Science versus Commercial Intentions - Example

Recently this blog discussed the issue of science versus sales, addressing the unfortunate truth that there are so called "science focused" subject matter experts with a primary, underlying ambition to increase sales for the organization they work for. A very current example shows, how such subject matter experts amend the interpretation of regulatory statements to their advantage, as well as trying to influence scientifically based positions to spin such position to the arguments used later in promotional activities.
A prime example of such behavior is the current pre-use/post-sterilization integrity test issue, which has been picked up by a major filter manufacturer to promote an integrity test system. But let's go back how it all started; EC Annex 1, paragraph 113 states that "The integrity of the sterilized filter should be verified before use...". This statement is not new, but existing since the early 90's. However, the statement became critical since a few regulators started enforcing this statement, adding confusion rather than clarity. A presentation given in 2008 at the PDA/FDA Conference pointed out that the enforcement of the statement will increase processing risks, since the sterilized downstream side requires manipulation and atmospheric pressure conditions to perform the integrity test. This was challenged by a prominent member of the mentioned major filter supplier. A task force formed by PDA analyzed multiple different filtration system designs and so far all risk assessments showed an increase in the risk probability number. The position has to be to encourage risk assessment and not thoughtless enforcement.
Coming back to the prominent "subject matter expert"; first the challenge in 2008 that the risk increase is not substantial, but then this same person tried to influence regulators and a position statement, which encourages risk assessment instead of standardizing to such pre-use test. The reason for the motivation to argue for such test just became obvious with an announcement of a webinar, promoting a test device which performs a pre-use test on single-use filter devices. Even in the webinar promotion, regulators are used to cause enforcement for the industry and statement are interpreted to the ambition of the supplier. Moreover, not just the test system is promoted, but also redundant filtration. 
Well, science versus commercial interests, this is a prime example. It is a disgrace that the industry is pushed by a vendor sales ambition into something which showed risk increase, which might not be scientifically sound and moreover into a re-design of all their processes. Vendors should support the end-user. So called subject matter expert need to stay scientific.