BSE, Polio vaccine and quality assurance

["bob" <bob.adsett@lineone.net>]

 I have some personal concerns about the safety of the oral polio 
vaccination that my children have just received in the UK.

The  vaccine manufactured by  CellTec Medeva
 has been found to use foetal calf serum obtained from the UK. The use of UK
bovine material  is
contrary to a 1989 (YES 1989) UK government Committee on the Safety of
Medicines (CSM) guidance that placed a ban on the use of this material due
to the potential risk of contracting CJD (Mad Cow disease). This CSM
Guidance was later replaced by European legislation in 1992. It begs the
question if this was banned material in 1989, why has it taken till 2000 to
discover that Medeva had been using this material?

I would like to share a couple of quotes from the circular being put out by
 local doctors issued by the Department of Health.

Q: What is the problem which has been identified with oral polio
vaccine(OPV)?

A: Following extra checks by the medicine control agency it has been
discovered that - contrary to information previously supplied by the
manufacturer - Medeva's OPV does not comply with manufacturing guidelines

(It does not comply because it used UK sourced foetal calf serum.)

A pretty serious error, I wonder what quality control/ assurance this
company was using - sadly there appears to be similarity with the debate
about the
Ford/Firestone issue.

I wonder what the stimulus was that prompted the medicines control agency to
make these 'extra checks' although it took them 11 years to make the
discovery.

Somewhat more worrying is another Q & A which states:

Q: Is there a public health concern?
A: Not that we can identify. Taking into account the tissues used and the
processing any risk associated with OPV is incalculably small.

I might be acting a bit thick here but, if the company has been lying about
what material it has been using what credibility can we give to any
assurances that they offer about the processes that they have used? Or do we
optimistically assume that this is just a one-off event and the organisation
does not have a culture of deceit?
Is this just another example of political spin and wishful thinking?

It goes on to state that "Studies of the disease indicate that the vaccine
appears to have no role in the occurrence of vCJD"
But is this an accurate statement or is it a short-hand way of saying there
has been no research  carried out into the possible linkages between  new
varient CJD
and vaccine based upon foetal calf serum?

Have we in the UK lost faith in what we are told by professionals, civil
servants and scientists? Sadly yes, the days of unquestioning belief in what
we are told is over -- and many would say not before time.

And as always somewhat later in the document the government starts the hunt
for someone to blame

Q:We (the government) were told that UK vaccines were free of UK sources
bovine material and therefore not potentially contaminated with BSE.
This is not true - why did this happen? Who is at fault?
A: many vaccines use bovine material in the manufacturing process, but the
processes used are designed to remove unwanted protein such as foetal calf
serum. No vaccine on the UK market uses bovine material as an active
ingredient.

A very reassuring answer, but not to the question that was put. But if there
was a perceived risk associated with the use of this material why wasn't a
system devised to ensure that it could not have happened?

Other comments are similar, with a final one saying:

"Any risk associated with OPV is so small that the balance of benefit to
risk is overwhelmingly favourable"
I hear a booming voice saying "Show me the data"

One final reassurance offered by the Department of Health states
"The OPV available from Smithkline Beecham does not use any UK sourced
bovine material"

With 100 new cases of BSE surfacing in France in the last couple of weeks
following the introduction of a new screening test on bovine carcasses, I
wonder how long we will have to wait before we discover BSE in New Zealand
cattle - the current source of bovine foetal serum?

Will Smithkline Beecham  be reviewing their quality assurance programme and
 revise what material they use in future for developing vaccines? In
view of the litigious environment of the US I can't help thinking that more
care might be exercised in the US than in Europe.

And before any non-European readers start to get a warm smug feeling that
this could never happen there, remember considerable quantities of EU
produced vaccines find their way onto the world market.


bob

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Bob Adsett
Bingley, Yorkshire, UK

Tel.   +44 (0) 1274 77 95 02
Mobile +44 (0) 7980 85 22 34
e-Mail bob.adsett@lineone.net
---
The great tragedy of science ­ the slaying of an original, beautiful
hypothesis by an ugly fact.