Re: Dr. 's account of 1992 FDA hearings . . . VERY intersti

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Wow that was very interesting! My question is did Dr. ever admit that the saline are at least as bad as the silicone? Love, Anita Dr. 's account of 1992 FDA hearings . . . VERY intersting Thanks to Carolyn Wolf who sent this. One note . . . Dr. Kessler, mentioned here, spoke tothe women who attended the March on Washington, D. C.He spoke in our support. I believe that was 1993. ============================Dr. Henry 's Fascinating Accounting of theFebruary 1992 FDA Hearings Here is a bit of historythat I had never read before... All this time, and we are still fighting to keepthese bags of poison off the market... Carolyn FDA MEETING - FEBRUARY 1992 Early in November 1991, FDA commissioner A.Kessler planned a meeting to announce that siliconegel-filled breast implants would remain on the market.Under normal conditions this would not have affectedDr. Norman , Professor of Internal Medicine at Hopkins Medical Center and Chairman of the FDA'sPlastic Surgery Advisory Panel. He believed that thesilicone gel implants were safe for the public. As oneof the nine voting members of the Panel, he haddecided to vote in favor of the implants. A day or sobefore that announcement, however, came intopossession of some documents implicating Dow Corningin fraudulent conduct regarding cover-up researchwhich described the dangers of gel implants. Later on, discovered that these Dow Corning documentshad been court-protected since the mid-1980's; thatthe FDA's legal branch had the opportunity to crackthese court orders but, for their own reasons, chosenot to do so. wrote a letter to Kessler urging him to placean immediate moratorium on the implants. Kessler actedupon the letter, and on November 9, 1991, the FDAimposed a 90 day moratorium on all sales andmanufacture of gel-filled implants. Without givingcredit to , Kessler initiated the moratoriumas if it were his own idea. In response to pressurefrom the manufacturers and plastic surgeons, Kesslercalled for an emergency three day meeting to be heldFebruary 18-20, 1992 in Bethesda. Three days beforethe hearing, Kessler phoned , told him he wasbiased, and removed 's right to a vote. On theday before the hearing, Kessler said to , "Itwould be best if you resigned completely from theAdvisory Panel." refused and it was at thispoint when he joined the side of the consumer. I alsopersonally experienced the FDA's modus operandi afterhaving been invited to be one of the speakers at thehearing. It was the morning before the meeting whilehaving breakfast at the Bethesda Marriott Hotel that Ireceived a call from the FDA's Executive Secretary, Tilton. Tilton was in charge of the arrangementsfor the meeting, the one who determined who wouldspeak and who would not. We had always had pleasantconversations by phone whenever I had spoken to himfrom my home in California. Now Tilton was on thephone saying "Dr. , I don't know how to breakthis to you but the manufacturers have put pressure onus and we cannot allow you to speak." Since I wastaking this call from the breakfast lounge and in thepresence of some of the others who were attending thehearing, I suggested that he call me back a fewminutes later in my room in order to speak freely.The call came and Tilton repeated his statement. Isaid, "Wait a minute. Are you telling me that themanufacturers put pressure on you, and you're yieldingto them? You are a government branch, an agency toprotect the consumer, in this case, the women. This isa public meeting, nothing private, no secrets!"Throughout my tirade, Tilton kept repeating, "Well,you know we can't change anything now and I'm sorry Iwas unable to reach you sooner." He had sent me a faxwhich I had not received since I had already left forthe east coast. The fax read, "It's urgent, call me athome, do anything you can to reach me." I had onlyfound out upon my return to California that Tilton wastrying to tell me not to come to Washington, D.C."Don't feel sorry, Tilton" I replied. "First of all,if you think that after having flown out here at myown expense and that after not having been allowed tospeak after so many years, "I'm going to accept a gagorder from the upper echelons of the manufacturers,you are wrong! Furthermore, if I'm not allowed tospeak, I'm going to raise the biggest scene that theFda has ever seen. If I do speak, what are you goingto do, call the police and have me arrested? This is apublic meeting and as far as I recall, we still livein a country of free speech. At least, that is what wehave been telling the rest of the world." When Tiltonfinally understood that in no way would I restrainmyself, he became concerned and suggested we try tohandle this a bit differently. He then proposed that Iremain in my room for another 20 minutes which wouldgive him time to discuss it with others. "Sure," Iresponded. "As a matter of fact, I'll stay here in theroom for one more hour and then I'm leaving with mywife for a visit to the White House and town."He agreed and seemed relieved. I waited the hour.Tilton never called me back. Because of my personalinvolvement and knowledge, I was probably the one manyfeared the most. It had been 18 years since I hadwarned the FDA, manufacturers and plastic surgeons ofthe dangers of liquid silicone had silicone gel. Noneof the people attending the hearing had been involvedfor that length of time. After all many had assumedthat I was living peacefully in Switzerland. Thensuddenly I reappeared out of nowhere.This is what I suspect happened behind the scene: Themanufacturers; McGhan, Mentor, Bioplasty and DowCorning, after having hated each other for so manyyears, were now forced to band together to save thesilicone gel-filled implant. Together they managed toconvince Kessler and Tilton not to allow me to speakknowing that my testimony would be devastating.The FDA was also on edge. They knew that if I wereallowed to speak, I would publicly remind them aboutmy repeated warnings to them between 1974 and 1981. Iwas the only plastic surgeon in the country who couldsay, "I told you so. I gave you paraffin tissue blockcontaining the pseudo-capsule of a patient with anintact Dow Corning implant, and yet your expertsfailed to perform their own histology as they weresupposed to do." On the first day of the hearings,plastic surgeons and FDA scientists presented theirwork on various aspects of silicone implants. Much ofthis was not new. One of the speakers was Boyd Burkhart, a plasticsurgeon who described in glowing detail the benefitsof gel-filled implants. When one of the women on thePanel asked him what type of breast implants he wasusing in his practice, he had to admit that he onlyused saline-filled implants. It might have been ofgreat interest to the public and the panel members toknow that Burkhart had been deeply involved withMentor. He even posed for a centerfold picture,dignified in a surgical mask, for Mentor's 1985 reportto the stockholders. What is even more incredible isthat he as a professional was conned by Conway,President of Mentor and Condon, Conway's go-for, intotestifying at this hearing. Dr. Stuart Nightingale of the FDA presented a paper onJapanese research with injected liquid silicone, aninteresting retrospective study which for the mostpart, went over everyone's head. The few of us whounderstood the problem first hand were not allowed toask a question, as no question/answer format wasoffered. The FDA's a Wilkerson presented a positiveassessment of the saline-filled implant, which I tookas the best compliment the FDA could give me. It isunfortunate that Tilton and Kessler did not take thetime to listen to some of their own people.The next morning was filled with euphoric testimony byrepresentatives of Dow Corning and Mentor, followed bythose of McGhan and Bioplasty. They all expressedinterest in conducting research which they had coveredup in the past, claiming grave concern about thehealth of the women using their products. Everyspeaker promised to spend a fortune on futureresearch, no matter what the cost. Why hadn't they done diligent research back in 1978after having heard my warnings? Well, the truth isthey did do research but alas, they did not like whatresearch was proving. So, they simply covered up theresults. In an indirect allusion to Dan Bolton's successfullawsuit against Dow Corning alleging fraud, thecorporation's CEO, McKennon, announced: "DowCorning will not use the court orders to protect theirmaterial but will offer it to the FDA. If it becomesnecessary to publish any of the protected material,Dow Corning will do so." Upon hearing this statement,Kessler seemed to be moved. He took the microphone andwith emotion in his voice, expressed his gratitude toDow Corning. This was truly a significant moment inthe sense that it exposed Kessler's gullibility. Theevening session commenced at 7 o'clock on the secondday of the FDA hearing. The moratorium was already ineffect since the gel-filled implants were now reputedto be dangerous, even lethal, according to articlesand the news on television. The room was stale and the 500 plus crowd was tired,restless and ready to go home. Totally dominating thehearing so far had been the pro-implant speakers frommanufacturing corporations, and plastic surgeons.Together they had applied their best efforts in tryingto convince the FDA that the gel-filled breast implantshould be allowed to remain on the market. This last time slot had strategically been scheduledfor the so-called "lesser" speakers. This groupincluded Tom Talcott, a chemical engineer, Resch, a mechanical engineer, Dan Bolton, a plaintiffattorney, Pierre Blais, a biochemist and me. While thepro-implant speakers had each been allotted thirtyminutes to testify, we were limited to a mere tenminutes each. In addition to this, we were not alloweda question/answer period. This scheme, according toNorman , had been planned at the last momentby the FDA and the manufacturers. Everything wasprecisely arranged as in Kafka's The Trial. The audience included the nine voting members of theFDA's General and Plastic Surgery Advisory Panel, thenon-voting members, women personally affected by thegel-filled implants, women promoting the gel-filledimplants, manufacturers, plastic surgeons, attorneys,major television networks, newspapers, radio stations,etc. That evening several women spoke about problems withtheir breast implants. One of the speakers was Mrs.Janet Shrout, whose moving account of her daughter'sdeath was described in "Criminal Negligence." Soon it would be time for my ten minute speech. Yes, Iwas finally allowed to speak, but it was touch and gountil four hours before my presentation. Luck had itthat I was to speak just before Dan Bolton, known byeveryone as the San Francisco attorney who had won the$7.3 million award for his breast implant client,nne Hopkins. By now most of the women present had learned that Iwas Dr. , inventor of the saline-filled implant.Some of my adversaries were present. Don McGhanmanaged a strained smile. Some of the Mentor peoplelooked seasick around me. As one would naturally avoidanyone with the plague, so was the attitude of severalof the plastic surgeons towards me. By the time it wasmy turn to speak, it was 8 o'clock, people attendingwere tired and many had already left to catch a planehome. The audience had shrunk. Originally, I had prepared a very precise summary ofmy personal involvement in the breast implant affair.It was only after all the harassment and intimidationon behalf of the FDA and manufacturers that I feltcompelled to change the tune of my testimony. I hadbeen suppressed so long that my intact immune systemhad developed marvelous antibodies. So I decided tosteady the tiller and navigate directly into thestorm. It was truly exhilarating to finally be able topublicly blurt out the truth, noting every sing detailof their attempts to silence me. My testimony had tobe concise since my time was very limited. Having tosummarize my fifteen year involvement with implants inten minutes was no easy feat. I briefly referred to myfirst meeting with Mr. Rudy Schulte and the creationof the first saline-filled breast implant in 1968. Howthe FDA had claimed to have "lost" my first paper in1974, and had ignored the devastating histologicalevidence sent to them in 1978. During my testimony, Tilton was whisperingsomething into the ear of Connell. I stoppedin mid-phrase, fixed my glance on Tilton who continuedto whisper totally oblivious to the fact that the roomhad become dead silent. After what seemed like severalminutes, a doctor sitting to the right of Tilton,elbowed him to attention. Pointing my steady finger athim, I locked into his eyes and declared: "You Mr.Tilton, you are the very man who told me that themanufacturers had put pressure on everybody, and thatI would not be allowed to speak. I am talking to you,Mr. Tilton. It was due to the same damn pressure that,in 1978, you, the FDA, failed to take the necessarysteps to prevent what is happening today." Moments late, I was interrupted by Connell whoreminded me that I had three minutes remaining. Thiswas to moment to pack in the clincher: "Dr. Kessler,what we all have been discussing here for the last twodays is really a DRUG DELIVERY SYSTEM, and the drug isliquid silicone, the use of which has never beenlegalized. Therefore, a very elegant way for you toget out of your present predicament is to simplyclassify the implant as a drug delivery system." Mystatement was immediately followed by applause fromthe audience. Dr. Kessler quickly took the microphoneand hushed up the audience by saying that ifnecessary, they were fully prepared to enforce order.Connell interrupted again to inform me that my timewas up. Now, with my feet firmly planted near thepodium, I leaned still closer into the microphone and,looking directly at Connell, said: "Dr. Connell, I hadthe courtesy to wait while you and Mr. Tilton had yourprivate conversation during my testimony. Now I wouldexpect you show that same courtesy by letting mefinish what I have to say." More applause. I quicklysummed up my talk and sat down to more cheering andapproval by an enthusiastic and fired-up crowd. Dan Bolton was next to speak. In clear, logical termshe explained to the panel members that the jury in thecase of Hopkins v. Dow Corning found Dow Corningguilty of fraud. He mentioned how at one point, DowCorning had a count down of days to produce theimplant. They could not meet the deadline, so theysimply marketed the new implant anyway, in spite ofnot having properly completed the quality control. Tom Talcott, chemical engineer, next spoke on siliconegel and its components. He had previously worked withDow Corning but said he chose to leave the corporationin 1962 because he was unable to go along with whatthey were doing. He had observed in laboratory testshow the gel they were marketing was bleeding liquidsilicone. He said, "Let's find out why," and theyreplied, "no, we'll just sell it. Tom Talcott waslater employed by Heyer-Schulte, which is when I firstmet him. Over the years I came to know him well and torespect his integrity. Through the meeting, there were murmers passed thatTom Talcott had been fired. In addition, Dow Corningresearcher, Dr. LeVier, had publicly brandedTalcott a "junk scientist." This of course, coloredthe opinions of Panel members prior to Talcott'stestimony. Taking the bull by the horns, Talcott said,"Andy by the way, I want the Panel members to knowthat one of your members, and I know which one, hasspread the rumor that I was fired. It is untrue and Iexpect a letter of apology." Tom Talcott elucidated the dangers of making theenvelope thinner and the gel less viscous in order tomarket a more natural feeling implant. He pointed outthat women would be exposed to more and more liquidsilicone, and that the thin envelope would break mucheasier exposing body tissue directly to the siliconegel. Dr. Mike Resch, a mechanical engineer at theUniversity of Nebraska, said in clear and simple termsthat the silicone gel implants were never made forlongevity. "They were designed to last between fiveand seven years. The last speaker was Dr. Pierre Blais, undoubtedly themost knowledgeable Biochemist in North America, whopossesses a formidable background in the field ofsilicone prostheses. He held the job as director ofthe Canadian equivalent of the FDA. In 1991 he haddeclared the polyurethane covered breast implants tobe dangerous and prohibited the sale of the product inCanada. Due to direct pressure from Surgitek, aMinnesota-based manufacturer of polyurethane coveredbreast implants and its main distributor in Montreal,as well as pressure from Bristol-Myers Squibb, he hadto resign from his job. Over the last fifteen years,Dr. Blais has accumulated a great number of explantedbreast implants of all varieties. He discovered thatone group obviously showed gross rupture, anothershowed small areas of abrasion and areas of impendingfailure. Many of the cultures obtained from theseimplants that are sent to him from all over the world,are positive for staphylococcus epidermidis,staphylococcus aureus, Escherichia coli and others.Furthermore, he has discovered fungus growing inimplant material. The audience once again broke into laughter andapplause when Piere Blais, in his brilliant yet benignmanner, apologetically stated, "Members of the Panel,I'm afraid that if the implant were a horse, you wouldhave to shoot it." Despite all the setbacks, the hearing was a success,although I am sure the press did not fully grasp theextent of the scandal. There were some women in theaudience who taped it The Advisory Panel voted totake the silicone gel implant off the market, exceptfor use by a few breast surgery patients in controlledstudies. They declared that the only legally availablebreast prosthesis was the saline-filled inflatableimplant. What was the cause of this success? Certainly not thefew of us who told the truth.It was tanks to the women and the lawyers. The votingmembers of the Panel had read the newspapers, watchedtelevision and listed to the radio. They knew hundredsof women were seriously ill and they had heard fromattorney Dan Bolton that $6.5 million of the $7.3million dollars awarded by the jury to nneHopkins represented Punitive damages and notcompensatory damages for her enormous medicalexpenses. Why? Because the jury found Dow Corningguilty of fraud. Still no one acknowledged that themanufacturers had done anything wrong. No apologiescame forth. On the second day of the hearing, Dow Corning hadannounced that they would spend any amount of money onresearch. On the third day, one Panel Member made amotion regarding the permissibility of the use of thegel-filled breast implants. The chairwoman, Connell,was asked to repeat it so that the motion could beseconded. Not for all the tea in China was she able torepeat that simple motion. After her secondunsuccessful attempt, she capitulated and someone elsehad to restate it. A well-trained parakeet would havedone much better. After the Advisory Panel voted down the gel implantsand the FDA backed their decision, Dow Corning statedat a press conference that they would NOT make theirimplant anymore. So much for the promise made only theday before when Dow announced their eagerness to spendany amount of money on research! It was time to moveon and make their millions in other areas. To be sure, Dr. Kessler is in a very difficultsituation. What this country desperately needs is toreplace Kessler with a capable person who alsopossesses the principles and integrity necessary towithstand any amount of pressure from powerfulentities. The government is supposed to protect theconsumer and if that breach is mandate, they become ofnegligence, even fraud and criminal conduct.[Retyped from the book, "Siliconegate" - by Henry MD - pages 225 - 238]