Vaccines in the short-term may accelerate the transition from subclinical MS to overt autoimmunity in patients with existing disease

Vaccines and the Risk of Multiple Sclerosis and Other Central Nervous System Demyelinating Diseases

JAMA Neurol. Published online October 20, 2014. doi:10.1001/jamaneurol.2014.2633

Importance  Because vaccinations are common, even a small increased risk of multiple sclerosis (MS) or other acquired central nervous system demyelinating syndromes (CNS ADS) could have a significant effect on public health.

Objective  To determine whether vaccines, particularly those for hepatitis B (HepB) and human papillomavirus (HPV), increase the risk of MS or other CNS ADS.

Design, Setting, and Participants  A nested case-control study was conducted using data obtained from the complete electronic health records of Kaiser Permanente Southern California (KPSC) members. Cases were identified through the KPSC CNS ADS cohort between 2008 and 2011, which included extensive review of medical records by an MS specialist. Five controls per case were matched on age, sex, and zip code.

Exposures  Vaccination of any type (particularly HepB and HPV) identified through the electronic vaccination records system.

Main Outcomes and Measures  All forms of CNS ADS were analyzed using conditional logistic regression adjusted for race/ethnicity, health care utilization, comorbid diseases, and infectious illnesses before symptom onset.

Results  We identified 780 incident cases of CNS ADS and 3885 controls; 92 cases and 459 controls were females aged 9 to 26 years, which is the indicated age range for HPV vaccination. There were no associations between HepB vaccination (odds ratio [OR], 1.12; 95% CI, 0.72-1.73), HPV vaccination (OR, 1.05; 95% CI, 0.62-1.78), or any vaccination (OR, 1.03; 95% CI, 0.86-1.22) and the risk of CNS ADS up to 3 years later. Vaccination of any type was associated with an increased risk of CNS ADS onset within the first 30 days after vaccination only in younger (<50 years) individuals (OR, 2.32; 95% CI, 1.18-4.57).

Conclusions and Relevance  We found no longer-term association of vaccines with MS or any other CNS ADS, which argues against a causal association. The short-term increase in risk suggests that vaccines may accelerate the transition from subclinical to overt autoimmunity in patients with existing disease. Our findings support clinical anecdotes of CNS ADS symptom onset shortly after vaccination but do not suggest a need for a change in vaccine policy.

Continue reading “Vaccines in the short-term may accelerate the transition from subclinical MS to overt autoimmunity in patients with existing disease”

Long-term use of common heartburn and ulcer medications linked to vitamin B12 deficiency

Contact: Cyrus Hedayati chedayati@golinharris.com 415-318-4377 Kaiser Permanente

OAKLAND, Calif. — Long-term use of commonly prescribed heartburn and ulcer medications is linked to a higher risk of vitamin B12 deficiency, according to a new study published in the Journal of the American Medical Association. Continue reading “Long-term use of common heartburn and ulcer medications linked to vitamin B12 deficiency”

Whooping Cough Vaccine is obsolete ” Bulk of the cases were in fully vaccinated children ” few cases among unvaccinated children

Why Whooping Cough Vaccines Are Wearing Off

Doctors race to protect kids as whooping cough vaccines wear off

By Maryn McKenna  | Tuesday, October 1, 2013

By late summer 2010 an alarming number of children in California had developed pertussis, or whooping cough—five times as many as in the first half of 2009. David Witt, a physician and infectious disease specialist who works at Kaiser Permanente San Rafael Medical Center, cared for some of those sick children. His practice lies in the heart of Marin County, the famously counterculture spit of land north of San Francisco. At first, he assumed that the outbreak was a consequence of parents refusing vaccinations for their children. As the incidence continued to climb month after month, however—not just in northern California but all across the state—Witt began to wonder whether something else was going on.

Working with his college-age son Maxwell and his pediatrician colleague Paul Katz, Witt retrieved the records for 132 Kaiser Permanente patients younger than 18 who had tested positive for pertussis between March and October 2010.

“The bulk of the cases were in fully vaccinated children between eight and 12 years old,” Witt says. “That was a total surprise.”

As Witt’s small study spotted, and larger ones have since confirmed, protection granted by the vaccine, which has been used for the past two decades, is wearing off much faster than public health planners anticipated. Rates of pertussis increased at least threefold between 2011 and 2012 in 21 states. Whereas some of these cases occurred among children who had never been vaccinated, most of the affected children had in fact received vaccines; those inoculations simply failed to safeguard them over the long term.

Now health authorities are scrambling to devise new strategies for protecting kids. There are no easy solutions. No one is developing a better vaccine to replace the current one. Attempting to recommend additional shots would trigger years of public health debate, and it is not clear whether extra doses of vaccine would make a difference. Even discussing the problem provokes uneasiness: with antivaccine sentiments and vaccine refusal at historic highs, nobody wants to impeach one of public health’s crucial tools.

Adverse Reactions Before a vaccine became available in the 1940s, many parents learned firsthand that pertussis was a terrible disease. The bacterium that causes it, Bordetella pertussis, produces a toxin that damages the tiny sweeping hairs that coat the lining of the lungs, preventing them from clearing the airways of mucus and the microbial invaders. Following uncontrollable coughing fits—some of which are strong enough to cause seizures and brain damage—children wheeze and gasp for breath, giving the illness its name. In the pre-vaccine era, whooping cough afflicted as many as 200,000 children each year in the U.S. and killed about 8,000. The new vaccine shrank the incidence of pertussis from around 157 cases for every 100,000 members of the population to one in 100,000.

This success came at a cost, though. Researchers crafted the original pertussis vaccine from dead pertussis bacteria that could not reproduce but retained many microbial proteins by which immune cells could recognize and attack B. pertussis before it caused disease. Unfortunately, those whole-cell preparations also contained other molecular components that could cause unwanted immune system reactions, such as swelling near the injection site and, in rare cases, high fevers that could dangerously inflame the brain. “People didn’t pay much attention to the reactions in the early days, because the death rate before the vaccine came along had been so staggering,” says James Cherry, a longtime professor of pediatrics and vaccine researcher at the David Geffen School of Medicine at U.C.L.A.

Over the next few decades, however, concern surrounding the vaccine’s side effects intensified. In the 1970s Sweden and Japan ceased using the vaccine altogether. A government study published in England in 1981 concluded that the vaccine caused permanent brain damage once in every 310,000 doses (a result that was later disputed). And in 1982 an NBC broadcast aired criticisms of the vaccine, turning public opinion against it and jump-starting the U.S. antivaccine movement.

The U.S. and other countries began industry-wide efforts to find a better vaccine, focusing on “acellular” formulas that used a few purified bacterial proteins to establish immunity rather than the whole cell, reducing the risk of inflammatory reactions. Researchers combined the new pertussis vaccine with vaccines against tetanus and diphtheria. DTaP, as it was known, was ready for the doctor’s office in 1992. In the U.S., children receive it at two, four and six months; once between 15 and 18 months; and once between the ages of four and six, before they enter school.

From the start, public health authorities understood that an acellular vaccine might confer more temporary immunity than the problematic whole-cell vaccine. So, in 2005, they added a booster to the regimen to guarantee that children would be protected throughout adolescence. Officials determined the booster would be most effective for 11- to 12-year-olds but authorized it for use in any adult, eventually including pregnant women.

A Failure to Protect After California’s 2010 pertussis outbreak, additional outbreaks hit Wisconsin, Vermont and Washington, among other states, in 2012. Analyses of who was getting sick revealed the same pattern every time. Tom Clark, a physician and pertussis expert at the Centers for Disease Control and Prevention, describes it as a “striking stair-step appearance, rising by year: six, seven, eight, nine, 10 years old. If you go back several years [to when whole-cell vaccines were used], that stair-step is not there.”

The stair-step indicated that the more time elapsed since a child’s most recent pertussis shot, the more likely the child would develop whooping cough after exposure to the bacteria. Many of these children were too young to have received their booster, so researchers hoped that once children got their additional shots, the unpredicted vulnerability would cease. New data from the Washington State outbreak quashed that hope: 13- and 14-year-olds were catching pertussis even after they received their booster shot. Other studies demonstrated that the vaccine was behaving differently from the older, reactive one: children who had received even one dose of the older, whole-cell formula while it was still on the market were better protected against pertussis than those who received only the newer vaccine. (Of course, children who received the new vaccine were still better off than those who had never been vaccinated.)

Clark points out that the original research on acellular vaccine in the 1980s tested whether it would protect but not for how long it would protect. Some diseases for which acellular vaccines are typically used, such as Hib meningitis, are only dangerous to children for a short time early in life, so long-lasting immunity is not necessary. Today, however, immunologists have better laboratory tools and a much more nuanced understanding of how immunity is evoked and sustained. “A lot of what you would do to develop a vaccine today was never done for the pertussis vaccine,” Clark says.

“The big answer is that we need a better vaccine,” says Mark Sawyer, a professor of clinical pediatrics at the University of California, San Diego, and chair of a working group collaborating with the Advisory Committee on Immunization Practices (ACIP), which helps to set federal vaccine policy. “But the ACIP can’t just make that happen. That is up to the scientists who would do a study of what would make a better vaccine, and it is up to the pharmaceutical companies.”

If a new vaccine were formulated, demonstrating its superiority would be challenging. Every developed country vaccinates its children against pertussis, so there is no large unprotected population that could help prove a new vaccine’s worth. And before encouraging manufacturers to consider developing a new vaccine, federal planners would have to weigh the unintended consequences of the endeavor. Diverting too much of the manufacturers’ limited resources to one new vaccine could cause shortages of others, for example. Another concern is whether parents would heed the advice to bring children in for yet more shots.

The ACIP has been researching the problem for more than a year. The committee is in uncharted territory because this type of failure has never occurred with any other vaccine. In June the working group concluded that because the booster’s protection against pertussis is so short-lived, adding more shots to the typical regimen would do little to reduce the overall prevalence of pertussis. The group therefore advised the committee not to change policy to include a second booster in adulthood but rather to increase the number of pregnant women who get their booster in the first place. The CDC estimates that currently only 6 percent of pregnant women receive the shot. Yet newborns, who cannot be vaccinated, are the most vulnerable to the dangerous effects of pertussis; improving the immunity of their closest contacts could be the best way to prevent pertussis deaths.

Given the current vaccine’s faults, Clark says bluntly that in the general population “there’s going to be a lot of pertussis.” But he adds that although pertussis cases are increasing, deaths are not; when vaccinated children develop whooping cough, they have milder symptoms. So the newer pertussis vaccines are still valuable because they reduce not just the likelihood of death and severe illness but also the health care spending—not to mention emotional trauma—that accompany those dire results. On that basis, Sawyer says, public health officials should urge the 90 percent of American teens and adults who failed to get their booster shot to receive one and thereby protect both themselves and the most vulnerable among us. “We do need a new vaccine,” he says. “But we can do a lot better with the ones we have.”

http://www.scientificamerican.com/article.cfm?id=why-whooping-cough-vaccines-are-wearing-off

BPA linked to obesity risk in puberty-age girls

Contact: Catherine Hylas Saunders csaunders@golinharris.com 202-585-2603 Kaiser Permanente

OAKLAND, Calif., June 12 —Girls between 9 and 12 years of age with higher-than-average levels of bisphenol-A (BPA) in their urine had double the risk of being obese than girls with lower levels of BPA, according to a Kaiser Permanente study published today in the journal PLOS ONE.

“This study provides evidence from a human population that confirms the findings from animal studies — that high BPA exposure levels could increase the risk of overweight or obesity,” said De-Kun Li, MD, PhD, principal investigator of the study and a reproductive and perinatal epidemiologist at the Kaiser Permanente Division of Research in Oakland, Calif.

BPA is used to make plastics and other materials, such as cash register receipts. It is a known endocrine disruptor with estrogenic properties. In children and adolescents, BPA is likely to enter the body primarily through the ingestion of foods and liquids that have come into contact with BPA-containing materials, Dr. Li said.

“Girls in the midst of puberty may be more sensitive to the impacts of BPA on their energy balance and fat metabolism,” Dr. Li said.  While BPA is still being examined, he said it has been shown to interfere with a body’s process of relating fat content and distribution.

The study — the first specifically designed to examine the relationship between BPA and obesity in school-age children — was conducted in Shanghai as part of a larger national study of puberty and adolescent health.

Dr. Li and colleagues studied 1,326 male and female children in grades 4 to 12 at three Shanghai schools (one elementary, one middle and one high school). In addition to urine samples collected with BPA-free materials, they obtained information on other risk factors for childhood obesity, such as dietary patterns, physical activity, mental health and family history.

The researchers found that in girls between 9 and 12 years old, a higher-than-average level of BPA in urine (2 micrograms per liter or greater) was associated with twice the risk of having a body weight in the top 10th percentile for girls of their age in the same population.

The impact was particularly pronounced among 9- to 12-year-old girls with extremely high levels of BPA in their urine (more than 10 micrograms per liter): their risk of being overweight (in the top 10th percentile) was five times greater.

The researchers did not identify significant BPA effects in any other groups studied, including girls over 12 years of age and boys of all ages.

Among all the 9- to 12-year-old girls studied, 36 percent of those with a higher-than-average level of BPA in their urine were overweight or obese compared with 21 percent of those with a lower-than-average level of BPA.

“Our study suggests that BPA could be a potential new environmental obesogen, a chemical compound that can disrupt the normal development and balance of lipid metabolism, which can lead to obesity,” Dr. Li and co-authors wrote in PLOS ONE. “Worldwide exposure to BPA in the human population may be contributing to the worldwide obesity epidemic.”

The PLOS ONE study is the latest in a series published by Dr. Li and his colleagues examining the effects of BPA in humans:

  • A 2009 study in Human Reproduction found that exposure to high levels of BPA in the workplace increased the risk of sexual dysfunction in men. 

     

  • A 2010 study in the Journal of Andrology found that increasing BPA levels in urine were associated with worsening male sexual function. 

     

  • A 2011 study in the journal Fertility and Sterility showed that increasing urine BPA levels were significantly associated with decreased sperm concentration, decreased total sperm count, decreased sperm vitality and decreased sperm motility. 

     

  • A 2011 study in the Journal of Reproductive Toxicology showed that parental exposure to BPA during pregnancy was associated with decreased birth weight in offspring. 

     

  • A 2011 study in Birth Defects Research (Part A) found that in-utero exposure to BPA was related to anogenital distance (the physical distance between the anus and the genitalia) in male offspring. 

     

  • A 2013 study in Fertility and Sterility showed that male workers exposed to BPA in a chemical plant for 6 months or more had lower testosterone levels in their blood than with those who were not exposed to BPA in workplace. 

Kaiser Permanente is committed to researching and sourcing safer alternatives to products that may contain potentially harmful chemicals such as BPA. To that end, Kaiser Permanente’s Sustainability Scorecard for Medical Products requires suppliers and manufacturers to disclose the presence of BPA in products. Most recently, the organization was able to eliminate BPA from packaging of supplemental nutrition and infant formula products.

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In addition to Dr. Li, co-authors of the study were: Maohua Miao, MD, PhD, Xiaoqin Liu, MD, Siqui Wang, PhD, Department of Epidemiology and Social Science on Reproductive Health, Shanghai Institute of Planned Parenthood Research and WHO Collaborating Center for Occupational Health, Shanghai; ZhiJun Zhou, MD, PhD, Chunhua Wu, PhD, School of Public Health, Key Lab for Public Health and Safety and WHO Collaborating Center for Occupational Health, Fudan University, Shanghai; Huijing Shi, PhD, Department of Child and Adolescent Health, Fudan University, Shanghai; and Wei Yuan, MD, PhD, National Population and Family Planning Key Laboratory of Contraceptive Drugs and Devices, Shanghai.

The study was funded in part by National Natural Science Foundation of China (#81172684).

About the Kaiser Permanente Division of Research

The Kaiser Permanente Division of Research conducts, publishes and disseminates epidemiologic and health services research to improve the health and medical care of Kaiser Permanente members and society at large. It seeks to understand the determinants of illness and well-being, and to improve the quality and cost-effectiveness of health care. Currently, DOR’s 550-plus staff is working on more than 250 epidemiological and health services research projects. For more information, visit http://www.dor.kaiser.org.

About Kaiser Permanente

Kaiser Permanente is committed to helping shape the future of health care. We are recognized as one of America’s leading health care providers and not-for-profit health plans. Founded in 1945, our mission is to provide high-quality, affordable health care services and to improve the health of our members and the communities we serve. We currently serve more than 9.1 million members in nine states and the District of Columbia. Care for members and patients is focused on their total health and guided by their personal physicians, specialists and team of caregivers. Our expert and caring medical teams are empowered and supported by industry-leading technology advances and tools for health promotion, disease prevention, state-of-the-art care delivery and world-class chronic disease management. Kaiser Permanente is dedicated to care innovations, clinical research, health education and the support of community health. For more information, go to: kp.org/newscenter.

Reducing unnecessary and high-dose pediatric CT scans could cut associated cancers by 62 percent

Contact: Phyllis Brown phyllis.brown@ucdmc.ucdavis.edu 916-734-9023 University of California – Davis Health System

(SACRAMENTO, Calif.) — A study examining trends in X-ray computed tomography (CT) use in children in the United States has found that reducing unnecessary scans and lowering the doses for the highest-dose scans could lower the overall lifetime risk of future imaging-related cancers by 62 percent. The research by a UC Davis Health System scientist is published online today in JAMA Pediatrics.

The 4 million CT scans of the most commonly imaged organs conducted in children each year could result in approximately 4,870 future cancers, the study found. Reducing the highest 25 percent of radiation doses could prevent 2,090 — or 43 percent — of these future cancers. By also eliminating unnecessary imaging, 3,020 — or 62 percent — of cancers could be prevented, said Diana Miglioretti, lead study author and Dean’s Professor in Biostatistics in the Department of Public Health Sciences at UC Davis Health System.

“There are potential harms from CT, meaning that there is a cancer risk, albeit very small in individual children, so it’s important to reduce this risk in two ways,” Miglioretti said. “The first is to only do a CT when it’s medically necessary, and use alternative imaging when possible. The second is to dose CT appropriately for children.”

Computed tomography is a procedure used to generate cross-sectional images of the body in diagnostic and therapeutic settings. It frequently is used in young children who may have experienced trauma, for example. Miglioretti noted its use has increased dramatically because the technology is effective and offers greater convenience than other imaging methods that do not involve ionizing radiation, such as magnetic resonance imaging (MRI), which requires that a child remain still in a scanner for an extended period of time. Ultrasound imaging can be time consuming. Radiation doses delivered by CT are 100 to 500 times higher than for conventional radiography, Miglioretti said.

The retrospective study was conducted in diverse male and female children under 15 who were enrolled in seven integrated health-care systems: Group Health Cooperative in Washington; Kaiser Permanente in Colorado, Georgia, Hawaii, and the Northwest and Marshfield Clinic in Wisconsin, as well as Henry Ford Health Systems in Michigan. Miglioretti conducted the research while employed at Group Health Cooperative, where she maintains a joint appointment.

The researchers examined CT utilization data from six of the health-care systems between 1996 and 2010. Radiation dosage and estimated cancer risk were calculated by examining 744 random CTs of the head, abdomen/ pelvis, chest and spine conducted from 2001 through 2011 at five of the health systems. The researchers said exams from these regions of the body account for more than 95 percent of all CT scans.

Estimated lifetime attributable risks of cancers were calculated using the Biological Effects of Ionizing Radiation (BEIR) VII report for breast, colon, liver, lung, ovarian, prostate, stomach, thyroid, bladder, and uterine cancers and leukemia, and using models developed with similar methods for oral, esophageal, rectal, pancreatic, kidney and brain cancers, which account for as much as 85 percent of all U.S. cancer incidence.

The study found that CT use increased between 1996 and 2005. Among children under 5, CT use doubled from 11 in 1,000 in 1996 to 20 in 1,000 in 2005-2007, then decreased to 15.8 in 1,000 in 2010. Among children 5 to 14, CT use almost tripled, from 10.5 in 1,000 in 1996 to a peak of 27 in 1,000 in 2005 before decreasing to 23.9 in 1,000 in 2010.

The researchers also found that patient radiation doses were highly variable for exams of the same anatomic region.

The risk of radiation-induced leukemia and brain cancers are highest for head CT, the most commonly performed CT in children. While the effective dose for head CT is relatively low, the brain and red bone marrow doses are relatively high for young children, resulting in the greatest risk of brain cancer and leukemia for imaged organs. The risk of radiation-induced solid cancer is highest for CTs of the abdomen and pelvis, which also had the most dramatic increase in use, especially among older children. Breast, thyroid and lung cancers and leukemia account for 68 percent of projected cancers in exposed girls; brain, lung and colon cancer and leukemia account for 51 percent of future cancers in boys.

Miglioretti explained that children’s organs are at an increased risk of cancer from CT scans because children still are growing and their cells are dividing rapidly. In addition, lifetime risk of cancer is greater among children because they are at the beginning of their lives — they have longer to live.

She noted that physicians can reduce dosage amounts using a number of different strategies, including reducing scan length by focusing solely on the ‘zone of interest’ — the region requiring imaging. For example, when the zone of interest is the abdomen, physicians should avoid also scanning the pelvis. She said dosage guidelines for imaging pediatric patients should be followed closely.

The Image Gently campaign, an initiative of the Alliance for Radiation Safety in Pediatric Imaging that encompasses the Society for Pediatric Radiology, American Association of Physicists in Medicine, American College of Radiology and American Association of Radiologic Technicians, aims to change practice by increasing awareness of opportunities to promote radiation protection in medical imaging of children.

“A smaller person needs a lower dose to come out of the machine to create an image of adequate quality for making a clinical diagnosis,” Miglioretti said.

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The research was supported by grant # U19CA79689 from the National Cancer Institute Cancer Research Network Across Health Care Systems; grant #R21CA131698 from the National Cancer Institute; and grant #K24CA125036.

Other study authors include Rebecca Smith-Bindman, UC San Francisco; Eric Johnson of Group Health Research Institute; Andrew Williams, Center for Health Research, Kaiser Permanente, Hawaii; Robert T Greenlee of the Epidemiology Research Center, Marshfield Clinic Research Foundation; Sheila Weinmann, Center for Health Research, Kaiser Permanente, Northwest; Leif I. Solberg, Health Partners Institute for Education and Research, Kaiser Permanente, Denver; Douglas Roblin, Center for Health Research, Kaiser Permanente, Southeast; Michael J. Flynn, Henry Ford Health System; and Nicholas Vanneman, Institute of General Practice, Johann Wolfgang Goethe University, Germany.

UC Davis Health System is improving lives and transforming health care by providing excellent patient care, conducting groundbreaking research, fostering innovative, interprofessional education, and creating dynamic, productive partnerships with the community. The academic health system includes one of the country’s best medical schools, a 619-bed acute-care teaching hospital, a 1000-member physician’s practice group and the new Betty Irene Moore School of Nursing. It is home to a National Cancer Institute-designated comprehensive cancer center, an international neurodevelopmental institute, a stem cell institute and a comprehensive children’s hospital. Other nationally prominent centers focus on advancing telemedicine, improving vascular care, eliminating health disparities and translating research findings into new treatments for patients. Together, they make UC Davis a hub of innovation that is transforming health for all. For more information, visit healthsystem.ucdavis.edu.

Individuals had a 40 percent increased risk of pertussis for each additional acellular dose received (as compared to receipt of a DTwP dose) between ages 1-24 months

Contact: Vincent Staupe vstaupe@golinharris.com 415-318-4386 Kaiser Permanente

Whole-cell vaccine was more effective than acellular vaccine during California pertussis outbreak

OAKLAND, Calif., May 20, 2013 — Whole-cell pertussis vaccines were more effective at protecting against pertussis than acellular pertussis vaccines during a large recent outbreak, according to a new Kaiser Permanente study published in Pediatrics.

Whole-cell pertussis vaccines, also called DTwP, were available from the 1940s to 1990s, but were associated with safety concerns that ultimately led to the development of acellular pertussis vaccines, which are also called DTaP. By the late 1990s, the United States had switched from whole-cell to acellular vaccines for all five recommended infant and childhood doses.

The study, which followed the 2010-2011 pertussis outbreak in California, examined 10- to 17-year-olds who received the recommended four pertussis-containing vaccines. The researchers evaluated the risk of pertussis during the outbreak according to the number of whole-cell and/or acellular pertussis vaccines these participants had received as infants and toddlers.

Despite high levels of vaccine coverage, pertussis epidemics have arisen every three to five years since the 1980s, with progressively higher incidence rates over time. “Studies have suggested that protection following the acellular pertussis vaccine is less enduring than following the whole-cell pertussis vaccine,” said lead author Nicola Klein, MD, PhD, co-director of the Kaiser Permanente Vaccine Study Center and a pediatrician. “Although reasons for the recurrent pertussis outbreaks are complex, waning protection following five doses of acellular pertussis vaccine plays a central role, at least in recent epidemics.”

The study included 138 individuals with confirmed pertussis, 899 individuals who had a lab test indicating they did not have pertussis, and 54,339 individuals who were similar to those with confirmed pertussis on sex, race/ethnicity, medical clinic, and membership status.

Increased number of acellular doses from zero to four was significantly associated with an increasing percent of positive pertussis tests. On average, individuals had a 40 percent increased risk of pertussis for each additional acellular dose received (as compared to receipt of a DTwP dose) between ages 1-24 months.

Teenagers who were vaccinated with four doses of acellular vaccines were at almost six times higher risk of pertussis than were those who had received four doses of whole-cell vaccines. Persons who received mixed whole-cell and acellular vaccines had an intermediate level of risk between those who received all whole-cell or all acellular vaccines. Those who received mixed vaccines were at nearly four times higher risk of pertussis than were those who received all whole-cell vaccines.

Earlier studies by Kaiser Permanente have shown that protection from the fifth dose of acellular pertussis vaccine wanes substantially during the five years after vaccination among children 4 to 12 years of age who have only received the acellular vaccine. The current study included only individuals born in 1999 or earlier, for whom at least five years had passed since receipt of the fifth pertussis vaccine.

Since 2005, the Advisory Committee on Immunization Practices has recommended boosting with reduced antigen content acellular pertussis vaccine, also known as Tdap, for persons 11 years and older. The study found that a booster dose of Tdap did not overcome the advantage in protection from pertussis seen among those who had received four doses of the whole-cell vaccine.

“The results indicate that a booster dose of Tdap does not overcome the advantage in protection from pertussis afforded to those who previously received four doses of the whole-cell vaccine,” Dr. Klein said. “Despite this, boosting the newly emerging cohort of acellular pertussis vaccine-only teenagers with Tdap remains the best means currently available to help protect this group against disease.”

Studies demonstrate that whole-cell and acellular pertussis vaccines administered to infants trigger different immune responses that at least partially persist through the teenage years, but long-term clinical consequences of such differences have been unknown. The results of this study, the researchers said, suggest that variations in immune responses induced by primary immunization during infancy play a central role in protection from disease years later. Additionally, the study highlights the need for new pertussis vaccines that provide both an improved safety profile and long lasting immunity.

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Additional authors on the study include Joan Bartlett, MPH, MPP; Bruce Fireman, MA; Ali Rowhani-Rahbar, MD, MPH, PhD; and Roger Baxter, MD, of  Kaiser Permanente Division of Research in Northern California.

This research was supported by funding from Kaiser Permanente.

About the Kaiser Permanente Division of Research

The Kaiser Permanente Division of Research conducts, publishes and disseminates epidemiologic and health services research to improve the health and medical care of Kaiser Permanente members and the society at large. It seeks to understand the determinants of illness and well-being and to improve the quality and cost-effectiveness of health care. Currently, DOR’s 600-plus staff is working on more than 250 epidemiological and health services research projects. For more information, visit http://www.dor.kaiser.org.

About Kaiser Permanente

Kaiser Permanente is committed to helping shape the future of health care. We are recognized as one of America’s leading health care providers and not-for-profit health plans. Founded in 1945, our mission is to provide high-quality, affordable health care services and to improve the health of our members and the communities we serve. We currently serve more than 9.1 million members in nine states and the District of Columbia. Care for members and patients is focused on their total health and guided by their personal physicians, specialists and team of caregivers. Our expert and caring medical teams are empowered and supported by industry-leading technology advances and tools for health promotion, disease prevention, state-of-the-art care delivery and world-class chronic disease management. Kaiser Permanente is dedicated to care innovations, clinical research, health education and the support of community health. For more information, go to: kp.org/newscenter.

Fired for Reporting ICU Risks, Kaiser Nurse Says

 

By WILLIAM DOTINGA

 

OAKLAND, Calif. (CN) – A nurse claims that Kaiser Permanente managers fired her after she complained about sub-standard conditions in the neonatal intensive care unit of a newly-opened facility.

Dawn Smith sued the Permanente Medical Group, Kaiser Foundation Hospitals, Kaiser Foundation Health Plan and two managers at Kaiser’s Modesto, Calif. facility. Besides the safety code violations, Smith also brings defamation and wrongful termination actions in the suit filed in Alameda County court.

Smith claims that after Kaiser opened its Modesto facility and hired her in 2008, she complained about “patient, hospital and staffing safety” in its neonatal intensive care unit (NICU). According to her complaint, Smith says she brought the issues to the attention of hospital management at monthly staffing meetings.

According to the complaint, most of Smith’s concerns centered on the lack of admission criteria and lack of staffing in the NICU. She also voiced concerns that premature newborns were sent to post-partum too quickly, and that babies were sent home despite being jaundiced with high bilirubin levels.

Smith says Kaiser staff started harassing her after she complained that a doctor did not properly “bag” a baby after delivery, while another failed to order blood work, an IV or monitoring equipment for a baby who showed signs of distress. In 2011, hospital managers Judy Moore and Gail Willingham – both defendants in the complaint – placed Smith on 30-day administrative leave “to look into some concerns we have.”

According to Smith, Moore and Willingham falsely accused her of failing to follow “neonatal resuscitation guidelines on three separate instances. The nurse says that in each of the three instances, she was either not at fault or the managers failed to interview all the parties involved in the deliveries – but Kaiser management handed her a second 30-day suspension without pay, the complaint states.

After several other incidents at the end of 2011 – including the near-death of a term infant – Smith says she complained again to Moore and Willingham. They responded by firing her, according to the complaint.

“Plaintiff’s termination letter was authored by Willingham and Moore and alleges ‘… a witness saw you vigorously handling the newborn, without taping the central [IV] lines securely in place. Your actions resulted in the central lines dislodging, which required replacement at a time when delay in care could be detrimental to the child. … Following a thorough investigation, it has been concluded that this incident was inappropriate; you have failed to follow the following policy: Policy on Obligations Regarding Umbilical Vessel Catheter Management – “Once placement has been verified, tape securely in place using the goal post method” [and] “Ensure the umbilical catheter is securely anchored to the skin.” [Due to] your continued failure to adhere to our policies and work rules, your employment with Kaiser Foundation Hospitals is being terminated effectively immediately,” Smith says in her complaint. (Ellipses in original.)

Smith says that in reality, the delivery doctor failed to secure the catheters in the newborn’s umbilical cord during the incident that cost her her job. She says she actually held the catheters in place until the doctor returned and reinserted the IV.

In addition to Kaiser’s refusal to address her safety concerns, Smith says the blame Willingham and Moore placed on her shoulders for troubles in the NICU damaged her occupation and reputation. She seeks compensatory and punitive damages for both the defamation and her wrongful termination.

Smith is represented by Lawrance Bohm of Sacramento

http://www.courthousenews.com/2013/02/12/54770.htm

Workplace BPA exposure increases risk of male sexual dysfunction

2009 study posted for filing

Contact: Danielle Cass danielle.x.cass@kp.org 510-267-5354 Kaiser Permanente

First human study to measure effects of BPA on male reproductive system

November 11, 2009 (Oakland, Calif.) – High levels of workplace exposure to Bisphenol-A may increase the risk of reduced sexual function in men, according to a Kaiser Permanente study appearing in the journal Human Reproduction, published by Oxford Journals. [1]

The five-year study examined 634 workers in factories in China, comparing workers in BPA manufacturing facilities with a control group of workers in factories where no BPA was present. The study found that the workers in the BPA facilities had quadruple the risk of erectile dysfunction, and seven times more risk of ejaculation difficulty.

This is the first research study to look at the effect of BPA on the male reproductive system in humans. Previous animal studies have shown that BPA has a detrimental effect on male reproductive system in mice and rats.

Funded by the U.S. National Institute of Occupational Safety and Health, this study adds to the body of evidence questioning the safety of BPA, a chemical made in the production of polycarbonated plastics and epoxy resins found in baby bottles, plastic containers, the lining of cans used for food and beverages, and in dental sealants.

The BPA levels experienced by the exposed factory workers in the study were 50 times higher than what the average American male faces in the United States, the researchers said.

“Because the BPA levels in this study were very high, more research needs to be done to see how low a level of BPA exposure may have effects on our reproductive system,” said the study’s lead author. De-Kun Li, MD, Ph.D., a reproductive and perinatal epidemiologist at Kaiser Permanente’s Division of Research in Oakland, Calif. “This study raises the question: Is there a safe level for BPA exposure, and what is that level? More studies like this, which examine the effect of BPA on humans, are critically needed to help establish prevention strategies and regulatory policies.”

The researchers explained that BPA is believed by some to be a highly suspect human endocrine disrupter, likely affecting both male and female reproductive systems. This first epidemiological study of BPA effects on the male reproductive system provides evidence that has been lacking as the U.S. Food and Drug Administration, and various U.S. government panels have explored this controversial topic.

This study is the first of series of studies that examine the BPA effect in humans and are to be published by Dr. Li and his colleagues.

The study finding, Dr. Li also points out, may have implications of adverse BPA effects beyond male sexual dysfunction. Male sexual dysfunction could be a more sensitive early indicator for adverse BPA effects than other disease endpoints that are more difficult to study, such as cancer or metabolic diseases.

For this study, researchers compared 230 workers exposed to high levels of BPA in their jobs as packagers, technical supervisors, laboratory technicians and maintenance workers in one BPA manufacturing facility and three facilities using BPA to manufacture epoxy resin, in several regions near Shanghai, to a control group of 404 workers in the same city from factories where no BPA exposure in the workplace was recorded. The factories with no BPA exposure produced construction materials, water supplies, machinery, garments, textiles, and electronics. The workers from the two groups were matched by age, education, gender, and employment history.

Researchers gauged BPA levels by conducting spot air sampling, personal air sample monitoring and walk-through evaluations, by reviewing factory records and interviewing factory leaders and workers about personal hygiene habits, use of protective equipment, and exposures to other chemicals. A subset of workers also provided urine samples for assaying urine BPA level to confirm the higher BPA exposure level among the workers with occupational BPA exposure.

Researchers measured sexual function based on in-person interviews using a standard male sexual function inventory that measures four categories of male sexual function including erectile function, ejaculation capability, sexual desire, and overall satisfaction with sex life.

After adjusting for age, education, marital status, current smoking status, a history of chronic diseases and exposure to other chemicals, and employment history, the researchers found the BPA-exposed workers had a significantly higher risk of sexual dysfunction compared to the unexposed workers.

The BPA-exposed workers had a nearly four-fold increased risk of reduced sexual desire and overall satisfaction with their sex life, greater than four-fold increased risk of erection difficulty, and more than seven-fold increased risk of ejaculation difficulty.

A dose-response relationship was observed with an increasing level of cumulative BPA exposure associated with a higher risk of sexual dysfunction. Furthermore, compared to the unexposed workers, BPA-exposed workers reported significantly higher frequencies of reduced sexual function within one year of employment in the BPA-exposed factories.

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Other authors on this study include: X. Weng, Ph.D., J.R. Ferber, MPH, and L.J. Herrinton of the Kaiser Permanente Division of Research; Z. Zhou, Ph.D., MD, Y. He, Ph.D., and T. Wu MD, Ph.D. of the Department of Occupational Health and Toxicology, School of Public Health & WHO Collaborating Center for Occupational Health, Fudan University, Shanghai, China; D. Qing, , M. Miao, PhD, J. Wang, Ph.D, Q. Zhu, MD, E. Gao, MD, MPH, Ph.D., and W. Yuan of Shanghai Institute of Planned Parenthood Research and National Population & Family Planning Key Laboratory of Contraceptive Drugs and Devices; and H. Checkoway, Ph.D. of Department of Environmental Health, University of Washington, Seattle.

Notes

[1] Occupational exposure to bisphenol-A (BPA) and the risk of self-reported male sexual dysfunction. Human Reproduction journal. doi:10.1093/humrep/dep381

http://www.oxfordjournals.org/news/dep381.pdf

About the Kaiser Permanente Division of Research (http://www.dor.kaiser.org/)

The Kaiser Permanente Division of Research conducts, publishes, and disseminates epidemiologic and health services research to improve the health and medical care of Kaiser Permanente members and the society at large. It seeks to understand the determinants of illness and well-being and to improve the quality and cost-effectiveness of health care. Currently, DOR’s 400-plus staff is working on more than 250 epidemiological and health services research projects.

About Kaiser Permanente

Kaiser Permanente is committed to helping shape the future of health care. We are recognized as one of America’s leading health care providers and not-for-profit health plans. Founded in 1945, our mission is to provide high-quality, affordable health care services to improve the health of our members and the communities we serve. We currently serve 8.6 million members in nine states and the District of Columbia. Care for members and patients is focused on their total health and guided by their personal physicians, specialists and team of caregivers. Our expert and caring medical teams are empowered and supported by industry-leading technology advances and tools for health promotion, disease prevention, state-of-the art care delivery and world-class chronic disease management. Kaiser Permanente is dedicated to care innovations, clinical research, health education and the support of community health. For more information, go to: www.kp.org/newscenter.

Measles, Mumps, Rubella vaccine linked with 2-fold risk of seizures

Contact: Danielle Cass danielle.x.cass@kp.org 510-267-5354 Kaiser Permanente

Combination MMRV vaccine linked with 2-fold risk of seizures

Electronic health records study of 459,000 children sparked new CDC recommendations

Oakland, CA (June 28) – The combination vaccine for measles, mumps, rubella and chickenpox (MMRV) is associated with double the risk of febrile seizures for 1- to 2-year-old children compared with same-day administration of the separate vaccine for MMR (measles, mumps, rubella) and the varicella (V) vaccine for chicken pox, according to a Kaiser Permanente Division of Research study appearing online in the journal Pediatrics. A febrile seizure is a brief, fever-related convulsion but it does not lead to epilepsy or seizure disorders, researchers explained.

Funded by the U.S. Centers for Disease Control, the study analyzed 459,000 children 12 to 23 months old from numerous health systems across the United States receiving their first dose of measles-containing vaccine and found MMRV to be associated with a two-fold increased risk of fever and febrile seizures 7-10 days after vaccination compared with same-day administration of a separate shot for MMR and the varicella (chickenpox) vaccine. This study found that the risk for a febrile seizure after the first dose of MMRV vaccine is low, although it is higher than after MMR vaccine and varicella vaccine administered as separate injections.

The study found no evidence of an increased febrile seizure risk after any measles vaccine beyond 7-10 days post vaccination.

“Because the risk of febrile seizure is higher for the quadrivalent (combination) vaccine, providers recommending MMRV should communicate to parents that it increases the risk of fever and febrile seizure over that already associated with measles-containing vaccines,” said the study’s lead investigator Nicola Klein, MD, Ph.D., co-director of the Kaiser Permanente Vaccine Study Center. “But concerned parents should understand that the risk for febrile seizures after any measles-containing vaccine is low: less than 1 febrile seizure per 1,000 injections.”

The CDC recently recommended that either vaccine may be used for first dose for 1-2 year olds, however families without a strong preference for MMRV should receive separate MMR +V vaccines, Klein said. The CDC reiterates that providers who consider using MMRV should discuss with families and caregivers the risk and benefits.

“While this study and the resulting CDC recommendations are very important and ones our pediatricians will follow, it is also important to emphasize that it is more common for a child to have a febrile seizure caused by a simple cold than by an immunization. And though febrile seizures are a very scary event for a family, they are not dangerous and do not lead to later epilepsy or seizure disorders,” said Randy Bergen, MD, a Kaiser Permanente pediatrician and infectious disease specialist at Kaiser Permanente-Walnut Creek.

Kaiser Permanente researchers used its electronic health records and Vaccine Safety Datalink data from 2000 to 2008 to assess seizures and fever visits among children aged 12-23 months following MMRV and separate MMR +V. They compared seizure risk following MMRV to MMR +V using regression analyses and by incorporating chart-reviewed febrile seizure cases.

The Vaccine Safety Datalink project is a collaborative effort between CDC’s Immunization Safety Office and eight managed care organizations: Kaiser Permanente Northern California, Kaiser Permanente Southern California, Kaiser Permanente Colorado, Kaiser Permanente Northwest, Health Partners, Group Health Cooperative, Marshfield Clinic and Harvard Pilgrim Health Care. The VSD project was established in 1990 to monitor immunization safety and address the gaps in scientific knowledge about rare and serious events following immunization. The VSD shares electronic health records from the organizations’ health systems.

MMRV was licensed by the FDA in 2005.  MMRV was subsequently recommended by the Advisory Committee on Immunization Practices (ACIP) in 2006. Although prelicensure studies of MMRV among 1-2 year olds noted higher rates of fever and measles-like rash one to two weeks post vaccination when compared with separate MMR + V, it was unknown at the time of MMRV’s licensure whether a higher rate of fevers was similarly associated with increased risk of febrile seizures.  In February 2008, Kaiser Permanente researchers alerted the ACIP to preliminary evidence of an increased risk of febrile seizures following MMRV. This study represents additional data on twice as many vaccines.

“The Vaccine Safety Datalink, which we used to conduct this study, is a premiere example of how different managed care organizations can leverage their electronic medical records to improve vaccine safety and monitoring,” Klein said.

This is the latest in a series of Kaiser Permanente studies undertaken to better understand the protective effects and risks of vaccines. Recent published studies found children of parents who refuse vaccines are nine times more likely to get chickenpox and 23 times more likely to get whooping cough compared to fully immunized children. A study published last year found that herpes zoster, also known as shingles, is very rare among children who have been vaccinated against chicken pox. A recent study in the Journal of the American Medical Association found that the pneumococcal vaccination is not associated with a reduced risk of heart attacks or strokes in middle-aged men.

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* Requested Repost