Prof Sir Michael Rawlins
WS Q’s
7.5 - What was the point of considering the source of blood donations?
Was there ever a time he can recall where the source of blood donations made any material difference to a licensing decision?
Should it have done? / Why?
Could the CSM have imposed restrictions on blood donation sources?
What steps did the CSM take to ensure the information provided in relation to blood donation sources was accurate?
7.6 - Same questions as above in relation to pool size
Could the CSM have imposed limits on pool size?
Would he accept that, in relation to blood products, source and pool size are two of the most important factors relating to safety?
Would he agree that without having any restrictions on these, the CSM was playing a somewhat passive role?
7.9 - Is it right to understand his observation was that where alternative treatment options are available for a condition, bigger safety studies should be undertaken?
And that is because where there is an alternative treatment option, you want to be even more sure that you are not unnecessarily exposing a patient to risk or additional risk?
9.2(b) How would “quality” be defined?
9.3 - Can he expand upon (at this time) “our knowledge had grown about the risk of AIDS”?
15.4 - Conflicts with newspapers cuttings in additional docs
16.21 - The concerns about “reduced their life expectancy” - does he recall any factual basis for that concern had a reversion to cryo taken place?
16.21 - He says it’s not possible to say what the level of risk would need to have been to withdraw. Does he agree that there should have been some (even very broad) benchmark of risk at which a withdrawal should take place? A more formal risk assessment system?
16.21 - He says if we knew then what we know now urgent action would have been taken…
What action would likely have been taken?
Does he agree that even this bar (knowing what we know now) is too high? By that I mean, a significant proportion of haemophiliacs were infected with HIV and the vast majority of them are now dead. Surely there was a point before knowing that now, that urgent action should have been taken? Where would he put that point in time?
19.2 - Is he willing to remove the word “perhaps” from his opening sentence?
Non WS & Additional Docs
Was it within the CSM’s power to tell a product manufacturer that the warnings in regards to viruses on labels must be more accurately stated?
For example “This product is assumed to be infected with hepatitis” as opposed to “cannot be assumed to be free of”.
Was it within the CSM’s power to say, for example, “this product can be licensed but only when you have found a way to subject it to viral inactivation” ?
Was it within the CSM’s power to revoke a product licence on the grounds that virtually all of the product was infected with a potentially lethal virus?
Who was responsible for determining whether wide scale use of CTX’s / named-patient usage was acceptable? / Bypassing the more formal mechanisms of product licensing in an inappropriate way?
Was it within the CSM’s power to force a manufacturer (be that BPL or commercial) to issue a product recall?
