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Group Chairs Seek Role Running NCTN
Is the new National Clinical Trials Network set up for success or heading for failure?
The National Cancer Advisory Board Sept. 9 attempted to review the early signals coming from the institute’s revamped clinical trials system to determine whether it could use early tweaks.
The institute’s new network, configured to conduct new-generation “smart” trials of targeted agents, creates new mandates and capabilities, but—overall—it provides no new money to the clinical trials system. Also:
Stand Up To Cancer More, a non-profit cancer group that conducts televised fundraising events, raised over $109 million last weekend.
The group’s triumphant Sept. 7 press release, awash with pictures of participating Hollywood celebrities, hailed this achievement. However, the group also became a target for criticism for failing to mention that three high-level donors have ties to the tobacco industry.
SU2C officials aren’t denying the connection.
Following our discovery that my wife’s occult uterine cancer was morcellated using a gynecological power morcellator, we initiated a vigorous campaign to protect others from this avoidable harm.
It is now increasingly clear that one in 350-500 women with symptomatic fibroids have occult or missed uterine cancer lurking in what a majority of gynecological surgeons have assumed to be benign tumors.
The American Association for Cancer Research urged FDA to regulate high-risk laboratory-developed tests, a category of assays that has escaped scrutiny because of loopholes in the regulatory process.
Normally, FDA requires that diagnostic tests developed by manufacturers adhere to three measures: analytic validity, clinical validity, and clinical utility. However, laboratories can get around this requirement by using laboratory-developed tests, or LDTs.
Albert and Mary Lasker Foundation announce 2014 award winners
Andreas Hochhaus and Robert Gale named editors-in-chief of Leukemia
Georgetown Lombardi Comprehensive Cancer Center receives five-year p30 Cancer Center Support Grant
Louis DeGennaro named president and CEO of Leukemia and Lymphoma Society
Stanford University launches genetics and genomics certificate program
Timeline Pinpoints the Role of Cancer Scandal
In a Progression Leading to Perry’s Indictment
The indictment of Texas Governor Rick Perry by a Travis County grand jury brings together two complex subplots:
• The controversy over the Cancer Prevention and Research Institute of Texas, which came into public view May 8, 2012, with the resignation of its scientific leader, Nobel Laureate Alfred Gilman, who claimed that political interference had caused a departure from standard peer review in the handling of a proposal to fund a $20 million “biotechnology incubator” at MD Anderson Cancer Center, triggering a delay in funding of previously reviewed grants.
• The political wrangling that followed the April 12, 2013, drunk driving arrest of Travis County District Attorney Rosemary Lehmberg, whose duties include administering the Public Integrity Unit, which investigates corruption of state officials.
A German company that makes devices now under FDA scrutiny for their potential to spread sarcoma threatened legal action against the U.S. surgeon whose wife’s cancer cells were disseminated during routine surgery to remove fibroids.
Setting decorum aside, Hooman Noorchashm has been haranguing FDA, Congress, and the gynecology and oncology profession into partial abandonment of the procedure. Though he hasn’t sued anyone, several law firms are looking for women harmed by the procedure who would be willing to take part in litigation.
The Cancer Prevention and Research Institute of Texas last month awarded 101 new grants: 84 for research, 15 for prevention and two for product development.
CPRIT received nearly 600 grant applications, and after review, awarded grants to cancer researchers, prevention initiatives and product development projects from institutions and organizations across the state.
NCI launched another in a series of targeted treatment trials referred to as the Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial.
ALCHEMIST seeks to identify mutations in early-stage lung cancer patients, and uses this information to assign them to treatments targeted for those mutations.
The College of American Pathologists published recommendations for active surveillance of patients with prostate cancer.
The report highlighted key pathologic parameters for identifying patients likely to succeed with active surveillance, including: sampling, submission, and processing issues in needle biopsies; tumor extent in needle biopsies; biopsy reporting for all and special cases; Gleason scores; and precision medicine markers.
The American Association for Cancer Research and the American Society of Clinical Oncology urged the FDA to regulate all tobacco products, including e-cigarettes.
Additionally, 24 public health and medical organizations filed public comments in response to an FDA proposal to extend its regulatory authority over tobacco products.
ObituariesJessie Gruman, 60, CFAH Founder and President
Jessie Gruman, founder and president of the Center for Advancing Health since 1992, died July 14.
Jesse Leonard Steinfeld, 87, U.S. Surgeon General
Jesse Leonard Steinfeld, U.S. surgeon general from 1969 to 1973, died Aug. 5.
George Weiner to become president of AACI
Stanton Gerson named AACI president-elect
Charles LeMaistre and Hans Mark named University of Texas System chancellors emeriti
James Davis elected chairman of the Leukemia & Lymphoma Society
Joyce Wong named certified pediatric nurse of the year by Oncology Nursing Certification Corporation
Patrick Soon-Shiong named global bioinformatics director of Providence Health and Services
Shawn Cline Tomasello appointed Pharmacyclics chief commercial officer
Jeffrey Litwin named editor-in-chief of the Journal of Clinical Trial Results
MD Anderson and Memorial Hermann Health System to form partnership
LIVESTRONG Foundation to launch LIVESTRONG Cancer Institutes
MD Anderson opens diagnostic imaging center in West Houston
FDA grants accelerated approval for Keytruda in metastatic melanoma
FDA approves Cologuard; CMS issues national coverage determination
FDA approves new use for Avastin in late-stage cervical cancer
European Medicines Agency acclerates assessment of lenvatinib
As an apparent result of this campaign by Noorchashm and his wife Amy Reed, top institutions—including Brigham and Women’s Hospital, where Reed underwent the procedure—are moving away from routine use of morcellation, and some insurers are refusing to pay for the procedure.
One of the largest manufacturers of these devices—Ethicon, a unit of Johnson & Johnson—recently voluntarily withdrew the devices, which cost between $1,500 and $3,000 each.
Power morcellation is performed on an estimated 100,000 women in the U.S. a year with a minimally invasive device that pulverizes a patient’s fibroids into fragments for easy removal through a small incision. The problems occur when power morcellators disseminate cells from undetected cancers.
The Karl Storz Group, the company that Noorchashm says made the device that was used in Reed’s surgery, is taking a different approach.
The Letter from the Karl Storz Group to Noorchashm Threatening Legal Action
Dear Dr. Noorchashm,
This refers to several emails which you addressed—amongst others—to Dr. h.c. mult. Sybill Storz, the CEO of the KARL STORZ Group.
In your emails, you requested Dr. Storz to “recall your Rotocut morcellator device from the market”, arguing that it caused harm to patients. You also urged Dr. Storz that she “must do right by all those who have been harmed’’ (21 May 2014) and you sent her (and other recipients) a collage of “30 women, some dead’; calling them “Your victims. Victims of your standard of care and using your robotic a power morcellator devices”. Again, in this email (24 June 2014) you imply that the power morcellator was the cause of some women’s deaths.
A Story in Mugshots: from left, Jerald Cobbs, former CPRIT chief commercialization officer; Texas Governor Rick Perry; and Travis County District Attorney Rosemary Lehmberg.
By Paul Goldberg
The plot lines crossed on Dec. 7, 2012, when the Travis County DA initiated a criminal investigation of CPRIT, and they stayed together through the Dec. 3, 2013 indictment of CPRIT’s chief commercialization officer, Jerald Cobbs, on charges stemming from his failure to conduct peer review of a proposal before awarding $11 million in Texas taxpayers’ money.
It’s possible that molecular testing is doing a lot of good, pinpointing cancer therapies that are most likely (or least likely) to work.
It’s also possible that Medicare is paying for molecular tests that are marketed aggressively despite being based on flimsy evidence.
The latter picture is painted in a suit filed by two former employees of Caris Life Sciences Inc., a company that markets the “Caris Molecular Intelligence” test, a panel of assays previously called “Target Now.”
The whistleblowers allege that their former employer violated the federal anti-kickback statute by routinely waiving some of its fees to induce referrals to federal healthcare programs.
Tumor profiling information Caris Life Sciences provides in its reports isn’t backed by sufficient evidence to justify some clinical decisions, said Daniel Hayes, a breast cancer expert at the University of Michigan.
Hayes, the university’s Stuart B. Padnos Professor of Breast Cancer Research and a member of a recent Institute of Medicine committee that issued a report on omics, was clicking through the Caris website as he spoke with Paul Goldberg, editor and publisher of The Cancer Letter.
The Cancer Letter submitted seven questions to Caris Life Sciences regarding their suite of molecular diagnostic tests.
Questions focused on the costs of the tests, who pays for them, and how much of the information they provide is actionable.
The next issue will be published Sept. 5.
NCI awarded 53 five-year grants for multi-site clinical trials and care delivery research studies through the NCI Community Oncology Research Program. The program will provide $93 million each year.
Emmanuel Farber, a pathologist who made contributions to the understanding of chemical carcinogenesis, died Sunday, Aug. 3.
Peter Pisters named CEO of University Health Network in Toronto
MD Anderson and Hospital Israelita Albert Einstein form partnership
Richard Wahl named head of radiology at Washington University in St. Louis
David Espey steps down as acting director of CDC Division of Cancer Prevention and Control
Michael Bookman named medical director of US Oncology Research Gynecology Research Program
Richard David named professor of urology at UCLA
Jennifer Zeitzer named deputy director of FASEB public affairs office
Jeffrey Albers named CEO of Blueprint Medicines
Conquer Cancer Foundations names Raj Mantena and Aaron Sasson to board of directors
Dr. Susan Love Research Foundation receives NIH grant to develop low-cost, portable ultrasound
Massachusetts General Hospital receives award from American Hospital Association
Association of Community Cancer Centers launches online drug database
Bristol-Myers Squibb forms agreement with Leica Biosystems
AstraZeneca and Qiagen to collaborate on companion diagnostic
Optim Oncology and Urology Centers of Oklahoma join The US Oncology Network
FDA and EMA grant orphan designation to AbbVie's ABT-414
Ethicon, the Johnson & Johnson subsidiary that manufactures nearly three-quarters of laparoscopic power morcellators on the market, has requested a withdrawal of the controversial devices.
“Immediately review inventory to determine if you have any Ethicon Morcellation Devices which are the subject of this market withdrawal,” the company wrote in a letter to hospitals worldwide.
“If you have provided Ethicon Morcellation Devices to any hospital within your system, you are responsible for notifying the appropriate parties immediately,” said the letter dated July 31.
FDA announced two plans to resolve a cluster of problems that have emerged as impediments to personalized cancer care:
• Targeted drugs will need to be approved simultaneously with companion diagnostics that would determine who should—and shouldn’t—get the drug.
• At the same time, the agency will begin phasing in oversight of an essentially unregulated terrain: “laboratory-developed tests.”
Tests that are intended to select therapy for deadly diseases including cancer would be among the first to be subjected to regulation.
The surgeon general issued a call to action this week, addressing the rising epidemic of skin cancer in the U.S. and around the world.
Skin cancer is the most commonly diagnosed cancer in the U.S., but is also easily preventable. Billions can be saved on treatment if we adopt new standards and strategies, argued acting Surgeon General Boris Lushniak.
The Patient-Centered Outcomes Research Institute approved $54.8 million for 33 clinical effectiveness projects.
The projects, approved by the institute’s board of governors July 29, will study ways to improve outcomes for patients with cancer and other diseases, including diabetes, nervous system disorders, cardiovascular diseases, mental health conditions and kidney diseases.
The Oregon Health & Science University Knight Cancer Institute moved one step closer to meeting a spectacular fundraising goal.
The institution said it received a $100 million gift from an anonymous donor, leaving the institution 17 months to raise the remaining $82 million needed to match the $500 million challenge set by Nike co-founder Phil Knight and his wife, Penny.
By Minesh P. Mehta, Katja Langen and William F. Regine
The Cancer Letter recently published information regarding proton therapy facilities in the U.S., highlighting a contention that 85 percent of patients treated with protons have prostate cancer, the logical implication of which would be that this important resource is utilized minimally for other cancers. In this response, we wish to correct this erroneous impression and also wish to highlight the direction that this technology is moving in.
IOM Cancer Policy Forum names six at-large members
Allyson Kinzel named chief compliance officer at MD Anderson
Michael Sapienza receives award from American Society of Colon and Rectal Surgeons
Joel Helmke named oncology VP of WellStar Health System
W. Michael Alberts receives title of master fellow from American College of Chest Physicians
NCI consolidates central communications functions into one office
Study: Diagnosing breast cancer is more expensive in the U.S. than Europe
Zydelig approved in three B-cell blood cancers
FDA approves Imbruvica in chronic lymphocytic leukemia
Avastin granted Priority Review in metastatic cervical cancer
FDA issues drug safety communication for docetaxel
European committee delivers positive opinion for Imbruvica in two blood cancers
In a heated two-day hearing, several members of an FDA advisory panel on medical devices expressed low confidence in power morcellation as a treatment for uterine fibroids, and focused on alternative methods for performing hysterectomies and fibroid removal.
There was no formal consensus on either an outright ban on power morcellators or issuance of a “black box” warning label.
Photo: Families harmed by power morcellation pose on FDA's White Oak campus July 11, following a two-day hearing on the controversial surgical procedure
More women would die from open surgery each year if the FDA decides to ban power morcellation, said Jubilee Brown, an associate professor at MD Anderson Cancer Center and a spokesperson of the American Association of Gynecologic Laparoscopists.
Sen. Tom Harkin introduced a bill that would set NIH on a path to recoup the purchasing power it has lost since 2003, and make funding biomedical research a national priority.
The bill is not an appropriations bill, and does not authorize spending any money. It would, however, raise the limits set in place for NIH by the 2011 Budget Control Act and sequestration, allowing Congress to appropriate $46.2 billion by 2021—a level near where NIH funding would be, had it kept pace with inflation.
The Department of Defense appropriations measure for the fiscal year 2015, approved by the Senate Appropriations Committee July 17, decreased overall funding for peer-reviewed cancer research programs by 4.5 percent.
V. Craig Jordan to join MD Anderson Cancer Center
Georgetown's Kevin FitzGerald named to Pontifical Council for Culture
John Birkmeyer named executive VP for enterprise support systems at Dartmouth-Hitchcock health system.
Ellen Miller Sonet named chief strategy and alliance officer of CancerCare
Rep. Henry Waxman receives lifetime achievement award from 340B Coalition
The American Association of University Professors has authorized a formal investigation of MD Anderson Cancer Center, a move that could result in censure.
The investigation was triggered by refusal on the part of MD Anderson’s administration to provide justification for denying tenure renewals to two faculty members.
The faculty members in question—Kapil Mehta and Zhengxin Wang—received unanimous votes in favor of renewal from the Faculty Senate Promotions & Tenure Committee, but the institution’s president, Ronald DePinho, ultimately decided not to extend their tenure.
MD Anderson Cancer Center’s uninterrupted seven-year stretch as the top cancer hospital in the U.S. News & World Report rankings has come to an end.
Memorial Sloan Kettering Cancer Center has broken the spell of being the perpetual runner-up and moved to the lead.
The result is as close as cancer care can come to a photo finish:
• MSKCC: 100 percent.
• MD Anderson: 99.9 percent.
A coalition of advocacy groups focused on colorectal cancer asked Congress to fix the loophole in Medicare coverage of colonoscopies.
The group, organized by Fight CRC and the American Cancer Society Cancer Action Network, met July 16 to lobby for proposed legislation that would ensure cost is not a barrier to colon cancer screenings.
University of Arizona forms plan with Banner Health to build statewide health system
Roswell Park Cancer Institute granted approval for genome trials by New York State Department of Health
Medical College of Wisconsin receives $2.6 million grant from NCI
Dana-Farber Cancer Institute forms three-year immuno-oncology lung cancer collaboration with Johnson & Johnson and Janssen Biotech
Eli Lilly and Company and Immunocore Limited form collaboration
The Ohio State University and the University of Michigan sign agreement with Venture Therapeutics Inc.
• MD Anderson: 99.9 percent.