The project has been scrapped after the Treatment Action Campaign asked the national government to intervene.
The Eastern Cape Health Department has instructed hospitals to give an untested medicine to patients with tuberculosis. It has not received ethical approval to proceed with this clinical trial. Now it appears the project has been scrapped, apparently after the Treatment Action Campaign (TAC) asked the national government to intervene.
GroundUp has obtained a memo that the manager of the Nelson Mandela Bay Health district, Dr LP Mayekiso, sent to three hospitals on 27 January. The memo instructs the hospitals to start dispensing Immutides Spray to patients with tuberculosis (TB) from 1 March. “The goal is to boost the immune system of patients so badly affected by TB that they need admission to hospital,” says the memo. It also says, “All these patients must stay on Immutides for the remainder of their TB treatment.”
According to Stats SA data, TB is the infectious disease responsible for the most number of annual recorded deaths in South Africa. People with HIV are at particularly high risk of dying from TB. There are effective medicines that cure TB and they are available in the public health system.
Mayekiso wrote that a “research project must be launched that will evaluate the effect of adding Immutides Spray to the treatment regimen of all TB patients admitted to a TB hospital.” This project would have run for six months and a report on it would have to be ready by the end of October. “During November 2014, the research report will be evaluated by the Top Management of [the health district] and the future use of Immutides Spray will be evaluated,” the memo said.
There is no mention of whether patients will be asked to consent before taking the spray; this is a requirement before giving untested medicines to people. As far as GroundUp can ascertain, no ethics board has given the go-ahead for this research and the Medicines Control Council has not authorised it. Yet these are steps that are required in South Africa before testing a medicine on people, whether it is considered "complimentary", as this one is, or not.
The spray is manufactured from bovine colostrum, which is a precursor to cow milk. The closed corporation that distributes it is called Saulez Agencies. One of its owners is Mike Xego, a former ANC Member of the Eastern Cape Legislature (MPL).
When a medicine is tested in humans, it is called a clinical trial. Before a clinical trial can be started, researchers must show that it is plausible that the medicine will be effective against the disease. They must do this by doing laboratory research. This research is usually published in medical journals for other scientists to consider. A GroundUp search in the online Public Library of Medicine, where nearly all credible medical research is made available, found no studies showing that bovine colostrum is a plausible treatment for TB.
Clinical trials are complex and require meticulous protocols. There are none here. For example, there is no control group. This is a group of patients who do not take the medicine but are also followed closely. At the end of the trial, researchers compare the control group patients to the patients who took the medicine and see who did better. Without a control group, you cannot know how effective a medicine is.
This is not the first time the government has involved itself in unlawful trials. In the mid-2000s a vitamin salesman, Matthias Rath, ran an unauthorised clinical trial on AIDS patients. Rath was close to the National Minister of Health at the time, the late Manto Tshabalala-Msimang. She had refused to stop Rath’s activities. In 2008 -- in a case brought by the TAC -- the Cape High Court ordered Rath to halt his trial and also ordered the minister to take steps to stop it. But Rath had left the country by that time and no government action was taken against him.
The TAC is again trying to stop this trial. According to the organisation’s General Secretary, Vuyiseka Dubula (pictured), TAC has attempted to contact the Eastern Cape Department of Health to convince its officials not to proceed with the trial. “We [also] contacted the National Department of Health’s Director-General, Ms Precious Matsoso,” said Dubula. “She assured me that she will instruct the Medicines Control Council to send inspectors as soon as possible. She confirmed that the experiment has been blocked and that a meeting has been held with Dr Mayekiso.”
“We were assured that Dr Mayekiso acted alone but we would like a formal response indicating this. And we would like the Eastern Cape health department to deal decisively with Dr Mayekiso’s unethical conduct.”
Dubula said she hoped to receive the report by Medicines Control Council inspectors as soon as possible.
GroundUp tried to get hold of Dr Mayekiso for comment, but she could not be reached. When we phoned her office on Tuesday afternoon, we were told that she was not available and would be attending a two-day planning meeting. GroundUp was then told that Dr Mayekiso was not at liberty to speak to the media. Instead we were directed to two spokespeople. The first was on leave and the other’s cellphone went unanswered.
GroundUp then tried to contact Eastern Cape Health MEC Sicelo Gqobana. He did not answer his cellphone; instead we got a message saying Gqobana’s mailbox was full. The MEC also did not respond to an SMS asking to return the call.
When GroundUp contacted the office of the National Director-General of Health, Precious Matsoso, we were referred to Dr Yogan Pillay, the head of the HIV, TB and mother-and-child programmes. Pillay was not available and GroundUp was directed to his personal email address instead.
GroundUp did manage to speak to Mike Xego, former Nelson Mandela Bay councillor, and Thobile Mbengashe, who is the head of the Health Department's HIV/AIDS and STI unit. Xego claimed that the Immutides spray was from Arizona. He said he had helped two men who received a certificate from the National Department of Health to sell and market the product around South Africa. But government stopped it and he was now a businessman and had nothing to do with the spray.
Mbengashe said the trial had been blocked and scrapped because it did not follow due process and it was not recognised by the National Department of Health. “It was supposed to start on 1 March but that will not happen.”
On Thursday afternoon, Dr Mayekiso responded to an email sent to her by GroundUp with a list of questions. Her response was, “The project has been cancelled and further input in this regard [sic].”
Medicine regulation expert and expert on clinical trial ethics, Andy Gray, said he was disturbed that a district manager would send out such a directive. “This needs to be carefully investigated by the health department. Clinical trials need to go through the Medicines Control Council. I am just perturbed.