20160129 - Jan 29, 2016
ISSUE 4 – JAN. 29, 2016PDF



Slamming the Door

How Al Gilman Taught Texas A Lesson in Science

Alfred Gilman’s approach to distributing public funds wasn’t particularly difficult to understand: he wanted to pay for the best science available. Period.

The pot of money entrusted to Gilman was vast. In 2007, Texas voters approved the largest investment in cancer research outside the federal government: $3 billion, to be spent over 10 years. By way of comparison, NCI grants going to Texas researchers and institutions added up to $240 million a year. CPRIT more than doubled that money. Only Texans were eligible to apply.

Gilman accepted the CPRIT job at age 68, because he thought that it would be a significant contribution to a major research effort, and a nice way to finish out a long career.

Sixty-Nine Cancer Centers Urge HPV VaccinationIn an unprecedented move, 69 NCI-designated cancer centers have come together to advocate for HPV vaccination as a preventive measure against many HPV-related cancers.

“HPV vaccination is our best defense in stopping HPV infection in our youth and preventing HPV-related cancers in our communities,” the centers said in a consensus statement published Jan. 27. “The HPV vaccine is cancer prevention.”

PCORI Passes $1.2 Billion in Total Research Funding

The Patient-Centered Outcomes Research Institute approved $70 million for nine new patient-centered research projects focused on conditions including ductal carcinoma in situ, diabetes, chronic lung disease and migraines.

With these latest awards, PCORI has now approved or awarded more than $1.2 billion in research funding.

In Brief

  • Minesh Mehta named deputy director at Miami Cancer Institute
  • Carmen Solórzano named chief of Division of Surgical Oncology at Vanderbilt
  • Judy Keen named ASTRO director of scientific affairs
  • Tara Yates joins Wistar Institute as director of communications
  • Ovarian Cancer National Alliance and Ovarian Cancer Research Fund merge
  • UC San Diego Health selects e+CancerCare to operate Chula Vista radiation center
  • Harvard Business School launches Precision Trials Challenge
Drugs and Targets

  • FDA expands Opdivo-Yervoy Label with accelerated approval in melanoma
  • Halaven approved for unresectable or metastatic liposarcoma
  • Zepatier approved for treatment of chronic hepatitis C
20160122 - Jan 22, 2016
ISSUE 3 – JAN. 22, 2016PDF



Biden’s Cancer Moonshot to Focus
On Bioinformatics and Data Sharing

The Obama administration will find the money to create a comprehensive oncology bioinformatics system, Vice President Joe Biden pledged Jan. 19 at a meeting of international cancer experts at the World Economic Forum in Davos-Klosters, Switzerland.

Biden, whose son Beau died of brain cancer in May 2015 at age 46, is leading the White House “moonshot” program, which was announced by President Barack Obama during his final State of the Union address Jan. 12 (The Cancer Letter, Jan. 15).

Obama is expected to announce the details of funding the moonshot in his budget proposal Feb. 9.

 Biden: Cancer Moonshot Seeks Quantum Leaps, Not Incremental Change

The text of Vice President Joe Biden’s Jan. 19 remarks at a World Economic Forum meeting of international cancer experts in Davos-Klosters, Switzerland, follows:

Almost everyone in the world, as you all know, has a family member who’s had cancer. Every year, around the world, 14 million people are diagnosed with cancer and 8 million people succumb to it, die, from cancer.

And like many of you, I have experienced in my family the dreaded C-word that I think is the most frightening word that most people—as these docs and scientists can tell you—that anyone wants to hear walking out of a doctor’s office.

     

    Guest Editorial

    The False Allure of The Cancer Cure

    By Robert Cook-Deegan

    Over the past century, we have had many wars on cancer, and now we have a national “moonshot” to be spearheaded by Vice President Joe Biden, announced in President Barack Obama’s Jan. 12 State of the Union Address.

    In 1937, even as Congress was establishing the National Cancer Institute as the first of the National Institutes of Health, the American Committee to Combat Cancer was organizing the “Women’s Field Army” to mobilize against cancer, especially uterine, ovarian, and breast cancers. The main argument was that the nation was spending vastly more per person affected, and per death, on polio than it was on cancer. It was framed as a war.

      In Brief

      • James Willson named chief scientific officer of CPRIT

      • Mary-Claire King wins the Szent-Györgyi Prize for Progress in Cancer Research

      • Mylin Torres named director of Glenn Family Breast Center at Winship
      • New York Genome Center receives $100 million grant from the Simons Foundation and Carson Family Charitable Trust

      • MD Anderson Cancer Center and AbbVie form immuno-oncology collaboration

      Drugs and Targets

      • Venetoclax receives Breakthrough Therapy Designation from FDA

      • FDA grants Priority Review to lenvatinib

      20160115 - Jan 15, 2016
      ISSUE 2 – JAN. 15, 2016PDF



      Obama Announces Moonshot to Cure Cancer

      President Barack Obama announced a moonshot aimed at curing cancer, a project to be led by Vice President Joe Biden.

      The United States can do “so much more,” Obama said in his seventh and final State of the Union address Jan. 12. “Last year, Vice President Biden said that with a new moonshot, America can cure cancer. Last month, he worked with this Congress to give scientists at the National Institutes of Health the strongest resources they’ve had over a decade.

      “Tonight, I’m announcing a new national effort to get it done. And because he’s gone to the mat for all of us, on so many issues over the past 40 years, I’m putting Joe in charge of mission control. For the loved ones we’ve all lost, for the family we can still save—let’s make America the country that cures cancer once and for all.”

       When Moonshots Collide

      Did Patrick Soon-Shiong attempt to scoop President Barack Obama’s State of the Union address?

      Several days before Obama announced the federal government’s moonshot to cure cancer, Soon-Shiong put out a draft press release, claiming that the White House, NIH, FDA and pharmaceutical companies have united in “Cancer MoonShot 2020,” an immunotherapy clinical trials program he devised.

      Soon-Shiong, founder and CEO of NantWorks and the Chan Soon-Shiong Institute of Molecular Medicine, ultimately announced his moonshot on Jan. 11, a day before Obama announced his.

       Conversation with The Cancer Letter

      Soon-Shiong Says FDA & NCI are Onboard For His Moonshot; Feds Deny Involvement

      Government agencies said the biotechnology billionaire Patrick Soon-Shiong had overstated the extent of their involvement in “Cancer MoonShot 2020,” the immunotherapy clinical trials program he put together.

      In an in-depth conversation with Matthew Bin Han Ong, a reporter with The Cancer Letter, Soon-Shiong said that while his program doesn’t seek federal funds, it has the support of NCI and FDA officials.

      Soon-Shiong said he and Vice President Joe Biden met to discuss their interlocking missions and are now pursuing them.

      USPSTF Recommends Biennial Mammography Screening For Women Ages 50-74

      The U.S. Preventive Services Task Force published its final recommendation statement on screening for breast cancer, delivering a B rating for mammography screening every two years in women between ages 50 and 74.

      The task force also recommended selectively offering mammography to women below age 50, saying that the decision to begin that screening should be an individual one. The USPSTF gave this age group a C recommendation.

      “Women who place a higher value on the potential benefit than the potential harms may choose to begin biennial screening between the ages of 40 and 49 years,” the task force wrote in its recommendations.

       Campaign for Tobacco-Free Kids Demands Recall of Gold Standard Accreditation of U.S. Chamber of Commerce

      The Campaign for Tobacco-Free Kids said the U.S. Chamber of Commerce is undeserving of its Gold Standard accreditation by the CEO Roundtable on Cancer, saying it should be rescinded because of the trade group’s lobbying efforts against tobacco regulations.

      In Brief

      • Leonard Zon receives Knudsen cancer genetics award from NCI
      • Amy McKee named acting deputy office director at FDA OHOP
      • Paul Kluetz appointed associate director of clinical science at FDA OHOP
      • Dean Tsarwhas named medical director at Northwestern Medicine Lake Forest Hospital
      • Rafat Abonour named medical liaison for the International Myeloma Foundation
      • Ravi Salgia joins City of Hope as chair of Department of Medical Oncology
      • FASEB publishes recommendations for research reproducibility
      • COA elects new board and executive committee members
      Drugs and Targets

      • Blincyto receives conditional approval from Health Canada
      • FDA grants priority review to venetoclax in CLL
      • Sorrento Therapeutics and Karolinska Institutet form collaboration
      • Eisai submits MAA to European Medicines Agency for lenvatinib
      • MD Anderson and DelMar Pharmaceuticals form collaboration
      • Debiopharm International SA collaborates in EORTC trial
      20160108 - Jan 8, 2016
      ISSUE 1 – JAN. 8, 2016PDF



      Ellen Stovall, Pioneering Advocate For Survivorship, Dies at 69

      Ellen Stovall, one of the most respected and knowledgeable cancer advocates in Washington, died Jan. 5.

      The cause of death was a heart attack.

      Stovall, 69, was first diagnosed with Hodgkin’s lymphoma in 1971. Her disease recurred in 1983. In 2007, she had bilateral mastectomies due to the late effects of the radiation treatment. Her heart disease and chronic pain were also attributed to her original treatment.

      “Ellen is a rare transformational figure in cancer care, who saw an enormous unfilled need and led the development of the entire concept of cancer survivorship,” said Norman Coleman, head of the Experimental Therapeutics Section and associate director of the NCI Division of Cancer Treatment and Diagnosis, and senior medical advisor at the HHS Office of the Assistant Secretary for Preparedness and Response.

      Nobel Laureate Alfred Gilman,
      Defender of Good Science, Dies at 74

      Alfred G. Gilman, a Nobel laureate who concluded his academic career in the role of chief scientific officer of the Cancer Prevention and Research Institute of Texas, died Dec. 23, 2015. Gilman, 74, had pancreatic cancer.

      Gilman shared the 1994 Nobel Prize in Physiology or Medicine with Martin Rodbell of the National Institute of Environmental Health Sciences for their discovery of G proteins—guanine nucleotide-binding regulatory proteins. G proteins are central to signaling transduction, the process of receiving signals from outside the cell and activating a range of cellular responses.

      G proteins are found in nearly all cells, and are central to body processes that include vision, smell, hormone secretion, and thinking in humans. Problems in G-protein signaling contribute to a range of diseases, including cholera, whooping cough, and cancer.

      Cancer Death Rate Continues Steady Drop

      Steady reductions in smoking combined with advances in cancer prevention, early detection, and treatment have resulted in a 23 percent drop in the cancer death rate since its peak in 1991, according to the annual Cancer Statistics report from the American Cancer Society.

      The drop translates to more than 1.7 million cancer deaths averted through 2012. The findings were published in CA: A Cancer Journal for Clinicians. The report estimates there will be 1,685,210 new cancer cases and 595,690 cancer deaths in the United States in 2016.

      Lab-Developed Tests

      AMP Responds to FDA Report On Regulation and Oversight

      The Association for Molecular Pathology responded to the FDA’s call for oversight of laboratory developed tests, rebutting 20 case studies published by the federal agency that illustrated possible harms inflicted on patients when laboratories did not follow FDA requirements.

      The AMP said the agency’s collection of case studies “grossly misrepresents the public health concerns of laboratory developed testing procedures,” and said that FDA oversight would likely prevent few of the potential patient harms.

      In the case of clinical trials performed at Duke University using a faulty genomics predictor to assign cancer treatment to individual patients, the AMP said that that test did not cause patient harm, and was not used in a clinical setting.

      Funding Opportunity

      AACR and Bayer Offering Research Grants

      The American Association for Cancer Research and Bayer announced the 2016 AACR-Bayer Innovation and Discovery Grants program for meritorious projects that examine novel targets and biomarkers in oncology research.

      In Brief

      • St. Jude to open new Graduate School for Biomedical Sciences
      • Research!America unveils 2016 policy wish list
      • Memorial Sloan Kettering opens outpatient surgery center
      • Inova and George Mason University form research partnership
      • St. Jude receives $20 million commitment from Steven & Alexandra Cohen Foundation
      Drugs and Targets

      • FDA grants Breakthrough Therapy Designation to Boehringer Ingelheim TKI Inhibitor in NSCLC
      • Stem Cell Theranostics and CapellaBio launch collaboration on cardiotoxicity
      • Amgen enters into agreement with GSK to reclaim rights to Prolia, XGEVA, and Vectibix
      20151218 - Dec 18, 2015
      ISSUE 46 – DEC. 18, 2015PDF



      How Medical Devices Do Harm

      Friends call him The Hoomanator, a darkly comical conflation of his first name, Hooman, and morcellator, the medical device he has aggressively campaigned against.

      Enemies—who are great in number—call him much worse.

      Over the past two years, Hooman Noorchashm, a cardiac surgeon at Thomas Jefferson University Hospital, has been accused of launching a “campaign of distortions,” threatened with legal action, subjected to security searches and publicly chastised.

      Over a two-year investigation, The Cancer Letter tracked Noorchashm and his wife, Amy Reed, as they challenged FDA, Congress, hospitals, the gynecology profession and manufacturers of medical devices. Their struggle began with a routine hysterectomy, during which a device called a power morcellator disseminated Reed’s undetected sarcoma. Today, as Amy’s aggressive disease spreads, the couple continues to draw public attention to the blind spots in the U.S. medical device regulatory system.

      Two Docs Who Broke the Code

      Hooman Noorchashm sends out several scathing emails each day.

      Consider the subject lines of some recent emails that went to hospital administrators, with copies to members of Congress and the press: “Your ethical lapse and negligence.” “Outrageous!” “Your corruption.” “The Fouled Ethics of Your Specialty.” “Do read with care.”

      “The time for diplomacy has passed,” Noorchashm said to The Cancer Letter. “I have no time to play politics. I have a wife with advanced cancer and six young children.”

      His wife, Amy Reed, is battling advanced leiomyosarcoma. Since her undetected cancer was spread via power morcellation performed at Brigham & Women’s Hospital in October 2013, Reed has been in treatment for metastatic disease.

      “Every time I see her go through these different phases and I think about the implications of it, it gives me a little bit more resolve to look at the root cause of this thing and hit it as hard as I can,” Noorchashm said.

      The Root Causes of Harm From Medical Devices

      The FDA Office of Criminal Investigations is being asked to determine why the agency has failed to detect the upstaging of cancers in women who had been operated on with a power morcellator.

      These devices, widely used to shred uterine tissue in minimally invasive gynecological surgery, are now known to upstage undetected cancers that, according to FDA, occur in one of about 350 patients undergoing hysterectomies and myomectomies.

      It took over two decades for the agency to realize that thousands of women may have died from metastatic uterine sarcoma upstaged by power morcellators, Rep. Mike Fitzpatrick (R-Pa.) wrote in a Dec. 18 letter to the agency.

      Conversation with The Cancer Letter

      Vodra: 510(k) Process Does Not Assess Risk; Needs to Be Broken Up Into Multiple Risk Groups

      FDA’s Class II 510(k) clearance process for medium-risk devices—a category that includes the power morcellator—is inadequate, because it does not focus on risk assessment, according to Bill Vodra, a former associate chief counsel for drugs at FDA.

      Instead, the 510(k) process relies on “substantial equivalence” to predicate devices, thereby allowing subsequent iterations of a device to introduce risk without active FDA surveillance.

      “A huge variety of devices are now in Class II, and they pose extraordinarily different kinds of risk,” Vodra said. “The current test for clearance of a 510(k) is, ‘Is the proposed device substantially equivalent to another device (the predicate device or device chain) that has been marketed?’ “The answer may be yes, but that does not tell you much about risk of the proposed device or its predicates.”

      Pilot: Don’t Change 510(k), Put More Money Into Enforcing Reporting Laws

      Patients are being harmed because FDA doesn’t commit sufficient resources to enforce federal requirements for hospitals and manufacturers to report adverse outcomes caused by medical devices, according to Larry Pilot, one of the original authors of FDA’s 510(k) device clearance process.

      There is no need to revamp the 510(k) process, Pilot said. The agency should instead enforce existing laws to make device manufacturers and user facilities report adverse outcomes.

      “It’s a good system we have now, but FDA needs to allocate more resources to enforcement, especially for user facilities,” Pilot said. “That’s why FDA, with its authority, and this opportunity to put the emphasis on reporting to the user facility required by law, and then by specific regulation, should be going for money penalties for user facilities that do not abide by the reporting requirement.”

      Daniel: FDA Does Not Have a Reliable Surveillance System for Medical Devices

      Devices aren’t tracked with the same rigor as drugs, because FDA does not have a data system that can reliably track medical devices and identify potential safety problems, according to Gregory Daniel, fellow and managing director of the Center for Health Policy at Brookings Institution.

      “Without having such a data system that can be used for active safety surveillance—i.e., safety monitoring that doesn’t rely on reporting of adverse events by providers or manufacturers—it is challenging to quickly identify potential safety issues with devices early on,” Daniel said.

      Capitol Hill

      Congress Passes $1.1 Trillion Omnibus Bill

      Boosting NIH Budget by $2 Billion

      Congress passed a $1.1 trillion government spending bill Friday morning, increasing the NIH budget by $2 billion. The measure now moves to the president’s desk for approval.

      Editorial

      The Year in Review

      As the New Year approaches, we are preparing to revamp our website and launch an app. The work on it is almost done—a January launch seems likely.

      In 2015, we got to report some cool stories, win national journalism awards and successfully deflect Amgen’s attack on our First Amendment rights.

      In Brief

      • Raymond DuBois named dean of MUSC College of Medicine
      • John “Drew” Ridge elected medical staff president at Fox Chase – Temple Health
      • Bhramar Mukherjee appointed associate director for population science at University of Michigan Comprehensive Cancer Center
      • Joseph Smith Jr. awarded Huggins Medal from the Society of Urologic Oncology
      • Society of Toxicology honors award recipients, including Richard Adamson with the Founders Award
      • Albert Einstein Cancer Center awarded NIH grant
      • OHSU and Cancer Research UK to collaborate on early detection
      • St. Jude opens proton therapy center
      • IU Simon Cancer Center taking high school and college applicants for its Summer Research Program
      • HealthWell Foundation launches fund for underinsured multiple myeloma patients
      Drugs and Targets

      • FDA approves Bendeka injection, a bendamustine formulation for infusion
      • Stem Cell Theranostics and CapellaBio launch collaboration on cardiotoxicity
      • Amgen enters into agreement with GSK to reclaim rights to Prolia, XGEVA, and Vectibix

       

      The Cancer Letter will take a publishing break and return Jan. 8, 2016.

      20151211 - Dec 11, 2015
      ISSUE 45 – DEC. 11, 2015PDF



      Core Grants of Newer, Smaller Centers

      Slated to Get Immediate Funding Boost

      NCI is implementing a less draconian formula for increasing the core grants of newer cancer centers.

      The plan, which was unveiled at the Dec. 1 joint meeting of the Board of Scientific Advisors and the National Cancer Advisory Board, seeks to correct an acknowledged inequity: by virtue of being in the NCI program longer, more established cancer centers had more incremental increases, thus amassing larger core grants.

      In a unanimous vote, BSA asked for some refinements to the plan, but seemed to be fine with its main features.

      An earlier version of the plan called for fundamental changes in the funding formula, which—according to NCI modeling—would have reduced the core grants of some of the older, larger cancer centers and gave these funds to the newer centers.

      Capitol Hill

      NIH Looks For $1-2 Billion Raise in FY 2016

      As Congress Approaches Another Deadline

      NIH is slated to receive a $2 billion increase under the Senate appropriations bill, but only $1.1 billion under the House plan for the current 2016 fiscal year.

      The Senate version would bring NIH finding up to $32 billion, with NCI receiving $5.204 billion. The House version would total just above $31 billion for NIH, including $5.081 billion for NCI.

      Both chambers of Congress are setting aside $200 million for the Precision Medicine Initiative, which would include $70 million for NCI.

      Guest Editorial

      The Academic Difference

      By George J. Weiner

      Academic cancer centers have a major and unique role to play in enhancing cancer research, clinical care and education. This role will increase in value as our understanding of the complexity of cancer grows and is applied to care of patients.

      Academic cancer centers leverage synergies among these various missions, with the result being a positive impact on patient health and the economy at the local, regional and national levels. Accelerating progress in cancer medicine is dependent on the success of academic cancer centers and development of new models of collaboration between academic cancer centers and community oncology.

      ACS and ASCO Jointly Publish Breast Cancer Survivorship Guideline for Primary Physicians

      The American Society for Clinical Oncology and the American Cancer Society published a joint guideline for primary care physicians on managing the long-term care of breast cancer survivors, recommending regular surveillance for recurrence, but not performing laboratory or imaging tests in patients not displaying symptoms.

      In Brief

      • Carlos Rodriguez-Galindo to lead St. Jude’s international outreach
      • Daniel Simon named president of UH Case Medical Center
      • Terrill Jordan named president and CEO of Regional Cancer Care Associates
      • Gustave Roussy institute recruiting young doctors
      • Baylor to collaborate with Biocept on blood-based cancer tests
      Drugs and Targets

      • FDA grants accelerated approval to Alecensa for ALK-positive NSCLC patients
      • FDA approves Vistogard for emergency treatment of certain chemotherapy overdoses
      • FDA clears cooling cap for preventing hair loss during chemotherapy
      • EMA grants orphan designation ot Debio 1143
      • Amgen submits expanded application for Kyprolis in the EU
      • AstraZeneca and Voluntis to test digital support service in ovarian cancer trials
      • Eli Lilly and Merck to collaborate on abemaciclib-Keytruda phase I trial
      20151204 - Dec 4, 2015
      ISSUE 44 – DEC. 4, 2015PDF



      Mary Pazdur, 63, Dies of Cancer;

      What Her Husband Has Learned

      The job interview wouldn’t last more than 15 minutes, Richard Pazdur believed.

      So, on a June morning in 1999, his wife Mary settled down to wait at a restaurant near the FDA buildings alongside Rockville Pike.

      The restaurant turned out to be Hooters, and Mary ended up spending three hours at the joint known for all-you-can-eat chicken wings served by scantily clad waitresses known as Hooters Girls.

      “How much Hooters coffee can you drink?” Mary said frequently, retelling the story of her introduction to FDA, Washington and cancer politics.

      Rick’s Search for Meaning

      On Nov. 17, Richard Pazdur, director at the FDA Office of Hematology and Oncology Products, spoke about the role that has been thrust upon him: that of a “regulator/advocate.”

      “What we’re seeing now is not a patient voice but a patient cry—wanting to have their position heard,” said Pazdur, speaking at a Washington conference sponsored by Friends of Cancer Research.

      NCI Director’s Report

      Lowy: Higher RPG Success Rates in 2015;

      Continuing Resolutions Will Slow Progress

      NCI awarded about 635 R01s in 2015, up from 629 in 2014, said NCI Acting Director Doug Lowy at a recent joint meeting of the National Cancer Advisory Board and the NCI Board of Scientific Advisors.

      The number of R01 awards fell short of pre-sequestration levels, but there has been a substantial increase in R21 applications—from 225 in 2012 to about 355 in 2015.

      Funding Opportunity

      Debbie’s Dream Foundation Offering $200,000 in Grants

      Debbie’s Dream Foundation: Curing Stomach Cancer launched two research grants totaling $200,000 for the 2015-2016 grant cycle. A Career Development Award for $150,000 and a Young Fellowship Grant for $50,000 are being offered.

      In Brief

      • Jennifer Nam Choi named chief of oncodermatology at Northwestern Memorial
      • Robert Hauser named vice president of clinical analytics at Cancer Treatment Centers of America
      • Mia Levy to be director of health information and strategy at Vanderbilt-Ingram Cancer Center
      • City of Hope announces three personnel changes
      • David Flockhart, board member of the Personalized Medicine Coalition, died Nov. 26
      • Fox Chase-Temple Health form collaboration with Accutest Research Labs in India
      • Manipal Hospitals to use IBM Watson technology
      • ASTRO publishes template for long-term survivor plans
      • West Cancer Center opens its East Campus
      • National Health Care Anti-Fraud Association names it’s 2015 Investigation of the Year
      Drugs and Targets

      • FDA approves Opdivo in renal cell carcinoma
      • European Commission grants marketing authorization for Kyprolis in multiple myeloma
      • EMA accepts anamorelin application for review
      • MD Anderson and Boehringer Ingleheim announce collaboration
      • Morphotek and Targeted Alpha Therapy Group to collaborate in ovarian cancer
      • Roche and Upsher-Smith Laboratories to develop VAP-1 inhibitor
      • Caris Life Sciences and Syapse to collaborate on genomic information
      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