Sport And Asthma: GA2LEN Researchers Follow European Olympic Athletes To Beijing

The pan-European study will allow scientists to specify the prevalence of asthma, exercise induced asthma and other allergic diseases among European athletes qualified for the Beijing Olympics, while identifying the differences in prevalence between a wide range of sports and between the different European regions. The study is part of GAВІLEN joint research activities on sports and allergic diseases (2).

GAВІLEN centres in ten countries are currently involved in the study, representing all geographical areas of Europe: Denmark, England, Finland, Germany, Greece, Italy, Norway, Poland, Portugal and Spain.

Up to 2,000 athletes (3) could be followed before, during and after the Olympic Games with regular clinical examinations measuring their lung function, bronchial responsiveness and asthma symptoms. Allergies will be examined with a skin prick test, and airways inflammation by means of exhaled nitric oxide will be measured. A respiratory laboratory run by GAВІLEN scientists will be available in the Olympic Village in Beijing to provide care for athletes in need, in accordance to doping regulations. Clinical follow-up should also allow assessment of the impact of the local environment on potential symptoms.

According to earlier studies, about 20 percent of summer sports athletes have asthma . This proportion varies between different types of sports. Endurance sports in particular such as runners, swimmers, and cyclists, have been reported to have a high prevalence.

It is suspected that endurance sports show higher levels of asthma due to the prolonged periods with highly increased ventilation (4) and the duration of high level physical activity performed in these types of sports together with some environmental factors such as chlorine in water for swimmers or polluted air for cyclists and runners.

This study is the first pan-European study on allergy and asthma in athletes. It was first designed in Norway in agreement with the National Olympic Committee, to follow athletes and provide optimal care if needed. The scientists were also interested in learning more about the affect of air quality and pollution on the athletes. The protocol will be applied in the ten participating centres. This will allow scientists to collect comparable data on the degree of asthma and allergies in European athletes and to validate tools for further studies. This will also contribute to a better understanding of exercise-induced asthma.

The control of asthma, which include the ability to do normal physical activities and exercise, and even sport at Olympic level, is a focus of this year’s World Asthma Day, an event, held each year on the first Tuesday in May.

1. GAВІLEN, the Global Allergy and Asthma European Network is a “Network of Excellence” funded by the European Union 6th Framework programme for research. It consists of 26 research centres, as well as the European Academy of Allergy and Clinical Immunology (EAACI) and the European Federation of Allergy Patients Associations (EFA). For more information, please visit ga2len

2. The GAВІLEN work package on sports, asthma and allergic diseases is led by Prof. Kai-Hakon Carlsen, Norway. Notably, GAВІLEN experts contributed to the Joint Task Force on Exercise-induced Asthma, Respiratory and Allergic disorders in sports and the relationship to doping, set up by the European Respiratory Society (ERS) and the European Academy of Allergy and Clinical Immunology (EAACI), a member of GAВІLEN. The Task Force led to two scientific publications in the April and May issues of the Allergy journal.

a. K. H. Carlsen et al. (2008) Allergy 63 (4) 387-403
b. K. H. Carlsen et al. (2008) Allergy 63 (5) , 492-505

3. Depending on the number of athletes qualifying in each country.

4. Endurance athletes have an highly increased ventilation, which is adequate and in relationship to the demands of their exercising body. This is different to the hyperventilation asthma patients can experience: an increased ventilation out of relationship to the demand.


Combination ACE Inhibitor Therapy Increases Risk Of Kidney Failure And Death

Elderly patients prescribed combination angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARB) had a higher risk of kidney failure and death, according to a study published in CMAJ (Canadian Medical Association Journal)

This study, by researchers from the University of Alberta and the University of Calgary, sought to determine the safety of combination therapy of ACE inhibitors and ARB in the clinical setting as some randomized trials indicate an increased risk of kidney failure. Randomized trials may over or underestimate the risk of adverse events possibly because of patient selection bias, higher drug doses and increased monitoring.

The researchers looked at 32 312 seniors in Alberta, Canada, aged 65 and older who were prescribed an ACE inhibitor and/or an ARB. They compared patients receiving both drugs together with patients who received only one of the drugs. They found a higher risk of adverse events such as high creatinine levels, end-stage renal disease and death in people taking combination therapy.

“We found that less than one-seventh of the elderly residents of Alberta who were given combination therapy in clinical practice had either of the conditions for which this therapy has been proven beneficial in randomized trials (i.e., proteinuria or symptomatic left ventricular systolic dysfunction despite treatment with and ACE inhibitor or an angiotensin-receptor blocker alone,” writes Dr. Finlay McAlister, University of Alberta, with coauthors.

As well, they observed that within three months, most patients stopped the combination therapy. The authors speculate this may have been due to low blood pressure.

“Our most striking findings were that combination therapy was commonly prescribed for patients who did not have the trial-proven indications and that it was frequently stopped after only a few months, even when hyperkalemia or renal dysfunction did not occur,” conclude the researchers.

Link to Article

Canadian Medical Association Journal

Union Survey On Influenza Pandemic Finds Lack Of Adequate Health And Safety Measures For Health Care Workers

A new union survey of more than 100 health care facilities across the country reveals that many are not adequately prepared to protect workers’ health and safety during an influenza pandemic. The report, “Healthcare Workers In Peril: Preparing to Protect Worker Health and Safety During Pandemic Influenza,” conducted by the American Federation of State, County and Municipal Employees (AFSCME), the AFL-CIO and other unions, concludes that workers face a very high risk of becoming infected when caring for patients with pandemic flu unless adequate health and safety measures are in place in advance of a pandemic.

“Our survey has identified serious deficiencies in the preparedness of health care facilities,” said AFSCME International President Gerald W. McEntee. “Unless hospitals, nursing homes and other facilities do a better job of addressing all health and safety areas surveyed, workers will become sick and, as a consequence, be unavailable to care for sick patients.”

With no existing comprehensive federal Occupational Safety and Health Administration (OSHA) standard on airborne diseases designed to protect health care workers, the pandemic flu preparedness survey was conducted to assess the extent of employer efforts in planning adequate safety and health measures.

More than a hundred surveys were collected by six unions in fourteen states. The collected surveys indicate that health care facilities have made some progress in preparing for a flu pandemic, but much more needs to be done. Results show:

– Only 4 percent of the respondents reported that their facility was “very ready” to respond to a flu pandemic.

– Less than half the facilities surveyed (43 percent) have provided pandemic flu training to their workers, one of the fundamental elements of protecting workers from occupational hazards.

– One-third of the facilities have yet to develop a written plan for responding to pandemic flu.

– Only 54 percent of the facilities have identified health care workers who will be at some risk of occupational exposure to the pandemic flu virus.

“In order to provide care for patients infected with pandemic flu and protect health care worker from exposure, plans for safety and health issues should be made before the flu arrives,” McEntee said.

The report recommends that employers prepare now by identifying health care workers who will provide care for infected patients, implement worker training and secure adequate supplies of antiviral drugs and vaccine. A vital aspect of worker protection will be the use of personal protective equipment (PPE) — the respirators, gowns, gloves, face shields, eye protection and other equipment by health care workers in their patient care responsibilities.

A numbers of government actions are recommended in the report to address the problem of protecting health care workers, including: a mandatory workplace standard issued by OSHA that broadly addresses airborne transmissible disease; a request that Congress identify a mechanism to assure that public health care facilities not cover by the OSHAct — such as hospitals, nursing home and Veterans Administration hospitals in certain states — be required to comply with the provisions of an OSHA airborne transmissible disease standard; and a requirement that state and public health departments strengthen the worker health and safety elements of their state pandemic influenza plans.

McEntee praised President Obama’s quick response to the current flu outbreak, including the administration’s request for $1.5 billion in supplemental funding. “State and local governments are going to need funding to help them deal with this crisis, which comes at a time when health and public safety budgets are already being squeezed,” McEntee said.

Unions participating in the survey report include the AFL-CIO, American Federation of State, County and Municipal Employees (AFSCME), American Federation of Teachers (AFT), Communications Workers of America (CWA), Service Employees International Union (SEIU), United American Nurses (UAN) and United Food and Commercial Workers (UFCW).

AFSCME’s 1.6 million members provide the vital services that make America happen. With members in hundreds of different occupations – from nurses to corrections officers, child care providers to sanitation workers – AFSCME advocates for fairness in the workplace, excellence in public services and prosperity and opportunity for all working families.

Source: American Federation of State County
Further information on Swine Flu

See a Map Of H1N1 Outbreaks
See our Mexico Swine Flu Blog

Donor age has no affect on long-term liver transplant survival

A new study on the effect of donor age on survival and recurrence of hepatitis C after liver transplantation found that
it influenced short-term survival, but had no long-term effect.

The results of this study appear in the April 2005 issue of Liver Transplantation, the official journal of the American
Association for the Study of Liver Diseases (AASLD) and the International Liver Transplantation Society (ILTS). The journal
is published on behalf of the societies by John Wiley & Sons, Inc. and is available online via Wiley InterScience at interscience.wiley/journal/livertransplantation.

Patients who undergo liver transplantation for cirrhosis due to hepatitis C are invariably re-infected with the virus after
transplantation. When the disease recurs it often has a more rapid and aggressive course than in patients who have not
undergone liver transplantation. Survival rates of these patients appear to be worsening during the past few years, but
recent studies have shown conflicting results about whether a donor’s age can be associated with a poor outcome. The current
study examined the impact of donor age, immunosuppression, and other factors on short and long term survival after liver
transplant, as well as fibrosis in these patients.

Led by Dimitrios N. Samonakis, of the Liver Transplantation and Hepatobiliary Unit of the Royal Free Hospital in London, the
study examined 195 transplantations due to end stage cirrhosis related to hepatitis C that took place between 1989 and June
2003. The median donor age was 41.5 years and 47 patients had a donor who was 30 years old or younger. Donor age was not
associated with the development of severe fibrosis, whereas patients receiving treatment with maintenance steroids and/or
azathioprine tended not to develop severe fibrosis, even if later discontinued; acute hepatitis C was an independent factor
associated with worse fibrosis.

“Donor age did affect survival, but only during the early critical post-operative period, but not survival after 3 months,
despite having in our cohort 30 percent of donors over 50 years,” the authors state. They found maintenance azathioprine to
be an independent factor associated with survival advantage, overall and from 3 months. In addition, while several studies
have suggested that less immunosuppression may seem to be a viable strategy in minimizing progression of hepatitis C
post-transplant, the authors found the situation to be more complex. They state that “the rapid withdrawal of steroids (but
also of azathioprine) prevalent in recent years, may have allowed an early reconstitution of the immune system and its
exposure to a large number of HCV [hepatitis C] infected liver cells, leading to immune mediated severe liver damage and thus
to more frequent and severe forms of HCV recurrence.”

The authors conclude that while donor age did not influence the progression of recurrent hepatitis C, the absence of steroids
and azathioprine did play a role and maintain that these associations need to be tested in a prospective randomized fashion.

Article: “Immunosuppression and Donor Age with Respect to Severity of HCV Recurrence After Liver Transplantation,” Dimitrios
N. Samonakis, Christos K. Triantos, Ulrich Thalheimer, Alberto Quaglia, Gioacchino Leandro, Rosвngela Teixeira, George V.
Papatheodoridis, Caroline A. Sabin, Nancy Rolando, Susan Davies, Amar P. Dhillon, Paul Griffiths, Vincent Emery, David W.
Patch, Brian R. Davidson, Keith Rolles, Andrew K. Burroughs, Liver Transplantation; April 2005; Volume 14, Issue 4 (Published
Online: March 17, 2005).

John Wiley & Sons, Inc.

Why Should Prednisolone Suppress Hepatic Ischemia-Reperfusion Injury?

Hepatic ischemia-reperfusion injury is a serious complication but unavoidable problem in liver surgery including liver transplantation and hepatic resection. The most important consequence of this pathological process is multiple organ failure with a high mortality rate. Steroid therapy suppresses liver injury by a variety of mechanisms, including increased tissue blood flow and suppression of oxygen free radicals, arachidonic acid derivatives, lysosomal proteases (cathepsins) and cytokine production. However, the exact intracellular mechanisms of steroid action on hepatic ischemia-reperfusion injury remains unknown.

A research article published in the World Journal of Gastroenterology addresses this question. This research team was led by Prof. Meng Wang from Eastern Hepatobiliary Surgery Hospital of Shanghai.

The hepatic ischemia-reperfusion injury model was performed through clamped the left lateral and median lobes of rat liver (68%) for 60 minutes and followed by 120 minutes reperfusion. Prednisolone was administered at 1.0, 3.0, or 10 mg/kg at 30 min before ischemia. In addition to biochemical and microscopic analyses, activation of calpain mu was determined using specific antibodies against the intermediate (activated) form of calpain. Degradation of talin was also studied by Western blotting.

They found that in the control and prednisolone (1.0 mg/kg) groups, serum aspartate transaminase (AST) and alanine transaminase (ALT) level were elevated, and cell membrane bleb formation was observed after 120 min of reperfusion. Moreover, calpain mu activation and talin degradation were detected. Infusion of prednisolone at 3.0 or 10 mg/kg significantly suppressed serum AST and ALT, and prevented cell membrane bleb formation. At 10 mg/kg, prednisolone markedly suppressed calpain mu activation and talin degradation.

Their results indicate that prednisolone can suppress ischemia-reperfusion injury of the rat liver. Its cytoprotective effect is closely associated with the suppression of calpain mu activation and talin degradation.


Reference: Wang M, Shen F, Shi LH, Xi T, Li XF, Chen X, Wu MC. Protective effect of prednisolone on ischemia-induced liver injury rats. World J Gastroenterol 2008;14(27):4332-4337

Correspondence to: Meng Wang, MD, Ph.D, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, 225, Changhai Road, Shanghai 200438, China.

About World Journal of Gastroenterology

World Journal of Gastroenterology (WJG), a leading international journal in gastroenterology and hepatology, has established a reputation for publishing first class research on esophageal cancer, gastric cancer, liver cancer, viral hepatitis, colorectal cancer, and H pylori infection and provides a forum for both clinicians and scientists. WJG has been indexed and abstracted in Current Contents/Clinical Medicine, Science Citation Index Expanded (also known as SciSearch) and Journal Citation Reports/Science Edition, Index Medicus, MEDLINE and PubMed, Chemical Abstracts, EMBASE/Excerpta Medica, Abstracts Journals, Nature Clinical Practice Gastroenterology and Hepatology, CAB Abstracts and Global Health. ISI JCR 2003-2000 IF: 3.318, 2.532, 1.445 and 0.993. WJG is a weekly journal published by WJG Press. The publication dates are the 7th, 14th, 21st, and 28th day of every month. WJG is supported by The National Natural Science Foundation of China, No. 30224801 and No. 30424812, and was founded with the name of China National Journal of New Gastroenterology on October 1, 1995, and renamed WJG on January 25, 1998.

About The WJG Press

The WJG Press mainly publishes World Journal of Gastroenterology.

Source: Lai-Fu Li

World Journal of Gastroenterology

Unigene Reports Positive Results On A Novel Peptide For Reducing Food Consumption in animals

Unigene Laboratories, Inc. will present data this week regarding a novel peptide that has been shown to reduce food consumption in animals. The poster, entitled “Reduction in Food Consumption and Weight in Dogs by Oral Delivery of a Novel Anorexigenic Peptide,” will be presented at the Keystone Symposium Conference on “Obesity: Novel Aspects of the Regulation of Body Weight” in Alberta, Canada.

The peptide, currently designated UGL269, is an analog of a natural peptide hormone, and was designed by Unigene scientists. It was tested against two other peptides in a placebo-controlled crossover study and demonstrated significant reductions in food intake and body weight when orally administered to dogs. The ability of UGL269 to reduce food intake was superior to that of other peptides reported to decrease food intake, including an analog of peptide PYY.

In the studies, oral administration of UGL269 resulted in a decrease in food intake by up to 50% and a significant decrease in body weight. Oral administration of an analog of peptide PYY resulted in a smaller reduction in food intake and minimal change in weight. Cessation of treatment with UGL269 resulted in a resumption of food intake to pre-dosing levels. Administration of placebo capsules had no effect on food intake.

“Therapies that modify feeding behavior and result in weight loss represent a significant unmet medical need,” commented Dr. Warren Levy, President and CEO of Unigene. “UGL269, which can be manufactured and orally delivered using our patented Secrapep® and Enteripep® technologies respectively, may offer a new, orally administered approach for weight loss through appetite reduction.”

About Unigene

Unigene Laboratories, Inc. is a biopharmaceutical company focusing on the oral and nasal delivery of large-market peptide drugs. Due to the size of the worldwide osteoporosis market, Unigene is targeting its initial efforts on developing calcitonin and PTH-based therapies. Fortical®, Unigene’s nasal calcitonin product for the treatment of postmenopausal osteoporosis, received FDA approval and was launched in August 2005. Unigene has licensed the U.S. rights for Fortical® to Upsher-Smith Laboratories, worldwide rights for its oral PTH technology to GlaxoSmithKline and worldwide rights for its calcitonin manufacturing technology to Novartis. Unigene’s patented oral delivery technology has successfully delivered, in preclinical and/or clinical trials, various peptides including calcitonin, PTH and insulin. Unigene’s patented manufacturing technology is designed to cost-effectively produce peptides in quantities sufficient to support their worldwide commercialization as oral or nasal therapeutics. For more information about Unigene, call (973) 265-1100 or visit www.unigene. For information about Fortical, visit fortical.

Safe Harbor statements under the Private Securities Litigation Reform Act of 1995: This press release contains forward-looking statements regarding us and our business, financial condition, results of operations and prospects. Such forward-looking statements include those which express plans, anticipation, intent, contingency, goals, targets or future development and/or otherwise are not statements of historical fact. We have based these forward-looking statements on our current expectations and projections about future events and they are subject to risks and uncertainties known and unknown which could cause actual results and developments to differ materially from those expressed or implied in such statements. These forward-looking statements include statements about the following: general economic and business conditions, our financial condition, competition, our dependence on other companies to commercialize, manufacture and sell products using our technologies, the ability of our products to gain market acceptance and increase market share, the uncertainty of results of animal and human testing, the risk of product liability and liability for human trials, our dependence on patents and other proprietary rights, dependence on key management officials, the availability and cost of capital, the availability of qualified personnel, changes in, or the failure to comply with, governmental regulations, the failure to obtain regulatory approvals for our products and other risk factors discussed in our Securities and Exchange Commission filings. Words such as “anticipates,” “expects,” “intends,” “plans,” “predicts,” “believes,” “seeks,” “estimates,” “may,” “will,” “should,” “would,” “potential,” “continue,” and variations of these words (or negatives of these words) or similar expressions, are intended to identify forward-looking statements. In addition, any statements that refer to expectations, projections, or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These forward-looking statements are not guarantees of future performance and are subject to certain risks, uncertainties, and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various risk factors.

Unigene Laboratories, Inc.

Options In Prostate Cancer Surgery: Perineal Prostatectomy In The Age Of Minimally Invasive Surgery

UroToday – In the age of minimally invasive surgery, laparoscopic and robotic assisted laparoscopic prostatectomy has been associated with a substantial increase in operative costs without a significant improvement in outcomes to date. As a result, there has been renewed interest in one of the original approaches to prostate cancer. In this presentation we compare the MUSC experience with perineal prostatectomy (RPP) to published results using laparoscopic and robot-assisted laparoscopic prostatectomy (LRP, RALP).

Our experience with over 300 consecutive perineal prostatectomies is presented and operative technique reviewed in detail. Issues such as hospital stay, intra-operative blood loss, length of catheterization, complications, both long and short term, and outcomes will be reviewed. Selective indications for a perineal prostatectomy will be defined and discussed.

The mean operative time for RPP was less than that for LRP or RALP. Estimated blood loss was equivalent for RPP and RALP and less than that for LRP. Length of catheterization in the RPP group was longer but was based on a care map and has been modified to 7 days without problems in the last 75 pts. Length of hospital stay was equivalent for all techniques and hospital costs were significantly less for RPP vs. the alternatives.

A detailed discussion of the current evidence and its quality concerning the various approaches will be undertaken and the audience should have a clear understanding of the current issues at the end of the presentation.

Presented by: Thomas Keane, MD, at the Masters in Urology Meeting – July 31, 2008 – August 2, 2008 – Elbow Beach Resort, Bermuda

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Healthy People With Elevated Levels Of Uric Acid Are At Risk Of Developing Kidney Disease

Elevated uric acid levels in the blood indicate an increased risk of new-onset kidney disease, according to a study appearing in the December 2008 issue of the Journal of the American Society Nephrology (JASN). The results suggest that it may be appropriate to prescribe uric acid-lowering drugs, such as allopurinol and probenecid, to these otherwise healthy individuals.

High levels of uric acid in the blood, called hyperuricaemia, can be caused by a diet high in purines or by impaired excretion by the kidneys. Studies have linked hyperuricaemia to kidney failure, hypertension, and cardiovascular disease, but most of these studies have been conducted in people with metabolic abnormalities.

Rudolf Obermayr, MD, of Sozialmedizinisches Zentrum Ost der Stadt Wien, in Vienna, Austria, and his colleagues wished to determine the risks of elevated levels of uric acid in healthy individuals, particularly as they relate to kidney disease.

The investigators recruited 21,475 healthy volunteers from the general Viennese population, performing an initial examination and following up with three examinations over an average of seven years. Volunteers were categorized as having normal blood levels of uric acid, slightly elevated levels, or elevated levels. During follow-up examinations, the researchers assessed patients’ glomerular filtration rates, noting that low rates indicate decreased kidney function.

Dr. Obermayr’s team found that with increasing uric acid groups, glomerular filtration rates decreased. After eliminating all other potential risk factors that might contribute to kidney disease, the researchers determined that individuals in the slightly elevated uric acid group were 1.26 times as likely to develop kidney disease as those in the low uric acid group. The odds of developing kidney disease among volunteers in the elevated uric acid group were 1.63 times greater than that of individuals in the low uric acid group.

The risk of developing new-onset kidney disease was more evident in women than in men. It also was particularly high in individuals with hypertension. Dr. Obermayr noted that this finding may be important from a public health viewpoint, because the prevalence of prehypertension and hypertension in adults is approximately 60%, and the prevalence of hyperuricaemia is approximately 17%.

According to Dr. Obermayr, this study indicates that clinical trials assessing the potential of uric acid-lowering drugs for preventing kidney disease should be initiated. These agents, such as allopurinol and probenecid, are available worldwide and are safe and inexpensive.

This study was financially supported by the Medizinische Forschungsgesellschaft Donaustadt and by grants from the Austrian Science Fund (FWF P-18325) and the Austrian Academy of Science (OELZELT EST370/04).

The article, entitled “Elevated Uric Acid Levels Increase the Risk for New-Onset Kidney Disease,” appeared online at jasn.asnjournals on Wednesday, September 17, 2008, and in the December 2008 print issue of JASN.

ASN is a not-for-profit organization of 11,000 physicians and scientists dedicated to the study of nephrology and committed to providing a forum for the promulgation of information regarding the latest research and clinical findings on kidney disease. ASN publishes JASN, the Clinical Journal of the American Society of Nephrology (CJASN), and the Nephrology Self-Assessment Program (NephSAP). In January 2009, the Society will launch ASN Kidney News, a newsmagazine for nephrologists, scientists, allied health professionals, and staff.

Journal of the American Society Nephrology (JASN)

New Method Decodes Cell Movements, Accurately Predicts How Cells Will Divide

Researchers at Rensselaer Polytechnic Institute have discovered a new method for predicting – with up to 99 percent accuracy – the fate of stem cells.

Using advanced computer vision technology to detect subtle cell movements that are impossible to discern with the human eye, Professor Badri Roysam and his former student Andrew Cohen ’89 can successfully forecast how a stem cell will split and what key characteristics the daughter cells will exhibit.

By allowing the isolation of cells with specific capabilities, this discovery could one day lead to effective methods for growing stem cells on a large scale for therapeutic use.

“If you have many cells in a culture, they all look the same. But our new method senses all sorts of tiny differences in the shapes and movements of the cells, and uses these cues to predict what kind of cells it will divide into,” said Roysam, professor of electrical, computer, and systems engineering at Rensselaer. “We believe this method will be beneficial for one day taking cells from a patient, and then growing large amounts of the kind of cells that patient is in need of. This could enable many new and exciting types of medical treatments using stem cells.”

Results of the study, titled “Computational prediction of neural progenitor cell fates,” were published recently in the journal Nature Methods.

In order to achieve successful stem cell-based therapies, researchers require access to large amounts of specific cells. This has proven difficult, as there are currently no methods for controlling or manipulating the division of bulk quantities of cells. When stem cells or progenitor cells divide via mitosis, the resulting daughter cells can be self-renewing or terminal. A self-renewing cell will go on to split into two daughter cells, while a terminally differentiated cell is fated to be a specific, specialized cell type. Researchers want the ability to influence this division in order to produce large volumes of the correct type of cells.

Roysam and Cohen tracked the development of rat retinal progenitor cells cultured in their collaborator’s laboratory at McGill University. The computer system they developed took images of the cells every five minutes, and employed algorithmic information theoretic prediction (AITP) to observe the behavior of the cells, analyze the behavior, and discern whether each individual cell is fated to split into self-replicating or terminal daughter cells. This process occurs in real time, so researchers know the fate of cells before they actually divide.

The researchers predicted with 99 percent accuracy if the rat retinal progenitor cells would split into self-renewing or specialized cells, and predicted with 87 percent accuracy certain characteristics of the specialized cells.

“Our results suggest that stem cells display subtle dynamic patterns that can be sensed computationally to predict the outcome of their next division using AITP,” Roysam said. “In theory, AITP can be used to analyze nearly any type of cell, and could lead to advances in many different fields.”

Roysam said prototyping and development of the system leveraged the processing power of Rensselaer’s supercomputer, the Computational Center for Nanotechnology Innovations (CCNI).

Co-authors of the paper are Michel Cayouette and Francisco Gomes of the Cellular Neurobiology Research Unit at the Institut de Recherces Cliniques de Monteal; and Roysam’s former student Cohen, now an assistant professor of electrical engineering and computer science at the University of Wisconsin, Milwaukee.

This project was supported in part by the U.S. National Science Foundation Center for Subsurface Sensing and Imaging Systems, the Canadian Institutes of Health Research, and the Foundation Fighting Blindness-Canada.

Michael Mullaney
Rensselaer Polytechnic Institute

Electronic Cigarette Distributors Warned By FDA Regarding Unsubstantiated Claims

Warning letters were sent to five different electronic cigarette distributors by the FDA (Food and Drug Administration) for making unsubstantiated claims, as well as poor manufacturing practices. The FDA also informed the Electronic Cigarette Association that it means to regulate electronic cigarettes and related products “in a manner consistent with its mission of protecting the public health.”

A drug product is required to demonstrate its safety to the FDA, it also needs to prove it is effective for its intended use. Manufacturing methods have to be shown to be adequate so that the strength, quality and purity of the product is preserved, the Agency added.

In the letter to the Electronic Cigarette Association, the FDA wrote:

FDA invites electronic cigarette firms to work in cooperation with the agency toward the goal of assuring that electronic cigarettes sold in the United States are lawfully marketed.

Electronic cigarettes are subject to FDA regulation as drugs, the Agency has determined. It explains in its warning letters that under FDCA (Federal Food, Drug, and Cosmetic Act), if a company makes a claim to treat or mitigate a disease, such as nicotine addiction, it is required to prove its safety and effectiveness.

All five electronic cigarette distributing companies make this claim, but with no relevant evidence that their products help users give up smoking.

Warning letters were sent to the following companies:

E-CigaretteDirect LLC
Ruyan America Inc.
Gamucci America (Smokey Bayou Inc.)
E-Cig Technology Inc.
Johnson’s Creek Enterprises LLC.

Some firms received warning letters for other reasons too:

E-Cig Technology sells drugs in unapproved liquid forms, such as tadalafil, the active ingredient for the erectile dysfunction drug Cyalis, as well as rimonabant, a weight loss drug which has not been approved in the USA yet. Rimonabant is the active ingredient in the following brand named weight loss drugs, Acomplia, Bethin, Monaslim, Remonabent, Riobant, Slimona, Rimoslim, Zimulti, and Riomont. These liquid medications are designed to refill e-cigarette cartridges to that they may be inhaled through vapour.
Johnson Creek Enterprises, distributor of Smoke Juice, a liquid solution used to refill empty e-cigarette cartridges, is cited by the FDA for several faults in its manufacturing process, including not establishing quality control and testing procedures required under the FDCA.

What are e-cigarettes?
E-cigarettes, also known as personal vaporizers, or electronic cigarettes, are battery-powered devices that look like cigarettes which provide inhaled doses of nicotine in a vaporized solution – some may also provide non-nicotine vaporized solutions. They are sold as alternatives to smoked tobacco products, such as pipes, cigars and cigarettes.

E-cigarettes are said to provide a flavor and physical sensation similar to what a tobacco smoker experiences, but without the smoke or combustion (you don’t light it up).

Some e-cigarettes look just like cigarettes, while others look like ballpoint pens, and even pipes.

The majority of e-cigarettes are reusable and have replaceable and refillable parts. Some of them are disposable.

E-cigarettes in Europe – electronic cigarettes were brought to Europe in April 2006, and officially launched in Austria. Estimates place the number of regular e-cigarette users in Europe at over half-a-million.

E-cigarettes in the USA – classed as a drug by the FDA, and subject to market approval before sale under the FDCA. In January 2010 a federal judge overturned the FDA classification. However, an appeals court overruled the judge’s classification in March 2010. Several online e-cigarette companies have emerged online in America.

Sources: FDA, Wikipedia.