Thursday, January 31, 2008

Group to try Pfizer drug as gel "condom"

WASHINGTON (Reuters) - Researchers dedicated to finding a gel or cream that could work invisibly to protect women from AIDS the way a condom does said on Wednesday they got permission from Pfizer Inc. to use its newest HIV drug.

The International Partnership for Microbicides said Pfizer gave it a royalty-free license to try to develop maraviroc in a cream or gel for the prevention of HIV infection.

Maraviroc, sold under the brand names of Selzentry and Celsentri, is one of a new class of HIV drugs called CCR5 blockers, which prevents the virus from getting into the cells it infects.

"This agreement adds a promising new compound to IPM's pipeline, allowing us to explore new ways to prevent HIV infection," Dr. Zeda Rosenberg, chief executive officer of the group, said in a statement

Microbicides are products, such as gels or creams, that could be applied vaginally or anally to prevent transmission of the human immunodeficiency virus that causes AIDS.

So far, attempts to create a microbicide have failed.

Under this agreement, IPM may develop, manufacture and distribute a maraviroc-based microbicide in developing countries without paying a royalty.

"In addition to developing new drugs to treat AIDS, we are committed to searching for ways our drugs can be used to slow down or stop this epidemic," said Pfizer vice President Dr. Jack Watters.

The AIDS virus infects 33 million people globally, according to the World Health Organization. It has killed 25 million, and there is no vaccine to prevent the fatal and incurable virus.

Condoms can protect men and women, but health experts note that many men refuse to use them. In many countries, a women who demands that her husband or partner use a condom can face refusal or even a beating.

According to the United Nations, in sub-Saharan Africa, almost 61 percent of adults infected with HIV are women.

"Women in the developing world are especially vulnerable to HIV, and urgently need new ways to protect themselves," said Dr. Tachi Yamada, president of the Bill & Melinda Gates Foundation's Global Health Program.

"For Pfizer to offer one of its most important new drugs to benefit the poorest of the poor shows a special act of commitment. I hope their example will point the way for other companies to consider how they can address major global health challenges as well."

The microbicides group also has an agreements with Johnson & Johnson subsidiary Tibotec Pharmaceuticals Ltd., Merck & Co., Bristol-Myers Squibb and Gilead Sciences Inc. to develop some of their HIV drugs.

Patients on AIDS drugs don't transmit virus: Swiss panel

GENEVA (AFP) - AIDS patients who take effective retroviral drugs do not pass on the virus even through unprotected sex, Switzerland's state commission on the disease claimed on Wednesday.

Couples were one partner is HIV positive do not need to use a condom to prevent transmitting the disease, as long as retroviral therapy is followed regularly and has suppressed the virus in the blood for at least six months, the Federal AIDS Commission said in a report.

The patient must also be free of any other sexually-transmitted disease.

"These findings come from four different studies," said Bernard Hirschel, co-author of the report and an HIV/AIDS specialist at Geneva's University Hospital.

The claim sparked concern against AIDS charities who noted that the scientific research is focused on heterosexual couples and vaginal rather than anal sex.

One of the research studies was carried out in Spain from 1990 to 2003 on 393 heterosexual couples where one person was HIV positive.

The results showed that none of the HIV negative partners was infected by a patient taking retrovirals, according to a paper published in the Swiss Bulletin of Medicine.

Another study in Brazil found that out of 93 couples where 43 were HIV positive, only six people were infected and this was due to their partners not following their treatment regime.

Two other studies, one in Uganda and one on pregnant women, arrived at the same conclusions, Hirschel said.

However other health authorities and AIDS charities reacted with scepticism and alarm to the news.

"The real thing missing (from the Swiss advice) is about anal sex and getting a new sexually transmitted infection," said Roger Peabody of the London-based Terrence Higgins Trust AIDS charity.

"We don't feel the scientific evidence is conclusive and there are some key issues that are not covered in this advice," he added.

But Hirschel was adamant that publishing the results of the findings was in the best interests of the public.

"I know that these conclusions can provoke certain fears, but I think such credible information which relies on proven and certain facts should be made known," he said.

French AIDS charity Act Up said that only a small number of HIV patients would be affected by the findings, and that 40 percent of retroviral patients still carry the virus residually despite following their treatment to the letter.

France's National AIDS Council warned that the findings were not robust enough to extrapolate wider conclusions from the individual cases cited.

Integration Of Family Planning, Reproductive Health, Antiretroviral Services Could Reduce HIV/AIDS Cases In Africa, Experts Say

Integrating family planning, reproductive health and antiretroviral drug services could reduce the number of new HIV cases in Africa, experts said recently at the fifth African Population Conference in Arusha, Tanzania, the New Vision/ reports. Researchers, demographers, policymakers and others attending the conference said that offering a combination of related services at a single health center also could reduce costs and stigma, as well as increase accessibility to services and provide additional health benefits.

"Integration of services into one-stop health care centers makes systems more supportive, especially for people living with HIV/AIDS," William Stone of the department of obstetrics and gynecology at the University of Aga Khan in Nairobi, Kenya, said. He said that most developing countries with high HIV/AIDS burdens focus on prevention of mother-to-child transmission programs but added that "it should be a whole package of preventing infections, unwanted pregnancies, postabortion care, PMTCT, treatment and care." Stone discussed the findings of two pilot projects in Ghana and Uganda. One study found that 39,000 HIV-positive births were prevented through PMTCT while 71,000 were prevented by family planning programs. "When you avoid unintended pregnancies, you avert more infections," he said.

According to Elly Mugumya, executive director of Reproductive Health Uganda, integration of services is long overdue. "Given that HIV is a sexuality issue and interlinked, we should have considered integration right from the beginning of our fight against the scourge," Mugumya said. "Let's not wait to give [antiretrovirals] and build orphanages. This can only be possible through integration" of family planning, reproductive health and HIV/AIDS treatment, Mugumya added.

Henry Kakande of ACQUIRE Project, a USAID-funded pilot program in Uganda, said that a "one-stop health care center would address" HIV/AIDS-related stigma and discrimination, as well as the lack of awareness about the disease. Providers also would be "empowered to handle such clients as they come because they are not comfortable opening up to different people and this undermines our efforts" to fight the disease and improve child and maternal health, he said.

According to the 2006 State of Uganda Population report, integration would increase efficiency and convenience for patients, as well as opportunities to promote reproductive health and HIV/AIDS awareness. However, the report found that shortages of health care workers might hinder the benefits of integration because demand could overload staff and diminish the quality of care. "Weak logistics systems are another issue, and each aspect requires strong supervision and referrals for management plus follow-up," the report said (Nabusoba/Emasu, New Vision/, 1/28).

HIV 'cure' doctor sues science academy

27 November 2007
Source: SciDev.Net
Reporter: Christina Scott

The Nigerian Academy of Science is being sued by a doctor after casting doubt on his unproven claims to have invented a vaccine for HIV.

And although The Lancet reported that the Nigerian government banned the unauthorised vaccine in 2000, the doctor confirmed this month that he is continuing to provide the treatment.

In 2004 Jeremiah Abalaka — owner of the Medicrest Specialist Hospital, a private clinic in Gwagwalada, north of the Nigerian capital Abuja — had his unproven claim published in the journal Vaccine. He continues to cite the article as evidence of his legitimacy.

"I have HIV prophylactic and therapeutic vaccines for prevention and treatment of HIV infection respectively. Both are made from the blood of HIV-infected patients. They are just human blood components," Abalaka alleged in an email.

The vaccines cost 5000 Nigerian Naira (around US$40) per injection. The patient decides on the dose and how many injections to receive. Abalaka claims that the illegal vaccine "has literally no side effects'' and refers further enquiries to his Vaccine paper.

Abalaka is thought to have injected a minimum of 4000 patients and he claims, himself with ''treated'' HIV positive blood.

''This man was having a lot of patients coming to him and was making a lot of money,'' said Akin Adubifa, executive secretary of the Lagos-based Nigerian Academy of Science.

''The academy wanted to verify his claim and made arrangements to visit his clinic. The findings of the representatives were that his claim could not be scientifically verified,'' Adubifa told SciDev.Net.

The academy subsequently issued a critical report to the Nigerian Ministry of Health. After the report was published in newspapers, Abalaka sued the academy and its representatives on the grounds that they have damaged his business.

Abalaka has claimed in several media reports, without providing evidence, that he is the victim of an international conspiracy to rob him of profits from the vaccine. Although all the profits appear to go to his clinic, he claims that testing the vaccine will undermine his intellectual property rights.

''Abalaka hasn't even got the facilities in the lab to produce any vaccine. His lab is virtually bare,'' Olusegun Oke, vice-president of the Nigerian Academy of Science and former vice-chancellor of the University of Technology in Ogbomoso, told SciDev.Net.

Oke confirmed that a court case had been underway for three years and was currently pending in the High Court in Abuja. He said the 30-year-old Academy "was not coping with the legal costs".

Akin Jimoh of Development Communications Network, a media training and monitoring organisation based in Lagos, was critical of the fact that the Nigerian Ministry of Health has not yet acted against Abalaka, and that it took some time for the academy to investigate him.

''It took so long for the authorities to investigate that Abalaka had already won over public opinion in the media. It was a lost opportunity,'' said Jimoh.

He noted that Abalaka had also tried to sue Diran Onifade, the Nigerian broadcast executive who is vice-president of the World Federation of Science Journalists, on similar claims. Onifade says the case was dropped without explanation.

There are no HIV vaccines in use at present, although a number of trials are planned. The International AIDS Vaccine Initiative has confirmed that Abalaka has no link with any known vaccine research teams.

Farouk Auwalu, the only surviving member of 30 Nigerian peacekeeping soldiers sent to Abalaka's clinic by the army for treatment, denied reports that Abalaka was overseas or had stopped offering the illegal vaccine.

A SciDev.Net reporter who travelled to the clinic confirmed in discussions with staff that the unauthorised vaccine is still being dispensed.

Ray Spier, editor of Vaccine, declined to comment on Abalaka continuing to provide an untested vaccine in exchange for cash or if he now regrets publishing the paper.

At the time, Spier wrote an editorial saying Abalaka's study was published as a report and not as a peer-reviewed research paper, a distinction that Abalaka has not emphasised. Spier's editorial said "desperate situations call for desperate measures" and said it would be "churlish" to push aside "a mass of data".