‘Social jet lag’ linked to poorly controlled diabetes

(Reuters Health) – Diabetics with irregular sleep schedules that diverge from their internal body clocks may be at increased risk for dangerously high blood sugar, a small study suggests.

Much as jetting across time zones can force a person to wake-up, eat and work at times that conflict with their body’s idea of what time it is, so-called social jet lag happens when social pressures like work or school cause people to be active at times that conflict with their natural internal clock. In the study, researchers measured social jet lag by tracking the degree to which people followed one sleep schedule on work days and another on days off.

The study team found that diabetics who had social jet lag of more than 90 minutes tended to have higher blood sugar than their counterparts who didn’t experience as much variation in their bedtimes and wake-up times on work days and non-work days.

“A general piece of advice, not only for patients with diabetes but for everyone, is to try to live our lives in harmony with our circadian clock as much as possible,” said Andrew Coogan, senior author of the study and a researcher at the National University of Ireland, Maynooth.

“Unfortunately, for many this is very difficult,” Coogan said by email. “If we have to be at work for 8:30 a.m. and have an hour commute, then we simply have to get up at 7 a.m., although at the weekend we might not wake until after 9 a.m.”

Some previous research has linked what’s known as an evening chronotype – or a preference for being awake later at night – with an increased risk of poor blood sugar control with diabetes, researchers note in Sleep Medicine.

All of the patients in the current study had type 2 diabetes, which is associated with obesity and aging and happens when the body can’t properly use or make enough of the hormone insulin to convert blood sugar into energy.

Almost two-thirds of the patients were obese, and one in four were had severe obesity.

Half of them had lived with diabetes for at least seven years.

At the start of the study, many of the participants had poorly controlled diabetes, based on blood tests that show the percentage of hemoglobin (a molecule on red blood cells) that is coated with sugar. These so-called hemoglobin A1c levels reflect average blood sugar levels over about three months. Readings above 6.5 signal diabetes, and half of the patients in the study had readings of at least 6.9, which is considered poorly controlled blood sugar.

Although higher degrees of social jetlag, or circadian misalignment, were linked to poor blood sugar control, chronotype didn’t appear to directly impact blood sugar levels.

“Our findings suggest that this misalignment between our circadian clocks and our social schedule might be associated with more severe disease in patients with type 2 diabetes,” Coogan said.

The study wasn’t designed to prove whether or how sleep schedules or divergence from natural circadian rhythms might directly impact blood sugar in people with diabetes.

“We do not understand how this discrepancy between biological and societal time results in the adverse effects it is associated with, but suspect that the tension of social jetlag somehow weakens the circadian system,” Coogan said.

SOURCE: bit.ly/2Hxt3aC Sleep Medicine, online August 5, 2019.

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Gold nanoparticles used successfully in prostate tumour trial

Researchers at the Icahn School of Medicine, Mount Sinai, New York have reported a pilot clinical trial with a “nanoparticle-based photothermal cancer therapy” for prostate cancers. Their work with this targeted therapy is published in a study titled, “Gold nanoshell-localized photothermal ablation of prostate tumors in a clinical pilot device study,” in the latest issue of the journal Proceedings of National Academy of Science.

Art Rastinehad, DO, Associated Professor of Urology and Radiology at the Icahn School of Medicine at Mount Sinai, is leading the first clinical trial of gold nanoparticles to treat prostate cancer.

Art Rastinehad, DO, Associated Professor of Urology and Radiology at the Icahn School of Medicine at Mount Sinai, is leading the first clinical trial of gold nanoparticles to treat prostate cancer.

They write that prostate cancers are one of the commonest non-skin cancers in the United States and affects around 10 percent of all men in their lifetime. The team explained that the prostate cancer usually lie close to several important and vital lower abdominal structures such as the urethra, nerves and blood vessels and treating the cancer becomes difficult without injuring or harming these adjacent structures.

The team devised these Gold-silica nanoparticles that were designed to absorb “near-infrared light at wavelengths of high tissue transparency”. These nanoparticles were then used to provided localized treatment to the prostate cancer. They explained that this targeted therapy helped save the adjacent organs and also reduced the treatment related side effects. The authors of the study write introducing the gold nanoparticles, “Gold nanoparticles absorb light intensely, giving rise to the vivid optical coloration of stained glass windows popularized during medieval times, a property now known as collective electronic excitation or plasmon resonance.”

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They explained, “…hollow gold nanoparticles could substantially shift resonances to longer wavelengths than solid gold nanoparticles, with a resonant frequency controlled by the spherical shell dimensions.” They wrote that near-infrared nanomedicine could be used in, “probe-based imaging of tumor margin”, “remotely triggerable drug or gene delivery” etc. The most promising field where this technology could be used, they write is the “targeted photothermal cancer therapy.” They called the gold-silica nanoparticles or GSNs Auroshells.

The team wrote that these “biocompatible gold nanoparticles”. Have a special ability to absorb the light at near-infrared wavelength and turn it into heat. This localized generation of the heat helps in killing the targeted tumour cells and ultimately reduced the tumour without affecting the healthy cells. The study showed that use of these nanoparticles helped prolong the remission of the cancer patients when used alongside “magnetic resonance–ultrasound fusion imaging” that was used to locally burn away the “low-intermediate-grade tumors within the prostate.”

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The researchers wrote, “AuroLase Therapy (Nanospectra Biosciences, Inc., Houston, TX) is a focal ablation modality that relies on laser excitation of GSN to selectively target and treat focal lesions within the prostate.” In this therapy the particles collect in the solid tumor tissue where they can act. The therapy based technology is devised by Rice University by engineer and chemist Naomi Halas, PhD, and Duke University bioengineer Jennifer West, PhD. Lead author Ardeshir Rastinehad, DO, Associate Professor of Urology, and Radiology, at the Icahn School of Medicine at Mount Sinai went ahead to devise the clinical therapy that could be used in the pilot study.

For this study the team included 16 men (aged between 58 and 79 years) with diagnosis of “low- or intermediate-risk localized prostate cancer.” They were all given intravenous infusions of gold silica nanoparticles and “high-precision laser ablation”, along with “multiparametric MRI of the prostate at 48 to 72 hours.” For these patients ultrasound guided biopsies were taken from the tumours at 3 and 12 months after the therapy. Along with these targeted fusion biopsies, the patients also underwent 12 core systematic biopsy at 12 months after the therapy.

Results revealed that patients on gold silica nanoparticles showed better local ablation of the tumour (in 94 percent cases or 15 of the 16 patients). Among all the men treated, “International Prostate Symptom Score or Sexual Health Inventory for Men” scores were collected and results showed that the scores were similar in all men receiving the treatment. Overall the treatment protocol was found to be safe and feasible for men presenting with low or intermediate risk localized cancer of the prostate or cancer that has not spread to other organs. This treatment did not affect the genitourinary system of the patients and there were no serious complications.

Dr. Rastinehad said in a statement, “Gold-silica nanoshells infusion allows for a focused therapy that treats the cancer, while sparing the rest of the prostate, thus preserving a patient’s quality of life by reducing unwanted side effects, which could include erectile dysfunction and/or the leakage of urine.”

Authors wrote in conclusion, “This current pilot device study demonstrates that GSN-directed laser excitation and ablation is a safe and technically feasible procedure for the targeted destruction of prostate tumors.” Dr. Ash Tewari, Chair of the Department of Urology at the Mount Sinai Health System and the Kyung Hyun Kim, MD Professor of Urology at the Icahn School of Medicine at Mount Sinai, in a statement said, “Mount Sinai’s interventional urology program is research-driven and offers patients minimally invasive treatment therapies that improve quality of life. Dr. Rastinehad’s gold nanoparticle research shows that patients are not only benefiting from this treatment, but also experiencing minimal side effects.”

Journal reference:

Gold nanoshell-localized photothermal ablation of prostate tumors in a clinical pilot device study, Ardeshir R. Rastinehad, Harry Anastos, Ethan Wajswol, Jared S. Winoker, John P. Sfakianos, Sai K. Doppalapudi, Michael R. Carrick, Cynthia J. Knauer, Bachir Taouli, Sara C. Lewis, Ashutosh K. Tewari, Jon A. Schwartz, Steven E. Canfield, Arvin K. George, Jennifer L. West, Naomi J. Halas, Proceedings of the National Academy of Sciences Aug 2019, 201906929; DOI: 10.1073/pnas.1906929116, https://www.pnas.org/content/early/2019/08/20/1906929116

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In Rural Utah, Preventing Suicide Means Meeting Gun Owners Where They Are

A gun show might not be the first place you would expect to talk about suicide prevention — especially in a place like rural northeastern Utah, where firearms are deeply embedded in the culture.

But one Friday at the Vernal Gun & Knife Show, four women stood behind a folding table for the Northeastern Counseling Center with precisely that in mind.

Amid a maze of tables displaying brightly varnished rifle stocks, shotguns and the occasional AR-15 assault-style rifle, they waited, ready to talk with show attendees.

“Lethal access to lethal means makes a difference,” said one of the women, Robin Hatch, a prevention coordinator with Northeastern Counseling for nearly 23 years.

Utah has one of the highest rates of suicide in the U.S. And from 2006 to 2015, 85% of firearm deaths in the state were suicides. According to Utah’s health department, suicide rates vary widely by location. For example, the suicide rate in this corner of Utah is 58% higher than the rest of the state.

Suicide by gun is a particular problem: The rate in rural areas is double that in urban areas, according to state officials. A major factor is the easy access to firearms in Utah — and the grim fact that suicide attempts involving guns have a higher mortality rate than by other means.

Northeastern Counseling Center prevention specialist Robin Hatch gave out gun socks screen-printed with the National Suicide Prevention Lifeline information at the Vernal Gun & Knife Show in Vernal, Utah.(Erik Neumann/KUER)

This was the first time Hatch and her colleagues at Northeastern Counseling did outreach at a gun show. As the auditorium filled with firearm sellers and hunters, the counselors stacked their folding tables with neat piles of free cable locks that thread into a gun to prevent rounds from being loaded, and water-resistant gun socks screen-printed with the National Suicide Prevention Lifeline number.

The idea behind distributing both devices is to slow a person down during a moment of crisis. “Anything that we can do to get people off track a little bit, thinking something different,” Hatch said. “We believe that will help make a difference in our suicide rates.”

Unpredictable Employment Adds Stress

Northeastern Utah is home to oil and gas fields, cattle ranches and the Uintah and Ouray Indian reservation.

Health experts say factors contributing to the area’s high suicide rates include limited access to mental health services in rural communities and the unpredictability of the ranching and oil and gas industries. The boom-bust cycles, along with physical and mental stress, take a toll on workers.

“Injuries and accidents, keeping your job, having a job tomorrow — it’s so up and down,” said Val Middleton, a former oil and gas safety instructor at Uintah Basin Technical College in Vernal. “The guys don’t eat right, typically. No exercise, hard work, long hours, no sleep. That’s what adds up. The divorce rate is high, really high. The family life is low.”

Add high gun ownership and the risks rise.

Dee Cairoli is the pastor at Roosevelt Christian Assembly in a nearby town. He also works part time as an NRA concealed-carry handgun instructor. When hosting classes, Cairoli explains how gun owners can intervene if another gun owner shows signs of a mental health crisis.

“I’ve done it a couple of times as a pastor where I’ve gone to somebody’s house and said, ‘Look, maybe you need to listen to me for a minute. I know what I’m talking about. I promise I’ll keep it in my [gun] safe, but let me have your gun.’”

Cairoli speaks with authority. When he was 15, his father killed himself with a gun.

“It was very tragic, but I never hated the gun. I never blamed the gun. I knew that it was just his desperate moment and that he had just chosen that,” Cairoli said.

He believes that personal tragedy, along with the credibility he brings as a gun user and local pastor, allows people in crisis to trust him.

Gun socks with the National Suicide Prevention Lifeline information at the Vernal Gun & Knife Show in Vernal, Utah. Utah has one of the highest rates of suicide in the U.S.(Erik Neumann/KUER)

Not Just A Rural Issue

How to talk about suicide with guns isn’t just an issue in rural Utah. It’s a topic that state Rep. Steve Eliason of Sandy, a large Salt Lake City suburb, also tackles. The Republican has sponsored legislation focused on firearms, suicide prevention and mental health services. It is personal for him, too.

“I’ve lost three extended family members to suicide. All firearm suicides. Young men,” Eliason said.

This year, he worked on bills to fund firearm safety and suicide prevention programs, supply gun locks, create new mental health treatment programs and expand crisis response in rural Utah.

Eliason describes these issues as nonpartisan, but with Utah’s proud gun culture, he’s also careful with his approach. He describes advice he got from a politically liberal friend in public health about how to bring together opposing perspectives about firearms.

“Obviously, there’s kind of two schools of thought on firearms,” he said. “Those two schools of thought, if they were circles, they would overlap into a small oval — that oval is the culture of safety. And she says, ‘I would recommend that you dwell within that oval.’ That’s what I’ve tried to do.”

That perspective led the Utah legislature to appropriate money to fund a study by the Harvard T.H. Chan School of Public Health, in consultation with the Utah Shooting Sports Council.

That study spurred discussions about the problem of firearms and suicide and formed the basis of at least one of Eliason’s 2019 bills, to expand access to gun locks.

Like Eliason’s work at the state policy level, Hatch’s suicide prevention work in her community depends on relationships and trust.

Hatch’s table at the gun show was less busy than others. But the women gave out hundreds of gun locks and gun socks over the course of the day. And attendees said having them there was a fitting way to bring up the subject of suicide and firearms.

“You need to know your community, and you need to address it in a way that your community will accept it,” Hatch said.

If you or someone you know has talked about contemplating suicide, call the National Suicide Prevention Lifeline at 1-800-273-8255, or use the online Lifeline Crisis Chat, both available 24 hours a day, seven days a week.

This story is part of a partnership that includes KUER, NPR and Kaiser Health News.

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U.S. judge rules for Sanofi in Amgen patent fight

FILE PHOTO: A logo of Sanofi is pictured during the company’s shareholder meeting in Paris, France, April 30, 2019. REUTERS/Benoit Tessier/File Photo

(Reuters) – A U.S. judge on Wednesday largely set aside a jury verdict that Amgen Inc patents on its cholesterol drug Repatha were valid, handing a victory to Regeneron Pharmaceuticals Inc and Sanofi SA (SASY.PA), which make a rival drug.

The ruling from a Wilmington, Delaware, judge was the latest reversal of fortune in a long-running lawsuit in which Amgen is seeking to stop Sanofi and Regeneron from selling their Praluent, a medicine that competes with Repatha and is intended to lower bad LDL cholesterol by blocking a protein known as PCSK9.

Reporting by Jan Wolfe; editing by Jonathan Oatis

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FDA flags serious risks with hepatitis C drugs from AbbVie, Gilead and Merck

FILE PHOTO: The headquarters of the U.S. Food and Drug Administration (FDA) is shown in Silver Spring, Maryland, November 4, 2009. REUTERS/Jason Reed/File Photo

(Reuters) – The U.S. Food and Drug Administration said on Wednesday it had identified 63 cases of worsening liver function in certain patients taking hepatitis C medicines made by drugmakers Merck & Co Inc, Gilead Sciences and AbbVie Inc.

The agency said that while the treatments are safe and effective, it had received reports of rare but serious instances of worsening liver function or failure when they were taken by patients with advanced liver disease. (reut.rs/2Zu2xoN)

Hepatitis C, a liver disease caused by a blood-borne virus, can be cured with antiviral medicines. Given this, the market for such drugs in the United States has been steadily shrinking as the impact of the disease lessens. If left untreated, the virus can cause cirrhosis or liver cancer.

The World Health Organization estimates that 71 million people suffer from chronic hepatitis C virus infection globally.

The FDA said it had received reports from submissions to the agency as well as other sources, which helped identify cases of worsening liver function, including some cases of liver failure or death in patients that used AbbVie’s Mavyret, Merck’s Zepatier and Gilead’s Vosevi.

In most patients, symptoms resolved or liver function improved after stopping the medicine, the agency said.

These medicines are not indicated for use in patients with moderate to severe liver impairment, but are safe and effective in patients with no or mild liver impairment, the FDA said.

The companies did not immediately respond to Reuters requests for comment.

Reporting by Tamara Mathias in Bengaluru; Editing by Shailesh Kuber

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Dodge Dementia With Healthy Lifestyle

News Picture: Dodge Dementia With Healthy LifestyleBy Amy Norton
HealthDay Reporter

Latest Alzheimer’s News

MONDAY, Aug. 26, 2019 (HealthDay News) — Seniors, here’s a recipe for preventing dementia: eat well, exercise and don’t smoke.

The only catch, according to a new study? If you carry genes that leave you vulnerable to the memory-robbing disease, lifestyle might not be enough.

In the study, researchers found that of over 6,300 adults aged 55 and older, those with healthy habits had a lower risk of being diagnosed with dementia over the next 15 years. That was true, at least, for people at low or intermediate risk of dementia because of their genes.

Among people who carried high-risk genes, there was no evidence that lifestyle swayed the odds of developing dementia.

The findings, published Aug. 26 in the journal Nature Medicine, support a number of past studies suggesting that heart-healthy habits may also protect the brain.

But they are at odds with some past research, too: Other studies have suggested that lifestyle choices do, in fact, make a difference for people at high genetic risk for dementia.

The reasons for the differing findings are unclear. But the age of the study participants could be a factor, according to lead researcher Dr. Silvan Licher, of Erasmus MC-University Medical Center, in Rotterdam, the Netherlands.

People in his study were about 69 years old, on average, when their lifestyle habits were measured. But it might be healthy habits earlier in life — middle-age or sooner — that are critical for countering a high genetic risk for dementia.

So, the point is not to discourage anyone from following a healthy lifestyle, Licher stressed.

“These results should not alter the message about the importance of a healthy lifestyle to lower the risk of dementia,” he said.

If anything, he added, the findings offer “an extra incentive” to adopt healthy habits now instead of later. The benefits, Licher noted, are numerous — including lower risks of heart disease and stroke.

For the study, the researchers assigned participants into groups based on the genes they carried. The investigators used two different approaches to do that. In one, they focused on the APOE gene; certain variants of that gene are linked to a relatively higher risk of Alzheimer’s disease. In the second, they considered an array of genes that have been tied to dementia risk — assigning each participant a “polygenic” score.

Licher’s team also scored the participants based on certain lifestyle and health factors: exercise habits; diet and alcohol intake; smoking; and whether they had diabetes, depression or were socially isolated.

Over the next 15 years, people with a “favorable” lifestyle score were less likely to develop dementia — if they were not at high genetic risk, the findings showed.

The difference was clear, for example, among people with low-risk APOE scores: Those with a favorable lifestyle had a much lower rate of dementia — less than 13%, versus 32% of those with an unhealthy lifestyle.

A similar pattern turned up among people at intermediate APOE risk, which the majority of study participants were.

The picture was different for people at high APOE risk. About 18% of those with a healthy lifestyle developed dementia, versus 19.5% of those with unhealthy habits.

It’s hard to know the reasons for that finding — or why it conflicts with some past studies, according to Rebecca Edelmayer, director of scientific engagement at the Alzheimer’s Association.

But she agreed that the message about lifestyle remains unchanged. “We have a body of evidence suggesting that adopting a healthy lifestyle is not only good for cardiovascular health, but for brain health, too,” Edelmayer said.

Ultimately, she added, it will take clinical trials to get more solid answers.

The Alzheimer’s Association is currently funding a trial, called U.S. Pointer, which is testing a combination of measures — including exercise, mental stimulation, and better control of blood pressure and diabetes. It’s looking at whether those steps can help prevent mental decline in older adults believed to be at increased risk.

It would be much harder to run a similar trial in middle-aged adults — since it would take many years to see any effects, Edelmayer noted. But in general, she said, it’s thought that people stand to benefit the most by making healthy changes as early as possible.

“It’s never too early to start,” she said.

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SOURCES: Silvan Licher, M.D., Ph.D. candidate, department of epidemiology, Erasmus MC-University Medical Center, Rotterdam, the Netherlands; Rebecca Edelmayer, Ph.D., director, scientific engagement, Alzheimer’s Association, Chicago; Aug. 26, 2019, Nature Medicine, online


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One of the first symptoms of Alzheimer’s disease is __________________.
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Gold nanoparticles shown to safely, effectively ablate low- to intermediate-grade prostate tumors

Biocompatible gold nanoparticles designed to convert near-infrared light to heat have been shown to safely and effectively ablate low- to intermediate-grade tumors within the prostate, according to a study conducted at the Icahn School of Medicine and published in the journal Proceedings of the National Academy of Sciences. This treatment could offer patients a targeted therapy option that would preserve critical structures within the prostate, thus avoiding side effects associated with whole-gland treatment such as prostatectomies.

Prostate cancer is the second leading cause of cancer deaths in men in the United States?11 percent of men will be diagnosed with the disease in their lifetime. Removal or other whole-gland treatment of the prostate carries risks of urinary incontinence and erectile dysfunction. However, technological advances have provided clinicians with options for focal therapies with fewer complications.

In this study, researchers tested the effectiveness of AuroLase® Therapy, a treatment from medical device company Nanospectra Biosciences that is based on technology invented at Rice University by engineer and chemist Naomi Halas, PhD, and Duke University bioengineer Jennifer West, PhD. The Principal Investigator and lead author, Ardeshir Rastinehad, DO, Associate Professor of Urology, and Radiology, at the Icahn School of Medicine at Mount Sinai, invented the technique used in the clinical trial to target and treat the prostate cancer cells using a custom-built MR US fusion guided platform in collaboration with Philips Healthcare.

AuroLase® uses gold-silica nanoshells (GSN), particles Dr. Halas invented that are composed of a silica core and a gold shell with a diameter of 150 nanometers. AuroShells® are designed to absorb energy from near-infrared light and convert it to heat, resulting in selective hyperthermic cell death, without affecting adjacent non-tumorous tissue. The treatment was effectively demonstrated in previous cell studies and animal models. Following treatment, the particles are cleared through the liver, while some remain sequestered in the liver and spleen. There are no known side effects.

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Sixteen men aged 58 to 79 with low- to intermediate-grade prostate cancer (Gleason score of 4+3) received GSN infusion. All were diagnosed and treated at The Mount Sinai Hospital using a targeted biopsy technique called magnetic resonance-ultrasound fusion imaging, which uses MRI technology to extract a tissue sample directly from the tumor. Patients underwent GSN infusion and high-precision laser ablation, and received an MRI of the prostate 48-72 hours after the procedure, MRI-targeted fusion biopsies at 3 and 12 months, and a standard biopsy at 12 months. Patients were discharged on the same day as the procedure after several hours of monitoring.

GSN-mediated focal laser ablation was successful in 87.5 percent of lesions treated at one year of follow-up. The goal of researchers was to find an eradication of cancer cells during biopsy.

Gold-silica nanoshells infusion allows for a focused therapy that treats the cancer, while sparing the rest of the prostate, thus preserving a patient’s quality of life by reducing unwanted side effects, which could include erectile dysfunction and/or the leakage of urine.”

Ardeshir Rastinehad, DO, Associate Professor of Urology, and Radiology, at the Icahn School of Medicine at Mount Sinai

“Mount Sinai’s interventional urology program is research-driven and offers patients minimally invasive treatment therapies that improve quality of life,” said Ash Tewari, MBBS, MCh, Chair of the Department of Urology at the Mount Sinai Health System and the Kyung Hyun Kim, MD Professor of Urology at the Icahn School of Medicine at Mount Sinai. “Dr. Rastinehad’s gold nanoparticle research shows that patients are not only benefiting from this treatment, but also experiencing minimal side effects.”

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Purdue Pharma in discussion on $10 billion-$12 billion offer to settle opioid claims: sources

(Reuters) – OxyContin maker Purdue Pharma and its owners, the Sackler family, is in discussion to settle more than 2,000 lawsuits against the company for $10 billion to $12 billion, two people familiar with the matter said on Tuesday.

FILE PHOTO: Bottles of prescription painkiller OxyContin pills, made by Purdue Pharma sit on a counter at a local pharmacy in Provo, Utah, U.S., April 25, 2017. REUTERS/George Frey/File Photo

Purdue is among several drugmakers and distributors that are facing lawsuits, seeking to hold them responsible for fueling the U.S. opioid addiction crisis, which has claimed thousands of lives.

Purdue said it was actively working with state attorneys general and other plaintiffs to reach a resolution, without specifying a settlement amount.

Representatives for Purdue and the Sackler family held discussions with cities, counties and states on the contours of the potential multibillion-dollar settlement last week in Cleveland, said a person familiar with the matter.

On Monday, an Oklahoma judge ordered Johnson & Johnson (JNJ.N) to pay $572.1 million to the state for deceptively marketing addictive painkillers.

Purdue reached a settlement in March for $270 million to resolve a similar lawsuit by the state of Oklahoma.

NBC reported that the potential deal stemmed from a confidential meeting held in Cleveland, Ohio, last week between state attorneys general, plaintiffs’ attorneys and Purdue’s lawyers.

Asked about the NBC report, Paul Hanly, a lead attorney for the cities and counties in the opioid litigation, in an e-mail to Reuters it was “made up” and “ridiculous.” He could not be immediately reached to clarify.

Attorney Mary Jo White, who represents one wing of the Sackler family in the opioid litigation, declined to comment on the reported settlement offer. A Sackler spokeswoman also declined to comment.

A representative for the state attorneys general did not immediately respond to a request for comment.

The lawsuits have accused the Stamford, Connecticut-based company of aggressively marketing prescription opioids while misleading prescribers and consumers about risks from their prolonged use.

Opioids were involved in almost 400,000 overdose deaths from 1999 to 2017, according to the U.S. Centers for Disease Control and Prevention.

About 2,500 lawsuits, most by local governments across the United States have sought to hold drugmakers and distributors liable for the crisis. Around 2,000 cases have been consolidated before a federal judge in Cleveland.

Reporting by Jessica DiNapoli and Mike Spector in New York; Ankit Ajmera in Bengaluru; Editing by Shailesh Kuber and Grant McCool

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J&J liable for $572 million in Oklahoma opioid epidemic trial; shares rise

NORMAN, Okla./BOSTON (Reuters) – An Oklahoma judge on Monday ordered Johnson & Johnson (JNJ.N) to pay $572.1 million to the state for its part in fueling an opioid epidemic by deceptively marketing addictive painkillers, a sum that was substantially less than investors had expected, driving up J&J’s shares.

The state’s attorney general had filed the lawsuit, seeking $17 billion to address the impact of the drug crisis on Oklahoma. It had been considered a bellwether for other litigation nationwide over the opioid epidemic.

“The expectation was this was going to be a $1.5 billion to $2 billion fine,” said Jared Holz, healthcare strategist for Jefferies & Co. “$572 million is a much lower number than had been feared.”

J&J said it would appeal the decision.

Shares of J&J were up 2% in extended trading following the decision, after an initial gain of more than 5%. Other drugmakers that sell opioid painkillers and are defending against similar lawsuits also rose after-hours, including Teva Pharmaceutical Industries Ltd (TEVA.TA) up 2.6%, and Endo International Plc (ENDP.O), up 1.4% higher.

Opioids were involved in almost 400,000 overdose deaths from 1999 to 2017, according to the U.S. Centers for Disease Control and Prevention. Since 2000, some 6,000 Oklahomans have died from opioid overdoses, according to the state’s lawyers.

Roughly 2,500 lawsuits have been brought by states, counties and municipalities nationally seeking to hold drugmakers responsible for opioid abuse nationwide. Oklahoma’s case was the first to go to trial. Some drugmakers have chosen to settle cases.

In holding J&J liable after a seven-week, non-jury trial, Judge Thad Balkman of Cleveland County District Court in Norman, Oklahoma, said the state proved that J&J’s misleading marketing and promotion of its Duragesic and Nucynta painkillers created a public nuisance.

“The opioid crisis is an imminent danger and menace to Oklahomans,” Balkman said.

Oklahoma wanted J&J to help it address the epidemic for the next 30 years by funding addiction treatment and prevention programs.

Balkman said in his written ruling that the award covered only one year of addressing the crisis because Oklahoma did not demonstrate the time and costs needed beyond that.

Lance Lang, a 36-year-old recovering user of opioids turned activist in Oklahoma City, said it was “short sighted” for the judge to have only ordered funding for a year. “There’s going to be people struggling with this for years,” he said in an interview.

J&J said it will ask that the award be put on hold during an appeal process that could stretch into 2021. The company also said Oklahoma failed to show that its products and activities had created a public nuisance.

“You can’t sue your way out of the opioid abuse crisis,” Sabrina Strong, a lawyer for J&J, said at a news conference after the verdict. “Everyone must come together to address this. But J&J did not cause the opioid crisis.”

“ACCOUNTABLE FOR DEATHS AND ADDICTIONS”

The case was brought by Oklahoma Attorney General Mike Hunter, who alleged that J&J’s marketing practices helped fuel the opioid epidemic by flooding the market with painkillers.

“Johnson & Johnson will finally be held accountable for thousands of deaths and addictions caused by their actions,” Hunter said.

The trial came after Oklahoma had resolved claims against OxyContin maker Purdue Pharma LP in March for $270 million and Teva in May for $85 million, leaving J&J as the lone defendant.

FILE PHOTO: The Johnson & Johnson logo is displayed on a screen on the floor of the New York Stock Exchange (NYSE) in New York, U.S., May 29, 2019. REUTERS/Brendan McDermid/File Photo

The verdict came as two Ohio counties prepare for a scheduled October trial before a federal judge in Cleveland. About 2,000 lawsuits out of some 2,500 filed nationwide are consolidated in the case in Cleveland.

Endo International Plc (ENDP.O) and Allergan Plc (AGN.N) last week agreed to pay $15 million to avoid going to trial in October in a case by two Ohio counties, subject to court approval.

Some plaintiffs’ lawyers have compared the opioid cases to litigation by states against the tobacco industry that led to a $246 billion settlement in 1998.

Joe Rice, a lead plaintiff’s attorney for municipalities in the federal litigation, said if the Oklahoma award were extrapolated to other states, it could mean an annual abatement cost of around $38 billion.

“It does indicate that if I’m in the pharmaceutical business, I’ve got to think long and hard about annual payments of my share of that,” he said.

The judge overseeing the federal litigation in Ohio has been pushing for a global settlement.

J&J, which is among multiple pharmaceutical companies that are defendants in the federal litigation, said it remains “open to viable options” to resolve the Ohio case, including through settlement.

During the Oklahoma trial, lawyers for the state argued that J&J carried out a years-long marketing campaign that minimized the painkillers’ addiction risks and promoted their benefits.

The lawyers called J&J an opioid “kingpin” and argued that its marketing created a public nuisance as doctors over-prescribed the drugs, leading to a surge in overdose deaths.

J&J countered that its marketing claims had scientific support and its painkillers accounted for a tiny fraction of opioids prescribed in Oklahoma. The company said in a statement that since 2008, its painkillers accounted for less than 1% of the U.S. market, including generics.

Slideshow (2 Images)

Teva said the ruling supported its rationale for settling the case before trial, and said it was preparing to defend itself in the upcoming trial in Ohio.

Purdue, which is also among the defendants in the Ohio litigation, did not immediately respond to a request for comment.

Reporting by Heide Brandes in Norman, Oklahoma, and Nate Raymond in Boston; Additional reporting by Julie Steenhuysen in Chicago and Jonathan Stempel in New York; Writing by Tom Hals; Editing by Noeleen Walder, Bill Berkrot and Leslie Adler

Our Standards:The Thomson Reuters Trust Principles.

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Deep Brain ‘Zap’ Restores Vivid Memories to Alzheimer’s Patients

News Picture: Deep Brain 'Zap' Restores Vivid Memories to Alzheimer's PatientsBy Dennis Thompson
HealthDay Reporter

Latest Alzheimer’s News

WEDNESDAY, Aug. 21, 2019 (HealthDay News) — Could a pacemaker for the brain improve the memories of people with dementia or Alzheimer’s disease?

New research suggests it might be possible one day: Electrical stimulation directed at key memory regions of the brain created intense flashbacks in some Alzheimer’s patients, including sensations of emotions, smells, taste and temperature.

In one case, a patient suddenly recalled “an entire experience of being inebriated while drinking a margarita at a resort in Aruba,” researchers said. In another, a man had a vivid flashback of feeling very full after eating sardines on his front porch two decades previously.

In fact, about half of the 42 Alzheimer’s patients in the clinical trial experienced electrically induced flashbacks from decades prior, stretching back as far as the Vietnam War era, said lead researcher Dr. Wissam Deeb, an assistant professor of neurology at the University of Florida.

“These memory recollections were very vivid for some people,” Deeb said. “They were associated with a lot of emotional content when patients remembered them, because they were memories they hadn’t even thought of for such a long time.”

Researchers cautioned that the deep brain stimulation did not create overall improvement in patients’ thinking, reasoning or memory abilities.

However, these induced memory recalls could help scientists better understand how memory works and thus lead to therapies that might improve memory in people with dementia, Deeb added.

Deep brain stimulation involves drilling a hole in the skull and running electrical leads into specific areas of the brain. This therapy already is being used to help treat the movement symptoms associated with Parkinson’s disease, most notably in actor Michael J. Fox.

For this trial, Alzheimer’s patients had electrical leads installed targeting the fornix, a brain structure that’s important for memory formation, Deeb said.

“We wanted to see if doing this type of stimulation — which is similar to a pacemaker’s stimulation — could improve memories,” Deeb said.

The stimulation did improve memories, but not in the way researchers expected.

People’s overall ability to recall memories did not improve, but 20 of the patients reported having vivid flashbacks of previous events in their lives.

“As the voltage of stimulation was increased, the intensity of the memory or the vividness of the memory was more detailed, including information about emotion, smell and taste,” Deeb said.

In one example, a 7-volt stimulation prompted a patient to recall “helping a guy find something on his property.” With an increase to 8 volts, the memory sharpened to include the presence of the man’s son. At 10 volts, the patient remembered that the event occurred at night around Halloween.

“It’s very unclear what the clinical significance is of these memory recollections, but they at least help us with understanding how memory forms and which portions of the brain seem to be related to retrieving and forming memories,” Deeb said.

Researchers now are analyzing images of the patients’ brains in detail, so they can more accurately identify the brain regions stimulated by the voltage, Deeb said. A second phase of the study is underway.

Keith Fargo, director of scientific programs and outreach at the Alzheimer’s Association, said he “definitely thinks” deep brain stimulation holds some promise for treating dementia.

“It occurs to me, given what we do know about the fornix, it’s the major output from the hippocampus and the hippocampus is where you see some of the earliest changes in Alzheimer’s disease,” said Fargo, who wasn’t part of the study. “It’s a reasonable thought to have that adding activity to the fornix might prove beneficial.

“As people get older and lose those memories from earlier and earlier in their life, this could hold some promise for holding onto those memories longer,” Fargo continued. “This would seem to indicate that the memories are still there, it’s a matter of whether the hippocampus is strong enough to stimulate the rest of the brain to find them and bring them back, to allow that kind of recall.”

But Fargo added that it’s not clear whether this sort of stimulation would better help people with Alzheimer’s or people suffering from some kind of amnesia.

“The way the brain works and the way memory works is still a mystery in many ways,” Fargo said. “It’s unpredictable what the benefits of this will be ultimately, but it is predictable there will be benefits.”

The study was published Aug. 22 in the New England Journal of Medicine.

MedicalNews
Copyright © 2019 HealthDay. All rights reserved.

SOURCES: Wissam Deeb, M.D., assistant professor, neurology, University of Florida, Gainesville; Keith Fargo, Ph.D., director, scientific programs and outreach, Alzheimer’s Association; Aug. 22, 2019, New England Journal of Medicine


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One of the first symptoms of Alzheimer’s disease is __________________.
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