20151120 - Nov 20, 2015
ISSUE 43 – NOV. 20, 2015PDF



Congressional Panel Chair Questions Whether J&J, Brigham Reported Morcellation Adverse Events to FDA

The House Committee on Energy & Commerce has stepped into a key role in the controversy over power morcellation.

At a hearing earlier this week, Rep. Tim Murphy (R-Pa.), chairman of the Subcommittee on Oversight and Investigations questioned whether Johnson & Johnson and Brigham & Women’s Hospital violated federal law by not reporting adverse outcomes resulting from power morcellation.

At the Nov. 17 hearing by the Subcommittee on Health, Murphy quizzed Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health, in an apparent effort to determine whether manufacturers of power morcellators as well as hospitals that used these devices had failed to notify FDA that patients were being harmed.

Also:

CBER’s All-Day Voyage into Slippery Science Ends in 18-6 Vote against Bladder Therapy

One might surmise that by the time FDA asks an advisory committee to vet an application, the questions would deal primarily with clinical utility.

By that stage in the game, advisors would be asked to discuss the outcomes, as opposed to the biological mechanisms for achieving them.

This was even before the agency’s reorganization of its oncology units more than a decade ago. In those days, small-molecule compounds went to one bureaucratic unit of the FDA Center for Drugs Evaluation and Research—while biologics, including monoclonal antibodies and growth factors, went to the Center for Biologics Evaluation and Research.

Capitol HillFDA Lists Potentially Avoidable Harms in 20 LDT Case Studies, Including Tests from Duke, Caris and Genomic Health

Ahead of a Capitol Hill hearing this week on the role of the FDA in the regulation of laboratory-developed tests, the federal agency published a report of 20 case studies that illustrated the possible harms presented to patients when laboratories do not comply with FDA requirements.

The case studies included LDTs such as the Target Now cancer biomarker test, developed by Caris Life Sciences Inc.; the Oncotype DX HER2 RT-PCR breast cancer test; and the Duke University Chemotherapy Assessment genetic tumor assay.

NCI Announces Winners of Outstanding Investigator Awards

NCI named the inaugural 43 recipients of its Outstanding Investigator Awards.

Developed last year, the grant program provides funding to investigators with outstanding records of productivity in cancer research to support projects of unusual potential in cancer research.

The award provides funding of up to $600,000 in direct costs each year for seven years. One goal of the award is to provide investigators with substantial time to break new ground or extend previous discoveries to advance biomedical, behavioral or clinical cancer research.

In Brief

  • Kantoff named chair of MSKCC Department of Medicine
  • Michael Lang named CPRIT chief product development officer
  • Alexandra Levine receives award from Los Angeles County Medical Association
  • Steven Rosen receives Lifetime Achievement Award from the Israel Cancer Research Fund
  • International Cancer Genome Consortium publishes 1,200 whole cancer genome sequences online
  • ASCO publishes 11 principles for CMS payment systems
  • MD Anderson and Codiack BioSciences form research agreement
  • Pan-Mass Challenge donates $45 million to Dana-Farber
  • AARP publishes report on drug retail prices and median household income
Drugs and Targets

  • Darzalex granted accelerated approval in multiple myeloma
  • Ninlaro first protesome inhibitor approved in multiple myeloma
  • Eli Lilly and Merck extend phase III Alimta-Keytruda study collaboration

 

The Cancer Letter will take a publication break

for Thanksgiving, and return Dec. 4.

20151119 - Nov 19, 2015
SPECIAL REPORT – NOV. 18, 2015 



Congressional Panel Chair Questions Whether J&J, Brigham Reported Morcellation Adverse Events to FDA

The House Committee on Energy & Commerce has stepped into a key role in the controversy over power morcellation.

At a hearing earlier this week, Rep. Tim Murphy (R-Pa.), chairman of the Subcommittee on Oversight and Investigations questioned whether Johnson & Johnson and Brigham & Women’s Hospital violated federal law by not reporting adverse outcomes resulting from power morcellation.

At the Nov. 17 hearing by the Subcommittee on Health, Murphy quizzed Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health, in an apparent effort to determine whether manufacturers of power morcellators as well as hospitals that used these devices had failed to notify FDA that patients were being harmed.

FDA: Federal Law Requires Reporting of Morcellation Adverse Events, But None Were Brought to Agency’s Attention For 8 Years

FDA officials said the agency didn’t receive any reports of adverse outcomes resulting from power morcellation prior to December 2013.

“Of note, prior to December, the FDA had received no MDRs specifically on cancer and upstaging/dissemination,” the agency said in response to questions from The Cancer Letter. “Since then, the agency has become aware of about two dozen that have discussed ‘cancer’ and ‘upstaging or dissemination’ as of November 2014. All of these reports pertained to procedures that took place prior to December 2013.”

photoJ&J Says There Were No Reportable Morcellation Events; Whistleblower Disagrees—and Produces Letters

Johnson & Johnson officials said the company was unaware of any reportable adverse events resulting from the use of power morcellators prior to 2013.

“[J&J subsidiary] Ethicon was not aware of any reportable events related to morcellators and the possibility of upstaged cancer prior to December 2013,” a company spokesman said to The Cancer Letter. “Since that time, we have filed reports with the FDA for all reportable events that have come to our attention.”

Ethicon responded to The Cancer Letter’s questions after the Nov. 17 hearing by the Subcommittee on Health, where Rep. Tim Murphy (R-Pa.) noted that the company had received a report about the dangers of power morcellators.

20151113 - Nov 13, 2015
ISSUE 42 – NOV. 13, 2015PDF

ORI’s Deal with Potti Doesn’t Address the Role Duke Deans Played in Scandal

After a five-year investigation, the HHS Office of Research Integrity announced that it has settled with former Duke University researcher Anil Potti.

Under the agreement published in the Federal Register Nov. 9, Potti admits no wrongdoing and agrees to be barred from research funded through Public Health Service for five years.

The report doesn’t address the subject of responsibility on the part of Duke, the institution that employed Potti and conducted three clinical trials based on his model for choosing cancer therapies.


 

Guest Editorial

Penalty Too Light

By Keith Baggerly and C.K. Gunsalus

What does it say about our national commitment to research integrity that the Department of Health and Human Services’ Office of Research Integrity has concluded that a five-year ban on federal research funding for one individual researcher is a sufficient response to a case involving millions of taxpayer dollars, completely fabricated data, and hundreds to thousands of patients in invasive clinical trials?

This week, ORI released a notice of “final action” in the case of Anil Potti, M.D. The ORI found that Dr. Potti engaged in several instances of research misconduct and banned him from receiving federal funding for five years.


 

Congressman Says Brigham Invoked Security Threat to Get Even with Docs Who Triggered Morcellation Debate

Rep. Mike Fitzpatrick accused top leaders of Brigham & Women’s Hospital of retaliating against patient advocates Amy Reed and Hooman Noorchashm when a hospital administrator declared the couple a security threat and subjected them to a physical search.

Noorchashm had to submit to being tailed by a security guard while his wife was undergoing an urgent cancer surgery Nov. 2.

“As Dr. Reed’s and Dr. Noorchashm’s Representative in Congress, I am deeply concerned about what appears to be an effort to retaliate against their advocacy and silence their First Amendment Rights,” Fitzpatrick (R-Pa.) wrote in a letter Nov. 5 to Ron Walls, executive vice president and chief operating officer at Brigham.

With Letters From:

Rep. Mike Fitzpatrick: Brigham Retaliated Against My Constituents

Dr. Walls,

As you may be aware, my constituent Dr. Amy Reed has been courageously battling an aggressive leiomyosarcoma that was spread throughout her body by a dangerous medical device known as a laparoscopic power morcellator.

This device has taken the lives of hundreds, if not thousands, of women since it was allowed on the market by the Food and Drug Administration. This tragic reality hangs over this mother of six’s head every single day.

Ron Walls: Noorchashm’s “Campaign of Distortions”

Dear Congressman Fitzpatrick:

I am in receipt of your letter dated November 5.

I appreciate your interest in this matter, but want to be very clear that the security measures taken during Dr. Noorchashm’s visit were the direct result of the fear and anxiety expressed by faculty and staff on learning that Dr. Noorchashm would be returning to the hospital.

Since December 2013, Dr. Noorchashm has sent thousands of emails to faculty and staff at Brigham and Women’s Hospital, many of which contained language that recipients found disturbing and threatening.

Amy Reed: Please Stop This Craziness, Dr. Walls

Dear Dr. Walls,

Hello. My name is Amy Reed. Last week I had surgery at BWH by an excellent surgeon who works at your hospital. The surgery, as I’m sure you know, went very well and we were able to return home to our family mid-week. Your hospital has some of the best doctors in their fields.

Between visits to my oncologist, who we have a wonderful relationship with, specialists and sub-specialists, including surgeons, who have now operated on me twice, I can’t begin to count the number of times we have pulled up Francis Street to the front of BWH.

Hooman Noorchashm: Nice Try, Professor Walls

Dear Editor,

Thank you for forwarding Dr. Walls’ letter of Nov. 10, 2015, in response to Pennsylvania Congressman Rep. Mike Fitzpatrick, to me.

I assure you that the BWH corporate leadership requires public exposure—because this leadership is ethically corrupted and protectionist in a way unbecoming of trusted physicians at one of the most powerful hospitals in our nation.

 

Capitol Hill

Advocacy Organizations Urge Congress to Consider FDA’s Role in Regulating LDTs

A group of 42 organizations sent an open letter to a congressional committee urging them to consider the important role of the FDA in the regulation of laboratory-developed tests.

Ahead of next week’s hearing of the House Energy and Commerce Committee, titled “Examining the Regulation of Diagnostic Tests and Laboratory Operations,” the letter addressed concerns that agency involvement would impede patient access to LDTs, saying that the FDA has a track record of approving new technologies in a timely manner.

    In Brief

    • Michael Zinner named CEO of Miami Cancer Institute

    • Stuart Orkin receives Lifetime Impact Award from Boston Children’s

    • City of Hope announces faculty appointments

    • Sidney Kimmel Cancer Center makes personnel changes

    • St. Jude, Scripps Research Institute, and others launch Dark Proteome Initiative

    • American College of Radiology and other colorectal care advocacy agencies lobby Congress to pass Medicare coverage for CT colonography screening
    Drugs and Targets

    • Tagrisso receives accelerated approval in non-small cell lung cancer

    • Cotellic receives approval in metastatic melanoma

    20151106 - Nov 6, 2015
    ISSUE 41 – NOV. 6, 2015PDF

    DeVita: 50 Years of Stories

    On Cancer Wars and Skirmishes

     

    Vincent T. DeVita Jr. has seen the cancer field as a confident young doc eager to challenge the system, as a general in the War on Cancer, as an academic oncologist and, most recently, as a patient.

    “I’ve been in a unique position. Partly, the War on Cancer happened because of what we were doing. I watched it grow, and then I ran it at the NCI. And then I came out of the NCI and I watched it from a private cancer center and a university cancer center,” said DeVita, co-author, with his daughter, Elizabeth DeVita-Raeburn, of The Death of Cancer: After Fifty Years on the Front Lines of Medicine, a Pioneering Oncologist Reveals Why the War on Cancer Is Winnable—and How We Can Get There, a just-published memoir.

    “There are very few people who have been in that position. But I felt I owed it to the field to give a description of how I saw it, from the beginning to watching it from the outside—watching the field go through some very exciting times.”

     

    Book Review

    DeVita’s History of Oncology

    Told with Candor and Optimism

    By Otis W. Brawley

    “The Emperor of All Maladies” was a history of oncology, and a good one. “The Death of Cancer” is a memoir of one of the greats of medical oncology. It is a history from someone who was there, making history.

    In scientific terms, Siddhartha Mukherjee’s book has the limitations of a retrospective study; Vince DeVita’s book is more like a prospective clinical trial.

    I trained at the NCI in the 1980’s. I openly admit that Otis Brawley the medical oncology fellow was intimidated by the mere mention of “Dr. DeVita.”

      Judge Rebukes Brigham for Placing
      Morcellation Critic Under Guard
      While His Wife Underwent Surgery

      A Boston judge ruled Nov. 3 that Brigham & Women’s Hospital had violated the First Amendment rights of a couple who led an aggressive national campaign to stop power morcellation, a surgical procedure routinely used by gynecologists.

        NCI Funds Eight SPORE Grants

        NCI awarded eight new, competing and renewed grants as part of its funding for its Specialized Programs of Research Excellence. The grantees will receive $2,185,000 per year for five years.

           

          Funding Opportunity

          NCI Taking Applications for Research Specialist Award

          NCI is taking applications for its Research Specialist Award, which is designed to encourage the development of stable research career opportunities for scientists who want to pursue research within the context of an existing cancer research program, but not serve as independent investigators.

            In Brief

            • Edith Perez steps down as vice chair of Alliance for Clinical Trials in Oncology; named VP for Genentech and Roche

            • Stand Up To Cancer, Cancer Research UK and Lustgarten Foundation form pancreatic cancer dream team

            • NCI names 11 winners of its Cancer Clinical Investigator Team Leadership Awards

            • AACR launches international genomic data sharing project

            • CancerCare announces co-payment assistance for pancreatic cancer patients

            • SRI International awarded contract for NCI PREVENT program
            Drugs and Targets

            • TCGA Researchers identify seven subtypes of prostate cancer; two drivers of renal cell carcinoma

            • FDA grants Breakthrough Therapy designation to pexidartinib

            • MD Anderson and CytomX launch collaboration

            20151103_10 - Nov 3, 2015
            SPECIAL REPORT – NOV. 3, 2015 

            Judge Rebukes Brigham for Placing Morcellation Critic Under Guard While His Wife Was in Surgery

            A Boston judge ruled Nov. 3 that Brigham & Women’s Hospital had violated the First Amendment rights of a couple who led an aggressive national campaign to stop power morcellation, a surgical procedure routinely used by gynecologists.

            Earlier this week, Brigham provided care to Amy Reed, who needed an emergency surgery for a cancer recurrence. However, her husband, Hooman Noorchashm, had to submit to being searched and accompanied by a security guard.

            Both Reed and Noorchashm are physicians. She is an anesthesiologist who was formerly employed at Beth Israel Deaconess Medical Center, and he is a cardiothoracic surgeon who had practiced at Brigham.

            20151030 - Oct 30, 2015
            ISSUE 40 – OCT. 30, 2015PDF

            How Much is a Drug Worth?

            A Provocative Model Puts a Price on Benefit

             

            Eli Lilly & Co. didn’t ask Dan Goldstein, an oncologist at the Winship Cancer Institute at Emory University, to price their drugs, but he volunteered his services anyway.

            Indeed, Lilly Oncology is unlikely in the extreme to concur with the price he proposed for necitumumab, a front-line treatment for locally advanced or metastatic squamous non-small cell lung cancer.

            Necitumumab, which at this writing is awaiting FDA approval, would be used in combination with a doublet treatment of gemcitabine and cisplatin. This Biologics License Application is all the more important because the treatment of squamous NSCLC hasn’t changed in over 15 years.
             

            Conversation with The Cancer Letter

            Lilly’s PACE Continuous Innovation Indicators

            Visualize Progress and Value in Research

            Lilly Oncology has launched a novel value assessment tool that aggregates 40 years of oncology data to measure progress and identify unmet needs in cancer treatments.

            The tool, called PACE Continuous Innovation Indicators, or PACE CII, is an effort to visualize progress in cancer treatments with the flexibility to accommodate different cancer subtypes.

            PACE CII, launched earlier this year, contains data on 12 solid tumors: namely cancers of the breast, colon, rectum, liver, pancreas, and prostate, as well as melanoma, non-small cell lung cancer, gastric cancer, renal cancer, testicular cancer and endometrial cancer.

              Capitol Hill

              Budget Deal Eases Sequestration,

              Includes Medicare Site Neutrality

              Congress passed a two-year budget deal that would raise government spending as well as the debt ceiling.

              The bill includes an $80 billion total budget increase, divided evenly between non-military and military programs, and raises the previous caps set by sequestration. The bill also suspends the debt limit until March 2017.

                A Third of Hospitals Will Drop Out of 340B if HRSA Enacts New Guidance, Survey Finds

                Hospitals serving large populations of low-income patients stand to lose up to seven figures a year in drug discounts if proposed regulatory changes to the 340B program are enacted, the program’s supporters say.

                The Health Resources and Services Administration issued a sweeping guidance that would provide stricter definitions for which patients and entities should be covered.

                  In Brief

                  • Kathy Helzlsouer named chief medical officer and associate director of NCI DCCPS

                  • Thomas Graves and Jeanny Aragon-Ching join Inova cancer institute

                  • Friends of Cancer Research honors Marlene Malek, Reps. Diana DeGette and Fred Upton

                  • MD Anderson Cancer Center expands Moon Shots Program

                  • CureSearch for Children’s Cancer awards $260,000 in grants

                  Drugs and Targets

                  • Amgen’s Imlygic approved as first U.S. oncolytic viral cancer therapy

                  • Imbruvica wins 2015 Prix Galien Award

                  • FDA grants priority review to MCNA in certain bladder cancer patients

                  20151023 - Oct 23, 2015
                  ISSUE 39 – OCT. 23, 2015PDF

                  Pazdur: “The Primary Endpoint of Any Trial Should be the Patient.”

                   

                  RICHARD PAZDUR and ELLEN GOODMAN were honored by the National Coalition for Cancer Survivorship for their contributions to cancer care at the “Focus on the Care” reception Oct. 21 in Washington, D.C.

                  Pazdur is the director of the FDA Office of Hematology and Oncology Products, and Goodman is a Pulitzer Prize-winning columnist, author and the founder of The Conversation Project, a national public health campaign focused on end-of-life care.

                  Goodman received the inaugural Jessie Gruman Award for Patient Engagement, established with a grant from the Center for Advancing Health.

                   

                  ACS Recommends First Mammogram at 45, Transitioning to Biennial Screening After 55

                  The American Cancer Society published a breast cancer screening guideline that seems to steer toward the middle course in deciding when mammography screening should start and how often it should be performed.

                  • The ACS guideline now says 45 is a good age to get the first mammogram. In the past, the society recommended starting at 40. The U.S. Preventative Services Task Force gives a “C” rating to screening before age 50.

                  • Repeating mammograms every other year after age 55 is acceptable, the society now states. In the past, the society recommended annual mammography screening. USPSTF said screening should be biennial after age 50.

                  Conversation with The Cancer Letter Wender: ACS Guideline Hinges on Shared Decision Making

                  The Cancer Letter invited Richard Wender, chief cancer control officer of the American Cancer Society, to describe the rationale for the society’s new guideline for breast cancer screening.

                  Guest Editorial Brawley on Mammography: What we Know, What we Don’t Know, and What we Believe

                  By Otis W. Brawley

                  I have watched the rhetoric and heated debate about screening at age 40, now 45, and 50 for 25 years and am miffed that the discussion consistently ignores the obvious things we can do to save lives.

                  National Academy of Medicine Elects 80 Members

                  The National Academy of Medicine elected 80 members during its annual meeting, including at least 17 whose work focuses on cancer treatment and research.

                  “Our newly elected members represent the brightest, most influential, and passionate people in health, science, and medicine in our nation and internationally,” said Victor Dzau, president of the academy, formerly known as the Institute of Medicine.

                  Vice President Biden Calls For A National Commitment to Cancer Research Funding

                  Vice President Joe Biden, in a Rose Garden address announcing his decision to not run for president, called for a national commitment to end cancer—expressing that, were he to run and be elected, it would be a goal of his presidency.

                  “If I could be anything, I would have wanted to have been the president that ended cancer, because it’s possible,” Biden said Oct. 21. He said that his window of opportunity to mount a winning campaign had closed. “While I will not be a candidate, I will not be silent,” he said.

                  In Brief

                  • Pazdur and Goodman honored by NCCS
                  • ACCC announces six winners of 2015 Innovator Awards
                  • Jodi Daniel joins Crowell & Moring LLP
                  • Kids v Cancer awarded Drucker Prize for Nonprofit Innovation
                  • ACCC publishes white paper on integrated health care systems
                  Drugs and Targets

                  • FDA approves Onivyde in metastatic pancreatic adenocarcinoma
                  • Yondelis approved for liposarcoma and leiomyosarcoma
                  • FDA grants de novo clearance to Sonablate 450 for prostate tissue

                  CORRECTION: A previous version of last week’s In Brief was unclear in its headline referring to Beth Israel Deaconess cancer center. It has been corrected to say that Manuel Hidalgo was named director of the Leon V. & Marilyn L. Rosenberg Clinical Cancer Center and chief of the Division of Hematology-Oncology at Beth Israel Deaconess Medical Center. Hidalgo will oversee all clinical cancer programs, reporting to Pier Paolo Pandolfi, director of the BIDMC Cancer Center and its Cancer Research Institute.
                  20151016 - Oct 16, 2015
                  ISSUE 38 – OCT. 16, 2015PDF

                  Judge Nixes HRSA’s Second Attempt

                  To Enact Orphan Drug Discounts in 340B

                   

                  A federal judge has ruled against the Health Resources and Services Administration over provider access to 340B Drug Pricing Program discounts for orphan drugs.

                  Judge Rudolph Contreras of the U.S. District Court for the District of Columbia vacated a HRSA “interpretive rule,” in which HRSA sought to make drug companies provide discounts on some uses of orphan drugs.

                  Contreras determined that Congress specifically excluded all uses of orphan drugs from the 340B program.

                  340B Guidance to Scale Back Discounts;

                  Hospitals Will Need to Show Patient Benefit

                  The 340B Drug Discount Program—designed to help hospitals that serve needy patients—is on the brink of a major revamp.

                  The Health Resources and Services Administration issued a sweeping guidance that would provide stricter definitions for which patients and entities should be covered (The Cancer Letter, Sept. 11).

                  The draft guidance, called the 340B Program Omnibus Guidance, was issued Aug. 28. Its public comment period ends Oct. 27.

                  NCCN Unveils Evidence Blocks as Part of Oncology Guidelines

                  The National Comprehensive Cancer Network unveiled a new initiative—NCCN Evidence Blocks—in the new versions of the NCCN Clinical Practice Guidelines in Oncology for Chronic Myelogenous Leukemia and Multiple Myeloma.

                    Funding Opportunity

                    Stand Up To Cancer Offering $7.5 Million in Funding For Early-Career Investigators

                    Stand Up To Cancer is making $7.5 million in research funding available to early-career scientists who are pursuing innovative approaches to cancer. Proposals may focus on any discipline within basic, translational, or clinical research.

                      In Brief

                      • Manuel Hidalgo Named Director of BIDMC Clinical Cancer Programs

                      • Alec Kimmelman named chair of radiation oncology at NYU Langone

                      • Maciej Lesniak named chair of neurological surgery at Northwestern University

                      • Ann Nattinger appointed senior associate dean for research at Medical College of Wisconsin

                      • Edward Schaeffer joins Northwestern as chair of urology

                      • Peter Kanetsky elected president of American Society of Preventive Oncology

                      • IBM acquires Merge Healthcare Inc.

                      • American College of Gastroenterology holds first annual SCOPY awards

                      • Eli Lilly and Co. to expand its NYC research center

                      Drugs and Targets

                      • FDA approves Opdivo in non-squamous NSCLC

                      • FDA Orphan Designation granted to Blueprint’s BLU-554

                      • European Orphan Designations granted to CF102 and ENMD-2076

                      • Genentech and Arvinas enter into license agreement

                      • Ontario Institute for Cancer Research, Novera, and Janssen to collaborate on small molecule drugs for hematological cancers

                      • Eli Lilly and Innovent expand their anti-PD-1 collaboration

                      • Sequenom to collaborate with University Medical Center Hamburg-Eppendorf

                      • MedImmune joins Human Vaccine Project

                      20151009 - Oct 9, 2015
                      ISSUE 37 – OCT. 9, 2015PDF

                      CT Colonography and Stool DNA

                      Fail to Make USPSTF A-List

                       

                       

                      CT colonography and stool DNA failed to get on the list of preferred tools for screening for colorectal cancer.

                      A draft guideline from the U.S. Preventive Services Task Force released Oct. 6 calls for using one of three strategies:

                      • Fecal immunochemical test or high-sensitivity guaiac-based fecal occult blood test every year;

                      • Flexible sigmoidoscopy every ten years, plus FIT every year; or

                      • Colonoscopy every ten years.

                      Capitol Hill

                      Collins to Congress: A Flat, Year-long CR Would Be “Devastating” to NIH Research

                      If Congress passes another year-long, flat-funding resolution, the effect on NIH “would be simply devastating,” Director Francis Collins told a Senate appropriations subcommittee during a hearing Oct. 7.

                      “I can’t emphasize enough how much we are worried about this,” Collins said, sitting alongside NCI Acting Director Douglas Lowy and other institute directors.

                        CMS Issues Updated Pricing For Clinical Lab Fee Schedule

                        Centers for Medicare and Medicaid Services issued updated pricing determinations for the Clinical Laboratory Fee Schedule, which reversed a payment cut for the Oncotype DX breast cancer test.

                          Letter to the Editor from the Coalition for 21st Century Medicine

                          Dear Editor,

                          We are writing to clarify a few points in your Oct. 2 article, “CMS to Trim Spending on Diagnostic Lab Tests,” as it mistakenly intertwines two issues.

                            In Brief

                            • Tomas Lindahl, Paul Modrich, and Aziz Sancar win the Nobel Prize

                            • Alexander Eggermont’s directorship of Institut Gustave Roussy extended by 5 years

                            • Victoria Seewaldt joins City of Hope

                            • NYU Langone names Shohei Koide to lead new biologics research program

                            • Memorial Sloan Kettering and Cornell University to launch nanomedicine center

                            • Oncology Nursing Society launches clinical resource platform

                            • SWOG to fund Veterans Affairs Department medical centers

                            Drugs and Targets

                            • FDA grants breakthrough therapy designation to abemaciclib in breast cancer

                            • Merck and Bionomics Ltd. extend collaboration

                            • Immunovia and OHSU form pancreatic cancer collaboration

                            • MD Anderson and Theraclone Sciences launch OncoResponse company

                            20151002 - Oct 2, 2015
                            ISSUE 36 – OCT. 2, 2015PDF

                            CMS to Trim Spending on Diagnostic Lab Tests

                            The Centers for Medicare and Medicaid Services appear to be executing a two-step strategy to shrink the $8 billion annual price tag of clinical diagnostic laboratory tests.

                            On Sept. 25, CMS released a final payment determination for the Clinical Laboratory Fee Schedule that cuts payment by over 90 percent for some tests.

                            One of the industry leaders, Genomic Health, saw payments for Oncotype DX breast cancer tests drop by 15 percent, and a 79 percent drop for its colon cancer test. The determination involves a set of nine codes for advanced diagnostic laboratory tests.

                            Guest Editorial

                            Local Medicare Contractors Bring Chaos to CMS Coverage of Next Generation Tests

                            By Dane Dickson

                            Yesterday, two Medicare administrative contractors—National Government Services and Cahaba Government Benefit Administrators—released draft local coverage determinations for next generation sequencing in advanced lung cancer.

                            The NGS LCD covers the initial diagnosis of lung cancer and Cahaba’s LCD covers patients who have been re-biopsied to test for additional mutations that may have been missed on testing of the initial biopsy by older technology.

                              BMS Combination Approved in Melanoma;

                              Dana-Farber Challenges BMS Patent Rights

                              A combination of two Bristol-Myers Squibb immuno-oncology agents—Opdivo (nivolumab) and Yervoy (ipilimumab)—received an accelerated approval for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.

                              The Oct. 1 announcement marks the first time FDA has approved a combination regimen of two immuno-oncology agents in cancer—both drugs had previously been approved as monotherapies for the same indication.

                                Capitol Hill

                                Congress Averts Shutdown, Funds NIH Through December

                                Congress passed a continuing resolution Sept. 30—averting a shutdown—that will fund the federal government at current levels through Dec. 11.

                                Funding for both NIH and NCI dipped slightly as part of a 0.21 percent cut to all non-defense discretionary agencies.

                                  USPSTF Speaks on its Role In the Affordable Care Act

                                  The U.S. Preventive Services Task Force published a viewpoint in the Journal of the American Medical Association to clarify how their recommendations are linked to the Affordable Care Act coverage mandate—and how they believe clinicians, payers, and the public should interpret their recommendations.

                                  The viewpoint, titled “Evidence-Based Clinical Prevention in the Era of the Patient Protection and Affordable Care Act: The Role of the US Preventive Services Task Force,” describes how some have misinterpreted task force grades of C or I as recommendations against screening or even against coverage.

                                    Funding Opportunity

                                    Pershing Square Sohn Cancer Research Alliance Prize For Young Investigators

                                    The Pershing Square Sohn Cancer Research Alliance is taking applications for its Prize for Young Investigators in Cancer Research.

                                      In Brief

                                      • Richard O’Reilly to step down as chair of pediatrics at MSKCC

                                      • James Wade named deputy director at Inova cancer institute

                                      • MSKCC’s Lorenz Studer named MacArthur Fellow

                                      • Three investigators named winners of the Paul Marks Prize

                                      • Kesari joins Providence Saint John’s Health Center

                                      • Turaga named endowed professor in sarcoma research at Medical College of Wisconsin

                                      • Jan Schluchter named CCO at Myriad Genetics GmbH

                                      • Stand Up to Cancer Canada Dream Team members announced

                                      • Center to Advance Palliative Care publishes state-by-state report card
                                      Drugs and Targets

                                      • FDA grants accelerated approval to Keytruda in NSCLC

                                      • EMA CHMP grants two positive opinions to Kyprolis and Blincyto

                                      • FDA grants priority review to defibrotide for hepatic VOD

                                      • Aspen Park acquires Ohio State’s APP-111

                                      • UbiVac and Janssen form collaboration

                                      • City of Hope and Sorrento Therapeutics form LA Cell Inc.

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