Minister missed an opportunity with Rath
While it is noble and indeed critical for Dr Manto Tshabalala-Msimang to warn researchers against infringing on the human rights of trial participants who are mostly from poor households, it is hard to understand why some so-called scientists have been allowed to get away with conducting unethical trials while others are rapped over the knuckles.
For over a year, the Dr Rath Health Foundation has, been distributing so-called multi-vitamin products in poverty-stricken areas such as Khayelithsa in Cape Town, KwaMashu in Durban and Mdantsane in East London. They have been assisted by the South African National Civics Organisation and the National Association of the People living with HIV/Aids,
Some Rath Foundation agents advise HIV-positive patients against taking anti-retroviral drugs, claiming in a number of cases that the Rath vitamins will cure them or prevent any further opportunistic infections.
Dr Matthias Rath has on more than one occasion admitted that he had conducted ‘clinical studies’ on patients in Khayelitsha using his multi-vitamins. The health department claimed it conducted an investigation and director-general Thami Mseleku has indicated on more than one occasion that the department had no problem with Rath’s conduct.
However, the minister made several comments at the microbicides conference that smack of double standards. It appears that the minister and her department have one set of standards for ‘western’ medicine and another, for products that, they deem to be ‘alternative medicines’. The jury is still out on whether Rath’s products fall within the ambit of a medicine. Most experts agree that they should be treated as medicine, given that a number of the vitamin doses exceed recommended daily allowances. But the health department says it views the Rath products as ‘food supplements’
‘One of the issues that this conference needs to address is ethical recruitment of candidates for clinical trials. In a community that is poor, providing financial compensation could prove to be perverse incentives,’ the Minister told the microbicide gathering
Yet, patients of the Dr Rath Health Foundation say they were promised anything from groceries to money and housing if they took the vitamins.
‘As we know, the poor may become desperate to receive these incentives despite the risk,’ continued the minister. ‘Therefore, informed consent becomes even more critical in this context.’
But some Rath patients were told to take up to 20 tablets a day, ordered to undress before being photographed and in some instances blood samples were taken. The Rath Foundation has failed to refute any of these allegations.
Said the minister: ‘We need to ensure that research participants receive the necessary care for the management of conditions that they may be exposed to. One of the key issues that this conference needs to address is what happens when there are complications from a clinical trial.’
More than one HIV-positive Rath patient died while using his products. Most of these people had opportunistic infections, but had been advised that ARVs were toxic. One woman told Health-e that her critically ill sister refused to call an ambulance because the Rath agents had advised her against doing so.
‘As a Health minister, it is my responsibility to ensure that the health of citizens of our country, particularly woman is not adversely affected in the process of research,’ said the Minister
Most of the Rath patients who died or shared their stories are women.
‘As you know,’ the minister continued, ‘increasing research activity, competition and an attractive research environment may sometimes results in unethical practices.’
Reports and affidavits from residents and healthworkers in Khayelithsa show that the Dr Rath Health Foundation conducted unethical trials on poor and ill patients. Although Rath confirmed in a newspaper report, on a radio station, on his website and in his Foundation’s publication ‘You Can’ to conducting ‘clinical studies’, none of these activities were registered with an ethics committee.
The minister continued: ‘As we utilize the opportunities presented by this environment, we need to ensure that we protect human rights particularly of research participants as entrenched in our Constitution and the National Health Act.’
The Treatment Action Campaign has launched a court action, charging the health department and the minister with failing to stop Rath’s activities. The activist group is charging Rath and his sidekicks with making false claims that his medicines treat HIV/AIDS, distributing unregistered medicines and conducting an illegal clinical trial on people in Khayelitsha and Hout Bay.
Unethical and illegal clinical trials that exploit poor, desperate people should have no place in our society. Government’s job is to protect its citizens against this kind of exploitation. In the case of Rath, Government failed to do so
The only way to redeem itself would be to conduct a transparent and vigorous investigation into the Rath Foundation’s activities and bring the guilty parties to book. The next step should be to close the loopholes that allowed him to do what he did in the first place.
The Health Minister’s support for untested products such as Virodene, Ubhejane and Rath products, has been to the detriment of poor and desperate people living with HIV. Unless the government regulates all such products with an even hand, South Africa will continue to be a haven for crooked scientists intent on using poor people to try to prove their quack theories.
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Minister missed an opportunity with Rath
by Health-e News, Health-e News
May 9, 2006