FDA Seeks Advisory Panel on Tobacco Industry

The US Food and Drug Administration (FDA) is creating a panel to advise the agency on "the impact of menthol in cigarettes, the use of descriptors such as Ôlight' on tobacco packages, and other sensitive issues as the agency grapples with implementing new powers to oversee the massive tobacco industry," according to a report in the Wall Street Journal.

The agency is seeking nominations for twelve panel members. Eight of the members will be experts in medicine, medical ethics science, and tobacco technology, according to a press release from the FDA. Three members will be representatives from the tobacco industry and one will be from the general public.

Tobacco legislation passed this year bans companies from selling flavored tobacco products, but not menthol cigarettes. In June, President Obama signed legislation that gives the FDA the authority to regulate the tobacco industry, allowing the agency to restrict tobacco advertising and promotions, collect user fees from tobacco companies, and stop illegal sales of cigarettes and other products to children.

The panel is expected to advise the agency on how smokeless tobacco affects public health, particularly that of children, and on setting benchmarks for what data are necessary to determine the risks associated with tobacco products.

Colorectal Cancer Mortality Risk Reduced With Aspirin
Regular aspirin use after the diagnosis of colorectal cancer is associated with a lower risk of colorectalcancer–specific and overall mortality, especially among individuals with tumors that overexpress COX-2, according to a study in the Journal of the American Medical Association.

The observational study, conducted by researchers at Harvard Medical School, Massachusetts General Hospital, and the Dana-Farber Cancer Institute, followed 1,279 men and women with nonmetastatic colorectal cancer for an average of 12 years.

Investigators recorded a total of 193 (35%) deaths and 81 (15%) colorectal-cancer–associated deaths among 549 patients who regularly used aspirin. There were 287 (39%) total deaths and 141 (19%) colorectal-cancer–specific deaths among 730 participants who did not use aspirin on a regular basis, the study authors said. Among the 719 participants who had not used aspirin before their diagnosis, those who began taking it after their diagnosis had a 47% lower risk of dying from the cancer and a 32% lower risk for dying prematurely from any cause during the study.

Organization Calls for Universal Comprehensive Eye Examinations for Children
Children may be more successful in school if they undergo mandatory universal comprehensive eye examinations before they return to school in the fall, according to a report from the National Commission on Vision and Health.

The report, "Building a Comprehensive Child Vision Care System," found that children have their eyes examined at low rates and that those who do often fail to receive necessary follow-up and treatment, particularly children without health insurance and those living in poverty. Although many states require that children receive some type of vision screening prior to entering public schools, most states do not use the most sophisticated screening tests and neglect to enforce follow-up for children who fail the examination, according to the report. Currently, Kentucky, Illinois, and Missouri are the only states that require comprehensive eye examinations for children entering school. Fifteen states do not require any form of eye screenings or examinations. The inconsistency among states is creating a public health emergency for millions of children, the commission declared.

The commission recommended that agencies at the federal, state, and local levels collaborate with academic institutions, businesses, providers, and the public to create a comprehensive vision care system that will ensure all children are assessed for potential eye and vision problems, both before they enter school and throughout their education. In addition to universal access to vision care, the commission recommended accountability within local public health agencies, a national education campaign, and ongoing data collection to monitor the use and efficacy of vision examinations for children.

Smoking During Pregnancy Associated With Pancreatic Cancer
A woman who smokes during pregnancy and while raising a daughter may increase the child's risk of developing pancreatic cancer, according to a study published in Cancer Epidemiology, Biomarkers, and Prevention.

Researchers at Harvard University and Imperial College London examined pancreatic cancer rates in the Nurse's Health Study, which followed 86,673 women over 24 years. Over that period of time, 384 women were diagnosed with pancreatic cancer. The rates of pancreatic cancer were significantly higher for women whose mothers smoked around them when they were young. Paternal smoking was not associated with the risk, the study authors said.

FDA Warns About the Dangers of Body-building Supplements
The FDA sent a warning letter to American Cellular Laboratories, Inc., a manufacturer of body building supplements that include TREN-Xtreme, MASS Xtreme, ESTRO Xtreme, AH-89-Xtreme, HMG Xtreme, MMA-3 Xtreme, VNS-9 Xtreme, and TT-40-Xtreme. The FDA stated that the company claims these products contain steroid-like ingredients, but in fact contain synthetic steroids. Synthetic steroids are unapproved new drugs that have not been reviewed by the FDA for safety and effectiveness.

According to an FDA public health advisory, the agency has received reports of serious adverse events associated with the use of these products and other similar products marketed as alternatives to anabolic steroids for increasing athletes' muscle mass and strength. The adverse events reported generally involve men between the ages of 22 and 55 and include cases of serious liver injury, stroke, kidney failure, and pulmonary embolism.

The FDA recommends that consumers immediately stop using all body-building products that claim to contain steroids or steroid-like substances. Consumers are advised to consult their health care professional if they are experiencing symptoms possibly associated with these products, particularly nausea, weakness or fatigue, fever, abdominal pain, chest pain, shortness of breath, jaundice, or brown or discolored urine. Furthermore, the FDA requests health care professionals to ask their patients about any over-the-counter products they may be using, including products marketed as dietary supplements, and to be aware of the warning signs that may be associated with the use of steroids or steroid-like substances.

Migrating to the United States Increased the Risk of Some Cancers in Hispanics
Hispanics who move to the United States are 40% more likely to develop certain cancers than those who remain in their native countries, according to a study in Cancer Epidemiology, Biomarkers, and Prevention.

Paulo S. Pinheiro, MD, PhD, MSc, of the University of Miami Miller School of Medicine, and colleagues analyzed data from the 301,944 cancer cases that were reported to the Florida Cancer Data system between 1999 and 2001.

The researchers found that "substantial variability in cancer rates occurs among Hispanic subpopulations." For example, among Florida Hispanics, Puerto Ricans had the highest rates, followed by Cubans, and Mexicans had the lowest rates. Cubans, like whites, have low rates of cervical and stomach cancers. First generation Puerto Ricans and Cubans in Florida showed rates of colorectal, endometrial, and prostate cancers similar to whites in the state.

Rates for Hispanics in Florida were at least 40% higher than Hispanics in their countries of origin. Because rates of cancer are markedly lower in Hispanic countries, the investigators advised that the increased risk for cancer among Cubans, Mexicans, and Puerto Ricans who move to the United States should be further studied.

David S. Boyer, MD, is a Clinical Professor of Ophthalmology at the University of Southern California Keck School of Medicine, Department of Ophthalmology, in Los Angeles. He is a member of the Retina Today Editorial Board. Dr. Boyer may be reached at +1 310 854 6201; fax +1 310 652 7250; or via e-mail: vitdoc@aol.com.