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Paediatrics ethics question

New Delhi, Jan. 25: Doctors have questioned the ethics of decisions by India’s apex body of paediatricians to accept funds from drug or vaccine firms and release guidelines for vaccinations without declaring any conflict of interest.

During 2011-12, the Indian Academy of Pediatrics (IAP) accepted from six companies sums adding up to Rs 26.76 lakh that were credited to a fund for the IAP’s committee on immunisation (IAPCOI), the academy’s annual report has shown.

Physicians tracking ethics in medicine say the decision to accept money from the companies seems a violation of paragraphs 6.8 and 6.8.1 of a code of conduct notified by the Medical Council of India on December 10, 2009.

The notification, intended for “doctors and professional associations of doctors”, specifies that medical practitioners shall not receive any cash or monetary grants from the industry.

A journal of drugs, the Monthly Index of Medical Specialities (MIMS), India, has used the academy’s annual accounts statements to calculate that overall, it received funds totalling about Rs 2.5 crore from at least nine drug or vaccine companies in 2011-12.

“The Medical Council of India needs to investigate such violations of its notification,” Chandra Gulhati, a physician and the editor of MIMS India, told The Telegraph.

The academy has denied any breach of ethics or violation of the notification. “There’s absolutely nothing wrong --- like other professional doctors’ associations, the IAP has used funds from the industry for its scientific activities,” Rohit Agrawal, co-chairperson of the IAPCOI, told this newspaper.

The IAPCOI, a panel of paediatricians drawn from the academy’s membership, had been tasked by the academy with drawing up a set of “consensus recommendations on immunisation”, listing a schedule of vaccinations that private paediatricians were expected to prescribe.

The academy’s annual report suggests that part of the IAPCOI funds was used to cover travel and accommodation expenses associated with three meetings of the panel’s members in February 2011, July 2011 and December 2011.

Agrawal said the academy had decided in 2009 to pool contributions from various companies to create a corpus to be used for the expenses on IAPCOI meetings. “Before 2009, each meeting of the IAPCOI would be sponsored by a single company. We wanted to put an end to that practice.”

The IAPCOI published its guidelines for vaccinations in the academy journal, Indian Pediatrics, in July 2012 with the claim that the exercise had not received any funding and faced no competing interests.

“If the IAPCOI had received funds from the industry ---- as its own accounts show ---- it would be misleading and unethical not to disclose that in the recommendations on vaccinations for the nation,” said Sanjiv Lewin, professor of paediatrics and ethics at the St John’s Medical College Hospital, Bangalore.

The IAPCOI recommendations contain an ideal schedule for vaccines to protect children from a range of life-threatening or crippling infections, from polio and measles to hepatitis B, meningitis and rotavirus infections.

“At this point, we’re not questioning the contents of the recommendations or the outcome of the IAPCOI’s exercise,” said Amar Jesani, a physician and coordinator for the Centre for Studies in Ethics and Rights, Mumbai.

“While the outcome itself may not be bad, the process through which that outcome emerged should be flawless.”

The controversy has already stirred the academy into action. “This was not a practice in the past but, In the interests of transparency, we’ve now made it mandatory for all members of expert committees to disclose conflicts of interest, if any,” academy president Chaitanya Bansal told this newspaper.

The academy’s journal itself had stated in the past that competing interests for a scientific document exist when the authors have ties that could inappropriately influence their judgement —whether or not the judgement is in fact affected.

“The issue is purely ethical,” Lewin said. “A code of ethics enables us to maintain trust between physicians and patients, which is the cornerstone of good healthcare delivery. Declarations of conflicts of interest are vital to maintaining doctor-patient trust.”

Academy officials have claimed that the Medical Council of India’s code of conduct prohibits individuals from receiving industry funds. But Gulhati cited how the council had a few years ago punished the Indian Medical Association for endorsing brands — another violation of the code of conduct.