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ISSUE 43 – NOV. 20, 2015PDF



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.

Also:

CBER’s All-Day Voyage into Slippery Science Ends in 18-6 Vote against Bladder Therapy

One might surmise that by the time FDA asks an advisory committee to vet an application, the questions would deal primarily with clinical utility.

By that stage in the game, advisors would be asked to discuss the outcomes, as opposed to the biological mechanisms for achieving them.

This was even before the agency’s reorganization of its oncology units more than a decade ago. In those days, small-molecule compounds went to one bureaucratic unit of the FDA Center for Drugs Evaluation and Research—while biologics, including monoclonal antibodies and growth factors, went to the Center for Biologics Evaluation and Research.

Capitol HillFDA Lists Potentially Avoidable Harms in 20 LDT Case Studies, Including Tests from Duke, Caris and Genomic Health

Ahead of a Capitol Hill hearing this week on the role of the FDA in the regulation of laboratory-developed tests, the federal agency published a report of 20 case studies that illustrated the possible harms presented to patients when laboratories do not comply with FDA requirements.

The case studies included LDTs such as the Target Now cancer biomarker test, developed by Caris Life Sciences Inc.; the Oncotype DX HER2 RT-PCR breast cancer test; and the Duke University Chemotherapy Assessment genetic tumor assay.

NCI Announces Winners of Outstanding Investigator Awards

NCI named the inaugural 43 recipients of its Outstanding Investigator Awards.

Developed last year, the grant program provides funding to investigators with outstanding records of productivity in cancer research to support projects of unusual potential in cancer research.

The award provides funding of up to $600,000 in direct costs each year for seven years. One goal of the award is to provide investigators with substantial time to break new ground or extend previous discoveries to advance biomedical, behavioral or clinical cancer research.

In Brief

  • Kantoff named chair of MSKCC Department of Medicine
  • Michael Lang named CPRIT chief product development officer
  • Alexandra Levine receives award from Los Angeles County Medical Association
  • Steven Rosen receives Lifetime Achievement Award from the Israel Cancer Research Fund
  • International Cancer Genome Consortium publishes 1,200 whole cancer genome sequences online
  • ASCO publishes 11 principles for CMS payment systems
  • MD Anderson and Codiack BioSciences form research agreement
  • Pan-Mass Challenge donates $45 million to Dana-Farber
  • AARP publishes report on drug retail prices and median household income
Drugs and Targets

  • Darzalex granted accelerated approval in multiple myeloma
  • Ninlaro first protesome inhibitor approved in multiple myeloma
  • Eli Lilly and Merck extend phase III Alimta-Keytruda study collaboration

 

The Cancer Letter will take a publication break

for Thanksgiving, and return Dec. 4.

20151120 - Nov. 20, 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.

20151119 - Nov. 19, 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

    20151113 - Nov. 13, 2015