Category: General Health

The ‘one size fits all,’ approach to outpatient care is no longer fit for purpose.

This is the message from the Royal College of Physicians. In a new report Outpatients: The future – Adding value through sustainability, published today, NHS England medical director, Professor Stephen Powis, says it’s time to ‘grasp the nettle’ to help reduce some of the 118 million outpatient appointments every year – many of which are unnecessary.

The report argues that the cost to patients and public health of the current approach must be considered alongside the financial cost to the NHS. Not only are patients frustrated by poor communication and long waiting times, they have to spend time and money on things like childcare and travel when attending appointments.

The RCP in its report, says the ‘one size fits all’ model should be replaced with a person-centred approach that recognises that people have varying health needs, personal pressures and abilities to self-care or manage. It calls for patients to be at the centre of a redesign process that better utilises technology already available, and says patient centred care means there should be a clear health benefit when asking people to travel to appointments, taking time off work and school.

In the foreword, Professor Powis who backs the RCP’s recommendations, says it might sometimes appear to patients that the outpatient visit has been designed in clinicians’ interests rather than their own, whereas clinicians are often just as frustrated with antiquated processes in their own clinics.

“The outpatient system is older than the NHS and the time has come to grasp the nettle and use tech and other innovations to improve patients’ experience and care. As part of the long-term plan for the NHS, it’s right we look at ways to cut unnecessary appointments, save thousands of journeys, reduce traffic and pollution and make the NHS more efficient.”

Co-author Dr Toby Hillman, clinical lead for the RCP Sustainability Programme and a consultant respiratory physician, said: “Having re-evaluated the purpose of outpatient care and aligned its objectives with modern-day living and expectations, we must ensure that the benefits are measured in terms of long-term value for patients, the population and the environment, not just short-term financial savings.”

In calling on the NHS to enlist the power of technology and innovation, Professor Powis said: “For many people, care can be delivered more timely and conveniently closer to home, by specialists at the GP surgery or by using technology in new and exciting ways. This report shows a snapshot of exciting new models already working successfully through apps, skype, text messaging and remote monitoring systems that are changing the shape of care; we need to bottle and spread those examples building a new consensus for the future based on the views of clinicians and patients.”

Laura Perryman expected her medical company, Stimwave Technologies Inc, would have to wait several years for its painkilling device to win U.S. approval as a treatment for chronic migraines.

She now thinks it could be done in months, thanks to a new initiative by the U.S. Food and Drug Administration to use medical device-based treatments, diagnostic tests and mobile medical apps to address the country’s opioid crisis.

When President Donald Trump declared a public health emergency over the abuse of heavy-duty painkillers like oxycodone and hydrocodone, he ordered all government agencies to take action in response to the death of 70,000 Americans last year from drug overdoses.

The FDA told Reuters it has received over 200 submissions from companies seeking a speedy approval process for their devices. These range from Stimwave’s Halo to painkilling products made by Abbott Laboratories and other industry heavyweights as an alternative to opioids.

“We’re pleased by the robust interest in this innovation challenge and the acknowledgement from developers about the unique and important role medical devices, including digital health technologies like mobile medical apps, have the potential to play in tackling the opioid crisis,” FDA Commissioner Scott Gottlieb said.

Perryman’s Halo devices, which look like angel hair pasta and are so small they can be injected into a nerve, took four years to get U.S. approval under other names for easing leg and back pain.

She hopes a spot on the FDA program will see Halo approved within a year as an alternative to opioids, which are currently used to treat an estimated 50 percent of patients who come to emergency rooms with migraines.

“This is kind of perfect for something like ours…since the device is shown to be safe already,” said Perryman, who founded privately-held Stimwave in South Florida seven years ago.

The FDA has been increasingly reluctant to greenlight new opioids for market but earlier this month approved a potent opioid-based painkiller from AcelRx Pharmaceuticals Inc placing tight restrictions on its distribution and use. In a rare move, Gottlieb made a public statement at the time, explaining the decision.

The regulator’s push for alternatives to opioids has helped drive interest from venture capital funds and institutional investors this year in firms promising to develop alternatives, according to interviews with device companies, financial services firms and brokerage Cowen & Co.

For example, privately-held Virpax Pharmaceuticals, which makes an aerosol spray that delivers a non-opioid pain drug, said it had four or five banks interested in running its Series A investment round this summer versus just one in the past.

STIMULATION
Abbott, like rivals Boston Scientific Corp and Nevro Corp, makes neuromodulation implants which stimulate the nervous system to mask pain signals before they reach the brain.

Abbott has submitted an entry for the competition in the hope it will slash waiting times, which often stretch several months just to get an initial meeting, according to Dr. Allen Burton, Abbott’s medical director of neuromodulation.

“Devices that are part of this (program) will be streamlined… their meeting will go to the top of the pile,” said Burton.

While neuromodulation is only a small part of Abbott’s large medical device business, the unit is seen as a growth engine for the company. Burton estimates between 10-to-20 percent of the growth Abbott has seen in its neuromodulation business could be tied to doctors prescribing its devices for pain after surgery or from injury to patients that are opioid averse.

Boston Scientific did not apply for the contest, but the company is investing “heavily” in its neuromodulation unit, which was its fastest-growing at nearly 23 percent in the latest quarter, according to Maulik Nanavaty, senior vice president at the device maker.

“We continue to make external investments in early (neuromodulation) technology,” he told Reuters.

To be sure, these devices are not seen as a silver bullet for opioid addiction. Nirad Jain, a partner at consulting firm Bain & Co, believes many of the solutions on the table are just tinkering at the edges of a problem that needs to be solved by doctors simply settling for fewer or less potent opioids.

ADDICTION
Academics and charitable groups dealing with the social fallout of the crisis say the bulk of the rise in deaths stems from misuse of prescription painkillers. That has put the onus on regulators in September to issue new rules cracking down on prescribing by doctors.

“The goal is that these guidelines will provide evidence-based information on the proper number of opioid doses that should be dispensed,” Gottlieb said in a statement at the time.

“Our goal is to help prevent patients from becoming addicted by decreasing unnecessary or inappropriate exposure to opioids.”

Although the FDA contest is limited to devices and app-based solutions for pain and addiction, the current regulatory climate is also conducive to companies developing opioid-alternative pharmaceuticals.

Drugmakers including Pfizer Inc, Eli Lilly and Co, Regeneron Pharmaceuticals Inc and Teva Pharmaceutical Industries Inc have been packing their pipelines with potential solutions to the crisis and there are 120 non-opioid drugs under FDA review this year, up some 650 percent since 2013, according to business intelligence firm Informa.

Privately-held SPR Therapeutics Inc told Reuters it has entered its “temporary” neuromodulation device in the contest. Similarly to Stimwave’s, its product is implanted into the body but can be surgically removed after about two months. Josh Boggs, a senior executive at the company, expects to get quicker feedback from the FDA and shorter review times in the wake of the crisis.

After years in the business, he believes the crisis has increased the agency’s desire to collaborate with medical technology companies like his.

“I feel like (FDA) people are coming well prepared to meetings and are very engaged in it. It feels like an atmosphere that’s conducive to finding a solution,” he said.

Early signs of type 2 diabetes can be identified more than 20 years before diagnosis, according to new research presented at this year’s European Association for the Study of Diabetes (EASD) Annual Meeting in Berlin, Germany (1-5 October).

The Japanese study tracked over 27,000 non-diabetic adults (average age 49 years) between 2005 and 2016 and found that increased fasting glucose, higher body mass index (BMI) and impaired insulin sensitivity were detectable up to 10 years before the diagnosis of diabetes as well as prediabetes.

“As the vast majority of people with type 2 diabetes go through the stage of prediabetes, our findings suggest that elevated metabolic markers for diabetes are detectable more than 20 years before its diagnosis,” says Dr Hiroyuki Sagesaka from Aizawa Hospital in Matsumoto, Japan who led the research, along with Professor Mitsuhisa Komatsu, Shinshu University Graduate School of Medicine, Matsumoto, Japan and colleagues.

Previous research suggests that risk factors like obesity and elevated fasting glucose may be present up to 10 years before someone is diagnosed with diabetes. However, the time point at which individuals who go on to develop diabetes and those who don’t first become substantially different from each other was not known until now.

Sagesaka and colleagues assessed the trajectories of fasting blood glucose, BMI, and insulin sensitivity in individuals who developed diabetes and prediabetes separately. At the start of the study, 27,392 non-diabetic individuals had a fasting glucose and average blood glucose (HbA1c) measured and were followed until a diagnosis of type 2 diabetes or prediabetes, or the end of 2016, whichever came first.

Over the study period, 1067 new type 2 diabetes cases were identified. Findings showed that on average, several risk factors were more common among individuals who went on to develop type 2 diabetes compared with those who didn’t. In particular, BMI, fasting glucose, and insulin resistance were increased up to 10 years before diagnosis, and these differences widened over time.

For example, mean fasting glucose: 10 years before diagnosis — 101.5 mg/dL developed diabetes vs 94.5 mg/dL those who didn’t; 5 years before diagnosis — 105 mg/dL vs 94 mg/dL; and 1 year before — 110 mg/dL vs 94 mg/dL.

Of 15,778 individuals with normal blood glucose at the initial health exam, 4781 went on to develop prediabetes over the study period, and the same abnormalities, although to a milder degree, were present at least 10 years before diagnosis of prediabetes.

The research has important implications given that an estimated 425 million adults (aged 20-79 years) were living with diabetes in 2017, and this is predicted to rise to 629 million by 2045.

“Because trials of prevention in people with prediabetes seem to be less successful over long term follow up, we may need to intervene much earlier than the prediabetes stage to prevent progression to full blown diabetes. A much earlier intervention trail, either drug or lifestyle related, is warranted,” says Dr Sagesaka.

This is an observational study, so no firm conclusions can be drawn about cause and effect, and the authors point to several limitations including that the length of time between diagnosis of prediabetes and diabetes is not known, so the entire timeline of diabetes evolution remains to be clarified.