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Dr. Blais on Platinum

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Thanks Lea,

=========================

Ilena,

Hope this will help on the platinum issue. I have

gone by Blais when I claim that the platinum in our

implants is like the Platinol. Hope there is no legal

reason to NOT post it. It has circulated for years.

Think the women will find it interesting.

Dr Pierre Blais is an expert on implants and has been

correct in all of his predications and observations.

He has 21 years of implant experience. Let’s let him

explain about the PLATINUM in our implants.

Chlorplatinic acid. This information on platinum was

taken from a deposition given by Pierre Blais in 1993.

This portion begins at a discussion regarding the

leaching and leakage of the implant content back into

the patient, and the term ‘bleed,’ not just as the

leakage of silicone oil. There are some unessential

comments omitted and indicated by (..................)

Blais: It has to be now perceived as leakage of oil

plus a chemically reactive, pharmacologically active

entity, a catalyst.

Attorney: When was the first time that you recall

testifying that a catalyst was now something that had

to be considered in connection with this issue,

silicone issue?.......

Blais: The issue of the collectivity of substances

that effuse, diffuse, and somehow permeate and are

released to the patient incidental to its dwell time

was broached in virtually every deposition I’ve ever

given on this topic. ...............

However, the one that raised the issue and developed

it to the greatest degree up to now is the deposition

of versus Baxter HealthCare, and that goes back

almost two years. {approx 1991}

Att: Now, insofar as the effusion, diffusion, and I

think you used the term osmosis to group the types of

action that have been improperly characterized as

bleed heretofore -- am I correct on that:

Blais: Correct

Att: Are you simply raising that to say that when you

have this effusion, diffusion, or osmosis not only

will it involve silicone, but it might involve this

PLATINUM?

Blais: As well as many other things.

Att: We are just talking about those two now.

Blais: For the sake of this discussion, given that

the catalyst forma a measurable and calculable part of

the mobile component, the oil, then it follows that

the oil will entrain this catalyst in a proportional

way: therefore, making this oil a solution, not an

oil.

Att: You mean that’s because the catalyst is in

solution in the oil?

Blais: Correct. It’s dispersed, distributed somehow,

made available through an oil vehicle.

Att: It's actually in solution, you’re saying?

Blais: A part of it is in solution, part of it is

there as an aggega, a molecule, a larger molecule; but

as I may have -- as I have mentioned to you before, I

believe in the closing of the last deposition, bleed

is an incorrect term. It’s actually leakage through

holes, and if it moves, it gets out.

Att: Now, just to complete the picture so that I

understand it, assuming some amount gets out, there is

something called trace amounts known in this area of

science we are discussing.

Blais: Well, the term ‘trace’ is not descriptive.

Att: Just define trace as it is generally used, if

you can. If not, fine.

Blais: I’ve never, ever used that term in any of my

publications. The spirit of trace means very small,

parasitic amounts that are of no consequence. I do not

agree with the term for that reason.

Att: Well, let’s just not use the term, then, if you

don’t want -- like or agree with it. Let me just ask

you this: There are certain measurements of quantities

of amounts, correct?

Blais: That is correct.

Att: As you’ve explained it to me with such patience

today, the quantities may be different or vary from

implant to implant, manufacturer to manufacturer,

batch to batch, correct?

Blais: Yes.

Att: We are talking about the quantities in this

particular case of the catalyst?

Blais: Correct.

Att: So that measurements done even in this protocol

of this study that you are talking about, where they

are measuring catalysts that may be involved in

certain patients, as against normal controls, or

unexposed controls, it might tell you what’s involved

in that situation, but it might not equate to some

other manufacturer or some other implant because of

the difference in quantities, correct?

Blais: Correct.

Att: Then as I understand the procedure, it would

then be to at some point determine whether the amount,

let’s say there is an amount shown in this Houston

study just for the sake of argument, the amount of

catalyst shown is responsible for any clinical

symptomology or damage? That would be the next step?

Blais: Well that relates more to clinical causation,

and there we may reenter into published literature.

Att: When you say you may reenter into published

literature, you may look at literature that’s already

published?

Blais: Correct.

Att: You may also, if that doesn’t give you an

answer, you may have to design a study to test that

property.

Blais: That is possible; but it is a strange time to

initiate such a study.

Att: You may not want to do it now, but I’m just

saying it may not be answerable without a study, if

it’s not answerable by literature, depending upon

what, of course, is determined by the initial

study...............(lawyer dialogue)........... Are

you answering whether a study might be necessary, or

are you saying something else, now? You can tell me

that.

Blais: I’m saying at the point where such a study

could be designed, there is already a body of

literature dealing with the causation of

organoplatinates in terms of neurologic symptoms, and

in fact it’s very, very common literature.

Att: All right, fine.

Blais: And if, perhaps to round out the deposition,

we could file an exhibit to that effect ---

Att: Well, that’s certainly something that you might

very well consider. I would have no objection to you

doing that, and it might be very helpful. You have

that information with you? You’re saying to round out

the deposition right now?

Blais: Right. You can file an exhibit that would make

life somewhat easier, and it would probably circumvent

a lot of discussion. What I have here is an extract

from the Physician Desk Reference, the PRD, which is

one of the most common publications in the

medico-pharmacological area, and in one of its

subheadings under the Bristol-Meyers oncology product,

I have a compound registered as PLATINOL, also known

as CISPLATIN, referenced through my Exhibit 1, and it

describes one of those compounds, the most water

soluble version of it, as being very well known and

very well characterized in terms of medical and

neurological side effects.

Att: Well, thank you so much . I appreciate that.

(discussion on marking Exhibit 8)......

Blais: If it assists you (meaning the defense

attorney) I can use the last minute of the deposition

or whatever time you wish to locate, to bridge the

exhibits, therefore forming a closed and coherent

circle.

Att: I’ll allow you to do that, but I want to ask one

question before that. Other than Defendants’, are you

aware of any other literature on this particular

issue, that is, the issue of the potential or the

actual causing of any injuries or other problems by

what you have termed ‘Cisplatinum?’ [sic] (Cisplatin)

Blais: There is a comparatively large body of

literature on the pharmacology and adverse reactions

surrounding the use of platinates. I have not brought

this file with me. My own file is not complete, but it

is substantial.

Att: Now, you were going to tie Exhibit 8 to Exhibit

1.

Blais: Correct. In Exhibit 1, the compound which is

shown on the extreme left hand, what is labeled in my

exhibit as Cisplatin, trademark, as in Exhibit 8,

right in the first paragraph, whereas the trade name

for it is Platinol..

Att: I see it as saying this is H3N, and you have

H2N.

Blais: Well, no, the molecule is the same. It’s a

diamino. There might be a misprint there.

Att: Misprint where:

Blais: In the PDR.

Defense: The PDR has a misprint?

Blais: It should be a diamino if the printing is

correct. It does show a 3.

Actually, no. It’s correct if we take into

consideration that that molecule is also incomplete.

It is hydrated. What has happened, they have shown the

third hydrogen borrowed from the hydrated molecule,

whereas here I’ve shown it as simply a balanced core.

Att: I wanted to point out that it wasn’t exactly the

same, as opposed to what you have said..........but

you can still bring it to a circle.

Blais: Basically, I’ve drawn the same molecule using

a different convention. The items -- the item was

introduced in the first place in Exhibit 1 because it

forms part of the discussion, and it links back to the

earlier days when people were seeking antitumor

agents, and it was found that the choloroplatinates in

general had antitumor activity. They were basically

alkylating agents: whereas they could cause cancer,

they could also cure it. So there was a lot of initial

work and initial fervor in using it for resolution of

progressive tumors of the prostate and the ovarian

area.

However, during the discovery, much of which is

credible to Bristol- Meyers researchers, they very

quickly established that the members of this family,

which were lipid-liking lipophilics, were also

extremely neurotoxic and they were rejected on the

first round. Instead, they chose to make the molecule

more water-liking by making it instead a diamino,

instead of an alkyl or disilyl, therefore, EXPLAINING

WHY THE CATALYST USED FOR SILICONES IS NOT A GOOD

PHARMACEUTICAL BECAUSE IT IS TOO NEUROTOXIC, and

EXPLAINS CONVERSELY WHY THE DRUG CISPLATIN OR PLATINOL

IS NOT A GOOD CATALYST FOR MAKING PROSTHESES, because

it is water soluable, and in our case we wish to have

an oil soluable entity, and that is where we sit at

the moment.

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