NIH-Sponsored AIDS Drugs Tests on Mothers and Babies

[Guest guest]

1 Jul 2005 19:55:15 -0000

NIH-Sponsored AIDS Drugs Tests on Mothers and Babies

press-release

 

 

The Institute of Science in Society Science

Society Sustainability http://www.i-sis.org.uk

 

General Enquiries sam Website/Mailing

List press-release ISIS Director

m.w.ho

==================================================

======

 

ISIS Press Release 01/07/05

 

NIH-Sponsored AIDS Drugs Tests on Mothers and

Babies

 

***********************************************

 

Sam Burcher

 

Sources for this report are available in the ISIS

members site. Full details here

 

Deaths and adverse events in Uganda

 

***********************************

 

The United States National Institutes of Health

(NIH) began studies on mother-to-child

transmission of HIV in Uganda in 1997. A single

dose of nevirapine was given to labouring mothers

and to their newborn child. Those studies were

reported to have lowered transmission of HIV by

50% [1].

 

But by 2002 , problems with the US-funded drug

trials had been disclosed by an NIH auditor,

medical experts and Boehringer Ingelheim, the

makers of nevirapine [2].

 

The NIH hired Westat-Corp, a professional medical

auditing firm to audit the Ugandan testing sites.

Westat-Corp's report stated [3], " It appears

likely in fact, that many adverse events and

perhaps a significant number of serious adverse

events for both mother and infant may not have

been collected or reported in a timely manner. "

The " adverse events " included 14 deaths and

thousands of severe reactions that went

undisclosed. The NIH subsequently recorded all

deaths and the majority of adverse reactions, but

blamed them on the poor health of the patients,

not on nevirapine.

 

In December 2004 , the Associated Press claimed

that the adverse events in Uganda were censored

and unknown to President Bush in 2002 when he

announced his $500 million plan to push nevirapine

across Africa to a million women a year. But

before the plan went into effect, The NIH shut

down the Ugandan research until the summer of 2003

to review the science and to make the necessary

amends. They asked the National Academy of

Sciences to investigate the case and spent

millions of dollars on improving record keeping

and safety monitoring. A top NIH disease official

reviewing the case concluded that the use of

nevirapine even in single doses could confer

instant drug resistance to HIV - positive

patients, which would prevent the use of any other

available antiretroviral drugs for future

treatment. Therefore it was unsuitable as a first

drug of choice.

 

South African journalist and lawyer Anthony Brink

published an article, The trouble with nevirapine

[4 ], which revealed that all the pregnant women

were on either AZT or nevirapine. There were no

placebo groups. Brink saw the results of the

unblinded trials, which c oncluded with an

official recommendation for nevirapine. Side

effects such as severe rash, pneumonia, blood

cell-death , insufficient oxygen to tissues and

blood , and tissue infection were recorded at 20

percent in both the AZT and nevirapine groups .

Thirty-eight babies died; 22 in the AZT group and

16 in the nevirapine group. A further 16 deaths

came to light in documents recently disclosed by

Boerhingher Ingelheim, mostly in the Nevirapine

group. But nevirapine gained approval because the

rate of viral infection measured with PCR (a non -

diagnostic test) was 13.1 percent in newborns.

 

Although all the women had tested positive for

HIV, it is known that pregnancy produces

antibodies that can give a false positive test

result. A further anomaly noted by journalist Liam

Scheff was that the newborn babies were tested for

HIV transmission at 6 weeks and 14 weeks using a

PCR testing kit called " the amplicor HIV-1 monitor

test " , But PCR is not approved for viral testing

and the manufacturers specifically warn against

using it for the purpose of diagnosing HIV (Roche

PCR HIV-1 Monitor Test). Furthermore, eighteen

months is considered the earliest age for testing

mother to child transmission of HIV [5].

 

In contrast, a study conducted on 561 expectant

African mothers to assess the rates of mother-to-

child transmission of HIV using no drugs, pills or

placebos was 12 percent [6].

 

Boeringher Ingelheim had donated 411,000 doses of

nevirapine to Africa, but withdrew its application

to the FDA for approval for use in single dose on

infants in America on the premise that better

treatments have emerged.

 

Africans used as guinea pigs

 

****************************

 

The South African government responded to the

Associated Press revelations by carrying an

article in the ANC online journal ANC Today on 17

December 2004, accusing top US officials of

treating Africans like guinea pigs and telling

lies to promote the sale of AIDS drugs [7]. Jesse

Jackson, the black civil rights activist and

official US envoy to Africa, called for an US

congressional investigation and demanded that

nevirapine no longer be distributed in Africa. He

said, " This was not a thoughtful and reasonable

decision, but a crime against humanity. Research

standards and drug quality that are unacceptable

in the US and other Western countries must never

be pushed onto Africa " [8]. (But see " Guinea-pig

kids " , this series)

 

Some doctors in Africa support the use of the drug

, however; saying that without it many more babies

would be born with HIV.

 

Kenyan study confirm s low effic a cy of

nevirapine

 

A study on nevirapine in a hospital setting in

Kenya examined the results of 172 breastfeeding

women who presented their newborns for follow-up

test after receiving a single dose of the drug.

Blood samples were taken from babies at 6 weeks

and 14 weeks after birth. Before the availability

of antiretrovirals, HIV mother to baby

transmission rate at the Coast Province General

Hospital was 21.7 percent. After the use of

nevirapine, the transmission rate was similar at

18.1 percent. The overall prevalence of HIV at the

hospital is 14 percent, which has remained steady

since 1995 [9].

 

The study concluded that the limited effect of

nevirapine confirms the lack of benefits for

maternal health and justifies the concerns about

drug resistance. It also questions the enormous

development of resources to provide nevirapine and

recommends that the true health gains of

nevirapine should be reconsidered.

 

Nevirapine tested on US mothers to be

 

**************************************

 

But African mothers are not alone in being used as

test subjects for nevirapine. Nevirapine is known

as viramune in the US. The NIH sponsored a trial

of viramune with expectant mothers in 2004 [10].

Joyce Halford was persuaded to take part in the

trial by her doctors because she had tested HIV -

positive during her pregnancy; otherwise she was a

healthy 33 year-old . Some way into the trial, her

doctors knew her liver was failing, but she was

kept on viramune and died two weeks later of drug

- induced hepatitis. Her child was cut from her in

her dying moments. She and her family had not been

shown the explicit warning on the viramune label

that specifically states, " Patients with signs or

symptoms of hepatitis must discontinue viramune

and seek medical evaluation immediately. "

 

 

==================================================

====== This article can be found on the I-SIS

website at http://www.i-sis.org.uk/

 

If you like this original article from the

Institute of Science in Society, and would like to

continue receiving articles of this calibre,

please consider making a donation or purchase on

our website

 

http://www.i-sis.org.uk/donations.

 

ISIS is an independent, not-for-profit

organisation dedicated to providing critical

public information on cutting edge science, and to

promoting social accountability and ecological

sustainability in science.

 

If you would prefer to receive future mailings as

HTML please let us know. If you would like to be

removed from our mailing list at

 

http://www.i-

sis.org.uk/mailinglist/.php

==================================================

====== CONTACT DETAILS

 

The Institute of Science in Society, PO Box 32097,

London NW1 OXR

 

telephone: [44 20 8452 2729] [44 20 7272 5636]

 

General Enquiries sam Website/Mailing

List press-release ISIS Director

m.w.ho

 

MATERIAL IN THIS EMAIL MAY BE REPRODUCED IN ANY

FORM WITHOUT PERMISSION, ON CONDITION THAT IT IS

ACCREDITED ACCORDINGLY AND CONTAINS A LINK TO

http://www.i-sis.org.uk/