The Mediterranean diet may protect against age-related cognitive decline, according to 2 studies published in JAMA.

The diet, which is long on vegetables, fruits, whole grains and fish, and short on red meat and poultry, has already been lauded for its cardio-protective and cancer preventing effects.

The first of the 2 studies, organized by Nikolaos Scarmeas and colleagues at Columbia, showed that the diet and physical activity were independently associated with a reduced risk of Alzheimer’s disease.

Scarmeas’ team enrolled 1,880 older patients with no cognitive impairment at study onset, and performed neuropsychological testing every 18 months for a mean follow-up of 5.4 years.

Alzheimer’s disease was diagnosed in 282 subjects during the study. Subjects who followed the Mediterranean diet were 40% less likely to develop Alzheimer’s than those who did not.

Similarly, a high amount of physical activity, which the scientists defined for this elderly population to be 1.3 hours of vigorous, 2.4 hours of moderate, or 4 hours of light physical activity per week, cut the risk of Alzheimer’s by 33%.

In the second study, Catherine Feart and colleagues at Universite Victor Segalen showed that the Mediterranean diet slowed cognitive decline, though it did not decrease the risk of dementia per se.

In particular, Feart’s team found that those adhering to the diet had fewer errors on the Mini Mental State Examination, but performed no better on 3 other tests of cognition.

In an accompanying editorial, the Mayo Clinic’s David Knopman said the 2 studies “provide moderately compelling evidence that adherence to the Mediterranean-type diet is linked to less late-life cognitive impairment.”

Whether these findings “should be translated into recommendations for the public is the question,” added Knopman. “For now, it is reasonable to nibble on these findings and savor them, but not to swallow them whole.”

Four years ago, the Federal Communications Commission adopted “network neutrality” principles that protected consumers’ rights to use Internet-based applications, services, content and devices of their choosing, and to foster competition among Internet providers.

Last week, FCC chairman Julius Genachowski proposed formalizing these rules and adding an additional one designed to prevent Internet providers from discriminating against certain applications or content by using bans or service degradations against offerings that compete with their own.

Genachowski also proposed that the rules should apply to wireless networks, which had not heretofore been subject to the network neutrality principles.

The FCC invoked network neutrality last year when it called-out Comcast for attempting to degrade the Internet connections of users who were attempting to use a particular kind of file-sharing software. Comcast appealed the ruling on grounds that the neutrality principles had not been formally adopted.

Formal adoption of the rules promises to be a time consuming process since it requires an extended period for public comment. During this phase, the communications industry is sure to raise several objections.

In particular, some providers want to offer faster connections to companies that pay a premium for the service, such as those who provide high-definition movies online.

Public advocates fear that such services can transform the Internet into a tiered service in which premium offerings are available only to well-endowed users.

Genachowski will likely compromise in this area, allowing experimentation with premium services while assuring that sites which do not pay extra continue receiving service levels to which they have become  accustomed.

The formalization process should begin later this month. A final plan could be voted on by next spring.

Cal Tech scientists may have figured out why some people have a notably annoying tendency to get too close during conversations, on subway trains or in restrooms.

The culprit turns out to be a malfunction in an almond-sized structure known as the amygdala, which is located in both temporal lobes of the brain. The amygdala processes negative emotions like anger and fear, but its role in social interaction had not previously been studied.

Daniel Kennedy, Ralph Adolphs and colleagus made the association by studying a 42-year-old woman known as SM, who has severe, isolated damage to her amygdala.

The scientists had known that SM couldn’t recognize fear in the expressions of others, or judge their trustworthiness, and had shown these abnormalities to be caused by her amygdala lesions.
 
While observing SM over time, Adolphs also noticed that she seemed to be too friendly, and frequently violated what others perceived to be their own personal space.

“She is extremely friendly, and she wants to approach people more than normal. It’s something that immediately becomes apparent as you interact with her,” Kennedy told BurrillReport.
 
So the scientists decided to compare SM’s sense of personal space to normal volunteers using the stop-distance technique, in which subjects approach a person until they reach a point where they feel most comfortable, and this distance is recorded.

Among the normal volunteers, the mean preferred distance was about 2 feet, but SM came in much tighter than that, about a foot. And unlike normal subjects who reported feeling uncomfortable when the experimenter approached to a distance within their preferred range, SM never became uncomfortable.

Even cheek to cheek, she was relaxed, and her feelings changed not a whit regardless of who the experimenter was or how well she knew them.

The write-up appears in Nature Neuroscience.

Preventive services for patients with Type II diabetes do reduce future health-care costs, but even in the long term, the initial expenses are not completely recovered according to a study published in Health Affairs earlier this month. 

To reach these conclusions, Michael O’Grady and colleagues compiled data from several clinical trials that used an aggressive but doable program to manage all phases of the disease.

They found that federally-insured patients enrolled in such a program would cost over $1,000 per person per year, and that even after 25 years, only ¾ of those costs would be returned via reduced spending on dialysis, amputations and coronary heart disease.

The only group in whom preventive services actually reduced long-term costs were those in their mid-20s at study onset.

“There’s no free lunch here,” concluded O’Grady in an interview with the Washington Post.

President Obama, House Speaker Nancy Pelosi and others claim that health reform will save money, in part by preventing the costs of future diseases by increasing access to preventive services.

Pelosi and Senator Tom Harkin frequently criticize the Congressional Budget Office for adopting a long-enough time horizon in estimating the cost impact of such programs.

The new study supports their position. Most savings accrued well after the 10-year horizon typically used by CBO. The study authors propose a 25-year time horizon for calculating the impact of such programs.

CBO Director Douglas Elmendorf seemed open to the suggestion, indicating the study was “exactly the sort of research that we use in building our cost estimates. We will consider these findings in future estimates we do in this area.”

Earlier this month, the CBO concluded that the costs of widespread cancer screening and cholesterol management programs were going to far outweigh any savings, even in the long term.

In a finding that would be laughable if it weren’t so scary, scientists have determined that the chemicals which helped avoid a potential global environmental catastrophe—the hole in the ozone layer—are contributing to another one: global warming.

The compounds in question are hydrofluorocarbons, also known as HFCs.

They were introduced a decade ago as replacements for chlorofluorocarbons, ozone-depleting gases that had been used in refrigerators, air conditioners, and the production of foam insulation.

The ozone hole is shrinking all right, but hydrofluorocarbons are basically greenhouse gases on steroids: molecule for molecule, they have 5,000 times the heat-trapping power of carbon dioxide.

And unless we find replacements for the replacements, scientists warn these puppies can cancel out other efforts to combat global warming.

“Whatever targets you thought you were going to make,” David Fahey, a physicist at the National Oceanic and Atmospheric Administration told the Washington Post, “it will be undermined by the fact that you have . . . additional emissions that you hadn’t planned on.”

Hydroflurocarbons now account for nearly 2% of US-based climate-warming emissions, according to the EPA.  Good old carbon dioxide, a byproduct of burning fossil fuels, is responsible for 85% of the problem. Methane, which comes from farm animals (don’t ask) and decomposing trash causes most of the rest.

But the HFC problem is growing rapidly. By 2050, scientists believe, HFCs in the atmosphere will be equivalent to about 6 years’ worth carbon dioxide emissions.

“You have this moment when you could nip this problem in the bud and avoid this very large growth of a dangerous chemical,” David Doniger, a policy director at the Natural Resources Defense Council’s climate center told the Post. “Now, in the next couple of years, is when you have to do this.”

Not long ago, FDA deputy commissioner Joshua Sharfstein criticized the process his Agency used to approve ReGen’s Menaflex knee device,  claiming that “extreme” pressure from New Jersey Congressmen had compromised its integrity.

He added that the skullduggery was a factor in prompting his decision to review the FDA’s 510 (k) program, which fast-tracks approval of medical devices by requiring less rigorous clinical testing than the standard process.

“It’s autumn, and change is in the air. This is particularly true for our 510k program,” echoed Donna-Bea Tillman, head of the device evaluation office, in an email to her staff that was obtained by The Wall Street Journal.

The very thought of change to 510k goes over like a lead balloon for device makers like Johnson & Johnson, who warn that tampering with it would end up robbing the public of rapid access to a stream of live-saving, quality improving (not to mention money making) instruments.

J & J spokesperson Carol Goodrich said that 510k streamlines clearance for devices deemed “substantially equivalent” to those on the market, “builds on ever-expanding knowledge,” and accelerates innovation.

Tighter approval standards, she said, “would raise development costs substantially while also creating barriers to market entry that would reduce competition.”

About a third of J & J’s $64 billion in annual world-wide revenues derives from the sale of medical devices and diagnostic equipment.

The FDA’s move was just the latest bad news for the device industry.

Congressional Democrats for example, are pitching a tax on device makers to help pay for  health reform. If passed, the proposal could cost the industry $40 billion over 10 years.

To be sure, the Advanced Medical Technology Association, a lobbying group that represents device makers, is working overtime in Washington to set things straight on both counts.

Why do you suppose physicians frequently prescribe medications for non-FDA approved uses?

A recent survey has confirmed the worst possible reason ends up causing a lot of it: physicians simply don’t know what the FDA has approved, and what it hasn’t.

That’s the discouraging news from a study designed by G. Caleb Alexander and colleagues from the University of Chicago to characterize physicians’ knowledge of the FDA-approved indications of commonly prescribed drugs.

The scientists found in particular that a nationally representative sample of PCPs and psychiatrists knew the correct FDA-approval status for only 55% of drug-indication pairs.

That dismal performance increased to 60% for drugs actually prescribed by the physicians within the last year.

In the study, physicians were asked to complete a questionnaire focusing on 14 common drug-indication pairs, which varied with respect to FDA-approval status and level of supporting evidence. Subjects were asked to indicate whether each pair had FDA approval.

The drug-indication pairs included valproic acid for bipolar disorder and mania, gabapentin for diabetic neuropathy, Lexapro for panic disorder, trazodone for insomnia, Seroquel for dementia with agitation and Effexor for adjustment disorder.

41% of subjects believed that at least one drug-indication pair with uncertain or no supporting evidence had FDA approval, as is the case for the use of Seroquel in patients having dementia and agitation.

Psychiatrists showed better knowledge of FDA approval status than PCPs (66% vs 42%).

“These results indicate an urgent need for effective methods of disseminating information to physicians about the level of evidence supporting off-label drug uses, with specific attention to common off-label uses known to be ineffective or to carry unacceptable risk of harm,” concluded the authors.

The write-up appears in Pharmacoepidemiology and Drug Safety.

The new deputy commissioner of the Food and Drug Administration has criticized his Agency’s approval of ReGen’s Menaflex knee device last December in a report claiming that “extreme” pressure from New Jersey Democratic Congressmen compromised the integrity of the process.

In his report, Joshua Sharfstein asserted that the Congressional heat was “the most extreme (the FDA’s Congressional liaison) had seen. In addition, “the FDA’s acquiescence to (ReGen’s) demands was unprecedented.”

The events undermined the Agency’s ability to “counter the suggestion that lobbying on behalf of ReGen affected the decision,” according to the report which was obtained by the Wall Street Journal.

The Congressmen, Senators Robert Menendez and Frank Lautenberg, and Representatives Frank Pallone Jr. and Steve Rothman apparently encouraged the Agency to hasten its review of New Jersey-based ReGen’s device, which is a collagen meniscus implant designed to guide new tissue growth following surgical repair in patients with tears or loss of meniscus tissue.

Sharfstein added however, that his report does not constitute grounds for Menaflex recipients to panic and that the device remains on the market. The Agency, he said, will begin a review to determine whether that continues to be the case.

The 4 Congressmen countered that their involvement was a simple case of helping a constituent get fair treatment from the FDA.

The case could have far-reaching implications for the medical device industry. It is one reason why the FDA has undertaken a comprehensive review of the 510 (k) program which fast-tracks approval of medical devices by requiring less rigorous clinical testing before approval is granted.

ReGen claims that its product is safe and effective. Former FDA Commissioner Andrew von Eschenbach wasn’t available to comment.

Java junkies rejoice!

New studies suggest that caffeine reduces cerebral beta amyloid deposits and improves memory and overall cognitive function in aged mice genetically altered to develop a murine form of Alzheimer’s disease.

What is more, reductions in levels of the protein marker and the improved behavioral performance showed up after the mice received the equivalent of just 2 Grande Starbucks per day for 2 months.

To reach these conclusions, Gary Arendash and colleagues at the University of South Florida studied 55 mice.

After cognitive testing confirmed the little fellows were losing their marbles, the scientists added caffeine to the drinking water of half the subjects. The unlucky others just got the water.

After 2 months, the mice that received the Joe outperformed their counterparts on a battery of  memory and cognitive skills, and in fact their recall essentially matched that of normal, age-matched mice.

The scientists then showed that brains of the caffeinated mice had nearly 50% less beta amyloid, the notorious plaque-building protein that is the pathologic sine qua non of Alzheimer’s disease.

“The findings provide evidence that caffeine could be a viable treatment for established Alzheimer’s disease, and not simply a protective strategy,” Arendash told BurrillReport. “Caffeine is a safe drug for most people, it easily enters the brain, and it appears to directly affect the disease process.”

Arendash’s group performed follow-up experiments which suggested the wonder drug appears to work by down-regulating the process by which beta amyloid is produced, and by reducing cerebral inflammatory changes that stimulate beta amyloid production.

The write-up appears in the Journal of Alzheimer’s Disease. The scientists hope to begin human trials shortly. Getting people to volunteer for the studies is not expected to be problematic.

Scientists have identified a single-gene mutation that enables people to function effectively with far less sleep than most, a discovery that could lead to improved understanding of sleep cycles and open up new paths toward the treatment of insomnia and other sleep disorders.

Ying-Hui Fu and colleagues at UCSF made the find while conducting routine DNA screening on blood samples from people that had participated in several sleep studies.

The scientists had been searching for gene variations that affect circadian rhythms and other aspects of the sleep cycle. When they identified 2 specimens having unusual mutations of the so-called DEC2 gene, they traced them back and found a mother and daughter who routinely functioned on 6 hours of sleep per night. The average requirement is 8 to 8.5 hours per night.

The scientists then bred mice to have the same mutation, and found they required less sleep and recovered more easily from experimental sleep deprivation than regular mice.

The study “opens up a window to understanding the genetic basis of individual differences in sleep duration. You have a piece of the puzzle and you can begin trace back,” Charles Czeisler told the New York Times. He’s chief of sleep medicine at Brigham and Women’s Hospital.

The 2 women turn in around 10 or 10:30 each night and wake up ready to rock and roll at 4 or 4:30 in the morning, according to Fu.

Many people sleep for six or fewer hours per night, but have to use stimulants and alarm clocks to pull off the feat. “That’s a very different thing,” Fu told the Times. “Our body needs 8 to 8.5 hours.” (more…)