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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.
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.
Timeline Pinpoints the Role of Cancer Scandal
In a Progression Leading to Perry’s Indictment
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 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.
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.
NCI took another step toward adopting a new formula for determining the size of cancer center support grants, with the National Cancer Advisory Board accepting a report from a working group that has been working on the problem since the fall of 2012.
The schema proposed by the working group was accepted by the advisory board at its meeting June 23. It recommends broad organizing principles rather than specific numbers.
An article in the June 6 issue of The Cancer Letter described plenary presentations at ASCO 2014. One presentation was the adjuvant breast cancer clinical trial ALTTO in HER2-positive disease, which “was chosen [for the plenary session] because it addressed the reliability of pathological complete response as a surrogate for patient benefit.”
As always, I both enjoyed and learned something interesting from Dr. Don Berry, one of the great biostatisticians of our era. I find, reading his analysis of ALTTO and NeoALTTO, much that I agree with. I am certainly no statistician, and must bow to his statistical analysis of ALTTO and NeoALTTO. And yet at the same time I think it misses the point. So I will beg to differ.
Also: Don Berry's Rejoinder
The American Association for Cancer Research ushered in the year 2000 with a round logo that combined the lamp of knowledge with a map of the Americas and an aspirational slogan in Latin.
The 26-year-old logo gave way to one that looked more corporate. However, AACR didn’t stop at just one redesign. It changed the logo four more times.
The NIH has published a funding opportunity announcement for the Outstanding Investigator Award in any area of cancer research.
Three appointed to leadership positions at St. Jude
Duke's Amy Abernethy named chief medical officer at Flatiron Health
William Hogan joins University of Florida as director of bioinformatics
J. Alan Diehl named associate director of basic sciences at MUSC
Vincent O'Neill named chief medical officer of Exosome Diagnostics
Joseph Haywood named president of FASEB
Thomas Jefferson University receives $110 million gift
Stand Up to Cancer Canada launched
Bristol-Myers Squibb announces collaboration with Duke University
Pew Charitable Trusts announce class of cancer research scholars
Steven Bangert named CEO of the Year by the American Cancer Society
Breakthrough Therapy designation granted to CTL019 in ALL
European Commission approves Halaven for metastatic breast cancer
Breakthrough Therapy designation granted to blinatumomab in Ph- ALL
Mylan launches generic Carboplatin Injection in multi-dose vials
On Oct. 17, 2013, a surgical instrument called a power morcellator tore into the uterus of Amy Reed, an anesthesiologist at Beth Israel Deaconess Medical Center, pulverizing what were believed to be benign fibroids.
Reed’s “minimally invasive” hysterectomy, a routine procedure, was performed at the Brigham and Women’s Hospital, a teaching hospital of Harvard Medical School.
Alas, Reed’s uterus contained an occult sarcoma, which the morcellator proceeded to spread through her abdominal pelvic cavity. Over ensuing months, as Reed battled to stay alive, her husband, Hooman Noorchashm, a cardiothoracic surgeon and, at the time, a lecturer at Harvard, waged a national campaign to put an end to the practice of power morcellation.
The Cancer Letter asked David Challoner, emeritus vice president for health affairs at the University of Florida, to discuss FDA’s 510(k) medical device clearance process.
The process has come under scrutiny after laparoscopic power morcellation procedures were found to spread previously undetected sarcomas inside benign fibroids.
Challoner chaired an Institute of Medicine committee tasked by FDA and Congress in 2009 to review the 510(k) approval process.
“We know that this improves patient care,” Bertagnolli said in an interview with Matthew Bin Han Ong, a reporter with The Cancer Letter. “In a case such as this one, close communication between the oncology and general gynecology communities is a key requirement for reducing morbidity and deaths due to uterine sarcomas.”
Question: What’s more expensive than proton beam radiation therapy?
Answer: Carbon ion radiation therapy.
With CIRT centers costing about $300 million to construct—about twice as much as proton beam centers—the potential adoption of this technology threatens to further inflate health spending worldwide.
Li Ma and Jeffrey Tyner receive Wachter Award from AAAS
John Cleveland named associate director of basic science at Moffitt Cancer Center
The Community Oncology Alliance appoints new officers
Roswell Park Cancer Institute receives "outstanding" distinction from NCI
The American Society for Radiation Oncology names 30 new fellows