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Silicone Breast Implants Back on the Market:

On Friday, the FDA lifted most restrictions on the sale of silicone breast implants, almost fourteen years after FDA chairman David Kessler ordered the implants off the markets, in a decision motivated by politics, not evidence.

Indeed, the end of the FDA ban marks the conclusion of what amounted to a massive scams. Political activists, politicians, trial lawyers, and media sensationalists joined forces to promote the view, wholly lacking in scientific support, that implants caused systemic disease. First, they claimed it caused cancer; when studies rejected that assertion, they claimed it caused immune system diseases; when that was debunked, they moved on to the claim that it caused "atypical" immune system diseases. The latter claim had the advantage of being very difficult to disprove, because no ever ever defined what these "atypical" diseases were. Nevertheless, the best evidence available rejects that claim, as well. It should be emphasized that there was never any sound scientific evidence supporting any of these claims; that didn't stop plaintiffs and their attorneys from collecting $10 billion or so in damages.

The victims of the scam included implant manufacturers (which, admittedly, were not exactly poster children for corporate responsibility) and their shareholders, such as the Dow Corning Corporation, which went bankrupt; women who, frightened by media reports about "dangerous" implants, had unnecessary surgery to explant their implants, or avoided pregnancy to prevent injury to their unborn children from "toxic" silicone; biomedical research, which for a time seemed in danger of collapse due to the phony claims against silicone implants--who would test and market any product to be used inside the body, much less one involving silicone, if invented claims with no scientific basis could result in billions of dollars of liability for breast implant manufacturers?; and public trust in the American legal system, which quite properly suffered severe criticism for doling out billions for no good reason.

Perhaps not surprisingly, I have seen no sign of contrition from any of the actors who were most responsible for the breast implant fiasco. For example, the Times reports that "Dr. Sidney Wolfe, chief of Public Citizen's Health Research Group, which claimed in the 1980s that breast implants cause cancer, called the implants "the most defective medical device ever approved by the F.D.A. The approval makes a mockery of the legal standard that requires 'reasonable assurance of safety.'"

You can read my review of the whole mess, including substantiation of what I wrote in the first three paragraphs of this post, in "The Breast Implant Fiasco," 87 California Law Review 457 (1999). An earlier version is posted at SSRN.

Mike BUSL07 (mail) (www):
Truly a great day for our nation generally, and its strippers in particular. Also, what exactly were the politics behind the ban? I presume that feminists didn't like the idea of women "having to" get breast implants to be more appealing, and this idea was embraced by their fellow travelers. Is that correct?
11.20.2006 3:32pm
Anderson (mail) (www):
"Silicone Breasts Bounce Back" would've been a nice post title.
11.20.2006 3:40pm
HalS:
You won't hear contrition from Sydney Wolfe because he still says he's right
11.20.2006 3:46pm
Mike BUSL07 (mail) (www):
Anderson, well done.
11.20.2006 3:46pm
John Kindley (mail) (www):
The breast implant litigation has long been of particular interest to me as it compares to potential litigation based on the evidence linking induced abortion with increased breast cancer risk. In the first case, billions were transferred on the basis of virtually no scientific evidence linking implants with immune deficiency disease; in the second case, despite a large preponderance of epidemiological evidence, supported by animal studies and a very plausible biological hypothesis, abortion providers to this day deny that there is a link and deny that they even have a duty to inform women considering abortion about this "potential" risk. Hence, I believe that when this body of evidence finally becomes more commonly known and recognized, there will be a tidal wave of litigation that surpasses the tobacco and asbestos and breast implant litigation. I authored a law review article while a student at the University of Wisconsin outlining the viability of such lawsuits -- "The Fit Between the Elements for an Informed Consent Cause of Action and the Scientific Evidence Linking Induced Abortion with Increased Breast Cancer Risk," 1998 WIS L REV 1595, which was distributed to every member of the U.S. House of Reps by Congressman Dave Weldon, M.D. The article is available on my website, www.johnkindley.com. I was also lead counsel in an ill-fated false advertising lawsuit in North Dakota that should have put this evidence and women's right to know about it on the legal map. We lost at the North Dakota Supreme Court not on the merits, which were rock solid for what we were claiming to prove, but on a legal point, in an unprincipled reversal, or reinterpretation I suppose the Court would say, of the Court's precedent on its false advertising statute. They apparently, for whatever reason, really did not want to be the ones to put this right on the legal map, no matter how many people were later hurt and deceived as a result of their failure of nerve and principle (to put it charitably). The briefs and opinion in the case, Kjolsrud v. MKB Management dba Red River Women's Clinic, can be easily found by doing a search on the North Dakota Supreme Court's website. If you do a Google search on abortion and breast cancer you will see that the National Cancer Institute (and other cancer organizations who follow the NCI with its government research money) does not agree that there is a link. I can only say in response to that that the argument from authority is the least persuasive, that politics is for obvious reasons a major potential factor, and that a patently and absurdly false statement from an NCI fact sheet ("There is no evidence of a relationship between breast cancer and abortion") was at the heart of the North Dakota false advertising case, as it was quoted by the defendants in their commercial brochures (despite coming from an outdated NCI fact sheet, though the statement was as absurdly false when the NCI first made it as it was when the defendants adopted it).
11.20.2006 3:54pm
Alan P (mail):

If you do a Google search on abortion and breast cancer you will see that the National Cancer Institute (and other cancer organizations who follow the NCI with its government research money) does not agree that there is a link. I can only say in response to that that the argument from authority is the least persuasive, that politics is for obvious reasons a major potential factor



Its nice to see that junk science is not restrcited to liberals.
11.20.2006 4:00pm
David Chesler (mail) (www):
They're still not apologetic. According to the CNN report on this, Public Citizen (Dr. Sydney Wolfe, although the article doesn't mention it) shows the double standard by comparing these to fake silicon testicles:

It is a terrible reminder of the double standard for women versus men that the FDA has not approved silicone gel testicular implants because of the inadequacy of clinical trials on these devices.


Who would want silicone testicles? (A brass pair I could understand, but even more than breast prostheses that feel lifelike [about which I blogged here, asking "Who is going to be feeling them?"]) what does it matter?)
11.20.2006 4:17pm
John Kindley (mail) (www):
"Its nice to see that junk science is not restrcited to liberals."

It's sad to see that prejudgment, closemindedness, blind following of authority, lack of healthy skepticism, etc., are totally unrestricted from your brain and mouth, Alan. You may not want to take the time to read the careful legal arguments that have been made for disclosure of this evidence, but it is small-minded of you to dismiss them out of hand without doing so, simply because a government agency tells you what to think on this subject.
11.20.2006 4:23pm
GregC (mail):
John Kindley,

The underlying conclusion of your most persuasive scientific paper is that "In our 1996 comprehensive review and meta-analysis on induced abortion and breast cancer, we reported an overall, statistically significant odds ratio (OR) of 1.3" (Brind, www.jpands.org/vol10no4/brind.pdf). That is, Brind and his colleagues concluded that induced abortion raised the relative risk of breat cancer by 30 percent.

But epidemiologists generally view increases in relative risk of less than 100 percent (or an odds ratio lower than 2.00) to be essentially meaningless. When risk factors are lower than that, it is nearly impossible to separate a signal in the data from the statistical noise. Therefore, a small finding is generally treated as no finding at all.

The National Science Panel appointed by U.S. District Court Judge Sam Pointer (N.D. Ala ) in the Silicone Gel Breast Implant Products Litigation (http://www.fjc.gov/BREIMLIT/SCIENCE/summary.htm), examined the available epidemiological evidence available as of 1999 and concluded that breast implants increase the relative risk of rheumatoid arthritis and other autoimmune and rheumatic conditions by 15 percent (not statistically significant); dermatomyositis and polymyositis by 52 percent (not statistically significant); definite connective tissue diseases by 14 percent (statistically significant at the 95 percent confidence level); and Sjögren’s Syndrome by 47 percent (statistically significant).

Thus, neither the silicon gel breast implant litigants, nor you, have a valid scientific argument.
11.20.2006 4:41pm
DavidBernstein (mail):
Mike, feminists had little to do with it. Read the paper and you'll find out.
11.20.2006 4:46pm
happylee:
Go get them, JK.
For a general idea of how bad science can survive scientific scrutiny (eg, HIV-AIDS or flouride in drinking water) see Celia Fabers lovely essay on Duesberg.

Sadly, science is no more about truth than politics is about "solving problems." It's about power. And just as a bunch of politicos might pull together a useful road or such, so BigPharma and BigMed sometimes actually cure or heal something. But I doubt that solving-curing-healing is the real goal.

As for silicone breasts, I hope Bernstein's paper enlightens me. If I recall correctly, silicone paved the way for tobacco, and tobacco has paved the way for fast food suits. Of course, liquor and unprotected-sex-without-a-license is next.
11.20.2006 4:55pm
ksd:
GregC, you wrote:

"That is, Brind and his colleagues concluded that induced abortion raised the relative risk of breat [sic] cancer by 30 percent."

and

"The National Science Panel appointed ... examined the available epidemiological evidence available as of 1999 and concluded that breast implants increase the relative risk of...."

I haven't checked your references, but I'd be willing to bet that neither statement is accurate. Instead, I'd bet that in both cases they found that the presence of silicone gel breast implants was correlated with increased incidence of the mentioned diseases. The presence of such a correlation, of course, is not causation. Thus, it is inaccurate to claim that the data demonstrate that implants "increase the risk" of contracting a disease, even by a small amount (as you acknowledge), because that data does not address causation.
11.20.2006 4:58pm
GregC (mail):
ksd,

You wrote:

I'd bet that in both cases they found that the presence of silicone gel breast implants was correlated with increased incidence of the mentioned diseases.

Fair enough.
11.20.2006 5:02pm
Henri LeCompte (mail):
This whole silicon implant debacle makes me shake my head in dismay at the absurdities of the lawsuit culture we have created. David-- yes, feminists may not have been directly involved in the lawsuits that doomed Dow Corning (and common sense), but feminism set the background against which these lawsuits were seen.

Breast implants seemed "wrong" and demeaning to women, so the company that made them was easy to demonize. Feminism created the atmosphere that made railroading these companies a piece of cake. What scientist was willing to stand-up-- in leftist academia no less-- and defend the "greedy," Playmate creators?

What is more, this is another perfect example of rampant media bias. For the left-leaning media, breast implants causing cancer was an irony too delicious not to be true. And so they made it true. How? By just presenting one side of the argument, and demonizing the other side. Anyone see a resemblance to global warming here?
11.20.2006 5:16pm
Mike BUSL07 (mail) (www):
Henri, the global warming thought definitely crossed my mind. I didn't bring it up out of fear for starting a flame war, but yeah, the similarities are definitely there.
11.20.2006 5:27pm
Toby:
Clearly, breast implants, used injudiciously, increase the incidence of unprotected sex and undesirable marriages by attracting the wrong sort of men, i.e., men interested in superficialities. These in turn, lead to increased incidenc of abortions. And those lead to increased cancer.

sorry, I couldn't help it
11.20.2006 5:30pm
Houston Lawyer:
The courtroom is a horrible place to settle scientific issues. In most cases you have judges, with a slight understanding of the science, giving instructions to jurors, who are generally not terribly interested in what the science actually proves.

There should be some method of pre-screening the sufficiency of evidence before it even gets to a judge.
11.20.2006 5:32pm
Aultimer:

By just presenting one side of the argument, and demonizing the other side. Anyone see a resemblance to global warming here?


As it's appropriate to correct "cause" with "correlate" regarding implants and cancer, it's appropriate to correct "global warming" to "anthropogenic global warming" here. The earth is warming at present, the issue is whether people made it happen (more).
11.20.2006 5:41pm
Daniel Chapman (mail):
Toby, you have just tied with Anderson for the prestigious "Comment of the Week" award.
11.20.2006 5:44pm
John Kindley (mail) (www):
"But epidemiologists generally view increases in relative risk of less than 100 percent (or an odds ratio lower than 2.00) to be essentially meaningless. When risk factors are lower than that, it is nearly impossible to separate a signal in the data from the statistical noise. Therefore, a small finding is generally treated as no finding at all."

This is absolutely not true. I don't know where you got that from, but it wasn't from any standard epidemiology texts. What is true is that with weaker relative risks researchers have to be more cognizant of the possibility that some artifact of the study (e.g. confounding factors or methodological bias) is accounting for the risk increase. You can certainly "separate a signal in the data from the statistical noise," if what you mean by that is the possibility of random error, simply by constructing a study with a sample size large enough to achieve statistical significance (generally, greater than 95% certainty that the result is not due to random error). Research into the abortion-breast cancer link had to take into account and rule out as best it could potential confounding factors and other potential sources of methodological bias, and had to achieve statistical significance, and a preponderance of that research does so.

As far as findings of weaker relative risks being essentially meaningless -- when the background risk is already relatively large (as it is with breast cancer), any risk increase is going to be proportionately smaller. This fact is generally taken to explain why cigarette smoking increases the risk of lung cancer (low backround risk for nonsmokers) by a factor of 10 but increases risk of cardiovascular disease (high background risk for nonsmokers) by a factor of only 1.3 or so. And because the risk is high to begin with, this smaller relative risk increase is still very substantial in terms of absolute increase in risk (as is the case with the abortion-breast cancer link). Despite the low relative risk increase, the smoking-heart disease link is generally accepted as true by scientists, as are many other relative risks that are in that 1.0 to 2.0 range that you identify. So again, I don't know where you got that idea you express, but no credentialed epidemiologist would say it.

You characterize the 1996 meta-analysis as my "most persuasive scientific paper," but I would also highlight a study published in the Journal of the National Cancer Institute by Janet Daling et al in 1994. That study reported an overall risk increase of 50%, but it also found that among those women who had abortions before age 18 the risk was increased 150% (RR 2.5), and among such under age 18 abortion patients who also had a family history of breast cancer the relative risk was reported as "infinite," since every such subject in the study had developed breast cancer. Hardly a small relative risk increase that could readily be explained away by confounding factors, methodological bias or chance.

What I've just said was basically already addressed in my Wisconsin Law Review article. I'd urge anyone with a genuine interest in this subject to read or skim that first before telling me something similar to "You don't have a valid scientific argument because findings of small relative risk are generally treated as no findings at all."

The real clincher and no-brainer in my legal argument (as opposed to my scientific argument), however, is that even if you're not absolutely convinced that abortion increases breast cancer risk, or even if you believe that abortion "more likely than not" does NOT increase breast cancer risk, there is still more than enough solidly credible scientific evidence that it does increase risk, that women considering abortion have the legal right to at least know about this potential risk. A 50% chance that an extra 1 in 25 risk of getting cancer is not "real" still amounts to a real 1 in 50 risk of getting cancer, and any sane informed consent policy would disclose such a "potential risk," which are actual risks for patients facing a decision. (The above paragraph is simply for the sake of argument and to make what I think is the crucial legal point, as I believe that the overwhelming preponderance of evidence does indicate increased risk.)
11.20.2006 5:46pm
Dick King:
Widespread use of breast implants is obviously related to global warming. They increase the size of the world's warm fronts.

-dk
11.20.2006 5:52pm
J. F. Thomas (mail):
The courtroom is a horrible place to settle scientific issues.

So, apparently, is a legal blog. Look at this thread. We've got one crackpot telling us that abortions cause cancer and others somehow using this to demonstrate that global warming is hoax too.

And of course the real victim in all of this was poor Dow Corning, who was forced into bankruptcy. Nevermind that corporate bankruptcy laws are practically written to protect corporations from these types of lawsuits and both Dow and Corning and their myriad of subsidiaries were able to dodge all liabality.
11.20.2006 5:52pm
J. F. Thomas (mail):
Research into the abortion-breast cancer link had to take into account and rule out as best it could potential confounding factors and other potential sources of methodological bias, and had to achieve statistical significance, and a preponderance of that research does so.

I would like to know what possible mechanism could account for the increase in breast cancer risk from induced abortion as opposed to natural termination of a pregnancy through miscarriage or spontaneous abortion.
11.20.2006 5:58pm
Steve:
There should be some method of pre-screening the sufficiency of evidence before it even gets to a judge.

I'd love to hear such a method, cause the typical judge deciding a Daubert motion doesn't tend to come off as the second coming of Stephen Hawking either.

I wish we could have a political solution to these mass-tort issues, like a Congressional hearing where both sides of the issue air their views, followed by passage of a law that either grants immunity or sets up a fund for victims to be compensated, depending on how the evidence comes out. But I'm afraid that such an idealized system exists only in my dreams. In the real world I see no evidence that Congress weighs the evidence any more carefully than your typical jury, the major difference being that at least the jury usually tries.
11.20.2006 5:58pm
Mike BUSL07 (mail) (www):
JF Thomas, are you suggesting that the verdicts against Dow Corning were justified because, while unsupported by evidence, they also, (you argue), failed to damage the companies?

And I don't think anyone said global warming is a hoax - I'd appreciate if you didn't put words in my mouth. I happen to believe it's both real and human-caused, which is irrelevant to the issue of how the press has covered the debate.
11.20.2006 6:01pm
Mike BUSL07 (mail) (www):

I wish we could have a political solution to these mass-tort issues, like a Congressional hearing where both sides of the issue air their views

Specialization is a big justification for having administrative agencies. Why Congress can't provide for adjudication before the FDA in these types of cases is pretty much beyond me.
11.20.2006 6:04pm
A. Zarkov (mail):
Henri LeCompte:

“Anyone see a resemblance to global warming here?”

You beat me to it. If global warming turns out to be junk science, the cost to the US and the world will make the silicon breast implant” saga look like petty change.

What makes it eerily similar is the way the whole issue is promoted. If you read Al Gore’s book An Inconvenient Truth (same content as the movie) you see he gives no references for any of his all encompassing assertions. No footnotes, no endnotes, no reference section, not even a Table of Contents (so far as I can tell from the Amazon images). Yet I hear people say the movie “proves” the menace of global warming. Skeptics of Global Warming are often viscously attacked. For example Scientific American ran an 11 page hit piece on Bjorn Lomborg.

In general the weaker the science, the more you see ad hominem arguments.
11.20.2006 6:11pm
Greedy Clerk (mail):
I think David (as do I) has an inherent conflict in speaking about silicone breast implants as a heterosexual male.
11.20.2006 6:44pm
Bruce Hayden (mail) (www):
I would like to know what possible mechanism could account for the increase in breast cancer risk from induced abortion as opposed to natural termination of a pregnancy through miscarriage or spontaneous abortion.
I am not sure if I understand the difference between a miscarriage and a spontaneous abortion - I know that there are MDs who read this, and would be interested in this, if there is one.

That said, I presume that, the justification for also looking at miscarriages, etc. and breast cancer is that the same mechanism is most likely at play there. However, one theory that I have seen is that pregnancy results in breast growth and maturation, and if a woman were to get preganent again shortly after a miscarriage (which often happens), and then carry to term, whatever ill effects may have been started by the miscarriage, could then be at least partially reduced. Of course, at this point, we don't know what is happening here, if anything.

But it shouldn't affect John Kindley's point. Abortions are voluntary, whereas miscarriages are involuntary. My vote is for informing the women of the possibility, should his studies have credibility - we are warned about possibly connections that seems a lot more tenuous on a daily basis.
11.20.2006 6:47pm
Bruce Hayden (mail) (www):
The difference between Global Warming, at least so far, and the Silicon Implant issue is that the lawyers haven't gotten involved, raking in millions in fees, while destroying any number of companies. Of course, this may change, as Global Warming becomes more accepted by the American people, regardless of merit.

Of course, the flip side is that it could turn out to be just as fictitious, and cost a lot more, in what turn out to be ill advised mandates to industry. We shall see.
11.20.2006 6:52pm
Greedy Clerk (mail):
The difference between Global Warming, at least so far, and the Silicon Implant issue is that the lawyers haven't gotten involved, raking in millions in fees, while destroying any number of companies.

A difference, not the difference. Another difference is that global warming is turning out not to be junk science -- as many skeptics -- including me -- once thought. I suggest you read up on global warming and the science behind it; it is quite solid. Only those who buy Rush Limbaugh's silly argument that the environmental movement is the new communist movement (that is his serious argument) seriously deny the science behind global warming. Now, there are some arguments about its causes and the extent of the contribution of mankind (not that mankind does contribute which it does) to it. Furthermore, whether and what we can do about global warming -- and the costs of doing so -- are also legitimate topics of debate. This is particularly the case because historic climate changes have happened more dramatically without mankind causing it. But denying the existence of global warming is in fact what is junk science in that debate. And let me just say that it is not surprising that the same people who are pushing the science of creationism intelligent design also are pushing the global warming is bunk theory.
11.20.2006 7:01pm
John Kindley (mail) (www):
"I would like to know what possible mechanism could account for the increase in breast cancer risk from induced abortion as opposed to natural termination of a pregnancy through miscarriage or spontaneous abortion."

There's a very simple answer to that question, recognized by both sides of the scientific controversy, in my law review article, www.johnkindley.com. I won't waste my time explaining it to you here, since you view me as a crackpot. Look it up yourself. I agree that a legal blog, or a newspaper editorial, is not the place to resolve complex scientific issues (though these issues are not necessarily as complex as some believe). If you really want to know the truth, you have to do a little digging. However, it is the place to make a legal argument like I did above about the legal duty to disclose material risks, even if they are but potential risks and not generally acknowledged by the scientific establishment.

Similarly, one doesn't need to go deep into the science to make the following observation with regard to breast implants: I seem to recall from a law review article I read about the breast implant litigation that much of the companies' liability rested on the fact that they did not test and make sure their products were safe before sending them off to be put in human bodies. "If" that is true, that kind of conduct certainly would seem to constitute egregious negligence and recklessness to me. "If" that is true, kind of makes it hard to feel sorry for poor Dow Corning et al, if the juries just kind of assumed causation because the lack of evidence on the causation question was in the first place due to the defendants' own neglect.
11.20.2006 7:08pm
Anderson (mail) (www):
Toby, you have just tied with Anderson for the prestigious "Comment of the Week" award.

Aw great, now I have to split the prize money. Anyone got change for a quarter?
11.20.2006 7:44pm
happylee:
Contrary to what some folks think, the courtroom is a fabulous place to put junk science on trial. In modern debates, truth gets buried in well-organized publicity campaigns. Just look at the Manmade Global Warming campaign. Every time someone disagrees with the ruling elite he gets his funding cut, faces public ridicule and has to turn to saving his own job.
In the courtroom, on the other hand, a firm judge could make sure everyone gets a chance to tell his story. The jury could sit and weigh the evidence. It could be the great equalizer. Real experts (not UN lackeys seeking yet another cushy position in the dark empire) could present real evidence (not newsreleases like "Man Causing End of World Tomorrow!!! Repent.").
11.20.2006 8:09pm
TDPerkins (mail):
Kindley wrote:

"If" that is true, that kind of conduct certainly would seem to constitute egregious negligence and recklessness to me.


That would be reasonable only if there were any plausible mechanism by which they might not be safe, and there was none.

Yours, TDP, ml, msl, &pfpp
11.20.2006 8:42pm
J. F. Thomas (mail):
If you really want to know the truth, you have to do a little digging.

So I suppose you are all for informing women that getting an abortion is safer than carrying a child to term since all you are concerned about is presenting the "facts" to them.
11.20.2006 9:36pm
A. Zarkov (mail):
“I suggest you read up on global warming and the science behind it; it is quite solid.”

If you read up on global warming you will see that the science behind it has as yet unresolved uncertainties. The primary greenhouse gas in the sense of the greatest absorber of infrared radiation is water vapor. The atmosphere has a lot of it. An increase in co2 concentration will produce some small warming, and if that warming increases the amount of water vapor then a positive feedback loop gets set up. In other words, water vapor amplifies the co2 effect. However the physical processes that govern the atmosphere are very complex. An increase in water vapor could increase the cloud cover and absorb more incoming radiation in the visible part of the spectrum canceling out the feedback effect. To my knowledge this issue has not been resolved unless you take at face value the GCM model calculations. That’s a tall order. It would also be nice if the authors of these models would give disinterested parties their source codes, data and working parameters. Then there are the effects of warming. What are they and how serious are they? What temperature do you use for the effects prediction-- the low end at 1.5 C, or the high end at 5 C? That’s the range of uncertainty in warming by 2070 for a doubling of co2 concentration.
11.20.2006 9:36pm
Toby:
To extend the replies already made to JF Thomas...

I would like to know what possible mechanism could account for the increase in breast cancer risk from induced abortion as opposed to natural termination of a pregnancy through miscarriage or spontaneous abortion

Even if there is exactly *NO DIFEERENCE* ( although several sources of difference could be cited andsome have been above), it is no rebuttal.

Assume:
- Stopping Pregnancy early increases chnace of Breast Cancer. This includes miscarriage, spontaneous abortion, induced abrotion.
Question:
- Does the some of all three of them go up in a world of easy access to legal abortion? Yes it does. Is it possible for this increase to be a greater risk to health than (pick a product a crusading lawyer needs to make a million off of) Yes.

Version 2, not requiring any facts from above:
Assume that Breast feeding, i.e. using them for what they were designed for reduces risks of Breast Cancer (why yes, literature suggests nursing full time before 22 almost completely eliminates risk of Breast Cancer)

Does presence availability of easy access to legal abortion increase or reduce the percent of women spending a year breast-feeding before age 22. I think there is no disputing the answer: it increases it.

Could both the above be true at the same time? Why yes, I belive they can.

Now, it is another argument entirely whether the these risks are greater or less than that of pregnancy, or whether the Nanny state should require, in the interests of health, that all women be prevented from eating junk food or McDonalds and also that they must have babies at age 20. Whatever the merits and lacunae of those arguments, the facts on *this* statement are pretty straight-forward.
11.20.2006 10:05pm
J. F. Thomas (mail):
In the courtroom, on the other hand, a firm judge could make sure everyone gets a chance to tell his story. The jury could sit and weigh the evidence. It could be the great equalizer. Real experts (not UN lackeys seeking yet another cushy position in the dark empire) could present real evidence (not newsreleases like "Man Causing End of World Tomorrow!!! Repent.").

Oh yeah, two advesarial lawyers with no scientific training questioning bought-and-paid-for experts being moderated by another attorney with no scientific training and then having 12 jurors with even less scientific training (in a country where more than half the people don't even believe in evolution) decide issues of fact. That is the perfect way to settle scientific controversies.
11.20.2006 11:01pm
John Kindley (mail) (www):
"That would be reasonable only if there were any plausible mechanism by which they might not be safe, and there was none."

If that's the case that there was no plausible mechanism and no reason to believe the implants could be harmful, then I would agree.

"So I suppose you are all for informing women that getting an abortion is safer than carrying a child to term since all you are concerned about is presenting the "facts" to them."

Sure, but abortion providers already tell women this as often as they can. In fact, the defendant in the North Dakota lawsuit included this statement, that abortion is 10 times safer than childbirth, in one of the commercial brochures we were suing over. The problem is, while this might be true of short term risks (and this refers to statistics about immediate risks of death, which are very remote for both childbirth and abortion, so this "10X" difference is actually quite small in terms of absolute risk difference), when the long-term increase in breast cancer risk is taken into account, childbirth is far safer than abortion. In fact, it IS generally accepted in the scientific community that a full-term pregnancy confers significant long-term protection against breast cancer, and that a woman who has an abortion forgoes this protection she would otherwise gain (the studies I've been referring to examine the hypothesis of an additional, independent increased risk due to abortion itself). When just this undisputed protective effect of childbirth is taken into account, it is clear that childbirth is far safer than abortion, and that abortion providers' statements to the contrary are false. Whether this protective effect be called a benefit of childbirth or its loss a risk of abortion, its effect on the woman's breast cancer risk is exactly the same, and women have a right to know about it, especially when abortion providers are explicitly making this comparison of the risks of childbirth relative to abortion.
11.20.2006 11:04pm
J. F. Thomas (mail):
Contrary to what some folks think, the courtroom is a fabulous place to put junk science on trial.

That's the problem with lawyers, they think they are experts on everything. Look at Bernstein. He apparently thinks he is an expert on physiology and medicine. He's a freaking history major!
11.20.2006 11:06pm
Kazinski:
As I drift closer to retirement and I look back at my various professionial accomplishments, nothing gives me greater satisfaction than when I worked in a breast implant factory in Santa Barbara back in the 70's. When I think of the pair of custom 1300cc implants I helped to fashion for a Vegas stripper (the largest "stock" size was 900cc) I still swell with pride.
11.20.2006 11:40pm
vic:
The problem with law blogs especially with musings of trial lawyers is that they are ( i am sorry ther is no polite word that i can think of) statistically ignorant

That is, Brind and his colleagues concluded that induced abortion raised the relative risk of breat cancer by 30 percent.

But epidemiologists generally view increases in relative risk of less than 100 percent (or an odds ratio lower than 2.00) to be essentially meaningless. When risk factors are lower than that, it is nearly impossible to separate a signal in the data from the statistical noise. Therefore, a small finding is generally treated as no finding at all.


the odds ratio or relative risk by itself is meaningless. what you need to see is the 95 % confidence interval. simply put if the odds ratio for effect x is 2.0 but the confidence interval is between 0.75 and 3.1 + no effect, on the other hand relative risk of 1.27 but 95% conf interval ( 1.25-1.290 MIHGHT ACTUALLY IN SOME CASES BE STYAISTICALLY SIGNIFICANT .

But if I am to understand David Bernstein correctly - the problem is not silicone or abortions - it is that junk science was and is used by an unholy cabal of trial lawyers and rabble rousers to enrich themselves and further their own ends - this leads to a travesty in the name of justice. and eventuially gives our legal system a deservedly bad reputation.
11.20.2006 11:46pm
vic:
"firm judge" is that an oxymoron?

I digress

Houston Lawyer:
The courtroom is a horrible place to settle scientific issues. In most cases you have judges, with a slight understanding of the science, giving instructions to jurors, who are generally not terribly interested in what the science actually proves.

There should be some method of pre-screening the sufficiency of evidence before it even gets to a judge.


Mike BUSL07 (mail) (www):


I wish we could have a political solution to these mass-tort issues, like a Congressional hearing where both sides of the issue air their views


Specialization is a big justification for having administrative agencies. Why Congress can't provide for adjudication before the FDA in these types of cases is pretty much beyond me.


OR
let the jury of ones peers actually comprise peers. let the juries in tort actions be comprised of court appointed experts/ specialists randomly selected from a large pool.

or

let us stop having "buy an expert witness" let the xpert witnesses be court appointed and paid for?
11.20.2006 11:59pm
John Kindley (mail) (www):
Since others on this thread besides J.F. Thomas, who called me a crackpot, have wondered about the biological mechanism behind the induced abortion / breast cancer link (as opposed to miscarriage and spontaneous abortion), in the interest of clarity here's the "biologic plausibility" section of my Wisconsin Law Review article, at www.johnkindley.com:

Biologic plausibility is an important factor in judging the likelihood that a statistical association reflects a causal link. [FN73] The biologic plausibility of the ABC link rests on its consistency with existing knowledge about the "hormonal disruption that occurs when a woman's *1610 pregnancy is interrupted." [FN74] Two independent hormonal effects are implicated: the cancer-promoting effect of early pregnancy and the protective effect of late pregnancy. [FN75]

Within a few days after a woman conceives, her body begins to secrete large quantities of estrogen, a hormone that causes "immature" breast cell tissue to grow. [FN76] These proliferating cells are in a transitional state and thus especially susceptible to carcinogenic stimuli and cancerous mutations. [FN77] "The more the cells proliferate, the greater the chance that a replication will go awry, producing a cancerous cell." [FN78] Most other acknowledged risk factors for breast cancer are likewise associated with estrogen exposure, including early first menstruation and late menopause. [FN79] On the other hand, miscarriage, which has generally not been statistically associated with an increased risk of breast cancer, [FN80] typically occurs when estrogen levels fail to rise above normal, non-pregnant levels. [FN81]

In late pregnancy, other hormones induce the breast tissue to differentiate into mature, milk-producing cells that are no longer susceptible to potentially cancerous growth. [FN82] "It is known that having a full-term pregnancy early in a woman's childbearing years is protective against breast cancer." [FN83] Delaying this protective, differentiating effect of a completed pregnancy presumably "increases the time period during *1611 which undifferentiated breast tissue can accumulate potentially [cancerous] mutations." [FN84]

Induced abortion, therefore, increases a woman's risk of breast cancer in two independent ways: first, by subjecting the breasts to a prolonged high dosage of estrogen, which may promote tumor growth as well as the proliferation of immature, vulnerable cells; and second, by abrogating a completed pregnancy's protective effect. [FN85] Strictly speaking, the pregnancy itself, not its termination, increases the estrogen exposure. However, the induced abortion not only forgoes the protective effect, but does so at a time when estrogen overexposure has left the breasts with an abnormally high number of cells vulnerable to cancerous growth.

The plausibility of this biological explanation for the statistical association between induced abortion and breast cancer is admitted even by those reluctant to draw a causal inference. According to Dr. Clark Heath, Vice President of the American Cancer Society, if the division and maturation of the breast cells are "interrupted at a stage early on, perhaps that will lead to an increased risk of cancer, of carcinogenesis, which is more frequent when cells are rapidly dividing and are young." [FN86] Planned Parenthood acknowledges that "[i]nterruption during the first trimester of a first pregnancy causes a cessation of cell differentiation, which may result in a subsequent increase in the risk of cancerous growth in these tissues." [FN87]
11.21.2006 12:15am
TDPerkins (mail):
Mr. Kindley, I have some familiarity with how hormone level rise in pregnancy, charts are easily available on the internet which show the same. The "breast cancer protective" hormone progesterone also rises almost linearly during a pregnancy.

Your statement that hormone levels rise precipitously within hours of conception are only relatively true. There is almost no estrogen rise until implantation, so "abortifacients" such as the morning after pill would cause no increased risk, for example.

Estrogen level rise continuously and almost linearly throughout the pregnancy. There should be an exact correlation to increased rates of breast cancer which is linearly related to the duration of a pregnancy which ends for any reason prior to the protective effects of breastfeeding being undertaken for some time. Under the theory you've brought to our notice, there would be no difference in breast cancer rates among women who had either an abortion or a miscarriage at about the same time in a pregnancy. Is this what the study claims?

In any case, there is no reason for the FDA to impugn or interfere with the conduct of abortions on the basis of this or any similar study, because the imputate risk as such is one people should be able to make up their own minds about.

In short your study is of limited relevance to a situation such as the breast implant controversy, where there is no increased risk of any dire outcome over any other generic elective surgery. Also, women could avoid the increased breast cancer risk your study associates with pregnancy, in your theory, by taking hormones to chemically emulate a completed pregnancy. Or they could chose not to do so.

I suggest people should be able to choose to spend their resources on elective surgery, all in all, because those resources are theirs.
11.21.2006 6:23am
vic:
Beam me up scotty! there is no intellegent life on this planet.

As a physician who is not an OBGYN I feel reluctant to weigh in on the abortion discussion above.

Obviously it doesnt prevent lawyers with little or no science/ medicine background.

I gues it also explains why the tort courts have degenerated to a excersise in enrichment of lawyers.
11.21.2006 8:55am
Whadonna More:
Kindley seems not to realize that a patient who aborts may later have a full term pregnancy. Or perhaps he does realize and fails to inform.
11.21.2006 9:34am
TDPerkins (mail):
Whadonna More, perhaps the "protective" period of lactation must follow in the usual time after the rise in hormones in order to have the protective effect. Your comment is pregnant with impugning Kindley's good will.

Yours, TDP, ml, msl, &pfpp
11.21.2006 10:28am
Xmas (mail) (www):
I can't believe I'm stepping in to this, but...

If you are going to talk about abortions increasing the risk of breast cancer, you also need to talk about early and/or multiple pregnancies decreasing the risk of breast cancer. Women who don't get pregnant at all have a higher risk of breast cancer than women who get pregnant early or have multiple babies. If you're going to start throwing breast cancer risks around, you've also got to mention that.

Meanwhile, the American Cancer Society says that abortions and stillbirths aren't a significant risk factor for breast cancer.
11.21.2006 10:45am
Glenn W. Bowen (mail):

"Silicone Breasts Bounce Back" would've been a nice post title.


well, first of all, they don't really "bounce".
11.21.2006 10:58am
David Chesler (mail) (www):
Version 2, not requiring any facts from above:
Assume that Breast feeding, i.e. using them for what they were designed for reduces risks of Breast Cancer


Unlike Toby, I wasn't there when they were designed, and as Stephen Jay Gould points out "Causes of historical origin must always be separated from current utilities" but noting that many mammals that lack breasts still nurse their young it seems to me that the "purpose" of breasts is to signal to potential mates that the bearer is a healthy young woman who may be presumed to be fertile.
11.21.2006 11:28am
Ryan Waxx:
... there is still more than enough solidly credible scientific evidence that it does increase risk, that women considering abortion have the legal right to at least know about this potential risk.


Why certainly they do have that right. And all they have to do is a search on the internet, and find the info.

But somehow I suspect that you aren't at all concerned with a woman's 'right to know'... instead you have in mind some form of compelling others to tell her.

And the bar for forcing doctors to give possibly invalid information (via law or via threat of lawsuit) must necessarily be high. Far higher than a 'right to know' would suggest.
11.21.2006 12:31pm
rarango (mail):
The President of the AMA at the time, Dr. Marcia Angel, wrote a scathing editorial in JAMA on the dow-corning decision as being based totally on junk science (and in fairness, perhaps not "junk science," but the scientific illiteracy and ilnumeracy of many in the legal system coupled with paid for "experts."
11.21.2006 1:51pm
happylee:
Hey Vic: Speaking of "enrichment" what do you think about Milton Friedman's wonderful essay on the AMA guild in his Free to Choose? The AMA was founded with the express purpose of limiting the supply of docs to encourage an increase in the price of services. And despite a severe shortage of docs in the US of A, the AMA continues to challenge any attempt to increase the number of docs. And guess what, people die, Vic. They die because the AMA cares about money more than people. Docs hate trial attorneys because trial attorneys pull back the curtain and let the light in.
11.21.2006 3:50pm
John Kindley (mail) (www):
"Estrogen level rise continuously and almost linearly throughout the pregnancy. There should be an exact correlation to increased rates of breast cancer which is linearly related to the duration of a pregnancy which ends for any reason prior to the protective effects of breastfeeding being undertaken for some time. Under the theory you've brought to our notice, there would be no difference in breast cancer rates among women who had either an abortion or a miscarriage at about the same time in a pregnancy."

One study, the 1997 Melbye study (discussed in my law review article), did explicity look at this dose-response effect and reported that "with each one-week increase in the gestational age of the fetus there was a 3 percent increase in the risk of breast cancer," a trend which was statistically significant. Again, you would not ordinarily expect this effect of increased risk from a pregnancy that ends in miscarriage because miscarriages typically occur when estrogen levels fail to rise above normal, non-pregnant levels. (A miscarriage of a healthy pregnancy caused by an auto accident, on the other hand, would presumably increase risk in the same way as an induced abortion.)

"Also, women could avoid the increased breast cancer risk your study associates with pregnancy, in your theory, by taking hormones to chemically emulate a completed pregnancy."

Research efforts have been made, I believe, along these lines, but currently the medical technology to safely and effectively do this apparently does not exist.

"Kindley seems not to realize that a patient who aborts may later have a full term pregnancy. Or perhaps he does realize and fails to inform."

Of course I realize the obvious. How is my failure to state the obvious a "failure to inform"? But this fact isn't really relevant. The earlier a woman has a full-term pregnancy, the more her breast cancer risk is reduced, so a woman who forgoes that protection by having an abortion is increasing her risk to some extent, even if she has a child one year later (which seems unlikely), and many women will not have a full-term pregnancy for many years after an abortion. In fact, there seems to be no protective effect when first childbirth occurs after age 30 or so. Also, I am not aware of any studies that suggest that a subsequent full-term pregnancy before age 30, while conferring a measure of protection and presumably offsetting to some extent the increased risk from a previous abortion, would somehow negate the risk increase caused by that previous induced abortion. Bottom line -- a woman considering abortion has to be told that it may increase her risk of breast cancer, even if you want to give her the additional information that a subsequent full-term pregancy (which may never happen) may mitigate the increased risk.

"But somehow I suspect that you aren't at all concerned with a woman's 'right to know'... instead you have in mind some form of compelling others to tell her."

There is legal precedent (see, e.g., Harbeson v. Parke Davis, a 9th Circuit opinion cited in my Wisconsin Law Review article) indicating physicians do have a duty to inform patients about "potential" or debatable risks. Why shouldn't a doctor have to tell a patient about this known potential risk, which, if real, could lead to serious disease and death? Drug companies clearly seem to believe they have such a duty. Witness all the drug commercials with the disclaimers that include "some studies suggest . . ."
11.21.2006 5:41pm
John Kindley (mail) (www):
"As a physician who is not an OBGYN I feel reluctant to weigh in on the abortion discussion above.
Obviously it doesnt prevent lawyers with little or no science/ medicine background."

"[It is a] false belief that medical research is somehow too complex to be understood by nonscientists. This may be true of the details of any given study, but it is not true of the broad outlines. The general approach is easy to understand, because it is largely a matter of common sense. If nonscientists had a better feeling for the approach, they could gauge the probable strength of many scientific claims while knowing very little of the technical details on which they are based." -- Marcia Angell, Science on Trial: The Clash of Medical Evidence and the Law in the Breast Implant Case 91 (1997)
11.21.2006 6:02pm
vic:
Hey Vic: Speaking of "enrichment" what do you think about Milton Friedman's wonderful essay on the AMA guild in his Free to Choose? The AMA was founded with the express purpose of limiting the supply of docs to encourage an increase in the price of services. And despite a severe shortage of docs in the US of A, the AMA continues to challenge any attempt to increase the number of docs. And guess what, people die, Vic. They die because the AMA cares about money more than people. Docs hate trial attorneys because trial attorneys pull back the curtain and let the light in.

I guess I am not a member of the AMA for that reason, as a foreign born foreign trained physician, I have had strong reservations on what the AMA has stood for. Tho in fairness I would say that they are changing some of their long held positions of late.

But all said and done the AMA's travesties dont hold a candle to the ATLA's extrortion racketeering.
11.21.2006 10:26pm
Kent G. Budge (mail):
There's a couple of aspects of statistical significance that are being glossed over here.

First, the 95% confidence P-interval test is not exactly gold-plated. It still means that there is a 1-in-20 chance the results are purely random. When you consider that null outcomes are less likely to be published than statistically significant outcomes, you see considerably potential for published work to be less significant than it appears. There was, in fact, a recent statistical analysis in one of the biomedical journals (can't remember which off the top of my head) with a title something like "Why Most Published Results Are Wrong." If anyone's sufficiently interested, I can try digging around for it.

Y'all are lawyers, so you must be aware of the danger of statistical clusters. My home town had a brain tumor cluster a few years back, with 10 times the expected number of cases. These were attributed by activists to the nearby nuclear laboratory. Significant? Probably not. A comprehensive study of all forms of cancer showed an overall rate lower than the national average; the conclusion was that the cluster of a particularly narrowly defined and uncommon type of cancer was a statistical fluke. Since then the brain tumor rate has been roughly normal — an illustration of what statisticians call "regression to the mean." But by then the press had lost interest in the story, so the cancer cluster is what stuck in our neighbor's minds.

There is also the matter of systematics, which are not random errors and therefore cannot be beaten into the ground with a large sample. One kind of systematic is a poorly-calibrated piece of measuring apparatus. We have little choice here but to trust the scientists to do their jobs correctly, and for other scientists to call "foul" if they can't reproduce one laboratory's results.

Another kind of systematic is a confounding variable, and their existence is the real reason why an epidemiological risk factor less than 3 is questionable regardless of sample size. Confounding variables are present in any epidemiological study. A known confounding variable can be adjusted for — though often imperfectly — but there's no statistical test to show that you've missed one. A risk factor of 1.3 is just laughable, because of the vast number of potential confounding variables that can crop up that close to the point of no increased risk.

For what it's worth, the risk factor for direct tobacco consumption is in the 10-15 range. That's why only a tobacco company's camp follower can claim with a straight face that tobacco is not a significant health risk.

Finally, there is the rule that correlation does not equal causation. Suppose we find that A is correlated with B. There are four possibilities here: The correlation is random chance. A causes B. B causes A. Both A and B are caused by C, which we have not considered. The latter is pretty much the situation with a confounding variable.

It's possible that something in the background of women who want breast implants also predisposes them to immune disorders. It's even possible that something about women with immune disorders predisposes them to want breast implants; I can't think what it would be but the scientific life is full of surprises. The only way to run down the nature and direction of a correlation with any confidence is to find the mechanism. No credible mechanism was ever found for silicone to trigger an immune response of the kind claimed. Silicone is about as immunologically inert a substance as you could hope to find.

On the matter of abortions and breast cancer: I consider elective abortion a positive moral evil and Roe vs. Wade an appalling contortion of constitutional law. Nevertheless, I also loathe the use of junk science to support the pro-life movement. It's "lying for God," which is deeply suspect. Furthermore, it concedes the whole debate, since it shifts the argument from the moral evil to the convenience of the mother. Once it's all about the mother, you've lost the debate. So, John Kindley ... I don't want you on my side in this debate. All anyone has to do here is point out how greatly the health risk of carrying a baby to term overwhelms the purported 30% increase in breast cancer following an abortion, and your whole argument collapses like a house of cards. Stick with the moral evil argument.
11.22.2006 2:57pm
John Kindley (mail) (www):
"Nevertheless, I also loathe the use of junk science to support the pro-life movement. It's "lying for God," which is deeply suspect. Furthermore, it concedes the whole debate, since it shifts the argument from the moral evil to the convenience of the mother. Once it's all about the mother, you've lost the debate. So, John Kindley ... I don't want you on my side in this debate. All anyone has to do here is point out how greatly the health risk of carrying a baby to term overwhelms the purported 30% increase in breast cancer following an abortion, and your whole argument collapses like a house of cards. Stick with the moral evil argument."

Despite your attempt to come across as taking the scientific and moral high ground, you apparently have just glossed over or ignored my actual posts on this subject, which pretty much address all the "concerns" you've raised. I don't appreciate being called a liar by someone who is either willfully ignorant or a liar himself.

With regard to research on the abortion-breast cancer link, especially in light of the politics involved and the outright deception I've witnessed in the literature and on cross-examination of expert witnesses, it's actually more likely that studies finding a positive association would have been suppressed and unpublished than the contrary. You only have to look at the uncritical and undeserved approval given to Melbye et al for their seriously-flawed 1997 study in the NEJM reporting no overall risk increase (but which also has the clearest evidence of a dose-response effect correllating with duration of pregnancy) for strong evidence that "publication bias" goes in this direction if any.

I don't consider the abortion-breast cancer issue to be a "pro-life" issue, except to the extent that being anti-cancer is pro-life. For me its about the value of self-determination, and the hypocrisy of abortion providers who keep this information from women while spouting rhetoric about choice. Your ad hominem assumptions about me say a lot about you.

So, Kent Budge ... I don't want you on my side in this debate, or any debate for that matter, either.
11.22.2006 10:19pm
vic:
kent:

I couldnt agree with you more. I am alittle more ambivalent about abortion for a variety of reasons but on pure logic and reason grounds i have a hard time thinking of it as anything other than state sanctioned murder.

your statistical synopsis is dead on.

i think John Kindlay is just trying to advance an agenda which he hopes will end up his successfully suing abortion providers.
11.22.2006 11:22pm
professays (mail):
I've heard that silicone breast implants can cause cancer. Is it correct?
11.23.2006 5:39am