Poor man: A guinea pig
Unauthorised clinical trials & flourishing kidney trade have wreaked havoc in hinterlands of Andhra
Visakhapatnam port sustains on mines and forests in the neighbouring districts and states in the hinterland. The same areas also serve as the hinterland for hospitals here. However, illegal kidney transplantations, unauthorised clinical trials treating patients as guinea pigs, and other such cases, that have come to light in the recent past, have shattered public trust. Unfortunately, the tendency to break or circumvent laws, rules, regulations and systems through unethical practices, for their gain, has become the common norm, not only in this beach-city but also in hospitals across the country.
Earlier, people used to hear about the lucrative trade of kidneys in Mumbai and elsewhere in the country. In the recent past, Vizag has also caught up. Cases have been booked against the Seven Hills corporate hospital and Shraddha. The modus operandi is the same in all such hospitals. The middlemen lure poor people with big money for parting with one of their kidneys and show the deal as a donation by a relative in order to circumvent the law that prohibits such a sale. For this, they use forged Aadhaar cards and fake records. In the absence of exemplary and instant punishment, these rackets are now flourishing trade; out of the over Rs 30 lakhs charged from the patient, the poor man is paid only a pittance; the rest is apportioned among the middlemen, doctors, and the hospital.
It is again the same lure for money, from Drug Companies, that is the raison d'être for the state-run King George Hospital being in the news for unauthorised clinical trials. No doubt, such trials are essential for improving therapeutic regimens and ensuring advancement in medical practice. But the poor of the north coast of AP, and those from neighbouring states, who are targeted, are gripped with a sense of suspicion, fear and anxiety.
Till recent times, clinical trials was a grey area in the country's health regime. A total of 24,117 cases of deaths and Serious Adverse Events (SAEs) occurred between January 2005 and September 2016. Inducing people with money, Drug companies even used to take their thumb impressions on the information sheets, without even briefing them about the adverse consequences of the clinical trial. In 2009, over 24,000 tribal girls were enrolled from Gujarat and Andhra Pradesh by the Union Ministry of Health and Family Welfare, among others, in a Human Papilloma Virus (HPV) vaccination trial for the treatment of cervical cancer. Several months into the trial, seven girls were reported to be dead. When investigated, it was found that the parents did not understand fully what they were signing up for. Experts say that these illiterate poor people were only attracted by the money offered.
However, following the Supreme Court's intervention in 2013, the Drugs and Cosmetics Act has been amended; rules and guidelines framed; Institutional Ethics Committees have been put in place. It is also mandated that clinical trials conducted are registered with Clinical Trials Registry–India (CTRI) after clearances from the Ethics Committee and the Drugs Controller General of India, so that every detail of the progress made in the trial is captured by them. Even the earlier arbitrariness in exempting some new medicines from clinical trials has been dispensed with by clearly defining five situations, like life-threatening disease, serious disease, a disease which is specifically suited to Indian conditions, etc. Further, guidelines were issued in compliance with the SC order making it mandatory for the drug companies to inform patients about possible adverse effects and for the audio-video recording of their informed consent. More importantly, specific formula, based on several factors, has been defined for working out the compensation to be paid.
The pivot in the reformed system is the Institutional Ethics Committee, comprising of professionals, non-professionals and laymen. It is their responsibility to ensure that medical experiments and research on humans are carried out in an ethical manner so that the dignity, rights, safety and well-being of all research participants are safeguarded. It is also their responsibility to complete investigations within 30 days from the date of death or serious adverse event (SAE) or permanent disability and work out the compensation to be paid based on the given formula, which is in addition to the expenses incurred in the medical management of the subject.
All the reformatory ideas put on paper look very sound. But, pharmaceutical companies are increasingly taking advantage of the lacunae, which is resulting in a spurt in cases of SAEs and deaths of clinical subjects. Of the 590, 443, and 341 cases of SAEs resulting in death reported in 2013, 2014, and 2015, compensation was paid only in 45, 21 and 4 cases respectively. There are many cases which do not come to light; either their records are not maintained or they vanish from the institutions. King George Hospital of Vizag is one such hospital.
In the past, the Institutional Ethics Committees of KGH had never raised questions about the clinical trials conducted by the hospital, although their nod was a prerequisite. However, with Padmashri Dr K Surya Rao taking over as the new Chairman of the EC in the recent past, and with the relatives of a patient, Rama Rao, getting suspicious about his death, the lid was blown off the facts that were hitherto not known to the public.
Rama Rao, a renal patient, undergoing treatment in the nephrology department for over two months, was subject to clinical trials. A few days after his discharge, he fell seriously sick. It was when his family came to know that he was undergoing a clinical trial. When he died soon thereafter, the panicked doctors began the hushing up work, concealing even the post-mortem report.
In the meanwhile, the new EC began working as per the letter and spirit of its mandate. Thus, when they came to know about the clinical trials of over 300 children as against the maximum of 100 permitted, for a new anti-viral medicine, they sought the records. In response, the hospital authorities issued stern instructions for them not to interfere with the clinical trials. The EC sought the explanations from a number of doctors; there was no response.
The very fact that trials were being conducted without the mandatory EC clearance is evident from a simple incident. A PG student appeared before the IEC for permission for clinical trials for treating patients for sound pollution. Impressed with his answers, IEC gave him permission. At the same time, when they asked how much time he would need for these trials, casually he answered that he had already finished trials and that his paper was almost ready for presentation in a conference in a couple of days. The IEC was shocked.
At this juncture, the news of Rama Rao's death a couple of months ago came to the notice of the EC. Finding that the hospital authorities did not inform them as required, they issued notices for production of all the relevant records. In response, the hospital only claimed that the death was due to natural causes since he was also a TB patient. EC began questioning why such a patient was chosen for the trial; and why he was discharged instead of keeping him under observation during the trial. They had no answer. There was a tug-of-war.
The EC had already issued notices seeking details of all the trials conducted, the SAEs and deaths; as well as the compensation paid; and also details of funds received from Drug companies and their utilisation. But, the hospital had no records to produce. This fact was noticed by the officials of the Central Drugs Standard Control Organisation (CDSCO) also, but they treated the enquiry very casually; the reasons could be any.
Now, finding that Pandora's Box was being opened by Dr Surya Rao, he was pressured through political quarters to take matters easy. And when he was reticent, he was eased out of his position as Chairman of the EC. Such is the power of the players involved that even the Parliamentary Committee, in its 59th report on family and healthcare, had established "collusive nexus between drug manufacturers, some functionaries of the CDSCO and some medical experts". Laws, guidelines, etc., across the country, are followed only in the breach and ignoring their mandate, even the ECs turn a blind eye to the violations. Moreover, since there are no stringent provisions of punishment for violations of the Act, which indeed amount to fraud, the nexus among the players only continues.
While the unauthorised trials are an area of serious concern, even the compensation mandated does not reach the victims or their families adequately and easily. The process of establishing the link between the injury/death, and the medicine in question is very complex, and hence, cumbersome. In spite of clear norms in place, the challenge remains in manoeuvring through the available data to establish the desired link. Institutional non-cooperation adds to the hurdles faced by the EC in its investigations. Thus, there are either delays, or it is never given at all, rendering the systems torturous.
It is hoped that the new CM of AP, who has promised a corruption-free government, would get all the matters raised by the EC of the KGH, along with the flourishing kidney trade, enquired into and punish the guilty to set things right. At the same time, it is hoped that the Drugs Controller General of India and the Ayush ministry would also realise the gravity of the matter and take immediate corrective measures in every state.
(Dr N Dilip Kumar is a retired IPS officer and a former member of Public Grievances Commission, Delhi. The views expressed are strictly personal)