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Wednesday, September 19, 2018

Opioid crisis grows among seniors


Against the backdrop of an unrelenting opioid crisis, two new government reports warn that America’s seniors are succumbing to the pitfalls of prescription painkillers.
Issued by the Agency for Healthcare Research and Quality (AHRQ), the reports reveal that millions of older Americans are now filling prescriptions for many different opioid medications at the same time, while hundreds of thousands are winding up in the hospital with opioid-related complications.
“These reports underscore the growing and under-recognized concerns with opioid use disorder in older populations, including those who suffer from chronic pain and are at risk for adverse events from opioids,” said Dr. Arlene Bierman. She is the director of AHRQ’s Center for Evidence and Practice.
Bierman was part of a team that focused on trends regarding opioid-related hospitalizations and emergency department visits among U.S. seniors.
The agency’s second report analyzed opioid prescription patterns among older Americans.
Bierman and her colleagues pointed out that chronic pain is common among seniors, as eight in 10 struggle with multiple health conditions, including heart disease, diabetes, arthritis and depression.
To cope, many seniors take opioids, which inevitably raises the risk for side effects and negative drug interactions.
And in fact, the team found, opioid-driven complications were the cause for nearly 125,000 hospitalizations — and more than 36,000 emergency department visits — among seniors in 2015.
The report also uncovered other alarming trends. Between 2010 and 2015, there was a 34 percent jump in the number of opioid-related inpatient hospital admissions among seniors, even as non-opioid-related inpatient hospitalizations dropped by 17 percent.
Similarly, AHRQ investigators found that opioid-related emergency department visits among seniors shot up by 74 percent, while non-opioid related emergency department visits only increased 17 percent.
At the same time, AHRQ’s second report found that nearly 20 percent of seniors filled at least one opioid prescription between 2015 and 2016, equal to about 10 million seniors. And more than 7 percent — or about 4 million seniors — filled prescriptions for four or more opioids, which was characterized as “frequent” use.
Frequent use was found to be notably more common among seniors who were either poor or low-income, insured through Medicare or another form of public insurance, and/or residents of rural areas.
Opioid use also went up dramatically depending on a person’s perceived health status. For example, only 9 percent of seniors in “excellent” health filled out opioid prescriptions, compared with nearly 30 percent in “fair” health and 40 percent in “poor” health.
The challenge, said Bierman, “is safe-prescribing for those who need opioids for pain, while avoiding overuse or misuse.”
Clinicians, she advised, could address that concern “by using non-opioid pain medications and non-pharmacologic treatments before considering the use of opioids.” And she suggested that if and when opioids are needed, “the lowest possible dose should be used.”
Dr. Anita Everett is chief medical officer for the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA). She said that the findings shouldn’t come as a surprise.
“As a society, we don’t typically think of persons in the grandparent generation as having opioid use disorder,” she said. But when common chronic pain is paired with “the generation of physicians that were taught that opioid medication, when used for pain, was not likely to become addictive,” the result is a senior citizen opioid problem.
And, Everett said, the problem is likely more acute among the rural and the poor, who “often are in situations wherein they have fewer resources, less alternative treatments and may not know about the chances of becoming addicted to a prescription medication.”
Shame, stigma and social isolation among older people may also complicate efforts to prevent addiction or tackle it when it occurs, she added.
The solution? Everett suggested that caregivers have to be educated about the risk.
“SAMHSA supports early training for all health professionals so that addiction can be avoided, identified and treatment offered as early as possible,” she said.
More information
There’s more on opioid treatment among seniors at SAMHSA.
SOURCES: Arlene Bierman, M.D., M.S. director, Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, Rockville, Md.; Anita Everett, M.D., chief medical officer, Substance Abuse and Mental Health Services Administration, Rockville, Md.; September 2018, Agency for Healthcare Research and Quality, reports

1 in 6 Americans Over 40 Has Been Knocked Unconscious: Study


 Brain injury research typically focuses on football players and military veterans, but a new study suggests head injuries are far more widespread than estimated.
About 1 in every 6 U.S. adults — roughly 23 million people aged 40 or older — have been knocked out by a head injury, researchers report.
“Those numbers are huge,” said lead researcher Dr. Andrea Schneider, a neurologist with Johns Hopkins University in Baltimore. “Head injury in the United States is much more common than we thought.”
Further, these head injuries are associated with neurological and psychological problems such as depression, sleep disorders, stroke and alcoholism, the researchers found.
For this study, Schneider and her colleagues relied on data gathered by the National Health and Nutrition Examination Survey, which is conducted by the U.S. Centers for Disease Control and Prevention.
The data showed that nearly 16 percent of U.S. adults aged 40 and older answered yes to the question, “Have you ever had loss of consciousness because of a head injury?”
Men were nearly twice as likely to have answered yes, about 20 percent compared with 12 percent among women.
This could be because men are more involved in careers and pastimes with an increased risk of head injury, such as military service or contact sports, Schneider said.
People who reported a head injury that knocked them out were 54 percent more likely to have a sleep disorder, 68 percent more likely to have had a stroke, twice as likely to be a heavy drinker, and more than twice as likely to have symptoms of depression.
However, researchers can’t say from this data which way the relationship runs between head injury and these health problems, Schneider said.
It could be that depression or sleeplessness or heavy drinking make you more likely to suffer a head injury. It also could be that a head injury increases your risk to subsequently suffer from these problems.
“More prospective studies are needed to look into the directionality of these relationships,” Schneider said.
Kristen Dams-O’Connor, co-director of the Brain Injury Research Center of Mount Sinai in New York City, suspects the relationship runs both ways. Head injuries are prompted by these neurological and psychological problems, but the injuries also can either cause new problems or make existing problems worse.
“We may be talking about people who are associated with previous risk factors, and you’ve now got a traumatic brain injury overlaid upon whatever they were suffering before,” said Dams-O’Connor, who wasn’t involved with the study.
She believes the number of people who’ve suffered a brain injury is even higher than found here.
“I think the numbers are impressive. The numbers are staggering. They certainly support the notion that we need to learn a heck of a lot more about how to prevent this injury,” Dams-O’Connor said. “But at the end of the day, I think this is definitely an undercount.”
The single question used in this survey does not capture all of the potential scenarios in which a traumatic brain injury could occur, Dams-O’Connor explained.
For example, the survey question would not reflect people who were dazed or confused by a blow to the head that did not cause them to lose consciousness, she said.
“That would meet the criteria for a mild traumatic brain injury, and none of those people are even included in this estimate,” Dams-O’Connor noted.
It’s unknown whether these 23 million or more people are at increased risk for neurological problems like dementia or Parkinson’s disease down the road, Dams-O’Connor added.
It’s widely suspected that one traumatic brain injury (TBI) doesn’t result in the kind of long-term damage caused by repeated brain injuries, she said.
“A substantial number of people sustain a TBI that heals and they return to their normal,” Dams-O’Connor said. “These are the lucky ones who go back to their baseline and they don’t have long-term symptoms that don’t go away. Overall, most people who survive a brain injury are not going to develop these terrible outcomes.”
The findings appear in a letter published Sept. 19 in the New England Journal of Medicine.
More information
There’s more from the U.S. National Institutes of Health about traumatic brain injury.
SOURCES: Andrea Schneider, M.D., Ph.D., neurologist, Johns Hopkins University, Baltimore; Kristen Dams-O’Connor, Ph.D., co-director, Brain Injury Research Center of Mount Sinai, New York City; Sept. 19, 2018, New England Journal of Medicine

Adverum gets FDA fast track for macular degeneration gene therapy


Adverum Biotechnologies announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ADVM-022. ADVM-022 is a novel gene therapy candidate for the treatment of wet age-related macular degeneration (wAMD). A Fast Track designation is intended to facilitate the development and expedite the review of drugs and biologics to treat serious conditions and fill unmet medical needs. The designation enables more frequent communication with the FDA throughout a product candidate’s development and review process. The designation also provides eligibility for Priority Review and Accelerated Approval, which may potentially result in a shorter FDA review process.
https://thefly.com/landingPageNews.php?id=2792831

Fitbit launches connected healthcare platform for insurers, employers


Fitbit launched a new connected health platform for insurance plans, employers and health systems, combining coaching, virtual care and personalized digital interventions.
Through its apps and wearable activity trackers, Fitbit aims to guide plan participants toward goals in weight management and tobacco cessation—as well as through the management of conditions including diabetes, hypertension, depression, chronic obstructive pulmonary disease and congestive heart failure.
The system, Fitbit Care, follows the company’s acquisition of health coaching company Twine Health earlier this year. A spinout from MIT’s Media Lab, Twine carried data from some small trials that showed digital approaches could help lower blood pressure and average blood sugar levels.
“Supporting patients beyond the walls of the doctor’s office is one of the most important things we can do to drive successful outcomes, and as a clinician I see great potential for Fitbit Care to help tackle some of the biggest challenges in healthcare and improve health outcomes at scale,” John Moore, M.D., Ph.D., Fitbit Health Solutions’ medical director, said in a statement.
Alongside the launch, Fitbit revealed that health insurance giant Humana will use the platform as the preferred coaching solution for its employer group plans, with its more than 5 million members gaining access through the Humana Employee Assistance Program and other avenues.
A 2015 study of Humana associates enrolled in Go365, the company’s rewards program, found that members who were actively engaged over three years had lower average claim costs and absenteeism rates. Since the companies partnered in 2013, members have used their health rewards points to redeem more than 170,000 Fitbit devices, the companies said.
The move comes as Fitbit looks to broaden its base beyond direct-to-consumer product sales. The new bundled subscription offering is aimed at the company’s more than 1,600 enterprise health customers, as well as over 100 health plans, according to Adam Pellegrini, general manager of Fitbit Health Solutions.
With a user’s consent, the Fitbit Care program will provide their real-time health data to care teams for more personalized recommendations, including guided workouts and motivations to make more healthy decisions as well as other interventions.
Coaches will be able to work with participants and providers through the new Fitbit Plus app, as well as over the phone and in person. The app will also support integration of health metrics including blood glucose, blood pressure and medication adherence, as well as data from third-party devices, the company said.

U.K. court invalidates Gilead’s Truvada patent extension, allowing PrEP generics


Activists in the U.S. are asking authorities to break Gilead’s patents on Truvada in an effort to help end the HIV epidemic. Now, a court in the U.K. has done just that, potentially allowing for widespread use of generics as a pre-exposure prophylaxis.
The U.K.’s High Court overturned a patent extension for Truvada, meaning “that unbranded versions of the drug can be legally prescribed,” National AIDS Trust chief executive Deborah Gold said in a statement.
She added that the development “represents a huge cost saving to buying a drug that would save public money, even at full price.” National AIDS Trust is calling on NHS England to fund the medicine by April 2019, arguing that a current trial program isn’t reaching everyone at need.
A Gilead spokesperson told pharmaphorum that the company is disappointed with the decision and will appeal. Teva, Accord, Lupin and Mylan brought the patent challenge.

Truvada’s EU patent expired last year, according to the company’s annual SEC filing. Gilead secured supplementary protection certificates in several countries, which have come under legal challenges. The company’s U.S. patent expires in 2021, according to the filing. Gilead also has a patent settlement with Teva, allowing that company to launch a U.S. generic at an undisclosed date.
Gilead’s Truvada can be taken regularly as an HIV prevention tool, and activists in the U.S. recently penned a New York Times op-ed calling on the government to break Gilead’s patents to ensure equal access. Part of the activists’ “national strategy” to end the HIV epidemic includes “insisting that federal agencies use their statutory authority to break Gilead’s undeserved monopoly,” they wrote.
Less than 10% of people in the U.S. who could benefit from the drug in the PrEP setting are getting it, according to the authors.

At the time, a Gilead representative said the company is “committed to ensuring that people who are at high risk for HIV infection have access to Truvada for PrEP.” He noted that the company supports “comprehensive payer coverage” and maintains an access program for “qualified uninsured and underinsured people” in the U.S. The company also supports education programs, according to the spokesman.
Gilead this year launched a TV advertising campaign recommending viewers talk to their doctors about HIV prevention options.
Truvada brought in about $3.1 billion in sales around the world last year.

UK rejects adult Novartis CAR-T therapy, after ‘yes’ in kids


Health authorities in England have rejected a pricey CAR-T cell therapy from Novartis for adults with blood cancer, two weeks after endorsing its use in children and young people.

The National Institute for Health and Care Excellence (NICE) said Kymriah was not cost-effective for adult lymphoma. That contrasts with a green light for youngsters with aggressive leukaemia when other drugs have failed.
NICE said the Swiss drugmaker had offered a confidential discount on the list price of 282,000 pounds per patient, but this was still above the level considered to be an acceptable use of resources.
Despite the preliminary rebuttal, NICE said it welcomed “further discussions” around the cost-effectiveness of Kymriah. NICE is the body that decides if new treatments are worth using on the state health service in England and Wales.
The decision on Kymriah in adults is in line with the rejection of a rival CAR-T treatment for adult lymphoma from Gilead Sciences.
Still, Novartis said it was surprised and disappointed, adding it would work with NICE to find a way to make Kymriah available to adults.
“This relates to individuals who have already failed two previous therapies, and for the vast majority of this population, life expectancy can be counted in months rather than years,” the company said.
Kymriah and Gilead’s Yescarta are chimeric antigen receptor T-cell therapies, or CAR-Ts, which reprogramme the body’s own immune cells to attack malignant cells.
The treatments represents a new approach to fighting cancer, since the therapy involves extraction of infection-fighting cells from a patient. These cells are then genetically engineered to recognise cancer cells and infused back.
The process is complex and expensive but it offers hope for people with certain kinds of blood cancer who have exhausted all other treatment options.

SEC sues U.S. breast-implant company Sientra’s ex-CEO after stock dive


The U.S. Securities and Exchange Commission on Wednesday sued the founder and former chief executive of Sientra Inc for fraudulently concealing problems with his company’s breast and other implants as it was raising $61.4 million in a public stock offering.

Hani Zeini, 54, was accused of letting the offering close on Sept. 23, 2015, despite having learned three days earlier from the chief executive of the company’s sole supplier that European implant sales would be suspended because contamination had been detected in an audit of manufacturing procedures.
Sientra’s share price sank 52.9 percent on Sept. 24, 2015, to $9.70 from $20.58, after it disclosed that the U.K. Medicines and Healthcare Products Regulatory Agency had suspended the certificate needed for the supplier, Brazil’s Silimed, to sell the implants.
Zeini could not immediately be reached for comment, and a lawyer for him could not immediately be identified.
The SEC said Zeini had hid “damaging” details from “every other professional” working on his Santa Barbara, California-based company’s 3 million share offering, including its chief financial officer, directors, lawyers, auditors and bankers, and tried to cover his tracks after it was done.
“Zeini acted knowingly, recklessly and without reasonable care,” the complaint said.
The SEC is seeking a civil fine and an officer and director ban for Zeini. It filed its lawsuit with the U.S. District Court in Los Angeles.
Sientra settled related charges, but was not fined after providing “extensive” cooperation, the SEC said. The company did not admit or deny wrongdoing. Silimed was not charged.
The SEC did not respond to a request for comment.
According to his LinkedIn profile, Zeini is now the owner of Elissar Advisors & Investment Co in Santa Barbara. He stepped down as Sientra’s chief executive in November 2015.
Sientra announced in January 2016 that independent testing showed that its implants were safe.
Its shares traded down 39 cents at $23.76 in Wednesday afternoon trading on the Nasdaq.
The case is SEC v Zeini, U.S. District Court, Central District of California, No. 18-08103.