http://www.bloomberg.com/news/articles/2016-08-29/questions-linger-on-china-drug-safety-even-as-sales-rise-in-u-s

China Drug Sales to the U.S. Grow Despite Safety Concerns at Home

By Bloomberg News
August 29, 2016

Chinese drugs and pharmaceutical ingredients are found in medicine cabinets as far away as New York and Chicago, and the country's exports of pharmaceutical products and health supplements worldwide jumped 3 percent to $56 billion last year.

Yet even as China's drug industry has grown in global stature, so have questions about the safety of its products.

Consider: Last year, about 700 Chinese firms were told by regulators in China to review their pending applications to sell new drugs and voluntarily withdraw any that were false or incomplete. Within months, about 75 percent had been retracted by the manufacturers or rejected by Chinese officials.

Among those were some medicines that were separately approved for sale in the U.S. by the Food and Drug Administration. Some of the companies say their data in China were flawed because of faulty information by local research firms, and their applications for the U.S. usually include tests done by research firms in North America -- indicating those drugs should be safe. Chinese pharma exports to the U.S. rose 4 percent last year.

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International Expansion

Another company, China Resources Saike Pharmaceutical Co., in December also pulled an application to sell an epilepsy medicine called levetiracetam in China, acknowledging that clinical trial data submitted with that application were flawed. Two weeks later, the same drug was approved for sale in the U.S.

Saike said the U.S. FDA waived a requirement to do human trials on the medicine and that other materials it submitted met the agency’s requirements for generic drug approvals. It didn’t respond to questions on where its tests were done.

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https://www.aap.org/en-us/about-the-aap/aap-press-room/Pages/American-Academy-of-Pediatrics-Publishes-New-Policies-to-Boost-Child-Immunization-Rates.aspx

American Academy of Pediatrics Publishes New Policies to Boost Child Immunization Rates

8/29/2016
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AAP offers advice for pediatricians in counseling families to vaccinate their children; urges states to enact policies to support high immunization rates

Elk Grove Village, IL – Most parents who are hesitant about vaccines are not opposed to immunizing their children, but rather are unsure or have questions. And the best source of answers is their pediatrician.

To equip pediatricians for these conversations, the American Academy of Pediatrics is publishing a new clinical report, "Countering Vaccine Hesitancy" in the September 2016 Pediatrics (published online Aug. 29). The AAP advises pediatricians to have compassionate dialogues with parents to clear up misconceptions around vaccines, provide accurate information about the safety and importance of vaccines, and strive over time to help parents make the decision to vaccinate their child.

To protect all children in every community, the AAP also urges state governments to enact policies that will result in high immunization rates. In the policy statement, "Medical Versus Nonmedical Immunization Exemptions for Child Care and School Attendance​," published the same day, the AAP recommends only medical exemptions be allowed for vaccine requirements for child care and school attendance.

“Parents, pediatricians, and policy-makers all have a role here in protecting children from diseases like measles and whooping cough,” said AAP President Benard P. Dreyer, MD, FAAP. “As pediatricians, we care about every individual child in our practices, and we know that vaccines are an important way to protect them from disease. We also care about the broader communities where our patients live, play and learn, and high immunization rates are critical to keeping disease outbreaks at bay. No child should have to suffer through a disease that could have been prevented by a vaccine.”

According to the AAP, non-medical exemption laws have failed.

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http://pediatrics.aappublications.org/content/early/2016/03/17/peds.2015-4230

Pediatrics
March 2016, VOLUME 137 / ISSUE 3
Childhood Vaccine Exemption Policy: The Case for a Less Restrictive Alternative
Douglas J. Opel, Matthew P. Kronman, Douglas S. Diekema, Edgar K. Marcuse, Jeffrey S. Duchin, Eric Kodish

Abbreviations: MV — measles vaccine, NME — nonmedical exemption, VPD — vaccine-preventable disease

Efforts to restrict parents’ ability to exempt children from receiving vaccinations required for school entry have recently reached a pinnacle. The American Medical Association voiced support for eliminating nonmedical exemptions (NMEs) from school vaccine requirements,1 and California enacted legislation doing so.2 Although laudable in their objective, policies eliminating NMEs from all vaccines are scientifically and ethically problematic. In the present article, we argue for an exemption policy that eliminates NMEs just for the measles vaccine (MV) and is pursued only after other less restrictive approaches have been implemented and deemed unsuccessful.

Published By American Academy of Pediatrics
Copyright © 2016 by the American Academy of Pediatrics

Author Information: Douglas J. Opel, MD, MPHa,b, Matthew P. Kronman, MD, MSCEb, Douglas S. Diekema, MD, MPHa,b,c, Edgar K. Marcuse, MD, MPHb, Jeffrey S. Duchin, MDd,e,f, and Eric Kodish, MDg

aTreuman Katz Center for Pediatric Bioethics, Seattle Children’s Research Institute, and
bDepartments of Pediatrics and
dMedicine, University of Washington School of Medicine, Seattle, Washington;
cDepartments of Health Services and
eEpidemiology, University of Washington School of Public Health, Seattle, Washington;
fCommunicable Disease Epidemiology and Immunization Section, Public Health–Seattle and King County, Seattle, Washington; and
gDepartment of Bioethics, Center for Ethics, Humanities and Spiritual Care, Cleveland Clinic, Cleveland, Ohio

Dr Opel conceptualized and designed the study and drafted the initial manuscript; and Drs Kronman, Diekema, Marcuse, Duchin, and Kodish reviewed and revised the manuscript. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

http://www.acog.org/Resources-And-Publications/Committee-Opinions/Committee-on-Ethics/Refusal-of-Medically-Recommended-Treatment-During-Pregnancy

OB/GYN Group Says Pregnant Women Have Right to Informed Consent and Refusal of Doctor Recommendations

1. The American College of Obstetricians and Gynecologists. Refusal of Medically Recommended Treatment During Pregnancy.
ACOG.org No. 664, June 2016.

2. McClain L. New ACOG Statement Says Forcing Treatment on Pregnant Women is Unethical.
Mothering June 10, 2016.

http://file.scirp.org/html/22932.html

Open Journal of Pediatrics, 2012, 2, 228-235

OJPed http://dx.doi.org/10.4236/ojped.2012.23036
Published Online September 2012 http://www.SciRP.org/journal/ojped/

Vaccination practices among physicians and their children

Michael Martin1, Vahe Badalyan2
1Department of Pediatrics, Inova Fairfax Hospital for Children, Falls Church, USA
2Department of Gastroenterology, Children’s National Medical Center, Washington DC, USA

Received 1 May 2012; revised 3 July 2012; accepted 30 July 2012

ABSTRACT

The purpose of this study was to identify vaccination patterns of both general pediatricians and subspecialists with regards to their own children and projected progeny. A 14 question survey was sent randomly to 1000 members of the Academy of Pediatrics in 2009. Two categories of questions included 1) how physicians with children vaccinated them in the past, and 2) how all respondents would vaccinate a child in 2009. A comparison was made between the answers of general and specialty pediatricians. 582 valid questionnaires were received (58.2% response rate) of which 431 were general pediatricians and 151 sub-specialists. No statistical difference was found between general and specialty pediatricians on how they vaccinated their children up until 2009 (95% vs 93%). When asked about vaccinating a future child, a significant proportion of respondents would deviate from CDC guidelines, specialists more than general pediatricians (21% vs 9%). Generalists were more likely to give a future child Hepatitis A (OR: 3.6; 95% CI 1.3 - 10.4), Rotavirus (OR: 2.2; 95% CI 1.1 - 4.4), Meningococcal (OR: 9.9; 95% CI 3.3 - 29.9), and influenza (OR: 5.4; 95% CI 1.1 - 26.7) vaccines. Specialists were more likely to postpone MMR vaccination (OR: 4.4 95% CI 2.3 - 8.6). Safety was listed by both groups as the most common reason for altering the recommended immunization schedule. Until 2009, general pediatricians and pediatric specialists have largely adhered to ACIP recommendations, but due to vaccine safety and other concerns, both groups, albeit a higher percentage of specialists, reported greater numbers willing to diverge from these recommendations.

https://www.washingtonpost.com/news/wonk/wp/2014/09/29/our-infant-mortality-rate-is-a-national-embarrassment/

Our infant mortality rate is a national embarrassment

By Christopher Ingraham
September 29, 2014



The United States has a higher infant mortality rate than any of the other 27 wealthy countries, according to a new report from the Centers for Disease Control. A baby born in the U.S. is nearly three times as likely to die during her first year of life as one born in Finland or Japan. That same American baby is about twice as likely to die in her first year as a Spanish or Korean one.

Despite healthcare spending levels that are significantly higher than any other country in the world, a baby born in the U.S. is less likely to see his first birthday than one born in Hungary, Poland or Slovakia. Or in Belarus. Or in Cuba, for that matter.

The U.S. rate of 6.1 infant deaths per 1,000 live births masks considerable state-level variation. If Alabama were a country, its rate of 8.7 infant deaths per 1,000 would place it slightly behind Lebanon in the world rankings. Mississippi, with its 9.6 deaths, would be somewhere between Botswana and Bahrain.

We're the wealthiest nation in the world. How did we end up like this?

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More at link.

https://www.theguardian.com/world/2016/jul/25/colombia-declares-end-to-zika-epidemic

Colombia declares end to Zika epidemic as spread of virus levels off

by Sibylla Brodzinsky in Bogotá
Monday 25 July 2016

Colombia has declared an end to its Zika epidemic with the spread of the virus leveling off in the country after infecting nearly 100,000 people – even as it continues to sweep through other areas of Latin America, and is keeping some athletes away from the Olympic Games in Brazil.

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Colombia has closely monitored 17,730 pregnant women believed to have been infected with Zika. Of those 12,587 have given birth and health officials have confirmed 21 cases of Zika-related microcephaly among the newborns. One hundred and sixty other cases are still under study.

The Colombian government originally projected it could see some 500-600 cases of Zika-related microcephaly but later revised the projection downward and maintains an estimate of 100-300 cases.

With the end of the epidemic phase, Colombia has lifted the recommendation made at the peak of the epidemic that women postpone pregnancy.

The surge in birth defects has been much more noticeable in Brazil, the country hardest-hit by Zika, with almost 166,000 cases this year. Health officials in that country have confirmed more than 1,700 cases of microcephaly related to Zika infections in mothers.

However, nearly 90% of those birth defects have been concentrated in an area in the north-eastern tip of the country, leading researchers at Brazil’s health minister to suspect that other factors are in play in the rise in microcephaly cases, according to the journal Nature.

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http://www.nature.com/news/brazil-asks-whether-zika-acts-alone-to-cause-birth-defects-1.20309

Brazil asks whether Zika acts alone to cause birth defects
Puzzling distribution of cases suggests Zika is not the only factor in reported microcephaly surge.

by Declan Butler
25 July 2016

Government researchers in Brazil are set to explore the country's peculiar distribution of Zika-linked microcephaly — babies born with abnormally small heads.

Zika virus has spread throughout Brazil, but extremely high rates of microcephaly have been reported only in the country's northeast. Although evidence suggests that Zika can cause microcephaly, the clustering pattern hints that other environmental, socio-economic or biological factors could be at play.

“We suspect that something more than Zika virus is causing the high intensity and severity of cases,” says Fatima Marinho, director of information and health analysis at Brazil’s ministry of health. If that turns out to be true, it could change researchers' assessment of the risk that Zika poses to pregnant women and their children.

The idea has long been on Brazilian researchers' radar. "This is being discussed in almost every scientific meeting," says Lavinia Schüler-Faccini, a researcher at the Federal University of Rio Grande do Sul. But the enquiry marks the first time that scientists at the health ministry have taken up the hypothesis.

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"I think they may be on to something," says Linda Birnbaum, director of the US National Institute of Environmental Health Sciences (NIEHS). Zika was discovered in 1947 and hadn’t been implicated in birth defects until now; and current strains of the virus don’t show any significant mutations that might have increased its virulence. "So why now?" she asks.

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http://www.whca.net/2016win.htm

White House Correspondents' Association Announces 2016 JOURNALISM AWARDS

The White House Correspondents' Association, founded in 1914 and dedicated to full coverage of the President of the United States, is proud to announce the winners of its annual awards for distinguished print and broadcast journalism.

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The Edgar A. Poe awards, which recognizes excellence in coverage of events or investigative topics of regional or national interest, will be shared this year by Terrence McCoy of The Washington Post and Neela Banerjee, John Cushman Jr., David Hasemyer and Lisa Song of InsideClimate News.

The Edgar A. Poe Award

The Edgar A. Poe Award honors excellence in news coverage of subjects and events of significant national or regional importance, written with fairness and objectivity. A prize of $2,500 was established by the New Orleans Times-Picayune and Newhouse Newspapers in honor of their distinguished correspondent, Edgar A. Poe.

From the Judges on Terrence McCoy of The Washington Post: After African-American Freddie Gray died in police custody in Baltimore, McCoy investigated the fact overlooked by others that Gray ingested lead paint as a child, leaving him permanently disabled. McCoy learned Gray was among tens of thousands of poor black Baltimore residents similarly poisoned as children. Gray had received a settlement from a 2008 lead poisoning lawsuit, with the money distributed over years to assure that plaintiffs, often unsophisticated in financial matters, didn't spend all the money at once. But Gray sold the payouts to a company called Access Funding in return for a lump- sum payment that cost him several hundred thousand dollars in lost payouts. McCoy's investigation found access funding had struck similar deals with many other lead poisoning victims. His findings led to substantial reforms aimed at protecting these vulnerable citizens.



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https://insideclimatenews.org/news/25042016/icn-honored-white-house-correspondents-association-award-exxon-exxonknew

White House Correspondents' Association Honors ICN's #ExxonKnew With Poe Award
The Edgar A. Poe Award annually honors journalistic work of national or regional significance.

By ICN Staff
Apr 25, 2016


President Obama speaks at the White House Correspondent's Association annual dinner, where the journalism awards are presented. Credit: Olivier Douliery-Pool/Getty Images

InsideClimate News' Exxon: The Road Not Taken series was awarded the Edgar A. Poe Award by the White House Correspondents Association, which annually honors "excellence in news coverage of subjects and events of significant national or regional importance, written with fairness and objectivity."

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The award was shared by Terrence McCoy of the Washington Post, who explored the issue of lead poisoning among poor black children in Baltimore after Freddie Gray died in custody in a high-profile case of alleged police abuse. Gray, like many similar poisoning victims, had been exploited for his cash settlement.

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https://www.theguardian.com/us-news/2016/aug/05/korryn-gaines-baltimore-lead-poisoning-crisis

Korryn Gaines: police killing highlights Baltimore's lead poisoning crisis
Both Gaines and Freddie Gray, who died in police custody last year, suffered from lead poisoning, something that has been pointed to as racist public policy

By Baynard Woods in Baltimore
Friday 5 August 2016 09.43 EDT