Past issues are only available to subscribers. If you are not a member, click here to join.

ISSUE 3 – JAN. 23, 2015PDF

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.

 


 

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. 

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.

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

20150123 - Jan. 23, 2015
ISSUE 2 – JAN. 16, 2015PDF

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

20150116 - Jan. 16, 2015
ISSUE 1 – JAN. 9, 2015PDF

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

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

20150109 - Jan. 9, 2015