Govt, WHO clash over HIV Study-leaked report

Govt worried that WHO prematurely released Report


A publication of HIV drug study findings placed on the World Health Organization (WHO) website has strained the WHO’s relations with the Botswana government.
The preliminary findings of the study carried out by Botswana Harvard Partnership (BHP), in collaboration with the Ministry of Health and Wellness on the usage an antiviral Dolutegravir (DTG) Drug on HIV positive women indicated cases of neural tube birth defects to the brain, spine, or spinal cord in the first month of pregnancy, often before a woman even knows that she is pregnant.
The Government of Botswana has raised a formal complaint with the international health body for the transgression after the latter’s published the preliminary findings of a report that portrayed Botswana in a bad light.
The report, among other findings, concluded that there had been four cases of neural tube defects identified in 426 women. All the women in the ongoing study were taking DTG before they became pregnant.
Minister of Health and Wellness Hon. Dr Alfred Madigele confirmed that they have lodged a complaint with the WHO but declined to go into specifics. When pressed further, he said the report was a preliminary report and said they do not know how it could have gone to WHO before the defects were fully investigated by the experts. “There are a lot of factors that are considered when analyzing defects and we had not gone into those to ascertain the link between these factors and the use of the drug-DTG,” Madigela said.
WHO representative to Botswana, Martins Ovberedjo was unable to assist when contacted, saying he still had to consult and inform himself further on the matter.
Although WHO has acknowledged the anomaly and apologised, the Ministry of Health and Wellness has assured Batswana that though the published report carries the preliminary findings, its contents remain accurate, and that Batswana should rest assured that DTG has proven to be highly effective medication in Botswana and the rest of the world.
Madigele assured Batswana that preliminary data suggested that potential safety issues arise in women exposed to DTG at the time of conception. Madigele said since its approval by WHO in 2013, and officially adopted by Botswana in June 2016, the drug had been widely accepted as it led to faster and sustained viral suppression.
“The potential safety issue of DTG is related to the development of the spinal cord, the brain and the surrounding tissues (neural tube development) within the first 28 days of conception” read a statement issued by MoHW last week, “In simplifying the neural tube development this happens when part of the spinal cord grows outside the body or either in the brain, and that often children who develop the ailment don’t survive after birth.” The Minister advised that other factors contributing to neural tube defects relate to folate deficiency, pregnant mothers who indulge in alcohol while pregnant and those who are obese.
MoHW advises that it continues to monitor the use of DTG among women of child bearing age and that they are advised to use the medication with caution. It further states that HIV positive women who are currently on DTG and desiring to have a child, should consult healthcare providers for appropriate advice and that those who are pregnant and have conceived while on DTG should alert their healthcare providers so that they can be counseled and advised appropriately.