Millions more faulty condoms recalled in South Africa

The South African Department of Health has called for the return of millions of condoms distributed as part of the government's HIV prevention efforts, after some were found to be defective.

This new development comes two months after the government recalled 20 million faulty condoms made by a company called Zalatex. An official from the South African Bureau of Standards (SABS) has been accused of accepting bribes to approve the Zalatex condoms, which failed to meet quality standards.

Now it has emerged that five batches of condoms made by Kohrs Medical Supplies have failed an air burst test. This shows the condoms were not as strong as they should have been, though it does not necessarily mean they would have burst during normal use. There is no evidence that bribes were involved in this case.

One million Kohrs condoms are already in quarantine and the government is appealing for the return of all others bearing the batch number 6809/MED. It is thought that up to four million such condoms may be in circulation. So far barely half of the 20 million Zalatex condoms have been recovered.

Experts fear the recalls could undermine public confidence in condoms and jeopardise South Africa's HIV prevention campaigns.

"It's very frustrating. Condoms are one of the few things we are getting right on prevention," said Dr Francois Venter, president of the Southern African HIV Clinicians' Society. "Heads should roll."

The government has cancelled its contracts with Zalatex and Kohrs. This leaves five companies supplying the 425 million condoms distributed each year.

In a statement to the media, South Africa's Minister of Health, Dr. Manto Tshabalala-Msimang, sought to reassure the public.

"The SABS has indicated that extensive controls and verifications have been implemented throughout the testing and certification process to ensure that all condoms supplied under the SABS mark and under the Choice brand, comply with standards set by the World Health Organisation," said the health minister.

"The two incidents involving Zalatex and Kohrs should not be allowed to impact negatively on the significant progress we have made in promoting condom use in the country."

AVERT.org has more about AIDS in South Africa.

AIDS vaccine may have worsened risk of HIV infection

Hundreds of South Africans who received an experimental AIDS vaccine have been warned that it may have increased their risk of HIV infection.

The study, which began in January, was meant to establish whether a product made by the pharmaceutical company Merck could protect people from HIV. It was stopped last month after researchers found no evidence of effectiveness.

Now it has been revealed that the infection rate was higher among people who received the vaccine than among those given a placebo. Nineteen vaccinated volunteers acquired HIV, compared to eleven in the placebo half of the study.

Every trial participant is now being told whether they received the vaccine or the placebo, and is being warned of the possible consequences.

Merck's vaccine candidate was separately trialled in 3,000 volunteers from the USA, Canada, Australia, Peru and the Caribbean. That study, which began in 2004, was halted at the same time as the South African trial. The ethics board has yet to decide whether to inform the participants - mostly gay men - if they received the vaccine or the placebo.

Experts say the vaccine itself could not have caused HIV infection, but it may have increased the risk of transmission by affecting immune responses.

"Given the complexity of the issue, we feel the best conclusions will be reached when all the data are analyzed in their entirety," said Mark Feinberg, vice president for medical affairs and policy for Merck.

More details are likely to emerge when vaccine researchers meet in Seattle early next month.

Not only is this outcome a major disappointment for researchers, but it may also affect people's willingness to take part in similar trials in the future. A trial of an HIV microbicide was stopped in January after it too found more infections in the treated group compared to those who received a placebo.

AVERT.org has more about AIDS vaccines and microbicides.

Mbeki still unconvinced of HIV/AIDS link, says biographer

A new biography of the South African President, Thabo Mbeki, has uncovered ongoing ‘dissident’ beliefs about HIV and AIDS, an article in The Guardian newspaper has revealed.

Mbeki courted much controversy in 1999 by questioning the safety and efficacy of AZT, one of the first antiretroviral drugs. He then caused a similar storm in 2000 by repeatedly casting doubt on the widely held belief that HIV is the cause of AIDS.

Mbeki officially withdrew from the debate on the cause of AIDS in 2000, though arguments continued within the government. In 2002, Pregs Govender, the chair of a parliamentary committee on the status of women resigned over the issue, and several fellow members of the government strongly criticised Mbeki's views. The President has stayed away from the debate in recent years, though the new biography by the respected author Mark Gevisser reveals that he remains unconvinced of the HIV/AIDS connection to this day, and is aggrieved that he was silenced by colleagues who believed his opinions to be damaging for the country. Though Mbeki has never expressly said that HIV does not cause AIDS, his obvious scepticism has had a deep impact on the government’s reaction to the AIDS crisis. His views are also now shared by the country’s health minister, Manto Tshabalala-Msimang.

In the book, Gevisser describes how Mbeki contacted him personally to tell him of a paper he had secretly authored six years previously and distributed anonymously among senior members of the Africa National Congress. The paper, which Mbeki took care to have personally delivered to Gevisser, compared AIDS scientists to Nazi concentration camp doctors and depicted black people who accepted the standard rhetoric on AIDS as victims of a slave mentality. The paper also describes the "HIV/Aids thesis" as entrenched in "centuries-old white racist beliefs and concepts about Africans".

Much of Mbeki’s career was spent fighting against Apartheid during the many years that South Africa was a nation divided by race. As a consequence, says Gevisser, Mbeki holds a deep suspicion of white ‘colonial’ orthodoxies, and believes AIDS to be a prime example of racist attempts to demean and repress black Africans. He also believes that much of the Western world is in league with pharmaceutical companies in their attempts to make money out of AIDS by selling potentially dangerous treatments.

Over two million people have died of AIDS in South Africa since the first cases were reported, and about nineteen percent of adults are thought to be infected with HIV. The government has in recent years made greater efforts to address the epidemic, and began to distribute antiretroviral drugs in 2003, "but that did not mean, in any way, that [Mbeki] had changed his mind," writes Mr Gevisser. "When I asked him in 2007 how he felt about having to withdraw from the Aids debate, he told me it was 'very unfortunate' that his initiative had been 'drowned'."

Mark Gevisser's biography of Thabo Mbeki goes on sale in South Africa from 7th November.

Generic antiretroviral manufacture has saved Brazil US$ 1 billion.

Brazil’s policy on AIDS drugs has saved the country around US$ 1 billion since 2001, a new study in PLOS medicine has found.

In 1996, Brazil became the first developing country to commit to universal access to antiretroviral AIDS drugs for all HIV positive Brazilians that needed them. To achieve this goal, the country significantly expanded its drug manufacturing capabilities, and today produces eight different antiretroviral drugs (ARVs) in ‘generic’ (i.e. copied) forms. For drugs that are still within their patent period and cannot be copied under intellectual property laws, Brazil has either broken the patent using a compulsory license (in the case of efavirenz) so it can import generic versions from abroad, or it has negotiated significant price reductions for the brand named versions.

The bold programme has proven controversial with major pharmaceutical companies and the US Trade Representative, as they see it as breaching the intellectual property rights of the original manufacturer. However, under World Trade Organisation guidelines, Brazil’s actions are completely legal.

The study, published by researchers at the Harvard School of Public Health in the United States, described Brazil’s efforts and the $ 1 billion saving as “remarkable”, yet they also warned that the relatively high cost of generic ARVs in Brazil, and the increasing HIV positive population may cause problems in the future. The lack of competition for generics manufactured in the country (all are produced on government orders) means that they are more expensive than generics found in other nations (such as in India). The country has an adult HIV prevalence rate of 0.5% and is currently treating around 180,000 people, with numbers growing all the time.

The study’s authors hope that their work will be of use to other developing countries facing an ever-expanding bill for antiretroviral treatment.

“The trends this study highlights provide important information about how AIDS treatment costs are likely to evolve in other developing countries as efforts are made to provide universal access to life-saving ARVs.” the researchers stated. “The specific application of the Brazilian model to other countries will depend, however, on the strength of their health systems, intellectual property regulations, epidemiological profiles, AIDS treatment guidelines, and differing capacities to produce drugs locally.”

AVERT.org has more about AIDS in Brazil and generic antiretroviral treatment.

CDC set to announce big rise in US HIV infections

The US Centers for Disease Control and Prevention (CDC) is set to announce a dramatic increase in the annual number of HIV infections occurring in the USA, an article in the Washington Blade has claimed.

Current CDC literature states that around 40,000 people become infected with HIV every year, a rate that has remained stable since 1992. However, sources at the CDC have told the Washington Blade that the actual figure may now be over 60,000.

It is unclear exactly what has caused the increase, and the CDC is officially remaining tight-lipped on the subject. Greater HIV testing in a wider range of venues, a CDC initiative introduced last year, may be one explanation. Two employees of the agency have also suggested that more accurate reporting techniques recently introduced across the US may have contributed to the rise. If this were the case, it would suggest that annual incidence may have been underreported for some years.

“My view is it’s both better data collection and increased testing as well as a higher rate of [HIV] conversion that is causing the spike in the CDC numbers,” said David Reznik, the head of an HIV dental clinic in Atlanta, Georgia, and former member of the Presidential Advisory Council on HIV/AIDS.

“However, our prevention messages aren’t reaching those at most risk,” Reznik said. “And I believe it’s time to rethink our prevention strategy.”

Government prevention efforts in the USA mainly consist of encouraging greater HIV testing, and there is currently no national scheme to encourage safer sex. If the new statistics are accurate, it is likely that many AIDS organisations will call for a reappraisal of this situation.

The CDC has admitted it is unlikely it will publish the new data, or its annual HIV/AIDS surveillance report, before World AIDS Day this year, stating that it needs more time to subject the data to peer review. Such a move has however drawn accusations of an attempted cover-up.

“The word we’re hearing now is they’re leaning against releasing such bad news on World AIDS Day,” said Jim Driscoll, a Washington adviser to the AIDS Healthcare Foundation. “There’s some talk of them releasing the new figures during the week between Christmas and New Year’s, when the fewest possible people will be paying attention.”

While a quiet launch of the figures may cause less embarrassment for the CDC, it would represent a major missed opportunity to highlight the ongoing seriousness of the AIDS epidemic in the United States.

To find out more about AIDS in the USA, please visit our HIV & AIDS in America section.

UNAIDS releases dramatically revised global HIV estimates

The joint United Nations Programme on AIDS (UNAIDS) has dramatically reduced its estimate of the number of people living with HIV around the world. According to the new statistics, there are now 33.2 million people living with HIV globally, down from the 39.5 million estimate made at the end of 2006.

Much of the reduction can be attributed to better surveillance techniques now being used in many countries, most notably India. Earlier this year, India reduced its HIV estimate by around 3 million people after numbers from a large household survey showed HIV prevalence was much lower than previous antenatal clinic and surveillance site data had suggested. This trend has been echoed in several other countries, and has led UNAIDS to adjust antenatal survey estimates downwards by an average factor of 0.8 for the 2007 report. Antenatal surveys are considered less accurate than more general population sampling, as many of the women that access antenatal clinics will be (by default) more sexually active than other members of the population, and at a higher risk of having HIV.

Not all of the reductions in the new report are attributable solely to technical changes however. Encouragingly, in countries such as Kenya, Zimbabwe and Côte d’Ivoire, HIV prevalence has dropped, a trend which country officials say is due to behaviour change and greater awareness of AIDS. In Sub-Saharan Africa as a whole, there were an estimated 1.7 million new HIV infections in 2007 – considerably fewer than in 2001, when comparatively accurate monitoring of HIV rates first began.

Deaths from AIDS have also fallen, with an estimated 2.1 million people dying in 2007, down from around 2.3 million in 2005.

“For the first time, we are seeing a decline in global AIDS deaths," said Dr. Kevin De Cock, director of the AIDS department at the World Health Organization.

He attributed this decline to better global access to antiretroviral drugs, as well as the fall in HIV prevalence now being seen in many African countries.

"These improved data present us with a clear picture of the AIDS epidemic," added UNAIDS Executive Director, Dr. Peter Piot. "Unquestionably, we are beginning to see a return on investment."

Not everyone believes that the current statistics are any more accurate than previous estimates however. The AIDS Healthcare Foundation in the USA is arguing that the uncertainty highlights fundemental problems in the world's approach to AIDS.

"These figures are rough numbers based upon extrapolations gleaned from unreliable data, since so few people are being tested," said Michael Weinstein, the AHF's president. "Let's stop guessing and make routine testing worldwide a priority."

If the numbers in the new report are accurate, it would imply that the overall numbers of people infected with HIV are still increasing - revised estimates showed there were 2.5 million new infections last year. But HIV incidence - the rate at which new infections occur - is going down, and UNAIDS now believe that it may have peaked in the late 1990s.

UNAIDS has urged for the new statistics not be taken as an excuse to become complacent, or cut funding for AIDS. Dr Dr. Paul De Lay, director of Evidence, Monitoring and Policy at the organisation said that even with the downward revisions, the US$ 40 billion per year recommended for a comprehensive response to AIDS by 2010 would only drop to US$ 38 billion.

Infectiousness Of HIV May Be Reduced By Suppressing Herpes Virus

A recent study of men co-infected with herpes simplex virus type 2 (HSV-2) and HIV revealed that drugs used to suppress HSV decrease the levels of HIV in the blood and rectal secretions, which may make patients less likely to transmit the virus. This study is published in the Journal of Infectious Diseases, now available online.

Most HIV-infected persons are also infected with HSV-2, which is the major cause of genital herpes. Prior studies demonstrated that the risk of passing HIV to a sexual partner is greater when the HIV-infected person has genital ulcers caused by HSV. Previous studies among HIV/HSV-2 co-infected persons and test-tube research have also demonstrated that HIV levels are increased during genital HSV reactivation.

In a pilot study of the effect of HSV-2 suppression on levels of HIV infectiousness, Connie Celum, MD, MPH, Richard Zuckerman, MD, MPH, and a team of researchers at the University of Washington and the research organization Impacta, in Lima, Peru performed a randomized, placebo-controlled cross-over study of daily HSV suppressive treatment in a small group of HIV/HSV-2 co-infected men who have sex with men.

Twenty men aged 22 to 41 enrolled in this trial, which took place in Peru. The men studied had no prior antiretroviral therapy and were not currently receiving antiretroviral therapy for HIV infection. Subjects were randomly assigned to the anti-HSV drug, valacyclovir 500 mg, twice daily or matching placebo for initial treatment. After eight weeks, subjects had a "washout period" in which they received twice daily placebo. Subjects then crossed over to the alternative treatment (placebo or valacyclovir) for eight weeks. Participants visited the clinic three times a week during each treatment arm. At each visit, rectal secretions were collected and weekly blood samples were obtained to determine levels of HIV.

Dr. Celum and her team of researchers found significantly reduced levels of HIV in blood by about 50 percent and rectal secretions by about 30 percent during the 8 weeks when the HIV/HSV-2 co-infected men received valacyclovir to suppress reactivation of HSV. This reduction in HIV levels could have a significant impact on transmission of HIV. Since the only intervention was daily valacyclovir to suppress HSV, this study adds weight to the other evidence that HSV-2 reactivation increases HIV replication. According to the researchers, additional "ongoing randomized trials will answer whether HSV suppression can reduce HIV transmission and address the potential for HSV suppression to delay anti-HIV therapy (antiretroviral) initiation."