New Delhi: The Supreme Court on Thursday frowned on the government’s failure to halt unethical clinical trials by multinational drug companies on Indian patients who were used as “guinea pigs”.
Referring to a May 2012 report of the Parliamentary Standing Committee on health and family welfare, judges R M Lodha and Anil R Dave said “it really pains us that illiterate people and children of India are being used as guinea pigs by the multinational drug companies.
“We want to know why the government of India is shying away from its responsibility?” the court asked.
“We want you to arrest this trend. It appears that the drug controller is a misnomer. If it can’t do it, who will do it?”
The court was hearing a public interest litigation (PIL) by a Madhya Pradesh-based NGO Swasthya Adhikar Manch, which alleged that clinical trials were being conducted in the state without the knowledge of the patients.
Slamming the casualness with which the Central Drugs Standard Control Organisation (CDSCO) was discharging its responsibilities, the court directed that until further orders, all clinical trials would be conducted “strictly in accordance with the procedure under the direct supervision of secretary, ministry of health and family welfare”.
Justice Lodha said the question was the “implementation and enforcement of the law”.
The court said this when Additional Solicitor General Sidharth Luthra sought to persuade the court that the CDSCO was carrying out its mandate in regulating the clinical trials of the chemical entities by the drug manufacturers.
The court asked Luthra what steps had been taken by the CDSCO after its indictment by the Parliamentary Standing Committee.
Taking note of the parliamentary panel saying that the CDSCO was highly deficient in its working, the court said: “We have to change the mindset.”
“You have slipped into deep slumber and did nothing for the last seven months (since the May 2012 Standing Committee report).
“You have no respect for the parliamentary committee. Do you need court’s orders to frame draft rules?” asked Justice Lodha.
As the court was told that there were ethics committees overseeing the field trials, senior counsel Colin Gonsalves, appearing for the petitioner, told the court that these committees were manned by government doctors and their colleagues were engaged in clinical trials.
The court also issued notice to the central government and the Madhya Pradesh government on an application by NGO Bhopal Gas Peedit seeking “full details” of the clinical trials conducted by the Bhopal Memorial Hospital and Research Centre on victims of the Bhopal gas tragedy.
The application mentioned by senior counsel Sanjay Parikh sought initiation of civil and criminal proceedings against all those involved in the clinical trials and payment of compensation to the victims. [Source: IANS]
The report of parliamentary committee is highly biased and not flawless.
A wrong perception is being created about the conduct of clinical research in India.
The motives of the people behind this movement are not necessarily in public interest.
The country is becoming a looser in the cutting edge of clinical research.
The reports about patients being enrolled in the trials without consent are false.
The adverse events and deaths are reported from all over the world during the trials
And most of them are due to natural causes or the course of the illness itself,
But the court is being wrongly told as if all of them are due to the trial and the subjects are being denied
Compensation.
Use of the word Guineapig is an insult to hundreds of thousand of trually altruistic patients and
Families who participate in clinical trials knowing well that they may not benefit by participating in it,
They give consent for the benefit of society and advance of science.
I have conducted four clinical trials in Bihar, India with newer drugs for the treatment of Kala azar a disease of the poorest of the poor with drugs like Miltefosine(First ever oral drug for KA), Paromomycin, Sitamaquine and Combination therapies. The disease was reported in India for more than hundred years and there was only one drug Antimony compound for saving the life of Kala azar patients since 1920. It is in the last two decades that newer drugs have been brought in the market through clinical trials.
To condemn clinical trials by saying that Indian patients are been used as guinea pigs is not proper. The disease is prevalent in India,Bangla Desh and Nepal, then where will the trial take place?. I agree that there should be strong guidelines for Clinical Trials in India.
P.K.Sinha,MD
Deputy Director, RMRIMS(ICMR),Patna.
I fully agree with Neerja & Dr.P.K.Sinha point of view.
‘Clinical trials are done without the knowledge of the participents, need to be checked,verified & brought out incase if it is true!!!.
We have good regulations in India for clinical trials only we may be failing in the part of implementation.Eg.Clinical Registery of India-requires all the clinical trials to be registered before the start of the trial.(There are some exceptions to this, some studies not harming the current status of the patient need not be registered) Here an ammendment may be made to include all Drug Clinical trials on Human beings.If the unethical trials are being conducted then the involved Clinical Trial team to be severly punished, without delay & mercy.
Word Guinea pigs should be stopped to be used in the context of Clinical trials as it not only pains to doctors conducting Ethical clinical trials also the participents who are voluntering to take part in the trials and also the large public who are being mislead & misinformed through medias.
A well planned ,sustained campaign by some people in media and politics is making ridiculous allegations like:
*Trials are being done on CHILDREN !
I fail to understand how can vaccines or drugs for children be not tested in children
The bivalent polio vaccine which has helped the eradication of disease was tested in a trial on neonates.
It can be not be tested in adults.
* Trails are being done on Mental patients!
How can we develop drugs for psychiatric illnesses without testing then in mental patients?
* Trials are being done on poor illiterate patients!
Government hospitals cater to poor patients only.
The demographic profile of trial participants will be reflecting the type of people attending
That’s the reason it is being recommended that majority of the trials in India should be done in public
Hospitals so that all ethnic groups are well represented in research
It is high time that the research community in India come forward to dispel the myths and propaganda against trials.
A clinical drug trial is conducted to know the efficacy and safety of any new drug discovered after it has been tested in experimental animals to know the dosage and adverse effects.The media has to understand that unless clinical drug trials are done, no new drugs can be introduced into market.The principal investigator chosen to conduct the drug trial is carefully selected and the trial will start only after ethical committee approval.The patient can withdraw from the study at anytime without telling the reason.patient can complain against the principal investigator to the ethics committee whenever he had doubt.The private media is now engaged in negative campaigning calling the patients participating in clinical drug trials as rats,guinea pigs etc.Quacks giving injections and drugs of their choice causing harm many times worse than clinical drug trials.I have not seen any private TV channel or newspaper canvasing against these quacks who give spurious drugs and even banned drugs. A well regulated clinical drug trial is good for the patient.The risk is far less than the treatment by a quack who are too many in every corner of the country. Private TV channels or news papers are simply not interested in protecting the health of innocent people from these quacks.They have no right to worry about very few people who are taking drugs under the supervision of a qualified doctor.
Any clinical drug trial should be conducted in a proper way.But some of the doctors tend to think that giving information about the risks is not all that necessary.This is causing problem for them.If the patient who takes the drug given during drug trial develops fever or vomitting,he will blame the doctor even though the drug is being tested for his condition like cancer. Media and state governments want to have control over the pharmaceutical industry conducting the clinical drug trials through doctors for reason known to any corrupt person in our country.Truth is very simple.If you do not test new drugs,many will die of diseases and there won’t be improvement in health care.The highly corrupt political system and too many rules to extract money from the users will naturally attract unethical practices. There are many people who were detained and kept in jail for months on suspicion without trial by the police.There are many instances where the deserving candidates were denied job or promotion.The debate on punishments for rape is going on forgetting the fact that corrupt political system and police have been the main reason for lack of fear and violence on women. Media should highlight unethical practices in all walks of life.
Why Clinical Trials in Children are Important
Clinical trials yield important information on a medical product’s safety, dosing, and effectiveness, which is the basis for FDA approval and product labeling. Health care providers use labeling information toprescribe the right product for their patients and to monitor them for potential side effects. This includes prescribing the right drug at the rightdose.
Historically, only 20–30% of drugs approved by FDA have been labeled for use in children. So, by necessity, doctors routinely give drugs to children off label.” We need to do clinical trials in children so that a child will not be an experiment of one every time a doctor prescribes a drug,” says Murphy.
Children’s responses to drugs can’t always be predicted from data collected in adult studies, says FDA’s Pediatric Bioethicist Robert Nelson,