sábado, 31 de agosto de 2019

Hyundai Hope On Wheels announces a combined $13.2 million grant for pediatric cancer research

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Reviewed by James Ives, M.Psych. (Editor)Aug 31 2019

Hyundai Hope On Wheels® (HHOW), a 501(c)(3) nonprofit organization, supported by Hyundai Motor America and its U.S. dealers, continues its fight against pediatric cancer and announces plans for Childhood Cancer Awareness month. For September, the non-profit organization has selected 52 new grant winners to receive a combined $13.2 million for pediatric cancer research. In addition to grants announced earlier this year, this brings the Hyundai Hope On Wheels donations to pediatric cancer research to just over $160 million in the United States, since 1998.

The September campaign theme for the 10th year is Every Handprint Tells A Story. There are 15,000 new cases of pediatric cancer - about 44 children a day - diagnosed in the United States each year. Although 80% of kids with cancer can be cured, pediatric cancer remains the leading cause of death by disease among U.S. children. With its Every Handprint Tells A Story campaign, Hyundai Hope On Wheels brings together the many stakeholders - the child, families, doctors, hospitals, advocates, donors, and others - who work to identify new ways to find a cure and improve care for children with battling pediatric cancer. When a child is diagnosed, it not only changes their life, but his/her family and broader communal network.

Hyundai is an international company with big ideas and a bold vision to make the world better, with a corporate philosophy of Lifetime partner in automobile and beyond. Key to our vision of a better world is the health, safety, and well-being of children. That's why for the past 21 years, Hyundai and our U.S. dealers have joined the fight against pediatric cancer. Children are our future; they deserve every opportunity to succeed. We are funding life-saving research, and we are raising more awareness about the importance of the cause with Hyundai Hope On Wheels. Because children deserve to win!"
Jose Munoz, President and CEO, Hyundai Motor North America

Hyundai Hope On Wheels is one of the largest funders of pediatric cancer research in the nation. With five (5) different grant categories - ranging from $100,000 to $2.5 million - grants are awarded to Children's Oncology Group member institutions through a competitive doctor peer reviewed process. The Scholar Hope Grant ($300,000) and The Young Investigator ($200,000) grants are awarded during the month of September. This month, additional donations are made to Dana-Farber Cancer Institute/The Jimmy Fund Walk of the Boston Marathon (9/22) and The Run-4-Hope 5K-10K run/walk benefiting the Hyundai Cancer Institute at Children's Hospital of Orange County (9/29).

Every 36 minutes a child is diagnosed with pediatric cancer. Children deserve to enjoy the simple milestones of childhood like having a birthday party, a first day of school, losing a first tooth, obtaining a driver's license, or getting a part-time job. These ordinary milestones of childhood are often missed, when a child is diagnosed with pediatric cancer. In its place are times spent confined to a hospital room, countless surgeries, hair loss, needles and medicines, and even loss of limbs. The reality is there is nothing fun about being a kid with cancer. However, there are so many brave and amazing children whose stories of courage, bravery and hope inspires us.

"As the board chair for Hyundai Hope On Wheels, there is no greater joy than for me than to meet the faces of brave pediatric cancer fighters at children's hospitals across the nation," says Scott Fink, Board Chair and Hyundai dealer-owner, Hyundai of New Port Richey (New Port Richey, FL) and Hyundai of Wesley Chapel (Wesley Chapel, FL). "These amazing kids embody the word hope. They exemplify all that's wonderful about childhood, and they show us as adults the courage of facing adversity. The Hyundai dealers of America joined the fight against pediatric cancer in 1998. For so many children fighting the disease, they travel an uncertain journey to recovery. And, sadly, for far too many others, the battle with the disease is not won. With Hyundai Hope On Wheels, we'll continue this fight to not only survive the disease, but to thrive."

Returning for a second year, Ms. Elizabeth Blair (age 12 of Phoenix, AZ) and Carter Gates (age 14 of Colorado Springs, CO) served as the 2019 National Youth Ambassadors. Each will travel the country visiting children's hospitals and attending events to share their unique messages of hope and courage.

2019 Every Handprint Tells A Story Campaign elements

The Hyundai Hope On Wheels September campaign, Every Handprint Tells A Story, is an exciting multimedia communications plan and a national event strategy to increase awareness and to engage more involvement for the cause. Including,

Nationwide tour to 52 new grants winners
National TV commercial
Handprint Ceremony pop-up events
Billboard in Times Square (54th and Broadway) for Pediatric Cancer Awareness Month
Annual DC Days event
Thought Leaders' Conference
Interactive website experience at HyundaiHopeOnWheels.org
Social media childhood cancer survivor and doctor-researcher videos
Hope vehicles - Kona, Tucson, Santa Fe Hope, and Palisades
National Press Conference
Satellite Media Tour
Media communications: The Hearst Media online, and The USA Today
The Dana-Farber Cancer Institute's Jimmy Fund Walk of the Boston Marathon, presented by Hyundai
The Run-4-Hope 5K-10K, benefiting The Hyundai Cancer Institute at the Children's Hospital of Orange County (CHOC)
Hyundai owner appreciation decals
Dealership handprint sale
And more….

Additional information about this year's HHOW grant winners, campaign videos and consumer public engagement opportunities can be found on the re-designed website, HyundaiHopeOnWheels.org, or social media (Facebook, Twitter and Instagram).

Throughout the month of September, the Hope Vehicles will travel the nation to capture the stories of brave kids battling cancer, raise awareness of the disease, and to inspire hope for a cure. At each event we conduct our signature handprint ceremony, at which the Hope Vehicle is decorated with the handprints of children across the country fighting the disease. These handprints represent the dreams, journey and hopes of kids fighting cancer. Every Handprint Tells A Story!

The gold ribbon is the symbol for childhood cancer. The public is invited to help spread awareness about Hyundai Hope On Wheels and its related efforts to help end childhood cancer and to visit the website, HyundaiHopeOnWheels.org to learn more ways to support the cause.

Source:

Hyundai Hope On Wheels

Study finds transplantation of Hepatitis C-infected donor kidneys to uninfected recipients to be safe

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Reviewed by Kate Anderton, B.Sc. (Editor)Aug 30 2019

Transplantation of kidneys from Hepatitis C-infected donors to uninfected recipients is safe and can be successfully implemented as a standard of care, according to an observational study by physicians at the University of Tennessee Health Science Center and the James D. Eason Transplant Institute at Methodist University Hospital.

The practice, which has been tested in two smaller clinical trials, could greatly expand the number of kidneys available for transplantation and reduce wait times for donors, said Miklos Z. Molnar, MD, PhD, FEBTM, FERA, FASN, associate professor of Medicine at UTHSC, transplant nephrologist at the James D. Eason Transplant Institute, and director of the Transplant Nephrology Fellowship program at UTHSC. Dr. Molnar is the principal author of the study published by the American Journal of Transplantation.

In current practice, Hepatitis C-infected kidneys are transplanted only to patients already infected with the disease, Dr. Molnar said. The number of these available kidneys greatly exceeds the infected population. As a result, up to 1,000 Hepatitis C-infected kidneys or more are discarded annually.

"Our thought was using these kidneys, which are usually pretty good, other than the Hepatitis C," he said.

The Memphis team began its study in March 2018. To date, more than 80 uninfected recipients have received Hepatitis C-infected kidneys. The paper cites 53 patients, since the remainder are too soon after transplant to evaluate fully.

All patients consented to the surgery in three separate steps, after being made aware that by receiving an infected kidney, they would be infected with Hepatitis C. All were successfully transplanted, and after receiving 12 weeks of antiviral therapy, show no signs of Hepatitis C and are considered cured. "We did not lose any patients, but there were some unexpected complications," Dr. Molnar said. High volume of BK virus, common after transplantation and generally treatable, was evidenced in a number of the recipients.

While this factor will demand further research, Dr. Molnar said the study results are positive for patients in need of transplant. "These people would not get this offering (a transplant) without these kidneys," he said. "If you're willing to accept these kidneys, the waiting time can go down by two years."

The five-year survival rate on dialysis is 50 percent, Dr. Molnar said. "We are losing 10 percent of the patients every year on dialysis."

Dr. Molnar said the study indicates that transplantation of Hepatitis C-infected kidneys to Hepatitis C-negative recipients has potential to become the standard of care in the United States. "Otherwise, the patients would be on dialysis and die," he said. "These patients have good kidney graft function. The transplantation of Hep C-infected kidney to non-Hep C-infected recipients can be done and should be done."

Director of the Transplant Institute James Eason, MD, said:

This is a landmark paper outlining a novel approach to using kidneys, that would otherwise be discarded, to save more lives."

Source:

University of Tennessee Health Science Center

Journal reference:

Molnar, M.Z. et al. (2019) Transplantation of kidneys from hepatitis C–infected donors to hepatitis C–negative recipients: Single center experience. American Journal of Transplantation. doi.org/10.1111/ajt.15530.

Leukemia is not just one disease

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Reviewed by Kate Anderton, B.Sc. (Editor)Aug 30 2019

An estimated 61,780 new cases of leukemia will be diagnosed in the United States this year, with some 2,000 cases in New Jersey, according to the American Cancer Society. Although leukemias are thought to occur in childhood, they can actually present at any age in both children and adults. However, not all leukemias are created equal.

There are four main types of leukemia. There are 'acute' versus 'chronic' - and there are those that emerge from 'myeloid' versus 'lymphoid' cells.

Types of leukemia considered acute (e.g. acute myeloid leukemia, acute lymphocytic leukemia) present suddenly with severe symptoms and are treated more aggressively, while chronic leukemias (e.g. chronic myeloid leukemia, chronic lymphocytic leukemia) develop more slowly and are easier to treat and manage. Other blood cancers in this spectrum include myeloproliferative neoplasms, myelodysplasia and systemic mastocytosis.

Our blood is composed of cells that fight infection (i.e., white blood cells), carry oxygen and allow us to clot and stop bleeding (platelets). Leukemia symptoms are therefore tied to irregularities that may develop in the cells of our blood. These may occur gradually in some who present with nosebleeds, bruising, fevers and/or recurrent infections. In others, these irregularities are identified through blood work and symptoms may occur more rapidly. In addition, lymphocytic leukemias may also present with enlargement of the spleen and/or lymph nodes. It is therefore important to be evaluated by a healthcare professional if presenting with symptoms that are unusual for you.

There are highly effective treatments in leukemia with the best options being individualized to the exact disease subtype and the individual patient. Chemotherapy is often part of curative treatment for acute leukemias. However, some subtypes of acute leukemia (e.g., acute promyelocytic leukemia) are treated with highly targeted treatments including novel oral medications. For the treatment of chronic leukemias, there are a multitude of new and effective targeted treatments becoming available, whether monoclonal antibiodies that target the surface of the leukemia cell or specialized inhibitors that target the DNA and RNA inside the cell. In addition, there are some leukemia conditions that do not need immediate therapy and can be managed with a "watch and wait" approach for several years.

Physician-scientists at Rutgers Cancer Institute of New Jersey are at the forefront of studying the causes of leukemia and developing new treatment options for blood cancers. As a National Cancer Institute-designated Comprehensive Cancer Center and a member of the Big Ten Cancer Research Consortium, our team works collaboratively with colleagues across the country to improve patient outcomes for leukemias and other forms of cancer. Information about hematologic malignancies can be found at http://www.cinj.org/treatment/leukemia.html.

Even though leukemias each behave differently and may even differ between patients, they are highly treatable. The best thing to do is to consult with a healthcare provider that specializes in leukemia to discuss an individualized treatment plan.

Source:

Rutgers Cancer Institute of New Jersey

Statement on FDA and CDC collaboration to investigate respiratory illnesses related to e-cigarette use

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Reviewed by Kate Anderton, B.Sc. (Editor)Aug 30 2019

Both the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention are working tirelessly to investigate the distressing incidents of severe respiratory disease associated with use of e-cigarette products. We were deeply saddened last week to learn of the death of an adult in Illinois who had been hospitalized with a severe respiratory illness following the use of an e-cigarette product. We are working closely with state and local health officials to investigate these incidents as quickly as possible, and we are committed to taking appropriate actions as a clearer picture of the facts emerges.

We've also made it a top priority to communicate with the public about our efforts. Today, we are providing several updates about efforts between FDA, CDC and state health officials to investigate these incidents that have impacted both youth and adults across the country. First, we are updating the number of potential cases of respiratory illnesses reported after use of e-cigarette products. Additionally, we are sharing more details about the work CDC and FDA are undertaking as part of the investigation, including its current status. We are also providing the public and our health partners across the country with information to help mitigate the risk of additional incidents and what health officials and clinicians can do to help us gather as much data as possible to better understand these illness and potential causes.

As of Aug. 27, 2019, 215 possible cases have been reported from 25 states, and additional reports of pulmonary illness are under investigation. States are completing their own investigations and verifications of cases based on CDC's recently released standardized case definition. While some cases in each of the states are similar and appear to be linked to e-cigarette product use, more information is needed to determine what is causing the respiratory illnesses. In many cases, patients reported a gradual start of symptoms, including breathing difficulty, shortness of breath, and/or chest pain before hospitalization. Some cases reported mild to moderate gastrointestinal illness including vomiting and diarrhea, or other symptoms such as fevers or fatigue. In many cases, patients have also acknowledged recent use of tetrahydrocannabinol (THC)-containing e-cigarette products while speaking to healthcare personnel, or in follow-up interviews by health department staff.

Even though cases appear similar, it is not clear if these cases have a common cause or if they are different diseases with similar presentations, which is why our ongoing investigation is critical. CDC and the FDA are providing consultation to state health departments and working closely with them to gather information on any products or substances used. For example, our agencies are working to standardize information collection at the state level to help build a more comprehensive picture of these incidents. This includes investigating the brand and types of e-cigarette products, whether any of them are products that would fall within the FDA's regulatory authority, as well as where they were obtained.

CDC is helping involved states investigate whether the illnesses may be linked to specific devices, ingredients or contaminants in the devices, or substances associated with e-cigarette product use, with the FDA's assistance. Current assistance to states includes deploying CDC staff to Illinois and Wisconsin to assist their state health departments with the respective state investigations; releasing a Clinician Outreach and Communication Activity (COCA) Clinical Action Alert describing this investigation and asking providers to report possible cases to their state health departments; developing and distributing to involved states a standardized case definition, medical chart abstraction form, and case interview questionnaire with input from states who are running investigations; reviewing and providing feedback on data collection and health messaging tools for states; and facilitating information sharing between states with possible cases.

In addition to daily meetings between our federal agencies, as well as frequent communication with state health officials, the FDA has been and will continue to provide laboratory assistance. The FDA has received about 80 samples and continues to receive requests from states to send more samples for the FDA to analyze. The samples represent a variety of different types of products and substances - a number of which contained incomplete information about the product. The FDA is analyzing those samples for their contents, whether they contain nicotine, substances, such as THC or other cannabinoids, or other chemicals and ingredients. The results of that testing will be shared with the respective states to aid in their investigations and will help inform the federal response.

More information is needed to better understand whether there's a relationship between any specific products or substances and the reported illnesses. At this time, there does not appear to be one product involved in all of the cases, although THC and cannabinoids use has been reported in many cases. At this time, the specific substances within the e-cigarette products that cause illness are not known and could involve a variety of substances. We continue to gather information about the names of the products used, where they were purchased, and how the products were used. That information is critical to help determine whether patterns emerge on which we can take additional action. While we continue to gather more information about these incidents and any specific products or substances involved, we also believe it's important to provide the public with useful information to help protect themselves and their loved ones, as well as continue to notify health care professionals about the illnesses, what to watch for, and how to collect and report information on these cases. As part of that commitment, CDC today issued a Health Alert Network (HAN) Health Advisory. The advisory includes the recommendation that while this investigation is ongoing, if you are concerned about these specific health risks, consider refraining from the use of e-cigarette products.

Anyone who does use e-cigarette products should not buy these products off the street (e.g., e-cigarette products with THC or other cannabinoids) and should not modify e-cigarette products or add any substances to these products that are not intended by the manufacturer. Regardless of the ongoing investigation, e-cigarette products should not be used by youth, young adults, pregnant women, and adults who do not currently use tobacco products. If you use e-cigarette products, monitor yourself for symptoms (e.g., cough, shortness of breaths, chest pain) and promptly seek medical attention if you have concerns about your health. CDC and the FDA will continue to advise and alert the public as more information becomes available. Adult smokers who are attempting to quit should use evidence-based treatments, including counseling and FDA-approved medications. If you need help quitting tobacco products, including e-cigarettes, contact your doctor. If you are concerned about harmful effects from e-cigarette products, call your local poison control center at: 1-800-222-1222. We also continue to encourage the public to submit detailed reports of any unexpected tobacco- or e-cigarette-related health or product issues to the FDA via the online Safety Reporting Portal.

As this investigation continues, our agencies remain committed to working as quickly as possible, in collaboration with our state and local public health partners and the clinical community, to find out as much as we can about these cases and potential causes and communicating with the public about these efforts to protect and promote the public health. Our ongoing oversight and educational efforts related to e-cigarettes is critical to our public health mission and, especially, to protecting youth from the dangers of nicotine addiction and tobacco-related disease and death.

Source:

U.S. Food and Drug Administration

Academy of Nutrition and Dietetics raises awareness about prevention and treatment of malnutrition

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Reviewed by Kate Anderton, B.Sc. (Editor)Aug 30 2019

Preventing a patient from becoming malnourished can shorten his or her hospital stay, decrease hospital fees and, most importantly, improve the patient's quality of life. For those reasons, identifying and treating patients with malnutrition warrants the attention of health care providers and policymakers.

During its September Spotlight on Malnutrition, the Academy of Nutrition and Dietetics raises awareness of malnutrition and promotes the crucial role of registered dietitian nutritionists and nutrition and dietetics technicians, registered in identifying and treating this serious condition. In addition, the Academy provides educational resources for the public and Academy members.

Identifying and treating people who show early signs of malnutrition can enhance a person's mental and physical health. In the case of seniors, delivering nutritious meals and snacks preserves their dignity and functional status by enabling them to age in place and reduce expensive hospital stays."
Academy President Terri J. Raymond, registered dietitian nutritionist

During September, the Academy and its members will emphasize specific aspects of malnutrition to include the following focus areas:

Prevention and Well-Being
Hospital Care and Health Systems
Food and Nutrition Safety and Security

The September issue of the Journal of the Academy of Nutrition and Dietetics will feature a special supplement that includes articles about how the prevention and treatment of malnutrition present outstanding opportunities to improve the overall quality of patient care, enhance quality clinical outcomes and reduce health care costs.

Much of the information for the supplement was provided by the Malnutrition Quality Improvement Initiative, a project of the Academy, Avalere Health and other stakeholders who collaborated to support quality improvement measures for malnutrition care and provide resources for the implementation of those measures.

Source:

Academy of Nutrition and Dietetics

Non-medical use of prescription amphetamines for ADHD linked to hospitalization, fatal outcomes

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Reviewed by Kate Anderton, B.Sc. (Editor)Aug 30 2019

New findings on the serious adverse outcomes associated with non-medical use (NMU) of prescription amphetamines for attention deficit hyperactivity disorder (ADHD) were recently published in the September 2019 issue of the Journal of Attention Disorders. The findings, based on an analysis of call data from the U.S. National Poison Data System (NPDS), demonstrate that NMU of these medicines by oral, nasal (snorting or sniffing) or IV injection routes significantly increases the risk of hospitalization, and is also linked to an increased risk of other serious outcomes including admission to critical care and psychiatric units, attempted suicide and even death.

The non-medical use of these important medications for ADHD is a significant and growing problem that causes devastating consequences for individuals, families and communities. These real-world findings reinforce the need to educate policymakers, patients, caregivers and the public about the severe and dangerous outcomes of non-medical amphetamine use, especially by nasal and injection routes of administration."
Study author Stephen Faraone, PhD, Distinguished Professor of Psychiatry and Neuroscience & Physiology at SUNY Upstate Medical University

The analysis was based on reports of intentional or unintentional use of prescription stimulant amphetamines processed by regional poison centers and uploaded to the NPDS between 2012 and 2016. A total of 15,876 records (6,163 adolescents and 9,713 adults) were analyzed. Researchers defined three groups based on intentional oral (n=11,161), nasal (n=598) or IV injection (n=164) NMU and compared them to a control group of people reporting of unintentional oral exposure to amphetamine (n=3,953).

Key findings

People who intentionally misused or abused prescription amphetamines were at higher risk for adverse outcomes compared to the control group, with the greatest number of serious outcomes in the injection group followed by the nasal and oral administration groups.

The odds of dying were approximately 22 times greater for people who non-medically used amphetamines by injection compared to the control group (1.2% IV versus 0.03% control), and approximately 13 times greater for the nasal administration group (0.5% intranasal versus 0.03% control).

Rates of hospitalization across the NMU groups (68% for the injection group, 64.7% for the oral group and 49% for the nasal group) were statistically significantly higher than those of the control group (22%). Those who non-medically used amphetamines by injection were also at greatest risk of being admitted to a critical care unit (36.6% versus 24.6% for oral NMU, 21.1% for nasal NMU and 7.9% for the control group), indicating that many of these patients were seriously ill.

Suspected suicide attempts were more common among people reporting oral NMU of amphetamines (74.1%) than those who misused or abused by injection (20.7%) and nasal (15.6%) routes. Rates of oral NMU and suicide attempts increased simultaneously over the five years of the NPDS data analysis, suggesting that NMU of amphetamines is increasing as a method for suicide attempts. Moreover, admissions to a psychiatric unit were significantly higher in the oral NMU group compared with the injection and nasal NMU groups.

Data from this study shows that amphetamine NMU is associated with high morbidity and mortality, and that educational initiatives are needed to alert prescribers to the existence of NMU and the potential consequences for their patients.

Source:

SUNY Upstate Medical University

Journal reference:

Faraone, S.V. et al. (2019) Prevalence and Consequences of the Nonmedical Use of Amphetamine Among Persons Calling Poison Control Centers. Journal of Attention Disorders. doi.org/10.1177/1087054719843182.

Several maternal fluoride-offspring IQ studies should provoke moratorium on fluoridation

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Reviewed by James Ives, M.Psych. (Editor)Aug 31 2019

Critics of the fluoride-IQ study published this month in JAMA Pediatrics claimed it needed replication. However, the Canadian study by Green (2019) was already a replication of another U.S. government-funded study published in 2017 by Bashash which found similar effects, reports the Fluoride Action Network (FAN).

Both were Mother-Offspring studies that used urinary fluoride levels during pregnancy to assess cognition in the paired offspring.

Both studies have shown a strong relationship between maternal exposure to fluoride and lowered IQ in offspring. Each revealed that the fetal stage appears to be the most vulnerable time period for fluoride's neurotoxicity.

Actually, FAN points out that there have been five studies that have found this relationship between maternal exposure and lowered IQ in children (see listing below). However, the Canadian study is the first to compare fluoridated vs non-fluoridated cities. The pregnant women in Canada with higher urinary fluoride levels had offspring with lower IQs and were from the fluoridated cities.

Paul Connett, PhD, FAN Executive Director, says:

For years promoters of fluoridation have argued that there is no harm from fluoridation; these and other studies indicate that there is potential harm and it is serious. It is unconscionable to continue fluoridation until this is resolved. For those who doubt the current findings more studies can be done once a moratorium on fluoridation is in place. To do otherwise is to condone a human experiment on millions of children."

Connett adds:

To ignore brain health and continue fluoridation in name of dental health is a huge disservice to the children of this country. FAN argues that there are more effective programs to reduce dental inequities (eg, 'Childsmile' in Scotland) and communities can easily implement them."

The Mother-Offspring studies, listed below, can be accessed at http://fluoridealert.org/issues/moms2b/mother-offspring-studies/

Green (2019). Largest study with 512 mother-offspring. Lower IQ in children 3- 4 years of age.

Bashash (2017). Longest study. 299 mother-offspring pairs in Mexico. Lower IQ in children 4 and 6-12 years of age.

Thomas (2018). 401 mother-offspring pairs in Mexico. Lower IQ in children 1-3 years of age Only the abstract has been published.

Valdez Jiménez (2017). Lower IQ between the ages of 3-15 months with 65 mother-offspring pairs in Mexico.

Li (2004). Significant differences in the neonatal behavioral neurological assessment score in 91 offspring aged 1-3 days old.

Source:

Fluoride Action Network

St. Jude Children's Research Hospital brings communities together to end childhood cancer

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Reviewed by James Ives, M.Psych. (Editor)Aug 31 2019

This September during Childhood Cancer Awareness Month, St. Jude Children's Research Hospital® is inspiring hundreds of thousands of people across the nation to unite behind a shared goal of ending childhood cancer.

September was proclaimed National Childhood Cancer Awareness Month in 2012 to bring awareness to pediatric cancer, which remains the leading cause of death by disease for children under the age of 15. Since then, St. Jude has led the movement and conversation during this critical timeframe by mobilizing supporters, partners, celebrities and influencers to support the hospital's mission: Finding cures. Saving children.®

Throughout September, St. Jude supporters from coast to coast will join St. Jude Walk/Run events taking place in 63 communities. Supporters can also register for the St. Jude Walk/Run Virtual Event to walk, run and fundraise for the kids of St. Jude. Funds raised through events like these help ensure families never receive a bill from St. Jude for treatment, travel, housing or food—because all a family should worry about is helping their child live.

Each year, approximately 16,000 children and teens in the U.S. are diagnosed with cancer. Around the world, that number is about 400,000. Because St. Jude freely shares the discoveries it makes, every child saved at St. Jude means doctors and scientists worldwide can use that knowledge to save thousands more children around the world.

It is inspiring to see these communities come together and know that they are making an impact locally as well as nationally by supporting the St. Jude mission: Finding cures. Saving children.®. We are grateful to all of the partners and St. Jude Walk/Run teams who have rallied together behind a shared goal of raising funds and awareness for childhood cancer."
Richard Shadyac Jr., president and CEO of ALSAC, the fundraising and awareness organization for St. Jude Children's Research Hospital

In addition to events taking place nationwide, more than 30 national partners are supporting St. Jude through various Childhood Cancer Awareness Month activities in September. Partners include Kmart, Chili's® Bar & Grill, Pier 1, Amazon, Shaw Floors, CBS Sports, Touchdowns Against Cancer, CARS, Varsity Brands, Window World, Paypal, Lancôme, Jewelers for Children, Cox Automotive, Del Frisco's Double Eagle Steakhouse, ARS Rescue Rooter, Texas de Brazil, Nora Fleming, Publishers Clearing House, Pollo Campero, Nurse Mates, My Salon Suite, Coton Colors, Bimbo USA, Blo Blow Dry Bar, Winston Flowers, Sears, Ocean Spray, Alamo Drafthouse Cinema, SAINT, Lamps Plus and New Balance.

After supporting St. Jude for nearly 20 years, Target returns as this year's National Series Sponsor for the St. Jude Walk/Run. Nearly two dozen corporations and organizations joined the St. Jude Walk/Run as National Team Partners, including Greystar, Window World, Lancôme, Chili's, Domino's, Tri Delta, DXL Group, Tau Kappa Epsilon, Sigma Gamma Rho, Delta Sigma Theta, New York & Company, Epsilon Sigma Alpha, Brooks Brothers, Phi Delta Chi, Lambda Theta Alpha, Iota Phi Theta, Amazon, American Airlines, Trane, H&R Block and Kmart/Sears.

Individuals can also join the cause by donating to participants or volunteering at one of the events. Learn more at stjude.org/together or register for one of the St. Jude Walk/Run events by visiting stjude.org/walkrun.

Source:

St. Jude Children’s Research Hospital

FDA recommends health care facilities to transition away from fixed endcap duodenoscope models

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Reviewed by James Ives, M.Psych. (Editor)Aug 31 2019

Today, the U.S. Food and Drug Administration is recommending that duodenoscope manufacturers and health care facilities transition to different types of duodenoscopes that may pose less risk to patient safety. Specifically, because of challenges with cleaning these devices for reuse (reprocessing) and persistent high levels of contamination, the agency is recommending moving away from using duodenoscopes with fixed endcaps to those with disposable components that include disposable endcaps—or to fully disposable duodenoscopes when they become available. Disposable designs simplify or eliminate the need for reprocessing, which may reduce between-patient duodenoscope contamination as compared to reusable, or fixed endcaps.

We recognize that a full transition away from conventional duodenoscopes to innovative models will take time and immediate transition is not possible for all health care facilities due to cost and market availability. This is why we're communicating with health care facilities now—so they can begin developing a transition plan to replace conventional duodenoscopes—and those facilities that are purchasing duodenoscopes with fixed endcaps can invest in the newer, innovative models. We are also encouraging the manufacturers of these duodenoscope models to assist health care facilities with their transition plans. We continue to work with manufacturers to increase the supply of disposable cap duodenoscopes and the development of other new and innovative device designs that will further minimize or eliminate the risk of patient infection. Duodenoscopes remain critical to life-saving care for many patients in the U.S.
While the risk of infection from inadequate reprocessing is relatively low, we are taking action because of continuing elevated levels of contamination in duodenoscopes. Today we're also announcing additional actions we've taken to advance continued efforts to help assure the safety of patients undergoing procedures with duodenoscopes, including FDA ordering new postmarket surveillance studies on duodenoscopes with disposable endcaps, requesting the inclusion of real-world contamination rates in duodenoscope labeling and issuing letters to manufacturers of certain test strips used to assess duodenoscope cleanliness that have not been through proper FDA premarket review. These actions announced today are part of our robust, ongoing effort to gather information on the effectiveness of duodenoscope reprocessing to prevent between-patient contamination."
Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health

Duodenoscopes—flexible, lighted tubes that are threaded through the mouth, throat and stomach into the top of the small intestine (duodenum)—are used in more than 500,000 endoscopic retrograde cholangiopancreatography (ERCP) procedures a year, a potentially life-saving procedure to diagnose and treat problems in the pancreas and bile ducts. These complex devices include reusable and hard-to-clean components and must be cleaned and sanitized to be re-used, known as reprocessing, after each patient through a lengthy procedure - one that currently consists of hundreds of steps. Reprocessing of duodenoscopes involves cleaning outside surfaces, interior channels and the elevator recess to remove tissue and fluids, followed by treatment to kill microorganisms. After thorough cleaning, high-level disinfection is intended to reduce harmful microbes so that the device is reasonably assured to be free of the risk of disease transmission. Failure to correctly reprocess a duodenoscope could result in tissue or fluid from one patient remaining in a duodenoscope and potential for disease transmission. Information from postmarket surveillance human factors studies indicate that many steps in the reprocessing instructions cannot be reliably followed by health care facilities.

The safety communication issued today also outlines results of postmarket human factors studies the FDA required of each U.S. duodenoscope manufacturer (Fujifilm, Olympus and Pentax) to evaluate whether health care facility staff could understand and follow the manufacturer's reprocessing instructions in real-world health care settings. The results of these studies suggest that users frequently had difficulty understanding and following manufacturers' reprocessing instructions and were not able to successfully complete reprocessing, which may leave the duodenoscopes contaminated. The FDA continues to work with manufacturers to conduct additional testing and revise reprocessing instruction manuals, as appropriate. However, the best path to reducing the risk of disease transmission by duodenoscopes is through innovative device designs, such as those with disposable components, that make reprocessing easier, more effective or unnecessary.

Fixed endcap duodenoscopes have a plastic or rubber cap permanently glued to the metal edges around the distal end to prevent tissue injury from the metal edges on the scopes, but when permanently affixed, the endcaps also limit the accessibility to clean the crevices at the distal end.

The FDA is recommending health care facilities transition away from fixed endcap models including Olympus Corporation's TJF-Q160, TJF-Q180V, PJF-160 and JF-140F; Fujifilm Medical Systems USA's ED-530XT; and Pentax Medical's ED-3490TK. The FDA has cleared two duodenoscopes with disposable end caps: Fujifilm Corporation, model ED-580XT and Pentax Medical, model ED34-i10T. Additionally, other firms have publicly announced plans to develop fully disposable duodenoscopes.

The FDA previously required postmarket surveillance studies from each U.S. duodenoscope manufacturer (Olympus, Fujifilm and Pentax) to determine the real-world contamination rates for duodenoscopes and serve as measures for the effectiveness of reprocessing. Because these studies continue to show elevated rates of contamination in fixed endcap duodenoscopes, including the presence of organisms more often associated with disease transmission, such as E. coli, the FDA believes that incorporating disposable components can simplify cleaning, reduce contamination and reduce disease transmission following reprocessing. While not every exposure to a contaminated scope leads to infection, any rate of contamination is concerning, which is why the FDA is taking multiple steps to address the issue.

The FDA is recommending a gradual transition to duodenoscopes with disposable components because full market withdrawal of conventional, fixed endcap duodenoscopes is not feasible at this time. Removing these devices from the market too quickly could create a shortage of duodenoscopes and prevent patients from accessing this beneficial and often life-saving procedure. The FDA believes, at this time, the continued availability of these devices is in the best interest of the public health.

The FDA is reminding patients that the risk of infection from inadequate reprocessing is relatively low and patients should not cancel or delay any planned procedure without first discussing the benefits and risks with a health care professional.

In addition to transitioning to safer devices, the FDA is communicating with device manufacturers to encourage them to develop innovative approaches for the entire duodenoscope reprocessing procedure to provide a high margin of safety and reduce the risk of infection associated with reprocessed duodenoscopes.

Also, the FDA announced that it has ordered manufacturers of duodenoscopes with disposable endcaps to conduct postmarket surveillance studies to gather more information and verify that the new designs reduce the contamination rate. The FDA believes that designs, such as ones with disposable endcaps, that need fewer reprocessing steps and allow for instructions that are easier to follow, can lower contamination rates and thus, help protect patients from the risk of infection. Upon completion of the postmarket surveillance studies, the FDA expects the labeling on duodenoscopes with disposable endcaps to be updated with contamination rate data. Including the contamination rate would allow patients and health care professionals to make informed decisions about the potential risks associated with the duodenoscope. In addition, after the May 2019 Centers for Disease Control Healthcare Infection Control Practices Advisory Committee, the FDA requested the inclusion of real-world contamination rates on the label of fixed endcap duodenoscopes.

In addition, the FDA also announced today that it is aware that some health care facilities are using adenosine triphosphate, or ATP, test strips, to assess duodenoscope cleaning. These test strips claim to indicate the presence of live microbes inside of duodenoscopes. However, to date, the FDA is not aware of any legally marketed ATP test strips cleared by the agency for this use, which means the FDA has not reviewed them for effectiveness in assessing reprocessing. Prior to being legally marketed in the U.S., an FDA premarket review is necessary to help assure that ATP test strips are adequately validated and properly labeled. The FDA has contacted manufacturers of ATP test strips advising them of the FDA's requirements for manufacturing, testing and labeling for medical devices marketed for assessing duodenoscope reprocessing and has requested they submit data to support the clearance of the strips for this use. As for any unauthorized use of a medical device, if the companies do not come into compliance, the agency will consider whether to take enforcement action if necessary. In the meantime, the FDA is asking health care facilities not to rely on these test strips to assess duodenoscope cleaning.

Lastly, the FDA plans to convene a General Hospital and Personal Use Devices Panel of the Medical Device Advisory Committee in late 2019 to discuss these issues, including duodenoscope contamination rates, expanding validated reprocessing methods, options to improve reprocessing, potential for sterilization of duodenoscopes, approaches for new device designs or technology to reduce infection transmission by duodenoscopes and challenges that may delay the transition to these designs and technologies. The meeting date will be available in the FDA Advisory Committee Calendar when available.

The FDA will keep the public informed if significant new information becomes available.

Source:

U.S. Food and Drug Administration

sábado, 31 de agosto de 2019

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