Editor's Note: I asked John Gilmartin to comment on the results of the Danish study we posted earlier this week (Massive study finds no evidence...") Don't miss his last paragraph which John recalls Jim Grant's views on "the real purpose" of getting programmes like vaccination up and running in developing countries.
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Hi Tom,
No I didn’t see it. I try to avoid most of whatever Bobby jr is stirring up.
I haven’t heard of the aluminum nonsense. I can just assure you there is no aluminum in contact with any vaccine manufacture. It isn’t in any reagent or growth medium, and it certainly isn’t used as a storage container or any other device in contact with any modern vaccine. Originally vaccines were processed in glass of all sorts and sizes. Starting around fifty or sixty years it all shifted to high quality stainless steel. Glass is still used in the smallest stages of what’s called seed production. These are Petri dishes and similar culture media containers.
Everything used in vaccine production and generally testing as well must be able to endure steam sterilization cleaning. In every step of modern manufacturing there is a process called validation that rigorously examines each process to find any variation from the expected results. If aluminum was somehow getting into a part of the process the qc, qa, and the validation testing would pick it up. I would say it’s nonsense, and irrelevant to actual vaccine manufacturing.
You’re probably already aware that there is a group of people determined to discredit vaccines in any manner they can, regardless of the truth of their accusations.
When I was working in Unicef’s vaccine supply we maintained a strong close relationship with the WHO vaccine quality section. Unicef made it policy that we never tested any vaccine, or spoke directly on the quality of a given vaccine issue, we relied on WHO to provide all the assurances and answers to all questions. In those days that section had a very capable team, and they in turn had all the actual testing performed by excellent national testing laboratories. When there was a problem, the lab selected would explain their testing and assure the worried press or government of their results. We were able to draw on several of the finest labs globally to do this work. In those days these labs were credible enough to deal with the doubters. We rarely encountered an actual vaccine quality issue. When we did the problem was investigated. I had the chance to be part of one of those investigations, in a Hungarian labs DTP, and then part of the response to the Serbian min of health.
Saying there is an aluminum problem with the processes in general is way too broad for a simple process analysis. That’s not to say these accusations should not be taken seriously or addressed. Again, if I were back in the supply dept I’d be advocating that we and WHO partner with a group of excellent national control authorities, not just the FDA, or UK Medicines board but a whole group of the best NCA’s, and ask them to take up the accusation of Aluminum in vaccine and to provide a timely response. I’d also be asking the unicef communications group to get involved with WHO to come up with a strategy to address the public side of this sort of accusations. In my view, there is no actual aluminum issue, but there very much is a vaccine communication issue much larger than aluminum or any other odd accusation. These accusations are hard to respond to, but can’t be left dangling without a good answer. The real purpose of discrediting vaccines is to discredit public health programs. And, it’s not just the public health department being discredited its purpose is to sew confusion and doubt that government and national laboratories etc are not to be trusted. The Times ran a series on Active Measures awhile ago, it’s worth looking at.
Last, I am reminded of a talk that Jim Grant gave to anyone in unicef wanting to listen on the purpose of immunization programs. I wish it had been recorded and used as a policy doctrine, perhaps there is such a document. Anyway what Jim talked about to the staff who were mainly the General Service folks that came to listen to this informal meeting was the real purpose of helping governments put immunization in place was not to immunize their children. That of course was the immediate result of the program and a net positive. But, the real purpose of getting these programs up and running in a poor country was to demonstrate to the leadership of that country that THEY were capable of taking responsibility for their children’s health and welfare without committing to a huge expensive complex activity. Jim was passionate about proving to leaders in young poor countries that THEY were capable of self determining their children’s future. That immunization was simply one of the tools available to them, that it was low cost and manageable for their governments. I remember there were a few senior staff in attendance, and them looking around in surprise that Jim was not committed to pushing vaccines or ORS or vitamins or breast milk. Fuad might have been attending and maybe he can comment on this aspect.
.......
Hi Tom,
No I didn’t see it. I try to avoid most of whatever Bobby jr is stirring up.
I haven’t heard of the aluminum nonsense. I can just assure you there is no aluminum in contact with any vaccine manufacture. It isn’t in any reagent or growth medium, and it certainly isn’t used as a storage container or any other device in contact with any modern vaccine. Originally vaccines were processed in glass of all sorts and sizes. Starting around fifty or sixty years it all shifted to high quality stainless steel. Glass is still used in the smallest stages of what’s called seed production. These are Petri dishes and similar culture media containers.
Everything used in vaccine production and generally testing as well must be able to endure steam sterilization cleaning. In every step of modern manufacturing there is a process called validation that rigorously examines each process to find any variation from the expected results. If aluminum was somehow getting into a part of the process the qc, qa, and the validation testing would pick it up. I would say it’s nonsense, and irrelevant to actual vaccine manufacturing.
You’re probably already aware that there is a group of people determined to discredit vaccines in any manner they can, regardless of the truth of their accusations.
When I was working in Unicef’s vaccine supply we maintained a strong close relationship with the WHO vaccine quality section. Unicef made it policy that we never tested any vaccine, or spoke directly on the quality of a given vaccine issue, we relied on WHO to provide all the assurances and answers to all questions. In those days that section had a very capable team, and they in turn had all the actual testing performed by excellent national testing laboratories. When there was a problem, the lab selected would explain their testing and assure the worried press or government of their results. We were able to draw on several of the finest labs globally to do this work. In those days these labs were credible enough to deal with the doubters. We rarely encountered an actual vaccine quality issue. When we did the problem was investigated. I had the chance to be part of one of those investigations, in a Hungarian labs DTP, and then part of the response to the Serbian min of health.
Saying there is an aluminum problem with the processes in general is way too broad for a simple process analysis. That’s not to say these accusations should not be taken seriously or addressed. Again, if I were back in the supply dept I’d be advocating that we and WHO partner with a group of excellent national control authorities, not just the FDA, or UK Medicines board but a whole group of the best NCA’s, and ask them to take up the accusation of Aluminum in vaccine and to provide a timely response. I’d also be asking the unicef communications group to get involved with WHO to come up with a strategy to address the public side of this sort of accusations. In my view, there is no actual aluminum issue, but there very much is a vaccine communication issue much larger than aluminum or any other odd accusation. These accusations are hard to respond to, but can’t be left dangling without a good answer. The real purpose of discrediting vaccines is to discredit public health programs. And, it’s not just the public health department being discredited its purpose is to sew confusion and doubt that government and national laboratories etc are not to be trusted. The Times ran a series on Active Measures awhile ago, it’s worth looking at.
Last, I am reminded of a talk that Jim Grant gave to anyone in unicef wanting to listen on the purpose of immunization programs. I wish it had been recorded and used as a policy doctrine, perhaps there is such a document. Anyway what Jim talked about to the staff who were mainly the General Service folks that came to listen to this informal meeting was the real purpose of helping governments put immunization in place was not to immunize their children. That of course was the immediate result of the program and a net positive. But, the real purpose of getting these programs up and running in a poor country was to demonstrate to the leadership of that country that THEY were capable of taking responsibility for their children’s health and welfare without committing to a huge expensive complex activity. Jim was passionate about proving to leaders in young poor countries that THEY were capable of self determining their children’s future. That immunization was simply one of the tools available to them, that it was low cost and manageable for their governments. I remember there were a few senior staff in attendance, and them looking around in surprise that Jim was not committed to pushing vaccines or ORS or vitamins or breast milk. Fuad might have been attending and maybe he can comment on this aspect.
John, your last para on Jim Grant's philosophy and purpose should be a must-read for all UNICEF staff. The importance of pointing at and insisting on the accountability of host governments to their own citizens is absolutely paramount. It is unfortunate that this principle has been overturned for the last 20 years by UNICEF and other UN agencies, especially after the onset of the UN reform - by agency practice and rhetoric insisting that it is them who save lifes and 'deliver development'.
ReplyDeleteI cannot remember that particular meeting, but like Detlef I deplore the change in rhetoric that maintains what the UN agency is doing rather than what the assisted country should be doing. In the early years I recall that every project document had a section called “Govt matching” where we showed their inputs to the activity. Over time this disappeared, sadly.
ReplyDeleteI agree that that the genius of JPG ‘s approach was highlighting the national efforts , not the UN inputs and giving primary importance to others, rather than to unicef.
Oops sorry the above is from Fouad.
ReplyDelete