20150130 - Jan 30, 2015
ISSUE 4 – JAN. 30, 2015PDF

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.

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

20150123 - Jan 23, 2015
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

20150116 - Jan 16, 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