Clinical Briefs April 2010

by U.S. Medicine

April 19, 2010

Survey Highlights Substance-Use Treatment Need Among Uninsured

An estimated 3 million full-time workers in America without health insurance (16.3% of all full-time workers without health care insurance) needed substance-use treatment in the past year according to a national survey conducted by SAMHSA. Levels of need were particularly high among those in this category who were aged 18 to 25 (24.4%) and males (19.2%).

The survey also revealed that among these uninsured workers in need of substance use-treatment only 12.6% received treatment at a specialty facility. More than 80 percent of uninsured full-time workers needing treatment in the past year did not perceive a need for treatment and while the remaining 6.6% of all workers in need of treatment did perceive the need for treatment they did not receive it.

“This tremendous unmet need for substance-use disorder treatment among this workforce has a devastating public health and economic effect on our nation,” said SAMHSA administrator Pamela S Hyde, in a statement. “We cannot afford to ignore this problem. Substance-use disorder treatment has proven to be a cost-effective investment for promoting safe and productive workplaces as well as renewed hope for those affected by this disease.”

A major benefit/cost evaluation of overall substance treatment programs determined that every $1 invested in substance abuse treatment yielded $7 in benefits to society in the form of such things as reduced crime costs and increased employer earnings. Other studies have shown that employees receiving needed substance-use treatment have dramatically reduced rates of absenteeism, tardiness, on-the-job injuries, mistakes, and disagreements with supervisors.

The report, Substance Use Treatment Need Among Uninsured Workers, is based on data collected during 2007 to 2008 from a nationally representative sample of 10,210 adults ages 18 to 64 employed full time and without health insurance who participated in SAMHSA’s National Survey on Drug Use and Health.

AHRQ and American College of Cardiology Partner on Implantable Defibrillator Study


A $3.5 million research project that will study the long-term benefits and risks of implantable cardioverter defibrillators in patients at risk of death from ventricular fibrillation will be supported by AHRQ and the American College of Cardiology. The project is being conducted in cooperation with the National Heart, Lung, and Blood Institute.

Ventricular fibrillation requires prompt attention; if the abnormal rhythm continues for more than a few seconds, blood circulation will cease, and sudden cardiac death may occur in minutes.

Patients at risk for ventricular fibrillation sometimes have ICDs implanted in their chests. These battery-powered devices, which are typically about three inches high and two inches wide, monitor the heart for abnormal heartbeats. If they detect potentially life-threatening rhythms, they deliver an electric shock to restore normal rhythm.

“This study will provide critically important data from the real world of everyday medicine to inform discussions about the long-term benefits of ICD use,” explained AHRQ Director Dr Carolyn M Clancy. “This study is an excellent example of how government and the private sector can work together to advance research and improve the quality and safety of health care services.”

The new three year study will be conducted by members of the AHRQ-supported HMO Research Network, a consortium of 15 health care delivery systems that conduct research on various topics, including medical effectiveness and safety. The systems are also part of NHLBI’s Cardiovascular Research Network.

The study will follow 3,500 patients with ICDs from the Cardiovascular Research Network to determine how often the devices deliver shocks, whether the shocks are appropriate, and to identify those patients who are most likely to require ICD shocks. AHRQ is providing $2.1 million to construct the study sample and collect ICD shock data within the first two years of the study. The American College of Cardiology Foundation is providing $1.4 million to collect and analyze shock data during the remainder of the study.

New Safety Plan Approved for Chemotherapy-Related Anemia Treatments


In order to ensure the appropriate administration of drugs treating chemotherapy-related anemia, FDA is requiring a risk management program to inform healthcare providers and their patients about the risks of a class of drugs called Erythropoiesis-Stimulating Agents. ESAs, which include epoetin alfa (marketed as Procrit® and Epogen®) and darbepoetin alfa (marketed as Aranesp®), are manufactured by Amgen Inc. ESAs are forms of the human protein erythropoietin, which stimulates bone marrow to make red blood cells.

In April 2008, FDA required Amgen Inc to establish this risk management program based on studies that found that ESAs caused tumors to grow faster and resulted in earlier deaths in some cancer patients. Amgen’s risk evaluation and mitigation strategy requires health care professionals to provide their patients receiving an ESA with a Medication Guide that contains information for patients on how to safely use a drug.

In addition, the company’s APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe Use of ESAs) program, which is part of the REMS, requires specific training and certification of health care professionals who administer chemotherapy to patients with cancer and counseling of their patients. It does not apply to patients being treated with an ESA for anemia due to other circumstances.

Through the risk management program, Amgen must ensure that health care professionals who treat patients with cancer register and maintain active enrollment in the ESA APPRISE program; complete a special training module on how to use ESAs in patients with cancer; and discuss the risks, benefits, and FDA-approved uses of ESAs with patients. Amgen is also required to oversee and monitor health care professionals and hospitals that use ESAs for patients with cancer to ensure that these caregivers are fully compliant with all aspects of the overall risk management program.

ESAs are approved for the treatment of anemia that may occur as a result of kidney failure, from certain kinds of chemotherapy, from the drug AZT, which can be used for the treatment of HIV infection, and for the treatment of anemia among certain patients undergoing surgery.

FDA Partners to Help Develop Pneumococcus Vaccine


The FDA is working in collaboration with the international nonprofit organization PATH to advance development of a vaccine to protect children against diseases caused by Streptococcus pneumoniae (pneumococcus), especially pneumonia. Worldwide, the bacterium also causes infections of the brain (meningitis), blood (sepsis), and middle ear (otitis media) and each year kills about 1 million children younger than five years of age. The collaboration aims to improve the techniques used to produce effective, safe, and affordable vaccines against pneumococcal disease for children in the developing world. The Seattle-based PATH works to create sustainable, culturally relevant, and affordable solutions to help communities worldwide to break cycles of poor health.

The collaborative project, expected to run for two years, is being conducted under the Cooperative Research and Development Agreement program. The program allows federal laboratories and businesses to form partnerships that help expedite research activities. Under the agreement, PATH will help the FDA obtain materials needed for the agency to develop the conjugate vaccine technology. PATH also will provide approximately $480,000 to the FDA for the development of both the conjugation technology and tests to determine if the carrier proteins are properly linked to the polysaccharides.

The goal of the CRADA is to evaluate the application of Center for Biologics Evaluation and Research conjugation technology to pneumococcal vaccines. If it holds promise for fulfilling the goal of providing safe, effective, and affordable pneumococcal vaccines, the CRADA permits transfer of the technology to the China National Biotec Group’s Chengdu Institute of Biological Products, and eventually to groups in other developing countries as appropriate.

The goal of the FDA’s work is to improve the efficiency of a key technology in the development of pneumococcal conjugate vaccine candidates. The technology is used to link a piece of the bacterium’s surface coating, a polysaccharide made up of long chains of sugars, to a special molecule called a carrier protein in a process called conjugation. When carrier proteins are joined with the polysaccharides, they significantly increase the strength of the immune response. Without these proteins, the polysaccharides by themselves would not trigger an adequate immune response in young children.

CBER conjugation technology has already been used by the Meningitis Vaccine Project—a partnership between PATH and the World Health Organization—for the development of a conjugate vaccine to prevent meningococcal meningitis in Africa.

Analysis Confirms Heart Disease Risk With Postmenopausal Hormone Therapy


New analyses from the Women’s Health Initiative confirm that combination hormone therapy increases the risk of heart disease in healthy postmenopausal women. Researchers report a trend toward an increased risk of heart disease during the first two years of hormone therapy among women who began therapy within 10 years of menopause, and a more marked elevation of risk among women who began hormone therapy more than 10 years after menopause. Analyses indicate that, overall, a woman’s risk of heart disease more than doubles within the first two years of taking combination HT. Also, the difference in the initial level of risk does not appear related to age, based on findings that the increased risk of heart disease was similar between women in their 50s on combination hormone therapy and women in their 60s. The study, sponsored by the NHLBI, was published in the Feb. 16, 2010, Annals of Internal Medicine.

Researchers from the Harvard School of Public Health and the NHLBI reanalyzed data from the landmark WHI clinical trial of the effects of combination hormone therapy in 16,608 postmenopausal women with an intact uterus, ages 50 to 79 years (average age of 63) at enrollment.

Inthenewanalyses,theresearcherscomparedtheeffectsofhormonetherapyonheartdiseaseriskamongwomenwhobeganhormonetherapywithin 10 years of menopause and women who began therapy more than 10 years after menopause. The researchers used models that adjusted for adherence, or the actual amount of medication that participants took during the study. They also studied the effects of hormone therapy on heart disease over time (up to eight years). In addition, they compared the findings with similar analyses of 34,575 women in the Nurses Health Study, an observational study with an average follow-up of 9.3 years. The researchers report similar effects of hormone therapy from both studies.

Overall, among the 8,506 women assigned to combination hormone therapy during the study, there were 188 cases of coronary heart disease (80 in the first two years), compared to 147 heart disease cases (51 in the first two years) among the 8,102 women on placebo. When adjusted for adherence, the analysis shows that women on combination hormone therapy were about 2.4 times more likely to develop heart disease in the first two years. At eight years, the women on combination hormone therapy were 69% more likely to develop heart disease.

The new analyses also showed that women who were within 10 years of menopause had a trend toward an increased risk of heart disease, with a 29% higher risk at two years from the start of hormone therapy. Women who started combination hormone therapy less than 10 years after menopause remained at increased risk of heart disease on average for about six years, after which those in the treatment group appeared to have a lower risk of heart disease compared to similar women who were not on combination hormone therapy.

In contrast, women who started hormone therapy 10 years or more after menopause were nearly three times more likely to develop heart disease within the first two years of treatment compared to women on placebo. These women continued to be at increased risk of heart disease throughout the eight years of follow-up.

According to researchers, it is not clear why the heart disease risk appears to be higher in women who start combination hormone therapy a decade after menopause than in women who begin combination hormone therapy within 10 years after menopause. The risk of heart disease may depend on when women start hormone therapy and how long they are on the treatment.

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