FDA permits marketing of first mobile medical app

USA’s Food & Drug Administration has permitted marketing of the first mobile medical application to help treat substance use disorders (SUD). It is planned that the reSET application, to be marketed by Pear Therapeutics, will be used with outpatient therapy to treat alcohol, cocaine, marijuana and stimulant SUDs but will not treat opioid dependence.

The reSET device was reviewed through the de novo premarket review pathway, a regulatory pathway for some low to moderate-risk devices that are novel and for which there is no legally marketed predicate device to which the device can claim substantial equivalence.

Carlos Peña, Director of the Division of Neurological & Physical Medicine Devices at the FDA’s Centre for Devices & Radiological Health commented: “This is an example of how innovative digital technologies can help provide patients access to additional tools during their treatment.” Peña continued, “More therapy tools means a greater potential to help improve outcomes, including abstinence, for patients with substance use disorder.”

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The reSET device is a mobile medical app containing a patient application and clinician dashboard. The device delivers cognitive behavioural therapy to patients to teach the user skills that aid in the treatment of SUD and are intended to increase abstinence from substance abuse and increase retention in outpatient therapy programmes.

The FDA reviewed data from a multi-site, unblinded 12-week clinical trial of 399 patients who received either standard treatment or standard treatment with the addition of a desktop-based version of reSET which could be accessed at the clinic or at home. The data showed a statistically significant increase in adherence to abstinence for the patients with alcohol, cocaine, marijuana and stimulant SUD in those who used reSET (40.3%) compared to the patients who did not (17.6%).

The reSET device is indicated as a prescription-only adjunct treatment for patients with SUD who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or whose primary substance of abuse is not opioids.

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Belfast scientists say aspirin could reverse tooth decay

Aspirin has long been prized for its painkilling properties, while low-dose aspirin is a popular systemic cardiovascular treatment, but new research shows that it could also reverse tooth decay.

According to a BBC report, the effects of tooth decay could potentially be reversed by the use of aspirin and lead to fewer fillings being needed in the future, researchers in Belfast have said. Tooth decay, the most common dental disease, leads to the inflammation of the tooth nerve, causing toothache.

Initial research at Queen’s University found aspirin stimulates stem cells in teeth, enhancing tooth regeneration. Current treatment for tooth decay involves fillings, which may need to be replaced many times during the lifetime of the tooth.

The British Dental Association reported in 2016 that 72% of 15-year-olds in Northern Ireland have dental decay. That figure compared to 44% in England and 63% in Wales.

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Teeth naturally have limited regenerative abilities. They can produce a thin band of dentine, the layer just below the enamel, if the inner dental pulp becomes exposed, but this cannot repair a large cavity.

The research findings, to be presented later this week at the British Society for Oral and Dental Research annual conference, show that aspirin can enhance the function of those stem cells, thus helping self-repair by regenerating lost tooth structure.

The researchers collated large amounts of previous research data to identify aspirin as a compound that can induce the gene signature needed to generate new dentine.

 

Ibuprofen associated with blood pressure rise in arthritis patients at CVD risk

According to the European Society of Cardiology, ibuprofen is associated with increased blood pressure and hypertension compared to celecoxib in patients with osteoarthritis or rheumatoid arthritis and increased risk of cardiovascular disease.

Nonsteroidal anti-inflammatory drugs (NSAIDs), both non-selective and selective cyclooxygenase-2 (COX-2) inhibitors, are among the most widely prescribed drugs worldwide, but are now linked with increased blood pressure and adverse cardiovascular events.

NSAID labels include warnings about potential increases in blood pressure but there is little data on the effects of individual drugs. Maintaining or achieving blood pressure control in patients with arthritis and concomitant hypertension could avoid more than 70,000 deaths from stroke and 60,000 deaths from coronary heart disease each year.

The study which found the results, PRECISION-ABPM, was a prospective, double blind, randomised, non-inferiority cardiovascular safety trial. It was conducted at 60 sites in the US and included 444 patients, of whom 408 (92%) had osteoarthritis and 36 (8%) had rheumatoid arthritis. All patients had evidence of, or were at increased risk for, coronary artery disease.

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Patients were randomised in a 1:1:1 fashion to receive celecoxib (100–200mg twice a day), ibuprofen (600–800mg three times a day), or naproxen (375–500mg twice a day) with matching placebos.

Principal investigator Prof Frank Ruschitzka, professor of cardiology and co-head, Department of Cardiology, University Heart Centre, Zurich, Switzerland, said: “PRECISION-ABPM showed differential blood pressure effects between the different NSAIDs, ibuprofen and naproxen, and the COX-2 inhibitor celecoxib. While celecoxib and naproxen produced either a slight decrease (celecoxib) or a relatively small increase (naproxen) in blood pressure, ibuprofen was associated with a significant increase in ambulatory systolic blood pressure of more than 3mmHg.”

“Patients receiving ibuprofen had a 61% higher incidence of de novo hypertension compared to those receiving celecoxib,” Prof Ruschitzka continued.

These results support and extend the findings of the PRECISION trial, demonstrating non-inferiority for the primary cardiovascular outcomes for moderate doses of celecoxib compared with naproxen or ibuprofen.

HIV / AIDS home test kits seized over potential false results

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has seized 114 Hightop HIV/AIDS Home Test Kits, which could be potentially misleading in providing false results. The agency has advised that anyone who has used the kit should seek a further HIV test at a local sexual health clinic or through a GP.

A statement issued by the MHRA stated: “All UK based stock of Hightop HIV/AIDS Home Test Kit have been seized by MHRA and all sales of the product into the UK market have been stopped by the manufacturer”

The statement continued: “The HIV kits, manufactured by Qingdao Hightop Biotech Co Ltd, do not have a valid CE mark which means the product has not met a number of regulatory requirements concerning test performance, labelling and instructions for use.”

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Self-testing kits for HIV became legal in the UK from 6 April 2014, but buyers have always been warned to carefully check the CE mark before purchasing any kit. Self-test kit users who purchase kits online or from the high street should know what they are buying is safe and reliable. MHRA is currently investigating the issue with experts at Public Health England.

John Wilkinson, MHRA’s director of devices commented: “If you are concerned you may have used an unreliable test kit, speak to your GP, sexual health clinic, pharmacist or other healthcare professional”. He further added: “Make sure the kit has a CE mark and clearly states that it is intended for home self-testing. Don’t use a test kit if it’s damaged or the seal is broken.”

MHRA strongly suggests consumers should only buy a self-test kit from a reputable source, such as an online pharmacy registered with the MHRA. In the UK, online pharmacies must be registered with the MHRA and display the European common logo on every page of their website. While home self-test kits for HIV and STIs have many benefits, including letting people test in their own space and on their own terms, there’s equal concern surrounding their use.

According to recent surveys there are more than 100,000 people living with HIV in the UK and around a quarter of them don’t know they’re HIV positive.

Smartphone app may help older adults manage serious mental illness and chronic health conditions

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The use of new technologies in geriatric psychiatry shows promise for advancing personalised medicine and improving patient care. A new study in The American Journal of Geriatric Psychiatry describes the successful adaptation of an integrated medical and psychiatric self-management intervention to a smartphone application for middle-aged and older adults with serious mental illness.

Care of middle-aged and older patients with serious mental illness can be difficult. Often these patients suffer from other medical conditions and are at increased risk of premature death. In order to help patients cope with their illness, researchers from Dartmouth developed a smartphone-based intervention using adaptive systems engineering framework and principles of user-centred design.BJHC_elderlylady_mobile_mini_0_8

“The use of mobile health interventions by adults with serious mental illness is a promising approach that has been shown to be highly feasible and acceptable,” explained lead investigator Karen L. Fortuna, PhD, of the Dartmouth Centers for Health and Aging and the Geisel School of Medicine at Dartmouth.

They found that even patients with limited technical abilities could use this app successfully. The app and intervention protocol were developed using commercially available products from Wellframe.

Following multiple design iterations, investigators tested the app’s usability and found Ten participants with serious mental illness and other chronic health conditions reported a high level of usability and satisfaction with the smartphone application.

The app takes patients through 10 sessions over a period of around three months, covering topics such as stress vulnerability and illness, medication adherence and strategies, and substance and medication abuse. Physicians can remotely monitor app use, and intervene when problems are detected, facilitating telemedicine for less accessible populations.

This study is part of a special issue of The American Journal of Geriatric Psychiatry that captures an important moment in the evolving relationship between technology and the clinical care of

 

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

 

 

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.