Rep. Waxman Questions CMS On Premium Increases For Medicare Prescription Drug Plans

House Oversight and Government Reform Committee Chair Henry Waxman (D-Calif.) on Tuesday wrote a letter to acting CMS Administrator Kerry Weems expressing concern for how premium increases for the Medicare prescription drug benefit will affect beneficiaries, CQ HealthBeat reports. According to CQ HealthBeat, Waxman believes that CMS was “misleading” when it stated that during the open enrollment period beginning Nov. 15, beneficiaries would have access to drug plans with lower premiums than the previous year.

In a Sept. 25 statement, CMS said that beneficiaries nationwide would have access to “at least one prescription drug plan with premiums of less than $20 a month” and that “97% of beneficiaries enrolled in a stand-alone prescription drug plan will have access to Medicare drug and health plans in 2009 whose premiums would be the same or less than their coverage in 2008.” According to data gathered by Waxman’s staff, 16.3 million Medicare beneficiaries, including 92% of all drug plan members, will pay higher monthly premiums if they stay with the same plan next year. He also stated that in January 2009, average premiums for the drug benefit will increase by 22%, from $31.15 per month to $38.07 per month.

Waxman said since the beginning of the drug benefit the average Medicare drug plan premium has increased “by almost 50%, costing the average senior an additional $150 annually.” He also noted that 2009 will be the third consecutive year that drug plan premiums have risen above the inflation rate. “These price increases are causing significant hardships, particularly seniors who live on fixed incomes, and who are already faced with rapidly increasing costs for food, gasoline and shelter,” Waxman added.

Waxman requested that CMS provide his panel with information on the cause of premium increases; their effect on the program’s enrollment, costs and beneficiaries; and estimates of increases for 2010 through 2012. He asked that the information be presented by the end of the month.

CMS spokesperson Peter Ashkenaz said the agency is collecting data to respond to Waxman. “We have been telling beneficiaries since August (when we announced the benchmarks) that they will need to compare the value of their current plan by looking at the plan coverage and costs as they enter the open enrollment period,” he said, adding, “Ninety-seven percent of beneficiaries do have access to lower cost options, but as we have said before, they may need to change plans” (Vadala, CQ HealthBeat, 10/16).

Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation.?  All rights reserved. Continue reading

Fat Outside Of The Arteries Linked To Cardiovascular Disease

Researchers at the University of Cincinnati (UC) have found that fat around the outside of arteries may lead to the development of cardiovascular disease and could be linked to its onset in individuals with diabetes.

David Manka, PhD, a researcher in the division of cardiovascular diseases, and his team found that this fat – known as perivascular adipose tissue – could possibly lead to the formation of fatty buildup inside of arteries and could cause existing buildup to break loose, leading to stroke or heart attack.

These findings are being presented at the American Heart Association’s Russell Ross Memorial Lectureship in Vascular Biology: Emerging Concepts in Vascular Disease on Nov. 16.

“Obesity is a growing problem, but most information that is coming from scientists and clinicians involves visceral adipose tissue – or the beer belly – which leads to a higher risk of cardiovascular disease,” Manka says. “The fat that grows around the larger arteries throughout the body has been largely ignored. With this study, we wanted to see if it had any effect on the onset of cardiovascular disease, particularly in diabetics or those who are at risk.”

Manka and his team transplanted fat tissue around the arteries of knockout mouse models that were predisposed for cardiovascular disease and diabetes.

“Your typical mouse doesn’t naturally have that perivascular adipose tissue outside of the artery,” he explains. “We found that disease and buildup formed right inside of the artery next to the transplanted fat in these mice models. Besides the disease, we found that this fat tissue caused smaller blood vessels to grow around the larger blood vessles, called the vasa vassorum, which we don’t see otherwise. Both of these effects are local effects on the adjacent artery.”

Manka says this is the first time this development has been observed.

“Before this, we didn’t know which came first – the vasa vassorum formation or the fat formation in the arteries,” he says. “If you don’t have the fat outside of the vessel, you won’t have the activation of the vasa vassorum, which is thought to cause fat deposits to rupture, leading to stroke or heart attack. We are trying to establish cause and effect between the vasa vasorum and plaque instability, and now we have the model to test this.”

Manka says these results show that perivascular fat is sensitive to metabolic cues and could be the link between metabolic dysfunction and vascular disease.

“This may be one of the reasons diabetics have increased rates of cardiovascular disease,” he says. “We still don’t know exactly what that link is. The perivascular fat is sensing these metabolic stimuli and is becoming dysfunctional itself, translating to local inflammation of vessel.”

Manka says the next step for researchers is to identify the molecular pathways that are differentially regulated in the various kinds of fat to see which cause disease and which are linked to inflammation.

“We can then try to find ways to target them and stop or reverse the adverse effects of this perivascular fat on vascular disease,” he says. “These findings will help us discover targeted therapies and may lead to quicker diagnosis, impacting the way physicians diagnose and treat cardiovascular disease.”

This study was funded by the National Institutes of Health.

Source:
University of Cincinnati Academic Health Center

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Virginia Tech engineer investigates enzyme link to neurological disease, TGases

Several neurologically based afflictions, such as Huntington’s, Parkinson’s, and Alzheimer diseases, have been correlated to a higher than normal presence of a specific type of enzymes, called transglutaminases (TGase) in the human body. TGases, whose function is to catalyze covalent bonds among proteins, are commonly found in several different human tissues.

In the presence of unusually high levels of these enzymes, some proteins tend to form denser clusters than normal in vivo. If the aggregates grow in size, it can lead to a build-up of insoluble plaques that can block neurovascular transport and cause neural cell death.

“If higher TGase concentrations in cerebrospinal fluid and in the brain lead to protein agglomeration, then their inhibition could reduce symptoms, delay the onset of agglomeration, and maintain viable neural cell health extending the quality of life for those afflicted,” hypothesizes Brian Love, a professor of materials science and engineering (MSE) at Virginia Tech.

Love, who focuses his research on tissue and cell engineering, and Elena Fernandez Burguera, a post-doctoral research associate, are evaluating specific therapies to fight the abnormally high TGase binding. Based upon the prior work of several others who are conducting clinical trials, Love and Burguera are developing an in vitro model to evaluate the ability of several inhibitors to block protein aggregation by TGases.

Again, based on the work of other scientists, “several compounds show some positive effects,” Love says. These include creatine, cystamine hydrochloride, and a few others. “The development of an inhibition protocol may help test the efficacy of other inhibitors as well,” the engineer adds.

The Virginia Tech researchers are looking at the enzymatic binding of protein-bound polystyrene particles as models. Groups of particles are dispersed in calcium-rich aqueous solutions containing TGases. Once mixed, the particle binding begins. The bigger agglomerates attempt to settle out of the solution, and Love and Burguera track particle sedimentation.

The tracking method, called Z-axis Translating Laser Light Scattering (ZATLLS), is unique to Virginia Tech and based on key concepts in transport phenomena. It has been used to gauge how other complex fluids, such as paints and sealants, are dispersed. Now Love and Burguera are resolving when protein coated particles are effectively dispersed in vitro and under what conditions they are unstable enough to agglomerate.

They track in situ sedimentation of protein-coated particles exposed to transglutaminase, both in the presence of and without transglutaminase inhibitors. “We can use ZATLLS to resolve whether inhibitors prevent agglomeration of protein coated particles by TGase if the inhibitors lower the particle sedimentation velocity,” Love says. “Our goal is to find the safest and most effective inhibitors that prevent the agglomeration-based crosslinking found throughout these neurological disorders.”

This work is funded by the Commonwealth Health Research Board.

Love is a participating member in the School of Biomedical Engineering and Science (SBES), a joint venture between Virginia Tech’s College of Engineering and the Wake Forest University School of Medicine. SBES is the partnership of the two eminent educational institutions. Virginia Tech’s highly acclaimed engineering college has long been the university’s educational centerpiece. Since 1987, when U.S. News & World Report starting ranking the top undergraduate engineering program, and later, the graduate schools, Virginia Tech’s College of Engineering has consistently appeared in the magazine’s listings. And, today, the National Science Foundation lists the College among the top 15 for research expenditures. Wake Forest University Baptist Medical Center gained nearly $10 million in funding from the National Institutes of Health (NIH) for the fiscal year that ended on Sept. 30, 2004, reaching $114,768,124 and ranking 36th overall among 125 American medical schools.

Lynn Nystrom
tansyvt.edu
540-231-4371
Virginia Tech
vtnews.vt.edu Continue reading

Philadelphia Inquirer Series Examines Difficulties Of Obtaining Affordable Coverage For People With Chronic Health Conditions

The Philadelphia Inquirer on Tuesday — in the second article of a series titled “Falling Through: Casualties of the Health Insurance Crisis” — examined how people with chronic illnesses face challenges in obtaining affordable health coverage.

The article profiles a small business owner who allowed his health coverage to lapse and then was diagnosed with Crohn’s disease. The man tried to purchase private insurance, but monthly premiums and copayments were unaffordable because of the pre-existing condition and he was forced to pay for treatment out-of-pocket. His children are enrolled in FamilyCare, New Jersey’s version of SCHIP, but he and his wife do not qualify for the program because their income is too high. The man now is in debt and relies on discounts from health care providers, charity care, and skipping or reducing doses of medication to save money on health care (Vitez, Philadelphia Inquirer, 9/30).

Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation.?  All rights reserved. Continue reading

Cutting Calories May Be Key To Evolutionary Fitness

Charles Darwin and his contemporaries postulated that food consumption in birds and mammals was limited by resource levels, that is, animals would eat as much as they could while food was plentiful and produce as many offspring as this would allow them to. However, recent research has shown that, even when food is abundant, energy intake reaches a limit, even in animals with high nutrient demands, such as lactating females. Scientists at the Research Institute of Wildlife Ecology in Vienna suggest that this is due to active control of maternal investment in offspring in order to maintain long-term reproductive fitness.

The research, presented by Dr Teresa Valencak at the Society for Experimental Biology Annual Meeting in Glasgow has shown that, when their energy reserves are low or when their offspring are kept in cooler temperatures, Brown hares are able to increase their energy turnover and rate of milk production above that normally observed. This indicates that, ordinarily, the hares are operating at below their maximum capacity and shows that this is not due to any kind of physiological constraint, such as length of digestive tract or maximum capacity of mammary glands. Also, as the hares were provided with plentiful food, there could be no limitation of energy turnover due to food availability.

The way that females regulated their energy expenditure according to pup demand and their own fat reserves but did not exceed certain levels fitted with the group’s theory that using energy at close to the maximum rate has costs for animals which may compromise their ability to successfully reproduce in the future. If a hare puts most of its energy into a litter of pups then it will have little left over for growth and body repairs for example, which may shorten its life or make it less able to produce or care for young in the future. By actively limiting the rate of energy turnover, a mother can prevent this and maintain a higher level of reproductive success over her lifetime.

Source:
Tess Livermore

Society for Experimental Biology Continue reading

VHA Health Foundation Convenes First Disaster Preparedness Conference Exclusively For Hospital Leaders

Leaders of American hospitals from
throughout the nation met here today for two days of talks with high-level
health care and government officials on better preparing American
communities to cope with the next inevitable disaster.

Admiral John O. Agwunobi, MD, MBA, MPH, Assistant Secretary of the
Department of Health and Human Services, told the nearly 200 leaders
attending the VHA Health Foundation forum that disaster planning should not
begin with the actual event. Instead, disaster plans should start with
recovery and considerations of what the situation will be like 30 days
after the catastrophe occurs.

“The greatest stress on hospitals … is after the event rather than
during or before,” he said. “Yet in disaster planning, we spend time
planning for the 30 minutes before the disaster hits but rarely get to the
recovery phase in our planning exercises.”

The meeting was the first devoted exclusively to helping hospital CEOs
determine if their hospital has done everything necessary to assure they
are prepared to assist their communities through man-made or natural
disasters. The VHA Health Foundation, sponsor of the event, is a national
resource for senior hospital leaders seeking information on innovation in
health care and disaster readiness.

“People turn to hospitals in a crisis because they know hospitals deal
with emergencies every single day,” said Linda DeWolf, President of the VHA
Health Foundation. “And hospitals know that to meet their responsibilities
they must be ready to deal with unanticipated disruptions in
communications, staffing, facilities and logistics. Most importantly,
hospitals need to recognize that the community relationships they build now
are crucial to their ability to weather a crisis.”

Aaron Brown, former CNN NewsNight anchor highlighted the need for
leaders to be in control of their response to a crisis and demonstrate
unwavering “commitment to getting it done,” even in the most desperate of
situations. Brown, over a career spanning 30 years, covered such disasters
as September 11, the shootings in Columbine and earthquakes in California.
James Lee Witt, former FEMA director, was expected to share insights later
in the day Thursday from more than 25 years of managing disasters.

Agwunobi said “true preparedness” has three levels:

— The ability to understand the unique nuances in any given hazard;

— The assurance of “modular general competencies”; and

— The creation of a culture of preparedness.

“Every hazard has its own unique characteristics,” he said, reviewing
the nuances between preparing for an earthquake, which is a single event in
which many patients suffer crush injuries, and pandemics where half the
hospital staff could fall ill and the course of the disease could last
months or years. Planning requires that hospitals consider the unique
circumstances of each crisis and plan the appropriate response.”

General competencies include planning for the basics like power, food,
water, staffing and supplies. “Almost all hospitals now have generators
that can supply power for two to seven days, but in Florida, the average
power outage was two weeks,” he said.

“Have you asked yourself the question, ‘What would break down if we
didn’t have power for 30 days?’” he said. “What would happen if all the
workers who fix water mains were ill? Or, what would you do if it took
three times as long as usual for pharmaceuticals to be replenished?”

Agwunobi also reminded hospital executives that hospital disaster
planning should not happen in a vacuum but must be coordinated at the
community level with the government, other health care providers and other
hospitals. “You can be as prepared as you think you can be, but if your
community is not prepared, if you’re the only one, then you’ll be
overwhelmed in any crisis … If you’re the only light in the darkness,
you’ll quickly get all the oxygen patients; if you’re the only source of
water, you’ll get all the dialysis patients.”

Part of hospital planning must be to create a “culture of community
preparedness,” including close cooperation with other hospitals, agencies
and community resources. He urged hospitals that might normally be
competitors to share their disaster preparedness plans, adding “in a true
crisis, there is no competition.”

The meeting sought to address discrepancies in hospital preparedness.
Earlier this year, a report from the Trust for America’s Health said the
nation’s level of emergency preparedness warranted a D+ and hospitals
didn’t rank much better.

The forum agenda included a scenario planning session and the
introduction of a new tool for measuring hospital CEO preparedness. Public
release of the results of the preparedness assessment is expected early
first quarter of 2007. Those at the conference saw first-hand the
rebuilding of New Orleans with local hospital executives who managed
through Hurricane Katrina. A media panel shed light on what the press
expects from hospitals as critical sources of information during a
disaster.

The VHA Health Foundation, located in Irving, Texas, is a public
foundation created by VHA Inc. to encourage leadership and innovation in
addressing health and health care issues. Efforts benefit VHA member health
care organizations as well as non-members. The VHA Health Foundation
supports programs that focus on new approaches to health and health care
that make a difference, generate synergies that bring resources to add
value and enhance outcomes, and diffuse knowledge and best practices. For
more information, visit vhahf.

VHA Health Foundation
vhahf Continue reading

Marshall Edwards Announces Final Results From Halted Phase 3 Clinical Trial Of Phenoxodiol

Marshall Edwards, Inc. (NASDAQ: MSHL), an oncology company focused on the clinical development of novel anti-cancer therapeutics, announced that a final analysis of its Phase 3 OVATURE trial of orally administered phenoxodiol in women with recurrent ovarian cancer determined that the trial did not show a statistically significant improvement in its primary (progression-free survival) or secondary (overall survival) endpoints. As previously announced, the trial was closed for recruitment before completion of enrolment with only 142 out of a planned 340 patients enrolled.

This multi-center, randomized, double-blind trial assessed the safety and efficacy of daily phenoxodiol in combination with weekly carboplatin versus weekly carboplatin with placebo in patients with platinum-resistant or platinum-refractory, late-stage epithelial ovarian, fallopian or primary peritoneal cancer following at least second line platinum therapy.

“Owing to the fact that this trial was significantly underpowered due to the small number of patients enrolled, we were disappointed, but not entirely surprised by the final outcome,” said Dr. Daniel P. Gold, newly appointed Chief Executive Officer of Marshall Edwards. “However, we remain confident that our investigational isoflavone platform, including triphendiol, a potentially more potent, second-generation analogue of phenoxodiol, may be of benefit to women with ovarian cancer, particularly when administered intravenously.

“Previously reported results of a Phase 2 trial,” continued Dr. Gold, “which tested the activity of intravenous phenoxodiol plus weekly cisplatin in a similar platinum-resistant or refractory patient population, demonstrated a 30% response rate (6 out of 20) compared to less than 1% (1 out of 142) in the OVATURE study in which phenoxodiol was administered orally. In addition, we remain excited with the progress of another product candidate in our pipeline, NV-128, a novel isoflavone analogue with a mode of action distinct from both phenoxodiol and triphendiol.

“Lastly, I want to take this opportunity to personally thank the patients and their families for their participation in this trial. I would also like to thank the clinical investigators and trial coordinators for their dedication and support.”

Safety Outcomes

As previously noted, phenoxodiol had a good safety profile and was well tolerated. The number of patients experiencing at least one adverse event was similar in each treatment group, as was the number of patients experiencing adverse events of Grade 3 or higher.

About OVATURE and the Phenoxodiol Clinical Program

The OVATURE (“OVArian TUmor REsponse”) trial was a multi-center international Phase 3 clinical trial of orally administered investigational drug phenoxodiol in combination with carboplatin in women with advanced ovarian cancer resistant or refractory to platinum-based drugs to determine its safety and effectiveness when used in combination with carboplatin.

The trial recruited ovarian cancer patients whose cancer initially responded to chemotherapy, but had since become resistant or refractory to traditional platinum treatments. The study was closed to enrolment in April 2009 at which time 142 patients had been randomized to the study. Changes in standards of care over the period of the trial and the stringency of inclusion/exclusion criteria of the OVATURE protocol had slowed patient recruitment rates and consequently the Company deemed it prudent not to continue the trial to completion. The Independent Data Monitoring Committee (IDMC) supported the Company’s decision to close the study to accrual, and, in a review of the available safety data, the IDMC confirmed that there were no safety concerns with phenoxodiol in these subjects.

About Phenoxodiol

Phenoxodiol is being developed as a chemosensitizing agent in combination with platinum drugs for late stage, chemoresistant ovarian cancer and as a monotherapy for prostate and cervical cancers. It is believed to have a unique mechanism of action, binding to cancer cells via a cell membrane oxidase, causing major downstream disturbances in expression of proteins necessary for cancer cell survival and responsible for the development of drug resistance.

Phenoxodiol appears to selectively inhibit the regulator known as S-1-P (sphingosine-1-phosphate) that is overexpressed in cancer cells. In response to phenoxodiol, S-1-P content is decreased, with a consequent decrease in expression of the pro-survival proteins XIAP and FLIP, inducing cell death via caspase expression and promoting sensitivity to other chemotherapeutics. In laboratory studies, it has been demonstrated that drug-resistant ovarian cancer cells pre-treated with phenoxodiol were killed with lower doses of chemotherapy drugs. Importantly, phenoxodiol has been shown not to adversely affect normal cells in animal and laboratory testing.

Phenoxodiol has been granted Fast Track status from the FDA to facilitate its development as a therapy for recurrent ovarian and prostate cancers. Fast Track designation is designed to facilitate the review of products that address serious or potentially life-threatening conditions for which there is an unmet medical need and provides the option to file a New Drug Application on a rolling basis. This permits the FDA to review the filing as it is received, expediting the review process. Phenoxodiol is an investigational drug and, as such, is not commercially available. Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical trials and approved by FDA as being safe and effective for the intended use.

Source
Marshall Edwards, Inc. Continue reading

Penn Study: Brain Structure Assists In Immune Response

For the first time, a team of researchers at the University of Pennsylvania School of Veterinary Medicine have imaged in real time the body’s immune response to a parasitic infection in the brain.

The complete findings, published in the current issue of the journal Immunity, provide unexpected insights into how immune cells are regulated in the brain and have implications for treatment of any inflammatory condition that affects the brain.

Toxoplasma, a common parasite of humans, is found in the brains of approximately 30 percent of the population. Yet, because the brain lacks its own lymphatic system for localized immune response and the blood brain barrier limits antibody entry, researchers have found it provides unique challenges for the immune system to control local infection. Therefore, little is known about the processes by which T cells access the central nervous system during toxoplasma infection or how the immune system keeps this parasite in check.

In this Penn study, researchers aimed to better understand how the immune system is able to control infection in the brain. Using recent advances in two-photon microscopy that allow the visualization of T-cell populations in the brain, Chris Hunter’s lab focused on the visualization of effector CD8+ T cells during toxoplasmic encephalitis.

“We found, quite unexpectedly, that the movement of infiltrating T cells was closely associated with an infection-induced reticular system of fibers in the brain,” lead author Emma Wilson said. “These structures were not present in normal brain tissue.”

“This observation suggests that in the brain, specialized structures are induced by inflammation that guide migration of T cells in this immune-privileged environment and allow them to perform a search-and-destroy type of mission required to find abnormal cells or microbes with the brain,” Hunter, professor and chair of the Department of Pathobiology at Penn Vet, said.

The study was supported by a grant from the National Institutes of Health and the Commonwealth of Pennsylvania. The study was performed by Wilson of Penn, now at the Department of Biomedical Sciences at the University of California, Riverside; Tajie H. Harris, Beena John, Elia Tait, Marion Pepper and Hunter of the Department of Pathobiology at Penn Vet; Wolfgang Weninger, Paulus Mrass and E. John Wherry of The Wistar Institute (Weninger and Mrass are now at the Centenary Institute for Cancer Medicine and Cell Biology in Sydney); Florence Dzierzinski of the Institute of Parasitology at McGill University; Philip G. Haydon of the Department of Neuroscience at Tufts University; Gregory F. Wu and Terri M. Laufer of the Department of Medicine at the University of Pennsylvania School of Medicine; and David Roos of the Department of Biology at Penn.

###

Source: Jordan Reese

University of Pennsylvania Continue reading

Tiny Laser-Scanning Microscope Images Brain Cells In Freely Moving Animals

The majority of our life is spent moving around a static world and we generate our impression of the world using visual and other senses simultaneously. It is the ability to freely explore our environment that is essential for the view we form of our local surroundings. When we walk down the street and enter a shop to buy fruit, the street, shop and fruit are not moving, we are. What our brain is probably doing is constantly updating our position based on the information received from our sensory inputs such as eyes, ears, skin as well as our motor and vestibular systems, all in real time. The problem for researchers trying to understand how this occurs has always been how to record meaningful signals from the brain cells that do the calculations while we are in motion.

To get around this problem researchers at the Max Planck Institute for Biological Cybernetics in T??bingen have developed a way of actually watching the activity of many brain cells simultaneously in an animal that is free to move around the environment. By developing a small, light-weight laser-scanning microscope, researchers were able to, for the first time, image activity from fluorescent neurons in animals that were awake and moving around, while tracking the exact position of the animal in space. The microscope uses a high-powered pulsing laser and fiber optics to scan cells below the surface of the brain, eliminating the need to insert electrodes, which are traditionally used. Because of this, the microscope is non-invasive to the brain tissue.

The traditional approach to solving these sorts of questions is to restrain the animal and present it with a series of scenes or movies or images. The miniaturized microscope allows the researchers to turn this paradigm around and allow the animal to freely move around in its environment, while still allowing the scientists to monitor the activity of the brain cells responsible for processing visual information. It is clear that the brain does not work one cell at a time to recognize the environment, so the microscope records from many cells at a time, allowing for the first time the ability to look at how the brain is able to generate an internal representation of the outside world, while using natural vision.

“We need to let the animal behave as naturally as possible if we want to understand how its brain operates during interaction with complex environments. The new technology is a major milestone on the way to helping us understand how perception and attention work”, says Jason Kerr, lead author of the study.

Source: Jason Kerr

Max-Planck-Gesellschaft Continue reading

How vitamin D can benefit men’s health

How can we get American men interested in vitamin D? Most men could care less. Say vitamin D did something men find really important, like improve athletic performance or induce hair growth? Or, say it improved sexual performance or increased virility? Nothing would get men treating their vitamin D deficiency like a study that showed vitamin D increased organ size!

Sixteen years ago, Professor Walter Stumpf (who taught me at UNC School of Medicine) first made the case that vitamin D is intimately involved with sex and reproduction. Male genital tissue contains lots of vitamin D receptors but their significance and function remain unknown. One researcher actually gave a vitamin D-like-drug to see if it improved sexual performance in patients with renal failure! To bad for the instant popularity of vitamin D, the results showed no improvement.
Am J Obstet Gynecol. 1989 Nov;161(5):1375-84
Clin Nephrol. 1980 May;13(5):208-14

Vitamin D does appear to improve virility. Conception peaks in the summer, when vitamin D levels are highest, and ebbs in the winter, when vitamin D stores are low. Vitamin D deficiency has profound effects on rat testicles, including dramatically reducing spermatogenesis. Vitamin D deficient male rats were 73% less likely to successfully father pups than vitamin D sufficient males. Vitamin D restored virility to vitamin D deficient male rats and should do the same for vitamin D deficient male humans.
Hum Reprod. 1992 Jul;7(6):735-45
Ann Nutr Metab. 1992;36(4):203-8
Ann Nutr Metab. 1995;39(2):95-8
J Nutr. 1989 May;119(5):741-4

What else are men interested in besides sex? Hair growth! In fact, hair follicles have large numbers of vitamin D receptors but their function is unknown. Although there are no human studies showing vitamin D will grow men a new head of hair, vitamin D like drugs do grow hair in mice. (By the way, both my wife and my barber have told me my head has stopped balding and I’ve kept my 25(OH)-vitamin D level around 50 ng/ml for several years.) One relevant animal study should get the
attention of men; the title contains two of their favorite words: “nude” and “hair growth.”
Endocrinology. 2002 Nov;143(11):4389-96

What about weight? Can you see the headlines in the men’s’ fitness magazines: “Vitamin D Reduces Weight.” Although dozens of studies have found that those with the highest 25(OH)-vitamin D blood levels weigh the least, most vitamin D scientists explain this by pointing out that vitamin D is stored in fat tissue, thus lowering blood levels. Of course that does not preclude vitamin D from also having either a direct or indirect effect on weight.
J Clin Endocrinol Metab. 2003 Jan;88(1):157-61
J Clin Endocrinol Metab. 2004 Mar;89(3):1196-9
J Clin Endocrinol Metab. 2005 Feb;90(2):635-40
Am J Clin Nutr. 2000 Sep;72(3):690-3

One study tried to answer that question by looking directly at vitamin D intake and body weight. The authors found an inverse correlation. That is, the more vitamin D in your diet, the less you weighed! If you have a few minutes, test your knowledge by taking our quiz on obesity and vitamin D.
J Nutr. 2003 Jan;133(1):102-6
Obesity and Vitamin D Quiz.

Finally, we turn to athletic performance. After sex, hair growth, and obesity, improving athletic performance would certainly make American men pay attention to vitamin D. Actually, what we are asking is: “Does the most potent steroid hormone system in the human body have any effects on balance, muscle strength, muscle mass, reaction time, etc?” When asked that way, it would be surprising if it had none. In fact, dozens of studies suggest vitamin D will improve athletic performance.

If vitamin D improves athletic performance, then we’d predict physical fitness should peak in the late summer when 25(OH)-vitamin D levels peak. The only two studies that looked at season of the year and athletic performance of trained athletes found physical fitness peaked exactly then.
Acta Physiol Pol. 1981 Nov-Dec;32(6):629-36
Rom J Physiol. 2000 Jan-Dec;37(1-4):51-8

Genetic ablation of vitamin D receptors caused profound impairment in the motor functions of mice. Furthermore, mice without the vitamin D receptor gene showed increased anxiety; performance anxiety is something all men want to avoid. Babies born to vitamin D deficient rats are permanently and irreversibly brain damaged, proving that vitamin D has profound effects on developing neural tissue. (We will have more on this important, and tragic, research coming out of Australia in a future
newsletter.)
Brain Res Bull. 2004 Jul 30;64(1):25-9

Muscle strength is important to athletes and it correlated with 25(OH)-vitamin D levels in older men. A vitamin D like drug improved muscle strength in vitamin D deficient older women. In fact, it did the same thing to a group of vitamin D deficient younger women. Furthermore, improved lower extremity function was directly associated with higher 25(OH)-vitamin D levels.
Arch Phys Med Rehabil. 1999 Jan;80(1):54-8

Athletes need to be quick. A single injection of 600,000-units of vitamin D significantly improved reaction times in older adults. Furthermore, higher 25(OH)-vitamin D levels were also independently associated with better reaction time and better performance time.
Age Ageing. 2004 Nov;33(6):589-95

Athletes need good balance. The beneficial effect vitamin D has on balance (reduced falls) is not limited to profoundly vitamin D deficient populations; a vitamin D-like-drug improved balance in the general elder population, even those with “normal” 25(OH)-vitamin D levels. A more recent study showed higher 25(OH)-vitamin D levels correlated with better gait speed, balance and muscle strength.
J Steroid Biochem Mol Biol. 2004 May;89-90(1-5):497-501.

Vitamin D also appears to maintain muscle mass in older people but, no one has reported similar studies of young adults. A recent review concluded that vitamin D is an authentic strength preserving hormone, at least in the elderly. There is no reason to think it has any less effect on vitamin D deficient younger persons.
J Clin Endocrinol Metab. 2003 Dec;88(12):5766-72

Finally, debilitating chronic pain sidelines many athletes. One Mayo clinic study found that virtually all patients treated for chronic pain have low 25(OH)-vitamin D levels. Furthermore, in what must be one of the largest open studies ever reported, 360 patients with low back pain in Saudi Arabia responded exceptionally well to treatment with physiological doses of vitamin D. Like virtually all areas of vitamin D research, we are still awaiting definitive research.
Mayo Clin Proc. 2003 Dec;78(12):1463-70

An impressive scientific literature suggests that vitamin D may improve athletic performance. This should surprise no one as other steroid hormone systems improve athletic performance. One difference is that the U.S. government is going to find it hard to regulate the vitamin D steroid hormone system; the sun is both a free and robust source of vitamin D. Of course, oral vitamin D is toxic in overdose and vitamin D toxicity would greatly impair athletic performance. Smart athletes would
get enough sun, or take enough cholecalciferol, to keep their 25(OH)-vitamin D levels around 50 ng/ml, year around. But then, smart non-athletes would do the same.

What would happen if researchers gave physiological doses of cholecalciferol to men for a year or two and studied their sex life, hair growth, weight and athletic performance? Would vitamin D improve men’s sex life? Would it make them more virile? Would they stop going bald? Would they lose weight? Would they become better athletes?

We don’t know. However, a rapidly expanding scientific literature indicates vitamin D lowers their risk of heart disease, diabetes, hypertension, multiple sclerosis, autoimmune illness, depression and seventeen different types of cancer. It now appears likely that vitamin D has an important role in treating those killer diseases as well.

But that doesn’t really interest most American men. Men want to know about the important stuff. Why not start taking 2,000 units of cholecalciferol every day and see if your sex life improves, your hair grows back, you lose weight, and you become a better athlete? (And, don’t forget to measure down there; after all, you never know).

John Cannell, MD
The Vitamin D Council
9100 San Gregorio Road
Atascadero, CA 93422
www.vitamindcouncil Continue reading