11 July 2011
That clinical trials in India are fraught with danger and have no compensation mechanism is well known. What comes as a greater surprise is how the so-called ethics committees constituted to clear such experiments are raking in big money doing precious little. Rema Nagarajan investigates the sordid story for TOI
In most cases, no one seems to know what exactly are these entities that proclaim themselves to be independent ethics committees; who owns them and who collects the revenue earned; how is it distributed and to whom, and how do they decide what amount to charge? With no law governing the funding mechanism of these bodies, they charge arbitrary amounts and earn fat packets from the business of vetting — actually, approving — trials.
Take, for example, the BioMedical Ethics Committee based in Delhi, which describes itself on its website as “an independent ethics committee constituted with the objective of facilitating clinical research”. There is no detail about who constituted it, or when or how the members were selected. The website has a ratecard listing “ethics review fees” for different kinds of studies and trials. It starts from Rs 10,000 and goes up to Rs 50,000. There are various other fees for procedures like adverse event reports. The Independent Ethics Committee of Mumbai charges Rs 25,000 per project with Rs 5,000 extra for each additional centre.
Hence, the role of these ethics committees is no more that of a regulator and they owe nothing to the subjects (people on whom the trials are conducted), those whose interests they are supposed to guard,” says Dr C M Gulhati, editor of the Monthly Index of Medical Specialties.
Director-general of the Indian Council for Medical Research (ICMR) Dr V M Katoch says he had no idea about the existence of such IECs until even recently.
“We will have to regulate them. How can just anyone declare themselves to be an IEC? It is an obvious loophole and we intend to plug it right away. This is an obvious gap in the implementation of Schedule Y of the Drugs and Cosmetics Act (which lays down the rules for clinical trials in the country). I will be taking it up with the drug controller general,” he says. On the issue of IECs charging arbitrarily for approving trials, Katoch says it is absolutely illegal and corrupt. “The government will not accept it. They cannot charge for approving trials. The process has not been properly defined and that is why such things are happening.”
Members of such independent ethics committees are often well-known medical professionals. Dr Y K Gupta, for instance. The current head of pharmacology at the prestigious All India Institute of Medical Sciences, he is on several government committees dealing with drugs; he is also a member of an IEC called BioMedical Ethics Committee.
There seems to be no concern about conflict of interest in him being a member of this committee. Gupta told TOI that he did not know anything about the financial transactions of the committee and that he has decided to resign from the committee with immediate effect. Former drug controller general of India (DGCI) Ashwani Kumar, too, is associated with this committee. There are no details about the remuneration received by these persons for being members.
In fact, there seem to be no clear-cut rules regarding who can form an IEC or how it is supposed to function. There seems to be no need to register it either. The result is that even clinical research organizations (CROs) that get contracts from companies to conduct trials can float their own independent ethics committees to clear trials without any hitch. A case in point: the Ahmedabad-based Veeda Clinical Research Ltd, which conducts clinical trials, also runs an IEC.
Schedule Y merely states that an ethics committee, whether institutional or independent, should have at least seven members, and that for the review of the protocol of each trial the quorum should be at least five members, including basic medical scientists (preferably one pharmacologist), clinicians, a legal expert, a social scientist or NGO representative, ethicist or theologian and a lay person. Hence, anyone who can put together a bunch of seven people fitting this rather loose description can run an IEC and charge to clear clinical trials.
Given the way clearance is being granted to drug trials and the way ethics committees, supposed to protect the interests of patients enrolled for them, are being run, it is hardly surprising that more than 1,500 people involved in such experiments have died in just 28 months between January 2008 and August 2010. Hardly any of the families were compensated.
IECs need not be stand-alone entities. Even institutional ethics committees or those attached to hospitals seem to be leasing out their services to approve trials that are not taking place in their own hospitals — in short, functioning as IECs for anyone who needs their service. It is a good revenue earner for the hospital if the money being charged for approving trials is any indication.
Kotbagi is a 100-bed hospital in Pune. It also has an IEC that has been approving trials for Emcure Pharmaceuticals Ltd, a Pune-based company. It has approved trials for three different drugs for the company. It is not hospitals or doctors who approach Kotbagi for approving the trials. The trials are brought to the Pune-based IEC by the company and approval is given en-bloc for trials at sites scattered across the country from Mumbai and Vadodara to Nashik and Varanasi. Similarly, the approval for trials for an insomnia drug by the Ahmedabadbased Intas Pharmaceutical was given by an IEC in the same city — the Siddhant Ethics Committee.
According to Katoch, it is illegal for any institution which has an ethics committee to seek approval for trials from an IEC outside the institution. However, several trials conducted by MGM Medical College in Indore got approval from IECs despite the college having a committee of its own. This was reported in a preliminary enquiry report which examined complaints regarding trials being conducted in MGM Medical College.
Dr Prakash Kotbagi agrees that an ethics committee being in some faraway city could make monitoring difficult. “Doctors are busy people. If a complaint comes from Punjab, it would be difficult for a doctor in the ethics committee from Pune to go all the way there to look into it,” he says. “Even within the same institute, monitoring is a difficult task. There are lots of lacunae in the rules regarding clinical trials. Maybe the rules have to be changed to limit the geographical distance between the location of ethics committees and the trial sites. There is a need for an appellate authority too.”
But till such time as that happens, more lives will be put at risk while ethics committees continue to make heaps of money in the name of monitoring trials.
The Many Duties Of An Ethics Committee (In Schedule Y of Drugs and Cosmetics Act)
- To safeguard the rights, safety and wellbeing of all subjects involved in trials approved by it
- Take particular care to safeguard rights of vulnerable trial subjects such as prisoners, patients with incurable diseases, the unemployed or impoverished, nomads, refugees, minors or those incapable of giving consent
- Store documents of standard operating procedures and maintain a record of its proceedings
- At appropriate intervals it needs to review protocol(s) based on periodic study progress reports furnished by investigators
- Monitor internal audit reports furnished by the sponsor (usually the drug company)
- Visit and review study sites
- If approval for trial is revoked, it must record the reasons why it was and communicate the same to the investigator and the licensing authority