31 October 2009

Hospitals Changing Rules Due To Swine Flu

from WVNS TV

The H1N1 virus, or the swine flu, is big news lately. Everyone is talking about it and no one wants to catch it. That's why Stonewall Jackson Memorial Hospital has changed its visitation rules. The biggest change is that no one under 18 will be allowed to visit patients.

"The influenza that's around right now is affecting children 18 and younger, more than people older than that. So what we're trying to do is cut down on the people that are getting it the most from bringing it into our hospital to our patients and our staff," said Diane Bennett, an infection control nurse at Stonewall Jackson Memorial Hospital.

The number of visitors has also been limited to two people at a time, and all visitors must wash their hands before entering and leaving patient rooms. For some, these rules make sense.

"If someone has the flu or just getting it or something, then they won't spread it out to everybody else," said Hayward Wright, a Lewis County resident.

"I think that anything that can reduce the number of germs and help our family members and you know, people coming in being sick, I think it's going to help," said Ann Marie Chidester, a Virginia resident visiting her grandfather in the hospital.

"There are also new visitation rules in the birthing unit. Only significant others and grandparents of the baby will be allowed to visit the newborn. Siblings and other relatives will have to wait until the baby is brought home.

"We understand that having a child is a really special time. But right now, at this time, our patients and our mothers and babies are our top priority," said Bennett.

Bennett said in addition to the new visitation rules, the hospital has placed swine flu masks, tissues and hand sanitizers in a variety of locations to help stop the spread of the swine flu and other illnesses.

She said anyone coming to the emergency department with flu-like symptoms will be asked to wear a mask, or disposable respirator, which is a rule UHC is also following.

Flu Death In Minnesota Raises Questions


It's a scenario that strikes terror in most any parent: A perfectly healthy first-grader dies of flu in the ambulance outside his home. How could it happen?

In the most recent H1N1 flu death in Minnesota, the Hennepin County Medical Examiner's office said that 6-year-old Nathanael Schilling of Corcoran died on Sept. 24 from an inflammation of the heart, a rare complication that can result from a flu infection.

He was a first-grader at St. John's Lutheran School in Corcoran, according to his newspaper funeral notice.

It was the seventh death from H1N1 in Minnesota, and the second time this year that an otherwise healthy child died after becoming infected with the new flu strain.

Health officials say they still expect the new virus to be no more deadly than ordinary seasonal flu, which kills 36,000 Americans in an average year. What's different this year is that children appear to be more vulnerable to the new strain than to seasonal flu.

The previous child fatality in Minnesota, which occurred in July, also involved an otherwise healthy child. That 2-year-old died because of a co-occurring bacterial infection -- pneumococcus, which causes pneumonia, said Dr. Ruth Lynfield, Minnesota state epidemiologist.

Alone, it's not usually dangerous in someone who is healthy. But the flu virus opens a door, allowing the non-threatening agent to overwhelm the body and become lethal. It's the combination of the two that often kills otherwise healthy children and adults.

If symptoms worsen, act

"That's why we tell people who get the flu that if they are getting better and then symptoms get worse with high fever and bad cough, they should seek care right away," Lynfield said.

A recent study by the Centers for Disease Control and Prevention (CDC) found that of the 36 children who died from H1N1 from April to August, six had no chronic health conditions. But all of them had a co-occurring bacterial infection.

The most common co-occurring infection that causes flu-related deaths is staphylococcus aureus, commonly known as staph, said Pat Schlievert, a microbiologist at the University of Minnesota and an expert on staph-related deaths. A third of the population carries it on their body, most in their noses or on their skin. Often it's benign or causes minor skin infections. Schlievert has studied dozens of cases of children who died unexpectedly from flu combined with staph.

"The [flu] causes upper respiratory damage, which allows the staph to get where it's not supposed to be. It makes it's way into the lungs," he said.

So far in Minnesota three of the seven deaths from H1N1 have been children and only the first, who died in June, had an underlying health problem that put her at greater risk. The other deaths were adults, one elderly, and three middle-aged, all with chronic health conditions such as asthma, obesity or suppressed immune systems.

That's a sharp contrast to the pattern of fatalities seen with seasonal influenza. Most years, 90 percent of the people who die from complications of flu are elderly, and most others have chronic health problems that make them vulnerable.

Most recover

The vast majority of people who become infected with H1N1 recover, Lynfield said, "but some do get severe disease."

The good news this week is that vaccine has arrived in Minnesota.

The first shipment of nasal spray vaccine was distributed to staff at some hospitals, including Children's Hospitals of Minneapolis and St. Paul, and some area public health agencies. The rest of the first order of 28,000 doses is expected to arrive throughout the rest of the week.

The nasal vaccine, which contains a live virus, is going to health care workers, who are third on the priority list for vaccine distribution. It's not safe for the two groups at the top of the list, young children or pregnant women, who are considered most at risk.

Health care workers are at high risk of exposure to the virus, and are in a position to infect vulnerable patients.

Injectable vaccines, which will go to those high risk groups first, are not expected to arrive in the state until mid-October.

In the meantime, however, clinics are already gearing up for the deluge of people who want the vaccine. "People are asking about it," said Dr. Ron Jankowski, medical director of the Fremont Clinics in Minneapolis.

Like many clinics across the country, Fremont now has a prompt on its phone line that leads patients to a long message about seasonal flu and H1N1 vaccine.

Federal health officials have said that more than 150 million doses of vaccine will be available nationally, meaning everyone who wants the vaccine should be able to get it.

"The question is, will [swine flu] come and go before the vaccine is available to everyone?" said Jankowski. "Who knows?'

29 October 2009

Does Running On Concrete Increase Injury Risks?

from the Globe and Mail

New research contradicts earlier studies that say we adapt our running stride so that hard and soft surfaces administer roughly the same shock to the body

In a study to be published later this year, Brazilian researchers found that your feet feel about 12 per cent more pressure with each foot strike when running on asphalt compared with grass.

Thanks for that newsflash, Captain Obvious, you might say.

But the findings actually contradict several earlier studies, which – despite what our intuition tells us – have found that we seem to automatically adapt our running stride so that hard and soft surfaces administer roughly the same shock to the body.

In fact, it may be the smoothness of paved surfaces that makes them dangerous to runners, rather than their hardness. And softer, less even surfaces carry their own injury risks, so the best answer may lie somewhere in the middle.

“Understanding why and how runners get injured, and the role of the surface, would be like winning the Nobel Prize of sports science research,” says Katherine Boyer, a Canadian biomechanics researcher now at Stanford University in California.

The surprising idea that your body can make adjustments for different running surfaces dates back to studies in the 1990s. Researchers found that when they varied the stiffness of a running surface, runners adjusted the effective stiffness of their legs in the opposite direction – by bending their knees slightly more or less and by tensing their muscles – so that their total up-and-down motion remained perfectly constant.

In support of this notion, a 2002 study by Mark Tillman of the University of Florida, using force-sensing  running shoe inserts, found no difference in the forces created by running on asphalt, concrete, grass and a synthetic track.

The 12-per-cent difference found by Vitor Tessuti of the University of Sao Paulo, which will appear in the Journal of Science and Medicine in Sport later this year, is still relatively small. And a companion study, yet to be published, found no difference between asphalt, concrete and a synthetic track.

Even when the forces on the feet are the same, though, the slight differences in knee angle and other parameters could theoretically translate into greater likelihood of injury on one surface compared with another, Dr. Tillman cautions.

The bottom line, for now, is that the simple picture – harder surface leads to more pounding leads to injury – isn't supported by the existing evidence. Indeed, on-the-ground studies such as one from 2003 that followed 844 runners preparing for the 10-kilometre Vancouver Sun Run have failed to find any association between running surface and injury rate.

But there are other factors to consider, Dr. Boyer says. Smooth, flat, paved surfaces will result in every stride being basically the same, so your muscles and joints are stressed in exactly the same way throughout the run.

On unpaved surfaces, in contrast, no two steps are the same, which provides slight variations in the impacts on your body, reducing the chance of an overuse injury. Too much unevenness, though, carries risks such as a turned ankle.

“The key is to find the balance between stress and overstressing the system,” Dr. Boyer says.

The principle of specificity also applies: If you do all your training on one surface, your body may not be adequately prepared to run on other surfaces – especially in long, demanding races.

“I do make a calculated effort to run more on the roads when preparing for a marathon,” says Dylan Wykes, Canada's second finisher at last summer's World Championships in Athletics marathon in Berlin.

Mr. Wykes's normal training regimen is about half on roads and half on grass and gravel trails, but he increases the road component to 75 per cent before marathons to make sure his legs are prepared for the unchanging impacts of 42.2 kilometres of smooth asphalt.

This approach, incorporating a healthy mix of different surfaces, is one most runners would do well to emulate – at least until biomechanics researchers reach a firmer conclusion. Still, the pile of conflicting research results suggests that, if your circumstances do force you to run exclusively on paved surfaces, it doesn't mean instant injury.

17,000 Child Deaths Linked To Lack Of Insurance

Kids without coverage are more apt to die while hospitalized, study finds
U.S. News & World Report

An estimated 17,000 children in the United States might have died unnecessarily over nearly two decades because they didn't have health insurance, according to a report from researchers at Johns Hopkins Children's Center in Baltimore.

They found that kids who lacked health insurance were 60 percent more likely to die in the hospital than were kids who had insurance. After adjusting for such differences as race and gender, uninsured kids were still 37.8 percent more likely to die than kids with insurance coverage.

David C. Chang, co-director of the pediatric surgery outcomes research group at Hopkins and a study co-author, said he could not think of a medical treatment that has such a dramatic impact on health outcomes as health insurance seemingly does.

"This is actually something we as a society ... can choose to do something about," he said. "It's literally with the stroke of somebody's pen, this could be changed."

The article was published online Oct. 30 in the Journal of Public Health.

Bruce Lesley, president of First Focus, a bipartisan child and family advocacy group, noted that data from the U.S. Institute of Medicine have shown that people who are uninsured have a higher mortality rate.

"You knew that it existed, you knew that there were cases [of child deaths related to lack of insurance], but I think this data is pretty shocking and really points to the need for national health reform," Lesley said.

In one of his first acts after taking office in January, President Barack Obama signed legislation reauthorizing the Children's Health Insurance Program (CHIP). The measure also provided funding for states to add several million more children to the rolls though 2013.

"CHIP has really worked and been very important and insures about 7 million kids in the country," Lesley said. Still, he said, roughly 6.5 million children who are eligible for Medicaid or CHIP remain uninsured -- for whatever reason.

Enrollment barriers are part of the problem, explained Lesley, whose organization endorses legislative proposals to move toward a "default enrollment" system. "The presumption should be the kid's enrolled, and let's figure out what program they're in," he said.

The Johns Hopkins team looked at the relationship between insurance status and kids' mortality to better inform the CHIP debate.

Using records from two large databases, lead author Dr. Fizan Abdullah, Chang and colleagues examined more than 23 million hospitalizations of people younger than 18.

Over an 18-year period though 2005, 117 million children were hospitalized - in standard and children's hospitals. Nearly 6 million kids were uninsured at the time of admission. In all, 38,649 children died while hospitalized.

Uninsured kids were 1.6 times more likely to die than children who had insurance.

Assuming that the insured and uninsured populations are identical, the difference in risk of mortality was 60 percent. The authors' actual predicted mortality is lower, however, because factors such as age, race and gender are associated with risks that affect outcomes, Chang explained.

"The 60 percent is the theoretical difference, and the 37 percent is the actual difference that you see in real life," he said. "Our extrapolation is based on that more conservative number."

The study includes some data from the period before CHIP was enacted in 1997. Though fewer kids are uninsured today than two decades ago, Chang said, that would not skew the risk of death from lack of insurance.

And though the study does not prove that being uninsured boosts a child's mortality risk, it does suggest a strong association between insurance status and odds of dying.

"I think the message is insurance is a choice we can make as a society, and this is something that we should consider," Chang said.

28 October 2009

Researchers Hope For Early Detection Of Alzheimer's

Lubbock Online

Doctor Sid O'Bryant is the director for rural health research at 
Texas Tech University Health Sciences Center. He recently won 
an award for his research on Alzheimer's disease and rural health

It's hard for family doctors, let alone relatives and friends, to recognize when forgetfulness might hint of the early stages of Alzheimer's disease.

But what if a simple blood test could catch the brain-ravaging illness when modern medicines help the most?

Sid O'Bryant, an assistant professor in neurology and director of rural health research at Texas Tech's Health Sciences Center, and researchers from four Texas universities hope to find telltale signs of the illness lurking in a patient's blood.

"If there was a blood test that accurately and reliably detected the disease in its earliest stages, this would allow many more patients to receive treatment early on when our current medications are most effective," O'Bryant said.

Alzheimer's disease breaks down healthy brain tissue, eventually interfering with a patient's ability to think, reason and remember.

More than 340,000 Texans will suffer from Alzheimer's disease by 2010, according to the Texas Alzheimer's Research Consortium.

Twice that many patients will face the disease over the next two decades, according to the consortium.

But the slight forgetfulness and occasional confusion that signify the early symptoms can be easy to miss. A full diagnosis requires a medical examination, tests on the brain and the nervous system and brain imaging, O'Bryant said.

"It takes a clinician with expertise in dementia syndromes to recognize the early signs (of Alzheimer's disease)," he said.

O'Bryant and his colleagues at HSC think an Alzheimer's test would help doctors diagnose the disease and researchers design new therapies and identify variations of the disease that might respond better to different treatments.

By joining a consortium of four other Texas institutions - Baylor College of Medicine, The University of Texas Southwestern Medical Center, the University of North Texas Health Sciences Center and the University of Texas Health Science Center at San Antonio - the Lubbock researchers recently secured part of a $6.85 million grant to find Alzheimer's disease "markers" in the blood and genes, and use them to improve diagnosis and treatment.

The 35-year-old researcher, who graduated from University of Albany, State University of New York, hunts for blood proteins that point to early signs of the disease. The 500 patients already in the ongoing study have helped him find some proteins related to Alzheimer's and a new way to measure how the disease progresses, he said.

His work on Alzheimer's disease, as well a broader study on the health of people in two rural West Texas counties, earned O'Bryant a 2009 Early Career Award from the National Academy of Neuropsychology, which recognizes research excellence achieved within 10 years of completing formal training, according to the organization's Web site.

"The finalists this year were all well qualified," said Chris Higginson, chair of the awards committee. "But Dr. O'Bryant's credentials were particularly impressive. The (consortium) is fortunate to have him as a member of their clinical team."

Jim Hinds, project coordinator of the consortium, called O'Bryant's work a "ground breaking" effort toward identifying early-stage Alzheimer's disease.

"He is a gifted researcher," Hinds said.

Local Alzheimer's disease patients ages 50 and older can be part of the Alzheimer's study, O'Bryant said.

Those in the study receive a two-hour consultation, a memory and thinking test, and a blood draw. They will be asked to come back for an annual check up, he said.

O'Bryant said while his work focused on basic biology, he hopes a better understanding of the disease will improve treatment options.

"Our currently available medications for Alzheimer's disease slow progression, which is very important in prolonging life quality (but) they do not halt or reverse the disease process," he said. "We are hoping that a better understanding of the biological pathways associated with the disease will lead to novel treatments that halt progression."

27 October 2009

The Science Of Junk Food

from Tonic.com

It’s a nutrition study that totally puts the crack in pork cracklings.

As ScienceNews reports, a neuroscience study reveals why our sense of self-control may get tossed out the window when the salty, fatty snacks are close at hand. An investigation into the linkage between nutrition and the brain indicates that brain circuitry is actually rewired as a result of consuming certain junk foods, closely mirroring the changes in the brain that stem from heroin use.

Study co-author Paul Johnson of the Scripps Research Institute in Florida observes of his team’s findings that “[t]his is the most complete evidence to date that suggests obesity and drug addiction have common neurobiological underpinnings.”

According to ScienceNews, the study began with Johnson and team returning from the grocery store loaded with such fare as snack cakes, bacon, sausage and other tasty-but-ghastly treats. Half of the team’s test rats were fed appropriately portioned nutritious food, and the other half were given all-you-can-eat buffet privileges at the junk food cafe set up for the study.

Those in the latter group were observed to lose any sense of moderation, going back for more on a routine basis, taking in double the caloric intake of their healthy diet peers, and rapidly developing obesity.

The gluttonous behavior resulted from changes that occurred in the brain. Johnson and team discovered that the junk food diet activated the pleasure and reward functions in the brain, and altered them permanently. Precisely in the same manner observed in those addicted to drugs such as opiates, more and more of the substance — in this case, junk food — was required to activate the reward response in the brain.

Tourette's Eased By Deep Brain Stimulation

from the Los Angeles Times

Deep brain stimulation, already used for treating Parkinson's disease, essential tremor and dystonia, can ease the tics and other symptoms associated with Tourette's syndrome, British researchers reported today in the journal Neurology. Tourette's is a congenital neuropsychiatric disease affecting an estimated 1% of the population. It is characterized by physical tics, such as eye blinking, shoulder shrugging and head-and-shoulder jerking. It is also marked by vocal outbursts, many of which are obscene, providing great embarrassment. Sufferers often also have obsessive-compulsive disorder, depression, anxiety or attention deficit hyperactivity disorder. There is no cure for Tourette's and no medication that works in all patients.

Deep brain stimulation involves embedding electrodes deep in the brain--often called a brain pacemaker--and applying a minute electrical current to specific areas of the brain, depending on the condition being treated. Its underlying mechanisms are still not fully understood.

Isolated case reports have suggested that the technique might be useful in Tourette's, so Dr. Andrea Cavanna of the University of Birmingham and her colleagues decided to perform a formal study. They treated 18 patients, with an average age of 30, who also had obsessive-compulsive disorder and who did not respond to other forms of therapy.

Three of the patients were lost to follow-up. But the other 15, who were followed for two years, had an average of 52% fewer tics and a 26% to 33% improvement in the symptoms of OCD, depression and anxiety. The treatment did not interfere with their cognitive abilities. "Our findings hold promise for helping people with severe Tourette syndrome, who are in need of new treatment options to improve their quality of life," Cavanna said.

The study was funded by the Italian Tourette Syndrome Assn., the National Hospital Research and Development Fund and Tourettes Action-UK.

26 October 2009

Emergency Use Of Peramivir OK'd For H1N1

From the Wall Street Journal

The U.S. Food and Drug Administration is allowing the use of an experimental antiviral drug to treat severe cases of H1N1 or swine flu.

The drug, peramivir, is currently being developed by BioCryst Pharmaceuticals, Inc. (BCRX) and is undergoing testing required for regular FDA approval.

The FDA issued a so-called emergency use authorization late Friday that allows doctors to use peramivir, which is delivered intravenously, in certain hospitalized adult and pediatric patients with confirmed or suspected H1N1 influenza.

A handful of doctors have already treated patients with severe cases of H1N1 using peramivir obtained through the agency's expanded access rules that allow individual patients to obtain experimental drugs if certain conditions are met. The emergency-use authorization allows use of the drug without prior FDA approval.

The FDA said there's only limited clinical data about whether peramivir is safe and effective, but "based upon the totality of scientific evidence available, it is reasonable to believe that peramivir IV may be effective in certain patients."

The company said it is completing production of approximately 130,000 courses of peramivir and is prepared to make more, if required.

The FDA said peramivir should only be used in patients who have not responded to or can't take the oral antiviral drug Tamiflu, made by Roche (ROG.VX) or Relenza, which is an inhaled drug made by GlaxoSmithKline PLC (GSK, GSK.LN). Like Tamiflu and Relenza, Peramivir works by inhibiting neuraminidase, an enzyme that's involved with the spread of the influenza virus within the body.

The federal Centers for Disease Control and Prevention asked the FDA to grant peramivir emergency use to help cope with the influenza pandemic which has killed more than 1,000 people in the U.S. since April and hospitalized thousands more. The CDC will control and track distribution of peramivir to hospitals.

As of Oct. 17, 46 states were reporting "widespread" influenza activity and many doctors offices have been swamped with swine-flu patients. The CDC said more than 7% of outpatients visits in the week that ended Oct. 17 were attributed to influenza-like illnesses--a rate higher than during the peak of the last few seasonal influenza seasons. The CDC said "many millions" of Americans have been sickened with H1N1 influenza since the virus was first discovered in April.

The U.S. government has ordered enough vaccine to make up to 251 million doses if needed, but production has been slower than originally anticipated.

A total of 11.3 million doses of vaccine had been shipped to U.S. doctors, hospitals, and clinics as of Wednesday, according to the CDC, out of a total of 14.1 million doses that manufacturers had shipped to warehouses by that time. By Friday, 16.1 million doses of vaccine had been shipped to warehouses, the CDC said.

The total is far below the government's most recent estimate that by the end of this month, about 28 million to 30 million doses would be shipped to warehouses for further distribution. That estimate itself is a revision, made last week, from a prior expectation of about 40 million doses by the end of the month. In July, the government had predicted that about 100 million doses would be ready in October.

Anitdepressants Appear To Work 'Instantly'

From BBC News

Antidepressants get to work immediately to lift mood, contrary to current belief, UK researchers say.

Although patients may not notice the effects until months into the therapy, the team say they work subconsciously.

The action is rapid, beginning within hours of taking the drugs, and changes negative thoughts, according to the Oxford University researchers.

These subtle, positive cues may add up over time to lift the depression, the American Journal of Psychiatry reports.

It may also explain why talking therapies designed to break negative thought cycles can also help.

Psychiatrist Dr Catherine Harmer and her team at Oxford University closely studied the reactions of 33 depressed patients and 31 healthy controls given either an antidepressant or a dummy drug.

The depressed patients who took the active drug showed positive improvements in three specific measures within three hours of taking them.

These patients were more likely to think about themselves in a positive light, rather than dwelling on their bad points, the researchers said.

They were also more likely to see the positive in others.

For example, if they saw a grumpy person they no longer internalised this to think that they must have done something wrong to upset the person.

New Drugs

This was despite feeling no improvement in mood or anxiety.

Dr Harmer said: "We found the antidepressants target the negative thoughts before the patient is aware of any change in feeling subjectively.

"Over time, this will affect our mood and how we feel because we are receiving more positive information."

She said the findings could help scientists looking for new drugs to treat depression.

Dr Michael Thase, a psychiatrist from the University of Pennsylvania, said the findings challenged conventional wisdoms and were potentially "paradigm-changing".

But he said much more research was needed.

"The highest research priority is to confirm that the rapid effects observed in this study are predictive of eventual clinical benefit."

He said it was possible that switching off the negative thoughts was a crucial part of the therapy.

Alternatively, it might merely be a sign that the drug was beginning to work at the cell level in the brain.

Paul Farmer, chief executive of Mind, said: "This research may contribute to our understanding of how our bodies respond to antidepressants, but the changes recorded can't always be felt by patients and it can be some weeks before they begin to feel the symptoms of depression easing.

"We must also remember that the side-effects of medication can often be felt straight away long before the benefits really kick in, and this will always affect people's experiences in the initial stages of treatment."

24 October 2009

'Smart Choices' Program Suspended

from Chicago Tribune

Three days after federal regulators unveiled plans to crack down on potentially misleading food labels, a major nutrition labeling initiative by some of the country's largest packaged food makers announced Friday that it would voluntarily "postpone active operations."

Still, the "Smart Choices" nutrition label from several major food makers -- including Northfield-based Kraft Foods Inc. -- won't likely disappear any time soon.

Earlier this week, the U.S. Food and Drug Administration said it will review the front labels of food packages bearing symbols or language that suggest the product is healthier than actually merited by its ingredients.

The FDA didn't single out Smart Choices, but FDA Commissioner Margaret Hamburg noted during a call with journalists that some products bearing the logo "are almost 50 percent sugar."

Smart Choices was unveiled a year ago and launched in supermarkets in August. The idea: affix to packages an easy-to-read label with a green check mark accompanied by the term "Smart Choices," an indication that the product is essentially in line with what the government deems a healthy diet.

On Friday, the Smart Choices program said it is not encouraging wider use of its logo by new or current members. But a spokeswoman for the group said that most member firms will continue using the Smart Choices mark on products upon which it already appears.

That's what Kraft plans to do, said spokeswoman Susan Davison. "At this point, we don't have any plans to change (Smart Choices) packaging," she said.

When Smart Choices was announced last year, its backers said it was meant to bring some standardization to the thicket of competing health claims in groceries.

21 October 2009

The Bionic Eye: New Worlds Of Sight For The Blind


This retinal prosthesis has been implanted in the eyes of 32 patients. 
The device receives wireless data from the camera which it then 
translates into electronic signals that are sent to the brain, restoring sight.

Stem cells and electronics can help restore vision to people who've been blinded by retinal diseases, scientists reported in Chicago at Neuroscience 2009, the annual meeting of the Society for Neuroscience.

Diseases of the retina cause blindness by damaging the cells that line the back of the eye, where images of the world are normally transformed into nerve impulses that go to the brain.

"There's very little therapeutic treatment out there right now for people with diseased retinas," says Brian Mech, a vice president of Second Sight Medical Products in Sylmar, Calif.

But Second Sight is hoping to change that. The company has developed an experimental bionic eye that has been tried in more than 30 patients with macular degeneration or retinitis pigmentosa

Building An Artificial Retina

Each patient wears a pair of glasses that incorporates a video camera, Mech says. The video signal from the camera is sent to an implant on the eye itself, which in turns communicates with an array of electrodes attached to the patient's retina.

And those electrodes do what the old retina can't anymore: send electrical signals to the brain that allow sight.

Mech says it usually takes patients' brains a little while to make sense of the new signals.

"They learn to use the device better over time," he says. "Someone that has had the device for a year will do better than they did at three months."

The artificial eye uses just 60 electrodes to replace millions of retinal cells. Mech says that means the restored vision is rudimentary, so people can find doors and follow lines on the floor. But most can't read, and those who can are only able to make out very large letters.

At the neuroscience meeting, Second Sight presented a study showing that patients could use the artificial eye to tell which direction an object was moving.

Despite the limitations of the artificial eye, Mech says patients who have received one tend to get emotional when they realize they can see even a little bit.

"There's a lot of crying, a lot of smiling," he says. "It's a sensory input that they haven't had in a very long time, and so they're excited."

Growing New Retina Cells

A team led by Robert Aramant of the University of California, Irvine, offered a different approach to restoring sight.

Since the 1980s, Aramant has been working to fix retinas damaged by diseases including macular degeneration and retinitis pigmentosa.

And for several years now, the team has been treating patients using fetal retinal cells. Their approach is to retrieve an intact sheet of fetal retinal cells and transplant the entire sheet into a damaged eye.

The transplanted cells then mature the same way they would in a developing fetus, creating all the layers of a normal retina, Aramant says.

The team has treated just 10 patients so far, because of funding constraints. But Aramant says seven of those patients got better, including one woman whose vision went from 20-800, which is severely impaired, to 20-200, which is good enough for many daily tasks.

After treatment, Aramant says, the woman was able to play computer games, write emails, and read a large-print version of Reader's Digest.

Also at the meeting in Chicago, scientists presented studies showing ways to create new light-sensitive molecules in the eye, and to use stem cells to grow specific types of retinal cells.

20 October 2009

New Federal Policy On Medical Marijuana: Lighten Up

NY Times

People who use marijuana for medical purposes and those who distribute it to them should not face federal prosecution, provided they act according to state law, the Justice Department said Monday in a directive with far-reaching political and legal implications.

In a memorandum to federal prosecutors in the 14 states that make some allowance for the use of marijuana for medical purposes, the department said that it was committed to the “efficient and rational use” of its resources and that prosecuting patients and distributors who are in “clear and unambiguous compliance” with state laws did not meet that standard.

The new stance was hardly an enthusiastic embrace of medical marijuana, or the laws that allow it in some states, but signaled clearly that the administration thought there were more important priorities for prosecutors.

“It will not be a priority to use federal resources to prosecute patients with serious illnesses or their caregivers who are complying with state laws on medical marijuana,” Attorney General Eric H. Holder Jr. said in a statement accompanying the memo, “but we will not tolerate drug traffickers who hide behind claims of compliance with state law to mask activities that are clearly illegal.”

Emphasizing that it would continue to pursue those who use the concept of medical marijuana as a ruse, the department said, “Marijuana distribution in the United States remains the single largest source of revenue for the Mexican cartels,” and pursuing the makers and sellers of illegal drugs, including marijuana, will remain a “core priority.”

The new policy was tbe laszThe politics swirling around marijuana cross ideological lines. For instance, in effectively deferring to the states on some issues involving marijuana, the Obama administration is taking what could be seen as a states’ rights stance, more commonly associated with conservatives. That was a theme that echoed on many conservative and libertarian Internet sites in the wake of Monday’s announcement.

But one prominent conservative, Representative Lamar Smith of Texas, criticized the Justice Department’s position, saying it would weaken federal enforcement of drug laws.

“By directing federal law enforcement officers to ignore federal drug laws, the administration is tacitly condoning the use of marijuana in the United States,” said Mr. Smith, the senior Republican on the House Judiciary Committee. “If we want to win the war on drugs, federal prosecutors have a responsibility to investigate and prosecute all medical marijuana dispensaries and not just those that are merely fronts for illegal marijuana distribution.”

Polls have shown for years that there is widespread public support for making marijuana available to relieve the suffering of people who are very ill. But repeated efforts in Congress to block federal prosecution of medical marijuana have fallen short, and the new policy was a sharp departure from that of the Bush administration, in which the Drug Enforcement Administration raided medical marijuana distributors even if the distributors appeared to be complying with state laws.

The new policy, which reflects positions that Mr. Obama took as a presidential candidate and that Mr. Holder laid out in March, came in a memo from David W. Ogden, the deputy attorney general, to the United States attorneys in the affected states, most notably California.

The White House sought to turn aside any impression that Mr. Obama would like other states to follow the example of the 14 that make some allowance for medical marijuana.

“I’m not going to get into what states should do,” said the president’s chief spokesman, Robert Gibbs.

Mr. Gibbs said the memo to federal prosecutors “simply adds guidelines to a decision that Attorney General Holder talked about in mid-March and has been administration policy since the beginning of this administration in January.”

The guidelines give specific examples of conduct that would causes prosecutors to look at a case involving marijuana even if a user or distributor said it was for medical use. The examples include unlawful possession or use of a firearm, sales to minors and evidence of money laundering activity.

Graham Boyd, director of the Drug Law Reform Project at the American Civil Liberties Union, called the Justice Department’s move “an enormous step in the right direction and, no doubt, a great relief to the thousands of Americans who benefit from the medical use of marijuana.”

Mr. Boyd predicted that states and cities “will have a strong incentive to create regulated, safe and sensible means of getting marijuana to patients who need it.”

The new policy follows a series of changes, including the appointment of Richard Gil Kerlikowske, a former police chief of Seattle, to be Mr. Obama’s top drug policy adviser.

Medical marijuana thrived in Seattle on Mr. Kerlikowske’s watch, and advocates of more liberal marijuana laws hoped that his appointment to the office, which he assumed in May, signaled the administration’s willingness to decriminalize medical marijuana.

Some federal law enforcement officials are opposed to the administration’s position.

Privately, some federal law enforcement officials complained that medical marijuana and marijuana being smuggled in from Mexico are one and the same, and that the Obama administration has backed away from necessary enforcement of drug laws. Agents from the D.E.A. often work alongside local police officers.

As Mr. Ogden’s memo was being made public, the Web site of the Drug Enforcement Administration outlined its position on medical marijuana: “Smoked marijuana has not withstood the rigors of science — it is not medicine and it is not safe. D.E.A. targets criminals engaged in cultivation and trafficking, not the sick and dying.”

Advocates of medical marijuana say it can reduce chronic pain, nausea and additional symptoms associated with cancer and other serious illnesses. In 1996, California became the first state to make it legal to sell marijuana to people with doctors’ prescriptions. The other states that allow some use of marijuana for medical purposes are Alaska, Colorado, Hawaii, Maine, Maryland, Michigan, Montana, Nevada, New Mexico, Oregon, Rhode Island, Vermont and Washington.

3 Minnesota Pigs Confirmed With H1N1

NY Times

Three pigs at the Minnesota State Fair tested positive in late August for H1N1, the flu virus that is causing the current pandemic, the Agriculture Department reported Friday.

The department said the test results were preliminary and would not be confirmed for a few days. But if the results are confirmed, the pigs will be the first in this country found to harbor the virus. Infected pigs have been found in eight other countries.

The virus does not seem to make pigs very sick. Of 103 pigs tested at the Minnesota fair, in St Paul, only three were found to be carrying the virus, and all appeared healthy. They probably caught the virus from infected people, researchers said.

Officials at many state fairs this year worried that people would infect pigs and that reports of infected pigs would create a scare that would harm the pork industry, even though there is no risk of infection from eating cooked meat.

It is not clear what the findings mean for public health, scientists said. The virus is already spreading widely among people, and in fact is far more common in humans than in pigs, so people seem far less likely to catch it from pigs than from one another.

“It’s not surprising to find it in pigs,” said Dr. Jeff Bender, director of animal health and food safety at the University of Minnesota, who conducted the testing along with researchers from the University of Iowa. “We do know that viruses move between species.”

One concern about animals’ harboring the virus is the possibility that viruses will change as they move back and forth between species, perhaps by mixing with other viruses.

A veterinarian for the Minnesota State Fair, Dr. Tom Hagerty, was traveling on the East Coast late Friday and said he had not heard of the test findings. Dr. Hagerty sounded surprised at the news but not alarmed, because most of the pigs, or perhaps all, that were at the state fair at the same time as a group of 4-H children who became ill were to be sent to the slaughterhouse shortly afterward.

“I would be much more bothered if I heard that these had been breeding pigs,” he said.

16 October 2009

H1N1 Vaccination Poses Challenge To Health Community


The U.S. government's $6.4 billion swine flu vaccination program is likely to put the American public health sector under unprecedented strain and expose serious shortcomings, experts say.

As the first mass U.S. immunization program in a generation ramps up to deliver tens of millions of doses each week, public health experts disagree about how well the country's network of state and local health departments might perform.

But many say the sector never received the money it needed for large-scale immunizations despite years of planning for pandemics after the reemergence of bird flu in Hong Kong and South Korea in 2003.

"The worst-case scenario is that there is vaccine in a particular state or locale but that state or locale hasn't sufficiently planned to distribute it," said Leonard Marcus of the Harvard School of Public Health.

Marcus, who studied the 2005 Hurricane Katrina disaster, said the H1N1 immunization program could encounter similar breakdowns in leadership and coordination wherever local public health systems are underfunded or poorly managed.

"Some bureaucrat is going to say he doesn't have authority or needs a signature and it's going to stop the system from moving. That could very well cause panic," he said in a telephone interview.

Experts give the Obama administration high marks for creating a program capable of procuring 250 million doses and distributing them to 90,000 sites nationwide so that every American who wants the vaccine can get it.

The government has ordered vaccine from five companies -- Sanofi-Aventis SA, CSL Ltd, Novartis AG, GlaxoSmithKline and the AstraZeneca unit MedImmune.


Bob Hutchens, a vaccine distribution expert with consulting firm Booz & Co, expects overall success.

"There will be some long lines, there may need to be some late hours and people may not be able to get it the day they want it," he said. "But if we approach this soundly and rationally, I suspect we'll be just fine."

But with the United States struggling to recover from an economic recession, staffing could be an issue.

Local health departments eliminated 8,000 positions in the first half of this year, after 7,000 job cuts in 2008, according to the National Association of County and City Health Officials. Another 12,000 employees have been subjected to reduced hours or mandatory furloughs this year.

The Association of State and Territorial Health Officials says three-quarters of states have cut public health funding this year, while 61 percent expect smaller budgets in 2010. Seven states have cut back specifically on immunization.

Layoffs have targeted people needed for the H1N1 program -- nurses, nurse's aides and switchboard operators and receptionists who would help field public queries.

"The problem is that there's a big rusty faucet at the end of the vaccine pipeline," said the University of Minnesota's Michael Osterholm, who warns public fears could flare quickly if H1N1 overwhelms hospitals and their intensive care units.

A poll by the American College of Emergency Physicians says almost 90 percent of emergency room doctors worry hospitals could have a hard time responding to a surge in H1N1 flu.

"Public health is the life raft," Osterholm said. "But are they big enough to get everybody on board and how will they navigate those rough waters?"

Experts were careful not to criticize the caliber of public health staff, widely respected for their energy and devotion.

But they said meager resources, combined with the scale and speed of the national immunization program, will bring unprecedented strains.


That could mean bad news for 46 million Americans with no health insurance, who could flood public health offices where vaccinations will be free.

"It could overload some systems in terms of staffing and frayed nerves," Hutchens said.

The Obama administration has sought to smooth the program's path by giving health departments and hospitals $1.4 billion to help plan and implement the vaccination effort, including the hiring of additional staff and contractors.

"We can't do this ourselves," said Fran Phillips, deputy secretary of Maryland's public health services, whose staff has assembled 3,000 private vaccinators to supplement two-dozen local public health departments. Maryland has received $24 million in federal grants to help with the effort.

Preparations appear to be less uniform in states like Michigan, where much of the authority rests with local health departments. Michigan received $34 million in federal money.

"They're really in the process right now of utilizing the funds, hiring folks or contracting with vaccinators," said Dr. Eden Wells of the Michigan Department of Community Health.

"It's too early to make a judgment about whether the (federal) money is enough."

14 October 2009

Dialysis Machines On The Go

Story from the Economist

DIALYSIS is not as bad as dying, but it is pretty unpleasant, nonetheless. It involves being hooked up to a huge machine, three times a week, in order to have your blood cleansed of waste that would normally be voided, via the kidneys, as urine. To make matters worse, three times a week does not appear to be enough. Research now suggests that daily dialysis is better. But who wants to tied to a machine—often in a hospital or a clinic—for hours every day for the rest of his life?

Victor Gura, of the University of California, Los Angeles, hopes to solve this problem with an invention that is now undergoing clinical trials. By going back to basics, he has come up with a completely new sort of dialyser—one you can wear.

A traditional dialyser uses around 120 litres of water to clean an individual’s blood. This water flows past one side of a membrane while blood is pumped past the other side. The membrane is impermeable to blood cells and large molecules such as proteins, but small ones can get through it. Substances such as urea (a leftover from protein metabolism) and excess phosphate ions therefore flow from the blood to the water. The good stuff, such as sodium and chloride ions, stays in the blood because the cleansing water has these substances dissolved in it as well, and so does not absorb more of them.

Both water and blood require a lot of pumping. Those pumps are heavy and need electrical power. The first thing Dr Gura did, therefore, was dispose of them. The reason for using big pumps is to keep dialysis sessions short. If machines are portable that matters less. So Dr Gura replaced the 10kg pumps of a traditional machine with small ones weighing only 380 grams. Besides being light, these smaller pumps use less power. That means batteries can be employed instead of mains electricity—and modern lithium-ion batteries, the ones Dr Gura chose, are also light, and thus portable.

To reduce the other source of weight, the water, Dr Gura and his team designed disposable cartridges containing materials that capture toxins from the cleansing water, so that it can be recycled. The upshot is a device that weighs around 5kg and can be strapped to a user’s waist. Indeed, at a recent demonstration in London, one patient was able to dance while wearing the dialyser—for joy, presumably, at no longer having to go to hospital so often.

13 October 2009

Pfizer Suspends Lung Cancer Study

Story from Forbes

The news is another setback for Pfizer as it makes a big push into cancer drugs.

Pfizer has stopped entering new patients into the most advanced clinical trial of its experimental lung cancer drug because those who received it were more likely to suffer serious side effects and die.

The conclusions are not definitive. Patients enrolled in the study will continue to get the drug, figitumumab. Another phase three trial testing figitumumab with Tarceva, made by Roche and OSI Pharmaceuticals, will continue. A third late-stage trial of the drug has not yet started.

But the news is another setback for Pfizer as it makes a big push into cancer drugs, an effort that led it to create a new business unit and push more than a dozen experimental medicines into human testing. GlaxoSmithKline and AstraZeneca have been making a similarly broad push into developing such medicines.

One trial of Sutent, Pfizer's marketed cancer pill, failed in April to help breast cancer patients better than Xeloda, another pill developed by Roche. A clinical trial of axitinib, a drug that Pfizer had high hopes for in pancreatic cancer, was stopped because it was unlikely to show a benefit for the disease. Cancer remains one of the hottest areas for research at Pfizer, which is struggling to come up with new drugs as it faces the patent expiration of its cholesterol-lowerer Lipitor, the biggest drug ever, in a year. Pfizer is also in the midst of closing its $60 billion acquisition of rival Wyeth.

Figitumumab should be an especially promising entrant. It is an antibody designed to block the insulin-like growth factor 1. John Mendelsohn, president of M.D. Anderson Cancer Center and co-inventor of Erbitux, sold by Eli Lilly and Bristol-Myers Squibb, has called it "the second big pathway that seems to be important for growth in many cancer cells," after the epidermal growth factor (EGF) pathway targeted by Erbitux and Tarceva, made by Roche and tiny OSI Pharmaceuticals.

Merck is in the midst of testing its own IGF-1 drug in colon cancer, but Pfizer had been in the lead with its lung cancer studies. But the current study tested as a first choice in the patients who shouldn't get Roche's Avastin because of their difficult types of tumors.

Pfizer says an independent Data Safety Monitoring Committee took a routine look at the results for the trial and found that patients who were receiving figitumumab with carboplatin and Taxol were experiencing more "serious adverse events, including fatalities" than those who were getting carboplatin and Taxol alone. The decision was made to stop entering new patients in the trial. Pfizer and the committee will conduct "a thorough review."

The news of the cancellation was first reported on the blog of Sally Church, a management consultant to the pharma and biotech industry.

12 October 2009

FDA Grants Approval For Kidney-Cancer Drug

Story from the Wall Street Journal

A Food and Drug Administration panel Monday unanimously backed a proposed GlaxoSmithKline PLC drug for treating kidney cancer, despite agency concerns about a risk of severe liver injury.

Glaxo is seeking FDA approval of the drug, pazopanib, to treat patients with advanced kidney cancer. The product was reviewed by outside medical experts who serve on the agency's oncologic drugs advisory committee.

The panel voted 10-0 in favor of whether the benefit-to-risk profile was acceptable for the treatment of patients with advanced kidney cancer. The vote amounts to a recommendation that the FDA approve pazopanib. The FDA has an Oct. 19 deadline to act on pazopanib's application.

If approved, the drug would be sold under the brand name Votrient.

An FDA staff review of pazopanib said the product was associated with a risk of severe liver injury and questioned whether the drug should be approved given that similar drugs are on the market.

Pazopanib, a tablet taken orally, works by attacking a protein involved with cancer tumor growth and blood vessels that help tumors grow.

It falls into the same class of other targeted cancer drugs approved for use in kidney cancer like Pfizer Inc.'s Sutent and Nexavar, marketed by Bayer Pharmaceuticals Corp. and Onyx Pharmaceuticals Inc. The FDA has approved five kidney-cancer treatments since December 2005, including Sutent and Nexavar.

The FDA said pazopanib appeared to work equally as well as Sutent and Nexavar.

The FDA said there were three deaths seen in clinical trials of pazopanib from liver injury that were "related to or associated with pazopanib." The agency's scientists said the "findings strongly suggest that pazopanib may be associated with a significant risk of severe idiosyncratic hepatic injury if used in a larger population."

But panel members, who included experts in liver injury, said it wasn't clear if the three deaths were from drug-induced liver injury.

During the panel meeting, representatives from GlaxoSmithKline noted that the other cancer drugs have different side effects, making some drugs better for some patients than others, a view backed by the FDA panel.

10 October 2009

Virus May Be Responsible For Chronic Fatigue

From the NY Times

Many people with chronic fatigue syndrome are infected with a little known virus that may cause or at least contribute to their illness, researchers are reporting.

The syndrome, which causes prolonged and severe fatigue, body aches and other symptoms, has long been a mystery ailment, and patients have sometimes been suspected of malingering or having psychiatric problems rather than genuine physical ones. Worldwide, 17 million people have the syndrome, including at least one million Americans.

An article published online Thursday in the journal Science reports that 68 of 101 patients with the syndrome, or 67 percent, were infected with an infectious virus, xenotropic murine leukemia virus-related virus, or XMRV. By contrast, only 3.7 percent of 218 healthy people were infected. Continuing work after the paper was published has found the virus in nearly 98 percent of about 300 patients with the syndrome, said Dr. Judy A. Mikovits, the lead author of the paper.

XMRV is a retrovirus, a member of the same family of viruses as the AIDS virus. These viruses carry their genetic information in RNA rather than DNA, and they insert themselves into their hosts’ genetic material and stay for life.

“I think this establishes what had always been considered a psychiatric disease as an infectious disease,”

Dr. Mikovits and other scientists cautioned that they had not yet proved that the virus causes the syndrome. In theory, people with the syndrome may have some other, underlying health problem that makes them prone to being infected by the virus, which could be just a bystander. More studies are needed to explain the connection.

But Dr. Mikovits said she thought the virus would turn out to be the cause, not just of chronic fatigue, but of other illnesses as well. Previous studies have found it in cells taken from prostate cancers.

“I think this establishes what had always been considered a psychiatric disease as an infectious disease,” said Dr. Mikovits, who is research director at the Whittemore Peterson Institute in Reno, a nonprofit center created by the parents of a woman who has a severe case of the syndrome. Her co-authors include scientists from the National Cancer Institute and the Cleveland Clinic.

Dr. Mikovits said she and her colleagues were drawing up plans to test antiretroviral drugs — some of the same ones used to treat HIV infection — to see whether they could help patients with chronic fatigue. If the drugs work, that will help prove that the virus is causing the illness. She said patients and doctors should wait for the studies to be finished before trying the drugs.

Dr. William Schaffner, an infectious disease expert at Vanderbilt University, said the discovery was exciting and made sense.

“My first reaction is, ‘At last,’ ” Dr. Schaffner said. “In interacting with patients with chronic fatigue syndrome, you get the distinct impression that there’s got to be something there.”

He said the illness is intensely frustrating to doctors because it is not understood, there is no effective treatment and many patients are sick for a long time.

He added, “This is going to create an avalanche of subsequent studies.”

09 October 2009

Food Tracking: From The Barnyard To Your Table

From the Economist

Bar codes that let shoppers trace their food back to the field

DESPITE its preoccupation with hygiene, America’s dirty secret is that it is one of the most dangerous places in the developed world to eat. Every year 76 million Americans become ill because they have consumed contaminated food—a staggering 26,000 cases per 100,000 population. In Britain, where people consume far fewer hamburgers, generally eat out less often and buy nowhere near as many ready-meals, there are 3,400 cases of food poisoning per 100,000 population annually. France is safer still, with only 1,200 annual instances per 100,000 people.

Most cases of food poisoning are mild, with victims recovering in a day or two. Sometimes, however, foodborne illnesses kill or cause permanent health problems. In the United States around 5,000 people die and a further 325,000 wind up in hospital each year as a result of food poisoning. The annual cost to the country, in medical treatment and lost productivity, is more than $35 billion.

The wave of food scares that has swept America over the past few years has caused a crisis in the country’s $1 trillion food industry. One of the most notorious outbreaks, caused by the virulent Escherichia coli O157:H7 bacterium, happened in 1993. Four children died, dozens of people went to hospital with kidney failure and hundreds more became seriously ill after eating undercooked hamburgers from the Jack-in-the-Box chain of restaurants. Since then, the regulations governing the sale of ground beef have been tightened considerably.

The deadliest foods to be found on the stalls in street markets and the shelves of supermarkets, though, are not meat or poultry but leafy vegetables and fruit. That is because unlike ground beef, which is cooked at a temperatures which destroy bugs, fruit and leafy vegetables tend to be eaten raw. The outbreak of O157 in 2006, which killed five people and made a further 205 ill, was tied to raw spinach. Meanwhile, America’s largest epidemic of foodborne disease in over a decade—last year’s Salmonella infection that claimed two lives, hospitalised 250 people and affected more than 1,300 others—was traced back through the supply chain initially to tomatoes and then to jalapeƱo peppers. Now there are doubts whether either was really to blame.

Tracking down the source of a foodborne infection is notoriously difficult. The vast majority of incidents are transitory in nature—a leaky toilet, a wandering animal, a momentary lapse of hygiene in the field or factory. But mounting concern about this lack of traceability has prompted the food industry itself, as well as the American government, to take action.

In October 2007 producers in the United States and Canada joined forces to launch a plan called the Produce Traceability Initiative. This uses bar-codes to track fruit and vegetables through the distribution system. Although participation in this particular plan is voluntary, it may soon become compulsory to provide traceability of some sort.

That is because lawmakers on Capitol Hill want to give the Food and Drug Administration (FDA) sweeping new powers to oversee food production. A bill introduced in the House of Representatives by John Dingell, a Democratic congressmen from Michigan, was passed in July, though it has yet to be taken up by the Senate. But with the White House, the food industry and the FDA behind it, the bill could be law before the end of the year. If it is, then companies selling food in America will have to adopt a tracking system that can identify the farmer, the field, the picker, the packer, the shipper, the wholesaler and the shop—all within two business days of a case of food poisoning being reported.

The technology for doing so is readily available. Radio-frequency identification (RFID) tags used for tracking items like shipping containers and pallets of goods have been around for years. The attraction of these tiny passive chips, which emit a stream of digital data only when energised by a radio beam, is that it is not necessary to see a tag to read it.

Unfortunately, though simple RFIDs cost less than 30 cents apiece, they are still way too expensive for tagging a bag of cut lettuce or a bunch of grapes. By contrast, the bar-codes printed on supermarket products cost less than half a cent each. Their disadvantage is that they have to be scanned physically by a line-of-sight reading device. It is also tricky to capture the data in the field and stick the bar-code labels on the produce as it is picked and packed. Managing the supply-chain database is no trivial matter either.

The Consumers Union, which campaigns on behalf of individual customers, wants Congress to require food producers to use an electronic tracking system like the one Federal Express employs for parcels. But tracking produce is not that simple. A parcel delivered by Federal Express, or any other courier service, stays under one firm’s control all the way. By contrast, a bunch of grapes travels from the farm to a packer, to a shipping centre, to a warehouse, to a shop and finally to a consumer’s fridge. Each stage is handled by a different organisation with a different way of doing things.

That has created opportunities for new firms like YottaMark of Redwood City, California, and FoodLogiq of Durham, North Carolina. Both have developed sophisticated software for tracing the origin and freshness of food. If their technology is deployed, the next time a big food scare occurs, the damage done to consumers and producers alike should be far more easily contained.

But apart from safety, the new traceability software should also allow packers and shippers to combine their tracking functions with marketing exercises. Both YottaMark and FoodLogiq offer systems that let shoppers type a text code into a mobile phone or home computer, or scan a bar-code using a phone’s built-in camera, to find out when the tomatoes on the shelf were picked and which field they came from.

That can be an attractive proposition for producers. YottaMark’s traceability label (“HarvestMark”) has been attached to almost a billion food items so far. What the food industry has learned in the process is that it not only gives consumers the confidence to buy, but also builds customer loyalty and trust in a particular brand, a region and even an individual producer. Some 85% of consumers polled by YottaMark said that, all things being equal, they would choose a traceable item over an untraceable one.

Bringing the farmer electronically into the kitchen this way can make the experience of buying produce as personal as shopping in a local farmer’s market—but with a far wider range of products to choose from. As Elliott Grant of YottaMark observes, marketing foodstuffs these days is becoming more a matter of “locale” and less about being merely “local”.

08 October 2009

FDA OK's Wider Use Of HIV Drug From Pfizer

From Business Week

Federal health advisers said Thursday that Pfizer's HIV drug Selzentry should be approved for use by patients who have not already taken other drugs to combat the virus.

The Food and Drug Administration's panel of virus experts voted 10-4 in favor of the new use, despite some inconsistency in company studies of the drug. Selzentry is approved as a secondary option for HIV patients who are not responding to other antiviral drugs. New York-based Pfizer is asking the FDA to approve the drug as an initial treatment.

Pfizer's initial study comparing Selzentry with Bristol-Myers Squibb's Sustiva failed to meet the goal of showing it was at least as effective at suppressing HIV.

But when Pfizer reanalyzed the results using a different test to screen patients, the study met its goal.

FDA reviewers raised concerns about higher levels of viral activity in patients taking Selzentry compared with Sustiva. About 32 percent of patients did not adequately respond to Pfizer's drug, compared with 24 percent of patients taking the alternative.

A majority of panelists ultimately said the drug works and should be made available as an option for patients, though they expressed lingering concerns about the strength of its effect.

"It's clearly an active drug, it demonstrated effectiveness," said Dr. Russell Van Dyke, of the Tulane University School of Medicine. "But I'm worried it's not as potent as we might like."

Other panelists said they were not comfortable backing a product that could be inferior to drugs already on the market.

"There's a lot that's promising about this drug, but this trial doesn't convince me," said Dr. Barbara McGovern, of Tufts University Medical School.

Panelists said Pfizer should continue collecting data on the drug's effectiveness, particularly in minority populations.

The FDA is not required to follow the advice of its panels, though it usually does.

Selzentry is part of a recently developed class of treatments that block HIV from entering white blood cells through a pathway present in some patients. While more than 1 million people in the U.S. are HIV positive, only a subset of that group respond to Pfizer's pill. The drug works by blocking the so-called CCR5 receptor.

HIV attacks the body's immune system, eventually causing AIDS.

Pfizer said the meeting "marks an important step in expanding available treatment options for patients with HIV infection."

Selzentry had sales of $46 million last year, according to Pfizer.

07 October 2009

Meat Inspection Needs Beefing Up

From NY Times

Stephanie Smith, a children’s dance instructor, thought she had a stomach virus. The aches and cramping were tolerable that first day, and she finished her classes.

Then her diarrhea turned bloody. Her kidneys shut down. Seizures knocked her unconscious. The convulsions grew so relentless that doctors had to put her in a coma for nine weeks. When she emerged, she could no longer walk. The affliction had ravaged her nervous system and left her paralyzed.

Ms. Smith, 22, was found to have a severe form of food-borne illness caused by E. coli, which Minnesota officials traced to the hamburger that her mother had grilled for their Sunday dinner in early fall 2007.

“I ask myself every day, ‘Why me?’ and ‘Why from a hamburger?’ ”Ms. Smith said. In the simplest terms, she ran out of luck in a food-safety game of chance whose rules and risks are not widely known.

Interactive: Anatomy of a Burger.

Meat companies and grocers have been barred from selling ground beef tainted by the virulent strain of E. coli known as O157:H7 since 1994, after an outbreak at Jack in the Box restaurants left four children dead. Yet tens of thousands of people are still sickened annually by this pathogen, federal health officials estimate, with hamburger being the biggest culprit. Ground beef has been blamed for 16 outbreaks in the last three years alone, including the one that left Ms. Smith paralyzed from the waist down. This summer, contamination led to the recall of beef from nearly 3,000 grocers in 41 states.

Ms. Smith’s reaction to the virulent strain of E. coli was extreme, but tracing the story of her burger, through interviews and government and corporate records obtained by The New York Times, shows why eating ground beef is still a gamble. Neither the system meant to make the meat safe, nor the meat itself, is what consumers have been led to believe.

Ground beef is usually not simply a chunk of meat run through a grinder. Instead, records and interviews show, a single portion of hamburger meat is often an amalgam of various grades of meat from different parts of cows and even from different slaughterhouses. These cuts of meat are particularly vulnerable to E. coli contamination, food experts and officials say. Despite this, there is no federal requirement for grinders to test their ingredients for the pathogen.

Stephanie Smith was in a coma for nine weeks after being infected with E. coli.

The frozen hamburgers that the Smiths ate, which were made by the food giant Cargill, were labeled “American Chef’s Selection Angus Beef Patties.” Yet confidential grinding logs and other Cargill records show that the hamburgers were made from a mix of slaughterhouse trimmings and a mash-like product derived from scraps that were ground together at a plant in Wisconsin. The ingredients came from slaughterhouses in Nebraska, Texas and Uruguay, and from a South Dakota company that processes fatty trimmings and treats them with ammonia to kill bacteria.

Using a combination of sources — a practice followed by most large producers of fresh and packaged hamburger — allowed Cargill to spend about 25 percent less than it would have for cuts of whole meat.

Those low-grade ingredients are cut from areas of the cow that are more likely to have had contact with feces, which carries E. coli, industry research shows. Yet Cargill, like most meat companies, relies on its suppliers to check for the bacteria and does its own testing only after the ingredients are ground together. The United States Department of Agriculture, which allows grinders to devise their own safety plans, has encouraged them to test ingredients first as a way of increasing the chance of finding contamination.

Unwritten agreements between some companies appear to stand in the way of ingredient testing. Many big slaughterhouses will sell only to grinders who agree not to test their shipments for E. coli, according to officials at two large grinding companies. Slaughterhouses fear that one grinder’s discovery of E. coli will set off a recall of ingredients they sold to others.

“Ground beef is not a completely safe product,” said Dr. Jeffrey Bender, a food safety expert at the University of Minnesota who helped develop systems for tracing E. coli contamination. He said that while outbreaks had been on the decline, “unfortunately it looks like we are going a bit in the opposite direction.”

Food scientists have registered increasing concern about the virulence of this pathogen since only a few stray cells can make someone sick, and they warn that federal guidance to cook meat thoroughly and to wash up afterward is not sufficient. A test by The Times found that the safe handling instructions are not enough to prevent the bacteria from spreading in the kitchen.

Read Entire Article at the NY Times

H1N1 Questions Receiving Answers

Story from CNN Health

For 13-year-old Brandon Marti, the intranasal vaccine felt "good," "cold" and "watery" at the Children's Hospital at Montefiore in the Bronx, New York, on Tuesday.

Marti, among the first to get vaccinated against the novel H1N1 influenza virus this week, said he would tell his friends and classmates that "the swine flu vaccine is good, and protects me from getting the swine flu."

New York has received a shipment of 68,000 doses of the FluMist variety vaccine. This form was made available before the injectable kind because it was ready first, said Thomas Skinner, spokesperson for the Centers for Disease Control and Prevention.

As states across the country receive and distribute the vaccine, questions still linger about who should get it and why. Here are some guidelines:

Nathan Stein, 7, participated in a clinical trial for the H1N1 vaccine over the summer.

Where is the vaccine?

The campaign to inoculate millions of Americans against H1N1 flu began Monday. Every state is developing a vaccine delivery plan, according to the CDC.

All states in the United States have ordered vaccine, said Dr. Thomas Frieden, director of the CDC, at a briefing Tuesday. Each Friday, the CDC will provide information about how much vaccine is available to states and how much has been ordered. So far, about 2.2 million doses out of the available 2.4 million have been ordered, he said.

The vaccine is being made available as soon as it comes off the production line, Frieden said. This week the intranasal mist variety, called FluMist, became available, and next week the injectable form will made available, he said.

Frieden acknowledged that these first few weeks will be "bumpy" in terms of distributing the vaccine, and that demand is currently greater than supply. However, he expects that supply will soon outstrip demand.

"It will take some time to get the whole system, from the manufacturer through the distributor to the providers and to people who want to get vaccinated, up and running," he said.

Who should get it?

The CDC recommends that specific groups of people get vaccinated first, but there are no rankings within the priority groups, Frieden said.

The nasal spray version of the vaccine should be used only in people 2 to 49 and who do not have an underlying health problem, Frieden said. The priority groups for it include health care workers, children and people who care for infants, he said. Pregnant women should not have the FluMist version because it contains the live virus.

Health care and emergency medical services personnel should be in the priority group because vulnerable patients could potentially contract the flu from them, the CDC said. Already, infections among health care workers have been reported, and the health care system capacity could become significantly lowered if large numbers of these workers are absent, the CDC said.

Once the injectable shot becomes available, all priority groups should be vaccinated, the CDC said. These include pregnant women, because they are at higher risk of complications and may be able to provide protection to unvaccinated infants. People from 6 months to 24 years old should also receive the vaccine, and people from 25 to 64 should get it they have a chronic health disorder or a compromised immune system, the CDC said.

According to a CNN/Opinion Corp. poll in late August, two-thirds of Americans said they plan to be vaccinated against H1N1 flu.

Does anyone have to get it?

There are no formal penalties for those who do not get the vaccine, but people in the military are required to receive it, according to the American Forces Press Service. The state government of New York has said that health care workers must get the vaccine, although no law outlines penalties for noncompliance. Still, some workers fear they'll lose their jobs if they don't get vaccinated.

How many doses do you need?

For people 10 and older, the U.S. Food and Drug Administration has approved the use of one dose of the vaccine. For children 9 and younger, two doses may be required, Frieden said. The CDC recommends that three to four weeks pass between the first and second dose.

What if the virus mutates?

The virus has not changed much since the spring, Frieden said. In fact, the part of the virus that determines whether it's very deadly is different from the part that determines whether the vaccine will fight against it, he said, meaning that vaccination will still most likely offer protection even if the H1N1 flu becomes more deadly.

Why should you get it?

Frieden said the flu can range from mild to severe. It can make a person sick for one, two or three days, leading to absence from school or work, and some people may even need hospitalization. "Tragically, some people may die from it," he said. Still, it is not a disease that sends a lot of people to the hospital, he said.

The vaccine is also safe, Frieden said. The novel flu vaccine is made in the same production facilities by the same companies with the same methods as the seasonal flu vaccine, and it is the same kind of vaccine that has been given each year, he said. His own children will get it, as will the families of other public health experts, he said.

Some people are concerned that it is too late to get vaccinated against the novel virus, but Frieden also dismissed this.

"It's too soon to say it's too late because we don't know what the rest of the season will bring," he said.

Hospitals Learning: Better Care Is Cheaper Care

Story from the Wall Street Journal

Be it cereal or cars, buyers usually have an idea of how good the products are and how much they cost before they buy them.

That's not how U.S. health care works. Patients rarely know which hospitals offer top-quality lung or aortic surgery, and which are more likely to harm them. Hospitals don't compete on price and rarely publish measurements of their quality, if they measure it at all.

Except in Pennsylvania. For two decades, a state agency has published "medical outcomes" -- death and complication rates -- from more than 50 types of treatments and surgery at hospitals. The state has found that publishing results can prompt hospitals to improve, and that good medical treatment is often less expensive than bad care.

One reason is that high-quality treatment usually results in shorter hospital stays and fewer readmissions. The state has had less success in publishing hospital prices and has drawn criticism from hospitals that disagree with its reporting methods. But companies or unions in Pennsylvania that have agreed to work only with the best-performing hospitals say they have been able to drive down medical costs.

"High-quality care costs less -- always," says David B. Nash, a medical-quality expert and dean at Thomas Jefferson University's School of Population Health in Philadelphia. "If the federal government could behave like a savvy shopper, that would change the health-cost game overnight. But the government is a bill payer, not a savvy shopper."

Walter McClure, who helped spark Pennsylvania's efforts, was an early advocate of publicizing medical outcomes and fostering competition among hospitals.

The Senate Finance Committee could vote late this week on its sweeping health bill, seen as the backbone for any final legislation. That bill would make available $75 million annually for the U.S. Department of Health and Human Services to develop methods of improving quality, including potentially publishing outcomes.

Although at times premium care can be exorbitant, there's evidence some in Pennsylvania saved money using top-rated hospitals. Hershey Co. offered workers medical coverage based on the state agency's reported outcomes, and cut the company's expenses by 50% over several years. The Philadelphia police union's benefits-management company says it uses the state reports to steer officers to the best hospitals; as a result, it say its costs fall about 17% below those of comparable plans.

Tom Lamb, administrator of Philadelphia police health benefits, says he frequently explains to members why they should go to hospitals with better outcomes. "If an officer's 7-year-old daughter has to go in for surgery," he says, "I'll sit down with the father and say, 'Are you just going to shake your head yes when your pediatrician wants to send her to his golfing buddy?' "

Quality Ratings

The Delaware Valley Health Care Coalition, a group of union and municipal health funds covering 1.3 million people, is beginning the process of picking about 20 hospitals based on the state's quality ratings. Capital BlueCross in Harrisburg has designed a plan that selects hospitals based on the reports. Mark Dever, benefits manager at Duquesne Light in Pittsburgh, says his company recently got an offer from a hospital chain to treat the company's workers. But after reviewing state quality data and comparing prices, he rejected it.

An August 2008 study in the American Journal of Medical Quality reported that Pennsylvania in-hospital odds of death were 21% to 41% lower than those in other states. The research focused on heart attacks, congestive heart failure, brain hemorrhage, stroke, pneumonia and septic infections.

The Obama administration is allotting $1 billion for research to compare effectiveness of medical treatments. Some hope comparing hospital outcomes will be part of that. "As a patient," says Michael Pine, who runs a medical quality-measuring business in Chicago, "I would generally be more interested in whether Hospital A or Hospital B gets better results, more than whether drug A is more effective than surgery."

The theory underlying the Pennsylvania program is that, to create a truly competitive health-care market, consumers need hard information showing which hospitals perform better.

Curbing Infections

For example, Pennsylvania three years ago published its first report on hospitals' infection rates that arise largely from intravenous catheters and tubes left in too long. Infection numbers the following year fell 7.8%, as hospitals responded with steps designed to lower infections.

The average payment in 2006 for hospitalization where a patient acquired an infection was $53,915; with no infection, the average payment was $8,311, according to state reports.

By simply getting rid of preventable infections, Pennsylvania estimates its hospitals could lower expenses by nearly $1 billion.

Where are the insurance companies? They are the major payers. They should be driving this data collection and management of the system.

The White House is looking at publishing information possibly including medical outcomes as part of overhaul efforts, officials say. Quality data could also be used in existing programs. "There is a clear understanding from the Obama administration that both Medicare and Medicaid need to move in the direction of what's happening in Pennsylvania," says Jonathan Blum, director of the government's Center for Medicare Management.

The Philadelphia police health fund benefit-management company, covering 26,000 people, adopted a plan pegged to the state's hospital-quality results seven years ago. Mr. Lamb says the police fund has saved as much as $5 million a year using the information.

Sent Home

One retired Philadelphia police officer benefited from the state reports in an unusual way -- by learning he didn't need the coronary angioplasty he had been prescribed. Ed Gillespie, of Cape May, N.J., says he was told by his doctor six years ago that he needed angioplasty to clear out heart arteries. After consulting with Mr. Lamb, he learned state reports showed good results at Jefferson Medical College in Philadelphia. He decided to go there.

While he was on the gurney awaiting angioplasty, his cardiologist asked colleagues to study the films more carefully -- and concluded he could go home without treatment, Mr. Gillespie recalls. "I get checked every year, and I've been OK," he says.

Pennsylvania's agency -- called the Pennsylvania Health Care Cost Containment Council, or PHC4 -- has its critics. Hospitals have complained its data are imprecise or unnecessary.

P.J. Brennan, chief medical officer of the University of Pennsylvania Health System, says that PHC4 reports -- even though they are adjusted for certain risk factors -- still aren't comprehensive enough to take into account the very sickest patients, the sort treated at academic medical centers. "These reports are very important for transparency, but I don't think you can look at a PHC4 report and conclude you should not go to that hospital," he says.

In the state's most recent report, the Hospital of the University of Pennsylvania performed well in many categories but had worse-than-expected death rates in treating septicemia, or blood infections.

State legislators have tentatively cut the PHC4's budget to $2.8 million this year from $5.4 million in 2008, largely because of a state deficit.

The program got its start in the 1980s. Alarmed by health-cost inflation, business and labor leaders sought out Walter McClure, a Minnesotan who had pioneered a medical-quality program. Dr. McClure, who has a Ph.D. in physics, made a presentation to the Pennsylvania Business Roundtable in 1985.

Dr. McClure called on the executives to foment competition among hospitals. "We used to say to a patient, 'Go anywhere, regardless of cost, and we will pay the bill,' " he said in his speech. "Quality was assumed. That was dumb."

In 1986, Pennsylvania legislators created the PHC4. Three years later, the agency published its first report comparing death rates at about 180 hospitals.

Hahnemann University Hospital in Philadelphia fared poorly at first on several quality measures. Its ratings were significantly "worse than expected" on eight of 55 procedures in the first PHC4 "Hospital Effectiveness Report." The report included data for July 1, 1989, to June 30, 1990.

John Russell, then president of the Hospital Association of Pennsylvania, says Hahnemann and others complained, but "within about six weeks, they cleaned up their act." In the second Hospital Effectiveness Report, Hahnemann improved its ratings on seven of the eight procedures. The hospital declined to comment.

PHC4's first report on infections in 2006 showed Hamot Medical Center in Erie with a relatively high infection rate, in part because the hospital was early to use computers to track such rates. Emily McCracken, the hospital's epidemiologist, says the report "put a spotlight on something that needed a spotlight."

The hospital has since lowered the infection rate by about 20% by cleaning IV catheters more often and removing them earlier.

Care Disparities

Over the years, PHC4 sought a wider variety of data and started producing reports on infection rates, readmissions and lengths of stay due to complications. The reports revealed startling disparities among hospitals and even individual doctors.

The hospital-performance reports use data compiled from medical records. Results are "risk adjusted," meaning the agency collects laboratory and medical-chart information about the age and overall health of patients so hospitals taking on difficult cases won't be unduly penalized.

The agency estimates the cost to the state's 172 acute-care hospitals of collecting the data annually is $7 million. The state's hospital association says it is $10 million or more.

The state agency hasn't been as successful in obtaining the prices that insurers pay to hospitals, information that would be important because it would allow patients and payers to factor in prices when choosing hospitals. The agency has legal power to get that information from insurers and publish it, but it has done so only for heart surgery. An agency spokesman says insurers didn't refuse, and that lack of manpower at the agency explains this omission. One person familiar with the events says many insurers wouldn't divulge prices.

Hershey came to rely on the state's hospital reports. In the early 1990s, medical costs for its 15,000 workers and dependents were soaring. "I told the human-resources department we needed to do something," says then-Chief Executive Richard Zimmerman.

Richard C. Dreyfuss, compensation and benefits manager, and his boss, William Lehr Jr., scrutinized the state's data for 23 hospitals. Mr. Dreyfuss ranked hospitals based 70% on medical outcomes and 30% on hospital prices, which the company obtained from insurers on its own. He focused on 21 costly procedures such as heart bypass and diabetes care.

Cost Correlation

Results shocked him. "The correlation between cost and quality was zero," he says. "You go in thinking that all hospitals are pretty much equal, but this was eye-opening. Generally, higher-cost hospitals had poorer outcomes."

Mr. Dreyfuss devised a plan called Health Styles in which only 10 hospitals would be included -- and 13 left out. Employees had other plans to choose from, but Health Styles was cheaper than the relatively inexpensive health maintenance organizations Hershey offered, Mr. Dreyfuss says.

The 13 excluded hospitals weren't happy -- especially the highly regarded Penn State University's Milton S. Hershey Medical Center, founded by the family that created the chocolate company.

C. McCollister Evarts, dean of the hospital's medical school, told Messrs. Dreyfuss and Lehr that the state agency's information was wrong and "you don't understand what an academic medical center does," Messrs. Dreyfuss and Lehr recall.

Dr. Evarts confirms his remark and says he believes such measurements have become far more precise over the years. In recent years, Hershey Medical was reinstated under the company's plans. The hospital declined to comment.

The Health Styles plan took effect in 1994. About 40% of employees in central Pennsylvania signed up. The company, which was self-insured, was able to hold its medical-care cost increases annually to 4%, about half the national rate, saving about $10 million in the first five years. "This thing was a real winner," says Mr. Dreyfuss. He and other former Hershey executives say the company cut its annual medical expense by 50% for several years.

Dennis Bomberger, business manager of Chocolate Workers Local 464, says Hershey's Health Styles "was an excellent plan" that "employees liked the best."

The plan was discarded two years ago, however, when a new Hershey management team changed health coverage, Mr. Bomberger says. A Hershey spokesman declined to comment.

Former Hershey vice president Mr. Lehr is now chairman and chief executive of Capital BlueCross, where he has installed a plan for customers that would use PHC4 data to select hospitals. He would like to see hospital-quality information available across the country. "I would ask officials in Washington to push for mandatory compiling of medical data."