Over half a century ago, Prof.
J S Mitchell CBE, FRS of Cambridge University UK, delivered a series of lectures on just one theme—“Cancer: If curable, why not cured?” This question still remains unanswered. The cancer patient is normally treated with surgery, radiation and chemotherapy or a combination thereof. The chemotherapy invariably becomes an integral part of cancer treatment despite high costs and serious side effects of anti-cancer drugs. Therefore, newer chemo-drugs with greater efficacy and less side effects are being constantly developed by several multinational pharmaceutical companies.
In general, the development of new drugs begins with the testing for their efficacy on suitable in-vitro cell systems followed by experiments on laboratory-bred small animals like rodents. Such animal experiments are monitored and regulated by institutional animal ethics committees constituted under The Prevention of Cruelty to Animals Act 1960, amended in 1982. The promising drugs are then firstly tested for their toxicity in healthy human volunteers in Phase-I trials. Subsequently, the drug enters into Phase-II trials and is tested for efficacy on a limited number of identified patients against the existing standard care. If there be definite positive results, the new drug is tried on a larger population of patients in a randomized manner—the Phase III trials. It then qualifies to be submitted to the regulatory authorities for clearance to be marketed for human use.
India emerged as the most favoured place for such studies since costs involved in clinical trials are far less than in the Western countries. There is abundance of patients with a large ethnic diversity and a highly trained medical manpower that is gullible and always willing to give the go-by to rules and regulations for some favours. In the recent past, numerous clinical trials were being conducted unethically but were never publicised till the ill-famed Indore Trials at MGM Medical College and MY Hospital conducted during 2005-2010, where doctors were reported to have illegally earned in the range of `40 lakh–56 lakh. Oddly enough, 77 per cent of the patients in these trials were reported to be children and some others were undergoing treatment in psychiatric clinics. These trials were not even approved by any institutional ethics committee, which is the basic statutory requirement in the country. The public uproar awakened the drug regulators leading to promulgation of stringent new rules to the great displeasure of the pharma companies and greedy physicians. The flourishing clinical research industry in India nosedived.
Now as it stands, all clinical trials are to be cleared and approved by the institutional review boards (IRBs) or institutional ethics committees (IECs), which look into the scientific merits of the project as well as the ethical aspects of patient care. The IRBs and IECs are constituted according to guidelines of the Indian Council of Medical Research and are required to be registered with the Drug Controller General of India (DCGI). All clinical trials using new drugs are also to be registered with the DCGI. To further facilitate clinical trials in India, a number of independent Clinical Research Organisations (CROs) have also emerged with their own IRBs.
It is to be emphasised that in all clinical trials the informed consent of patients is mandatory. It ought to be of free will, without fear or force and coercion or allurement of any kind. It is the responsibility of the investigating clinician to explain to the patient and ensure that the patient understands the objectives of the research; the risks involved in it and also assure the patient at the same time that there would be no disadvantages on declining to participate. The regulatory authorities now require video recording of the event while the patient is being explained by the investigating clinician.
Under such circumstances, the consent of children or mentally sick patients is not acceptable. So is the case of prison inmates, students and junior staff working with the investigating clinical team who might be coerced or forced. These are vulnerable subjects and special care has to be taken while they are recruited in the clinical trials.
Cancer is the most dreaded disease. The patient is half-dead on hearing the word. It is this already half-dead person who is likely to be included in cancer related clinical trials. Is then a cancer patient a vulnerable person? Yes, because vulnerability arises from weaknesses—physical, mental and financial. In the Indian context, the very word “cancer” makes a person psychologically vulnerable. It is more so when the poorer section of our society is involved. The illiterate and psychologically depressed skeleton-like cancer patient, when asked to give his consent, often faces a white apron clad well-dressed highly educated clinician. Can he/she say “NO”? He will be prepared to agree to anything that may give him some hope to live a little longer, maybe, to fulfill his family obligations. He is mentally disadvantaged to imbibe the essence of the lecture that the investigating clinician gives to obtain his consent. He would just nod to have understood what was spoken. The court may not agree to this.
In the case of an adivasi girl, Sonia, in 2012, the Bombay High Court disagreed with the conclusions of the highly specialised hospital committee assessing her average IQ value for kidney donation and observed: “It is submitted that Petitioner No.1 is a tribal from Chhattisgarh and that considering her education and social background she would not be in a position to answer the questions put by the Hospital Committee or the Authorization Committee in the manner in which the committee members residing in Mumbai would expect a lady of her age to answer.”
In such circumstances, a cancer patient is certainly a vulnerable person and needs special care while giving consent for inclusion in clinical trials. An independent person ought to be present to certify that the information given by the investigating clinician has been understood by the patient sufficiently enough to give consent.
The present system of an attesting witness signing on the patient’s Informed Consent Form is inadequate and would prove bad in law.
The author is a practising lawyer and a retired scientist formerly with BARC, Mumbai, and IAEA, Vienna.
Email: drbbsingh2010@gmail.com