Vaccines and Mad Cow

[Guest guest]

Oral polio vaccine is one that is made with fetal bovine serum as well as

some DTP....

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K Note: There is an article in the NY Times today concerning the

threat of mad cow contamination or bovine spongiform encephalopathy (BSE) in

vaccines. The article focuses on a meeting held at the FDA on June 1, 2000.

The link to the article is below. If you click there you will have to sign

into the NY Times which is a free service. There are also many good links

there if you want to read more articles.

http://www.nytimes.com/2001/02/08/health/08COW.html?pagewanted=all

The following is excerpted from the transcript of the FDA meeting. The

exchanges listed below take place between Dr. Lurie of Public Citizen,

Dr. Kahn from Kline Beecham, Dr. Orenstein of the National

Immunization Program and Barbara Loe Fisher, NVIC president and consumer

voting member on the FDA committee.The full transcript is available on the

internet at http://www/fda.gov/ohrms/dockets/ac/00/transcripts/3635t1.rtf

for those who want to do further research

MS FISHER: Dr. Orenstein, as the head of the immunization program for the

CDC, do you support strict guidelines for manufacturers to make sure that

there is no transmission of BSE to American babies through vaccines using

bovine sources for production?

DR. ORENSTEIN: I think that there should be guidelines for manufacturers,

and I think that, to the extent possible, that risk needs to be as close to

zero as possible, hopefully zero. But I think, with all of these things,

we're going to have to weigh risks and benefits.My hope is it's zero, and I

think that we ought to try and go for zero, but with other vaccines we have

to weigh the risks and benefits, and I think we need to understand what the

magnitude of risk would be in order to put that into the equation of

risk-benefit evaluation.

DR. LURIE: This is a question for Dr. Kahn. As you know, on December 17,

1993, the FDA wrote to a number of drug companies insisting that they no

longer source their bovine derived materials from cattle which have resided

in BSE countries.I'm going to make the hypothetical assumptions that the

fact that your company has made a presentation and flown in an expert from

Britain that you're here for a reason that may be related to your having

produced one of those vaccines. And assuming that my hypothetical

assumption is correct, my question is: Why did you ignore the December 17,

1993, FDA letter?

DR. KAHN: I just want to say, and I'm sure this is common with other

manufacturers, that we take all such letters and guidance and

recommendations, as these were, seriously, and we have recommendations from

multiple countries' regulatory bodies.Our policy -- I'm sure this is common

with others -- is to move away from any risk or perception of risk, and even

perception of risk can be a problem today. I can say that, even as early as

1990, we made the concerted decision to make all bulk manufacturing, all

routine manufacturing steps -- the serum would be sourced from countries

which include New Zealand, Australia, and go away from any country that

would be listed or a risk country.

Other materials would have come from Europe and other countries which were

non-BSE. There's an evolution in the list of countries that are causing a

problem. So we are always looking for ways to come into line. Now having

said that, for some of the source materials, assumptions were made by our

company. Maybe they are considered unwarranted today, but they were made in

full, good faith of disclosure and the fact that the starting materials are

non-infective. I think the non-infectivity of starting materials is the

cornerstone for what you do in vaccine manufacture, and very important to

us.

We have written, shared all of this information with the agency, and I can

honestly and we also, by the way, improved traceability, decreased the

chances of cross-contamination in collection. All those things were put

into place as soon as any hint of a risk was mentioned from the Eighties. SB

is working very closely right now with FDA to evaluate and to implement any

changes that are considered necessary to address even the perception of

risk.

DR. LURIE: So you did ignore it then.

DR. KAHN: No, we don't ignore their letters.

DR. LURIE; I mean, I guess the overall point, though, is that it's very

difficult for this committee to make any kind of real assessment of risk. I

understand we're not voting on anything, but it's difficult even to discuss

in the absence of our knowledge of what vaccines are an issue, what numbers

of vaccines have been injected into people, what numbers of vaccines remain

on the shelf, how long it would take for particular vaccines to replenish,

you know, what the lag time would be. And all of this is beyond a

theoretical discussion, and it only becomes real and our deliberations only

become of much use, it seems to me, at the point that that sort of

information is available.

CHAIRMAN BROWN: Well, , you've been on the committee long enough to

know that we never make decisions based on scientific evidence, and we're

not going to start today. Thank you, Dr. Kahn.

LATER...

MS. FISHER: I do have a comment. I think that Dr. Berkower summed it up

best, at least for me as a consumer rep, when he said there are many factors

we would like to know but don't know at this time. What I've learned here

today is that when bovine derived materials are used in vaccine production,

especially materials from countries where BSE is known to exist, there is at

least a theoretical risk of TSE transmission and that this risk is made more

possible by the technology limitations to detect adventitious agents.

I think that, if there is a risk, even a theoretical risk, from a consumer's

standpoint that you have to tell the people who are using the product.

There has to be full public disclosure, and I would encourage the FDA to

look at requiring the manufacturers to have something in the product

manufacturer insert to reflect this theoretical risk.

CHAIRMAN BROWN: Thank you. That is an interesting issue. Of course, it's

one of the FDA options to be able to do it, and I'm sure as consumer rep you

recognize that the likely reaction -- and I'm all for public disclosure --

of a letter which says " Dear Doctor, it has come to our attention recently

that this vaccine contains fetal bovine serum that was processed from Great

Britain which has, as you know, killed a number of people from mad cow

disease. We thought you ought to know -- You know, you wonder whether or

not the risk is sufficient even to cause this much anxiety, because it does.

MS. FISHER: It may be a difficult thing to address, but I don't think

that -- I think the public trust is important and, if you're truthful with

the public and forthcoming with the public all along the way, then there are

no surprises for anybody in the future.

I think that people cannot be elitist and decide what is best for other

people. You have to have full public disclosure about even a theoretical

risk, and I think in the long run it's going to serve the vaccine program

better than to basically have people be finding out that we knew but didn't

tell.

CHAIRMAN BROWN: Yes. I, a hundred percent, absolutely agree with that, and

it's a long process of education and people have to -- You have to take the

flak for a while until people understand that when you're telling them that

there is a theoretical risk, that that's exactly what you mean, there's a

theoretical risk. And they gradually begin to appreciate the remoteness of

that risk and, therefore, accept it. But I agree that it's entirely better

to do it that way, accept the reaction you're going to get from that subset

of the population that always at zero risk as the only alternative, and

gradually they will come to understand that there really wasn't any risk,

but still --

MS. FISHER: At least you were honest.At least you were above-board.

CHAIRMAN BROWN: Yes, right, exactly. At least you were above-board. Go

ahead, please.

DR. LURIE: I think those are very important points. Let me just make one

sort of introductory point and then follow up on Ms. Fisher's point. As I

see the very worst case scenario here, which is not, of course, the only

one, and Dr. Vann's presentation, the fermenter under the worst scenario --

and again, it is the worst scenario -- is infected. That's one in 20

million. It's not one in 40 billion, and one in 20 million -- Again, we

don't know how many vaccine doses, because we don't know which vaccines,

etcetera, etcetera -- points I've made before.

Certainly, that doesn't take very long for 20 million shots to be

administered in this country. But having said that, I think that Ms.

Fisher's point is absolutely right on. I think that the fact of -- There

are two reasons to disclose.One is a moral one, that the patient would like

to know and, I believe, has the right to know about a risk like this.

Certainly, I would like to know if I had been exposed to a minimal risk or

not. So I think that's a moral issue, and I do think we should steer away

from paternalistic ideas about what is best for patients. I think that's

the sort of thing this country has been leading the world in moving away

from.

The second point is, frankly, a political one. The fact of the matter is

that in this room today there are a number of members of the press, and they

are going to write stories about this, and those stories are going to be on

the Internet by tomorrow, and they are going to be out there for people to

talk about. It is going to do no good for this committee or the public

health or for public confidence in vaccines for that kind of stuff to be out

there and we taking a position that somehow patients should not be

adequately informed in some fashion.

So I think that, for political reasons as well as moral reasons, we do

inform. The question to me is not so much whether to inform, because it's

informing via Reuters and the AMA News versus informing by the FDA, the

manufacturers or the doctor. That's really the question.

So I think the question we should be asking is how to inform, and my own

feeling is that a letter to doctors explaining this can be written. It would

be difficult to do, but I'm sure the FDA can write a letter that will

explain how small the risk is, but still provide the information to doctors

who will need to be answering the questions posed by the patients who read

about this on the Internet tomorrow.

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