Participants had been assured - by jubilant advance publicity -- that they would be immune from the deadly infection while being injected with these drugs. Five clinics in South Africa participated in the trials.
These failed Merck HIV-vaccine trials were announced amidst a blaze of jubilant pre-publicity about this 'promising HIV-vaccine which holds out hope for millions."
Poor black participants in South Africa also were lured by the relatively large sums of cash handed out during such human drug trials. A couple of thousand dollars isn't all that much money in Western countries - but in South Africa, it's a small fortune to unemployed shack-dwellers who can't even afford the bus-fare to the local hospitals.
Now, just one month after the Merck HIV-vaccine fiasco, yet another two antibiotics, both 'promising TB-treatment candidates' are being market-tested in Cape Town, South Africa. http://www.tballiance.org/newscenter/view-innews.php?id=741
This time the companies testing the two new drugs are Chiron in California and the New-Jersey-based Bayer Pharmaceuticals, working with a non-profit organisation called "The TB-Alliance".
Being tested are a drug designated only as PA824, developed by Chiron, and the antibiotic doxifloxacin, being hailed by Bayer as 'one of the most advanced potential new TB drugs in development."
It has just launched the so-called RemoxTB trials with some '2000 volunteers' in Kenya, SA, Tanzania and Zambia."
In the Moxifloxacin trials, these 2000 TB-patients will be subjected to replace their current standard four-drug cocktail's ethambutol or isoniazid with this antibiotic moxifloxacin for a period of 4 months.
Then they will assess whether this approach gives better results in their African guinea-pigs i.e. whether they would become more willing to continue taking this horrendous cocktail of drugs.
This trial is being backed up by University College London and the British Medical Research Council.
The PA824 trial is much smaller: it involves 60 NEWLY-DIAGNOSED TB-AIDS patients. Thirty patients will be given PA-824 for 14 days before starting standard treatment. The rest will get the standard treatment straight away. There will not be a healthy control group to test whether the drug has any side-effects in healthy people.
- This trial is even more tricky: in South Africa it is often found that TB+AIDS co-infected patients die within 20 to 30 days of diagnoses if they fail to respond to any of the drug-cocktails.
Scientists want to compare how well PA-824 fought the TB bacteria infection in the first fourteen days of treatment.
- They don't do this to try and cure the patient of TB: they just want to see whether the patient would 'tolerate" PA-824 better than current medications when co-infected with TB+HIV and while taking antiretroviral medicines at the same time.
Neither of these two so-called TB-vaccines were designed to cure anything -- they only hope to shorten the treatment period for drug-resistant Tuberculosis by two months with these experimental drugs.
Yet once again the press releases are jubilant and the SA news media remains totally uncritical -- blithely publishing these claims by the TB Alliance. Dr Maria C Freire, the CEO of the TB Alliance, is widely quoted as saying that 'there are now two promising new TB drugs in our portfolio moving forward in clinic trials; and that it's 'a historic milestone in our accelerated drive to develop new TB drugs that fight the disease in different, faster and better ways to help save millions of lives...'
What she doesn't say -- although she should -- is that in South Africa, her 'groundbreaking' new TB-drugs are going to be tested on yet another batch of empoverished, often poorly-educated human beings who will get large bonuses.
Only one of these two new TB drugs, PA-824, tries to address the co-epidemics of drug-resistant TB + AIDS. The much larger trial with Moxifloxacin ignores the AIDS-factor altogether.
- In South Africa more than 350,000 people have died of the combined drug-resistant TB+AIDS co-infection last year and more than 6-m people are estimated to be infected with AIDS, of whom 60% are also co-infected with TB.
These two experimental drugs are only hoped to shorten the time of treatment for the TB patients so that the patients will "comply" better.
- What does that mean, 'comply'? These scientists refer to those dreadfully-ill patients who can't bear the harrowing side-effects of these huge drugs-cocktails any longer, and walk away from treatment in isolation-wards to die at home, where they then infect others.
The problem here does not lie with the drugs and 'non-compliance' -- but with the SA government's policy which states that they do not want such infectious XDR-TB patients to be placed in enforced isolation, claiming that their individual human rights are being violated while totally ignoring the rights of the entire community to be protected from infection. This is a political issue which cannot be cured with a magic pill.
Said Freire: "A shorter TB regimen, which COULD be possible with new drugs such as moxifloxacin and PA-824, SHOULD lead to improved patient compliance...'I urge the TB-alliance to by all means, go and test these drugs on human beings in other parts of the world and make certain that these people are much better-informed, more literate, far less poor and far less desperate than those South African patients.
The incredible suffering of these TB+AIDS infected S.Africans does not need to be increased by holding out false hope in drugs-trials which aren't even designed to try and begin to cure their conditions.
I urge drug companies and the TB Alliance to stop lying to these people and to above all, stop using the African continent as one gigantic human laboratory. Africa isn't Auschwitz.
TB alliance's "Compassionate/Emergency Use of Experimental TB Alliance Drugs outside the scope of clinical trials"