Cold laser 3 effects and absorption, hump day realignment part 3

May 16th, 2012

Cold laser is red light that can be absorbed by the mitochondria and used for an abundant supply of energy, instead of just sugar for ATP. Laser has 3 mechanisms: at the site, the spreading and use around that spot, and the blood that absorbs the light and travels to other areas of the body.

Cold Laser red light wave frequency range, hump day realignment part 2

May 9th, 2012

Cold laser has super pulsed penetration, red light, and infared light. The laser penetrates 2 inches deep to get to the middle of the knee and shoulder etc so that healing can be faster The other two are absorbed more by the skin and has pain relief qualities.  Watch the video.

Counties with Thriving Small Business have Healthier Residents says LSU and Baylor

May 7th, 2012

My opinion:  LSU and Baylor analyzed census data. They found communities with higher amounts of small businesses tend to have an increase in important non-economic rewards to the local residents of that community. This includes:with lower rates of mortality, obesity and diabetes — than do those that rely on large companies with “absentee” owners.   It appears there is an entrepreneurial culture that promotes public health through a can-do climate, a practical problem-solving approach that takes control of its own community.  There was a trend to work for big corporations but with recent outsourcing and forced part time work with little or no benefits…the gap between small business perk deficiencies and big corp are becoming less.

BATON ROUGE – Counties and parishes with a greater concentration of small, locally-owned businesses have healthier populations — with lower rates of mortality, obesity and diabetes — than do those that rely on large companies with “absentee” owners, according to a national study by sociologists at LSU and Baylor University.
“What stands out about this research is that we often think of the economic benefits and job growth that small business generates, but we don’t think of the social benefits to small communities,” said Troy C. Blanchard, Ph.D., lead author and associate professor of sociology at LSU. “This study highlights not only the economic benefits of small business, but its contributions to health and well-being.”
The study of 3,060 counties and parishes in the contiguous United States,  published online in the Cambridge Journal of Regions, Economy and Society and forthcoming in its March print issue, brings new evidence to a body of research literature and a debate among sociologists, who traditionally have advanced two competing hypotheses about how small business impacts public health.
Some sociologists argue that small businesses — unlike chain retail “big box” stores and large manufacturing plants — have a greater investment in the community and thus have more at stake when it comes to employee health.  The LSU and Baylor researchers, who analyzed national population, health, business and housing data, found that the greater the proportion of small businesses, the healthier the population.
“It appears there is an entrepreneurial culture that promotes public health through a can-do climate, a practical problem-solving approach that takes control of its own community,” said co-author Charles M. Tolbert, Ph.D., chair of the sociology department at Baylor. “The alternative is the attitude that ‘Things are out of our control.’”
Communities may become dependent on outside investment to solve problems, the researchers wrote.
Their findings are a departure from the traditional conclusion that “bigger is better.”
Beginning in the 1970s, communities courted large employers from the outside, with a goal of providing high-paying jobs with benefits. In contrast, small local employers offered lower pay, few — if any — benefits, little chance for advancement, vulnerability to competition and sometimes, practice of nepotism, the researchers wrote.
“The old way of thinking was that you wanted to work for a big company because of pension plans, health insurance, dental insurance,” said co-author Carson Mencken, Ph.D., professor of sociology at Baylor University. “But many of them have moved overseas to cheaper labor markets. So what we see are larger retailers, usually next to interstates, that pay low wages and may not even offer full-time jobs with benefits, but instead hire people to work 30 hours a week. There’s a high turnover.”
Larger companies showed a large drop in wages — 33 percent in real dollars — and access to health insurance between 1988 and 2003, previous research has shown. Amid restructuring and globalization, some large businesses are giving employees furloughs from full-time jobs, then rehiring them as short-time contract workers with no benefits.
While locally owned businesses are not adding greater compensation or benefits, the gap is shrinking.
“It’s in their financial interest to take a stake in the community, to make it a place where people want to live and work,” Mencken said.
“When someone creates a ‘mom and pop’ business, it’s a huge step to bring that first employee on board,” said Tolbert. “If it’s a relative or neighbor, they’ll bend over backward. They’re going to bring on board somebody they trust, and they’ll pull every hair and every tooth in their head before they lay off someone who’s their neighbor.”
For some workers, self-employment is way to escape the “roller coaster” cycle of furloughs and call-backs. Given that health insurance and access to medical care will be limited, poorer health might be expected of those workers.
But small businesses are more likely to support bond issues for health infrastructures, recruit physicians, push for local anti-smoking legislation, promote community health programs and activities and support local farmers’ markets, researchers said.
They found that counties with a greater proportion of small businesses have a healthier population, with lower rates of mortality, obesity and diabetes. They analyzed the number of small businesses per 100,000 people, categorizing small business as those with four or fewer employees; large manufacturing establishments as those with 500 or more employees; and large retailers as those with 100 or more employees.
“Our findings suggest that the rewards of a vibrant small business sector are multidimensional,” said Blanchard.  “In addition to job creation, small businesses yield important noneconomic rewards to communities that may improve the health of local residents.”
LSU and Baylor researchers analyzed data from the 2000 Census of Population and Housing, the 2007 Centers for Disease Control Obesity and Diabetes Estimates, the National Center for Health Statistics Compressed Mortality records from 1994 to 2006, the 2002 County Business Patterns and the 2002 Nonemployer Statistics.
The research paper is based on work supported by the U.S. Department of Agriculture, the National Research Initiative and the Social and Economic Sciences Division of the National Science Foundation.

 http://www.lsu.edu/ur/ocur/lsunews/MediaCenter/News/2012/02/item43081.html

Ashley  Berthelot 

02/07/2012 10:54 AM

Cold Laser invented by Russians , Hump Day Realignment part 1

May 2nd, 2012

Russians invented cold laser by doing surgery from laser and patients healing faster. There are over 2300 studies on laser.   Watch this quick video.

20 percent increase in Cardio risk with One soda a day

April 25th, 2012

SUMMARY: 40K men involved in the study. It was found that one soft drink a day can increase risk of a heart attack by 20%.  Diet drinkers did not have the risk. Yet again the controversy over diet soda cancer risk vs sugar risk is alive and well.  Tests on blood samples showed those who drank the sugary beverages tended to have higher levels of dangerous blood fats and of proteins linked to heart disease.  Sugary and diet(more so with diet) drinks also contribute to diabetes and weight gain. Water, coffee, tea, and low fat milk are the best alternative choices.

——

Drinkng one sugar-laden soft drink every day could dramatically increase the odds of having a heart attack.

A study of more than 40,000 men suggested that a daily sugar-sweetened drink raised the chances of having a heart attack – including a deadly one – by 20 per cent.

In contrast, diet varieties that use artificial sweeteners were given a clean bill of health by the study’s authors.

 Risk: A study of more than 40,000 men suggested that a daily sugar-sweetened drink raised the chances of having a heart attack – including a deadly one – by 20 per cent

Researcher Lawrence de Koning said the body may compensate for the sugar rush of soft drinks by making its own supply of fats, and some of these will be bad for the heart.

  Tests on blood samples showed those who drank the sugary beverages tended to have higher levels of dangerous blood fats and of proteins linked to heart disease. Levels of ‘good’ cholesterol were lower, the journal Circulation reported.

The study also found that the more sugary drinks someone had, including still fruit squashes to which sugar is added during manufacturing, the more the risk rose.

‘Water, coffee and tea are the best choices’

Importantly, the link stood when other factors such as smoking, weight, alcohol and exercise were taken into account. 

The U.S. research team made their link after analysing information provided by men who were asked every two years between 1986 and 2008 to provide detailed information about  their diet.

Tallying the information showed that compared to never drinking sugary soft drinks, having 350ml a day – a standard can contains 330ml – raised the risk of a heart attack by 20 per cent.

Danger: The research found that soft drinks raise the chance of heart attacks in men

Previous research has linked sugary drinks with diabetes and weight gain.

Dr de Koning, of Harvard University, said that although his study did not link diet soft drinks with heart problems, ‘better choices’ are available.

He said: ‘Water, coffee and tea are probably the best choices, after that would be low-fat milk. It is not clear whether fruit juice is a good replacement. There is a lot of sugar in it but it does have added benefits such as vitamins and fibre.’

Tea and coffee should be taken without sugar, he added.

Frank Hu, the study’s lead author and a professor of nutrition, said: ‘This study adds to the growing evidence that sugary beverages are detrimental to cardiovascular health.

 Study: Research was conducted at Harvard University in Cambridge, Massachusetts

‘Certainly, it provides strong justification for reducing sugary beverage consumption among patients and, more importantly, in the general population.’ 

The results of the study were firmly rejected by the British Soft Drinks Association.

Research published last year linked diet soft drinks with bulging waistlines, even when drun in small quantities’

A spokesman said: ‘Drinking sweetened beverages does not cause an increased risk of heart disease – not based on this study nor any other study in the available science.

‘The authors found an association between consuming sweetened beverages and cardiovascular risk, but this could have been the result of other lifestyle changes over the 22-year study period.’

Separate U.S. research published last year linked diet soft drinks with bulging waistlines, even when drun in small quantities. The researchers said they were not a healthy alternative to sugar-laden versions and warned they may foster a sweet tooth, distort appetite and even damage brain cells involved in feelings of fullness.

Tracy Parker, from the British Heart Foundation, said: ‘While we need more research to understand how else  sugary drinks may affect our heart health, the study reminds us that  they shouldn’t be a daily part of our diet.

‘Go for healthier alternatives such as water, low-fat milk, or unsweetened juices, which are kinder to our waistlines as well as our heart.’

Read more: http://www.dailymail.co.uk/health/article-2114123/One-soft-drink-day-raises-heart-attack-danger-20-cent-according-U-S-study.html#ixzz1p0jIwbh1

http://www.dailymail.co.uk/health/article-2114123/One-soft-drink-day-raises-heart-attack-danger-20-cent-according-U-S-study.html?ITO=1490

By FIONA MACRAE

Sleep deprivation issues

April 19th, 2012

SUMMARY: Sleep experts tell us adults need seven to nine hours a day. But one-third of all Americans are getting LESS than that.   Less than 1% of people are truely Short sleepers, meaning they function best with 4-6 hours per night.  The other 99% are sleep deprived.   The sleep deprived are seen to have more cardiovascular disease, diabetes and mood problems.  Obesity can also be turned on because  a hormone called Leptin, which is released from fat cells, tells your body when it is full, and that hormone level goes down when you’re sleep-deprived.  Also some pretty anecdotal evidence can show it improves sport performance if you are well rested.

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We advanced our clocks an hour for Daylight Saving Time . . . which for most of us means an hour of lost sleep. An hour of lost sleep you can add to the countless others we accumulate . . . hours of lost sleep that can take a toll. Which is why we’ll be hearing some learned pillow talk this morning from Barry Petersen:

In the original story, Sleeping Beauty was out of it for a hundred years. Rip Van Winkle dozed for a mere twenty. While in “Groundhog Day,” sleep meant waking up to the same day, lived over . . . and over.

We might envy Hollywood having so much fun with sleep – because most of us DON’T.

Sleep experts tell us adults need seven to nine hours a day. But one-third of all Americans are getting LESS than that.

And scientists see a dangerous downside. Unless you happen to be among the lucky few who seem perfectly cast for our frantic email/cell phone/iPad/instant messaging sleep-deprived world.

Researcher Ying-Hui Fu was altering the genes of lab rats to study their sleep habits. When she reached out to ordinary people to see how they compared, she discovered a whole new class of what she calls short sleepers.

“They function very well with just four to six hours of sleep,” Fu said.

Georges Halpern, who sleeps only four hours a night, is one of them. He often goes to bed at midnight or later, and wakes up early, to work with fellow scientists in Asia and Europe.

“This is a wonderful opportunity to go to my office and to start working with the people who are awake in their office, in their labs, when it’s 5:00 in the morning right here,” Halpern said.

Scientists think history is full of short sleepers, from Ben Franklin to Bill Clinton.

And they have very distinct personalities: “They’re very energetic, they are very optimistic,” said Fu. “They are resistant to failure. So many of them are very successful.”

Again, short sleepers are rare, perhaps one percent of us or less. And that doesn’t include people who sleep fewer hours during the week and then sleep in on weekends to “catch up.”

They aren’t short sleepers . . . they’re just sleep-deprived.

And sleep deprivation, says new research, is the root of a lot of bad news for our bodies.

It’s associated with cardiovascular disease, diabetes and mood problems, said Dr. Nate Watson, co-director of the University of Washington Sleep Center in Seattle.

He says the metabolism of sleep deprivation makes it every dieter’s nightmare: “When you sleep less, genetic factors that are associated with obesity seem to be turned on. For instance, there’s a hormone called Leptin, which is released from fat cells. That tells your body that you’re full when you’ve eaten. That hormone level goes down when you’re sleep-deprived.

“You think you’re still hungry – you’re craving high-fat, high-carbohydrate foods,” Dr. Watson said.

Kent and Kevin Wilson are identical twins in Watson’s study. Using twins means the genetics are the same, so weight change comes from other factors, like lack of sleep.

Both get only five-and-a-half hours of sleep a night – and tip the scales in the high 300s.

Their lives are crammed, with their involvement in church, taking kids to drill practice, and making time for wives and family.

So, like many of us, they make sleep a low priority.

“Can’t do it right now, because of the busy schedule, with family, work, school and church,” said Kent.   ”And sleep comes last in that list?” Petersen said. “Sleep wasn’t even ON that list!”

But early in their lives, they toured with rap artist MC Hammer. To weather the travel, and be rested for each night’s performance, they skipped the party-hardy life and set a pretty dull routine.

“When you get on the bus, in the hotels, we slept probably literally ten, 12 hours a day,” said Kent. “Until it was show time, you know. We wanted to make sure we gave the audience our best. So actually I slept more, you know, as an entertainer.”

Kent says he also weighed less.

When he hit 250 pounds, Larry McLean also turned to Dr. Watson for help, in making an environment that was more conducive to sleep. Dr. Watson got Larry sleeping eight hours a night.

Now Larry, who works in technology, is 50 pounds lighter – and still losing.

“So my bedroom is a place where I go to sleep,” McLean said. “At night, light some candles, get the bedroom kind of a peaceful place. But I’ve also eliminated any electronics – no televisions, no stereo, nothing. It’s gone.”

Truth is, sound sleep requires no artificial ingredients. And when you mess with a restful night, you’re messing with success.   Just ask the sleep doctor and his beloved Seattle Seahawks. When they travel East, that three-hour time difference disrupts their internal time-clocks.  ”When the kickoff happens, in Giants Stadium, it’s going to feel like 10:00 a.m. to the Seahawk players, so they’re not going to be prepared, mentally, physically,” said Dr. Watson. “They’re just going to feel off their game a little bit. And as a result they might start slow, not perform up to their standards, and that’s going to put them at a disadvantage.”

And what a disadvantage! Nine straight away losses to East Coast teams since December 2007, until their first win this past season.

The Stanford University basketball team helped researchers PROVE that adding sleep adds points.   Players who got by on less than seven hours a night were told to sleep for 10.

Results: A nine-percent increase in both free throw accuracy and making three-point baskets.

Cheri Mah, a researcher at the Stanford Sleep Disorders Clinic, ran the study. She said there’s very little research in the specific relationship between sleep and athletic performance, “or how your body clock impacts performance in athletes.”

And not just athletes. Your average high school teenager needs about nine hours of sleep. But most schools open early.

“We started at 7:40 in the morning,” said Principal Mathew Zito of California’s Menlo-Atherton High School. “We realized that students often fall asleep during zero and first class. The typical high school schedule really goes against their biological clock.”

So Zito decided it was time to let his students sleep in. “By starting at 8:40 or 9:30, a lot our students are getting an extra 90 minutes, even two hours of sleep,” he said.

That means kids are more awake, and better able to gets As instead of Bs or Cs.  But what about the most important question: How much sleep do YOU need?

Dr. Watson has a way each of us can figure it out: “Next time you’re on vacation, sleep as much as you can. Go to bed when you’re tired, wake up spontaneously, when you’re rested. And then at the end of that vacation measure how long that time is. And that’s how much time you need to sleep.

. . . And perchance, to dream of waking up tomorrow . . . rested and raring to go.

© 2012 CBS Interactive Inc.. All Rights Reserved.

http://www.cbsnews.com/8301-3445_162-57394985/the-perils-of-sleep-deprivation/

Chiropractic adjustments better than medicine for neck pain even after one year

April 13th, 2012

Recent study published January 3rd in The Annals of Internal Medicine showed that spinal manipulation and exercise can be more effective for neck pain than medications.    272 adults with neck pain from no known cause were separated into three groups and followed for three months.  One group got chiropractic on average of 15 visits.  Second group took acetaminphen and narcotics and muscle relaxants.  Third group met twice and were given simple, gentle exercises that they can do at home (5-10 repetitions up to 8 times per day).  After 12 weeks the non medication groups did significantly better.  57% of the chiropractic patients and 48% of exercise group reported at least 75% reduction in pain, and the medicine group only got 33%.   The non medicine groups maintained their improvements for over a year.

GMO food why doesn’t biotech push for it on labels if they are so great

April 10th, 2012

Are you ready for another fear mongering article? Shouldn’t the bio tech industry put GMO labels on food if they think they are such great things for the world to eat?

 • Fortified with extra GMOs!
• Genetically Modified to grow strong bones!
• Now with GMO technology in every delicious bite!

The big question is, why are they doing the opposite and fighting legislation to even have the mere fact that a product contains genetic modified ingredients.  What are they hiding?   The article about midway to the end goes on a few rants of how bad they are and compares them to some pretty distasteful things.  The problem is, he doesn’t actually say anything of what the bad really is or how it’s bad etc.  Thanks for the awareness of GMO but unless you show some evidence, I’m not convinced.

——————

Genetically engineered foods will “feed the world,” say Bill Gates and all the rest of the GMO pushers. GM crops are the result of “high-tech agriculture” and “advanced technology” created by super-smart agricultural geniuses who onlyenhancethe properties of food crops. GMOs arebetter than God, better than Mother Nature, and one of the great gifts of science to humankind — sort of like electricity, only more edible.
If this is all true, then why doesn’t the GMO industry want credit for all this effort on food labels? Shouldn’t the industry leap at the opportunity to have foods labeled with things like:

• Fortified with extra GMOs!
• Genetically Modified to grow strong bones!
• Now with GMO technology in every delicious bite!

If GMOs are so wonderful, in other words, then why wouldn’t the industry tout all its amazing technology right on the labels of the foods containing GMOs?

The reality? GMOs are poison

But no, instead of the industry begging for regulatory permission to place GMO bragging rights on food labels, the industry has done exactly the opposite: It hasdemanded that consumers be kept in the dark about GMOs!

• They don’t want consumers to even know they’re eating GMOs!
• They believe consumer ignorance is preferable to consumer choice.
• They want consumers kept in the dark, uninformed and unable to avoid GMOs.

The GMO industry, in fact, is already viciously fighting a proposed GMO labeling mandate in California — a law that would merely require foods to be truthfully labeled when they contain genetically modified ingredients. What could be wrong with that? But in an age when consumers want to knowmoreinformation about what they’re buying, notless, the GMO industry somehow believesconsumer ignorance is victory!

So when GMO pushers like Bill Gates say they want to “feed the world,” what they really mean is they want tosecretly force-feed the worldmystery ingredients that are not listed on the labels so that consumers won’t even be aware of what they’re eating. (Such as the deadly insecticide found in every kernel of GM corn…)

Commonsense food rule: Beware of anything the food companies don’t want to put on the label

If the ag giants and food companies don’t want to put something on a food label, that’s a pretty strong sign thatyou probably shouldn’t eat it.  If it was good for you, they would obviously want to brag about it on the label. All natural! Fortified with minerals! Low in sodium!  So how come the industry doesn’t want to claim, “High in GMOs!” on every food box? Want some flaked corn breakfast cereal? It’s on sale for $1.99 a box, and it’shigh in GMOs!  How about some corn tortillas for your Mexican fiesta dinner? Those corn tortillas arefortified with extra GMOs, too!  Thirsty? Grab yourself a 12-pack of that famous brandsports drink– it’s sweetened with genetically modified corn syrup! Plus,it’s got electrolytes!  Or how about a super-sized box of Genetically Modified Corn Flakes for breakfast? You can even eat it with a bowl of pasteurized, homogenized, Bovine Growth Hormone-contaminated, pus-filled factory-processed cow’s milk! Yumm!

But you don’t see any of this marketing material at the grocery store, do you? GMOs remainthe dirty little secret of the food industry — even at places like Whole Foods, which sort of try to imply they’re against GMOs, but then they turn around and sell all sorts of GM foods anyway.

GMOs are worse than skeletons in the closet

GMOs are to the food industry what gay public toilet sex is to a pro-family Republican candidate. Or hidden camera photos of the naked choir boys and the Catholic priest. GMOs are the bones buried under the basement slab of a mass murderer who’s also running for Governor. They’re the prostitution ring records that reveal one very busy repeat customer named “Eliot Spitzer.”

GMOs are the leaked Stratfor emails that reveal the U.S. is already on the ground working to destroy Syria’s infrastructure. GMOs are the proof of election fraud in a so-called “free nation.” GMOs are not just Big Ag’s skeletons in the closet; they are the skeletons in a closet full of beaten, gagged children who have been kidnapped by CPS officials and sold into “white slavery” to the local community’s business leaders who run the children’s foundations.

GMOs are the dirty food secret that’s so dirty,virtually no one would buy any food known to contain GMOs. They are worse than the plague. They areanti-food. Labeling foods with GMOs is essentially the same as slapping a large skull and crossbones on the package, and that’s exactly why the death-worshipping, profit-sucking corporate whores who work for the biotech industry are fighting so hard to prevent GMO labels from appearing on foods. “Holy crap! We can’t have consumers knowing the TRUTH, can we?”

Isn’t it fascinating that the GMO industry depends entirely onhiding its productsin order to stay in business? What other industry is so steeped in destructive, hateful products that it has to actively seek to HIDE THEM from consumers? Biotech is an industry whose products are sold entirely throughtrickery and deceit, not honest labeling and full disclosure.

Why we will win this fight for the right to know what we are eating

But make no mistake, my friends, for the People shall be victorious against this insidious brand of agricultural imperialism. As I publicly shared just the other day, I had a vision (or was it a dream?) of a massive army of American farmers and consumers who marched on Monsanto, arrested all its employees and burned its buildings to the ground.

I believe that day may very well come true in the near future, and I can only hope it will be followed by a series of very public trials where the GMO scientists, corporate CEOs and top marketing executives are all charged withcrimes against humanityand tried by a jury of their peers. The genetic modification of seeds and the open planting of those seeds in the natural world should, I believe, bea crime against nature met by a most severe punishment such as life in prisonfor anyone found guilty of those crimes in a Constitutional court that abides by due process. Almost no punishment is too great against these criminals, because those who sow genetically modified seeds upon our natural worldrisk the death of billions of peoplein their careless arrogance. Some might even argue that the death sentence would be justifiable in such cases.

“Mystery” food?

Just remember: the next time you go shopping at the grocery store, take a closer look at the label of a food product and ask yourself, “What are they NOT telling me about what’s in this product?”

Because much of the time, you’re actually buying “mystery food” containing all sorts of toxins, poisons or horrifying ingredients that are never listed on the label (by design, of course).

And that’s the way Big Ag and Big Food like it –keep consumers in the dark!The less they know about how processed food is made, where it comes from and what it contains,the better!And the more ignorant consumers can be kept, the more GMOs the biotech industry can shove down their gullible little throats.

Wednesday, March 07, 2012
by Mike Adams, the Health Ranger
Editor of NaturalNews.com

Learn more:http://www.naturalnews.com/035174_GMOs_food_packaging_biotech_industry.html#ixzz1oRsbtJWn

Bad Sleep Linked to Alzheimer’s

April 2nd, 2012

By MICHAEL SMITH, MedPage Today Staff Writer

Feb 15, 2012

Disturbed sleep is associated with preclinical signs of Alzheimer’s disease, researchers found.

In a small cohort study in cognitively normal people, frequent awakenings and a habit of lying awake were linked to higher levels of markers of the brain plaques that are a hallmark of Alzheimer’s disease, according to Yo-El Ju, MD, of Washington University School of Medicine in St. Louis, and colleagues.

The full study is slated for presentation at the annual meeting of the American Academy of Neurology in New Orleans in April, but some of the data were released early.

Ju and colleagues cautioned that it’s not clear if there’s a cause-and-effect relationship or, if there is, which way it runs. “Further research is needed to determine why this is happening and whether sleep changes may predict cognitive decline,” Ju said in a statement.

Alzheimer’s disease begins long before there any symptoms, the researchers noted, but signs of the beta-amyloid plaques that build up in the brains of Alzheimer’s patients can be detected in some cognitively normal people.

There is also evidence from animal studies that sleep disruption causes a build-up in those beta-amyloid markers, they said.

To investigate the link in humans, they turned to the Adult Children Study, a cohort of which half the members have a family history of Alzheimer’s. For this analysis, 100 participants, ages 45 to 80, were given standardized assessments and shown to be cognitively normal.

Participants wore an actigraph for 14 days to measure sleep in an objective fashion; sleep diaries and questionnaires were used to gather subjective measures.

The researchers also measured levels of amyloid beta-42 in cerebrospinal fluid and looked for increased retention of Pittsburgh compound B during amyloid imaging by positron emission tomography — 25% of participants had preclinical signs of Alzheimer’s.

On average, participants spent about eight hours in bed, as measured by both actigraph results and subjective reports, but average sleep time on the actigraph was 6.5 hours (significantly shorter at P<0.05) because of brief awakenings during the night.

Those who woke up more than five times an hour were more likely to have abnormal biomarkers indicating amyloid pathology.

And more of those with low sleep efficiency – defined as sleep time divided by time in bed of less than 85% — had such signs compared with those with high sleep efficiency.

Such research is critical for the study of Alzheimer’s disease, commented Judy Willis, MD, an educator and neurologist in Santa Barbara, Calif., and a member of the neurology academy.

“Interventions, once the disease has progressed to symptomatic diagnosis, are limited,” Willis told MedPage Today in an email, “and there is no cure or even strong support for any treatment that can reverse the development of amyloid plaques in humans once they form.”

But it may be possible to intervene at an earlier stage, especially if it turns out the disordered sleep actually causes the amyloid pathology, Willis said.

“Studies finding correlation are inadequate to confirm causality,” she noted, adding it’s equally possible that disrupted sleep has a role in the development of the disease or that it’s an early sign of a disease already developing.

But studies in mice have found that interfering with their sleep led to increases in amyloid pathology. Although mice do not get Alzheimer’s, that finding suggests that improved sleep might be a pathway to better mental health.

Even if disrupted sleep is just a predictor, it could be useful in pointing people toward future clinical trials, Willis said.

Ju said longer studies following sleep over years will be needed to tease out the cause-and-effect relationship. “Our study lays the groundwork for investigating whether manipulating sleep is a possible strategy in the prevention or slowing of Alzheimer’s disease,” she said.

 

http://abcnews.go.com/Health/Alzheimers/bad-sleep-linked-alzheimers/story?id=15642108

Big Pharma putting profits before patients, No Really?

March 29th, 2012

My summary based on cut and paste : Legislators and biotech companies have been trying to use the FDA accelerated approval process to make important reforms at the FDA that will help speed innovative medicines to market. The upstart biotechs are focusing on more specialized diseases, like rare cancers, where they can conduct inexpensive clinical trials, and gain approval after mid-stage phase II studies, using what’s known as the accelerated approval process.  instead of having to wait to learn if a drug actually can extend the survival of cancer patients, the FDA might now approve a drug based on evidence that the drug shrinks tumors because tumor shrinkage is considered reasonably likely to predict a real clinical benefit.  The way it is now, small biotechs are forced to partner with the big pharma companies to get their drugs to market. The biotechs are forced to give up the economic upside of success for their innovations, while big pharma skims the cream off of biotech pipelines for their own purposes. If small biotech companies could get their drugs tentatively approved after inexpensive phase II studies, they would have far less need to partner those drugs with big pharma. They could keep the upside themselves and attract far more interest from investors. Big pharma, on the other hand, would be without its largest source for innovative new medicines: the small biotech farm team.  Big pharma was all too happy to jump onto the “consumer safety” bandwagon. “Big pharma says ‘don’t dilute safety measures for new drugs,’” said University of Michigan professor Erik Gordon in a Bloomberg interview. “That sounds better than ‘we want to keep our cut of the action.’”

2/15/2012  Avik Roy

With all the controversy around whether or not insurers should be forced by Washington to cover birth control pills, there’s another big drugs story that has gotten short shrift: the quintennial reauthorization of the Prescription Drug User Fee Act, the law that has come to govern the pharmaceutical regulatory process at the FDA. This time around, legislators and biotech concerns have been trying to use the process to make important reforms at the FDA that will help speed innovative medicines to market. But they have been undermined by a seemingly unlikely source: big pharma.

One of the best ways to save lives, one that helps charge rather than retard the economy, is medical innovation. However, as former FDA Commissioner Andrew von Eschenbach notes in yesterday’s Wall Street Journal, thanks to bureaucratic inertia at the FDA, clinical trials from 2003-2006 were 70 percent longer, requiring far more complexity and cost, than those conducted from 1999-2002. As he points out, the problems are especially bad in the most common diseases like heart disease and diabetes.

The old, constrained “accelerated approval” process

 

 

As a result of this inertia, medicine’s innovators in the biotechnology have mostly opted out of addressing these large, common disorders, leaving them in the hands of the lumbering R&D giants like GlaxoSmithKline and Pfizer. Instead, increasingly, the upstart biotechs are focusing on more specialized diseases, like rare cancers, where they can conduct inexpensive clinical trials, and gain approval after mid-stage phase II studies, using what’s known as the accelerated approval process.

The accelerated approval process, instituted in 1992 at the behest of AIDS activists, gives the FDA a mechanism to tentatively approve drugs after phase II if a drug shows promise in a serious disease using a surrogate endpoint. “For example,” explains the FDA on its web site, “instead of having to wait to learn if a drug actually can extend the survival of cancer patients, the FDA might now approve a drug based on evidence that the drug shrinks tumors because tumor shrinkage is considered reasonably likely to predict a real clinical benefit.  In this example, an approval based upon tumor shrinkage can occur far sooner than waiting to learn whether patients actually lived longer.”

A real-world example of the accelerated approval process was the approval of Avastin in breast cancer. Avastin was approved in 2008 based on evidence that the drug improved progression-free survival in combination with Taxol, compared to patients on Taxol alone. (Progression-free survival indicates that a patient continued to live without growth in the size of her tumors.) But the drug failed to show a benefit on the more rigorous overall survival endpoint, which measures how long patients lived, irrespective of tumor growth. Last year, the FDA revoked its approval of Avastin in breast cancer, based on the new information.

The problem with the accelerated approval process is that it is only used in very narrow areas, such as cancer and AIDS, where the FDA has to its satisfaction established surrogate markers that it believes to correlate to broader clinical outcomes (such as tumor shrinkage being a surrogate for cancer survival). But there are a lot of areas where surrogate markers aren’t as easy to define. In addition, the FDA focuses on using the accelerated approval process to address life-threatening diseases like cancer, neglecting serious but more chronic ailments such as diabetes, where the cost of clinical trials is prohibitive.

A slower FDA is a boon to big pharma

While this problem has harmed patients by making it harder for them to gain access to new treatments, it’s been great for the big pharmaceutical companies. As my colleague Matthew Herper recently showed, from 1997 to 2011, twelve multinational pharma companies spent $802 billion to gain approval for just 139 drugs: a staggering $5.8 billion per drug. While these companies have been remarkably unproductive on the R&D front, they do have one huge advantage: they generate billions of cash from their already-approved drugs, a luxury that smaller biotech companies don’t have.

As a result, the small biotechs are forced to partner with the big pharma companies to get their drugs to market. The biotechs are forced to give up the economic upside of success for their innovations, while big pharma skims the cream off of biotech pipelines for their own purposes.

Sen. Kay Hagan (R., N.C.) is attempting to do something to address this problem. Today, she is introducing a bill called the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act, which seeks, among other things, to incrementally the accelerated approval process.

But what you didn’t hear from Sen. Hagan today is what happened behind the scenes. It turns out that big pharma helped to kill an earlier version of the TREAT Act, which would have created an entirely new “progressive and exceptional approval” pathway for innovative new drugs: something that could have turbocharged drug development in several fields.

A bold new pathway for “progressive and exceptional approvals”

The new pathway would have addressed a much broader range of drugs than the existing accelerated approval process, such as: the first drug approved for a specific and identifiable disease subpopulation; patients unresponsive to, or intolerant of, existing treatments; improvement in patient outcomes due to either improved safety or efficacy; or “otherwise satisfy an unmet medical need.”

Unlike the accelerated approval process, which requires an FDA-sanctioned surrogate marker, the new process would involve a case-by-case negotiation between the industry sponsor and the FDA, in which both sides could come to an agreement as to what would demonstrate an early signal of clinical benefit. If confirmatory phase III studies didn’t reproduce that benefit, the FDA could revoke its approval, as with the Avastin case.

Sen. Hagan’s proposal would have been devastating to the big pharma R&D oligopoly