From:    EEFRISCH--MIDV01   
     

Date and Time:  01/28/92  16:04:28

 

To:  LCHALL--MIDV01

 

NOTE FROM: E. E. Frisch--835-7450

    Consultant, 1311 Glendale, Midland, MI 48642

SUBJECT:  PS advisory panel & AAOS - Please copy

 

I have been planning to attend the AAOS meeting, albeit we haven't discussed this.  I made hotel reservations some time ago because of the need to do these in advance ($75.00/night).  I will proceed to make air reservations so as to get discounted $216.00 RT price.  Since the PS advisory panel is apparently just before AAOS I propose to attend these meetings also.  I admit that I have no plan to participate unless information is requested on ASTM standards for plastic surgery devices.  FDA's "silicone conference" may also be discussed, I've been contacted twice during the week by Don Galloway of FDA, he is doing final editing in order to have the proceedings published. My presence might also make Talcott be a little careful on his comments, if any, but he is difficult to contain.  I had lunch with him in San Diego in Nov. during ASTM in order to discuss his negatives, but it broke down to somewhat raised voices and a few swear words.  After lunch he slammed hard at the ASTM Main Committee meeting, so its difficult to know what he will do next.  Probably claim that ASTM is controlled by the medical/industry complex.

 

I have encouraged Dr. Chaffee to contact FDA and request time to address the advisory panel at this meeting.  He thought Scott Spear should speak for ASPRS.  While this may be true, his request for time is justified since he is chairman of the mammary implant task force.  His comments would reinforce whatever Spear could accomplish.

 

I am usually optimistice, but it is hard to be in the current situation.  Kessler has apparently made up his mind that silicone gel breast implants should be banned.  Now he is trying to sway public opinion to support his position so that the objections of manufacturers and plastic surgeons will not lead to media and political criticisms when FDA takes this action.  His training as a lawyer has resulted in approaching this as a court trial.  FDA is both the prosecutor and judge.  FDA selects the jury, determines who is allowed to testify as witnesses and the nature and extent of the evidence that will be allowed and perhaps even how it will be interpreted.  Factual science and reason are being ignored and misrepresented at every opportunity.  This should raise a warning flag, concern for the safety and effectiveness of drugs/devices and food in this country--FDA's actions are so illogicalin claiming that these devices are unsafe that they are likely to err to the same extent in the opposite direction and not act to correct genuine safety issues.

 

I agree that we must go public in an attempt to influence public/political opinion.  This will not be easy, since FDA has dictated what we must release and after reading most of the documents there are may that could be misrepresented and taken out of context.  1992 implants and materials are not the same as those discussed in documents 17 years ago.  FDA apparently wants to ban current implants on the basis of obsolete technologies.  However, in all information released DCW must be certain that it is verified and accurate.  There are a variety of errors in the materials I have received, and those will be jumped on by critics, such as Talcott, to further discredit DC.  From discussions with him I know he has a lot of detail burned in his memory, in his thoughts he often lives in the past.  He has a hatred for Art Rathjen and in part his actions are a way of getting at him.  He seems to believe that his disagreements with Art in task force activities were the basis for his bad preformance review which led to his leaving.  In any event, the information released must be accurate and probably udnerstated rather than over stated.  Dow Corning has done enough good in the world and health care that we don't need to exaggerate.

 

I also think it would be a mistake to cite Swanson implans and fluid injections in these releases.  This is not a good time to draw attention to the silicone orthopaedic products, it may serve to bring them under attack.  While we think our supporting data is (illegible), we also know there are opponents to these devides and FDA is likely to side with the opponents and discredit the significance of our data.  No manner how we feelt about fluid injection uses, FDA, the public and a large segment of the medical profession believes any injection dangerous, evil, unethical and perhaps a criminal act.  I have noted several references to the non-reactivity of injected fluid to support gel safety, and I think these will have a netavie rather than a positive impact and will probably be picked up by FDA and other criticsto condemn DC's actions.

 

Sorry for taking so long you have probably considered all of this before, but at least I've gotten some of the thoughts communicated to you.

 

If you have problems with the PS advisory panel or AAOS please let me know.

 

Regards, Eldon

ELDON