Morning Break: Deaths Derail AML Drug: Flawed Generic Rx Trials; 'Chill' Says Dr. Murthy

Reuters looks behind the clinic door to expose questionable practices used by India’s booming genetic drug testing business. Zeba Siddiqui reports.

The FDA put early-stage trials of vadastuximab talirine, Seattle Genetics’ acute myeloid leukemia drug, on clinical hold after four patients died. (CNBC)

Actress Carrie Fisher, who was hospitalized following a heart attack that occurred while she was on an airplane flight from London to Los Angeles, died Tuesday at age 60. (The New York Times)

The Federal Trade Commission has approved Abbott Laboratories’ $25 billion purchase of device maker St. Jude Medical. (Reuters)

Healthcare costs for children increased by 56% between 1996 and 2013, researchers found. (HealthDay News via U.S. News & World Report)

Everyone needs to better learn how to deal with stress, says outgoing surgeon general Vivek Murthy, MD. (The New York Times)

Anthera Pharmaceuticals Inc said on Tuesday that sollpura, its novel cystic fibrosis drug, failed in a late-stage study. (Reuters)

Meals on Wheels is working to become the healthcare “eyes and ears” of seniors. (Kaiser Health News via CNN)

The House will vote on Obamacare repeal as one of its first agenda items when it returns in early January. (CQ Roll Call via Modern Healthcare)

The heart failure drug cimaglermin demonstrated safety in a small Phase 1 trial. (CBS News)

In other clinical trial news, a researcher retracted a study showing that a hormone found in the liver appeared to encourage the production of insulin-producing cells in mice, perhaps suggesting a way for a new approach to treating diabetes. (STAT News)

Families living near Dartmouth College are concerned that the school’s disposal of dead mice from its science labs may be contaminating the local groundwater. (Associated Press via the Washington Post)

Safety-net hospitals are worried about what Obamacare repeal will mean for them. (The New York Times)

Making physicians work 28-hour shifts teaches them that their own well-being is not a priority, says Stephanie Waggel, MD. (

Morning Break is a daily guide to what’s new and interesting on the Web for healthcare professionals, powered by the MedPage Today community. Got a tip? Send it to us:


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2016's Top 5 Advances in Oncology

MedPage Today asked specialists in oncology around the country to tell us what they thought were the most important clinical developments in 2016. These were the five most commonly mentioned.

1. Immunotherapy

More than half of the oncologists who responded to our request cited one or more developments in immunotherapy/immuno-oncology. Some made general comments (“continued emergence and evolution of immunotherapy”), whereas other participants in the informal survey cited specific studies or other examples:

  • Superiority of combination immunotherapy to a single agent for conditions other than melanoma (non-small cell lung cancer [NSCLC], for example)
  • New insights into the mechanisms of immunotherapy resistance
  • Immunotherapy outperformed conventional chemotherapy as first- or second-line treatment for NSCLC

The story will continue to unfold in the coming year.

“This year, we saw several studies showing dramatic results for immunotherapy in heavily pretreated breast cancer patients with advanced triple-negative breast cancer,” said Anees Chagpar, MD, of Yale Cancer Center in New Haven, Conn. “This has led to new clinical trials to evaluate immune checkpoint inhibitors in patients with earlier-stage disease — stay tuned!”

2. CAR T-Cell Therapy

As MedPage Today reported earlier this month, a positive multicenter trial showed that the dramatic activity of chimeric antigen receptor T-cell therapy seen in small, single-center trials could be pulled off on a larger scale, involving centers and investigators with little or no prior experience with the technology. The success sets the stage for broader application and availability of the therapy.

“We have observed impressive responses with CAR T-cell immunotherapy in [hematologic malignancies] and now we are seeing some activity in solid tumors,” said Jonathan S. Berek, MD, of Stanford University in Stanford, Calif.

3. CDK4/6 Inhibitors for Breast Cancer

Results of recent trials of palbociclib (Ibrance) and ribociclib suggested that the CDK4/6-inhibitor class will have a practice-changing impact on the management hormone receptor-positive breast cancer.

4. PARP Inhibitors for Ovarian Cancer

The FDA has approved two drugs in the class, and a recently completed trial of niraparib suggested the drugs might have broader activity in ovarian cancer than previously recognized.

5. Lifestyle Interventions

Perhaps a surprising entry in this list of high-tech interventions; lifestyle and behavioral interventions have won more respect in the oncology field, as factors such as diet, physical activity, and obesity have emerged as significant contributors to cancer risk, including recurrence.

“Most clinicians, if not all, would agree that many of the illnesses we treat can be prevented or treated with lifestyle changes,” said Candida D. Suffridge, MD, PhD, of Baylor Scott & White Health System in Georgetown, Texas.


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New comprehensive study lists top personal health expenses in the U.S.

Just 20 conditions make up more than half of all spending on health care in the United States, according to a new comprehensive financial analysis that examines spending by diseases and injuries.

The most expensive condition, diabetes, totaled $101 billion in diagnoses and treatments, growing 36 times faster than the cost of ischemic heart disease, the number-one cause of death, over the past 18 years. While these two conditions typically affect individuals 65 and older, low back and neck pain, the third-most expensive condition, primarily strikes adults of working age.

These three top spending categories, along with hypertension and injuries from falls, comprise 18% of all personal health spending, and totaled $437 billion in 2013.

This study, published today in JAMA, distinguishes spending on public health programs from personal health spending, including both individual out-of-pocket costs and spending by private and government insurance programs. It covers 155 conditions.

“While it is well known that the US spends more than any other nation on health care, very little is known about what diseases drive that spending.” said Dr. Joseph Dieleman, lead author of the paper and Assistant Professor at the Institute for Health Metrics and Evaluation (IHME) at the University of Washington. “IHME is trying to fill the information gap so that decision-makers in the public and private sectors can understand the spending landscape, and plan and allocate health resources more effectively.”

In addition to the $2.1 trillion spent on the 155 conditions examined in the study, Dr. Dieleman estimates that approximately $300 billion in costs, such as those of over-the-counter medications and privately funded home health care, remain unaccounted for, indicating total personal health care costs in the US reached $2.4 trillion in 2013.

Other expensive conditions among the top 20 include musculoskeletal disorders, such as tendinitis, carpal tunnel syndrome, and rheumatoid arthritis; well-care associated with dental visits; and pregnancy and postpartum care.

The paper, “US Spending on Personal Health Care and Public Health, 1996-2013,” tracks a total of $30.1 trillion in personal health care spending over 18 years. While the majority of those costs were associated with non-communicable diseases, the top infectious disease category was respiratory infections, such as bronchitis and pneumonia.

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Other key findings from the paper include: Women ages 85 and older spent the most per person in 2013, at more than $31,000 per person. More than half of this spending (58%) occurred in nursing facilities, while 40% was expended on cardiovascular diseases, Alzheimer’s disease, and falls. Men ages 85 and older spent $24,000 per person in 2013, with only 37% on nursing facilities, largely because women live longer and men more often have a spouse at home to provide care. Less than 10% of personal health care spending is on nursing care facilities, and less than 5% of spending is on emergency department care. The conditions leading to the most spending in nursing care facilities are Alzheimer’s and stroke, while the condition leading to the most spending in emergency departments is falls. Public health education and advocacy initiatives, such as anti-tobacco and cancer awareness campaigns, totaled an estimated $77.9 billion in 2013, less than 3% of total health spending. Only 6% of personal health care spending was on well-care, which is all care unrelated to the diagnosis and treatment of illnesses or injuries. Of this, nearly a third of the spending was on pregnancy and postpartum care, which was the 10th-largest category of spending.

“This paper offers private insurers, physicians, health policy experts, and government leaders a comprehensive review,” said IHME’s Director, Dr. Christopher Murray. “As the United States explores ways to deliver services more effectively and efficiently, our findings provide important metrics to influence the future, both in short- and long-term planning.”

The top 10 most costly health expenses in 2013 were:

1. Diabetes – $101.4 billion

2. Ischemic heart disease – $88.1 billion

3. Low back and neck pain – $87.6 billion

4. Hypertension – $83.9 billion

5. Injuries from falls – $76.3 billion

6. Depressive disorders – $71.1 billion

7. Oral-related problems – $66.4 billion

8. Vision and hearing problems – $59 billion

9. Skin-related problems, such as cellulitis and acne – $55.7 billion

10. Pregnancy and postpartum care – $55.6 billion


Institute for Health Metrics and Evaluation

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U.S. posts rules for addressing cyber bugs in medical devices

By Jim Finkle

The U.S. government on Tuesday issued rules for addressing cyber vulnerabilities in medical devices, providing manufacturers with guidelines for fixing security bugs in equipment, including pacemakers, insulin pumps and imaging systems.

“Cybersecurity threats are real, ever-present and continuously changing,” Suzanne Schwartz, a senior Food and Drug Administration official who helped draft the new rules, said in a blog post. “And as hackers become more sophisticated, these cybersecurity risks will evolve.”

The FDA released the 30-page guidance as the agency investigates claims from a short-selling firm and security researchers that heart devices from St. Jude Medical Inc are vulnerable to life-threatening hacks. The allegations, which surfaced in August, underscore the need for clear government rules on identifying and mitigating the impact of security vulnerabilities in medical equipment.

The FDA has been grappling with such issues for several years in response to a surge in research on potentially life- threatening security bugs in medical devices from so-called “white hat” hackers looking to identify flaws before they are exploited to harm patients.

The agency in 2014 issued guidance on how manufacturers should address cyber security when developing new products, though the rules did not cover equipment that was already on the market.

In 2015 the FDA advised hospitals to halt use of one of Hospira Inc’s infusion pumps, saying a security vulnerability could allow cyber attackers to take remote control of the system.

The new guidelines detail how manufacturers should identify and fix cyber vulnerabilities in products that are already on the market. The rules encourage medical device makers to establish programs to make it easy for security researchers to report new bugs.

“There is greater clarity for manufacturers, patients and hospitals,” said Josh Corman, an expert on medical device security who is director of the Atlantic Council’s Cyber Statecraft Initiative.

(Reporting by Jim Finkle in Boston; Editing by Dan Grebler)

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Hospitalized Seniors Say No One Coordinates Their Care

A survey of more than a thousand seniors shows the gaps in care coordination for some of the nation’s most costly and most vulnerable patients, and highlights the need for better, more innovative care management.

The Harris Poll survey found that 85% of respondents had been diagnosed with some type of health condition. More than 64% said they have seen at least three healthcare providers during the past year.

However, 69% of respondents said they rely on themselves or a family member to coordinate their care, and 63% who have been hospitalized said no one helps coordinate their care for the first few months following discharge.

Less than half of those surveyed (43%) reported that they were asked about the treatments or medications prescribed by other doctors, highlighting possible risks to patient safety and good outcomes.

However, nearly all seniors (95%) said they are satisfied with the care they receive from their provider — typically a primary care physician or his or her staff (85%).

More than three-quarters of seniors said their healthcare provider takes an active role in helping them manage their health (78%), gives them the support they need to live healthier lives (84%), and is a partner in helping them take care of their health (82%).

That doesn’t mean they wouldn’t appreciate more help or recognize the need for it. Some 28% said they would like their healthcare provider to have a person in their office call them regularly to ask if they have questions about treatment or medications.

More than half (52%) said they want their provider to offer access people or programs that could help them understand their current treatment plans and manage their health.

The survey was conducted between September 26 and October 13, and included 1,005 respondents in the United States age 65 or older. It was commissioned by Anthem subsidiary CareMore, an operationally independent, senior-focused health plan and medical group.

“Responses to the survey reinforce the importance of engaging patients by providing access to a comprehensive health care team and services to enable access to optimal care and coordination,” CareMore stated in its overview of the survey.

This report is brought to you by HealthLeaders Media.


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Quicker weight bearing may be safe with knee cartilage surgery

By Madeline Kennedy

(Reuters Health) – People receiving a graft of their own knee cartilage cells may be better off returning to full weight bearing after six weeks instead of the standard eight, a small study suggests.

Knee surgery patients put on a six-week recovery track were able to get back to work and other activities like sports more quickly, and even reported slightly better results at 24 months than those who had followed an eight-week recovery plan after surgery, researchers report in the American Journal of Sports Medicine.

People with damaged cartilage in their knees can undergo so-called matrix-induced autologous chondrocyte implantation, or MACI, surgery to fix the defects that cause pain and swelling.

In the two-stage MACI surgery, healthy cartilage is collected from unaffected parts of the damaged knee and sent to a lab where it’s used to grow more cartilage on a scaffold-like material. The surgeon then implants this graft into the damaged parts of the knee where it’s expected to integrate with surrounding cartilage.

Standard practice has been to keep weight off the knee for at least eight weeks and up to three months for fear of damaging the delicate new tissue. But there’s evidence that the forces of weight and movement promote growth by the cartilage cells, the authors write, so putting some weight on the implant earlier might help speed recovery of the knee.

“The regimens employed internationally were very conservative in fear of overloading the early repair tissue and jeopardizing the final outcome,” lead author Jay Ebert told Reuters Health by email.

Besides the obvious lifestyle benefits of shorter recovery times, there are clinical benefits as well, said Ebert, of the University of Western Australia in Crawley. Returning to walking more quickly may reduce the amount of muscle lost and the level of joint stiffness after surgery, he said.

To explore whether people could heal as well from surgery if they only kept off of their feet for six weeks instead of eight, the study team recruited 37 MACI surgery patients between 2010 and 2014.

The participants were randomly assigned to an eight-week return to weight-bearing group or an accelerated six-week recovery group.

They answered questions before and after their surgeries about their pain, symptoms, daily functioning and sports ability.

At three, six, 12 and 24 months after surgery, participants’ knee function was tested, including flexing, extending and walking abilities.

Two years after surgery, the patients had their knees scanned by MRI to assess how well the cartilage had integrated and they answered questionnaires about their satisfaction with the procedure.

Overall, the results were good for both groups. There were two cases of graft failure, both in the eight-week recovery group.

The two groups had similar results on all tests of knee function, with the accelerated group performing slightly better. For instance their repaired knees, on average, had returned to 94 percent of the peak strength of the undamaged knee, compared to 88 percent in the eight-week recovery group.

The MRI scans showed the patients in the faster recovery group had significantly better healing on two out of eight visible measures, compared with the eight-week group.

Overall, 83 percent of patients in the eight-week group were satisfied with their surgery, while 88 percent of patients in the six-week group reported being satisfied.

“With any new surgical procedure the rehabilitation will tend to be on the conservative side,” said Karen Hambly, a senior lecturer at the University of Kent in England who was not involved in the study.

“Taking the patient perspective is important. Why would someone want to be on crutches 2 weeks longer than they need to be?” Hambly said by email.

Returning to walking too early can damage the new cartilage, however, Hambly cautioned. “Anyone considering undergoing a cartilage repair procedure should read up on the surgery and the rehabilitation so that they can appreciate the need to protect the new, delicate repair tissue and the need for the post-operative recovery times,” she said.

“MACI surgery produces excellent clinical results, very satisfied patients and a durable regenerative cartilage tissue, which also permits a faster return to work and daily activities,” Ebert said.

SOURCE: American Journal of Sports Medicine, online November 23, 2016.

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