Flu Cases on Upswing as New Medicine Arrives

Jan. 7, 2019 — As predictable as post-holiday bills and weight loss resolutions, flu activity is on the rise in the U.S., the CDC reports.
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Slideshow: Foods for the Flu

For the week ending Dec. 29, 2018, 19 states and New York City reported high flu activity, compared to 9 states and New York City the previous week. More than 1,000 lab-confirmed cases of influenza-related hospitalizations have been reported, and as of Dec. 29, 13 children have died of flu this season.

Experts hesitate to predict how bad a flu season will be, but they say several points are worth noting about year’s flu season:

A new drug to treat flu, Xofluza, is now available to pharmacies nationwide. It joins Tamiflu, the most commonly prescribed treatment.
It’s not too late to get a flu shot.
While symptoms can make you miserable, preventing complications is most important.

New Drug on the Block

Xofluza (baloxavir marboxil) was approved by the FDA in late October and treats flu symptoms, says Andrew Villani, a spokesperson for Genentech, which distributes the prescription medicine. However, when WebMD checked six pharmacies last week, just one had it in stock, although all offered to order it.

Xofluza is a single dose oral medication, and like other medicines for flu, needs to be taken quickly after symptoms start. The ideal window, doctors say, is to start it within 48 hours after symptoms begin.

Xofluza is approved for people 12 years old and older, based on results of a study that pitted the drug against a placebo. The study found the median time to symptoms improving was 54 hours on the drug and 80 hours on placebo, Villani says. “Xofluza helps you recover from the symptoms of the flu in just over 2 days,” he says.

Xofluza Availability

In a telephone spot check of major drug chains in Los Angeles, Chicago, New York City, Minneapolis, Atlanta, and Kankakee, Il., only the Minneapolis drug store had it in stock.

Staff at the other stores said they could order it, giving various timelines about how long it would take to get it in.
Old Standbys

Tamiflu has been on the market since 1999. In 2016, a generic version was approved. It comes in pill or liquid form and can be taken by people 14 days old and older.

It is typically taken twice daily for 5 days. (It can also be prescribed to prevent flu; that regimen is once a day for 7 days.) Besides Tamiflu and Xofluza, the FDA has approved zanamivir (Relenza) to treat flu in people 7 years old and older. A powder that is inhaled, it is usually taken twice daily for 5 days.

Another drug, peramivir (Rapivab), is given in a vein by a health care professional. The FDA approved it for people 2 years old and older. The one-time dose usually takes less than 30 minutes to administer.

More on Tamiflu, Xofluza

Advocates of Xofluza mention the convenience of the single dose vs. 5 days’ worth of Tamiflu doses. While the drugs require different doses and work differently, they have the same result, according to William Schaffner, MD, medical director of the National Foundation for Infectious Diseases. Both interfere with the flu virus’ ability to reproduce and multiply, he says.
Facts About the Flu Vaccine

No studies have looked at head-to-head comparisons of Xofluza and Tamiflu, says Villani of Genentech, which also markets Tamiflu.

The CDC does not recommend Xofluza for pregnant women or breastfeeding mothers, and it’s also not recommended for flu prevention or patients in the hospital.

Patients don’t seem to know about the newer drug, says Lisa Dabby, MD, an emergency medicine doctor at the UCLA Medical Center in Santa Monica, CA. “Not one person has asked me to prescribe it,” she says of Xofluza. “People know Tamiflu and they ask for it.”

If someone did request the new drug, she would consider prescribing it, she says, but first would want to be sure local pharmacies are stocking it to save patients frustration in finding it. And she reminds them: “These antivirals are not the be-all, end-alls.” They shorten how long symptoms last, but they don’t make them disappear instantly, she reminds patients.

As for side effects, patients on these antivirals most often complain of diarrhea and nausea, she says. Others report headache and common cold symptoms.

In kids, Tamiflu has been linked with some psychiatric side effects, such as irritability and occasional seizures. Those reports have caused some pediatricians to hesitate to prescribe it, Schaffner says. But those symptoms go away once the drug is stopped.
Tamiflu, Xofluza Costs

On a wholesale level, the cost of Xofluza is about $150 and of Tamiflu about $152, Villani says.

Insurance coverage and copays for these two drugs vary. But those who have commercial insurance that covers Xofluza can use a coupon available on the drug’s website and ”may pay as little as $30,” he says. Those without insurance may reduce their costs for it by about $60, with a net cost of about $90, he says.

The generic version of Tamiflu is sold online, without insurance, for about $50.

More Stats on the Flu Season

Usually, flu activity peaks from December through February, the CDC says, and February has been the most common peak month in the past 36 years.

This year, the circulating viruses are predominantly influenza A (H1N1)pdm09 and H3N2, with influenza B viruses also circulating, the CDC says.

The H1N1 viruses have been most prevalent in the United States, but the influenza A (H3) has been most common in the southeastern U.S., the CDC says.

And some good news: Most of the circulating viruses analyzed are similar to the viruses in this season’s vaccine.

Focusing on Complications, Risks

While patients with the flu are eager to feel better and get back to work or family responsibilities, doctors are focused on more than that, Schaffner says. “The main thing we want to do is prevent the serious complications of influenza.”

These include pneumonia, inflammation of the heart, and organ failure. Those at high risk of flu complications include anyone 65 and older, children younger than 5, pregnant women and women who have delivered a baby within the past 2 weeks, Native Americans, Alaska Natives, and nursing home or long-term care home residents. In addition, anyone with health conditions such as asthma, sickle cell disease, lung or heart disease, diabetes, kidney or liver problems, the very obese (BMI of 40 or more), immune system issues such as HIV, or cancer is at high risk of getting complications.

When his patients come back for a follow-up visit after getting through the flu, griping about time off work or flu misery in general, Schaffner says he often tells them: “I’m glad you are [still] here to complain.”

Left brain vs. right brain: How does one dominate?

The two hemispheres of our brain — left and right — specialize in different tasks. A recent study asks how this occurs and reaches a surprising conclusion.

Hemispheric dominance, also known as lateralization of brain function, describes the tendency for either the left or the right side of the brain to carry out specific brain activities.

Even though both sides of the brain are almost identical, one hemisphere primarily carries out some functions over others.

For instance, the left hemisphere houses brain regions linked to speech (or the right hemisphere in left-handed people).

Previously, scientists thought humans were the only creatures to exhibit this phenomenon. However, recent research has found lateralized brain function throughout the animal kingdom — from insects, such as honeybees, to aquatic mammals, including killer whales.

The corpus callosum — a thick tract of nerve cells, known as commissural fibers — connects the two hemispheres. Exactly how dominance is produced remains uncertain.

Recently, researchers from Ruhr-Universität Bochum in Germany set out to investigate this question. They chose to study the visual system of pigeons, and they have published their findings in the journal Cell Reports.

Bird brains and old ideas

Previously, scientists have theorized that one side of the brain simply inhibits the other, allowing it to take dominance.

Co-lead author Prof. Onur Güntürkün explains that “[i]n the past, it had been assumed that the dominant hemisphere transmits inhibitory signals to the other hemisphere via the commissures, thus suppressing specific functions in that region.”

In effect, the dominant hemisphere is thought to overpower its neighbor. However, scientists have also noted that excitatory messages run both ways, so there must be more to this interaction.

The researchers decided to use a pigeon model because other studies have described hemispheric dominance in this species in some detail over recent years.

For instance, in pigeon brains, the left hemisphere takes the lead when it comes to visual processing of patterns and colors. Conversely, the right brain more often deals with social or emotionally charged stimuli.

The scientists trained the birds to perform a color differentiation task. In particular, this challenge involves part of the brain that uses visual information to guide motor activity. In this type of task, the left side of the brain is dominant.

To understand how cross-talk between hemispheres influences dominance, Prof. Güntürkün and co-author Dr. Qian Xiao intermittently switched off some of the neurons that run between the two sides of the brain.

Interfering in cross-talk

After blocking specific neurons running from one side, they would observe the activity of the neurons that usually receive their input on the opposite side. In this way, they could pick apart the way in which the dominant hemisphere exerts its control.

The researchers showed that, rather than merely inhibiting the right side of the brain during this task, the left brain could delay the response of the right brain, so preventing it from getting involved.

As Prof. Güntürkün explains, “The right hemisphere simply acts too late to control the response.”

Rather than merely inhibiting the response, the right brain still operates, but its signals are too late to the party to make a difference to the bird’s behavior.

“These results show that hemispheric dominance is based on a sophisticated mechanism. It does not hinge on one general inhibitory or excitatory influence; rather it is caused by minute temporal delays in the activity of nerve cells in the other hemisphere.”

Prof. Onur Güntürkün

The findings provide an entirely new way to look at hemispheric dominance. Research is bound to continue into this rather peculiar phenomenon that evolution has lovingly conserved throughout many branches of life.

However, it is likely to be quite some time before we understand why dividing tasks between the hemispheres is so evolutionarily advantageous.

Just a Little Weightlifting Can Help Your Heart

By Maureen Salamon | HealthDay Reporter

TUESDAY, Nov. 27, 2018 (HealthDay News) — An hour or less of weightlifting each week might significantly cut your risk of heart attack or stroke, new research suggests.

Evaluating nearly 12,600 adults over more than a decade, scientists found that small amounts of resistance exercise weekly were linked to between 40 percent and 70 percent fewer cardiovascular events.

But doing more weightlifting didn’t reduce these risks further.

“Strength training is not just to make yourself look good to be shirtless on the beach,” said Dr. Alon Gitig, a cardiologist at Mount Sinai Riverside Medical Group in Yonkers, N.Y.

“It has definite health benefits … and seems to directly impact on cardiovascular health,” added Gitig, who wasn’t involved in the study.

Weightlifting uses muscle resistance to strengthen and build muscles. Other types of resistance exercise include pushups, sit-ups or lunges.

Study author Duck-chul Lee said, “Traditionally, weightlifting was for athletes, and that’s why I think there is less evidence on its health benefits, specifically for the heart.” Lee is an associate professor of kinesiology at Iowa State University.

“People know that running or cardio exercise is good for the cardiovascular system, but there are benefits of weightlifting on the heart that were not [previously] well-studied,” Lee added.

In research published separately, Lee and his colleagues found that less than an hour of weightlifting per week also reduced the risk for high cholesterol and metabolic syndrome, a cluster of conditions linked to diabetes. Those reports are in the journal Mayo Clinic Proceedings.

For the heart and stroke study, the researchers studied nearly 12,600 participants (average age 47) who had undergone at least two clinical examinations between 1987 and 2006. The participants self-reported their levels of resistance exercise, and follow-ups were done about five and 10 years later.

The results indicated that the benefits of resistance exercise on heart and stroke risk were independent of aerobic exercise such as walking or running, Lee said.

Compared with participants who did no resistance exercise, those who took part from one to three times and up to 59 minutes in all each week experienced a risk reduction of up to 70 percent.

The study didn’t prove that weightlifting prevents heart attack or stroke, only that an association exists, however.

“We found benefits of resistance exercise without body mass index [changes],” Lee added. “It means that even though you don’t lose weight, you can still get benefits for the heart. People believe the benefits of exercise are from losing weight, but that’s not true.”

Gitig, however, expressed caution about the findings. He said the cardiovascular benefits “seem to be a lot higher than we would expect from strength training.”

In addition, Gitig noted that most participants were male and white, coming voluntarily to the clinic where the study was held. “The question is if confounding variables made these people healthier to begin with,” he said.

Still, Gitig said he wasn’t as surprised by learning about the cardiovascular benefits linked to weightlifting as he might have been five or 10 years ago.

He and Lee agreed that easing into a weightlifting routine should be safe for anyone who’s healthy overall and doesn’t have symptoms of cardiovascular or kidney disease. If you do, check with your doctor first, they said.

“I would counsel my patients that [the research] is very eye-opening and suggests that strength exercise is definitely a good thing overall and may have more powerful benefits than previously thought,” said Gitig, also an assistant professor of medicine at Icahn School of Medicine at Mount Sinai in New York City.

And what if you don’t have access to free weights or weight-training machines? Digging in the yard and lugging heavy shopping bags provide strength-training benefits, too, Lee noted.

The study was published online recently in the journal Medicine & Science in Sports & Exercise.

How safe are probiotics?

Amid the increasing rise of probiotic use in Western society, a recent journal article asks whether we should evaluate the products’ safety with a little more scrutiny.

For millennia, humans have consumed foods rich with live bacteria.

Yogurt, for instance, dates back to at least 5000 B.C., and in Korea, kimchi — fermented vegetables — has also been consumed for thousands of years.

Today, however, live microorganisms are added to a range of products advertised as providing a wide array of medical benefits.

Creative marketing and a general fascination for gut bacteria have combined to create a huge market for probiotics.

Perhaps surprisingly, to sell a product that contains live microorganisms there is no legal requirement to provide evidence that it works or, importantly, that it is safe.

An article published this week in JAMA Internal Medicine argues that this is a dangerous state of affairs. The piece was written by Dr. Pieter A. Cohen from the Cambridge Health Alliance at the Harvard Medical School in Boston, MA.


The state of the evidence

Dr. Cohen begins by outlining the proven benefits of probiotics. For instance, Saccharomyces boulardii has been shown to help treat some types of diarrhea in children and reduce recurrence of Clostridium difficile infections in adults.

In spite of the specific cases mentioned, he argues that the strains used in foods and supplements have not been proven to benefit health and neither have they been shown to be safe.

Manufacturers claim that probiotics help maintain respiratory, cardiovascular, reproductive, and psychological health. However, Dr. Cohen writes that “[d]espite the advertised indications, there are no large, long-term clinical trials proving that probiotics offer clinical benefits for people who are already healthy.” He continues:

“Widespread use, particularly among people who are healthy, has greatly outpaced the science.”

For instance, a comprehensive review of relevant literature published earlier this year concluded that “[t]he feasibility of probiotics consumption to provide benefits in healthy adults requires further investigation.”

In other words, there may be benefits, but the evidence simply does not exist to definitively say either way.

Despite this, manufacturers are legally permitted to tell consumers that their products “support the immune system” or “boost digestive health.” Perhaps even more worryingly, they are not required to add information regarding potential adverse effects.

What are the possible dangers?

Over the years, dozens of case reports have underscored the potential hazards of probiotic supplementation. Risks include fungemia and bacteremia — the presence of fungi or bacteria in the blood, respectively.

Individuals with compromised immune systems are most at risk, including the very young and old. These organisms have evolved to infect, after all.

Because many probiotic trials do not report adverse events sufficiently, the exact scope of this problem is not known.

Aside from the risk of opportunistic infections sparked by probiotic consumption, there is the potential threat of low quality and contaminated products.

Although the United States Food and Drug Administration (FDA) have stringent safety rules for the manufacturing of supplements, these are not always followed.

According to Dr. Cohen, an inspection of 656 facilities in 2017 found “violations in more than half.” He continues:

“These violations were not trivial: Most commonly, companies had failed to establish the identity, purity, strength, or composition of their final product.”

This potential threat is brought into stark focus by the case of an 8-day-old infant who developed a fatal fungal infection following the use of a probiotic supplement that had been contaminated with fungi.

As Dr. Cohen notes, although following FDA regulations more closely would help reduce the risk of product contamination, it would still not ensure that the probiotic itself was entirely safe.

The author ends his article by calling for more stringent controls from the FDA. He writes:

“The agency should […] require manufacturers, as Canadian authorities already do, to provide the specific strain or strains, and the number of live microorganisms per serving, on every bottle of probiotic supplements.”

He also urges them to introduce extra safety testing, focusing especially on “potentially transferable antibiotic resistance genes.” As it stands, we do not know how consuming bacteria with an array of new genes might impact antibiotic resistance now or in the future.

Dr. Cohen’s take-home message is clear and concise:

“Consumers and physicians should not assume that the label on probiotic supplements provides adequate information to determine if consuming the live microorganism is worth the risk.”

CDC: Don’t Eat Any Romaine Lettuce, Throw It Out

Just in time for Thanksgiving, the CDC says don’t eat any romaine lettuce and throw it away if it’s in your house. It could cause an E. coli infection.

The CDC says stores and restaurants should also not serve or sell any until more about the outbreak is known. This investigation is ongoing and the advice will be updated as more information is available.

In this case, romaine lettuce means any kind of romaine: whole heads, hearts of romaine, and bags and boxes of precut lettuce and salad mixes that contain romaine, including baby romaine, spring mix, and Caesar salad.

If you do not know if the lettuce is romaine or whether a salad mix contains romaine, do not eat it and throw it away, the CDC says.

But don’t stop there. Wash and sanitize drawers or shelves in refrigerators where romaine was stored, the CDC warns.

Thirty-two people have been infected with the outbreak strain of Shiga toxin-producing E. coli O157:H7 in 11 states.

Illnesses began Oct. 8, and the most recent was confirmed Oct. 31. Thirteen people have been hospitalized. No deaths have been reported.

Those who became sick from this outbreak were infected with E. coli with the same DNA as the strain responsible for a 2017 outbreak.

But, the CDC says, this particular outbreak is not related to a multistate outbreak earlier this year.

Cases of rare, polio-like condition in U.S. highest since 2016

A rare, polio-like condition has sickened 116 people in the United States so far this year, the highest number of cases since 2016, the U.S. Centers for Disease Control and Prevention said on Monday.

CDC officials have said they do not know what causes acute flaccid myelitis or AFM, which affects the nervous system and triggers weakness and even paralysis in one or more limbs. The vast majority of patients are children.

In 2014, when 120 patients were diagnosed, the CDC began investigating cases of the disease, which it estimates affects one out of 1 million people in the United States.

Since 2014, the number of cases has spiked every two years in the United States. Last year, the nation had 33 confirmed cases, while in 2016 it had 149.

“It is pretty concerning that it’s going up and we still haven’t figured out specifically how to prevent this or how to treat it,” Dr. Emmanuelle Tiongson, pediatric neurologist at Children’s Hospital Los Angeles who has evaluated and treated patients with the condition, said in a phone interview.

One phenomenon researchers have observed is the illness is particularly prevalent between August and October, a period when many viruses commonly circulate, according to the CDC.

The disease could be spread through infection, which would explain why there have been clusters of cases in certain states, Tiongson said.

The CDC on Monday provided a state-by-state breakdown of cases for the first time this year.

Colorado reported 15 confirmed cases of the disease and Texas had 14, followed by Pennsylvania, Ohio, Washington state and Minnesota, which each had eight cases, according to the CDC.

States with large populations or good methods for reporting the disease are more likely to have a larger number of cases, according to the CDC.

In some patients, the partial paralysis they suffer due to the illness will be a lifelong condition, Tiongson said.

One size fits all outpatient care is ‘unfit for purpose’

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.”

U.S. regulators snip red tape for medical devices to curb opioid crisis

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.

Diabetes may begin more than 20 years before diagnosis

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.