A few days ago while in Abuja, I was surprised to hear the news presenter announce that a Federal High Court had “lifted the ban” on Dr Abalaka’s “vaccine” against HIV. The presenter went on to say that, although the vaccine had been approved by influential international bodies more than a decade ago, the then Federal Government had banned it and that last year the court had ruled that the ban was illegal.
On hearing this, I was struck by a number of things – an abiding discomfort at the quality of reporting on science and health matters in the Nigerian media; a sense of guilt that, in failing to tell our stories, younger Nigerians are at risk of repeating missteps of the past; and a fear that many, misled by the news item, may put their lives at risk.
Listening to that programme took me back nearly 15 years to when I was a young doctor in Abuja, struggling to manage patients in a Nigeria where anti-retroviral drugs were so costly that there were virtually unavailable. As we had little to offer patients that we diagnosed with HIV then, it was little surprise that many desperately turned to whatever non-orthodox options were being offered, and there were many willing to step into that breach. Dr Abalaka was one of these, and many turned to him, selling all that they had to partake of his “treatment”.
However, many scientists and doctors were concerned that most of the claims were not being assessed through a randomised clinical trial (the best type of study design to determine whether a treatment is effective) and the publishing of the results in a peer reviewed medium. There were also many anecdotal reports of patients who, after an initial improvement while on these treatments, subsequently relapsed and in some cases died. We had patients come back to us at the hospital where I then worked after such failures.
The media did not help matters, largely due to a lack of understanding of the scientific process as the late Omololu Falobi, founder of Journalists Against AIDS, eloquently pointed out in areport, in which he describes how at least 10 Newspapers carried the “Abalaka Saga” as cover stories. But this was in 1999 – 2000.
Now that the judgment is back in the news, it is important to make a number of points clear:
Firstly, it is not the place of any court to determine the effectiveness or otherwise of any treatment; that is not their area of expertise. The registration of drugs and related products for use in Nigeria is the responsibility of the National Agency for Food and Drug Administration and Control.
While it appears that there may have been a loophole (the decree establishing NAFDAC refers only to “drugs”, and Dr Abalaka had argued that, as he used blood products, his vaccine was not subject to NAFDAC’s purview, which regulates drugs made from animal and chemical substances only), the newly signed National Health Act includes a section on the regulation of the use of blood products, hopefully closing that loophole.
What the court can (and appears to have done in this case – although we have not seen the full judgment) do is to determine whether the law has been applied or not.
In our view, the court was not saying that the claimed treatment works but that the process the government followed in banning it was not in accordance with the law.
The fact that it is legal to sell something does not mean that it is effective or that it works. There are many weight-loss and cosmetic products that make various claims, often unfounded but which are sold legally.
Another point to clarify is the assertion that the results were published in Vaccine, an international journal in 2004. There was indeed a report by Dr Abalaka in Vaccine, but it was not peer-reviewed and the editor of Vaccine, Ray Spier was later criticised in Nature for publishing it:
“How supremely irresponsible of Vaccine to publish something of such potential importance without peer review! Has science been served by the decision? The only thing that has come out of it is undue support for a man who is now in a stronger position to put the lives of thousands of people at risk.”
Thankfully, the Network of People Living With HIV/AIDS Nigeria (NEWPHAN) has said that it will embark on an awareness campaign so that people understand that there is still no known cure for HIVand avoid putting themselves at risk.
Also the Medical and Dental Council of Nigeria has come out strongly to say that it will appeal the judgement. While that is to be applauded, it is hard to rationalise how Dr Abalaka remained unsanctioned by the Council. In many other countries, people that make such claims without proper trials are struck off the medical register. This is important because his was just one of several “cure” claims of that era, but his claim gained credibility because he was a certified medical doctor, with the inherent assumption that he had observed best practice as stipulated by the profession’s norms and practices. This was simply not the case. The profession must speak out loudly against issues like this. While some lack of clarity may have been understood in the uncertain era of the 1990s, this is 2015, and there is much better understanding of HIV and its management and what is possible.
The whole saga underlines many points – the weakness of our regulatory frameworks, the poor public understanding of science and scientific processes, even among health reporters and the need for better communication and awareness.
We hope that the Federal Government will appeal this judgment. There are 3.5 million Nigerians living with HIV today. Our priority must be to increase the number of people (500,000 in 2012) that have access to the anti-retroviral treatment that has unequivocally been shown to work.
Source: Ike Anya