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Opinion: How To Understand The WHO’s Zika ‘Emergency’ (And Not Be Terrified By It)

CommonHealth (WBUR) - Tue, 02/02/2016 - 6:09pm

Jaqueline Vieira, left, watches as her 3-month-old son Daniel, who was born with microcephaly, undergoes physical therapy at the Altino Ventura foundation in Recife, Brazil. (Felipe Dana/AP)

The director-general of the World Health Organization has declared Zika virus a “public health emergency of international concern” — a PHEIC, pronounced “fike,” rhymes with spike, if you want to sound like a member of the WHO emergency committee.

It’s natural to be concerned when the WHO declares an epidemic — it has only done so three other times in its history: the 2009 influenza outbreak, an upswing in polio cases in 2014, and the West African Ebola outbreak in 2015. The question is: What makes the WHO concerned and how concerned should we be?

In this case, the disease itself is not as scary as the complications that have been linked to the virus — associations that have not yet been confirmed. Declaring a PHEIC allows the WHO to coordinate the international response, release emergency funds to better study the virus and confirm those potential complications as quickly as possible.

Here’s what we know. First, we know the virus is spreading quickly. The mosquito that carries the virus can be found from South America up to our hot and humid southeastern states in the U.S. And because the virus only arrived in the Western Hemisphere in 2014 — perhaps because of the World Cup or other sporting events — no one here has immunity to it, making it easy for mosquitoes to spread the virus. Some experts believe the virus can spread throughout the Americas, wherever the mosquito lives.

All this makes Zika sound scary, but we also know that up to 80 percent of people who catch the virus do not even display any symptoms. Those that do tend to have a mild illness with joint pain, a rash, red eyes and a fever, all of which resolve in four to seven days. No deaths have been reported so far that directly link to the virus. This is a far cry from Ebola, which causes a hemorrhagic syndrome that leads to death in as many as 50 percent of cases. Zika virus is worrisome in that it may cause horrible birth defects, but, put simply, it is not as scary as Ebola.

Still, it is the unknown that also concerns the WHO. While we know there has been an uptick in cases of children born with small heads (called microcephaly) in Brazil, it is not yet clear whether Zika virus caused the birth defect. There has also been an increase in cases of Guillain-Barré syndrome, a very rare neurological complication of some viral illnesses, and these cases may also be linked to Zika virus. So far, none of these links have been proven, which is why the WHO and CDC are calling for a rapid response to address Zika transmission and study the virus so we know better what we’re dealing with.

PHEICs can be declared in cases like Ebola to raise awareness about extremely dangerous pathogens. But Ebola-like situations are not the only reason to declare a PHEIC. The WHO can also declare one to rapidly advance the scientific agenda to confirm or debunk worrisome but unproven syndromes associated with an illness. That, it seems, is the WHO scenario with Zika.

In short, not all epidemics of international concern are equally dangerous. Sometimes, declaring a PHEIC is the fastest, most efficient way to marshal the resources to help us get answers to the most burning questions as quickly as possible.

Ebola is terrifying; Zika isn’t there — at least, not yet. But all of these studies will help tell us how much of a public health threat the virus truly is.

David Scales, M.D., Ph.D. is a third year resident in internal medicine at Cambridge Health Alliance who wrote his dissertation on how the WHO plans for and responds to health crises.

Categories: Health Care

CDC Warns Of Fetal Alcohol Exposure, Says Drinking Any Time In Pregnancy Is Risky

CommonHealth (WBUR) - Tue, 02/02/2016 - 3:55pm

(Source: “Vital Signs: Alcohol-Exposed Pregnancies — United States, 2011–2013″)

If you’re a sexually active woman of childbearing age and not using birth control, public health officials say you should stop drinking alcohol — completely. That includes beer, wine or any other alcoholic beverage you might be considering.

In a report out Tuesday,  the U.S. Centers for Disease Control and Prevention notes that exposure to alcohol, even in the first weeks of pregnancy, puts developing babies at risk for fetal alcohol spectrum disorders, “characterized by lifelong physical, behavioral, and intellectual disabilities.” Because these disorders are completely preventable by abstaining from alcohol, and because officials say there is “no known safe amount of alcohol” that women can drink at any time during pregnancy, their basic message is: “Why take the risk?”

“Women wanting a pregnancy should be advised to stop drinking at the same time contraception is discontinued,” the report concludes. “Health care providers should advise women not to drink at all if they are pregnant or there is any chance they might be pregnant.”

Here’s more from the CDC news release:

An estimated 3.3 million U.S. women between the ages of 15 and 44 years are at risk for exposing their developing baby to alcohol because they are drinking, sexually active, and not using birth control to prevent pregnancy, according to a new CDC Vital Signs report. The report also found that 3 in 4 women who want to get pregnant as soon as possible do not stop drinking alcohol.

Alcohol use during pregnancy, even within the first few weeks and before a woman knows she is pregnant, can cause lasting physical, behavioral, and intellectual disabilities that can last for a child’s lifetime. These disabilities are known as fetal alcohol spectrum disorders (FASDs). There is no known safe amount of alcohol – even beer or wine – that is safe for a woman to drink at any stage of pregnancy.

About half of all pregnancies in the U.S. are unplanned and, even if planned, most women will not know they are pregnant until they are 4-6 weeks into the pregnancy when they still might be drinking.

During a telephone briefing with reporters, Anne Schuchat, the CDC’s deputy director, said:

What we’re recommending is women who are not trying to get pregnant make sure they have a conversation about birth control and how to avoid becoming pregnant. If they are not using contraception and are fertile and are drinking they could be at risk… One in two deliveries in this country occurs to someone who wasn’t actually trying to get pregnant when they got pregnant. So we do think that fertile woman that are not using contraception ought to be aware that they may become pregnant and that drinking during even that first couple of weeks of pregnancy can be risky.

The American College of Obstetricians and Gynecologists responded to the CDC report in a statement from its president, Mark DeFrancesco:

Obstetrician-gynecologists have long recognized that use of alcohol during pregnancy can lead to fetal alcohol spectrum disorders (FASD), and that the effects of fetal alcohol exposure can last a lifetime. During gestation, alcohol can quickly reach the fetus’s underdeveloped liver and brain through the placenta, leading to a wide range of birth defects and developmental disorders. That’s why ACOG recommends that women completely abstain from alcohol during pregnancy.

Ob-gyns should routinely screen women regarding their alcohol use, both before and during pregnancy, and should provide support for women to stop use of alcohol when planning a pregnancy or when becoming pregnant.

However, as the CDC notes, roughly half of all pregnancies in the United States are unintended. In many cases of unintended pregnancy, women inadvertently expose their fetuses to alcohol and its teratogenic effects prior to discovering that they are pregnant. This is just another reason why it’s so important that health care providers counsel women about how to prevent unintended pregnancy through use of the contraceptive method that is right for them. There are many benefits to helping women become pregnant only when they are ready, and avoiding alcohol exposure is one of them.

The birth defects associated with alcohol during pregnancy are completely preventable. It is essential that all health care providers, especially ob-gyns, make clear to their patients that there is no amount of alcohol use that is safe during pregnancy. ACOG thanks the CDC for this important report, which will help to raise awareness of the risk associated with any use of alcohol during pregnancy.

Categories: Health Care

Bosses Find Part-Time Workers Can Come With Full-Time Headaches

Kaiser Health News - Tue, 02/02/2016 - 2:49pm

Starting in 2016, the federal health law requires small employers to offer their full-time workers health insurance. In anticipation of the change, some fast-food restaurants looked to get around the law by making more workers part time. Now some owners are rethinking that approach.

At a Burger King off Highway 99 in California’s Central Valley, a half-dozen workers in black uniforms scurry around, grabbing packets of ketchup and stuffing paper bags with french fries.

Tiana Mua has worked here part time for almost a year. She’d like to be full time, but at this Burger King only the managers are full time. (The company didn’t respond to an interview request.)

Mua said that’s the situation at fast-food joints all over town. “They’re cutting back on all the jobs, and a lot of people have been let go and everything already,” Mua said.

One reason: The local economy is bad. People aren’t eating out as much, and sales are down. But there’s another reason that might explain why fast-food employees aren’t getting more hours: Obamacare.

Starting Jan. 1, businesses with 50 or more full-time employees must offer health insurance to all full-time staff or pay a hefty fine. Employers with 100 or more workers had to start offering coverage last year. But smaller businesses that operate on lower margins, especially restaurants, complained loudly about the cost.

This story is part of a partnership that includes KQED, NPR and Kaiser Health News. It can be republished for free. (details)

And some fast-food franchise owners figured out a way to avoid paying for coverage: Just make as many workers as possible part time. A U.S. Chamber of Commerce survey found nearly 60 percent of small franchise businesses said they would make personnel changes like this.

“The ones that did it successfully did it three or four years ago,” says Kaya Bromley, an attorney who helps employers comply with the Affordable Care Act. But, Bromley said, some of the restaurant owners who cut hours to sidestep the health law now regret it.

“A lot of the fast-food franchisees that did this,” she said, “are now coming back and saying, ‘It was a great idea for reducing the number of people that I have to offer benefits, but now I can’t run my restaurants.’ ”

They tell her it has been a nightmare trying to manage a part-time staff.

“Because you’ve got people who are less loyal, you’ve got people who are less skilled — who don’t understand the business,” she said. There’s also more employee turnover.

Bromley has seen many of those restaurants reverse course. “Employers think that there’s a shortcut here or there, and then they realize, yeah, that shortcut really hurt me more than it helped me,” she said.

The people hurt most by all the workforce management gymnastics are the people at the bottom of the restaurant pecking order who want to advance, but can’t, said Angelo Amador, vice president of labor and workforce policy for the National Restaurant Association.

“Someone who’s working part time, but wants more hours so they can move up the ladder, they can’t get the hours,” he said. “It ends up taking out that middle rung of employees.”

Amador said Obamacare has made restaurants less flexible, mainly because it defines full-time work as 30 hours a week or more, and most other laws restaurants have to comply with, like overtime pay, define full time as 40 hours. He thinks the Affordable Care Act should be changed for consistency.

“It would be much easier if we could have one definition of full time,” he said.

At the Carl’s Jr. in Chowchilla, California, manager Silvia Campos tries to keep as many workers full time as possible. She says it makes her job easier. “It’s a small town,” she said. “For me, it’s hard to find a really good employee.”

But some workers don’t want more hours. Their part-time salary is low enough that they’re eligible for government coverage in California through Medicaid.

Some workers say they’re better off making less money and getting their coverage free from the state.

This story is part of a partnership that includes KQED, NPR and Kaiser Health News.

Categories: Health Care

Study Finds No Harm In Allowing Surgeons-In-Training To Work Longer Shifts

Kaiser Health News - Tue, 02/02/2016 - 11:30am

Patients suffered no extra harm when doctors training to be surgeons were allowed to work longer shifts, a study released Tuesday concludes, adding to a push to relax the strictest limits on resident hours.

The New England Journal of Medicine study comes as the Accreditation Council for Graduate Medical Education is reassessing requirements that prevent residents from working extremely long stretches or back-to-back shifts. Those rules were enacted in 2003 and strengthened in 2011 amid concerns that sleep-deprived residents were more likely to make serious errors.

Since then there has been push back from residency program directors concerned that the rules created new dangers for patients by abruptly forcing interns to leave in the middle of treating a patient or surgery. They also complain the rules interfere with resident education because it is harder for a trainee to follow their patients.

The study released Tuesday conducted a direct experiment by tracking patient outcomes after loosening the rules for doctors in 58 surgical residency programs. It found that their patients did not die or suffer complications any more than at 59 residency programs that did not waver from the current rules.

“We believe the trial results say it’s safe to provide some flexibility in duty hours,” said Dr. Karl Bilimoria, the main author and a professor of surgery at the Feinberg School of Medicine at Northwestern University in Chicago.

Some previous studies had come to similar conclusions, but this one has been anticipated because of its more rigorous methods. The trial has drawn protests from Public Citizen and the American Medical Student Association, which said researchers put patients and residents at risk by waiving the rules.

Use Our Content This KHN story can be republished for free (details).

The groups assert that the experiment, funded by the American Board of Surgery, the American College of Surgeons and the accreditation council, was never likely to find a significant difference in patient outcomes, since most elements of patient care — the physicians, specialists, nurses and other clinical workers — remained unchanged.

“Research on the deleterious effects of chronic sleep deprivation is just overwhelming,” said Dr. Deborah Hall, president of the medical student association. “I’m concerned we’re going to walk away from a lot of progress that’s been made without overwhelming data [showing] that residents aren’t subject to the ordinary limits of human neurobiology.”

In an editorial also published in the journal, Dr. John Birkmeyer, chief academic officer at Dartmouth-Hitchcock, a health system in New Hampshire, came to a different conclusion than Bilimoria did. Birkmeyer wrote the experiment’s results “effectively debunks concerns that patients will suffer as a result of increased handoffs and breaks in continuity of care.”

Rather than roll back the rules on duty hours, he argued that surgeons should find safer ways to treat patients without relying on “overworked” residents.

“To many current residents and medical students, 80-hour (or even 72-hour) workweeks and 24-hour shifts probably seem long enough,” Birkmeyer wrote. “Although few surgical residents would ever acknowledge this publicly, I’m sure that many would love to hear, ‘We can take care of this without you. Go home, see your family, and come in fresh tomorrow.’”

The research was conducted in the academic year that began in fall 2014. One group of residency programs followed the existing rules, while the other programs were allowed to remove several strictures.

Residents in the experimental group could stay at the hospital longer than 28 hours in a row, the current maximum. They did not have to be given at least eight hours off between shifts. Residents who worked a 24-hour shift no longer had to wait 14 hours before returning to the hospital. And first-year residents could work more than 16 hours in a row, a limit set in 2011.

After analyzing medical records for 65,849 patients in the control group and 72,842 in the experimental group, the researchers found no significant difference in death or complication rates. They also surveyed 4,330 general surgery residents and found that those with the more flexible schedules rated their overall well-being and morale no different than did those with strict rules.

“We’re very encouraged by the findings,” said Dr. Maya Babu, a neurological surgery resident at the Mayo Clinic and president of the Resident and Associate Society of the American College of Surgeons. “We feel very strongly that flexibility is important to provide opportunities to learn and to have patient ownership, to see patients from the time they’re admitted through surgery the next day.”

Seven percent of residents exempted from the duty limitations said they left during an operation at least once a month, while 13 percent of those following the rules said they left. Thirty percent of the experimental group said they missed an operation at least once a month, while 42 percent of those with standard rules said they missed one. A third of the test group said they turned a patient over to another doctor in the middle of dealing with them, while nearly half of the control group recalled doing so.

Dr. Michael Carome, director of Public Citizen’s Health Research Group, a patient safety advocacy organization, said the study should have objectively assessed the hours residents worked and the effects on their health and patients, rather than rely on surveys. He said the study also did not track whether residents in the control group adhered to the stricter limits on how long they could work.

“The study didn’t collect any meaningful data on resident health outcomes,” Carome said.

The most major restrictions on resident duty hours put into place in 2003, such as a maximum workweek of 80 hours a week and a minimum of one day off every seven, were not tested in the study and are expected to remain in place.

The paper was scheduled to be presented Tuesday at the Academic Surgical Congress in Jacksonville, Florida. A similar experiment, looking at internal medicine residents, is still in progress.

Categories: Health Care

Insurer’s Approval Of Genetic Testing For Some Cancers Raises Questions

Kaiser Health News - Tue, 02/02/2016 - 5:00am

Pennsylvania-based Independence Blue Cross’ announcement that it will cover a complex type of genetic testing for some cancer patients thrusts the insurer into an ongoing debate about how to handle an increasing array of these expensive tests.

Independence — with its approximately 3 million members — became the largest insurer to cover whole genome sequencing for select cancer patients. The analysis looks at the entire sequence of each tumor’s DNA and identifies mutated genes. Physicians can request this sequencing for children with tumors, patients with rare cancers, people with a type of breast cancer called triple negative and patients who have exhausted conventional therapies for metastatic cancer.

While the hope is the results will help patients and their doctors pinpoint the best treatments based on genetic differences, there may not be any such drug regimens yet available. It’s also unclear whether the information the tests provide make any difference in a patient’s treatment and prognosis.

This KHN story also ran in USA Today. It can be republished for free (details).

“Only some of the information is useful,” said Donna Messner, vice president and senior research director with the Center for Medical Technology Policy, a nonprofit organization working with insurers, genetic test companies, patient groups and clinicians to try to develop a common approach to insurance coverage. “That’s a challenge for payers.”

Cost is also a factor. Estimates of national spending on genetic and molecular testing vary, partly because there are so many different types of tests for different conditions. A 2012 analysis by UnitedHealth Group of national trends estimated the U.S. could see overall spending on genetic tests reach between $15 billion and $25 billion by 2021, up from $5 billion in 2010.

Despite the uncertainties, Independence CEO Daniel J. Hilferty said the insurer felt it was important to try to help some members learn more about their disease. He declined to say how much the program would cost but said the expected number of patients would be small, perhaps in the hundreds.

“Let’s jump in the pool,” said Hilferty of the decision to cover the complex test for a limited group of cancer types. “If evidence shows it works and is helpful, then we can do more.”

The testing “identifies genes for which there may be a target [treatment] available today — or maybe a target tomorrow when new drugs come to market,” said Don Liss, Independence’s medical director.

What Can Be Found In The Sequence?

Overall, genetic testing is available for more than 2,500 conditions and can be used to identify an inherited risk of a disease, the presence of a disease or whether a particular drug treatment might be effective against the specific disease.

Some types of genetic tests are already commonly covered by insurers. Patients diagnosed with breast cancer, for example, get a test that determines whether their tumors express a type of protein against which a widely available anti-cancer drug is effective.

The testing that Independence will cover goes further — outlining a tumor’s entire genetic makeup and searching for anomalies in more than 20,000 genes. Medicare and most private insurers do not cover whole genome testing for cancer tumors.

UnitedHealth Group in December said it would cover whole genome profiling for stage IV non-small cell lung cancer, but not the other cancers that Independence will cover.

Priority Health, a small insurer in Michigan last year began covering whole genome sequencing of tumors for certain late-stage, complex cancers in an effort to help target treatments. Patient advocacy groups, particularly those for people with lung cancer, are pushing hard for such testing, part of a campaign with the slogan, “Don’t guess. Test.”

“A lot of insurers decide on a case-by-case basis about these tests,” said Lynn Matrisian, vice president of scientific and medical affairs for the Pancreatic Cancer Action Network, a patient advocacy group. “Knowing that it’s covered, I think goes a long way in reassuring the patient that they will be able to get some of these therapies.”

The hope is that the analysis will help determine the subset of the type of cancer a patient has or detect characteristics of another type of cancer. Then oncologists could look for drugs that target the patient’s particular genetic profile. Sometimes that could involve prescribing a drug that is “off label,” a common practice in which a doctor prescribes a drug for a condition for which it was not initially approved by federal officials. A breast cancer drug, for example, might prove useful in another type of cancer.

While researchers believe the efforts are promising, evidence is scant. A study done in France found that “off label” use didn’t prove more effective than standard chemotherapy.

Still, as scientists increasingly study the genetic variations in cancer, researchers say more patients should have their tumors analyzed with whole genome sequencing — and the data gathered and shared. That could speed the development of new drugs, vaccines or combinations of treatments, part of the current focus on “precision medicines” and President Obama’s “moon shot on cancer.”

“The key to all this is if we’re going to advance this whole personalized medicine thing efficiently, we have to get all the insurance companies working in some kind of similar policy … and to incentivize standardized data that can be shared,” said Sean Tunis, founder of the Center for Medical Technology Policy.

The collaborative has recommended changes in coverage guidelines so that tests that assess five to 50 genes would no longer be considered “investigational” and would be covered by all U.S. health plans.

Patients who want whole genome sequencing analysis even if it’s not covered by their insurer can sometimes get it done at an academic medical center as part of a research trial, or pay for it themselves. Prices can run anywhere from $1,000 to $5,000 or more, advocacy groups say.

When Tetyana Murza’s husband was diagnosed with pancreatic cancer three years ago, their insurer would not cover a whole genome analysis of the tumor. So they spent $2,000 to pay for it.

“When you pretty much have a terminal disease … you’re looking for all the options,” said Murza, managing director at the Genetic Alliance, a Washington-based coalition of disease advocacy groups, academic institutions and private companies. “You always have a hope that something will come up. Doing sequencing was that for us … we’re hoping to find those targets we can attack with medicine.”

They learned that her husband, Michael Mariotte, has a gene mutation that is not standard for pancreatic cancer but is more commonly seen in breast and some other types of cancer. She said there is a drug approved for another type of cancer that might work on that mutation. They haven’t tried it yet.

Instead, they’ve gone through several rounds of chemotherapy commonly used for pancreatic cancer. Now, there’s another new drug on the market for pancreatic cancer, and one their insurer says they must try first before moving on to the other.

Even though it hasn’t changed the course of his treatment, Murza says her husband is glad they did the sequencing: “He says it’s still good for him as a cancer patient to know there is another target, that something else can come up.”

Categories: Health Care


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