Marion Edmunds
The government is considering taking disciplinary action against an Eastern Cape public health specialist who last year suspended the use of a cheap Korean hepatitis B vaccine in 14 East London clinics because he doubted its efficacy.
The head of the department of public health at Cecilia Makiwane Hospital, Dr Costa Gazi, said he believed Heppacine B was ineffective and ordered that it no longer be used in 14 clinics under his supervision after a field trial conducted there by the National Institute of Virology in 1996 showed it was ineffective.
The study’s results showed a 44% seroconversion rate, which is alarmingly low for a vaccine. (Seroconversion describes the build-up of antibodies in the blood stream, activated by a vaccine.)
“I felt I had to take action because I was in charge of the clinics,” said Gazi. “I follow the national immunisation list, but not blindly. I look forward to defending myself from charges if they are laid.”
Hepatitis B is transmitted through sexual contact and blood-products, and can be transmitted by pregnant mothers to unborn children. Toddlers can also transmit it to each other. The younger the age at infection, the higher the probability of the infected child becoming a carrier – thus the need for a vaccine for infants younger than one year.
Heppacine B, a generic plasma-derived drug, is favoured by the government because it is considerably cheaper than a competing genetically engineered vaccine, Engerix-B. However, the supply of vaccines is lucrative business, and the 1995 Heppacine B consignment is said to have cost the government R12-million.
Gazi believes a cheaper vaccine is a waste of resources if it is not effective, and says his stand against the department is on ethical grounds.
The provincial health department sent out letters last month to the 14 clinics, overriding Gazi’s instructions. The department also threatened Gazi with disciplinary action.
The department’s acting permanent secretary, Dr Peter Milligan, said Gazi lacked the authority to act as he did: “It is not appropriate for an individual to suspend the activity of the vaccine. Gazi never drew the department’s attention to the issues, nor said let’s take this up with the national department.” Gazi said he had informed the department of his actions.
Despite strong support for Heppacine B by the South African health authorities, doubts over the vaccine’s effectiveness persist, partly because it is administered in an extremely small dose of 1,5 micrograms.
Published research from a study done in the Solomon Islands in 1995, by a New Zealand expert, Professor Alex Milne, showed that Heppacine B failed dismally there as a vaccine against hepatitis B.
However, World Health Organisation representatives have urged the international community to ignore the Milne study and not to question the use or dosage of the Korean drug, because of its success in countries such as South Africa, Gambia and the Philippines.
The health department referred the Mail & Guardian to a 1995 study by Professor Sunette Aspinall, which showed a 93% success rate in the use of the vaccine on infants in Shoshanguve and North West province.
Professor Barry Shoub, the director of the National Institute of Virology, this week cited the Aspinall success story, and cast doubt on his institute’s own 1996 research, saying the results were probably misleading and the researchers who compiled them “inexperienced”.
Controversy over the 1996 results has led to further, more rigorous research, whose results are to be published later this year.