20141024 - Oct 24, 2014
ISSUE 40 – OCT. 24, 2014PDF

40 Years Later
Doctor and Patient Reflect on the Cure

On Oct. 21, 1974, John Cleland lay in a hospital bed at Indiana University Hospital.

At 23, he had just graduated from 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.

Conversation with The Cancer Letter
Einhorn: “I Still Harbor Hope For Similar Success Stories”

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.

photoIn Brief

  • 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

photoDrugs and Targets

  • 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

20141017 - Oct 17, 2014
ISSUE 39 – OCT. 17, 2014PDF

Indiana to Close Proton Beam Facility
Amid Nationwide Building Boom

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.

Conversation with The Cancer Letter
IU’s Loehrer Discusses “Business Decision” To Close Bloomington Proton Beam Center

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. 

Funding Opportunity

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.

photoIn Brief

  • 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

photoDrugs and Targets

  • FDA approves Velcade in mantle cell lymphoma

  • Priority Review granted to lenvatinib in thyroid cancer

  • Blinatumomab granted Priority Review in acute lymphoblastic leukemia

20141010 - Oct 10, 2014
ISSUE 38 – OCT. 10, 2014PDF

NCI Failed to Publish Two Bypass Budgets

As Funds Tightened and Sequestration Set In

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.

Guest Editorial
Andrew Vickers on PSA Skepticism, Rational and Irrational

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.

Study: Drug Discounts Used For Wealthier Patients In Many 340B-Enrolled Hospitals

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.

photoIn Brief

  • 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
photoDrugs and Targets

  • 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
20141003 - Oct 3, 2014
ISSUE 37 – OCT. 3, 2014PDF

Genentech Move Nixes Hospital Discounts

Avastin, Herceptin, Rituxan Now Sold Under Tighter Control by Drug Maker

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. 

Conversation with The Cancer Letter
Scott Soefje: “These are Life-Saving Drugs. I’m Not Going To Stop Treating Patients, Right?”

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.

Gonzalez-Angulo To Serve 10 Years In Poisoning Case

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 Publishes Two Guidances for Lab-Developed Tests

FDA published two draft guidance documents Oct. 3 for regulatory oversight, notification and medical device reporting for laboratory developed tests.

Groups Push for CMS Coverage for LDCT Lung Screening

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.

Funding Opportunity
NYC-based Research Alliance Offering $200,000 Per Year for Young Investigators

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.

photoIn Brief

  • 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

20140926 - Sep 26, 2014
ISSUE 36 – SEPT. 26, 2014PDF

Colorado Institutions Vying to Build First Carbon Ion Center in the U.S.

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.

Conversation with The Cancer Letter
Pat White: NIH Funding “Our Only Concern”

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.

Guest Editorial
“Gizmo Idolatry” and Marketing Da Vinci’s Radical Robot

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. 

MD Anderson Expands Reach Into Florida, Ohio

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 Starts “Exceptional Responders” Study

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. 

photoIn Brief

  • 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

20140919 - Sep 19, 2014
ISSUE 35 – SEPT. 19, 2014PDF

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.

Sept. 9 NCAB Meeting
Varmus: Expect Another CR For Funding The NIH Through Mid-December

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.

Funding Opportunities
AACR Accepting Submissions for Two Dream Team Grants

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.

photoIn Brief

  • 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

20140912 - Sep 12, 2014
ISSUE 34 – SEPT. 12, 2014PDF

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. 


Tobacco Interests Contribute a Portion Of the $109 Million Raised by Stand Up To Cancer

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.

Guest Editorial
Learning from the Power Morcellation Fiasco:
Government Must Do More to Regulate Devices

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. 

AACR Urges FDA to Regulate High Risk Lab-Developed Tests

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.

Funding Opportunity
PanCAN Offering $4.1 Million in Research Grants

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.

photoIn Brief

  • 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

20140905 - Sep 5, 2014
ISSUE 33 – SEPT. 5, 2014PDF

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.

Device Maker Threatens Legal Action Against Doctor Who Launched Campaign to End Power Morcellation

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.

CPRIT Awards $107.2 Million Round of Grants

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.

CAP Issues Active Surveillance Guidance
For Prostate Cancer

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.

Health Groups Urge FDA To Regulate Tobacco Products, Including E-Cigarettes

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. 


Jessie 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.  

photoIn Brief

  • 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

photoDrug Approvals

  • 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

20140825 - Aug 25, 2014


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.

The case was unrelated to the MD Anderson-led incubator. Cobbs’s trial is expected to begin later this year.

The CPRIT issue has become important because attorneys defending Perry on felony charges of abuse of official capacity and coercion of a public servant have made efforts to defuse it.

“The CPRIT issue the Democrats are trying to peddle is a red herring and a phony issue,” Benjamin Ginsberg, the governor’s attorney, said in a recent telephone conference with reporters. The Perry defense team said they have obtained an affidavit in which a former Travis County Public Integrity Unit investigator said that the governor was not the target of the CPRIT investigation.

CPRIT is a taxpayer-funded initiative that dispenses $300 million a year in state funds for cancer causes.

To examine the plausibility of the issues that emerged in the context of the CPRIT investigation playing a role in the case against Perry, The Cancer Letter put together a timeline that reflects development of these two subplots. The timeline combines legal and political analysis with detailed coverage of controversies at CPRIT and MD Anderson in an effort to examine their potential role in Perry’s indictment.

At the time Lehmberg saw the lights of a police cruiser, her office was going into the fifth month of investigation of irregularities at CPRIT.

That probe involved examination of the role played by at least one major Republican donor—Charles Tate—who emerged as a central figure in the MD Anderson incubator controversy.

Tate’s role can be traced through thousands of pages of documents obtained by The Cancer Letter and several Texas newspapers.

Also, the timeline shows that prosecutors at the Travis County Public Integrity Unit pressed forward on the CPRIT case even after Perry vetoed the state contribution to the prosecutors’ budget, causing a reduction in workforce and a scramble for funds.

Most importantly, during the eight months that elapsed between Lehmberg’s drunk driving scandal and the Cobbs indictment, no one outside the investigation could have been expected to have the capability to gauge the direction of the probe.

Yet, even those tracking the investigation from the sidelines would have been able to see that Travis County investigators, as they conducted interviews, were focusing on some of the most important players in Texas politics.

Consider Tate. A list of his contributions to candidates and political action committees can be found through a simple search of the Texas Ethics Commission website. His beneficiaries include the governor, the lieutenant governor, and the state attorney general, to name a few.

As prosecutors announced the Cobbs indictment, they stated that no further prosecution would be expected in the CPRIT case. However, this doesn’t rule out the possibility that CPRIT figures in the Perry indictment. This is because the Cobbs case turns on whether peer review of a grant proposal was ever conducted, while the Perry case is about exercise of undue influence.

In these two different contexts, the same facts can have very different implications.

By establishing the flow of events, timelines can be used to rule out implausible hypotheses. Nobody outside the investigation knows precisely what the grand jury saw. However, based on analysis of the progression of events, the hypothesis that the CPRIT investigation figured in the events that led to Perry’s indictment cannot be eliminated.


Cobbs, Lehmberg and Perry

Travis County, a blue stronghold in a red state, operates the corruption investigations unit, which many state politicians wish to transfer to the office of the attorney general.

Lehmberg’s drunk driving arrest and less than decorous behavior, which was captured on camera and posted on the Internet, was a godsend to anyone wishing to weaken her office.

Though Lehmberg’s anti-corruption office has prosecuted more Democrats than Republicans, one of its biggest successes was the conviction of another national Republican figure, former Rep. Tom DeLay, who was convicted on criminal charges of conspiracy to violate election law. (The judgment was later overturned by a higher court, and the dismissal of the case is under review by the Texas Court of Criminal Appeals.)

Several CPRIT insiders characterized Cobbs, the indicted CPRIT official, as a functionary directed by a “commercialization” panel—the panel headed by Tate.

Internal CPRIT emails obtained by The Cancer Letter show that Tate played a key role in devising the MD Anderson proposal for a biotech incubator and moving it through the system (The Cancer Letter, Sept. 28, 2012).

The MD Anderson controversy didn’t figure in the Cobbs indictment. The former official was charged with securing execution of a document by deception, a first-degree felony.

It’s not publicly known why Cobbs didn’t conduct a formal review of the $11 million funding proposal from a company called Peloton Therapeutics Inc. of Dallas before deciding to award the grant in 2011.

No information has emerged to suggest that Peloton officials have sought special treatment, or that the company’s science would not have withstood scrutiny. In fact, the company’s science has survived due diligence performed by The Column Group, a venture capital firm that led a Series A financing round investing $18 million in the startup.

Also, Texas billionaire Peter O’Donnell—whose foundation picked up a portion of the salaries of CPRIT officials, and paid for dinners of peer reviewers—was among those investing in Peloton. However, sources say that O’Donnell bought Peloton stock well after the company was funded, and then transferred stock ownership to UT Southwestern.

The stakes in the CPRIT controversy were high: nearly all of the $300 million CPRIT was dispensing every year went through a rigorous peer review system engineered by Gilman.

Under Gilman’s stewardship, CPRIT didn’t promise the cures. Rather, the institute promised well-run study sections that funded good science.

Meanwhile, MD Anderson President Ronald DePinho, then a newcomer to Texas, was seeking to use a portion of CPRIT funds for his $3 billion “Moon Shots Program” to eventually eradicate eight cancers (The Cancer Letter, Sept. 7, 2012, Sept. 21, 2012).

After quitting CPRIT, Gilman and his former chief scientific advisor Phillip Sharp, a fellow Nobel laureate, offered words of caution to guide CPRIT (The Cancer Letter, Oct. 19, 2012).

“Reliance on peer review to identify the best science must continue to guide CPRIT in the future,” Gilman and Sharp wrote. “Of course, there are other ways to distribute public funds, but they are worse. Their side effects include infamy and they end in irrelevance.”

Top Texas officials didn’t seem to feel the sting of Gilman and Sharp’s words. In a joint letter, three politicos promised to go beyond funding basic science and place an increased emphasis of commercial projects (The Cancer Letter, Oct. 26, 2012).

“It is now time for CPRIT to take further steps to fulfill its statutory mission and expedite innovation that will deliver new cancer treatments to patients within three to five years,” the three officials said in a letter.

The troika included Speaker of the House Joe Strauss, Lieutenant Governor David Dewhurst—and Governor Perry.

The Timeline:

This timeline draws on over two years of The Cancer Letter’s coverage of the controversy at the Cancer Prevention and Research Institute of Texas and MD Anderson Cancer Center.

The objective is to enrich the existing timelines that have been put together by The Texas Tribune and Texas Lawyer and examine the role the CPRIT and MD Anderson controversies may have played in the indictment of Texas Governor Rick Perry.

May 8, 2012:
Alfred Gilman, a Nobel laureate, submits a letter of resignation from his position as chief scientific officer of the Cancer Prevention and Research Institute of Texas.

His resignation is triggered by two events:

• Efforts to fund a $20 million biotechnology incubator led by MD Anderson Cancer Center. Gilman contends that the proposal is a scientific project disguised as a commercialization project and that it has to go through scientific review. The proposal’s proponents say that it doesn’t.

• Failure to fund multi-institution grants that had previously gone through successful peer review (The Cancer Letter, May 25, 2012).

This is the first time the public learns about irregularities at CPRIT.

By turning whistleblower, Gilman brings into focus efforts by top Texas officials to shift CPRIT’s emphasis from peer reviewed research to commercial projects.

Documents subsequently obtained by The Cancer Letter show a deep rift between basic science and commercialization efforts, focusing on the role played by Tate, the Texas financier, Republican donor, and chief of the CPRIT commercialization panel.

Tate was involved in formulating the proposal for the MD Anderson-led incubator. The key meetings included MD Anderson President Ronald DePinho and his wife Lynda Chin, a senior scientist at MD Anderson (The Cancer Letter, Sept. 28, 2012).

• March 29, 2012:
The CPRIT Oversight Committee approves funding for a $20 million biotech incubator co-directed by MD Anderson and Rice University.

The money was intended to fund the MD Anderson Institute for Applied Cancer Science, which is, in effect, functions a lot like a drug company operating within the cancer center. The idea behind the institute is to be able to move rapidly to start—and discontinue—projects.

Tate was the author of an earlier plan to exempt technology incubators from scientific review.

In emails obtained by The Cancer Letter, Chin said that the decision to combine the Rice and MD Anderson proposals was made on Dec. 1, 2011, at a meeting with Tate.

Emails show that Jerald Cobbs was the official who received the proposal from MD Anderson’s IACS. The proposal was sent to Cobbs as an attachment to an email from an official at MD Anderson.

The proposal appears to depart from two standard procedures for submission or research grants: (1) it was never reviewed by the MD Anderson provost; and (2) it went directly to Cobbs, bypassing the CPRIT portal, which must be used for submission of applications.

Prior to submission—in early March 2012—Cobbs asked Gilman to look over the IACS proposal. Gilman said that the document lacked scientific content: there were no targets mentioned, no molecules, no diseases, and no intellectual property. There was nothing to review.

Gilman said the proposal should be submitted as a large, multi-investigator grant, accompanied by sufficient detail. Cobbs concurred, telling Gilman that the Chin proposal would go nowhere, at least until the problems are resolved.

Documents show that, unbeknownst to Gilman, Tate was working on a plan to combine the proposals and get them to oversight committee.

On March 14, 2012, in an email to Cobbs, CPRIT Executive Director Bill Gimson stated that Tate had warned him about considering the Rice proposal first, to be followed by the MD Anderson proposal: “Jerry: Charles just called me—he is concerned about timing and bifurcated approach of the Rice/IACS Incubator.”

Even though funding for the MD Anderson-led project was approved, no money changed hands.

• Oct. 12, 2012:
Gilman leaves CPRIT. Many top-level scientists who participated in the study sections follow, submitting blistering letters of resignation (The Cancer Letter, Oct. 12, 2012, Oct. 26, 2012).

• Nov. 16, 2012:
Cobbs unexpectedly resigns as chief commercialization officer of CPRIT, stating that he plans to return to the private sector. The agency officials declined to elaborate on the departure, initially describing it as a “personnel matter” (The Cancer Letter, Nov. 30, 2012).

• Nov. 29, 2012:
The Peloton problem is announced in a press release. CPRIT officials state that, in the course of a compliance review, they discovered that the company’s proposal received $11 million without any peer review. The state agency said it has notified Peloton and placed a hold on future funding (The Cancer Letter, Nov. 30, 2012).

• Nov. 30, 2012:
Two state legislators who wrote the legislation that created CPRIT write a letter to express “deep concern” about the agency funding a grant to Peloton without formal peer review.

“As the authors of the original CPRIT statute—and subsequent legislation to strengthen the institute’s guidelines to ensure transparency and prevent conflicts of interest—we require an explanation in writing as to how this occurred. That explanation should include a description of what occurred, when and how the problem was discovered, what actions have been taken to rectify the situation, and how CPRIT proposes to prevent such oversight from occurring in the future,” wrote State Sen. Jane Nelson (R-Flower Mound) and Rep. Jim Keffer, (R-Eastland) in a letter to CPRIT (The Cancer Letter, Dec. 14, 2012).

• Dec. 7, 2012:
The Travis County district attorney opens a criminal investigation of the “award of grants” by CPRIT. No grant is specified. The matter is assigned to the Public Integrity Unit. (The Cancer Letter, Dec. 14, 2012).

• Dec. 8, 2012:
CPRIT Oversight Committee Chairman Jimmy Mansour asks for an investigation by the Texas attorney general and an audit by Deloitte Touche. His email to CPRIT Executive Director Bill Gimson reads: “Please contact the Attorney General’s office and request that he direct his attorneys to seek affidavits from all individuals related to or associated with Peloton past and present. Please encourage them to return to us as soon as possible. Please contact the Governor’s Office requesting an emergency waiver approval for an audit of CPRIT by Deloitte Touche. Please contact DIR and request forensic assistance in recovering all lost email between Gerry Cobb, Al Gilman and Bob Ulrich relating to [Peloton]. Also, please send this note to the Board.”

A subsequent email reads: “We need to know if they have any financial interest in Peloton or benefited in some related way from it receiving approval.”

• Dec. 10, 2012:
CPRIT Executive Director Gimson submits a letter of resignation. 
Margaret Kripke’s acceptance of the job of CPRIT chief scientific officer is announced (The Cancer Letter, Dec. 14, 2012).

Texas Attorney General Greg Abbott informs CPRIT that it has opened an inquiry into “the flawed grant that [CPRIT] awarded to Peloton Therapeutics.”

The letter states that “the review will include—but is not limited to—any financial interest CPRIT staff or any other individual may have had in the Peloton grant award. Abbott was a member of the CPRIT oversight committee. (The Cancer Letter, Dec. 14, 2012). The investigation hasn’t resulted in any actions.

April 12, 2013: Travis County District Attorney Rosemary Lehmberg is charged with driving while intoxicated. She was traveling in the bike lane for a mile. An open bottle of vodka is found in the car’s passenger area.

• April 19, 2013:
Lehmberg pleads guilty to a misdemeanor and begins a 45-day sentence in jail.

• April 29, 2013:
Travis County Attorney David Escamilla files a lawsuit seeking to remove Lehmberg from office because of the drunk driving incident.

• May 24, 2013:
Lehmberg counters by claiming that the Texas statute that enables removal of government officials for drunkenness is unconstitutional. Also, habitual drunkenness—as opposed to one incident—should be required.

• June 17, 2013:
A line-item veto by Perry strikes $7.57 million in funds for the Public Integrity Unit of the Travis County District Attorney Office. Perry says he denied state funding because Lehmberg had “lost public confidence.”

• July 2, 2013:
The Travis County Commissioners Court vote to send “reduction in force” notices to over 30 employees of the Public Integrity Unit, effective Sept. 30, 2013. The jobs are being eliminated because Perry had vetoed the funding.

• July 8, 2013:
San Antonio lawyer Michael McCrum, former DA of Brazos County, is appointed to investigate a criminal complaint against Lehmberg. The allegation: Lehmberg committed a felony when she threatened jailers following her DWI arrest.

McCrum, whose political leanings are unclear, was appointed by Judge Bert Richardson, who continues to preside over the case.

Richardson, a Bush appointee, identifies himself as a conservative. He serves as a senior judge in regions spanning the area from San Antonio to Del Rio and Austin to El Paso.

In his current campaign for a seat on the Court of Criminal Appeals, Richardson has the endorsements of groups that include Conservative Republicans of Texas, Kaufman County Tea Party, and the Texas Coalition of Christian Candidates

• Aug. 12, 2013: The Travis County commissioners direct the budget office to move $1.76 million to the Travis County District Attorney’s Public Integrity Unit. Lehmberg will also contribute $734,000 from another account.

• Aug. 19, 2013:
McCrum takes the oath to investigate whether Gov. Perry committed crimes when he vetoed funding for the Travis County Public Integrity Unit.

• Sept. 6, 2013:
The judge overseeing the criminal complaint against Perry chooses members of the grand jury.

  Oct. 4, 2013: A grand jury declines to indict Lehmberg on a complaint that she committed a felony when she threatened jailers following her drunk driving arrest.

• Dec. 3, 2013:
A grand jury in Travis County indicts Cobbs for bypassing peer review in awarding an $11 million grant to Dallas-based Peloton.

Announcing the Cobbs indictment, Travis County Assistant District Attorney Rob Drummond says that the grand jury was asked to review the materials stemming from the MD Anderson IACS controversy and materials related to CTNeT, a now-defunct statewide network focused on cancer clinical trials. “The grand jury didn’t choose to issue indictments related to those matters,” Drummond said (The Cancer Letter, Dec. 17, 2013).

The Public Integrity Unit also investigated the allegations of conflicts of interest and financial improprieties related to the CPRIT Foundation, and conflicts related to the business interests of members of CPRIT’s oversight committee. However, these matters were not presented to the grand jury, Drummond said. Investigators saw no fault on the part of Peloton.

“No charges were considered against anyone connected to Peloton,” Drummond said. “The evidence indicated that they were unaware that their grant award had bypassed the required review committees.”

The company received a portion of the $11 million awarded by the state, and has since reapplied to receive the rest of the funds, but has not as yet received any additional funding.

Peloton was founded by Steven McKnight, who holds the Distinguished Chair in Basic Biomedical Research and the Sam G. Winstead and F. Andrew Bell Distinguished Chair in Biochemistry at UT Southwestern. He is a member of the National Academy of Sciences.

Prosecutors said they would seek no additional indictments on matters connected to CPRIT.

Dec. 11, 2013: Visiting Judge David Peeples denies the state’s petition to remove Lehmberg from office.

• Aug. 15, 2014:
A Travis County grand jury indicts Gov. Perry for two felony counts: abuse of official capacity and coercion of a public servant.

In a statement issued the next day, Perry says he is a victim of political prosecution:

“This indictment amounts to nothing more than an abuse of power and I cannot, and will not, allow that to happen. I intend to fight against those who would erode our state’s constitution and laws purely for political purposes, and I intend to win. I will explore every legal avenue to expedite this matter and bring it to a swift conclusion. I am confident we will ultimately prevail, that this farce of a prosecution will be revealed for what it is, and that those responsible will be held to account.”

• Aug. 19, 2014:
Perry is booked.

20140808 - Aug 8, 2014
ISSUE 32 – AUG. 8, 2014PDF

“Wild West” of Molecular Testing?

Caris Engaged in Aggressive Marketing, Improper Medicare Billing, Lawsuit Alleges

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.

Conversation with The Cancer Letter
Daniel Hayes Leads Tour of Caris Website

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.

Caris Officials Respond To Questions Submitted By 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 Cancer Letter is taking a Summer Break

The next issue will be published Sept. 5.

NCI Launches NCORP with 53 Grants Totaling $465 Million

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, Experimental Pathologist, Dies at Age 95

Emmanuel Farber, a pathologist who made contributions to the understanding of chemical carcinogenesis, died Sunday, Aug. 3. 

photoIn Brief

  • 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