AFRO-NETS> Illegal Drug Trials in Developing Countries

["Dr. Arun Grover" <grovers@id.eth.net>]

Illegal Drug Trials in Developing Countries
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Articles which came in the INDIAN NEWS recently....

John Hopkins using Kerala patients as guinea pigs: RCC

THIRUVANANTHAPURAM: A major controversy seems to be brewing over the
alleged trial of a drug on unsuspecting cancer patients at a hospital
here by the world-famous Johns Hopkins University of the US. The
drug, tetramethyl nordihydroguiaretic acid or NDGA (M4N), was alleg-
edly tested on 24 patients over the last two years at the Regional
Cancer Centre (RCC) here, soon after it was tested on 36 mice in the
US. Reports in the local media said the drug was tried on patients
suffering from head and neck tumors during 1999-2000. Several com-
plaints have already reached Chief Minister A.K. Antony's office.
Also, some of the RCC doctors are planning to take matters to court.
The trial of another drug, Foscan, at the RCC has raised hackles as
the Food and Drug Administration (FDA) of the US and the European
committee empowered to give approval for drugs have more than once
blocked clearance. A senior RCC doctor said the issue came to light
"when one of the doctors in RCC found out that his patients were be-
ing used as guinea pigs for this new derivative, without his consent.
"When he protested he was sidelined and he has now approached the
State Human Rights Commission and the Kerala High Court for justice."
"The team led by the RCC director Dr M. Krishnan Nair instead of re-
moving the tumors on the 24 patients as soon as they were detected,
delayed the surgical intervention for varying periods to find out the
efficacy of the chemical on cancer cells," he said. In fact, Nair, in
a press statement on February 28, took a joint credit with John Hop-
kins University in announcing that the drug had been effective in
treating certain cancers caused by viruses, the media reports have
said. However, sources said the RCC had no role in the development of
the drug except in its trial on patients. However Nair added: "We got
the consent of all the patients and moreover the ethical committee
has also cleared this." But a senior doctor at the RCC alleged that
Nair allowed phase III trials of an untested chemical on unsuspecting
patients by making them believe they were being treated with the lat-
est drug from the US. Phase I and II trials in all countries pertain
to human trials. Earlier, in 1996, the university was the target of a
huge public outcry after the state government gave it the go-ahead
for its Asian School of Public Health at Munnar. People feared the
local population would be used as guinea pigs for medical research.
(IANS )
http://timesofindia.indiatimes.com/articleshow.asp?catkey878156304&art_id2 
145455933&sType1


Saturday, July 28, 2001 (Thiruvananthapuram, INDIA):

Thiruvananthapuram Regional Cancer Centre (RCC) admits it had not ob-
tained the Drugs Controller-General's permission before drug trials.
The Centre has been accused of using poor patients as guinea pigs to
test unapproved cancer drugs. What is more shocking is that a member
of the RCC's ethical committee says new drugs are often tried out
even before the trials are cleared. Facing charges of having used un-
suspecting cancer patients to test unapproved drugs, the Thiruvanan-
thapuram Regional Cancer Centre has been busy issuing denials. But,
at its first press conference after the story broke, the institute
has almost indicted itself. By its own admission, the RCC's drug tri-
als on behalf of the US-based Johns Hopkins University had no prior
permission from drugs control authorities in India. Dr M Krishnan
Nair, Director, Regional Cancer Centre, Thiruvananthapuram, said, "We
agree to a lapse on our part in this. But the Drugs Controller-
General's permission is not at all required for drug trials. If the
ethical committee and the hospital's doctors are ready to conduct a
drug trial, that is possible."
http://www.ndtv.com/morenews/showmorestory.asp?id15267

Other links on the same NEWS:
http://timesofindia.indiatimes.com/articleshow.asp?catkey2128672765&art_id 
1200939353&sType1
http://timesofindia.indiatimes.com/articleshow.asp?catkey878156304&art_id521154873&sType1
http://timesofindia.indiatimes.com/articleshow.asp?catkey878156304&art_id41242079&sType1
http://www.ndtv.com/morenews/showmorestory.asp?id15171

--
Dr. Arun Grover
BDS, MSc.(London), DDPHRCS (England)
1, Shakti Vihar
Pitampura
Delhi 110034, India
mailto:grovers@id.eth.net


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