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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 Launches ALCHEMIST

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. 

photo

Obituaries
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

20140905 - Sep. 5, 2014
August 2014PDF

Leukemia 
Arzerra Maintenance Therapy Extends PFS In Phase III Trial, Compared to Observation

A phase III trial of Arzerra as a maintenance therapy for chronic lymphocytic leukemia met its primary endpoint of extending progression-free survival at an interim analysis.

The study evaluated Arzerra (ofatumumab) maintenance therapy versus no further treatment and observation in patients with relapsed CLL who responded to treatment at relapse.

The independent data monitoring committee did not identify any new safety signals and will continue to monitor patients for safety until all study patients complete therapy.  

Stomach Cancer

TCGA Researchers Discover Stomach Cancer Falls Into Four Distinct Molecular Subtypes

Researchers with The Cancer Genome Atlas Network found that stomach cancers fall into four distinct molecular subtypes.

Previous attempts to examine the clinical characteristics of gastric cancer were hindered by how differently cancer cells can look under a microscope, even when from the same tumor. Researchers say the new classification system can serve as a valuable adjunct to the current pathology classification system, which has two categories: diffuse and intestinal.

The researchers identified the new subgroups through complex statistical analyses of molecular data from 295 tumors. They used six molecular analysis platforms including DNA sequencing, RNA sequencing, and protein arrays. The study was published in Nature.

Breast Cancer

Lymphoma
Researchers Find Two Types Of MCL Drug Resistance
Human Papillomavirus
International Working Group Suggests Earlier Endpoints For HPV Vaccine Trials
Multiple Myeloma
Phase III Kyprolis Trial Fails OS Primary Endpoint
Kidney Cancer
Researchers Plan to Extend Phase IIa Asonep Trial
Smoking & Survivorship
Study: Nine Years After Diagnosis 9.3% of Survivors Still Smoke
NCI CTEP-Approved Trials for the Month of August
FDA Approvals

  • Avastin combination approved for late-stage cervical cancer

  • FDA approves Cologuard screening test; CMS proposes national coverage determination

  • Health Canada approves Abraxane for first-line treatment of metastatic pancreatic cancer

  • European Medicines Agency approves request for accelerated assessment of lenvatini

  • Sanofi US launches generic Eloxatin

20140830 - Aug. 30, 2014

perry.html


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.

20140825 - Aug. 25, 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.

photoObituary
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

20140808 - Aug. 8, 2014
ISSUE 31 – AUG. 1, 2014PDF



J&J Withdraws Power Morcellators, Citing Risk of Disseminating Cancer

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 Moves to Regulate Lab-Developed Tests

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. 

Surgeon General Issues Call To Reduce Skin Cancer Rates

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.

PCORI Approves $54.8 Million For Clinical Effectiveness Research

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.

Anonymous $100 Million Gift Moves OHSU Within $82 Million Of Reaching $1 Billion Goal

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.

photoLetter to the Editor
Expanding the Horizons Of Proton Beam Therapy

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.

photoIn Brief

  • 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

photoFDA News

  • 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

20140801 - Aug. 1, 2014
July 2014PDF

Colorectal Cancer 
Trifluridine and Tipiracil Hydrochloride Increase OS, PFS in Phase III Trial

A phase III trial of trifluridine and tipiracil hydrochloride significantly improved both overall and progression-free survival in refractory metastatic colorectal cancer that had progressed after standard therapies. 

Data from the trial of the oral anticancer combination, also known as TAS-102, were presented at the European Society for Medical Oncology World Congress on Gastrointestinal Cancer in Barcelona, Spain.

The global, randomized, double-blind trial, named RECOURSE, met the primary efficacy endpoint of statistically significant improvement in overall survival versus placebo (HR=0.68, p < 0.0001). TAS-102 reduced the risk of mortality by 32 percent when compared to placebo. 

Melanoma

IDMC Halts Mekinist-Tafinlar Trial Early Due to OS Benefit; Recommends Crossover

An independent data monitoring committee recommended an early stop a phase III trial of Mekinist and Tafinlar in patients with BRAF V600E or V600K mutation-positive unresectable or metastatic cutaneous melanoma, following a demonstrated overall survival benefit.

The randomized, open-label study, named COMBI-v, compared the combination of Mekinist (trametinib) and Tafinlar (dabrafenib) to vemurafenib in subjects with unresectable (Stage IIIC) or metastatic (Stage IV) BRAF V600E/K mutation-positive cutaneous melanoma. 

Also:
Gastroenteropancreatic Neuroendocrine Tumors
Somatuline Demonstrates 65.1 Percent Of Patients Progression-Free at 96 Weeks

By priming pancreatic ductal adenocarcinomas with a therapeutic vaccine and a low-dose chemotherapy combination prior to surgery, researchers converted PDACs into cancers that may respond to immunotherapy.

Researchers pretreated PDAC patients with the vaccine GVAX and low doses of the chemotherapy cyclophosphamide, which caused the aggregation of immune cells inside the patients’ tumors, and many of these immune cells expressed proteins that may make these cancers amenable to immunotherapies such as PD-1 inhibitors.

The trial was published in Cancer Immunology Research, a journal of the American Association for Cancer Research, produced in collaboration with the Cancer Research Institute).

Acute Myeloid Leukemia
Volasertib and LDAC Doubled Response in Older Patients
Cervical Cancer
Study: Negative HPV Test More Accurate than Negative Pap Test In Predicting Cancer Risk
Proton Therapy
Phase II Study: Proton Therapy Can Have Similar Success Rate, Smaller Level of Risk in Treatment of Hodgkin Lymphoma
NCI CTEP-Approved Trials for the Month of July
FDA Approvals

  • Zydelig tablets approved for three blood cancers

  • Imbruvica approved in chronic lymphocytic leukemia

  • Avastin granted priority review in metastatic cervical cancer

  • Blinatumomab granted breakthrough therapy designation in acute lymphoblastic leukemia

  • CTL019 granted breakthrough therapy designation in adult and pedtiatric ALL

  • European Commission approves Halaven for metastatic breast cancer

  • Mylan Inc. launches generic carboplatin injection in multi-dose vials

  • FDA approves IBA Cone Beam Computed Tomography proton therapy solution

  • FDA issues drug safety communication regarding docetaxel

20140731 - Jul. 31, 2014
ISSUE 30 – JULY 25, 2014PDF



FDA Advisors Debate Ban, Black Box

And Status Quo of Power Morcellators

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

The Numbers
GYN Group: Open Surgery Would Cost More Lives than Morcellation

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.

Capitol Hill
Sen. Harkin Introduces NIH Funding Bill That Boosts Budget to $46.2 Billion by 2021

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. 

photoAppropriations
Senate Committee Approves 4.5 Percent Cut to Defense Department Cancer Research Funding

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. 

photoIn Brief

  • 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

20140725 - Jul. 25, 2014
ISSUE 29 – JULY 18, 2014PDF



DePinho’s Handling of MD Anderson Tenure Dispute Triggers Formal Investigation by AAUP

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. 

Memorial Sloan Kettering Seizes Top Cancer Hospital Prize from MD Anderson in U.S. News & World Report Rankings

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.

photoCapitol Hill 
Advocates Lobby Congress To Close Medicare Loophole For Colonoscopy Coverage

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.

photoIn Brief

  • 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.

20140718 - Jul. 18, 2014
SPECIAL REPORT – JULY 15, 2014


Memorial Sloan Kettering Seizes Top Cancer Hospital Prize from MD Anderson in U.S. News & World Report Ranking

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.

20140715 - Jul. 15, 2014
ISSUE 28 – JULY 11, 2014PDF



NCI to Implement More Transparent Formula
For Calculating Cancer Center Support Grants

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. 

After the Plenary
Don Berry: In NeoALTTO & ALTTO Trials, Neoadjuvant Response Predicts Adjuvant

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.”  

photoCounterpoint
George Sledge Responds To Berry’s Letter: Neoadjuvant Doesn’t Predict Adjuvant In Breast Cancer

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

photoAACR Changes Its Logo— For the Fifth Time Since 2000

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. 

photoNIH Funding Opportunity
Outstanding Investigator Award In Cancer Research Available

The NIH has published a funding opportunity announcement for the Outstanding Investigator Award in any area of cancer research.

photoIn Brief

  • 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

photoDrug Development

  • 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

20140711 - Jul. 11, 2014
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