FDA Staff Efforts To Issue Warning Letters On Procrit Ads Were Stopped By Counsel

From The Cancer Letter, May 9, 2008:

Internal FDA documents show that the agency made a series of unsuccessful attempts to stop a direct-to-consumer advertising campaign that claimed that Johnson & Johnson’s erythropoiesis-stimulating agent Proctit (epoetin alfa) improved “fatigue” associated with chemotherapy-induced anemia.

The advertising campaign, which is widely credited with making ESAs into the biggest-selling class of oncology drugs, was allowed to proceed with relatively minor changes after the FDA Office of Chief Counsel became involved in the controversy.

The details of the doomed effort by FDA staff to modify the Procrit campaign emerged in the documents that were placed in the public record at the May 8 hearing of the Subcommittee on Oversight and Investigation of the House Committee on Energy and Commerce.

Click on The Cancer Letter Archive at left to download the May 9 issue (subscription required).
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tags: FDA

J&J To Eliminate Ortho Biotech Unit

From The Cancer Letter, May 2, 2008:

Johnson & Johnson is eliminating the separate business unit Ortho Biotech, which has developed the market for  erythropiesis-stimulating agents by claiming in  direct-to-consumer advertising that they improved cancer patients’ quality of life.

On April 29, the company told its employees that Ortho Biotech would be combined with another J&J company, Centocor Inc., which markets the agent Remicade, a treatment for autoimmune diseases, now the company’s highest grossing drug.

Click on The Cancer Letter Archive at left to download the May 2 issue (subscription required).
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tags: drug development

New Policy on Minor Protocol Changes Requires Halt In Enrollment

From The Cancer Letter, April 25, 2008:

In a bout of regulatory wrestling over human subject protections, NCI seems to have lost to the Department of Health and Human Services.

The result has the institute's cooperative groups and cancer centers scrambling to minimize interterruptions in the enrollment of patients on clinical trials.

Click on The Cancer Letter Archive at left to download the April 25 issue (subscription required).
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tags: clinical trials|  cooperative groups

Indoor Tanning Industry Funded Author of NEJM Review On Vitamin D

From The Cancer Letter, April 18, 2008:

The UV Foundation is a cheerful, sunny name. The non-profit has sponsored the research of Michael Holick, a Boston University  rofessor, whose work advocates “sensible sun exposure.”

Research support from the foundation was acknowledged in Holick’s  review article in the July 19, 2007, issue of The New England Journal of Medicine that suggests that a few minutes in the sun or at a tanning salon can help avoid the purported deadly consequences of vitamin D deprivation.

However, the disclosure didn’t mention that the UV Foundation is an offshoot of the Indoor Tanning Association and that all of its board members also serve as fiduciaries of the parent trade association, which represents the artificial tanning industry.

Click here to view the rest of the story.

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tags: research funding

Cancer Clinical Trials Take Too Long To Begin, NCI Says

From The Cancer Letter, April 11, 2008:

NCI and its clinical trials cooperative groups and cancer centers need to work together to cut the time it takes to activate cancer clinical trials, an Institute official told an NCI advisory group.

“It takes on average 800 days to go from an idea—the documentation of the idea—to the time the study is ready to go to a comprehensive cancer center to be initiated,” said James Doroshow, director of the NCI Division of Cancer Treatment and Diagnosis. “It takes another three to six months at a cancer center for it to open that trial,” Doroshow said. “That’s the median. If you look at the maximum [times], it’s worse. In some cases it takes five years.”

NCI Director John Niederhuber has vowed to cut the trials activation time in half, Doroshow said.

Click on The Cancer Letter Archives at left to download the issue (subscription required).
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tags: clinical trials

NEJM Does About-Face, Issues Correction

From The Cancer Letter, April 4, 2008:

The New England Journal of Medicine published a correction, a clarification, and an editorial addressing the conflicts of interest that were not disclosed by a group of researchers who advocate computed tomography screening for lung cancer.

The corrective actions taken by the NEJM on April 2 represent an about-face in the handling of the controversy over publication of a paper  by the International Early Lung Cancer Action Program.

Earlier, the journal’s editors argued that the I-ELCAP leaders Claudia Henschke and David Yankelevitz, both of Weill Cornell Medical College, had properly declared their conflicts, but the editors deemed these not relevant to the paper, which was published in the Oct. 26, 2006, issue of the journal.

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tags: cancer screening|  research funding

Tobacco Company Liggett Gave $3.6 Million To Henschke For CT Screening Research

Lung cancer researcher Claudia Henschke accepted $3.6 million from the parent company of cigarette maker Liggett Group Ltd., The Cancer Letter has found.

The maker of Grand Prix, Pyramid, Liggett Select, Quest and Eve cigarettes provided the money in four installments between 2000 and 2003, and Henschke placed the funds in a non-profit group where she serves as president, tax documents show.

In her scientific articles, Henschke doesn’t disclose receiving money from Liggett. Instead, she declares support from the Foundation for Lung Cancer Early Detection, Prevention & Treatment, the non-profit that received the tobacco company money and which uses it to fund the work of the International Early Lung Cancer Action Program.

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tags: cancer screening|  research funding

Further Restrictions Likely On ESA Use

From The Cancer Letter, March 21, 2008:

Last year, the companies that market erythropoiesis-stimulating agents could still argue before Wall Street analysts that chemotherapy-related anemia was largely undertreated and that the franchise would once again continue to expand.

Now, expansion is no longer an option. As utilization of ESAs continues to decline amid safety concerns, FDA officials are discussing the recommendations they received at the March 13 meeting of the Oncologic Drugs Advisory Committee.

The sponsors will not be in a position of strength as they negotiate label changes, because FDA has been granted the power to act unilaterally and mandate studies in cases where safety issues are involved. The new authorities will become effective on March 25.

Click on "The Cancer Letter Archive" at left to download the March 21 issue and read the rest of the story.
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tags: FDA|  drug development

NEJM Says Henschke Conflicts Irrelevant; Propriety of Granting CME Questioned

From The Cancer Letter, March 14, 2008:

The study claiming dramatic benefits of computed tomography screening for lung cancer had the look of a landmark in medicine. The conclusion that a regimen of low-dose spiral CT scans could make lung cancer a curable disease was its most astounding feature.

More than a year after publication, the paper reporting the results of a single-arm trial by the International Early Lung Cancer Action Program is becoming a landmark of a different sort as its publisher, The New England Journal of Medicine, stands confronted with reports that the study’s principal authors were named as inventors on one issued U.S. patent and 26 patent applications worldwide, and that the first of these inventions was licensed by the leading manufacturer of CT scanners in 2001 (The Cancer Letter, Jan. 18).

Yet, the disclosure statement on the paper published in the Oct. 26, 2006, issue of the journal reads: “No potential conflict of interest relevant to this article was reported.”

Click on "The Cancer Letter Archive" at left to download the March 14 issue and read the rest of the story.
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tags: cancer screening

NCI R01 Payline Falls To 12th Percentile

From The Cancer Letter, March 7, 2008:

NCI's payline for investigator-initiated grants will drop to the 12th percentile this fiscal year, from the 15th percentile in FY07, as the institute plans to fund fewer grants with a budget that has remained flat for the past five years.

"Something has to give," NCI Director John Niederhuber said to the NCI Board of Scientific Advisors at its March 3 meeting. "We need to inject a little bit of reality into this process. We can't continue to increase the grant pool with a flat budget."

The cancer clinical trials system is "slowly unraveling" due to NCI's budget difficulties, said Allen Lichter, executive vice president and CEO of the American Society of Clinical Oncology.

Click on "The Cancer Letter Archive" at left to download the March 7 issue and read the rest of the story.
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tags: NCI|  research funding

PFS "A Benefit In The Right Context," FDA's Pazdur Says

From The Cancer Letter, Feb. 29, 2008:

The Cancer Letter asked Richard Pazdur, director of the FDA Office of Oncology Drug Products, to comment on the agency's decision last week to approve the Genentech drug Avastin for front-line treatment of metastatic breast cancer.

The agency's action was something of a regulatory cliff-hanger that was watched closely by drug developers and patient advocates.

Read the interview by clicking "The Cancer Letter Archive" at left to download the Feb. 29 issue.
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tags: drug development

Patient Groups Split On PFS In Front Line Breast Cancer

From The Cancer Letter, Feb. 22, 2008:

Sometime before Feb. 23, FDA will announce its decision on the Genentech drug Avastin.  Disputes over Avastin have caused rifts within patient advocacy groups and among drug developers. Opponents argue that acceptance of PFS for this indication would lower the bar for drug approval. Proponents counter that a highly statistically significant delay in progression of disease is a tangible benefit.

Click "The Cancer Letter Archive" at left to download this story.
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tags: drug development