Shocking revelations on Aids drug

A drug that is being vigorously promoted in Zimbabwe as the answer to solving the mother-to-child transmission of HIV may have serious side-effects, especially if used as a single dose.

Reports now surfacing show that the drug, nevirapine, may cause long-term resistance to AIDS drugs if used as a lone dose, thus foreclosing other treatment options.

Associated Press says while the United States’ National Institute of Health (NIH) knew about the problems way back in 2002, it did not tell the White House before President George W Bush launched a plan to spread nevirapine throughout Africa.

The NIH’s AIDS division chief, Dr Edmund Tramont, even doctored a report by one of his subordinates, Dr Betsy Smith, that showed some of the negative safety concerns that had been discovered in Uganda during clinical trials there.

Tramont’s report, submitted shortly before Bush’s visit to Africa from July 7-12 2003, concluded that nevirapine was safe even when used as a single dose. Bush visited Botswana, South Africa, Uganda, Nigeria and Senegal.

“HIVNET 012 has demonstrated the safety of single dose nevirapine for the prevention of maternal to child transmission of HIV infection,” the doctored report said.

It added that although discrepancies were found in the database and some unreported adverse effects were discovered during the re-monitoring process, these were not clinically important in determining the safety of the drug.

According to Associated Press, Tramont’s juniors and Jonathan Fishbein, an expert hired by the NIH to improve the agency’s research practices, had argued that they needed more time to rectify some of the safety concerns that had been raised. These problems had forced a 15-month stop on research into using a single dose of nevirapine to prevent the mother-to-child transmission of HIV.

Tramont argued that the research should resume because the monitors did not understand HIV/AIDS. And they had “very little sense or feeling for the local culture”.

“I personally have been involved with this site’s problems and I am convinced that this site is ready to resume given the limitations of doing research in any resource-poor under-developed country,” Tramont wrote to his juniors.

“I want this restriction lifted ASAP (As Soon As Possible) because the site is now the best in Africa run by black Africans and everyone has worked so hard to get it right as evidenced by the fact that the lab is now certified.”

Tramont’s deputy, Jonathan Kagan, argued that he did not see any harm in giving Fishbein time to review the data on the Uganda research site.

“I think Fishbein deserves to see what those reports said and what evidence there is that the deficiencies were corrected. If we have the data, it shouldn’t take a long time for him to review this and I believe both he and DAIDS (Division of AIDS) deserve the time to do this,” Kagan wrote.

“From his vantage point , Ed, it must look like we have something to hide.

“Let him find out what was wrong and what was done about it. Where’s the harm? Ed, what your note is essentially saying is that you want the site opened.

“I think we’re cutting off our noses to spite our face here. It’s not going to matter if the site opens this week, or next or even the next. We should not be motivated by political gain and it’s dangerous for you, of all people, to be diminishing the value of our monitors.”

Tramont would not budge. He closed debate on the subject, saying: “HIVNET012 has been reviewed, re-monitored, debated and scrutinised. To do anymore would be beyond reason.”

The director of the Medicines Control Authority of Zimbabwe, Mafios Dauramanzi, said nevirapine was registered in the country as an antiviral drug and was to be used in triple combination and not as a single dose. He said it was not registered to prevent mother-to-child transmission of HIV, but was being used for this as “operational research”.

Drug information on nevirapine from the NIH clearly states that the drug can cause severe life-threatening liver damage and skin reactions that can be fatal.

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