28 January 2013

Breast Cancer Patients: Lumpectomy is Less Risky than Mastectomy

Story first appeared on Counsel & Heal News

For women who are diagnosed with breast cancer in its early stages, lumpectomy followed by radiation offers more survival chances than mastectomy, a recent study reveals.

The research was led by E. Shelley Hwang, M.D., MPH, chief of breast surgery at Duke Cancer Institute, and the analysis was published in the journal Cancer.

Lumpectomy is a preferred surgical procedure where the lump in the breast is removed; this lump is usually a benign tumor or breast cancer. The procedure is non-invasive as it involves the removal of minimal tissues. Mastectomy, on the other hand, involves the partial or complete removal of one or both the breasts surgically. This research also justified the decision of certain patients to undergo lumpectomy to preserve their breasts.

In the research, data spanning 14 years was collected from the California Cancer Registry, which has detailed information on the result of the cancer. The researchers found that people opting for the less-invasive technique like lumpectomy have a higher survival rate than those opting for a mastectomy. This held true for patients from different age groups and also for those who were either hormone-resistant or sensitive.

For women who were 50 years or above and had been diagnosed with hormone-sensitive breast cancer, lumpectomy gave them 13 percent more survival chances from breast cancer and 19 percent more survival chances from any disease as compared to mastectomy.

"Our findings support the notion that less invasive treatment can provide superior survival to mastectomy in stage I or stage II breast cancer. Given the recent interest in mastectomy to treat early stage breast cancers, despite the research supporting lumpectomy, our study sought to further explore outcomes of breast-conserving treatments in the general population comparing outcomes between younger and older women," Hwang was quoted as saying in Medicalxpress.

"We found that lumpectomy plus radiation was an effective alternative to mastectomy for early stage disease, regardless of age or tumor type. Even patients we thought might benefit less from localized treatment, like younger patients with hormone-resistant disease, can remain confident in lumpectomy as an equivalent and possibly better treatment option," Hwang added

New Norovirus Strain and other Clinical Notes

Story first appeared on MedPage Today -

Most norovirus outbreaks seen recently in the U.S. were caused by a novel strain known as GII.4 Sydney, the CDC reported. Also this week: a name change is urged for polycystic ovary syndrome.

New Norovirus Strain Causing Most Outbreaks -

Most norovirus outbreaks seen late last year in the U.S. were caused by a novel strain known as GII.4 Sydney that appears to have largely replaced the previous dominant strain, the CDC reported.

The clinical importance remains uncertain, however, as there is no vaccine to prevent infections nor any ways to treat them other than supportive care.

According to a report in Morbidity and Mortality Weekly Report, 141 of 266 norovirus outbreaks tracked from September to December 2012 were caused by the novel strain.

"Right now, it's too soon to tell whether the new strain of norovirus will lead to more outbreaks than in previous years. However, CDC continues to work with state partners to watch this closely and see if the strain is associated with more severe illness," said CDC epidemiologist Aron Hall, DVM, MSPH, in an agency press release.

Name Change Urged for PCOS -

"Polycystic ovary syndrome" (PCOS) needs a new name, a panel assembled by the National Institutes of Health has recommended.

The four-member committee found that "the name 'PCOS' is a distraction and impediment to progress" because the presence of ovarian cysts "is neither necessary nor sufficient to diagnose the syndrome."

"It is time to expeditiously assign a name that reflects the complex metabolic, hypothalamic, pituitary, ovarian,
and adrenal interactions that characterize the syndrome -- and their reproductive implications," they added. "The right name will enhance recognition of this major public health issue for women, educational outreach, 'branding,' and public relations and will assist in expanding research support."

But their report, stemming from a 2-day workshop held in December 2012 in which panel members heard from more than two dozen speakers, was missing one thing -- a suggested new name for the condition.

It did, however, recommend keeping the Rotterdam criteria for diagnosing the condition as well as more research on the condition's etiology, diagnosis, and management.

Bird Flu Experts End Research Moratorium -

Prominent virologists who agreed last January to a voluntary moratorium on research involving virulence factors in the H5N1 avian influenza virus have now ended it.

In a letter published online in Science and Nature, Ron Fouchier and 39 colleagues around the world indicated that "the aims of this voluntary moratorium have been met in some countries and are close to being met in others."

The concern had been that the work could lead to development in the laboratory of new H5N1 variants that would make it highly infectious in humans (wild-type strains are not) and highly lethal. Such a supervirus might emerge by accident or, in the hands of terrorists, on purpose.

Fouchier and colleagues indicated that during the past year, the World Health Organization and national regulators have set safety standards for such research. The issues are now well understood by governments and the research community.

As a result, "we declare an end to the voluntary moratorium on avian flu transmission studies," they wrote.

Eye Surgery Devices Recalled -

More than 100 lots of Bausch and Lomb's 27G sterile disposable cannulas packed with the company's Amvisc 1.2% and Amvisc Plus 1.6% sodium hyaluronate ophthalmic surgical device kits have been recalled, the FDA said.

The cannulas are prone to leakage or detachment from the syringe to which they are supposed to be attached. They are used in delivery of the gel-like material in front of, or behind the iris, during cataract surgery and other ocular procedures.

"In rare [instances], detachment has resulted in serious patient injury," the FDA said.

Lot numbers covered by the recall were included in the FDA's announcement posted on its website.

Dengue Vaccine Passes Early Test -

A vaccine against the four major strains of dengue virus induced strong antibody responses and appeared to be well tolerated in a phase I clinical trial, according to the National Institute of Allergy and Infectious Diseases, which had developed the vaccine.

Several versions of the tetravalent vaccine were tested in the trial. All were found to be safe, but only one was strongly immunogenic after a single dose.

NIAID said that formulation produced antibody responses to all four virus strains in 45% of participants, with another 45% showing responses to three strains.

The agency added that the vaccine would be relatively cheap to produce, at less than $1 per dose, making it
potentially affordable in less developed tropical nations where the disease is most rampant.

Dengue fever also appears to have gained a foothold in the Florida Keys and there are concerns that, with climate change, its range may extend further into the U.S.

24 January 2013

Lafayette Towers being revamped for young professionals by Detroit Developers

Story first appeared on The Detroit News

The Lafayette Towers, like the rest of the Lafayette Park neighborhood, was once considered a shining example of urban revitalization.

Designed by famed architect Ludwig Mies van der Rohe and built in 1961, the apartment towers were part of a planned community that included a shopping center, a 19-acre park and a school to attract young professionals to live near downtown.  There is a spinal cord injury Detroit service leader available.

Today, as the city undergoes its latest round of urban renewal, investor and lifelong Detroiter Gregory Jackson said he wants to use the aging modernist-style glass and aluminum high-rise community to reinvent Detroit living.

He bought the 22-story, 584-unit apartment complex from the city for $5.8 million in November with a promise that he would pay to bring the iconic structures back to their original glory.  A brain injury Detroit physician is near this location.

"I wanted to be part of the renaissance that's taking shape in Detroit," said Jackson, who lives on the city's west side.

The renaissance that Jackson and other developers refer to is tied to rising demand in certain neighborhoods for rental housing for the city's new class of young professionals. Their migration has resulted in a more than 90 percent occupancy rate in Midtown and surrounding areas, according to Midtown Detroit Inc., which tracks housing trends.

State and federal tax incentives as well as easier availability of financing make renovating empty and historic buildings more appealing for Detroit investors than new construction, real estate experts said.

In October, Bloomfield Hills-based Princeton Enterprises bought the shuttered, historic Milner Hotel in downtown with preliminary plans to convert the 10-story building into apartments and rename it The Ashley.

In November, the 34-story Broderick Tower accepted its first tenants after completion of a two-year renovation project. And as investors bid on the Free Press Building on Lafayette Boulevard, there was talk that the historic structure would be converted into housing.

"The city has prioritized restoration rather than new construction. Detroit would like to see the empty buildings back into the market," said Richard Baron, chairman of the St. Louis-based development firm McCormack Baron Salazar.

Baron, who has years of experience rehabilitating historic buildings, is in talks with Susan Mosey of Midtown Detroit Inc. on a $25 million project to restore a vacant building on Alexandrine, just west of Woodward Avenue, into rental residences.

Though demand for housing in certain areas continues to climb, incentives for developers to embark on new construction projects aren't there, Baron said.

Jackson said an investment of as little as $5 million could help attract new, younger tenants.

The Lafayette Towers, he said, noting that it is more than 50 percent occupied, already has some amenities that would appeal to potential younger tenants. The complex is equipped with an Olympic-sized pool, fitness center and 360-degree panoramic views of the city. It's also within walking distance of Greektown.

Rents at Lafayette Towers range from $500 a month for a studio to $1,400 a month and up for a three-bedroom unit, with approximately 30 units that qualify for government subsidies.

Jackson said units can run as low as $1 per square foot, compared to other units downtown where rentals such as the Broderick Towner and other recently renovated buildings charge a much higher rate.

The rates at Lafayette Towers will eventually go up, but Jackson said he does not plan to raise rents until after all renovations are made.

Preliminary improvements, he said, will include adding shuffleboard courts and cabanas to the rooftop pool area, replacing equipment and offering classes in the fitness center, and updating kitchens and bathrooms in apartment units. Jackson said he also plans to install bicycle racks, improve Wi-Fi service and allow residents to use rooftop lounge spaces to hold receptions.

Jackson said he hopes to have initial renovations completed within 18 months.

Molly Dougherty, 24, a high school English teacher, moved into the complex in August with her fiancé.

"(We) decided to move to an exciting part of town," Dougherty said.

Dougherty came to Detroit about a year and a half ago from Omaha, Neb., to volunteer at Cristo del Rey High School. She eventually got hired permanently at the parochial school and decided to move out of a roommate situation in the Mexicantown neighborhood to a more cosmopolitan living experience.

"There's a certain energy in an urban area. I like all the diversity — every day you see different people," said Dougherty, who regularly walks to Greektown for its restaurants, bars and casino.

Wilbert Sherrod, 73, a retired dentist who has lived in Lafayette Towers for 38 years, shared similar sentiments. When he moved into the city more than 40 years ago, he was immediately drawn to the air of affluence that the complex inspired.

"As soon as I came into the city," Sherrod said, "I said, 'I want to live here.' "

Sherrod said he loves summer walks to the RiverWalk, Renaissance Center and Greektown. He does most of his grocery shopping at Lafayette Foods down the street. In fact, after retirement he sold his car and rents one occasionally if he needs to go to the suburbs for errands.

But Sherrod said security and maintenance declined at the complex over the years.

By this past summer, Lafayette Towers was in danger of being sold by the U.S. Department of Housing and Urban Development in a foreclosure auction after then-owner Northern Group failed to make mortgage payments. The city stepped in and bought the property, with the understanding that it would seek a private buyer who would invest in its long-term revival.

When Jackson heard about its financial woes, he approached the city.

"I've been looking for an opportunity to invest in a city that I love," Jackson said.

Sherrod, who lives in a unit overlooking Ford Field, Comerica Park and Gratiot Avenue, said he is ready for the proposed revival.

"I hope this gentleman is truthful with his promise," he said.

23 January 2013

Michigan native is the center of Hepatitis probe

Story first appeared on The Detroit News

Medical Tech facing charges he infected

When David Kwiatkowski attended Plymouth Canton High School in the late 1990s, he was known as a leader on the baseball team and a guy who came from a great family.  Do you want to major in healthcare admin?

His life has since taken a dark turn that has left friends and former teammates stunned. 

Kwiatkowski, 33, a traveling medical technician, is accused of engaging in crimes that led to one of the most widespread medical investigations in the United States linked to an outbreak of hepatitis C — a virus that can lead to liver failure, cancer and even death. 

It began after Kwiatkowski, who was infected with hepatitis C, allegedly passed the virus to patients after stealing potent pain relievers, injecting himself and leaving behind syringes he filled with saline and tainted needles that eventually were used on patients.

Kwiatkowski worked in eight states, including Michigan, and scores of people who may have come in contact with him have been tested. More than 30 patients have tested positive for the virus, with the majority of the victims in New Hampshire. None live in Michigan.  There is Hepatitis C treatment Detroit metro area if you are concerned.

Last month, Kwiatkowski pleaded not guilty to seven charges of obtaining controlled substances by fraud and seven charges of tampering with a consumer product. He is in a New Hampshire jail awaiting a federal trial that isn't expected to begin until fall. It involves the Centers for Disease Control and Prevention, as well as several state health departments. 

If convicted, he faces up to 10 years in prison for each count of tampering with a consumer product and four years for each count of getting controlled substances by fraud.

Scott Dickey, a Canton resident and former high school baseball coach of Kwiatkowski's, said: "Everybody is in shock."

'A good, solid kid'

Kwiatkowski, a Canton native, graduated from Plymouth Canton High School in 1998. He was a catcher on the varsity baseball team and was named captain during his senior year.  Find a spinal cord injury Detroit physician today.

Kwiatkowski's family did not respond to requests for interviews. But others recalled him as someone who was competitive, worked hard and wanted to win. Other people said he was a leader, stood up for his teammates and came from a great family.

"He was a good, solid kid," Dickey said. "His brothers were the same way. I cannot say enough about the parents. My wife almost started crying when she heard the story, thinking about his mom and dad. I had no idea what happened. Nobody does."  Interested in a healthcare admin major?

Kwiatkowski began to face challenges not long after high school, a friend said.

After graduation, he attended Madonna University, a Catholic university in Livonia. He received a bachelor's degree in allied health administration in 2005.

According to his resume, Kwiatkowski began his professional life as a student X-ray technician in 2001 at William Beaumont Hospital, Royal Oak, and later was hired full time.

In 2003, he joined St. Joseph Mercy Hospital in Ann Arbor as an emergency room tech. A year later, he was hired to work in emergency room radiology at the Detroit Medical Center but was promoted after four months to CAT scan technician in the cardiac catheter laboratory.  Seek a Cardiac cath Southfield doctor today.

Soon after, he had troubles that involved the Canton police.

A series of jobs

In January 2005, Kwiatkowski went to the police department and reported that his brothers had some friends over to their apartment where he believed that someone had stolen prescription drugs. The drugs included prednisone, which prevents inflammation in the body, and Vicodin, a pain reliever.

According to the police report, Kwiatkowski stated he needed to report the drugs stolen to get another prescription.

A few months later, Kwiatkowski was arrested and jailed for allegedly operating a vehicle while intoxicated.

In 2006, University of Michigan hospital officials hired him as an interventional radiologic technologist.

Within weeks, investigations were launched after hospital officials discovered vials of narcotics were stolen on three separate occasions during the three-month period he worked in the interventional radiology department.  Seeking a Cardiac cath Detroit area physician?

When he was interviewed by investigators, Kwiatkowski denied taking the drugs.

There wasn't enough information to turn the case over to the prosecutor's office for charges, officials said. Not long after the third incident, Kwiatkowski left the hospital in December.

"He was suspended at the time of the investigation into larceny of drugs," said Diane Brown, a spokeswoman for U-M campus police. "He resigned during that suspension."

Stops in several states

Kwiatkowski left Michigan around 2007 and started working as a traveling medical technician in several states, including Arizona, Georgia, Kansas, Maryland, New Hampshire, New York and Pennsylvania.

Last May, several patients tested positive for hepatitis C at Exeter Hospital in New Hampshire. Nearly all of them had undergone a procedure at the hospital's cardiac catheter lab and had the same strain of hepatitis C that Kwiatkowski is believed to have had since 2010.

He was arrested in July. Widespread testing of patients in the states where he worked was launched soon after.

Pete Sokol, a New Hampshire resident who learned he contracted hepatitis C while being treated for a heart attack at Exeter Hospital, told The Detroit News he felt sorry for Kwiatkowski — at first. He said he heard Kwiatkowski had a serious drug addiction.

But Sokol's sympathy has evolved into fury not only for himself, but other patients who now live with the virus.

"I hope he gets as much time as he can because he infected (dozens) of people," Sokol said. "It's not just us; it's our family and our friends. You're talking about a lot of people whose lives he's messed up."

Johnson & Johnson Aware of the 40% Hip Implant Failure

Story first appeared on The New York Times

An internal analysis conducted by Johnson & Johnson in 2011 not long after it recalled a troubled hip implant estimated that the all-metal device would fail within five years in nearly 40 percent of patients who received it, newly disclosed court records show.

Johnson & Johnson never released those projections for the device, the Articular Surface Replacement, or A.S.R., which the company recalled in mid-2010. But at the same time that the medical products giant was performing that analysis, it was publicly playing down similar findings from a British implant registry about the device’s early failure rate.

The company’s analysis also suggests that the implant is likely to fail prematurely over the next few years in thousands more patients in addition to those who have already had painful and costly procedures to replace it.

The internal Johnson & Johnson analysis is among hundreds of internal company documents expected to become public as the first of over 10,000 lawsuits by patients who got an A.S.R. prepares to go to trial this week. The episode represents one of the biggest medical device failures in recent decades and the forthcoming trial is expected to shed light on what officials of Johnson & Johnson’s DePuy Orthopedics division knew about the device’s problem before its recall and the actions they took or did not take.

The trial, which is expected to begin Friday in California Superior Court in Los Angeles, may also provide a guide to the consequences of the A.S.R. episode to Johnson & Johnson, both for the company’s finances and its reputation. Last year, the company took a $3 billion special charge, much of it related to medical and legal costs associated with the device. DePuy has offered to pay patient costs for replacement procedures.

The A.S.R. belonged to a once-popular class of hip implants in which a device’s cup and ball component were both made of metal. While the A.S.R. was the most failure-prone of those implants, surgeons have largely abandoned using such devices in standard hip replacement because their components can grind together, releasing metallic debris that damages a patient’s tissue and bone.

On Friday, Judge J. Stephen Czuleger, who is presiding over the Los Angeles case, unsealed a number of motions that contained portions of pretrial depositions of DePuy officials as well as related company records. Those disclosures, like the company’s estimate of the A.S.R.’s failure rate, represent only a tiny fraction of the information that will become public if the trial proceeds. Over the last two years, plaintiffs’ lawyers working on A.S.R.-related lawsuits have reviewed tens of thousands of internal DePuy documents and taken depositions from dozens of company executives.

Executives of DePuy have long insisted that their handling of the A.S.R. was forthright and appropriate. In mid-2010, when DePuy recalled the implant, officials said they were doing so because data that year from the National Joint Registry of England and Wales showed for the first time that it was failing prematurely at a higher rate than competing implants. In 2011, the British implant registry updated its projected failure rates for A.S.R. patients who had had it the longest, saying it was failing in one-third of them. It was that estimate that was challenged by DePuy.

About 7,000 of the A.S.R. lawsuits have been consolidated in a federal court in Ohio. An additional 2,000 cases have been consolidated in a California state court. The California case chosen to go to trial this week was selected because the plaintiff, a man named Loren Kransky, has cancer and may not live much longer, lawyers involved in the case said. DePuy has already settled a few A.S.R. cases before trial and it may choose to do so in Mr. Kransky’s case as well.

About 93,000 patients worldwide received an A.S.R., about one-third of them in the United States.

There are two versions of the A.S.R., one used in standard hip implants and the other used in an alternative replacement procedure known as resurfacing. Only the standard implant was sold in the United States. Both versions of the A.S.R., however, used the same metal hip cup as part of their design.

Asked for comment about the company’s internal analysis, a spokeswoman for DePuy, Mindy Tinsley, said in a statement that it “was based on a small, limited set of data that could not be used to generalize” the overall failure rate for the A.S.R.
In 2011, when DePuy challenged the British joint registry’s findings, the company made similar comments. Other medical organizations, however, have also projected very high failure rates for the A.S.R.

Hip implants, which are generally made from metal and plastic, often last for 15 years before they wear out and need to be replaced. Such devices can fail prematurely for a variety of reasons, but the early replacement rate is typically 1 percent after a year, or 5 percent at five years.

In pretrial testimony, Paul Voorhorst, DePuy’s director of biostatistics and data management, said that the company performed several reviews of A.S.R. failures in patients in fall 2011, a year after it recalled the model.

Based on the number of patients who had already undergone device replacement at the time, DePuy estimated that about 37 percent of patients who got an A.S.R. might need to have it replaced within five years of receiving it.

Last year, The New York Times reported that DePuy executives decided in 2009 to phase out the A.S.R. and sell off its inventories weeks after the Food and Drug Administration asked the company in a letter for additional safety data about the implant.

The F.D.A. also told the company at that time that it was rejecting its efforts to sell the resurfacing version of the device in the United States because of concerns about “high concentration of metal ions” in the blood of patients who received it.

In other pretrial testimony released Friday, a DePuy engineer stated that company officials were aware in 2008 of reports by an English surgeon that the resurfacing version of the A.S.R. was releasing high levels of metallic ions, particularly in women. As a result of the reports, company officials felt they had to move quickly to redesign the implant.

Narcolepsy Linked to GSK Swine Flu Shot

Story first appeared on Reuters

Emelie Olsson is plagued by hallucinations and nightmares. When she wakes up, she's often paralyzed, unable to breathe properly or call for help. During the day she can barely stay awake, and often misses school or having fun with friends. She is only 14, but at times she has wondered if her life is worth living. 

Emelie is one of around 800 children in Sweden and elsewhere in Europe who developed narcolepsy, an incurable sleep disorder, after being immunized with the Pandemrix H1N1 swine flu vaccine made by British drug maker GlaxoSmithKline in 2009.  A Sleep Specialist Detroit, MI is monitoring the ongoing findings.

Finland, Norway, Ireland and France have seen spikes in narcolepsy cases, too, and people familiar with the results of a soon-to-be-published study in Britain have told Reuters it will show a similar pattern in children there.

Their fate, coping with an illness that all but destroys normal life, is developing into what the health official who coordinated Sweden's vaccination campaign calls a "medical tragedy" that will demand rising scientific and medical attention.

Europe's drugs regulator has ruled Pandemrix should no longer be used in people aged under 20. The chief medical officer at GSK's vaccines division, Norman Begg, says his firm views the issue extremely seriously and is "absolutely committed to getting to the bottom of this", but adds there is not yet enough data or evidence to suggest a causal link.

Others - including Emmanuel Mignot, one of the world's leading experts on narcolepsy, who is being funded by GSK to investigate further - agree more research is needed but say the evidence is already clearly pointing in one direction.

"There's no doubt in my mind whatsoever that Pandemrix increased the occurrence of narcolepsy onset in children in some countries - and probably in most countries," says Mignot, a specialist in the sleep disorder at Stanford University in the United States.


In total, the GSK shot was given to more than 30 million people in 47 countries during the 2009-2010 H1N1 swine flu pandemic. Because it contains an adjuvant, or booster, it was not used in the United States because drug regulators there are wary of adjuvanted vaccines.

GSK says 795 people across Europe have reported developing narcolepsy since the vaccine's use began in 2009.

Questions about how the narcolepsy cases are linked to Pandemrix, what the triggers and biological mechanisms might have been, and whether there might be a genetic susceptibility are currently the subject of deep scientific investigation.

But experts on all sides are wary. Rare adverse reactions can swiftly develop into "vaccine scares" that spiral out of proportion and cast what one of Europe's top flu experts calls a "long shadow" over public confidence in vaccines that control potential killers like measles and polio.

"No-one wants to be the next Wakefield," said Mignot, referring to the now discredited British doctor Andrew Wakefield who sparked a decades-long backlash against the measles, mumps and rubella (MMR) shot with false claims of links to autism.

With the narcolepsy studies, there is no suggestion that the findings are the work of one rogue doctor.

Independent teams of scientists have published peer-reviewed studies from Sweden, Finland and Ireland showing the risk of developing narcolepsy after the 2009-2010 immunization campaign was between seven and 13 times higher for children who had Pandemrix than for their unvaccinated peers.

"We really do want to get to the bottom of this. It's not in anyone's interests if there is a safety issue that needs to be addressed," said GSK's Begg.


Emelie's parents, Charles and Marie Olsson, say she was a top student who loved playing the piano, taking tennis lessons, creating art and having fun with friends. But her life started to change in early 2010, a few months after she had Pandemrix. In the spring of 2010, they noticed she was often tired, needing to sleep when she came home from school.

But it wasn't until May, when she began collapsing at school, that it became clear something serious was happening.

As well as the life-limiting bouts of daytime sleepiness, narcolepsy brings nightmares, hallucinations, sleep paralysis and episodes of cataplexy - when strong emotions trigger a sudden and dramatic loss of muscle strength.

In Emelie's case, having fun is the emotional trigger. "I can't laugh or joke about with my friends anymore, because when I do I get cataplexies and collapse," she said in an interview at her home in the Swedish capital.

Narcolepsy is estimated to affect between 200 and 500 people per million and is a lifelong condition. It has no known cure and scientists don't really know what causes it. But they do know patients have a deficit of a brain neurotransmitter called orexin, also known as hypocretin, which regulates wakefulness.

Research has found that some people are born with a variant in a gene known as HLA that means they have low hypocretin, making them more susceptible to narcolepsy. Around 25 percent of Europeans are thought to have this genetic vulnerability.

When results of Emelie's hypocretin test came back in November last year, it showed she had 15 percent of the normal amount, typical of heavy narcolepsy with cataplexy.

The seriousness of her strange new illness has forced her to contemplate life far more than many other young teens: "In the beginning I didn't really want to live any more, but now I have learned to handle things better," she said.


Scientists investigating these cases are looking in detail at Pandemrix's adjuvant, called AS03, for clues.

Some suggest AS03, or maybe its boosting effect, or even the H1N1 flu itself, may have triggered the onset of narcolepsy in those who have the susceptible HLA gene variant.

Angus Nicoll, a flu expert at the European Centre for Disease Prevention and Control (ECDC), says genes may well play a part, but don't tell the whole story.

"Yes, there's a genetic predisposition to this condition, but that alone cannot explain these cases," he said. "There was also something to do with receiving this specific vaccination. Whether it was the vaccine plus the genetic disposition alone or a third factor as well - like another infection - we simply do not know yet."

GSK is funding a study in Canada, where its adjuvanted vaccine Arepanrix, similar to Pandemrix, was used during the 2009-2010 pandemic. The study won't be completed until 2014, and some experts fear it may not shed much light since the vaccines were similar but not precisely the same.

It all leaves this investigation with far more questions than answers, and a lot more research ahead.


In his glass-topped office building overlooking the Maria Magdalena church in Stockholm, Goran Stiernstedt, a doctor turned public health official, has spent many difficult hours going over what happened in his country during the swine flu pandemic, wondering if things should have been different.

"The big question is was it worth it? And retrospectively I have to say it was not," he told Reuters in an interview.

Being a wealthy country, Sweden was at the front of the queue for pandemic vaccines. It got Pandemrix from GSK almost as soon as it was available, and a nationwide campaign got uptake of the vaccine to 59 percent, meaning around 5 million people got the shot.

Stiernstedt, director for health and social care at the Swedish Association of Local Authorities and Regions, helped coordinate the vaccination campaign across Sweden's 21 regions.

The World Health Organisation (WHO) says the 2009-2010 pandemic killed 18,500 people, although a study last year said that total might be up to 15 times higher.

While estimates vary, Stiernstedt says Sweden's mass vaccination saved between 30 and 60 people from swine flu death. Yet since the pandemic ended, more than 200 cases of narcolepsy have been reported in Sweden.

With hindsight, this risk-benefit balance is unacceptable. "This is a medical tragedy," he said. "Hundreds of young people have had their lives almost destroyed."


Yet the problem with risk-benefit analyses is that they often look radically different when the world is facing a pandemic with the potential to wipe out millions than they do when it has emerged relatively unscathed from one, like H1N1, which turned out to be much milder than first feared.

David Salisbury, the British government's director of immunization, says "therein lies the risk, and the difficulty, of working in public health" when a viral emergency hits.

"In the event of a severe pandemic, the risk of death is far higher than the risk of narcolepsy," he told Reuters. "If we spent longer developing and testing the vaccine on very large numbers of people and waited to see whether any of them developed narcolepsy, much of the population might be dead."

Pandemrix was authorized by European drug regulators using a so-called "mock-up procedure" that allows a vaccine to be authorized ahead of a possible pandemic using another flu strain. In Pandemrix's case, the substitute was H5N1 bird flu.

When the WHO declared a pandemic, GSK replaced the mock-up's strain with the pandemic-causing H1N1 strain to form Pandemrix.

GSK says the final H1N1 version was tested in trials involving around 3,600 patients, including children, adolescents, adults and the elderly, before it was rolled out.

The ECDC's Nicoll says early warning systems that give a more accurate analysis of a flu strain's threat are the best way to minimize risks of this kind of tragedy happening in future.

Salisbury agrees, and says progress towards a universal flu vaccine - one that wouldn't need last-minute changes made when a new strain emerged - would cuts risks further.

"Ideally, we would have a better vaccine that would work against all strains of influenza and we wouldn't need to worry about this ever again," he said. "But that's a long way off."

With scientists facing years of investigation and research, Emelie just wants to make the best of her life.

She reluctantly accepts that to do so, she needs a cocktail of drugs to try to control the narcolepsy symptoms. The stimulant Ritalin and the sleeping pill Sobril are prescribed for Emelie's daytime sleepiness and night terrors. Then there's Prozac to try to stabilize her and limit her cataplexies.

"That's one of the things that makes me feel most uncomfortable," she explains. "Before I got this condition I didn't take any pills, and now I have to take lots - maybe for the rest of my life. It's not good to take so many medicines, especially when you know they have side effects."

21 January 2013

Debates over paid sick-time laws getting plenty of fuel during the Flu season

Story first appeared on AP News

Despite being groggy and concerned about having caught the flu, Diana Zavalda, still went to work because she felt she couldn’t afford to miss a day.

A school speech therapist who works as an independent contractor, she doesn't have paid sick days. So the mother of two reported to work and hoped for the best - and was aching, shivering and coughing by the end of the day. She stayed home the next day, then loaded up on medicine and returned to work.

"It's a balancing act" between physical health and financial well-being, she said.

An unusually early and vigorous flu season is drawing attention to a cause that has scored victories but also hit roadblocks in recent years: mandatory paid sick leave for a third of civilian workers - more than 40 million people - who don't have it.

Supporters and opponents are particularly watching New York City, where lawmakers are weighing a sick leave proposal amid a competitive mayoral race.

Pointing to a flu outbreak that the governor has called a public health emergency, dozens of doctors, nurses, lawmakers and activists - some in surgical masks - rallied Friday on the City Hall steps to call for passage of the measure, which has awaited a City Council vote for nearly three years. Two likely mayoral contenders have also pressed the point.

The flu spike is making people more aware of the argument for sick pay, said Ellen Bravo, executive director of Family Values at Work, which promotes paid sick time initiatives around the country. "There's people who say, 'OK, I get it - you don't want your server coughing on your food,'" she said.

Advocates have cast paid sick time as both a workforce issue akin to parental leave and "living wage" laws, and a public health priority.

But to some business owners, paid sick leave is an impractical and unfair burden for small operations. Critics also say the timing is bad, given the choppy economy and the hardships inflicted by Super Storm Sandy.

Michael Sinensky, an owner of seven bars and restaurants around the city, was against the sick time proposal before Sandy. And after the storm shut down four of his restaurants for days or weeks, costing hundreds of thousands of dollars that his insurers have yet to pay, "we're in survival mode."

"We're at the point, right now, where we cannot afford additional social initiatives," said Sinensky, whose roughly 500 employees switch shifts if they can't work, an arrangement that some restaurateurs say benefits workers because paid sick time wouldn't include tips.

Employees without sick days are more likely to go to work with a contagious illness, send an ill child to school or day care and use hospital emergency rooms for care, according to a 2010 survey by the University of Chicago's National Opinion Research Center. A 2011 study in the American Journal of Public Health estimated that a lack of sick time helped spread 5 million cases of flu-like illness during the 2009 swine flu outbreak.

To be sure, many employees entitled to sick time go to work ill anyway, out of dedication or at least a desire to project it. But the work-through-it ethic is shifting somewhat amid growing awareness about spreading sickness.

"Right now, where companies' incentives lie is butting right up against this concern over people coming into the workplace, infecting others and bringing productivity of a whole company down," said John A. Challenger, CEO of employer consulting firm Challenger, Gray & Christmas.

Paid sick day requirements are often popular in polls, but only four places have them: San Francisco, Seattle, Washington, D.C., and the state of Connecticut. The specific provisions vary.

Milwaukee voters approved a sick time requirement in 2008, but the state Legislature passed a law blocking it. Philadelphia's mayor vetoed a sick leave measure in 2011; lawmakers have since instituted a sick time requirement for businesses with city contracts. Voters rejected a paid sick day measure in Denver in 2011.

In New York, City Councilwoman Gale Brewer's proposal would require up to five paid sick days a year at businesses with at least five employees. It wouldn't include independent contractors, such as Zavala, who supports the idea nonetheless.

The idea boasts such supporters as feminist Gloria Steinem and "Sex and the City" actress Cynthia Nixon, as well as a majority of City Council members and a coalition of unions, women's groups and public health advocates. But it also faces influential opponents, including business groups, Mayor Michael Bloomberg and City Council Speaker Christine Quinn, who have virtually complete control over what matters come to a vote.

Quinn, who is expected to run for mayor, said she considers paid sick leave a worthy goal but doesn't think it would be wise to implement it in a sluggish economy. Two of her likely opponents, Public Advocate Bill de Blasio and Comptroller John Liu, have reiterated calls for paid sick leave in light of the flu season.

While the debate plays out, Emilio Palaguachi is recovering from the flu and looking for a job. The father of four was abruptly fired without explanation earlier this month from his job at a deli after taking a day off to go to a doctor, he said. His former employer couldn't be reached by telephone.

“I needed work, but, I needed to see the doctor because I’m sick, “ Palaguachi stated after the Friday City Hall rally.

Brain pacemakers being tested for Alzheimer’s damage

Story first appeared on AP News

It sounds like something out of a science fiction film:  Shooting mild jolts of electricity into someone’s brain in an attempt to hold off the spreading memory loss brought on by Alzheimer’s disease.

And it's not easy. Holes are drilled into the patient's skull so tiny wires can be implanted into just the right spot.

A dramatic shift is beginning in the disappointing struggle to find something to slow the damage of this epidemic: The first U.S. experiments with "brain pacemakers" for Alzheimer's are getting under way. Scientists are looking beyond drugs to implants in the hunt for much-needed new treatments.

The research is in its infancy. Only a few dozen people with early-stage Alzheimer's will be implanted in a handful of hospitals. No one knows if it might work, and if it does how long the effects might last.

Kathy Sanford was among the first to sign up. The Ohio woman's early-stage Alzheimer's was gradually getting worse. She still lived independently; posting reminders to herself, but no longer could work. The usual medicines weren't helping.

Then doctors at Ohio State University explained the hope - that constant electrical stimulation of brain circuits involved in memory and thinking might keep those neural networks active for longer, essentially bypassing some of dementia's damage.

Sanford decided it was worth a shot.

"The reason I'm doing it is, it's really hard to not be able, sometimes, to remember," Sanford, 57, said from her Lancaster, Ohio, home.

Her father is blunter.

"What's our choice? To participate in a program or sit here and watch her slowly deteriorate?" asked Joe Jester, 78. He drives his daughter to follow-up testing, hoping to spot improvement.

A few months after the five-hour operation, the hair shaved for her brain surgery was growing back and Sanford said she felt good, with an occasional tingling that she attributes to the electrodes. A battery-powered generator near her collarbone powers them, sending the tiny shocks up her neck and into her brain.

It's too soon to know how she'll fare; scientists will track her for two years.

"This is an ongoing evaluation right now that we are optimistic about," is how Ohio State neurosurgeon Dr. Ali Rezai cautiously puts it.

More than 5 million Americans have Alzheimer's or similar dementias, and that number is expected to rise rapidly as the baby boomers age. Today's drugs only temporarily help some symptoms. Attempts to attack Alzheimer's presumed cause, a brain-clogging gunk, so far haven't panned out.

"We're getting tired of not having other things work," said Ohio State neurologist Dr. Douglas Scharre.

The new approach is called deep brain stimulation, or DBS. While it won't attack Alzheimer's root cause either, "maybe we can make the brain work better," he said.

Implanting electrodes into the brain isn't new.

Between 85,000 and 100,000 people around the world have had DBS to block the tremors of Parkinson's disease and other movement disorders. The continuous jolts quiet overactive nerve cells, with few side effects. Scientists also are testing whether stimulating other parts of the brain might help lift depression or curb appetite among the obese.

It was in one of those experiments that Canadian researchers back in 2003 stumbled onto the Alzheimer's possibility. They switched on the electrical jolts in the brain of an obese man and unlocked a flood of old memories. Continuing his DBS also improved his ability to learn. He didn't have dementia, but the researchers wondered if they could spur memory-making networks in someone who did.

But wait a minute.

Alzheimer's doesn't just steal memories. It eventually robs sufferers of the ability to do the simplest of tasks. How could stimulating a brain so damaged do any good?

A healthy brain is a connected brain. One circuit signals another to switch on and retrieve the memories needed to, say, drive a car or cook a meal.

At least early in the disease, Alzheimer's kills only certain spots. But the disease's hallmark gunky plaques act as a roadblock, stopping the "on" switch so that healthy circuits farther away are deactivated, explained Dr. Andres Lozano, a neurosurgeon at Toronto Western Hospital whose research sparked the interest.

So the plan was to put the electrodes into hubs where brain pathways for memory, behavior, concentration and other cognitive functions converge, to see if the jolts reactivate those silenced circuits, added Ohio State's Rezai.

"It's like going through Grand Central Station and trying to affect all the trains going in and coming out," he said.

Lozano's team found the first clue that it's possible by implanting six Alzheimer's patients in Canada. After at least 12 months of continuous stimulation, brain scans showed a sign of more activity in areas targeted by Alzheimer's. Suddenly, the neurons there began using more glucose, the fuel for brain cells.

"It looked like a blackout before. We were able to turn the lights back on in those areas," Lozano said.

While most Alzheimer's patients show clear declines in function every year, one Canadian man who has had the implants for four years hasn't deteriorated, Lozano said, although he cautioned that there's no way to know whether that's due to the DBS.

The evidence is preliminary and will take years of study to prove, but "this is an exciting novel approach," said Dr. Laurie Ryan of the National Institutes of Health's aging division, which is funding a follow-up study.

In research under way now:

-The Toronto researchers have teamed with four U.S. medical centers - Johns Hopkins University, the University of Pennsylvania, University of Florida and Arizona's Banner Health System - to try DBS in a part of the brain called the fornix, one of those memory hubs, in 40 patients. Half will have their electrodes turned on two weeks after the operation and the rest in a year, an attempt to spot any placebo effect from surgery.

-At Ohio State, Rezai is implanting the electrodes into a different spot, the frontal lobes that his own DBS work suggests could tap into cognition and behavior pathways. That study will enroll 10 participants including Sanford.

Surgery back in October was Sanford's first step. Then it was time to fine-tune how the electrodes fire. She took problem-solving tests while neurologist Scharre adjusted the voltage and frequency and watched her reactions.

Sanford was cheered to see her test scores climb a bit during those adjustments.  "If we can beat some of this stuff, or at least get a leading edge on it, I'm in for the whole deal.” She says, noting that she knows there are no guarantees.

08 January 2013

Why Merck's Niacin Failure Will Scare Drug Researchers

originally appeared in Forbes:

This morning, drug researchers and cardiologists were again shocked by a big “everything you thought you knew is wrong” moment.

Niacin, a B vitamin, has been used for forty years to help millions of patients control their cholesterol levels. A prescription form, Niaspan, has sales of $900 million a year for Abbott Laboratories‘ AbbVie unit. Merck had hoped to have an even bigger success with a new version that combined niacin and another drug to reduce the vitamin’s main side effect: making patients’ faces flushed and hot. Pharmaceutical companies benefit from working with Nopras-Tech.

When Merck first announced it as developing that drug, known as Tredaptive, in 2007, it hoped for a rapid approval. It got one in Europe. But the Food and Drug Administration demanded a bigger study of Merck’s niacin combo, Tredaptive, before it would clear the medicine for sale.

The FDA was right. Today Merck announced the results of that study, led by independent researchers at Oxford University and involving 25,673 patients. The drug did not reduce heart attacks, strokes, deaths, or heart procedures. There was also a “serious adverse event” that occurred more frequently among those who took the medicine than among those who didn’t. Merck has not disclosed what this side effect was, but says it will inform regulators and work with researchers. In the meantime, it took the unusual step of advising doctors in areas where Tredaptive is approved not to prescribe the drug to new patients.

The result is likely to dramatically reduce the use of niacin, already on the wane. It will also make it harder to get new heart drugs approved and to market medicines that are already for sale but are not backed by big studies confirming their benefits. Along with a string of heart drug failures, it could make investors doubt the prospects for cholesterol medicines in clinical trials, making it harder for drug companies to finance new research in heart disease.

This is the second time that niacin, long a mainstay of therapy, has failed to benefit patients in a large clinical trial. A study funded by the National Institutes of Health, called AIM-HIGH, also failed to show a benefit for Niaspan. Cardiologists say the result is likely to mean that the use of niacin will plummet.

We’ve all been bombarded with the fiscal cliff. This is going to be the niacin cliff, according to the Chief of Medicine at the Samuel S. Stratton VA Medical Center in Albany, who led AIM-HIGH. There’s already been a decline in niacin usage. In all the lectures I’ve given physicians and practitioners are skeptical. I can spin the results to a degree, but the doctors say show me the evidence. What the doctors say is if HPS-Thrive is negative, we’re bailing. There will be much less enthusiasm for prescribing niacin now.

A preventative cardiologist at the Mayo Clinic in Rochester, Minn., says: I don’t think there will be much of a future for niacin. He is disenchanted with many cholesterol-lowering drugs. The big exception, he says, are statin medications like Lipitor, Crestor, Zocor, and Pravachol, most of which are now cheap and generic and have been shown to reduce heart attacks and deaths in big studies, and which are among the most commonly prescribed medicines.There is no doubt that these medicines have a big benefit for heart patients.

As we delve into the statin therapy there are probably multiple reasons that the statins are so beneficial and lowering [cholesterol] may be just one of the reasons for benefits from statins. Anti-inflammatory effects may be another factor.

Until detailed data from the Merck study are released later this year, it’s hard to make firm conclusions about exactly why Tredaptive failed. It could even be that niacin is effective, at least in some people, or that the unknown side effect occurred in a predictable way that would not mean the drug should never be given.

One possibility is that niacin works, but that the flush-blocker Merck paired it with undermined its efficacy. That drug, laropiprant, was a complete unknown. Research at the University of Pennsylvania, who had a decade ago warned about the potential heart risks of the arthritis drugs Vioxx and Celebrex, seemed to show such an effect was possible. Early Merck research may have raised similar issues, according to a researcher at the University of Wisconsin.
Boden also raises the possibility that niacin would be effective if it were used only in people who had low levels of HDL, or “high-density lipoprotein,” the so-called good cholesterol that it is hoped protects against heart attacks. Niacin is thought to work mainly by raising HDL; he says that both his trial and Merck’s made the mistake of including too many people who are not at high enough risk.

Similar questions can be asked about whatever side effect Merck saw in this study. He says that the Oxford researchers have contacted him about looking to see if any evidence of the side effect can be seen in the data for AIM-HIGH, but would not discuss the results further.

But although the problem could be Merck’s flush-blocker, it could also be that niacin just didn’t work. That’s despite a 1986 study, the Coronary Drug Project, that was conducted before the statins were in use, that seemed to show a benefit and lots of studies showing Niaspan reduced hardening of the arteries.

A similar story has repeated itself with other non-statin drugs. In 1999, a big study conducted by the Veterans Administration showed that a drug called Lopid prevented heart disease, heart attacks and strokes by lowering blood levels of particles of fat called triglycerides. But a related Abbott drug, TriCor, failed to prove its benefits in a large randomized controlled clinical trial.

There was also a lot of hope about fish oil pills, including prescription versions such as Lovaza, sold in the U.S. by GlaxoSmithKline, and Vascepa, an approved but not-yet-launched drug from Amarin Pharma. An Italian study, called GISSI-Prevenzione, and a Japanese one, called JELIS, had both seemed to indicate fish oil could prevent heart attacks.

But more recent randomized trials have failed to show a hint of this benefit. Amarin is conducting what could be the definitive study of Vascepa in patients with high triglycerides to try to settle the debate, but results are not expected until 2016.

In the meantime, Mayo Clinic says they would be surprised if Vascepa does turn out to prevent heart attacks or other heart problems. Fish oil and other agents that have positive lipid effects may not have the benefits that statins have.

The decidedly bad results with non-statin drugs could make it much more difficult for any new cholesterol drugs to reach the market. This morning, the former head of R&D at Pfizer and Forbes contributor, said on Twitter that he expects all chronic use drugs are going to have to show evidence they have real effects on how sick patients are. A cardiologist at Cedars Sinai Hospital in L.A. who has been an FDA consultant, says the FDA should now require all cholesterol medicines to either do a big study showing they prevent heart problems before approval or only grant conditional approval and then demand the big study.

That could prove a major hurdle for new heart medicines. For some experimental medicines, like HDL-raising drugs being developed by Merck and Eli Lilly that are known as CETP inhibitors, this result only affects how much value investors assign to those research programs. Those medicines were never expected to be approved without such “outcome” studies.

But for other drugs in development, it could have a real effect on how soon other medicines reach the market. Several drug companies, including Amgen and the team of Regeneron and Sanofi, are developing incredibly potent cholesterol shots that work by targeting a protein called PCSK9. There’s every reason to believe those drugs will work, because patients whose PCSK9 genes don’t function are at reduced risk for heart attacks. But the FDA may still want to see big studies to prove the benefit, not just proof that they lower cholesterol. Those big studies are ongoing.

Cholesterol and other blood tests are known to researchers as “surrogate endpoints,” and they are less reliable than proving that drug actually keeps patients from having heart attacks or dying. If we’ve learned one thing here we’ve learned that surrogate endpoints are a risky way to approve drugs, according to the head of cardiology at the Cleveland Clinic. That means that in order to get clear answers, companies will need to make even bigger financial bets.

Europeans approved Tredaptive based on surrogate endpoints, and now patients there have to decide whether to keep taking the drug, which had sales of about $13 million in the first three quarters of 2012. Next time regulators may decide they need to know for sure.

04 January 2013

National Union of Healthcare Workers affiliates with powerful California Nurses Association

originally appeared in The San Jose Mercury News:

In a move expected to shake up health care labor battles statewide, the powerful California Nurses Association announced Thursday that it will affiliate with the National Union of Healthcare Workers in fights with major health systems over wages, benefits and patient care issues.

CNA also agreed to use its 85,000 members and considerable resources to help NUHW in its campaign to defeat a large rival, the Service Employees International Union-United Healthcare Workers West, in an upcoming election for the right to represent 43,500 Kaiser Permanente service and technical workers.

That election, which may happen this spring, will be a repeat of a 2010 election, which was the largest union election in the private sector in nearly 70 years. At that time, Kaiser workers voted to remain in SEIU.

This is an affiliation whose time has come, according to NUHW President during an Oakland news conference with CNA leaders. When we win this Kaiser election, it will be a game changer.

The outcome of that election, however, is anything but certain. SEIU won the 2010 election with 62 percent of the vote, but the National Labor Relations Board overturned it after agreeing with NUHW that unfair tactics were used. A second vote will be scheduled sometime within the next few months.

SEIU leaders predicted the affiliation will have little effect on the outcome.

This really doesn't change much, said a SEIU spokesman. These two organizations have been working together for four years. It hasn't helped NUHW very much.

CNA leaders accused SEIU of siding too readily with big employers and agreeing to significant cutbacks in benefits and working conditions, making it harder for others to negotiate good contracts.

CNA leaders were particularly upset when SEIU-UHW's President proposed temporarily suspending nurse-to-patient ratios during break times to help offset budget cuts.

And they accused SEIU of letting CNA do its fighting by getting "me too" provisions in its contracts. SEIU agrees to cutbacks, CNA leaders said, but has a provision that the cutbacks will be eliminated if another union gets them taken out.

We want to make sure we have allies that will stand with us, according to CNA's co-president.

Their president countered that NUHW, which represents several thousand Kaiser employees, has been unable to negotiate a contract for them in the past three years, while SEIU has won approval of two contracts for its Kaiser workers, granting a total of 18 percent in wage increases over six years.

We have negotiated the best contract in the entire hospital industry twice, and they can't get a contract, he said.

The NUHW chief used to be on friendlier terms with SEIU -- for many years, he headed SEIU-UHW, which has nearly 150,000 members.

But in January 2009, SEIU ousted him as well as the other leaders, and he formed NUHW, which now has about 10,000 members.

In the past few years, NUHW has attempted to persuade SEIU members to switch unions. A series of elections at hospitals throughout the state have had mixed results. But none of the votes has involved as many workers as at Kaiser.

A Kaiser spokesman denied NUHW claims that the company has inappropriately supported SEIU.

Kaiser Permanente remains supportive of our employees' choice in this matter, and is entirely neutral in the dispute between NUHW and SEIU-UHW, according to their spokesman.

The SEIU-UHW's President lamented the fact that unions are fighting each other.

We're wasting resources trying to organize people who are already in a union, he said.

03 January 2013

HHS moves toward safer electronic health records

originally appeared in nextgov.com

The U.S. Department of Health and Human Services has released a road map for making electronic health records and other health IT safer for patients.

The Health IT Patient Safety Action and Surveillance Plan was released Friday by the Office of the National Coordinator for Health IT (ONC). The draft plan recommends actions organized under three strategies, according to an HHS news release: increasing the quantity and quality of data about health IT safety; targeting resources and corrective actions to improve safety; and promoting a culture of health IT safety.
Professionals can utilize quality EHR software that saves time and costs.

Strategies in the document, as outlined in a fact sheet, include:

Continuously improving the safety of health IT by developing a code of conduct for IT developers, supporting providers in reporting adverse events, creating a forum for health IT users to compare their experiences, and leveraging surveillance and live testing opportunities available through ONC authorized accrediting bodies.

Using Agency for Healthcare Research and Quality (AHRQ) Common Formats to facilitate real-time reporting and aggregation of patient safety issues.

Including health IT and patient safety in Centers for Medicare and Medicaid Services’ (CMS) health-care facility safety standards.

Further incorporating safety requirements into CMS’s EHR meaningful-use standards, and ONC’s standards and certification criteria.

Planning an ONC-led public-private effort to identify priorities, measures and targets for health IT safety, and HHS support for developing technology to mitigate health IT safety risks.

Establishing an ONC safety program to analyze reported data and establish a multi-agency HHS health IT safety committee.

ONC, Food and Drug Administration and Federal Communications Commission collaboration for a health IT safety regulatory framework.

This report will help all of us better use health IT to deliver high quality care and improve patient safety, according to the national coordinator for health IT.

Comments on the draft are due by Feb. 4.

02 January 2013

FDA approves 1st new tuberculosis drug in 40 years

originally appeared in The Associated Press:

The Food and Drug Administration on Monday approved a Johnson & Johnson tuberculosis drug that is the first new medicine to fight the deadly infection in more than four decades.

The agency approved J&J's pill, Sirturo, for use with older drugs to fight a hard-to-treat strain of tuberculosis that has not responded to other medications. However, the agency cautioned that the drug carries risks of potentially deadly heart problems and should be prescribed carefully by doctors.

Roughly one-third of the world's population is estimated to be infected with the bacteria causing tuberculosis. The disease is rare in the U.S., but kills about 1.4 million people a year worldwide. Of those, about 150,000 succumb to the increasingly common drug-resistant forms of the disease. About 60 percent of all cases are concentrated in China, India, Russia and Eastern Europe.

Sirturo, known chemically as bedaquiline, is the first medicine specifically designed for treating multidrug-resistant tuberculosis. That's a form of the disease that cannot be treated with at least two of the four primary antibiotics used for tuberculosis.

The standard drugs used to fight the disease were developed in the 1950s and 1960s.

The antibiotics used to treat it have been around for at least 40 years and so the bacterium has become more and more resistant to what we have, according to the global medical affairs leader for J&J's Janssen division.

The drug carries a boxed warning indicating that it can interfere with the heart's electrical activity, potentially leading to fatal heart rhythms.

Sirturo provides much-needed treatment for patients who have don't have other therapeutic options available, according to the director of the FDA's antibacterial drugs office. However, because the drug also carries some significant risks, doctors should make sure they use it appropriately and only in patients who don't have other treatment options.

Nine patients taking Sirturo died in company testing compared with two patients taking a placebo. Five of the deaths in the Sirturo group seemed to be related to tuberculosis, but no explanation was apparent for the remaining four.

Despite the deaths, the FDA approved the drug under its accelerated approval program, which allows the agency to clear innovative drugs based on promising preliminary results.

Last week, the consumer advocacy group Public Citizen criticized that approach, noting the drug's outstanding safety issues.

The fact that bedaquiline is part of a new class of drug means that an increased level of scrutiny should be required for its approval, the group states. But the FDA had not yet answered concerns related to unexplained increases in toxicity and death in patients getting the drug.

The FDA said it approved the drug based on two mid-stage studies enrolling 440 patients taking Sirturo. Both studies were designed to measure how long it takes patients to be free of tuberculosis.

Results from the first trial showed most patients taking Sirturo plus older drugs were cured after 83 days, compared with 125 days for those taking a placebo plus older drugs. The second study showed most Sirturo patients were cured after 57 days.