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Sunday, September 30, 2018

Employers jump into providing care as health costs rise


Autoworkers in this blue-collar, central Indiana city have an eager helper waiting to pick up the bill at their next doctor visit.
Fiat Chrysler is offering free  for most of its employees and their families—about 22,000 people—through a clinic the carmaker opened this summer near one of five factories it operates in the area. The company pays for basic  like doctor visits and consults with a dietitian and even an exercise physiologist. Workers don’t pay a cent, not even a co-pay.
The idea: Spend more now to improve care and eventually pare the more than $100 million that Fiat Chrysler Automobiles pays annually for  care, just in Indiana.
“We looked at how do we change the  system, that’s really what employers are asking,” Fiat Chrysler executive Kathleen Neal said.
Corporate America is jumping deeper into the care its workers receive beyond just giving them insurance cards and a list of doctors they can visit. Companies are opening clinics on or near their worksites or bringing in temporary setups to make sure their employees get annual physicals.
In many cases employers are offering free primary care or charging only a small fee. Many believe the cost is worthwhile because they can improve  health and cut even bigger bills in the future that stem from unmanaged chronic conditions like diabetes or unnecessary emergency room visits.
Offering convenient care can also help attract new workers and cut down on time away from the job. But this shift means workers will have to change how they use the health care system. And companies, which don’t see individual medical records, have to patiently wait for some potential benefits from their investment like a drop in .
Employers jump into providing care as health costs rise
Dr. John Lynch meets with patient Jeff Thieke during his visit to the Fiat Chrysler Automotive Clinic in Anderson, Ind., Tuesday, Sept. 4, 2018. Fiat Chrysler is offering free care for its employees and their families, about 22,000 people, …more
“It is really, really hard to change behavior,” said Carolyn Engelhard, an associate professor at the University of Virginia’s medical school who studies health policy.
Big companies have long offered services to help employees recover from workplace injuries, and now more are delving into primary care.
Fifty-six percent of large employers will have on-site or nearby health centers by 2019, up from 47 percent in 2016, according to the National Business Group on Health.
Most of the businesses surveyed by the nonprofit, which represents large companies, have 10,000 employees or more. But benefits experts also see this trend in smaller businesses too, with some companies joining forces to pay for a nearby clinic that they share.
Office buildings also have started adding clinics to attract tenants that want the convenience for their employees, according to Dr. Jeff Dobro, a partner with the benefits consultant Mercer.
Mattress maker Serta Simmons Bedding started rolling out mobile health clinics to all 28 of its U.S. factories a couple years ago to help its largely male workforce get annual physicals, with the company covering the cost.
“Most people just don’t get their screenings, and a lot of men just don’t have a relationship” with their doctor, said company executive Steven Wilkinson.
Employers jump into providing care as health costs rise
Medical assistant Adrea Colliings collects vital signs from patient Jeff Thieke at the Fiat Chrysler Automotive Clinic in Anderson, Ind., Tuesday, Sept. 4, 2018. Fiat Chrysler is offering free care for its employees and their families, …more
Fiat Chrysler opened its clinic after learning that 40 percent of its employees in the Kokomo area didn’t have a doctor, and many defaulted to emergency rooms for care that wasn’t dire.
Company spokeswoman Val Oehmke declined to say how much the clinic cost to build, but she said Fiat Chrysler expects to make back what it spent in about two years by improving employee health and cutting medical costs.
The health center comes with exam rooms, an X-ray machine and space for minor procedures. Aside from a small memorial photo of former Fiat Chrysler CEO Sergio Marchionne on a waiting room table, few signs inside the clinic connect it to the hulking transmission factory nearby.
The carmaker pays a local hospital operator, St. Vincent, to run its clinic exclusively for employees and family members.
Dr. John Lynch spent almost an hour with a patient during a recent physical. That compares to the 10 or 15 minutes he used to get once or twice a year in other practices.
“It was frustrating that I couldn’t do more for them,” he said.
Forklift operator Amanda Chipps took her toddler, McCoy, to the clinic after he developed a fever and a rash and she couldn’t get in to see their regular doctor. Chipps said that visit felt more like an annual checkup. Before eventually prescribing antibiotics, a doctor and nurse asked about McCoy’s medical history, diet and personality.
Employers jump into providing care as health costs rise
The Fiat Chrysler Automotive Clinic is shown in Anderson, Ind., Tuesday, Sept. 4, 2018. Fiat Chrysler is offering free care for its employees and their families, about 22,000 people, through a clinic the carmaker opened this summer near one …more
“They were really just getting to know … everything about him,” she said. “It was just real nice, a different setting from most doctors’ offices.”
United Shore Financial Services opened a similar clinic in its suburban Detroit headquarters for its 2,600 employees a couple years ago after executives saw workers coming in sick during flu season. The clinic logged about 4,200 visits in 2017, its first full year.
Account executive Sean McHugh said he seeks clinic help when back trouble flares up during the day. That saves him from losing time by driving home for care and then back to work.
“It really makes the work environment here appealing because it gives you your time outside of the office,” the 36-year-old said.
Employers often find that it takes time for workers to get used to a major change in health benefits.
But these clinics can catch on quickly, said David Keyt, a Mercer executive who works with employers to set them up. He said having clinics on or near the worksite removes two big hurdles—cost and convenience— that prevent people from getting care.
“What we’re trying to get to is the provider-patient relationship and all the barriers that prevent that … from happening,” he said.

Bacteria as Weapon Against Cancer


It’s a perfect case of the enemy of my enemy is my friend.
A potentially dangerous bacteria appears to target malignant cells and could provide a new means of fighting cancer, a small, preliminary study reports.
The bacteria, Clostridium novyi-NT, can cause gas gangrene and sepsis if infection is allowed to run amok in a wound.
But when injected into a tumor, Clostridium novyi-NT appears to both attack the cancer directly and encourage the body’s immune response against the cancer cells, said lead researcher Dr. Filip Janku. He is an associate professor at the department of investigational cancer therapeutics at the University of Texas MD Anderson Cancer Center, in Houston.
“Patients only had one week of exposure to the bacteria, but even with that limited exposure we saw quite interesting and, in some patients, clinically meaningful activity,” Janku said.
Clostridium novyi has been linked to human illness. In 2000, the U.S. Centers for Disease Control and Prevention reported that a handful of drug users in the United Kingdom fell ill or died after their injection sites became infected with the bacteria.
The strain used in this clinical trial, Clostridium novyi-NT, had been weakened to prevent it from producing its toxin, which can be lethal in humans, Janku said. The NT stands for “non-toxic.”
Clostridium novyi flourishes in low-oxygen environments. Researchers thought this might make the bacteria a prime candidate for cancer fighting, by keeping the infection focused on the tumor site.
“Normal tissues, even if they are low on oxygen, they always have enough oxygen to not allow this bacteria to germinate and proliferate,” Janku explained. “Cancerous tissue is low in oxygen, most often in the center of the cancers.”
To test whether the bacteria could help fight cancer, researchers injected the tumors of 24 patients with a single dose of Clostridium novyi-NT, ranging from 10,000 to 3 million spores.
Fifteen of the patients had sarcoma, two patients had melanoma, and seven had a variety of cancers, the researchers said.
The scientists expected Clostridium novyi-NT to help fight the tumor in two ways.
First, the bacterial infection itself could cause direct destruction of the tumor cells, Janku said.
“If that happens, it actually helps to increase the presence of tumor-specific antigens, which are proteins that make a tumor more obvious to the immune system,” Janku said. “It can prime the immune system to attack the cancer.”
The bacteria also could activate the immune system to fight the cancer even if the infection didn’t kill off tumor cells, Janku added.
Patients in this clinical trial were left with the bacterial infection for one week, and then everyone was given antibiotics to kill off the Clostridium novyi-NT, Janku said.
Clostridium is actually quite susceptible to antibiotics,” Janku noted.
The bacteria germinated in the cancers of 11 out of the 24 patients, with tumor cells dying off as a result.
Tumor shrinkage of greater than 10 percent was observed in 23 percent of patients. However, Janku said this could be an underestimate since the infection causes surrounding tissue to become inflamed, making the lesion appear larger than it actually is.
Following bacterial therapy, cancer stabilized in 21 patients. When both injected and uninjected lesions were included, the stable disease rate was 86 percent, the researchers reported.
The potential for Clostridium novyi-NT to prompt an immune response against cancer is intriguing, said Sacha Gnjatic, who is associate director of the Human Immune Monitoring Center at Mount Sinai in New York City.
“That’s where the promise of this type of therapy lies. You would expect that the injected lesion would have some type of response because you’re disrupting the tumor cells,” Gnjatic said. “What would be interesting is if this could prime an immune response that would eventually also take care of the non-injected tumors. That’s the holy grail of immunotherapy.”
Janku said he’s particularly excited by the ability of the bacteria to battle sarcomas, which are cancers that occur in bone, muscle and soft tissues.
“Classic immunotherapy which is now approved or being heavily investigated doesn’t seem to be working for a majority of sarcomas,” Janku explained.
Researchers have moved on to the next phase, in which patients taking the immunotherapy drug pembrolizumab (Keytruda) will also be treated with a single injection of Clostridium novyi-NT, Janku said. The researchers suspect the two therapies used in combination will create a strong immune response against cancers.
However, they will have to keep an eye on potential side effects from Clostridium novyi-NT, Janku added.
Two patients treated with the heaviest dose of 3 million spores of Clostridium novyi-NT fell ill with sepsis and/or gas gangrene, leading researchers to set the maximum tolerated dose at 1 million spores.
Researchers also found the bacteria in the bloodstream of a couple of patients, meaning that the infection will need to be carefully tracked, Janku said.
“That didn’t result in clostridium seeding anywhere else outside the injected region, but it’s a theoretical possibility since we were able to detect it in the blood culture of one or two patients,” Janku said.
Patients also could be susceptible to immune response side effects, such as low blood pressure or fever, he added.
The trial results were to be presented Sunday at the International Cancer Immunotherapy Conference, in New York City. The meeting is jointly sponsored by the Cancer Research Institute, the Association for Cancer Immunotherapy, the European Academy of Tumor Immunology, and the American Association for Cancer Research.
Research presented at meetings should be considered preliminary until published in a peer-reviewed journal.
More information
The U.S. National Cancer Institute has more about cancer treatment.
SOURCES: Filip Janku, M.D., Ph.D., associate professor, department of investigational cancer therapeutics, University of Texas MD Anderson Cancer Center, Houston; Sacha Gnjatic, Ph.D., associate director, Human Immune Monitoring Center, Mount Sinai, and associate professor, The Tisch Cancer Institute, Icahn School of Medicine, New York City; Sept. 30, 2018, presentation, International Cancer Immunotherapy Conference, New York City

Safe Weight Loss Drug That Works


Hello. I’m Dr Charles Vega, and I am a clinical professor of family medicine at the University of California at Irvine. Welcome to Medscape Morning Report, our 1-minute news story for primary care.
Weight loss drugs are underused. That is the opinion voiced by numerous obesity medicine experts. Surveys of clinicians have found that only a small number of us use them. Why is that? Some suggest that it is a holdover from the “fen/phen” days, with safety fears causing clinicians to shy away from them.
Will the results of a 3-year randomized trial involving 12,000 overweight and obese patients put those fears to rest? The CAMELLIA-TIMI 61 trial was an industry-supported cardiovascular outcomes study of adults with established cardiovascular disease, type 2 diabetes, or cardiovascular risk factors. The mean age of the participants was 64 years and 60% were men. The study concluded that lorcaserin, sold under the brand name Belviq, did not increase the risk for major adverse cardiovascular events when compared with placebo.
For the first time, a rigorous outcome study has demonstrated cardiovascular safety for a pharmacologic weight loss agent.
And safety was not all. The drug, when added to diet and lifestyle, resulted in modest weight loss, with about double the number of treated patients losing 5% of body weight at 1 year—39% versus 17%. Additionally, among patients with prediabetes at baseline, the rate of new-onset diabetes was 19% lower in the active treatment group. Cardiovascular outcomes, however, while somewhat improved in the treatment group, did not significantly vary between the two groups.
Clearly this was a high-risk population and results may not be the same for obese patients without this much cardiovascular risk. But when diet and lifestyle alone are not working, are we doing our patients a disserve to not offer them this option?

Osteoporotic Fracture Risk High in Men


Older adults who experienced a first major osteoporotic fracture had an increased risk for having an additional subsequent fracture, with the risk being higher among men than women.
Men had a three-fold higher risk of sustaining a second fracture within the first year after their index fracture compared with men without a previous fracture (HR 3.3, 95% CI 2.6-4.1), whereas among women with an index fracture, the risk of a second fracture was elevated but to a lesser extent (HR 1.8, 95% CI 1.7-2), according to Suzanne N. Morin, MD of McGill University in Montreal, and colleagues.
“These results underscore the importance of timely recognition of fracture events, especially in men, a population in whom secondary prevention is vastly under-implemented,” Morin said in a press release.
“Fragility fractures are associated with subsequent major osteoporotic fractures and excess mortality,” she said during a plenary session at the American Society for Bone and Mineral Research annual meeting.
It’s been recognized that there is a clustering in time of subsequent osteoporotic and hip fractures soon after an initial fracture, but how this risk evolves over time and whether the evolution is similar in men and women is uncertain. Morin’s group undertook a retrospective matched cohort study of men and women included in the Manitoba linked healthcare databases who experienced an initial fracture from 1989 to 2006.
They ensured that there had been no previous fractures in the 5 years prior to the index fracture for each patient, and allowed for at least 10 years and up to 25 years of follow-up to assess for incident fractures.
For each case, they identified three age and sex-matched controls, and all were followed through 2016.
They identified 29,694 index major osteoporotic fractures, with sites being the wrist in 11,028, the hip in 9,313, the humerus in 5,799, and the spine in 3,554. The annual rate of subsequent major osteoporotic fractures was 18.5 (95% CI 17.3-19.8) per 1,000 person years in men and 29.6 (95% CI 28.8-30.4) per 1,000 among women.
The cumulative incidence of subsequent major osteoporotic fractures was higher in cases than in controls in both men and women, and was consistent across all age groups except in the very elderly, where the relationship was reversed because of the competing risk of mortality, she explained.
After the first year, there was a gradual attenuation of risk, but it remained elevated even 15 years after the initial fracture, at which time the hazard ratio for an additional major osteoporotic or hip fracture was 1.8 (95% CI 1.4-2.4) in men and 1.5 (95% CI 1.3-1.6) in women.
This analysis has multiple strengths, according to Morin, including its large, population-based cohort, the long period of follow-up, and the inclusion of a large number of men. Limitations included the reliance on administrative data that did not take into account comorbidities and medication use.
Morin disclosed no relevant relationships with industry.

Biotech week ahead, Oct. 1


Biotech shares saw further momentum last week, following up on the gains of the previous two weeks.
Will the momentum continue in the upcoming week? Here are the catalytic events that could drive the sector.

Conferences

  • American Society for Bone and Mineral Research, or ASBMR, 2018 Annual Meeting – Sept. 28 – Oct. 1 in Montréal, Québec, Canada
  • 12th International Conference on Endocrinology,Diabetes and Metabolism – Oct. 1-2, in Osaka, Japan
  • 12th International Conference on Allergy, Asthma & Clinical Immunology – Oct. 1-2, in Moscow, Russia
  • 3rd World Congress on Pediatric Neurology and Pediatric Surgery – Oct. 1-2, in Osaka
  • 13th World Conference on Neurology and Neuromuscular Disorders – Oct. 1-2, in London
  • Cantor Global Healthcare Conference – Oct. 1-3, in New York City
  • Ladenburg Thalmann 2018 Healthcare Conference – Oct. 2, in New York City
  • 3rd International conference on Neuroscience, Neuroradiology & Imaging – Oct. 3-4, in Osaka
  • 2nd International Conference on Cancer Biology, Therapeutics and Drug Discovery & Delivery – Oct. 3-4, in Los Angeles
  • 10th Annual Congress on Biomarkers, Clinical Research & Therapeutics – Oct. 3-4, in Los Angeles
  • American Heart Congress – CVD – Oct. 5-6, in Los Angeles
  • 4th International Conference on Wound Care, Wound Nursing, Tissue Repair & Regenerative Medicine – Oct. 5-6, in Los Angeles
  • World Congress on Fetal and Maternal Medicine – Oct. 5-6, in Osaka

PDUFA Dates

Roche Holdings AG Basel ADR RHHBY 0.49%‘s Genentech unit awaits FDA nod for an expanded indication for its Hemlibra. Hemlibra has already been approved for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with haemophilia A with factor VIII inhibitor. This time around the company is seeking clearance for treating adults and children with haemophilia A without factor VIII inhibitors. The PDUFA date is set for Thursday, Oct. 4.
The FDA is set to rule on Bausch Health Companies Inc BHC 2.31%‘s NDA for its plaque psoriasis treatment IDP-122 lotion Friday, Oct. 5.
Ionis Pharmaceuticals Inc IONS 0.29%, and its affiliate Akcea Therapeutics Inc AKCA 0.77% look ahead to FDA approval of their Inotersen, a RNA-targeted therapeutic for hATTR amyloidosis. PTC Therapeutics, Inc. PTCT 0.13% has a collaboration agreement to market Inotersen in Latin America. The PDUFA date for Inotersen, which has already been approved in the EU, is set for Saturday, Oct. 6.
Paratek Pharmaceuticals Inc PRTK 3.19%‘s broad spectrum antibiotic Omadacycline is being evaluated by the FDA for two indications, namely Community-acquired pneumonia, or CAB, and acute bacterial skin and skin structure infections, or ABSSSI. The company indicated the PDUFA date is likely to be in early October.

Clinical Trial Results

Unum Therapeutics Inc UMRX 2.42% is set to present Sept. 30 initial Phase 1 data for its ACTR707 in combination with Roche’s Rituxan for treating non-Hodgkin lymphoma.
Viking Therapeutics Inc VKTX 2.35% is due to present already-released Phase 2 data for its acute hip fracture treatment VK5211 at the ASBMR 2018 annual meeting on Sept. 30. Recently, the company reported positive results for its non-alcoholic fatty liver disease candidate.
Protalix Biotherapeutics Inc PLX 1.66% will present preliminary Phase 3 open label data for its Fabry disease treatment Pegunigalsidase alfa on Oct. 5.
Audentes Therapeutics Inc BOLD 3.29% is due to release updated Phase 1/2 data for AT132, its treatment candidate for X-linked myotubular myopathy on Oct. 5.

IPO

Guardant Health, which develops non-invasive blood-based cancer diagnostics tests, is set to offer 12.5 million shares in an IPO, with an estimated price range of $15 to $17. The shares are to be listed on the Nasdaq under the ticker symbol GH.
Kodiak Sciences will offer 9 million shares priced between $13 and $15 in an IPO. The company, which develops anti-VEGF inhibitors for wet AMD, plans to list the shares on the Nasdaq under the ticker symbol KOD.

Sanofi: Hanmi’s new diabetes drug to take on Lilly’s in tests


Sanofi said it would begin global phase-3 clinical trials to compare Hanmi Pharmaceuticals new obesity and diabetes treatment Efpeglenatide with a rival drug by Lilly.
Sanofi, the partner firm for Hanmi, announced on Wednesday that it officially registered the comparison study on online registry disclosure site clinicaltrials.gov. The trials will assess Efpeglenatides noninferiority to Trulicity (dulaglutide) in 900 patients with type-2 diabetes inadequately controlled with metformin, a widely used oral medicine for diabetes.
By administering Efpeglenatide and Trulicity once a week for 56 weeks, the study will compare the drug safety, blood glucose control and weight control effect, changes in blood sugar in empty stomach, and hypoglycemia symptoms.
The French pharmaceutical company is conducting two other types of phase-3 trials globally. The studies aim to compare Efpeglenatide with placebo and to verify the drugs cardiovascular risk.
Efpeglenatide is a long-acting glucagon-like peptide-1 (GLP-1) biological treatment for diabetes. In 2015, Sanofi obtained its license from Hanmi and had since been conducting multiple phase-3 trials simultaneously around the world.
Various trials are swiftly undergoing to prove Efpeglenatides global competitiveness. We will closely work with our partner company to accelerate commercialization of the drug, Hanmi Pharmaceutical CEO Kwon Se-chang said.

Pfizer: UK regulator certifies use of some out-of-date EpiPens over shortages


Children with severe allergies who need to carry life-saving medication are being forced to rely on out-of-date EpiPens due to a global shortage of the adrenaline shots.
EpiPen and EpiPen Junior devices, which are supplied by Mylan and produced by Pfizer, have faced shortages in the UK and other countries for months. But the crisis has deepened with the Junior version now unavailable.
The latest stock shortages have led the medicines regulator to certify some batches of expired EpiPens as safe amid fears those with severe allergies who go into anaphylactic shock would be left with no alternative.
It was forced to extend the use-by-date of some EpiPens by four months after concerns were raised from users that their current shots were due to expire and they had been unable to get replacements. However, the extension does not apply to the Junior version.
A statement issued to healthcare providers on behalf of the Department of Health noted: “EpiPen and EpiPen Junior will be subject to limited availability for the remainder of 2018. Mylan are now out of stock of EpiPen Junior and interruptions in the supply are anticipated to continue for the coming months.”
More of the Junior devices are expected in stock in October, but it is not clear whether these will meet demand.
Manufacturing problems in the US have meant disruption for suppliers of EpiPens – the most common adrenaline auto-injectors (AAIs) are prescribed to those who suffer severe allergies such as to nuts, milk, fish, shellfish, eggs or some fruits.
Those affected are usually recommended to keep two AAIs with them at all times in case of a reaction. EpiPens can only be used once and have an expiry date of at least 12 months.
The standard device contains 300mcg of adrenaline. Smaller 150mcg Junior AAIs are issued to children who weigh 30kg (4st 10lb) or less.
Adults and older children are being advised they can use their devices up to four months beyond the listed expiry date in an attempt to maintain supply levels but the extension does not apply to the 150mcg devices for younger children.
A statement from the Department of Health and Social Care to healthcare providers said: “Mylan have obtained acceptance from the medicines and healthcare products regulatory agency (MHRA) to extend the use of specific batch numbers of EpiPen 300mcg auto-injectors beyond the labelled expiry date for four months.”
Last week an inquest heard that 15-year-old Natasha Ednan-Laperouse died on a flight after suffering a serious allergic reaction to a Pret A Manger baguette containing sesame seeds. This was despite her father injecting her with two EpiPen devices.
EpiPens make up three-quarters of the 340,000 adrenaline auto-injectors prescribed annually.
There are two other adrenaline auto-injector devices available in the UK: Emerade and Jext. Suppliers of both medicines are working to increase their supplies to the UK over the coming months.
The health department guidance said that if people were left with nothing but expired AAIs they should keep them – until they get replacements – and be prepared to use them.
While AAIs become less effective after their expiry date, they are not harmful, and it is better to use an expired AAI than none at all, it said.
It added that “careful management” of existing supplies would prevent the need for using expired pens.
The health minister, James  O’Shaughnessy, said: “We are doing everything we can to ensure patients continue to access the medications they need and we have issued detailed guidance to healthcare professionals.
“Other brands of adrenaline auto-injectors are available in the UK and we are working closely with Mylan and Pfizer to find a solution to the problem as soon as possible. Any patient unable to obtain supplies of EpiPen should speak to their clinician about using an alternative brand.”