DR. ZUCKERMAN: Thank you.

I just want to briefly say that I come to be here -- oh, I should start with my conflicts of interest. I'm donating my time, and my
transportation here all the way from Bethesda, and my answers to the other conflict of interest questions are no.

My background is in epidemiology and psychology, and I've also talked to hundreds of women with breast implants of the last ten years, and so my goal today is to put those two things together.

I know that we as scientists are not supposed to focus on anecdotes, but sometimes when we listen to patients, it tells us something important, and when we tie that in with what the research does or doesn't tell us, I think it can be very important and give us some insights into where we go next.

I'm very concerned about the loss of patients to follow-up in the studies that you've heard about, and I'm particularly concerned about it because I've talked to a lot of implant patients who have told us, told me personally of experiences where they try to tell their doctor that they have problems.

And it isn't getting registered in the studies that they are supposed to be in, or they get so turned off by doctors who do not seem to believe that their health problems can possibly be related to their implants that they stop seeing those doctors and go find other doctors.

And so I think it is not a minor issue that there is this loss of patients to follow-up, and several of you have raised that question, and then I feel it's sort of gotten lost. It's the long day and it's the end of the day, and so I want to bring you back to that issue, that perhaps part of the reason why the women who had problems sound one way and the research seems so entirely different is because some of those women at least are getting lost.

And of course, we don't know how many there are, and that's very important, and I think that's a big issue, certainly for me, and I hope it will be for you.

I also want to talk a little bit about the quality of the data, and that ties in again. I mean obviously a study of depression that has no comparison sample or control group, I mean it reduces the credibility of the whole package to me to have something like that be supposed to be evidence that these women are getting better because, of course, women who have just had surgery for breast cancer are going to be depressed.

I used to do research on depression. I promise you that's true. They are going to feel better, and without a comparison sample, you don't know anything about how effective this particular treatment is for those women.

I also have some concerns about whether all of the right questions were asked in these studies. Pain is a big issue for a long of the women I talk to. I'm not at all convinced that the research that was presented today really deals with pain in a meaningful way.

Obviously if women say they're really satisfied with their implants, you have to assume that pain is not a big problem, but let's remember that the follow-up was quite short for these studies. Three years is not a very long time.

When I've talked to women, most of these women have been very happy with their implants for the first few years. It's only after three or four or five or six or more likely seven or eight years that they start having serious problems.

And let me also mention that part of that is that when they do have problems initially their doctors say, "Don't worry. It's going to get better," and so they have this hope, and they may feel quite satisfied because they think that the problems that they have of pain or numbness in the nipple area or whatever it might be, that those problems are going to go away and they're going to feel better soon.

If you follow them for a longer period of time, they might feel quite differently about how satisfied they are and how they feel about it.

Let me briefly say I'm on the Scientific Advisory Committee for the NCI study of breast implants. I was very surprised that that study wasn't mentioned here today. I Know that the data are not -- nobody knows better than me the data are not public yet.

I would have thought FDA would have asked for those data. I would have thought they would have presented those data to you. Although it's not published yet, some of those data are already analyzed, and one of the people at FDA is a co-author of those studies.

Those are studies of cancer, breast cancer and other cancers, and a study of connective tissue disease. Those are relevant data. Those are important data. It's a very large study, the largest study that's ever been done, and I don't understand why you didn't get it, and I hope that FDA will ask for it and look at those data before any kind of final decision is made.

I'm almost done here.

There's one thing I just have to address, and that's the issue of connective tissue disease. When I was asked to speak today and all the other public comment people were told stick with saline implants, and I'm happy to do that, but the studies on connective tissue disease do not do that.

I may be one of the few people in America who's actually read all of these epidemiological studies on connective tissue disease and breast implants. Here they are. I've read all of the. I've done a review of them.

And let me tell you that of the 17 studies that are most often quoted in the Institute of Medicine report, as well as other reports that have been done, only one, one study looked at saline breast implanted women and analyzed them separately. None of the other studies did.

Most of the studies had no women with saline implants or very small numbers that were not analyzed separately. If you want to assume that the data on silicone gel implants are relevant to saline, that's a decision to make, but it's kind of an unusual decision to make. Usually you would study, you know, one product at a time and base your decision on that one product.

Finally, I just want to say that there is a lack of long term data. I think that's serious, and I commend your concern about that and your asking for more data.

As someone who's done survey research, I don't think there's any way in the world you're going to get questionnaire data ten years out. You may say it's impossible to get, you know, actively women coming back in, but you're sure never going to get questionnaire data like that.

If you think that long term data are important -- I personally think they're very important -- I don't know how you're going to create an incentive for the manufacturer to do that if you approve these devices. If they haven't done it up till now when they had all these years to do their studies, what's going to give them the incentive to do it in the future?

And my understanding is that FDA does not have post market surveillance resources or perhaps authority for medical devices. So if you think that the data that's been presented are not sufficient to prove safety, and I know that some of you have said that here today, then you have to think very carefully about how you're going to make sure that happens when I think there is actually no other way to make sure it happens.

And my last comment is just to say that breast cancer patients are a special case, and Dr. -- not doctor -- Ms. Dubler and I commend your concern about them, and I share it.

I've worked with a lot of breast cancer activists, and I actually met with them very recently to talk about this issue, and there's a wide range of feelings among the breast cancer community about breast implants. Most groups have been neutral on the issue. They all do want good data.

We do women no favor, whether they're breast cancer patients or any other patients, we do them no favor by leaving something on the market that is not proven safe for them.

Thank you.


Finally we have -- Dr. Zuckerman, if you'd stay at the podium, there's a question.


DR. BLUMENSTEIN: This NCI study, I did not know about it, and I think that it has a possible impact on what other kinds of data we require of the manufacturers, and I would like to know some more details about it.

CHAIRMAN WHALEN: Well, before you go into any details about that, Dr. Witten, would you like to comment upon the whole process we're about in terms of what PMAs are and what we can review?

DR. WITTEN: Yeah. I just want to reiterate what I had mentioned this morning, which is we want you to base your safety and effectiveness assessments on the information contained in the PMAs, and in addition, your scientific knowledge, including, you know, what you know from publicly available scientific literature.

CHAIRMAN WHALEN: Which is what we are mandatorily directed to do.

DR. WITTEN: Which is what we're directed to do.

DR. ZUCKERMAN: No, and I understand that, but I have heard people say, "We don't have to worry about cancer or connective tissue disease because the studies show there are no problems," and I am not at liberty to say what's in those studies even though I have seen them. I am not allowed to talk about them.

I'm only saying I think that that would be something that FDA would want you all to look at and would want to look at.