Above: Transplants are not only costly surgeries, but also carry huge risks for the recipients as well/Photo: UNI
A doctor in Kerala has filed a petition in the apex court seeking directives to the state and the centre to provide clear guidelines on declaring people dead
~By NV Ravindranathan Nair in Kollam
Death has been a topic of research for both the medical and the legal fraternities for ages. One of the most interesting part of it has been how to declare a person brain-dead. The conflict has been between the concept of brain death and brain stem death. While the world has failed to come to a consensus, in India it has grabbed attention after a doctor filed a PIL in the Supreme Court.
Dr S Ganapathy, who describes himself as a surgeon with a special interest in brain death, organ transplant and ethical medical practice has filed a petition in the apex court to draw its attention to alleged malpractices in declaring a patient brain dead when he is in fact not dead, with the intention of harvesting organs for transplant. The case had first come up in the Kerala High Court which said the state and the centre should issue guidelines about declaring people brain dead. Last week, the apex court gave the respondents time to submit their counter affidavits.
Dr Ganapathy says that the state of being brain-dead is medically unproven (irreversibility of brain death not proved), legal fiction (cannot stand the scrutiny of law anywhere in the world), ethically wrong (you cannot kill a person to save another). According to him, brain-dead patients are not really dead as their heart beats normally; their blood pressure and pulse are normal; temperature is normal; they can take in food—digest, absorb and excrete; take in fluid—absorb and pass urine; the electrolyte balance is maintained; may develop infection—be treated and cured; and may develop secondary sexual characteristics, as in women can become pregnant.
He has challenged the Standard Operative Procedure (SOP) announced by the state government in the Kerala High Court. According to him, the most common and easy test is EEG to certify brain death. But this is not being carried out in most cases; instead, there is an insistence on conducting the apnoea test. That also is not properly done, and the hapless relatives of patients are misled while in a traumatic state.
What the law says
Brain stem death has to be certified by an authorised panel
Though, in most countries, brain death qualifies as death, medical experts have argued over the years that in patients fulfilling brain death criteria, there is isolated metabolic or electrical activity in dispersed cells which might be a sign that the patient may be alive.
In India, brain stem death is medically and legally defined as the total and irreversible cessation of all brain stem functions. According to the Transplant of Human Organs and Tissues Rules, 2014, the authorisation committee needs to certify a person as brainstem-dead to discontinue artificial ventilation and obtain legal consent for organ donation from relatives.
According to the Rules, the diagnosis should be made by a team of four medical experts—medical administrator in-charge of the hospital, authorised specialist, authorised neurologist/neurosurgeon, and a medical officer treating the patient. Where a neurologist or a neurosurgeon is not available, an anesthetist or intensivist, who is not part of the transplant team, nominated by the head of the hospital duly empanelled by the appropriate authority, may certify the brain stem death.
The conditions to diagnose brain stem death are:
- Patient should be on a ventilator
- Patient should be deeply comatose
- All brain stem reflexes should be absent—pupillary light reflex, oculocephalic reflex, corneal reflex, pharyngeal/gag reflex, cough reflex, vestibulo-occular reflex.
- No motor response to stimulation within any cranial nerve distribution
- Apnoea test
All tests should be repeated at a minimum interval of six hours.
—Usha Rani Das
“Private hospitals don’t want to conduct all matching tests”
Dr S Ganapathy, who has filed a petition in the apex court to draw the attention of the Court to alleged malpractices in declaring a patient brain-dead, talks to India Legal
What prompted you to go to the Court. Are you against organ transplant?
I am not against organ transplant. In fact, I am fighting against the killing of patients to harvest organs to amass money for private hospitals.
Why do you say hospitals are declaring people “brain-dead” when they are not?
In 2015, I had to undergo a bypass surgery at a Chennai hospital. I had sent a mail to the doctor conducting the surgery asking him not to place me on a ventilator for more than 24 hours in case of any complications. I had wanted him to distribute the organs to the seriously ill patients. In case such patients pay an amount, the same must be sent to the Prime Minister’s Relief Fund. But my operation was a success and I returned to life. My daughter had objected to sending such a mail pointing out that it would be used for endangering my life. I started research on transplants taking place across the globe. I came to understand that many were clear cases of killing under the cover of declaring “brain-dead”. I had details of over 20 brain-dead people returning to life.
With the advancement of medical science many suffering from serious illnesses are getting their lives extended through organ transplants. That being the case, why do you oppose it?
First of all, the state of being brain-dead is a myth. It has not withstood legal scrutiny. You have no right to kill a person to save another. Moreover, the survival rate is very low.
There are instances of several patients returning to life after the transplant. If that is possible why should transplants be objected to?
The claim that transplants are successful is not true. In any methodology of treatment, success is counted by the rate of survival. The vast majority of patients undergoing transplants are not surviving beyond a year. Moreover, a heart attack is not the end of life. If patients restrict activity, they could extend their life even without a transplant. What is the point in transplanting a kidney if one has to go for dialysis six months after the transplant?
What is the reason for the failure? Is it the business motive?
As private hospitals are in a hurry to conduct transplants to mint money, they don’t want to conduct all matching tests. They go for just group matching while important tests like HLA are avoided.
Is the government taking serious note of the scenario?
Not at all. That was why I went to the Court. As the appropriate authority is the director of medical education and is preoccupied with other duties, a nodal officer was appointed for the Kerala Network of Organ Sharing (KNOS). Three doctors from one hospital and one from another government hospital will constitute the board of doctors to certify brain death. The KNOS is in the dark regarding the data on transplants.
Why do you insist on EEG and oppose apnoea test for declaring brain death?
Apnoea test is cumbersome. If more carbon dioxide is given to stimulate the brain stem, it can kill the patient. EEG is easier and risk-free.
Private hospitals can easily commit fraud as there is no opportunity for the patients’ relatives to understand it. In all parts of the world, Apnoea test is causing problems. But in Kerala, where 560 tests have been conducted, no complication was reported. The fact is that they are not conducting the test as mandated.
He said that private hospitals in Kerala are allegedly prompting doctors to declare poor and young patients brain-dead when the patient is in fact not brain dead as the hospitals want to harvest their organs.
In his petition, he said that Kerala started cadaver (brain dead) organ transplant in mid-2013. In less than three years, by 2016, Kerala recorded 72 brain deaths—the highest in India.
The conversion rate in Kerala was an unbelievable 90 percent (if 100 patients are brain dead, 90 patients’ organs are transplanted). In Tamil Nadu, it is 65 percent and in the US it is 50 percent. However, during the pendency of his PIL, brain deaths came down to 18. In 2018, only one brain death has been certified so far.
In India, two brain death examinations (the CNS exam and the apnoea test) at an interval of six hours need to be done. Most institutions in the US require two EEG exams at an interval of 24 hours. In Brazil, Norway and most European countries, apart from EEG, brain perfusion studies (like angiogram, Doppler, isotope, etc., to prove there is no blood flow to the brain) have to be performed in a span of 24 hours.
The fact that brain-dead patients still have signs of life can be proven by certain case studies. In Germany alone, nine brain-dead women continued their pregnancies for two to eight weeks, delivered normal babies, and then the mother’s organs were transplanted. Frankielen da Silva Zampoli Padiha in Campo Logo, Brazil, though certified brain-dead, continued her pregnancy for 123 days—the longest in medical history—and gave birth to healthy twins.
The Kerala Network of Organ Sharing (KNOS) has stated that 180 liver transplants were conducted from brain stem dead patients since 2010. While one of these surgeries was conducted in a government hospital, 179 were in private hospitals. The KNOS has no information on the number of patients who died within five years of transplant. The KNOS says there were 394 cases of kidney transplant since 2010. A total of 222 brain-dead patients donated 606 organs from January 2003 to July 2016. While 456 of them were in private hospitals, 139 were in government hospitals. But none of the organs were given to government hospitals.
Out of the 38 heart transplants, private hospitals conducted 26 while three were in government hospitals. Nine hearts were sent to hospitals outside the state.
Dr Ganapathy says private hospitals amassed Rs 140 crore from these transplants. Those private hospitals where the patients were pronounced dead mader Rs 12 crore. Pharmaceutical companies also benefitted to the tune of Rs 30 crore by selling immune suppressant drugs.
The International Society of Heart and Lung Transplantation says 72.5 percent of patients generally survived for more than five years and 21 percent more than 20 years. But in Kerala, as of October 2016, 43 heart transplants were performed of which only two patients survived more than a year.
While the blood group compatibility test, HLA test and serum-white cell cross matching test are must for successful transplants, in Kerala the HLA test is not being done. Dr Ganapathy told India Legal: “As private hospitals are in a hurry to conduct the transplant to mint money, they don’t want to perform all matching tests. They go for group matching and important tests like HLA are avoided.”
In two or three days in the ventilator, patients run up a bill of over Rs 3 lakh and are often unable to pay. At this stage, trained counsellors step in to hook the hapless families of the patients: “If you can’t pay the bills, why don’t you donate the organs? Your son can save the life of five other patients who are on the verge of death. He can continue to see all of you after his eyes are transplanted,” and so on.
In the multi-million dollar organ transplant industry, money talks and more often than not, manages to coax parents or relatives to fall prey.
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