DAILY UPDATE

Sebelius: Pressure after rollout was 'awful'

Outgoing Health and Human Services (HHS) Secretary Kathleen Sebelius said she was "flat-out wrong" to believe that HealthCare.gov was ready to go on Oct. 1, 2013. Sebelius made the comment to NBC's Andrea Mitchell on "Meet the Press" in her first post-resignation interview. The secretary has only a handful of weeks left at the HHS until her replacement is confirmed.

In candid remarks about the healthcare rollout, Sebelius said she regretted not taking a different approach when HealthCare.gov was under construction.

"If I had a magic wand and could go back to mid-September and ask different questions based on what I know now," I would, she said. "I thought I was getting the best information from the best experts but clearly that didn't go well."

"The launch of the website was terribly flawed, terribly difficult," she added. "Could we have used more time and testing? You bet."

The former Kansas governor handed in her resignation to President Obama in early March, when the enrollment numbers on the exchanges began to rise. She said she knew around the time of the election that she would not stay through the second term, though she started discussing her departure with Obama after Jan. 1.

Asked whether she was pushed out of the administration, Sebelius insisted the departure was her choice. "I thought that at the end of open enrollment was a logical time to leave," though there is "never a good time," Sebelius said.

As the official in charge of the healthcare rollout, Sebelius was blamed for the massive technical problems with the federal enrollment website, and soon became the target of partisan attacks over the law itself.

She said Sunday that while the exchanges were a "moving target" — states were still deciding in early 2013 whether to run their own systems — "clearly, the estimate that it was ready to go Oct. 1 was flat-out wrong."

"That was very alarming" when HealthCare.gov crashed for the first time, she said, "because that took some real diagnostics in terms of what the problems where and then analysis" about whether the system could be fixed.

"The good news was that we said it would be fixed in eight weeks, it was fixed in eight weeks and we announced last week that 7 million people ... had enrolled," she said.

Sebelius did not mince words when describing the pressure of last fall, calling October and November a "dismal time." It was a "pretty scary thing" preparing for Dec. 1, the administration's publicly announced deadline for making the site work, she said.

Visit the Hill for the story.

Deadly virus's spread raises alarms in Mideast

Saudi Arabia on Sunday confirmed a surge of cases of a deadly virus in the kingdom over the past two weeks, even as it tried to counter criticism that it wasn't doing enough to contain the outbreak.

The United Arab Emirates over the weekend separately announced six confirmed cases of Middle East Respiratory Syndrome, or MERS, among paramedics there, one of whom died of the illness. The high number of cases among medical workers raised questions about how effective Arab Gulf governments have been in controlling the 1½-year-old outbreak.

"I'm not pretty sure that they are actually seeing how big this thing is," a Saudi doctor said on Sunday at King Fahd General Hospital, the large public hospital in Jeddah that has been hardest hit by a spike in the city this month.

The hospital reopened its emergency room on Friday after shutting it briefly for what authorities said was disinfection measures against MERS. But patients were avoiding the hospital, and health workers were "very worried" after the MERS death of one colleague and sickness in another, the doctor said. "What I really wish for is to shut the whole hospital down" until the spread subsides, she said.

Last week marked the biggest number of cases since the outbreak began, Dr. Ian M. Mackay, an Australian epidemiologist who has tracked the outbreak, wrote on Sunday.

About 50 of the overall cases have been in healthcare workers, he said, a strong warning sign about measures being taken to control the outbreak, he and others have said. "As far as we know, MERS-CoV does not spread easily from person-to-person, so these clusters suggest a breakdown in infection prevention and control."

Saudi Arabia and other Arab Gulf countries have said they are taking adequate measures against infection since the first laboratory-confirmed cases of MERS, which kills largely through respiratory infections, in September 2012. Since then, the WHO says it has confirmed 228 cases, 92 of them fatal.

The number rose sharply this month. In just the four days to last Thursday, Saudi Arabia notified the World Health Organization of 15 new confirmed MERS cases, including two deaths, the WHO posted on its official Twitter account late Sunday.

The Saudi Ministry of Health said late Sunday that government precautions to control the disease were sufficient and up to scientific standards. Ministry of Health officials didn't respond to email and phone requests to comment on the reason for the surge in cases in healthcare workers. The World Health Organization said it couldn't immediately respond to similar questions Sunday evening.

The majority of cases have occurred in Saudi Arabia. Authorities have confirmed other cases as far afield as Europe, all of which were believed linked to the Middle East. Yemen's government on Sunday said it confirmed the first known case there.

Medical studies say camels are at least one host of the virus that causes MERS, though the disease also has been confirmed to spread in limited fashion from person to person.

Saudi health officials said last year that they were requiring all health workers to treat arriving patients with respiratory problems as potential MERS cases, and take precautions against patient-to-nurse exposure. The doctor at the Jeddah hospital said authorities this month gave health workers there infection-control pamphlets and face masks. Visit the Wall Street Journal for the story.

Deadly H5N1 bird flu needs just 5 mutations to spread easily in people

It’s a flu virus so deadly that scientists once halted research on the disease because governments feared it might be used by terrorists to stage a biological attack. Yet despite the fact that the H5N1 avian influenza has killed 60% of the 650 humans known to be infected since it was identified in Hong Kong 17 years ago, the “bird flu” virus has yet to evolve a means of spreading easily among people.

Now Dutch researchers have found that the virus needs only five favorable gene mutations to become transmissible through coughing or sneezing, like regular flu viruses.

World health officials have long feared that the H5N1 virus will someday evolve a knack for airborne transmission, setting off a devastating pandemic. While the new study suggests the mutations needed are relatively few, it remains unclear whether they’re likely to happen outside the laboratory.

“This certainly does not mean that H5N1 is now more likely to cause a pandemic,” said Ron Fouchier, a virologist at Erasmus University Medical Center in Rotterdam, Netherlands, and coauthor of the study published in the journal Cell.

In the new study, the authors set out to determine the minimum number of mutations necessary for airborne infection. To do this, the researchers took a strain of the virus that had previously infected a human and altered its genes in the lab. Then they sprayed the altered version of the virus into a ferret’s nose and placed the animal in a specially constructed cage with a second ferret who had not been exposed to the virus.

The layout of the cages prevented direct contact between the animals, but allowed them to share airflow. When the healthy ferret developed flu symptoms researchers knew the virus had spread through the air. By exposing ferrets and human tissue samples to a variety of genetically altered viruses, study authors identified five key gene mutations.

Two of them improved the virus’ ability to latch onto cells in the animal’s upper respiratory tract. Once there, it could enter the cell, disgorge its genetic material and cause the cell to mass-produce copies of the virus. “Another mutation increases the stability of the virus,” Fouchier said. “The remaining mutations enable the virus to replicate more efficiently.”

The altered virus was much less deadly than the natural version. Only two of the ferrets in the study died, but neither death was caused by the flu.

Fouchier said he thought this was because the virus attacked cells in the upper airway instead of the lower airway and was therefore less likely to cause pneumonia.

Virologists who were not involved in the study said the findings were important, as they provided health authorities with a means of discerning whether mutations observed in the wild are dangerous to people.

“This is important work,” said Yoshihiro Kawaoka, a virologist at the University of Wisconsin School of Veterinary Medicine. “This could contribute to surveillance of avian influenza viruses in nature.”

Fouchier, Kawaoka and other researchers touched off an international biosecurity furor in 2011 when they demonstrated that the H5N1 virus could be made transmissible among ferrets. As a result of the controversy, the U.S. National Science Advisory Board for Biosecurity asked the virologists to omit some details of their work before publishing it in the journals Science and Nature. Scientists responded by imposing a temporary moratorium on their research.

Also, because of the Dutch government’s concern that the virus could be weaponized, it successfully sued Fouchier and now requires him to apply for and receive an “export permit” before publishing his studies. Visit the Los Angeles Times for the article.

Largo hospital's Clearwater facility will be latest in trend of standalone ERs

CLEARWATER — When Largo Medical Center executives broke ground for a standalone emergency room on one of Clearwater's busiest thoroughfares, they were mirroring a national trend: hospitals carving out highly profitable ER niches in each other's territory.

Clearwater's Morton Plant Hospital did the same thing six years ago, opening one of the state's first standalone ERs in Bardmoor in Largo Med's back yard. The Largo hospital's Clearwater ER will be the third standalone in Tampa Bay — Brandon Regional Hospital also has one in Plant City. There are 12 in Florida and more than 450 nationwide.

Hospitals want standalone ERs because they can charge hospital prices without the overhead of a massive campus. They can build them without having to prove a public health need to the state, as they must with hospital construction. And the ERs are a useful funnel to the main hospital if patients need more care, experts say.

Healthcare consumers love them. That's the tack taken by executives of Largo Med and its owner, HCA, at the groundbreaking for the $8 million, 10,600-square-foot ER the hospital estimates will serve 18,000 a year on the site of a former car lot at 2339 Gulf-to-Bay Blvd.

Standalone ERs also help hospitals compete against the explosive expansion of urgent care clinics, which charge much less than standalone ERs and are often a better option for less serious conditions, Ho said.

But in Florida, the 400 or so urgent care clinics must post a menu of services and their prices. Standalone ERs aren't required to do that. The different rules can "create an uneven playing field for urgent care," said Sam Yates, founder of the Urgent Care Association of Florida.

Largo Med CEO Anthony Degina argues that eastern Clearwater has a demonstrable need for a standalone ER due to distance from other facilities and heavy traffic.

Largo Med's Clearwater ER will offer more comprehensive services than a typical urgent care clinic, he said. It will have CAT scan equipment, radiology, laboratory services and

six board-certified ER physicians, and it will be open 24 hours a day. But it won't be a cheaper alternative. Fees will be the same as at the hospital-based ER, a Largo Med spokeswoman said. And a patient transported by ambulance to a standalone ER who then must be taken to a hospital for admission may face two bills from the transport service. Visit Tampa Bay Times for the story.

Amerinet Members to benefit from new agreement for healthcare apparel from Cardinal Health

Amerinet Inc., announced a new agreement for protective healthcare apparel from Cardinal Health. Through this agreement, Amerinet members will receive significant discounts on a variety of protective apparel, including isolation gowns, lab coats/jackets, coveralls, shoe/hair covers and bouffant caps.

Cardinal Health is a participant in the Amerinet Strategic Savings Program (SSP). Amerinet’s SSP provides facilities best pricing on essential products in exchange for manageable spend commitment. This contract is currently effective through December 31, 2016.

Cost of drugs used by Medicare doctors can vary greatly by region, analysis finds

An analysis of government data released shows that the cost of drugs administered by doctors accounts for a growing piece of Medicare’s spending and varies widely from region to region in the United States, raising questions about whether some physicians may be misusing the pharmaceuticals.

Most of the 4,000 doctors who received at least $1 million from Medicare in 2012 billed mainly for giving patients injections, infusions and other drug treatments, those records show. A drugmaker’s tactics may be one reason taxpayers and patients are paying unnecessary billions.

The data, an unprecedented trove of millions of billing records from Medicare — as well as interviews with doctors — highlight the role of pharmaceuticals in the nation’s staggering health-care costs. Of $64 billion Medicare paid to doctors in 2012, $8.6 billion was used to cover drugs, an amount that has been rising for years.

Yet Medicare seeking to rein in drug costs has been stymied by rules that forbid the government to negotiate lower prices. In 2010, they even lost the ability to mandate, when two equivalent drugs are available, that physicians be paid only for the cheapest. At the same time, pharmaceutical companies have offered physicians incentives, such as discounts, to use large volumes.

Now, with the data released by Medicare, the public has a clearer view of individual doctors’ drug practices. Many of the physicians who have submitted multimillion-dollar bills to Medicare blame high drug prices and say the pharmaceutical industry is taking most of the money. Typically, Medicare reimburses a physician for the price of the drug plus 6 percent.

The chief lobbying group for the pharmaceutical industry said the idea that medicine prices play a significant role in the nation’s healthcare costs is “off base and not supported by the data on healthcare spending.”

Josephine Martin, executive vice president of Pharmaceutical Research and Manufacturers of America (PhRMA), said in a statement, “The spending growth rate in several important areas of healthcare exceeds that of medicines, which has dropped significantly in recent years and is lower than growth in medical costs overall.”

The data reflect what appears to be an astonishing variety in how and when physicians in different parts of the country use drugs. For example, Medicare spends far more on drugs administered by physicians in some areas than in others, leading to questions about whether pharmaceuticals may be overused in some areas or underused in others.

Doctors around Huntsville, AL, for example, annually bill for nearly $600 per Medicare beneficiary for drugs administered in medical facilities. This is about the same as in places such as Sarasota, FL, and Fresno, CA. But it is about five times the amount doctors around Boise, ID, and Mason City, IA, bill for such drugs, according to a Washington Post analysis.

There could be differences in the rates of disease, “but that’s not enough to explain a $500 difference” between what Medicare pays for drugs in those cities, said Jonathan Skinner, an economist at Dartmouth College, where researchers were the first to analyze geographical variations in medical practices. He added that there may be differences in medical opinion not “supported by medical evidence.”

Jonathan Blum, principal deputy administrator of the Centers for Medicare and Medicaid Services, said, “If we see more procedures, more spending going to one part of the country than another, without necessarily a difference in quality or satisfaction of care, that’s an important question to be asking.”

Some oncologists say they tend to treat cancer more aggressively and may tend to use a drug such as Neulasta, which helps fight infection during chemotherapy.

Because Medicare generally has paid a doctor the sale price of a drug plus 6 percent, economists and some doctors have long noted that this system gives physicians an economic incentive to use a more expensive medicine: After all, the 6 percent take for doctors rises when the drug’s price does. Most physicians say financial matters do not affect their drug choices, however.

But the case of epoetin alfa, a drug used to treat anemia in dialysis patients, shows that when the financial incentive is taken away, doctors may use less of the drug.

In 2011, a change by Medicare removed the 6 percent payment incentive; instead, dialysis centers were paid per overall patient treatment. The use of the drug in dialysis patients has dropped 34 percent since then, said Dennis Cotter, president of the Medical Technology and Practice Patterns Institute, a nonprofit think tank based in Bethesda, MD. Visit the Washington Post for the article.

Mass faintings in Cambodian factories affect 118 workers; food poisoning and poor conditions may be to blame

One of the most dishonorable effects of globalization is the increasing use of the Third World as a sweatshop to manufacture products for First World brands. Last year, the horrors of big business' exploitation of less developed countries made headlines with the collapse of a building in Bangladesh, which killed more than 1,110 workers. The workers produced products for companies such as Walmart and made the world wonder who really was to blame: poor construction or consumerism? Recently another tragedy struck when 118 workers fainted at a series of factories in Cambodia.

The factories manufactured materials for companies such as Puma and Adidas. Reports claim that in the past week over 200 workers have fainted at factories in this region. Although the corporations are looking to blame food poisoning for the mass faintings, workers’ rights groups point to dangerous working conditions, which led to poor health.

The faintings occurred at the Shen Zhou and Daqian Textile factories in the city of Phnom Penh. Many workers reported serious symptoms such as vomiting and diarrhea. Both Puma and Adidas are carrying out an investigation to discover what caused workers to fall ill. The companies are analyzing food samples from the factories’ cafeteria to determine if food poisoning was the cause.

This week’s mass sickness is not an isolated case. In 2011 alone, more than 1,000 cases of fainting were reported in Cambodia factories. Safety issues are usually tied to these faintings. Many of the factories use harsh chemicals to manufacture the goods, and the building have poor ventilation systems. In Cambodia, the nearly 650,000 workers bring in annual revenue of $5 billion for the impoverished country. Many see this week’s incident as a sign of a larger problem in the overseas garment industry and remember last year’s disaster in Bangladesh, which claimed 1,100 lives. Visit Medical Daily for the story.

Global insulin delivery devices market value to achieve $13.8 billion by 2019, as China and India see rapid insulin pen adoption

As the prevalence of diabetes continues to expand rapidly across the world, the insulin delivery devices market value is expected to increase from $8.78 billion in 2012 to $13.8 billion by 2019, at a significant Compound Annual Growth Rate (CAGR) of 7%, says business intelligence provider GBI Research.

According to the company’s latest report, insulin delivery devices market growth in the US and Europe is due to an increasing preference for insulin pumps and the uptake of technical advances, such as artificial pancreas devices, in the long term. Meanwhile, the high prevalence of diabetes and low penetration of insulin delivery devices in developing countries will also contribute towards the market expansion.

Srikanth Venkataraman, Analyst for GBI Research, says: “Insulin pumps will continue to undergo rapid adoption in North America, where patients are shifting from conventional insulin delivery devices, such as syringes and pens, to insulin pumps. This is due to the need for improved glucose control and flexible, lifestyle-compatible treatment options. The European market will be driven by insulin pen sales thanks to their low cost and ease of use.”

GBI Research states that the worldwide prevalence of diabetes was 381.8 million in 2013, and this is expected to increase by 55%, reaching 591.1 million by 2035. At this current rate, diabetes prevalence in China and India is forecast to increase to 142.7 million and 109 million by 2035, respectively.

Venkataraman concludes: “In previous years, fear of injections, coupled with a cultural misconception that the use of injections over oral tablets is a sign of deteriorating health, has impacted negatively on the adoption of insulin delivery devices in Asia-Pacific. However, increasing awareness of the benefits of insulin in managing diabetes will significantly improve the uptake of syringes and pens in this region over the coming years.”

Visit GBI for the study.