Dr. on silicone antibody testing

[Guest guest]

http://www.ivanhoe.com/channels/p_channelstory.cfm?storyid=338 Garry, Ph.D., Professor of Microbiology and Immunology, Tulane Medical School, New Orleans, LA

TOPIC: SILICONE BREAST IMPLANT TEST, #950

How did this test come about?

Dr. Garry: Like

many scientific discoveries it was almost by accident. We knew that

some people had reported that women with silicone breast implants had

conditions like people with autoimmune diseases. So we were looking for

some traditional auto antigens and antibody responses in these women.

What we found was something completely different, we found an antibody

response to polymers which was totally unexpected.

What are polymers?

Dr. Garry:

Polymers are long repeating sub units and they are a common chemical

structure. Many parts of our body have these polymeric components in

them and silicone which is used to make the breast implants is also a

polymeric substance. So it's kind of a generic term.

So you started out looking for other autoimmune responses?

Dr. Garry: We

started looking for traditional auto antibodies that people with

diseases like systemic lupus or scleroderma have and we really didn't

find those in our breast implant recipients but we did find this other

response.

These polymers are related to the silicone in breast implants?

Dr. Garry:

Chemically they're related. We are certainly not sure that it's exactly

the silicone polymers that are inducing the response, it could be some

other polymeric substance in the body. They're all related so I think

we're just picking up a footprint of a common foot.

Why is this controversial, has this been tested elsewhere and not come up with these results?

Dr. Garry:

Nobody has looked at this exact response that we're looking for and we

certainly didn't set out to look for it. We more or less came upon it

by accident. People that have looked for traditional autoimmune

diseases or known autoimmune diseases in patients with implants haven't

found them. What we found is people with more typical kind of

conditions, fatigue, muscle pain and other symptoms, are the people

that have these antibodies.

Are these necessarily silicone patients or can people without the silicone have this?

Dr. Garry: It's

more rare in the normal population. There is a background of people

that do get this antibody response. Of course silicone is pretty common

in our modern environment, it's present in a lot of foods and

medicines, it's present in make up so we don't know that the antibodies

we're detecting in people without silicone breast implants might not be

due to some other form of silicone exposure. Are you finding large amounts in the women who do have the implants?

Dr. Garry:

Certainly they have these implants in their bodies and the silicone

does tend to leak out of them, sometimes the implants rupture so

they're getting a very large, continuous exposure. The other types of

silicone exposures that you might get from the environment or medicines

are much smaller.

Do you see a correlation there?

Dr. Garry: Yes.

With the implants the silicone exposure is continuous, if the implant

has ruptured it's going to be pretty dramatic. So that's one reason why

we may have picked up the antibodies in this population whereas a

population without implants their silicone exposure is going to be a

lot less.

What kind of test is this, what's the procedure?

Dr. Garry: First

you draw blood from the patient and then you collect a fraction of the

blood called serum from it, it's a traditional serum antibody test.

Then we look to see if the serum has these particular antibodies, the

ones that are reacting to the polymers. The test is a fairly simple one

you just put the polymers on a little strip and then add the serum with

the antibodies in it. If the antibodies are present they'll bind to the

polymers on the strip and we can come back and detect the binding of

the antibodies to that strip.

It comes out almost like a photograph?

Dr. Garry: Yes.

If the antibodies are bound we can come back with some reagents which

will give us a color and the color will precipitate right on the strip

so you get a nice little line if the antibody is present.

How many people have you tested with this?

Dr. Garry: We've

tested several thousand silicone breast implant recipients, we've

tested patients with known autoimmune diseases, we've tested healthy

blood donors. We've tested quite a few patients and our results seem to

hold up over a fairly broad range of individuals.

In the several thousand breast patients how many have come up positive?

Dr. Garry: It's

about 50% and one reason we think it might not be higher is that we're

really testing for a surrogate. We may not be testing exactly for the

polymer that people have been exposed to, in other words the silicone

itself. The polymer we put on our assay is not silicone per se. The

antibody response is a cross reactive one so that's why we think we're

only picking it up in about half of the patients. The interesting thing

is that the sicker the patient, the more well-developed symptoms,

fatigue or work related disabilities, they are much more likely to have

the antibody than a woman with the implant who is relatively healthy.

What kind of women are you seeing coming in here, the really sick ones, what are their symptoms?

Dr. Garry: Here

we don't really see the women, we mostly see their blood and blood

products. We're a diagnostic development lab, we're not clinical

rheumatologists. We do work closely with a lot of rheumatologists in

the city and across the country that send us these samples from the

patients. The typical profile of the patient that we found with these

antibodies would have muscle pain, unremitting fatigue, restless sleep,

they tend to be disabled in their ability to perform their normal

everyday tasks. So it's not a typical rheumatic disease where you might

have a butterfly rash, or a kidney, or a heart involvement like lupus

but a different set of symptoms.

Now that we have this information what can be done with it to help these patients?

Dr. Garry: The

first thing is that is if the antibodies are important in the disease

process we might be able to remove the source of the antigen that's

soliciting the antibodies. In fact many patients with silicone breast

implants that have them removed do get relief from these symptoms

eventually as the silicone is cleared from their bodies. So that's one

thing that can be done initially. On the other hand we realize that

biomedical silicone is very important, in fact most of the things that

are put into the body during surgery in operations have silicone

polymers in them. So what we would like to be able to be able to do is

to design a silicone polymer or some other polymer that didn't illicit

this antibody response. We would hope that, that would be much safer

than the current polymers that are used in breast implants and other

medical devices.

What do you say to your critics?

Dr. Garry:

There's always going to be people that are skeptical and a little

skepticism in science is important. We feel obliged to demonstrate that

our test is important and predictive in the most scientific rigorous

terms possible. We've done a blinded trial, we received samples that we

didn't know the identities of we had many controls with them and so

we've tried to do the best scientific tradition to prove that our test

is really valid.

What's the process, do you now go to the FDA, is there a procedure?

Dr. Garry:

That's part of the process, you need approval from the FDA to market a

new diagnostic test in certain ways. We certainly have only done one

large trial and it was a blinded trial but it was only from a single

center. We need to test other parts of the country to make sure the

response we saw in Arizona is also going to happen in Pennsylvania. We

expect that to happen but we're going to test it again in a larger

multicenter study.

Does the test cost anything right now or will it cost as it goes on?

Dr. Garry: It's

a fairly simple test but like any other medical procedure you have to

collect blood and you have to have the assay run by a trained

professional. So right now Tulane isn't running a test but there is a

company in New Orleans that is running a test and that test is

available for a fee from Auto Immune Technologies.

Do you know what the fee is?

Dr. Garry: It's

two hundred dollars, which covers some of the cost which we're

undergoing and the licensing from the university. It's really quite a

reasonable cost actually considering what other people charge for these

tests.

You feel like in the past maybe everybody was just looking at the wrong thing?

Dr. Garry: If

you look for a traditional or a known autoimmune disease in patients

with implants you'll find some patients that have the disease but

perhaps not at a higher level than in just the healthy normal

population. What people that have looked in implant patients have found

now is this a typical rheumatic condition with the muscle aches and

fatigue that really doesn't fit into any known rheumatic disease

classification. So it's a new disease not one that people have

described before.

This is a pretty amazing discovery.

Dr. Garry: The

importance of the test is that it confirms the clinical judgement of

the people that have been diagnosing this new rheumatic condition. If

the test had not correlated with the symptoms then you could question

the rheumatologist's judgment. If the test didn't correlate with

disease then you could question the test too but both things together

are sort of like a double edged sword.

What's your reaction to 'finally there is proof'?

Dr. Garry:

There's been a lot of controversy about it, I'm hopeful that our work

here can sort of resolve some of those controversial aspects of it and

let people focus in on the real disease that's being caused by these

implants and the other diseases lupus, and rheumatoid arthritis, I mean

those are important diseases too and maybe we can learn a little bit

about those by studying this new rheumatic disease. We are interested

in getting to the scientific controversy and I think our test will help

that.

END OF INTERVIEW

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