August 19, 2014

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In This Issue

 
 

Community Health Systems says personal data stolen in cyber attack

 

U.S. hospital operator Community Health Systems Inc. said on Monday personal data, including patient names and addresses, of about 4.5 million people were stolen by hackers from its computer network, likely in April and June.

 

The company said the data, considered protected under the Health Insurance Portability and Accountability Act, included patient names, addresses, birth dates, telephone numbers and Social Security numbers. It did not include patient credit card or medical information, Community Health Systems said in a regulatory filing.

 

It said the security breach had affected about 4.5 million people who were referred for or received services from doctors affiliated with the hospital group in the last five years.

 

The FBI warned healthcare providers in April that their cybersecurity systems were lax compared to other sectors, making them vulnerable to hackers looking for details that could be used to access bank accounts or obtain prescriptions, Reuters previously reported.  

 

The company said it and its security contractor, FireEye Inc. unit Mandiant, believed the attackers originated from China. They did not provide further information about why they believed this was the case. They said they used malware and other technology to copy and transfer this data and information from its system.

 

Community Health, which is one of the largest hospital operators in the country with 206 hospitals in 29 states, said it was working with federal law enforcement authorities in connection with their investigation into the attack. It said federal authorities said these attacks are typically aimed at gathering intellectual property, such as medical device and equipment development data.

 

It said that prior to filing the regulatory document, it had eradicated the malware from its systems and finalized the implementation of remediation efforts. It is notifying patients and regulatory agencies as required by law, it said. It also said it is insured against such losses and does not at this time expect a material adverse effect on financial results. Visit Reuters for the article
 
 

Ebola outbreak delays Mercy Ships sail to Africa

 

TENERIFE, CANARY ISLANDS - Collateral hardship from the Ebola epidemic now includes a delay for Mercy Ships, which operates the world's largest civilian hospital ship in ports on the West Coast of Africa. Already with one canceled deployment to Guinea, where Ebola first broke out last December, the Mercy Ship now waits in the water with crew and staff, pending an end-of-August decision on field service in Benin.

 

The Mercy Ship was due to sail for the port of Cotonou, Benin, for its 10-month field service last week but has delayed that sail pending further assessment due to the virulence of the outbreak in neighboring Nigeria. Earlier, in April, Mercy Ships made the difficult decision to cancel the hospital ship's planned deployment to Guinea, where the Ebola outbreak began last December.

 

Currently docked in the Canary Islands, following the vessel's annual maintenance phase, the 16,500-ton Mercy Ship is designed to deploy specialized surgical expertise and educational support. It is unequipped to treat viral epidemics, according to the charity's president and founder Don Stephens.

 

Stephens said the organization is closely monitoring the situation on the whole of the African continent. The ship's crew of 400 represents 40 nations, with up to 60 children onboard at any time.

 

Following the US Center for Disease Control recommendations, Mercy Ships has banned crew travel to Guinea, Sierra Leone, Liberia and Nigeria. Likewise, crew guests and day crew may not board the Mercy Ship for at least 21 days after they have visited one of the four affected countries.

 

Docking in an African port, the ship brings high-tech equipment, state-of-the-art facilities, highly skilled doctors, free specialized surgeries, healthcare training including instrument sterilization and disease prevention, agricultural training and more.  Mercy Ships provides many types of surgeries:  maxillofacial, plastic reconstructive, orthopaedic, and general.  The organization also offers dental care and eye care, and it works alongside local government and healthcare providers to improve local healthcare delivery systems.

 

Since the first arrival of a Mercy Ship in 1991 to Togo, 23 of the 35 years of Mercy Ships service have been focused in Africa.  For more information visit Mercy Ships.

 

Huge variations in blood test charges 'irrational'  

 

One California hospital charged $10 for a blood cholesterol test, while another hospital that ran the same test charged $10,169 -- over 1,000 times more. For another common blood test called a basic metabolic panel, the average hospital charge was $371, but prices ranged from a low of $35 to a high of $7,303, more than 200 times more. The wide disparity in hospitals' listed charges for routine blood tests at California hospitals was revealed in a study published in the August issue of BMJ Open. The study examined the listed charges for routine blood tests performed in 2011.  

 

Researchers said their analysis found no rational explanation for the stark variation in listed prices, though teaching hospitals and government hospitals generally set lower charges than other facilities.  

 

"People say our healthcare system needs to be more marketplace-driven, but the charging system and payment system are irrational," said Renee Hsia, MD, MSc, the paper's lead author, an associate professor of emergency medicine at University of California San Francisco. "When people try to understand why prices are the way they are, we have no ability to explain it. That is the take-home message. That is what is so disturbing."  

 

"If you ask an automotive maker, they will know how much it costs to make a Honda. If you ask a hospital CEO how much an appendicitis admission costs, they will not be able to tell you. They have never been asked to determine prices that way."  

 

Officials with the California Hospital Association dismissed the report as irrelevant, saying that the vast majority of patients pay discounted rates that have been negotiated by their insurance plans.

 

"Charges are meaningless data -- virtually no one pays charges," said Jan Emerson-Shea, the association's vice president for external affairs. "It is true that an uninsured person will receive a hospital bill based on charges," she said, but California law requires the bill to "include text referencing the availability of free or discounted care to persons who meet income guidelines." Those discounted fees must be based on what government programs pay for services, under California law, she said.  

 

But researchers say the list prices are a starting point for negotiations with insurers and patients, so they play a role in driving up healthcare costs. Some uninsured patients, as well those with insurance who have gone out of network, may also be billed for the full charges.  

 

Earlier studies by Hsia identified variations in listed charges for labor and deliveries and for appendectomies in California, with labor and delivery charges varying eight- to 11-fold between hospitals, and charges for a routine appendectomy ranging from $1,500 to $182,955. But, she said, she did not expect to see so much variation on a single line item like a blood test.  

 

"This was even more surprising to me," Hsia said. "There is always some variation in patients, even among young healthy adults, and there are variations in physician practice. But these are very basic, standard blood tests. It doesn't matter if you're sick or not, a complete blood count is a complete blood count. You draw the blood, send it to the lab, and put it in a machine."  

 

In addition, she said, patients are increasingly being asked to play a role in keeping healthcare costs down by being smart shoppers, but it is almost impossible to get prices of healthcare services in advance and comparison shop. The study's findings suggest that price setting for many services is arbitrary, since there is little difference between standard blood tests done at different institutions.  

 

While the disparities in charges for cholesterol tests were the most extreme, they were not an aberration. Charges for a complete blood cell count and a thyroid stimulating hormone assay ranged from as low as $20 in some hospitals to as much as $7,439 and $8,392, respectively. The smallest discrepancy in charges was for a creatine kinase assay, often used to diagnose a heart attack; the lowest listed charge was $10 but some hospitals charged as much as $628. (Kaiser Health News) Visit MedPage Today for the article.


Riddle Hospital donates beds to Ebola-ravaged Sierra Leone

 

MIDDLETOWN, DE - Two weeks ago, administrative supervisor Ibrahim Conteh deviated from his regular shift and was working during the day at Riddle Hospital when he got into an elevator with Marianne Collins, and they struck up a conversation. They began to talk about a few dozen beds that the hospital was planning to replace in its orthopedic and maternity wings.

 

Ibrahim and his brothers, Osman and Abdul, grew up in Sierra Leone before moving to the United States in 1988 when their parents, Santigie and Kadiatu Conteh, came to pursue their studies in education. Since then, Ibrahim and Osman went to college and gained employment at Riddle Hospital while their brother, Abdul, spends 10 months of the year as a missionary working in the African country.

 

Even prior to the Ebola outbreak, the conditions in the country were dire - no clean, running water, sporadic electricity and very little resources. Visitors to hospitals there lay on mats on the floor, sometimes two to a bed. So, the idea that the country could receive full, wheeled hospital beds from the United States was a blessing.

 

This week, Riddle Hospital staff and volunteers moved 45 beds from the maternity and fourth-floor orthopedic wings into a former MRI facility, where they will stay until the travel ban for Sierra Leone has been lifted. When it's removed, the Conteh brothers will take it upon themselves to pay for and to see that the beds are delivered to the 34 military hospitals in Freetown, where thousands of people receive treatment annually.

 

Collins credited the Riddle administration, including Director of Finance Ed McKillip, for their support, as well as the entire hospital community.

The brothers tried to describe the conditions in Sierra Leone. "You have hospitals where ... you have two patients on a bed and you could have people laying on a floor on mats," Abdul said. "You have no plumbing, no electricity at times."

 

Ibrahim added, "It's not like the United States where you come into the hospital, there is a minimum standard, a standard of expectation. We have no standard back home. We don't have the basic supplies like Band Aids, like IV needles. Over there, they're using a needle on you and then the next patient comes and they use that same needle on them. You can just imagine if you have something how easily something can spread."

 

Abdul said nurses must wear one pair of gloves throughout the entire day.

 

"They don't have enough gloves to change it for every patient," he said. "They just don't have it. Nothing in the United States can compare to Sierra Leone. It's a country that has been at war, it still looks like a war zone. You have hospitals where the infrastructure is terrible. You have hospitals that were built in the early 1900s. You do with what you have over there and what you have is pretty much nothing. He spoke of hospital shelves barren except for one container of medication.

 

That's why the 37-year-old has worked at Riddle for nine years, earlier as a nurse and now as an administrative supervisor. His brother, Osman, 39, has been a nurse at Riddle for 11 years. In the meantime, the Conteh brothers here in the United States continue to collect used items to uplift the people of Sierra Leone.

 

More information about their efforts can also be seen at SaltandLightforAfrica.com.  

 

Visit the Delaware County Daily Times for the story.


CDC scientist took shortcuts handling deadly bird flu virus, investigation finds

 

An investigation into the mistaken shipment of deadly bird flu virus from a government laboratory earlier this year found that a scientist took shortcuts to speed up the work and accidentally contaminated the samples, the Centers for Disease Control and Prevention reported last week.

 

As a result, the CDC shipped a virulent avian flu virus rather than a relatively benign animal strain to a poultry research laboratory of the Department of Agriculture. No one became infected or fell ill, and the pathogen was destroyed. But after CDC lab members learned of the safety lapse, they didn't notify supervisors up the chain of command until more than six seeks weeks later. The CDC investigation said the primary factors behind the reporting delay were the "lack of sound professional judgment" by individuals aware of the contamination and "insufficient or ambiguous" reporting requirements.

 

CDC Director Tom Frieden has called the reporting delay the "most distressing" aspect of several recent incidents involving the mishandling of dangerous pathogens at the nation's labs, including potentially exposing dozens of employees to live anthrax. Last month, several vials of long-forgotten smallpox virus were discovered in a building on the Bethesda campus of the National Institutes of Health.

 

The internal CDC investigation into the flu lab incident found that the scientist failed to follow best practices and no approved laboratory-specific operating procedures existed for the work being done, the report said. The errors most likely happened because the scientist was growing cell cultures from both virus strains at the same time at the same work station, the report found. There were no written records to document the procedures performed.

 

"We're pretty sure the person took short cuts," said Anne Schuchat, director of CDC's National Center for Immunization and Respiratory Diseases. "In laboratory work, it's so important to follow every step, and when you're working with unusual pathogens, it's even more important that every single step is followed." She added: "This wasn't a question of someone who was poorly trained. There was substantial experience and knowledge."

 

It should have taken the scientist a minimum of 90 minutes to process the specimens, including 30 minutes for decontamination. But the scientist spent only 51 minutes in the lab--based on card key readers showing lab entry and exit times--including time spent to shower and change into street clothes, the report said.

 

The contamination took place Jan. 17, when the scientist began growing a supply of virulent H5N1 strain and the less-dangerous H9N2 strain. The scientist "acknowledged being rushed to attend a laboratory meeting" due to begin 15 minutes after leaving the lab, the report said. At the time, the influenza division had a heavy work load preparing for an upcoming vaccine meeting of the World Health Organization. The scientist and the team leader are experienced researchers in the CDC's influenza division, said the report, which did not identify any individuals.

 

Frieden has said that it's possible that for scientists who work with deadly organisms "day in and day out for weeks, months and years, you can get a little careless. And that's something that may have happened."

 

Schuchat and other top CDC officials have called the lapses unacceptable. The flu incident involves a lab that works with exotic flu viruses. It has been closed since July 9, when senior CDC leaders were told about the contamination. The CDC's work on seasonal flu surveillance and vaccines has not been affected and is ongoing, officials said.

 

The deficiencies described in the report come at a time when the CDC is the spotlight for its role battling the worsening Ebola outbreak in West Africa. The agency has about 30 specialists in the countries hardest hit--Sierra Leone, Liberia, Guinea and Nigeria. Another 50 specialists are expected to arrive by the end of August. In the United States, the CDC has the only lab capable of performing diagnostic tests for suspected cases of Ebola.

 

The agency is also testing all preparations done by the flu lab scientist dating from a year ago; it is also testing preparations sent by the influenza division to other labs over the last year. All influenza labs must now have daily record-keeping.

 

Staff must also undergo training to understand when events must be reported. Researchers did not report the bird flu contamination initially because they didn't think the incident qualified as a release of a "select agent," a designation reserved for the most dangerous pathogens.

 

The report disclosed that another lab at CDC had also received contaminated flu samples. That team noticed that its experiments were producing atypical results, and asked the flu lab to doublecheck the cell culture.

 

The investigations were prompted by a June incident when as many as 84 workers may have been exposed to live anthrax after employees unknowingly sent samples of the bacterium from one CDC lab to other CDC labs. During the anthrax investigation, agency officials learned about the bird flu incident and three other instances where deadly pathogens had been improperly sent to other laboratories over the past decade.

A special unit of the USDA is also investigating the incidents; its report has not been made public, a CDC spokesman said. Visit the Washington Post for the story.


Shoppers ditching Colgate Total amid Triclosan fears

 

Wal-Mart and other retailers are under mounting pressure to eliminate products with triclosan, an antibacterial chemical used in hand soaps and Colgate-Palmolive's Total toothpaste. Total is a tiny percentage of Colgate-Palmolive Co.'s sales, but it's inextricably entwined with the Colgate brand so the triclosan controversy could inflict long-term damage, said Michael Stone, who runs Beanstalk, a New York-based brand-licensing agency owned by Omnicom Group Inc.

 

While Colgate has said Total's approval in 1997 followed a rigorous Food and Drug Administration process, Bloomberg News reported earlier this week that the agency relied on company-backed science and withheld toxicology studies on triclosan, which were released only this year. Since the story's publication, consumers have e-mailed Bloomberg News to ask if the toothpaste is safe and have taken to social media. Colgate, meanwhile, has fired off almost 50 Twitter posts so far in response to questions about and criticism of Total.

 

"Consumers around the world choose Colgate Total because of the important, proven health benefits it provides in fighting gingivitis," Tom DiPiazza, a company spokesman, said in an e-mailed statement. "Its efficacy and safety have been affirmed by regulators in the U.S., the EU, Australia and Canada based on 20 years of scientific reviews. Colgate Total is part of a full range of toothpastes we offer to meet differing consumer needs."

 

Unlike Procter & Gamble Co., which sells an array of cleaning, personal and beauty products, Colgate's identity is closely tied to oral care. As such, the company has spent years developing a relationship with dentists. Amid a growing drumbeat of warnings about triclosan in recent years, some have stopped recommending Colgate products to their patients.

 

In a recent statement, the American Dental Association's Council on Scientific Affairs said it will continue to closely monitor and evaluate existing and new scientific information on triclosan as it becomes available. The ADA also recommended that individuals continue to follow FDA recommendations on the use of oral health care products that contain the chemical. The FDA's November 2013 Consumer Update states that the FDA does not have sufficient safety evidence to recommend changing consumer use of products that contain triclosan at this time.

 

Activists, meanwhile, are pressuring Wal-Mart Stores Inc. and other retailers to eliminate products with triclosan, which is also used in hand soaps. Next month Wal-Mart and Target Corp. meet with suppliers in Chicago at the Beauty and Personal Care Products Sustainability Summit, where they'll evaluate the environmental and social impact of their wares. Visit Bloomberg for the story.


Pfizer is liable for harm caused by a generic version of its drug: Court

 

Should brand-name drug makers be held liable if consumers are harmed by a medicine made by a generic rival? The Alabama Supreme Court believes the answer is yes. And the court has upheld its own controversial ruling that Pfizer can be sued by an Alabama man who claimed he was injured by a generic version of its Reglan heartburn medicine. Why? The brand-name drug maker purportedly failed to warn his physician about the risks.

 

The decision is potentially significant, because this is one of the few cases in which a court has found that a brand-name drug maker can be sued, even though a consumer had taken only the generic version. Consequently, the ruling may be considered by other courts deciding similar cases and prompt still more such lawsuits.

 

The issue has been under a microscope ever since the U.S. Supreme Court limited claims against generic drug makers. In 2011, the court decided generic drug makers are unable to make changes to product labeling, even when alerted to side effects, unless a brand-name drug maker has made such a change. This meant generic drug makers should not be held accountable for a failure to warn against risks.

 

In the case in Alabama, the man was prescribed a generic version of Reglan and developed tardive dyskinesia, a serious and permanent movement disorder. He later accused Wyeth, which was bought by Pfizer, of failing to warn his physician of the long-term use of the drug. For its part, Pfizer argued it did not have a direct relationship with the consumer and, therefore, had no responsibility.

 

But the Alabama court disagreed. Pfizer's argument "completely ignored the nature of prescription medication," the court wrote. The consumer "cannot obtain Reglan or any other prescription medication directly from a prescription-drug manufacturer. The only way for a consumer to [do so] is for a physician or other medical professional authorized to write prescription to prescribe the medication to his or her patient.

 

"When the warning to the prescribing healthcare professional is inadequate, however, the manufacturer is directly liable to the patient for damage resulting from that failure," the court continued, noting that the warning would first have to emanate from a brand-name drug maker before a generic drug could follow suit.

 

Consequently, the Alabama Supreme Court decided that "it is not fundamentally unfair to hold the brand-name manufacturer liable for warnings on a product it did not produce."

 

Pfizer was not pleased. In a statement, the drug maker says the ruling is "an outlier" and contends that "virtually every other court" that has considered this issue since the initial Alabama Supreme Court decision early last year has rejected the notion that brand-name drug makers should be held liable for injuries caused by a generic version of its medicine.

 

Pfizer then trots out some numbers - 29 other courts have disagreed with the Alabama court, including the Iowa Supreme Court and six federal courts of appeals. And overall, 98 courts applying the laws of 30 different states have also rejected the idea that a brand-name drug maker should be held liable under such circumstances, according to Pfizer.

 

The FDA has proposed a new rule that would let generic drug makers independently add new side effect information to product labeling. The proposal was made in response to the 2011 U.S. Supreme Court ruling, which consumer advocates complained could place patients at risk, especially at a time when generics are so widely used. Generic drug makers, however, maintain the proposed rule would add $4 billion to the nation's health care bill, mostly due to higher litigation costs that may ensue. Two months ago, a pair of Republican lawmakers agreed with that argument and wrote the White House to question the authority the FDA has to issue such a rule. Visit the Wall Street Journal for the article.


Commercial textiles' superior sustainability verified by independent analysis  

 

An independent study, commissioned by TRSA, the global textile services trade association, indicates reusable textile products (cloth) have less environmental impact when substituted for disposable counterparts (paper/synthetic) in three common commercial scenarios: Using a napkin in a mid-priced or upscale restaurant; Wearing a shoulder-to-shin gown to protect clothing in a hospital; and Wiping oil, grease, solvent, chemicals and other soils in an industrial setting.  

 

The research quantifies the natural resources needed and waste generated in the manufacturing, distribution, use and disposal of various reusable and disposable versions of these products. "The findings suggest that across the wide variety of available products' materials and weights, reusables have the lowest environmental impact throughout their normal life cycle," explained TRSA President and CEO Joseph Ricci.

 

Results of this product life cycle assessment reinforce TRSA members' longstanding competitive advantage over disposables manufacturers due to the favorable economics of textile reuse and commercial laundering. Now reusables' lower environmental impact can be added to the case that they are the more sustainable option for businesses.

 

For isolation gowns and wipers, the assessment found that regardless of product weight, resource consumption or waste, a disposable always contributes more to global warming than its reusable equivalent. Even the most resource-conservative and least wasteful disposables have a greater impact than the worst reusables.

 

According to the study, disposables' impacts are driven primarily by raw materials, followed by manufacturing energy. Reusables' impacts are dominated by laundering and, to a limited extent, by raw materials production.

 

The independent study was conducted by Exponent, an engineering and scientific consulting company that offers multidisciplinary teams of scientists, physicians, engineers and regulatory consultants to perform in-depth scientific research and analysis across a range of industries. Visit TRSA for more information at www.trsa.org.


 
 
 
 
 

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