FDA Approves Viibryd to Treat Major Depressive Disorder

/PRNewswire/ -- The U.S. Food and Drug Administration today approved Viibryd tablets (vilazodone hydrochloride) to treat major depressive disorder in adults.

Major depressive disorder, also called major depression, is characterized by symptoms that interfere with a person's ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Episodes of major depression often recur throughout a person's lifetime, although some may experience only a single occurrence.

Signs and symptoms of major depression include: depressed mood, loss of interest in usual activities, significant change in weight or appetite, insomnia or excessive sleeping (hypersomnia), restlessness/pacing (psychomotor agitation), increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicide attempts or thoughts of suicide. All people with major depression do not experience the same symptoms.

"Major depressive disorder is disabling and prevents a person from functioning normally," said Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. "Medications affect everyone differently, so it is important to have a variety of treatment options available to patients who suffer from depression."

The most frequent adverse reactions reported by patients taking Viibryd in clinical trials included diarrhea, nausea, vomiting, and insomnia.

The drug will be available in 10, 20 and 40 milligram tablets.

Viibryd and all other antidepressant drugs have a boxed warning and a patient medication guide describing the increased risk of suicidal thinking and behavior in children, adolescents, and young adults ages 18 to 24 during initial treatment.

The warning also says data did not show this increased risk in adults older than 24 and that patients ages 65 and older who take antidepressants have a decreased risk of suicidal thinking and behavior. The warning says depression and other serious psychiatric disorders themselves are the most important causes of suicide and that close monitoring of patients starting these medications is necessary.

Viibryd is manufactured by PGxHealth, New Haven, Conn.

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FDA approves opioid analgesic to help cancer patients manage pain

The U.S. Food and Drug Administration today approved Abstral (fentanyl) transmucosal tablets to manage breakthrough pain for adults with cancer. Fentanyl immediate-release transmucosal medications are administered on the soft surfaces of the mouth (inside of the cheek, gums, tongue), or the nasal passages or throat where they dissolve and are absorbed.

“This is an important step for patients with cancer pain to have options for the treatment of their breakthrough pain,” said John Jenkins, M.D., director of FDA’s Office of New Drugs in the Center for Drug Evaluation and Research.

Abstral is indicated for the management of breakthrough pain in patients with cancer, ages 18 years and older, who already use opioid pain medication around the clock and who need and are able to safely use high doses of an additional opioid medicine. Breakthrough pain is pain that comes on suddenly for short periods of time and is not alleviated by a patient’s normal pain management plan. These patients are considered opioid tolerant because of their current opioid medication use. Only health care professionals skilled in the use of Schedule II opioids to treat pain should prescribe this drug product.

Abstral is available only through a Risk Evaluation and Mitigation Strategy (REMS) program, which is intended to minimize the risk of misuse, abuse, addiction and overdose. Under this program, pharmacies, distributors, and health care professionals who prescribe to outpatients are required to enroll in the program to prescribe, dispense and distribute this product. FDA has standardized key components of the REMS program to facilitate the adoption of a single shared system. These components include the REMS document, the Patient-Prescriber Agreement, and the enrollment form. These components can be used by all sponsors of immediate release transmucosal fentanyl products to develop individual REMS programs such as the program approved for Abstral. FDA has also directed the sponsors of this class of products to work together on a single shared system to implement the REMS.

“This approval is also a significant step toward reducing the burden on the health care system of implementing REMS programs,” added Dr. Jenkins. “When fully implemented, FDA expects that prescribers, pharmacies, and distributors of all immediate release transmucosal fentanyl products will be able to use standardized materials and a single shared system to implement the REMS.”

The safety of Abstral was evaluated in 311 opioid-tolerant cancer patients with breakthrough pain. Two hundred and seventy of these patients were treated in multiple-dose studies. The duration of therapy for patients in multiple-dose studies ranged from 1-405 days with an average duration of 131 days and with 44 patients treated for at least 12 months.

Common adverse reactions include nausea, constipation, drowsiness and headache. Serious adverse events, including deaths, have been reported in patients with other immediate-release transmucosal fentanyl products. The deaths occurred as a result of improper patient selection and/or improper dosing.

Consumers and health care professionals are encouraged to report adverse side effects or medication errors from the use of Abstral to the FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.

Abstral is manufactured by ProStraken Inc., based in Bedminister, N.J.

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CDC Unveils New Adult Vaccination Rates; nfid Surveys Illuminate Barriers to Vaccine Uptake

/PRNewswire/ -- New data from the Centers for Disease Control and Prevention (CDC) show that adults remain largely unvaccinated against preventable infectious illnesses. At a news conference convened today by the National Foundation for Infectious Diseases (NFID), experts in public health, infectious disease, oncology and other medical specialties discussed the data and the health consequences for adults who skip vaccines. They collectively called on all adults and health care providers to improve vaccination rates.

"For more than six decades, vaccines have protected us from infectious illnesses that have a wide range of consequences, from lost work days and inability to meet our daily obligations, to pain, discomfort, hospitalization, long-term disability and death," said Susan J. Rehm, M.D., NFID medical director. According to Dr. Rehm, by foregoing needed vaccines, adults not only leave themselves vulnerable to sickness, but they expose those around them to unnecessary risks, too.

This problem is evident right now, as pertussis (whooping cough) continues to claim the lives of infants in California, while adults, who are frequently responsible for transmitting the disease to infants, fail to get the one-time pertussis booster vaccine. The impact of other vaccine-preventable infections may not be as immediately apparent, but they are no less important. Other vaccines for adults protect against viruses that cause several types of cancer, reactivation of the chickenpox virus that causes shingles later in life, and infection with bacteria that are the leading cause of community-acquired pneumonia.

New survey results from NFID suggest that doctor/patient communication challenges may be at least part of the problem. While physicians perceive they are encouraging their adult patients to be vaccinated, patients say the topic of vaccination rarely comes up during their doctor visits.

Vaccination rates highest among seniors; lowest among minority groups

In unveiling the adult vaccination data from the 2009 National Health Interview Survey (NHIS), Melinda Wharton, M.D., M.P.H., deputy director of the National Center for Immunization and Respiratory Diseases at the CDC, noted that the highest immunization rates are among older Americans, who tend to be vaccinated against influenza and pneumococcal infections. She suggested that one reason for this might be that older persons tend to have more routine visits with health care providers, providing more opportunities to learn about and adopt good preventive care behaviors.

"A good ongoing relationship with your medical provider is positive for so many reasons," said Dr. Wharton, "not least of which is that you will have an ongoing opportunity learn about the best ways to stay healthy, including the best preventive care choices like vaccines."

While adult vaccination rates are showing slow improvement overall, one vaccination trend Dr. Wharton specifically noted is the 7.4 percent decrease in pneumococcal vaccination rate in high-risk adults 19 to 64 years of age. She pointed out that this is not because people are suddenly foregoing this vaccine. Rather, the decrease reflects the recent addition of new risk groups -- namely smokers and people with asthma -- increasing the pool of people who should get the vaccine. Dr. Wharton called on smokers and people with asthma to check with their physicians or other health care providers about this vaccine.

In addition to generally low adult vaccination rates, Dr. Wharton touched on the problem of racial and ethnic vaccination disparities. While strides have been made to close racial and ethnic gaps, some significant vaccination gaps continue to exist among Whites, Blacks and Hispanics.

Vaccine (age and/or risk status)	Non- Hispanic White (%)	Non- Hispanic Black (%)	Hispanic or Latino (%)
Tetanus, diphtheria, pertussis (19-64 years)	51	54	49
Pneumococcal (65 years and older)	65	45	40
Pneumococcal (19-64 years, high risk)	18	18	12
Hepatitis B (19-49 years, high risk)	43	44	37
HPV (19-26 years)	20	13	13
Shingles (60 years and older)	11	4	5
Influenza (65 years and older)	69	51	51
Influenza (50-64 years)	42	37	31

The NHIS survey also reported vaccination rates in health care professionals for influenza (up 7 percent, to 53 percent), hepatitis B (up 2.5 percent, to 65 percent) and Tdap (up 1.6 percent, to 58 percent). "It's gratifying to see health care worker vaccination rates continue to increase," said CDC's Melinda Wharton. "By modeling good preventive care behaviors our health care professionals are truly leading the way as good partners in their relationship with patients." The NHIS vaccination data include anyone employed in a health care occupation or setting. In contrast, physician-only vaccination rates are much higher (>90 percent for influenza) as reported in two separate NFID surveys fielded before and during the current influenza season.

Doctor/patient communication breakdown a factor in low vaccination rates

A dramatic physician-patient communication disconnect was revealed by new data from two NFID surveys. Nearly 90 percent of primary care physicians say they discuss vaccines with their patients, yet in a separate survey of consumers, almost half cannot recall ever discussing vaccines with their physicians. As further evidence of the communication gap between physicians and their patients, 99 percent of physicians say that they or their staff initiates vaccine discussions, but just 44 percent of patients say that is true.

"Busy primary care physicians think they're doing a good job recommending vaccines, but the survey indicates that patients aren't getting the message," suggested Dr. Rehm. "Consumers overwhelmingly said they look to physicians for vaccine recommendations and are likely to act on those recommendations, so it's clear that we physicians need to be more effective in communicating with our patients."

Among the positive findings, consumer familiarity with vaccine-preventable illnesses is rising, although still limited. Familiarity with specific vaccine-preventable diseases rose 4 to 12 percent compared with results from a 2009 survey, with the largest increase for pertussis vaccine. The only vaccine-preventable disease not to register an increase in familiarity is pneumococcal vaccine. Consumers also report that they rarely refuse vaccines if their physicians recommend them.

A realized consequence: disease resurgence

The ongoing pertussis epidemic in California demonstrates the danger still posed by diseases once thought to be gone in the U.S. There are reports of more than 6,400 cases so far in California this year, the most since 1958. While pertussis can affect people of any age and in fact, national rates have been rising in adults, it is the infants who adults pass this on to who bear the burden. Ten infants, all younger than three months, have died from whooping cough in California this year.

Patrick Joseph, M.D., a California infectious disease physician who is NFID's vice president, implored adults to get the one-time booster vaccine, "While the epidemic is in adults, the tragedy is in kids. The situation is grave when babies too young to be immunized are dying."

Dr. Joseph said this crisis means California doesn't have the luxury of bringing people along slowly. The time to increase vaccination rates for pertussis is now. The California Department of Public Health recommends pertussis boosters for all adults, including those over 65, a move supported by the CDC's Advisory Committee on Immunization Practices (ACIP). At its October meeting, ACIP voted to extend pertussis booster vaccination recommendations to include adults 65 and older nationwide.

While California has been hardest hit so far, many other areas have seen increased cases this year, including Ohio, South Carolina, Michigan, Texas, Idaho, upstate New York and the Philadelphia suburbs. Since pertussis knows no boundaries, Dr. Joseph voiced his hope that adults outside his home state would also take notice and seek a Tdap vaccine now to protect themselves and infants around them.

Importance of pneumococcal and influenza vaccines also highlighted

AARP board member Catherine Georges, R.N., Ed.D., reminded adults that the time to get an influenza vaccine is now. "We know it's important for Americans of all ages to go out now and get the flu vaccine, but it's even more critical for people 50-plus," said Dr. Georges, a registered nurse and professor and chair of the department of nursing at Lehman College and the Graduate Center at the City University of New York. "Older Americans are often caring for their children and for older loved ones. Getting vaccinated not only protects you, but also helps protect your family and friends." Dr. Georges echoed the universal recommendation from CDC for influenza vaccination of all Americans six months and older.

Since pneumococcal infection is an all too frequent complication of influenza, Dr. Georges reminded Americans that, "pneumococcal and influenza vaccines can be given at the same medical visit." Pneumococcal vaccine is recommended for everyone 65 and older and for younger adults with certain risk factors or conditions like asthma, smoking, heart disease and diabetes. For most people, pneumococcal is a one-time vaccination.

Alarmingly few Americans immunized against debilitating disease of shingles

The lowest vaccination rate for a routinely recommended vaccine is for the shingles vaccine, which is recommended for everyone starting at age 60. Only ten percent of eligible persons have received the shingles vaccine. Not only does the likelihood of getting shingles increase with age, so does the severity of shingles pain, which can last long after the shingles rash has disappeared (this pain is known as post-herpetic neuralgia, or PHN). This pain diminishes quality of life and functional capacity as much as congestive heart failure, a heart attack, type II diabetes or major depression.

Adults in the NFID survey say they are familiar with shingles, but further questioning reveals knowledge gaps; for instance, 42 percent do not know that anyone who has had chickenpox is at risk for shingles. Still, adults are aware of the pain of the disease; 55 percent say they "know someone who has had it and it was terrible." Unfortunately, only half of adults even know there is a shingles vaccine available and just 16 percent know it is currently recommended for everyone 60 and older.

"Shingles can be a terribly painful and debilitating disease, particularly in the elderly," said Jeffrey Cohen, M.D., chief of the Laboratory of Infectious Disease at the National Institute of Allergy and Infectious Diseases. "Shingles pain can be very difficult to treat. Current therapies are only somewhat effective and often associated with frequent and problematic side effects, especially in older people, which is why it is vitally important that we educate Americans about the vaccine."

Vaccines prevent cancer

"Human papillomavirus (HPV) not only causes cervical cancer, but also a growing portion of head and neck cancers," according to Maura Gillison, M.D., Ph.D, Jeg Coughlin Chair of Cancer Research at the Ohio State University College of Medicine. "Twenty years ago about 40 percent of these cancers were due to HPV; today that number is over 60 percent in the U.S. Even more alarming is that these cancers are happening in younger people without traditional risk factors—smoking and alcohol consumption."

The hepatitis B vaccine also protects against certain cancers. The hepatitis B virus causes 30 percent of all liver cancers in the U.S. and doubles the risk of non-Hodgkin's lymphoma. Both HPV and hepatitis B viruses are common. An estimated 70 percent of Americans will be infected with HPV in their lifetime and up to 1.4 million Americans have chronic hepatitis B infection.

CDC recommends HPV vaccine for all women 19 to 26 years of age if not previously vaccinated and recommends the hepatitis B vaccine for all sexually active adults who are not in a long-term, mutually monogamous relationship and others in more defined risk groups.

"I urge everyone to get the HPV and hepatitis B vaccines as recommended," said Dr. Gillison. "These vaccines are truly life-saving. As a cancer-specialist, I can tell you that prevention is a far better option than treatment. These are not cancers you want to have or want your kids to have."

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Patients Who Survive Sepsis Infections Are More Than Three Times as Likely to Develop Cognitive Problems

/PRNewswire/ -- Older adults who survive severe sepsis are at higher risk for long-term cognitive impairment and physical limitations than those hospitalized for other reasons, according to researchers from the University of Michigan Health System.

Research to be published Oct. 27 today in the Journal of the American Medical Association showed that 60 percent of hospitalizations for severe sepsis were associated with worsened cognitive and physical function among surviving older adults. The odds of acquiring moderate to severe cognitive impairment were 3.3 times higher following an episode of sepsis than for other hospitalizations.

Severe sepsis also was associated with greater risk for the development of new functional limitations following hospitalization, says lead author, Theodore (Jack) Iwashyna, M.D., Ph.D., assistant professor of internal medicine at U-M.

Among patients who had no limitations before sepsis, more than 40% developed trouble with walking. Nearly 1 in 5 developed new problems with shopping or preparing a meal. Patients often developed new problems with such basic things as bathing and toileting themselves.

"We used to think of sepsis as just a medical emergency, an infection that you get sick with and then recover," said Iwashyna, "But we discovered a significant number of people face years of problems afterwards.

"Those problems are bigger and more common than we expected. Most older Americans suffer real brain and body problems. We need new treatments, not just for the sepsis infection, but to prevent these new disabilities afterwards."

Sepsis is an overwhelming infection that can result in failure of multiple organ systems. The initial infections are often common problems, such as pneumonia or a urinary tract infection. About 40 percent of those with severe sepsis die from the infection.

Anyone can get sepsis, but older people and those with weakened immune systems are most vulnerable. Sepsis is probably the most common cause of critical illness in the United States.

The best data available are from the 1990s, when it was estimated that 750,000 people each year were diagnosed with sepsis. Researchers believe that number has doubled each decade.

"These new data show a majority of older patients suffer with real life-changing burdens after beating sepsis. This is an underrecognized public health problem with major implications for patients, families and the health care system," Iwashyna says.

"We need to make sure families have the resources they need to care for survivors of sepsis when they go home. It's not enough just to get them through the acute episode. We need to start preparing them for the years of problems they may have afterwards."

"This research underscores the need for physicians who care for older adults to focus early on preventing infections that can lead to sepsis," says study co-author Kenneth M. Langa, M.D., Ph.D., a core investigator for the Ann Arbor Veterans Administration Health Services Research and Development Service's Center of Excellence and professor of internal medicine at U-M.

Older patients need to get their flu and pneumonia vaccines in order to decrease their risk for infections, and physicians need to be aware of the long-term risk for cognitive and physical disabilities that many patients may face, Langa said.

"In contrast to Alzheimer's disease and other forms of dementia, the cognitive impairment associated with sepsis is likely at least partially preventable through better acute care of the sepsis episode and better rehabilitation efforts afterwards," Langa says.

"We need to start working early – from the beginning of the hospitalization – to make sure patients do not develop new disability. There are innovative new ways to care for people that might help prevent this disability," Iwashyna says.

The research was supported primarily by the National Institute on Aging and the National Heart, Lung and Blood Institute.

The researchers used data from the NIA-supported Health and Retirement Study , a long-term study that collects information on the health, economic, and social factors influencing the health and well-being of a nationally representative sample Americans over age 50.

"This research makes clearer how acute medical problems in older adults may have an important lasting impact and contribute to a downward trajectory in both cognitive and physical function," says Richard Suzman, Ph.D., director of the NIA's Division of Behavioral and Social Research, which supports the HRS.

"The unique nature of the rich HRS dataset that links both survey data and Medicare administrative data made this innovative study possible and will also facilitate future studies of the long-term impact of critical illness on older adults and the family members that care for them."

The HRS, now in its 18th year, follows more than 22,000 people over the age of 50, collecting data every two years, from pre-retirement to advanced age.

The NIA leads the federal effort supporting and conducting research on aging and the medical, social and behavioral issues of older people. For more information on research and aging, go to www.nia.nih.gov.

Additional authors: E. Wesley Ely, M.D., M.P.H. of the Tennessee Valley Veteran's Affairs (VA) Healthcare System and Vanderbilt University; Dylan M. Smith, Ph.D., of Stony Brook University Medical Center.

Journal reference: Journal of the American Medical Association, 2010; 304(16): 1787-1794.

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Improvements in Sexual and Reproductive Health of Teens and Young Adults

After a period of improvement, trends in the sexual and reproductive health of U.S. teens and young adults have flattened, or in some instances may be worsening, according to a new report from the Centers for Disease Control and Prevention.

CDC analyzed data from 2002-2007 from the National Vital Statistics System and numerous CDC reports and surveys including the Youth Risk Behavior Survey of high school students, the National Health and Nutrition Examination Survey (NHANES), the National Survey of Family Growth, the HIV/AIDS Reporting System, and the National Electronic Injury Surveillance System.

The data are reported in a Morbidity and Mortality Weekly Report Surveillance Summary, "Sexual and Reproductive Health of Persons Aged 10-24 Years - United States, 2002-2007." All the data are not new, but the goal of this report is to present data from multiple sources in order to summarize trends in the sexual and reproductive health of America's young people.

Findings include:
* There were approximately 745,000 pregnancies among U.S. females under age 20 in 2004.

* In 2006, the majority of new diagnoses of HIV infection among adolescents and young adults between the ages of 10 and 24 occurred among those aged 20-24 years and among males.

* About 1 million adolescents and young adults aged 10-24 years were reported to have chlamydia, gonorrhea, or syphilis in 2006. Nearly a quarter of females aged 15-19 years, and 45 percent of those aged 20-24 years, had a human papillomavirus (HPV) infection during 2003-2004.

* Approximately 100,000 females aged 10-24 years visited a hospital emergency department for a nonfatal sexual assault injury during 2004-2006.

Although the sexual risk behaviors and negative health outcomes tended to increase with age, the youngest age group - youth 10-14 years of age - were also affected:

* An estimated 16,000 pregnancies were reported among females in this age group in 2004.

* Approximately 17,000 young people in this age group were reported to have a sexually transmitted infection in 2006.

* During 2004-2006, 30,000 females in this age group visited a hospital emergency department because of a nonfatal sexual assault injury.

* Approximately one third of adolescents had not received instruction on methods of birth control before age 18.

"This report identifies a number of concerns regarding the sexual and reproductive health of our nation's young people. It is disheartening that after years of improvement with respect to teen pregnancy and sexually transmitted diseases, we now see signs that progress is stalling and many of these trends are going in the wrong direction," said Janet Collins, Ph.D., director of CDC's National Center for Chronic Disease Prevention and Health Promotion.

Among the signs that progress has halted in some areas:

* Teen birth rates increased in 2006 and 2007, following large declines from 1991-2005.

* Rates of AIDS cases among males aged 15-24 years increased during 1997-2006 (AIDS data reflects people with HIV who have already progressed to AIDS.)

* Syphilis cases among teens and young adults aged 15-19 and 20-24 years have increased in both males and females in recent years.

The report also identifies a number of racial/ethnic disparities.

Hispanic teens aged 15-19 are much more likely to become pregnant (132.8 births per 1,000 females) compared to their non-Hispanic black (128 per 1,000) and non-Hispanic white (45.2 per 1,000) peers. Additionally, rates of new HIV and AIDS diagnoses among young adults were highest among non-Hispanic black youth across all age groups.

"This report serves as a reminder that adolescents and young adults in this country continue to be impacted by STDs, including HIV," said Kevin Fenton, M.D., director of CDC's National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention. "It is imperative that all of us at the national and community level work together to ensure STD and HIV prevention programs are reaching young people, particularly in communities with the greatest burden of disease."

The full report is available at www.cdc.gov/mmwr.

(Note: this came out in July, but we missed it, thought you may have also... )

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Number of U.S. Adults Reporting Disabilities is Increasing

The number of U.S. adults reporting a disability increased by 3.4 million between 1999 and 2005, according to a recent report released by the Centers for Disease Control and Prevention.

The study in today's Morbidity and Mortality Weekly Report also finds an estimated 1 in 5 U.S. adults (47.5 million, or 21.8 percent) report a disability. The three most common causes of disability among adults in the United States are arthritis or rheumatism, back or spine problems, and heart disease.

"It is likely we will see more dramatic increases in the number of adults with a disability as the baby boomer population begins to enter higher risk, older age groups over the next 20 years," said Chad Helmick, M.D., CDC medical epidemiologist and coauthor of the study. "CDC is working with state health departments and communities to expand the availability of self-management education programs and interventions, such as appropriate physical activity programs, that can reduce the impact of disability."

The study of data collected from the U.S. Census Bureau's Survey of Income and Program Participation found that women (24.4 percent) have a higher prevalence of disability compared with men (19.9 percent) at all ages. The study also found that disability prevalence doubled for each successive age group -- 11.0 percent for ages 18-44, 23.9 percent for ages 45-64, and 51.8 percent for ages 65 or older.

Arthritis encompasses more than 100 diseases and conditions that affect joints and other connective tissue. For more information on arthritis visit www.cdc.gov/arthritis. For information on disabilities visit www.cdc.gov/ncbddd/disabilities.htm. For information on heart disease visit http://www.cdc.gov/heartdisease.

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U.S. Adults 'Needlessly Vulnerable' to Vaccine-Preventable Diseases, According to New Report

/PRNewswire/ -- Fifty thousand American adults die every year from vaccine-preventable diseases. Hundreds of thousands more are hospitalized and miss work because of infections that could be prevented with vaccines. Yet, most Americans continue to think of vaccines as benefiting only children, not adults.

In an effort to raise awareness about the importance of the adult immunization schedule, the National Foundation for Infectious Diseases (NFID), with support from the nation's leading health organizations, has issued a Call to Action to improve low vaccination rates among adults. Most adults are not protected against vaccine-preventable diseases, leaving them vulnerable to long-term suffering that could result in a high price tag for society.

To help educate the public, healthcare providers and the media, NFID launched a new comprehensive Web site on the importance of adult vaccination at www.adultvaccination.com. The Web site includes critical information on 13 adult diseases and the vaccines recommended to protect against them. The Call to Action also is available for download on the Web site.

"Vaccines are as crucial to our long-term health as are screenings for certain cancers. Unfortunately, many adults associate vaccinations with childhood, or assume influenza is the only vaccine they need," said William Schaffner, MD, President-Elect of NFID and chairman of the Department of Preventive Medicine at Vanderbilt University School of Medicine. "Vaccines are currently available to protect adults against many serious illnesses, but they are significantly under-used, elevating the risk of illness and even death."

NFID announced its Call to Action and online resources at an Interactive Online Scientific Symposium on April 2, 2009, which provided an in-depth medical briefing on recommended adult vaccines and the power of immunity.

"Unfortunately, adult vaccines are not on patients' radar. Increased education is needed to help ensure adults understand the importance of vaccination and know which vaccines they should receive. Healthcare providers also must commit to recommending vaccination for their adult patients," said Susan J. Rehm, MD, NFID Medical Director and Vice Chair of the Department of Infectious Disease at Cleveland Clinic. "Bottom line - it is a public health imperative to protect more adults from vaccine-preventable diseases."

Saving Lives: Integrating Vaccines for Adults into Routine Care

NFID's Call to Action, "Saving Lives: Integrating Vaccines for Adults into Routine Care," was developed based on dialogue with top health organizations, including the American College of Obstetricians and Gynecologists, American College of Physicians, American Medical Association, Centers for Disease Control and Prevention and Infectious Diseases Society of America. The Call to Action emphasizes the impact that vaccine-preventable diseases have on adults, and the benefits of vaccination for individuals and the community at large.

The Call to Action highlights barriers to immunization and presents practical strategies that can be used to improve adult vaccination rates, including:

-- Increasing awareness of the adult immunization schedule; communicating
who should be vaccinated and when.
-- Educating individuals about their potential for spreading disease
among family/friends if they remain unvaccinated.
-- Making adult immunization a part of routine patient care; discussing
vaccines with all patients and immunizing at all opportunities (well,
sick and follow-up visits).
-- Prompting patients to ask about vaccines and prompting healthcare
providers to adopt processes to ensure patient immunizations are up to
date.


AdultVaccination.com Provides Tools and Information for the Public and Medical Professionals

NFID's new adult vaccination Web site (www.adultvaccination.com) is a comprehensive resource on adult vaccine-preventable diseases for the general public, healthcare providers and the media. Content includes disease-specific resources and important prevention information, including which vaccines adults should receive, and the top ten reasons to get vaccinated.

Resources for healthcare providers include tools to assist in improving adult vaccination rates, such as reminder postcards and phone scripts, patient education materials, and sample standing orders for a variety of diseases and vaccines. Information for the media includes backgrounders on adult vaccine-preventable diseases and downloadable graphics.

Select materials are also available in Spanish.

Impact of Adult Vaccine-Preventable Diseases

Approximately 50,000 American adults die every year from vaccine-preventable diseases. Millions more miss work, cannot care for those who depend on them and risk passing their infections on to others. Yet, a 2008 NFID consumer survey on adult immunization found a significant knowledge gap and lack of concern about vaccination. For example, 40 percent of respondents said because they had vaccines as a child, they did not need them again, and more than one-third (34 percent) reported a lack of concern about catching vaccine-preventable diseases.

The burden of many adult vaccine-preventable diseases in terms of cost and lives lost is high. For example:

-- Influenza kills an average of 36,000 people annually and is associated
with over $10 billion in costs with a moderately severe seasonal
outbreak.
-- Pertussis, with an estimated one to three million cases each year, can
lead to pneumonia and exposure of infants, who are at greatest risk of
death from pertussis.
-- Pneumococcal disease, which causes pneumonia and invasive infections,
kills approximately 5,000 annually.
-- HPV infects more than 6 million females per year; two HPV strains
included in the vaccine cause 70 percent of all cervical cancers.
-- Shingles will affect one in three Americans in their lifetime. The
accompanying severe pain syndrome (post-herpetic neuralgia) may last
months or years after the shingles rash heals.
-- Hepatitis B-related liver disease kills about 5,000 Americans and
costs $700 million annually.

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Mayo Clinic Study Finds Increased Risk of Pneumococcal Disease in Asthma Patients

/PRNewswire-USNewswire/ -- Mayo Clinic research shows adults with asthma are at increased risk of serious pneumococcal disease caused by Streptococcus pneumoniae, the most common bacteria causing middle ear infections and community acquired pneumonia. It also causes blood stream infections and brain infections. According to the Centers for Disease Control, pneumococcal infection is one of the leading causes of death from a vaccine-preventable disease. The researchers recommend including asthma as an indication for pneumococcal vaccination in adults. The results of the study were recently published in the October edition of the Journal of Allergy and Clinical Immunology.

"We found that adults with invasive pneumococcal disease, a serious, potentially fatal disease, are seven times more likely to be asthmatics. Our study also showed that 17 percent of the burden of invasive pneumococcal disease can be attributable to asthma at a population level. This is quite a significant impact on the burden of invasive pneumococcal disease," says Young Juhn, M.D., a pediatric and adolescent medicine physician-scientist at Mayo Clinic and lead author of the study. "Invasive pneumococcal disease is a vaccine-preventable disease. The implication is that we have the ability to significantly reduce instances of this potentially fatal disease by expanding the indication for the pneumococcal vaccine to include adults with asthma."

Researchers used a population-based, retrospective case-control study of 3,941 records from the Rochester, Minn. population to see if there was a higher incidence of pneumococcal disease among people with asthma. Adults diagnosed with asthma were almost seven times more likely to develop invasive pneumococcal diseases than adults who were not diagnosed with asthma. In children the sample size for was not large enough to draw a definitive conclusion.

"The Advisory Committee on Immunization Practices (ACIP), which is the governing body for immunization practices in the United States, voted unanimously to include asthma as a pneumococcal vaccine condition at the recent ACIP meeting in October, 2008. Adults with asthma should receive the pneumococcal vaccine," says Dr. Juhn.

Further research implications include finding out why a connection exists between instances of pneumococcal disease and asthma, determining whether the connection between asthma and this particular bacterial infection also exists with other bacterial infections, such as pertussis (whooping cough), and the connection between asthma and other non-infectious diseases, such as inflammatory bowel disease, juvenile diabetes, and rheumatoid arthritis. Dr. Juhn does not believe all asthmatic patients react the same way. He is looking for a subset of asthmatic patients who have an increased susceptibility to microbial infection.

Study authors, in addition to Dr. Juhn, include Hirohito Kita, M.D., Department of Allergic Diseases Research, Mayo Clinic; Barbara Yawn, M.D., Department of Epidemiology, Mayo Clinic; Thomas Boyce, M.D., Department of Pediatric Infectious Diseases, Mayo Clinic; Kwang Yoo, M.D., Ph.D., Department of Internal Medicine, Kunkook University, Republic of Korea; Michaela McGree, Department of Biostatistics, Mayo Clinic; Amy Weaver, Department of Biostatistics, Mayo Clinic; Peter Wollan, Ph.D., Department of Epidemiology, Mayo Clinic; and Robert Jacobson, M.D., Department of Pediatric and Adolescent Medicine, Mayo Clinic.

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