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>>>

>>>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.

>>>Letís

>>>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 ìbleed,î 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 Iíve 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. {appx 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 thatís because the catalyst is in solution in the oil?

>>>

>>>Blais: Correct. Itís dispersed, distributed somehow, made available

>>>through

>>>an oil vehicle.

>>>

>>>Att: Itís actually in solution, youíre 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 Itís 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 discussingî

>>>

>>>Blais: Well, the term ìtraceî is not descriptive.

>>>

>>>Att: Just define trace as it is generally used, if you can. If not,

>>>fine.

>>>

>>>Blais: Iíve 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, letís just not use the term, then, if you donít 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 youíve 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 whatís 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, letís 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 thatís already published?

>>>

>>>Blais: Correct.

>>>

>>>Att: You may also, if that doesnít 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 Iím just saying it may not be

>>>answerable without a study, if itís 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: Iím 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 itís 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, thatís 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? Youíre 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: Iíll allow you to do that, but I want to ask one question before

>>>that.

>>>Other than Defendantsí 8, 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 ìCisplatinum?î

>>>[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. Itís 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. Itís 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 her Iíve

>>>shown it

>>>as simply a balanced core.

>>>

>>>Att: I wanted to point out that it wasnít exactly the same, as opposed

>>>to

>>>what you have said..........but you can still bring it to a circle.

>>>

>>>Blais: Basically, Iíve 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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