INVITED COMMENTS ON CANCER: Thoughts from Distinguished Cancer Center Members
FDA Issues Proposal to Extend Authority Over Additional Tobacco Products
The following piece was written by Dr. Erika Trapl, Associate Director of the Prevention Research Center for Healthy Neighborhoods, and Assistant Professor of Epidemiology & Biostatistics at CWRU. Dr. Trapl was invited to write this guest commentary based on her extensive research in with e-cigarettes and other tobacco products.
The Food and Drug Administration's (FDA) Center for Tobacco Products recently proposed a new rule to extend their regulatory authority to cover alternative tobacco products –including e-cigarettes, cigars, pipe tobacco, nicotine gels, waterpipe (hookah) tobacco, and dissolvables. For those involved in tobacco control, this announcement from the FDA is long overdue and is just the first step in beginning to exercise the regulatory actions needed to continue to reduce tobacco use in the U.S.
In 2009, the Family Smoking Prevention and Tobacco Control Act was enacted, creating the Center for Tobacco Policy (CTP) within the FDA. The CTP gave the FDA regulatory authority over the manufacture, marketing, and distribution of tobacco products to protect public health and to reduce tobacco by1:
- Requiring tobacco product manufacturers to register with FDA.
- Establishing standards for tobacco products, such as tar and nicotine levels, in an effort to reduce their toxicity and addictiveness.
- Establishing limits on the sale and distribution of tobacco products.
- Requiring premarket review for new and modified risk tobacco products to protect the public health.
However, the FDA's regulatory authority has been limited to cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco, which allowed tobacco companies to skirt regulations and entice a new generation of smokers by marketing alternative tobacco products. While FDA was able to ban flavored cigarettes in 2009, that ban did not extend to flavored cigars, cigarillos and little cigars or the shisha tobacco used in hookah pipes, products that are heavily marketed to youth and young adults.
Our local surveillance data in Cuyahoga County has revealed that high school youth are using other tobacco products at the higher rates than cigarettes. Specifically, in 2013, only 10.4% of high school youth reported smoking cigarettes in the past 30 days, compared to 10.6% reporting current hookah use and 16.9% reporting current cigar, little cigar, or cigarillo use2.
Recently, electronic cigarettes (e-cigarettes) have been receiving a significant amount of attention in the media. While not a tobacco product, these devices are designed to look like a cigarette and deliver nicotine through an inhaled aerosol. Only e-cigarettes marketed for therapeutic purposes are regulated by the FDA; the vast majority of products on the market are currently unregulated. Without regulation, e-cigarette manufacturers are not obligated to report the contents of the e-cigarette cartridges; the use of flavors is widespread and may make the product more appealing to youth. Similarly, there are no limitations placed on marketing or promotion practices, and tobacco control advocates have noted that e-cigarette companies are using strategies used by tobacco companies in the past to attract the youth market.
Proponents of e-cigarettes argue that these products are useful cessation aids, that the contents of e-cigarettes are significantly safer than smoking tobacco, and that these products are being marketed to current smokers. There are many more questions to be answered before knowing the full risk of these products. However, extending FDA regulatory authority to these products is the one of the surest ways to protect the public's health, especially youth.
The FDA's proposed new rule would close the loophole for alternative tobacco products by:
- Requiring tobacco companies to register with the FDA and report product & ingredient listings.
- Only allowing tobacco companies to market new tobacco products after completing an FDA review.
- Only allowing tobacco companies to make direct and implied claims of reduced risk if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health as a whole.
- Preventing tobacco companies from distributing free samples.
The proposed new rule is just a first step to make an impact on U.S. smoking rates. The FDA must next look to apply rules currently enacted for cigarettes to alternative tobacco products, including banning flavored products, the use and messaging of warning labels, and restricting marketing practices from targeting youth.
Tobacco use remains the leading cause of preventable death and disease, including cancer and cancer death, in the United States today3. By supporting the FDA's proposed new rule extending its regulatory authority over these alternative tobacco products, we can help to reduce the 440,000 deaths attributable to tobacco each year, including the nearly 40% of these deaths caused by cancer.
2Trapl ES, Frank JL, Yoder LD, Jewett-Tennant J, Borawski EA (Jan. 2014). Youth Data Brief: Youth Smoking in Cuyahoga County. Cleveland, OH: Prevention Research Center for Healthy Neighborhoods at Case Western Reserve University
3U.S. Department of Health and Human Services. The Health Consequences of Smoking–50 Years of Progress. A Report of the Surgeon General. Atlanta: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2014 [accessed 2014 May 6].
CASE CCC IN THE NEWS
ARRS: Higher Chemo Odds for Non-Screened Breast CA Patients
Doctor's Lounge - May 9, 2014
Middle-aged breast cancer patients undergoing screening mammography are statistically less likely to be treated with chemotherapy compared to non-screened patients, according to a study presented at the annual meeting of the American Roentgen Ray Society, held from May 4 to 9 in San Diego. Nelly Salem, M.D., from University Hospitals-Case Western Reserve in Cleveland, and colleagues compared the use of chemotherapy for treatment of breast cancer in women ages 40 to 49 undergoing screening mammography (screened; 149 patients) compared to women diagnosed after diagnostic evaluation (non-screened; 81 patients)...
Lakewood and University Heights women face down cancer with help of The Gathering Place: Faces of the Suns
The Plan Dealer - May 7, 2014
The following two profiles focus on local women who have found the resources to face their battles with cancer at The Gathering Place, a non-profit agency that provides comfort, support and multiple resources for individuals facing cancer, as well as their families and friends... And just when she needed it most, her doctor threw her a lifeline. Dr. Julian Kim, her surgeon at University Hospital, handed her a packet of brochures from The Gathering Place while on an office visit...Aside from her doctors,Dr. Henry Koon and Dr. Julian Kim, whom she says delivered the "one-two punch" in her battle with cancer, the agency provides her with support and encouragement she could not find elsewhere.
RESEARCH HIGHLIGHTS/MEMBER NEWS
Jackson Lab Research Highlighted by Mammary Cell News
A publication by the Jackson lab was highlighted in the most recent issue of Mammary Cell News. The paper, "Conserved Oncogenic Behavior of the FAM83 Family Regulates MAPK Signaling in Human Cancer" (Mol Cancer Res Online First Apr 15, 2014), found FAM83 proteins represent a novel family of oncogenes suitable for the development of cancer therapies aimed at suppressing MAPK signaling.
Alex's Lemonade Stand Foundation
Alex's Lemonade Stand Foundation is accepting applications for the following funding opportunities:
- The purpose of the 'A' Award Program encourage the best and brightest early career researchers to build lifelong careers and become leaders in the field of pediatric cancer research. To advance research that will lead to new treatments and cures impacting children with cancer.
Deadline: May 23
- The purpose of the Reach Award is to advance ALSF's mission to find cures and better treatments for childhood cancers by providing support to move hypothesis-driven research into the clinic. Significant barriers exist that impede the translation of innovative and important ideas to the clinic. The Reach Award seeks to remove one of these barriers by providing support for important pre-clinical projects that are necessary to move a study from the pre-clinical arena into a clinical trial. Thus, the goal of this award is to support selected "late translational" studies needed to ultimately initiate a clinical trial. Preference will be given to those research projects which, if funded, will result in the initiation of a clinical trial within two to three years.
Deadline: May 30
- The Bio-Therapeutics Impact award provides funding to support investigator-initiated clinical trials using biologic therapies, including but not limited to immunotherapy, gene therapy and small molecules. This grant category was initiated to accelerate the development of clinical trials for promising biologic approaches to treat childhood cancers through clinical trials. ALSF's Travel Fund is available to patients enrolled in the clinical trials supported by the Bio-Therapeutics Impact Award. Transportation, lodging, and meal accommodations are available to eligible families who meet our criteria as listed in the Travel Fund guidelines. A medical representative can apply on behalf of the family using our online form; you must specify the clinical trial and that it is funded by ALSF's Bio-Therapeutics Impact Award.
Deadline: June 12
Elsa U. Pardee Foundation
The Elsa U. Pardee Foundation funds research to investigators in United States non-profit institutions proposing research directed toward identifying new treatments or cures for cancer. The Foundation particularly encourages grant applications for a one year period which will allow establishment of capabilities of new cancer researchers, or new cancer approaches by established cancer researchers. It is anticipated that this early stage funding by the Foundation may lead to subsequent and expanded support using government agency funding. Project relevance to cancer detection, treatment, or cure should be clearly identified.
Deadline: June 1; Oct 1; Feb 1
DoD Prostate Cancer Research Program
Applications to the Fiscal Year 2014 (FY14) Prostate Cancer Research Program (PCRP) are being solicited for the Assistant Secretary of Defense for Health Affairs, Defense Health Program, by the U.S. Army Medical Research Acquisitions Activity.
- The Idea Development Award supports new ideas that represent innovative approaches to prostate cancer research and have the potential to make an important contribution to the PCRP mission. Although groundbreaking research often involves a degree of risk, applications should be based on a sound scientific rationale that is established through logical reasoning and/or critical review and analysis of the literature. Due to this award's emphasis on innovation, the presentation of preliminary data relevant to prostate cancer and the proposed project is encouraged but not required. Research deemed innovative may represent a new paradigm, challenge current paradigms, look at existing problems from new perspectives, or exhibit other highly creative qualities. Research that is an incremental advance upon published data is not considered innovative.
Pre-Application (Preproposal) Deadline: June 12
Application Deadline: September 24
- The Synergistic Idea Development Award supports new ideas that represent innovative approaches to prostate cancer research involving two or three independent, faculty-level (or equivalent) Principal Investigators (PIs). These investigators should utilize their complementary and synergistic perspectives to address a central problem or question in prostate cancer research. This award is designed to support both new and pre-existing partnerships. The overall goal of this award is to significantly accelerate advances in prostate cancer research to support the PCRP vision of conquering prostate cancer. The PCRP seeks applications from investigators working in a wide spectrum of disciplines including, but not limited to, basic science, engineering, bioinformatics, population science, translational research, and clinical research. In addition, applicants are expected to address at least one of the PCRP focus areas and are highly encouraged to address one of the PCRP overarching challenges.
Pre-Application (Preproposal) Deadline: June 12
Application Deadline: September 24
- The PCRP Biomarker Development Award was introduced in FY12 to fund near-term validation or qualification studies that will advance known prostate cancer biomarkers into the clinical setting. Specifically, this award will support high-impact research aimed at multi-institutional validation and/or qualification of prostate cancer biomarkers for crucial decision making in prostate cancer management, including detection of aggressive disease, prognosis and progression, and prediction and assessment of response to therapy.
Pre-Application (Preproposal) Deadline: June 18
Application Deadline: September 24
Join Our Team - Race for the Place
Walk or run with the Case Comprehensive Cancer Center team at the Race for the Place, June 1, 2014. This great event helps The Gathering Place to offer services to anyone touched by cancer, no matter their economic situation. Anyone is welcome to join our team. If you can't make the Race in person, please consider making a donation to support our efforts. Click here to view our team page.
MARK YOUR CALENDARS
Meso Scale Discovery Seminar
Come learn more about an ultrasensitive multiplexing platform that provides consistent results at an informational seminar on Wednesday, May 14 at 12 pm in Wolstein Research Building 1-413. The Meso Scale Discovery utilizes electrochemiluminescent detection and multiplex enabled carbon electrodes to offer customers a platform with rapid read times (1-3 minutes per plate), robust instrumentation, unsurpassed sensitivity, and large dynamic ranges. MSD now offers even greater flexibility with V-PLEX, a fully validated and customizable product line with easier protocols and delivery time of 1-3 days.
To learn more about MSD or to RSVP for the seminar by Tuesday, May 13, contact Brian Gribble, Account Manager, at 412.302.7368 or firstname.lastname@example.org. This seminar sponsored by Dr. John Pink and Paul Hartman of the Translational Research & Pharmacology Core Facility.
nanoString Technologies Seminar
Come hear about some of the latest products and technology offered by nanoString Technologies. On Thursday, May 15 at 11 am in Wolstein Research Building 2-136, representatives from nanoString Technologies will present on Applications of nanoString's nCounter System for Translational Oncology Research: Molecules that count™. nanoString Counter is a digital nucleic acid quantification platform used for gene expression, single cell, miRNA, CNV, and ChIP/RIP-String analysis projects and applications.
Society for Integrative Oncology 11th International Conference
The Society for Integrative Oncology has opened its Call for Abstracts for SIO's 11th International Conference, to be held October 26-28 in Houston, Texas. The abstract submission deadline has been extended to May 15 at 11:59 pm ET. In keeping with this year's conference theme of "Personalized Integrative Oncology: Targeted Approaches for Optimal Outcome," individuals submitting abstracts are encouraged to consider the targeted and personalized approaches of their work and its relevance to integrative cancer care.
CME Event - Screening for Cancer in Women: 2014
Registration is open for Screening for Cancer in Women: 2014, Wednesday, May 21 from 8 am - 3:35 pm at the Embassy Suites Hotel in Independence.
This conference will feature speakers from health centers across Northeast Ohio working together to fight cancer, who will offer expert insight, updates, and advice on screening for cancer in women.
KEYNOTE ADDRESS: Cancer Screening and Prevention in High-Risk Women
Allison Kurian, MD, MSc, Assistant Professor, Medicine (Oncology) and Health Research & Policy, Associate Director, Stanford Program in Clinical Cancer Genetics, Physician Leader, Stanford Women's Cancer Genetics Clinic, Stanford University
PRESENTERS AND PANELISTS
Stan Gerson, MD: Welcome
Holly Marshall, MD: Breast Cancer Screening
Jeff Marks, MD: Update on Colon Cancer Screening in Women
Brian Bolwell, MD: Affordable Care Act
Allison Vidimos, MD: Skin Cancer Screening in Women
Phyllis Nsiah-Kumi, MD, MPH: Cancer Disparities
Allison Kurian, MD, MSc; Andrea Sikon, MD, FACP; Shaveta Vinayak, MD; Cindy Zelis, MD: Panel Discussion
Charles Lau, MD, MBA: Lung Screening
Kim Gecsi, MD: Gynecologic Cancer Screening
Paula Silverman, MD: Closing Remarks
Donna Plecha, MD, Activity Director
Paula Silverman, MD, Chair
Lyndsay N. Harris, MD
Halle Moore, MD
Primary care physicians, hematologists, medical oncologists, and nurses should attend this course.
CME credit will be offered. Visit the conference website for more details and registration information.
Call for Abstracts: Case CCC Annual Scientific Retreat
Thewill be held July 10-11, 2014. We will kick-off the retreat in late afternoon on Thursday, July 10 at the Wolstein Research Building with a keynote presentation by Kevin Shannon, MD from UCSF, an expert in Myc and RAS in cancer. A cocktail reception with heavy hors d'oeuvres will follow, allowing you the chance to network with your colleagues. New this year, there will be discussion of new members and their research, including poster presentations during the reception.
The retreat will continue Friday, July 11 at Corporate College East. We have a full scientific line-up of talks from Cancer Center members. A mid-day breakout for each scientific program to discuss new initiatives, collaborations, and requests for Cancer Center support through research pilot project and core resources will be one of the highlights of the day.
Finally, we will once again have poster presentations by the next generation of cancer researchers. All trainees, fellows and students are encouraged to submit an abstract. Monetary prizes will be awarded.
Pre-registration to attend the retreat is required. The retreat is open to Cancer Center members, Core Facility Directors/Managers, and students, fellows or postdocs who present posters..
NCRM Cancer Stem Cell Conference
The first CWRU: National Center for Regenerative Medicine Cancer Stem Cell Conference will be held in Cleveland, August 17-20, 2014. This conference is guaranteed to have incredible research from a variety of backgrounds in the Cancer Stem Cell field, and will feature keynote speakers from over 25 different institutions from around the world.
Attendees are invited to submit abstracts of original investigation for consideration in the conference poster session and possible short talk podium presentations. Accepted abstracts will be published online on the conference website and the conference program. Abstract submission deadline is June 1.
In addition, the conference will offer Cancer Stem Cell Conference Abstract Awards that are sponsored by the CWRU School of Medicine Dean's Office. Six outstanding graduate students will be chosen to receive free registration to attend this conference and present their abstracts. This opportunity is open to all graduate students interested in attending this conference. Contact Lyn Haselton (email@example.com; 216.844.5375) for more information.
PREVIOUSLY ANNOUNCED OPPORTUNITIES
2014 AACR Outstanding Investigator Award for Breast Cancer Research, funded by Susan G. Komen®
Vilcek Prizes For Creative Promise in Biomedical Science
NIH BULLETIN – Notices and Funding Opportunities
Notice of National Cancer Institute (NCI) Participation in PAR 14-191 "Genomic Resource Grants for Community Resource Projects (U41)"(NOT-CA-14-034)
Request for Information (RFI): Global Cookstove Distribution Programs and Projects for Evaluation of Health Benefits (NOT-TW-14-008)
Pilot Studies in Pancreatic Cancer (R03)(PA-11-298)
Research on Malignancies in the Context of HIV/AIDS (R01)(PA-13-377)
Paul Calabresi Career Development Award for Clinical Oncology (K12)(PAR-13-201)
Center for Inherited Disease Research (CIDR) High Throughput Sequencing and Genotyping Resource Access (X01)(PAR-14-207)
HELP US HELP YOU!
If you have a new grant, recently won an award, or have other newsworthy items, please let us know so we can publicize them in the newsletter and other media outlets. You deserve the accolades! Send items to Gillian Irwin firstname.lastname@example.org.