In February 2014, a woman in Bangalore was admitted to the city’s prestigious MS Ramaiah Memorial Hospital for the removal of uterine fibroids, which are benign tumours found on the walls of the uterus. According to news reports, the doctors conducted a blood transfusion to improve her platelet count and she was asked to return for the surgery a few days later. Unfortunately, the operation never took place. When the patient returned to the hospital, she was diagnosed as HIV positive.
Earlier this year, the woman’s brother, who asked not to be named, had filed a legal complaint against MS Ramaiah Hospital.
“I am fighting the case, I know what I am going through. Will you fight with me?” he said. “Many of the facts appearing in the press are wrong.”
Dr Nanda Kishor, the blood bank officer at MS Ramaiah Memorial Hospital, claims that the woman was infected with HIV before she was admitted to the hospital. “We have all the documents to prove our case,” he said. “In the last 20 years that I have been a blood bank officer, this is the first time I have faced a complaint.”
Incidentally, the complainant has also alleged forgery and false documentation.
What the data shows
According to National Aids Control Organisation, India had 86,000 new HIV infections last year. A recent Right To Information request revealed that many of them may have been infected through blood transfusions. In response to the request for information, NACO has revealed that some 2,234 people have been infected with HIV through blood transfusions in the last 17 months.
In the past, NACO has said that the figures are from self-reported data and that patients claim to have been infected with HIV through blood transfusions – rather than reveal other sources of infection – as it is socially more acceptable. RTI activist Chetan Kothari who filed the request, said that he did so after reading about a transfusion-related case in the newspaper. “The numbers are significant enough for it to be a public health concern, and NACO should have released the information to the public even if they were self-reported,” he said.
In India, blood banks are regulated by the Drugs & Cosmetics Act. Since 1989, testing of human blood for HIV antibodies has been mandatory before transfusion.
“As per regulations, every unit of blood has to be tested for HIV, if it is reactive (tested positive for HIV antibodies) it has to be discarded,” said Dr Poonam Shrivastava, medical director of Lions Blood Bank in Delhi.
In India, the mandatory serological test, a blood test that looks for antibodies, is the enzyme-linked immunosorbent assay or ELISA., which is widely used by blood banks and hospitals to ensure that the blood is safe for transfusion. However, the test can pass potentially infected blood as safe if the donor is still in the “window period” – the early stages of an infection that could lead to a false negative. Window periods vary depending on the tests used, and many blood banks have adopted nucleic acid testing or NAT, as an add-on to ELISA, which brings down the window period from weeks to a few days.
MS Ramaiah Hospital, the site of this new claim of HIV infection through blood transfusion, does not use NAT testing yet. The blood bank at the hospital is going to adapt NAT in a month or so, said blood bank officer Kishor.
Matter of cost
“I strongly believe that the NAT should be made mandatory,” said Shrivastava with regard to improving blood safety and reducing the risk of transfusion-led HIV.
However, not everyone is convinced that widespread adoption of NAT is the way to go for India due to the high costs involved – both the cost of nationwide adoption of the new technology, as well as the cost of the test itself increases the price of blood per unit. Earlier this year, the medical journal Asian Journal of Transfusion Science published a paper on why NAT is not a viable option for a developing country like India. According to the authors, in HIV positive blood donors, the virus may go down to undetectable levels but HIV antibodies will continue to be produced. Unlike ELISA, which detects antibodies, NAT can only detect the presence of the HIV virus. Therefore, even blood banks that have adopted NAT have to continue to use ELISA. This would mean that testing a single unit of blood would cost Rs 1,651 – Rs 1,450 for NAT and Rs 201 for ELISA.
Further, experts caution that it is important to differentiate between mini-pool NAT that tests blood acquired from a number of samples pooled together and individual donor NAT. Mini-pool NAT is relatively inexpensive compared to individual donor NAT and can be a second level of check after an ELISA test since it does not require sophisticated equipment. However, unscrupulous blood banks have been known torun the cheaper mini-pool tests and charge a premium, touting their “NAT” status.
The authors of the paper recommend following the World Health Organisation’s advice on blood safety, which focuses on repeat voluntary donors who donate blood or any of its components of their free will and receive no payment, either in cash or in kind. Repeat voluntary blood donations from low-risk populations are widely acceptedas the safest means of acquiring blood for transfusions.
Sketchy quality standards
The transfusion industry in India is fragmented, poorly regulated and standards are not uniform across the country. Further, the demand for blood outweighs supply, which has led to a thriving “red market” industry involving paid blood donations, which is illegal in India.
“Whatever technology and due processes are followed, the blood has to be come from an altruistic voluntary donor, which improves overall standards,” said Dr P Srinivasan, doctor and co-founder of Jeevan Blood Bank in Chennai, which was established in 1995. “And this black market for blood, is well, quite the bloody business.”
While also highlighting the importance of voluntary donations to improve the safety profile of blood, Dr RN Makroo, director of transfusion medicine at Indraprastha Apollo Hospitals and president of the Indian Society of Transfusion Medicine, said, “Blood transfusions cannot be hundred-percent risk free. We should stop using blood as a tonic, the khoon chadado, theek hojayega – transfuse blood and he will be okay – attitude is not good. Doctors should think of alternatives before recommending transfusion.”
Makroo also added that doctors should always take informed consent, as the patient has the right to know the risks involved.
Almost 20 years ago, at the time of delivering her second child, a young woman in Maharashtra was infected with HIV through a blood transfusion. Lawyers Collective, an organisation offering legal assistance to the underprivileged, argued that consent had not been taken from the woman or her relatives. Only in March this year, the woman was awarded compensation through the National Consumer Disputes Redressal Commission.
Transfusion-related HIV cases are hard to fight on the grounds of negligence, said Anand Grover, senior advocate and director of the HIV/AIDS unit at Lawyers Collective. “The main problem is that the courts don’t want to hold doctors liable. They are highly revered. But here, people are dying. We had represented a man based in Tamil Nadu whose wife contracted HIV through blood transfusion and died,” he said.
Where victims do survive, both the disease and the stigma of HIV take a toll on their lives; like for the woman who won at the consumer court. “Her husband divorced her and she lost her baby,” said Grover.