App “as effective as the contraceptive pill”

A revolutionary form of contraception, especially available over-the-counter, has been long awaited. This year alone we have seen trials in male contraceptive injections and demands for numerous OTC contraceptive pills. Drastic change and action have long been in high demand.

What started out as a hobby project for Elina Berglund Scherwitzl has now become approved as the world’s first contraceptive app. The nuclear physicist, who had been working on the team that discovered the Higgs boson, felt finished with hormonal contraceptives and their physical and mental pitfalls, but was not yet ready to have a baby.

With a wealth of data skills, Elina was determined to find an alternative form of contraception. “Like many women I had tried many different contraception options since my teenage years and hadn’t really found a solution that fit me,” she explained. “It was in my quest for an effective natural alternative that I discovered that you can see when you’re fertile by your temperature, and for me that was really a revelation.”

Using complex mathematics and data analysis, Elina began developing an algorithm designed to be so accurate that it could identify exactly when in her cycle she would ovulate. This then enabled planning for when she would need to use protection, to a much higher degree of certainty than natural planning methods, which many women with timely periods are able to use.

These results proved to be so accurate that, together with her husband, fellow physicist, Raoul Scherwitzl, Elina set about founding her own business, Natural Cycles.

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Natural Cycles is an app designed to help women around the world with their fertility and contraception needs, allowing them to collect their own temperature datasets and closely monitor their cycle trends in the process.

Launched in 2014, the app now has some 300,000 users, who pay a monthly or annual fee for the service. Following several medical trials, the app became the first tech-based device on the planet to be formally certified for use as contraception, in February this year. It gained approval for use across the EU after getting the green light from the German inspection and certification organisation Tuv Sud.

The start-up now markets itself as being “as effective as the pill” following one of the largest clinical studies in contraception involving more than 4,000 women, published in the peer-reviewed European Journal of Contraception and Reproductive Health Care.

The researchers, which included the co-founding couple, found that 7% of women who used the app in a “typical” way (allowing for some human error) got pregnant, compared to 9% taking the pill and less than 1% using IUD coils. “Just like the pill we need some effort from the user on a daily basis. But we really hope to be the default alternative if you don’t want to use hormonal contraception or IUDs,” Elina commented.

While the product is only currently certified in the EU, where its users are concentrated in the UK and the Nordics, it is available worldwide and, despite its earlier controversies, has attracted users in some 160 countries.

Are wearables wearing thin?

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The wearables market has had a rollercoaster ride in recent months. This time a year ago analysts were penning multi-billion dollar forecasts for the developers of health trackers and smartwatches. Apple was setting the stakes high, brazenly selling a gold edition of the Apple Watch for US$10,000.

More recently though, once popular fitness tracker brand, Jawbone, confirmed to TechCrunch that it would be leaving the consumer market in order to focus on healthcare providers. Microsoft have also removed its Fitness Band from its online store (although it is still available on Amazon); most significantly they will no longer provide the Band developer kits.

Fitbit remains a leading brand name, and is still very much the heart of the fitness tracker revolution. Fitbit recently acquired one of its rivals, Pebble Watch. However, on the downside, it was reported that the company were making staff cuts and founder James Park said the firm had experienced “softer than expected” sales during the 2016 Christmas period.

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Numerous devices claim to measure heart rate, sleep activity and count calories. Counting steps is seemingly the most common use for wearable devices, which has been edifying for many in terms of daily exercise expectations. Recently, though, experts have questioned whether the golden goal of walking 10,000 steps a day is actually worthwhile, and a US study concluded that health trackers did not aid weight loss.

Mr Bryant from Futuresource says many wearables aren’t yet independent enough and rely on being tethered to a smartphone, or replicate functionality, such as step counting, that the handset already has. However, Mr Bryant believes that while wearables may be down, they are not yet out.

“We feel the slowdown is temporary and the market will accelerate this year,” he said. He thinks that improved power, appearance, and mobile pay options could give them a boost alongside a maturing user group.

Wearable Devices will be one of many themes explored at our 28th Annual OTC INSIGHT European Conference & Action Workshop, being held in Munich in just over a month! The wider conference will focus on the theme of Making the Most of New Technology. To reserve one of our final few places, please contact lianne.hill@NicholasHall.com

New advice says eat 10 fruit & veg per day

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A study by Imperial College London has suggested we should eat 10 portions of fruit & vegetables a day. The study said that such eating habits could prevent 7.8 million premature deaths each year. The study also identified particular fruit & vegetables that reduced the risk of cancer and heart disease.

A portion counts as 80g (3oz) of fruit or vegetables, which is equal to a small banana, a pear, or three heaped tablespoons of spinach or peas. The findings were based on pooled data on 95 separate studies, involving the eating habits of two million people.

Lower risk of cancer was linked to eating green vegetables such as spinach and kale, yellow vegetables and cauliflower. Lower risk of heart disease and strokes was linked to eating apples, pears, citrus fruits and leafy greens.

The results, published in the International Journal of Epidemiology, also assessed the risk of dying before your time. Compared with eating no fruit or veg a day, it showed:

  • 200g cut the risk of cardiovascular disease by 13% while 800g cut the risk by 28%
  • 200g cut the risk of cancer by 4%, while 800g cut the risk by 13%
  • 200g cut the risk of a premature death by 15%, while 800g cut the risk by 31%

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The researchers do not know if eating even more fruit & vegetables than the newly suggested 10 portions would have even greater health benefits, as there is little evidence out there to review.

Dr Dagfinn Aune, one of the researchers, said: “Fruit & vegetables have been shown to reduce cholesterol levels, blood pressure and to boost the health of our blood vessels and immune system.” He continued: “This may be due to the complex network of nutrients they hold, including many antioxidants, which may reduce DNA damage and lead to a reduction in cancer risk.”

However the study also said that the benefits of this would be hard to integrate as many people struggle to even eat the five a day (400g) which is recommended by the World Health Organization. In the UK, only about one in three people eat this recommended portion, showing the huge potential for VMS marketers in terms of targeting their supplements at people that don’t eat their 10 fruit & veg a day.

Wearable Sensor Device Helps Visually Impaired Sense Environment

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VTT TecVTT Technical Research Centre of Finland has developed a wearable assistive device for the visually impaired, which enables them to sense their environment and move around more safely. The device, which is worn like a heart rate monitor, has been clinically tested.

The device functions on the basis of a radar system developed by VTT. The radar sends information to the user in the form of vibrations or voice feedback. It senses a majority of obstacles in the user’s surroundings, however difficulties do however remain in sensing objects such as thin branches and bushes.

“The novel aspect lies in a wearable sensor device which functions based on radio waves, so the signal is able to pass through clothing. This means that it can be worn discreetly under a coat, for example,” says Tero Kiuru, a Senior Scientist at VTT.

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The radar has already been clinically tested in device trials approved by the National Supervisory Authority for Welfare and Health (Valvira), in which VTT’s partners were Kuopio University Hospital and the Finnish Federation of the Visually Impaired (FFVI). The test group included a total of 25 visually impaired people, of whom 14 were blind, 7 partially sighted and 4 were deaf-blind.

“A clear majority of the testers felt that the radar improved their ability to perceive their environment and increased their self-confidence when moving around,” says Kiuru. A total of 92% of the trial users felt that the device helped them to perceive their surroundings, 80% felt that their trust in their ability to move around independently had increased and 32% would immediately start using the test device in its current form.

On the other hand, they were not satisfied with distance control and vibration-based feedback. The research will continue with selected test users and the device will be further developed. A global market is believed to exist for the radar, since there are around 300 million visually impaired people in the world.

Vit D shows metabolic syndrome benefits

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It is well known to some that a diet high in fat can trigger a metabolic syndrome; a group of symptoms that pose as risk factors for diabetes and heart disease. Scientists have now discovered that vitamin D deficiency is necessary for this syndrome in mice, with primary disturbances in gut bacteria.

If these findings can be validated in humans, sunbathing and vitamin D supplements may be affordable approaches to improve or even prevent metabolic syndrome.

“Based on this study, we believe that keeping vitamin D levels high, either through sun exposure, diet or supplementation, is beneficial for prevention and treatment of metabolic syndrome,” says Professor Stephen Pandol, at Cedars-Sinai Medical Center, USA, who collaborated with Yuan-Ping Han’s research group at Sichuan University, China in the study.

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Metabolic syndrome affects nearly one-fourth of the world’s adult population. Characteristic symptoms include obesity around the waistline and at least two of the following: high blood sugar levels, high blood pressure or high cholesterol; sufferers also typically have excess fat in their liver.

Vitamin D deficiency decreases the production of defensins, which are antimicrobial molecules essential to maintain healthy gut flora. As expected, an oral supply of a synthetic defensin recovers gut bacteria balance, decreases blood sugar levels and improves fatty liver.

In summary, a high fat diet alone is not enough to cause metabolic syndrome but ultimately it is needed in combination with vitamin D deficiency.

FDA takes steps to improve hearing aid accessibility

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The U.S. Food and Drug Administration (FDA) have announced important steps to better support consumer access to hearing aids. The FDA will consider creating a category of OTC hearing aids that could deliver new, innovative and lower-cost products to millions of consumers.

The agency also announced important steps to better support consumer access to hearing aids. In a guidance document, the agency explains that it does not intend to enforce the requirement that people aged 18+ years receive a medical evaluation or sign a waiver prior to purchasing most hearing aids. Under the new guidance, the FDA will continue to enforce the medical evaluation required for people under 18 years of age.

The agency also requires that consumers are provided with information and instructions about hearing aids before any purchase from a licensed hearing aid dispenser. This guidance is effective immediately.

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FDA Commissioner Robert Califf, M.D commented “Today’s actions are an example of the FDA considering flexible approaches to regulation that encourage innovation in areas of rapid scientific progress,”Califf continued “The guidance will support consumer access to most hearing aids while the FDA takes the steps necessary to propose to modify our regulations to create a category of OTC hearing aids that could help many Americans improve their quality of life through better hearing.”

The FDA has cited that hearing loss affects some 30 million people in the United States and can have a significant impact on communication, social participation and overall health and quality of life.

Q3 Results Reveal USA Slowdown

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The Q3 2016 results are now available on Nicholas Hall’s DB6 database, and the trend information will soon be updated on the OTC DASHBOARD website. In this week’s blog, we take a closer look at the latest growth trends for the Top 20 OTC markets in the world.

Overall, the global OTC market performed steadily in Q3 2016 with a 4.3% rise, the same growth rate as we saw in Q2 2016. However, this performance can be seen as mediocre compared to the full-year 2015 period, when OTC sales were up by 5.5%.

The global No.1 market, USA, showed signs of deceleration in Q3, with sales up by only 2.2%. This is largely owing to the slowing down of sales for major switches, such as Flonase allergy remedy and Pfizer’s Nexium 24HR antacid. That said, the USA should enjoy an upturn in the new year with switches such as GSK’s Flonase Sensimist (allergy remedy) and Galderma’s Differin Gel (acne remedy) in the pipeline. Compared to other categories, Lifestyle OTCs in the USA showed continued dynamism in Q3 2016, with sales up by a steady 5.0%; this was owing in part to double-digit growth for obesity treatments (+43.4%).

China’s growth also continued to lose steam in Q3 2016, where sales were up by 6.0%. China’s OTC market continues to grow year-on-year, but in recent years growth has gradually slowed; this is considered to be owing to a weaker economy, new regulations and also the crackdown on MNCs and domestic companies. Weaker growth overall in Q3 came despite continued growth for analgesics, which were up by 8.4%, making it the most dynamic OTC category in China, thanks to high levels of innovation and advertising in this area.

In Q3, growth also weakened in Japan and Europe as a result of low levels of Rx-to-OTC switch activity and weak cough, cold & allergy growth in early 2016. Italy was an exception to sluggish growth in Europe, where sales of OTCs were up by 3.5%; this was thanks to strong growth for Lifestyle OTCs (+11.1%), with a particularly dynamic performance from emergency hormonal contraceptives, sales of which rose by 226%.

Latin America remains the strongest performing region, with growth up by 15%. This is thanks to significant growth from Venezuela, up by 39% in Q3, owing to high levels of inflation. Despite a tough economic climate in Brazil, the OTC market remains robust with sales up by 9.5%, as a result of increased awareness of health and wellbeing.

Elsewhere in Q3 2016, India’s growth accelerated with sales up by 9.5%, owing to a strong performance from gastrointestinals (+10.3%). Turkey also performed well with growth up by 6.8%, thanks to VMS sales and a strong upturn for Lifestyle OTCs.