20151119 - Nov 19, 2015
SPECIAL REPORT – NOV. 18, 2015 



Congressional Panel Chair Questions Whether J&J, Brigham Reported Morcellation Adverse Events to FDA

The House Committee on Energy & Commerce has stepped into a key role in the controversy over power morcellation.

At a hearing earlier this week, Rep. Tim Murphy (R-Pa.), chairman of the Subcommittee on Oversight and Investigations questioned whether Johnson & Johnson and Brigham & Women’s Hospital violated federal law by not reporting adverse outcomes resulting from power morcellation.

At the Nov. 17 hearing by the Subcommittee on Health, Murphy quizzed Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health, in an apparent effort to determine whether manufacturers of power morcellators as well as hospitals that used these devices had failed to notify FDA that patients were being harmed.

FDA: Federal Law Requires Reporting of Morcellation Adverse Events, But None Were Brought to Agency’s Attention For 8 Years

FDA officials said the agency didn’t receive any reports of adverse outcomes resulting from power morcellation prior to December 2013.

“Of note, prior to December, the FDA had received no MDRs specifically on cancer and upstaging/dissemination,” the agency said in response to questions from The Cancer Letter. “Since then, the agency has become aware of about two dozen that have discussed ‘cancer’ and ‘upstaging or dissemination’ as of November 2014. All of these reports pertained to procedures that took place prior to December 2013.”

photoJ&J Says There Were No Reportable Morcellation Events; Whistleblower Disagrees—and Produces Letters

Johnson & Johnson officials said the company was unaware of any reportable adverse events resulting from the use of power morcellators prior to 2013.

“[J&J subsidiary] Ethicon was not aware of any reportable events related to morcellators and the possibility of upstaged cancer prior to December 2013,” a company spokesman said to The Cancer Letter. “Since that time, we have filed reports with the FDA for all reportable events that have come to our attention.”

Ethicon responded to The Cancer Letter’s questions after the Nov. 17 hearing by the Subcommittee on Health, where Rep. Tim Murphy (R-Pa.) noted that the company had received a report about the dangers of power morcellators.

20151113 - Nov 13, 2015
ISSUE 42 – NOV. 13, 2015PDF

ORI’s Deal with Potti Doesn’t Address the Role Duke Deans Played in Scandal

After a five-year investigation, the HHS Office of Research Integrity announced that it has settled with former Duke University researcher Anil Potti.

Under the agreement published in the Federal Register Nov. 9, Potti admits no wrongdoing and agrees to be barred from research funded through Public Health Service for five years.

The report doesn’t address the subject of responsibility on the part of Duke, the institution that employed Potti and conducted three clinical trials based on his model for choosing cancer therapies.


 

Guest Editorial

Penalty Too Light

By Keith Baggerly and C.K. Gunsalus

What does it say about our national commitment to research integrity that the Department of Health and Human Services’ Office of Research Integrity has concluded that a five-year ban on federal research funding for one individual researcher is a sufficient response to a case involving millions of taxpayer dollars, completely fabricated data, and hundreds to thousands of patients in invasive clinical trials?

This week, ORI released a notice of “final action” in the case of Anil Potti, M.D. The ORI found that Dr. Potti engaged in several instances of research misconduct and banned him from receiving federal funding for five years.


 

Congressman Says Brigham Invoked Security Threat to Get Even with Docs Who Triggered Morcellation Debate

Rep. Mike Fitzpatrick accused top leaders of Brigham & Women’s Hospital of retaliating against patient advocates Amy Reed and Hooman Noorchashm when a hospital administrator declared the couple a security threat and subjected them to a physical search.

Noorchashm had to submit to being tailed by a security guard while his wife was undergoing an urgent cancer surgery Nov. 2.

“As Dr. Reed’s and Dr. Noorchashm’s Representative in Congress, I am deeply concerned about what appears to be an effort to retaliate against their advocacy and silence their First Amendment Rights,” Fitzpatrick (R-Pa.) wrote in a letter Nov. 5 to Ron Walls, executive vice president and chief operating officer at Brigham.

With Letters From:

Rep. Mike Fitzpatrick: Brigham Retaliated Against My Constituents

Dr. Walls,

As you may be aware, my constituent Dr. Amy Reed has been courageously battling an aggressive leiomyosarcoma that was spread throughout her body by a dangerous medical device known as a laparoscopic power morcellator.

This device has taken the lives of hundreds, if not thousands, of women since it was allowed on the market by the Food and Drug Administration. This tragic reality hangs over this mother of six’s head every single day.

Ron Walls: Noorchashm’s “Campaign of Distortions”

Dear Congressman Fitzpatrick:

I am in receipt of your letter dated November 5.

I appreciate your interest in this matter, but want to be very clear that the security measures taken during Dr. Noorchashm’s visit were the direct result of the fear and anxiety expressed by faculty and staff on learning that Dr. Noorchashm would be returning to the hospital.

Since December 2013, Dr. Noorchashm has sent thousands of emails to faculty and staff at Brigham and Women’s Hospital, many of which contained language that recipients found disturbing and threatening.

Amy Reed: Please Stop This Craziness, Dr. Walls

Dear Dr. Walls,

Hello. My name is Amy Reed. Last week I had surgery at BWH by an excellent surgeon who works at your hospital. The surgery, as I’m sure you know, went very well and we were able to return home to our family mid-week. Your hospital has some of the best doctors in their fields.

Between visits to my oncologist, who we have a wonderful relationship with, specialists and sub-specialists, including surgeons, who have now operated on me twice, I can’t begin to count the number of times we have pulled up Francis Street to the front of BWH.

Hooman Noorchashm: Nice Try, Professor Walls

Dear Editor,

Thank you for forwarding Dr. Walls’ letter of Nov. 10, 2015, in response to Pennsylvania Congressman Rep. Mike Fitzpatrick, to me.

I assure you that the BWH corporate leadership requires public exposure—because this leadership is ethically corrupted and protectionist in a way unbecoming of trusted physicians at one of the most powerful hospitals in our nation.

 

Capitol Hill

Advocacy Organizations Urge Congress to Consider FDA’s Role in Regulating LDTs

A group of 42 organizations sent an open letter to a congressional committee urging them to consider the important role of the FDA in the regulation of laboratory-developed tests.

Ahead of next week’s hearing of the House Energy and Commerce Committee, titled “Examining the Regulation of Diagnostic Tests and Laboratory Operations,” the letter addressed concerns that agency involvement would impede patient access to LDTs, saying that the FDA has a track record of approving new technologies in a timely manner.

    In Brief

    • Michael Zinner named CEO of Miami Cancer Institute

    • Stuart Orkin receives Lifetime Impact Award from Boston Children’s

    • City of Hope announces faculty appointments

    • Sidney Kimmel Cancer Center makes personnel changes

    • St. Jude, Scripps Research Institute, and others launch Dark Proteome Initiative

    • American College of Radiology and other colorectal care advocacy agencies lobby Congress to pass Medicare coverage for CT colonography screening
    Drugs and Targets

    • Tagrisso receives accelerated approval in non-small cell lung cancer

    • Cotellic receives approval in metastatic melanoma

    20151106 - Nov 6, 2015
    ISSUE 41 – NOV. 6, 2015PDF

    DeVita: 50 Years of Stories

    On Cancer Wars and Skirmishes

     

    Vincent T. DeVita Jr. has seen the cancer field as a confident young doc eager to challenge the system, as a general in the War on Cancer, as an academic oncologist and, most recently, as a patient.

    “I’ve been in a unique position. Partly, the War on Cancer happened because of what we were doing. I watched it grow, and then I ran it at the NCI. And then I came out of the NCI and I watched it from a private cancer center and a university cancer center,” said DeVita, co-author, with his daughter, Elizabeth DeVita-Raeburn, of The Death of Cancer: After Fifty Years on the Front Lines of Medicine, a Pioneering Oncologist Reveals Why the War on Cancer Is Winnable—and How We Can Get There, a just-published memoir.

    “There are very few people who have been in that position. But I felt I owed it to the field to give a description of how I saw it, from the beginning to watching it from the outside—watching the field go through some very exciting times.”

     

    Book Review

    DeVita’s History of Oncology

    Told with Candor and Optimism

    By Otis W. Brawley

    “The Emperor of All Maladies” was a history of oncology, and a good one. “The Death of Cancer” is a memoir of one of the greats of medical oncology. It is a history from someone who was there, making history.

    In scientific terms, Siddhartha Mukherjee’s book has the limitations of a retrospective study; Vince DeVita’s book is more like a prospective clinical trial.

    I trained at the NCI in the 1980’s. I openly admit that Otis Brawley the medical oncology fellow was intimidated by the mere mention of “Dr. DeVita.”

      Judge Rebukes Brigham for Placing
      Morcellation Critic Under Guard
      While His Wife Underwent Surgery

      A Boston judge ruled Nov. 3 that Brigham & Women’s Hospital had violated the First Amendment rights of a couple who led an aggressive national campaign to stop power morcellation, a surgical procedure routinely used by gynecologists.

        NCI Funds Eight SPORE Grants

        NCI awarded eight new, competing and renewed grants as part of its funding for its Specialized Programs of Research Excellence. The grantees will receive $2,185,000 per year for five years.

           

          Funding Opportunity

          NCI Taking Applications for Research Specialist Award

          NCI is taking applications for its Research Specialist Award, which is designed to encourage the development of stable research career opportunities for scientists who want to pursue research within the context of an existing cancer research program, but not serve as independent investigators.

            In Brief

            • Edith Perez steps down as vice chair of Alliance for Clinical Trials in Oncology; named VP for Genentech and Roche

            • Stand Up To Cancer, Cancer Research UK and Lustgarten Foundation form pancreatic cancer dream team

            • NCI names 11 winners of its Cancer Clinical Investigator Team Leadership Awards

            • AACR launches international genomic data sharing project

            • CancerCare announces co-payment assistance for pancreatic cancer patients

            • SRI International awarded contract for NCI PREVENT program
            Drugs and Targets

            • TCGA Researchers identify seven subtypes of prostate cancer; two drivers of renal cell carcinoma

            • FDA grants Breakthrough Therapy designation to pexidartinib

            • MD Anderson and CytomX launch collaboration