Can the folks from Nyumbani refute this story/Shame of children used in experime

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It just bothers us on what is going on!!

Shame of children used in experiments on Aids

Story by SUNDAY NATION TEAM

Publication Date: 05/23/2004

D'Agostino

Nyumbani Children's Home is again at the centre of a controversy over

unauthorised research on HIV/Aids babies under its care.

The controversy was sparked off by scientists from Britain's

Cambridge University launching a new Aids study using children at the

Nairobi orphanage, despite the home being under investigation by the

Kenya Government for allowing another UK university to conduct tests

without permission two years ago.

Dr , a researcher from Cambridge University who left

Nairobi just over a week ago having spent about a month at Nyumbani

orphanage, confirmed to the Sunday Nation that he was aware the home

was at the centre of a bitter dispute pitting Kenyan researchers and

the Government against scientists from the University of Oxford's

Human Immunology Unit.

The controversy centred around the export of blood and other samples

to Britain without permission from the Kenyan Government.

Dr said he would continue his research although he conceded

that he had not met scientific protocols which include getting

ethical clearance from the National Council for Science and

Technology and being affiliated to a local institute licensed to

undertake research.

Nyumbani Children's Home, which caters for orphans whose parents have

died from HIV/Aids, is not authorised to undertake the kind of

research he was conducting.

It would seem Dr , who was accompanied by a colleague, was

acting on the assumption that since scientists led by Dr

Rowland- of the University of Oxford's Nuffield Department of

Medicine had not only taken blood and other samples from the children

but also exported the materials to Britain without the authority or

ethical clearance from the government, he too could do the same.

The orphanage, which is officially registered as a limited company

under Cap 486 of the Companies Act, is home to 70 children but

indirectly caters for about 1,000 others through community projects

in the city's slum areas. It raises funds from the United States

Agency for International Development (Usaid), among other

international aid agencies.

Earlier investigation

Mr Godo

The Permanent Secretary for Health, Mr Wellington Godo, told the

Sunday Nation last week that he had instructed the Director of

Medical Services, Dr Nyikal, and the Director of the Kenya

Medical Research Institute, Dr Davy Koech, to follow up on an earlier

investigation into the controversial Aids research, which was ordered

by a former Minister for Health, Prof Sam Ongeri.

The earlier investigation came about after a senior research

scientist and head of virology at the Institute of Primate Research,

Dr Moses Otsyula, who had set up a diagnostic laboratory at the

orphanage on behalf of the institute for continuous monitoring of the

infected children, blew the whistle on the clandestine study that he

discovered was being carried out in April 2001 by Dr Rowland-

and her students, Rana Chakraborty and Jedidah Dixon.

Dr Otsyula's complaint was based on the grounds that the University

of Oxford researchers had taken blood samples from the children

without the permission of either the Government or the home's board

of directors, a position the then chairman of the home, long-serving

diplomat Dennis Afande, had confirmed.

Also being questioned was a decision by Father Angelo D'Agostino –

the Catholic priest running the orphanage – to allow the British

researchers to export to the UK both fresh blood samples and frozen

ones.

The researchers from the University of Oxford, despite conceding that

the protests from Dr Otsyula were valid and that they had breached

scientific protocol since no permission was sought from the ministry

of health or ethical clearance obtained from the government, went

ahead to publish their report in scientific journals and to present

papers at international meetings.

The Sunday Nation has established that Prof Ongeri, then Permanent

Secretary Prof Julius Meme, and a former Director of Medical

Services, Dr Muga, were informed about the goings-on at the

orphanage and an investigation team headed by Dr Koech was set up,

but its work was disrupted by the 2002 General Election that saw Kanu

lose power to the National Rainbow Coalition.

Dr Muga, before he was replaced late last year, had sought additional

information about the research. The documentary evidence presented to

the ministry in September last year, and which was made available to

the Sunday Nation, indicates that besides the illegal research at the

orphanage, and export of the blood samples, the Oxford researchers

had published two articles.

The first paper was published in the ls of Tropical Paediatrics

(2002) 22: 125-131 and is titled The Post-mortem Pathology of HIV-1

infected African Children. It is authored by Rana Chakraborty, Angelo

D'Agostino and others. Fr D'Agostino is not a scientist.

No consent given

Dr Koech

But that is not where the inconsistences end. On page 127, the report

indicated that consent to publish the findings was obtained from

Internal Ethical Review Board of the orphanage. This board, the

Sunday Nation has been reliably informed, has no mandate to give such

consent as it is not affiliated to the Health Sciences Specialist

Committee of the National Council for Science and Technology.

The second research was published on March 26, 2003 in the Clinical

Infections Disease Journal pages 36: 922-924. The article was titled

Viral Co-infections Among African Children Infected with Human

Immunodeficiency Virus Type 1. The authors are given as Rana

Chakraborty, Gereth Rees, Dimitra Bourboulia, Jedidah Dhon, andra

M. Cross and Angelo D' Agostino.

The report indicates that the samples used to reach the conclusions

in the research were obtained from Nyumbani Children's Home in

Nairobi. The article also indicates that informed consent was

obtained from the legal guardian of the children. It is also

indicated that the Research Ethics Committees at the University of

Oxford and the National Council of Science and Technology in Nairobi

approved all the studies.

But the only ethical clearance granted in connection with tests at

Nyumbani was to Dr Otsyula, through the Institute of Primate

Research, on January 8, 2001. It is, however, not transferrable as a

researcher has to submit a proposal which is reviewed before the go-

ahead is granted.

Kenyan researchers say that lack of ethical clearance and the

questionable export of blood samples have undermined the credibility

of the study.

Fr D'Agostino was said to be out of the country. He will return in

the first week of June. The chief manager at Nyumbani, who said he

was in charge in the absence of Fr D'Agostino, Mr Protus Lumiti,

acknowledged that Dr from Cambridge University visited

Nyumbani last month along with his friends to explore the possibility

of working with the Home on a research on food supplements.

Once the Home received his proposal in April this year, Mr Lumiti

said, they handed it over to the relevant authorities for the

necesssary action. He was aware that Dr visited other

institutions which include the University of Nairobi and the Kenya

Medical Research Institute and talked to their scientists with a view

to selling his idea to them.

Saying that it was the second time Dr was visiting the Home,

Mr Lumiti denied that any blood or other samples were taken from the

children and exported to Cambridge. If, indeed, any samples were

taken from the children, " I would be the first one to know as I am

with the children 24 hours a day''.

" No blood or any other samples taken from the children were

exported,'' said Mr Lumiti.

Dr Nyikal

He said that although the government had recognised the Home as the

legal custodian of the children, no research would be undertaken

there without its consent.

Mr Lumiti laughed it off when he was informed that the Home was being

investigated for allowing research on HIV/Aids without consent from

the relevant government authorities. He said those allegations had

been raised all along since the Home was set up 10 years ago.

A member of the Nyumbani Board of Directors, Sister Owens, said

she was not qualified to comment on the status of scientific research

undertaken at the home.

She said: " I am not aware of any unauthorised studies at the Home as

I am not a medical doctor and, therefore, would not know if the

children are being used as guinea pigs. I am only a counsellor.''

Fr D'Agostino is on record as having denied allowing any research at

the Home, despite publication of the two articles. However, he has

sought to justify the export of the blood samples on the grounds that

Kenya does not have the laboratory facilities required to undertake

the kind of study done at the University of Oxford.

In the March 26, 2003 article, the authors assert that they received

informed consent from the children's guardian, but the guardian of

the children is not Fr D'Agostino; it is the orphanage's board of

directors. It is understod that the board turned down the request

from the researchers.

Besides, the Sunday Nation has been made to understand that, even if

the cleric was qualified to be the children's legal guardian, it

would be unethical for him to carry out research on the same

children.

Compiled by Okwembah, Victor Bwire and Nzioka

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