30 December 2009

The Future Of Brain-Controlled Devices


In the shimmering fantasy realm of the hit movie "Avatar," a paraplegic Marine leaves his wheelchair behind and finds his feet in a new virtual world thanks to "the link," a sophisticated chamber that connects his brain to a surrogate alien, via computer.

This type of interface is a classic tool in gee-whiz science fiction. But the hard science behind it is even more wow-inducing.

Researchers are already using brain-computer interfaces to aid the disabled, treat diseases like Parkinson's and Alzheimer's, and provide therapy for depression and post-traumatic stress disorder. Work is under way on devices that may eventually let you communicate with friends telepathically, give you superhuman hearing and vision or even let you download data directly into your brain, a la "The Matrix."

Researchers are practically giddy over the prospects. "We don't know what the limits are yet," says Melody Moore Jackson, director of Georgia Tech University's BrainLab.

Adds Emory University neuroscience professor Michael Crutcher, "Anything can happen."

At the root of all this technology is the 3-pound generator we all carry in our head. It produces electricity at the microvolt level. But the signals are strong enough to move robots, wheelchairs and prosthetic limbs -- with the help of an external processor.

Harnessing that power "opens up a whole new paradigm for us as human beings," says neuroscientist Rajesh Rao of the University of Washington.

Brain-computer interfaces (BCI) come in two varieties. Noninvasive techniques use electrodes placed on the scalp to measure electrical activity. Invasive procedures implant electrodes directly into the brain. In both cases, the devices interact with a computer to produce a wide variety of applications, ranging from medical breakthroughs and military-tech advances to futuristic video games and toys.

Much of the research focuses on neuroprosthetics, which offer a way for the brain to compensate for injuries and illness. Jackson helped develop an intelligent wheelchair called the Aware Chair, which can be guided by neural activity.

She is also working on communication programs for people who have been paralyzed by strokes or spinal-cord injuries. Implanted electrodes allow "locked in" patients to spell out messages by manipulating a computer cursor with their thoughts alone.

Rao is tapping into that same concept to help paralyzed people manipulate robots to fetch items or move things around the house. With cameras to provide visual feedback, the patients and robots don't even need to be in the same room, or the same city. Rao says the technology "frees the mind from the constraints of the body."

Cochlear implants are the most common neuroprosthetic. They help the brain interpret sounds and are sometimes called "bionic ears" for the deaf. Other researchers are looking for similar ways to help blind people see. Neurobiologist Ed Boyden of MIT says miniature optical devices can be implanted to convert photoreceptors into workable cameras for the brain.

None of this comes cheap. Most research is funded by deep pockets such as the National Institutes of Health, the defense department and NASA.

But every breakthrough brings the most advanced BCI technologies closer to the mass market. Jackson says she foresees a day when people with disabilities can spend a few hundred dollars instead of $20,000 on a workable system.

Mainstreaming the technology raises some troubling issues for Crutcher, who teaches a course at Emory in neuro-ethics. He fears that expensive eye and ear implants could produce a computer-enhanced elite.

"If only the rich can afford it, it puts everyone else at a disadvantage," says Crutcher, who believes many aspects of BCI are ripe for abuse. Just the idea of mucking about with a person's brain "raises questions about safety and efficacy," he says.

One of the more controversial uses under development is telepathy. It would require at least two people to be implanted with electrodes that send and receive signals back and forth.

DARPA, the Pentagon's technology research division, is currently working on an initiative called "Silent Talk," which would let soldiers on secret missions communicate with their thoughts alone. This stealth component is attractive, but naysayers fear that such soldiers could become manipulated for evil means.

Telepathy implants won't replace Facebook and Twitter anytime soon, but that possibility is problematic as well.

"You can imagine communicating with your friends through the devices, and that opens up a lot of ethical issues," Rao says. Would you want your friends and family to know everything you are thinking? Would little white lies become obsolete?

These questions of morality and liability are not a huge factor for the toy makers and video game developers who are already bringing the most basic BCI technology to consumers.

Games like Mindflex and the Star Wars Force Trainer use headsets with simple electrodes to monitor levels of concentration and relaxation. The signals trigger a fan that can move a ball up or down, depending on how hard you're thinking. Jackson calls it a "fascinating application of a very sophisticated technology in a very cheap package."

The headsets used in both games were designed by the California company Neurosky. Its corporate partners are working on games that help Alzheimer's patients improve memory techniques, teach concentration skills to kids with ADHD and let stressed- out CEOs work on relaxing.

Software entrepreneurs and executives are streaming into Boyden's neuro-ventures class at MIT, looking for ways to capitalize on the array of potential uses for brain-computer interfaces.

Some ventures are already up and running. NeuroVigil in California is working on iBrain, designed, in part, to help provide instant feedback to drivers who start falling asleep at the wheel. Eos Neuroscience is developing light-sensitive protein-based sensors that can treat blindness.

Numerous companies are developing video games based on direct brain-computer interfacing. Neurosky sells a wireless headset that connects to any computer for a series of brain-training games. NeuroBoy lets you set targets on fire just by concentrating on them. Relax, and your character levitates. Another application lets you see a colorful visualization of your brain-wave activity.

Boyden expects to see many more such products hitting shelves sooner rather than later. He says the possibilities are endless if just a "fraction of the business leaders" taking his class start "bringing the technology into the world."

Jackson, of Georgia Tech, agrees: "Nothing is out of the realm of possibility."

Senior Citizen Volunteers Fight Medicare Fraud

ABC News

The first box that arrived at Shirley Shupp's door was filled with braces to help with her arthritis. Then came a motorized scooter, just like the one the 69-year-old already owned. She hadn't asked for any of it — but Medicare was apparently footing the bill.

"There was just something that wasn't right about it," the Houston woman said.

So Shupp contacted her local Senior Medicare Patrol, which did its own research and then referred the matter to investigators. The equipment, worth thousands of dollars, was returned, the case was handed over to prosecutors and the perpetrators were charged with Medicare fraud.

The Senior Medicare Patrol is one of the least-known forces in the government's effort to eliminate such fraud, which drains billions of dollars a year. But it is seen as a valuable part of the Obama administration's bid to overhaul health care and bring down costs.

The 4,700 senior citizen volunteers who serve as the government's eyes and ears have been credited with saving taxpayers more than $100 million since 1997. The program relies on elderly people to apply a lifetime's worth of common sense and skepticism.

"They can tell when something just doesn't feel right to them," said Anne Gray, who works on the SMP program in Santa Ana, Calif.

The patrol, which evolved from another program founded in 1995, now has at least one unit in every state.

SMP sends its volunteers to senior centers, retirement communities and elsewhere to encourage Medicare beneficiaries to guard their personal information, beware of too-good-to-be-true offers on medical equipment and carefully review their benefit statements. The patrol also collects tips on potential scams and fields calls from senior citizens who believe their Medicare accounts have been fraudulently billed.

When all they have is a whiff of something fishy, SMP participants often keep probing until they have enough information to send on to the FBI and investigators with the Centers for Medicare and Medicaid Services.

"It really is detective work," said Barbara McGinity, director of the SMP in Houston.

Patrol volunteers have witnessed all kinds of schemes. There are fly-by-night clinics where patients endure multiple tests at the hands of staff members with dubious credentials. Patients may be followed home from the hospital by companies selling home health services, scooters, glucose monitors or treatments for rheumatoid arthritis.

Often, senior citizens are persuaded to give up their personal information with an offer of something they need, such as transportation to kidney dialysis appointments.

"They get their number and they pass it around," Gray said. "They have a ring where they're selling it."

Beneficiaries may have no idea their identities have been wrongly used unless their accounts are frozen for unusual activity or they try to obtain something the government already bought for them, such as a pricey hospital bed or wheelchair.

The Obama administration says eliminating Medicare fraud is key to overhauling the health care system. But agents and prosecutors tackling the issue are relatively sparse. The patrol helps fill in the gaps.

"There is no substitute for beneficiaries and on-the-ground resources to help us know where fraud is occurring and where problems are arising," said Kimberly Brandt, who oversees Michigan Medicare plans anti-fraud efforts at CMS.

All told, scam artists are believed to have stolen about $47 billion from Medicare in the 2009 fiscal year, nearly triple the toll a year earlier. Medicare spokesman Peter Ashkanaz said that since the Justice Department and Health and Human Services formed a task force after President Barack Obama took office, charges have been filed against 103 defendants in cases involving more than $100 million in Medicare fraud.

For every Medicare thief the senior citizen volunteers successfully pursue, McGinity said, it seems there are dozens more.

"Sometimes we feel like we're really beating our heads against the wall," she said.

Spectranetics Pays $5 Million To End Federal Investigation

USA Today

Spectranetics (SPNC) said Wednesday it will pay $5 million to end a government investigation into allegations it imported and marketed medical lasers that had not been cleared by regulators.

The U.S. Department of Justice said Spectranetics illegally imported the devices and marketed them for purposes that had not been approved by the Food and Drug Administration, which led to false claims being filed with Medicare between 2003 and 2008. It also said a Spectranetics clinical trial called CORAL did not meet federal standards.

The Colorado-based company agreed to pay $4.9 million to resolve the investigation, which began in 2008, and will forfeit another $100,000 in cash or property in the near future. The Justice Department said Spectranetics is cooperating with the investigation, but the agreement means the company will avoid prosecution. Spectranetics accepted responsibility for its conduct and instituted safeguards in response, the Justice Department said.

Spectranetics did not immediately return requests for comment.

The CORAL study evaluated lasers as a treatment for arterial plaque. The government said a second study also did not meet regulatory requirements. Products involved included the CVX-300 medical laser and the CliRpath turbo laser catheter, the TURBO elite laser ablation catheter, and the TURBO-Booster laser guide catheter.

In September 2008, the Food and Drug Administration and U.S. Immigration and Customs Enforcement served Spectranetics with a search warrant to get information related to the marketing, use and testing of a product, and payments to medical personnel. They also sought details of catheter guidewires and balloon catheters made by other companies, two post-market studies, and compensation packages for personnel.

Spectranetics shares jumped to an annual high on the news, rising 81 cents, or 13%, to $6.85. The stock peaked earlier at $7.77, its highest price since Sept. 4, 2008, the day the investigation was disclosed.

29 December 2009

Tylenol Issues Voluntary Recall Of Arthritis Caplet

Business Week

Johnson & Johnson is expanding a voluntary recall of Tylenol Arthritis Caplets due to consumer reports of a moldy smell that can cause nausea and sickness.

According to a statement posted to the Food and Drug Administration Web site on Tuesday, the New Brunswick, N.J., company is now recalling all product lots of the Arthritis Pain Caplet 100 count bottles with the red EZ-Open Cap.

Johnson & Johnson had recalled five lots of the product last month after consumers complained of a musty, mildew-like odor that triggered nausea, stomach pain, vomiting and diarrhea.

The health care company said the odor results from trace amounts of a chemical called 2,4,6-tribromoanisole. That chemical is believed to result from the breakdown of another chemical used to treat wooden pallets that transport and store packaging materials.

To date, the side effects, which also include vomiting and diarrhea, have been "temporary and non-serious," although the health effects of the compound have not been studied.

The recall only affects the specific lots cited. All other Tylenol Arthritis pain products remain available.

The company will reintroduce Tylenol Arthritis Pain Caplets 100 count by January after moving production to a new facility.

Consumers seeking a refund or replacement of the arthritis medication can call J&J at 1-888-222-6036.

Company shares rose 45 cents to $65.39 in morning trading Tuesday.

Vivus Requests FDA Approval For Obesity Drug

LA Times

Drugmaker Vivus Inc. said Tuesday it asked regulators to approve its drug candidate Qnexa as a treatment for obesity.

Vivus said it has filed a new drug application with the Food and Drug Administration. A week ago, competitor Arena Pharmaceuticals Inc. said it filed for approval of its own experimental obesity drug, lorcaserin. Orexigen Therapeutics plans to request marketing approval for its product Contrave32 in the first half of 2010.

Vivus reported positive results from two late-stage clinical trials of Qnexa in September. Qnexa, lorcaserin and Contrave32 could all reach the market around the same time, and some analysts say they believe Qnexa could be the top seller of the group based on the weight loss observed in clinical testing.

In morning trading, Vivus shares rose 17 cents to $9.84.

24 December 2009

Dogs Excel At Sniffing Out Cancer

NY Times

In the small world of people who train dogs to sniff cancer, a little-known Northern California clinic has made a big claim: that it has trained five dogs - three Labradors and two Portuguese water dogs - to detect lung cancer in the breath of cancer sufferers with 99 percent accuracy.

The study was based on well-established concepts. It has been known since the 80's that tumors exude tiny amounts of alkanes and benzene derivatives not found in healthy tissue.

Other researchers have shown that dogs, whose noses can pick up odors in the low parts-per-billion range, can be trained to detect skin cancers or react differently to dried urine from healthy people and those with bladder cancer, but never with such remarkable consistency.

The near-perfection in the clinic's study, as Dr. Donald Berry, the chairman of biostatistics at M. D. Anderson Cancer Center in Houston, put it, "is off the charts: there are no laboratory tests as good as this, not Pap tests, not diabetes tests, nothing."

As a result, he and other cancer experts say they are skeptical, but intrigued. Michael McCulloch, research director for the Pine Street Foundation in Marin County, Calif., and the lead researcher on the study, acknowledged that the results seemed too good to be true. (For breast cancer, with a smaller number of samples, the dogs were right about 88 percent of the time with almost no false positives, which compares favorably to mammograms.)

"Yes, we were astounded, as well," Mr. McCulloch said. "And that's why it needs to be replicated with other dogs, plus chemical analysis of what's in the breath."

He is applying for National Science Foundation grants to try just that, he said. The fact that the study was carried out by a clinic supported by the Pine Street Foundation that combines traditional chemotherapy with acupuncture and herbal medicine raised suspicions, as did the fact that it is to be published by a little-known journal, Integrative Cancer Therapies. (The journal published it online last year.)

But experts who read the study could not find any obvious fatal flaw in its methodology, and the idea that dogs can detect cancer is "not crazy at all," said Dr. Ted Gansler, director of medical content in health information for the American Cancer Society. "It's biologically plausible," he said, "but there has to be a lot more study and confirmation of effectiveness."

Dr. Berry, too, was interested but suspicious. "If true, it's huge," he said. "Which is one reason to be skeptical."

Dr. Berry noted, half-jokingly, that Gregor Mendel, the 19th-century discoverer of the laws of genetics, also reported data on his crossbreeding of green and yellow peas that was too good to be true: he repeatedly came up with the perfect 3-1 ratios he predicted. "But we've forgiven Mendel and his gardener," Dr. Berry added, "because his theory turned out to be right."

In Mr. McCulloch's study, the five dogs, borrowed from owners and Guide Dogs for the Blind, were trained as if detecting bombs. They repeatedly heard a clicker and got a treat when they found a desired odor in many identical smelling spots.

The clinic collected breath samples in plastic tubes filled with polypropylene wool from 55 people just after biopsies found lung cancer and from 31 patients with breast cancer, as well as from 83 healthy volunteers.

The tubes were numbered, and then placed in plastic boxes and presented to the dogs, five at a time. If the dog smelled cancer, it was supposed to sit.

For breath from lung cancer patients, Mr. McCulloch reported, the dogs correctly sat 564 times and incorrectly 10 times. (By adjusting for other factors, the researchers determined the accuracy rate at 99 percent.)

For the breath from healthy patients, they sat 4 times and did not sit 708 times.

Experts who read the study raised various objections: The smells of chemotherapy or smoking would be clues, they said. Or the healthy breath samples could have been collected in a different room on different days. Or the dogs could pick up subtle cues - like the tiny, unintentional movements of observers picked up by Clever Hans, the 19th-century "counting horse," as he neared a correct answer. But Mr. McCulloch said cancer patients who had begun chemotherapy were excluded, smokers were included in both groups and the breath samples were collected in the same rooms on the same days. The tubes were numbered elsewhere, he said, and the only assistant who knew which samples were cancerous was out of the room while the dogs were working.

"The fact that dogs did this is kind of beside the point," he said. "What this proved is that there are detectable differences in the breath of cancer patients. Now technology has to rise to that challenge."

The next step, he said, will be to analyze breath samples with a gas chromatograph to figure out exactly which mixes of chemicals the dogs are reacting to.

Even if the dogs are accurate in repeat experiments, Dr. Gansler of the American Cancer Society said, it will be useful only as a preliminary scan. "It's not like someone would start chemotherapy based on a dog test," he said. "They'd still get a biopsy."

Not All Generics May Be Equal To Brand Name Drugs


The Generic Pharmaceutical Association’s slogan is “Same Medicine, Same Results.” Unfortunately this is not always the case, according to an article in the New York Times.

Patients, doctors and everyone else are all in agreement over the value of generic drugs. Not only do they save Americans 10 billion dollars a years, make medication accessible to those who need it, but also force down the price of brand name drugs.

“For many drugs, generics are just fine,” says Dr. Kimford Meador, a professor of neurology at Emory University.  “But when you are taking a seizure medication…If the absorption of the drug is slightly different between brand and generic then the patient could have a seizure and that seizure could lead to serious injury or perhaps death.”

although both products released the same amount of the active ingredient over 16 hours, the generic version released almost half of its medication after four hours and the brand name only one-quarter

According to Vitals.com, Dr. Meador completed his medical degree and residency at the Medical College of Georgia School of Medicine.

The FDA ensures the public that to be marketed in the United States these drugs must “bioequivilant” to their brand name equivalents, meaning the same doses of the same active ingredient is delivered in the same way according to the same standards of quality.

But some specialists worry that the allowable range is too wide, especially for patients taking medication to control problems like arrhythmias or seizures. Studies that were published in the journal Neurology, reported patients who switched to generics products had more seizures and higher hospitalization rates

Kathleen Jaeger, president of the Generic Pharmaceutical Association, sees this controversy as a propagandist plot masterminded by brand name drug companies. But doctors and psycho pharmacologists believe the FDA is ignoring the reality that in certain cases generic drugs can create serious problems for patients.

“If a patient with heart arrhythmia gets a blood thinner for which the levels are too low there is a risk for stroke and if the levels are too high it could result in bleeding,” says Dr. James A. Reiffel, a cardiologist and professor of clinical medicine at Columbia.

According to Vitals.com, Dr. Reiffel completed his medical degree and residency at Columbia University.

Wellbutrin XL, the fourth-most prescribed antidepressant in the United States with 20.184 million prescription sold in 2007, is an example of an effective brand name drug whose generic equivalent disappointed many.

Joe and Teresa Graedon publish a popular syndicated column, The People’s Pharmacy, and are founders of a respected multimedia clearinghouse. In the summer of 2007 they had received so many complaints about the generic version of Wellbutrin XL, they decided to do an independent study collaborating with ConsumerLab.com. The results were astounding.

Among their many findings they discovered that although both products released the same amount of the active ingredient over 16 hours, the generic version released almost half of its medication after four hours and the brand name only one-quarter. This accounted for the side effects so many patients were experiencing, including irritability, headaches, insomnia and a depressed mood toward the end of the cycle.

Nowadays generics constitute almost 70 percent of all prescriptions dispensed nationwide and work well for many people. But with health insurers pressuring patients to use these drugs, patients and doctors need to be vigilant. When switching from a brand name to a generic, keep tabs on how they are affecting you. Report all your concerns to your doctor or to the FDA’s adverse events monitoring system, called MedWatch (www.fda.gov/medwatch).

2 Doctors Unlocking Mysteries Of Dystonia

Washington Post

In 1970, a Japanese pediatric neurologist named Masaya Segawa examined two girls. The girls were cousins and they seemed to be suffering from the same puzzling ailment: a contraction of the muscles that caused their limbs to twist uncontrollably, a condition known as dystonia. Six years later, Segawa encountered a 51-year-old woman who had been experiencing the same symptoms since the age of 8.

Segawa discovered that in all three cases the symptoms could be controlled by small doses of L-dopa, which the body converts into the neurotransmitter dopamine. The disorder goes by the name dopa-responsive dystonia but it's also known as Segawa's disease, after that observant Japanese doctor, one of the grand old men of pediatric neurology. It affects girls three to four times more frequently than boys. In 1993, researchers were able to find the gene that causes the abnormality, mapping it to chromosome 14q.

In 2003, Morgan Campagna was an 8-year-old girl living in Guantanamo Bay, Cuba, with her mother, Christie, and sister, Ashlyn. From the age of 4, Morgan had been experiencing strange symptoms, including a limp that worsened as the day progressed. Odder still, Morgan would draw her arms up to her chest, her hands twisting in on themselves.

"Doctors would tell me she was going to grow out of it, but nobody would tell me what 'it' was," her mother said.

A Navy doctor visiting the base decided this was not something Morgan was going to grow out of. The doctor arranged for Morgan to be seen by Mark Batshaw at Children's National Medical Center in Washington and his colleague Bennett Lavenstein.

"Dr. Batshaw invited me to see her and asked what I thought of her gait," said Lavenstein, a pediatric neurologist. "We put our heads together and, quite frankly, I thought L-dopa."

Dopamine has a lot of roles in the nervous system. With Segawa's disease, Lavenstein said, "we're focusing on predominantly dopamine in the basal ganglia of the brain, which is inherently responsible for controlling smooth, graded motions, as opposed to concentrations elsewhere, which may relate to attention deficit disorder, schizophrenia or the pleasure centers."

Because of an enzymatic deficiency, Segawa's patients are unable to synthesize dopamine properly, unable to control some of their muscles. The disease is similar to Parkinson's disease, without that ailment's inevitable downward spiral.

Morgan underwent a battery of tests -- liver function, amino acids, copper metabolism -- but her doctors at Children's were pretty sure they knew the answer. The correct diagnosis would be confirmed by the treatment. They started Morgan on a twice-a-day regimen of Sinemet, a pill used to treat Parkinson's. Within a week, her symptoms were almost gone.

Morgan is 16 now. Her family lives in Manassas. She likes science, likes to read, likes to draw her own comic books. She goes on walks without tiring easily, as she once did. She marvels at the fact she was once unable to control her body, remembering how strange it was to look down and find her hands up near her chin when she'd never intended to move them there.

"When I was little, I just thought I was normal," Morgan told me recently. "I didn't really know what normal was."

23 December 2009

When Joints Take A Turn For The Worse

The Times Of India

Joint pain is often associated with old age. However, now, the young are also suffering from this as inactive lifestyles take hold. If the pains are resulting from arthritis, winter can prove to be a testing time for the sufferer, because low temperature causes the condition to worsen, said doctors.

They added that earlier, the season caused an increase in the number of old people complaining of joint pains, but now, the young were also being affected by the condition as they did not exercise much and tended to avoid other physical activity.

They stated that the young adult category had seen an increase in patient numbers by 20%.

“Generally, more women are prone to joint pains especially emerging from osteo-arthritis. The second major cause for this in women’s case tends to be rheumatoid arthritis. As the age of people contacting this condition is falling, it is leading to a lot of concern. Cold weather also causes more people to be affected. It also slows down the healing process for surgical stitches,” said Dr Harpreet Singh Gill, senior consultant and head of orthopaedics department, Apollo hospital.

He added that earlier, the average age of patients receiving rheumatoid arthritis treatments tended to be 50 and now many of them were in their 30s, with women being the worst-affected group. He stated that the way prevent the condition was having a good diet and exercising properly. Dr Gill added that on an average, 20 young women came to the OPD daily with these problems, while the number used to be just two or three a few years back. “Squatting too much, having an inactive lifestyle or being deficient in vitamin D are the main causes and the major modes of treatment are physiotherapy, lifestyle modification and medication,” he added.

Associate professor at Dayanand Medical College and Hospital, Dr Sanjeev Mahajan, said that the young could easily avoid the condition with more physical activity, which they were quite capable of. “Early diagnosis and change in lifestyle are effective in arthritis pain management,” he added. He mentioned that arthritis-related swelling tended to get worse as weather got cold. Dr Jagdip Madan, orthopaedician at Guru Teg Bahadur Hospital, said that young women were getting arthritis and the reason for that could be genetic or having a generally negligent attitude towards joints. Dr Madan said that in his hospital, about 15 to 20 young women came for treatment daily, which was quite a lot as arthritis was a problem encountered mostly in sexagenarians.

21 December 2009

Over 45 Million Americans Without Health Insurance

USA Today

In the first six months of this year, 45.4 million Americans of all ages — or 15.1% of the population — had no health insurance, according to new National Health Interview Survey statistics released Wednesday.

In addition, 58.4 million (19.4%) people of all ages had been uninsured for at least part of the year prior to the interview, and 31.9 million (10.6%) had been uninsured for more than a year at the time of interview, according to a report from the U.S. Centers for Disease Control and Prevention's National Center for Health Statistics.

The findings are from data analyses of almost 32,700 respondents. NHIS data, collected since 1957, is widely used to monitor health trends.

Among the other results from January to June:

— The percentage of children under age 18 without insurance at the time of interview was 8.2%.

— Among adults up to 64 years old, 60.6% of those who were unemployed had been uninsured for at least part of the past year, and 21.8% of those who had jobs had gone without insurance. Also, 32.9% of unemployed adults and 13.3% of employed adults in this age group had been without insurance for more than one year.

— Among those under age 65 with private health insurance, 22.7% were enrolled in a high deductible health plan (HDHP), including 6.4% who were enrolled in a consumer-directed health plan (CDHP).

— Nearly 50% of those with a private plan obtained by means other than through an employer were in a HDHP, and about 20% of those with a private plan were in a family with a flexible spending account (FSA) for medical expenses.

--- Nearly 1.3 Million state residents lacked a Michigan health insurance provider

— At the time of interview, 12.3% of poor children and 11.6% of near-poor children didn't have insurance.

— The percentage of near-poor children who lacked insurance at the time of interview decreased from 15.6% in 2008 to 11.6% in the first six months of 2009.

— At the time of interview, 80.9% of poor children and 57.8% of near-poor children were covered by a public health plan.

— The increase in public coverage for near-poor children increased from 53.4% in 2008 to 57.8% in the first six months of 2009. This was not a significant increase, according to researchers.

— At the time of interview, 8.4% of poor children and 35.1% of near-poor children were covered by private health insurance. Between 2008 and the first six months of 2009, there was no significant change in private coverage for poor, near-poor and not-poor children.

— The percentage of near-poor adults younger than 65 who didn't have insurance at the time of interview increased from 2008 to the first half of 2009.

--- Many Seniors are still in need of Michigan medicare plans

— Lack of health insurance coverage was highest in the South and West.

Doctors Approve Of Electronic Records, But Privacy Still A Concern

USA Today

U.S. physicians support the use of electronic medical records, but widespread concerns exist about privacy problems, two new studies show.

One study of more than 1,000 family practice and specialist doctors in Massachusetts found that 86% believed electronic health information exchange (HIE) would improve patient quality of care, 70% thought it would reduce costs and 76% said it would save time.

However, 16% said they were "very concerned" about possible privacy breaches, especially children's doctors, while a further 55% were "somewhat concerned." The study also found that none of the doctors wanted to pay the suggested $150 monthly fee for HIE and about half said they weren't willing to pay any fee.

The second study, which included 56 psychiatrists, psychologists, nurses and therapists at an academic medical center, found that most believed electronic health records healthcare pacs records were clearer and more complete than paper records, but not necessarily more factual.

However, 63% said they were less willing to record highly confidential information in a patient's electronic health record than on a paper record. And 83% said if they were a patient, they wouldn't want their mental health records to be routinely accessed by other health-care providers.

"Designers of future task management software systems will need to enhance electronic file security and simultaneously maintain legitimate accessibility in order to preserve confidence in psychiatric and other [electronic health record] systems," the researchers concluded.

Both studies are published in the January issue of the Journal of the American Medical Informatics Association.

13 December 2009

Study Questions Use Of Anthracyclines By Breast-Cancer Patients

Wall Street Journal

Researchers presented new findings Saturday at a breast-cancer symposium here suggesting that the risks associated with anthracyclines, a class of chemotherapy drugs widely used to treat the disease, outweighed their benefits in some patients.

The findings renewed a debate over whether anthracyclines, which have been around since the 1960s, should remain the standard of care in treating breast cancer, or whether newer drugs should be used more frequently instead.

Anthracyclines are effective but can damage the heart, particularly when used in combination with Roche Holding AG's Herceptin, a highly effective medication used to treat women with HER2-positive cancer.

The researchers, from the Breast Cancer International Research Group, evaluated the efficacy and safety of two separate regimens to treat breast cancer, one comprised of Herceptin and anthracyclines and another comprised of Herceptin and non-anthracycline drugs. The researchers compared the two treatment regimens to a control group receiving anthracyclines, but not Herceptin.

The 10-year study, which includes 3,222 women with Her2-positive breast cancer, is sponsored by French pharmaceutical company Sanofi-Aventis SA and supported by Genentech, a subsidiary of Roche. The data presented Saturday was collected at the study's halfway point.

The data showed that, after five years, women in both Herceptin groups were significantly more likely to remain alive than those in the control group, and there wasn't a statistically significant difference in overall survival between those who received anthracyclines and those who got non-anthracyclines, according to Dennis Slamon, one of the study investigators and director of the women's cancer research program at the Jonsson Comprehensive Cancer Center at the University of California, Los Angeles.

But, women receiving the combination of Herceptin and anthracyclines had significantly more heart damage, including cases of congestive heart failure, than those getting Herceptin and non-anthracyclines. They also had more cases of leukemia, a secondary consequence of the chemotherapy. "The damage we're doing to the heart is not transient," said Dr. Slamon.

The results are consistent with an earlier analysis of less comprehensive data in 2005, which provoked considerable debate in the field. One group of oncologists, including Dr. Slamon, believes that doctors should move away from using anthracyclines as a uniform treatment for all cases of breast cancer and instead use it only in subgroups of patients, such as those who express both the Her2 gene and another one called the Topo gene.

"I don't know why we keep pushing the anthracycline agenda," said Dr. Slamon, who called these latest results a "direct assault" on these drugs.

However, other experts disagree, saying the data aren't convincing enough to change the standard of care.

"What the data show is that there's certainly no superiority" of the non-anthracycline treatment, said Eric Winer, director of the Breast Oncology Center at the Dana-Farber Cancer Institute in Boston. But because the two treatment groups aren't significantly different on efficacy, "I'm just not of the view that [non-anthracycline therapy] is the preferred regimen," said Dr. Winer. "We have to be cautious before adapting new standards."

Dr. Winer also pointed out that, even though there wasn't a statistically significant difference in survival between the two Herceptin groups, there were a greater number of deaths among the patients who got Herceptin and non-anthracyclines than among those who got Herceptin and anthracyclines. The difference was 214 deaths to 185.

Gary Lyman, a professor of medicine at Duke University's Comprehensive Cancer Center, said he didn't think the results would change much the use of anthracyclines. His patients want the best treatment for the cancer they are facing at the moment and are less concerned about the potential future safety concerns. "When I go back home, they are not going to want to compromise the most effective treatment for cancer" because of concerns over heart damage or leukemia, he said.

However, "patients should be warned; they should be informed about these issues," said Dr Lyman.

11 December 2009

Experts Hopeful About Steady Drop In Cancer Deaths

Business Week

Less smoking, earlier detection, and improved treatments are credited for gains against lung, colon, prostate, and breast cancer

The latest federal cancer numbers, released on Dec. 7, show a modest but steady decline in the U.S. over six years for both deaths from the disease and new diagnoses. The improvement is driven largely by declines in the big four cancer killers—lung, colon, prostate, and breast. Specialists attributed the declines to a reduction in the smoking rate, better and earlier detection, and improved treatments, particularly those that can be matched to a patient's specific tumor type.

New diagnoses for all types of cancer decreased almost 1% per year on average from 1999 to 2006, while cancer deaths decreased 1.6% per year from 2001 to 2006. However, experts in the field warn that these successes could be wiped out in coming years by the nation's obesity crisis. Because fat cells fuel tumor growth, about one-third of cancer cases today can be linked to obesity. "The increase in obesity is a real concern and could eventually cause this very welcome decline to reverse," says Dr. Edward J. Benz, president of Dana-Farber Cancer Institute in Boston. "We don't know yet but it is quite possible that obesity will become as much or more of a factor in causing cancer than smoking."

Cancer is currently the nation's second-largest killer after heart disease. An estimated 562,340 people in the U.S. will die from the disease this year, accounting for nearly 1 in 4 deaths. The six-year declines—reported by the National Cancer Institute, the Centers for Disease Control & Prevention, the American Cancer Society, and the North American Association of Central Cancer Registries, or NAACCR—are far from a home run. The annual federal cancer report had shown small declines in the death rate in each of the past five years, but this is only the second year that a decline in diagnoses was recorded (after 2008). And both drops were considered "significant" in the cancer world, where anything more than a 1% decline is something to celebrate when placed against such a formidable disease. The persistence of the declines gives cancer specialists encouragement that steady progress is finally being made in treatment, screening, and prevention, after decades when the trend lines barely budged.

"We still have a long, long way to go but I am optimistic," says Dr. Raymond DuBois, provost of M.D. Anderson Cancer Center in Houston. "If these trends continue for another few years, we will be certain that the progress is real."
Under-50 Mammograms

Even though early detection was considered a key factor in the declines, specialists said the findings did not undercut the recommendation on Nov. 16 by the U.S. Preventive Services Task Force that annual mammograms are not needed until age 50 for women who are at low risk for breast cancer. "These new statistics weren't broken down by age," says Benz. "Although I think that early detection by mammograms does contribute to these improvements, whether the results are due to screening starting at age 40 or age 50 cannot be determined."

The task force based its recommendation on an analysis that found that almost 2,000 mammograms would have to be performed on women ages 40 to 49 over 10 years to prevent one breast-cancer death. All those mammograms do pick up a high number of false positives, however, with resulting unnecessary follow-up procedures such as biopsies that can be stressful, costly, and sometimes harmful. That raises concerns that mass screening of younger women is doing more harm than good.

Overall, the new report found that cancer rates were higher for men than for women, but men experienced the greatest declines in new cases and death rates. For both men and women, however, there was little progress in many less common cancers, such as kidney cancer, and even some increases.

Colon and rectal cancer, usually categorized together as colorectal cancer, had the biggest declines. Deaths dropped by 3.9% per year for men and 3.4% per year for women over the six-year period. Colorectal is the third-leading cause of cancer death and much of the improvement was linked to a greater adoption of colon screening, which can be very effective at not only detecting tumors but removing the polyps that could later turn cancerous. However, the researchers noted that there is an increasing incidence of colorectal cancer in men and women under age 50. Colorectal cancer has been linked in some studies to obesity and a high-fat diet.

Incidence-Rate Declines

The report found that, in men, incidence rates have declined for cancers of the lung, prostate, colon/rectum, oral cavity, stomach, and brain. But incidence rates continue to rise for kidney/renal, liver, and esophageal cancer, melanoma, and blood cancers. In women, incidence rates decreased for breast, colorectal, uterine, ovarian, cervical, and oral cavity cancers, but increased for lung, thyroid, pancreatic, bladder, and kidney cancers, as well as for non-Hodgkin lymphoma, melanoma, and leukemia.

"The continued decline in incidence and death rates for all cancers combined is extremely encouraging, but progress has been more limited for certain types of cancer, including many cancers that are currently less amenable to screening, such as cancer of the esophagus, liver, and pancreas," said Betsy Kohler, executive director of NAACCR.

The three leading causes of cancer death for all men, with the exception of Asians/Pacific Islanders, were lung, prostate, and colorectal cancer. Lung, liver, and colorectal cancers were the top three causes of cancer death in Asian/Pacific Islander men. For women, the three leading causes of cancer death were lung, breast, and colorectal cancer for all racial/ethnic groups except Hispanic women, for whom breast cancer ranked first.

09 December 2009

Women From Clinical Trial Sing The Praises Of Lysteda

Grand Rapids Press

It's certainly not an easy subject to talk about, but heavy menstrual bleeding can be debilitating for some women, and more than just a nuisance for others.

Rockford resident Karen Van Riper says her condition is so bad, she can't leave the house for several days each month.

Now, for the first time, hormone-free relief is on the way in form of a pill -- Lysteda -- just approved by the Food and Drug Administration after a two-year research clinical trial that included 100 West Michigan women like Van Riper.

"I'm a soccer mom; I'm a Girl Scout leader; I volunteer at my kids' school, but if my period happens, I can't do any of that," said Van Riper, 38. "It was incredibly life changing (to be on the drug)."

Female Pelvic Medicine & Urogynecology, an arm of Grand Rapids Michigan Women's Health group, was the largest participant in the study that led to Lysteda, also known as Tranexamic acid, being set to hit the market next spring.

Beth Rogers, the practice's research director and coordinator of the study in Grand Rapids, said the West Michigan women first participated in a blind trial in which some received the drug while others took a sugar pill. It was almost immediately obvious who was receiving the real thing, she said.

"These are women that always have to carry an extra set of clothing with them -- it was that bad," Rogers said. "These are women that their doctors told them, 'You know it's just part of being a woman.' And now they have another option."

The drug, manufactured by Kentucky-based Xanodyne Pharmaceuticals, works by stabilizing a protein that helps blood to clot. It is currently used to reduce and prevent bleeding following tooth extraction in patients with hemophilia, a hereditary disorder that prevents blood from clotting.

According to the FDA, about 3 million U.S. women of reproductive age suffer from the condition, known as menorrhagia.

Dr. Douglas Van Drie, who led the study in Grand Rapids, estimates about 20 percent to 30 percent of women have a period so heavy that it interferes with their life, causing severe anemia, pain, fatigue and embarrassing leaks.

Treating the condition with low-dose birth control pills is not an option for all women, and it's not always effective, he said.

"If you look back to the 1950s, probably a lot of these things were suffered silently," Van Drie said. "But with more women in the workplace, it's not practical."

Stephanie Chandler's heavy bleeding had led her to take vacation days once a month from her job at an area call center, consider filing for unpaid leave under a federal law, or even confining herself to the bathroom.

The 39-year-old Grand Rapids resident said she participated in the study because heavy bleeding has been a problem since she was a teenager and caused fatigue from dangerously low blood iron levels. Chandler said she has tried birth control and minor surgery and even considered a partial hysterectomy to relieve her symptoms.

"Taking (Lysteda) literally changed my life," she said.

Cancer Survivor, Radiologist Speak Out About New Mammogram Guidelines


SWARTZ CREEK, Michigan — Three times was the charm for Swartz Creek breast cancer survivor Carla Lazar.

Lazar, 42, has had three mammograms since age 38, each ordered by her primary care physician as a routine part of her preventive health care program.

She’ll never forget the third, done Dec. 22 of 2008 at the age of 41.

It’s the one that saved her life.

It’s also a mammogram she never would’ve had, under controversial new mammography guidelines from the United States Preventive Services Task Force.

The new federal guidelines — which no longer recommend  routine screening for women ages 40-49 unless they are genetically predisposed to breast cancer, and once every two years rather than annually for women ages 50-74 — have caused an uproar within the medical and patient advocacy communities since being released on Nov. 16.

Diagnosed with stage one breast cancer, Lazar underwent lumpectomy surgery to remove the tumor, then three months of chemotherapy followed by seven weeks of radiation.

She credits her medical team and the support of friends and family for her survival — but none of that would’ve been possible without the test that detected the disease, she said.

“My prognosis now is good, God willing. Luckily for me that’s how it played out because I had no symptoms, no risk factors. If my doctor wasn’t diligent in ordering these tests, this might’ve been a very different conversation,” said Lazar.

“If these new guidelines were already in place, I wouldn’t even get my first mammogram until I turn 50. By then, we probably wouldn’t even be having this conversation.”

That’s exactly what has alarmed physicians like radiologist Dr. Linda  Lawrence Murphy, director of imaging for McLaren Regional Medical Center and McLaren Imaging Center.

“We are diagnosing women younger and younger all the time. We’ve gotten so much better at detecting breast cancer at a smaller stage when it is curable. So many are women under age 50. This is a huge step backwards in early detection,” said Lawrence Murphy. “I feel like we are going back to the dark ages in women’s health care.”

Supporters of the Task Force report have said the findings simply indicate not enough lives of younger women are being saved to justify the expense, stress and risk of unnecessary mammography.

Lazar finds that notion disturbing.

“I don’t know if this is about insurance companies not wanting to pay for all these tests but if they save one life, it’s worth it. It’s my life. It may be your own,” said Lazar. “I can understand not putting women through biopsies and additional testing that end up not being anything, but what if it was  something like in my case? I’m so grateful we have a system in place now that is ready to treat this right at the offset.”

Lazar was also bothered that the report advised against teaching women to do breast self-exams.

“I can’t imagine how it could hurt to be proactive with our own bodies. It’s got to be a good thing anytime a woman is in tune with her own body enough to recognize a change,” said Lazar.

Lawrence Murphy said the study had a very big, basic flaw: it was based on results from an older style of film screen mammography that is rapidly being replaced by more accurate digital screening.

“Probably close to 80 percent of women are getting digitals now, which is far superior in detecting cancer in women under age 50, those with dense breasts and those who are peri-menopausal,” said Lawrence Murphy.

Lawrence Murphy said the report distorted the reality of unnecessary biopsies too.

“It’s true mammograms aren’t perfect and we do some biospies that are benign. But these are not major surgeries in the hospital. Most are done using a simple needle under local anestheisa. The patient has a bandaid when she leaves,” said Lawrence Murphy.

Meanwhile, groups like the American Cancer Society, Black Women’s Health Imperative and American Society of Breast Surgeons continue to line up in opposition to the guidelines, which some fear could eventually eliminate mammography coverage as a prevention service and negatively impact Michigan women's health.

“Nobody involved with this report is looking at what we are saving on the other end by curing these women earlier, before it requires more expensive surgery and could’ve spread to other organs,” said Lawrence Murphy. “It’s like telling someone don’t look both ways before you cross the street because it causes anxiety and hasn’t been shown to save lives. It’s just ridiculous.”

06 December 2009

Public Health Officials Refusing New Patients

NBC Los Angeles

The "unprecedented fiscal challenges" claimed another victim this week as health officials decided to discontinue a cigarette tax-funded program that pays for breast cancer screenings for low-income women.

Mandatory changes were required this week by California Department of Public Health to the division, Every Woman Counts. The specialized division provides a cancer detection program for California's medically underserved women by giving them access to screening and diagnostic services for breast and cervical cancer.

The two biggest changes to the program according to a release are:

    * They will stop paying for breast cancer screening for women under 50.

    * They will stop enrolling all new patients for breast cancer screening until July 1.

The changes according to their Web site are based on the lack of state funding, and the only way to keep within their budget.

A statement released by Dr. Mark Horton, the state health officer, said "the short-term increases in state funding for the program have not been enough to keep pace with the growing demand for and cost of providing breast cancer screening services to the women in this program.

This comes on the heels of the recommendation by the U.S. Preventive Services Task Force. The task force suggested that women younger than 50 do not need regular mammograms. The Los Angeles Times printed a response by Dr. Willie Goffney to the claims of the task force.

Dr. Willie Goffney, a surgical cancer doctor who serves on the board of directors for the California division of the American Cancer Society, said he was disappointed by the state's decision to put the free screening program on hiatus and then limit who can enroll.

“We feel we are moving in the wrong direction. We know that screening for breast cancer and having access to that screening saves lives,” Goffney said. “So to take those resources from people who need that access means more people will fall through the cracks, and will lead to more deaths from breast cancer.”

Many in the industry of providing mammography services are worried that their businesses will not be able to survive, and more importantly, that these changes will deter women under 50 from being tested.

03 December 2009

Tumour-Attacking Virus May Offer Brain Cancer Treatment

DNA India

Washington: Scientists at Ohio State University have developed a tumour-attacking virus that both kills brain-tumour cells and blocks the growth of new tumour blood vessels. According to researchers, their study shows that viruses designed to kill cancer cells - oncolytic viruses - might be more effective against aggressive brain tumours if they also carry a gene for a protein that inhibits blood-vessel growth.

The protein, called vasculostatin, is normally produced in the brain.

In this study, an oncolytic virus containing the gene for this protein in some cases eliminated human glioblastoma tumours growing in animals and significantly slowed tumour recurrence in others.

Glioblastomas, which characteristically have a high number of blood vessels, are the most common and devastating form of human brain cancer.

People diagnosed with these tumours survive less than 15 months on average after diagnosis.

"This is the first study to report the effects of vasculostatin delivery into established tumours, and it supports further development of this novel virus as a possible cancer treatment," said study leader Balveen Kaur, associate professor of neurological surgery and a researcher with the Ohio State University Comprehensive Cancer Center-Arthur G James Cancer Hospital and Richard J Solove Research Institute.

"Our findings suggest that this oncolytic virus is a safe and promising strategy to pursue for the treatment of human brain tumours.

"This study shows the potential of combining an oncolytic virus with a natural blood-vessel growth inhibitor such as vasculostatin. Future studies will reveal the potential for safety and efficacy when used in combination with chemotherapy and radiation therapy," she added.

The findings were recently published online in the journal Molecular Therapy.

02 December 2009

OxyPharma Announces Positive Results In Arthritis Treatment

Pharma Live

Swedish drug development company OxyPharma today announced the preliminary results of its phase II clinical trial of Rabeximod, an orally administered disease-modifying anti-rheumatic drug (DMARD) for treatment of moderate or severe active rheumatoid arthritis. The study demonstrated clear therapeutic effects of Rabeximod in patients with rheumatoid arthritis, resulting in a significant effect on key biological and disease variables after 16 weeks.

The study was designed to reveal an effect of Rabeximod at 12 weeks (primary endpoint), based on the assumption of a similar onset of action as other disease-modifying anti-rheumatic drugs. Treatment with Rabeximod was given during 12 weeks to 224 patients with moderate or severe active rheumatoid arthritis that were not fully responsive to prior treatment withmethotrexate , with clinical follow-up visits through week 16. Patients, all on a stable dose of methotrexate, were randomized to one of three dosing regimens of Rabeximod (6.25 mg, 15 mg, or 37.5 mg once daily) or placebo. Principal Investigator was Professor Lars Klareskog, Head of Rheumatology Unit at Karolinska University Hospital, Stockholm, Sweden.

Rabeximod showed a delayed onset of action, which resulted in a significant therapeutic effect of the dosing regimen seen at 16 weeks rather than at the 12 week endpoint. At 16 weeks, the 15 mg Rabeximod dose group exhibited statistically significant (p<0.05) effects for seven of the key secondary endpoints of treatment: ACR20, DAS28 response rate, pain, subject global assessment, physician global assessment, number of swollen joints and number of tender joints. At 12 weeks, none of the treatment groups demonstrated a significant effect on the ACR20 response rate, which was the primary endpoint of the study.

The study also demonstrated a good safety profile of Rabeximod. The incidence of adverse events in the Rabeximod 6.25 mg, 15 mg and placebo groups were similar. Skin disorders were the most frequently reported adverse event, with the highest incidence in the 37.5 mg Rabeximod group, all rated mild to moderate in severity. No adverse synergistic effect was seen with methotrexate.

Based on the efficacy and safety results, 15 mg Rabeximod administered once daily appears to be the most optimal dose. These results indicate that the treatment duration of 12 weeks in the study was too short to reach an optimal clinical effect of Rabeximod in combination with methotrexate. The full potential of Rabeximod in the treatment of patients with rheumatoid arthritis will be revealed in studies designed with a longer duration of treatment.

“This is the first clinical trial evaluating the effect of Rabeximod for the treatment of moderate or severe rheumatoid arthritis”, said Ulf Bj√∂rklund, CEO, OxyPharma. “The study suggests that Rabeximod causes a beneficial modification of disease activity with a delayed onset of its therapeutic benefits. The results thus indicate that a three month treatment period was not sufficient to observe the full therapeutic effect of the drug. This outcome is what can be expected with a disease-modifying anti-rheumatic drug where the effect appears slowly and lasts longer, especially since the compound has a long half-life. As the main variables are statistically significant at week 16, OxyPharma is confident that studies with longer treatment duration will prove oral Rabeximod to be an effective, convenient and safe drug for commercialization”.

Partnering Strategy “The management and the board of OxyPharma consider the results very encouraging for further development of Rabeximod. We have therefore decided to invite pharmaceutical companies for partnering discussions. OxyPharma is in the process of appointing an advisor to assist in this process”, said Mr. Bj√∂rklund.

Rheumatoid Arthritis Market Estimates of the value of the global rheumatoid arthritis market vary between USD 6 and 13 billion annually. The market growth is significant. There are presently no effective, safe and oral drugs for rheumatoid arthritis treatments.

About Rabeximod: Rabeximod is an orally available small molecule that is first-in-class and classified as a disease-modifying anti-rheumatic drug. Its mechanism of action is an interaction with the inflammatory tissue type A cells, often described as macrophages. In vitro data on human peripheral blood cells show that Rabeximod suppresses the differentiation of monocytes into pro-inflammatory macrophages but not anti-inflammatory macrophages. The inflammatory macrophage is the central orchestrator of the inflammatory response leading to tissue destruction and clinical symptoms. Thus, the macrophages is a key cell in immune presentation of antigens and plays a role in both the initiating phase of the inflammation as well as in perpetuating the inflammatory process.

The commercial use of Rabeximod and related compounds as a rheumatoid arthritis medication is covered by strong patents.

Don't Wait Too Long To Talk About Elder Care

Indy Star

Through nearly 20 years working with the elderly, I've learned something profound. Most people don't fear dying -- they fear the aging process.

According to recent AARP survey, baby boomers are three times more worried about a having a major illness (48 percent) or winding up in a nursing home (48 percent) than about dying (17 percent). They're most concerned about becoming a financial, emotional or physical burden on their families.

The AARP also reports that 89 percent of survey respondents older than 50 want to stay in their own homes, surrounded by their lifetime possessions and comforting memories, for as long as possible. Over the past decade I've witnessed a growing trend to enable and accommodate seniors to stay in their own homes, rather than move into assisted-living facilities or nursing homes. Because there are so many questions around and fears about living situations for the elderly, I encourage my clients to plan well for the inevitable future.

In 2006, life expectancy at birth for the total population reached a record high of 78.1 years, according to the Centers for Disease Control and Prevention. Thanks to modern medicine and personal attention to living healthier lifestyles, today we can expect to live a lot longer than previous generations. What we can't expect or take for granted is quality of life.

Diseases of the heart and cancer still account for nearly half of all deaths for those older than 65. Progressive diseases such as diabetes, respiratory illnesses and Alzheimer's also are becoming more prevalent contributors to mortality. This means our parents may struggle for years with a debilitating illness.

I encourage my elderly clients and their family members to have open, honest dialogues about lifestyle expectations -- and to talk about it early and often. Yes, it can be scary and uncomfortable at first. But it's much worse to wait for a health crisis and then try to assume what your loved one wants. I've seen this unfortunate situation time and time again.

Some questions you should discuss include: How and where does your loved one want to live when they need assistance at home? If they can stay in their home with home health-care nursing, aide or companion assistance, will there be adequate insurance or savings to pay for these services? How much does home care cost compared to assisted living? Would your loved one rather stay with you or another family member?

If you're just too uncomfortable initiating or having the discussion with your parent, suggest having the discussion facilitated by a family friend or a clergyman. Another great resource is a geriatric care adviser. Usually a registered nurse, this professional helps seniors and their families through the complexities of aging; this can include everything from organizing medical information to coordinating care in a crisis. Also, be sure to talk to a financial planner about finances as well as long-term care and life insurance programs.

Since 1980, deaths from Alzheimer's disease have doubled with projected diagnoses expected to climb to 42.3 million by 2020. It's as good a time as any to start a conversation with your aging parent to help them -- and you -- face fears straight on and gain a little peace of mind about the future.

30 November 2009

4-Week Decline In Flu-Like Cases

USA Today

Federal health officials reported Monday that cases of flu-like illness in the USA have declined for four weeks in a row, though hospitalization rates remain high, especially for children younger than 4.

The steady decline in the USA and elsewhere prompted the World Health Organization to propose Friday that swine flu may have peaked in North America, the Caribbean and parts of Europe, though the "winter influenza season continues to be intense."

U.S. officials challenged WHO's hopeful assessment, saying it is too soon to declare that swine flu is tapering off.

"We are certainly nowhere near the end," says Daniel Jernigan of the Centers for Disease Control and Prevention, noting that, even after the monthlong decline, "we're still above the peak we had last winter."

Jernigan says there also was a drop in cases at this stage of the 1957 pandemic, which appears to offer the closest parallel to today's outbreak. But flu cases and deaths rebounded after the Christmas and New Year's holidays. "The conditions that influenza likes – winter with people crowding together – haven't even come yet," he says.

Deaths of children continue to mount, the CDC reported, with a record 27 during the week ending Nov. 21. That's the highest one-week total since swine flu, also known as H1N1, was identified in April. Doctors have reported about 200 pediatric swine flu deaths to the CDC, which says many more deaths probably have gone unreported.

As of Monday, 66 million doses of swine flu vaccine were available for states to order, and more were on the way, the CDC's Thomas Skinner says.

U.S. Redoubles Efforts On AIDS / HIV


The United States, which is preparing to lift a ban on visits by foreigners infected with HIV, will host a global AIDS conference in 2012 as a sign of redoubled U.S. commitment to fight the pandemic, U.S. Secretary of State Hillary Clinton said on Tuesday.

"We have to continue to seek a global solution to this global problem," Clinton told a news briefing announcing the 2012 biannual conference would take place in Washington D.C., the first time it has been on U.S. soil since 1990.

The International AIDS Society, which organizes the conference, hailed the change and urged other nations that maintain bans on HIV-positive visitors to follow suit.

"The return of the conference to the United States is the result of years of dedicated advocacy to end a misguided policy based on fear, rather than science," IAS President-elect Elly Katabira said in a statement.

Clinton said the end of the ban on HIV-positive visitors to the United States, enacted 22 years ago, would take effect in early January and would be "vigorously" enforced.

Health and Human Services Secretary Kathleen Sebelius said the end of the ban was an important shift.

"It was a policy that tore apart families, kept people from getting tested, forced others to hide their HIV status and forgo lifesaving medication ... and most of all it didn't reflect America's leadership in fighting the disease around the world," Sebelius told the news conference.

The AIDS virus infects 33 million people globally and around a million in the United States, but more people are living longer due to the availability of drugs, according to a recent United Nations report.

However, more than half of the people who need life-saving drugs are not getting them, according to the 2009 AIDS epidemic update by the World Health Organization and Joint UN Programme on HIV/AIDS.

Cocktails of drugs can control HIV but there is no cure.

While the Obama administration has vowed to continue the President's Emergency Program for AIDS Relief or PEPFAR, launched during the Bush administration, some AIDS activists have voiced concern that the issue may not get as much attention as Washington confronts a raft of other global problems.

Eric Goosby, the new U.S. global AIDS coordinator, told the news conference that a full report plotting the future of PEPFAR would be issued later this week and would show expanded U.S. support for the world battle against HIV/AIDS.

27 November 2009

Using Technology To Improve Health-Care: An Interview With Humana CIO Bruce Goodman

Wall Street Journal

A lot has changed in the way the health-care industry uses technology since Bruce Goodman became Humana Inc.'s chief information officer in 1999. And, he says, there's still a lot of work to be done.

Mr. Goodman, who joined the Louisville, Ky., health-insurance giant amid the Y2K frenzy over the ability of computers to deal with a year ending in 00, sees both technical and creative challenges looming for his industry. His primary goal is to get doctors, patients and insurers fuller information more quickly.

Mr. Goodman recently discussed these challenges and more with The Wall Street Journal. Here are edited excerpts of the conversation:
An Echo of Y2K

THE WALL STREET JOURNAL: Do you think we'll ever see something like Y2K again?

Mr. Goodman:
The health-care industry is going to go through something equivalent to Y2K in a couple of years. There is a new code that the government is promoting around how you describe medical procedures called ICD-10. And that significantly expands the code set when a doctor describes what they have done for a patient.

So the old code said, "broken leg." The new code set gets much more specific as to exactly what part of the leg is broken and why it got broken. Tennis accident, skiing accident; it is really detailed.

You have got to go through all the systems where those kinds of codes are carried and expand those fields and bring in those new code sets. A lot of it can be automated. But it means remediating millions of millions of lines of code across lots of systems—systems hospitals use, we use, doctors' offices use. [When completed] it gives you more capability. You can do much more refined studies in terms of what is going on.

WSJ: How much freedom do you give Humana employees when it comes to using technology?

Mr. Goodman: They have a lot of freedom, but we are in a highly regulated business. We have some very confidential information about our members, and we are very sensitive to the level of security and the devices employees use. Our data center is attacked millions of times a month from the Internet. So we don't have our users using devices that can bring viruses and worms and Trojans and phishing expeditions into the mother ship.

WSJ: How can you tell which ones meet that criteria?

Mr. Goodman: For example, currently the Apple iPhone doesn't. It is not a secure enough platform where we would allow our highly confidential data to move. We tightly control laptops and other things that we give to our people. BlackBerrys, by the way, do satisfy the requirement, and we have those.

WSJ: What's the difference between the iPhone and the BlackBerry?

Mr. Goodman:
The main difference is that if you lose a BlackBerry there are ways of ensuring that if somebody else picks it up, they can't get into the network and access your private data. There is a way of basically shutting it down. It's much more challenging to do that on the Apple devices.
Reforming the System

WSJ: There's a lot of talk now about using technology to reform the health-care system. What have you guys done to date?

Mr. Goodman: You want doctors to use your Web site for self service. The difficulty was that a typical doctor's office has patients from dozens of different health plans. So, each health plan has various degrees of advancement in terms of providing Web capability, right? And then the doctors would have to train their staff, which tends to have a fairly high turnover in the front office, to use all of those different systems. So, we got to a certain point of adoption and we were having a hard time getting beyond that.

We went and had a conversation with a competitor, Blue Cross Blue Shield of Florida, and said, "This is silly. Why don't we come up with a uniform Web portal for doctors?" Now more than 95% of all the doctors' offices in Florida use this capability, and it includes Aetna, UnitedHealth, Cigna, a lot of local plans and ourselves, so that the majority of patients that come into a doctor's office, they can go to that one Web site and get the information they need.

[We've since partnered with plans in other states and] we're rolling out in Texas, Illinois, Oklahoma and New Mexico. Not only has it been successful in terms of increasing adoption of the Web, but we have also gone off into clinical transactions, like e-prescribing. The venture has gone from practically no revenue to $70 million in revenue. And it does 600 million transactions a year.

WSJ: Is this the model for how technology can improve health care?

Mr. Goodman: Absolutely. What many people don't realize is that health plans are in a unique position to provide information about the patient.

If a member is seeing more than one doctor or is getting prescriptions from more than one doctor, we see all of that if we insure them. We know when a member didn't refill a prescription, so we can tell a doctor there is a gap in adherence. If doctors are doing e-prescribing using hand-held devices, we can show them lower-cost drug options for their patients at the time of the script writing.

More to Do

WSJ: What parts are missing now?

Mr. Goodman: A number of things. Very few doctors' offices have electronic medical-records systems. And patients don't do a personal health record because a lot of them don't see the value of it. And frankly until you connect all the pieces and crunch it with data analytics, there isn't a lot of value to it. Part of [what will drive] adoption is getting everybody hooked up, and then generating actionable information that is useful to everybody in the system. You could take a lot of money out of the system by doing that.

WSJ: Who has to make this happen?

Mr. Goodman: What's disappointing about what's going on in Washington is that health plans are viewed as the villains, and we're actually in the best position to promote some of these advances because we have the data. We can provide monetary incentives to the doctors and to the [patients] to take advantage of whatever data analytics we do and, therefore, drive the adoption. And with the adoption you improve quality of care and you lower the cost of care.

When you have a not-for-profit organization or a plan, [they just don't have the incentive] to connect the doctors. When you have somebody who's in it for a profit, you have a motivation to root out fraud and abuse and to try to really improve the quality of care, because it costs less if you have good care.

Looking Ahead

WSJ: How will the experience of being a patient be different in the future than it is now?

Mr. Goodman:
To get an appointment at a doctor's office you'd go onto the Web, whether you're using a smart phone or not. And when you show up at the doctor's office, let's say it was your first visit, a lot of information that normally they would ask you for has already been downloaded.

In the exam office, there is a monitor and the doctor has everything in front of him or her. If there is a prescription needed, the doctor can do that electronically and can find out what's the most cost-effective drug for you and make sure you don't have a drug interaction [issue], because you have already had all of your prescription information downloaded.

To pay, you have an ID card, or maybe your cellphone, that immediately connects you, and your claim is adjudicated in real time. There is no paperwork.

WSJ: We started by talking about 10 years ago. Looking ahead 10 years, what happens to IT?

Mr. Goodman:
I think there is always a place for people that really understand technology and can deliver an industrial-strength capability into the business. Maybe everybody will walk around with a contact lens that has 5G capability and an earplug, and you are integrated into the Internet.

I absolutely think [that sort of thing] is going to happen. I don't know if it is in 10 years, but bandwidth is going up. Cost of computers is going down. Size of computers is going down. Cost of storage, size of storage is going down. Those are the key trends. They make everything possible.

You get an embedded chip. Maybe it gets its energy from your stomach. You could burn 100 calories a day to keep your electronically embedded stuff going.

Rising Numbers Requesting Food Aid

Wall Street Journal

The U.S. Agriculture Department said Monday the number of households that reported struggling to buy enough food in 2008 jumped 31% over the previous year.

According to the USDA's annual poll, 17 million U.S. households reported some degree of food insecurity in 2008, up from 13 million households in 2007.

"It is time for America to get very serious about food security and hunger," said Agriculture Secretary Tom Vilsack, who is pressing Congress to expand such programs as food stamps and free school lunches that consume roughly 70% of his department's budget.

Comparable numbers for 2009 aren't available yet. Officials with organizations involved in feeding the hungry say the survey results square with growing demand at food pantries: the number of people seeking help this summer is up an average of 30% from the summer of 2008, according to a recent survey of food banks by Feeding America, a food-bank network.

The 2008 survey results suggest that almost 15% of U.S. households had trouble putting enough food on their tables, up from 11% in 2007; the proportion is the highest detected by the survey since it began in 1995. Put another way, about 49 million people, including about 17 million children, worried last year about getting enough to eat.

Maura Daly, vice president of government relations for Feeding America, said 90% of food banks in the recent survey reported that, according to anecdotal evidence, unemployment is the leading factor for the increased demand.

U.S. consumers in 2008 also saw a sudden acceleration in the cost of food. While the food inflation rate has stalled this year, some economists are worried that the move by many recession-weary farmers to cut production might ignite grocery prices again next year.

The global recession is helping swell the number of hungry people around the world to the highest levels since the early 1970s.

But the way USDA economists measure food worries in the U.S. is far more liberal than their gauge for other nations, where people are labeled food insecure only if they consume fewer than 2,100 calories a day. Few of the U.S. households labeled as food insecure by the USDA have it that tough.

Instead, the USDA's domestic survey tries to quantify the number of households that have difficulty providing enough food at some time during the year. Many of these families are able to avoid hunger by participating in such federal nutrition programs as food stamps, or by having their children participate in a free school-lunch program.

Still, the USDA survey indicates that someone in about one-third of food-insecure households experienced some hunger or came very close to it in 2008. In these households with very low food security, food consumption fell and normal eating patterns were disrupted.

According to the survey, 6.7 million U.S. households had very low food security in 2008, up 43% from 4.7 million households in 2007.

Breast-Screening Advice Upended

Wall Street Journal

For years, women have been taught to perform regular breast self-exams and those 40 and older told to undergo annual mammograms to detect breast cancer, a disease that kills about 40,000 people in the U.S. every year. Now, new guidelines released by an influential government-funded authority on screening offer this message: never mind.

The new U.S. Preventive Services Task Force guidelines, published Monday in the Annals of Internal Medicine, state that routine mammograms aren't necessary for women of average cancer risk in their 40s, and that women between 50 and 74 years old don't need to undergo mammograms more often than every other year. They also recommend that physicians abstain from teaching women how to examine their breasts for signs of cancer because of a lack of evidence that it is of any benefit.

The guidelines were based on a routine review of research published since the last set of recommendations and a new analysis of data. The guidelines were formed by weighing benefits of screening compared with the harms of false positives, such as anxiety and unnecessary additional tests and biopsies, which are expensive and time-consuming, according to Diana Petitti, vice-chairman of the task force.

The task-force recommendations only apply to women without a family risk of breast cancer and who don't have genetic mutations known to be associated with breast cancer, such as the presence of BRCA1 or BRCA2 genes.

By scrubbing the previous recommendation of annual mammograms for women 40 and older, the new guidelines are likely to be controversial and confusing. They also raise concerns that health insurers will curtail coverage and reimbursements for screenings that fall outside the guidelines, according to doctors and groups including the American Cancer Society.

Phil Evans, a professor of radiology at the University of Texas Southwestern Medical Center and president of the Society for Breast Imaging, says he was "shocked" by the changes. "There's a ton of scientific data in this country and others on screening that shows a significant benefit for women between 40 and 49 to be screened," he says.

The National Comprehensive Cancer Network, the American Cancer Society and the American Medical Association recommend annual mammograms for women starting at age 40, while the American College of Physicians recommends women in their 40s decide for themselves whether to seek annual exams.

USPSTF Breast Cancer Screening Guidelines: Then and Now

2002: Recommended every 1 to 2 years for all women older than 40
2009: Recommends against routine screening for women 40 to 49; recommends mammograms every 2 years for women 50 to 74; insufficient evidence to conclude benefit or harm of mammograms for women 75 and older

Breast Self-Examination

2002: Insufficient evidence to conclude benefit or harm
2009: Recommends against teaching BSE

Digital and MRI Mammography
2002: Not addressed in guidelines
2009: Insufficient evidence to conclude benefit or harm 
Source: U.S. Preventive Services Task Force guidelines published in 2002 and 2009

The task force, which receives funding from the federal Agency for Healthcare Research and Quality but is independent from the government, last issued guidelines for breast cancer in 2002. "The task force isn't saying there isn't a benefit" to screening women in their 40s, but "we're saying the benefit is small," Dr. Petitti said. "The change really is a change between do it routinely and don't do it routinely." Women 40 and older who are free of any symptoms should talk with their doctors and decide with them whether to put off screening for a few years, she said.

Dr. Petitti's advice is less nuanced about the issue of breast self-examinations. "Women should know it doesn't work," she said. Two large studies published since the last guidelines, involving 200,000 women in China and more than 100,000 in Russia, showed no benefits from breast self-examinations, she said.

There is agreement among scientists that mammography saves lives but that it also gives rise to numerous false positives. It reduces cancer death by about 15% in women ages 39 to 59, according to the task force's review of published data.

There are fewer cases of cancer in younger women, which means there are fewer absolute benefits when weighed against risks for women in their 40s. For each case of cancer death prevented among younger women, 1,900 women must be screened, according to the task force's review of published data. That ratio drops to 1 for 1,300 for women 50 to 59 years old, and 1 for 377 for women 60 to 69 years old, according to the task force.

The task force's interpretation of the data overstates the downsides of mammography for women in their 40s and doesn't take into account the fact that saving a younger woman leads to more "life years saved" than for older women, Dr. Evans says.

About $3.3 billion was spent on mammograms in the last 12 months, according to the American College of Radiology.

Whether the new guidelines lead to changes in insurance reimbursement is likely to be a big concern among health providers and patients.

The Centers for Medicare and Medicaid Services, which administers government health benefits for the elderly and the poor, says the new guidelines wouldn't change how it covers mammograms for Medicare patients. But that may not be the case for private insurance. The task force guidelines tend to influence public and private insurers' coverage decisions, though they aren't the only factor, according to John Ayanian, a professor of medicine and health-care policy at Harvard Medical School who published a paper last year on the impact of cost-sharing on mammogram usage rates in the New England Journal of Medicine.

Susan Pisano, spokeswoman for America's Health Insurance Plan, an industry trade group, says she anticipates mammogram coverage will continue even for those who fall outside the new guidelines' target age range. What may change, she says, are insurers' aggressive outreach efforts to get women to get their screening, such as the reminder postcards they used to receive about getting their annual mammogram.

Eric Winer, chief scientific adviser of Susan G. Komen for the Cure, a breast-cancer advocacy foundation, and director of the Breast Oncology Center at Dana-Farber Cancer Institute in Boston, says that "at a minimum, what we can say is that women and their doctors have a right to make a decision about whether they should be screened. If they don't have financial coverage, then they don't have that right."