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On Oct. 21, 1974, John Cleland lay in a hospital bed at Indiana University Hospital.
At 23, he had just graduated Purdue University and just married.
He was also three weeks into a fourth-line chemotherapy regimen for advanced metastatic testicular cancer. The disease had spread to his lungs.
Lawrence Einhorn, Cleland’s doctor, told him that this was the end of the road.
The Cancer Letter asked Lawrence Einhorn, distinguished professor of medicine and the Livestrong Foundation Professor of Oncology at the Indiana University Melvin and Bren Simon Cancer Center, to reflect on one of the most spectacular successes in the history of cancer research—his development of the curative regimen for testicular cancer.
Caris Life Sciences Lays Off Estimated 20 Percent of Staff
Caris Life Sciences Inc. last week reduced its workforce by 50 people—about 20 percent, sources said.
While a 50-person reduction in force is small by pharma industry standards, the development could be significant because Caris is a key player in the emerging market for molecular therapies.
HRSA: Discounts Owed on Some Orphan Drug Uses
The Health Resources and Services Administration last week warned pharmaceutical companies that they must continue to offer 340B Drug Pricing Program discounts on some uses of orphan drugs.
Cancer Support Community Reports on Patient Experiences
Cancer Support Community released the findings report from the first year-and-a-half of the Cancer Experience Registry.
Institute of Medicine Elects 80 New Members
The Institute of Medicine named 70 new members and 10 foreign associates during its 44th annual meeting.
New members are elected by current active members through a selective process that recognizes individuals who have made major contributions to the advancement of the medical sciences, health care, and public health.
Benjamin Neel named director of NYU Cancer Center
Brad Pollock named chair of public health department at UC Davis
Richard Zellars named chair of radiation oncology at IU School of Medicine
David Mauro named chief medical officer and VP of Advaxis Inc.
James Tulsky receives award from American Cancer Society
Mary Kozik named senior director of development at Winship Cancer Institute
Northwestern Mutual and Alex's Lemonade Stand fund eight young investigators
Association of Community Cancer Centers receives gift from Bristol-Myers Squibb
Stand Up To Cancer epigenetics dream team receives $7.5 million from Van Andel Research Institute
EU approves Imbruvica in MCL, CLL
CMS publishes two draft coverage determinations for molecular prostate cancer tests
Priority Health to cover FoundationOne genomic profiles
Celgene and Sutro Biopharma to collaborate on antibody-drug conjugates
At its opening a decade ago, the Indiana University Health Proton Therapy Center was one of four such facilities in the U.S.
Alas, money woes struck immediately. The center has run at a deficit for most of its existence—recently losing over $3.5 million in operating costs in fiscal 2013. And now the center is a landmark once again: On Jan. 1, 2015, it will become the first proton beam center in the U.S. to be closed.
The Cancer Letter asked Patrick Loehrer, director of the Indiana University Melvin & Bren Simon Cancer Center, to discuss his institution’s decision to close its 10-year-old proton beam center.
No other institution in the U.S. has closed such a facility.
Genentech Reps Not Welcome
Hospitals Urge Drug Maker to Reverse Policy
On Supplying Avastin, Rituxan, & Herceptin
Cancer centers and other hospitals, reeling from the loss of discounts and rebates on three widely used cancer drugs, are seeking to persuade drug maker Genentech to reverse its decision to channel these medications through six specialty distributors.
ASCO Endorses Guideline for Molecular Testing
The American Society of Clinical Oncology endorsed a joint clinical practice guideline on molecular testing published by the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology.
IARC Publishes Fourth Edition of European Code Against Cancer
The fourth edition of the European Code Against Cancer was published by the International Agency for Research on Cancer, with the participation of the European Commission.
Stand Up To Cancer Canada to Fund Two Dream Teams
Stand Up To Cancer Canada will support two, four-year cancer research dream teams with nearly $20 million USD raised by SU2C Canada collaborators and from the charity’s September telecast. The dream teams will focus their research on translational research in breast cancer and cancer stem cells.
Francis Giles named deputy director of Lurie Cancer Center
Zhu Chen honored by American Association for Cancer Research
Lili Yang receives $2.3 million award from NIH
Indiana University Simon Cancer Center re-designated as NCI cancer center
Cancer Treatment Centers of America launch fertility preservation program
Lurie Cancer Center to collaborate with Perthera Inc.
ASCO publishes survivorship care plan template
FDA approves Velcade in mantle cell lymphoma
Priority Review granted to lenvatinib in thyroid cancer
Blinatumomab granted Priority Review in acute lymphoblastic leukemia
What’s the NCI director’s professional judgment of opportunities in cancer research at a time of shrinking budgets, sequestration and conclusion of the windfall of the American Recovery and Reinvestment Act?
Under ordinary circumstances, this question wouldn’t have required a mind reader. The NCI director has an authority no other government executive enjoys: every year, he submits a summary of scientific opportunities directly to the White House, bypassing review by the NIH director and officials at the place ominously called “Downtown,” the brutalist-style HHS headquarters at the base of Capitol Hill.
I consider myself a prostate cancer screening skeptic. For example, in the title of the grand rounds lecture I have given for many years, I describe PSA as a “public health fiasco.”
I have also gone on the record to state: “PSA testing as it is commonly practiced in the U.S. is indefensible.”
UT Board Announces Support for MD Anderson Tenure System
The University of Texas System Board of Regents has—in response to the threat of censure by an external group—voted to continue support of MD Anderson Cancer Center’s seven-year term tenure system.
Hospitals that qualified for the 340B drug pricing program in 2004 or later were more likely to serve wealthier communities with higher rates of health insurance coverage, according to a study published Oct. 6 in the journal Health Affairs.
The primary purpose of the 340B program—established by Congress in 1992—was to provide significantly discounted outpatient drugs to low-income and uninsured patients.
ESMO Names Annual Award Winners
Phoenix Children's Hospital launches The Chan Soon-Shiong Children’s Precision Medicine Institute
C. Parker Gibbs Jr. appointed deputy director of medical affairs for the University of Florida Health Cancer Center.
MD Anderson Cancer Center's Sheikh Khalifa Bin Zayed Al Nahyan Institute for Personalized Cancer Therapy launches fellowship program
Ohio State University completes five-year pharmaceuticals center project
MD Anderson and VolitionRx Limited announce collaboration
Andrew Brenner receives $1.62 million grant from FDA
Akynzeo approved for chemotherapy-related nausea
DNX-2401 granted orphan drug designation
Caris Life Sciences launches pilot program through the U.K. National Health Service
Mayo Clinic partners with Second Genome Inc.
Bristol-Myers Squibb and MD Anderson collaborate on immunotherapies
PhRMA Report details nearly 800 cancer therapies currently in development
A move by Genentech has eliminated discounts and rebates hospitals receive when they purchase three of the company’s top-selling infused cancer drugs.
Beginning Oct. 1, hospitals can now order Avastin (bevacizumab), Herceptin (trastuzumab) and Rituxan (rituximab) exclusively from six specialty distributors authorized by the drug maker.
Genentech said the move will bypass more than 80 full-line wholesale drug distribution centers, with the objective of enhancing efficiency and security of the supply chain for these widely used medications.
The loss of discounts and rebates hospitals received for administering Genentech’s Avastin, Herceptin and Rituxan will increase costs to patients, said Scott Soefje, director of pharmacy at University Medical Center Brackenridge in Austin.
Fake Avastin, Paid for by Medicare, Administered to U.S. Patients
Two years ago, British authorities tested a shipment of chemotherapy drugs headed for North America.
They found that the agent, labeled as Genentech’s Avastin, contained no trace of Avastin’s active ingredient. The drugs were on the way to Canada, where they were to be sold to doctors throughout the U.S.
Ana Maria Gonzalez-Angulo, a 43-year-old oncologist at MD Anderson Cancer Center, was sentenced to 10 years in prison for poisoning her lover and colleague George Blumenschein.
The sentence, issued Sept. 29, makes Gonzalez-Angulo ineligible for probation, but under Texas law, she will be eligible for parole in 5 years.
FDA published two draft guidance documents Oct. 3 for regulatory oversight, notification and medical device reporting for laboratory developed tests.
A coalition of patient advocacy and medical organizations urged the Centers for Medicare & Medicaid Services to cover low-dose computed tomography for Medicare patients at high risk for lung cancer.
The Pershing Square Sohn Cancer Research Alliance is taking applications for its Prize for Young Investigators in Cancer Research. The prize of $200,000 per year for up to three years is awarded annually to five New York City-based scientists.
Leonidas Platanias named director of Lurie Comprehensive Cancer Center
Karmanos Cancer Institute and Wayne State sign new affiliation agreement
Robert Miller named medical director of ASCO Institute of Quality
MD Anderson Cancer Center receives $10 million from ExxonMobil
Jan Egberts appointed CEO of Agendia Inc.
Memorial Sloan Kettering to open largest suburban location
CancerCare receives $1.5 million from Susan G. Komen
The University of Colorado and Colorado State University are vying to become the first institution to build a carbon-ion radiotherapy research and treatment facility in the U.S. The treatment modality is available in Europe and Japan.
Officials at the two universities are exploring the feasibility of building a $300 million research and treatment facility at the University of Colorado Anschutz Medical Campus in Aurora.
Their first step is to conduct a $200,000 feasibility study for the project.
A lobbying campaign will make an effort to secure an immediate, significant funding increase for NIH.
The effort, called ACT for NIH: Advancing Cures Today, seeks to bring together patients, scientists, advocates, and lawmakers on both sides of the aisle. Their objective is to demonstrate the impact of a decade of clamping down on NIH funding. Adjusted for inflation, NIH receives nearly 25 percent less funding than it did in 2003.
Gonzalez-Angulo Found Guilty in MD Anderson Poisoning Case
HOUSTON—Ana Maria Gonzalez-Angulo, a 43-year-old breast cancer specialist at MD Anderson Cancer Center, was found guilty of poisoning her lover, George Blumenschein, another medical oncologist at MD Anderson.
A jury at the Harris County 248th District Criminal Court found Gonzalez-Angulo guilty of aggravated assault Sept. 26. The court immediately went into the penalty phase of the proceedings.
In America, cutting-edge inventions are seen as the gateway to the future. However, the hazard of credulously accepting new technology into medical practice was warned against in a 2008 Journal of the American Medical Association editorial “Gizmo Idolatry.”
The term “gizmo idolatry” describes the conviction that a high-tech approach is better than a low-tech approach, even if there’s no evidence to support that view. A glaring example of medical “gizmo idolatry” is the da Vinci Surgical System. Without credible data to prove its safety and benefit in complex surgeries, this costly robotic machine has been promoted into near ubiquitous use in hospitals across the nation.
Two institutions said they are in varying stages of completing partnerships with MD Anderson Cancer Center.
The two deals are a part of an expansion strategy that essentially means that the MD Anderson logo can light up almost anywhere, establishing the Houston-based cancer center as a potential competitor to almost any cancer center in the U.S.
NCI has launched a pilot study to investigate the molecular factors of tumors associated with exceptional treatment responses of cancer patients to drug therapies.
The Exceptional Responders Initiative seeks to identify the molecular features of tumors that predict whether a particular drug or class of drugs will be beneficial.
Doug Ulman named CEO of Pelotonia
Margaret Foti honored by Friends of Cancer Research
Wilshire Oncology Medical Group joins City of Hope
The West Clinic receives National Committee for Quality Assurance recognition
FDA awards Critical Path Institute $2.1 million
Beth Israel Deaconess Medical Center and Cancer Genetics Inc. enter collaboration
FASEB publishes factsheet on federal research funding by congressional district
Lisa Stockmon named City of Hope chief communications officer
FDA names recipients Drug Shortage Assistance Award
European Head and Neck Society calls for EU program
QVC and Fashion Footwear Association of New York present $240,000 to University of Pittsburgh Cancer Institute
DePinho Will Not Meet With AAUP
In Probe of Tenure Denial Dispute
MD Anderson Cancer Center President Ronald DePinho declined to meet with the investigation committee dispatched by the American Association of University Professors to his institution Thursday.
“We will not personally meet with representatives of a non-governing entity conducting an unauthorized investigation with a pre-determined outcome.” DePinho wrote in a Sept. 17 email to MD Anderson faculty and staff.
Officials: Poisoning Unrelated to MD Anderson;
Critics Allege Dysfunction in Handling of Affair
Images of the gleaming buildings and the distinctive logo of MD Anderson Cancer Center have been flashing on television screens and appearing on pages of respectable newspapers and scandal sheets alike.
The reason has nothing to do with the Moon Shots aimed at curing cancers. Rather, the name of the venerable cancer center is being dragged through the mud because one of its doctors stands accused of trying to poison another.
NCI Director Harold Varmus said Congress is moving slowly on appropriations bills, and a continuing resolution lasting until December is the best that can be expected in the short term.
“Depending on the outcome of the election in November, there may be an interest among the Republicans that if they regain the Senate that this should be postponed until after they’re back in charge in both sides of the bicameral legislature,” Varmus said at the Sept. 9 meeting of the National Cancer Advisory Board.
AACR 2014 Cancer Progress Report:
More Federal Funds Needed
The American Association for Cancer Research published its 2014 Cancer Progress Report Sept. 16, highlighting the need for greater federal investments in biomedical research.
The report is a “comprehensive educational tool that chronicles the progress that has been made against cancer…and calls on the administration and Congress to prioritize the growth of the NIH and NCI budgets,” according to AACR.
The American Association for Cancer Research is accepting submissions of ideas to two dream team grants: one offering $20 million for lung cancer research, and one for $6 million for ovarian cancer research.
Funding for the lung cancer research grant will be provided by Stand Up To Cancer, the American Cancer Society and Bristol-Myers Squibb. The ovarian cancer research grant provides funding over three years, and is sponsored by Stand Up To Cancer, the Ovarian Cancer Research Fund, the Ovarian Cancer National Alliance, and the National Ovarian Cancer Coalition.
David Tweardy named head of internal medicine at MD Anderson
Dan Glickman named to ACS Cancer Action Network board of directors
Memorial Sloan Kettering begins construction on 285,000-square-foot outpatient center in Middletown, N.J.
Boehringer Ingelheim and CureVac announce collaboration.
Soligenix Inc. reaches phase III protocol agreement with FDA
Sutro Biopharma and Merck KGaA form ADC collaboration
Denovo Biopharma acquires enzastaurin rights from Eli Lilly & Co.
Leukemia and Lymphoma Society partners with OncoPep
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.