President Proposes $1 Billion Increase For NIH

From The Cancer Letter, Feb. 5, 2010:

President Barack Obama’s FY2011 budget request includes $32.2 billion for NIH, an increase of $1 billion, or 3.2 percent.

Cancer and autism are listed as “high-priority areas” for the administration. NCI would receive $5.26 billion, an increase of $162.9 million—the largest dollar increase proposed for any of the NIH institutes—over the current budget of $5.1 billion.

Also in this issue:

• AHRQ Draft Report Finds No Benefit For Biomarker Testing In Oncology
  

For the rest of the story, click on The Cancer Letter Archive at left to read the Feb. 15 issue (subscription or day pass required).

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tags: White House|  research funding

Duke In Process To Restart Three Trials Using Microarray Analysis Of Tumors

From The Cancer Letter, Jan. 29, 2010:

Duke University said it is in the process of restarting three clinical trials using microarray analysis of patient tumors to predict their response to chemotherapy.

The university halted the trials to review their scientific underpinnings after a paper in the Annals of Applied Statistics said that the genomic technology developed at Duke and used in the trials incorporated errors and inaccurate calculations and could conceivably put patients at risk (The Cancer Letter, Oct. 2, Oct. 9, Oct. 23, 2009).

In a letter to the editor of The Cancer Letter, Duke officials said that the Institutional Review Board had consulted three directors of cancer centers, who recommended that the patients continue to receive the treatments.

For the rest of the story, click on The Cancer Letter Archive at left to read the Jan. 29 issue (subscription or day pass required).

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tags: clinical trials

I-ELCAP Moves From Weill Cornell To Arizona State

From The Cancer Letter, Jan. 22, 2010:

A controversial program aimed at screening current and former smokers for signs of early-stage lung cancer is in the process of departing from Weill Cornell Medical College.

The research group, called the International Early Lung Cancer Action Program, said it has moved its “coordinating site” to the Arizona State University’s Biodesign Institute in Tempe, and top academic leaders of the group now appear on the web site of Mount Sinai School of Medicine.

I-ELCAP, led by radiologist Claudia Henschke, has been plagued with problems, which included revelations of undisclosed conflicts of interest, receiving funding from a tobacco company, and retractions of key scientific claims about effectiveness of screening for early lung cancer.

Also in this issue:

• Ratain To Lead New Center For Personalized Therapeutics At University of Chicago
  

For the rest of the story, click on The Cancer Letter Archive at left to read the Jan. 15 issue (subscription or day pass required).

The Cancer Letter is no longer offered in a print edition. Former print subscribers: if you haven't already given us your email address, please use the Contact Us link at left.
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tags: cancer screening

Lawsuit Challenges FDA Authority To Regulate Off-Label Promotion

From The Cancer Letter, Jan. 15, 2010:

FDA’s authority to regulate what companies can say about off-label uses of drugs is once again being tested in federal courts.

Allergan Inc., the sponsor of the neurotoxin Botox, has filed a suit that broadly challenges the regulatory agency’s powers in the context of the First Amendment.

Though the issue of off-label promotion is important throughout medicine, it is particularly relevant to oncology, where such use of drugs is widespread. Allergan’s court challenge, filed in the U.S. District Court for the District of Columbia, is taken seriously by legal observers and FDA-watchers familiar with what can happen when the courts apply the constitutional filter to the agency’s regulatory practices.

Also in this issue:

• Harold Varmus plans to leave job as MSKCC president.
  

For the rest of the story, click on The Cancer Letter Archive at left to read the Jan. 15 issue (subscription or day pass required).

The Cancer Letter is no longer offered in a print edition. Former print subscribers: if you haven't already given us your email address, please us the Contact Us link at left.
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tags: FDA|  drug development

In Vote Against Tarceva As Maintenance, ODAC Seeks Stronger Survival Benefit

From The Cancer Letter, Dec. 18, 2009:

In a recommendation that will likely have broad implications for FDA approval of “maintenance” therapies for advanced cancer, the FDA Oncologic Drugs Advisory Committee voted 12-1 against approval of Tarceva (erlotinib) as maintenance in the treatment of non-small cell lung cancer.

For the rest of the story, which examines why Alimta got its NDA in this indication while Tarceva is likely headed for defeat, click on The Cancer Letter Archive at left to read the Dec. 18 issue (subscription or day pass required).

Also in this issue:

• President Obama signs bill giving 2.8 percent increase to NCI.

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tags: FDA|  drug development

NCI Grant Funding Payline Begins At 16th Percentile For FY2010

From The Cancer Letter, Dec. 11, 2009:

NCI’s grant funding payline will start at the 16th percentile for fiscal 2010, NCI Director John Niederhuber said earlier this week.

Eventually over the course of the fiscal year, through exceptions funding, Niederhuber said he hopes to be able to reach a 20 percent success rate overall for research project grants. This would be similar to the FY2009 level, without counting the 543 research project grants funded through the economic stimulus dollars the institute received under the American Recovery & Reinvestment Act.

For the rest of the story, click on The Cancer Letter Archive at left to read the Dec. 11 issue (subscription or day pass required).

Also in this issue:

• House approves 2.8 percent increase to NCI budget.
• Annual Report finds declines in overall cancer rates.
• NCI awards large contract for Cancer Information Service to Fred Hutchinson Cancer Research Center.
  

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tags: Congress|  NCI|  research funding

Task Force Alters Web Site To Clarify Recommendation On Mammography

From The Cancer Letter, Dec. 4, 2009:

Two weeks after an independent task force recommended against providing routine mammography screening for women between ages 40 and 49, the battle between skeptics and believers in this form of screening is showing no signs of subsiding.

The Obama administration quickly distanced itself from the recommendations by the U.S. Preventive Services Task Force as HHS Secretary Kathleen Sebelius urged women to make no changes in their screening strategies (The Cancer Letter, Nov. 20).

Then, in another extraordinary move, the text of the one-page summary of USPSTF recommendations on the task force’s website has been altered to clarify the recommendation against routine screening for younger women.

The clarification, set off in a pink box, quotes what appears to be a press interview by USPSTF Vice Chair Diana Petitti:

“So, what does this mean if you are a woman in your 40s? You should talk to your doctor and make an informed decision about whether a mammography [sic] is right for you based on your family history, general health, and personal values.” The statement is dated Nov. 19, three days after the release of the guideline.

Though the clarification is consistent with the guideline recommendation, resorting to postscripts
containing expert opinion is an obvious, embarrassing break with tradition for the task force, whose purpose is to rise above opinion of a single expert by relying on a panel of experts charged to apply pre-specified criteria for systematic, comprehensive review of scientific evidence.

For the rest of the story, click on The Cancer Letter Archive at left to read the Dec. 4 issue (subscription or day pass required).

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tags: cancer screening|  policy issues

HHS Secretary Rebukes Task Force Guidelines On Breast Cancer Screening

From The Cancer Letter, Nov. 20, 2009:

“Confusion” is the last thing a cancer screening guideline should be expected to cause.

Yet, two days after the U.S. Preventive Services Task Force set off a blast of accusations and name-calling by issuing a breast cancer screening guideline, HHS Secretary Kathleen Sebelius put some distance between the Obama administration and the non-partisan group of public health experts who reviewed the data and came up with a new set of screening recommendations.

“There is no question that the U.S. Preventive Services Task Force recommendations have caused a great deal of confusion and worry amongwomen and their families across this country,” Sebelius said in a statement Nov. 18. “I want to address that confusion head on. The U.S. Preventive Services Task Force is an outside independent panel of doctors and scientists who make recommendations.
“They do not set federal policy, and they don’t determine what services are covered by the federal government.”

Reviewing pooled data from randomized trials and relying on modeling, the group of academic experts recommended against routine screening of women between the ages of 40 and 49, and said that for older women, mammograms should be performed every two years.

For the rest of the story, click on The Cancer Letter Archive at left to read the Nov. 20 issue (subscription or day pass required).

Also in this issue, historical perspective: In part, the screening mammography controversy of this past week is just another step in a long and painful withdrawal from the “one simple message” of the 1980s.
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tags: cancer screening|  policy issues

Compendia Publishers Must Tell CMS How They Manage Conflicts Of Interest

From The Cancer Letter, Nov. 13, 2009:

The Centers for Medicare and Medicaid Services has instructed the publishers of drug compendia to provide information on their processes for managing conflicts of interest.

The compendia are immensely important in oncology. A listing in one of the compendia—there are four—is usually all a drug maker needs to ensure that off-label uses of a drug or biologic are eligible for coverage. Nonetheless, processes for determining conflicts of interests that can come into play as listing decisions are made vary from compendium to compendium.

For the rest of the story, click on The Cancer Letter Archive at left to read the Nov. 13 issue (subscription or day pass required).

Also in this issue: NCI rewrites proposed intellectual property language for research agreements with companies, quelling some of the concerns that cooperative groups expressed over the first version.
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tags: Medicare|  drug development|  policy issues

States Join Suit Alleging Amgen Offered Illegal Kickback To Doctors For Aranesp

From The Cancer Letter, Nov. 6, 2009:

State attorneys general have joined a whistleblower suit alleging that Amgen Inc. offered an illegal kickback to doctors by overfilling vials with the drug Aranesp and offering counseling on charging for this surplus.

The suit filed in the U.S. District Court for the District of Massachusetts Oct. 30 is focused on nephrology, but court documents state that the same practice was used in marketing Aranesp (darbepoetin) in oncology.

According to the suit, Aranesp single-dose vials used in oncology and nephrology contained up to 19 percent more drug than was needed, and company sales representatives assisted practices in getting
reimbursement for these “overfill micrograms.”

For the rest of the story, click on The Cancer Letter Archive at left to read the Nov. 6 issue (subscription or day pass required).

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tags: drug development

GAO Calls For Stronger FDA Enforcement Of Accelerated Approval Followup Studies

From The Cancer Letter, Oct. 30, 2009:

Has the FDA approach to accelerated approval of oncology drugs become dysfunctional?

—It has, says Sen. Chuck Grassley (R-Iowa). A report he requested from the Government Accountability Office tells the agency to force sponsors to conduct studies to demonstrate that drugs approved on surrogate endpoints provide clinical benefits.

—It has, agree the authors of a paper published in the Sept. 10 issue of the Journal of Clinical Oncology. According to the paper, by Elizabeth Richey et al., the proportion of accelerated approvals has dipped by more than half since the beginning of the decade. The authors also contend that the time required to process an accelerated approval drug in oncology is roughly the same as the time required for a regular approval.

Is FDA too generous to sponsors of drugs approved based on their impact on surrogate endpoints, as Grassley states? And is it, in fact, decelerating the accelerated approval process, as per the JCO paper?

For the rest of the story, click on The Cancer Letter Archive at left to read the Oct. 30 issue (subscription or day pass required).

Also in this issue, Richard Pazdur, director of the FDA Office of Oncology Drug Products, responds to the paper and provides the agency's own data showing that the median development time for an accelerated approval was a year shorter than a regular approval.

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tags: FDA|  drug development

Duke Halts Third Trial; Coauthor Disputes Claim That Data Validation Was Blinded

From The Cancer Letter, Oct. 23, 2009:

Duke University has suspended another clinical trial as part of an effort to check the scientific underpinnings of a genomic technology used to assign cancer patients to treatments.

The trial halted earlier this week was co-sponsored by Duke and the Department of Defense. A government-run database of clinical trials states that the trial was suspended on Oct. 19.

This is the third study to be stopped in connection with allegations that the genomic technology developed at Duke incorporated errors, which included poor handling of data and inaccurate calculations.

For the rest of the story, click on The Cancer Letter Archive at left to read the Oct. 23 issue (subscription or day pass required).


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tags: drug development|  policy issues