Federal Health Plan, Medicare Do Not Cover Routine HIV Screening As Recommended By CDC, Bloomberg Reports

Medicare and federal health care plans that provide coverage under the Federal Employees Health Benefit Plan do not offer payment for routine HIV screening of people ages 13 to 64 — a practice that was recommended by CDC in 2006 — Bloomberg reports. According to Bloomberg, FEHBP provides coverage for 8.5 million employees, and Medicare provides coverage for 7.1 million disabled people under age 65. CDC revised its recommendations because risk-based HIV screening often was not covered by insurance, and doctors often did not know which of their patients were considered high risk. In addition, more people outside high-risk groups — including women, minority groups and people living outside cities — were contracting the virus.

FEHBP, which costs $35 billion annually, pays 230 regional health plans nationwide to provide care for federal workers, including those employed by CDC, elected officials and their family members. FEHBP does not follow the CDC HIV screening guidelines but instead adheres to an alternative protocol adopted by the U.S. Preventive Services Task Force, which only covers high-risk individuals. In order to support screening recommendations, the task force requires that studies already have demonstrated the testing provides benefits, Ned Calonge, chair of the task force’s advisory panel, said. He added that although the CDC guidelines aim to identify more undiagnosed HIV cases, the agency has not proved yet that the guidelines will be successful. “I don’t think they have evidence that a universal testing strategy is going to lead to lower infection rates and less HIV,” Calonge said, adding, “There are some indications to be optimistic, but optimism and promise aren’t proof.”

Bernard Branson of CDC said that meeting the task force’s requirements could take years. CDC recommended universal testing for pregnant women in 1995, and the task force did not adopt the guidelines for 10 years, Branson said, adding that during those 10 years, studies showed the routine screening prevented thousands of cases of mother-to-child HIV transmission. In addition, another reason to support the CDC testing recommendations is that agency research has found as many as 70% of new HIV cases are transmitted by people who are unaware of their status, Branson said.

Medicare also does not cover routine HIV screening, according to a spokesperson. Although most Medicare beneficiaries are older than age 65 — the cut-off age under the CDC testing recommendations — about seven million younger disabled beneficiaries should be screened under the recommendations, Bloomberg reports.

Cornelius Baker, a policy adviser at the National Black Gay Men’s Advocacy Coalition, said that risk-based testing particularly endangers blacks in the U.S., about 2% of whom are living with HIV. Many physicians do not ask patients about their sexual behavior and make assumptions about who is at risk of HIV, Baker said, adding that blacks who do not consider themselves at risk will not be tested unless offered routine screening. “Some doctors are still making irrational decisions about HIV testing, deciding whether to screen someone based on what he or she looks like,’ Baker said, adding, “I can’t imagine any African-American not being screened for sickle-cell disease; why not for HIV, which is higher in prevalence?’

According to Branson, not following the CDC guidelines allows HIV to spread and prevents HIV-positive people from early diagnosis and treatment. “It’s a real paradox when one big federal agency makes a recommendation that another big federal agency won’t support,’ John Bartlett, a Johns Hopkins University physician, said. He added, “I think they’ve got to catch up. It’s a disease that’s lethal, and one of the major problems with HIV today is late entry into care.”

Some private insurers — including UnitedHealth Group, Aetna and Cigna — began covering routine HIV screening soon after the CDC guidelines were released, according to Bloomberg (Lauerman/Goldstein, Bloomberg, 7/31).

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.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved. Continue reading

Legislation Needed To Boost HIV/AIDS Efforts In Solomon Islands, Health Official Says

Isaac Muliloa — national coordinator of the HIV and sexually transmitted infections unit at the Solomon Islands’ Ministry of Health — recently said that a lack of national HIV/AIDS laws is hindering efforts to address the disease, the Solomon Times reports. Recent World Health Organization estimates said that the number of HIV cases in the Solomon Islands could reach 350 by 2010.

Muliloa said that legislation is needed to address continued discrimination against HIV-positive employees in the workplace. He added that the HIV/AIDS and STI unit is relatively new in the health ministry, as is the Solomon Islands’ National AIDS Council. According to Muliloa, officials are continuing to work toward implementing policies. The Times reports that the Solomon Islands does not have laws in place criminalizing the intentional transmission of HIV (Solomon Times, 5/27).

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

Children Often Neglected In HIV/AIDS Testing, Treatment, Rwandan Official Says

Children should be placed at the center of HIV/AIDS prevention efforts, Agnes Binagwaho, executive secretary of Rwanda’s National AIDS Control Commission, said recently, the New Times/AllAfrica reports. According to the Times/AllAfrica, neglecting the impact of HIV/AIDS on children “undermines hard-won gains” in child survival in some countries most affected by the disease.

UNAIDS estimates indicate that about 2.3 million children under age 15 were HIV-positive in 2007 and that nearly 90% of children with HIV, who mainly contracted the virus through mother-to-child transmission, live in sub-Saharan Africa. “If we don’t focus on children, we are going to lose the battle against HIV/AIDS because these children will be the driving force of the epidemic in the next generation,” Binagwaho said, adding, “Let’s put children at the center of our intervention programs; otherwise, they won’t forgive us.”

Binagwaho said that the Rwandan government, with assistance from the International Center for AIDS Care and Treatment Programs, has begun to address the issue through a decentralized pediatric HIV care and treatment program that was established in 2004. The program provides treatment to 500 HIV-positive children. However, Binagwaho said that in addition to HIV/AIDS-related stigma, inadequate pediatric HIV testing, treatment and counseling facilities are still impeding efforts to identify and provide treatment for HIV-positive children in Rwanda. She said efforts are ongoing to integrate HIV/AIDS programs in the country’s Economic Development and Poverty Reduction Strategy (Namata, New Times/AllAfrica, 6/11).

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.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved. Continue reading

454 Sequencing Identifies Early Stage HIV Drug Resistance– Low-level Mutations May Have Significant Impact On Clinical Outcomes

A research study published online this week in the Journal of Infectious Disease reports that HIV resistance mutations present in as little as 1% of the viral population have a significant impact on clinical outcomes. The paper outlines the results of a collaborative study between 454 Life Sciences, a Roche company, and a Yale School of Medicine researcher that used 454 Sequencing Systems to identify previously undetectable drug resistant HIV variants in research samples from an earlier performed clinical trial, called the FIRST Study (1).

The research study, lead by Michael Kozal, M.D. of the Yale University School of Medicine and the VA CT Health Care System, was a blinded-retrospectives analysis of 264 blood samples taken from HIV infected individuals before initiating drug treatment for research purposes. The FIRST Study samples were analyzed using Ultra-Deep Sequencing with the Genome Sequencer FLX System, a platform ideally suited for the sensitive detection of low-frequency mutations. Surprisingly, results showed that the fraction of patients harboring resistance variants was twice as high as previously thought. The second question answered by the study was whether or not the low-level mutations undetected with current methods may affect patient outcome. Remarkably, drug resistance levels as low as 1% were found which could lead to early antiretroviral treatment failure with statistical significance.

“Current technology available to clinicians is limited to detecting resistance mutations that are present at levels of approximately 20% or greater in the circulating viral population in a patient. Thus, the current test used in the clinic may miss many low-level resistant HIV strains which can grow rapidly under drug selection pressure and lead to therapy failure. “This retrospective research study shows that even resistance mutations present at the 1% level can lead to premature failure of therapy,” explained Michael Kozal, M.D., the senior author of the study. “In the future, hopefully clinicians may use this knowledge to choose better antiretroviral drug combinations that have the ability to suppress these resistant HIV strains which will lead to better clinical responses in patients.”

While HIV survival trends have increased tremendously over the past decade, a significant number of patients develop drug resistance shortly after treatment is initiated. This is particularly true in developed nations where antiretroviral drugs have been widely accessible for years, and is an increasing concern as more treatments reach developing nations with high prevalence of HIV infected populations. The availability of long-term clinical data from the FIRST Study, which lasted five years, enabled correlation of the sequence data with patient outcomes.

“We developed the Ultra Deep Sequencing method exactly to answer this type of question and are very pleased with the power demonstrated in this research study,” explained co-lead author Michael Egholm, Ph.D., Chief Technology Officer at 454 Life Sciences. “HIV drug-resistance is just one example of a real world problem that we may tackle with this powerful technology in future.”

454 Life Sciences, a center of excellence of Roche Applied Science, develops and commercializes the innovative 454 SequencingSsystem for ultra-high-throughput DNA sequencing. Specific applications include de novo sequencing and re-sequencing of genomes, metagenomics, RNA analysis, and targeted sequencing of DNA regions of interest. The hallmarks of the 454 Sequencing System are its simple, unbiased sample preparation and long, highly accurate sequence reads, including paired-end reads. The technology of the 454 Sequencing System has enabled hundreds of peer-reviewed studies in diverse research fields, such as cancer and infectious disease research, drug discovery, marine biology, anthropology, paleontology and many more.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world’s biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2008 sales by the Pharmaceuticals Division totalled 36.0 billion Swiss francs, and the Diagnostics Division posted sales of 9.7 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested nearly 9 billion Swiss francs in R&D in 2008. Worldwide, the Group employs about 80,000 people. Additional information is available on the Internet at roche.

The 454 GS FLX is sold for life science research use only.

454, 454 SEQUENCING, 454 LIFE SCIENCES and GS FLX TITANIUM are trademarks of Roche.

(1) Simen et al. Low-Abundance drug-resistant variants in chronically HIV-infected antiretroviral naive patients significantly impact treatment out comes. (2009) Journal of Infectious Disease. ePub online February 11.

Roche Continue reading

Lack Of Funding Undercuts Opportunities To Overcome Global Health Threats

World leaders assessing progress of the United Nations Millennium Development Goals (MDGs) in New York this week could transform the fight against two of the leading causes of childhood deaths-malnutrition and HIV/AIDS-by implementing an innovative funding mechanism for global health, the international medical humanitarian organization Doctors Without Borders/M?©decins Sans Fronti??res (MSF) said today.

The World Health Organization reports that an additional $37 billion needs to be spent on global health every year by 2015 in order to meet the health-related MDGs. The intergovernmental Leading Group recently estimated that a financial transaction tax-a levy as little as 0.005 percent on transactions of the world’s four most traded currencies-could generate an estimated $33 billion a year to implement the latest medical advances against global health threats, including malnutrition and HIV/AIDS.

“For many diseases, we know what we need to do to save lives,” said Sophie Delaunay, executive director of MSF in the U.S. “Our field teams are using new tools and approaches to release children from the deadly grip of malnutrition and to ensure children are born free of HIV, but there is not enough funding for long-term, widespread implementation of effective health interventions. A financial levy for health, by providing a dedicated and predictable funding stream, could mean that patients’ lives are no longer at the mercy of volatile markets and political agendas.”

The political response to recent global financial volatility has had a catastrophic effect on the reliability of funding and foreign aid commitments for global health issues. This has left considerable gaps in the financing of key institutions such as the Global Fund to Fight AIDS, TB, and Malaria, as some donor governments such as the United States, Germany, Italy and Spain, renege on previous commitments or stagnate or decrease their funding.

In Malawi, the government has submitted a Global Fund application for funding to provide lifelong antiretroviral treatment to all pregnant HIV positive women. This would dramatically reduce the transmission of HIV from pregnant women to their children. But given the Global Fund’s constrained budget and the pessimistic predictions around future contributions from donor nations, there is a risk that Malawi will not receive this grant and will not be able to fully implement a program that could greatly reduce the number of children born with HIV. Some countries have already been forced to implement 10 percent “efficiency cuts” to funds approved in the last round of grants

“It is no longer enough to reiterate a commitment to access to care and treatment – to maternal and child health, to the global AIDS fight, “said Delaunay. “Unless alternative funding models are put in place to guarantee long-term and sufficient funding, countries will continue to be limited and these stated commitments will be nothing but rhetoric.”

The lack of sustainable global health funding also undercuts the potential to expand the implementation of highly effective programs to prevent childhood malnutrition, a condition that contributes to the deaths of between 3.5 and 5 million children under five years of age every year. MSF has demonstrated how new treatment tools and approaches make it possible to not only cure, but also to prevent malnutrition for hundreds of thousands of children in the world’s malnutrition “hotspots.” For example, working alongside local organizations in Niger, MSF has treated 77,000 severely malnourished children so far this year. Since July, MSF has also been distributing food supplements to more than 143,000 young children to prevent them from becoming malnourished.

Efforts to combat malnutrition at an earlier stage, such as the ongoing Niger intervention, are crucial in dealing with the recurrent nutritional crises affecting many countries in Africa’s Sahel region. These efforts can only be sustained through long-term financial commitments from main international donors.

According to a World Bank evaluation, it costs $12.5 billion annually to adequately fund recognized effective nutrition interventions in the most-affected countries. An MSF analysis estimates that only a small fraction of this is actually spent annually – just $350 million in 2007.

A financial transaction tax for health could transform some of the world’s malnutrition “hotspots” and put governments much closer to adequately treating and preventing a main cause of childhood deaths worldwide.

One such funding mechanism for health already exists in the form of UNITAID, the international agency that finances HIV/AIDS treatment programs through miniscule taxes on airfares. The International Monetary Fund recently deemed financial transaction taxes feasible, and just this month a group of countries, including Brazil, Britain, Chile, Ethiopia, France, India, Japan, and South Africa, announced that at the MDG Summit they will propose a tax on international currency transactions to raise funds for development aid.

Source:

Doctors Without Borders / M?©decins Sans Fronti??res Continue reading

Proper Hand Hygiene Is Key To Avoiding Illness During Cold And Flu Season

Every three
minutes, a child puts a hand in his/her nose or mouth. Considering that
some viruses and bacteria can live two hours or longer on surfaces like
cafeteria tables, doorknobs, and desks that children touch throughout the
day, it is easy to see how clean hands are critical to avoiding sickness.

According to the Centers for Disease Control and Prevention (CDC),
keeping hands clean is one of the most important steps in avoiding getting
sick and spreading germs to others. With the common cold accounting for
nearly 22 million school days lost annually, according to the CDC, this is
a critical time for parents to teach–or remind–the whole family of proper
hand hygiene.

“There are plenty of unwashed hands out there. Only one in five of us
does the job properly,” says Dr. Charles Gerba, Professor of Environmental
Microbiology at the University of Arizona. “Everyone needs to be sure they
understand how to wash properly and how and when to use alcohol-based
instant hand sanitizers such as PURELL(R).”

Effective hand hygiene practices include washing hands frequently with
soap and water and, when soap and water are not available, using an
alcohol-based instant hand sanitizer containing at least 60 percent
alcohol. PURELL(R) Instant Hand Sanitizer kills 99.99% of the most common
germs that may cause illness.

Everyone, no matter what age, can benefit from a hand hygiene refresher
during cold and flu season. It comes down to three basic steps:

1. Tell your children why clean hands are so important. Proper hand
hygiene is critical to avoid getting sick and spreading germs to others.

2. Show your children how to wash hands properly, according to CDC
instructions:

— Wet your hands with clean, warm water and apply soap.

— Rub hands together to create lather and scrub all surfaces
(including between fingers and under nails).

— Continue rubbing hands for 20 seconds (about the time it takes to
sing Happy Birthday).

— Rinse hands under running water.

— Always dry hands thoroughly.

3. Help your children keep clean anywhere they are. When soap and water
are not available, alcohol-based instant hand sanitizers such as PURELL(R)
effectively kill 99.99% of germs that may cause illness. There is no
evidence that germs become resistant to alcohol — the main ingredient in
PURELL(R) — or to other antibiotics as a result of using alcohol-based
instant hand sanitizers. Show children how to use hand sanitizers properly:

– Apply alcohol-based hand sanitizer to the palm of one hand.

– Rub hands together — so that product covers all surfaces of hands
and fingers — until hands are dry.

Then: remind, remind, remind. Encourage your children to wash their
hands frequently throughout the day, particularly before eating, and after
using the bathroom and playing outside. Check with your school to see if
you can send your older children in with a travel-size container of
PURELL(R) to carry in their backpack, for quick and easy hand cleansing
when soap and water are not readily available.

PURELL(R) Instant Hand Sanitizer consumer products are marketed by
Johnson & Johnson Consumer Companies, Inc.

The CDC is not affiliated with Johnson & Johnson, Johnson & Johnson
Consumer Companies, Inc., any of its affiliated companies, or the PURELL(R)
brand.

Johnson & Johnson Consumer Companies, Inc.
jnj/home.htm Continue reading

President Bush Signs PEPFAR Reauthorization Bill

President Bush on Wednesday signed into law legislation (HR 5501) that reauthorizes the President’s Emergency Plan for AIDS Relief through 2013, the Washington Post reports (Eggen, Washington Post, 7/31).

The House last week approved the measure 303-115. The legislation allocates a total of $50 billion — $48 billion of which goes to PEPFAR and $2 billion of which goes to American Indian issues. The bill also includes an amendment intended to increase oversight of the Global Fund To Fight AIDS, Tuberculosis and Malaria and encourage cost-sharing and transition strategies as part of agreements with countries that receive PEPFAR aid. The bill does not mention family planning programs.

The measure also includes a provision that more than half of the program’s aid go toward HIV/AIDS treatment and care. In addition, it overturns an existing law that requires one-third of prevention funds be spent on abstinence and fidelity programs, instead requiring a report to Congress if countries do not spend half of prevention money on such programs. The bill also directs 10% of funding to programs for orphans and vulnerable children, as well as allocates $2 billion for the Global Fund in fiscal year 2009. The legislation contains an existing requirement that organizations receiving PEPFAR aid have a policy that opposes commercial sex work. The bill creates links between HIV/AIDS and nutrition programs and sets a target of recruiting 140,000 health care workers. In addition, the measure allocates $5 billion for malaria programs and $4 billion for TB initiatives (Kaiser Daily HIV/AIDS Report, 7/28).

Although the bill also includes a provision that eases U.S. HIV/AIDS travel restrictions, it is “unclear” whether HHS plans to address the restrictions in the near future, the Los Angeles Times reports. HHS in 1987 placed HIV on a list of diseases barring entry into the U.S., according to the Times. Although that prohibition is separate from the congressionally imposed travel restrictions eased in the PEPFAR bill, federal health officials are “no longer bound by law to keep HIV on the list,” the Times reports.

An HHS spokesperson did not return a call for comment on Wednesday. CDC — which is under the jurisdiction of HHS and would make recommendations about the travel restrictions — also could not be reached for comment, the Times reports. However, advocates of repealing the ban are “hopeful,” according to the Times (Patel, Los Angeles Times, 7/31).

Bush, White House Comments
Bush at the signing ceremony said, “Defeating HIV/AIDS once and for all will require an unprecedented investment over generations. But it is an investment that yields the best possible return — saved lives.” He added that “HIV/AIDS is still one of the world’s greatest humanitarian challenges, no question about it. But it is a challenge we’re meeting” (Dunham, Reuters, 7/30). Bush noted that the goal for the new funding level is to prevent 12 million new HIV cases, provide more than two million people with antiretroviral drugs, support care for 12 million people and train at least 140,000 new health care workers (Euphrat, AP/Google, 7/30). “We are a compassionate nation,” Bush said, adding, “And that’s what this bill says loud and clear” (Washington Post, 7/31).

The White House in a statement said PEPFAR is “the largest commitment by any nation to combat a single disease in human history.” When Bush “launched [PEPFAR] in 2003, about 50,000 people in all of sub-Saharan Africa were receiving antiretroviral treatment,” the White House said, adding, “Today, PEPFAR supports lifesaving antiretroviral treatment for nearly 1.7 million people in the region and tens of thousands more around the world, from Asia to Eastern Europe” (AFP/Google, 7/30).

Other Reaction
Rep. Howard Berman (D-Calif.), who sponsored the bill, said its passage is a “tribute to what we can achieve in foreign policy when the cause is right and all parties work together in goodwill” (Washington Post, 7/31). House Speaker Nancy Pelosi (D-Calif.) praised the bill for taking the global fight against AIDS, TB and malaria “from the emergency phase to the sustainability phase.” The new legislation “is our compact with developing nations across the globe,” Pelosi said in a statement, adding, “It says that America stands with them in this fight, that our commitment will not waver and shows them America’s true face of compassion.” Eric Friedman, senior global health policy adviser for Physicians for Human Rights, said the legislation is “the boldest act of any wealthy nation in ameliorating Africa’s disastrous health worker shortage.” He also praised the bill for lifting the HIV/AIDS-related travel restrictions but criticized the legislation for not linking HIV services with family planning. “That allows HIV to go unprevented and undetected for years, until a whole family is infected,” he said (AFP/Google, 7/30).

UNAIDS Executive Director Peter Piot said, “The generosity of the U.S. government has helped to truly transform the global response to AIDS and the course of the epidemic” (Reuters, 7/30). Bill and Melinda Gates, co-chairs of the Bill & Melinda Gates Foundation, in a statement said, “We congratulate President Bush and leaders in Congress for their achievement in getting PEPFAR reauthorized at an unprecedented level.” They added, “This bill renews and strengthens America’s commitment to the global fight against AIDS, TB and malaria.” They noted that they are “encouraged by the act’s strong emphasis on preventing new HIV infections,” as well as lifting the travel restrictions (Gates Foundation release, 7/30).

Michael Weinstein, president of the AIDS Healthcare Foundation, also praised Bush for signing the reauthorization bill. “Passage of this historic legislation is a crucial turning point in the battle to control AIDS around the world,” Weinstein said. He added, “We take our hats off to everyone who helped ensure that this lifesaving global AIDS bill became a reality” (AHF release, 7/30). Pamela Barnes, president and CEO of the Elizabeth Glaser Pediatric AIDS Foundation, said the signing of the bill into law “is a beacon of hope to millions around the world living with HIV/AIDS. It is an unmistakable signal of the United States’ continued commitment to preventing new HIV infections in the countries most affected by the pandemic.” She added that one of the “most significant challenges for the next five years is to scale up the delivery of [the prevention of mother-to-child HIV transmission] services, and to ensure that all infected children receive urgently needed antiretroviral treatment,” adding, “We are committed to achieving the target in the PEPFAR legislation of reaching 80% of these women in the next five years” (Elizabeth Glaser Pediatric AIDS Foundation release, 7/30).

Serra Sippel, executive director of the Center for Health and Gender Equity, welcomed passage of the legislation; however, she said the group will “continue to be disappointed that despite the findings and recommendations issued by U.S. government agencies, a Democratic-led Congress is continuing to impose arbitrary funding directives to encourage abstinence-only programs over effective, comprehensive prevention interventions.” She added, “With the amount of work that so many prevention advocates put into the reauthorization process, it is disheartening to see global AIDS prevention policy continue to emphasize ideology in the guise of political expediency” (CHANGE release, 7/30).

Wall Street Journal Examines Role of Generic Drugs in PEPFAR
In related news, the Wall Street Journal on Thursday examined how generic drugmakers, many of which are based in India, now “dominate” PEPFAR. Generics accounted for 57% of the $131 million the U.S. spent on PEPFAR in FY 2007, according to the Office of the U.S. Global AIDS Coordinator. Generics in 2005 accounted for 11% of PEPFAR’s funding. In 2005, the U.S. had approved few generic drugs for PEPFAR, so “most of the money went to buy brand-name drugs that are often more expensive,” according to the Journal. Some of the largest generic contributors to PEPFAR include Aurobindo Pharma, Ranbaxy Laboratories, Cipla and Aspen Pharmacare. PEPFAR’s “shift to generics” during the past two years follows a Bush administration “decision to set up a special approval” at FDA for the medicines, which cannot be marketed in the U.S. because of patent and exclusivity regulations, the Journal reports. “It’s pretty clear that the system is working well, and it protects African families just like American families are protected,” Ambassador Mark Dybul, the U.S. global AIDS coordinator who administers PEPFAR, said. He added, “We pretty methodically did what we said we were going to do.” Ranbaxy spokesperson Chuck Caprariello said that the “key is having affordable and accessible medicines, and I think the generic industry has made a contribution in a very positive way to PEPFAR.”

PEPFAR’s spending on brand-name drugs totaled about $56 million in FY 2007, a decrease from the $106 million spent in 2005. Some of the largest contributors of brand-name drugs to PEFPAR are Merck, GlaxoSmithKline and Abbott Laboratories, according to the Journal (Lueck, Wall Street Journal, 7/31).

The Christian Science Monitor on Thursday examined how PEPFAR is impacting other issues, such as food security, in Ethiopia. The Lancet also recently examined issues in the PEPFAR reauthorization bill.

A newly-released side-by-side from the Kaiser Family Foundation compares the original PEPFAR legislation created in 2003 with the five-year reauthorization just signed into law by Bush. The report is available online.

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.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved. Continue reading

eFoodSafety Formulates All-Natural Antibiotic “Proxorin(TM)”

eFoodSafety, Inc. (OTCBB: EFSF, efoodsafety), through its wholly-owned subsidiary Knock-Out Technologies Ltd., has developed and will begin clinical testing of Proxorin™, based on the company’s CitroxinTM formula, for use as a natural antibiotic/anti-microbial for treatment against a broad spectrum of common bacterial pathogens. Unlike many antibiotics, which often have a limited range of applications, Proxorin’s natural composition allows it to be used in a range of conditions where anti-microbials are needed.

As an antibiotic, Proxorin can offer several advantages over common drug-based antibiotics. Its ability to confer its benefits against both gram-negative and gram-positive bacteria enables it to be used to treat a broad spectrum of bacterial pathogens. Proxorin also produces far fewer side effects than other common antibiotic pharmaceuticals, thereby reducing the likelihood of rebound infections. In addition, Proxorin can provide benefits to those patients who experience allergic reactions to a spectrum of “cillin” drugs. Finally, an enormous problem for the normal armament of antibiotics is the potential for “bugs” to develop resistance to the beneficent effects of a given antibiotic-a scenario that is highly unlikely to occur with Proxorin.

Initial microbial inhibition tests prove Proxorin extremely effective in eradicating MRSA, the methicillin resistant form of Staphylococcus aurous, and other studies of the formula show a 100% kill rate for common bacteria including: Continue reading

All U.S. States To Begin Names-Based Reporting Of HIV Cases By End Of 2007

All U.S. states and Washington, D.C., by the end of 2007 will begin recording HIV cases using names-based reporting systems rather than code-based reporting systems, the AP/Springfield State Journal Register reports. Beginning this fiscal year, the funding formulas used by HHS to calculate Ryan White Program grants include only HIV data from states that use names-based reporting systems, the AP/Journal Register reports. Vermont, Maryland and Hawaii are the only states not currently using a names-based reporting system to track HIV cases. CDC in 1999 endorsed names-based reporting and in 2005 recommended that states use names-based reporting systems. Timothy Mastro, deputy director of CDC’s Division for HIV/AIDS Prevention, said, “After many evaluations of code-based systems, it became clear that those systems do not meet CDC standards for HIV data.” He added that syphilis, tuberculosis and AIDS cases are tracked by names-based systems.

Advocates’ Concerns
Many HIV/AIDS advocates are concerned that the transition to a names-based system will discourage some people from seeking HIV tests or treatment, the AP/Journal Register reports. “I’ve not so much changed my opinion as surrendered,” Ron Johnson — deputy executive director of Aids Action in Washington, D.C — said, adding, “I still believe code-based reporting is valid and is preferable for HIV reporting. It, for all practical purposes, has become a losing battle.” Some advocates also are concerned that security breaches could lead to the names of HIV-positive people being released. A 2005 security breach in Palm Beach County, Fla., involved the names of 6,500 HIV-positive people being erroneously e-mailed to 800 county health workers. Similar security breaches have occurred in California and Kentucky, the AP/ Journal Register reports. In addition, some advocates are worried that a names-based system would reduce the number of minorities and low-income people who receive HIV tests because they might be less likely to trust that the government would keep their names confidential. Catherine Hanssens of the New York City-based Center for HIV Law and Policy said that names-based reporting “can affect if (disadvantaged) people come back for care” and “how they describe to other people their experience of getting tested.” According to the AP/Journal Register, some physicians are telling HIV-positive people to use false names, but health officials say it is impossible to determine how many physicians and patients are not reporting their names. Health officials also say it will be impossible to determine whether any decline in HIV cases can be connected to names-based reporting. New HIV cases in Illinois decreased by 14% from 2005, the last year code-based reporting was used, to 2006, although there had been an 8% decrease in new HIV cases in 2005.

State Efforts To Protect Privacy
William Wong, medical director of the AIDS division of the Chicago Department of Public Health, said the state’s old code-based system, which assigned HIV-positive people a unique identification code, was “instituted to protect the people’s confidentiality because of fears of stigmatization and potential disclosure to insurance companies and family members.” The state in 2006 began using a names-based system. Under the new system, staff members who have access to the database must take an oath of confidentiality and undergo special training. The names also are stored on a stand-alone computer system that is in a locked area, according to the AP/Journal Register. A Vermont bill (SB 192) prohibits the storage or processing of any information that could identify HIV-positive people on network computers or laptops. The bill also allows civil lawsuits for malicious disclosure of such information, according to the AP/Journal Register (Johnson, AP/Springfield State Journal Register, 4/2).

“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

Wild Gorillas Carriers Of A SIV Virus Close To The AIDS Virus

In 2005, 40.3 million people in the world, including 25.8 million in Sub-Saharan Africa, were living with HIV. The question of the origin of HIV-1, responsible for the AIDS pandemic, has been stimulating the scientific community for many years.

Some months ago, the team of Martine Peeters, director of research at IRD, and Eric Delaporte, director of the mixed research unit UMR 145 jointly involving the IRD and the University of Montpellier 1, showed the chimpanzee subspecies living in the Congo Basin (2) to be the reservoir of HIV-1 virus group M, the source of the world pandemic and that of another, very rare variant, HIV-1 group N. However, the reservoir of the third HIV-1 group, group O which infects humans (3), remained unidentified up to now.

This team announces, in an article in the journal Nature, the discovery of a simian immunodeficiency virus (SIV) infection in wild gorillas. Samples of faeces collected from different communities of gorillas found in the remotest areas of the Cameroon tropical forest were found to contain antibodies against this virus, called SIVgor. The genetic characteristics of the virus were present again in three gorillas living more than 400 km apart. Phylogenetic analysis of SIVgor showed it to be related to HIV-1 group O found in humans, essentially in Cameroon and in neighbouring countries.

This discovery of an HIV-1 related virus in wild gorillas does not, however, call into question the fact that chimpanzees are the primary reservoir of SIV/HIV viruses that crop up again in gorillas and in humans. As Martine Peeters of the IRD says, “the viruses of groups M and N are, very clearly, the consequence of inter-species transmission from chimpanzee to humans, whereas the origin of HIV-1 group O is less apparent. It cannot be excluded that chimpanzees infected by HIV-1 group O might have contaminated humans and the gorilla independently, or that the gorilla, having been contaminated by the chimpanzee, might have contaminated humans”.

This work thus opens up a Pandora’s box on the questions and speculations concerning the ability of these viruses to cross over from one species to another. The main challenges facing these teams for future work will be determination of the prevalence, the geographical distribution and biology of SIV infections in these great apes, not forgetting the question of how the gorillas were contaminated. This last point remains a mystery, considered as rare.

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Key-Words:

Africa, AIDS, Contamination, Inter-species.

Footnotes:

1. UMR 145: Fran Van Heuverswijn, Cecile Neel, Florian Liegeois, Christelle Butel, Eric Delaporte and Martine Peeters jointly involving the IRD and the University of Montpellier1 University of Alabama (Beatrice Hahn and her colleagues), University of Nottingham (Paul Sharp and his colleagues) PRESICA Project of Cameroon headed by Eitel Mpoudi-Ngole.

2. Keele BF, Van Heuverswyn F, Li Y, Bailes E, Takehisa J, Santiago ML, Bibollet-Ruche F, Chen Y, Wain LV, Liegeois F, Loul S, Mpoudi Ngole E, Bienvenue Y, Delaporte E, Brookfield JF, Sharp PM, Shaw GM, Peeters M, Hahn BH. Chimpanzee Reservoirs of Pandemic and Nonpandemic HIV-1. Science. 2006 , 313 : 523-6

3. Scientists have known for a long time that the Aids virus shows a very strong genetic variability. Two main types of the virus exist: HIV 1 and HIV 2. HIV 1, the most widely spread in the world, embraces three groups (M, N,O) which manifest different genetic characteristics. Within group M, the most frequent, still 9 further subtypes can be distinguished (A, B, C, D, F, G, H, J, K), genetically close yet distinct.

Reference :

Human immunodeficiency viruses: SIV infection in wild gorillas. Article in Nature, 9 November 2006.
Fran Van Heuverswyn, Yingying Li, Cecile Neel, Elizabeth Bailes, Brandon F. Keele, Weimin Liu, Severin Loul, Christelle Butel, Florian Liegeois, Yanga Bienvenue, Eitel Mpoudi Ngolle, Paul M. Sharp, George M. Shaw, Eric Delaporte, Beatrice H. Hahn, Martine Peeters. This research benefited from the financial support of the ANRS, the IRD and NIH.

Contact: Aude Sonneville

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