Dean's World

I haven't heard of David Graham until now.

Do you have any links to these stories? I'm talking with a reporter who's been interviewing Fishbein for a while now, I may even get to interview him myself.

The silence from those who've been berating me for even raising questions about data on AIDS is rather deafening, isn't it?

Contrarly as that you assume, Jeremy, it is very important to known that these numbers are fudged, why the main arguments in favor of the virus come from the extension of the epidemy in Africa.
Fishbein is correct when he says that the hivnet012 seems to be flawed, and you can read this trial in Kenya, where the investigators theyselves express that the trials should be reconsidered.

link

Low efficacy of nevirapine (HIVNET012) in preventing perinatal HIV-1transmission in a real-life situation AIDS: Volume 18(13) 3 September 2004 pp 1854-1856




Quaghebeur, Anna; Mutunga, Lillianb; Mwanyumba, Fabianc; Mandaliya, Kishorc; Verhofstede, Chrisa; Temmerman, Marleenaa

International Centre for Reproductive Health, Ghent University, Ghent,Belgium; bInternational Centre for Reproductive Health, Mombasa, Kenya; and cCoast Province General Hospital, Mombasa, Kenya

Received: 13 May 2004; accepted: 25 May 2004.

Since 2001, the unrestricted use of HIVNET012 has been recommended for the prevention of mother-to-child transmission in low-resource settings, despite the lack of validated efficacy data outside research settings. We implemented the nevirapine regimen in a real-life situation in Kenya. The perinatal HIV-1 transmission rate at 14 weeks was 18.1%, similar to the 21.7% before the intervention. These data call for further evaluation of the simple nevirapine regimen in field conditions, and underline the need for
alternative strategies.

Since the publication of HIVNET012 [1], nevirapine has been introduced in many HIV-1 prevention of mother-to-child transmission programmes across sub-Saharan Africa [2-4]. However, few data are available on the efficacy of the regimen outside the context of a clinical trial. We implemented the HIVNET012 regimen in a field setting in Mombasa, Kenya, and determined the transmission rate of HIV-1 at 14-16 weeks in this breastfeeding population.

The study was conducted between April 2001 and October 2003, at Coast Province General Hospital in Mombasa, Kenya, a provincial hospital with approximately 6000 deliveries per year. Voluntary counselling and testing was offered by trained counsellors at the antenatal clinic. HIV-positive women were provided with nevirapine and instructions for use at the onset of labour. They were invited to participate in a follow-up study. Infant venous blood was collected at 6 and 14 weeks and was stored as DBS on filter paper (FTA Classic Card; Whatman International Ltd., UK). HIV-DNA polymerase chain reaction (PCR) analysis was performed at the AIDS Reference Laboratory of the Ghent University, Belgium. Two independent amplifications were performed for each sample. When no sample was available at 6 weeks, the PCR result of the 14 week sample was used to calculate the overall transmission of HIV-1. When there was no 14 week sample and the 6 week sample was negative, the result was not included in the calculation of the overall perinatal transmission rate. When the 6 week sample was positive with a missing value at 14 weeks, the child was considered positive.

Data were entered in Epi Info 6.04 and analysed using SPSS 10.0 (SPSS Inc., Chicago, IL, USA). Fisher's exact test was used to analyse the correlation between the intake of nevirapine and the PCR result.

The overall HIV-1 prevalence rate was 14%, similar to earlier findings in the same maternity setting [2,5]; 482 HIV-1-positive women were enrolled in the programme, of whom 172 presented for follow-up at 6 or 14 weeks. Over 58% of the women who came to Coast Province General Hospital for antenatal care delivered at the hospital, 19% delivered at home, and 22% delivered in another hospital. More than 85% of the women (147/172) reported taking the nevirapine tablet, 86.0% of babies (148/172) were given the suspension, and 82% (141/172) reported the administration of both the maternal and neonatal dose.

We obtained blood samples for 127 babies, and found an HIV-1 transmission rate of 18.1% at 14-16 weeks (Table 1). There was no correlation between the intake of nevirapine by the mother only, intake by the baby only, or the intake of nevirapine by both, and the neonatal HIV-DNA PCR results at 14 weeks (P = 0.887, P = 0.336, P = 0.529, respectively).

Table 1. Comparison between transmission rates at 6 and 14 weeks in a breastfeeding population in Coast Province General Hospital, Mombasa.CI, Confidence interval; CPGH, Coast Province General Hospital; RCT, randomized controlled trial.


In 1999, before the availability of nevirapine or any other antiretroviral drugs, we described an early perinatal transmission rate of 21.7% at 14 weeks. This is similar to the 18.1% transmission at 3 months since the introduction of the nevirapine intervention (relative risk 1.20; 95% confidence interval 0.78, 1.84; Table 1). Transmission rates beyond 6 weeks are scarce; the HIVNET012 study reported a rate of 13.1% at 14 weeks, which is lower than the 18.1% we found in the Mombasa setting.

Our findings question the usefulness of the current prevention of mother-to-child transmission recommendations based on HIVNET012, which have been implemented in resource-poor settings, based on just one observation in a clinical research setting. Our data could be subject to discussion because of the limited numbers, and because of the historical control. Nevertheless,
all characteristics of the population have largely remained unchanged over the years, including the HIV-1 prevalence rate of 14% since 1995.

These data, suggesting a rather limited effect of the widely recommended HIVNET012 intervention, call for further research on the long-term efficacy of the HIVNET012 regimen in a field setting. Taking into account the low coverage of the nevirapine regimen [5], the lack of benefit for maternal health, the concerns about resistance, the enormous deployment of resources needed to provide nevirapine within the current voluntary counselling and testing paradigm, and the reported lack of efficacy in real-life conditions,
the true health gains of the intervention should be reconsidered.

Acknowledgements
The luerlock syringes used for the neonatal dose were provided by Boehringer-Ingelheim.

Sponsorship: The study was funded by the Flemish Inter-University Council (VLIR). Ethical approval was obtained from the Ethical Board of the Ghent University, Belgium, and Coast Province General Hospital, Mombasa, Kenya.

A. Quaghebeur was the prinicipal investigator; L. Mutunga was responsible for administration and data management; F. Mwanyumba helped with clinical work, data management and analysis; K. Mandaliya guided the implementation of the programme; C. Verhofstede conducted the HIV-DNA PCR analyses; and M.Temmerman designed the study and edited the manuscript.

References
1. Guay LA, Musoke P, Fleming T, Bagenda D, Allen M, Nakabiito C, et al.
Intrapartum and neonatal single-dose nevirapine compared with zidovudine for
prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda:
HIVNET 012 randomised trial. Lancet 1999; 354:795-802.
2. Gaillard P, Mwanyumba F, Verhofstede C, Claeys P, Chohan V, Goetghebeur
E, et al. Vaginal lavage with chlorhexidine during labour to reduce
mother-to-child HIV transmission: clinical trial in Mombasa, Kenya. AIDS
2001; 16:389-396.
3. Stringer JSA, Sinkala M, Chapman V, Acosta EP, Aldrovandi GM, Mudenda V,
et al. Timing of the maternal drug dose and risk of perinatal HIV
transmission in the setting of intrapartum and neonatal single-dose
nevirapine. AIDS 2003; 17:1659-1665.
4. Ayouba A, Tene G, Cunin P, Foupouapouognigni Y, Menu E, Kfutwah A, et al.
Low rate of mother-to-child transmission of HIV-1 after nevirapine
intervention in a pilot public health program in Yaoundé, Cameroon. J
Acquired Immune Defic Syndr Hum Retrovirol 2003; 34:274-280.
5. Temmerman M, Quaghebeur A, Mwanyumba F, Mandaliya K. Mother-to-child HIV
transmission in resource poor settings: how to improve coverage? AIDS 2003;
17:1239-1242.
© 2004 Lippincott Williams &Wilkins, Inc.

"The NIH's AIDS department were crucial toward gaining worldwide endorsement of HIV as the "probable cause" of AIDS, and they control most of the funding for AIDS research."

What's the evidence for that?
Because it seems to me that scientists usually make up their minds by themselves.
(The scientists I work with are all pretty damn opinionated, and I don't think the NIH even HAS an opinion about their field)

The fact that NIH controls much of the funding does not explain to me why non-NIH researchers also believe the HIV hypothesis.

Wasn't all that hoopla just because of a war-caused famine in Ethiopia?
Africa's a big place, Hank.

BTW - In it's recent decision to provide PEP to the general public the CDC cited this very study as part of it's rational for it's efficacy and safety. There are consequences to these actions far beyond just one bad study.

Oh for crying out loud! What may have been misrepresented or fudged if you prefer was data regarding the efficacy of the treatment - NOT the prevalence of HIV or the consequences of HIV infection.

Look at some of the earlier non-NIH studies (mostly European or local studies). Depending upon the study, HIV positive children are anywhere between 5 and 10 times more likely to die before they reach the age of 5 than are HIV negative children. Up to 50% mortality before age 5 if youre' seropositive and 5-10% if you're seronegative. And that's without retrovirals.

As Jeremy said, the problems with this particular study or with NIH clinical trials in general, doesn't change the evidence that HIV causes AIDS.

make that:

and other vaulted institutions, I'm just supposed to keep the faith right?

Oh come on! We'd need a whole new thread to argue about inflated African Aids numbers. That's mainstream news. You want me to trust that one little tidbit of data over all else? I suppose you're in favor of giving the momma of these kids nevarapine in spite of what was revealed about the studies on it because "Africans deserve some leniancy in safety standards" too? Who cares if the studies are fudged we just want to help these poor dying souls? If you are so concerned about them - wouldn't it be nice to know for sure that your help is warranted?

More African trials ...

Moodley et al JAIDS 2003 (South African trial)

This trial compares two treatments Nevirapine &another (AZT + something else)

There were a total of 1331 infants born of whom 175 were HIV+ by 8 weeks of age. During trial, 38 died. Now if the drugs are causing problems and the fatalities, since most of the infants in this study were hiv negative, most of the dead infants should also be hiv negative. But 31 of 38 were hiv positive.

How is this data consistant with a "drugs cause AIDS" hypothesis?

Or this study ...LeRoy AIDS 16,601

Compares zidovudine with no treatment. About 40% more infants are HIV positive in the no treatment group (94 vs 68 treated with zidovudine). Deaths were 39 in the treated group and 68 in the untreated group. In both cases more than 75% of the children who died were confirmed to be HIV positive.

Again, if "drugs cause AIDS" shouldn't there have been more deaths in the treated children and shouldn't the deaths have been more evenly distributed between HIV positive and negative children if HIV is a harmless passenger virus?