Genetic
Immunity, a US/Hungarian clinical-stage biopharmaceutical company focusing
on the development of its patented immunotherapeutic platform technology,
announced clinical safety and immunogenicity data on its DermaVir Patch, a
topically administered HIV immune therapy. The presentation, titled,
“Single DermaVir Patch Treatment of HIV+ Individuals Induces Long Lasting,
High Magnitude and Broad HIV-Specific T Cell Responses,” was given at the
15th Annual Conference on Retroviruses and Opportunistic Infections (CROI)
in Boston, February 3-6, 2008.

Presently available antiretroviral drugs interfere with the viral life
cycle, but because of their toxicity and resistance profiles are typically
prescribed as late as possible in the disease progression. Recent findings
with DermaVir Patch treatment suggest that this innovative medicine induces
new HIV specific immune responses in HIV infected patients not achievable
by antiretroviral drugs. Such an alternative treatment approach has the
capability to address the needs of those HIV positive individuals who have
not yet begun drug therapy as well as those who are currently on drug
therapy.

Genetic Immunity studied nine HIV infected individuals on fully
suppressive antiretroviral therapy who were treated a single time with
either 0.1, 0.4 or 0.8 mg of multiple HIV antigens encoding plasmid DNA,
the active substance in DermaVir Patch. The same antiretroviral drug
regimen was continued during the one-year follow-up.

HIV-specific T cell Precursors with High Proliferative Capacity (PHPC)
were quantified via an assay performed by Franco Lori, M.D. and his
collaborators. The DermaVir Patch treatment resulted in significant
induction of PHPC counts in all nine patients in the study. Importantly,
these precursor T cell responses were long lasting, 10-100 fold increased
PHPC counts over baseline were detected during the one year follow up. An
independent study has demonstrated that PHPC count inversely correlates
with viral load.

Safety was assessed with standard clinical and laboratory evaluations,
and dermatological analysis of skin reaction. DermaVir Patch continued to
show a lack of dose limiting toxicities. Through multiple studies, the only
side effect seen so far has been limited to transient erythema (redness of
the skin).

Julianna Lisziewicz, Ph.D., Co-Founder and CEO of Genetic Immunity,
said, “The distinctive safety and immunogenicity data is consistent with
our primate studies showing viral load reduction associated with immune
responses induced by DermaVir Patch treatment. The Genetic Immunity team is
encouraged by this data, which suggests that the DermaVir Patch is on its
way to becoming the first immune therapy for HIV-infected individuals.”

Franco Lori, M.D., CEO of Virostatics said, “In an independent
experiment, we demonstrated that high PHPC counts significantly correlate
with low viral load. The clinical results of the DermaVir Patch suggest a
novel immunogenicity profile. We are hopeful that many patients may see
benefit from this truly innovative antiviral therapy.”

About Genetic Immunity(R)

Genetic Immunity is a US/Hungarian development stage company
establishing leadership in next-generation biopharmaceuticals. The Company
is leveraging its proprietary platform technology to create new markets for
infectious diseases, cancer and allergy through the discovery, development
and commercialization of topically administered immune therapies. These
indications represent significant unmet medical need and potential for
alternative treatment approaches. Genetic Immunity’s lead product, the
DermaVir Patch for the treatment of HIV/AIDS, was discovered by the
Company’s founders, and is in Phase II clinical development with the
opportunity to be the first immune therapy approved for HIV-infected
individuals.

About DermaVir Patch

The proprietary DermaVir Patch is a topically administered HIV immune
therapy, which emerged from the clinical observations of Genetic Immunity’s
founders. Their examination of the “Berlin Patient” proved that induction
of immune control of HIV replication is feasible in an infected patient.
The Company has developed the DermaVir Patch to induce the immune system to
kill HIV infected cells specifically and to make immune therapy accessible
for the majority of HIV infected individuals, including children. The
DermaVir Patch, currently in Phase II clinical trials, is comprised of two
patented components: NanoComp and DermaPrep. NanoComp is an antigen
composition platform that combines a disease-specific plasmid DNA with the
Company’s formulation technology. The unique DNA for the DermaVir Patch
product encodes the majority of HIV antigens, allowing a broad immune
response. DermaPrep is a topical administration device by which NanoComp is
delivered specifically into the dendritic cells.

Genetic Immunity
Genetic Immunity Continue reading →

Health officials recently held a regional consultation in Kenya to examine mother-to-child HIV transmission services and pediatric HIV/AIDS care in nine Eastern and Southern African countries, IRIN/PlusNews reports. The consultation — hosted by UNICEF, UNAIDS and the World Health Organization — included representatives from Ethiopia, Kenya, Malawi, Mozambique, South Africa, Swaziland, Tanzania, Uganda and Zambia.

The meeting addressed issues in MTCT prevention services — including the continued use of single-dose nevirapine instead of more effective combination therapies, as well as delays in diagnosing and initiating treatment — that are weakening prevention programs in focus countries. According to IRIN/PlusNews, 70% of pregnant women in Eastern and Southern African countries are seen by a health care provider at least once during pregnancy. However, 43% of HIV-positive pregnant women have a health care worker present during labor who can administer PMTCT treatment.

In Uganda, a national policy calls for all sub-county level health facilities to provide PMTCT services, but only 53% offer such services because of health worker shortages. Janet Kayita, regional PMTCT adviser for UNICEF, said, “We are doing a bad job of testing women for HIV and then following them up, and an even worse job of ensuring that infants receive appropriate prevention and treatment services.” She added that national PMTCT guidelines have not reached local levels. “These policies must become a reality for the people they were designed to help,” Kayita said, adding that primary health care systems at all levels must be strengthened (IRIN/PlusNews, 5/25).

Some officials at the meeting called on African governments to reach 80% of pregnant women, mothers and children with services; reduce by 50% the number of women and infants who do not receive follow-up care; and double the number of HIV-positive children who receive antiretroviral treatment. Xinhuanet reports that prevention services currently reach about 50% of pregnant women in all Eastern and Southern African countries.

At the close of the consultation, officials issued a set of recommendations for meeting PMTCT goals, including increased community involvement in prevention programs; reduced workloads for health workers; and increased coverage of and compliance with PMTCT regimens. In addition, the experts urged governments to prioritize regions with high HIV burdens and strengthen data management to better understand trends (Ooko, Xinhuanet, 5/25).

James Kamau, coordinator of the Kenya Treatment Access Movement, recommended that more women in the country deliver in hospitals in order to ensure that they receive PMTCT services (Mwaniki, Daily Nation, 5/25). David Alnwick, a UNICEF regional adviser, said, “It is critical at this juncture, when many countries are faced with shrinking budgets and competing demands, that we do not lose the momentum of what needs to be done to create an AIDS-free generation” (Xinhuanet, 5/25).

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

© 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved. Continue reading →

Pharmaceutical company Pharmaxis (ASX: PXS; Nasdaq: PXSL) today announced
that its Phase III clinical trial of Bronchitol in bronchiectasis has
reached the recruitment target of 354 subjects.

The double blinded placebo controlled trial, which commenced dosing
subjects in May 2006, is being conducted at 22 hospitals across Australia,
New Zealand and the United Kingdom. It is expected to complete and report
in the middle of 2007.

Subjects enrolled into the study receive Bronchitol or placebo for
three months and may voluntarily elect to continue treatment for an
additional nine months. Data on the effectiveness of Bronchitol is
collected after the first three months of treatment.

Dr Alan Robertson, Pharmaxis CEO said: “We believe Pharmaxis has the
only product in Phase III clinical trials for this indication worldwide and
we continue to supply the drug on a compassionate use basis to patients
throughout Australia. A positive outcome from this study will enable us to
seek approval to market Bronchitol.

“The trial has been conducted very smoothly which is a credit to
everyone involved. We look forward to the reporting of the trial and to the
next phase of the development of Bronchitol.”

Bronchiectasis is an incurable, degenerative and chronic lung condition
affecting more than half a million people worldwide. In the United States,
at least 110,000 people are receiving treatment for bronchiectasis,
medical-care expenditure is over US$630 million per year and patients spend
between US$6,000 and US$13,000 on treatment. Widespread availability of
high resolution scanners is leading to increases in diagnosis rates and the
understanding that bronchiectasis is more common than previously thought.
Pharmaxis is developing Bronchitol as a twice daily treatment administered
directly to the patient’s lungs.

For more about Bronchitol, bronchiectasis and Pharmaxis, visit
pharmaxis.au/products/bronchitol/bronchitol_home.cfm.

Forward-Looking Statements

The statements contained in this press release that are not purely
historical are forward-looking statements within the meaning of Section 21E
of the Securities Exchange Act of 1934, as amended. Forward-looking
statements in this press release include statements regarding our
expectations, beliefs, hopes, goals, intentions, initiatives or strategies,
including statements regarding the potential for Aridol and/or Bronchitol.
All forward-looking statements included in this press release are based
upon information available to us as of the date hereof, and we assume no
obligation to update any such forward-looking statement as a result of new
information, future events or otherwise. We can not guarantee that any
product candidate will receive FDA or other regulatory approval or that we
will seek any such approval. Factors that could cause or contribute to such
differences include, but are not limited to, factors discussed in the “Risk
Factors and Other Uncertainties” section of Form 20-F lodged with the U.S.
Securities and Exchange Commission.

Pharmaxis Ltd
pharmaxis.au Continue reading →

Brazil has reached an agreement with Abbott Laboratories that will lower the price of the company’s antiretroviral drug Kaletra per pill from $1.17 to 63 cents and protect the drug’s patent, the Brazilian Ministry of Health said Tuesday, the AP/Boston Herald reports (AP/Boston Herald, 10/12). Under the terms of the agreement, Brazilian manufacturers will not produce a generic version of the drug domestically and Abbott will lower the price of Kaletra, which will save the government $339 million over six years (St. Paul Pioneer Press, 10/12). Abbott also agreed to donate $3 million worth of other pharmaceuticals to Brazil (Reuters/ChicagoBusiness, 10/11). In July, Brazil’s health ministry and Abbott said they had reached an agreement for Abbott to keep the government’s annual expenses on Kaletra at current levels for the next six years and that Brazil would not break Abbott’s patent. However, less than a week after the agreement was announced, Brazilian Health Minister Jose Saraiva Felipe dismissed the agreement and said the country would continue to negotiate for a lower price or manufacturers would break its patent and produce the drug for 41 cents per pill (Kaiser Daily HIV/AIDS Report, 10/5). Brazil had requested a “voluntary license” from Abbott that would have transfered Kaletra’s patent to the government in the future; however, Abbott did not agree to that under the deal reached on Tuesday. In the future, Abbott will make available an enhanced version of Kaletra, called Meltrex, which will be sold at a price approximately 10% higher than the Kaletra price, a health ministry spokesperson said (Jeffris/Radowitz, Dow Jones, 10/11). The deal takes effect in March 2006 (Reuters/ChicagoBusiness, 10/11).

“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.

View drug information on Kaletra Capsules and Oral Solution. Continue reading →

Detecting food-borne diseases such as campylobacter and salmonella long before they enter the food chain would help ensure that the dinner on your table is safe to eat.

There is no quick and simple way to detect infectious bacteria on farms, or even in food processing and distribution plants. Samples have to be sent to labs for testing, a process that can take hours or days.

But what if tests for campylobacter and salmonella could be run on the spot in as little as half an hour? The result, say European researchers, would undoubtedly be a dramatic improvement in food safety.

Campylobacter and salmonella are particularly nasty bacteria that are responsible for most cases of food poisoning around the world.

The idea of a lab-on-a-chip, a device small enough for someone to carry around but able to perform many of the tests normally carried out in a full-sized laboratory, has been around ever since microelectromechanical systems (mems) technology made it possible to put sensors, fluid channels and optical components into a small space.

However, the costs of producing such a system and the failure of many developers to incorporate a means of preparing samples on the spot has meant that few have gone into commercial use.

From testing food to detecting disease

A team of European researchers has addressed those problems, creating one of only two prototype systems in the world that prepare samples and perform DNA tests on bacteria in a portable, easy-to-use and cost-effective chip.

Their work, carried out in the EU-funded OptoLabCard project, will lead to the development of portable devices that can detect bacteria in the food chain and diseases as diverse as cancer, hepatitis, AIDS and flu in humans. Their work could also be used to develop portable devices that can identify pathogens and pollution in water supplies.

“The uses for these devices are almost endless??¦ and the market is huge,” explains Jes??s M Ruano-L??pez, coordinator of the OptoLabCard project at Ikerlan-IK4 in Spain.

What sets the OptoLabCard prototype apart from previous devices is the material used to manufacture the components of the chip, and the way in which samples are prepared prior to testing.

Using a single material for most components – a negative thick photoresist – makes the chips simpler and cheaper to produce.

The chip itself is disposable, while a reader or base unit contains all the electronics and optics. Meanwhile, incorporating sample preparation into the chip means that users can effectively replicate laboratory processes out in the field.

“Sample preparation is perhaps the most crucial part but it was abandoned by earlier developers,” Ruano-L??pez notes. “After all, in order to detect the presence of bacteria it is essential to have a reliable sample.”

Rubbing a swab across a chicken carcass, for example, might produce a sample containing as few as ten bacteria, an amount that could go undetected once transferred into the device.

That inability to provide a representative sample could lead to the bird or the entire batch to be deemed clean, when in reality the meat may be covered with dangerous pathogens.

To get around the problem and to improve detection accuracy, the team incorporated a method of concentrating the sample before testing. They used magnetophoresis and the polymerase chain reaction (PCR) technique. PCR is a well-established method of replicating DNA to create higher concentrations.

“By using PCR for sample preparation we can create more concentrated bacteria samples, and because it works with DNA it means that the same device can be used to detect many different types of bacteria and diseases,” Ruano-L??pez says.

So far the device has been used experimentally to detect salmonella in faecal samples taken from hospitals, and will soon be used in Denmark to test for campylobacter on chicken farms.

Cutting the cost of gastrointestinal infections

Testing for campylobacter is a particularly practical use for this technology because of the bacteria’s high prevalence in poultry, explains Dang Duong Bang, a senior researcher at the Danish Institute for Food and Veterinary Research, which will conduct the trial.

“If the device works as promised and leads to commercial products it will offer major benefits for farmers, processors and especially consumers,” he says.

Doung Bang points to studies that suggest the cost of treating gastrointestinal infections caused by campylobacter amount to the equivalent of ?‚¬600 million in the USA and about ?‚¬200 million in Britain alone each year.

Faster and more effective testing would undoubtedly reduce the number of infected animals reaching the market.

Ruano-L??pez says a product based on the OptoLabCard prototype could be ready for use commercially within three years, but the project team are not stopping the development of the device.

Toward a lab-on-a-patch

A spin-off company, called microLIQUID has been set up to commercialise components built with SU-8, while several of the project partners have recently launched a new project, called LabOnFoil, in which they will seek to create sample processing and detection chips on foils instead of traditional silicon wafers.

This work would not only bring down the cost per test by a factor of ten, to between 50 cents and ?‚¬1.50, but it could lead to skin patches able to detect and monitor disease, contamination and drug abuse, says Ruano-L??pez. The patches would be able to be read by a smart card.

Such developments would certainly turn tiny, portable laboratories into a ubiquitous technology, able to detect disease and ensure the safety of food anywhere at any time.

OptoLabCard received funding from the EU’s Sixth Framework Programme for research, while LabOnFoil is being funded by the Seventh Framework Programme.

optolabcard
Source – ICT Results Continue reading →

Leading world experts in infectious disease have warned that the rapid spread of Clostridium difficile infection (CDI) has given rise to an epidemic, making it an urgent health priority.

The symposium, sponsored by Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR), at the 18th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Barcelona, Spain, highlighted the increasing prevalence of CDI. Dr. Ed. J. Kuijper, Medical Microbiologist at the Leiden University Medical Center, the Netherlands, said that the hyper-virulent NAP1/027 strain of Clostridium difficile was largely responsible for this emerging epidemic along with routine antibiotic use, and a lack of facilities for isolating infected patients.

“Epidemics involving type NAP1/027 have affected more than 250 hospitals in 17 European countries. This underlines the importance of continuous surveillance to observe changes in the epidemiology of individual C. difficile strains,” said Dr Kuijper.

The symposium, titled ‘Clostridium difficile-Associated Disease: Current Treatments and Challenges’ attracted over 400 clinical practitioners involved in the battle against infectious diseases. The meeting was co-chaired by John Bartlett, M.D., Professor of Medicine at the Johns Hopkins University of School of Medicine in Baltimore, Maryland and Carl-Erik Nord, M.D., Professor of Clinical Microbiology from the Department of Laboratory Medicine at the Karolinska University Hospital of the Karolinska Institute in Stockholm, Sweden.

CDI, responsible for the most common form of hospital-acquired diarrhea, affects over 500,000 people in the United States1 and one out of every 1,000 patients hospitalized in Europe2. Higher incidence and severity of CDI, increased treatment failures with standard therapies3, and the emergence of the highly virulent epidemic strain have combined to create a significant concern among public health officials, infectious diseases physicians, gastroenterologists, microbiologists and epidemiologists.

Patients who have been treated with broad spectrum antibiotics (those that affect a wide range of bacteria, including intestinal bacteria) are at greatest risk of CDI. Many of the patients affected are elderly with serious underlying illnesses. Most infections occur in hospitals but can also occur in primary care settings.

“Important milestones in meeting the CDI challenge include developing next-generation therapies to improve clinical outcomes and also finding ways to enhance the body’s immunity to this infection,” said Dr. Mark Miller, M.D., FRCPC., Chair of Infection Prevention and Control, Chief of the Division of Clinical Microbiology and Head of the Division of Infectious Diseases at the Jewish General Hospital, Montreal, Canada.

“The most-commonly used available treatment, metronidazole, is now recognized to be inadequate for patients with moderate to severe CDI, leaving us with only one other option: the antibiotic vancomycin, which also has limitations. Newer and more efficacious treatments are desperately needed for this life-threatening illness. Companies developing new CDI therapies should focus on three goals: speed up the time to recovery, prevent relapsing disease after the end of therapy, and eliminate death and disability from this infection.”

Optimer is currently conducting phase 3 clinical trials in North America and Europe for its lead drug candidate, OPT-80 (formerly known as PAR-101 or Difimicin), a first-in-class macrocyclic antibiotic for the treatment of CDI.

OPT-80, which has been granted Fast Track status by the US Food and Drug Administration, provides a narrow spectrum of activity that is bactericidal against Clostridia and does not disturb normal intestinal microbes. It has shown no cross resistance with other anti-infectives. If approved, Optimer believes OPT-80 will address many of the problems of existing treatments by accelerating time to clinical cure, reducing rates of recurrence, and decreasing daily dose requirements.

References-

1. Centers for Disease Control
2. “ESCMID Study Group Report: A European survey of diagnostic methods and testing protocols for Clostridium difficile”, Clinical Microbiology and Infection, Vol. 9 Issue 10: 989, October 2003.
3. McDonald LC, et. al (2005). “An epidemic, toxin gene-variant strain of Clostridium difficile”. N Engl J Med 353: 2433-41.

About Optimer

Optimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative anti-infective products for the treatment of serious infections. Optimer has two late-stage anti-infective product candidates in Phase 3 clinical trials. Additional information regarding Optimer can be found at optimerpharma.

Forward-looking Statements

Statements included in this press release that are not a description of historical facts are forward-looking statements, including without limitation all statements related to incidence of CDI and the ability of OPT-80 to address current treatment limitations. Words such as “believes,” “anticipates,” “plans,” “expects,” “intend,” “will,” “goal” and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Optimer that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Optimer’s business including, without limitation, risks relating to: the timing, progress and likelihood of success of its product research and development programs, the timing and status of its preclinical and clinical development of potential drugs and other risks detailed in Optimer’s filings with the Securities and Exchange Commission.

Optimer Pharmaceuticals, Inc. Continue reading →

Tufts University has been tapped by the United States Agency for International Development (USAID) as part of a multidisciplinary team that will receive a grant of up to $185-million to create better synergies among veterinarians, doctors, and public health officials in responding to emerging infectious diseases.

The 5-year initiative, which will be led by Bethesda-based DAI and also includes the University of Minnesota, will improve the capacity of countries in high-risk areas to respond to outbreaks of emergent zoonotic diseases that can be transmitted between animals and humans. With a focus on preventing zoonotic diseases from reaching the human population, the intent of the project is to identify and counter outbreaks while they are still within wildlife and livestock.

Known as RESPOND, the project will focus on the development of long-term field epidemiology training, short-term in-service training, and academic preparation of all health professionals using a “One Health” framework – drawing physicians, public health officials, and veterinarians together for a common purpose. Training will facilitate the merging of animal and human health dynamics into a comprehensive approach to disease detection and outbreak response. The twinning of US academic institutions with local academic institutions in partner countries is a key feature of the project.

“The threat to human health from emerging zoonotic infectious diseases is very real. Understanding and responding to this threat are key strengths of the Cummings School and Tufts,” said Deborah T. Kochevar, dean of the Cummings School of Veterinary Medicine, which will spearhead Tufts’ efforts. “The RESPOND team brings a breadth and depth of experience that crosses disciplines, spans species and taps the power of ‘One Health’ thinking.”

The RESPOND grant is one of five projects of the USAID Emerging Pandemic Threats program. The other four complementary projects are known as PREDICT (to monitor for emergence of infectious agents from high risk wildlife), IDENTIFY (to develop a robust laboratory network), PREPARE (to test pandemic preparedness plans), and PREVENT (focusing on behavior change communication to help people avoid high-risk practices that could lead to transmission from animals to humans). Taken together, these mechanisms aim to capitalize on recent successful global USAID sponsored efforts to understand and contain Highly Pathogenic Avian and pandemic influenza worldwide – and apply those key lessons learned to preventing newly emerging disease agents from becoming pandemics.

The Tufts team will be led by principal investigator Robyn G. Alders, Associate Professor in the Cummings School’s International Veterinary Medicine Section within the Department of Environmental and Population Health, and Co-Principal Investigator and Associate Professor of Public Health Joann M. Lindenmayer, DVM, MPH. Dr. Alders brings more than 20 years of international experience and a PhD in immunology to the project. Dr. Lindenmayer is a 1985 Cummings School graduate and alumna of the CDC’s Epidemic Intelligence Service. The project will draw from faculty of the Cummings School, Tufts School of Medicine, Tufts Feinstein International Center, and Tufts Center for the Enhancement of Learning and Teaching. Dr. Felicia Nutter, a 1993 Cummings School graduate, will be based in the Bethesda headquarters of DAI as the Senior Technical Officer. Dr. Nutter completed a combined residency/ Ph.D. program in wildlife medicine and epidemiology, is a diplomate of the American College of Zoological Medicine and has considerable international experience.

The Cummings School is no stranger to international veterinary work. In 1983, the school, along with Tufts’ Fletcher School of Law and Diplomacy, was tapped by USAID to optimize cattle production in Niger. This led to participation in a long term effort to eradicate from the world one of the most serious infectious diseases in cattle, rinderpest. Key contributions to this global effort included development of a heat stable vaccine and its application as well as developing infectious disease surveillance methods in remote areas of the world.

Since 2006, a team of Cummings School veterinarians has been working with the United Nations Food and Agriculture Organization and the Indonesian Ministry of Agriculture to develop a surveillance and control program for Highly Pathogenic Avian Influenza in Indonesia. Using a community-based educational approach, they have provided technical assistance and training for Indonesian veterinarians and the villagers who depend on their small flocks for food and income.

Source: Tom Keppeler

Tufts University, Health Sciences Continue reading →

In the midst of a massive E. coli O104:H4 outbreak centered in Germany, food safety attorney Bill Marler is calling on the U.S. Department of Agriculture (USDA), U.S. Food and Drug Administration (FDA) and food safety agencies worldwide to list all pathogenic non-O157 E. coli strains as adulterants in food and create science-based testing protocols.

Coming on the heels of an April 2011 E. coli O111 outbreak in Japan that killed 4 and sickened 100, the recent European outbreak continues to grow at a startling pace, thus far killing 17 and sickening 1,534. Of those, 470 people have contracted the often life-threatening hemolytic uremic syndrome (HUS) that can result in kidney failure.

At least one American tourist has fallen victim in the outbreak and is currently hospitalized in the Czech Republic. While the cause of the outbreak is currently unknown, produce from both Germany and Spain have been suspected. Recently Slugs were deemed a possible source.

Though considered dangerous by the United States Centers for Disease Control and Prevention (CDC), neither the USDA nor FDA presently regulate non-O157 E. coli bacteria. Food manufacturers, distributers and sellers are not required to test for these strains of pathogenic E. coli in the food supply, something Marler hopes will change in light of recent events.

“The tragedies in Germany and Japan should serve as a wakeup call to governments and businesses worldwide. The U.S. is seeing more and more E. coli outbreaks from non-O157 strains,” said Marler. “At this moment the USDA, FDA, and other public health agencies have an opportunity to exercise good policy by getting proactive about food safety and instituting science-based testing that will curb future outbreaks.”

Though catalyzed by the recent outbreaks, this is not the first instance in which Marler has called on the government to demand more of food producers. In 2009 he petitioned the USDA to declare all Shiga toxin-producing E. coli, including non-O157 serotypes, to be adulterants. In 2010 he spent $500,000 of his own money to fund a study testing for non-O157 E. coli in American grocery stores. In that study, he found both the E. coli O111 and E. coli O104 strains.

“These days some may say I spend more time advocating for food safety than I do litigating foodborne illness,” added Marler. “There may be some truth to that, but for good reason. When you’ve seen the horror involved in severe foodborne illness cases, you do everything in your power to prevent them from happening – a sentiment I hope the USDA, FDA, the President, and the international community share.”

Bill Marler travels frequently around the globe speaking on foodborne illness and is a leading expert on food safety. His firm Marler Clark, The Food Safety Law Firm, is the only law firm in the U.S. with a practice dedicated solely to representing victims of foodborne illness.

Source:

Marler Clark Continue reading →

A study in this week’s PLoS Medicine suggests that AIDS patients with cryptococcal meningitis who start HIV therapy are predisposed to immune reconstitution inflammatory syndrome (IRIS) – an exaggerated inflammatory immune response that kills up to one-third of affected people – if they have biomarkers (biochemicals) in their blood showing evidence of a damaged immune system that is not capable of clearing the fungal infection.

David Boulware and Paul Bohjanen from the University of Minnesota, Minneapolis, USA, and their colleagues, David Meya and Andrew Kambugu, at Makerere University in Kampala, Uganda enrolled 101 Ugandans with AIDS and recent cryptococcal meningitis who had not previously received HIV therapy and compared biomarker patterns in individuals who did and did not subsequently develop IRIS after starting HIV therapy. 45% of patients developed IRIS of whom 36% died, while only 21% of patients who did not develop IRIS died. Furthermore, the authors found that patients who later developed IRIS associated with cryptococcal meningitis after starting HIV therapy had 4-fold higher baseline concentrations of cryptococcal antigen and lower levels of several inflammatory cytokines in their blood compared to patients who did not develop CM-IRIS.

The authors say: “This study suggests that prediction of IRIS or death may be possible with measurement of pre-antiretroviral therapy serum biomarkers.” They add, “Although requiring validation, these biomarkers might be an objective tool to stratify the risk of CM-IRIS and death, and could be used clinically to guide when to start antiretroviral therapy or use prophylactic interventions.”

Funding: This work was supported by the University of Minnesota Academic Health Center (PRB, DBM), NIH National Institute of Allergy and Infectious Diseases (DRB: T32AI055433-03; L30AI066779; K12RR023247-04; K23AI073192. PRB: R03AI078750), Minnesota Medical Foundation (PRB, DRB, DBM), Tibotec REACH Initiative (PRB, DRB, DBM), University of Minnesota Dean’s Grant-in-Aid (DRB), Academic Alliance Foundation (AK, DBM), Mucosal and Vaccine Research Program Colorado (ENJ), and the Veterans Affairs Research Service (ENJ). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing Interests: The authors have declared that no competing interests exist.

Citation: Boulware DR, Meya DB, Bergemann TL, Wiesner DL, Rhein J, et al. (2010) Clinical Features and Serum Biomarkers in HIV Immune Reconstitution Inflammatory Syndrome after Cryptococcal Meningitis: A Prospective Cohort Study. PLoS Med 7(12): e1000384. doi:10.1371/journal.pmed.1000384

Source: PLoS Medicine Continue reading →

A report issued today by the Centers for Disease Control and Prevention (CDC) estimates that only 4.4 percent of the nation’s children aged 6 to 23 months were fully vaccinated against influenza during the 2002-03 influenza season, the first season CDC encouraged influenza vaccination for healthy children. This first CDC report on childhood influenza vaccination coverage also estimates that only 7.4 percent of the children aged 6 to 23 months had received at least one dose of the vaccine.

“Too few young children are protected against influenza, which for this age group, can be a very serious illness,” said Dr. Julie Gerberding, CDC director. “This season, CDC not only encourages flu shots for young children, we recommend them. We’re urging more parents to get their children vaccinated against influenza because annual flu shots will reduce cases of influenza and its complications, decrease hospitalizations, and save lives.”

To be fully vaccinated, previously unvaccinated children should receive two doses. Children who have received any dose of influenza vaccine in previous years require only one annual dose.

Recent studies show that children less than two years old, even healthy children, are more likely than older children to be hospitalized with serious complications if they get the flu. Because children younger than two are at increased risk for influenza-related hospitalization, vaccination is also recommended for their family members, other people living or working in their household and childcare providers. It is particularly important that people who are contacts of children younger than six months be vaccinated because influenza vaccination is not approved for children younger than six months of age.

During the 2003-2004 influenza season, CDC received reports of 152 flu-related deaths among children (under age 18) from 40 states. The vast majority of these children were not adequately vaccinated against flu. Almost half of the children had an underlying medical condition, but 40% were previously healthy.

The report being released today is based on data from the 2003 National Immunization Survey (NIS) and provides a baseline estimate for influenza vaccination for young children. The NIS is an ongoing survey that provides estimates of vaccination coverage among children. Childhood influenza vaccination status will now be routinely collected as part of the NIS and the data will be used to assess and report childhood influenza vaccination coverage among children in the United States.

For the full MMWR article, including state coverage rates, visit cdc/mmwr/preview/mmwrhtml/mm5337a1.htm.

Contact: CDC Media Relations
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