Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced the results of the Phase III clinical trial of its investigational Fluzone® Intradermal (Influenza Virus Vaccine) candidate compared to Fluzone (Influenza Virus Vaccine) administered via the traditional intramuscular method (IM). Data from the clinical trial assessing the immunogenicity and safety of the investigational intradermal vaccine were presented by Dr. Geoffrey J. Gorse at the 48th Annual Meeting of the Infectious Diseases Society of America in Vancouver, British Columbia.

Earlier this year, Sanofi Pasteur announced that it had filed a Supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) for Fluzone Intradermal vaccine. The file has been accepted for review by the FDA and an action date is anticipated in the first half of 2011.

“The results from this large Phase III study in adults show that administration of influenza vaccine with an intradermal microinjection system may reduce the amount of antigen required for an immune response similar to that seen with Fluzone vaccine,” said Geoffrey J. Gorse, M.D., Professor of Internal Medicine, Division of Infectious Diseases and Immunology, St. Louis University. “The reduced amount of antigen, smaller volume of vaccine administered and shorter needle associated with intradermal microinjection compared with traditional intramuscular injection are attractive attributes for health-care providers and their patients that are likely to lead to increased acceptance of influenza vaccination and increase population coverage.”

Phase III Study Design and Results

The immunogenicity and safety of the Fluzone Intradermal vaccine candidate was assessed in comparison to the licensed Fluzone influenza virus vaccine administered intramuscularly. Compared to licensed Fluzone vaccine, Fluzone Intradermal vaccine has a lower antigen content (9mcg HA vs. 15mcg HA per strain) and injection volume (0.1 mL vs. 0.5 mL). The multicenter, active-controlled, modified double-blind Phase III trial was conducted in the United States during the 2008-2009 influenza season among 4,292 adults, 18 through 64 years of age. Study participants were randomized 2:1 to receive either the investigational Fluzone Intradermal vaccine containing 9mcg hemagglutinin (HA) per each of the three vaccine strains or the licensed Fluzone vaccine administered intramuscularly containing 15mcg HA antigen per each of the three strains in the vaccine. Influenza strains in both vaccines were: A/Brisbane/59/07 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Florida/04/2006.

In the study, antibody titers to HA using a hemagglutination inhibition (HAI) assay were assessed in blood specimens obtained on the day of vaccination (Day 0) and 28 to 35 days later. Geometric mean titers (GMTs), rates of 4-fold rise in titers and seroprotection rates were calculated for each study group and each vaccine strain. Fluzone Intradermal vaccine was found to induce comparable immunologic responses to the licensed Fluzone vaccine.

Systemic reactogenicity of Fluzone Intradermal was comparable to that of Fluzone IM in the study. Injection-site reactions were reported more frequently in participants given Fluzone Intradermal compared with those given Fluzone IM, as was expected given that the vaccine antigens were administered into the dermal space. Most of the reported injection-site and systemic reactions were of Grade 1 or Grade 2 in intensity and resolved in three to seven days without sequelae.

About Intradermal Microinjection

Typically, adult vaccines are administered into the muscle (referred to as intramuscular or IM injection) utilizing a needle 1 inch to 1.5 inches in length (approximately 25 mm to 40 mm). Vaccination via the intradermal route involves introduction of the vaccine into the dermal layer of the skin, a procedure that can be technically challenging, particularly for providers who do not routinely perform this procedure. Sanofi Pasteur’s novel intradermal influenza vaccine candidate is designed to overcome the technical difficulties that have historically limited the use of this route of administration by incorporating a new, easy-to-use, pre-filled microinjection system developed in collaboration with Becton, Dickinson and Company (BD). The microinjection system uses an ultra-thin needle of only 1.5 mm in length, or less than one-tenth the length of the standard needles used for the traditional IM route of administration.

In addition to offering patients an option they may find preferable to the traditional intramuscular injection, intradermal vaccination differs from intramuscular injection by depositing the antigen in the dermal layer of the skin, a site that contains a high concentration of specialized immune cells.

Sanofi Pasteur is seeking licensure of Fluzone Intradermal vaccine in the U.S. for adults 18 years through 64 years of age. Sanofi Pasteur already has licensed a microinjection system influenza vaccine, marketed as Intanza® / IDflu®, in Europe, Australia, New Zealand, Argentina, Canada and other countries.

Forward Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential and statements regarding future performance. Forward-looking statements are generally identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans” and similar expressions. Although sanofi-aventis’ management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such products candidates, the absence of guarantee that the products candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group’s ability to benefit from external growth opportunities as well as those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in sanofi-aventis’ annual report on Form 20-F for the year ended December 31, 2009. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.

Source: Sanofi Pasteur

View drug information on Fluzone Preservative-free. Continue reading →

The recent recall of Roche’s antiretroviral drug Viracept worldwide has “disrupted treatment for tens of thousands of the world’s poorest patients, with no clear word from the manufacturer on when shipments will resume,” the New York Times reports (Rosenthal, New York Times, 7/23). The European Medicines Agency in June recalled Viracept because of contamination. Roche in a statement said that it is recalling all batches of the drug in cooperation with EMA and Swissmedic, Switzerland’s drug regulator, in Europe and other undisclosed countries. According to Roche, the drug was recalled after tests indicated that certain batches were contaminated with higher-than-normal levels of methane sulfonic acid ethyl ester — a chemical normally used in the drug in small quantities.

William Burns, CEO of Roche’s pharmaceutical division, said the impurity had been caused by the interaction of two chemicals in a vessel where the drug is produced. Investigators still are trying to determine what occurred in the Swiss plant where the drug is manufactured. It is believed that the contamination might have occurred in March and has affected supplies of the drug for three months. Roche later announced that it plans to establish patient registries to monitor the health of HIV-positive people who were taking the drug (Kaiser Daily HIV/AIDS Report, 6/25).

Although the recall “went largely unnoticed” in developing countries when it was announced, it has “caused growing concern among global health officials and in AIDS programs in many poor nations,” according to the Times. They say that Roche did an insufficient job of providing information to patients and officials about potential risks of Viracept and helping them to find affordable, alternative drugs, the Times reports. Roche said that it has been working with health officials worldwide and that risks associated with the affected Viracept batches are low. The company said it immediately notified health providers in affected countries to discontinue use of Viracept. Roche also said it would cover the “reasonable costs” of the recall but did not define “reasonable costs,” the Times reports.

Lembit Rago, an official with the World Health Organization, said that tens of thousands of people worldwide take Viracept, many of whom are impoverished and live in developing countries. The recall has “left those patients with the painful choice of discontinuing a lifesaving medicine or using a drug that might contain a dangerous contaminant,” according to the Times. WHO and EMA officials have said that Roche did not provide vital information for guarding public health, including where the affected drugs were shipped, the concentration of the contaminant and what the company plans to do for people taking the drug. EMA has canceled Roche’s license to manufacture Viracept, which also is known as nelfinavir.

Roche said that the recall affected “Europe and some other world regions” but has not been more specific, the Times reports. Although the company has been in talks with Pfizer about supplying Pfizer’s version of Viracept — which is made in the U.S., Canada and Japan — to some affected nations, regulatory and licensing issues could take “some time,” Roche spokesperson Martina Rupp said. Rupp said that Roche has shipped “at least one packet of Viracept with high levels of the impurity to 35 countries” but would not say which countries. Contaminants were “observed in batches of Viracept that had been released to countries since March 2007,” she added.

Rupp said that Roche made the worldwide recall to “avoid confusion,” adding that the company estimates about 45,000 people were affected by it. Roche is conducting studies on the issue, and the results will not be available for several months, according to Rupp.

In some countries, newer alternatives to Viracept are not available because they are not licensed or are too expensive, according to some people living with HIV and international health experts. In some countries, such as Panama, patients or treatment programs have made up the difference in cost between Viracept and more expensive alternatives. However, in countries like Venezuela, alternatives to the drug are unavailable.

Asia Russell, coordinator of international advocacy for Health Gap, said, “It seems that Roche has abandoned these patients since in many places there aren’t ready alternatives.” EMA spokesperson Martin Harvey-Allchurch said, “We have not gotten information, not even an order of magnitude.” Harvey-Allchurch added, “I understand sales figures are confidential, but I would have thought by now we would have this information” (New York Times, 7/23).

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

View drug information on VIRACEPT. Continue reading →

The National Institute on Drug Abuse (NIDA) has awarded a $3.5 million grant for AIDS vaccine research to Phillip Berman, professor and chair of biomolecular engineering at the Jack Baskin School of Engineering at the University of California, Santa Cruz.

With the new five-year grant, Berman’s group will follow up on promising findings they reported in the August issue of the Journal of Virology. The researchers identified a novel structural element in an HIV coat protein that could be useful for vaccine development.

Despite major efforts over the past 20 years to develop an AIDS vaccine, none of the vaccines tested in clinical trials has succeeded in preventing HIV infections. Berman oversaw one of those trials as head of research and development at VaxGen. Now he has gone “back to the drawing board” to take a new approach to AIDS vaccine development.

The focus of the research is on antibodies that are capable of neutralizing a wide range of HIV strains. Such “broadly neutralizing antibodies” are necessary to stop the virus because HIV is extremely variable, constantly evolving to evade the immune systems of infected individuals.

“One of the main hypotheses in HIV vaccine research is that if a vaccine could induce those broadly neutralizing antibodies, it would work. None of the current vaccines do that,” Berman said.

Our immune systems are capable of making broadly neutralizing antibodies against HIV, but studies have found that this happens in fewer than 25 percent of infected individuals and not until six to 12 months after infection. By then, it’s too late to stop the virus. “The antibodies have to be there before infection occurs. After the virus gets a foothold, it’s too late,” Berman said.

Berman’s lab, along with collaborators at Monogram Biosciences of South San Francisco, developed a new method called “swarm analysis” to investigate the natural variations in the virus that emerge in the early stages of HIV infections. The studies reported in the Journal of Virology paper were led by first author Sara O’Rourke, a research specialist in biomolecular engineering at UCSC.

“We’ve made use of the natural variation in viral gene sequences to identify the binding sites recognized by broadly neutralizing antibodies,” Berman said. “By looking at viruses from very early infections, we’re seeing variations that hadn’t been seen before.”

One of those variations appears to change the shape of an HIV coat protein in such a way that it becomes more sensitive to neutralization by antibodies. Working with William Scott, professor of chemistry and biochemistry at UCSC, Berman’s lab analyzed the effects of this genetic variant on the three-dimensional structure of the protein. The results indicate that the structural change exposes parts of the protein that are normally hidden from the immune system and are only exposed transiently during the infection process, when the viral membrane fuses with the membrane of a human cell.

In the Journal of Virology paper, the authors suggest that this novel structural variant could be exploited in designing new vaccines.

“We think that by making a vaccine based on this structure where the binding sites are exposed, it will stimulate a broadly neutralizing antibody response,” Berman said. “By having the protein in a different conformation, the immune system can see those binding sites and make antibodies that would then be effective against normal virus strains during that transient window when the sites are exposed.”

Studies are currently under way to examine the immunogenic potential of the variants identified in the study.

Meanwhile, the vaccine that Berman invented at Genentech in the mid-1990s, then evaluated in clinical trials at VaxGen, has been tested in a more recent clinical trial (RV 144) sponsored by U.S. and Thai government agencies. The manufacturing and intellectual property rights for the vaccine are now held by Global Solutions for Infectious Diseases (GSID). Results of the trial, which concluded earlier this year, are expected to be announced in October at the AIDS Vaccine 2009 international conference in Paris (hivvaccineenterprise/conference/2009/index.aspx). The clinical trial tested a “prime-boost” vaccine regimen, in which a vaccine developed by Aventis Pasteur was used as a “priming” vaccine, followed by the GSID vaccine as a “booster.” The community-based clinical trial involved 16,000 volunteers in southeast Thailand.

Berman said the research funded by the new grant will complement the data from the RV 144 trial. Using the “swarm analysis” technique and the bioinformatics and genomics expertise of his UCSC colleagues, Berman’s group will be studying the evolution of the virus and the host’s immune response during the early stages of HIV infection. Blood serum samples collected during earlier VaxGen clinical trials involving intravenous drug users are a crucial resource for these studies.

“It’s a lemons to lemonade kind of thing, building on information from a failed vaccine trial to move the field forward in a different way,” Berman said.

In addition to O’Rourke, Berman, and Scott, the coauthors of the Journal of Virology paper include Becky Schweighardt and Terri Wrin of Monogram Biosciences, Dora Fonseca of UCSC, and Faruk Sinangil of GSID. GSID is a nonprofit organization based in South San Francisco that focuses on vaccines for the developing world. The study was supported by a grant to GSID from the Bill and Melinda Gates Foundation and funding provided by UCSC.

Source:
Tim Stephens

University of California – Santa Cruz Continue reading →

Researchers have invented computational tools to decode and rapidly determine whether natural compounds collected in oceans and forests are new – or if these pharmaceutically promising compounds have already been described and are therefore not patentable.

This University of California, San Diego advance will finally enable scientists to rapidly characterize ring-shaped nonribosomal peptides (NRPs) – a class of natural compounds of intense interest due to their potential to yield or inspire new pharmaceuticals. The study will be published in the July 13 online issue of journal Nature Methods.

“These advances will speed the process by which we discover and describe new and biologically active molecules from organisms such as marine cyanobacteria, also known as blue-green algae. This, in turn, will accelerate the timeline for bringing new experimental therapies into clinical application,” said William Gerwick, an author on the paper and a professor with the UC San Diego Scripps Institution of Oceanography Center for Marine Biotechnology and Biomedicine and the UCSD Skaggs School of Pharmacy and Pharmaceutical Sciences. (Read about Gerwick’s work to discover drugs and protect Panama’s natural and cultural resources here)

Nonribosomal peptides (NRPs) often serve as chemical defenses for the bacteria that manufacture them. Starting from penicillin, NRPs have an unparalleled track record in pharmacology: most anti-cancer and anti-microbial agents are natural products or their derivatives. However, it is currently difficult, time-consuming and costly to determine the molecular structure of NRPs which, by definition, are not directly inscribed in the genomes of the organisms that produce them.

“NRPs are one of the last bastions of pharmacologically important biological compounds that remain virtually untouched by computational research. As a result, it is currently one of the most painfully slow processes, it is a real bottleneck that we have now removed,” said Pavel Pevzner, a computer science professor at UC San Diego’s Jacobs School of Engineering and the corresponding author on the Nature Methods paper.

Researchers can now separate known compounds from those that are unknown

“If I collect 1,000 ocean compounds, why waste time with compounds that are already known or patented?” added Nuno Bandeira, co-lead author on the paper, director of UC San Diego’s Center for Computational Mass Spectrometry (CCMS) and a researcher at the UC San Diego division of Calit2, the California Institute of Telecommunications and Information Technology.

“Our algorithms can tell natural product researchers what their compounds are. Manual annotations should be something of the past,” said Julio Ng, a co-lead author on the Nature Methods paper and a doctoral student in Bioinformatics at UC San Diego.

“Compound 879,” for example, is a cyclic NRP discussed in the Nature Methods paper that was thought to be novel when it was isolated. A lengthy and expensive patenting process, however, uncovered that compound 879 had already been described as an antibiotic and named neoviridogrisen. The new UC San Diego algorithms would have quickly identified this fact. These algorithms make sense of the flood of tiny peptide fragments that are generated by machines called mass spectrometers that blast nonribosomal peptides apart and determine their sizes.

Two complementary processes are used to glean insights from data generated from the mass spectrometers that break the cyclic peptides into smaller and smaller linear pieces.

First, the authors present new algorithms that computers use to piece these peptide fragments back together in order to determine the chemical structure of a cyclic NRP. This is called “De Novo sequencing of NRPs.”

Second, the researchers created “dereplication” tools for moving the other direction: taking the chemical structures of known NRPs and other related information and determining what the data signature would look like if a mass spectrometer had blown the compound part.

“Natural products have a long history in therapeutic development and many were discovered before the digital recording of mass spectrometry data. Therefore, we do not have an extensive mass spectrometry database for natural products as we do for proteomics. Our new tools enable dereplication without an experimental database to compare to,” said Pieter Dorrestein, assistant professor in the UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences and the Departments of Pharmacology, Chemistry and Biochemistry.

By using these two approaches, the researchers have created tools that enable researchers to both characterize the compound they have isolated and check to see if it, or something similar, has been previously described. With dereplication, researchers can leverage known information and are not forced to start from scratch each time a new compound needs to be identified.

“As long as the structure of the therapeutic or a related therapeutic or natural product is in the library, we can accurately dereplicate the molecule. This is the first generation of algorithms that can accomplish this and is a glimpse into the future of modern drug discovery.”

Performing de novo sequencing without knowing amino acid masses is completely novel, according to Bandeira. “Until we created them, there were no algorithmic approaches available to do this from mass spectrometry data and it was generally thought to be impossible,” said Bandeira, who earned his Ph.D. in computer science from the UC San Diego Jacobs School of Engineering.

The work allows mass spectrometry to go into the natural products field and actually do the identification and characterization of natural products in a high throughput fashion, explained Ng, a bioinformatics PhD student advised by Pavel Pevzner in computer science and Pieter Dorrestein in the Skaggs School of Pharmacy.

The researchers note that currently there is no one place to look for known NRPs, a situation they are trying to change with a new data repository effort.

The UC San Diego web-based tools for sequencing nonribosomal peptides (at not cost to researchers) are available at: bix.ucsd.edu/nrp

“This new study has shown that marine cyanobacteria are incredible sources of new molecules that may have medical value, especially in cancer, infectious diseases and neurological disorders,” said Gerwick.

Notes:
This project was supported by US National Institutes of Health grants 1-P41-RR024851-01, GM086283 and cA10u851, and by the PhRMA foundation.

“Dereplication and De Novo Sequencing of Nonribosomal Peptides,” by Julio Ng,1,8 Nuno Bandeira,2,8 Wei-Ting Liu,3 Majid Ghassemian,3 Thomas L. Simmons,4 William Gerwick,4,5 Roger Linington,6 Pieter Dorrestein,3,5 and Pavel Pevzner2,7

1 Bioinformatics Program, University of California San Diego, La Jolla, California 92093
2 Department of Computer Science and Engineering, University of California San Diego, La Jolla, California 92093
3 Department of Chemistry and Biochemistry, University of California San Diego, La Jolla, California 92093
4 Scripps Institution of Oceanography, University of California San Diego, La Jolla, California 92037
5 Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, La Jolla, California 92092
6 Department of Chemistry, University of California Santa Cruz, Santa Cruz, California 95064
7 Author: Pavel Pevzner
8 Authors contributed equally

CCMS is a joint effort between the Computer Science and Engineering (CSE) department of the Jacobs School of Engineering, and the UCSD division of the California Institute for Telecommunications and Information Technology (Calit2).

Pavel Pevzner is also director of the Calit2-based Center for Algorithmic and Systems Biology (CASB) and is a Howard Hughes Medical Institute (HHMI) professor.

Source:
Daniel Kane

University of California – San Diego Continue reading →

Amnis Corporation, a manufacturer of
advanced instrumentation for the life science research and diagnostics
markets, announced today the publication of a major new study in the field
of AIDS research. The pioneering work, involving the development of a
robust murine model for long-term KSHV infection, was carried out by Dr.
Dean Kedes and colleagues at the University of Virginia Health System.
KSHV, a gamma herpesvirus, is the etiologic agent of Kaposi’s sarcoma, the
most common AIDS-associated malignancy worldwide.

“The establishment of this mouse model for KSHV infection provides a
valuable tool that will enable us to achieve a better understanding of
longitudinal patterns of viral gene expression, cell tropism and immune
responses,” said Dr. Kedes, a member of the University’s Myles H. Thaler
Center for AIDS and Retrovirus Research. “We believe that this new
information will help in furthering our ability to understand how this
virus causes tumors and, in the future, to design better ways of preventing
or treating them.” The lead author of the paper describing the work, Dr.
Christopher Parsons, is also of the University of Virginia Health System.

“We are extremely gratified that the ImageStream system was employed
for this important research,” said David Basiji, Ph.D., Amnis’ President
and CEO. “Since its inception, we have been confident that ImageStream
technology would ultimately have a direct impact on human health. The
ImageStream system allowed Dr. Kedes and his colleagues to identify rare
splenocyte subpopulations containing the virus and quantitate their numbers
and level of infection with high specificity and sensitivity.”

Amnis Corporation, headquartered in Seattle, WA, develops, manufactures
and markets instrumentation for high speed imaging of cells in flow. Its
flagship product, the ImageStream cell analysis system, generates six high
resolution microscopic images of cells as they flow through the instrument
at rates up to 300 cells per second. The system is unique in its ability to
image tens of thousands of cells in minutes without the need to make
slides. The IDEAS(R) image analysis package, an integral part of the
ImageStream system, is a highly sophisticated yet easy to use tool for
processing hundreds of thousands of images at a time. IDEAS enables highly
advanced research applications in hematology, immunology, oncology and
provides a critical foundation for the company’s clinical applications
development.

Amnis Corporation

amnis/ Continue reading →

The New York Times on Monday profiled Allan Rosenfield, the dean of the Mailman School of Public Health at Columbia University, who for more than 40 years has “helped shape health care around the world, especially for women and people with HIV.” Rosenfield is seen “as a hero” within “liberal circles” and the field of public health for his work — which has included promoting condom use, needle-exchange programs for injection drug users and sex education and preventing mother-to-child HIV transmission, according to the Times. “Allan is one of a small number of people we can say has truly improved the world, especially for women,” Thomas Frieden, New York City health commissioner, said. According to Rosenfield, the “great tragedy” that has persisted in public health since he started in the field is that “in the developing world, girls and women don’t have the power to say no.” Rosenfield is living with amyotrophic lateral sclerosis and myasthenia gravis and has submitted his resignation as dean. He plans to stay in the position until a replacement is found and continue teaching and working towards making antiretroviral drugs to treat HIV/AIDS available in developing countries, the Times reports (Perez-Pena, New York Times, 6/12).

A webcast of a tribute to Rosenfield — which includes remarks from former President Bill Clinton, actor Richard Gere and U.N. Secretary-General Kofi Annan — is available online at kaisernetwork.

“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 →

The Lancet in its May 12 issue published several opinion pieces responding to studies conducted in Kenya and Uganda and published in the Feb. 23 issue of the journal that found routine male circumcision could reduce a man’s risk of HIV infection through heterosexual sex by 65% (Kaiser Daily HIV/AIDS Report, 2/23). Summaries of the opinion pieces appear below.

Robert Bailey et al., Lancet: “Whatever the mechanisms leading to [HIV] infection, there is no longer any doubt” that circumcision decreases HIV risk, Bailey of the Division of Epidemiology and Biostatistics at the University of Illinois-Chicago and colleagues write in an opinion piece. The authors add that although a meta-analysis of the three trials “would be welcome,” the studies’ findings “are so consistent that such an analysis is likely only to strengthen the conclusions.” In addition, the authors say that “[a]necdotes and speculation should not trump the consistent evidence” from the trials and 40 other observational studies (Bailey et al., Lancet, 5/12).

Devon Brewer et al., Lancet: The “epidemiological mechanism” for reduced HIV incidence among the studies’ participants “remains unclear,” Brewer of Interdisciplinary Scientific Research and colleagues write. According to the authors, additional studies that “involve comprehensive assessment of transmission modes” are needed to “determine the mechanism” that leads to reduced HIV incidence and to “understand whether interventions aside from circumcision would more directly, effectively and inexpensively activate this mechanism” (Brewer et al., Lancet, 5/12).

George Denniston and George Hill, Lancet: The studies have been “marred by poor science,” and the basis for circumcision “has been overturned,” Denniston and Hill from Doctors Opposing Circumcision write in an opinion piece. They write that “[g]iven the contradictory evidence, whether male circumcision will worsen or improve HIV infection is uncertain,” adding that additional studies are needed before circumcision programs are implemented (Denniston/Hill, Lancet, 5/12).

Seth Kalichman et al., Lancet: Although the studies’ results are “clearly important for HIV prevention, the benefits of male circumcision could be negated by behavior that increases HIV risk, especially by a drop in condom use or a rise in sexual partners,” Kalichman, a professor of psychology at the University of Connecticut, and colleagues write. The authors add that an “accurate assessment of the population impact of male circumcision needs to consider both the risk-reducing and potentially risk-enhancing effects of this procedure” (Kalichman et al., Lancet, 5/12).

Nigel O’Farrell et al., Lancet: “[U]ndertaking mass male circumcision in selected populations in Africa will be a huge task,” O’Farrell of the Ealing Hospital in London and colleagues write. The authors add that until a circumcision program is “successfully rolled out,” uncircumcised men should be “advised to achieve good standards of penile hygiene” because other studies “have shown that penile wetness is associated with HIV in uncircumcised men” (O’Farrell et al., Lancet, 5/12).

“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 →

The percentage of U.S. employees eligible for employer-sponsored health insurance who decided to enroll decreased from 85.3% in 1998 to 80.3% in 2003, according to a report released on Thursday by the Robert Wood Johnson Foundation, the AP/Houston Chronicle reports. For the report, researchers at the University of Minnesota examined employer surveys conducted annually by the federal government (AP/Houston Chronicle, 5/4). According to the report, the annual cost of health insurance premiums for an individual employee increased from an average of about $2,454 in 1998 dollars adjusted for inflation to about $3,481 in 2003, and employers paid about 82% of the cost in both 1998 and 2005. Three million fewer employees enrolled in optional employer-sponsored health insurance in 2003 than in 1998, in part because of the 42% increase in the cost of premiums, the report finds (Reuters/Los Angeles Times, 5/5). RWJF CEO Risa Lavizzo-Mourey said, “With premium rising each year for companies and their employees, millions of workers are no longer accepting the health insurance offered through their jobs. If trends continue, this could dramatically increase the number of working but uninsured people in this nation” (RWJF release, 5/4). Lavizzo-Mourey added, “This report should be as alarming to Congress as it is to the American people because employer-sponsored health insurance is the backbone of America’s health care system” (Reuters/Los Angeles Times, 5/5).

The report is available online. Note: You must have Adobe Acrobat Reader to view the report.

Related Broadcast Coverage
PBS’ “NOW” on Friday as part of “Cover the Uninsured Week” is scheduled to include a segment examining the approximately 45 million U.S. residents without health insurance, U.S. residents who purchase inexpensive policies that provide inadequate coverage, and a bill (SB 1955) sponsored by Sen. Mike Enzi (R-Wyo.) that would allow small businesses and trade associations to partner to offer group health plans on a statewide or nationwide basis. The segment also will profile a U.S. resident who purchased a policy from Mega Life & Health Insurance that did not provide benefits as advertised. The program’s Web site includes a photo essay, additional information about the legislation, consumer advice on selecting an insurance plan, links to related resources and a commentary by NOW new media senior producer Joel Schwartzberg (“NOW,” PBS, 5/5). A transcript of the program will be available online after the broadcast. Video of the program will be available online in RealPlayer after the broadcast.

“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 →

United Nations Secretary-General Ban Ki-moon on Monday at a meeting of the U.N. General Assembly to review the body’s response to the HIV/AIDS pandemic said he believes it is possible to halt and reverse the spread of the disease by 2015, despite the increasing number of cases worldwide, the AP/International Herald Tribune reports. U.N. member countries last year renewed pledges and set new targets to provide universal access to HIV prevention, treatment and care services by 2010. In addition, one of the U.N. Millennium Development Goals calls for stopping and reversing the spread of HIV by 2015.

Ban at the meeting said that ensuring access to treatment, prevention, care and support services is “critical” to reverse the spread of HIV/AIDS. Ban added that fighting the disease worldwide will remain a U.N. priority and that he will work to ensure funding for prevention and treatment services. Ban also said providing treatment for diseases associated with HIV, such as tuberculosis, and researching vaccines and microbicides are necessary to reduce the spread of the virus. Ban added that meeting U.N. targets “means mustering the political will to address the factors that drive the epidemic — including gender inequality, stigma and discrimination” (Hindy, AP/International Herald Tribune, 5/21).

According to a report submitted by Ban to the general assembly on Monday, progress has been made in moving toward universal access to antiretroviral drugs and in expanding care and prevention services. The report noted that despite progress, the number of HIV-positive people has increased in every region of the world since 2005, Xinhuanet reports (Xinhuanet, 5/21). About two million HIV-positive people worldwide, or 28% of the 7.1 million people in need, had access to antiretrovirals in 2006, up from 700,000 in 2005, according to the report. According to U.N. estimates, $18 billion will be needed in 2007 and $22 billion will be needed in 2008 to meet the U.N. goal of providing universal access to prevention and treatment services in low- and middle-income countries.

U.N. General Assembly President Sheikha Haya Rashed Al Khalifa at the meeting said that an increasing number of women are affected by HIV/AIDS worldwide, adding that the disease has a destructive impact on their lives. “Many women would rather not get the treatment they need to save their lives or stop their children from contracting HIV/AIDS because they do not want, or do not know how, to cope with the fear and stigma of HIV/AIDS,” she said.

Ban on Monday also appointed Elizabeth Mataka, executive director of the Zambia National AIDS Network, as special envoy for HIV/AIDS in Africa, the AP/Herald Tribune reports. Ban also renewed appointments for Nafis Sadik as envoy for Asia, Lars Kallings as envoy for Eastern Europe and Central Asia, and George Alleyne as envoy for Latin America and the Caribbean (AP/International Herald Tribune, 5/21).

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Michel Kazatchkine, France’s former global ambassador for HIV/AIDS and communicable diseases, on Monday will take over as the new executive director of the Global Fund To Fight AIDS, Tuberculosis and Malaria, the Boston Globe reports (Donnelly, Boston Globe, 4/22). The Global Fund in February announced that the organization’s board had selected Kazatchkine to replace former Executive Director Richard Feachem, whose contract ended in March (Kaiser Daily HIV/AIDS Report, 2/9). As the Global Fund executive director, Kazatchkine will lead a financing organization that has committed $7.1 billion over five years, including $1.9 billion from the U.S., to 136 countries. Kazatchkine said his early goals including quadrupling donations to the Global Fund to $8 million annually by 2010; developing stronger ties with other organizations working against HIV/AIDS, TB and malaria; and committing to “full accountability and transparency” of Global Fund operations. According to the Globe, the Global Fund is “trying to address the difficult question of how to sustain the work for decades to come.” Kazatchkine said that the Global Fund still is “in an emergency response” to the three diseases and that the organization needs to “start building (each) country’s ownership” of Global Fund programs. Anthony Fauci, director of NIH’s National Institute of Allergy and Infectious Diseases, said that Kazatchkine also should work to better define the Global Fund’s mission (Boston Globe, 4/22).

“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 →