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Avastin May Trigger Two FDA Decisions: One On Approval, Another On Withdrawal
From The Cancer Letter, Sept. 3, 2010:
FDA officials will likely have to make two separate decisions about the future of the Roche drug Avastin as a first-line treatment for metastatic breast cancer.
First, by Sept. 17, the agency is expected to decide whether to grant additional marketing claims and full approval for the indication. Approval is unlikely, considering that on July 20, the FDA Oncologic Drugs Advisory Committee voted unanimously against converting the drug from accelerated approval to full approval.
Second, the agency will have to decide whether to start formal proceedings aimed at revocation of the accelerated approval it had granted the drug in 2008.
For the rest of the story, download or purchase the Sept. 3, 2010 issue of The Cancer Letter under the Archive tab at left.
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Duke Finds "Issues of Substantial Concern" And Sanctions Potti
An investigation by Duke University officials found "issues of substantial concern" in the credentials of scientist Anil Potti, and has imposed sanctions against him, a university spokesman said Aug. 27. However, Potti will remain on administrative leave until a separate inquiry into his research has been completed. The university declined to release further details.
Following is the text of the statement by Michael Schoenfeld, Duke's vice president for public affairs:
When The Cancer Letter and other sources raised allegations of inaccuracies in Dr. Anil Potti’s curriculum vitae and research, Duke University immediately took the following actions:
- A complete review of the credentials and claims Dr. Potti made in his CV and biosketches, to be led by Provost Peter Lange.
- A research misconduct inquiry to be conducted as specified by Duke policies and Federal law; and
- Efforts to facilitate the initiation of an independent, external investigation of the science in question by one of the country’s leading research bodies, to which Duke would supply any and all data and information, but would otherwise have no involvement.
The first part of the investigation — the review of credentials — has now been completed. Issues of substantial concern were identified, and have resulted in corresponding sanctions. However, a final decision about Dr. Potti’s future status as a Duke employee and faculty member will also be informed by the results of the research misconduct inquiry and the independent external evaluation of the science. Until such time, he will remain on administrative leave from his research, teaching and clinical responsibilities.
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The Cancer Letter Is On Vacation
The Cancer Letter will not be published on Aug. 13, Aug. 20, or Aug. 27, 2010, unless important news makes it imperative that we publish an issue.
We are on vacation and assume many of our readers are as well. Enjoy the summer! Meanwhile, this is a good time to renew your subscription if you haven't done so already. The price of The Cancer Letter is scheduled to increase to $395 on Sept. 1.
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FDA To Reorganize Oncology Office
From The Cancer Letter, Aug. 6, 2010:
FDA is in the process of reorganizing its oncology unit to integrate the review of small molecule and biologic products.
Abandoning its current structure, which evaluates cancer drugs separately from biologics, the office will now be broken up into four divisions focused on specific malignancies. Changes will include the renaming the office from the Office of Oncology Drug Products to the Office of Hematology and Oncology Products.
The reorganization will take effect in 2011.
For the rest of the story, including an interview with FDA's Richard Pazdur, director of the Office of Oncology Drug Products, download or purchase the Aug. 6, 2010 issue of The Cancer Letter under the Archive tab at left.
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Varmus, Duke Ask IOM To Investigate Potti's Scientific Work, Clinical Trials
From The Cancer Letter, July 30, 2010:
In one of his first actions as NCI director, Harold Varmus has asked the Institute of Medicine National Cancer Policy Forum to lead an investigation of a scandal touched off by Duke University genomics researcher Anil Potti.
According to an internal email obtained by The Cancer Letter, the plan for IOM involvement was made in a three-way conversation between Varmus, Duke University’s Chancellor for Health Affairs Victor Dzau and IOM President Harvey Fineberg.
Though no final decision has been made, the email is remarkable, because it shows that at the highest policy levels, the Duke scandal is viewed as a potential threat to the discipline of genomics rather than as an isolated act of a rogue researcher.
For the rest of the story, download or purchase the July 30, 2010 issue of The Cancer Letter under the Archive tab at left.
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The Potti Scandal: Biostatisticians Send Letter to Varmus, Lancet Oncology Expresses Concern
From The Cancer Letter, July 23, 2010:
Updates in the scandal over Duke University scientist Anil Potti's falsification of his credentials:
—Thirty-three biostatisiticans sent a letter to NCI Director Harold Varmus asking NCI to investigate Potti's scientific work.
—The Lancet Oncology issued an "Expression of Concern" regarding a key paper by Potti.
—Duke University suspended Potti and for the second time stopped enrolling patients into three single-institution trials that used his genomic technology to assign patients to chemotherapy.
—American Cancer Society Chief Medical Officer Otis Brawley wrote to Duke University informing that payments on Potti's grant from the society have been suspended.
For the rest of the story, download The Cancer Letter's second special issue on The Potti Scandal.
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Note to Cancer Letter Subscribers for Friday, July 23
The first email you received today was a mistake. We were trying to send The Clinical Cancer Letter to its subscribers and sent it to Cancer Letter subscribers inadvertently. We are sorry to cause confusion when you couldn't open the link. Do not fret. You will receive another email a little later today with the correct link to today's issue of The Cancer Letter. Stay tuned!
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Prominent Duke Scientist Claimed Prizes He Didn't Win, Including Rhodes Scholarship
From The Cancer Letter, July 16, 2010:
A high-profile cancer genomics researcher at Duke University claimed in multiple grant applications that he had been a Rhodes scholar, when, in fact, the Rhodes Trust states flatly that he was not.
Documents obtained by The Cancer Letter show that in biographies submitted to NIH, Duke oncologist and genomics researcher Anil Potti claimed variously to have won the prestigious scholarship in 1995 or 1996, depending on the version of the biography.
Potti also made the Rhodes claim in an application that resulted in a $729,000 grant from the American Cancer Society.
For the rest of the story, download Free Special Issue.
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Harold Varmus Takes NCI Helm With No Promises, No Clichés
From The Cancer Letter, July 16, 2010:
With an energetic hop to the lectern, the new NCI director introduced himself at a town hall meeting at NIH July 12: “Good afternoon, I’m glad to be back in the Natcher Center. I’m Harold Varmus.”
Nobel laureate and former NIH director Varmus, who was sworn in as the 14th NCI director earlier that day by HHS Secretary Kathleen Sebelius, answered one key question and set forth some ground rules in his 45-minute appearance:
—Why did he take the job? “I like to work. I was looking for a new job, and, hey, this looks like a great job. So, we’ll see about that.”
—What to call him: “My first name is not Doctor. It’s Harold, and I like to be called Harold.”
—Style of operation: “Let’s try to avoid the classic NIH retort: ‘We’re already doing it.’”
—Words to avoid: “Never refer to an abstraction like the department, the White House, or Building 1. Let’s just talk about who said what to whom.”
—More words to avoid: “Never use ‘impact’ as a verb.”
Now, about that “NCI goal” established in 2003 by former NCI Director Andrew von Eschenbach to “eliminate suffering and death due to cancer” by 2015. (It was printed on the back of NCI business cards, according to an employee who asked Varmus to comment).
Varmus had this to say about that:
“In this administration, we are going to make every effort to control cancer through science. That’s as far as I go. We can’t make promises that will be elusive, and frankly—” The rest of his statement was drowned out by applause.
For the rest of the story, download Free Special Issue.
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In Exit Interview, Niederhuber Says Clinical Trials System Must Refocus To Emphasize Translational Studies
From The Cancer Letter, July 9, 2010:
NCI Director John Niederhuber sat down with editors of The Cancer Letter for an interview on June 29. Niederhuber, who has described himself as the “accidental director,” having taken over management of the institute in October 2005 after NCI Director Andrew von Eschenbach became FDA commissioner, will step down when President Obama’s appointee, Harold Varmus, arrives on July 12. He plans to remain at NCI working in the laboratory he established when he arrived at NCI as deputy director for clinical and translational sciences.
In the interview, Niederhuber expanded on his recent comments on restructuring the NCI clinical trials system, and said one regret he had was not being able to increase per-case payments for patient accrual to trials. He also had two words of advice for his successor: "Work hard."
For the rest of the story, go to The Cancer Letter Archive at left to download the July 9, 2010, issue (subscription or day pass required).
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Three Cooperative Groups To Combine Statistical Center Operations
From The Cancer Letter, July 2, 2010:
Three NCI-funded cooperative groups last week said they have started integrating “back end” operations of their statistical centers.
The groups will fuse the data management, quality control, standard operating procedures, administrative functions and information technology of Cancer and Leukemia Group B, North Central Cancer Treatment Group and the American College of Surgeons Oncology Group.
Scientific leadership of the biostatistics component of the three groups will remain separate.
Also in this issue: former cooperative group chairman Richard Schilsky responds to NCI Director John Niederhuber's comments last week.
For the rest of the story, go to The Cancer Letter Archive at left to download the July 2, 2010, issue (subscription or day pass required).
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Lame Duck NCI Director: Cancer Centers Should Run Cancer Clinical Trials System
From The Cancer Letter, June 25, 2010:
NCI’s clinical trials program should be structured around the country’s major cancer centers in “a single national program for clinical research” that would replace the existing cooperative group system, lame duck NCI Director John Niederhuber said to the National Cancer Advisory Board.
“We can continue down the road with a 50-year-old structure that we have used for clinical research, or we can become innovative and think about the future and how, if we were given the power and the opportunity, we would redesign the next 50 years in terms of translational and clinical trials structure,” Niederhuber said at the board’s meeting June 22.
For the rest of the story, go to The Cancer Letter Archive at left to download the June 25, 2010, issue (subscription or day pass required).
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