Reaction
Obey said, “On both sides of the aisle, there’s a recognition that this bill is far from excessive in meeting the investment needs of agencies under its jurisdiction.” Obey said there were no serious amendments offered to reduce the bill’s spending (Wayne, CQ Today, 7/11). House Appropriations Labor-HHS-Education Subcommittee ranking member James Walsh (R-N.Y.) said, “If I was chairman and I had this allocation, I’m not sure I would have done anything different” (CongressDaily, 7/12).

Committee ranking member Jerry Lewis (R-Calif.) said he was concerned about the possibility that Bush would veto the bill (Wayne, CQ Today, 7/11). Lewis said, “It’s important for all of us to know that all of these programs have grown by $85 billion in a little more than a decade. By anybody’s evaluation, that’s a sizable adjustment in the federal commitment, so sooner or later, we all must recognize that someone will bear the burden” (CongressDaily, 7/12).

Budget Deficit Smaller Than Predicted
In other budget news, the White House Office of Management and Budget on Wednesday released a new projection of the FY 2007 budget deficit that is $39 billion less than a February estimate, CQ Today reports. The new $205 billion estimate is less than half of the peak budget deficit during the Bush administration of $412 billion in 2004 (Clarke, CQ Today, 7/11).

According to the Wall Street Journal, Bush “seized on the latest … estimates,” arguing that Republican tax cuts and spending allocations are working and that “Democrats’ proposals to raise taxes and expand health care and other domestic programs pose a long-term threat to the country’s economic health” (McKinnon/Solomon, Wall Street Journal, 7/12). Bush said, “Tax and spend policies are the policies of the past, and I’m going to use my veto pen to keep it that way” (Taylor, AP/Houston Chronicle, 7/11).

OMB said that the prediction for the FY 2008 budget deficit has been increased to $258 billion, up from a $239 billion estimate in February, because of higher outlays for entitlement programs, such as Medicaid and Medicare and other spending. House Budget Committee Chair John Spratt (D-S.C.) said, “It’s hard to take a lecture on fiscal discipline from a president who has added $3.3 trillion to the national debt.” Spratt added, “Most of the increase, the lion’s share, comes from increased spending for national defense, and homeland defense, and we’ve funded it and gone along with it. For [Bush] to come back and blame us for that high level of expenditure, particularly for the war, is not fair, to say the least” (Wall Street Journal, 7/12).

“Reprinted with 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 . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

NERF will be housed on the IMEC campus where researchers will work in
cross-disciplinary teams, benefitting from IMEC’s state-of-the-art clean
room infrastructure and a new 1,000m2 neurolab. NERF will be organized
around teams of top-notch researchers doing world-class basic research.
They will be able to work closely together with a wide range of experts
from the 3 founding fathers, providing a unique leverage. By 2014, NERF
aims to expand its team to about 50 international top-researchers. NERF
starts off with a 3 million euro research grant from the Flemish
Government for the first 3 years. IMEC, VIB and K.U.Leuven will equally
invest in NERF.

“NERF fully leverages and complements IMEC’s semiconductor research and
infrastructure and that makes it unique in comparison to other
neuroscience centers. Today, both neurobiology and nanoelectronics work
at the same dimensions. Therefore, it becomes possible to develop
nanoscale structures that “listen in” to neural circuits, learn their
“language”, actively communicate with them and thus detect pathology at
an earlier stage than currently possible,” said Kris Verstreken,
director Human++/BioNanoElectronics at IMEC. “NERF researchers will
unravel the functioning of the brain and the peripheral nervous system
through intensive application of these new tools. This will yield vital
knowledge for the pharmaceutical and medical industry and is crucial for
the study of pathology such as Parkinson’s disease, Alzheimer’s disease
or even for psychiatric disorders. Advanced therapies are often a
serendipitous result of such fundamental research.”

“NERF will focus on basic neurobiological questions, best addressed
through an interdisciplinary approach using cell biology, genetics,
nanoelectronics and nanoscale engineering. Combining these approaches in
one new grassroots initiative is for the time being unique in the world
— and quite exciting, as can be seen from the very enthusiastic
response of the research community involved worldwide”, says Jo Bury,
Managing Director of VIB. “We capitalize on the tremendous opportunity
of having the background technologies and approaches available at high
excellence level in the research labs of the 3 founding partners of NERF.”

“The link of neurobiology and nanoelectronics with the imaging,
data-mining and translational medicine competencies available at
K.U.Leuven, makes our partnership unique and highly promising. We are
convinced that NERF will become the cornerstone of a vibrant, path
breaking community of scientists and engineers. We all look forward to
this unique research journey;” says Koenraad Debackere, Managing
Director of K.U.Leuven R&D.

NERF will officially take off on October 29, 2009 with a first assembly
of the scientific advisory board. On this occasion the founding partners
organize a unique neuroelectronics workshop to discuss the research
roadmap of NERF with some 50 top world experts in different disciplines
of importance to the success of NERF.

Source
IMEC, VIB and K.U.Leuven

The painless technique focuses on tiny structures in the skin known as Meissner corpuscles, which encapsulate the endings of microscopic nerves in our hands, feet, and other areas. When someone tickles your feet, or lightly brushes the palm of your hand, or gives you a kiss – it’s Meissner corpuscles that are detecting the touch. The tiny structures act like little sensors, allowing us to feel light touch and pressure.

Now a neurologist at the University of Rochester Medical Center, working together with scientists from Lucid Technologies in Rochester, N.Y., has demonstrated a new way to monitor the structures, which offer a direct window into a condition known as peripheral neuropathy. The team showed that reflectance confocal microscopy, a technology for looking just beneath the surface of the skin, can be used to see and count the number of the structures in a person’s fingers and hands. The work gives doctors a non-invasive way to detect and monitor the progression of nerve damage in patients.

The research appears in the journal Neurology.

Doctors have known that the number and density of Meissner corpuscles in a person’s hands and feet offer a snapshot into the degree of a patient’s nerve damage. As nerves degenerate and die, the corpuscles disappear. The difficulty has been actually visualizing and counting them.

Currently, doctors take a small biopsy of the skin, freeze and stain the tissue, and then count the structures. Neurologist David Herrmann, MBBCh, the lead author of the Neurology paper, helped develop and popularize skin biopsy about 10 years ago as a way to keep close track of the condition of nerves in patients. At the time, for some forms of peripheral neuropathy, it was a big improvement over previous methods, which required a much larger biopsy of a large nerve.

Even so, “Taking a small piece of skin is not ideal,” said Herrmann, associate professor of Neurology and of Pathology and Laboratory Medicine. “It can be painful for the patient; the processing can be time-consuming; and it’s impossible to measure the exact same area of skin year to year to track the progression of the disease.”

A few years ago Herrmann met a scientist from Lucid, a medical device and information company that is creating tools for physicians based on innovative technologies such as confocal microscopy. The technology uses light to actually look beyond the surface of skin tissue into the layers of skin below. The technology is being used more and more to track skin cancers and to look at tissue samples in the operating room.

Herrmann and the Lucid team began a study of some of the tiniest nerves in our body, those that reach into the furthest reaches of our hands and feet. Damage to those nerves leads to a variety of troublesome symptoms for the millions of Americans who have some type of peripheral neuropathy. Symptoms in the feet and hands can include numbness, burning, tingling, weakness, and pain.

While diabetes is the most common cause of neuropathy, it’s caused by a variety of other conditions as well. Patients with HIV are prone to getting it. Excess alcohol consumption can bring it on, as can some vitamin deficiencies, cancer treatments, and dozens of inherited disorders, most notably Charcot-Marie-Tooth disease.

“These patients are often dismissed, and many really suffer,” said Herrmann. “Diagnosis is often difficult. The small nerves in the skin are basically invisible to standard techniques for checking the function of a person’s nerves, such as conduction tests.”

So Herrmann lined up 15 little pinkies – well, 15 research subjects willing to put their little pinkies under the microscope. The group included 10 healthy people, and five who had neuropathies from various causes, such as diabetes or HIV.

The researchers found, as expected, that the healthy volunteers had many more Meissner corpuscles in the tip of the pinkie finger – about 12 such structures per square millimeter, compared to a mean of 2.8 in people with neuropathy. Patients with neuropathy also had fewer of the structures at the base of the thumb.

While the results were not surprising, attaining them so easily was. Volunteers simply held their pinkie finger under a microscope for a few minutes. No pain, no blood, no tissue preparation.

In an editorial about the research, Peter J. Dyck, M.D., of the Mayo Clinic wrote in the journal, “The approach may find use as the gold standard of tactile sensation and of large fiber sensorimotor polyneuropathy.” But he also pointed out some limitations of the work. Dyck said the technique needs to be tested in greater numbers of people, pointed out that the equipment needed for reflectance confocal microscopy is expensive, and mentioned the need to differentiate between healthy and abnormal Meissner corpuscles.

An advance in screening would be appreciated by millions of patients. More than half of people with diabetes will eventually develop neuropathy. Most of them won’t feel pain – they’ll simply lose sensation in their feet, making them vulnerable to wounds that can result in severe infections. Oftentimes sensation slips away so gradually that patients don’t even notice. A new screening tool would help doctors monitor patients more closely so that both they and patients are aware of nerve damage and can do everything they can to prevent further damage.

“Neuropathy is very difficult to treat, and part of the reason is that currently, we usually identify it too late, after there has been significant damage,” said Herrmann, director of the Peripheral Neuropathy Service at Strong Memorial Hospital. “Treatments might be more beneficial if we could detect the condition earlier.

“The idea is to move from an invasive biopsy for monitoring nerve endings, to non-invasive, painless approaches. A person could have this technique done as frequently as is necessary, for instance. That’s an attractive notion for tracking the condition of nerves in patients,” said Herrmann, who is now assessing the technique in 75 people, with funding from the National Institute of Neurological Disorders and Stroke.

###

In addition to Herrmann, authors of the paper from Lucid were pathologist J. Neil Boger, M.D.; Christi Alessi-Fox; and Cortney Jansen, who began work on the project when she was an undergraduate biomedical engineering major at the University of Rochester.

Source: Tom Rickey

University of Rochester Medical Center

“Our best advice to physicians prescribing codeine-containing products to nursing mothers is to prescribe the lowest dose needed for the shortest amount of time,” said Sandra Kweder, M.D., deputy director of the Office of New Drugs in FDA’s Center for Drug Evaluation and Research. “And nursing mothers should always consult their physicians before taking any codeine containing products.”

Codeine is an ingredient found in prescription and non-prescription medicines that are used to relieve pain or treat cough. Once in the body, some of the codeine is converted (metabolized) to morphine. Some people, due to their genetic makeup, metabolize codeine much faster and more completely than others. These people, called ultra-rapid metabolizers, are more likely to have higher-than-normal levels of morphine in their blood after taking codeine. Mothers who are ultra-rapid metabolizers may have higher-than-usual levels of morphine in breast milk.

According to the FDA, nursing mothers have used codeine safely for many years. In medical practice, codeine is generally considered the safest choice among narcotic pain relievers for nursing women and their babies. However, to raise awareness of this possible health risk and to prevent morphine overdose in nursing infants, FDA is requiring manufacturers of prescription codeine medicines to include information about codeine ultra-rapid metabolism in drug package insert information. In addition, FDA has posted information about this issue on the FDA website for healthcare providers and patients.

Nursing mothers taking codeine (or other narcotic pain relievers) should know how to watch for signs of overdose in their babies. Breast fed babies normally nurse every two to three hours and should not sleep for more than four hours at a time. Signs of morphine overdose in a nursing baby include increased sleepiness, difficulty breastfeeding, breathing difficulties or limpness.

The chance of being an ultra-rapid metabolizer varies among different population groups from less than 1 per 100 people to 28 per 100 people. For people who are ultra-rapid metabolizers, the risk of having an adverse event when taking codeine is not known. The only way to know if someone is an ultra-rapid metabolizer is to do a genetic test. There is a FDA-cleared test to check for ultra-rapid metabolism, but there is only limited information about using this test for codeine metabolism. At this time, the test result alone may not correctly predict if a mother’s breast milk will have too much morphine if she uses codeine to treat pain. This test cannot substitute for a doctor’s judgment.

Mothers and babies gain many health benefits from breastfeeding. When a nursing mother must take medicine, her infant may be exposed to some risks from that medicine. It is important for healthcare professionals and nursing women using codeine or other medicines to discuss these risks and benefits.

For more information, go to Use of Codeine Products in Nursing Mothers.

fda

Topical NSAIDs are usually applied as gels, creams or sprays, to the specific areas of the body where pain is felt. In many countries, they are routinely prescribed for local pain relief of mild to moderate pain. Topical NSAIDs are considered to pose less risk of adverse effects than oral drugs of the same type because they are rubbed into the skin and therefore do not reach high concentrations in the blood.

The researchers analysed data from 3,455 study participants who took part in 31 studies. Participants were given either topical NSAIDs or placebos, typically to treat short-term pain caused by sprains, strains or sports injuries. Most of those taking part were treated for between one week and a fortnight. NSAIDs were successful at reducing pain by 50% or more in over six out of ten cases, compared to four out of ten for placebos. Topical diclofenac, ibuprofen, ketoprofen and piroxicam seemed to provide the best results, but it was not possible to distinguish between them with certainty.

“Our study confirms that some NSAIDs are effective topical treatments for acute pain of the type caused by a sports injury,” said lead researcher Andrew Moore, of the Pain Research and Nuffield Department of Anaesthetics at the University of Oxford in Oxford, UK. “New formulations of topical NSAIDs are becoming available. We know relatively little about how these new formulations of drugs compare with older formulations, and this is an area that future research might address.”

There were few side effects of the drugs and skin reactions occurred only as often as they did with placebos. “The fact that there were only mild side effects in a few patients and no serious adverse events suggests that these are generally very safe treatments and could be particularly useful for treating pain in people who don’t cope well with oral NSAIDs,” said Moore.

Full citation: Massey T, Derry S, Moore RA, McQuay HJ. Topical NSAIDs for acute pain in adults. Cochrane Database of Systematic Reviews 2010, Issue 6. Art. No.: CD007402. DOI: 10.1002/14651858.CD007402.pub2

Source:
Jennifer Beal

Wiley-Blackwell

View drug information on Ketoprofen.

While there are guidelines outlining how health care providers communicate medical errors to patients, few exist in Canada or other countries for disclosing errors affecting large numbers of patients. Having national guidelines would help ensure more timely disclosure. The authors argue that governments and health care organizations should create clear guidelines around how large-scale adverse events should be addressed and disclosed to those affected by them.

“The disclosure of a large-scale medical error is not a single event, but rather an ongoing process,” write Dr. Roger Chafe and coauthors. They call for clear communications, an external analysis to identify cause and a review that focuses on actions to ensure quality of care rather than punishment.

Source:
Kim Barnhardt

Canadian Medical Association Journal

Health Department researchers will meet with WTC Health Registry enrollees and other community members tonight at the Second Annual Meeting and Resource Fair at Pace University to present these and other recent findings from the World Trade Center Health Registry initial survey, conducted in 2003 and 2004.

According to the survey, half of the 3,100 children enrolled in the registry developed at least one new or worsened respiratory symptom, such as a cough, between 9/11 and the time of the interview. A follow-up survey now underway will assess whether these symptoms persisted beyond the initial days and months after the event. Prior to 9/11, asthma rates among child enrollees were on par with national and regional rates, but at the time of the interview, about 6% of enrolled children had received a new asthma diagnosis. Children exposed to the dust cloud following the collapse of the towers were twice as likely to be diagnosed with asthma as those not caught in the dust cloud, the survey found.

The post-9/11 asthma rate among children under five years old may be as much as twice the regional (northeastern) rate for the same age group. Further research is needed to learn whether some of this increase is due to better detection of asthma in kids with WTC exposure or because parents of children with asthma symptoms were more likely to enroll their children in the registry.

The mental health portion of the survey showed that only 3% of the children surveyed had symptoms suggestive of post-traumatic stress disorder at the time of the interview, a level that is not above that in children elsewhere. As with asthma, however, children who were caught in the dust cloud experienced higher levels. The survey did not assess other mental health problems.

“We now know that some children, too, were affected by exposure to the dust cloud,” said Lorna Thorpe, Deputy Commissioner at the Health Department. “The Registry is helping us learn more about the health effects of 9/11 and share these findings with the public.”

This survey included children under 18 years of age on 9/11/01, who lived or went to school south of Canal Street (preschool and K-12) or were south of Chambers Street on 9/11.

The Health Department is now working on its second survey of the more than 71,000 enrollees. There are only four weeks left for adult enrollees to submit their responses. About 65% of all enrollees have completed the survey so far. Surveys for child enrollees (which are completed by parents for young children) must be submitted before March 2008. These responses will help determine if enrollees are still experiencing 9/11-related health problems and whether new symptoms or conditions have emerged in any group since 9/11.

“It is critical that enrollees help us continue this important work,” said Dr. Polly Thomas, Associate Professor for the Department of Preventive Medicine and Community Health at New Jersey Medical School and lead author of the pediatric study. “We urgently need more people to send in their surveys over the next four weeks.”

Other recent findings can be found at the new World Trade Center health website here. Its creation was one key recommendation of the Mayor’s Addressing the Health Impacts of 9/11 report. The comprehensive website offers one-stop shopping for 9/11 health-related issues, including latest information about scientific research and free or low-cost medical services. The website also includes information on treatment options for the different groups of affected people: rescue and recovery workers, residents, children, city employees and others.

About the Registry

The World Trade Center Health Registry, the largest public health registry in U.S. history, was launched in 2003 to track the health of people exposed to the collapse of the World Trade Center and those who worked at the WTC site. The registry is a collaborative effort involving the Health Department, the CDC’s Agency for Toxic Substances and Disease Registry (ATSDR), with funding from the Federal Emergency Management Agency (FEMA).

nyc

 
Held for the first time in Singapore, the 2006 Novartis International Biotechnology Leadership Camp (Biocamp 2006) counts in its speaker line-up top officials from the Ministry of Health; Economic Development Board’s Biomedical Sciences Group; Agency for Science, Technology and Research (A*STAR); Novartis Institute for Tropical Diseases (NITD); Genome Institute of Singapore (GIS); Institute of Molecular and Cell Biology (IMCB); National University of Singapore and Egon Zehnder International.  Thirty-four participants from top universities and business schools will meet and interact with renowned experts such as Paul Herrling (Chairman, NITD), Sir David Lane (Executive Director, IMCB) and Edison Liu (Executive Director, GIS).

 
“Novartis believes that talent with a global vision is the pillar of biotechnology development.  Through Biocamp, we aim to support Asia-Pacific countries in their local development of biotechnology by stimulating interest in the industry and creating opportunities for experts and talent to come together.  Biocamp facilitates networking, the exchange of ideas, knowledge and expertise, and promotes regional co-operation,” said Stefan Ziegler, Region Head, Asia/Pacific.

 
Biocamp was initiated in 2004 as a way of giving back to the societies in which Novartis operates.  “As a world-leading pharmaceutical company, we believe in being a responsible citizen wherever we are able to do so,” Ziegler added.  “Through Biocamp, we want to create a platform which promotes innovation and will therefore benefit patients in the long run.”

 
 
It is befitting that this year’s Biocamp is being held in Singapore, which has earned the reputation as a biomedical hub, attracting some of the world’s top talent in the sector.  Speaking at the opening of Biocamp 2006, A*STAR Chairman Philip Yeo underlined the government’s support for Biocamp. “I am very happy that Novartis has chosen to hold its international Biocamp here in Singapore this year, bringing together high potential post-graduate students from all over the world.  It is very much in line with Singapore’s vision to be an international biomedical sciences cluster, with a rapidly growing base of global scientific talent and partnerships with industry leaders, such as Novartis.”

 
About Biocamp

Biocamp is an annual biotechnology seminar for post-graduate students with high management and leadership potential.  Held for the first time in Taiwan in 2004, its three-day programme offers participants the chance to gain a broader view of the biotechnology sector, focusing on the sector’s development globally and across Asia-Pacific.  Biocamp provides a rare opportunity for students interested in biotechnology to interact with their peers, experts from academia, the industry and government officials.  Participating countries hold local Biocamps, and one or two top students from each country are selected to participate in the international programme held in a different country each year.  Biocamp 2006 participants come from Australia, Hong Kong, Indonesia, Japan, Korea, Malaysia, Philippines, Singapore, Switzerland, Taiwan, Thailand, and include Singapore-based post-graduate students from China, France, Hungary, India, Israel, and the United Kingdom.

 
About Novartis

Novartis AG (NYSE: NVS) is a world leader in offering medicines to protect health, treat disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. Novartis is the only company with leadership positions in both patented and generic pharmaceuticals. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. In 2005, the Group’s businesses achieved net sales of USD 32.2 billion and net income of USD 6.1 billion. Approximately USD 4.8 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 97,000 people and operate in over 140 countries around the world.

For more information, please visit novartis.

Various testosterone levels have been described to define castration, but to date 50 ng/dl is the most frequently used. This value derives from assay methods developed in the late 1960s with the use of the double-isotope derivate dilution technique but this cut-off point has not been updated, despite the availability of radioimmunoassay and chemiluminescence tests. A value of 20 ng/ml was proposed by an older edition of the NCCN guidelines on prostate cancer but it was not re-proposed in the subsequent versions. Specifically, castration levels as low as 50 ng/dl were reached in 95-98.9% of the patients using the classical leuproleide formulation, in 99-100% of those using the novel leuproleide formulation, and in 98.8% of those using triptorelin. Using such a breakpoint, only about 5% of patients being treated with GnRH agonist therapy fail to achieve castration. Applying the 20 ng/ml as cut-off point to define castration, 87-92%, 88-97.5%, and 96% of the patients receiving the classical leuproleide formulation, novel leuproleide formulation, and triptorelin reached castration, respectively.

On the whole, there are no prognostic factors useful to identify those patients who will not yield castration with GnRH agonists and, above all, the clinical relevance of the different levels of testosterone achieved during ADT is unknown because long-term data concerning the occurrence of androgen-independent prostate cancer and cancer-specific survival are not available. Further studies have to be performed to clarify these controversial issues.

Giacomo Novara, MD and Silvia Secco, MD as part of Beyond the Abstract on UroToday.

UroToday – the only urology website with original content global urology key opinion leaders actively engaged in clinical practice. To access the latest urology news releases from UroToday, go to:
www.urotoday

Copyright © 2009 – UroToday

BioMed Central anticipates that many other funding bodies worldwide will now follow the example set by NIH.

All NIH grantees now have a new factor to take into account when choosing where they wish to publish their research. To
fulfil the NIH request, authors publishing with most of the traditional subscription publishers will be expected to go
through a process of resubmitting their papers to the PubMed Central repository. In addition, they will often need to update
their manuscript version with the changes introduced in the publication process, as many publishers specify that only the
author’s version of the manuscript can be submitted to archives.

Those who choose to publish in any of BioMed Central’s Open Access journals, which cover all areas of biology and medicine,
are assured that the published version of their paper will be placed in PubMed Central for them, immediately and without any
need for additional work from them. Researchers are thus saved the time and effort of going through the deposition process
themselves.

This significant benefit is in addition to the rapid and high quality peer review, fast publication and high visibility of
BioMed Central’s Open Access journals.

BioMed Central urges all researchers in the life and medical sciences to fulfil the NIH request and to submit their future
manuscripts to one of the 130 Open Access journals published by BioMed Central.

The NIH announcement can be found in full at: nih/news/pr/feb2005/od-03.htm

Grace Baynes – pressbiomedcentral
BioMed Central