How can we determine conclusively whether a chemical is safe?
Thats the question Jerry Heindel, a top health scientist in the United States government, wanted to answer. And what better chemical to ask this question about than bisphenol A — one of the most researched chemicals in the world, and one of the most controversial.
BPA, as the chemical is known, is an industrial additive essential in the production of many plastic consumer goods: water bottles, plastic food containers, dental products. And yet, despite hundreds of studies dating back nearly a century, theres no scientific consensus on whether BPA is harmful to human health.
Thats in part because any effects the chemical has would be long-term, complicated and hard to detect. But its also because academic scientists and government regulators disagree on how best to evaluate the safety of chemicals.
The solution Heindel — at the time a health science administrator at the U.S. National Institute of Environmental Health Sciences — came up with was to design a study that would pull the two warring factions together in a single effort to assess the safety of BPA.
This is a story about what went wrong, and why scientists are no less sure than before about whether BPA is safe for human consumption.
Launched in 2012, Heindels study is the largest safety analysis ever attempted on the chemical. It mobilized scores of scientists and cost tens of millions of taxpayer dollars.
It has also failed, so far, in its goal of bridging the divide between scientists, imploding into acrimony last year when preliminary results published by the U.S. Food and Drug Administration sparked protests from the academics involved. A final conclusion on the safety of BPA also remains out of reach.
This is a story about what went wrong, and why scientists are no less sure than before about whether BPA — a chemical most of us probably have in our bodies — is safe for human consumption.
Rising worries about BPA coincided with the proliferation of plastics into every part of our economies and lives.
The word “plastics” covers a gamut of synthetic materials that are easy to manufacture, cheap to produce, and — with the help of chemical additives and processes — incredibly versatile. First mass-produced in the beginning of the 20th century, by the 1950s the material had became integral in everything from clothes and cars to furniture and food packaging.
“At the beginning it was just convenient to build a useful material,” Ninja Reineke, a senior policy adviser at the advocacy group ChemTrust, said. “They didnt take into account the potential implications.”
Researchers had known as early as the 1930s that BPA has a strange side-effect: It weakly mimics the hormone estrogen, which regulates the female reproductive system. But this curious consequence didnt stop petrochemical companies from using it — and using it a lot.
BPA is essential for the production of two blockbuster plastics: Epoxy resins, used as coatings for everything from electrical cables to shop receipts, and polycarbonate plastic, a hard, clear substance that has come to replace steel or glass in products from cars and electronics to water bottles and Tupperware.
By the late 1980s, nearly half a million tons of BPA were being produced per year in the U.S. alone.
Then, in 1992, scientists at Stanford University discovered that the chemical was “migrating” from the plastic, meaning it could be leaching from packaging into food or drinks and then into our bodies.
A sign in a French bio-supermarket | Joel Saget/AFP via Getty Images
In the early 2000s, a survey found BPA in the urine of more than 90 percent of Americans tested. What it couldnt say was whether that was a problem.
Evaluating the safety of substances that affect the hormone system, like BPA, is hard because they dont behave like most chemicals.
Traditionally, chemical regulation and the science it is based on rests on the assumption that the higher the concentration of a chemical, the more harmful it is. The dose makes the poison.
But a growing number of scientists believe that some widely used chemicals dont follow this trajectory, and can disrupt our hormonal systems even at very low levels. For these chemicals, they argue, setting strict exposure limits — a common form of regulation — is ineffective.
Effects on the endocrine system — which through a crowd of hormones regulates our metabolism, growth and development, tissue function, sexual function, reproduction, sleep, and mood — can be hard to trace, because the balance of hormones in the body is precarious and affected by many factors.
And yet, amid all this noise a signal is emerging, according to the members of the Endocrine Society, which is made up of some 18,000 scientists around the world who study the endocrine system: Endocrine-disrupting chemicals like BPA are wreaking havoc on our bodies.
“They can really program your genes and development differently” — Ninja Reineke, a senior policy adviser at ChemTrust
The negative effects listed by the Endocrine Society include reduced fertility, diabetes, obesity and prostate cancer for men, and breast cancer for women.
Those concerned about endocrine disrupters say this group of chemicals has a number of unusual properties that make them behave similarly to hormones: Not only can they cause adverse effects even in very low amounts, these effects dont necessarily have an obvious trajectory curve when you increase the dose.
Instead of a steadily increasing linear graph, the charts used by scientists to illustrate their effects often wiggle like a sine curve.
Members of the Endocrine Society say the effects of chemicals like BPA dont always show up immediately. Hormone balance is most critical for fetuses and babies. Too much or too little of a hormone — or one of its mimics — early in life can throw off the development trajectory.
“They can really program your genes and development differently,” Reineke from ChemTrust said. “But it may not be obvious until later in life.”
So far, these findings — most of them made by scientists conducting research in universities — have failed to sway the government bodies that regulate chemicals like BPA.
Studies given the most weight by the FDA have to abide by a stringent set of bookkeeping requirements and laboratory best practices. This set of “good laboratory practices” (GLP) originated in a push to make sure that scientists werent cutting corners or faking data, but has since become the gold standard for regulators.
But while good laboratory practices are the norm for scientists working at the FDA or in industry-funded labs, many academics dont have the resources to meet their stringent requirements. Besides, academics have their own gold standard: peer-reviewed journals and university oversight.
The result is a culture clash that can sometimes produce wildly different conclusions — with regulators often discounting studies conducted by academics when assessing chemical safety.
“[Regulators] tend to put much more weight on studies that have been done according to guidelines, with lots of animals and the kind of record-keeping that allows them to repeat,” said John Bucher, from the U.S.s National Institute of Environmental Health Sciences. “Those kinds of studies are rarely done in the literature.”
The U.S. FDA has assessed the chemical multiple times at the point | Spencer Platt/Getty Images
The clash is particularly acute in the debate over BPA. The FDA has assessed the chemical several times. Each time, it has found that its safe at the levels in which it is present in food.
In the FDAs latest review of studies dealing with BPAs potential health impacts in 2014, the agency looked at hundreds of studies, including dozens that found cause for concern at low doses, conducted mostly by university scientists. It determined that only four of them met the standards for setting policy. None of the four found low-dose effects.
An FDA spokesperson said the review was carried out using “predefined, scientifically supported criteria for ranking each study,” and that even if many studies didnt meet the bar for setting regulatory values, “some studies were identified that did contribute qualitative information to support general conclusions” about whether BPA was harmful. The spokesperson added that extensive reviews of “low-dose” literature on BPA indicated that fears about the chemicals low-dose effects are not warranted.
Academics in response accused the FDA of cherry-picking data to support a preconceived conclusion. They also said that by not considering the work by university researchers, regulators are ignoring some of the best science on chemicals.
“The scientific apparatus worldwide is more advanced than its ever been, and yet its being largely ignored in chemical regulation,” said Thomas Zoeller, who studies thyroid hormone action and brain development at University of Massachusetts Amherst.
Ends and means
The main point of disagreement is over what exactly indicates a negative effect.
When determining the impact of a chemical on a specific organ, scientists use an array of “endpoints,” or markers of health effects, to track any changes. These could be the weight of an organ, the development of tumors or lesions, indicators of a disease, or an increase in the release of a bodily fluid or hormone, to name a few.
The FDA maintains a list of “validated” endpoints, which it says are acceptable because the effects can be replicated and they “best characterize risk” posed by a chemical. Before a chemical is identified as hazardous, the FDA said, it must proven that it has not just an effect, but a negative effect, on the body.
Some academics disagree with the FDAs approach. The agencys endpoints look mostly for “gross abnormalities,” according to Heather Patisaul, who studies endocrine disruptors and the brain at North Carolina State University.
“Theyre using such an insensitive marker. Brain weight doesnt reflect brain function” — Thomas Zoeller, reseracher
For example, one traditional endpoint for studies on brain development is the weight of the brain — if a chemical causes smaller brains to develop, its pretty likely that something is wrong.
But academics like Zoeller and Patisaul say many traditional endpoints wouldnt pick up the subtleties that a disruption of the endocrine system could cause.
“Theyre using such an insensitive marker,” said Zoeller. “Brain weight doesnt reflect brain function. Its like, if the engine isnt working in your car, its not really going to be informative to pull the engine out and weigh it.”
They point out that the FDAs endpoints list hasnt been updated in decades, since before the debate about endocrine disrupters or low-dose effects began. Instead, they advocate what they call more “modern” endpoints, which focus on signs of specific diseases.
Looking for CLARITY
Enter Jerry Heindel. His idea was to combine regulator-approved practices with academic expertise and modern endpoints.
Have the FDA raise and treat enough animals to satisfy the criteria for their study, and then once theyve done their research, ship some of the rats off to independent specialists, who can then take a look. At the end, both sides could combine their findings and determine once and for all whether BPA is safe.
The projects unwieldy name — the Consortium Linking Academic and Regulatory Insights on bisphenol A ToxicitY — was shorthanded to the CLARITY study in an optimistic nod to its goal.
Funded by the U.S. government, the study has in the seven years since its inception attracted the attention of regulators around the world, both for its work on the specific chemical and as an experiment in bridging the rift between academic and regulatory studies.
The U.S. government has funded the CLARITY study | Mandel Ngan/AFP via Getty Images
The European Food Safety Authority, notably, postponed its plans to re-evaluate the safety of BPA until the CLARITY study was published. The agency has also assessed the safety of the substance several times, arrivingRead More – Source
World Bank and WHO Statement on Partnership & Deployment of Financing to WHO for Ebola Response in DRC
WASHINGTON, August 23, 2019—The World Bank and the World Health Organization (WHO), along with the G..
WASHINGTON, August 23, 2019—The World Bank and the World Health Organization (WHO), along with the Government and other key partners, are working in close partnership on the Ebola Crisis Response in the Democratic Republic of the Congo (DRC). Central to this partnership is the assessment of the financing needs, and deployment of resources, with the goal to put an end to the current deadly outbreak.
The World Bank is today announcing that US$50 million in funding is to be released to WHO for its lifesaving operational work on the frontlines of the outbreak. The WHO is announcing that this US$50 million in funds will close the financing gap for its emergency health response in DRC through to the end of September 2019, and is calling on other partners to mirror this generous support in order to fund the response through to December.
The funding comprises US$30 million from the Pandemic Emergency Financing Facility (PEF) and US$20 million from the World Bank. The US$50 million in grant funding is part of the larger financial package of approximately US$300 million that the World Bank announced last month to support the fourth Strategic Response Plan for the DRC Ebola outbreak.
“WHO is very grateful for the World Banks support, which fills a critical gap in our immediate needs for Ebola response efforts in DRC, and will enable the heroic workers on the frontlines of this fight to continue their lifesaving work,” said Dr. Tedros Adhanom Ghebreyesus, Director-General, World Health Organization. “We keenly await further funding from other partners to sustain the response through to the end of the year.”
The DRC government, working in collaboration with the World Bank, WHO, and other key partners, has finalized the Fourth Strategic Response Plan (SRP4), which outlines the total resources needed for the DRC Ebola Crisis Response from July to December 2019. The financing announced today is part of the World Banks previously announced financial package of up to US$300 million and covers over half of SRP4s needs, with the remainder requiring additional funding from other donors and partners.
“The World Bank is working closely with WHO, the Government of DRC, and all partners to do everything we can to put an end to the latest Ebola outbreak,” said Annette Dixon, Vice President, Human Development at the World Bank. “The partnership between our organizations and the Government is critical for responding to the emergency as well as rebuilding systems for delivery of basic services and to restoring the trust of communities.”
The Government of DRC requested US$30 million from the PEF Cash Window to be paid directly to WHO. The PEF Steering Body approved the request bringing the PEFs total contribution to fighting Ebola in DRC to US$61.4 million. The PEF is a financing mechanism housed at the World Bank; its Steering Body is co-chaired by the World Bank and WHO, and comprises donor country members from Japan, Germany and Australia. The quick and flexible financing it provides saves lives, by enabling governments and international responders to concentrate on fighting Ebola—not fundraising.
Borno State launches first Malaria Operational Plan, reawakens fight against malaria
Maiduguri, 13 August 2019 – Following recommendations from malaria interventions in Borno State Nige..
Maiduguri, 13 August 2019 – Following recommendations from malaria interventions in Borno State Nigeria, the Malaria Annual Operational Plan (MAOP) was developed and launched on 08 August 2019 with technical support from the World Health Organization (WHO) and partners. Aligned to the National Malaria Strategic Plan (2014 -2020), MAOP was developed through a broad-based stakeholders workshop involving malaria stakeholders, reviewed on different thematic areas and endorsed by the Commissioner for Health and Permanent Secretary, Borno State Ministry of Health.
Speaking during the launch, the Borno state Malaria Programme Manager, Mr Mala Waziri described the MAOP as the first to be endorsed and disseminated in Borno State. “WHO has made us proud by supporting the first ever Malaria Operational Plan right from development, review, printing to dissemination.”
Dr Ibrahim Kida, the Ministerial Secretary Borno State Ministry of Health and Incident Manager of the state, described the launch as “an historic event as stakeholders across the health sector made commitments to use the document as an implementation guide for all malaria programs”. The plan was also described as an advocacy tool for planning domestic funds mobilization.
The MAOP has seven objectives among which are: provide at least 50% of targeted population with appropriate preventive measures by 2020; ensure that all persons with suspected malaria who seek care are tested with Rapid Diagnostic Test (RDT) or microscopy by 2020 and all persons with confirmed malaria seen in private or public health facilities receive prompt treatment with an effective anti-malarial drug by 2020.
The MAOP will further ensure that at least 50% of the population practice appropriate malaria prevention and management by 2020, ensuring timely availability of appropriate anti-malarial medicines and commodities required for prevention, diagnosis and treatment of malaria in Borno State by 2020.
In addition, it seeks to ensure that all health facilities report on key malaria indicators routinely by 2020 and finally strengthen governance and coordination of all stakeholders for effective program implementation towards an A rating by 2020 on a standardized scorecard. These strategic objectives have specific targets and the MAOP takes into account the humanitarian response.
“Malaria remains a leading cause of poor health in Nigeria. According to the 2018 WHO Malaria Report, 53million cases are recorded annually in Nigeria, roughly 1 in 4 persons is infected with malaria contributing 25% of the global burden,” says Dr Nglass Ini Abasi, WHO Malaria Consultant for the North East.
“Furthermore, 81,640 deaths are recorded annually (9 deaths every hour), which accounts for 19% of global malaria deaths (1 in 5 global malaria deaths) and 45% malaria deaths in West Africa. The Nigeria Malaria Strategic Plan (NMSP) 2014-2020 has a goal to reduce malaria burden to pre-elimination levels and bring malaria-related mortality to zero and WHO is working assiduously with Government to ensure the burden is reduced accordingly.”
Results from WHO’s Early Warning, Alert and Response System (EWARS) week 30 report from 223 sites, (including 32 IDP camps) show that malaria was the leading cause of morbidity and mortality accounting for 35% of cases and 46% of reported deaths. In addition, results from the Nigeria Humanitarian Response Strategy (NHRS 2019-2021) indicate 7.1million people are in dire need of healthcare and 6.2million are targeted for immediate attention.
Despite recent improvements, insecurity remains a challenge limiting access to the functional health facilities. Easily preventable and treatable diseases such as malaria, acute respiratory infection and diarrheal diseases account for the greatest proportion of morbidity and mortality among the vulnerable population. Furthermore, Malaria is endemic in North East Nigeria and the transmission is perennial with a marked seasonal peak from July to November every year. (more…)
Nearly half of all dengue deaths in the Philippines are children under nine years old
Manila, August 16 – At least 300 children aged 5-9 have died in the recent Dengue outbreak in the Ph..
Manila, August 16 – At least 300 children aged 5-9 have died in the recent Dengue outbreak in the Philippines, Save the Children said today, amid fears the epidemic could claim many more lives before its brought under control. In the first seven months of 2019, some 170,000 people were infected with the disease, killing 720 people – 42 percent were children between 5 and 9 years old. Compared to the same period in 2018, this years dengue caseload is 97 per cent higher. The virus is disproportionately affecting children and young people with a staggering 73 per cent of recorded cases under the age of 19.
Albert Muyot, ceo of Save the Children in the Philippines, said: “Hundreds of children have sadly already died, we expect the numbers to rise. The rainy season started late and will continue this month, creating the perfect breeding ground for dengue mosquitoes.
“Children are particularly a vulnerable to the disease because their immune systems are weaker than adults and they tend to play outside where theres less protection against the mosquitos. Schools in particular are a hotbed of dengue because many have open windows and lack mosquito repellents.
“It is extremely important that health authorities step up their information campaigns in schools, communities and other places where people come together, so people know what to do if they suspect dengue. Also, the government must step up their fumigation campaign to kill adult dengue mosquitoes in densely populated areas.
“In the Philippines, we are working with schools and communities to improve awareness on how to prevent infection. To save lives, children need extra protection. Wearing long sleeves and trousers is one of the simple measures to protect against being bitten. Early diagnosis is critical and we are raising awareness of those symptoms, like fever and body pain, and encouraging all parents to take their children to hospital immediately if they have concerns.
“Save the Children is referring child dengue cases to health centers in vulnerable communities in Navotas, Caloocan and Malabon as well as in conflict-affected provinces in Bangsamoro Automous Region in Muslim Mindanao (BARMM).”
Notes to editors:
- Dengue causes flu-like illness, including a sudden high fever coming in separate waves, pain behind the eyes, muscle, joint and bone pain, severe headache, and a skin rash with red spots. People with symptoms get ill between 4 to 7 days after a bite from an infected Aedes mosquito.
- The illness can become the fatal Severe Dengue, characterised by severe abdominal pain, vomiting, diarrhoea, convulsions, bruising, uncontrolled bleeding, and high fever which can last from 2 to 7 days.
- Complications can lead to circulatory system failure, shock, and death.
- There were 167,607 dengue cases between January-July 2019, up from 85,011 in the same period in 2018.
- Of the 167,607 recorded cases of dengue between January and July 2019, 121,942 were under the age of 19.
- On August 6th, the government declared a national dengue epidemic.
- Read from source
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