Archive for February, 2010

Exercise: It’s better than you think

February 11th, 2010 | No Comments | Source: Wall Street Journal

Many people know that regular physical activity can reduce perceived stress, blood pressure, LDL (bad) cholesterol levels and the risk of Type 2 diabetes.

AerobicJumper 225x300 Exercise: Its better than you thinkIt turns out there are many more benefits than that.

For example, regular exercise can increase the body’s capacity to prevent viral and bacterial infections, and boost the body’s response to the influenza vaccine, making it more effective.

 It probably reduces cancer risk as well.

David Nieman, of Appalachian State University has published several randomized trials showing for example that people who walk briskly for 45 minutes, 5 days per week have fewer and less severe upper respiratory tract infections, and 25-50% fewer sick days than sedentary controls.

“No pill or nutritional supplement has the power of near-daily moderate activity in lowering the number of sick days people take,” Nieman told the Wall Street Journal.

Other studies suggest that regular exercise reduces breast cancer risk by 20-30%, and that for patients with hormone-responsive breast cancer, walking for 3-5 hours per week cuts mortality in half.

Still other research shows that exercise retards aging processes like telomere shortening. Telomeres are DNA strands at the tips of chromosomes. When they become too short, cells can’t divide and trigger biochemical processes associated with aging, cancer formation and death.

Two years ago, the Department of Health and Services issued national exercise guidelines for the first time. The guidelines recommend 2 ½ hours per week of moderate aerobic exercise, or 1 ¼ hour per week of vigorous exercise. The guidelines say that additional health benefits accrue to those who double these amounts. They also call for muscle-strengthening activities at least twice per week.

According to the CDC, 36% of US adults undertook no leisure-time physical activity in 2008.

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Things go better with Coke Vaccine

February 10th, 2010 | No Comments | Source: Archives Gen'l Psychiatry, Washington Post

Scientists have made some progress in their effort to develop a vaccine for cocaine addiction. The vaccine is actually a series of injections that trigger an immune response to cocaine. The newly-created antibodies prevent the drug from entering the brain and thus blunt its euphoric effects.

oldschool 300x208 Things go better with Coke VaccineTo assess the safety and efficacy of their coke vaccine, Thomas Kosten and colleagues at Baylor randomized 115 cocaine addicts to receive either 5 shots of the vaccine over a 12 week period or a series of similarly timed placebo injections.

They monitored cocaine intake using urinalyses.

Most subjects smoked crack cocaine. Many also used marijuana (18%), alcohol (10%), and narcotics (44%).
 
Among subjects who received all 5 shots, 38% achieved sufficient antibody levels to blunt the effects of the drug. Antibodies remained in the bloodstream for 8-10 weeks after the final stick.

In this subset, 53% of the subjects stopped using cocaine—significantly more than the 23% of subjects who did not produce enough antibodies.

The vaccine was well tolerated, with no treatment-related serious adverse events or deaths.

But the partial success was associated with some risk. Some subjects began snorting massive amounts of the drug in an effort to overcome the vaccine’s effects. Some amassed 10 times the amount in their systems than had been encountered before the trial began.

“After the vaccine, doing cocaine was a very disappointing experience for them,” Kosten told the Washington Post.  “Previous research has shown that a reduction in use is associated with a significant improvement in cocaine abusers’ social functioning and thus is therapeutically meaningful.”

Kosten plans to begin a larger vaccine trial this spring.

About 2.1 million Americans have used cocaine in the last month, studies show. 

The write-up appears in the Archives of General Psychiatry.

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G-Spot a Myth, Researchers Say

February 9th, 2010 | No Comments | Source: BBC, J. Sexual Medicine

The Gräfenberg Spot, or G-Spot is, according to popular culture and a few questionable scientific studies, an elusive erogenous zone located in the anterior vagina. When stimulated, the G-spot can lead to intense sexual arousal and hellacious orgasms that rival or surpass those provoked by clitoral stimulation.

devicemakersgopffffft 300x225 G Spot a Myth, Researchers SayAlas, the latest study on the matter suggests it doesn’t exist.

To reach these conclusions, Tim Spector and colleagues at King’s College London asked 1,800 women whether they had a G-spot, and if so, where it was located. All the women were pairs of identical and non-identical twins.

If a G-spot did exist, both identical twins (who have the same genes) would be expected to report having one in the same place. In fact, the scientists found that identical twins were no more likely to share a G-spot than non-identical twins (who share half their genes).

“This is by far the biggest study ever carried out and shows fairly conclusively that the idea of a G-spot is subjective,” Spector told the BBC.

Colleague Andrea Burri voiced concern that women who couldn’t find a G-spot might feel inadequate. “It is rather irresponsible to claim the existence of an entity that has never been proven and pressurize women and men too,” she said.

Commenting on the study, Petra Boynton, a psychologist at University College London, said “it’s fine to go looking for the G-spot but do not worry if you don’t find it. It should not be the only focus. Everyone is different.”

Sexologist Beverley Whipple, who helped popularize the G-spot concept, argued the study was flawed because the scientists failed to account for the impact of different sexual partners and different love-making techniques.

The write-up is in the Journal of Sexual Medicine.

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Cybersecurity Manpower Shortage

February 8th, 2010 | No Comments | Source: Washington Post

When a US embassy employee in East Asia clicked on an e-mail attachment in May, 2006, she inadvertently unleashed the largest cyberattack ever launched against the State Department. The breach permitted China-based attackers to insert malicious computer code into the department’s networks throughout the region.

hack 300x198 Cybersecurity Manpower ShortageA cyber-threat response team leapt into action and toiled 24/7 for 2 weeks to isolate the code and develop a patch that officials claim prevented a gargantuan breach.

Unfortunately, State is better equipped to handle cyberattacks than other parts of the federal government. And 2 months later, the Bureau of Industry and Security, a part of the Commerce Department that oversees exports of technology that has both commercial and military uses, was attacked in similar fashion.

The attack was not recognized for days and Commerce was never able to determine when the initial intrusion took place (Commerce claims there is no evidence data was compromised as a result).

Commerce and other parts of government are trying to improve their performance in this regard, but their efforts are often stymied by a marked shortage of skilled computer-security workers, from front-line technicians to so called Security Generals. 

Meanwhile, according to the Government Accountability Office, the number of probes, scans and attacks reported to the Homeland Security Department’s Computer Emergency Readiness Team more than tripled between 2006 and 2008, from 5,500 to 16,840.

The manpower shortage is impacting Pentagon efforts to staff-up a new Cyber Command and Homeland Security’s plans to increase it’s cyber-staff by 1,000 people over in the next 3 years.

The intense demand has sparked bidding wars among agencies and contractors for a small pool of special talent: skilled technicians with security clearances. Some young people with 3 years’ experience and a clearance are commanding salaries over $100,000. 

Philip Reitinger, deputy undersecretary of Homeland Security’s National Protection and Programs Directorate, conceded he couldn’t match private sector pay scales. “But in government,” he told the Washington Post, “one can have a bigger ability to effect change at an earlier place in your career than anywhere else.” he said.

Besides, Reitinger added, “your country needs you.”

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One Small Step Backward for MannKind

February 5th, 2010 | No Comments | Source: Pharmalot

MannKind Corporation recently accounced that it has encountered a disappointing setback in its efforts to bring Afrezza to market. The FDA, it turns out, wasn’t able to sign-off on the company’s new drug application for the ultra rapid-acting form of inhaled insulin by January 16, the date the FDA had previously set for itself as a deadline for making this decision.

exhaledinsulin 300x199 One Small Step Backward for MannKindApparently, the FDA has not completed inspecting the insulin manufacturing facilities of N.V. Organon, a third-party supplier to MannKind.

The FDA “must complete this inspection before it can finalize its review of our NDA,” said Alfred Mann, Chairman and CEO of MannKind. “To our knowledge, all other FDA inspections are complete. There are no pending answers to any FDA questions or other deliverables due on MannKind’s part.”

The FDA did not set a new date for completing the NDA.

Just one week before the FDA’s surprising announcement, Mannkind had suggested that FDA approval was in the bag.

According to Pharmalot, Mann has bet nearly half of his $2 billion fortune on Afrezza. Many competitors have given up on inhaled insulin products since Pfizer’s fiasco with a similar product, Exubera.

Some analysts were skeptical about the prospects for Afrezza in light of the recent surprise. For example, Hapoalim Securities’ Jon LeCroy said, “the fact that there is now no definite time-line for approval (is) a major negative, as drugs that have a missed PDUFA often take months to years to receive a final decision.”

However, Simos Simeonidis at Rodman & Renshaw believes there is a 75% chance the FDA will approve the drug this year.

Afrezza achieves peak insulin levels within 12-14 minutes of administration, which mimics the release of meal-time insulin in healthy individuals.

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Running Shoes: Bad for your Knees?

February 4th, 2010 | No Comments | Source: BurrillReport, PM&R

Running in commercially-available athletic footware puts more stress on the hip, knee and ankle joints than running barefoot, according to a new study. In fact, a good jog in those designer statements puts more stress on your joints than a walk in high-heeled shoes.
 
Runningshoes 300x254 Running Shoes: Bad for your Knees?To determine the effect of modern-day running shoes on lower extremity joint torques during running, D. Casey Kerrigan and colleagues from JKM Technologies and the University of Virginia recruited 68 healthy young adult runners (37 women) that used commercially-available running shoes.
Subjects had no history of musculoskeletal injury and ran at least 15 miles per week.

Running shoes with typical design characteristics were provided to all subjects. The subjects ran barefoot and with the shoes. Running speed was controlled by the scientists.

Kerrigan’s team analyzed their subjects’ strides using three-dimensional motion capture and ground reaction force with a tricked-out treadmill.
 
The team found that running shoes increased joint torques at the hip, knee and ankle compared with bare feet. In fact, the shoes were associated with a 54% increase in hip internal rotation torque, a 36% increase in knee flexion torque, and a 38% increase in knee varus torque.

The team also found that running shoes caused pronounced stress at anatomical sites of the knee that are prone to the development of osteoarthritis.

They speculated that their findings were caused by the elevated heel and the padding under the medial arch which are typical of modern running shoes. They also acknowledge that running shoes provide good support and protection for the foot itself.

Reducing joint torques with footwear to that of barefoot running, while providing meaningful footwear functions should be the goal of new footwear designs,” the authors wrote.

The write-up appears in PM&R.

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What’s in Your Rug Cleaner?

February 3rd, 2010 | No Comments | Source: Washington Post

You may or may not know by reading the label.

Nearly 20% of the 84,000 chemicals being used commercially in the US—from rust removers to driveway sealants—are being legally kept secret from the public, according to the Environmental Protection Agency.

blindfold 300x199 Whats in Your Rug Cleaner?That gaping problem arose after Congress passed the Toxic Substances Control Act in 1976 to help protect trade secrets but made it rather easy for manufacturers to bypass normal regulatory scrutiny, even when it involves chemicals that could pose harm to humans.

Nearly 95% of the notices for new chemicals received by the Feds in recent years requested the silent treatment. Roughly 700 chemicals are introduced each year to the American market.

Of the nearly 17,000 secret chemicals, most are probably harmless. But chemical producers have disclosed in mandatory reports to the Feds that many pose a “substantial risk” to public health or the environment.

In March, for example, over half of the 65 “substantial risk” reports received by the EPA involved secret chemicals.

151 of the secret chemicals are made in quantities equal to or greater than 1 million tons per year. Ten of them are used in products designed for children, the EPA reports.

Select EPA employees do know the identities of the secret chemicals but they are prohibited from sharing the information with other federal or state officials, emergency responders and the public.

“Even acknowledging what chemical is used or what is made at what facility could convey important information to competitors, and they can start to put the pieces together,” Mike Walls, vice president of the American Chemistry Council told the Washington Post.

The Obama administration wants Congress to make manufacturers prove a chemical should be kept confidential, and wants to allow EPA officials to share that confidential information with state regulators who implement most EPA mandates across the country. Stay tuned.

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Crestor the Magnificent

February 2nd, 2010 | No Comments | Source: Wall Street Journal

An expert panel has advised the Food and Drug Administration to green light Crestor, AstraZeneca’s cholesterol-buster, for a wider role in the prevention of cardiovascular disease. FDA acceptance of the panel’s recommendations could markedly increase utilization of Crestor and drugs like it.

applause 300x200 Crestor the MagnificentThe recommendation follows release of data from the so-called Jupiter trial, which was sponsored by AZ. In Jupiter, Crestor reduced the risk of heart attacks in apparently healthy adults with no prior history of cardiac disease and normal cholesterol levels.

Participants in Jupiter did have elevated levels of C-reactive protein (CRP), a non-specific marker for inflammation that identifies people at risk for cardiac events regardless of their cholesterol levels.

Jupiter participants who took Crestor experienced a 54% reduction in the risk of heart attack and a 48% reduction in the risk of stroke. They were 46% less likely to require angioplasty or coronary bypass surgery and had 20% lower mortality from all causes.

In reaching its decision, the expert panel noted that Crestor patients developed diabetes at a higher rate than the placebo group, and experienced more deaths due to GI disease and more episodes of mental confusion. But the panel felt these events were due to chance rather than Crestor itself.

AZ wants the FDA to authorize a discussion of the Jupiter study on Crestor’s label, since this would permit the company to market Crestor to a much wider patient population.

Crestor already generates $3.6 billion in annual revenues for AZ, which is good for 9% of the US market. Pfizer’s Lipitor (27%) and generic statins (49%) have the lion’s share of this market.

Both Lipitor and the generic simvastatin have been shown to lower CRP levels. It is estimated that the label modifications would apply to about 6 million US patients.

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Is Plavix Resistance due to Noncompliance?

February 1st, 2010 | No Comments | Source: Medscape

Plavix, the clot-busting blockbuster marketed by BMS and Sanofi, is never out of the news for long.

One story that developed legs in the last year for example, was the finding of apparent marked variability in responsiveness to the drug. This begat calls for personalized prescribing of Plavix based on genetic markers, and warnings that Nexium-The Plavix 150x51 Is Plavix Resistance due to Noncompliance?Purple Pill—impaired its effectiveness, thus creating an increased risk of vascular complications.

Now it seems, the worm has turned again on this story. Victor Serebruany and colleagues have reported that the issue of Plavix nonresponsiveness may be caused by something rather mundane: non-compliance with the drug.

To reach this conclusion, the scientists obtained blood samples from 422 heart disease patients and 209 poststroke patients that had platelet activity tests performed before and after Plavix use.

They tested these archived blood specimens for a chemically stable, carboxyl metabolite of Plavix, and then defined Plavix noncompliance to be a very low plasma concentration of this inactive metabolite.

They found that 138 patients (22%) were in fact noncompliant. Noncompliance was more frequent in stroke victims (38%) than cardiac disease patients (14%).

plavixnonresponder 150x108 Is Plavix Resistance due to Noncompliance?“Some of the patients whom we would classically describe as ‘resistant’ to clopidogrel, in that they showed low levels of platelet inhibition, in fact didn’t actually have clopidogrel on board,” Serebruany told Medscape.

“The whole variability issue with clopidogrel (Plavix) is not such a big deal,” Serebruany added. “It has been hyped by the manufacturers of the newer antiplatelet agents. If we did studies with these agents, they would show variability, too.”

“Future antiplatelet trials should recognize noncompliance as a critical confounding factor, and every attempt should be made to minimize and strictly monitor prescribed antiplatelet regimens,” the authors concluded.

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