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May 20, 2016
Fight Zika by making your smartphone into a supercomputer
You can help find a drug that could knock out the Zika virus, while you're playing Candy Crush on your smartphone. An international research effort
to identify potential drug compounds to combat the virus is being launched on a tech platform that turns a network of volunteers' personal computers,
as well as Android mobile phones and tablets, into a virtual supercomputer that can speedily process millions of calculations.
The #OpenZika project, announced Thursday, will run virtual experiments on potential compounds that could form drugs to address Zika. It's the
latest health-related research project by IBM's World Community Grid.
After a dozen years of operation, the platform has almost 750,000 people and 470 institutions across 80 countries, allowing researchers to tap their
3.5 million computers and mobile devices for latent processing power. The World Community Grid has been used to research diseases including
malaria, Ebola, tuberculosis and childhood neuroblastoma.
Volunteers download a World Community Grid app to their computer or devices. That allows researchers to run calculations on the devices, without
their owners noticing a difference in performance. Data generated from the #OpenZika project will be available to researchers on an open-source
basis around the world.
The #OpenZika project comes two months after the World Health Organization declared the Zika outbreaks occurring in Brazil and other countries a
public health emergency of international concern, and a week after U.S. health authorities said that more than 500 people in the United States have
been infected with the Zika virus while traveling abroad.
"When people hear about a crisis like this, they want to do something about it," said Stanley Litow IBM's vice president of corporate citizenship and
corporate affairs and president of IBM's Foundation. Litow said volunteers can track how many calculations were done on their computers or mobile
devices, can determine which research projects they want their computing power used for and can designate when they want the devices accessed.
He added that in the World Community Grid's history, despite many millions of computations performed, there has never been a security breach of
users' computers or devices.
Researchers at several of the institutions participating in the #OpenZika project said that getting access to the World Community Grid offers the
chance to dramatically speed up the experimental process as they seek a cure for the virus.
The amount of power is crucial when researching a disease such as Zika, according to Rutgers associate professor Joel Freundlich, who runs a lab
within the Center for Emerging and Re-Emerging Pathogens. Freundlich said that unlike a disease such as cancer, which has attracted massive
amounts of research over decades, the Zika virus until recently has drawn little interest among drug developers.
Getting access to IBM's grid, Freundlich said, "is a massive sort of jump start to the drug discovery effort," helping to weed out the many compounds
that aren't likely to address Zika, and identifying what will be relatively few compounds that offer a better chance of fighting it.
When the grid does identity potentially useful drug compounds, researches then will conduct experiments in real-world labs to test their efficacy on
the virus and their safety for human cells.
Visit CNBC for the story.
Theranos voids two years of Edison blood-test results
Theranos Inc. has told federal health regulators that the company voided two years of results from its Edison blood-testing devices, according to a
person familiar with the matter.
The Edison machines were touted as revolutionary and were the main basis for the $9 billion valuation attained by the Palo Alto, CA, company in a
funding round in 2014. But Theranos has now told regulators that it threw out all Edison test results from 2014 and 2015.
The company has told the Centers for Medicare and Medicaid Services that it has issued tens of thousands of corrected blood-test reports to doctors
and patients, voiding some results and revising others, according to the person familiar with the matter.
That means some patients received erroneous results that might have thrown off health decisions made with their doctors. The corrected reports
include the voided Edison results and many tests run on traditional laboratory machines, the person said.
Several physician practices in the Phoenix area confirmed receiving corrected test reports from Theranos in recent weeks.
The move is part of Theranos’s attempt to persuade the agency not to impose stiff sanctions it threatened in the aftermath of its inspection of the
company’s Newark, CA, laboratory. The voided and revised test results are one of the most dramatic steps yet taken by Theranos.
Company records reviewed during the inspection showed that the California lab ran about 890,000 tests a year. The inspection found that Edison
machines in the lab often failed to meet the company’s own accuracy requirements.
Theranos has told regulators that it used the Edison for 12 types of tests out of more than 200 offered to consumers and stopped using the devices
altogether in late June 2015, the person familiar with the matter said.
In response to questions from The Wall Street Journal about the blood-test corrections, Theranos spokeswoman Brooke Buchanan said: “Excellence
in quality and patient safety is our top priority and we’ve taken comprehensive corrective measures to address the issues CMS raised in their
observations. As these matters are currently under review, we have no further comment at this time.”
The company has said it has taken broad corrective actions in response to the government’s concerns. Among other steps, Theranos has filed a
detailed correction plan with regulators, hired a new director for the California lab and suspended most testing there.
CMS is expected to announce a final decision on the sanctions soon. If the agency decides to go through with any sanctions, Theranos could appeal
to an administrative law judge and then a departmental appeals board.
The company’s Arizona lab wasn’t part of last fall’s inspection, isn’t facing a sanctions threat and continues to run a variety of tests on samples
drawn from patients at 40 Theranos wellness centers at Walgreens drugstores.
A person familiar with the matter said the Arizona lab performed the blood-coagulation tests with a traditional machine from Siemens AG that was
programmed to the wrong settings by Theranos. The Arizona lab also failed several tests to gauge the purity of the water it uses in its Siemens
machines, which could affect the accuracy of some blood tests run on the devices, the person said.
Last week, Siemens delivered lab equipment to a Theranos facility in the Harrisburg, PA, area, according to the person familiar with the matter. The
person said Theranos is preparing to open there what would be the company’s third lab.
Visit the Wall Street Journal for the article.
B. Braun to pay up to $7.8M for selling contaminated needles
Medical device maker B. Braun will pay up to $7.8 million to resolve criminal charges stemming from its sale of contaminated saline syringes that
prosecutors said caused an outbreak of bacterial infections and led to at least five deaths, the U.S. Department of Justice announced Wednesday.
The German company with U.S. corporate headquarters in Bethlehem faced criminal liability for selling contaminated syringes manufactured by
another company under its brand. Under an agreement with the Justice Department, the company will avoid prosecution in exchange for
implementing procedures to improve oversight of its suppliers.
B. Braun will pay $4.8 million in penalties and forfeited profit and up to $3 million in restitution to victims of the outbreak as part of the agreement, the
Justice Department said.
"This involved a business relationship that ended over eight years ago relating to B. Braun's distribution of flush syringes manufactured by a third
party. B. Braun entered into a non-prosecution agreement, which resolves the matter," Constance Walker, B. Braun's director of marketing
communications, said in a statement. "We are fully committed to ensuring patient safety. In that regard, we have agreed to undertake additional
compliance measures related to the qualification and monitoring of third-party manufacturers of finished products distributed by B. Braun with the B.
Braun name on the label or logo."
The allegations against B. Braun stem from an investigation by U.S. Food and Drug Administration's Office of Criminal Investigations that began after
the 2007 outbreak sickened more than 100 patients nationwide.
According to the agreement, B. Braun in 2006 began buying saline syringes from AM2PAT Inc., which manufactured the product at a small facility in
North Carolina. The pre-filled sterile syringes were intended to be used to flush out intravenous medical devices, such as central lines and ports. It
was crucial that the saline solution was sterile, because some of it could enter a patient's blood during the flushing process.
B. Braun was aware of manufacturing problems at AM2PAT before it began buying the syringes, according to the agreement. Separate audits by the
FDA and B. Braun revealed AM2PAT's problems complying with good manufacturing practices.
AM2PAT told B. Braun in spring 2007 that it intended to move to a new manufacturing plant and change the company that sterilized the syringes
made for sale by B. Braun. But before B. Braun's quality department approved the changes, B. Braun began selling syringes made in the new plant
using the new sterilization company, the agreement says.
B. Braun later approved the changes even though it had received complaints about problems with the syringes made in the new plant. It also
approved AM2PAT's move without ever seeing the company's new facility or confirming that its clean room and equipment were up to standards
after the move.
Less than two months after B. Braun began selling syringes made in the new facility, it had to recall them because the sterilization process had
caused dangerous particles to appear in the saline solution.
After the recall, AM2PAT admitted it gave B. Braun incorrect information about its sterilization process and that it had not checked the operation of its
equipment after moving to the new facility.
Shortly after that, syringes manufactured by AM2PAT and sold by B. Braun that were contaminated by Serratia marcescens bacteria caused patients
to become ill, the agreement says. A nationwide recall of the syringes was issued in early 2008 as the Centers for Disease Control and Prevention
and FDA investigated the outbreak. B. Braun terminated its relationship with AM2PAT in early 2008.
The settlement follows the prosecution of three AM2PAT employees in federal court in North Carolina.
Visit McCall for the report.
Five health issues Presidential candidates aren’t talking about — but should be
References to the Affordable Care Act have been a regular feature of the current presidential campaign season. For months, Republican candidates
have pledged to repeal it, while Democrat Hillary Clinton wants to build on it and Democrat Bernie Sanders wants to replace it with a governmentfunded “Medicare for All” program.
But much of the policy discussion stops there. Yet the nation in the next few years faces many important decisions about healthcare — most of
which have little to do with the controversial federal health law. Here are five issues candidates should be discussing, but largely are not:
1. Out-of-pocket spending: Millions more people — roughly 20 million, at last count — now have health insurance, thanks to the new coverage
options created by the ACA. But most people are also paying more of their own medical bills than ever before. And they are noticing. A recent Gallup
survey found health costs to be the top financial problem faced by adults in the United States, outpacing low wages and housing costs.
Meanwhile, even in the most generous plans offered to those who buy their own coverage through the ACA’s marketplaces, the portion of healthcare
costs borne by consumers has left many unable to afford care.
As insurers have shortened their lists of “in network” doctors and hospitals, another out-of-pocket spending problem is becoming more common: The
“surprise medical bill.” Those are bills for services provided outside a patient’s insurance network that the patient did not know was out-of-network
when he or she sought care.
Some of the candidates — notably Clinton and Sanders — have talked about the issue. But serious discussion about ways to ensure healthcare
services remain broadly affordable have been overshadowed by the fight over the fate of the federal health law.
2. Drugs — more than prices: Rising drug prices at the pharmacy counter have also proved problematic for patients. And both Republican and
Democratic candidates have discussed proposals to address the cost of prescription drugs.
Drugmakers point out their industry is a risky one, and the big rewards on breakthrough drugs offset the losses for those that never make it to the
pharmacy. But at what point does the cost to society for a drug, like new treatments for hepatitis C that tally more than $80,000 for a course of
treatment, become prohibitive?
Meanwhile, scientists are rapidly approaching the point of being able to develop specific drugs for specific individuals, a trend known as
“personalized medicine” or “precision medicine.” But even if everyone could be screened so that they would only get the expensive drugs that will
help them specifically, how could those costs be spread over society as a whole?
And how fast should promising drugs be brought to market? Some decry the lengthy testing required for Food and Drug Administration approval.
They say people are dying who could potentially be helped. But others are equally concerned that putting a drug on the market too soon poses risks
to the public.
3. Long-term care: Every day, another 10,000 baby boomers turn 65 and qualify for Medicare. An estimated 70 percent of people who reach that
threshold will need some sort of long-term care. It’s not cheap. The annual cost of these services can range from approximately $46,000 for a home
health aide to $80,000 or more for a bed in a nursing home.
Yet Medicare, the health program for the elderly and some disabled, does not pay for most long-term care services. Medicare has both nursing home
and home care benefits, but they are temporary and limited to those with specific medical needs. Most people who need long-term care don’t need
special medical interventions, just help with “activities of daily living.”
By contrast, Medicaid, the joint state-federal health program for people with low incomes, paid just over half of the nation’s estimated $310 billion tab
for long-term care in 2013, the most recent year for which this information is available. But you either have to be very poor, or spend nearly all of
your savings, in order to qualify.
4. Medicare: Medicare, which provides health insurance to an estimated 55 million people — 46 million older than age 65 and another 9 million with
disabilities, is also in a financial bind. Medicare accounts for 14 percent of all federal spending, and that is expected to grow rapidly as those
boomers reach their highest health-spending years. The program already accounts for one of every five dollars spent on health care in the U.S.
The Obama administration contends that changing the way Medicare pays healthcare providers, as begun in the ACA, has helped put the program
on more sustainable footing.
Many Republicans, however, led by House Speaker Paul Ryan, R-WI, want to effectively privatize Medicare — which would transfer the risk for cost
increases from the government to private insurers.
But even smaller changes can kick up big political pushback from those who rely on Medicare for their livelihoods. A recent Obama administration
proposal to change the way the program pays for expensive drugs administered in doctors’ offices or clinics has brought cries of complaint from both
Democrats and Republicans.
5. Dental care: Lack of dental care is particularly significant for children. Dental problems are common in youngsters, and in addition to discomfort,
lead to school absences and poorer academic performance.
Visit Kaiser for the article.
Same-day hip replacements get patients back on their feet
At most hospitals, hip replacement patients can expect a one- to three-night hospital stay. Total hip replacement surgery is increasingly common,
with more than 300,000 procedures done every year in the U.S. The surgery is meant to restore range of motion and help relieve arthritic pain. The
procedure consists of removing the patient's worn out ball and socket joint and inserting an artificial socket. On the femur side, a stem is inserted into
the bone and a ball is on the tip of it.
NYU Langone Medical Center said it became the first academic medical center in New York City to implement a same-day hip replacement program,
in 2015.
Dr. Roy Davidovitch, director of NYU Langone's Hip Center, said he performs around 400 hip replacements a year and approximately 40 percent of
those patients will go home the same day.
Davidovitch said patients are happier going home sooner. "Nothing beats the comfort of your own home for recovery. And to be quite honest, if the
pain is controlled and the patient is healthy and medically completely stable there is no reason for them to be in the hospital. It really doesn't make
sense."
There are two common surgical approaches for a total hip replacement: anterior, which involves entering surgically through the front of the hip, and
posterior, or entering surgically through the side or buttocks.
According to research done by the American Academy of Orthopaedic Surgeons, there are no significant differences between either approach in
recovery outcomes six months after surgery.
Davidovitch favors the anterior approach, which he believes has a faster and less painful recovery period in the short term because doctors don't
have to cut through muscles or tendons to get to the hip like in the posterior approach. He does agree that in the long term, both procedures have
the same outcomes for patients.
But it's not the surgical approach alone that allows some of his patients to go home the same day, it's a combination of what happens before, during
and after surgery.
At NYU Langone patients have to do what's called pre-hab. Before the surgery they work with an occupational and physical therapist to learn
information on the procedure, learn exercises to do after the surgery and how to properly move around while they are recovering.
During the surgery, Davidovitch uses a short-acting spinal anesthetic that lasts about 2 ½ hours, and when closing the wound he injects "a cocktail of
medications" to help with the inflammation and pain.
Patients can be up and walking usually within three hours after the surgery. But they must have someone around the first night they are spending at
home post-surgery.
"The people who are against the whole idea for same-day discharge for hip replacement are concerned about the very rare instances where
somebody could develop a blood clot that goes to the lung, or a fracture of some sort," said Davidovitch. "The rates of blood clots or pulmonary
emboli is exceedingly low. And in general, if a patient is identified as a high risk or a higher risk we don't send them home the same day."
Davidovitch makes it clear that this kind of surgery is not one-size-fits-all. Patients are screened first to make sure they don't have risk factors like
obesity, chronic liver disease or cardiac problems. Those who have risk factors must plan on staying overnight in the hospital, not going right home.
Visit CBS News for the article.
Olympus launches the Olympus Knowledge Exchange System
Olympus, announced the launch of its Olympus Knowledge Exchange (KE) system, a next generation software platform offering facilities centralized
endoscope reprocessing record and image management through expanded connectivity of Olympus devices.
The KE modular platform is built around standard communication protocols HL7 and DICOM, which provides interoperability with most modern
electronic medical record (EMR), Radiology information system (RIS) and picture archiving and communication systems (PACS). When the KE
communication and endoscope reprocessing management modules are used together, patient and procedure data flows seamlessly between the
procedure and the reprocessing rooms.
In the procedure room the KE system can save time and reduce data entry errors by expanding the connectability of the Olympus CV-190 video
processor. Furthermore, the KE system provides users with the ability to transfer procedure images to a PACS or EMR system at the highest
resolutions available today.
Outside the procedure rooms, the KE system offers connectivity to the Olympus OER-Pro endoscope reprocessor. By adding the OER-Pro,
documentation of the endoscope reprocessing outcomes can be tracked electronically helping users identify quality issues that can adversely affect
patient safety.
The Olympus KE System was developed to assist hospitals in establishing and monitoring quality assurance programs in compliance with the
guidelines of several medical societies including the Society of Gastroenterology Nurses and Associates, Inc. (SGNA); Advancing Safety in
Healthcare Technology (AAMI), the American Society for Gastrointestinal Endoscopy (ASGE), and the Association of periOperative Registered
Nurses (AORN).
The Olympus KE System will be showcased at the SGNA annual meeting to be held on May 22-24 in Seattle, Wash. Healthcare providers are invited
to visit the Olympus Booth #404 for a hands-on product demonstration.
For more information, visit Olympus.
Rural hospitals often safer, cheaper for common surgeries
Having a commonplace surgery, such as a gallbladder removal, -- may be safer when done in a rural hospital compared to a suburban or city
hospital, a new study finds.
"This study gives credence to what rural surgeons long suspected -- that well-done rural surgery is safe and cost-effective," study author Dr. Tyler
Hughes said in a University of Michigan news release. Hughes is one of only two surgeons at McPherson Hospital in rural McPherson, KS, and a
director of the American Board of Surgery.
Rural hospitals are also called critical access hospitals. They're the closest option for tens of millions of patients living outside major cities and
suburban areas, the researchers said.
For the study, the researchers reviewed 1.6 million surgeries. They were performed at 828 rural hospitals or 3,600 larger hospitals. Specifically, the
researchers compared outcomes for Medicare patients who had one of four common operations: gallbladder removal, colon surgery, hernia repair
and appendix removal.
There was no difference between hospitals for the risk of dying within 30 days of an operation. However, researchers found the risk for developing a
major complication after surgery -- such as heart attack, pneumonia or kidney damage -- was lower at rural hospitals.
The study also revealed that it cost Medicare about $1,400 less for the same operation at a rural hospital than at a larger hospital.
Patients who had surgery at rural hospitals were also less likely than patients in larger hospitals to use skilled nursing facilities after their operations,
the researchers said.
The researchers noted that the patients operated on in rural hospitals tended to be healthier than those treated at larger hospitals, suggesting that
rural doctors select low-risk surgical patients and send more complicated cases to larger medical centers.
Study senior author Dr. Justin Dimick said, "While it may make sense to travel to a higher-volume hospital for a few of the most complex operations,
this study shows that having surgery locally is safe for many of our most common surgical procedures." Dimick is professor of surgery and leader of
the Center for Healthcare Outcomes and Policy at the University of Michigan.
Hospitals are eligible for critical access designation by Medicare if they have fewer than 25 inpatient beds and are more than 35 miles from another
hospital.
Currently, critical access hospitals are paid 101 percent of reasonable costs. Doctors who practice at these hospitals can also receive 115 percent of
the usual payment for traditional Medicare patients. This helps rural hospitals to remain open, the researchers said.
The researchers added that many rural hospitals are facing the threat of closure. That's because national policies that set medical and surgical rates
for these hospitals are under scrutiny.
Visit NIH for the study.
Some days everything goes wrong
Sometimes the best intentions go awry. Yesterday in the HPN Daily Update, that was exactly what happened. A wrong headline was used in a news
piece about Brent Johnson, an esteemed supply chain executive and friend to Healthcare Purchasing News, who is retiring as CEO of Intalere on
July 1.
Brent has spoken fondly of his future retirement, but nonetheless still an unexpected surprise when the official announcement came through. In case
you missed our folly, we somehow updated Brent’s last name in the news item to Brent James, who also happens to be another accomplished
supply chain executive and as CEO of Intermountain, Brent Johnson’s former boss. I’m sure Mr. James was surprised to read he was also retiring.
In our first version headline, we had Mr. Johnson’s successor’s name, Julius Heil, correct. Mr. Heil has an impressive pedigree and we’re sure he’ll
do well in his new role. However, somehow fate decided to do him one better and in our haste to correct an unthinkable error and return Mr. Johnson
back to his correct name in the headline, the finger gods took over and morphed Mr. Heils’s first name to James.
The best efforts of a team sometimes get derailed and in an attempt to fix a problem quickly – Murphy’s Law steps in. We apologize for 3 separate
emails to fix one news item message. We eventually did get it right but not with some intense hair pulling and angst. Please accept our embarrassed
apologies and forgive the multiple intrusions.
We’re hoping you are looking forward to a terrific weekend, and if you know anyone with the name of James, first or last, you’ll think of our folly and
smile. I know I will. My husband’s name just happens to be James.
TGIF.