Health officials fear they have another outbreak of infections linked to pain injections -- this one because at least seven people in two states developed abscesses after getting injections of steroid drugs. They're all linked to a single pharmacy: Main Street Family Pharmacy, a compounding pharmacy in Newbern, Tenn.

Tennessee state officials say the facility distributed the products to 13 states: Alabama, Arkansas, California, Florida, Kentucky, Illinois, Louisiana, Mississippi, New Mexico, North Carolina, South Carolina, Tennessee and Texas.

"Fortunately, we are aware of no serious events like meningitis, stroke or death in association with this cluster, but still our hearts go out to those affected by this event," Tennessee state health commissioner Dr. John Dreyzehner told reporters in a telephone briefing.

"Out of an abundance of caution, the FDA recommends that health care providers not administer any products labeled as sterile from Main Street and quarantine them until further guidance is provided," the Food and Drug Administration said in a statement.

"The reports of adverse events are all from patients who received preservative free methylprednisolone acetate (80 mg/mL) by injection. To date, the FDA has received seven reports," it added.

"Complications identified thus far are skin abscesses," the North Carolina Department of Health and Human Services said in a statement. "Health officials have not had any reports of meningitis, stroke, or death." North Carolina officials are investigating the cases of two patients injected with steroids from the Tennessee pharmacy.

The injections contain the same drug at the center of last year's deadly outbreak of fungal meningitis. More than 55 people have died and more than 740 others developed infections after receiving contaminated injections from the New England Compounding Center in Massachusetts.

The FDA says that at least one of the seven cases appears to be a fungal infection. The government recommends doctors stop using any sterile drugs distributed by the pharmacy. 

Illinois officials said they were checking on five patients who developed abcesses after getting the injections. They were given the steroids between January 3 and February 21, and diagnosed in April and May.

Tennessee officials say they are acting to track down anyone who may have received an injection from the pharmacy. "We are double checking and triple-checking to ensure that we have a good understanding of which products went to which facilities in which states," said Dr. Marion Kainer of Tennessee's state health department.

Dreyzehner said it's not clear whether any of the steroid injections from the pharmacy are actually contaminated. "We are acting as if they are," he said.

"Main Street Family Pharmacy, LLC, was licensed by the Tennessee Board of Pharmacy in 1985. It is currently on probation as a result of a recent inspection," the Tennessee Department of Health said. Officials said the problems had to do with drugs that were past their use-by date, as well as at least one unregistered technician.

The FDA has asked Congress to pass legislation giving it more power to regulate large-scale compounding pharmacies that ship products in bulk. The House and Senate both have measures in the works and leaders say they hope to have a bill ready soon.

FDA officials have repeatedly warned that it's a matter of when, not if, a new outbreak will occur because of poor regulation of compounding pharmacies.

Traditionally, compounding pharmacies mixed up drugs on a patient by patient basis, following a doctor's prescription. But in part because there's so much demand for specialty formulations, and because it's a lucrative business, large-scale compounders now mix up giant batches and ship them to hospitals and clinics ahead of anticipated need. Many operate across state lines.

"There’s no regulation that fits this new industry that’s grown up," FDA's Dr. Janet Woodcock told a House committee hearing on the issue on Thursday.

Woodcock says the FDA is often powerless to police these new, large compounders until there is a problem. Some members of Congress and consumer groups have accused the FDA of failing to do its job.

Since the outbreak linked to the Massachusetts pharmacy, FDA and state officials have stepped up inspections of compounding pharmacies, and found many operating with unsterile conditions.

Main Street Family Pharmacy said it was cooperating with the investigation. "As the FDA reported, an investigation into the exact source of the potential adverse effects from methylprednisolone acetate is inconclusive and ongoing. The company is fully supportive and compliant with the FDA’s recommendation that patients not be administered this compounded medicine until the investigation is complete," the company said in a statement.

Related stories:

• Senate moves closer to law to prevent more pharmacy outbreaks
• Months after outbreak, patients still being newly diagnosed
• FDA inspection prompts Fla. pharmacy recall

California has unveiled prices that consumers will pay for a selection of health plans offered through the state under the Affordable Care Act, providing a glimpse into how health care reform may look as it is rolled out across the nation.

Under the federal health care reform law, people who do not get or cannot afford health insurance through their jobs can buy coverage through an exchange, at a group rate negotiated by state regulators.

The cost to a 40-year-old who needs coverage would vary from about $40 to $300 per month for a mid-level plan in California, depending on income. Some young adults, who are less expensive to cover, could pay nothing, depending on how much they earn.

The prices in California, along with those announced in Washington, Vermont and other states, show that premiums under "Obamacare" can be more affordable than had previously been thought. Consumer advocates welcomed the new exchange.

"It's a revolutionary improvement to move from a broken market where people are charged by how sick they are, to a competitive market where people pay what they can afford, based on a percentage of their income, on a sliding scale," said Anthony Wright, executive director of advocacy group Health Access.

"Most consumers buying coverage in the individual market will get financial help and see their premiums go down," he said.

The sweeping federal reform law seeks to extend health insurance to many of the 49 million Americans without it, and alter how care is delivered so as to curb what has been an inexorable rise in healthcare spending.

Republicans who oppose the law had predicted that high premiums would sink Obamacare as the uninsured would not be able to afford coverage even with federal subsidies.

Even the modest rates announced Thursday do not really signal that the program will work, said California Republican Assemblyman Dan Logue.

"This is like a shell game to me," said Logue, co-chair of the assembly health committee, who predicted that taxes would go up to pay for the subsidies, forcing other prices to rise.

"They're not going to tell you that you're going to pay for it in your gas or your food or going to the show," he said.

About a dozen states have set up these exchanges, or large group plans, which are a key element of the giant national health reform effort. Several have already released rates for monthly premiums, and most say the cost will not go up as high as skeptics had feared.

In California, a 40-year-old who makes less than four times the federal poverty level - that is, $95,000 for a family of four or $46,000 for an individual - would pay as little as $40 per month for a mid-level plan in which about 70 percent of medical costs and all preventive care is covered. This excludes additional costs to cover children or a spouse.

The same plan for a person who makes too much to qualify for a subsidy would run about $300 per month on average, the state said. In addition, the total amount consumers would have to pay each year for co-payments and other out of pocket costs would be limited to $6,350 or less, depending on income.

Patients could choose plans that offer lower co-pays if they wished, but would pay higher premiums. In some cases, particularly for low and moderate income workers in their 20s, the premiums are free once a federal subsidy is factored in.

The exchange will also offer what it calls platinum plans, in which co-payments are very low or non-existent. These plans would cost $500 for those who do not qualify for subsidies, but as little as $300 per month for low-wage earners.

The biggest subsidies go to people who make less than 150 percent of the federal poverty level, or about $17,000 for a single person.

Peter V. Lee, a longtime health advocate recruited by the state to help set up and run its program, said costs had been expected to skyrocket because the Affordable Care Act requires health plans to offer more benefits and cover more people than they might otherwise have done.

For example, the plans must cover people with or without pre-existing conditions that would make their care more expensive. The actuarial firm Millman had predicted a 30 percent rise in the cost of monthly premiums for individuals in California under the new exchange.

But Lee said that did not happen. While rates without subsidies may be moderately higher for some consumers next year, most will pay less, he said. The rates announced on Thursday must still be approved by state regulators.

Democratic Congressman Henry Waxman, who backed the health reform act, said the program would protect millions from bankruptcy due to medical costs.

"Californians buying coverage on their own will now have access to the same quality coverage that people get through their employers at the same or lower rates," he said.

California's exchange will offer coverage from 13 insurers; more than 30 had applied to participate.

Among them are some of the biggest names, including Anthem Blue Cross, Blue Shield and Kaiser Permanente. Coverage will also be offered by some companies that had previously limited their activity to the Medicare and Medicaid markets.

Paul Markovich, president of Blue Shield of California, which is offering coverage under the plan, said that to keep prices low, doctors and hospitals had lowered some of their rates. Some insurers also agreed to limit profits, Lee said.

The policies vary in their provider networks, but Lee said consumers would have access to about 80 percent of doctors in the state, and some of its premier medical centers.

Consumers will be able to begin signing up on October 1 for plans that will go into effect in January. Next month, the California exchange will reveal plans and prices for insurance that small business owners can purchase for their employees.

Related:

• Health exchanges: Be ready to be overwhelmed
• Fewer than expected to be insured under health law
• Florida governor expands Medicaid

A cluster of mysterious respiratory illnesses that alarmed southeast Alabama turned out to be nothing more sinister than ordinary cold and seasonal flu, health officials said Thursday.

Lab tests by state and federal officials ruled out avian influenza and a novel coronavirus, now known as MERS, that has killed 22 people in the Middle East.

“There is no evidence of any new or unexpected virus circulating,” said Dr. Don Williamson, the Alabama state health officer, who said he wanted to put "closure to this cluster."

Seven people fell ill and two died earier this month in southeast Alabama after coming down with symptoms that included shortness of fever, shortness of breath and cough. All of the patients were adults ages 32 to 87. The people who died were 34 and 55, Williamson said.

Of the seven patients whose specimens were tested, six were found positive for influenza A or rhinovirus or a combination of the two and three patients were found to have bacterial pneumonia. 

“There wasn’t anything unusual or strange,” Williamson noted. He added that flu often continues to circulate in the spring and summer in his state.

Increased worries over the spread of two bird deadly flu viruses -- H5N3 and H7N9 -- and the identification of the new coronavirus likely contributed to the concerns about this cluster, he added.

“Because everybody is really worried about the possibility of either this novel coronavirus or the H7N9 flu from China, there was heightened awareness,” he said.”

He praised doctors and clinicians who raised questions about unusual respiratory illnesses because next time, it might be a new and deadly germ.

“If people aren’t attentive, we’re going to miss it,” Williamson said.

Related: 

• Mysterious respiratory illness strikes 7 in Ala.; 2 dead

In the most prominent challenge of its kind, Hobby Lobby Stores Inc. is asking a federal appeals court Thursday for an exemption from part of the federal health care law that requires it to offer employees health coverage that includes access to the morning-after pill.

The Oklahoma City-based arts-and-crafts chain argues that businesses — not just the currently exempted religious groups — should be allowed to seek exception from that part of the health law if it violates their religious beliefs.

"They ought to be able — just like a church, just like a charity — to have the right to opt out of a provision that infringes on their religious beliefs," said Kyle Duncan, who will argue before the 10th Circuit Court of Appeals on behalf of the Green family, the founders of Hobby Lobby Stores Inc. and a sister company, Christian booksellers Mardel Inc.

The Greens contend that emergency contraception is tantamount to abortion because it can prevent a fertilized egg from implanting in the womb. They also object to providing coverage for certain kinds of intrauterine devices.

Lower courts have rejected Hobby Lobby's claim, saying that for-profit businesses aren't covered by an exemption added to the law for religious organizations. That exemption applies to churches themselves, but not to affiliated nonprofit corporations, like hospitals, that do not rely primarily on members of the faith as employees.

In a decision issued late last year, a federal judge concluded simply, "Hobby Lobby and Mardel are not religious organizations."

But U.S. District Judge Joe Heaton in Oklahoma City also wrote that "the court is not unsympathetic" to Hobby Lobby's dilemma and that the question of compelling employer health coverage for certain procedures "involves largely uncharted waters."

Other businesses in multiple states are challenging the contraception mandate, too. Hobby Lobby is the most prominent company making the claim, and it is the first to be heard by a federal appeals court. The U.S. Justice Department will argue for the government that the contraception mandate should stay.

The 10th Circuit opted to hear the case before all nine judges, not the typical three-judge panel, indicating the case's importance.

In December, the 10th Circuit denied Hobby Lobby's request for an injunction to prevent it being subject to fines while its argument was on appeal. The U.S. Supreme Court also denied an injunction, with Justice Sonia Sotomayor writing that it was not "indisputably clear" that Hobby Lobby needed immediate protection.

In response, the company restructured its health insurance, Duncan said. But Hobby Lobby, which is self-insured, will face fines by July 1 if it does not provide the coverage, he said.

Hobby Lobby calls itself a "biblically founded business" and is closed on Sundays. Founded in 1972, the company now operates more than 500 stores in 41 states and employs more than 13,000 full-time employees who are eligible for health insurance.

The Hobby Lobby case has attracted broad interest from health groups and religious groups. A panel including reproductive rights organizations and the American Public Health Association banded together last year to ask the court to reject Hobby Lobby's claim. The groups argued it would be dangerous precedent to allow for-profit private businesses to use religious beliefs to deny coverage.

In a brief to the court filed last year, the health groups argued that allowing businesses not to cover some contraceptives would be like allowing businesses to tell employees they can't use wages to buy morning-after pills or other products that offend the employer's religious belief.

"Of course, no one would argue that (Hobby Lobby owners) could seek, on religious grounds, to preclude their employees from spending their wages on contraception. This same rationale requires rejecting employers' demands to impose their religious views on employees through restrictions on the use of health insurance benefits," the health groups argued.

Susan Polan, associate executive director of the American Public Health Association, said the Hobby Lobby case is an important test of how far businesses can go in seeking to exempt coverage of health procedures they don't like.

"We're talking about women's access to reproductive health. That should be a decision between a patient and her health care provider, not a patient and her employer," Polan said this week.

By Tom Miles and Stephanie Nebehay 
Reuters

The World Health Organization (WHO) warned countries with possible cases of the SARS-like novel coronavirus on Thursday that they must share information and not allow commercial labs to profit from the virus, which has killed 22 people worldwide.

Saudi Arabia, where the first case occurred, has said the development of diagnostic tests for the disease has been delayed by a foreign laboratory's patent rights on the SARS-like virus.

"Making deals between scientists because they want to take IP (intellectual property), because they want to be the world's first to publish in scientific journals, these are issues we need to address," WHO Director General Margaret Chan told health ministers attending the WHO's annual conference in Geneva.

"No IP will stand in the way of public health actions."

The virus was identified in September last year, three months after a scientist took a sample from Saudi Arabia to the Erasmus Medical Center in the Netherlands.

"There was a lag of three months where we were not aware of the discovery of the virus," Saudi Arabia's Deputy Health Minister Ziad Memish told the Geneva meeting.

He said it was taken out of the country without permission and Saudi Arabia only learned of its discovery from ProMED, a U.S.-based internet-based reporting system.

The Rotterdam-based Erasmus lab then patented the process for synthesising the virus, meaning that anyone else who wanted to use their method to study it would have to pay the lab.

The patenting had delayed the development of diagnostic kits and serologic tests for the disease, Memish said.

"The virus was sent out of the country and it was patented, contracts were signed with vaccine companies and anti-viral drug companies and that's why they have a MTA (Material Transfer Agreement) to be signed by anybody who can utilise that virus and that should not happen."

Earlier on Thursday, Saudi Arabia announced another death from the virus in its central al-Qassim region, bringing the total number of deaths in the kingdom to 17.

Jordan, Qatar, Tunisia, the United Arab Emirates, France and Britain have all had cases of the the virus.

"Burning House"  

Chan told the health ministers "you are the boss" and urged them to ensure scientists shared their specimens with WHO's network of collaborating laboratories.

The patent does not break WHO rules on sharing such information on a possible pandemic, which only apply to flu viruses, but there is a legal requirement for countries to notify WHO of any outbreak of disease of international concern.

Keiji Fukuda, WHO's assistant director-general for health security, said there was still a "huge amount" unknown about the virus and great concern about its potential to spread.

Among the gaps in the knowledge of the virus was information about its geographical spread, and many countries may only have minimal surveillance for the disease, he said.

The only test for the disease is the widely-available PCR (Polymerase Chain Reaction), but that is only useful while the patient has the virus. Once they beat the disease a serology test would be needed, but none has yet been developed to detect infection in communities.

"We think contact isolation needs to be applied, because some patients present with diarrhoea or vomiting, which we think could be the source of the transmission," Memish said.

Asked if he thought Erasmus had acted wrongly, Fukuda told reporters the WHO was completely focused on detecting the disease and preventing it from spreading further.

"When you have a house burning, you look at how you put the fire out, what do you do, where do you get the water from," he said. "That's what we're worried about right now. Then later on you might look at the neighbourhood and the other issues." (Reporting by Tom Miles and Stephanie Nebehay; editing by Andrew Roche) 

When a devastating tornado touched down in Moore, Okla., on Monday afternoon, Shayla Taylor was on the upper floor of the local hospital, in active labor with her second child.

As the floor shook “like an earthquake” beneath her and ceiling tiles and insulation fell overhead, the 25-year-old huddled with four nurses, braving both the peak contractions of childbirth and the wrath of the worst twister the veteran Oklahoman had ever endured.

“We were all just sitting there holding each other’s hands and praying,” Taylor told NBC News.

Norman Regional Health System

Jerome Taylor, left, Shayla Taylor, center, and Shaiden Taylor, right, welcomed baby Braeden Immanuel at the height of Monday's killer tornado in Moore, Okla.

Moore Medical Center, a 46-bed acute care hospital at 700 S. Telephone Road, took a direct hit from the F-5 tornado, with wind speeds that topped 200 miles per hour.

The blow devastated the hospital, as news photos plainly show, ripping away the roof and walls.

After the chaos, Taylor said she heard not the freight train sound described by so many witnesses, but the absolute silence of the storm’s center. Then she opened her eyes.

“All of a sudden I could see daylight and the wall was gone,” she said. “I look out and I see I-35 and part of the Warren theater,” which later became the triage center for victims of the tornado that killed 24 and injured more than 230 people.

Rick Wilking / Reuters

An aerial view of damage at the Moore Medical Center is shown in Moore, Okla., on May 21, after a tornado ravaged the suburb of Oklahoma City.

She had been dilated to 9 centimeters, nearly ready to deliver the baby, when nurses gave her a quick shot to slow labor during the height of the storm. 

Taylor was quickly reunited with her husband, Jerome Taylor, 29, who had taken their 4-year-old son, Shaiden, to wait out the tornado with others in the hospital cafeteria. With the help of hospital workers, she was carefully carried through the destroyed building and out to a waiting ambulance, which whisked her 5 miles to another hospital in the Norman Regional Health System.

Three hours later, after doctors determined that the petite Taylor would need a cesarean section due to the baby's size, she delivered Braeden Immanuel, a healthy 8-pound, 3-ounce boy.

“His middle name means ‘God is with us,’” said Taylor. “The name had been picked out for months. Now I know why.”

Taylor is among 30 patients and staffers at Moore Medical Center who survived the tornado, which destroyed the hospital, said Kelly Wells, a health system spokeswoman. No decision has been made yet about whether to rebuild or simply raze the site.

Two days after the storm, Taylor and her family are recovering from the trauma of the chaotic birth. The family can’t locate their car, a Toyota Camry, which had been parked in the hospital lot and is now nowhere to be found.

Sossy Dombourian / NBC News

Newborn Braeden Immanuel Taylor is fine after his harrowing birth, his mother says.

“I don’t know if it ended up inside the hospital or down the street,” she said.

Their home is safe, however, and Jerome Taylor, who works for The Hartford insurance company, has been overwhelmed trying to help his neighbors cope.

Oklahomans are used to tornado warnings and Taylor said she wasn’t particularly alarmed before Monday’s storm.

“I’m used to sirens,” she said. “If you panicked, you’d be in a constant panic.”

Now, however, she’s thinking twice about living in Tornado Alley.

“The tornadoes always track through here,” she said. “It’s not to say everybody’s going to pack and leave tomorrow, but they start to reconsider things.”

Related: 

• Post-tornado peril: Victims could face deadly fungal infections
• Tornado victims identified

CDC

The Mucor fungus was responsible for infections that sickened 13 patients, including five who died, after a 2011 tornado in Joplin, Mo. Health officials are urging Oklahoma doctors to be on the alert for similar infections after Monday's twister.

Doctors treating victims hurt badly in Monday’s devastating Moore, Okla., tornado should be alert for a rare but deadly complication of wind-whipped debris: fungal infections like those that killed five people after the Joplin, Mo., twister in 2011.

That’s the word from government experts in fungal infections, who documented 13 serious cases of necrotizing cutaneous mucormycosis -- terrible soft tissue infections -- after the Joplin tornado, including instances when visible mold started growing from the patients’ wounds.

“We want to encourage clinicians to be aware that these infections can happen,” said Dr. Benjamin Park, chief epidemiologist with the mycotic diseases branch at the Centers for Disease Control and Prevention.

It's not yet clear whether any fungal infections are suspected in the victims of this week's disaster. In Joplin, it took five days for the first infections to show up; within 10 days, 10 patients had been identified. 

"In the chaos of everything, it's very hard," said Dr. Gary Wells, medical director for the Norman Regional Health System emergency department, who was at the initial triage site during Monday's storm. "It is something you keep in the back of your mind."

Early detection and diagnosis are key to treating the infections, which occur when molds usually found in dirt, decaying wood and other matter become airborne during a heavy storm.  

“When they are picked up out of their natural environment and injected into the skin, we’re always concerned about infection,” Park said.

The molds can contaminate the wounds that occur after the blunt trauma, fractures and penetrating injuries common in tornadoes. The resulting infections can lead to serious illness and death. “The case fatality rate can be very high -- 50 percent,” Park noted.

The Joplin tornado struck at 5:34 p.m. on May 22, 2011, a monster of a storm rated EF-5, with winds exceeding 200 miles per hour on the Enhanced Fujita Scale used to measure tornadoes. More than 1,000 people were hurt and 162 died.

The Moore tornado was upgraded to an EF-5 late Tuesday. At least 24 deaths and 237 injuries have been reported. The injuries are typical of tornadoes: crush injuries, impalements and major cuts, according to NBC’s Dr. Nancy Snyderman, who spoke to trauma officials in Oklahoma.

Doctors and other health workers have been swamped caring for the victims, so it’s not clear what steps they’re taking to detect or treat potential fungal infections.

“I’m not sure that they’ve gotten that far yet,” said Pamela Williams, spokeswoman for the Oklahoma Department of Health.

The need for vigilance is clear, according to a 2012 review of the Joplin infections published in the New England Journal of Medicine. Skin-related Mucormycosis infections have been reported after other natural disasters, including a 1985 volcanic eruption in Colombia and after the 2004 Indian Ocean tsunami.

“The risk of complex wounds with foreign-body contamination during natural disasters is high, and wound management can pose considerable clinical challenge in post-disaster settings, especially when the local health care infrastructure has been damaged,” wrote authors from the CDC.

Related: 

• Joplin victims had rare fungus from dirt
• Okla. tornado injuries: Even the doctors are 'crying'
• Latest NBC coverage of the Oklahoma tornado

By Matthew Perrone
Associated Press

A federal panel of medical experts said that an experimental insomnia drug from Merck & Co. Inc. appears safe and effective, despite evidence from company trials that the pill can cause daytime sleepiness and difficulty driving. 

A majority of Food and Drug Administration panelists voted Wednesday that Merck's sleeping aid, suvorexant, helped patients get to sleep and stay asleep. In a separate set of votes, the panel voted that the drug appears safe at the starting doses proposed by the company.

The FDA is not required to follow the recommendations of its experts, though it often does.

The panel opinion was somewhat at odds with the agency's own scientists, who issued a negative review of the drug earlier in the day. FDA staff pointed out that suvorexant was associated with daytime drowsiness, driving difficulties and suicidal thinking in trials conducted by Merck.

"How much is it worth to try and make the drug safer? How many people are you willing to risk versus how much effort are you willing to make?" said Dr. Ronald Farkas, who presented the FDA's findings.

The FDA drew attention to five women, or roughly 5 percent of patients, who had to stop a supervised driving test because they were too sleepy to continue. In another case, a 59-year-old man reportedly fell asleep at a traffic light and later veered off the road while taking the drug.

The FDA suggested that a lower dose of 10 milligrams might be safer for patients than the higher doses proposed by Merck.

But a majority of panelists endorsed the safety of initial doses proposed by Merck: 15 milligrams or 20 milligrams a day for elderly patients or non-elderly patients, respectively. The panel backed their safety in a vote of 13-3, with one abstention.

"Start low and go slow is likely to be effective," said Dr. Matthew Rizzo of the University of Iowa. "I also think the safety profile of this drug is not any worse and likely better than the drugs we are already using."

Much the meeting's discussion focused on the shortcomings of sleeping pills already on the market, most of which are also associated with lingering drowsiness.

In January, the FDA required drugmakers of Ambien and similar sleeping pills to lower the doses of their medications, based on studies showing that the drugs remain in the bloodstream at levels high enough to interfere with driving.

The panel narrowly voted 8-7, with one abstention, against doses as high as 30 milligrams and 40 milligrams, saying they could exacerbate problems with drowsiness and narcolepsy.

"I think the risks are substantial and it seemed to go up with the higher dose," said Natalie Portis, the panel's patient representative.

Merck has suggested raising patients' prescriptions to the higher levels if they do not respond to lower doses.

If the FDA ultimately approves suvorexant, it will be the first in a new group of drugs that aid sleep by blocking chemical messengers that keep people awake.

A Merck spokeswoman said Wednesday the FDA is expected to issue a decision on suvorexant by mid-year. If approved the drug will have to be scheduled as a controlled substance by the Drug Enforcement Administration.

Shares of the Whitehouse Station, N.J., company fell 62 cents to close at $46.71. 

SAN FRANCISCO -- Thousands of healthcare workers walked off the job at the University of California's five medical centers on Tuesday, delaying surgeries, diagnostic procedures, treatments and emergency care throughout the state. 

The union representing nearly 13,000 vocational nurses, respiratory therapists and radiology technologists said they staged the strike -- scheduled to last two days -- to draw attention to staffing shortages that they say undermine patient care at the hospitals in San Francisco, Davis, Los Angeles, San Diego and Irvine.

Some of the public hospital system's estimated 3,400 pharmacists, social workers, psychologists, occupational therapists and lab scientists also walked out on Tuesday in a one-day sympathy strike at the five medical centers.

"The allegation is they're doing this for patient safety," UC spokeswoman Dianne Klein said. "If we had unsafe staffing levels, we wouldn't be in operation. I really don't understand how walking off the job and leaving patients stranded is helping them."

Todd Stenhouse, spokesman for the American Federation of State, County and Municipal Employees, which represents the striking workers, said the union's primary consideration was ensuring adequate staff for patient care.

"Our top concern is about safe staffing, and we need to put a stop to the diversion of resources away from patient care," he said. He said the workers have been working without a contract since September.

Klein said the sticking point in negotiations has been the union's unwillingness to agree to changes to a pension system that most of the university's other workers have already accepted. "What AFSCME wants is a special deal for them, and we don't think it's fair," she said.

Proposed changes include raising employee pension contributions, revising eligibility rules for retiree health benefits, and creating a second tier of retirement benefits for new workers.

Tim Thrush picketed outside UC San Francisco, where he works as a diagnostic sonographer, holding a sign saying, "Striking for our patients, our family and our future."

"I'm very excited and energized to be in the middle of hundreds of my co-workers who are standing up to UC and letting them know that their messed-up priorities that are shortchanging patient care on a daily basis need to stop," said Thrush, 46.

University of California Vice President for Human Resources Dwaine Duckett said his organization had offered the workers a four-year contract with up to 3.5 percent annual wage increases. The average employee in the union earns $55,000 a year, he said.

Fuse / Getty Images

The decision to withdraw life-sustaining care varies widely in intensive care units, ICUs, across the U.S., a new study finds.

If you land in an intensive care unit sick enough for doctors to consider withdrawing life support, be warned. Whether and when to pull the plug may depend in large part on the practices and culture of the ICU itself -- perhaps more than your needs or wishes, a new study finds.

That may be especially true if you’re so ill or incapacitated that you can’t make decisions about your own care, according to research being presented Tuesday at the American Thoracic Society International Conference.

After accounting for patient factors such as age, function, gender and race, the probability of having life support withdrawn ranged from 3.5 percent in some ICUs across the nation to 20.6 percent in others -- a six-fold variance.

“The really important message for patients and their families is, before you end up in an ICU, talk to your loved ones about what you would want,” said Dr. Caroline M. Quill, lead author of the study by researchers at the Perelman School of Medicine at the University of Pennsylvania.

Quill and her team analyzed records of more than 269,000 patients treated in 153 ICUs in the United States between 2001 and 2009. Overall, nearly 12 percent of patients had a decision made to go from a “full code” -- an all-out effort to save lives -- to some kind of limit on care.

That could have included: a DNR or do-not-resuscitate order; an order to withhold CPR or cardio-pulmonary resuscitation plus removing mechanical ventilation; dialysis or other life-saving treatments; or simply an order to provide only comfort measures or hospice care. About 59 percent of the patients died in the ICU and another 41 percent survived to discharge, the study found.

Particular patient characteristics accounted for most of the variability in decisions to withdraw life support, Quill acknowledged. But even after age, illness, functional status and other factors were analyzed, the variation among ICUs to authorize a DFLST -- decision to forgo life-sustaining therapy -- was striking.

“The finding of a six-fold variability among ICUs strongly suggests that the ICU to which a given patient is admitted strongly influences his or her odds of having a DFLST, regardless of personal or clinical characteristics,” the authors write.

The study didn't find particular variance by geography and the decision to withdraw care wasn't related to regional differences in cutting costs, Quill said.

End-of-life experts have known for years that individual doctor and ICU practices can affect the decision to withhold care, said Dr. J. Randall Curtis, director of the Palliative Care Center of Excellence at the University of Washington in Seattle.

In some ICUs, there’s a kind of heroic standard, an atmosphere in which doctors don’t talk about dying and every effort is made to sustain life, he said. In others, there’s an early effort to acknowledge the likelihood of death and to talk about the risks and benefits of care and how it fits into what a patient would want.

“I think there are still parts of our medical culture that say it’s our job to keep people alive no matter what,” he said. “As opposed to talking with patients and families about their values.

In the absence of instructions from the patient or their family members, the ICU’s culture is more likely to sway the decision about whether to prolong care -- or not.

Quill emphasizes that the study didn’t draw any conclusions about the rates of ICU decisions to withdraw support. “We don’t necessarily think that the 3.5 percent rate is too low or the 20.6 percent rate is too high,” she said.

Surprisingly, perhaps, there actually are no hard-and-fast guidelines in the critical care field about when to withdraw life support. That’s mostly because it would be too hard to envision every potential scenario, said Dr. Douglas White, an associate professor of critical care medicine and director of the program on ethics and decision making in critical illness at the University of Pittsburgh.

“These decisions about whether and when to withdraw life support are not scientific decisions,” he said.

In an ideal scenario, a patient would have made his or her wishes about end-of-life care known well in advance. In practice, however, although the number of people who spell out their wishes is growing, only about 10 percent of the general public has completed an advance directive or obtained a durable power of attorney for health care, Curtis noted.

That means that the final decision often is left to family members or other “surrogate” decision makers, and to doctors and clinicians.

“If the patient hasn’t articulated a clear preference, it’s very, very hard for doctors and families to work together to make the decision, “ White said. “(They’re) left to do the best that they can that generally reflects who the patient is as a person.”

It would be far better, experts agree, if more people anticipated the possibility of end-of-life decisions and left clear instructions. Ten years ago, that might have been preferences for -- or rejection of -- specific treatments such as CPR or mechanical ventilation, experts say.

Today, the discussion centers much more on the overall goals of care and the values of the patient. Take the end-of-life instructions drafted by Dr. John Luce, an emeritus professor of anesthesiology and medicine at the University of California, San Francisco.

Luce, who has researched and written about end-of-life care, said he values a “sentient existence” in which he retains the ability to  “think, read, speak, write and communicate with people.”

“Anything that could not restore me to this, I would not want it,” he said.

So that’s how Luce’s advance directive reads, if, heaven forbid, he should need it. The new research that underscores the variability of ICU practices should also emphasize the need for ordinary people to make their wishes known, Luce said.

“The really important thing is to get people talking with those who could become their surrogates,” he said. “The written document is less important than the conversation that leads up to the directive.”

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Federal health regulators say an experimental insomnia drug from Merck can help patients fall asleep, but it also carries worrisome side effects, including daytime drowsiness and suicidal thinking.

The Food and Drug Administration on Monday released its review of the company's sleep aid, suvorexant, ahead of a public meeting on Wednesday. The pill works by temporarily blocking chemical messengers that keep people awake.

The FDA said company trials show suvorexant is better than placebo at helping people fall asleep and stay asleep. And regulators said the drug's effectiveness was consistent across several doses tested by Merck & Co. Inc.

But patients taking the higher doses of the drug showed an eight-fold increase in daytime drowsiness, which sometimes interfered with driving the next morning. Patients taking 20 milligrams and 40 milligrams of suvorexant had trouble staying in their driving lanes when tested by company researchers. FDA notes that four women actually had to stop the driving test due to excessive sleepiness.

The FDA review also notes that suvorexant was associated with increased risk of suicidal thinking. Over 12 months, there were eight cases of suicidal thinking or behavior reported among patients taking the drug, compared with no cases among patients given placebo.

Merck has proposed a starting dose of 15 milligrams for seniors and 20 milligrams for non-seniors. Doctors would gradually raise these doses to 30 milligrams and 40 milligrams, respectively, or until the patient's insomnia has been successfully treated.

On Wednesday the FDA will ask a panel of outside experts to vote on questions of the drug's safety and effectiveness. The agency appears to favor eliminating most of the higher doses of the drug tested by Merck.

The FDA says Merck data suggest that a 10 milligram dose may be safer, while still being effective.

"Indeed, if a dosage strength lower than 15 milligrams is unavailable, we would need to consider if the drug could be marketed safely at all, if we believe that a substantial proportion of the indicated population needs a lower dose," the agency states in its review.

The agency plans to ask its advisers whether there is enough data to support a 10 milligram dose, according to draft questions posted online.

ISI Group analyst Mark Schoenebaum called the FDA's review "tough."

"The high dose is deemed unsafe, and the FDA wonders if there is enough data at the safer low dose to draw firm safety conclusions," Schoenebaum said in a note to investors. He says it could take Merck 18 months to resubmit its drug, if FDA requires another study of low-dose suvorexant. The potential impact on Merck's revenue is relatively small, since the drug is only expected to generate peak sales of $650 million by 2018.

In January, the FDA required drugmakers of Ambien and similar sleeping pills to lower the dosage of their drugs, based on studies suggesting a link to drowsiness-related injuries. The agency cited research showing that the drugs remain in the bloodstream at levels high enough to interfere with driving.

More than a decade ago, British parents refused to give measles shots to at least a million children because of a vaccine scare that raised the specter of autism. Now, health officials are scrambling to catch up and stop a growing epidemic of the highly contagious measles virus.

This year, the U.K. has had more than 1,200 cases of measles, after a record number of nearly 2,000 cases last year. The country once recorded only several dozen cases every year. It now ranks second in Europe, behind only Romania.

Last month, emergency vaccination clinics were held every weekend in Wales, the epicenter of the outbreak. Immunization drives have also started elsewhere in the country, with officials aiming to reach 1 million children aged 10 to 16.

"This is the legacy of the Wakefield scare," said Dr. David Elliman, spokesman for the Royal College of Paediatrics and Child Health. He’s referring to a study published in 1998 by Andrew Wakefield and colleagues.

That work suggested a link between autism and the combined childhood vaccine for measles, mumps and rubella, called the MMR vaccine.

Several large scientific studies failed to find any connection, the theory was rejected by at least a dozen major U.K. medical groups and the paper was eventually retracted by the journal that published it.

Britain's top medical board stripped Wakefield of the right to practice medicine in the U.K., ruling that he and two of his colleagues showed a "callous disregard" for the children in the study. Wakefield took blood samples from children at his son's birthday party, paying them about 5 pounds each ($7.60) and later joked about the incident.

Still, MMR immunization rates plummeted across the U.K. as fearful parents abandoned the vaccine — from rates of over 90 percent to 54 percent. Wakefield has won support from parents suspicious of vaccines, including Hollywood celebrities like Jenny McCarthy, who has an autistic son.

Nearly 15 years later, the rumors about MMR are still having an impact. Now there's "this group of older children who have never been immunized who are a large pool of infections," Elliman said.

The majority of those getting sick in the U.K. — including a significant number of older children and teens — had never been vaccinated. Almost 20 of the more than 100 seriously ill children have been hospitalized and 15 have suffered complications including pneumonia and meningitis. One adult with measles has died, though it's unclear if it was the infection that killed him.

The first measles vaccines were introduced in the 1960s. They dramatically cut cases of the virus, which causes a distinctive rash. Since 2001, measles deaths have dropped by about 70 percent worldwide; Cambodia recently went more than a year without a single case.

Globally, though, measles is still one of the leading causes of death in children under 5 and kills more than 150,000 people every year, mostly in developing countries. Measles is highly contagious and is spread by coughing, sneezing and close personal contact with infected people; symptoms include a fever, cough, and a rash on the face.

Across the U.K., about 90 percent of children under 5 are vaccinated against measles and have received the necessary two doses of the vaccine. But among children now aged 10 to 16, the vaccination rate is slightly below 50 percent in some regions.

To stop measles outbreaks, more than 95 percent of children need to be fully immunized. In some parts of the U.K., the rate is still below 80 percent.

Unlike in the United States, where most states require children to be vaccinated against measles before starting school, no such regulations exist in Britain. Parents are advised to have their children immunized, but Britain's Department of Health said it had no plans to consider introducing mandatory vaccination.

Last year, there were 55 reported cases of measles in the United States, where the measles vaccination rate is above 90 percent. So far this year, there have been 22 cases, including three that were traced to Britain. In previous years, the U.K. has sometimes exported more cases of measles to the U.S. than some countries in Africa.

Portia Ncube, a health worker at an East London clinic, said the struggle to convince parents to get the MMR shot is being helped by the measles epidemic in Wales.

"They see what's happening in Wales, so some of them are now sensible enough to come in and get their children vaccinated," she said.

Clinic patient Ellen Christensen, mother of an infant son, acknowledged she had previously had some "irrational qualms" about the MMR vaccine.

"But after reading more about it, I know now that immunization is not only good for your own child, it's good for everyone," she said.

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