Clinical trials in dock in Kerala

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There’s widespread scare over clinical trials and their impact on ill-informed patients, who are often victims of circumstances than willing collaborators in research. This was foreseen long back, which is why medical fraternity brought out the Helsinki Declaration: “Concern for interests of subjects must prevail over interests of science and society.’’

Kerala Health Minister V.S. Sivakumar may have constituted a high-level panel to probe allegations of illegal drug trials on humans, but it may not just be enough to deal with clandestine clinical research.

Recently a private centre near Thiruvananthapu- ram medical college hospital was sealed following reports that the institution had carried out more than 40 unauthorised tests.

There were also reports that about nearly one lakh people have been subjected to clinical trials in the state over the past five years.

Unconfirmed reports say more than 300 medicines were tested on patients and in many cases tests had proved lethal.

Indian Council of Medical Research (ICMR) guidelines stipulate that all institutions carrying out clinical trials should have ethics committees.

“I think we need to have a centralised ethics committee rather than individual panels for each institution.

Drug trials are inevitable, hence we need to put in place an effective mechanism,”’ said Dr Dallus, professor and head of medicine department, Thiruvananthapuram medical college.

While ICMR clearly points out that clinical trial has to be conducted in a fair, honest, impartial and transparent manner, the recent episode revealed that many of these parameters had been violated.

In many cases patients, who are subjected to trials, were not fully briefed about the research. Though the patients had signed consent forms, it was mainly because of their faith in doctors.

So the answer ? “I think major institutions are adhering to ICMR norms. But the main problem seems to be with the small institutions that do not have facilities,’’ said Dr Satheeshan B., director, Malabar Cancer Centre.

Experts say Institution Ethics Committees (IECs) need to be strengthened and made more transparent.

Members on such panels should be qualified to do a detailed analysis of the research proposals. Besides, it is also their duty to ensure the safety of patients who sign up for clinical trials.

A section of doctors says the present scare is uncalled for, as only Phase III trials are conducted here.

According to them, Phase II, which pertains to checking the dosage and toxicity, was not being conducted. They point out that all institutions should have committees with external members.

Despite the IMA and other medical organisations terming as “untrue” reports about illegal clinical trial, a section of people here believes a thorough probe is needed to bring out the truth.

There have been demands from various quarters, including Opposition leader V.S. Achuthanandan, to probe.
They feel a doctor’s panel probing doctors can be eyewash.

Many say free medical camps conducted by private hospitals are being used for ‘trials’. They say unless stringent action is taken against those indulging in such inhuman and illegal activities, the gullible will end up as guinea pigs.

‘expertise of medical person crucial’

For the drug trials starting from Phase 0 to Phase 3, human beings are necessary. In the Phase 0 a small amount of the drug will be given to the normal healthy volunteers to test for the safety and adverse effects.

After this, in Phase 1 again the drug will be given to healthy human volunteers to study the pharmaco-dynamics and pharmacokinetics.

If it proves to be safe in its adverse effects in the Phase 2 the drug will be given in prescribed doses to recruited patients and placebo to the other group of the same disease. The efficiency in curing the disease will be compared with the placebo.

If it proves to be effective than placebo and statistically significant, then the drug can enter the Phase 3 drug trial where the new drug will be compared with the existing standard drug for the disease.

Based on Phase 3 result, drugs will be given the license to sell in the market for the treatment of particular disease. Phase 4 will look into the post-market effect of drug in the community in large scales.

For any clinical trial the expertise of the medical person is crucial.

Dr R. Jayaprakash, associate professor of Paediatrics, Department of child health, SAT Hospital, Thiruvananthapuram.