Medically, crying is known to be a symptom of physical pain or stress. But now a Tel Aviv University evolutionary biologist looks to empirical evidence showing that tears have emotional benefits and can make interpersonal relationships stronger.

New analysis by Dr. Oren Hasson of TAU’s Department of Zoology shows that tears still signal physiological distress, but they also function as an evolution-based mechanism to bring people closer together.

“Crying is a highly evolved behavior,” explains Dr. Hasson. “Tears give clues and reliable information about submission, needs and social attachments between one another. My research is trying to answer what the evolutionary reasons are for having emotional tears.

“My analysis suggests that by blurring vision, tears lower defences and reliably function as signals of submission, a cry for help, and even in a mutual display of attachment and as a group display of cohesion,” he reports.

His research, published recently in Evolutionary Psychology, investigates the different kinds of tears we shed – tears of joy, sadness and grief – as well as the authenticity or sincerity of the tears. Crying, Dr. Hasson says, has unique benefits among friends and others in our various communities.

For crying out loud (and behind closed doors)

Approaching the topic with the deductive tools of an evolutionary biologist, Dr. Hasson investigated the use of tears in various emotional and social circumstances. Tears are used to elicit mercy from an antagonistic enemy, he claims. They are also useful in eliciting the sympathy – and perhaps more importantly the strategic assistance – of people who were not part of the enemy group.

“This is strictly human,” reasons Dr. Hasson. “Emotional tears also signal appeasement, a need for attachment in times of grief, and a validation of emotions among family, friends and members of a group.”

Crying enhances attachments and friendships, says Dr. Hasson, but taboos are still there in certain cases. In some cultures, societies or circumstances, the expression of emotions is received as a weakness and the production of tears is suppressed. For example, it is rarely acceptable to cry in front of your boss at work – especially if you are a man, he says.

Streets awash with tears?

Multiple studies across cultures show that crying helps us bond with our families, loved ones and allies, Dr. Hasson says. By blurring vision, tears reliably signal your vulnerability and that you love someone, a good evolutionary strategy to emotionally bind people closer to you.

“Of course,” Dr. Hasson adds, “the efficacy of this evolutionary behavior always depends on who you’re with when you cry those buckets of tears, and it probably won’t be effective in places, like at work, when emotions should be hidden.”

Dr. Hasson, a marriage therapist, uses his conclusions in his clinic. “It is important to legitimize emotional tears in relationships,” he says. “Too often, women who cry feel ashamed, silly or weak, when in reality they are simply connected with their feelings, and want sympathy and hugs from their partners.”

Source:
George Hunka

American Friends of Tel Aviv University Continue reading →

SkyePharma PLC and AstraZeneca today announce the completion of Phase III trials of a new version of AstraZeneca’s Pulmicort(R) (budesonide), an inhaled corticosteroid for the treatment of asthma. The Metered Dose aerosol Inhaler (MDI) uses a hydrofluoroalkane (HFA) propellant, replacing the chlorofluorocarbon (CFC) propellant used in the currently marketed MDI version of Pulmicort(R). CFCs are being withdrawn on environmental grounds because of their potential to damage the ozone layer. However the replacement of CFC propellants with HFAs can lead to substantial differences in MDI performance. Pulmicort(R) HFA-MDI incorporates proprietary SkyePharma formulation technology to ensure accurate and consistent delivery that matches the release profile of the current version of Pulmicort(R) MDI.

Under the terms of agreements signed in December 2001, SkyePharma is responsible for all pre-clinical and clinical development of Pulmicort(R) HFA-MDI, as well as compiling regulatory filings for marketing approval in Europe. AstraZeneca will pursue filing of the marketing application and following approval will market Pulmicort(R) HFA-MDI in Europe and other non-US territories. AstraZeneca is responsible for the commercial supply of the product and has recently appointed Inyx, Inc. (OTC BB: IYXI) as contract manufacturer responsible for scale-up activities and commercial production, initially for a three year period.

A milestone will become payable to SkyePharma upon delivery of the final Phase III Clinical Trial Reports and Stability Reports to AstraZeneca, expected in the autumn. This is part of the total milestone payments of up to US$ 12 million due to SkyePharma under this agreement. In addition, SkyePharma will receive royalties on net sales of Pulmicort(R) HFA-MDI.

Michael Ashton, Chief Executive of SkyePharma, said: ‘SkyePharma already has an established presence in the important and fast-growing pulmonary delivery market, with both breath-actuated dry-powder inhalers and metered-dose aerosol inhalers that use non-CFC propellants. The completion of the Phase III trial of the HFA-MDI version of Pulmicort(R) that we have developed for AstraZeneca is an important milestone towards eventual commercialisation and also towards validation of our MDI formulation technology.’

For further information please contact:

SkyePharma PLC +44 207 491 1777
Michael Ashton, Chief Executive Officer
Peter Laing, Director of Corporate Communications +44 207 491 5124
Sandra Haughton, US Investor Relations +1 212 753 5780
Buchanan Communications +44 207 466 5000
Tim Anderson / Mark Court

Notes for editors:

About SkyePharma

SkyePharma develops pharmaceutical products benefiting from world-leading drug delivery technologies that provide easier-to-use and more effective drug formulations. There are now ten approved products incorporating SkyePharma’s technologies in the areas of oral, injectable, inhaled and topical delivery, supported by advanced solubilisation capabilities. For more information, visit skyepharma

.About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world’s leading pharmaceutical companies with healthcare sales of over $18.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index. For more information, visit astrazeneca

About Inyx

Inyx, Inc. is an emerging specialty pharmaceutical company with niche aerosol drug delivery technologies and products. Inyx focuses its expertise on contract manufacturing of prescription and over-the-counter pharmaceutical products, and provides specialty pharmaceutical development and production consulting services to the international healthcare market.

About Pulmicort(R)

Pulmicort(R) (budesonide) is an inhaled corticosteroid that is available in about 90 countries for the treatment of asthma. Pulmicort(R) is also approved in a number of countries for the treatment of chronic obstructive pulmonary disease. First launched in 1981, it is available in both dry-powder inhaler and metered-dose aerosol inhaler versions and also as Pulmicort Respules(R) for use in nebulizers. In 2003 world sales were US$968 million.

About SkyePharma’s pulmonary delivery technologies

SkyePharma is one of the leading independent providers of inhaled pharmaceutical delivery technology. We can deliver pulmonary drugs either though our own breath-actuated multi-dose dry powder inhaler or by metered-dose aerosol inhalers powered by environmentally friendly hydrofluoroalkane (HFA) propellants. These propellants replace the widely-used chlorofluorocarbons (CFCs), now being phased out because of their potential to damage the ozone layer. Our formulation capability ensures consistent and accurate dose delivery even for hard-to-formulate materials.

SkyePharma has developed for Novartis Foradil(R) Certihaler(R), a multi-dose dry powder inhaler version of Novartis’ long-acting bronchodilator Foradil (formoterol). SkyePharma developed not only the SkyehalerTM dry powder inhaler device (to be marketed by Novartis as the Certihaler(R) for this specific product) but also the formulation technology that ensures accurate and consistent dosing. Foradil(R) Certihaler(R) has now received its first European approvals and the US Food & Drug Administration issued an ‘approvable’ letter in October last year. SkyePharma has also entered into a second agreement with Novartis to jointly develop a dry-powder inhaler version of QAB 149, Novartis’ novel long-acting bronchodilator. GlaxoSmithKline has also licensed SkyePharma’s formulation technologies for application to the delivery of respiratory drugs, either by breath-actuated dry powder inhaler or by metered-dose aerosol inhaler. SkyePharma has also demonstrated the successful delivery of macromolecules with the SkyeHalerTM device.

SkyePharma is developing various pulmonary drugs in HFA metered-dose aerosol inhalers. Apart from Pulmicort(R) HFA-MDI for AstraZeneca, these include the bronchodilator formoterol (which has now completed Phase II development) and the combination product FlutiformTM, SkyePharma’s proprietary fixed-dose combination of formoterol with the inhaled corticosteroid fluticasone.

Except for the historical information herein, the matters discussed in this news release include forward-looking statements that may involve a number of risks and uncertainties. Actual results may vary significantly based upon a number of factors, which are described in SkyePharma’s 20-F and other documents on file with the SEC. These include without limitation risks in obtaining and maintaining regulatory approval for existing, new or expanded indications for its products, other regulatory risks, risks relating to SkyePharma’s ability to manufacture pharmaceutical products on a large scale, risks that customer inventory will be greater than previously thought, risks concerning SkyePharma’s ability to manage growth, market a pharmaceutical product on a large scale and integrate and manage an internal sales and marketing organization and maintain or expand sales and market share for its products, risks relating to the ability to ensure regulatory compliance, risks related to the research, development and regulatory approval of new pharmaceutical products, risks related to research and development costs and capabilities, market acceptance of and continuing demand for SkyePharma’s products and the impact of increased competition, risks associated with anticipated top and bottom line growth and the possibility that upside potential will not be achieved, competitive products and pricing, and risks associated with the ownership and use of intellectual property rights.

SkyePharma undertakes no obligation to revise or update any such forward-looking statement to reflect events or circumstances after the date of this release.

View drug information on Foradil Aerolizer. Continue reading →

Research by the University of Warwick and the University of Manchester finds that psychological therapy could be 32 times more cost effective at making you happy than simply obtaining more money. The research has obvious implications for large compensation awards in law courts but also has wider implications for general public health.

Chris Boyce of the University of Warwick and Alex Wood of the University of Manchester compared large data sets where 1000s of people had reported on their well-being. They then looked at how well-being changed due to therapy compared to getting sudden increases in income, such as through lottery wins or pay rises. They found that a 4 month course of psychological therapy had a large effect on well-being. They then showed that the increase in well-being from an ??800 course of therapy was so large that it would take a pay rise of over ??25,000 to achieve an equivalent increase in well-being. The research therefore demonstrates that psychological therapy could be 32 times more cost effective at making you happy than simply obtaining more money.

Governments pursue economic growth in the belief that it will raise the well-being of its citizens. However, the research suggests that more money only leads to tiny increases in happiness and is an inefficient way to increase the happiness of a population. This research suggests that if policy makers were concerned about improving well-being they would be better off increasing the access and availability of mental health care as opposed to increasing economic growth.

The new research paper, entitled “Money or Mental Health: The Cost of Alleviating Psychological Distress with Monetary Compensation versus Psychological Therapy” is published online at: Health Economics, Policy and Law

This research helps to highlight how relatively ineffective extra income is at raising well-being. The researchers further draw on two striking pieces of independent evidence to illustrate their point – over the last 50 years developed countries have not seen any increases to national happiness in spite of huge economic gains. Mental health on the other hand appears to be deteriorating worldwide. The researchers argue that resources should be directed towards the things that have the best chance of improving the health and happiness of our nations – investment in mental health care by increasing the access and availability of psychological therapy could be a more effective way of improving national well-being than the pursuit of income growth.

The research also has important implications for the way in which “pain and suffering” is compensated in courts of law. Currently the default way in which individuals are compensated is with financial compensation. The research suggests that this is an inefficient way at repairing psychological harm following traumatic life events and that a more effective remedy would be to offer psychological therapy.

University of Warwick researcher Chris Boyce said: “We have shown that psychological therapy could be much more cost effective than financial compensation at alleviating psychological distress. This is not only important in courts of law, where huge financial awards are the default way in which pain and suffering are compensated, but has wider implications for public health and well-being.”

“Often the importance of money for improving our well-being and bringing greater happiness is vastly over-valued in our societies. The benefits of having good mental health, on the other hand, are often not fully appreciated and people do not realise the powerful effect that psychological therapy, such as non-directive counselling, can have on improving our well-being.”

Source: Christopher J. Boyce

University of Warwick Continue reading →

The House Appropriations Committee on Wednesday by voice vote approved a $607 billion fiscal year 2008 Labor-HHS-Education spending bill, CQ Today reports. The bill includes $151.5 billion in discretionary funds, exceeding FY 2007 discretionary spending by $7 billion and topping President Bush’s FY 2008 spending request by $10.6 billion (Wayne, CQ Today, 7/11).

The House bill would increase spending on health care for the uninsured by 9% above FY 2007 levels and Bush’s request for FY 2008. Funding for the uninsured includes a 10% increase on spending for community health centers. The $2.2 billion in total funding for community health centers would be enough to expand services to one million additional low-income patients, CongressDaily reports. The bill also includes $1.1 billion to prepare for a potential avian flu pandemic. Earmarks in the bill total $565 million — a 50% reduction from earmarked funds in the appropriations bill that was approved two years ago (Cohn, CongressDaily, 7/12).

The committee approved an amendment by Rep. Dave Weldon (R-Fla.) intended to remove a mercury-based preservative from children’s vaccines. That amendment also would have reduced CDC funding by $5.5 million, but $3.5 million of the funding was restored in a subsequent amendment by Committee Chair David Obey (D-Wis.). The House is expected to debate the bill next week.

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. Continue reading →

IMEC, Europe’s leading independent
nanoelectronics research center, VIB, Flanders’ leading life science
institute, and the Leuven University, K.U.Leuven, set up a joint basic
research initiative to unravel the neuronal circuitry of the human
brain: Neuroelectronics Research Flanders (NERF). Supported by the
Flemish Government, NERF will look into fundamental neuroscientific
questions through collaborative, interdisciplinary research combining
nanoelectronics with neurobiology. It intends to push the boundaries of
science, by zooming in on the working of neurons at an unprecedented
level of detail. In the long run, NERF will generate new insights in the
functional mapping of the brain, as well as research methodologies and
technologies for medical applications, i.e. diagnostics and treatment of
disorders of the central and peripheral nervous system.

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 Continue reading →

Scientists have demonstrated a new technique for detecting a painful nerve condition known as neuropathy, which affects millions of people with diabetes and many other patients as well.

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 Continue reading →

The U.S. Food and Drug Administration (FDA) is concerned that nursing infants may be at increased risk of morphine overdose if their mothers are taking codeine and are ultra-rapid metabolizers of codeine. The agency has reviewed all available information on this subject since a medical journal reported the death of a 13-day old breastfed infant who died from morphine overdose. The morphine levels in the mother’s milk were abnormally high after taking small doses of codeine to treat episiotomy pain. A genetic test showed that the mother was an ultra-rapid metabolizer of codeine.

“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 Continue reading →

Gels, creams and sprays containing painkillers such as ibuprofen, diclofenac, ketoprofen, and piroxicam are safe and effective treatments for local pain, according to Cochrane Researchers. A new systematic review they have conducted shows that topical non-steroidal anti-inflammatory drugs (NSAIDs) are more effective than placebos for treating short-term pain and have few side effects.

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. Continue reading →

National guidelines are needed for timely disclosure of medical errors and informing patients, write Toronto-based researchers in a review cmaj/press/pg1125.pdf in CMAJ (cmaj).

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

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Findings released by the Health Department provide the first broad snapshot of physical and mental health effects among children exposed to the World Trade Center disaster. The survey found that children under five had an increased likelihood of being diagnosed with asthma in the two to three years following the event, though not as sharp an increase as rescue workers. The survey did not find evidence of elevated levels of post-traumatic stress in children.

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).

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