Bowel surgery death rate 'too high'

Bowel surgery death rate warning

  • 30 June 2015
  • From the section Health

Too many patients are dying following emergency bowel surgery, experts who have done a comprehensive audit of care across England and Wales warn.

One in 10 patients dies within 30 days of undergoing urgent, unplanned laparotomy and some of these deaths could be avoided, the authors say.

The National Emergency Laparotomy Audit team found the care for these high-risk patients was lacking at some hospitals.

Expert supervision and best treatment was not always immediately on hand.

The audit, commissioned by the Healthcare Quality Improvement Partnership and funded by the government, looked at data from more than 20,000 patients from 192 of 195 eligible NHS hospitals.

It found:

  • wide variation in care between hospitals
  • expected standards of care were not met for 30-40% of patients in some hospitals
  • only half of the patients were seen by a consultant surgeon within the recommended 12 hours
  • one in six patients did not arrive in the operating theatre within the recommended timeframes, despite the urgent nature of the surgery
  • many patients at high risk of sepsis infection did not receive timely antibiotic therapy
  • post-operative access to critical or intensive care wards was patchy

More than 30,000 patients have this emergency surgery each year in NHS hospitals within England and Wales.

The procedure, done under general anaesthetic, involves making an incision to operate inside the abdomen to treat life-threatening conditions such as bowel obstruction, perforation or a bleed.

Miss Clare Marx, president of the Royal College of Surgeons, is concerned the mortality rate for the procedure remains too high.

“This audit demonstrates patients are still not accessing a consistently high standard of care from initial assessment through to post-operative care,” she said.

She said improving the outcomes for these patients should be made a top priority.

Iain Anderson, the lead surgeon involved in the audit, said many clinical teams had already reviewed and improved the way they delivered care. He urged other hospitals to follow suit.

“This audit is an essential step in helping all involved measure and continue that development and in indicating particularly to weaker teams how they might improve services and save lives,” he said.

Prof Mike Grocott, chairman of the audit, said even a modest improvement could have a substantial benefit.

He said the audit team would be following up with the best and worst hospitals to understand what was being done well, sharing best practice to improve performance where necessary.

It may be necessary to accept more delays for routine surgery so these emergency cases can be given a higher priority, say the report authors.

The Office for National Statistics will soon be releasing new hospital-level data on emergency laparoscopy death rates.

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Families speak out over Tawel Fan

Tawel Fan families speak out for first time over care

  • 30 June 2015
  • From the section North East Wales

Families have spoken out for the first time about the “deplorable” care their loved ones received at a Denbighshire mental health ward.

The damning report into the Tawel Fan ward at Glan Clwyd Hospital revealed patients were “kept like animals”.

Three families told BBC Wales’ Week In Week Out about their despair and shock at the brutality of care on the ward.

Betsi Cadwaladr University Health Board chairman Dr Peter Higson said the ward will never be used again.

The families said they are upset at the contents of the report, shocked at its findings and they are still worried about the consequences of speaking out.

One family member, Sandra, not her real name, first raised concerns about her husband’s care on the ward in November 2012, a year before it closed.

“I found him lying flat in a pool of stale urine. There was a brown mark which is a clear indication that the urine is old,” she said.

Families described patients being treated like animals in a zoo at the Tawel Fan unit

Sandra kept a log of incidents, including a member of staff slapping him and how he was head-butted by another patient.

The final straw for Sandra, a former nurse, was when she saw staff restraining her husband using furniture and shutting him in a dark room by himself.

“I was extremely disappointed, angry that my husband and others were treated in such a deplorable way by people who call themselves nurses,” she said.

A member of another family, Margaret, also not her real name, believes the ward should be bulldozed. Her mother was admitted to the ward in November 2012 with dementia.

“It should be destroyed. It should be obliterated,” she said.

“As for the staff… they know who they are. They have to hold their heads in shame.”

Family member Margaret, not her real name, talked of her distress at her mother’s treatment on the ward

Dr Higson said bulldozing the ward is a possibility and has said it will never be used again.

Week In Week Out has also revealed major new concerns over standards of care at another unit, the Gwanwyn Ward at Wrexham Maelor Hospital, following a spot check last December.

The programme has discovered there have been 47 allegations of assault on the ward over the past 12 months.

Richard Lumley, whose father died there last November following an incident where he sustained head injuries, said questions still surrounded his death.

“I believe, I try to recall now, being told by a member of staff that another patient had been involved in the incident which led to dad’s fall,” he claimed.

Dr Peter Higson said the health board would have no hesitation in closing another ward if necessary

Dr Higson said he will look into the allegations put to him by BBC Wales but he is not aware of any “undue concern”.

He has also spoken about the events that led to the health board being placed in special measures and the suspension of chief executive Trevor Purt.

The Welsh government has since appointed Simon Dean, the deputy head of the NHS in Wales, as interim chief executive of the health board. Progress will be reviewed in three months.

Week In Week Out: Kept like Animals, 22:40 BST, BBC1 Wales

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Novartis to test new pricing model with heart failure drug

The logo of Swiss drugmaker Novartis is seen at its headquarters in Basel October 22, 2013. REUTERS/Arnd Wiegmann

The logo of Swiss drugmaker Novartis is seen at its headquarters in Basel October 22, 2013.

Reuters/Arnd Wiegmann

Novartis plans to test a novel pricing model with some customers when it launches its keenly awaited new heart failure drug Entresto, the Swiss company’s head of pharmaceuticals said on Tuesday.

Entresto, also known as LCZ696, is the first new drug in decades for helping patients whose lives are in danger because their hearts cannot pump blood efficiently. As a result, it is widely expected to generate billions of dollars in annual sales.

How the product should be priced, however, is a dilemma for Novartis, since the company wants to reach as many patients as possible and it knows it will be competing with very cheap – though less effective – older medicines.

David Epstein said he was talking to several healthcare customers about a system under which they would get the drug at a discount but then pay Novartis more if, as expected, it successfully reduces the need for costly hospital visits.

“We are beginning to share the risk,” he said in an interview.

“When you buy other goods that don’t work you either take them back or get your money back. Our industry is a bit unique because historically if the drug doesn’t work it still gets paid for. I think that model will have to shift.”

The idea of moving from a simple pay-per-pill model to one based on clinical outcomes is being considered by several drugmakers, and Novartis already has such a system in place for one customer using its multiple sclerosis drug Gilenya.

But Entresto could be an important test case because the drug will push up immediate drug costs markedly for a large number of patients, while having the potential to reduce their long-term medical bills.

The issue of drug pricing has come to a head recently, thanks to the launch of extremely expensive new medicines for cancer and hepatitis C, which are straining healthcare systems and adding to co-payment costs for patients.

With Entresto on track for potential U.S. approval in August, Epstein said he expected some initial hurdles that would slow its uptake, with the important U.S. Medicare system, for example, likely to restrict use for six months or so after its launch.

Still, he remains very confident in the longer term, especially as Novartis is in the unusual situation of not having any rivals with similar drugs close to reaching the market.

There could be more upside, too. Entresto has currently only been shown to work in heart patients with reduced ejection fraction, where the heart muscle does not contract effectively. But Epstein said he was “pretty optimistic” it could also help a similar-sized group with preserved ejection fraction, where the ventricles do not relax as they should.

Epstein, whose team is in the final stages of deciding the price for Entresto, declined to detail a likely cost per pill. But he said it would take into account “cost offsets”, such as fewer hospitalizations, as well as the value added from improving patients’ lives.

“We going to try and be fair and reasonable,” he said.

(Reporting by Ben Hirschler; Editing by Mark Heinrich)

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Liberia records Ebola death after country declared virus-free

A health worker injects a woman with an Ebola vaccine during a trial in Monrovia, February 2, 2015. REUTERS/James Giahyue

A health worker injects a woman with an Ebola vaccine during a trial in Monrovia, February 2, 2015.

Reuters/James Giahyue

A Liberian has died of Ebola in the first recorded case of the disease since a country at the heart of an epidemic that has killed more than 11,000 people was declared virus-free on May 9 after going 42 days without a new case.

The body of a 17-year-old tested positive for Ebola in Margibi County and authorities have begun tracing people the victim may have come into contact with while infected, Deputy Health Minister Tolbert Nyenswah said on Tuesday.

“There is no need to panic. The corpse has been buried and our contact tracing has started work,” Nyenswah told Reuters. Margibi is a rural area close to the capital Monrovia, and is home to the country’s main international airport.

A total of 11,207 people died from Ebola in Liberia, neighboring Guinea and Sierra Leone since the outbreak began in December 2013, World Health Organization (WHO) spokesman Tarik Jasarevic told a news conference in Geneva.

Around 43 percent of those deaths were in Liberia, where the world’s worst outbreak of the disease peaked between last August and October with hundreds of cases a week.

New incidences have tapered this year, with 12 new confirmed cases reported in Guinea and eight in Sierra Leone in the week to June 21, according to WHO figures. Even so, health officials urge vigilance to prevent a resurgence of the disease.

The new case will test Liberia’s response capacity at a time when international health organizations have wound down their presence in the affected countries, said Fatoumata Lejeune-Kaba, spokeswoman for the U.N. Ebola response mission.

Liberia fought Ebola at a community level, adopting regular hand-washing and the safe burial of bodies among other measures and the discovery of the new case shows that systems for testing remain in place, she said.

“This should have been expected because as long as there is Ebola in the region no one country can be safe. Liberia is vulnerable because of Guinea and Sierra Leone.”

Ebola damaged the health care systems and economies of the three West African countries and caused global alarm that peaked in September and October when isolated cases were confirmed in countries such as the United States and Spain.

Nigeria, Senegal and Mali also recorded at least one case each before ending the epidemics in their countries.

(Additional reporting by Matthew Mpoke Bigg in Accra and Stephanie Nebehay in Geneva; Editing by Mark Heinrich)

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Overused Antibiotics Cause Havoc Among Nursing Home Patients

Action Points

  • Note that this study of antibiotic use in nursing homes found that nursing homes in the highest tertile of use also had higher rates of adverse events.
  • Be aware that, though adjustments for case-mix were performed, it is conceivable that some of this result is due to confounding by the fact that some nursing homes cater to sicker patients.

One in eight nursing home residents experienced an adverse event related to antibiotic prescribing, regardless of whether they personally took the antibiotics, researchers reported.

During a 2-year period, residents living in Ontario nursing homes that were in the highest one-third of antibiotic use facilities had a 24% higher risk for having an antibiotic-related adverse event, when compared with those living in the lower two-thirds of the 607 facilities housing over 110,000 residents (adjusted odds ratio 1.24, 95% CI 1.07-1.42, P=0.003), Nick Daneman, MD, MSc, of the University of Toronto, and colleagues reported in JAMA Internal Medicine.

“Antibiotics are one of the most frequently prescribed medications in [nursing homes] where 6% to 10% of residents are taking antibiotics at any given time and more than half receive at least one antibiotic prescription in a single year,” Lona Mody, MBBS, MSc, of the University of Michigan Medical School, and Christopher Crnich, MD, of the University of Wisconsin School of Medicine and Public Health, wrote in an editorial in JAMA Internal Medicine. “Much of this use is inappropriate.”

To place this study into the scope of U.S. healthcare, Mody and Crnich point out that more than 15,000 nursing homes are home to roughly 1.4 million seniors each year, and 3.3 million Medicare recipients spend short stays in nursing homes each year.

Mody and Crnich estimated that suspected urinary tract infections account for 30% to 56% of antibiotics that are being inappropriately prescribed, and up to one-third of those prescriptions are for nursing home residents with asymptomatic bacteriuria.

Based on the number needed to harm that Daneman’s team calculated in their sensitivity analysis (n=53), Mody and Crnich suggested that close to 20,000 residents of U.S. nursing homes experience an antibiotic-related harm each year by simply living at the facility.

Daneman’s group searched through Canadian healthcare databases for nursing home records from 2010 and 2011. To remove potential confounding of data from resident transfers to emergency department or hospital, the researchers created an open-cohort model of the 110,656 adults from 607 nursing homes across Ontario, and tallied antibiotic exposure based on days of use and resident days in the facility.

Facility usage was divided into low-use (20.4 to 45.7 days), medium-use (45.8 to 62.2 days), and high-use (62.3 to 192.9) tertiles.

Daneman’s team discovered that out of a total of 50,953,000 possible resident days, antibiotics were administered on 2,783,000 of them. That rate worked out to 55 antibiotic days per 1,000 resident days.

The rate varied quite a bit across facilities, as use ranged from 20.4 to 192.9 antibiotic days per 1,000 resident days.

The classes of antibiotic agents used throughout the different nursing homes were similar, with penicillin and second-generation fluoroquinolones as the most commonly prescribed.

Next, the researchers tracked negative outcomes associated with antibiotic use through ICD-10 codes and claims data. These included Clostridium difficile, diarrhea or gastroenteritis, antibiotic-resistant organisms, and allergic reactions.

Adverse events were more likely to occur in nursing homes in the top-tertile of antibiotic use with 13.3%, but still had high rates in the medium tertile homes at 12.4%. The lowest tertile had a rate of 11.4% of adverse events. (P<0.001).

Daneman’s group made a notable finding: the trend toward antibiotic-related adverse events persisted among residents who did not take antibiotics.

For residents who directly received the antibiotics, the risk of adverse events was roughly 1.0% to 1.5% higher in each tertile. For residents who did not receive antibiotics, the risk of an adverse event was 9.9% in the high-use and 8.7% in the low-use tertile (P=0.02)

The risk difference in adverse events between the high and low tertiles translated to a number needed to harm of 53, the authors wrote. But the outright number needed to harm was 71 for direct antibiotic recipients and 83 for nonrecipients.

In a sensitivity analysis, the researchers calculated that for each additional day of antibiotic use in the nursing home, the risk of residents experiencing antibiotic-related harms increased by 0.4% (adjusted OR 1.004, 95% CI 1.001-1.006, P=0.01).

Mody and Crnich found limitations in the study’s analytical approach to the study, suggesting that looking at the data by different measures of time, or antibiotic exposure metrics, such as facility-level antibiotic use, would have shifted the results. Also, Daneman’s team did not make adjustments for seasonal variation in the use of antibiotics in the current study.

Daneman, Bell, Gruneir, and Bronskill reported financial support from the Canadian Institutes of Health Research.

None of the authors reported any relevant financial relationships with industry.

  • Reviewed by
    F. Perry Wilson, MD, MSCE Assistant Professor, Section of Nephrology, Yale School of Medicine and Dorothy Caputo, MA, BSN, RN, Nurse Planner

last updated 06.29.2015

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Can-Fite reports further progress in continuing preclinical program of CF602 sexual dysfunction drug

Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, today reported further progress in its continuing preclinical program of its CF602 drug candidate as the Company prepares to file an investigational new drug (IND) application with the U.S. Food and Drug Administration to allow the initiation of a Phase I clinical study.

In additional preclinical studies, the Company established CF602’s efficacy in a diabetic rat preclinical study. The animals were treated twice daily with CF602 for a period of 1 and 5 days. The results demonstrated a significant response rate resulting in a 188% (p<0.01) and 250% (p<0.001) increase in penial intra-cavernosal pressure (ICP), respectively compared to placebo. CF602 was shown not to affect blood pressure in this model.

Preclinical studies to date, utilizing newly manufactured CF602 drug substance, have demonstrated good bioavailability and linear pharmacokinetics.

“New data resulting from the progress in our preclinical studies strengthen our belief that CF602 is a strong drug candidate to be developed for people suffering from sexual dysfunction. We have a robust intellectual property portfolio which includes an issued composition of matter patent and other pending patent applications protecting the use of CF602 for sexual dysfunction,” stated Can-Fite CEO Dr. Pnina Fishman.


Can-Fite BioPharma Ltd.

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Diabetes Drug Found Useless for Parkinson's

Action Points

  • Note that this trial of two doses of pioglitazone showed no effect compared with placebo in patients with Parkinson’s disease.
  • Be aware that animal studies that suggested this might be efficacious were conducted in toxin-induced Parkinson’s models.

The diabetes drug pioglitazone (Actos) isn’t likely to slow the progression of early Parkinson’s disease, researchers reported.

A futility study showed in several analyses that both doses of the drug that were tested (15 mg and 45 mg) were futile at slowing disease progression, Tanya Simuni, MD, of Northwestern University, and colleagues reported online in the Lancet Neurology.

“Our results show that pioglitazone is unlikely to be efficacious as a disease-modifying intervention in early Parkinson’s and therefore is not recommended for further testing for that indication,” they wrote. “Although our negative results are disappointing, the design of this futility study is an example of a useful and efficient study design that can exclude a compound unlikely to be successful in larger and more costly phase III studies.”

Simuni and colleagues conducted the analysis as part of the National Institute of Neurological Disorders and Stroke (NINDS)’s Exploratory Trials in Parkinson Disease (NET-PD), which was charged in 2001 with assessing therapies that may slow progression of Parkinson’s. The FS-Zone study specifically looks at the effects of pioglitazone on the disease.

Some work, particularly in animal models, had suggested that thiazolidinediones (TZDs) like pioglitazone might have neuroprotective effects in neurodegenerative diseases, and, in particular, pioglitazone may slow progression of Parkinson’s. The mechanism was thought to be the ability of TZDs — which are peroxisome proliferator-activated receptor-gamma (PPAR-gamma) agonists — to inhibit activation of microglia and astrocytes as well as the production of pro-inflammatory cytokines and nitric oxide.

This class of agents — including troglitazone (Resulin), rosiglitazone (Avandia), and pioglitazone (Actos) — had come under fire as diabetes treatments for ties to liver toxicity, heart disease, and bladder cancer, respectively. Troglitazone was pulled from the market in 2000, and the other two drugs remain on the market under FDA’s risk evaluation and mitigation strategy (REMS) program.

The investigators conducted their phase II futility study in 210 patients who had a diagnosis of early Parkinson’s and were taking either rasagiline or selegiline. These patients were randomized to one of two doses of pioglitazone (15 mg/day or 45 mg/day) or to placebo.

The primary outcome was the change in the total Unified Parkinson’s Disease Rating Scale (UPRDS) score after 44 weeks.

The mean changes in UPDRS scores — higher scores show worsening — across groups were:

  • 15-mg dose: 4.42
  • 45-mg dose: 5.13
  • Placebo: 6.25

In the main analysis, the difference between the 45-mg dose and placebo was futile, but the difference between the 15-mg group and placebo wasn’t.

In planned sensitivity analyses, the 15-mg dose was also found to be futile — but the 45-mg dose wasn’t. The investigators explained that the sensitivity analyses of the primary outcomes used “the last value carried forward (LVCF) to handle missing data and using the completers’ only sample.”

Finally, in a post-hoc repeated measures mixed model analysis, both doses proved futile, leading the researchers to conclude that pioglitazone has no role in Parkinson’s treatment.

“Unfortunately, this is another study in which animal models were not predictive of efficacy in human beings,” they wrote. “A possible explanation for negative outcomes is that toxin animal models are not reflective of Parkinson’s disease pathogenesis. Another possibility is that pioglitazone failed to reach the target nigral neurons and achieve sufficient drug exposure in this study.”

None of the adverse events — six in the 15-mg group, nine in the 45-mg group, and three in the placebo group — were determined to be related to the drug or placebo, the researchers said.

They wrote that attention in Parkinson’s research has switched to the “discovery and validation of biomarkers of disease progression, which we hope will accelerate the development of disease-modifying or curative agents.”

In an accompanying editorial, Fabrizio Stocchi, MD, of Institute for Research and Medical Care in San Raffaele in Italy, said the results “represent another disappointment in this difficult field.”

He agreed that the animal model in which the initial associations were made may be problematic since those models rely on administering toxins that may not provoke the same pathogenic processes as Parkinson’s. Nor do animal models always “recapitulate the progressive features of sporadic Parkinson’s, and the administration of the study drug is not always started after neurodegeneration is induced,” he wrote.

Stocchi added that the sensitivity of UPDRS is good, but it may not be as good in patients with early or mild disease: “A biomarker that could be used to confirm diagnosis or as an endpoint to measure disease progression and drug efficacy could solve the problems of sensitivity and subjectivity,” he added.

Simuni disclosed financial relationships with Acadia, AbbVie, Allergan, Eli Lilly, Harbor, Ibsen, Merz, UCB Pharma, US World Meds, GE Medical, Teva, Impax, Lundbeck, Auspex, Biotie, and Civitas.

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NHS wants negligence legal costs capped

Medical legal costs ‘excessive and should be capped’

  • 28 June 2015
  • From the section Health
Medical negligence claims are rising

The government intends to put strict limits on the “excessive fees” some lawyers claim in medical negligence cases against the NHS in England.

Officials want a defined limit on legal costs in cases where the claims are below £100,000, saying that some lawyers submit bills that charge more than patients receive in compensation.

But solicitors warn the move could deny patients access to justice.

Figures show the NHS was charged £259m in legal fees for claims in 2013-14.

The NHS did recoup £74m by challenging some claims made in 2013-14, but the Department of Health says taking these cases to court is costly and time-consuming and believes further savings could be made.

Officials say their proposals, which will be open to public consultation in the autumn, would ensure lawyer’s fees are more proportionate and reflect the amount of compensation patients receive

They give as an example once case where a patient received £11,800 in damages but the legal fees, which the NHS had to recompense, totalled £175,000.

Health Minister, Ben Gummer, said: “Safe, compassionate care is my upmost priority and to achieve this, the NHS must make sure every penny counts.

“Unscrupulously, some lawyers have used patient claims to load grossly excessive costs onto the NHS and charge far more than the patient receives in compensation.”

But a leading clinical negligence solicitor, Terry Donovan from the law firm Kingsley Napley, said costs are sometimes driven up by delays in the NHS admitting liability.

He added: “This sounds like another massive attack on access to justice for everybody.

“Fees are already tightly controlled, with the courts managing costs carefully as a result of recent reforms. Costs are already capped and limited.

“These so-called low value cases under £100,000 still involve cases where people have had serious injuries and lives have been destroyed.

“Costs can be very proportionate if the NHS will admit liability promptly when it’s appropriate.

“But defendants drive up costs if they don’t admit liability early on and the case ends up in court.”

Meanwhile, the Medical Defence Union, which offers doctors guidance on medico-legal issues, supported the move.

Dr Matthew Lee, professional services director for the MDU, said: “Patients often need to meet part or all of these costs themselves but the system must provide access to justice where patients have been negligently harmed.

“Legal fees must, therefore, be affordable and proportionate.

“If it was decided to introduce a well-thought-out, fixed-cost structure for legal costs in clinical negligence claims that could only be a good thing and should result in legal fees becoming more affordable and proportionate to the compensation claimed by the patient.”

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Meet the New Acting Administrator – First 100 Days, 6 Questions with Andy Slavitt

Meet the New Acting Administrator – First 100 Days, 6 Questions with Andy Slavitt

June 26

Earlier this year, Andy Slavitt was named Acting Administrator for the Centers for Medicare & Medicaid Services (CMS). As Acting Administrator, Andy oversees programs that provide access to health care for 140 million Americans, including Medicaid, Medicare, the Children’s Health Insurance Program, and the Health Insurance Marketplace. 

1. You’ve been at CMS 100 days. Tell us about how you’ve spent your time. 

The best way to learn anything is to ask a lot of questions. Over the last 100 days, I’ve met with over 300 CMS employees in Washington, Baltimore, and at regional offices and I’ve talked with many more staff at all our employee meetings. I’ve also conducted well over 100 external constituent meetings. When I meet with people I like to ask: How does CMS need to improve? How does your work contribute to CMS’s mission? What do you want CMS to be known for? As I ask questions, I share a little of my personal philosophy on leading, thoughts about our priorities, and how we should get our work done. I talk about the power of an execution mindset; the importance of keeping the people we serve at the center of our work; the need for us to be good partners, which means being clear, consistent, urgent and foster simplification; and to not just drive change, but support it. Over the last couple of months, I’ve really enjoyed the opportunity to learn more about the Agency. I’ve been close to Medicare and Medicaid my entire career, but there’s nothing like learning from the people who are most invested in the success of these programs.

2. What do you see as the biggest priorities for the agency? 

Our priority is simple – continue to improve our health care system by providing better care, with a smarter payment system that keeps people healthier. The progress that has been made as we stand here at the 50th Anniversary of Medicare and Medicaid and at the 5th anniversary of the passage of the Affordable Care Act is encouraging, but it’s only a start. The opportunities before us are exciting. We are at the center of change—with the opportunity to expand the impact we have as we cover more people in new programs and purchase care differently to reward physicians and hospitals who deliver high-quality care. At CMS, we need to focus on the changing needs of our consumers, on providing access to high quality care, and to delivering on our commitment to do everything we do transparently, with urgency and with accountability. 

3. What are your formative career and health care experiences? How have they prepared you for this job?

Like many people who work in health care, a personal experience was a big shaper of my career. I lost one of my closest friends at a young age and helped his wife deal with the threat of personal bankruptcy in the wake of his death because of the medical expenses he incurred. I learned it was far from uncommon for a young mother with two babies to start her life over in bankruptcy for no other reason than her husband’s illness and that situations like hers happened to countless people every year. I left my job to create a company, HealthAllies, with the goal of helping solve this problem through a consumer web-based service that contracted nationwide for affordable care for the underinsured like my friend’s family. I will never forget the feeling of vulnerability that’s at the center of all of our experiences with the health care system. 

In many ways, everything I experienced in the private sector was preparatory work for my work here at CMS. I’ve been involved in Medicare, Medicaid, Children’s Health Insurance Programs, and the private sector delivery of health care – and the transformation of it – for nearly my entire career. From building primary care practices to developing the largest data and analytics tools and measures to driving innovation by using health care technology and population health.  During these years, I learned that so much of what the federal government does impacts what happens on the ground – to consumers and to physicians. If there’s one thing local communities want from us it’s to simplify things to allow care givers to spend more productive time with patients, keeping them well and keeping them at home.  Leading CMS is an enormous privilege and I am committed to what drove me into health care – to remembering that health care is local and it’s personal. My job and every other CMS employee’s job is to help make the health care system stronger through listening to the needs of consumers and being good supportive partners with the delivery systems, states and other stakeholders.

4. What grounds you in this job?

Today CMS serves 140 million beneficiaries and consumers. I wake-up every day thinking about them. How many are in a hospital, aching to go home? How many are struggling to find good care for an asthmatic child? How many are between jobs and looking for coverage and hoping for something affordable? The fact is: serving close to half the people in the country means the daily needs and circumstances are diverse and profound. That’s why whenever I travel, I visit nursing homes, health centers, and ERs. I ask about the discharge planning. I ask what can be done to simplify their relationship with us. The first thing I do every morning is to read and personally answer emails from beneficiaries and make sure their situations are being followed up on. It’s the single action I can take that lets people know what I think is important. 

The other people that ground my thinking are taxpayers. There’s no doubt I bring a business performance perspective to the job. If beneficiaries are our customers, then in a private sector analogy, taxpayers are our shareholders. American families invest their tax dollars every year to support the Medicare and Medicaid programs; they expect these programs to not only perform well today but to be available for them when and if they need them in the future. 

On any given day, you’re not going to make everyone happy in a job like this. I just need to go to sleep every night feeling like we’ve done the best job possible for the people who count on us the most and will count on us in the future. 

5. What motivated you to join the team atCMS?

I have been working in health care my entire career. As a country, we are transitioning from a time when the action was all about debating policy to a time when the focus needs to be on getting it done and making it work. I believe in the adage that success is 90% about implementation. From overseeing the health insurance exchanges to implementing Accountable Care Organizations and making improvements to the long term health of Medicare, Medicaid or CHIP, I have this vision of CMS as an arm of government that is all about providing access to quality health care to millions of Americans but also getting the job done right. We have a lot of important things to accomplish. If we can bring the speed, the focus, the accountability and the transparency that exists in the best of organizations to the job we’re doing every day at CMS, millions of people benefit. Before I took this job, I don’t think I realized how many good things could get done every day. It’s one reason why I love this job. 

6. Finally, how about something personal. How does your familyfeel about your taking thisnew role?

I’m not going to pretend that being away from my wife and my two teenage sons is easy. I fly home to Minnesota every weekend. We’re quite aware that the kids’ time at home is limited and precious. The four of us are extremely close and spend a lot of time laughing together, having serious conversations about the world, and finding ways to support one another. My wife knows what it’s like for people who struggle economically and health wise and she’s one of the smartest and most capable people most people know. Doing public service is something of great importance to both my wife and me and she does everything in her power to make sure I can focus on the important opportunity I have to do the job in front of me.


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Xencor announces progress and expansion of proprietary pipeline of XmAb antibodies

Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune diseases, asthma and allergic diseases, and cancer, today announced updates on its lead product candidates, XmAb®5871 and XmAb®7195, and on its XmAb® bispecific oncology pipeline. Updates are being presented today at its R&D Day for analysts and investors in New York, NY.

“We are happy to report on the progress and expansion of our proprietary pipeline of XmAb antibodies,” said Bassil Dahiyat, Ph.D., president and chief executive officer of Xencor. “Today we will discuss the planned open-label pilot study of XmAb5871 in the rare autoimmune disorder IgG4-related disease (IgG4-RD), and provide an update on our progress for XmAb7195. We have added additional cohorts to the ongoing Phase 1a study of XmAb7195 and started this next phase of the trial, in which subjects will receive two infusions of XmAb7195, allowing us to examine IgE reduction and the safety profile in this setting. Further, we plan to initiate a Phase 1 study with a subcutaneous formulation of XmAb7195 in 2016. We have also selected our second bispecific antibody, XmAb13676, which will enter clinical testing for B-cell malignancies in 2016. This CD20xCD3 bispecific molecule is the beginning of a planned expansion of our bispecific oncology pipeline.”

Program Highlights:


XmAb5871 is a first-in-class monoclonal antibody that targets CD19 with its variable domain and that uses Xencor’s proprietary XmAb immune inhibitory Fc domain to target FcγRIIb, a receptor that inhibits B-cell function. The Company reported Phase 1b/2a data in rheumatoid arthritis (RA) patients at the European League Against Rheumatism (EULAR) 2015 Annual Meeting on June 10, 2015, which showed promising trends in improvement in RA disease activity by multiple disease activity measures and across multiple dose groups. The Company believes that XmAb5871 has potential clinical application across a number of autoimmune diseases, including IgG4-Related Disease (IgG4-RD), for which Xencor expects to initiate an open-label pilot study later in 2015.

Today, Xencor will provide an overview of its development plans for XmAb5871 for the treatment of the rare autoimmune disorder IgG4-RD. This open-label pilot trial will enroll approximately 15 subjects, treatment will continue for up to 24 weeks and the recently reported IgG4-RD Responder Index will be used to assess treatment activity (Carruthers 2012, International Journal of Rheumatology). Xencor’s planned lead investigator, John Stone, M.D., Ph.D., Professor of Medicine at Massachusetts General Hospital, will present background and insights from his experience in treating IgG4-RD patients.

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XmAb7195 is a monoclonal antibody in Phase 1a development as a potential treatment for allergic asthma. XmAb7195 targets IgE with its variable domain and uses Xencor’s XmAb immune inhibitor Fc domain to target FcγRIIb, resulting in three distinct mechanisms of action for reducing IgE levels. In multiple animal models, XmAb7195 has been shown to rapidly reduce free and total IgE and block production of IgE by immune cells.

Today, Xencor announced commencement of an expansion of the Phase 1a trial of XmAb7195, in which subjects will receive two doses of XmAb7195. This new part of the trial will allow the Company to examine IgE reduction and the safety profile of XmAb7195 after a second infusion. Data from this trial is expected in the first half of 2016. Additionally, the Company announced today that a Phase 1 trial with a subcutaneous formulation of XmAb7195 is planned for 2016.

Bispecific Oncology Pipeline

Xencor’s initial bispecific programs are tumor-targeted antibodies that contain both a tumor antigen binding domain and a cytotoxic T-cell binding domain (CD3). These bispecific antibodies activate T-cells for highly potent and targeted killing of malignant cells. XmAb Fc domains confer long circulating half-lives on the antibodies, up to a week in mice, and enable fine-tuning of the potency of the T-cell killing, potentially improving the tolerability of cancer immunotherapy.

Today, Xencor announced that it has selected XmAb13676, a CD20xCD3 bispecific antibody, for clinical testing for B-cell malignancies and expects to begin trials in 2016. This candidate joins XmAb14045, a CD123xCD3 bispecific antibody, and is the second of a growing portfolio of additional XmAb bispecific drug candidates which the Company plans to develop. In addition, the Company will introduce its efforts to modulate T-cell function with new bispecific approaches to target multiple checkpoint inhibitors and to target regulatory T-cells.

Tyler Curiel, M.D., M.P.H., Skinner Chair in Cancer Immunotherapy and Professor of Medicine, University of Texas Health Sciences Center San Antonio will review efforts to reprogram T-cells in oncology therapy and to understand points of intervention for T-cell targeting therapies.


Xencor, Inc.

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