National Cancer Institute NCI Cancer Bulletin: A Trusted Source for Cancer Research News
August 9, 2011 • Volume 8 / Number 16

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NCI Director Dr. Harold Varmus (Photo by Daniel Sone, NCI) NCI Director Dr. Harold Varmus (Photo by Daniel Sone, NCI)

Varmus Reflects on First Year as NCI Director

At a July 27 town hall meeting marking his first year as NCI director, Dr. Harold Varmus reflected on what he sees as the main accomplishments of his tenure so far and described five areas of "shared ambition" toward which he hopes to guide NCI in the near future.

A full videocast of the event is now online. 

Also available is a written summary of his remarks—which includes links to recent interviews with Dr. Varmus that appeared in Nature, Science, and The Cancer Letter.

 

DCEG's Chatterjee Wins Statistical Awards

Dr. Nilanjan Chatterjee receives the COPSS Presidents' Award from Dr. Xihong Lin. Dr. Nilanjan Chatterjee (left) receives the COPSS Presidents' Award from Dr. Xihong Lin, president of COPSS.

Dr. Nilanjan Chatterjee, chief of the Biostatistics Branch in NCI's Division of Cancer Epidemiology and Genetics, received the Presidents' Award from the Committee of Presidents of Statistical Societies (COPSS). In the field of statistics, the award is considered the most prestigious honor for early career contributions. Dr. Chatterjee is the first recipient from outside academia in the award's 30-year history.

This year, Dr. Chatterjee also received the prestigious COPSS George W. Snedecor Award that is given biannually to a statistician who has made significant contributions to the theory of biometry and authored a notable publication within the last 3 years.

These awards are jointly sponsored by five statistical societies: the American Statistical Association, Institute of Mathematical Sciences, Eastern North American Region of the International Biometrics Society, Western North American Region of the International Biometrics Society, and Statistical Society of Canada.

NCI Researchers Win NIH Director's Awards

NCI researchers won two individual and four group NIH Director's Awards at a ceremony hosted by NIH Director Dr. Francis Collins in Bethesda, MD, on August 2.

Drs. Christine Berg and Sanford Dawsey Drs. Christine Berg and Sanford Dawsey

Dr. Christine Berg, chief of the Early Detection Research Group in NCI's Division of Cancer Prevention, received an award for her work as co-director of the National Lung Screening Trial (NLST). NLST was a randomized national trial involving 53,454 current and former heavy smokers ages 55 to 74. The final results of NLST showed that screening current or former heavy smokers with low-dose helical computed tomography (CT) reduced deaths from lung cancer by 20 percent compared with screening by chest x-ray.

Dr. Sanford Dawsey, a senior investigator in the Nutritional Epidemiology Branch in NCI's Division of Cancer Epidemiology and Genetics, received the Ruth L. Kirschstein Mentoring Award, an honor bestowed on those who have displayed significant leadership, skill, and ability while serving as a mentor. Dr. Dawsey's research focuses on the causes, prevention, and early detection of esophageal and gastric cancers. He was nominated for this award by two of the many research fellows he has supported and trained to lead studies in these areas. 

NCI researchers also won group awards for the following projects and collaborations: the NIH Patient Reported Outcomes Measurement Information System (PROMIS) Working Group; the National Collaborative on Childhood Obesity Research; the Deepwater Horizon Gulf Oil Spill; and the Gulf Long-Term Follow-Up Study.

CCR's Gonzalez and Colleagues Honored for Diagnostic Test

Dr. Frank Gonzalez, Mojdeh Bahar, and Dr. Betty Tong Dr. Frank Gonzalez, Mojdeh Bahar, and Dr. Betty Tong

Dr. Frank Gonzalez, chief of the Laboratory of Metabolism in NCI's Center for Cancer Research (CCR), and Dr. Pedro Fernandez-Salguero, a former CCR fellow who is now a professor in Spain, received the 2011 Federal Laboratory Consortium Award for Excellence in Technology Transfer for developing and transferring a life-saving diagnostic test to the marketplace. The award recognizes those who have done an outstanding job in transferring technology developed in a federal laboratory to partners in the private sector.

Drs. Gonzalez and Fernandez-Salguero determined the molecular basis of 5-fluorouracil (5-FU)-linked toxicity. They discovered a splicing mutation in the gene that encodes dihydropyrimidine dehydrogenase (DPD), an enzyme that is normally involved in degradation of the drug. Patients' sensitivity to 5-FU is directly associated with the presence of a mutated DPD gene and low DPD enzyme activity levels, resulting in the accumulation of 5-FU in the body. 

As a result of this work, patients can now be screened for the mutation before 5-FU is administered, which reduces the risk of life-threatening toxicity. The test has been nonexclusively licensed to several companies in Europe and the United States. 

Mojdeh Bahar and Dr. Betty Tong of NIH's Office of Technology Transfer were recognized for their contribution to the successful transfer of this diagnostic technology to a number of licensees. 

In the United States, approximately 275,000 cancer patients receive 5-FU annually. The transfer of this technology through nonexclusive licenses has allowed this diagnostic test to be widely disseminated.

"As a result of these multiple licenses," noted Dr. Gonzalez, "many patients around the world can avoid being treated with a drug that may prove to do them more harm than good."

Comments Sought on Changes to Human Subject Protections

The U.S. government is considering changes to the rules governing research involving human subjects and is seeking public input on proposed changes related to the ethics, safety, and oversight of human research. The proposed changes are designed to strengthen protections for human research subjects.

The current regulations governing human subject research, often called the Common Rule, were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at a single site. Expansion of human subject research into many new scientific disciplines and venues and an increase in multisite studies have highlighted ambiguities in the current rules and have led to questions about whether the regulatory framework is keeping up with the needs of researchers and research subjects.

Comment is sought on the following:

  • Revising the existing risk-based framework to more accurately calibrate the level of review to the level of risk
  • Using a single Institutional Review Board review for all domestic sites of multisite studies
  • Updating the forms and processes used for informed consent
  • Establishing mandatory data security and information protection standards for all studies involving identifiable or potentially identifiable data
  • Implementing a systematic approach to the collection and analysis of data on unanticipated problems and adverse events across all trials to harmonize the complicated array of definitions and reporting requirements, and to make the collection of data more efficient
  • Extending federal regulatory protections to apply to all research conducted at U.S. institutions receiving funding from the Common Rule agencies
  • Providing uniform guidance on federal regulations

The deadline for comments is September 26. To submit a comment, visit http://www.regulations.gov, enter HHS-OPHS-2011-0005 in the "Enter Keyword or ID" field, and click "Submit a Comment."

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