It is easy to laugh at Dr Himanshu Bansal.
Over the course of a long telephone conversation, the orthopaedic surgeon from the town of Rudrapur in Uttarakhand promises to prove the superiority of Indian science, claims to have helped some “very rich people” recover from comatose states, and compares himself to Albert Einstein and Isaac Newton – “They too were received with scepticism.”
Dr Bansal believes that his controversial venture in the news recently – to conduct clinical trials on brain-dead patients to examine the possibility of their revival – is as pathbreaking as Einstein’s theory of relativity. He plans to bring the dead back to life using a mishmash of procedures – stem cells, lasers, peptides and nerve stimulation.
However, the medical community is not laughing. Doctors agree that the proposed trial is unscientific and unethical, but India’s regulatory bodies are unable or unwilling to step in for various reasons – lack of legal sanction, and jurisdiction issues.
Medical thriller, or research?
The ReAnima Project, a collaboration between Dr Bansal’s company Revita Life Sciences and US-based biotech company Bioquark Inc, will be conducted on people who have been declared brain dead – defined as the complete and irreversible loss of all brain functions. A patient determined to be brain dead is legally and clinically dead though a ventilator can keep the heart beating for some time. Unlike a person in a coma, there is no scope for recovery of any kind for a brain dead person.
According to the law, the diagnosis of brain death may be made only by a team of specialists, and only after a series of tests are conducted a few hours apart. Once a patient is determined to be brain dead, doctors are required to explain to the patient’s family that there is no hope whatsoever of the person’s revival. If the body has been maintained on a life support system, and the organs are fit for donation, the family may be approached for consent for donation. If they agree, the body is maintained until the organs can be removed, after which the life-support system is turned off.
The project will involve 20 subjects, and the tests will be conducted at the three-storey Anupam Hospital in Rudrapur, which is run by Dr Bansal.
Dr Bansal plans to approach hospitals in Rudrapur – a town with a 15.5 lakh population according to the 2011 Census – to get access to families of patients who are declared brain dead. Families who refuse permission for organ donation will be asked for permission to include the body in the ReAnima Project.
Under the project, the cadaver will be maintained on a life support system for 15 days during which time it will be submitted to various procedures – including the injection of stem cells collected from the cadaver itself – and monitored through electroencephalograms and other tests. This is a scenario straight out of Robin Cook’s medical thriller Coma.
Ira Pastor, the chief executive officer of Bioquark, the ReAnima project’s Philadelphia-based partner, said that the project will be conducted entirely in India for economic reasons. “The costs here will be less than one-tenth of the estimated $1million per patient for the two weeks of the trial it would cost in the US,” said Pastor.
But there are perhaps other reasons, which Pastor is unwilling to acknowledge. Primarily, it is the project would never have been permitted in the US because of ethical concerns, while in India, loopholes in the regulatory system make it possible for the trial to be held here.
Dr Bansal told this reporter that he had a letter from the Drugs Controller General of India exempting his project from regulatory review because it did not involve living humans.
But herein lies the catch.
The Drugs Controller General of India approves research on drugs geared towards the market. He doesn’t have any authority on this experiment because this is not a drug trial.
Dr Bansal also said that since he wants to meet ethical requirements, he has posted the project’s protocol on the Clinical Trials Registry, which is run by the Indian Council of Medical Research. In this registry, Dr Bansal’s project is described as a “proof of concept study with multimodality approach to attempt reversal of brain death due to traumatic diffuse axonal brain injury”.
He added that the project was reviewed by an “institutional committee for stem cell research and therapy” but refused to disclose the members’ names. He said that a contract research organisation, Nexus Clinical Research (India) Ltd, designed the protocol and drafted the informed consent form.
A staff member at the Navi Mumbai office of Nexus admitted that they had been in discussions with Dr Bansal but disputed his claim that it had finalised an agreement for the project.
With his proposed research, Dr Bansal said hopes to “revive 1% of the subjects.”
He added: “It will be a breakthrough.”
News of Dr Bansal’s plans has been met by outrage by the medical community.
“The trial seeks to create doubts, without any basis, on the current internationally recognised criteria for the diagnosis of brain death,” said gastrointestinal surgeon Samiran Nundy, one of the architects of the Transplantation of Human Organs Act, 1994, which introduced the concept of brain death into Indian law. “These criteria have been in existence for 50 years and to this date there has been no instance of reversal of brain death.”
Though Dr Bansal said he developed his study after he found anecdotal reports of people recovering from a brain death-like state, experts in the field assert that there is no evidence to support this research.
“There is no evidence, published in peer-reviewed, indexed journals, of anyone recovering from brain death,” said neurosurgeon Sunil Pandya, founding editor of the Indian Journal of Medical Ethics. “There is no scientific basis to the procedures described.”
Said Dr Farhat Moazam, director of the Centre for Biomedical Ethics and Culture in Karachi, “Based on our current scientific knowledge, there is absolutely no chance that this subject will get up and walk again with this experiment.”
Dr Pandya likens Dr Bansal’s project to that of Dr Dhani Ram Baruah, who, in 1997, transplanted a pig's heart into a human being, a procedure widely denounced as being without any scientific basis, and a case of medical malpractice.
The recipient of the pig’s heart, Purna Saikia, died shortly after the surgery.
Dr Baruah was arrested for violating the Transplantation of Human Organs Act but let off on a technicality. He pops up in the news periodically to announce his latest discovery – curing someone of cancer, AIDS, blindness and so on.
No prior research
A basic scientific and ethical principle expressed in international and national guidelines for research is that new research plans are based on previous knowledge that justifies the experiment. Thus, trials on human beings must be preceded by animal studies. This is reiterated in the guidelines of the International Society for Stem Cell Research, published this month.
Bioquark’s Pastor, who prefers to call the ReAnima Project “living cadaver work”, acknowledged that have been no animal studies on the procedures proposed by Dr Bansal.
Pastor couched his justification carefully: “We think living cadaver work fits into the spectrum of other existing niche models that have a direct-to-human component...” But in any case “good animal models [for brain death reversal] are few and far between… and they would provide us with quite limited answers to what we are seeking to learn.”
There is no evidence of published research in indexed journals on this work, said Dr Pandya, who called for a team of experts from reputed national medical institutes to study all aspects of the proposed research including Dr Bansal's expertise to head it, and the role of the ethics committee that Dr Bansal claims approved the research. “I feel confident that such a team will fail to find any merit in the proposed study,” said Dr Pandya.
Dr Bansal is more straightforward. “We don’t need to do such studies,” he said. “And I don’t need to tell you what has and hasn’t been done. You can go look it up if you like. I don’t care.”
Giving false hope
Others point out that the study will take advantage of grief-stricken families at a vulnerable time. Dr Nundy said that publicising an unscientific experiment with dubious findings could play havoc in a country where so many people found it difficult to judge the validity of claims and are swayed by sentiment, especially when loved ones are severely injured or declared brain dead.
“There is no doubt that this study, if it can be called that, will exploit desperate families who are willing to do anything to bring their loved ones back to life,” said Dr Moazam. “Bansal may try to get consent by raising hopes that their family members will become alive with this experiment.
She added: “This is easy to do in a society where doctors and researchers are gods, and families are poor and illiterate, thus the potential for coercion and deception.”
Dr Bansal refused to share a copy of the informed consent document template that he planned to use. But Bioquark’s Pastor made available a draft developed by Nexus Clinical Research (India) Ltd. It listed “reversal of brain death” as one possible benefit to the research subject.
“There are no ethical issues according to us,” said Dr Bansal. “We are trying to save people. They are brain dead, they are on their way to the funeral. I’m only stopping them along the way, for 15 days. If I am able to save them…”
He said that relatives would be informed that any expenses after the trial period would have to be borne by them. “Once we revive the patient we cannot take care of them for the rest of their lives,” said Dr Bansal.
But what about the trauma that relatives – hopeful of the return of their loved ones – will go through?
“Relatives will have an emotional reaction for a few days but they will get over it,” Dr Bansal said.
What regulatory framework?
But Dr Nundy asked how a small hospital in Uttaranchal – which does not have any track record in this or an allied field – had been allowed to conduct a trial that was being funded by a US company and was ethically and scientifically suspect.
That is because no one seems to be in charge.
Dr Soumya Swaminathan, director general of the Indian Council of Medical Research – the apex body for the formulation, coordination and promotion of biomedical research – expressed her inability to take any action as the ICMR is not a regulatory body.
The Indian Council of Medical Research plans to send a letter to Dr Bansal, and that’s about all it can do. “Until the Biomedical and Health Research Regulation Bill is passed we will not have the authority to take action,” said Dr Swaminathan. The draft legislation has been gathering dust since 2013.
Though Dr Bansal claimed that he has a letter from the Drugs Controller General of India exempting his study from regulatory review as his research is not on living human beings, no one has seen this letter so far. The clinical trials registry record says that Drugs Controller General of India clearance is “not applicable”.
Though the ReAnima Project proposes the use of stem cells, there is no regulator for stem cell research in India either.
Guidelines on stem cell research published by the Department of Biotechnology and the ICMR call for approval by an institutional ethics committee accredited by the Drugs Controller General of India, and by a national apex committee for stem cell research and therapy. However, “this is only a guidance at present, not a legal requirement,” said Dr Swaminathan.
Apparently Dr Bansal has, so far, not applied for clearance from the health ministry’s committee for collaborative research, which would have some authority on the transport of tissue samples out of the country. “As of now, the Medical Council of India and state regulatory bodies under the Clinical Establishments Act could take action,” added Dr Swaminathan.
But the Medical Council of India, which monitors the medical profession, has never acted against unethical doctors.
In March, a parliamentary committee report titled The Functioning of Medical Council of India presented before the Rajya Sabha indicted it for rampant corruption and for the poor state of healthcare in India.
The report said: “the present focus of the MCI is only on licensing of medical colleges. There is no emphasis given to the regulation of medical ethics… A separate board of medical ethics should be set up which will be responsible for developing mechanisms for the promotion of medical ethics.”
Dr Bansal was indignant at questions on the science and ethics of his project. “Who are you to ask me such questions?” he said. “Why don’t you ask Geeta Shroff who has been doing stem cell research for decades?”
Dr Geeta Shroff is a Delhi-based fertility specialist, who has been conducting procedures using stem cells and claiming to cure the incurable, for more than a decade now. Neither her methods nor her results have been published in any reputable medical journal. And she is not the only one. There are dozens of private clinics in India hawking untested stem cell procedures as miracle treatments for incurable and terminal diseases.
In 1997, the authorities were embarrassed to admit that they could not act against Baruah for the pig heart transplant. Almost 20 years later, various regulatory bodies remain toothless. “Evidently, we have learnt nothing from the Baruah experience,” said Dr Pandya. “Our monitoring agencies remain as clueless and impotent now as they were then.”
So, rather than laugh at Dr Bansal’s bluster, we should be outraged that he can announce a project that scientists and ethicists agree is unscientific, grossly unethical and certainly not research, but regulators don’t seem to know how to stop him, let alone punish him.
Sandhya Srinivasan is consulting editor with the Indian Journal of Medical Ethics.