Wednesday, August 1, 2012

Nestlé Buys U.S. Maker of 'Brain Health' Shake

Nestlé SA, NESN.VX +0.33% making a foray into "brain health products," said it bought a stake in a company that makes milkshakes for Alzheimer's patients.
Nestlé, better known as the maker of Kit Kat chocolate bars and Nescafe coffee, didn't disclose how much it invested in closely held Accera, which is based in Brookfield, Colo. It also declined to say how much of Accera it would own, but said it would take a seat on its board.
"The significance of this is not the size of the investment, but the fact that it is our first step in developing our brain health portfolio," said Luis Cantarell, president and chief executive of Nestlé Health Science, a subsidiary set up by the Vevey, Switzerland, company last year.
Nestlé has long been interested in the links between food and brain health. In 2006, it invested 25 million Swiss francs in a collaboration with ETH Lausanne, a leading Swiss technical university, to develop food products that protect the brain against diseases such as Alzheimer's. The company's interest in the field intensified last year with the launch of Nestlé Health Science.
Nestlé plans to invest around $500 million over the next 10 years to produce more food and drink products with health benefits. The subsidiary is focused on gastrointestinal, metabolic and brain health. Alzheimer's, which affects memory and cognitive function, is the most common adult form of dementia and affects five million in the U.S. alone, Nestlé said.
Accera sells Axona, an easy-mix powder that is added to milk or other liquids to make a once-daily drink. Axona is already given to 30,000 patients in the U.S. Axona is made from a compound derived from coconut oil that purports to provide an alternative energy source for the brain. In theory, this would help Alzheimer's patients because their brains are less able to use glucose for the energy they need.
Axona requires a prescription.
Because it is sold as a medical food, the Axona milkshake must meet truth-in-labeling requirements. It doesn't require approval from the U.S. Food and Drug Administration.
"We are not saying it is a cure for Alzheimer's. It has demonstrated in certain patient groups that it can be a source of energy for the brain and slow down cognitive decline," said Mr. Cantarell. He said the science merited further investment and clinical tests.
Accera has completed four trials involving more than 150 patients. The studies showed the product was safe and produced significant cognitive improvements in some patients with mild to moderate Alzheimer's, Nestlé said. Accera now plans a new trial involving 300 to 400 patients over a six-month period.
Nestlé signaled its intentions to expand in the health and wellness market last year by setting up NHS, which is focused on food with medical benefits, often called nutriceuticals. NHS has made a handful of small acquisitions since.
It is aiming to capture a bigger slice of a market that is expected to grow to $691 billion a year by 2015 from $600 billion in 2010, according to research by Euromonitor International.
Analysts said they didn't think the investment was large, but welcomed the move as a long-term investment in a growing market.
"This is a seed for the future, and is part of Nestlé's long-term strategy," said Jean-Philippe Bertschy, an analyst at Bank Vontobel in Zurich.

The Lasting Effects of Neglect: Altered Brain Structure in Children

Fortunately, good foster care can help neglected children catch up developmentally, in part
Kids who are neglected, growing up without normal emotional and social interaction, have measurably different brain structure from other kids, according to a new study from researchers at Boston Children’s Hospital.
The study compares kids raised in Romania’s infamous state-run orphanages with kids raised in normal Romanian family homes at the same time. MRI brain scans show that children raised in run-down institutions — typically with just one adult supervisor per 12 young kids — developed measurably lower grey matter volume and white matter volume in the cortex of the brain than children who grew up among their families.
However, children who spent their infancy in the orphanages but were then delivered to high-quality foster care as small children fared somewhat better than those left behind in the institutions. Those kids’ cortical white matter was no different from that among children who had always lived with families, the study shows. But the foster kids still had lower grey matter volume than normal.
The findings do show “the potential for developmental ‘catch-up’ in white matter growth, even following extreme environmental deprivation,” the study authors write. And that’s cause for optimism: it shows that some of the damage due to early childhood neglect can be undone.
White matter is important because it’s responsible for much of the connectivity between different regions of the brain; it’s the brain’s “information superhighway,” as one of the researchers puts it. But growth of grey matter — the part of the brain thought to control sensory perception and muscle control — tends to happen during concentrated periods of childhood, not all throughout childhood like white matter growth does. This may be why grey matter development seems harder to catch up on later, the authors write in their paper.
These latest findings about the long-term consequences of neglect are only the latest from a prolific research program known as the Bucharest Early Intervention Project (BEIP).
Under the authoritarian rule of Nicolae Ceausescu, starting in the late 1960s, Romania enacted laws to encourage women to have at least five children. Contraception and abortion were outlawed, so that sick and unwanted babies were abandoned in large, understaffed institutions.
The results were horrific. Kids went without adequate beds, clothes, bathroom facilities or adult supervision. By the end of the Ceausescu regime, in the last days of 1989, there were more than 100,000 children living in the institutions.
BEIP began a full decade later, in 2000, to assess the consequences of early childhood deprivation and to test the efficacy of new foster-care programs. The Project is run out of Boston Children’s Hospital’s Labs of Cognitive Neuroscience.
For their research, the Boston scientists recruited 136 young children who were institutionalized in 2001 in Bucharest, Romania. They randomized half the kids to enter high-quality foster care and half to stay in institutional care — which had been improved substantially since the Ceausescu era, although staff-to-children ratios remained high.
Through the years since BEIP has started, its researchers have shown that neglected kids fall short on IQ and language skills; that they are more prone to behavior disorders and repetitive motions like rocking, flapping and banging their heads against things; and that they even show signs of accelerated cell aging.
The latest results about brain structure, published online this week in the Proceedings of the National Academy of Sciences, are based on screenings conducted when the kids in the study were aged 8 to 11. These new findings seem consistent with previous BEIP research on cognitive development among institutionalized kids.
“These differences in brain structure appear to account for previously observed, but unexplained, differences in brain function,” lead researcher Margaret Sheridan told reporters.
And the importance of the findings remains grave. At least 8 million children worldwide currently live in institutions, according to UNICEF. Many of those kids continue to experience severe social or physical neglect.

Brain scans to detect Alzheimer's decades ahead

CHICAGO: The first Alzheimer's-related changes begin to develop some 25 years before memory and thinking problems appear, according to a new study that may offer a valuable guide for companies looking to test new treatments in people at an earlier stage.
The study, published on Wednesday in the New England Journal of Medicine, offers a timeline of changes in spinal fluid, brain size, the appearance of brain plaques and other factors that precede the onset of Alzheimer's in people who are genetically predestined to develop the brain-wasting disease.
"It's really the first report that we have in living people of these changes," said Dr. Randall Bateman of Washington University School of Medicine in St. Louis, Missouri who helped lead the study.
Current drugs for Alzheimer's only treat symptoms and none have yet been able to keep the fatal disease from progressing. Some researchers think that may be because the disease has been studied too late in its progression.
So scientists have been searching for ways to test treatments at an earlier stage, when many researchers think new therapies will have the best shot at doing some good.
Conducting such trials in people with the common form of Alzheimer's disease would need to be huge and last for decades.
Instead, the study by the team at Washington University focuses on families enrolled in the Dominantly Inherited Alzheimer's Network, a consortium that enrolls people who are genetically predisposed to develop the disease at an early age.
"On average, patients with this form get Alzheimer's Disease by 45," Bateman said in a telephone interview.
People in these families have a 50 percent chance of inheriting one of three genes that cause early Alzheimer's and most develop symptoms around the same time as their affected parent.
Bateman followed the progress of 129 individuals and used family histories to estimate when study subjects should begin to develop Alzheimer's symptoms. They developed a timeline of changes in the body leading up to the memory loss and declines in thinking skills associated with Alzheimer's.
The first of these changes, a drop in the level of a protein known as amyloid, can be detected in spinal fluid as early as 25 years before the disease is expected to develop.
At 15 years before onset of the disease, clumps of an Alzheimer's-related protein called beta amyloid become visible on brain scans. Other scans show shrinkage of brain structures, and levels of a toxic protein called tau start to rise in spinal fluid.
At 10 years before onset, the brain becomes less adept at using glucose and some slippage in certain kinds of memory skills can be detected.
Bateman said it is not clear whether the same timeline would apply to patients who have more common late-onset Alzheimer's disease, which usually develops after age 65. But he said the biomarkers are very similar to changes already used by doctors to characterize and track the disease.
"What we don't know is if the time, the order of magnitude and the size of these changes is similar or not," Bateman said. "It may be many years before we have this information."
Researchers plan to use information from the study to test drugs on these patients before symptoms develop.
Crenezumab, an experimental Alzheimer drug made by Roche's Genentech unit has already been selected for a similar kind of test in a large family of people in Colombia who develop early onset Alzheimer's disease.
While Bateman would not say which drugs will be tested in the study, he said they will likely test three compounds "that we think represent some of the best and most advanced compounds in development."
Results of two of the most advanced drugs being studied are expected this fall. They include late-stage studies of bapineuzumab being developed by Pfizer and Johnson & Johnson, and solanezumab, being developed by Eli Lilly .
Another drug in late-stage trials is intravenous immunoglobulin, an immune system treatment being studied by Baxter International Inc.
As many as five million Americans have Alzheimer's and the clock is ticking to find a cure.
Experts predict that without an effective treatment, the number of Americans with Alzheimer's will double by 2050 to more than 10 million, and related healthcare costs could soar to over $1 trillion a year.

BGU scientists overcome ‘blood brain barrier’

‘V-Smart technology’ unique targeted drug delivery system could improve treatment of neurological diseases.

BGU Team
After eight years of intensive work, a team of Ben-Gurion University scientists has overcome the “blood brain barrier” that prevents drugs from passing into the brain and reaching specific targets to fight disease.

The system of synthetic nanoscale structures, called V-Smart drug delivery technology, also allows oral medications to pass through the epithelial tissue of the intestinal wall and other biological membranes; thus, the Beersheba researchers hope that injectable-only drugs for a variety of diseases could eventually be made in pill form.

The breakthrough technology, which uses microscopic, bubble-like membranous structures known as vesicles, was developed by the interdisciplinary team of emeritus Prof. Eli Heldman of the university’s clinical biochemistry department, Dr. Sarina Grinberg of the chemistry department and Dr. Charles Linder of the Avram and Stella Goldstein- Goren Department of Biotechnology Engineering.

A New York biotech company, Lauren Sciences, has signed a licensing agreement with BGU’s technology transfer company BGN Technologies.

Articles on the technology have been published by the Negev-based team in the Journal of Controlled Release, the Journal of Chemistry and Physics of Lipids and the Journal of Liposome Research, among others.

Despite great advances in therapeutic drugs, the problem of unwanted side effects remains a serious obstacle to treating patients. Most adverse effects are the result of a drug’s interaction with locations in the patient’s body that are not relevant to its medicinal action. But if an effective delivery system can make medications more available at target locations, the amount of harmful side effects is much reduced.

The V-Smart delivery system could be especially relevant to diseases of the central nervous system, from Parkinson’s and Alzheimer’s to multiple sclerosis, amyotropic lateral sclerosis and neurological complications of HIV, as well as brain cancers.

The scientists administered V-Smart vesicles intravenously and orally to lab mice to deliver to the brain encapsulated material such as analgesic peptides that greatly reduced pain.

In an interview on Sunday with The Jerusalem Post, Heldman predicted that the technology could be used in clinical trials in about two years.

The technology is based on nano-sized vesicles formed from a combination of specifically designed structures called bolaamphiphiles.

The tiny sacs, which are somewhat like fat globules called liposomes, but synthetic, are highly stable and provide a controlledrelease mechanism that makes it possible for drugs to pass through biological barriers. It then pinpoints exactly where the drug will be released in the brain, thus making the drugs more efficient and reducing side effects.

The blood brain barrier was meant by the body to keep poisons out of the brain by separating circulating blood from the brain’s extracellular fluid in the central nervous system. It occurs along all capillaries and consists of tight junctions around the capillaries that do not exist in normal circulation.

But it also bars the entry of many beneficial drugs. Thus, using nanoparticles to deliver medications across this divide is very important.

The work on oral medication delivery is preliminary but very promising, Heldman said. Teams working elsewhere have found other methods, including the injection of hyperosmotic solutions that shrink cells or the injection of drugs into the brain.

“But our system is much better because it doesn’t break the blood brain barrier,” he explained. “It also has great stability, can target where the drug will be sent and releases the encapsulated drugs in a controlled manner at the target site.”

“Archi-bacteria, which are organisms that live under very extreme conditions, such as in volcanoes, triggered our ideas for the technology,” Heldman said. “To survive, they evolved lipids that gave them stability over a long period. But these lipids have to be very pure and it’s very difficult to synthesize them.”

He added that the team chose to create bola lipids, “which are like two-headed weapons and have a different kind of membrane. The result is a very stable and selective mechanism that makes it possible to release drugs in the spot we want beyond the blood brain barrier.”

The BGU scientist said the team was also working on a delivery system for use in specific parts of the brain for Parkinson’s disease.

“So far, the delivery system has been shown to work,” he said. “But it still needs a lot of development. I estimate that in six months we can persuasively prove that the system works.”

Heldman recently returned from the US National Institutes of Health, where he worked for three years on “small-interference RNA” to “silence” genes for the delivery of nucleic acids into the brain that he and his BGU team had first developed in Beersheba.

“Our patented technique could have major therapeutic potential for treating disease,” he said.

Heldman also said that BGU and Lauren Sciences, where he is chief scientific officer, had recently been awarded two prestigious research grants, one from the Michael J. Fox Foundation to develop the delivery of proteins in the treatment of Parkinson’s disease, the other from the Campbell Foundation for delivery of the antiretroviral drug Tenofovir for treatment of neuro- HIV.

“We hope that the success of these projects will improve these patients’ lives,” he said.

Prof. Shlomo Constantini, head of pediatric neurosurgery at the Dana Hospital of Tel Aviv Sourasky Medical Center, was impressed when he heard of the BGU development.

“This is exciting, fascinating and has huge potential,” Constantini said.

Patients warned of potential exposure to fatal brain disease

CHARLESTON, S.C., July 31 (Reuters) - A South Carolina hospital said it has notified 11 brain surgery patients that they could have been exposed to a rare brain disease through surgical instruments used on a patient who was later diagnosed with the fatal condition.
Greenville Hospital System officials said the patient was found to suffer from Creutzfeldt-Jakob disease, a degenerative brain illness that affects one to two people per million worldwide each year and is always fatal, according to the Centers for Disease Control.
Death usually results within one year of diagnosis.
The CDC recommends that instruments that have come into contact with Creutzfeldt-Jakob disease undergo additional sterilization procedures prescribed by the World Health Organization.
In this case, because the Creutzfeldt-Jakob diagnosis wasn't known at the time of the patient's surgery, the instruments were "sterilized according to rigorous U.S. protocols" but did not undergo any extra disinfecting, a hospital spokeswoman said.
Officials said they believe there was a low chance that the disease was transmitted to the other patients, who underwent neurological surgeries after the infected patient in February.
No cases of transmission of the brain disease from surgical equipment have been reported since 1976, according to the CDC.
"This is a very unusual event," said Dr. Thomas Diller, vice president of quality and patient safety for the Greenville Hospital System. "After a full assessment and discussion with the CDC, we believe the risk of transmission of Creutzfeldt-Jakob disease to any patient is extremely small."
"We also value transparency and thus notified all patients who could be affected by this potential exposure," he said.
Creutzfeldt-Jakob disease is diagnosed through an autopsy or brain biopsy, according to the CDC. The hospital would not confirm whether the patient with the diagnosis has died.
Greenville Hospital System said it has partnered with the CDC and the National Prion Disease Pathology Surveillance Center to investigate whether the 11 other patients were exposed.
Destroying equipment that comes into contact with the illness is the safest option but is not always possible, according to the CDC.
"Destruction of heat-resistant surgical instruments that come in contact with high infectivity tissues, albeit the safest and most unambiguous method as described in the WHO guidelines, may not be practical or cost effective," the CDC website says.

Which Is Bigger: A Human Brain Or The Universe?

Brain with exclamation point

Brain cloud

This is one of those fun-to-think-about questions. A brain isn't much to look at, after all. It's about the size of your two fists put together, three pounds to hold, but oh my, what it can do.
With our brains, we can think backwards, imagine forwards, conjure, create things that don't exist, leap vast distances. For example, suppose I say to you, close your eyes and imagine this:
...let's you and I rocket off the Earth and keep going, out past Neptune, then past the nearest star, then on and on across a patch of cold empty space until we reach an interstellar gas cloud glowing pale blue, and when we get there, let's fly to the top, hover near a small baby star softly glowing, and move in closer to see it peeking out from the top of the cloud...
Can you see this with me? I bet you can. You can fly with me across vast distances, go to impossibly faraway places because you have the tool that lets you — that hunk of flesh in your head.
"Our creatures are our thoughts," said the poet John Donne way back in the 1620s, and our thoughts "reach from east to west, from earth to heaven; that do not only bestride all the sea and land, but span the sun and firmament at once; my thoughts reach all, comprehend all."
If a brain can make crazy leaps across the cosmos and bring extra passengers along (like you when you listen to me), then in a metaphorical way, the brain is bigger than what's around it, wrote 19th century poet Emily Dickinson.
The brain is wider than the sky,
For, put them side by side,
The one the other will include
With ease, and you beside.
I like her confidence. The brain reaches where it pleases "with ease," so she figures it's bigger than everything. It can do things the physical universe can't, like go backwards. ("Let me tell you what happened to me yesterday...") And while I agree with Dickinson, the brain is formidable — does it get the crown?
Brain with crown

  Well, let's hear from the Universe; As critic Kathryn Schulz wrote recently, if you think of the cosmos the easy way, as a giant expanse with stars, planets and gas clouds, then yes, a mind can imagine all that ("and you beside"). But what if we make it a little harder, and consider the mysteries of dark energy, the space/time continuum, Higgs fields, teeny bits of energy popping up out of nowhere and then vanishing into the smallest imaginable spaces? What if I tell you that the faster you go, the bigger you get, until at the speed of light, your mass increases enormously?
That's Silly
"Many people think that this is silly," wrote astronomer Carl Sagan, "and every week or two I get a letter from someone who complains to me about it," but no matter how strange it seems, this happens to be true, experimentally, verifiably true. But truths like these aren't easy to take in. Our minds boggle.
"The universe is not only queerer than we suppose," said the biologist J.B.S. Haldane, "but queerer than we can suppose." In Haldane's view, the universe is bigger than the brain. There are things we just can't know, or even conjure with the brains we've got.
There are philosophers and scientists who say we will never understand the universe, we can't fathom the endless details or make good sense of the whole. We can try, but the universe is too big. The writer John Updike once explained the argument this way to reporter Jim Holt:
"It's beyond our intellectual limits as a species. Put yourself into the position of a dog. A dog is responsive, shows intuition, looks at us with eyes behind which there is intelligence of a sort, and yet a dog must not understand most of the things it sees people doing. It must have no idea how they invented, say, the internal combustion engine. So maybe what we need to do is imagine that we're dogs and that there are realms that go beyond our understanding."
Our brains are magnificent compared to other creatures here on Earth, but up against the universe, we are pitiful. That's the argument, anyway. So does the universe get the crown?
Sun behind clouds

I don't know. Carl Sagan thought that we humans are good at finding patterns in nature, and if we know the rules, we can skip the details and understand the outline, the essence. It's not necessary for us to know everything. The problem is we don't know how many rules the cosmos has. How many rules does it take to explain the mystery of non-life becoming life, the finite becoming infinite, matter becoming mind, nothing becoming something? A few? Millions? We don't know.
Yet the brain has its champions. "Consider the human brain," says physicist Sir Roger Penrose. "If you look at the entire physical cosmos, our brains are a tiny, tiny part of it. But they're the most perfectly organized part. Compared to the complexity of a brain, a galaxy is just an inert lump." Yes, it's small, but the human brain has a power that nothing we know of in all the galaxies can match.
So which, then? Brain? Universe? Curiosity versus mystery, which is bigger?
Go Universe!
Speaking personally, I'm rooting for the universe. I don't need, don't want, don't like the idea of one day knowing all there is to know. I don't think we can. I think about Job, the bible's just and honest man, being lifted up high into the heavens so he can see all of God's creation and shrinking painfully away from the sight of "Things too wonderful for me."
I'm not saying we shouldn't try. And even if we amplify our brains with powerful computers, my hunch is the universe will still outwit us, will still be "too wonderful" to be decoded, because we are, in the end, so much smaller than it is. And that's not a bad thing. To my mind, it's the search that matters, that sharpens us, gives us something noble to do.
As the physicist Steven Weinberg famously said, "The effort to understand the universe is one of the very few things that lifts human life a little above the level of farce, and gives it some of the grace of tragedy."
We live to wonder, to ask, to appreciate. Without wonder, why are we here?

I blame Kathryn Schulz for getting me thinking about all this. She wrote a brilliant, provocative review of Jim Holt's new book Why Does the World Exist? that is so much fun to read, you should run, not walk, to find it here. And then, because the review leaves you no option, you will, zombie-like, find yourself compelled to pick up Jim Holt's book (I'm halfway through and loving every page) which visits with a bunch of very smart scientists, novelists and philosophers and asks them why the universe came to be. They all have answers, but Jim knows — and they know — that nobody really knows. The conversations are sharp and fun and Jim writes well enough that I never felt too stupid to turn the page. That's rare.