Sleep-Wake Disorder Drug Hetlioz Gets Nod in Europe

The European Medicines Agency (EMA) has recommended marketing authorization for tasimelteon (Hetlioz), a melatonin-receptor agonist, for the treatment of adults with a chronic circadian rhythm condition called non–24-hour sleep-wake disorder (non-24).

Tasimelteon would represent the first European Union (EU) treatment for non-24, the agency said in a press release.

The drug was approved early last year by the US Food and Drug Administration (FDA), also the first FDA approval of a treatment for the disorder.

Non-24 is a rare condition that occurs almost exclusively in blind people. Because they don’t perceive light, these patients fall asleep and wake up at different times compared with the general population, often in a pattern that is closer to a 25-hour clock.

As a result, they have problems adjusting to the standard timetable of everyday life, often being awake or asleep at unusual times. Many experience excessive daytime sleepiness, which affects their quality of life and ability to follow a normal daily schedule.

Melatonin, produced by the pineal gland during hours of darkness, plays a key role in coordinating the body’s sleep cycle by acting on receptors in the brain.

The effectiveness of tasimelteon was demonstrated in two clinical trials. These studies showed that treatment resulted in significant improvement compared with placebo, both in increasing night-time sleep and decreasing daytime sleep duration.

The most common adverse effects include headache, drowsiness, and nightmares or unusual dreams.

Orphan Drug
In 2011, tasimelteon received an orphan designation in Europe. This designation and the associated incentives, such as scientific advice, are among the most important instruments to encourage the development of medicines for patients with rare diseases, said the press release.

The opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) at its meeting this month is an intermediary step on Hetlioz’s path to patient access. This opinion will now be sent to the European Commission for the adoption of a decision on EU-wide marketing authorization.

Once marketing authorization is granted, each Member State will decide on price and reimbursement, considering the potential role/use of this medicine in the context of the national health system of that country.

The marketing authorization applicant for Hetlioz is Vanda Pharmaceuticals Limited, United Kingdom. In the United States, the drug is manufactured by Vanda Pharmaceuticals Inc, Washington, DC.

According to the FDA, up to 100,000 Americans have non-24 and can’t perceive enough light to establish a normal night sleep schedule. If prescribed tasimelteon, they should take this drug at the same time every night before bedtime and limit activities after taking it.

Pesticides may harm growing brains

Two neonicotinoid chemicals may affect the developing nervous system in humans, according to the EU.

The European Food Safety Authority (EFSA) proposed that safe levels for exposure be lowered while further research is carried out.

They based their decision on studies that showed the chemicals had an impact on the brains of newborn rats.


One of the pesticides was banned in the EU last April amid concerns over its impact on bee populations.

Neonicotinoids are “systemic” pesticides that make every part of a plant toxic to predators.

They have become very popular across the world over the past two decades as they are considered less harmful to humans and the environment than older chemicals.

But a growing number of research papers have linked the use of these nicotine-like pesticides to a rapid fall in bee numbers.

New levels needed

In April, the European Union introduced a two year moratorium on the use of several types of these chemicals, despite opposition from the UK.

Now EFSA, in a statement, says that it has concerns that two types of neonicotinoids, imidacloprid and acetamiprid, may “affect the developing human nervous system“.

They have proposed that guidance levels for acceptable exposure be lowered while further research is carried out.

The decision has been based on a review of research carried out in rats.

In one study, young rodents exposed to imidacloprid suffered brain shrinkage, weight loss and reduced movement.

In the statement, EFSA said that the two neonicotinoids may “adversely affect the development of neurons and brain structures associated with functions such as learning and memory”.

Current guidelines, it went on, “may not be protective enough to protect against developmental neurotoxicity and should be reduced”.

According to EU Commission health spokesman Frederic Vincent, they would now allow the chemical companies involved to comment on the findings.

“In principle, the next step would then be to amend the reference values,” he said, indicating that this would begin next March.

In their findings, EFSA pointed out that the available evidence had limitations but that they believed the health concerns that have been raised are legitimate.

But other experts said the move by EFSA was more of a precaution than anything else.

“The reduction in the reference values in most cases was modest,” said Prof Alan Boobis, from Imperial College London.

“Whilst there is clearly a question mark over the possible effects of these compounds on the developing brain, the conclusions of EFSA do not suggest that exposure of humans to these compounds at the levels that occur normally in food or in the environment is a cause for concern.

US warning on antibacterial soaps.

US health watchdog cracks down on antibacterial soaps

A woman washes her hands with antibacterial soap in a September 2009 file photo
Scientists warn antibacterial products may create resistance to antibiotics in humans (file photo)

The US health regulator has warned that antibacterial chemicals in soaps and body washes may pose health risks.

The Food and Drug Administration (FDA) called for a safety review of such products.

It proposed a rule requiring manufacturers to prove such soaps are safe and more effective against infection than plain soap and water.

Recent studies indicate an ingredient in such products could scramble hormone levels and boost drug-proof bacteria.

The proposal rule does not apply to alcohol-based hand sanitizers and products used in healthcare settings.

Manufacturers have until the end of 2014 to submit the results of clinical trials on their products, the FDA said. The new regulations would be finalised in 2016.

‘Unanticipated hormonal effects’

“New data suggest that the risks associated with long-term, daily use of antibacterial soaps may outweigh the benefits,” Colleen Rogers, an FDA microbiologist, wrote in a statement on Monday.

Certain ingredients in such products – such as triclosan in liquid soaps and triclocarban in bar soaps – may contribute to bacterial resistance to antibiotics, the agency added.

Such products may also have “unanticipated hormonal effects that are of concern”, according to the statement.

Recent studies of such chemicals on animals have shown they may alter hormones, the FDA said, but such results have not yet been proven in humans.

“Because so many consumers use them, FDA believes that there should be clearly demonstrated benefits to balance any potential risks,” the statement added.

If the FDA’s proposed rule is finalised, companies would be required to provide data to support their product’s health claims.

If they cannot, the products would be reformulated or relabelled in order to remain on the market.

In March, a federal appeals court approved a lawsuit by the non-profit Natural Resources Defense Council, aimed at forcing the FDA to review the health impacts of triclosan.

Sensors used to monitor obesity

Hi-tech sensors aim to help prevent obesity

Overweight man and woman
Obesity causes 2.8 million deaths around the world each year

A range of hi-tech sensors that can measure food intake and activity in order to assess obesity risks is to be funded by the European Union.

Dubbed Splendid, the project aims to persuade youngsters to adopt healthier lifestyles and be more aware of their eating and exercise habits.

It is part of a push to use technology to create preventative healthcare.

Obesity causes an estimated 2.8 million deaths among adults around the world every year.

“The idea is that we try to investigate ways to prevent obesity and eating disorders,” said Prof Anastasios Delopoulos, the project co-ordinator who works for the department of electrical and computer engineering at the Aristotle University of Thessaloniki in Greece.

The system will be tested on around 200 secondary school students in Sweden and another set of children in the Netherlands.

A mandometer
One of the sensors will monitor how quickly people eat

Sensors will be used to measure the speed at which food is eaten as well as how food is chewed.

The time taken to consume food is one of the risk factors in obesity, according to Prof Delopoulos.

It will be measured using a mandometer, from Swedish firm AB Mando, which is currently used in a handful of clinics set up to treat eating disorders.

The sensor comprises a scale connected to a portable computer or a smartphone. A plate of food is put on the scale and the rate at which it leaves the plate is recorded, with an audible warning if it is being eaten too quickly for the person to realise they are full.

Swiss firm CSEM is developing the other two sensors that will be used in the project. ActiSmile is a wearable sensor, which rewards the wearer with a smiley face when enough exercise has been done.

The firm is also designing an acoustic sensor, which will take the form of a wearable microphone, and record how the user chews food.

Users will also input their own data, including how full they feel after a meal as well as daily intake and activity logs.

All the data will be processed and run through algorithms which will assess the risks for obesity and eating disorders.

In the later stages of the trial, the system will be used to help change the way at-risk youngsters eat and exercise.

“The goal is to modify eating and activity behaviour of individuals in a personalised way,” said Prof Delopoulos.

“A medical expert will assign goals, such as to eat more slowly or adopt more activity and the sensors will monitor whether the individual succeeds,” he added.

Daniel Kraft is a doctor and executive director of FutureMed, a healthcare education programme aimed at teaching medical professionals about new technologies.

He thinks that sensors will increasingly be integrated into healthcare.

“From connected scales to sensors that can track heart rate and activity levels… the patient can be empowered to understand their healthcare data,” he said.

“It brings you to an era of healthcare rather than sick care,” he added.

EU-approved ‘safe’ air pollution levels causing early deaths.

Published time: December 09, 2013 14:08
Edited time: December 10, 2013 08:37

General view of the Origny sugar factory in Sainte-Benoite near Saint-Quentin. (AFP Photo / Philippe Huguen)General view of the Origny sugar factory in Sainte-Benoite near Saint-Quentin. (AFP Photo / Philippe Huguen)

Air pollution in the European Union is causing premature deaths even when levels meet quality guidelines, a report has shown. Even in areas where pollution was much lower than the limit, scientists found there is a higher-than-normal risk of death.

The study, published the British Medical Association’s journal The Lancet, found that Europeans who have had prolonged exposure to pollution from industrial activities or road traffic have a higher chance of premature death. The increased risk to a person’s health is linked to tiny particles of soot and dust than can get lodged in the lungs and cause respiratory illnesses.

The study, carried out by Utrecht University in the Netherlands, found the particles measure 2.5 microns or 2.5 millionth of a meter. Exposure for “up to a few months” to particles of 2.5 microns can increase the risk of premature death.

“Although this does not seem to be much, you have to keep in mind that everybody is exposed to some level of air pollution and that it is not a voluntary exposure, in contrast to, for example, smoking,” scientist Rob Beelen, who led the study, told AFP.

The findings of the study echo the results of similar investigations carried out in North America and China.

“Our findings support health impact assessments of fine particles in Europe which were previously based almost entirely on North American studies,” Beelen said.

As part of the study the researchers drew on 22 previously published studies that documented the health of 367,000 people in 13 countries in Western Europe over 14 years. Beelen and his team then traveled to the areas where the participants lived and took traffic pollution readings that they used to calculate how much pollution local residents were exposed to.


AFP Photo / Frederick FlorinDuring the investigation, 29,000 of the 367,000 participants recruited in 1990 died. In order to increase accuracy, investigations also took into account such factors as physical exercise, body mass, education and smoking habits. 

European Union guidelines set the maximum exposure to particles of 25 micrograms per cubic meter. Beelen says the results of this study are evidence the EU needs to reset its safety limits to 10 micrograms per cubic meter.

“Despite major improvements in air quality in the past 50 years, the data from Beelen and his colleagues’ report draw attention to the continuing effects of air pollution on health,” Jeremy Langrish and Nicholas Mills, of the University of Edinburgh, told the Medical Press.

In China a red alert was issued for poor air quality was issued Thursday after pollution reached hazardous levels. The coastal city of Qingdao recorded PM2.5 Air Quality Index levels of over 300, while Nanjing saw a reading of 354 on Wednesday, according to local news portal

In light of the dangerous levels of pollution the Chinese government is considering the practice of ‘cloud seeding’ to clear toxic fog in the country. According to a document released by the China Meteorological Administration, from 2015 local meteorological authorities will be permitted to use cloud seeding to disperse pollution.

The World Health Organization has classified outdoor pollution as one of the principal causes of cancer and estimates around 3.2 million people die every year globally as a result of prolonged exposure.

Polio Virus in Syria and Israel May Endanger Europe.

Two infectious disease experts warn that a new polio outbreak in Syria caused by wild-type polio virus 1 (WPV1) and asymptomatic cases in Israel might endanger Europe and other neighboring regions, according to correspondence published online November 8 in the Lancet.

“[The World Health Organization] has confirmed an outbreak of at least ten cases of polio in Syria, where vaccination coverage has dramatically decreased during the civil war,” write Professor Martin Eichner, from the Institute of Clinical Epidemiology and Applied Biometry, University of Tübingen, and Stefan Brockmann, from the Department for Infection Control, Reutlingen Regional Public Health Office, Germany. “Furthermore, [WPV1] has been isolated from sewage and faeces from asymptomatic carriers in Israel since February, 2013.

“Moreover, hundreds of thousands of people are fleeing Syria and seek refuge in neighbouring countries and Europe,” they continue. During the Hajj in Saudi Arabia last month, visitors from countries with known polio transmission were vaccinated, but Syria was not included with those countries.

“The potential risk of transmission to [the European Union (EU)] and elsewhere documents the need for strong ongoing global efforts to eradicate this disease,” CDC Director Tom Frieden, MD, MPH, told Medscape Medical News. “Polio anywhere is a threat of polio everywhere.”

The situation in the Middle East, combined with the vaccination approach used in Europe, is concerning, according to the authors. Most EU countries currently use inactivated polio vaccine (IPV) rather than oral polio vaccination (OPV). Similar to many other regions, most EU states discontinued use of OPV because of rare reports that it caused acute flaccid paralysis (AFP), even though OPV offers high protection against acquiring and transmitting the infection. Only some EU member states still permit OPV use, and none has a stockpile of it.

In contrast, the more widely used IPV is highly effective in preventing AFP and active polio disease, but is only partially effective in preventing infection with polio virus. For decades, Europe has been free of circulating polio viruses and, therefore, IPV has been sufficient.

However, IPV will only continue to be effective in preventing transmission if vaccination coverage continues to be very high, if hygienic standards are good throughout the population, and if there is low crowding. These conditions could easily be disrupted by the present situation of large numbers of refugees fleeing from Syria to Europe and other neighboring countries.

If the polio virus is reintroduced into the community, herd immunity may be insufficient to prevent sustained transmission in European regions where vaccination coverage is low, such as Bosnia and Herzegovina (87%), Ukraine (74%), and Austria (IPV coverage rate 83%).

For every 200 WPV1 infections, only 1 results in symptomatic polio. Therefore, hundreds of individuals could be infected and the virus could circulate for nearly a year before an outbreak could be identified from a single case of AFP.

“Vaccinating only Syrian refugees — as has been recommended by the European Centre for Disease Prevention and Control — must be judged as insufficient; more comprehensive measures should be taken into consideration;” the authors conclude. “Routine screening of sewage for poliovirus has not been done in most European countries, but this intensified surveillance measure should be considered for settlements with large numbers of Syrian refugees.”

Implications for the United States

In the United States, routine vaccination against polio currently uses IPV, which may create concerns similar to those now affecting Europe.

“The IPV vaccine is effective at preventing disease, but [OPV] is more effective at preventing even asymptomatic infection,” Jennifer L. Lyons, MD, from the Division of Neurological Infections, Department of Neurology, Brigham and Women’s Hospital in Boston, Massachusetts, told Medscape Medical News. “However, the OPV has been associated with a low but known risk of vaccine-related infection and, as such, is no longer routinely used.”

“It is difficult to project the effect that this scenario will have on the US, but vigilance is always good practice,” Dr. Lyons said. “Adherence to vaccination guidelines and maintenance of proper hygiene are likely the best preventive measures to take.”

Dr. Frieden told Medscape Medical News that IPV is used in Israel, as well as in the EU and the United States. “There have been no cases of indigenous polio in these regions, an especially significant fact considering that poliovirus has been found in environmental sewage samples in Israel,” Dr. Frieden said. “IPV is effective in protecting individuals against polio. The US has been free of indigenous polio since 1979.”

He also noted that the risk of importations of any infectious disease, including polio, into the United States is always a concern and highlights the importance of being vaccinated and of working to control infectious diseases wherever they are spreading.

“CDC works to minimize the risk for polio in the US through its traveler’s health and global migration program and global health program,” Dr. Frieden concluded. “We collaborate closely with international organizations and other countries to implement international and US guidance on vaccination for immigrants. In response to the polio cases in the Middle East and Horn of Africa, CDC has issued new recommendations for polio vaccine use among high-risk refugee populations and is working with international partners to implement them. Through the Global Polio Eradication Initiative, CDC works intensively with international health partners and Rotary International to eradicate polio at its source.”

Wireless pacemaker comes to Europe.

A miniaturised, wireless pacemaker that can be inserted into the body without invasive surgery has been given approval for use in the European Union.

Developed by US start-up Nanostim, the device is designed to be implanted intravenously directly in the heart.

Nanostim pacemaker

It is less than 10% of the size of a conventional pacemaker and uses a built-in battery.

Experts said it was an “exciting development” but at a very early stage.

The pacemaker has yet to receive full US Food and Drug Administration (FDA) approval.

Conventional pacemakers require a patient to be cut open and a pocket created in the body to house the pacemaker and associated wires.

Such wires are regarded as the component of pacemakers most likely to fail. The pocket created for the pacemaker is also liable to infection.

By contrast the Nanostim pacemaker is delivered via a catheter inserted through the femoral vein near the groin.

It has a built-in battery, smaller than an AAA battery, that lasts between nine and 13 years. Eliminating the need for wires lowers the risk of infection or malfunction and means that patients are not restricted in the amount of activity they do, the firm behind the device claims.

The procedure to fit the pacemaker typically lasts around half an hour. The device is designed to be easily retrievable so that the battery can be replaced.

Because the device is delivered intravenously, it also means patients will have no scarring.

One doctor, involved in its trials, described it as “the future of pacemaking”.

“For the past 40 years the therapeutic promise of leadless pacing has been discussed, but until now, no-one has been able to overcome the technical challenges,” said Dr Johannes Sperzel of the Kerchhoff Klinik in Bad Nauheim, Germany.

“This revolutionary technology offers patients a safe, minimally-invasive option for pacemaker delivery that eliminates leads and surgical pockets,” he added.

Better understanding

But others were more cautious.

Prof Jeremy Pearson, associate medical director at the British Heart Foundation, said: “This is a potentially exciting development but it’s early days.

“Before this leadless pacemaker becomes widely available, we need a better understanding of how long it will last, as well as how easy it is to replace if necessary. As our knowledge of this new pacemaker widens, so too will the expertise needed to fit this potentially exciting device.”

The company behind the device has recently been bought by global medical device firm St Jude.

It has had several wire-based pacemakers recalled in recent years.

Other device makers are also planning to go wireless. The Wireless Cardiac Stimulation system has been developed by US start-up EBR Systems and UK-based tech firm Cambridge Consultants and uses a tiny wireless electrode no bigger than a grain of rice powered by an ultrasonic pulse generator, inserted lower down in the chest.

In 2011 the device was implanted in 100 patients in hospitals across Europe.

Cardiac pacemakers are used to treat slow heart rates. The devices monitor the heart and provide electrical stimulation when the heart beats too slowly.

The first pacemaker was fitted in 1958. Currently more than four million people around the world have some sort of cardiac rhythm device with an additional 700,000 people getting one each year.

GM yeast brews fuel from rubbish.

US researchers have used genetically modified yeast to enhance the production of biofuels from waste materials.

The new method solves some of the problems in using waste like straw to make bioethanol fuel.

The scientists involved say the development could help overcome reservations about using land for fuel production.

The research is published in the journal Nature Communications.


Many states around the world have plans to replace gasoline with bioethanol, but this has typically been by changing land-use from food crops to biofuel.

“Start Quote

We sort of rebuilt how yeast uses carbon”

Dr Jamie Cate University of California

Just this week, a representative of South Africa’s farming community announced that sorghum harvests would need to increase five fold to meet their government’s commitment to incorporate at least 2% bioethanol in petrol.

Sorghum is South Africa’s second biggest summer crop and is a staple food as well as being used in brewing and livestock feed.

However, scientists are now seeking more sustainable routes to generating biofuel – routes that would have a lighter impact on food prices and production.

Breakdown breakthrough

One is to consider using non-conventional plants such as seaweed. But among the most radical ideas is the suggestion that biowastes should be used to produce bioethanol, which is added to petrol replacing some fossil fuel.

“Wastes present a major opportunity in this respect. We have to start to think about wastes, such as sewage or landfill waste as resources – not problems to be disposed of,” Dr Gavin Collins, an environmental microbiologist at the National University of Ireland, Galway, told BBC News.

Using microbes to make fuel from biomass involves breaking down large complex biopolymer molecules.

These are indigestible to most bugs, and attempts to incorporate them into fuel production have slowed down the biotechnology, creating bottlenecks.

Biofuel boom.

Fuel plant

The European Union also has a declared aim that 10% of its transport energy should be from renewable sources, such as biofuels, by 2020.

To help meet this target, Europe’s largest biofuel plant opened this week at Crescentino, Italy.

It is designed to generate 75 million litres of ethanol a year from straw and a crop called Arundo donax, which can be grown on marginal land, and does not compete for resources with food.

One chemical that is produced when processing biowastes is a large sugar molecule called xylose.

When you try and use yeast to ferment xylose, rather than making alcohol for fuel directly, it generates acetic acid – essentially vinegar. This is poisonous to the yeast, and stops the fermentation.

Breaking down xylose and making acetic acid non-toxic are the two major problems that must be solved if biowastes such as straw are to be fermented to make fuel.

Now, US biotechnologists appear to have solved both problems, by developing a genetically engineered strain of yeast that simultaneously breaks down xylose and converts acetic acid to fuel.

“Xylose is a sugar; we can engineer yeast to ferment xylose,” said University of Illinois Prof Yong-Su Jin, one of the authors of the study.

“However, acetic acid is a toxic compound that kills yeast. That is one of the biggest problems in cellulosic ethanol production.”

The yeast digests the sugars in oxygen-poor conditions, making the process more efficient than digesters that rely on active mixing of air into the system.

Microbe driven

A new pathway, not yet discovered in nature, has been genetically engineered in the lab. This breakthrough means yeasts can be used much more efficiently to convert biowaste into biofuel.

“We sort of rebuilt how yeast uses carbon,” said principal investigator Dr Jamie Cate, of the University of California at Berkeley

One hurdle to implementing the discovery is that the new yeast that has been developed is genetically modified, and it is not yet clear how easily GM yeasts might be accepted for use on an industrial scale.

Dr Gavin Collins, however, remains upbeat about the prospects for biotechnology.

“We probably know the function of only about 0.01% of all living microbes on Earth,” he said.

“It may be that many of them can efficiently degrade even complex plant material and other wastes under anaerobic conditions. They may be present in nature but we haven’t found them yet.

“However, just look at what we have been able to do with the small fraction of microbes we understand – everything from antibiotic production; food and alcohol production; and biofuel production.

“Just think what we could do, or what we might discover, if we understood the function of just another 1%.”

Top Children’s Vitamin Brand Contains Aspartame, GMOs and Other Hazardous Ingredients

The #1 Children’s Vitamin Brand in the US contains ingredients that most parents would never intentionally expose their children to, so why aren’t more opting for healthier alternatives?

Kids vitamins are supposed to be healthy, right? Well then, what’s going on with Flintstones Vitamins, which proudly claims to be “Pediatricians’ #1 Choice”? Produced by the global pharmaceutical corporation Bayer, this wildly successful brand features a shocking list of unhealthy ingredients, including:


Cupric Oxide

Coal tar artificial coloring agents (FD&C Blue #2, Red #40, Yellow #6)

Zinc Oxide


Ferrous Fumarate

Hydrogenated Oil (Soybean)

GMO Corn starch

On Bayer Health Science’s Flintstones product page designed for healthcare professionals they lead into the product description with the following tidbit of information:

82% of kids aren’t eating all of their veggies1. Without enough vegetables, kids may not be getting all of the nutrients they need.

References: 1. Lorson BA, Melgar-Quinonez HR, Taylor CA. Correlates of fruit and vegetable intakes in US children. J Am Diet Assoc. 2009;109(3):474-478.

The implication? That Flintstones vitamins somehow fill this nutritional void. But let’s look a little closer at some of these presumably healthy ingredients….


Aspartame is a synthetic combination of the amino acids aspartic acid and l-phenylalanine, and is known to convert into highly toxic methanol and formaldehyde in the body. Aspartame has been linked to over 40 adverse health effects in the biomedical literature, and has been shown to exhibit both neurotoxicity and carcinogenicity [1] What business does a chemical like this have doing in a children’s vitamin, especially when non-toxic, non-synthetic non-nutritive sweeteners like stevia already exist?


Next, let’s look closer at Cupric Oxide, 2mg of which is included in each serving of Flinstone’s Complete chewable vitamins as a presumably ‘nutritional’ source of ‘copper,’ supplying “100% of the Daily Value (Ages 4+), according to Flintstones Vitamins Web site’s Nutritional Info.[2]
But what is Cupric Oxide? A nutrient or a chemical?

According to the European Union’s Dangerous Substance Directive, one of the main EU laws concerning chemical safety, Cupric Oxide is listed as a Hazardous substance, classified as both “Harmful (XN)” and “Dangerous for the environment” (N). Consider that it has industrial applications as a pigment in ceramics, and as a chemical in the production of rayon fabric and dry cell batteries. In may be technically correct to call it a mineral, but should it be listed as a nutrient in a children’s vitamin? We think not.



A well-known side effect of using synthetic dyes is attention-deficit hyperactivity disorder. For direct access to study abstracts on this topic view our Food Coloring research page.  There is also indication that the neurotoxicity of artificial food coloring agents increase when combined with aspartame, making the combination of ingredients in Flintstones even more concerning.


Each serving of Flinstones Complete Chewable vitamins contain 12 mg of zinc oxide, which the manufacturer claims delivers 75% of the Daily Value to children 2  & 3 years of age.  Widely used as a sun protection factor (SPF) in sunscreens, The EU’s Dangerous Substance Directive classifies it as an environmental Hazard, “Dangerous for the environment (N).”  How it can be dangerous to the environment, but not for humans ingesting it, escapes me.  One thing is for sure, if one is to ingest supplemental zinc, or market it for use by children, it makes much more sense using a form that is organically bound (i.e. ‘chelated’) to an amino acid like glycine, as it will be more bioavailable and less toxic.


Reports spark row over bee-bothering insecticides.

Pesticide manufacturer brands risk assessment ‘hurried and inadequate’.

Three reports by Europe’s food-safety body have stoked controversy over the possible links between the use of neonicotinoid insecticides and declining bee populations. One leading insecticide manufacturer has attacked the reports, calling them “hurried and inadequate”.

A number of scientific studies have linked neonicotinoids to adverse effects on bee colonies(see Nature video) but some researchers believe that the drop in bee numbers seen in the United States, Europe and elsewhere is attributable to a combination of factors.

Honey trap

The latest assessments from the European Food Safety Authority (EFSA) in Parma, Italy, are based on existing studies of three neonicotinoids: clothianidin, imidacloprid and thiamethoxam. The reports conclude that these chemicals should be used only on crops that are not attractive to honey bees, so that the insects are not exposed to the insecticides through pollen and nectar. Dust and plant sap contaminated with the chemicals may also pose a risk to bees, says the EFSA.

The EFSA is an independent advisory body, and any ban or restrictions on the use of the three chemicals would require legislation by the European Union (EU) or individual nations.

The work has attracted fierce criticism from John Atkin, chief operating officer at thiamethoxam manufacturer Syngenta, which is based in Basel, Switzerland. In a statement, Atkin said, “It is obvious to us that EFSA has found itself under political pressure to produce a hurried and inadequate risk assessment, which even they acknowledge contains a high level of uncertainty. Their report, compiled in under three months, has not taken account of the comprehensive scientific studies that preceded the launch of neonicotinoids, and many years of extensive monitoring in the field.”

EFSA did not respond to Nature‘s enquiries concerning these allegations.

Data gaps

The European Commission welcomed the EFSA’s assessments. The conclusions “are somewhat concerning when it comes to the potential impact of these particular products”, a commission spokesperson said, but “there are still many shortfalls in the scientific data that were analysed”.

Some EU member states are already scrutinizing neonicotinoids. In the United Kingdom, for example, the Department for Environment, Food and Rural Affairs (Defra) has commissioned field studies on the impact of the insecticides on bees. “If it is concluded that restrictions on the use of neonicotinoids are necessary, they will be brought in,” the agency said in a statement.

Bayer, a chemical company based in Leverkusen, Germany, which manufactures imidacloprid and clothianidin, said in a statement that it does not believe that the EFSA’s reports “alter the quality and validity” of previous risk assessments by the EU and member states that have permitted the use of its products. The chemical company pins most of the blame for bee declines on parasitic Varroamites.