 
Search the database online or call the HIV911 helpline
|
|
|
|
|
|
|
 |
TAC executive committee resolution on Medicines Control Council
TAC Press Release, 5 August 2002.
|
On 5 August 2002 the Treatment Action Campaign Executive resolved to: 1) Campaign for an independent Medicines Control Council committed to ensuring the safety, efficacy and quality of all medicines in the public interest.
2) Defend the registration of Nevirapine as a treatment and for the prevention of intra-partum HIV transmission unless the weight of scientific evidence shows that the medicine is not safe or effective.
3) Institute legal proceedings against the MCC and all its members to review any unjustifiable decision pertaining to the registration of nevirapine or the constant misinformatioon about the safety profile of the medication. The current situation represents an undermining of the judgment of the Constitutional Court in the nevirapine case.
Proposed: Zackie Achmat
Seconded: Theo Steele
--------------------------------------------------
Below is the transcript of an interview by the Registrar of Medicines (a position with the Medicines Control Council) on SAFM on 5 August 2002.
Ms Matsoso refers to a report that the MCC has before them. The TAC calls on the MCC to make this report available without delay, as it is clearly in the public interest to know the contents of it.
**********************************************
SAFM Live
Interviewer(I): The MCC has confirmed that it is reviewing its approval of Nevirapine. The MCC is expected to take a final decision next month whether HIV pregnant women in SA should continue to have access to the drug. This comes after the MCC questioned the drugs manufacturer Boehringer Ingelheim in a meeting two weeks ago . Well to look at this issue we're now joined on AM live by the registrar of the MCC Precious Matsoso. Welcome to AM live. What exactly in regard to Nevirapine are you evaluating at the MCC?
Precious Matsoso(PM): Thank-you very much. Good morning to you too. In March this year we had a report that there were problems with the data from the HIV Net 012 study and we released a press statement at the time- that we were reviewing the data and some of the problems that were highlighted -and that has been an ongoing matter - And I wish to correct the statement that 'AIDS medicines" is to be banned. I think that it is not entirely true and at this stage I wish to mention that the MCC has registered 17 ARV's including Nevirapine. SO meaning?I mean we cannot just pick on one drug and its not true that Nevirapine is going to be banned at all. It will still be used for the treatment of HIV/AIDS and our finding s have not been concluded as yet because we still awaiting a report which will then guide the MCC as to what decision to make and I think by the next month we will be able to finalize this matter.
I): Now you say you are prompted to do this review by the dispute with the FDA and Boehringer Ingelheim over the data. Do you have concerns about either the efficacy or the toxicity of the drug and if so what evaluations are you conducting?
PM): We have been given documentation that was submitted to the FDA and the company which we are reviewing at this stage and we are comparing notes - that's basically what we are doing. And on the basis of which we will then finalize our reports and I think we will be able to make that public in the coming month.
I): Now you say you're comparing the B.I data- what are you comparing it to?
PM): Its basically data that has been submitted?
I): From where and by who?
PM) Can I mention that - remember this indication?this application that BI submitted to us was in 1999 ?so that is awhile ago...long before the deficiencies on documentation were uncovered. So these are some of the things we are looking at - and I think these are regulatory issues which we have to deal with and we will be bale to confirm our findings in the coming month and we'll make that definitely publicly known to the South African community.
I.): Ms. Matsoso, if I can return to my earlier question...you said you were comparing the data that BI has with the other data and again my question- what data and where is it from?
PM): well let me indicate that when BI applied in 1999, the data at the time was only HIVNET which was presented before us?OK?so there could have been additional data that was submitted to the FDA which is of interest to us which we are looking at , at this point in time. But of course there are additional reports that we are awaiting from the NIH which are due to be submitted to us in September.
I): So you are comparing the original data with subsequent data generated by BI and other data from the National Institute of Health of the United States. Is that correct?
PM): Yes, that's correct
I): And are you using any data generated inside South Africa for points of comparison?
PM): Well, we have already evaluated the SAINTS and there were concerns that were communicated back to BI and what our concerns were. And these unfortunately we cannot deal with in the media- you know we're subject to confidentiality- Section 34- does not allow us to disclose some of the issues.
I): I'd just like clarification on another point. You said Nevirapine will still be used for the treatment of HIV/AIDS. Does that mean that Nevirapine will still be used for the treatment of HIV/AIDS in this particular context i.e MTCT because it has already been used and has long been registered for the treatment of adult AIDS ?
PM): yes, like I'm saying...I've indicated that there are some of the ARV's that is registered and I can indicate at this point in time that on the 26th of July we registered another combination called KALETRA. And I need to mention what people do not know, when the USA started the programme for MTCT, they introduced what is called the "ARV Pregnancy Registry"- now that is a monitoring programme that has been established between companies, the FDA and the NIH- they've been monitoring that and we've got data and information about years of experience of individual ARV' drugs that were used for pregnant women- something that has not been established in South Africa and for that reason we have established what is called "Focused Surveillance on ARV Therapy" at Medunsa and we also went to visit 18 sites as MCC to pick up what the problems are ??so we are not just talking from the cuff- we also went out there to collect information ourselves and we've got a report y'know before us that we are also considering.
I): Thank you very much. Ms Matsoso.
|
| Was this article helpful to you? |
 ?0%???? ?100%
|
|
Back
|
|
|
|
? Centre for HIV/AIDS Networking 2002 - 2005. All rights reserved. No reproduction, distribution, dissemination or replication of the contents hereof may be undertaken under any circumstances without the express prior written consent of HIVAN. All users acknowledge that they have read and understood our Terms Of Use. Contact Us by clicking here or reach the Webmaster by clicking here.
Please view this site with the latest versions of Explorer or Netscape
|
|
|
