A serious debate is on in the international science fraternity after an Indian surgeon registered a protocol to carry clinical test on patients declared “brain dead”
New Delhi: The medical fraternity is up in arms over the Indian Council of Medical Research (ICMR) registering a protocol by little-known spine surgeon of Rudrapur district town in Uttarakhand to carry out clinical test on 20 patients declared brain dead after traumatic injuries such as suffered in road accidents.
Surgeon Himanshu Bansal claims to have evolved in collaboration with a US-based company, Bioquark, the experimental protocol for using stem cells from the patients themselves, peptides supplied by the company and laser stimulation of the brain to reverse the brain death.
The ICMR officials sought to clarify that the council has neither approved nor reviewed the study as Dr Bansal has only registered with the clinical trials database which is just a registry where researchers can submit some details of their trial proposals.
The listing of a trial proposal in the database does not mean it has the ICMR’s approval as the clinical trials in India require regulatory approval from the Drugs Controller-General of India (DGCI) and, when they involve a foreign collaboration, also from the health ministry’s screening committee, said ICMR director general Sowmya Swaminathan, who also chairs the health ministry’s screening committee. He said Bansal’s proposal should have come to the committee as the study involves a foreign research partner.
Doctors consider brain death as an irreversible condition as it involves the irreversible loss of a part of the brain called the brain stem, which is responsible for the capacity for consciousness and independent breathing. There are standard guidelines on how and when to declare a patient brain dead.
A critical care medicine specialist said there is a medical consensus that the brain death is irreversible, but sometimes a patient is incorrectly diagnosed as brain dead and can therefore be revived. He said there are certain conditions that may mimic brain stem loss, and a proper brain death diagnosis needs to eliminate conditions that mimic it.
Bansal himself claimed that his study should be interpreted as an attempt to highlight and curb premature diagnoses of brain death, and not as an attempt to revive the dead. “We’re not suggesting that a brain dead person is going to wake up and start talking,” he said.
Under current medical practice, a patient may be declared brain dead after two sets of clinical tests separated by six hours. Doctors are allowed to withdraw life support equipment, such as ventilators, from patients declared brain dead after this six-hour gap.
“But in many instances, patients’ relatives want to wait. This is the situation where we would like to intervene. If one out of 100 or even 1,000 patients can be revived from the brain dead state into a coma or a minimally conscious state, it could mean that we need to change practice and add a few more hours of observation before someone is declared brain dead. Just adding to the six-hour window would be an achievement,” Dr Bansal said.