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An FDA advisory committee April 29 recommended approval of a metastatic melanoma treatment based on an attenuated Herpes Simplex Virus-1.

In a joint meeting, the agency’s Oncologic Drugs Advisory Committee and its Cellular, Tissue, and Gene Therapies Advisory Committee voted 22 to 1 to recommend full approval for talimogene laherparepvec, sponsored by Amgen Inc.

At the contentious all-day meeting, which ran twice as long as a standard session of ODAC, the unusually large group of advisors summoned by the FDA didn’t get the opportunity to clearly identify the group of patients who stand to benefit from the agent, also called T-VEC, or specify the agent’s place in a sequence of melanoma treatments.

	NIH Slated to Receive $10 Billion Increase In Second 21st Century Cures Draft Bill The House Committee on Energy and Commerce published the second “discussion draft” for a comprehensive bipartisan initiative aimed at streamlining development of drugs and medical devices. The proposed legislation, called “21st Century Cures,” was launched April 30, 2014, and is led by Rep. Fred Upton (R-Mich.), chairman of the committee, and Rep. Diana DeGette (D-Colo.), chief deputy whip. In addition to boosting NIH funding by $10 billion over five years and establishing a clinical trial data system for federally funded trials, the discussion draft includes provisions for developing the next line of antibiotics.
	Institute of Medicine to Become National Academy of Medicine The membership of the National Academy of Sciences voted April 28 at its 152nd annual meeting to change the name of the Institute of Medicine to the National Academy of Medicine, effective July 1. The National Academy of Medicine will continue to be an honorific society and will inherit the more than 1,900 current elected members and foreign associates of the IOM.
	Letter to the Editor MD Anderson Administration Behaves as a “Financially Privileged Elitist Group” To the Editor: Congratulations on your outstanding article entitled “MD Anderson Execs Get Big Raises In the Midst of Faculty Morale Woes.” As a 35-year faculty member of the MD Anderson Cancer Center, now retired, I am deeply disturbed at the endangered reputation of one of the greatest institutions of its kind in the world. Every other month seems to bring some embarrassing new revelation at the hands of the current leadership.
	An Appreciation Mike Katz, 61, Advocate, Educator By Michael D. Scott The cancer field is filled with advocates—advocates for research into specific forms of malignancy, advocates for access to care for patients with limited resources, advocates for pediatric cancers—you name it. Many of these people are motivated, passionate, determined, and successful in moving their specific agendas forward in the interests of patients, clinicians, researchers, and others.
	In Brief Margaret Kripke to retire as CPRIT chief scientist CPRIT to award two grants ASCO Conquer Cancer Foundation names annual award winners Karmanos Cancer Institute raises $2.8 million at annual dinner IU Simon Cancer Center raises $720,000 at CHUCKSTRONG tailgate gala Dana-Farber, Harvard School of Public Health, and Irish Cancer Society form collaboration St. Jude forms affiliate with Novant Health Geisinger Health System opens precision medicine center
	Drugs and Targets FDA grants orphan designation to Reolysin in malignant glioma Paclical receives market authorization in Russian Federation Celgene International II Sarl forms collaboration with MedImmune

20150424 - Apr 24, 2015

ISSUE 16 – APRIL 24, 2015

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Foes Immediately Vow to Nullify Task Force Guideline on Mammography for Women 40-49

The breast cancer screening recommendations proposed by the U.S. Preventive Services Task Force earlier this week are basically unchanged from the 2009 version.

WARNING: a reader’s yawn at this juncture would be misplaced.

The recommendations proposed and put in place five years ago were so politically radioactive that they could have jeopardized the passage of the Affordable Care Act.

Indeed, the ACA specifically excluded the task force’s 2009 recommendation on mammography.

Immediately after the 2009 draft recommendation was published, then HHS Secretary Kathleen Sebelius in effect urged women between 40 and 49 to disregard the panel’s evidence-based guideline. An amendment to the ACA, called the “Women’s Preventive Health Amendment,” finished the job of invalidating the guideline. (This made the ACA politically viable.)

Mammography: When, Really, is the Right Time? And at What Cost?

As a firestorm ignites around the U.S. Preventive Service Task Force draft recommendation on mammography, researchers and advocates are grappling with the questions at the heart of the controversy:

• Should women start screening for breast cancer at age 40 or 50?
• What is the prevalence of false-positives and overdiagnosis in these age groups?
• What are the costs of harm?

The USPSTF draft recommendation, published April 20, comes on the heels of a controversial study which estimates that the

U.S. spends $4 billion a year on unnecessary mammograms for women between the ages of 40 to 59.

	Mandl: Costs of Harm from Mammography Must Be Balanced Against Benefits The U.S. spends $4 billion on unnecessary mammograms each year, according to a study published in the April issue of Health Affairs. Titled “National Expenditure for False-Positive Mammograms and Breast Cancer Overdiagnoses Estimated at $4 Billion a Year,” the study, by Kenneth Mandl and Mei-Sing Ong, uses expenditure data from a major U.S. health care insurer for 702,154 women in 2011 to 2013. Of the $4 billion, $2.8 billion is attributed to false-positive mammograms, and $1.2 billion to breast cancer overdiagnosis. The study measures the rate of false positives at 11 percent and overdiagnosis at 22 percent.
	Wender: Mammography Guidelines Should Balance Benefits and Risks, Not Costs “Let me be really clear: I don’t think that article should have or will have any impact on the [US Preventive Services Task Force], and it will not have any impact on [the American Cancer Society] guidelines, either,” Wender said.
	Four Decades of Mammography Wars The latest draft guideline by the U.S. Preventive Services Task Force is part of nearly a four-decade war over the appropriateness of screening women between the ages of 40 and 49. In this war, Congress usually intervened, claiming that “common sense” dictates that mammography is efficacious in younger women. This war has often engulfed NCI. This timeline appeared in part in the Nov. 20, 2009, issue of The Cancer Letter.
	AACR Annual Meeting 2015 Jose Baselga becomes president of AACR Two Stand Up To Cancer Dream Teams launched in ovarian and lung cancer Multiple award winners named
	The Cancer Letter Receives Sigma Delta Chi Award The Cancer Letter won a 2014 Sigma Delta Chi Award for Public Service in Journalism from the Society of Professional Journalists on April 23. The Sigma Delta Chi Awards is a national competition dating back to 1932. The award recognizes Matthew Ong’s series “Power Morcellation: A Hazardous Practice” as the winner in the Newsletter category. “This award recognizes a newsletter that renders outstanding public services through extensive coverage of an issue facing the community it serves,” the description reads. Ong’s series, which includes an interview documentary, can be found here.

20150417 - Apr 17, 2015

ISSUE 15 – APRIL 17, 2015

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Lowy: “We Need to Continually Look at the Distribution of Funds That We Allocate to the Areas of Investment”

Douglas Lowy became the NCI acting director April 1. On April 16, Lowy spoke with Paul Goldberg, editor and publisher of The Cancer Letter.

Paul Goldberg: Congratulations, first of all. How is the job treating you?

Douglas Lowy: Well, it is certainly a lot of work, but it’s an incredible opportunity—I have the opportunity of working with terrific people every day. I love it.

PG: Did you want this job?

DL: I never thought of myself as either becoming acting NCI director or the permanent NCI director, and it was not something I lobbied for.

MD Anderson Execs Get Big Raises In the Midst of Faculty Morale Woes

Two top administrators at MD Anderson Cancer Center, whose job responsibilities include maintaining harmony with the faculty, received substantial pay increases for having “excelled beyond expectation” and “effectively” directing the center’s clinical activities.

According to documents obtained by The Cancer Letter under the Texas Public Information Act, MD Anderson Provost Ethan Dmitrovsky and Physician-in-Chief Thomas Buchholz received $200,000 each in deferred compensation in 2015.

With incentive pay, supplemental annuity and deferred compensation included, the 2015 raise could boost Dmitrovsky’s total paycheck by as much as 22.9 percent compared to fiscal 2014. Buchholz’s compensation could increase by 31.4 percent.

Related Coverage of Morale at MD Anderson

Lawmakers Repeal Medicare SGR in Bipartisan Vote

President Barack Obama signed the Medicare Access and Children’s Health Insurance Program Reauthorization Act on April 14, permanently repealing the Medicare sustainable growth rate formula.

The bill received overwhelming bipartisan support: The House of Representatives voted 392 to 37 on April 2, and the Senate approved it with a 92 to 8 vote April 14.

In Brief

NCI renews Purdue’s designation as an NCI Basic Science Cancer Center
Joseph Gulfo named executive director of the Rothman Institute at Fairleigh Dickinson University
Don Gabriel joins United BioSource Corp.
Children’s Hospital of Wisconsin opened its MACC Fund Center clinical and Northwestern Mutual Day Hospital
Roche acquires CAPP Medical

Drugs and Targets

Health Canada approves new indication for Xtandi
Bayer HealthCare expands global clinical development of copanlisib
Immunocore and MedImmune enter into second collaboration

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