Apple deal with device maker sign of more to come?

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Apple announced at its recent WorldWide Developers Conference in California that it would soon be offering users the chance to monitor their glucose levels. The company has partnered with medical device maker Dexcom and will link the company’s glucose monitoring device with the Apple Watch.

For some time now, Apple has been positioning itself as a dedicated health and fitness provider through the Apple Watch series. However, while Apple has previously marketed itself towards lifestyle and fitness fanatics, it has yet to enter the medical device sector.

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Apple has also previously been reported to be hiring a small team of biomechanical engineers to develop sensors that monitor the body’s blood sugar levels. The team are said to be working on non-invasive sensors that do no require users to prick their skin for blood testing.

Apple is also now home to our new OTC DASHBOARD app. To download it from the Apple Store now, click here.

App helps cancer patients extend life

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Scientists have discovered a new medical intervention that can extend the lives of cancer sufferers by a number of months. The discovery is not a novel drug or therapy, it is an app. Patients who reported their symptoms via a tablet survived for five months longer than those who did not, according to a large study which was presented at the world’s biggest oncology meeting yesterday.

The research highlighted the role that cheap and simple tech can play in providing healthcare at a time when drug makers are suffering controversy for the ever-rising cost of prescribed medicines.

Patients were told to report 12 symptoms such as sleeping and breathing difficulties using the app, which was referred to as an electronic patient report system or ePro. If patients took a turn for the worse, an automatic push notification was sent to alert a doctor or nurse. “The system proactively monitored symptoms, so that the care team was able to intervene earlier and catch things before they became more severe,” said Dr Ethan Basch, an oncologist and professor at the University of North Carolina, who led the trial.

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Dr Basch said patients using the app were able to stay on chemotherapy “for substantially longer” than others because they were less likely to turn up to the hospital in a weak state and as a repercussion, not be strong enough to handle the punishing treatment. The ePro patients were also less likely to be admitted to hospital, meaning they did not become bed-bound or acquire an infection like C. difficile while on the ward.

Oncologists have long believed that ePro apps can improve a person’s quality of life, but this is the first time that is has been proven to boost survival in a large number of patients with a broad and varied range of cancers. Patients who used the purpose-built app typically survived for 31 months versus 26 months for those who did not, according to the research, which was unveiled at the annual meeting of the American Society of Clinical Oncology (Asco).

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.

Self-care in Canada: Meandering Path to New Regulations

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Mathematically, the shortest distance between two points is a straight line. However, in public policy it is rare to chart such a clear direction. Reading through the “What was Heard” report from Health Canada’s public consultation on self-care regulation, which was conducted online in late 2016, there does not appear to be any real consensus over new proposals for an overhaul of all the regulations for non-prescription medicines, Natural Health Products (NHPs) and cosmetics.

Although the report was completed months ago, it was only released in late March this year, as a backgrounder to a series of town hall style discussions on a more detailed set of changes starting 4th April. While the government has developed a more detailed set of proposals that address some of the concerns set out in the report from last year’s consultation, it would appear that those attending the provincial feedback forums will not have the opportunity to digest these details prior to giving their advice. In fact, one of the key findings of the report was that all stakeholders felt that the original outline lacks enough specificity to make cogent comment.

Reading the report, it is interesting how what was heard may not actually be fully representative of what was said. For example, the report concludes that “many participants in the consultation see considerable value in the clarity that would be provided by a single regulatory approach to all three affected areas” (i.e. cosmetics, NHPs and OTCs). What the data show is that in virtually all stakeholder categories, the support across several key measures was only around 30%. Taken another way, roughly 70% or more of the stakeholders would not be more confident in these proposals.

The report notes that most of the concerns came from the NHP segment. This should not be a surprise since all previous consultations were only about moving OTCs out of the prescription drug regulations. For non-prescription medicines, this was round two of the discussions but for the NHP and cosmetics sectors this was novel territory. The visceral reaction was clear given that the NHP community spent years developing a set of regulations independent from drug classification and achieved it through a parliamentary process. They perceived that rolling all OTCs and NHPs into one single regulation was a step back in time, especially given the tone of the documents about claims-based barriers to market access.

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There weren’t many points where all stakeholders agreed. However, it seems there was a strong consensus that self-care products (OTCs, NHPs and cosmetics) “should not be regulated in the same manner as prescription drugs”. Far from an epiphany, this was the basis for the idea that OTCs should be granted their own regulations outside the prescription regulations, just as NHPs were granted such regulatory status. Cosmetics have never been in the prescription drug framework.

There was no consensus on the specific elements of the new framework. The risk-based approach was supported to the degree that most agreed that “products which pose a greater risk of harm should receive greater scrutiny and be subject to significant requirements”. Where the consensus fell into disarray was around the confusion between evaluating products for their individual risk and categorising products broadly into risk levels. The proposal seemed to set out a lower-risk category where claims would be limited and as such the government would not review and license them for sale. This type of product would be supported by pre-cleared information such as monographs.

The logic suffered in some stakeholders’ view since the model would seem to require lower-risk products to move into higher risk categorisation when clinical data would be provided to create greater confidence in the claims. The report notes that “there is no consensus that the proposed risk-based approach would create more confidence when purchasing self-care products”. In fact, 82% of consumers and healthcare professionals and 93% of cosmetics manufacturers said it would not give them more confidence.

The thought of requiring only “scientific” proof to justify health claims met with resistance from most stakeholders (except the five OTC drug companies). Only 30% of all respondents agreed with this notion and that was not highly differentiated across several segments. The support for stricter reliance on “science” (not defined but often assumed to be clinical trial data) was low with consumers (30%), healthcare professionals (33%), NHP companies (21%) and cosmetics manufacturers (30%). On the other side of the argument, academics and researchers were more supportive (60%).

A concept floated by government was that they would not evaluate and license certain types of products based on the types of claims being made. This was suggested to be accompanied by a disclaimer that Health Canada did not assess the claim. While cosmetics already enjoy a similar notification system, most stakeholders didn’t appear to support adopting a cosmetic-like system for OTCs and NHPs. The report notes that “participants are somewhat divided on the use of a disclaimer on products whose efficacy would not be reviewed”.

Despite the lack of consensus on a disclaimer, there would appear to be acceptance that changes could be made that would “facilitate informed consumer choice”. Some stakeholders have proposed adding labelling statements that would make it clearer when traditional evidence was used to support the claim. This, they feel, would add information that enhances consumer choice.

This consultation elicited a very strong response relative to most government consultations. Perhaps this was influenced by the fact that during the consultation period, Health Canada put out a very strong social media campaign and used traditional media stories to “clarify” some aspects of their proposals. With the communications efforts to ensure that the consultation garnered significant and reasoned responses, it should give some confidence in the results.

Perhaps one of the most telling observations related to the confidence stakeholders would have in the newly designed system. Consumers (78%), healthcare professionals (75%), NHP companies (80%) and cosmetics firms (63%) did not feel more confident with the new proposals. In a similar vein, 82% of consumers didn’t feel that the proposals adequately addressed their needs. The numbers were similar for healthcare professionals (78%), NHP companies (81%) and cosmetics businesses (74%). Only two OTC companies felt that their concerns were addressed.

The report concludes that “there is clearly a need for further detail on the proposed approach so that stakeholders may provide more specific feedback to Health Canada as the framework continues to be developed”. No doubt this is true and, as the government heads into the next phase of face-to face discussions, it would have been helpful to have that kind of detail available before asking stakeholders to respond.

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.

Vit D may prevent cold & flu

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“The sunshine vitamin”, also known as vitamin D, is vital for healthy bones and a strong immune system, says an analysis published in the British Medical Journal. This study also suggests that foods should be fortified with the vitamin.

Public Health England (PHE), however, argues that the infections data is not conclusive, although it does recommend the supplements to improve bone and muscle health.

According to the research, the immune system uses vitamin D to make antimicrobial weapons that puncture holes in bacteria and viruses. As vitamin D is made in the skin while out in the sun, many people, particularly in the UK, have low levels during colder seasons.

Trials on using supplements to prevent infections have so far given varied results, so researchers pooled data on 11,321 people from 25 separate trials to try to gain a more conclusive result. The team at Queen Mary University of London looked at respiratory tract infections, which covers a wide range of illnesses from a runny nose to flu to pneumonia.

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The study overall said one person would be spared infection for every 33 taking vitamin D supplements. That is more effective than a flu vaccination, which needs to treat 40 to prevent one case, although flu is far more serious than the common cold.

There were more beneficial results for those taking pills daily or weekly, rather than in monthly super-doses and in people who were lacking vitamin D in the first place. The main purpose of vitamin D supplements is to normalise the level of calcium and phosphate in the body, which are crucial for the growth and maintenance of healthy bones, teeth and muscles.

In extreme cases, low levels of vitamin D can cause rickets in children, where the bones become soft and weak and, in some cases, misshapen as they continue to grow. In adults, vitamin D deficiency can lead to osteomalacia, which leads to severe bone pain and muscle aches.

One of the researchers taking party in the study, Professor Adrian Martineau, commented: “Assuming a UK population of 65 million, and that 70% have at least one acute respiratory infection each year, then daily or weekly vitamin D supplements will mean 3.25 million fewer people would get at least one acute respiratory infection a year.”

For more vitamin D developments, please follow this link.

Male Contraceptive Clears Latest Hurdle

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Following recent trials for a hormone-based male contraceptive, another experimental new type of contraceptive, which blocks sperm flow with a gel, has been successful in monkey trials. Vasalgel creates a semi-permeable barrier which, once injected into the vas deferens, prevents sperm from crossing and causes them to be reabsorbed by the body.

The company behind the innovative creation says a two-year trial shows the gel works and is safe in primates. There will hopefully be enough evidence to begin tests in human males within a few years. If these are successful, regulatory approval will be requested to make the gel more extensively available.

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This would be the first new type of male contraceptive to hit the market in many decades. At the moment, men have two main options of contraceptive; to wear a condom to catch the sperm, or have a sterilising operation (vasectomy) to cut or seal the two tubes that carry sperm to the penis from where they are made in the testicles.

Vasalgel has the same end effect as vasectomy, but researchers plan to make the reversal easier and with a higher success rate, should a man later decide he wants to have children. The plans will be that another injection should dissolve the semi-permeable gel barrier, making sperm fertile once again. This worked in early tests in rabbits, but the researchers have yet to prove the same in monkeys and humans.

The non-profit company researching Vasalgel, the Parsemus Foundation, has used grants and fundraising to get this far. Researcher, Professor Pacey commented: “I would imagine there is a worldwide market for a new male contraceptive, but trials in humans and more long-term safety data are required before we will know if it is a success.”