Re: Chennai & Bangalore: Anti-AIDS gel trial called off

[Guest guest]

Dear All:

This is indeed a trying time for eggheads at CONRAD, and indeed everyone in the

AIDS community. It is a major set back for women among all of us.

The alertness and impartial role played by the Data Safety and Monitoring Board

must be commended for halting a second Phase III trial of Cellulose Sulphate

(CS) microbicide use. The data analysed for three African sites suggested that

cellulose sulphate – main ingredient in the vaginal cream – had led to increased

risk of HIV infection in women as determined by the number of incident HIV

infections among those who used the compound.

However, YRG Care in Chennai and St. 's in Bangalore have claimed that they

did not observe any seroconversion among 300 women, the Chennai followups seem

to have been for only 6 months as compared with longer followup at African

sites!

How many seroconversions would YRG Care have expected to determine if

microbicide was effective or detrimental. Were they using molecular diagnostics

to pick up early infections?

While one can argue several ways, the picture on the wider canvass is generally

missed in these debates.

Why should global efforts on vital clinical trials such as microbicides be

entrusted by the US government agencies to contractors such as CONRAD?.

US government has its own national research institutions and universities to do

a good, ethical job of these trials. Again, while the African side used

government institutions, the Indian side despite having good, ethical

institutions and universities used small NGOs for a clinical trial of such

global importance.

Somewhere, we sence a lack of will on the part of Indian govt to shrug its

responsibilities and let MNCs play, buy or bribe their agendas with vulnerable

NGOs. In this game, the end losers are women!

Having messed things up, can goverment agencies in India do a proper audit of

this trial and inform the world on how many women got infected due to the trial?

Did observations of animal stuides of cellulose sulphate on animal genitals

differ from what these trials observed in women genitals?

Till this is done, all US funded projects to these NGOs should be put on hold.

Deeply concerned....

Anon

[Guest guest]

Dear FORUM,

Ref: /message/6890

I would like to correct a number of factual inaccuracies in the previous

anonymous posting. CONRAD is not an MNC but rather part of the Eastern Virginia

Medical School and has a worldwide reputation for scientific competence and

integrity.

The trial in question has had rigorous review by ethical review groups both in

the US and in each of the localities where it has been conducted. In India,

this also included review by the Indian Council of Medical Research (ICMR), the

Drugs-Controller and the Health Ministry Screening Committee. One of the

previous safety studies on the product was conducted by WHO and included a

center in India.

CONRAD contacted Indian gov't institutions, as well, to see if they were able to

participate, but in fact, one of them NARI had just withdrawn from a US Gov't

study because of low incidence. CONRAD is actively collaborating with the ICMR

to evaluate other ICMR sites where incidence might be appropriate for future

studies. That said, YRG Care and St. 's are highly reputable organizations

that also are held in high regard by the international community.

The accusations of bribery and other inappropriate activities are nonsense.

It is indeed extremely disappointing that the cellulose sulphate gel trial ended

this way and we wish that these studies could be done without exposure to the

risk of HIV, but they cannot and all the volunteers receive extensive counseling

urging the use of condoms and to change their behavior to eliminate risk.

Unfortunately, that is not sufficient for if it were, we would not need

microbicides.

Henry L. Gabelnick, Ph.D.

Executive Director

CONRAD

1611 North Kent Street, Suite 806

Arlington, VA 22209

tel: 1-703-276-3904

fax: 1-703-524-4770

cell: 1-301-529-9078

www.conrad.org

e-mail: <hgabelnick@...>

[Guest guest]

Dear AIDS India forum members,

Re: /message/6890

I think everyone on this listserve would agree that it is absolutely

essential that HIV prevention research should be held to highest

ethical and scientific standards.

The Indian Campaign for Microbicides is a coalition of NGOs and individuals

working to both encourage more research into new prevention options like

microbicides, but also to make sure that this research is accountable, ethical,

and scientifically sound. Our concern for women's health, is the reason we

support this important research

Since the news of the cellulose sulfate trials was released we have

been working with our international counterpart, the Global Campaign

for Microbicides, and speaking directly to the researchers and

community advocates working on microbicides trials in India and

Africa to understand what happened in these trials and what the

follow-up process will be.

We agree that it is important at such times to raise questions, but

also to recognize that to some important questions, there are clear

answers...and answers that in this case, should lead us to feel more

comfortable with the research not less.

The reason that there was less follow up time in the Chennai and

Bangalore was because the trial through St. 's had just started

enrolling (frequently sites in a multi-center trial begin in a

staggered fashion). The Chennai site had begun earlier, but a

decision had already been taken to discontinue that site because the

HIV was too low to make it possible to evaluate the gel here. This

speaks to the prevention services and support being offered by YRG

care (and the lower than expected incidence in the women they are

serving).

The anonymous posting on Friday expressed concerns about partnering

with local NGOs rather than large government institutions.

In fact, other microbicides trials have partnered with the Indian

government to coordinate this important research. In India and

Africa , HIV prevention trials partner with organizations that have

the capacity to soundly and efficiently carry out the research and

have a strong and positive relationship with communities in which the

trials are being conducted.

From our discussions with the community, St. 's and YRG Care met

this criteria. In our view, it is a strength of this study to partner

with these NGOs, rather than a weakness. It ensures that those

implementing the research have a better understanding of the needs of

the communities that participate in these trials. The best

collaborations are those between people who understand research and

those who understand community.

In terms of the safety and testing of the product, it is important to

note that cellulose sulfate went through 11 safety trials in humans.

The research findings demonstrated that cellulose sulfate had a very

promising safety profile. Once the gel was tested in large-scale

effectiveness trials, all participants were informed that the

protective efficacy of the gel was unknown and they should always use

condoms to protect themselves. In addition to a provision of condoms

and counseling all participants received STI treatment if needed.

As for the means of identifying HIV infections, yes the study used

state of the art molecular diagnositcs to identify incident

infections.

Recall, that in all of the African sites, only 35 women became

infected overall, including women using both the CS gel and a

comparison gel without the active ingredient.

Given the shorter time that the women in the India trial sites had

been enrolled and the lower seroincidence in these sites, it is

entirely believable that no women had seroconverted at the time of

the interim analysis of the data.

There is still a small chance that when women from these sites come

in for their final visits, one or more women will have acquired HIV.

It is our understanding that the researchers have taken this into

account and will be allowing for adequate follow-up time.

As for the government's responsibility, we agree that more can and

should be done to support and monitor clinical research in India.

The Indian Council for Medical Research has begun to take these

steps, is involved in this area of research and is a part of the

National Working Group on microbicides(NWG)

We agree that as advocates, it is important to work together to hold

all research to the highest ethical and scientific standards. But

perhaps the real problem with medical research in India is the

proliferation of unchecked industry-sponsored research, not trials

like the cellulose sulfate trials that are done as collaborations of

not-for profit entities, designed to address a major Indian and

global public health need.

Indeed this is an opportunity for civil society and others to reflect

on the wider canvass of biomedical research in our communities and

think through how we can achieve ethical standards to which trial

participants are entitled, while pursuing the prevention and

treatment technologies that our communities urgently need.

The Global Campaign for Microbicides has been collecting advocate's

questions about the cellulose sulphate trial and is seeking to get

answers from microbicide experts, investigators and others. A list

of questions and answered collected to date is available at:

www.global-campaign.org/cellulose-sulfate.htm.

If advocates in India have additional concerns we encourage you to

post them to this forum. We will work hard to try to find the answers

and share them.

Sincerely,

Paramita Kundu

India campaign for microbicides

e-mail: <paramita@...>

[Guest guest]

Dear Forum,

Thanks that CONRAD has responded with some information, albeit with an angry

tone.

/message/6909

It has tactfully avoided denying that CONRAD is a contractor for USAID and/or

National Institutes of Health, USA for conducting these cellulose sulphate

microbicide trials in developing countries. Using tenofovir or neem containing

gels is understandable, but can some one also enlighten us why they used

cellulose sulphate. Next we might hear of a trial using toothpaste!

I also hope to see the response of Indian Council of Medical Research and Drug

Controller of India on this Forum since CONRAD claims of their clearances and

get information about what investigations Indian agencies are doing for women

who might have got infected during these trials in Chennai and Bangalore. Also,

an endorsement of safety that CONRAD claims was given by WHO will be reassuring

to this Forum if WHO also shared its findings with all of us.

It surprises me to see stoic silence of YRG Care, Chennai and St 's

hospital, Bangalore.

It is in public interest that these NGOs provide factual information justifying

their involvment in these trials.

Hidding behind US contractors is not a valid reason for us all to believe that

these NGOs did everything right! Wonder what human rights groups have to say

about this blunder...they can also remain anonymous.

Concerned....

Anon

[Guest guest]

Dear FORUM,

So many vested interests in HIV/AIDS are blocking progress!?

One of the predominent one is to link HIV with reproductive health.

THERE HAS NEVER BEEN A MICROBICIDE TRIAL THAT WORKED AGAINST HIV IN 20 YEARS.

Microbicides are spermicides which have some efficacy - not 100% but in the

order of 80% against unwanted pregnancy. Any adult woman knows that. When

Nonoxinol 9 showed effects against HIV in the test tubes there were hopes that

were very soon dashed by experiements in rich countries. However that did not

stop a trial of many years in Cameroon which shown N9 ENHANCED HIV Transmission.

To this day, ALL United Nations organizations, World Bank and private

stakeholders like Gates still mentions up front on the research agenda

" Microbicides " , (and fund-support-promote)this in spite of 18 years of counter

evidence.

At the same time, there is outrage whenever blood exposure to HIV is mentioned

and the lastest Dec 2006 UNAIDS update mentions HIV transmission among IVDU

sharing syringes every where. But, as usual, there is not one single mention of

the fact that poor people do share needles in India or Africa!

It is estimated that up to 25% of patients contract a nosocomial infection in

health care setting in Africa (figure mentioned by the Uganda Minister of Health

at the United Nations palace WHO event last fall, an estimate mentioned by

WHOAFRO as well). Yet, somehow, one can catch any bloodborn infection in a

hospital setting from lack of sterilisation but stangely enough not HIV!

What is the presumed difference between a poor patient and an IVDU user? What is

it that makes that dirty syringe safe in one

situation and unsafe in another?

Further, Recent studies have shown that malaria plays a role in increasing

SEXUAL transmission of HIV, this is because in the case of

co-infection, HIV viremia shoots up.

Now, one may wonder, which situation is more likely when person with HIV has an

acute malaria crisis:

He/She has lots of sex?

He/She goes into a health care center?

It would seem obvious that a lot of patients have co-infections in health care

settings which makes re-use of dirty needles extremely dangerous.

Last but not least: the issue of transmission of HIV/other bloodborn pathogenes

etc, makes life dangerous for PLWHAs seeking treatment. Contracting Hepatitis,

other HIV viruses, sometimes HIV viruses already resistant to ARV, is a life and

death issue for PLWHAS.

So to sum up: Seems to me that to speak out on non-sexual transmission of HIV

and to stop dirty injections is in everyone's interest, ney a MUST FOR THE RIGHT

TO HEALTH

However, the promotion of microbicides interest 1) people who have financial

investment in microbicies and 2) people who seek to

promote reproductive health.

Now, as a woman, I am in favor of reproductive health. But to push that agenda

using HIV as a trojan horse is disgusting, for it

will kill many women. It already has claimed 40 million lives

An angry reader

Garance Upham

e-mail: <g_upham@...>