleviate them.
	Obituary Dorothy "Dottie" Thomas, 92, "Mother of Bone Marrow Transplantation" Dorothy “Dottie” Thomas, wife and research partner to 1990 Nobel laureate E. Donnall Thomas, died Jan. 9, at her home near Seattle. She was 92. Don Thomas, pioneer of the bone marrow transplant and former director of the Clinical Research Division at Fred Hutchinson Cancer Research Center, preceded her in death on Oct. 20, 2012, also at age 92.
	In Brief MD Anderson's Andrew Lee moves to Texas Center for Proton Therapy A. Eugene Washington named chancellor for health affairs at Duke University Julie Brahmer named director of thoracic oncology at Johns Hopkins Kimmel Cancer Center Naiyer Rizvi named director of thoracic oncology at NewYork-Presbyterian/Columbia University Medical Center Seton Hall University and Hackensack University Health Network to form four-year, private medical school Roche acquires Bina Technologies Inc. Karmanos Cancer Institute receives $5 million grant from the Dresner Foundation ASCO and College of American Pathologists announce partnership Mount Sinai Health System and Valley Health System announce collaboration Pelotonia awards six grants to Ohio State Genentech and Human Longevity Inc. announce multi-year agreement MD Anderson, Intrexon, and Ziopharm announce sublicensing agreement with the University of Minnesota Amgen and MD Anderson announce research agreement

(in: The Cancer Letter) Jan 8, 2015

ISSUE 1 - JAN. 9, 2015

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Internal Emails Raise New Questions
Duke Officials Silenced Med Student Who Reported Trouble in Anil Potti's Lab

Duke University would have avoided embarrassment, a misconduct investigation and a lawsuit, had its top administrators paid closer attention to a thoughtful report by a medical student who saw problems in the lab of the disgraced scientist Anil Potti.

Documents obtained by The Cancer Letter show that Duke’s deans were warned about Potti’s misconduct in late March and early April 2008, at the time when clinical trials of the now discredited Duke genomic technology were getting started.

The three-page document was penned by Bradford Perez, then a third-year medical student and a Howard Hughes Medical Institute scholar.

Instead of rewarding the student’s brilliance with a plaque and a potted plant, Potti’s collaborator and protector, Joseph Nevins—aided by a phalanx of Duke deans—pressured the young man to refrain from making a final complaint and reporting the matter to HHMI.

	The Med Student's Memo Bradford Perez Submits His Research Concerns Nevins and Potti Respond To Perez's Questions and Worries A Timeline of The Duke Scandal The Cancer Letter's Previous Coverage
	An Appreciation Joseph McLaughlin, 66, Cancer Epidemiologist Joseph McLaughlin, an internationally recognized epidemiologist who made numerous contributions towards increasing understanding of the causes of cancer, died unexpectedly Dec. 10, 2014. He directed key research in the United States and abroad clarifying the roles of tobacco, obesity, diet, occupation and other factors in the etiology of several cancers, especially kidney cancer, for which he was considered among the world’s experts. He led some of the largest studies exploring the etiology of renal cell and renal pelvis cancers, quantifying levels of risk associated with multiple lifestyle and environmental factors.
	Obituary Anthony Murgo, of the FDA Office of Hematology and Oncology Products Anthony (Tony) J. Murgo, died Dec. 17, 2014 after a courageous year-long battle with cancer. He was a passionate research physician with a kind bedside manner. Murgo was a dedicated federal employee for 25 years, serving in multiple capacities at FDA and NCI. As the associate director of regulatory science of the FDA’s Office of Hematology and Oncology Products, Murgo was the liaison between that office and NCI’s Cancer Therapy Evaluation Program. Within OHOP, Murgo also served as a medical reviewer, a team leader and a division director for Division of Oncology Products 1.
	Drugs and Targets Accelerated Approval Granted to Opdivo in Metastatic Melanoma FDA approved a supplemental biologics license application for Gazyva FDA approved an updated version of MarginProbe FDA granted Fast Track designation to SGX301 Polaris Group’s lead product candidate, ADI-PEG 20 receives US and EU orphan designations Amgen and Kite Pharma entered into a strategic research collaboration Taiho Oncology Inc. submits NDA for TAS-102
	In Brief Donald Trump named CEO of Inova Cancer Care and Research Institute Dario Altieri named CEO of The Wistar Institute Sharmila Makhija named chair of the Department of Obstetrics & Gynecology and Women’s Health at Albert Einstein College of Medicine Nipun Merchant joins Sylvester Comprehensive Cancer Center St. Jude receives $2 million pledge from InfinityQS International Inc. NCI Director Harold Varmus addresses NCI staff and grantees with an outlook on the new year

(in: The Cancer Letter) Dec 19, 2014

ISSUE 47 - DEC. 19, 2014

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Congress Plans to Accelerate Development of Drugs, Devices

The House Committee on Energy and Commerce is spearheading legislation aimed streamlining development of drugs and medical devices.

The bipartisan initiative, called “21st Century Cures,” was launched April 30, and is led by Rep. Fred Upton (R-Mich.), chairman of the committee, and Rep. Diana DeGette (D-Colo.), chief deputy whip.

	Research Advocates Prepare to Face Republican-led Congress The 113th Congress staggered through its final spending bill, approving $1.1 trillion in a massive “cromnibus” Dec. 13, keeping most of the federal government funded through September 2015, and locking in a half-percent increase for NIH and NCI in FY2015. Biomedical research advocates bemoaned the modest increase in funding—$150 million for NIH and $27 million for NCI—and questioned Congress’s commitment to scientific progress.
	Half-Percent NIH, NCI Budget Raise Is Not Enough, Advocates Say The Cancer Letter asked leaders of science and cancer advocacy groups to comment on the half-percent increases in federal funding for NIH and NCI in fiscal 2015, and on the prospects of science funding when Republicans take control of Congress in January.
	Conversation with The Cancer Letter Is Republican Control Better Than Two-Party Stalemate? As Congress goes into recess and Democrats relinquish their eight-year control of the Senate, advocates for biomedical research are rethinking their approaches to a political reality not observed in nearly a decade: a Republican-controlled Congress. Jennifer Zeitzer, director of legislative relations at the Federation of American Societies for Experimental Biology, a coalition that represents 27 scientific societies and over 120,000 researchers worldwide, says she is optimistic about prospects for science funding in the 114th Congress. The reason: both sides have learned that stalemates benefit no one.
	ACS President & COO Resigns Unexpectedly; Was Seen as Contender for CEO Position Gregory Bontrager resigned from his position as chief operating officer and president of the American Cancer Society. His resignation was announced in an email from ACS Chief Executive Officer John Seffrin Dec. 18. No reason for the departure was cited. Bontrager, who became the COO in 2007 and president in 2013, was, in effect, the society’s second-most-powerful official, and one of the engineers of its current move to a centralized structure.
The Cancer Letter is taking a Holiday Break. The next issue will be published on Jan. 9, 2015.
	ODAC To Advise FDA on First Biosimilars Application Jan. 7 The FDA Oncologic Drugs Advisory Committee will meet Jan. 7, 2015, to discuss a biologics license application for a proposed biosimilar to Amgen Inc.’s Neupogen (filgrastim). The biosimilar application, submitted by Sandoz Inc., will be the first such application to be filed and discussed by an FDA advisory committee.
	NCI Advisory Board Approves Three Concepts At a meeting Dec. 2, the NCI Board of Scientific Advisors approved three concepts during a joint meeting with the National Cancer Advisory Board.
	Editorial A Record-Breaking Year for The Cancer Letter 2014 was a transformative year for The Cancer Letter. • We launched a new website that makes our content possible to read online without downloading PDF files. • We made the website “responsive,” enabling it to adapt to all screen sizes, including smartphones and tablets. Now, about a third of our readers use these devices. An app will be available shortly. Also: The Cancer Letter's Notable Stories of 2014
	Regulatory Approvals FDA expanded the approved use of Cyramza to include metastatic NSCLC FDA approves Somatuline Depot Injection (lanreotide) for metastatic GEP-NETs Lynparza (olaparib) and companion diagnostic approved in gBRCAm advanced ovarian cancer 510(k) clearance granted to Narrow Band Imaging for bladder cancer patient FDA clears Advaxis immunotherapy phase I/II trial IND application Genentech submits new drug application for cobimetinibn
	In Brief Fabien Calvo named chief scientific officer of Cancer Core Europe OSUCCC – James moves into new cancer hospital MD Anderson and UnitedHealthcare launch bundled payment program Ohio State University names 2014 James Hope Award winners Washington University at St. Louis genome center receives $25 million pledge George Washington University Cancer Institute receives $150,000 from Center for Advancing Health Northwestern University's Lurie Comprehensive Cancer Center enters research agreement with NeoGenomics Inc. Oregon Health & Science University and FEI expand Living Lab for Cell Biology agreement Cancer Treatment Centers of America select WIRB-Copernicus Group to help expand its clinical research program

(in: The Cancer Letter) Dec 12, 2014

ISSUE 46 - DEC. 12, 2014

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Is Everyone in Academic Medicine Unhappy?
Or is it Just MD Anderson?

Faculty members at MD Anderson Cancer Center are arguably the most intensely watched cohort in academic medicine. Their angst has been measured four times by three administrative entities over two years.

Now, the institution’s president, Ronald DePinho, is under a mandate from his bosses to improve faculty morale.

Are these folks an anomaly, or is everyone in academic medicine unhappy these days?

There is a place to obtain comparison data: the Faculty Forward Engagement Survey conducted by the Association of American Medical Colleges.

	Senate Debates $1.1 Trillion "Cromnibus" Bill That Includes a $150 Million Increase for NIH Early Friday morning, President Barack Obama signed a two-day funding resolution averting a government shutdown and giving the Senate time to debate a $1.1 trillion funding package passed by the House of Representatives late Thursday night. The year-long “cromnibus” bill—a Washington-speak portmanteau of continuing resolution and omnibus—passed by a 219-to-206 vote three hours before government funding expired.
	Daniel Hayes Elected President of ASCO Daniel Hayes was elected president of the American Society of Clinical Oncology. The three-year appointment begins with Hayes becoming president-elect on June 1, 2015. He will serve as president from June 1, 2016, to May 31, 2017, and will serve as immediate past-president for the year after.
	Varmus Discusses Grant Policy, Changes in Congress and Ebola NCI Director Harold Varmus addressed a joint meeting of the NCI Board of Scientific Advisors and the National Cancer Advisory Board Dec. 2, updating them on his proposed bypass budget for the institute, changes in Congressional leadership, and NCI and NIH grant policy.
	NCI's Douglas Lowy and John Schiller Honored with National Medal NCI’s Douglas Lowy and John Schiller were honored by President Barack Obama with a National Medal of Technology and Innovation, the nation’s highest honor for technological achievement, for their work in developing a vaccine for human papilloma virus.
	Obituary Lee Wattenberg, 92, "Father of Chemoprevention" Lee Wattenberg, emeritus professor of laboratory medicine and pathology at the University of Minnesota Masonic Cancer Center, died Dec. 9 at the age of 92. His research established the discipline of chemoprevention. Wattenberg first recognized that some compounds could effectively block the development of carcinogens in animals. In 1966, he published a paper in the journal Cancer Research that reviewed 36 years of animal studies on the effects of certain compounds on carcinogenesis and laid the framework for our understanding of how these compounds work. It was in this paper that he introduced the term chemoprophylaxis.
	Regulatory Approvals Gardasil 9 approved, which covers five additional HPV types FDA grants Fast Track designation to DPX-Survivac cancer vaccine FDA approves a new indication for Xgeva (denosumab) FDA approves MP Diagnostics HTLV Blot 2.4 test FDA grants clearance for SAVI SCOUT surgical guidance system
	In Brief Weldon Gage named CFO at MD Anderson Cancer Center Marcelo Bento Soares named senior associate dean at University of Illinois College of Medicine at Peoria Boris Kuvshinoff II named chief medical quality officer and interim chief medical officer at Roswell Park Cancer Institute David Currow named director of palliative medicine and hospice care at Dartmouth-Hitchcock Joanna Weiss appointed VP of revenue cycle management at Moffitt Cancer Center American Cancer Society publishes second edition of The Cancer Atlas Marlo Thomas receives Presidential Medal of Freedom RxTrials and Clinical Oncology Research Excellence form collaboration Yale University and Organovo Holdings Inc. partner to research 3D printed tissues Pharmacyclics receives award for Imbruvica The CrowdCare Foundation announces myeloma research crowdfunding initiative Seattle Children's launches Strong Against Cancer fundraiser

(in: The Cancer Letter) Dec 5, 2014

ISSUE 45 - DEC. 5, 2014

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Urgent FDA Action Turns Power Morcellation Into Rarely Used Gynecological Procedure

The power morcellator should no longer be used for hysterectomies or fibroid removal in the vast majority of women getting these procedures, FDA declared in a highly anticipated guidance document Nov. 24.

Using a new authority that bypasses public comment, the agency stopped short of imposing an outright ban on the device, but severely restricted its use.

Related Coverage of Power Morcellation

	Top NCI Officials Pledge No Further Consolidation of Clinical Trials System Top NCI officials made an unusual assurance that the reorganization of clinical trials cooperative groups isn’t a “prelude to reducing the commitment of the NCI to clinical trials-based research.” The document, published as a letter to the editor of the Journal of Clinical Oncology on Dec. 1, follows up on a meeting Sept. 23, where group chairs and directors of statistical centers asked NCI to assure them that no new cuts are in the works. Related Coverage of NCTN
	Brigham & Women's Suspends Controversial Morcellation Study As Apparent "Difference of Opinion" with FDA Comes to Light The Brigham & Women’s Hospital has halted a controversial study that combined power morcellators with “containment bags” intended to capture tissue during minimally invasive gynecological surgery. Launched earlier this summer, the study was designed to enroll 400 women to test dye leakage in several commercially available bags that have not been cleared by FDA for use with power morcellators.
	Varmus's 2016 Bypass Budget Seeks "Modest" Increase of $823 Million NCI has published the bypass budget for the fiscal year 2016, asking for $5.754 billion, an $823 million increase over the estimated budget of $4.931 billion.
	NYC Doctor Pays $2.35 Million To Settle False Claims Act Suit Over Radiosurgery Reimbursements A New York City radiation oncologist who specializes in fractionated stereotactic radiosurgery and stereotactic body radiation therapy agreed to pay $2.35 million to resolve a 10-year-old Medicare fraud lawsuit.
	Drugs and Targets Blincyto granted accelerated approval in R/R ALL Broad Institute, Harvard University, MIT and Editas Medicine form collaboration FDA grants clearance to IQQA-BodyImaging CMS issues final payment decision for Cologuard screening test
	In Brief David Chambers named deputy director for implementation science at NCI DCCPS Linda Weiss announces intention to retire from NCI Office of Cancer Centers 2014 John Scott Award winners announced Nicholas Petrelli receives clinical research award from the Association of Community Cancer Centers Anjen Chenn named VP of clinical operations at Metamark

Nov 26, 2014

SPECIAL REPORT - NOV. 26, 2014

Urgent FDA Action Turns Power Morcellation Into Rarely Used Gynecological Procedure

Using a new authority that bypasses public comment, the agency stopped short of imposing an outright ban on the device, but severely restricted its use.

Related Coverage of Power Morcellation

Brigham & Women's Suspends Controversial Morcellation Study As Apparent "Difference of Opinion" with FDA Comes to Light

The Brigham & Women’s Hospital has halted a controversial study that combined power morcellators with “containment bags” intended to capture tissue during minimally invasive gynecological surgery.

Launched earlier this summer, the study was designed to enroll 400 women to test dye leakage in several commercially available bags that have not been cleared by FDA for use with power morcellators.

Linda Weiss, director of NCI Office of Cancer Centers, to Retire in March 2015

Linda Weiss said she intends to retire from her job as director of the NCI Office of Cancer Centers.

Weiss’s retirement was announced in an email from NCI Director Harold Varmus Nov. 25.

(in: The Cancer Letter) Nov 21, 2014

ISSUE 44 - NOV. 21, 2014

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As FDA Weighs its Options on Morcellation, Debate Erupts Over Harvard Device Study

Here is what we know: A surgical device used to perform about 100,000 hysterectomies and myomectomies every year in the U.S. has been shown to spread cells from undetected or missed uterine cancers—rapidly upstaging the disease.

And here is what we don’t know: What will FDA do about it?

The agency is under pressure to respond to the growing outcry from patient advocates, who want a ban on the device.

	Conversation with The Cancer Letter Demetri: Morcellation Worsens Outcomes In Patients with Undiagnosed Cancers As an oncologist who treats sarcoma, George Demetri has seen the adverse consequences of power morcellation, the surgical technique widely used to perform laparoscopic hysterectomies and remove putative fibroids. In a small minority of cases, these fibroids instead represent unsuspected malignancies—including rare and aggressive leiomyosarcomas—which were impossible to detect prior to the morcellation procedure.
The Cancer Letter is taking a Thanksgiving Break. The next issue will be published on Dec. 5.
	CPRIT Awards 32 Grants The Cancer Prevention and Research Institute of Texas awarded 20 grants through its product development program, five grants through its prevention program, and seven recruitment grants through its research program, totaling more than $65 million.
	ASCO Proposes Principles For Future Debate on Medicaid The American Society of Clinical Oncology has proposed a set of principles for shaping future debate of the role of Medicaid.
	Obituary Connie Curran, 67, C-Change Executive Director Connie Curran, 67, the first executive director of C-Change, died Nov. 10. C-Change brings together leaders in cancer from the public, private, and not-for-profit sectors. Curran was born in Berlin, Wis. She held degrees from the University of Wisconsin, DePaul University, and Northern Illinois University. She also is a graduate of Harvard University Business School’s Owner/President Management program.
	FDA News FDA Taking Comments on "First Generic" ANDA Process Fast Track designation granted to MM-398 in pancreatic cancer Orphan Drug designation granted to JCAR015 in ALL
	In Brief D. Gary Gilliland Named President and Director of Fred Hutchinson Cancer Research Center Mark Gilbert named chief of Neuro-Oncology Branch at NIH Bert Vogelstein awarded Warren Triennial Prize by Massachusetts General Hospital Susan Mayne appointed director of FDA Center for Food Safety and Applied Nutrition Merck KGaA and Pfizer Inc. to co-develop anti-PD-LI antibody NYU Langone Medical Center and Lutheran Medical Center to create integrated healthcare network Dana-Farber Cancer Institute and Astellas Pharma Inc. announce three-year collaboration Tapimmune Inc. and Vaccine & Gene Therapy Institute of Florida form partnership St. Jude Children's Research Hospital opens Marlo Thomas Center Karmanos Cancer Institute honored by Michigan Cancer Consortium