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Friday, April 5, 2019

FDA Warns Lab Against Marketing Tests Linking Genes, Drug Reaction

The US Food and Drug Administration (FDA) has warned Inova Genomics Laboratory over illegal marketing of MediMap pharmacogenetic tests that claim to predict patients’ response to a variety of drugs, including those used for anesthesia and to treat cancers, infections, attention-deficit/hyperactivity disorder, depression, anxiety, and diabetes.
The warning letter said the following tests are being marketed without clearance or approvals: MediMap ADHD, the MediMap Mind, the MediMap Plus, the MediMap Heart, and the MediMap Baby.
The FDA has not reviewed the safety and effectiveness of the tests, and selecting or changing drug treatment in response to results from the tests could lead to “potentially serious health consequences for patients,” the agency said in a statement.
The FDA said it knows of no data that establish that the company’s tests can help patients or healthcare providers make appropriate treatment decisions regarding the listed drugs.
“Without appropriate evaluation to determine whether these tests work, patients are being put at risk — potentially impacting treatment decisions by providing false promise that they will respond well to a certain medicine or keeping them from using therapies that may benefit them,” Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in the statement.
Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said the FDA is “committed to supporting innovation” in pharmacogenetic testing but will also be “vigilant in protecting against the potential risks and are therefore issuing this warning letter to help protect patients and providers from acting on data that has not been demonstrated to promote the safe and effective use of drugs.”
Inova Genomics, of Falls Church, Virginia, has 3 weeks to notify the FDA in writing regarding how it will address the violations. Failure to do so may result in regulatory action that could involve seizure, fines, or injunctions.
Last year, the FDA warned consumers and healthcare providers about pharmacogenetic tests being marketed directly to consumers or being offered through healthcare providers that claim to predict how a patient will respond to specific medications.
Healthcare providers are encouraged to report any adverse events related to these or other genetic tests to MedWatch, the FDA’s safety information and adverse event reporting program.

Pain clinics could help cut opioid use

Chronic non-cancer pain is sometimes managed with high-dose opioids, which has partially contributed to the current opioid epidemic. New research from pain specialists at the University of Arizona and Banner – University Medicine may provide options other than opioids for patients with non-cancer chronic pain.
“Our study shows the possible potential of  clinics in helping to reduce  use while improving pain and function in patients on opioids suffering from non-cancer ,” said senior author Dr. Mohab Ibrahim, director of the Chronic Pain Management Clinic at Banner – University Medical Center South and an associate professor in the UA departments of anesthesiology and pharmacology.
The study evaluated the role of a pain management clinic with fellowship-trained pain physicians in reducing pain and opioid use in patients with chronic non-.
Patients were asked to rate their pain on a scale of zero to 10, with results showing the average pain score decreased by almost 34 percent. The pain frequency and number of pain episodes improved. Also, the patients reported better ability to sleep, work and perform chores. Finally, the patients were able to reduce their total opioid use by about 55 percent.
The findings were published Nov. 30 in the journal Pain Physician.
In the United States, as much as $300 billion is spent each year to manage pain. Chronic pain affects 100 million Americans – more than than diabetes, heart disease and cancer combined, according to the American Academy of Pain Medicine.
Doctors at pain clinics help patients manage chronic pain and improve their quality of life using not only medications and interventional procedures, but also modalities such as physical, behavioral and psychological therapies.
“Generally speaking, our pain clinic focuses on offering all available options to get people to decrease their opioids or get them off their opioids altogether,” Ibrahim said. “Those include physical therapy, acupuncture, yoga, chiropractors, tai-chi, non-opioid medications, interventional procedures, and sometimes seeking help from our surgical collogues with whom we have excellent and close collaborations.”
Tucson has about 15 pain management clinics, including the Comprehensive Pain Management Clinic. Ibrahim’s study was retrospective and used pain data from 296 patients treated at the clinic between July 2014 and January 2016.
During clinic visits, patients filled out a form asking about changes in the intensity, frequency and duration of their pain, and their ability to fall and stay asleep, work, exercise and perform chores. The team also analyzed patients’ initial opioid use and their opioid use at the most recent visit.
The most common types of chronic pain were: headaches, migraines, neuropathic pain, arthritic pain and abdominal pain. All of the patients were treated with conventional pain-management approaches, ranging from physical therapy to medical non-opioid management to interventional procedures, depending on the patients’ needs and the clinical scenario. For example, if a patient was in severe pain, then physical therapy may not be the best first option, since he or she may not be able to actively participate in .
Ibrahim and his co-authors – lead author Dr. Amol Patwardhan, Dr. Ryan Matika, Dr. Janalee Gordon, Brian Singer and Dr. Michelle Salloum – were able to demonstrate they could decrease pain and opioids at the same time, while maintaining patient satisfaction and improving their functionality. As Ibrahim said, that is really the whole purpose of pain medicine – to improve the functionality of the patients and decrease their reliance on medications.
“We were able to decrease the pain by about 30 to 40 percent while decreasing  by 50 percent,” Ibrahim said.
From 1999 to 2013, prescriptions for opioid painkillers quadrupled, as did opioid-related deaths in the United States. In 2013, an estimated 2 million Americans misused or abused prescription opioids, according to a paper published in BioMed Central in May 2018.
Ibrahim said opioids can cause a vicious circle because once a patients’ pain is no longer controlled, physicians may increase the dosage and the patient will feel better for a while; then, the pain gets worse. This can get to the point where the patient is on such a high dose of opioids it becomes unmanageable – and that is when things can go wrong. However, Ibrahim said he does not want to generalize because some patients’ pain is very well controlled with opioids.
“You can use a hammer to drive a nail through a wall and that’s a good function of the hammer; you are using the tool in the right way. But if someone else with bad intentions gets that hammer and breaks someone’s windshield, that’s a bad use of the tool. It does not mean that the hammer is good or bad, it is just whether the person who used it had good or bad understanding of its function. Same thing with drugs,” Ibrahim explained.
As the authors state, finding nonopioid solutions to treat chronic pain is a work in progress. Much potential exists for future research in pain clinics throughout Arizona and the U.S.
“Pain is better controlled when you approach it from several angles, not just one,” Ibrahim said.

Explore further

More information: Exploring the Role of Chronic Pain Clinics: Potential for Opioid Reduction. Pain Physician. 2018 Nov. www.painphysicianjournal.com/c … MA%3D%3D&journal=114
Journal information: BioMed Central

CDC: Violence against seniors on rise, especially among men

There has been an increase in the rates of violence among older adults, especially among older men, according to research published in the April 5 issue of the U.S. Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report.
J.E. Logan, Ph.D., from the CDC in Atlanta, and colleagues analyzed rates of nonfatal assaults and homicides against  (≥60 years) during 2002 to 2016 using data from the National Electronic Injury Surveillance System-All Injury Program and the National Vital Statistics System.
The researchers observed a 75.4 percent increase in the nonfatal assault rate during the 15-year period among men (from 77.7 to 136.3 per 100,000) and a 35.4 percent increase from 2007 to 2016 among women (from 43.8 to 59.3 per 100,000). The  increased by 7.1 percent among men from 2010 to 2016; among men aged 60 to 69 years, there was a 19.3 percent increase from 2013 to 2016.
“Violence against older adults is an emerging and underreported public health problem,” the authors write. “Emergency departments might be promising settings to identify older adults at risk for violence and treat and support those already affected.”

Explore further

More information: Abstract/Full Text

Whooping cough evolving to beat antibiotics and possibly vaccine

A new strain of Bordetella pertussis – the bacterium that causes whooping cough – has become resistant to antibiotic treatment and may also be resistant to the vaccine used in China. A UNSW Sydney academic says the growing threat of it spreading to Australia should be taken seriously.
A joint study led by Ph.D. student Zheng Xu, between UNSW Sydney and Xi’an Centre for Disease Control and Prevention, China examined 167 pertussis samples from China. They found that 98% of pertussis bacteria isolated were resistant to erythromycin, the main antibiotic used to treat whooping cough. The study also found that the new strain has a mutation in one of the vaccine antigen genes, which may help the bacteria evade the two-component acellular vaccine used in China.
In the paper published in the journal Emerging Microbes & Infections, co-author Professor Ruiting Lan, of UNSW School of Biotechnology and Biomolecular Sciences, said the pertussis strains appear to be adapting to the acellular vaccine used in China, as well as developing resistance to the antibiotic most commonly used to treat the disease.
“This has rendered the antibiotic ineffective for treatment and prophylaxis,” Professor Lan said.
“Our findings suggest that treatment with erythromycin and prevention with vaccination with the acellular vaccine used may be less effective in China. We hope that therapies and prevention strategies will adapt to these findings to reduce the public health burden of pertussis.”
Professor Lan said that looking ahead, the Chinese pertussis strain needed to be watched closely from within and outside China. He stressed that the potential threat of the new variant spreading globally was real.
“But exactly how high the threat is, we don’t know at this stage,” Professor Lan said.
“In Australia we use azithromycin, which is the same type but a newer drug than erythromycin, but the Chinese variants have also shown resistance to this antibiotic. The treatment and prophylaxis have an important role in curtailing the spread of , so if the strains are resistant to and not curtailed by the antibiotic used, there is definitely a potential to cause an epidemic in Australia.”
“We really need to find out how competitive the Chinese strains are in Australia with a different  – the one used in Australia has one more antigen component. And we also need to understand the organism better.”
“We want to know how likely it is that these strains spread globally, and how we can curtail the spread of such . And further ahead, we need to design more effective vaccines to control these new variants,” he says.
Professor Lan stressed the need to maintain our own high vaccination coverage to prevent this new strain from gaining a foothold.

Explore further

More information: Zheng Xu et al. Genomic epidemiology of erythromycin-resistant Bordetella pertussis in China, Emerging Microbes & Infections(2019). DOI: 10.1080/22221751.2019.1587315

Ways to cut debilitating complications for frail elderly trauma patients

A standardized interdisciplinary clinical pathway to identify and manage frailty in older patients has reduced the rate of one of the most debilitating complications for older patients–delirium–and kept patients from returning to the hospital within 30 days of treatment for traumatic injury. The pathway is being adapted for other surgical services as trauma surgeons from Brigham and Women’s Hospital, Boston, focus attention on the specific needs of elderly surgical patients. A study describing the pathway and its effects on outcomes appears as an “article in press” on the Journal of the American College of Surgeons website in advance of print publication.
As the U.S. population continues to age, increasing numbers of elderly patients will have a need for trauma surgery. By 2050, 40 percent of all trauma patients will be over age 65. While the elderly are at increased risk for morbidity and mortality after trauma, age itself is not the sole reason for poor outcomes. Frailty is a major contributor. Frail patients are more likely to have complications and loss of function after hospital care and require readmission for repeat trauma than more robust patients. As many as 50 percent of older trauma patients are frail, and 78 percent are functionally impaired.
Interdisciplinary inpatient care protocols involving consultation with geriatricians have improved outcomes for elderly hospitalized patients. However, there is a nationwide shortage of geriatricians.
“It’s just not feasible to have a geriatrician available for consultation all the time. We needed to become better equipped to provide dedicated geriatric-focused care on our own. So we put some processes in place to screen elderly trauma patients for frailty and stratify and direct our resources to provide the best possible care for them,” said Zara Cooper, MD, FACS, an associate professor of surgery, Harvard Medical School, and corresponding author of the study.
Since Brigham and Women’s Hospital’s trauma surgery service hired a geriatrician to consult on the care of elderly injury victims in 2014, it documented fewer complications, mortalities, readmissions and extended hospital stays. However, the surgeons noticed gaps in care when the geriatrician was not available and lack of overall uniformity in the way recommendations from the geriatric team were instituted.
The pathway for frail elderly trauma patients was created in 2016 to standardize processes of care a geriatrician would typically recommend: early ambulation, bowel and pain regimens, non-pharmacological delirium prevention, nutrition, physical therapy, and geriatric assessments.
Surgeons at Brigham and Women’s Hospital developed the Frailty Identification and Care Pathway over a six-month period with input from geriatrics, nursing, nutrition, physical and occupational therapy, speech and language pathology, social work, and care coordinators. The pathway makes use of the five-item FRAIL scale to identify vulnerable elderly trauma patients, a standardized set of orders for geriatric-focused care and consultations, family meetings, and fall prevention education.
In the present study, researchers compared outcomes for frail elderly trauma patients before and six months after implementation of the pathway. In addition to overall mortality, the investigators analyzed whether the pathway could prevent or quickly recognize and treat delirium (one of the most common causes of increased hospital length of stay), transfer to a nursing facility, and mortality within six months of hospital care.
In addition, the investigators tabulated the 30-day hospital readmission rate, which serves as an indicator of quality hospital care and effective use of resources.
Researchers reviewed the care of 125 patients who were treated before the pathway was implemented and 144 after it was in place for six months and found lower rates of delirium, in-hospital mortality, and readmission. Patients who were managed according to the pathway had a 9 percent less risk for delirium, 3 percent reduced risk for mortality, and 7 percent lower risk for readmission.
Interdisciplinary protocols represent a shift in perspective for trauma surgeons. “Trauma centers are primarily focused on hemorrhage and complications that are typical for young patients. The elderly, especially frail elderly, have very different needs. Innovative models for geriatric trauma patients are emerging in parts of the country that have a significant proportion of older adults,” Dr. Cooper said.
The pathway at Brigham and Women’s Hospital is fairly straightforward and makes use of resources that are readily available in other trauma centers and surgical services. The standardized approach is being expanded for pre- and post-operative elective operations for frail elderly patients. “We have to adapt the protocol here and there, but the basic framework relies on getting patients mobile and managing medications, nutrition, and communication with families,” Dr. Cooper said. “This is the type of care that matters to patients and should be universal.”

‘Heart, lung transplants from hepatitis-C infected donors considered safe’

A recent trial has shown that heart and lungs from donors infected with hepatitis C can be safely transplanted, without recipients becoming infected with the virus.
A four-week course of direct-acting antiviral agents prevented the establishment of infection in all recipients and those who have been followed for six months are still infection-free.
The study, which has been published in the New England Journal of Medicine, is the largest of its kind to assess the safety of transplanting the organs from donors infected with the hepatitis C virus (HCV).

Solving organ shortages

Lead author Ann Woolley, (Brigham and Women’s Hospital, Massachusetts, US) estimates that the ability to safely transplant hearts and lungs from HCV-infected donors could increase supply of the organs by at least one-quarter.
In the US, more than 5,000 patients are currently awaiting a lung or heart transplant, but the shortage of donor organ availability means around one thousand patients die each year while they wait for the replacement organs.
In the wake of the current opioid crisis, an increasing number of donated organs now come from IV drug users. However, the donation of HCV-infected organs has historically been associated with high transmission rates to recipients and they are not typically used for transplant.
Usually, organs are discarded if donors are even suspected of having HCV infection, which is the most common type of chronic blood infection in the US.

Antivirals have led to high cure rates for hepatitis C

However, the advent of a new antiviral regimen in 2014 that has proved well-tolerated and to have high cure rates for chronic HCV has laid the foundations for a new trial that started enrolling patients in March 2017. The usual criteria were used to screen potential donors, with the exception that they were not disqualified for having a current or past HCV infection.
Forty-four patients received HCV-positive hearts or lungs, 35 of whom were followed up for at least six months. Antiviral treatment was initiated within a few hours of surgery and the treatment regimen was continued for four weeks.
Immediately after transplantation, all recipients had hepatitis C viral loads proportional to those of the donors. The majority cleared the virus within a few days and all patients had undetectable viral loads by around the two-week mark, reports Woolley.

Hepatitis C was ‘undetectable’ in transplant recipients

Of the 35 patients who completed 6 months of follow-up, all had excellent graft function and an undetectable viral load, with no treatment-related serious adverse events reported.
In an associated editorial, professor of Medicine at the University of Pennsylvania, Emily Blumberg, says that at least in the short-term, transplants from HCV-positive donors offer a very promising way to get people transplanted faster and expand the donor pool.
The authors conclude:
The advent of direct-acting antiviral agents to treat hepatitis C virus (HCV) infection has raised the possibility of substantially increasing the donor organ pool by enabling the transplantation of hearts and lungs from HCV-infected donors into recipients who do not have HCV infection.”

LivaNova price target lowered to $100 from $115 at Stifel

Stifel analyst Rick Wise lowered his price target on LivaNova to $100 after its soft Q1 pre-announcement driven by “more intense FX headwinds”, challenges in the U.S. Neuromodulation segment, and the ongoing execution issues at Perceval pressuring the company’s Heart Valves sales by 11.4%. Longer term, the analyst is keeping his Buy rating on LivaNova however, citing its “dramatic and positive transformation” over the past 18 months with the divestiture of the lower-margin Cardiac Rhythm Management business and the hiring of a new and experienced management team. Wise believes that the company has the “solid foundation” to grow its revenue and earnings while supporting its “growth-enhancing pipeline investments.”
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