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Trial
And Error
Clinical
tests of a controversial drug at a Kerala cancer institute exposes the
vulnerability of the medical field to a larger malaise. An investigation
by INDIA TODAY Special Correspondent M.G. Radhakrishnan.
Sitting
in his tiny hotel room near Thiruvananthapuram's Regional Cancer Centre
(RCC), Muthuswami Gopalan shows his radiation-blackened neck. With what
seems like a great deal of effort, the 64-year-old tailor from Tiruppur
in Tamil Nadu whispers: "The pain is simply unbearable now."
Gopalan isn't the only cancer patient in this state. Like him, 24 others
underwent clinical trials for cancer in the neck or head at the state-funded
RCC for a drug called M4NDGA—tetramethyl nordihydroguaiaretic acid
(NGDA), or M4N in short—during 1999-2000. While two of them have
died, the others are battling for their lives in excruciating pain. But
far from evoking sympathy and action from the authorities, their plight
has only triggered an ugly controversy, necessitating a state inquiry.
Much of the row centres around the use of M4N, an NGDA derivative that
is extracted from a South American herb, Chaparral, but is banned by the
Food and Drug Association (FDA)of the US for what is believed to be its
toxic properties. But while the toxic nature of chapparel itself continues
to be a source of debate the world over, the RCC chose to test M4N, a
drug developed by a professor at the Johns Hopkins University (JHU), Baltimore,
USA, on human beings last year. Claiming that the project was a collaborative
effort between the centre and JHU, it went ahead and injected M4N into
the tumors of 25 patients who were at the centre.
The test results were less than encouraging. Worse, the JHU has completely
disassociated itself with the project, saying it had neither authorised
nor approved an existing proposal for the same. Already rocked by heavy
curbs clamped on its research by the US federal authorities following
the recent death of a health volunteer during trials for asthma treatment,
JHU insisted that the RCC's claims had come as a shocker and that it had
learned about the issue only from the media. It ordered an inquiry to
determine whether there had been violations of its policies regarding
the protection of human subjects for the proposed project. The probe found
that the study in question had indeed not been reviewed or approved by
any of the university's institutional review boards. The JHU has also
asked Professor Ru Chih C. Huang, the drug's brainchild and initiator
of the project with RCC, to cease all activities related to the study.
According to Huang and sources at the RCC, M4N is effective for oral and
cervical cancers as also Human Papilloma Virus (HPV or wart virus)-induced
tumours. And unlike NDGA, they say the tetramethyl derivative is not found
toxic. But many doctors say M4N has never been tested for its toxicity
and hence it was not correct to conclude that it was not toxic. "Until
the human trials held in RCC, M4N was not a drug, just a chemical,"
clarifies Dr V.N. Bhattathiri, associate professor at RCC who filed a
complaint to the state Human Rights Commission. "The revelation that
the JHU has never approved the study makes the issue even more serious.
It should be inquired not by a single expert as decided by the state government
but a panel of experts from various walks of life."
Echoing him is Dr V.P. Gangadharan, another associate professor at RCC
who alleges that this is only one among a series of murky deals going
on in the centre. The projects, he adds, treats poor patients like guinea
pigs to test drugs developed by multinational pharmaceutical companies.
In the Radiotherapy Department alone, he claims, trials are being done
for eight drugs, mostly funded by developed countries or transnational
pharmaceutical giants. "It is portrayed as a credit to the RCC. A
typical case of the poor in developing countries being used for deadly
experiments as the laws for human trials are stricter in developed countries,"
says Dr C.R. Soman of the Health Action for People (HAP), a voluntary
organisation fighting unfair practices in the medical field. RCC, incidentally,
is a collaborator with Quintiles Transnational, a global company organising
trials for drugs developed by pharmaceutical companies.
Dr M.Krishnan Nair, director, RCC, dismisses the allegations. "M4N
is a derivative of NDGA which is insoluble and has never been found toxic.
It was injected into the tumors which were surgically removed later and
hence can cause no systemic impact. No sideeffects have been seen in any
of the patients," he says. The Washington Post also quotes Huang
as having said that the medicine has no toxicity. "I can only say
that I have done good to the people of India by using this drug. It works
absolutely beautifully," Dr Huang has reportedly said.
Claiming that the RCC had obtained all the required clearances before
it started the human trials, Nair says this includes the Drugs Controller
General of India (DGCI) and the Ethical Committee of the RCC. However,
records at RCC show the clearance from the DGCI was received only in February
this year whereas the trials began as early as November 1999. "We
had discussions with the DGCI in March 1999 regarding the trials. There
was no objection raised and we have taken it as clearance," Nair
clarifies.
Another grave charge concerns the mandatory consent from the patients
before they are subjected to the trial. Though the RCC has all these consent
documents in their files, questions are being raised about the awareness
levels of the mostly poor and illiterate patients about the effects of
the drug. Says patient Gopalan: "I know only Tamil. But they read
out a consent form which was in English and Malayalam. I signed it only
because I thought it was similar to what one signs before one undergoes
any operation."
Experts point out that the signed consent is not evidence enough to justify
human trials in a developing country. The July 12 issue of the New England
Journal of Medicine, for instance, warns in an editorial about the unethical
practices followed by institutions of developed countries when human trials
are done on people in developing countries. "Obtaining a signature
on paper does not ensure that a participant understands the proposed research.
Although signed forms make it easy to audit informed consent—one
useful dividend of this process—there are other ways to ensure that
it has been obtained," write doctors H.T. Shapiro and E.M. Meslin,
chairman and executive director of the US National Bioethics Advisory
Commission. A moot point. And unless there is a system in place to check
such practices, charges like those against the RCC will continue as will
the suffering of patients like Gopalan.
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