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February 8, 2016
Zika virus resources for essential hospitals
Zika virus, named for its East Africa point of origin, a Ugandan forest, was first identified in 1947 and did not appear in humans until 1952.
Occurrences of the diseases had been limited until an outbreak in Brazil emerged in spring 2015. Since that time, the virus has infected at least 1
million people in more than 30 countries, including the United States.
The World Health Organization (WHO) has warned that the disease is “spreading explosively” in the Americas and could infect as many as 4 million
people by the end of 2016. Based on this estimate, WHO declared a public health emergency Feb. 1.
The Zika virus is spread to people primarily through the bite of an infected Aedes species mosquito. Its most common symptoms – fever, rash, joint
pain, and conjunctivitis – generally are mild and last from a few days to a week. Only one in five people infected with the virus develop symptoms,
and those who do usually don’t get sick enough to require hospitalization.
But of much greater concern is the link between Zika virus and microcephaly, a birth defect characterized by an irregularly small head. Researchers
also believe there may be a link between Zika and subsequent cases of Guillain-Barré syndrome.
America’s Essential Hospitals has established this resource page for its member hospitals and others with an interest in this emerging health crisis.
Essential hospitals provide a significant volume of public health and emergency preparedness services and stand ready to support the nation’s
response to Zika.
Visit America’s Essentials Hospitals for the article.
Zika found in saliva, urine in Brazil; U.S. offers advice
Authorities in Brazil said on Friday Zika has been detected in patients' saliva and urine, adding to the concern over the spread of the virus, while U.S.
officials offered new guidance on sex for people returning from Zika-hit regions.
Zika, linked to thousands of birth defects in Brazil, is primarily transmitted through mosquito bites, but word surfaced last week of infections through
sex and blood transfusions, and news of the presence of the virus in the saliva and urine of two patients prompted new worries.
The possibility of infection via body fluids could complicate efforts to contain the outbreak.
In fact, the president of the Brazilian federal biomedical research institution that made the announcement urged pregnant women not to kiss
strangers during the country's free-wheeling Carnival celebrations.
The U.S. Centers for Disease Control and Prevention recommended more stringent measures for monitoring pregnant women for Zika and for
preventing sexual transmission of the virus.
The CDC said men with a pregnant partner who live in or have traveled to an area of active Zika transmission should use condoms during sex with
their partner or abstain from sex for the duration of the pregnancy.
"The science is not clear on how long the risk should be avoided," the CDC said.
Zika has spread rapidly through the Americas, prompting the World Health Organization to declare an international public health emergency due to
its link to microcephaly, a condition in which infants are born with abnormally small heads and can suffer developmental problems.
There is no vaccine or treatment for Zika.
The Carnival celebrations are a raucous, five-day bacchanalia known for street parties and lots of alcohol and kissing. Some revelers even keep
track of the number of complete strangers they kiss.
The Oswaldo Cruz Foundation scientists said they used genetic testing to identify the virus in saliva and urine samples from the two patients, who
had symptoms caused by Zika infection, and determined that the virus was active, meaning it had the potential to cause infection. They said more
research was needed to determine whether Zika could be transmitted by either fluid. They said this marked the first time the virus had been detected
in either fluid.
The WHO said that between January 2014 and Feb. 5, 2016, a total of 33 countries have reported indigenous circulation of Zika virus. The U.N.
agency also said there was evidence of indirect local transmission in six other countries.
Reflecting concern over potential harm to fetuses, the CDC updated its guidelines on Friday for testing pregnant women who have traveled to
affected areas, saying even those without symptoms should be tested after returning home. The guidelines recommend pregnant women be offered
testing two to 12 weeks after returning home. The agency had earlier suggested tests only for those with symptoms of the illness, which causes a
fever, rash and red eyes.
CDC Director Tom Frieden and other U.S. health officials are due to testify before Congress on the Zika threat.
Brazilians have been rushing to buy repellant, creating a shortage of some brands on pharmacy shelves and boosting sales for the industry - a trend
some producers are preparing for elsewhere as the outbreak spreads.
Visit Reuters for the report.
Colombia confirms first three deaths of patients infected with Zika virus
Colombia has confirmed the first three deaths of patients infected with the Zika virus who had contracted a seemingly related disease that attacks
the nervous system and causes paralysis.
Alejandro Gaviria, the health minister, told the Guardian that another two deaths caused by the disease – known as Guillain-Barré syndrome (GBS)
– were still unconfirmed to be Zika-related. Health officials in the country’s second city, Medellín, reported on Thursday that a man and a woman
admitted from other areas died in the past week after presenting symptoms of Guillain-Barré, which include muscle weakness and paralysis. Another
man died in late November. All three tested positive for the Zika virus.
Gaviria said Colombia has registered about 100 cases of GBS that are believed to be related to the Zika virus. Overall, Colombia has recorded more
than 20,500 confirmed cases of Zika infection.
Guillain-Barré-related deaths are rare but Gaviria warned that recent cases of the disorder seen in Colombia have not responded to traditional
treatments of immunoglobulin.
Visit the Guardian for the story.
NIH researchers identify striking genomic signature shared by five types of cancer
National Institutes of Health researchers have identified a striking signature in tumor DNA that occurs in five different types of cancer. They hope this
finding will spur development of a blood test that can be used to diagnose a variety of cancers at early stages.
They also found evidence that this methylation signature may be present in many more types of cancer. The specific signature results from a
chemical modification of DNA called methylation, which can control the expression of genes like a dimmer on a light switch. Higher amounts of DNA
methylation (hypermethylation), like that found by the researchers in some tumor DNA, decreases a gene's activity.
Based on this advance, the researchers hope to spur development of a blood test that can be used to diagnose a variety of cancers at early stages,
when treatments can be most effective. The study appeared in The Journal of Molecular Diagnostics.
“Finding a distinctive methylation-based signature is like looking for a spruce tree in a pine forest,” said Laura Elnitski, Ph.D., a computational
biologist in the Division of Intramural Research at NIH’s National Human Genome Research Institute (NHGRI). “It’s a technical challenge to identify,
but we found an elevated methylation signature around the gene known as ZNF154 that is unique to tumors.” Dr. Elnitski is head of the Genomic
Functional Analysis Section and senior investigator in the Translational and Functional Genomics Branch at NHGRI.
In 2013, her research group discovered a methylation mark (or signature) around ZNF154 in 15 tumor types in 13 different organs and deemed it a
possible universal cancer biomarker. Biomarkers are biological molecules that indicate the presence of disease. Dr. Elnitski’s group identified the
methylation mark using DNA taken from solid tumors.
In this new study, they developed a series of steps that uncovered telltale methylation marks in colon, lung, breast, stomach and endometrial
cancers. They showed that all the tumor types and subtypes consistently produced the same methylation mark around ZNF154.
Dr. Elnitski will next begin screening blood samples from patients with bladder, breast, colon, pancreatic and prostate cancers to determine the
accuracy of detection at low levels of circulating DNA. Tumor DNA in a person with cancer typically comprises between 1 and 10 percent of all DNA
circulating in the bloodstream. The group noted that when 10 percent of the circulating DNA contains the tumor signature, their detection rate is quite
good. Because the methylation could be detected at such low levels, it should be adequate to detect advanced cancer as well as some intermediate
and early tumors, depending on the type.
Current blood tests are specific to a known tumor type. In other words, clinicians must first find the tumor, remove a sample of it and determine its
genome sequence. Once the tumor-specific mutations are known, they can be tracked for appearance in the blood. The potential of the new
approach is that no prior knowledge of cancer is required, it would be less intrusive than other screening approaches like colonoscopies and
mammograms and it could be used to follow individuals at high risk for cancer or to monitor the activity of a tumor during treatment. Once the blood
test is developed, the scientific community must conduct studies to ensure that it does not indicate the presence of cancer when it is not there or
miss cancer when it is there.
Visit NIH for the study.
Swedish Medical Center surgical technologist potentially put patients at risk of HIV, hepatitis
Swedish Medical Center in Englewood, CO, is asking about 2,900 patients to get tested for HIV, hepatitis B and hepatitis C after discovering that a
former employee may have stolen narcotic pain medicines.
A surgical technologist worked in operating rooms at the hospital from Aug. 17 to Jan. 22, officials said, and could have put at risk patients who had
surgery during that time. The hospital announced it is investigating possible exposures with the state Department of Public Health and Environment
and is reaching out to patients.
"At this point we have no evidence of any patient exposure," the hospital said. "However, we are taking a position of extreme caution by offering free
testing to all patients who had surgery at Swedish Medical Center in locations where this individual worked at any time during this individual's
employment, including those days the employee was not on the schedule or in the facility."
The Swedish investigation began after an employee allegedly was found diverting drugs Jan. 22. According to the state Division of Professions and
Occupations, Rocky Elbert Allen obtained a surgical technologist license in July. It was summarily suspended Jan. 29.
The suspension order noted that on Jan. 22, "in the beginning stages of a surgical procedure," Allen "removed a labeled Fentanyl syringe" from the
anesthesia work space "and replaced the Fentanyl syringe with another labeled syringe." Allen "submitted to a urinalysis which was positive for
Fentanyl and marijuana," the order said. Fentanyl is a potent narcotic pain medicine used by anesthesiologists.
The hospital did not explain how patients could have been exposed. Dr. Larry Wolk, executive director and chief medical officer of the state health
agency, said potential reuse of needles is the main concern. Because hospitals track the inventory of needles, one risk is that a drug thief "is taking
needles, not just drugs, and replacing them with used needles," he said.
In 2009, Denver surgical tech Kristen Diane Parker infected at least 18 hospital patients with hepatitis C by stealing liquid painkillers and leaving
behind her dirty syringes. Parker, who worked at Rose Medical Center and Audubon Surgery Center of Colorado Springs, was sentenced to 30
years in prison.
Colorado adopted tighter regulations of surgical technicians and surgical assistants in the wake of the Parker case. But state legislators are now
considering whether to sunset them.
The state Department of Regulatory Affairs reported recently that the regulations appeared to duplicate other state, federal and hospital
requirements, and a House hearing is scheduled Feb. 23 to consider whether they are needed.
Diana Protopapa, a lobbyist for state associations of surgical technologists and surgical assistants, said her clients favor state regulation. "I certainly
think another episode like this speaks to the need for regulation," she said, "and perhaps greater regulation than we have."
Two measures were signed into law in Colorado following the case of Kristen Parker. One law required employers to report healthcare workers
under suspicion to the state within two weeks and to make information about a case available to the public, including future employers.
The other law set up a statewide registry of surgical technologists and surgical assistants. Employers were required to verify those workers are in
good state standing before allowing them to work. That law is under review. Critics say it duplicates other state, federal and hospital requirements.
Although there are no known cases of HIV, hepatitis B or hepatitis C stemming from the drug-diversion case at Swedish Medical Center, hospital and
state health officials are urging about 2,900 patients who had surgeries from Aug. 17 to Jan. 22 to come in for free testing.
Visit Denver Post for the story.
Doctor gets 30 years to life for murders in L.A. case tied to patients' overdoses
A judge on Friday sentenced a Rowland Heights doctor to 30 years to life in prison for the murders of three of her patients who fatally overdosed,
ending a landmark case expected to reshape how doctors nationwide handle prescriptions across the country.
The sentence came after a Los Angeles jury last year found Dr. Hsiu-Ying “Lisa” Tseng guilty of second-degree murder, the first time a doctor had
been convicted of murder in the U.S. for overprescribing drugs.
Superior Court Judge George G. Lomeli said before sentencing Tseng that she had attempted to blame patients, pharmacists and other doctors
rather than take responsibility for her own actions.
The 46-year-old former general practitioner is among a small but growing number of doctors charged with murder for prescribing painkillers that
killed patients. A Florida doctor was acquitted of first-degree murder in September. Some experts fear that Tseng’s conviction will usher in a
precarious new reality – a scenario in which doctors fearful of prosecution are hesitant to prescribe potent painkillers to patients who need them.
During Tseng’s trial, Deputy Dist. Atty. John Niedermann told jurors that there were “red flags” in her prescribing habits.
The prosecutor told jurors that Tseng wrote a man’s name on prescriptions so his wife could get twice as many pills, openly referred to her patients
as “druggies” and sometimes made up medical records. Her motivation, Niedermann said, was financial.
Between 2007, when Tseng joined the Rowland Heights clinic where her husband worked, and 2010, tax returns show that their office made $5
million, he said.
Tseng was convicted of murder for the deaths of Vu Nguyen, 28, of Lake Forest; Steven Ogle, 25, of Palm Desert; and Joey Rovero, 21, an Arizona
State University student who prosecutors say traveled more than 300 miles with friends from Tempe, AZ, to obtain prescriptions from Tseng at her
Rowland Heights clinic.
The jury also found Tseng guilty on more than a dozen illegal-prescribing counts.
Visit the Los Angeles Times for the story.
How big is too big for medical device companies?
In the midst of rampant consolidation in the medical device sector, the calls for healthcare conglomerates like J&J and Novartis to break up are
growing louder.
Johnson & Johnson is not alone when it comes to calls for it to spin off its medical device businesses. Novartis has been questioned over the future
of its struggling Alcon eye treatments business, and Pfizer and GlaxoSmithKline face pressure to break up, according to the Financial Times.
In a time in which mergers seem all the rage in the medical device industry, it raises the question: Is there such a thing as getting too big and
diversified?
Some companies seem to have already decided on the “yes” side of the question. Philips, for example, is seeking to spin off its lighting business
from its healthcare business, though Bloomberg Business reports headwinds for the deal. Siemens last year separated its healthcare business from
the rest of the company.
In fact, the medical device industry can almost seem like a chess board.
Abbott spun off hospital products company Hospira in 2004 and acquired its way into pharma, only to split off the pharmaceuticals business in the
new AbbVie company at the start of 2013. Pfizer meanwhile acquired Hospira last year for $17 billion.
Baxter spun off its biotechnology and pharmaceuticals business, Baxalta, earlier this year.
Cardinal Health spun out CareFusion in 2009, and BD then snapped up CareFusion for $12 billion last year, at the same time that Cardinal Health
spent $2 billion on Johnson & Johnson’s Cordis unit.
Activist investor Artisan Partners Limited Partnership wants Johnson & Johnson to go beyond the Cordis deal, arguing that J&J’s sluggish medtech
and consumer sectors and its aggressive M&A strategy are killing the company.
Artisan has noted that J&J has spent more than $150 billion on mergers and acquisitions in the past decade, which include paying $17 billion for
Pfizer’s consumer business in 2006 and $19 billion for Synthes in 2012. J&J has announced that it has spent some $5 billion on restructuring costs
related to the Synthes merger, yet the purchase has failed to boost the profitability of J&J’s medical device segment. “Despite this $24 billion
investment, the medical device business is generating adjusted EBITA of less than $8 billion, roughly the same level of profit it made in 2010,” reads
part of a letter to J&J from Daniel J O’Keefe, managing director and portfolio manager at Artisan Partners.
Investors, however, don’t seem to be backing Artisan’s point of view just yet, with J&J CEO Alex Gorsky even defending the conglomerate model as
a “significant driver [of growth] in the past, and we expect it will be more important in the future,” according to the Financial Times. J&J executives
argue that the diverse model gives the company stability, especially when the Affordable Care Act is spurring so much change in the U.S. healthcare
industry.
If Johnson & Johnson does break apart someday, it could be but another chapter when it comes to the traditional drug and medtech realms gradually
eroding, being redrawn, and then eroding again.
Visit Qmed for the article.
Babies with genes from 3 people could be ethical, panel says
Would it be ethical for scientists to try to create babies that have genetic material from three different people? An influential panel of experts has
concluded the answer could be yes.
The 12-member panel, assembled by the National Academies of Sciences, Engineering and Medicine, released a 164-page report outlining a plan
for how scientists could ethically pursue the controversial research. "The committee concludes that it is ethically permissible" to conduct such
experiments, the report says, but then goes on to detail a long list of conditions that would have to be met first.
For example, scientists would have to perform extensive preliminary research in the laboratory and with animals to try to make sure it is safe. And
then researchers should initially try to make only male babies, because they would be incapable of passing their unusual amalgamation of DNA on to
future generations.
"Minimizing risk to future children should be of highest priority," the committee writes.
The report was requested by the Food and Drug Administration in response to applications by two groups of scientists in New York and Oregon to
conduct the experiments. Their goal is to help women have healthy babies even though they come from families plagued by genetic disorders.
A statement issued by the FDA immediately after the report's release raised questions about whether the FDA would permit the research to move
forward.
The FDA email praised the "thoughtful work" of the panel and said the agency would be "reviewing" the recommendations. But it noted that the latest
federal budget "prevents the FDA from using funds to review applications in which a human embryo is intentionally created or modified to include"
changes that could be passed down to future generations. As a result, the email says, any such research "cannot be performed in the United States"
at this time.
Critics of the research, meanwhile, say the number of women who could benefit from the experiments is so small that it's not worth crossing a line
that's long been considered off-limits — making genetic changes that could be passed down for generations.
The goal of the research is to help women carrying diseases known as mitochondrial disorders, which are only passed down by women through
defects in the genetic material in their eggs. Specifically, the defects are in a type of genetic material known as mitochondrial DNA.
Unlike the DNA that most people are familiar with — the 23 pairs of human chromosomes that program most of our body processes and traits —
mitochondrial DNA consists of just 37 genes inside mitochondria, which are structures inside cells that provide their energy.
Mitochondrial disorders range from mild to severe. In many cases there is no treatment, and the affected child dies early in life after suffering
progressive, debilitating symptoms.
Scientists want to create eggs free of mitochondrial defects by removing the defective mitochondrial DNA. It would be replaced with healthy
mitochondrial DNA from eggs donated by other women.
The British government recently approved such experiments in that country.
Visit NPR for the article.
Junior docs can work longer flex hours safely, study finds
Surgery patients fared just as well when junior doctors worked longer than mandated hours in the first major rigorous test of regulations many
physicians say hurt medical education.
Nationwide limits on work hours were established more than a decade ago because of concerns that sleep-deprived medical residents were a threat
to themselves and their patients. To test that, researchers randomly assigned more than 4,000 surgery residents to regulation hours or a more
flexible schedule that allowed them to continue with a case after their shifts ended. That sometimes meant working for more than 28 hours at a time.
The study looked at how many patients died or had serious complications in the month after surgery and found the same low rate - about 9 percent in both groups.
Residents' self-rated dissatisfaction with their education and with their well-being were similarly low - 11 percent and roughly 13 percent respectively
in each group.
It's a landmark study, testing "a hot button, controversial issue in healthcare," said lead author Dr. Karl Bilimoria, director of surgical outcomes and
quality improvement at Northwestern University's Feinberg medical school. Without flexibility, rookie doctors often have to end their shifts in the
middle of caring for patients, handing them off to another medical resident. That can happen at critical times, disrupting the doctor-patient
relationship, Bilimoria said. "Our hope would be that the evidence would be used ... to change policies fairly soon and allow flexibility back into
surgical residency," he said.
Residents' work limits were first set in 2003 by the Accreditation Council for Graduate Medical Education, and revised in 2011. The rules include 80hour maximum work weeks.
Visit the Associated Press for the story.