WASHINGTON, DC—Shortly after President Obama signed into law the historic bill giving the US Food and Drug Administration authority to regulate tobacco, the Institute of Medicine (IOM) released a new report at the National Press Club here calling for the armed forces and veterans to become tobacco free, among other recommendations.
The report, “Combating Tobacco Use in Military and Veteran Populations,” was requested by the Department of Defense (DoD) and the Department of Veterans Affairs (VA).
Currently, about 32% of active-duty military personnel and 22% of veterans smoke or use smokeless tobacco, said Stuart Bondurant, MD, Chair of the IOM committee that wrote the report and Professor of Medicine and Dean Emeritus at the University of North Carolina School of Medicine in Chapel Hill. These percentages are higher than the US average for tobacco use, which now stands at about 19.8%, he noted.
Not only does tobacco use in military and VA populations cost taxpayers hundreds of billions in smoking-related absenteeism and medical costs for cardiovascular, respiratory and lung diseases, and many kinds of cancers, but it also “exacts a significant toll on the readiness and effectiveness of our troops,” Dr. Bondurant said.
A study cited in the report found that the direct health care costs alone for prevention and diagnosis of and treatment for tobacco-related diseases in US military personnel in 1995 amounted to $584 million, mostly for hospitalization (77%) and physician fees (18%).
Ironically, “DoD indirectly encourages the use of tobacco by military personnel and dependents via the availability of discounted tobacco products in the exchange and commissary system in deployed and nondeployed locations,” the authors of the report wrote.
Dr. Bondurant noted that the stress experienced by active-duty men and women lends itself to tobacco use, and that there is some evidence that tobacco use is increasing among young soldiers deployed to Iraq and Afghanistan. Troops returning from those countries with post-traumatic stress syndrome (PTSD) often are smokers—“those two are known to be associated and need special kinds of attention,” he said.
Indeed despite strong and long-standing efforts by the VA and the DoD to cut tobacco use, the military culture fosters smoking, as typified by iconic photos of combat soldiers in fatigues with lit cigarettes hanging out of their mouths. The committee concluded that tobacco use in the military needs to be “de-normalized,” he said.
What the IOM committee wants is for the military to set a “date certain” by which the armed forces will be tobacco-free, said IOM committee member Kenneth W. Kizer, MD, MPH, Chairman of Medsphere Systems Corporation, an information technology company in Rocklin, CA, and former VA Under-Secretary for Health in the Clinton administration, as well as a former Director of the California Department of Health Services.
As for a timeline, Dr. Kizer said that “this could be done with effective leadership within five to 10 years.” He said the military within that time frame could: eliminate the sale of tobacco products on bases; provide smoke-free housing to military personnel; and offer smoking cessation not only to military personnel but also to their spouses, since a smoking spouse exposes a serviceman or woman to secondhand smoke and discourages him or her from quitting.
“This is a family problem; it's a long-term problem,” Dr. Kizer said.
Asked by OT if President Obama's openly admitted and discussed personal struggle in giving up cigarettes could help provide leadership at the top to reduce tobacco use in the military since he is Commander-in-Chief, Dr. Kizer said yes. “Frankly it's highly commendable that he has acknowledged his struggle,” Dr. Kizer said. “As [with him being] Commander-in-Chief of the armed forces, I can't think of a better place for such leadership to start.”
Asked if giving the FDA new powers to control tobacco is likely to boost efforts to reduce tobacco use in the military, Dr. Bondurant called the new law “a supportive development.” He said that under the new law, FDA will be able to regulate the approval of new products slated to be put on the market by the tobacco industry.
“Under this law the VA and DoD can see what's coming and develop programs to combat them,” he said.
The Institute of Medicine report makes the following recommendations, among others:
* The military should set a specific date to become tobacco-free and make compliance with that date in all the armed services mandatory.
* Military academies, officer-candidate training programs, and university-based ROTC programs should become tobacco-free first, followed by new enlisted personnel and then all other active-duty personnel.
* The Department of Defense, the armed services, and the VA should develop comprehensive, integrated tobacco-control programs with timelines for benchmarks and strategies for achieving them.
* Tobacco use should be eliminated on military installations and in VA medical facilities.
* The sale of tobacco products should be prohibited on all military installations. If tobacco products are sold, they should be sold not at discount but at prices at least equal to and preferably higher than local civilian retail prices.
* The authority for developing tobacco-control policies should be placed at high-level leadership entities within the DoD and VA.
* All DoD and VA staff and patients should have access to tobacco-cessation programs if they use tobacco.
* The Veterans Health Care Act of 1992 should be repealed to allow VA health-care facilities to become entirely tobacco-free.
* Smokeless-tobacco cessation treatment should be provided as well as smoking cessation treatment.
* DoD and the VA should follow VA/DoD and US Public Health Service guidelines for treating tobacco use in patients who have mental health disorders.
* DoD and the VA should develop and fund a joint comprehensive research plan on tobacco control in military and VA populations.
‘Out-of-Date Anachronistic Federal Law’
Although the VA has programs to help veterans quit smoking, it is thwarted by Congressional legislation that Dr. Kizer termed “an out-of-date and anachronistic federal law.” That law, the Veterans Health Care Act of 1992, requires VA medical facilities to provide designated smoking areas for both veterans and hospital employees.
The IOM committee decried that law, which is contrary to policies in most hospitals, stating that it prevents the VA “from protecting its patients, employees and visitors from possible exposure to secondhand smoke and prevents it from promoting the health of its more vulnerable patients, those who smoke.”
FDA Approvals for Dasatinib for CML Resistant to Prior Therapy & Bevacizumab for Glioblastoma Progression after Standard Therapy
Sprucel (dasatinib) has received full approval from the FDA for the treatment of adults in all phases of chronic myelogenous leukemia (CML) with resistance or intolerance to prior therapy.
The oral tyrosine kinase inhibitor was originally approved under accelerated approval regulations based on its effectiveness in producing hematologic and cytogenetic responses in CML. This new approval was based in part on results from a Phase III randomized, open-label dose-optimization study of 670 chronic-phase CML patients who were resistant to or couldn't tolerate imatinib.
Patients were followed for at least two years after beginning the recommended starting dose of dasatinib of 100 mg once daily. Results from 167 patients showed a progression-free survival rate of 80% and an overall survival rate of 91%. Sixty-three percent of patients achieved a major cytogenetic response, 93% of whom maintained it for 18 months.
The new approval for Avastin (bevacizumab) was for treatment of glioblastoma multiforme that continues to progress with standard therapy. The drug had already been approved for metastatic cancer of the colon or rectum, metastatic breast cancer, and non-squamous, non-small-cell lung cancer.
The new indication was granted under the FDA's accelerated approval program that allows provisional approval of medicines for cancer or other life-threatening diseases. The effectiveness in glioblastoma is based on an improvement in objective response rate, observed in 26% of 85 patients treated with the drug in an open-label, multicenter, non-comparative Phase II study that included 167 patients with glioblastoma that had progressed following initial treatment with temozolomide and radiation.
Currently, no data are available from randomized controlled trials demonstrating an improvement in disease-related symptoms or increased survival with bevacizumab in glioblastoma.
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