Conflict of Interest In Indian Vaccination Schedule.
Conflict of interest on recommendation of immunization schedule?
The vaccine schedule recommended by the Indian Academy of Paediatrics (IAP) includes almost every vaccine for children available in the Indian market.
Interestingly, of the fund of Rs 27.8 lakh with the Indian Academy of Pediatrics Committee of Immunisation (IAPCOI), Rs 26.8 lakh was contributed by vaccine manufacturers including Sanofi Pasteur, GSK, Merck, Pfizer and Serum Institute. This is stated in the IAP 2012 annual report. Yet, the IAPCOI insists that there is no conflict of interest in its recommendations.
The 2012 immunisation schedule of the IAP, which includes many of the newer and expensive vaccines not included in the national immunization programme, is supposed to be for paediatricians in "office practice" , ie private practice. In the December 2012 issue of the journal Indian Pediatrics, Dr Sanjiv Lewin from the Department of Paediatrics, Clinical Ethics and Medical Education in St John's Medical College Hospital in Bangalore raises the issue of huge profit margins and the ethics of physician-industry relationships saying that "methods used to market vaccinations are sometimes controversial with aggressive practices to market vaccines of questionable public health significance" .
Dr Lewin draws attention to the declaration of no competing interests by the authors of theIAPCOI schedule pointing out that "as physicians, we have much to gain, especially from vaccine prescriptions with excellent margins of profit" . He also points out how nine out of 10 special invitees to the meeting of the IAPCOI were from the vaccine industry, which he says is "certainly a gross conflict of interest" . In response, the IAPCOI convener states that going by Dr Lewin's yardstick, no practising physician should be eligible to participate in any decision making body. The industry, he points out, is "an integral part of the system that affects every aspect related to vaccines" .
IAPCOI convenor Dr Vipin Vashishtha stated that the committee was aware of the issues of conflict of interest and took great care to ensure it did not interfere with the recommendations. "Our funding might have been from the industry earlier. But as far as I know we now get funding from the IAP central body. We know there are huge margins, as much as Rs 600-700 per dose in the case of some vaccines. We are talking to the industry to reduce the margins to make the vaccines more cost effective," says Dr Vashishtha.
Non-mandatory vaccines for babies: A hefty dose of profit
Vaccinations for babies are proving to be excellent moneyspinners for doctors, especially the newer ones that have not been recommended by the government and are not part of the national immunisation programme. On a single dose, doctors can make a profit of anything from Rs 200 to over Rs 600 depending on the vaccine being given and the brand chosen. The profit margins are much higher for the non-mandatory vaccines (see table on right).
The Medical Council of India (MCI) has banned doctors from taking a gift of more than Rs 1,000 to ensure that they are not induced by companies to prescribe their products . However, the hefty profit margins being offered to doctors on every single dose could be an even better inducement and cumulatively worth much more than Rs 1,000.
At six weeks of age, by administering the first doses of pentavalent vaccine, the rotavirus vaccine and pneumococcal vaccine, the doctor could make anywhere between Rs 800 and Rs 1,400 per baby. This does not include the vaccination/consultation fee charged by the doctor, which is anywhere between Rs 200 and Rs 500. Many of these vaccines require three doses and hence the profit margin could be as high as Rs 2,400 to Rs 4,200 per baby vaccinated. By the time the baby is 15 months old, vaccines alone could cost parents between Rs 15,000 and Rs 28,000.
This practice had been highlighted in a 2010 study published in the Indian Journal of Medical Ethics. The study was done by Dr Rakesh Lodha of the Department of Paediatrics, AIIMS, and Dr Anurag Bhargav of Jan Swasthya Sahyog in Chhattisgarh.
Health minister Ghulam Nabi Azad had referred to it in April 2010 in his reply to a question in the Lok Sabha on doctors being bribed by pharmaceutical companies. He had said that though companies offered the vaccines to doctors at hugely reduced prices, patients were being charged the full price. However, even two years later, the health ministry has done nothing to address the problem.
"What the doctor is charging is legal since that is the marked price," argues a paediatrician. He maintains that patients are likely to suspect the quality of the vaccine if they are not charged the MRP. Tanushree, mother of a two-monthold baby, says parents have no idea about the profit margins doctors can rake in on vaccinations. "We just go by whatever the doctor bills us. The doctor opens the bottle, fills the syringe, injects the baby and then disposes the stuff in the dustbin. When do we get to see the MRP?" she asks.
"The doctor did tell us that the vaccines not listed in the immunisation programme are optional. He said they were good for the baby but not mandatory . We trust the doctor to do the best for the baby," says Tanushree. The important question here is whether doctors are betraying that trust.
This is not only a case of minting money. What the general public does not know is that vaccines have been linked to very severe side effects that lead to deaths, disability and serious chronic disorders. These studies have been published regularly in medical journals. The IAP deals with infants and children. Now they have also brought the youth under their ambit. This very sensitive population require the utmost protection and care that the doctors of the IAP are supposed to provide. It is highly unethical, and borders on the criminal, that this body throws their ward to the wolves. Very senior doctors of our country opine that the children were better off when they were under the care of regular MBBS doctors who took great care to ensure that they were minimally medicated. There was an unwritten code of a 1000 day "no medicine zone" starting from conception as it is well known that playing with the health of this susceptible population will certainly have serious repercussions. The epidemics of unexplained deaths, disabilities like autism, developmental delays, learning and behavioural disorders, neurological problems, paralysis, and chronic disorders like allergies, asthma, various cancers, diabetes etc points to the horrific fact that the doctors of the IAP are playing with the lives of children. This corrupt body should be dismantled forthwith and a process of inquiry should be started to nail the guilty doctors and suitably punish them. The entire vaccination schedule should be put under close scrutiny and a series of studies should be initiated by responsible medical bodies to study the various ingredients and the effect they are having on children, singly and in combination. Tests on primates and mice, both for single vaccines and for the entire schedule will bring to the fore the extent of damage being inflicted. The process should be under a committee consisting of honest and ethical doctors, medical scientists, health activists and members of the civil society. The practice of vaccination should be kept in abeyance till the results come to the fore and are shared in public domain. We cannot afford to play with the lives of the children and parents should no longer feel obliged to vaccinate without knowing explicitly the consequences. Medicine and its practitioners should be above greed. For this it is essential that health should be a state subject and medical education should be heavily subsidized. Privatizing health care has been a bane, the results of which are today reflected in our chronically sick population. We are being harmed by those very people who under the oath of "First do no harm" are inflicting the most severe damage to our health.