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correspondence

Indian Pediatr 2012;49: 1000-1001

Reply


Vipin M Vashishtha

Convener, IAP Committee on Immunization, Mangla Hospital& Research Center, Shakti Chowk,
Bijnor, Uttar Pradesh, 246701,India.
Email: [email protected]
 
 


Thanks for providing an opportunity to discuss in detail the issues related to conflict of interests.

No, you have not got everything wrong, but partially yes! I would not outrightly accuse you of possessing a prejudiced mindset considering the recent state of affairs where industry goes all out to pressurize academic bodies to get favorable recommendations. But probably you have not thoroughly gone through the recommendations which have many subtle and many not so subtle indications pointing toward impending change in its thinking and process of issuing recommendations. Conflict of interests issue is indeed a very serious matter, especially for the realm of vaccines and vaccination where controversies are brewed every now and then. This committee has two very specific topmost objectives, first, to settle the issue of conflict of interests for committee’s members and second, to initiate a new process of issuing evidence-based recommendations.. We have devised a new ‘code of conduct’ for every member, advisor, and office-bearer of the committee which will be mandatory for everyone to sign and follow before joining this committee. Each member and even invitee will have to declare their conflicts of interests before participating in any meeting of the committee. A three-member committee appointed by the executive board of the academy will decide whether a member has got ‘significant’ conflicts and whether he/she should be allowed to remain a part of the committee or of the decision making body. All these forms will be brought in to public domain very soon. So, we are not only for disclosing all the conflicts but also for resolving them by taking appropriate measures to ensure they do not affect the ultimate process of decision making. The ‘evidence based process’ and ‘conflicts of interest’ issues are interlinked and the former cannot be practiced without addressing the latter. As stated in the consensus recommendations [1], the main focus is on scientific evidence and transparency so that the system can be reproducible and can also be reviewed by other experts. The author probably has not visited IAPCOI website (www.iapcoi.com) which is recently also acknowledged by WHO as reliable source of obtaining information about vaccines and included in its list of websites that adhere to the credibility and content criteria of good information practices [2]. Hence, maintaining transparency is another agenda of current committee. Detailed proceedings of each meeting including agenda, detailed minutes, participants, presentations, etc are regularly posted to our website.

If we go by the author’s ‘yardstick’ of measuring competing interests, no practicing academician would be eligible for the membership of any decision making body. We need to be specific and should have some specific guidelines, codes, etc for dealing with specific issues.  

Regarding the issue of industry’s participation in the meeting, the author should know that the vaccine industry forms an important ingredient of practice of vaccine science today. They have become integral part of the system that affects every aspect related to vaccines, be it developing an antigen, planning and conducting a vaccine clinical trial, approval by a national regulatory authority, collaboration with experts, agencies, governments, philanthropic societies, NGOs, academic bodies, etc. The onus is on us how to best utilize this ‘unavoidable’ association without being influenced. The industry people are also invited regularly by CDC/WHO in their meetings whenever they need some brand-specific data on certain specific aspects. We also invited them with certain objectives. First, we wanted to gather information on post-marketing surveillance (PMS) on newer vaccines. Once a new vaccine is licensed in the country by the NRA (i.e. DCGI in India), the vaccine companies usually start a marketing blitzkrieg targeting different quarters but usually fail to apprise them of the post-marketing performance of these vaccines. Even NRA forgets to take notice about what is happening at the community level, i.e. the AEFI, the efficacy and  effectiveness, the impact on disease epidemiology, etc. The committee invited the industry people and requested them to share their data on PMS of some newer vaccines. They were also requested to initiate PMS of the vaccines where it did not exist. Secondly, we sought their help in developing a passive VPD surveillance system in the country so that some useful data can be gathered by the year end. IDSurv and the surveillance subcommittee of IAP are the steps in this direction. Another objective was to request them to cut the margins offered to practitioners (i.e. to reduce the MRP) on the sales of newer vaccines so that these vaccines could be made more affordable for the parents. Further, this committee is committed to support indigenous vaccine manufacturers in order to address the gap of demand and supply of some products, and also to make them affordable.     

This is just a beginning. The committee needs to be complimented for undertaking some new bold initiatives rather than castigating based on false presumptions and prejudices. 

References

1. IAPCOI. Consensus Recommendations on Immunization and IAP Immunization Timetable 2012. Indian Pediatr. 2012;49:549-64.

2. World Health Organization. Immunization safety. Vaccine safety web sites meeting credibility and content good information practices criteria. Available from: http://www.who.int/immunization_safety/safety_quality/approved_vaccine_safety_websites/en/index.html Accessed on September 6, 2012. 

 

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