Vitamin B3 could prevent miscarriages and birth defects

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An extra dose of vitamin B3 might help prevent certain kinds of complex birth defects, according to a new study. It is thought the vitamin can help compensate for defects in the body’s ability to make a molecule, nicotinamide adenine dinucleotide (NAD), which researchers have now linked for the first time to healthy fetal development in humans.

Every year 7.9 million babies are born with a birth defect worldwide. The discovery suggests the possibility that boosting levels of B3 in pregnant women’s diets might help lower overall rates of birth defects.

Researchers from the Victor Chang Institute in Sydney called it ‘a double breakthrough’ as they found both a cause and a preventative solution. The researchers analysed the DNA of four families where the mothers had suffered multiple miscarriages or their babies were born with multiple birth defects, such as heart, kidney, vertebrae and cleft palate problems.

They found mutations in two genes that caused the child to be deficient in a vital molecule known as Nicotinamide adenine dinucleotide (NAD), which allows cells to generate energy and organs to develop normally. Lead researcher Prof Sally Dunwoodie replicated these mutations in mice and found they could be corrected if the pregnant mother took niacin (vitamin B3).

“You can boost your levels of NAD and completely prevent the miscarriages and birth defects. It bypasses the genetic problem,” she said. “It’s rare that you find a cause and a prevention in the same study. And the prevention is so simple, it’s a vitamin,” she said.

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Back In 2005, Dunwoodie’s team dealt with a particularly severe case, a baby who had major defects in the heart, backbone, and ribs; the rib problems being so bad that the child’s lungs couldn’t fully inflate. The team found that the family carried a mutation in a gene related to the production of NAD, a molecule crucial for energy storage and DNA synthesis in cells. Both parents carried a mutation in one of their copies of the gene, and the affected baby had inherited two defective copies.

No one had reported any role for NAD in heart or bone development, Dunwoodie says. “We didn’t know what to do with it.”

To confirm the role of the mutations in organ and bone development, the researchers knocked out the two genes in mice to see whether similar birth defects appeared. At first all the pups were normal. But then the researchers realised that standard mouse chow is rich in niacin and that cells can use either niacin or nicotinamide—both known together as vitamin B3—to make NAD by an alternate pathway.

The work opens a potentially exciting new area of research for developmental biologists: Trying to understand how cell metabolism affects development

 

 

More than half of UK’s e-cig users give up tobacco

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A survey of 12,000 adults for Action on Smoking and Health (ASH) found some 1.5 million vapers are now ex-smokers, compared with 1.3 million who still use tobacco.

However, ASH stated that the message that vaping was much less harmful than smoking was still yet to get through to all smokers. Some 9mn still smoke in the UK despite a big rise in e-cigarette use.

In 2012, there were 700,000 vapers in the UK; now there are 2.9mn. The main reason ex-smokers give for vaping is to help them stop smoking. Current smokers say they do it principally to reduce the amount they smoke.

Scientists say evidence suggests that the risks of exposure to toxins for e-cigarette users are likely to be low – and much lower than with tobacco.

Deborah Arnott, the campaigning health charity’s chief executive, said the figures on vapers who had quit smoking were “excellent news” but added that the rate of people switching to electronic versions had peaked. “The rapid growth in e-cigarette use has come to an end,” she said.

This is owing to more than a third of smokers having still never tried e-cigarettes, as a result of concerns about their safety and addictiveness. However, research suggests that 26% of people think e-cigarettes are more – or as equally – harmful as smoking tobacco while only 13% believe they are a lot less harmful.

“It’s very important smokers realise that vaping is much, much less harmful than smoking,” Arnott continued.

People who combine electronic and standard cigarette smoking are still being exposed to the cancer-causing substances in tobacco smoke, increasing their risk of lung cancers, bronchitis and other diseases, although Public Health England believes levels of nicotine in e-cigarettes are unlikely to pose any significant health risk.

New Test Launched in European HIV Testing Week

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In its fourth year, and the second time hepatitis testing has been included, European HIV Testing Week is currently in action. Starting on 18th November, and finishing a week later, testing week is spanning the length and breadth of the continent with partners participating from over 50 European countries.

Prior to this, the world’s fastest HIV self-test kit went on sale last week in order to relieve pressure on overcrowded sexual health clinics.

bioLytical Laboratories, renowned for their production of rapid infectious disease tests, has developed the INSTI HIV Self Test, following research revealing that over 103,000 people are living with HIV in the UK and an estimated 18,100 remain unaware of their positive status.

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It was reported recently that funding cuts have resulted in clinic closures across the country meaning the pressure is on for remaining clinics. Failure to fund routine testing in GP surgeries is leading to late diagnosis when early treatment of the disease is highly beneficial.

With one prick to a finger and a droplet of blood, the INSTI HIV Self Test provides immediate results and is over 99% accurate. Other home testing kits can take up to 20 minutes to produce a result, and in some cases laboratory test results can take several days or weeks.

The INSTI HIV Self Test kit also includes a resource card on where to seek help or for those who have general questions on HIV screening.

The test is available now online at www.INSTI-HIVSelfTest.com and costs €29.95 (£25.95) per kit.

Vit D recommended for all

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A report by a committee of independent nutrition experts has recommended that everyone in the UK should take vitamin D supplements. This has been advised despite the initial thought that only certain groups of the population should take the supplement.

The new guidance advice, which applies to England and Wales, suggests that everyone over the age of four should take 10mcg of vitamin D everyday. The guidance advice also suggests that during the chillier seasons this is particularly advised.

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The report strongly suggests that pregnant and breastfeeding women, people from ethnic minority groups with dark skin, elderly people in care homes and those who wear clothing that covers a majority of the skin, should take 10mcg of vitamin D everyday all year round.

The Scientific Advisory Committee on Nutrition (SACN) looked at the issue and decided that, to ensure a majority of the population has enough vitamin D in their blood all year round, daily intake is advisable.

For pregnant women and some children up to and including the age of four, the supplements will be free under the government’s ‘Healthy Start’ scheme. The Department of Health will now have to decide whether to fund free supplements for other groups of the population.

Official estimates suggest one in five adults and one in six children in England may have low levels of the vitamin in their bodies.

Prince Harry gets pricked publicly; Faster OTC HIV test approved

Last Thursday, people all over the world watched the UK’s Prince Harry get his finger pricked when he streamed his HIV test, conducted in a clinic, live on Facebook.

 

People who prefer a less public test will benefit from bioLytical Laboratories’ new INSTI HIV Self Test, which was approved last week by the EU and will be available in retail and e-commerce sites by the fourth quarter of this year. According to bioLytical, INSTI is the world’s fastest HIV Self Test, providing instant results with just one drop of blood. The at-home test reportedly yields greater than 99% accuracy.

Getting tested for HIV is the first step in taking control of one’s health and preventing transmission to others, and it is a step that can be the hardest to take, according to healthcare professionals. “It’s amazing how quick it is,” said Harry about his bioLytical HIV test (negative), performed at the Burrell Street Sexual Health Centre in South London. “Once you get people through the door, that’s the hardest bit out of the way.”

“Accessibility, inconvenience, anxiety, lack of awareness, stigma and discrimination are some of the reasons why a person may hesitate to take an HIV test,” noted Rick Galli, Chief Technical Officer of bioLytical Laboratories, “and this is exactly why we commend Prince Harry’s efforts towards the cause.”

OTCs in Action also commends bioLytical Laboratories for its efforts to improve HIV testing in public and private. 

OTCs in Action Episode 62: Countries claiming climbing CAGRs!

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This week, OTCs are in Action all over the world as we post the top-performing markets in terms of compound annual growth rates. First, kudos to my colleagues on the DB6 OTC database team. Thanks to their amazing expertise and hard work, Nicholas Hall Companies has just published the DB6 global OTC database, which tracks sales at the brand level in 64 countries.

The leading OTC market in the world is the USA, with turnover of $31bn, while the smallest market is Slovenia, with OTC sales generating $61mn. Both are mature markets, with the US posting a CAGR of 3.3% from 2011-2015 — Slovenian OTCs were close behind, achieving growth of 3.2%.

Looking at the Emerging Markets, China’s performance was strong with CAGR of 7% and sales of $21.6bn last year. Russia’s CAGR was 12%, reaching $3.3bn in 2015. Brazil performed a point better with growth of 13% to achieve sales of $2.7bn, whilst India’s CAGR was significantly slower at 9% to generate sales of $2.6bn last year.

Turning to more mature markets, Japan’s OTC CAGR for the period was flat with sales of $7.1bn in 2015, while the $4.9bn Germany OTC cart sputtered forward with a CAGR of 2.3%. In France, CAGR was negative 1% to $3.9bn. The UK and Canada drifted equally with a 2.3% posted in both markets, with sales of $2.9bn and $2.1bn, respectively, in 2015.

Which markets were stimulated by Rx-to-OTC switches? Where in the Emerging Markets did Lifestyle OTCs outpace other categories? DB6 subscribers know the answers. Visit the DB6 OTC database 2016 website to learn more about this valuable service, used by leading OTC players around the world.

DB6 Global OTC Database

OTCs in Action Episode 32: ED in NZ, not .com

OTCinActionheaderIllegal internet sales of Rx and OTC drugs, as well as adulterated dietary supplements, put consumers at great risk. “Tainted Sexual Enhancement Products”, published on the FDA’s website, warns consumers:

“The FDA has identified an emerging trend where over-the-counter products, frequently represented as dietary supplements, contain hidden active ingredients that could be harmful. Consumers may unknowingly take products laced with varying quantities of approved prescription drug ingredients, controlled substances, and untested and unstudied pharmaceutically active ingredients. These deceptive products can harm you! Hidden ingredients are increasingly becoming a problem in products promoted for sexual enhancement. Remember, FDA cannot test all products on the market that contain potentially harmful hidden ingredients. Enforcement actions and consumer advisories for tainted products only cover a small fraction of the tainted over-the-counter products on the market.”

Last week, this blog’s sister publication, OTC.NewDirections, reported that an international crackdown on  illegal internet trade of medical products yielded $81.8mn worth of items from 115 different countries, and 156 arrests. In the UK, a record $25.1mn worth of counterfeit and unlicensed medicines and 15,000 devices was seized, including potentially harmful slimming pills, erectile dysfunction, anaemia and narcolepsy tablets. The US FDA took action against 1,050+ websites that illegally sell potentially dangerous, unapproved Rx medicines and medical devices.

In fact, regulators around the world are playing a high stakes game of Whack-a-Mole, a popular arcade game in which players hit cheeky little moles with mallets, but as soon as one is knocked out another appears elsewhere.

WHACK A MOLE_0However, the risky business is driven by consumer demand, and now OTCs are in Action in New Zealand to satisfy those needs safely and legally. One of the more common unapproved ingredients in the FDA’s list of adulterated products is sildenafil, more commonly known by its legal Rx brand name, Viagra. The Rx-to-OTC switch of Silvasta (sildenafil) erectile dysfunction treatment in New Zealand was approved in late 2014. Men aged 35-70 years can purchase Silvasta without an Rx following a screening process with a trained pharmacist. This spring Nicholas Hall & Company awarded Douglas Pharma its top marketing award for the launch of Silvasta. A consumer campaign includes TV ads featuring an “everyday” man explaining that help is at hand from pharmacies without the need to see a doctor, while a pharmacy finder website directs men to the nearest outlet.

Another interesting development that will ensure consumer access to safer drugs is the UK’s new requirement that online medicine sellers must be registered with the Medicines & Healthcare products Regulatory Agency. They must display on every page of their website the new European common logo, which will be linked to their entry in the MHRA’s list of registered online sellers. The medicine being offered online must be licensed in the member state where the purchaser is based, and the seller must be legally entitled to sell medicine in accordance with UK legislation. Registered pharmacies can sell general sales list and pharmacy medicines or supply Rx-only medicines that they have dispensed against a prescription. Other retailers can only sell GSL (self-selection OTC) products. The penalty for disobeying the registration and logo rules is up to two years in prison, a fine or both.

In an somewhat related matter, as it affects consumer safety and appropriate use of OTC medicines by reducing illicit methamphetamine manufacture, Acura Pharmaceuticals has entered into an agreement with OTC cold remedy giant Bayer to license its IMPEDE technology. IMPEDE technology, which is available in the US in Acura’s Nexafed, has demonstrated significantly reduced yields of methamphetamine compared to traditional formulations in lab tests and has been associated with a reduction in meth labs in local markets of up to 90%. OTCs in Action covered the launch of Acura’s Nexafed Sinus Pressure + Pain (pseudoephedrine and acetaminophen) in February.

Episode 17: Outwitting meth manufacturers