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May 4, 2016   Download print version

Study suggests medical errors now third leading cause of death in the U.S.

Valeant’s CEO was key force on pricing

Scientists pioneer 'game-changing' new antibiotic which could hold key to tackling drug resistant bacteria

Six marked by Hall of Fame for Healthcare Supply Chain Leadership as Future Famers

Researchers look to repurpose approved drugs to treat Zika virus

Johnson & Johnson just lost another huge talc-powder case

Playground concussions are on the rise

FDA warns about new impulse-control problems: Aripiprazole (Abilify, Abilify Maintena, Aristada)


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Self Study Series:
May 2016

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Study suggests medical errors now third leading cause of death in the U.S.

Analyzing medical death rate data over an eight-year period, Johns Hopkins patient safety experts have calculated that more than 250,000 deaths per year are due to medical error in the U.S. Their figure, published May 3 in The BMJ, surpasses the U.S. Centers for Disease Control and Prevention’s (CDC’s) third leading cause of death — respiratory disease, which kills close to 150,000 people per year.

The Johns Hopkins team says the CDC’s way of collecting national health statistics fails to classify medical errors separately on the death certificate. The researchers are advocating for updated criteria for classifying deaths on death certificates.

“Incidence rates for deaths directly attributable to medical care gone awry haven’t been recognized in any standardized method for collecting national statistics,” says Martin Makary, M.D., M.P.H., professor of surgery at the Johns Hopkins University School of Medicine and an authority on health reform. “The medical coding system was designed to maximize billing for physician services, not to collect national health statistics, as it is currently being used.”

In 1949, Makary says, the U.S. adopted an international form that used International Classification of Diseases (ICD) billing codes to tally causes of death.

The researchers say that since that time, national mortality statistics have been tabulated using billing codes, which don’t have a built-in way to recognize incidence rates of mortality due to medical care gone wrong.

According to the CDC, in 2013, 611,105 people died of heart disease, 584,881 died of cancer and 149,205 died of chronic respiratory disease — the top three causes of death in the U.S. The newly calculated figure for medical errors puts this cause of death behind cancer but ahead of respiratory disease.

“Top-ranked causes of death as reported by the CDC inform our country’s research funding and public health priorities,” says Makary. “Right now, cancer and heart disease get a ton of attention, but since medical errors don’t appear on the list, the problem doesn’t get the funding and attention it deserves.”

The researchers caution that most of medical errors aren’t due to inherently bad doctors, and that reporting these errors shouldn’t be addressed by punishment or legal action. Rather, they say, most errors represent systemic problems, including poorly coordinated care, fragmented insurance networks, the absence or underuse of safety nets, and other protocols, in addition to unwarranted variation in physician practice patterns that lack accountability.

“Unwarranted variation is endemic in healthcare. Developing consensus protocols that streamline the delivery of medicine and reduce variability can improve quality and lower costs in healthcare. More research on preventing medical errors from occurring is needed to address the problem,” says Makary.

Visit Johns Hopkins for the study.


Valeant’s CEO was key force on pricing

In early 2015, when Valeant Pharmaceuticals International Inc.’s top brass met to set prices on a soon-to-be-acquired cardiac drug, some executives suggested slow, staggered price increases. Chief Executive Michael Pearson disagreed.

To reach Valeant’s internal profit targets, Pearson lobbied for a single, sharp increase. Hospitals could still make a profit at the higher price, he argued, which meant patients would still have access to the drug. The team deferred. The day it completed its February 2015 purchase of the drug, called Nitropress, Valeant tripled the cost.

The exchange, recounted in a document reviewed by The Wall Street Journal, shows in greater detail than was previously known how Valeant and its now-outgoing CEO Pearson pursued quick, aggressive price increases on acquired drugs in recent years—a strategy that sparked widespread backlash and landed Pearson in front of a Senate investigative panel last week.

A spokeswoman for Valeant, Laurie Little, said, “We heard very clearly the concerns raised by the Senate Special Committee on Aging, and the board is working to map out a new path for the company going forward. That will include consideration both of how best to set drug prices and of the appropriate role of patient assistance programs in helping to ensure that patients can obtain the drugs that doctors prescribe for them.”

At last week’s Senate committee hearing Pearson said Valeant was “too aggressive” with drug price increases. Dozens of documents collected during the Senate investigation provide a deeper look at how Valeant arrived at sharp price hikes on some of the drugs it sells. The documents underscore the challenges Valeant faces now that it has promised to roll back some prices and rely less on acquisitions for which price increases are a major driver.

While Valeant did have a research program, Pearson said that most of Valeant’s R&D products are reformulations of existing drugs, such as a new delivery method for a glaucoma medicine, according to the Senate documents.

The Senate analysis referred to wholesale acquisition costs that hospitals and other purchasers pay for drugs.

Visit the Wall Street Journal for the article.


Scientists pioneer 'game-changing' new antibiotic which could hold key to tackling drug resistant bacteria

Scientists at the University of Lincoln, UK, have successfully produced two synthetic derivatives of Teixobactin - the world's first known antibiotic capable of destroying 'drug resistant' bacteria. Last year, the discovery of the antibiotic Teixobactin by researchers in the U.S was hailed as a 'game-changer' in the fight against antimicrobial resistance.

Teixobactin, which kills a range of pathogens without detectable resistance, was isolated from microorganisms (which do not grow under laboratory conditions) found in soil - the natural source of nearly all antibiotics developed since the 1940s.

However in order for it to be developed as a potential drug treatment, several versions of the antibiotic must be produced via chemical synthesis in order to overcome the hurdles of drug development. Researchers in laboratories around the world have been working towards this objective since last year's breakthrough.

Now Dr. Ishwar Singh from the University of Lincoln and his colleagues have become the first group of scientists to synthetically produce two derivatives of Teixobactin.

The bacteria against which Teixobactin is effective have, thus far, not shown any detectable resistance and given its mechanisms of attack, scientists are also confident that this is unlikely to occur in the future.

It has been predicted that by 2050 an additional 10 million people will succumb to drug resistant infections each year. The development of new antibiotics which can be used as a last resort when other drugs are ineffective is therefore a crucial area of study for healthcare researchers around the world. This new study by Dr. Singh and his team represents an important step towards this end goal.

The processes they used produced a yield of 22% for one of the derivatives of Teixobactin, making Dr. Singh's methods highly efficient.

Dr. Singh and his colleagues will now carry out further tests to more clearly understand the chemical properties of Teixobactin and to simplify the molecule so that other derivatives can be produced. He hopes to create a library of Teixobactin derivatives which could prove vital for the future development of the antibiotic.

Dr. Singh added: "The process of bringing an antibiotic to clinic is an extremely lengthy one and can often take around 10-15 years. There is much more extensive research and testing to be carried out before we can even consider Teixobactin as a viable medical treatment. This is a very rare occurrence - the last new class of antibiotics was discovered nearly 30 years ago - and a far-off possibility, however we are certainly making great strides in our work against drug resistant bacteria."

Visit Science Daily for the study.


Six marked by Hall of Fame for Healthcare Supply Chain Leadership as Future Famers

Bellwether League Inc., the Hall of Fame for Healthcare Supply Chain Leadership, recognized six professionals for their stellar contributions to supply chain operations during the first decade of their respective careers.

This new recognition honors individuals near the beginning of their healthcare supply chain careers who are demonstrating the innovative leadership qualities of an industry bellwether in making a difference for their organizations and the industry through a variety of projects. The 2016 Future Famers have spent fewer than 10 years in the healthcare supply chain industry but already are carving a pathway for career success decades down the road.

Bellwether League Inc. continues its mission to focus on identifying and honoring industry bellwethers who have spent the bulk of their careers delivering supply chain excellence. We see the Future Famers complementing and potentially pointing the way to Bellwether status but not overshadowing the significance of achieving Bellwether status. In short, Future Famers status represents a snapshot that hopefully foreshadows continued success; Bellwether status reflects on and represents an entire career that should serve as an example for all to emulate.

The Future Famers Class of 2016 includes the following individuals who have made significant strides in the healthcare supply chain industry so early in their employment:

·         Jimmy Henderson, Materials Manager, Outpatient Surgery Center of Jonesboro (AR)

·         Nisha Lulla, Associate Vice President, Operations, Rush University Medical Center, Chicago

·         Catherine “Kate” Polczyinski, Director, Procurement, Geisinger Health System, Danville, PA

·         Rob Proctor, Regional Vice President, Owens & Minor Inc., Nashville

·         Baljeet Sangha, Associate Administrator, Supply Chain, Zuckerberg San Francisco General Hospital and Trauma Center, and Associate Administrator, Business Operations, San Francisco Health Network

·         Erik Walerius, Chief Supply Chain Officer, University of Washington Medicine, Seattle

“As the Chairman of the Nominating Committee, I believe I can speak for our team when I say; we have a very strong group of Future Famers for 2016,” said Jamie Kowalski, Bellwether League Inc. Co-Founder and Board Member. “These supply chain professionals come from a variety of roles and organizations, and have made their contributions to healthcare supply chain management in many different ways. Our profession should keep watch on these leaders as they progress through their careers.”

John Gaida, Chairman, Bellwether League Inc. Board of Directors, welcomed the newest Future Famer class. “While we have spent the last almost nine years selecting and honoring Bellwethers who are at or near the sunset of their successful careers, we take great pride in recognizing these individuals at the early stages of their pursuit of healthcare supply chain excellence,” he said.

“Their accomplishments are varied, but they represent what is best to come of our future,” Gaida continued. “Just like Bellwethers, each brings a different set of accomplishments for not only themselves, but their employers and our organization as well. We are proud to honor them and wish them all the best as they strive to build upon these accomplishments and achieve others.”

The newest Future Famers will be recognized during the 9th Annual Bellwether Induction Dinner, Monday, October 3, at the Hyatt Regency O’Hare, in Rosemont, IL, near Chicago.

Visit Bellwether League for more information.


Researchers look to repurpose approved drugs to treat Zika virus

The need for drugs to prevent and treat Zika infections grows with every new patient diagnosed. The virus causes devastating birth defects and is strongly linked to a type of paralysis called Guillain-Barre syndrome.

There are currently no approved drugs against Zika; developing a new medication for any disease can take 10 to 20 years.

"The sense of urgency is enormous," said Mauro Martins Teixeira, who heads the immunopharmacology laboratory at the Federal University of Minas Gerais in Brazil. "In an emergency, everyone wants quick answers."

That's why many researchers are taking a closer look at older drugs, testing them to see if they might block infection with the virus or prevent it from harm the brain and nervous system, said Teixeira, who spoke Monday at a Zika conference at Atlanta's Emory University.

Virtually every researcher who works with antiviral drugs is testing them against Zika, Teixeira said.

The ideal drug would not just treat Zika, but also prevent it, much like the antimalarial drugs that travelers take before visiting tropical countries, said Raymond Schinazi, director of Emory's biochemical pharmacology lab. An anti-Zika drug would also have to be safe enough for pregnant women or women of reproductive age.

Schinazi has tested a 40-year-old drug that is safe during pregnancy. The drug has lost its patent, so it could be purchased relatively cheaply, said Schinazi, who has not released the name of the drug.

Teixeira is taking a different approach. Instead of preventing infection, he's looking to protect the brain from Zika's toxic effects. He has tested the Alzheimer's drug memantine, finding that it protects cells in lab dishes and animals.

Visit USA Today for the report.


Johnson & Johnson just lost another huge talc-powder case

Johnson & Johnson was ordered by a U.S. jury on Monday to pay $55 million to a woman who said that using the company’s talc-powder products for feminine hygiene caused her to develop ovarian cancer.

The verdict, which J&J plans to appeal, was the second straight trial loss for the company, which is facing about 1,200 lawsuits accusing it of not adequately warning consumers about its talc-based products’ cancer risks.

Following a three-week trial in Missouri state court, jurors deliberated for about a day before returning a verdict for Gloria Ristesund. She was awarded $5 million in compensatory damages and $50 million in punitive damages.

J&J spokeswoman Carol Goodrich said the verdict contradicted 30 years of research supporting the safety of cosmetic talc. The company intends to appeal and will keep defending its products’ safety, she said.

The verdict followed a $72 million jury award from the same court in February to the family of a woman who died from ovarian cancer after years of using talc powder for feminine hygiene.

That verdict, which J&J is appealing, sparked renewed interest in talc-powder lawsuits among plaintiffs’ lawyers, as well as consumers familiar with J&J’s powder products.

Plaintiffs in talc litigation, which is concentrated in Missouri and New Jersey state courts, have accused J&J of failing for years to warn that talc was linked to an increased risk for ovarian cancer. J&J has said it acted properly in developing and marketing the products.

Visit Fortune for the story.


Playground concussions are on the rise

Playground concussions are on the rise, according to a new government study, and monkey bars and swings are most often involved. Most injuries studied were mild, but all concussions are potentially serious and the researchers say the trend raises public health and safety concerns.

The federal Centers for Disease Control and Prevention study examined national 2001-2013 data on playground injuries to kids aged 14 and younger who received emergency-room treatment. Of almost 215,000 kids on average treated yearly, almost 10 percent — about 21,000 annually — had traumatic brain injuries including concussions. Only nonfatal injuries were included.

Here are some key findings, published in Pediatrics:

In 2005, 23 out of 100,000 kids had traumatic brain injuries, a rate that jumped to 48 out of 100,000 in 2013. The rate declined in the previous years but increased steadily after that. By 2013, the annual total was almost 30,000 kids treated for these brain injuries.

The rise may mean parents are becoming increasingly aware of the potential seriousness of concussions and the need for treatment. It’s also possible more kids are using playground equipment, the researchers said.

Only 3 percent of kids with concussions were hospitalized or transferred elsewhere for additional treatment; 95 percent were sent home after ER treatment. Half of the head injuries were in kids ages 5 to 9 and injuries were more common in boys. Symptoms weren’t listed but signs of concussions after a blow to the head can include headaches, dizziness, confusion, nausea and vomiting.

Dr. Jeneita Bell, a CDC brain injury specialist who co-authored the study, said the results highlight ‘‘that sports is not the only important cause of concussions and other traumatic brain injuries for children.’’  (Associated Press) Visit Boston Globe for the story.


FDA warns about new impulse-control problems: Aripiprazole (Abilify, Abilify Maintena, Aristada)

FDA is warning that compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of the antipsychotic drug aripiprazole (Abilify, Abilify Maintena, Aristada, and generics). These uncontrollable urges were reported to have stopped when the medicine was discontinued or the dose was reduced. These impulse-control problems are rare, but they may result in harm to the patient and others if not recognized. 

Although pathological gambling is listed as a reported side effect in the current aripiprazole drug labels, this description does not entirely reflect the nature of the impulse-control risk FDA identified. In addition, FDA has become aware of other compulsive behaviors associated with aripiprazole, such as compulsive eating, shopping, and sexual actions. These compulsive behaviors can affect anyone who is taking the medicine. As a result, FDA is adding new warnings about all of these compulsive behaviors to the drug labels and the patient Medication Guides for all aripiprazole products.

Aripiprazole is used to treat certain mental disorders, including schizophrenia, bipolar disorder, Tourette’s disorder, and irritability associated with autistic disorder. It may also be used in combination with antidepressants to treat depression. Aripiprazole can decrease hallucinations and other psychotic symptoms such as disorganized thinking. It can stabilize mood, improve depression, and decrease the tics of Tourette’s disorder. 

Healthcare professionals should make patients and caregivers aware of the risk of these uncontrollable urges when prescribing aripiprazole, and specifically ask patients about any new or increasing urges while they are being treated with aripiprazole. 

Visit the FDA for the safety watch.