The Volokh Conspiracy

Activist Mothers:

This story, about anti- "Big Food" activist Robyn O'Brien, reminds me of the story of Betty Mekdeci. In 1975, Mekdeci gave birth to a son with limb reduction birth defects; the cause of most such birth defects is unknown. Not satisfied with that answer, she began a quest to determine what caused her child's suffering, and persuaded herself that the culprit was the morning sickness drug Bendectin, which she had ingested during pregnancy. (Similarly, after one of her children suffered a severe food reaction, O'Brien decided that there is a "profit-driven global conspiracy whose collateral damage is an alarming increase in childhood food allergies".)

Mekdeci then hired famed torts lawyer Melvin Belli to represent her and her child in litigation against the manufacturer of Bendectin, Merrell Dow Pharmaceuticals. As I've written in the Michigan Law Review:

In 1977, when Mekdeci brought her lawsuit, fourteen epidemiological studies of varying strength and quality had examined the relationship between Bendectin and birth defects and found no association. While these studies were not powerful enough to rule out some connection between Bendectin and birth defects, they certainly provided no cause for alarm. Bendectin had been on the market since 1956 with no serious doubts raised regarding its safety in the scientific or medical community. Nor did Bendectin contain suspiciously toxic ingredients: one active ingredient of Bendectin was a simple B vitamin, and the other was an ingredient used in a popular over-the-counter sleeping pill.

Meanwhile, Mekdeci's evidence that Bendectin did cause birth defects was "remarkably thin." Many chemicals are known not to be teratogens in humans, so the mere fact that pregnant women ingested a pharmaceutical product such as Bendectin did not mean there was an inherent risk. Beyond the mere fact that she ingested Bendectin during pregnancy and later gave birth to a child with a limb reduction birth defect, Mekdeci's evidence of causation consisted primarily of eighty-six reports to the FDA of other women who had also given birth to children with limb reduction defects after taking Bendectin.

.... [T]he mere fact that dozens or even hundreds of children were reported to have been born with limb reductions after their mothers ingested Bendectin doesn't, by itself, even suggest a risk. Approximately thirty million women took Bendectin, and by chance alone there would be ten thousand limb reduction defects among children born to these women.

Nevertheless, with the help of Belli's publicity machine, the Bendectin litigation eventually drew thousands of plaintiffs and cost Merrell Dow several hundred million dollars in defense costs (though not a penny was ever paid to a claimant, the courts universally overturning the 40% or so of jury verdicts favoring plaintiffs.)

Despite FDA approval, Bendectin, the only drug proved safe and effective in combating nausea and vomiting in pregnancy, remains unavailable in the U.S. (but is available everywhere else), having been taken off the market at the height of the litigation to avoid further lawsuits. Studies have shown that the rate of limb birth defects in the U.S. has not been affected by the removal of Bendectin from the market, but hospitalizations for severe morning sickness have soared.

Meanwhile, the persistence of plaintiffs in pursuing the Bendectin litigation despite mounting evidence of Bendectin's safety and the complete lack of valid contrary evidence, combined with juries nevertheless frequently ruling in favor of the plaintiffs, eventually became the leading cause of a severe backlash in federal courts against "junk science," culminating in Daubert v. Merrell Dow Pharmaceuticals, itself a Bendectin case, and it progeny.

Professors Michael Green and Joseph Sanders have written rather similar books on the Bendectin saga, though Green tends to be more sympathetic to the plaintiffs. My own much briefer recap of the Bendectin litigation can be found in the Michigan article mentioned above.

Henri Le Compte (mail):
Is this Merrell Dow company in any way related to the Dow company that was later bankrupted by the silicon breast implant hysteria of the 1990's?

Unfortunately, juries are not made up of scientists, and some difficult questions (like causality vs. correlation) can be muddied by unscrupulous advocates for one side or the other. At this point, it doesn't seem that there is ever enough pre-marketing studies, safety studies, epidemiological studies, you-name-its, to protect a company from this kind of attack.

Especially with a sympathetic plaintiff.
1.10.2008 8:13am
ejo:
judges have to set a bar as well-can you blame a jury when a judge allows crap to be placed in front of them as the holy writ. we are seeing the same thing today with thimerosol-an actress who probably has a GED is the lead scientific expert for the relationship between the chemical and autism, actual facts be damned.
1.10.2008 8:29am
Temp Guest (mail):
As an aside on this issue: one of the current dimocrat candidates for President used junk science litigation to became a multi-millionnaire; as a side-effect, forcing OBGYNs in this country to perform literally millions of unneccessary, expensive, and dangerous Caesarean Sections.
1.10.2008 9:22am
JosephSlater (mail):
I understand and even have some sympathy for DB's critique of "junk science" in some products liability cases.

But is there any particular reason this post is titled "activist mothers"? I realize this particular person was a mother and an activist, but is there a problem, generally, with "mothers" being "activist"?
1.10.2008 9:30am
Lior:
I think a better formulation of the regret is:
Unfortunately, there are juries in US courtrooms.

The simplest fix is requiring the jury to sumbit a written report detailing the reasoning behind their ruling.
1.10.2008 9:40am
davidbernstein (mail):
I couldn't come up with a better title, and that's what O'Brien and Mekdeci have in common--they were driven to activism by things that happened to their children.
1.10.2008 9:41am
Grover Gardner (mail):
I think you're being a little unfair to Ms. O'Brien. She doesn't seem to be out to sue anybody or prevent products from reaching the market--though perhaps you may feel that it's only a matter of time. Our daughter is very sensitive to certain foods, and we've learned to watch out for "normal" or "harmless" foods that in fact don't agree with her, like milk, strawberries and certain kinds of tomato sauce. Her reactions can vary from an upset stomach to rashes and hives. She ate a hot dog at a friend's house a few weeks ago and had the most appalling skin reaction. But as long as we keep an eye on her she's very active and healthy and there are plenty of things she can enjoy.

That said, I'm like a lot of people in that I can't remember any kids dying from eating peanuts in my school when I was little. Food allergies just weren't something anyone paid much attention to back then. So what's the story--is it all in parents' or kids' minds nowadays? Did they really change the food, by using antibiotics or certain pesticides or genetically altered seeds? It's *possible* that there are more additives and chemicals in our meat, dairy, vegetables and processed foods than there used to be. Fact is that few of us really know how our food is grown.

Anyway, until this woman starts suing people and trying to ban your favorite brand of potato chip, I'd let her be. She's not doing any harm that I can see, and she may be helping people who've tried everything else.
1.10.2008 9:41am
Tio:

Despite FDA approval, Bendectin, the only drug proved safe and effective in combating nausea and vomiting and pregnancy, remains unavailable in the U.S.

This should probably be "Despite FDA approval, Bendectin, the only drug proved safe and effective in combating nausea and vomiting and during pregnancy, remains unavailable in the U.S. . . . ."


Although if it does combat pregnancy, that could be a winner for Merrill Dow.
1.10.2008 9:53am
Ralph Phelan (mail):
So they never lost a case, but they still were forced to withdraw the product due to the expense of their "victories."

The US really does need some form of "loser pays."
1.10.2008 10:01am
DavidBernstein (mail):
"I can't remember any kids dying from eating peanuts in my school when I was little."

You can't remember them now, either. According to the article, only 12 people in the United States were known to die of ANY food allergy last year.

I do wonder about the sudden prevalence of peanut allergy, as I don't remember even having heard of it when I was a kid, and now I know lots of kids who are said to be allergic to peanuts.
1.10.2008 10:08am
JosephSlater (mail):
100 points for Tio!
1.10.2008 10:09am
taney71:
Reminds me of the Julia Roberts movie. Anyone remember the name?
1.10.2008 10:10am
Matt P (mail):
Actually I do have a problem with 'Activist' mothers. Its the same problem I have with lawyers who act as their own council -- they are often too close to the events to be impartial or deal fairly with those on the other side and often fail to interpret facts realistically.

That isn't to say that some mothers can't be good activists, but by and large they remind me of their creepy cousin 'stage moms' who place too much of their identity into being their kid's parent. Activist moms eventually turn into professional victims who constantly put their child's disablement on display which keeps the kid from having as much of a normal life as they can.
1.10.2008 10:11am
DavidBernstein (mail):
When you go to O'Brien's website, you see, "AllergyKids addresses the impact that hidden chemicals in FOOD and VACCINES have on the lives of the 54.6% Americans with allergies and offers."

So she's one of the anti-vaccine nuts, too. These folks do in fact do real harm, by persuading people not to vaccinate their kids, encouraging lawsuits against vaccine makers, etc.
1.10.2008 10:14am
DavidBernstein (mail):
And here's this nonsensical gem: "According to the CDC, one out of every ten cases of breast cancer is linked to a genetic cause, suggesting that 9 out of every 10 cases of breast cancer could be prevented by addressing environmetal and dietary toxins."

Umm, "genetic cause" is actually the opposite of "environmental" cause.
1.10.2008 10:17am
Lior:
It seems that early exposure to peanuts increases the risk of peanut allergy. Peanut butter and other peanut-based foods are now a staple of the US diet, and children are exposed to them at a younger age.



A second effect is the shifting cultural view towards protecting children at all costs. Kids used to run around the neighbourhood and play by themselves -- now they must remain the back yard under supervision. It is now expected that parents of a child will alert others to the child's allergy (that's a good thing!).



Another effect is increased reporting. Low-probability events are given disproportionate media coverage, and create scares. If you know that peanut allergies exist, you are more likely to believe your child suffers from them.
1.10.2008 10:20am
Grover Gardner (mail):
"So she's one of the anti-vaccine nuts, too."

Whoa, now. Where on the web site does she advise against vaccinating your children?
1.10.2008 10:23am
Ralph Phelan (mail):
Echoing Matt P. above:

Assuming that there is indeed an increase in childhood food allergies, why assume it's food or drug additives? Why not the fact that houses are much cleaner these days, affecting a growing child's immune system? Or that modern hildren are much more sedentary, and spend a lot more time looking at TV and computer screens than in the past. Or that people nowadays are are exposed to a lot more organic solvents from plastics, construction materials, etc.

O'Brien's understandable emotional involvement has attached not to the issue as a whole, but to a particular group of hypotheses that may or may not be the right ones.
1.10.2008 10:25am
Allan (mail):
As a result of our extremely complex way of life, we are exposed to potentially harmful materials on a daily basis. But it is difficult to isolate the harm. Either we have litigation to have those responsible for the harm to pay or those who are harmed have no recourse. In the alternative, we can have society as a whole pay (funded by some sort of taxes).

Absent a good tort system (which many think we do not have), I would advocate the latter (with some sort of graduated system based upon scientifically based statistics).

The tort system would have three components:

1. Health care for all those harmed (might as well be universal).
2. Taxes to fund the system (based upon potential harm caused by various goods).
3. An effective government run system for punishing those who cause intentional harm (funded by the companies found lible).
4. An effective system for ensure those who cause harm are sanctioned.
1.10.2008 10:28am
Grover Gardner (mail):
"Umm, 'genetic cause' is actually the opposite of 'environmental' cause."

That's exactly what she wrote. If only one out of ten cancer cases is due to genetics, this suggests that the other nine are preventable.

So you're just now reading her web site? Or mis-reading it, I should say...?
1.10.2008 10:30am
davidbernstein (mail):
You're right, I misread it. Though I'm sure the CDC said "known genetic causes."
1.10.2008 10:33am
David Chesler (mail) (www):
"genetic cause" is actually the opposite of "environmental" cause.

I don't get the problem with this.
If 10% are genetic, then 90% are non-genetic, and if you can't think of anything besides genetic, environmental and dietary toxins, that leaves 90% to environmental and dietary toxins.
(Does enviornmental modify toxins or causes? I'd imagine a lot of the causes are radiation, including gamma rays [our generation's gremlins], radiation therapy for those who've had it, and whatever radiation is around from the water and soil. Mechanical stress can play a part.)
I guess the real answers is that genetic/environmental/dietary isn't exclusive, and most of the cases are idiopathic and not known to be from any of those three, so subtracting 10 from 100 isn't valid. Or is that the objection?
1.10.2008 10:40am
Grover Gardner (mail):
And now we'll address the ever-growing incidence of "knee-jerk syndrome," thought to be caused by an allergic reaction to a particular brand of printer's ink specific to the New York Times.

;-)
1.10.2008 10:41am
DavidBernstein (mail):
And here is O'Brien as anti-vaccine nut.
1.10.2008 10:42am
DavidBernstein (mail):
"I guess the real answers is that genetic/environmental/dietary isn't exclusive, and most of the cases are idiopathic and not known to be from any of those three, so subtracting 10 from 100 isn't valid. Or is that the objection?"

I misread it, but even as stated that's one problem. Another is that the fact that 10% of breast cancers are known to be of genetic origin doesn't mean that only 10% are. And finally, broadly speaking, she's right that if you subtract genetic from the total the rest must be environmental, including diet, in some sense, though not in the sense she probably means (as she seems to think non-organic foods are the root of all evil).
1.10.2008 10:46am
Aultimer:

AllergyKids addresses the impact that hidden chemicals in FOOD and VACCINES have on the lives of the 54.6% Americans with allergies and offers

Serious question - IANAEpidemiologist - why aren't there studies comparing the allergic impact of home-farmed (organically and from heirloom/Amish source) milk, peanuts and strawberries to the impact of mass-market stuff?

Wouldn't they address the "additives/GM" boogey-persons pretty directly?
1.10.2008 10:50am
DSM:
Her website may not encourage not taking vaccines, but I think it's fair to say that it's not exactly a big supporter of them.

Following the VACCINES link on the main page (after correcting the broken link) takes you to a blog post entitled "Vaccines Role in the Allergy Epidemic: Who is Protecting Whom?!!?".

the post in question

After reading it I believe that "anti-vaccine nut" is not an unfair characterisation, at least to first-order.
1.10.2008 10:52am
Randy R. (mail):
My best friend has a boy who has been allergic to any nuts from childhood. If he even touched anything that had nut oil, even the slightest bit, he would have trouble breathing. Twice, he went to the emergency room because he unknowingly came into contact with nuts. (which should quell any notions that it's 'in his head'). He was so fearful for most of his boyhood that he refused to eat anything that was not made at home by his parents. Now that he's older, he can tolerate a small amount of nuts.

So the nut allergy isn't a phantom.

I agree that this litigation is unfair, and the jury was probably swayed by junk science. But let's not let the corporations off the hook entirely. They have caused a climate where no matter how bad their behavior or their products, they deny it and block any means of redress. The Julia Roberts movie was Erin Brockovich, and that was a true story about a corporation that knew it produced harmful chemicals and released them in the water supply and stonewalled any action. (Brockovich, by the way, contracted the same disease because of her collecting samples of contaminated water).

Do I have to mention the tobacco companies? or Enron? and any of dozens of corporate scandals? Perhaps if corporations acted with a little more conscience, then there wouldn't be the automatic distrust between the public and corporations. WE didn't break the public trust, the corporations did.

I realize that's unfair. Perhaps Merril Dow is the model corporate citizen, and they are made to suffer for the sins of others. All the more reason good companies should welcome some form of oversight to protect the public trust.
1.10.2008 10:57am
Grover Gardner (mail):
"After reading it I believe that 'anti-vaccine nut' is not an unfair characterisation, at least to first-order."

I thoroughly disagree. I think there's an enormous difference between telling people not to vaccinate their children, and questioning the *safety* of some current vaccines.

I've met parents (and even doctors) who don't believe in vaccinating children. This isn't the same thing at all.
1.10.2008 10:59am
Wugong:
I do wonder about the sudden prevalence of peanut allergy, as I don't remember even having heard of it when I was a kid, and now I know lots of kids who are said to be allergic to peanuts.

I knew two kids who were allergic to peanuts when I was a kid (i.e. in the 70's) and the allergies were pretty horrific. Of the kids would get an instant red swelling if a peanut was rubbed on her skin and her parents were very careful to let her friends' parents know about her condition.

I do know far more kids who are allergic to peanuts these days and with this particular affliction it really does NOT seem to be a case of "said to be..." (with your implication that it's not true). Unlike something like ADHD (which is often in the eye of the beholder) or even lesser food sensitivities that result in gas or indigestion, peanut allergies always manifest in a very obvious allergic reaction that involves swelling, closing of the air passages, etc. As it's also something that was unlikely to be missed in years past, the substantial increase in recent years seems very real. A nurse who was trained in England recently told me and my wife that children there aren't given peanuts and related products until at least age 5 and that instances of nut allergies are far fewer. Don't know if it's true or not.
1.10.2008 11:01am
neurodoc:
As an aside on this issue: one of the current dimocrat (sic) candidates for President used junk science litigation to became (sic) a multi-millionnaire; as a side-effect, forcing OBGYNs in this country to perform literally millions of unneccessary, expensive, and dangerous Caesarean Sections.
Ask a child neurologist who among them is the leading expert on neurology of the newborn and you will almost certainly be told it is Joe Volpe at Boston Children's Hospital. Dr. Volpe is the author of "Neurology of the Newborn." In that highly regarded text, Volpe says, "(I)f one excludes premature infants, in whom the overwhelming balance of data shows that timing of injury is primarily postnatal, approximately 12 to 23% of cerebral palsy can be related to intrapartum asphyxia."

I have listened to Dr. Volpe speak at professional meetings, but I don't know him personally. I do know a child neurologist who is among the leading experts in the world on the epidemiology of cerebral palsy, and when I asked her about Volpe's 12 to 23% estimate, she smiled and said, "Joe isn't an epidemiologist." My friend took exception only to the magnitude of Volpe's estimate, though. Neither she, nor any of the many child neurologists that I know say that no case of cerebral palsy can be attributed to hypoxic ischemic encephalopathy (too little oxygen and/or blood to the brain) suffered during delivery. Indeed, the American College of Obstetrics and Gynecology acknowledges hypoxic ischemic injuries during the course of delivery as a cause of cerebral palsy.

So exactly what "junk science" did John Edwards use "to become a multi-millionaire"? In the birth injury cases that he litigated he advances theories that were scientifically incredible? Or based on your knowledge of the subject matter and the facts of those particular cases, do you believe that Edwards did not prove negligence on the part of the defendant doctors and that but for the alleged negligence the child would not have suffered an injury?

I don't mean to turn this thread into a discussion of birth injury cases and the medical science relevant thereto, nor the indications for a cesaerean section, nor the particulars in the cases Edwards pursued as a P attorney, nor Edwards as a candidate, etc. And I would be the last person to deny the existance of "junk science," especially in litigation, since I have personally had much experience of experts serving it up. But we ought to be straight about what is and what isn't "junk science."

[P.S. If you are concerned about "junk science" in the context of the current political campaigns, check out the fellow over on the Republican side who talks about immunizations "overwhelming" the immune systems of children and genetically modified foods as dangerous, and who is philosophically opposed to a Food and Drug Administration.]
1.10.2008 11:02am
Alan Gunn (mail):

Either we have litigation to have those responsible for the harm to pay or those who are harmed have no recourse.

Not all that many years ago, we let the market take care of this sort of thing. It's not perfect, but it's a lot better than the tort lottery. It's worth mentioning that this kind of litigation kills people as a side effect--if you can't get Bendectin, you take something that's been tested less; if your obstetrician does an unnecessary C-section, your risk of dying in childbirth goes up; if kids don't get vaccinated, controllable diseases resurface. One serious drawback of turning much of government over to lawyers is that most lawyers don't appreciate the good things that markets accomplish.
1.10.2008 11:04am
rarango (mail):
Is this the time to talk about the evils of "big pharma?" Or the effect of litigation on the American health care? As M. LeCompte mentioned in the very first post, this situation was precisely what happened in the breast implant case. That outcome was so questionable that Dr. Marcia Angell, President of the AMA, published an editorial in JAMA about the problem. There was absolutely no epidemiological evidence that breast implants caused the chronic pain plaintiffs were complaining about. So... if Juries for the most part lack the detailed knowledge of epidemiology to make an informed decision; if either side can hire and expert witnesses who will say exactly the opposite; and if most judges, I suspect, lack the scientific knowledge to make informed rulings on admissibility of evidence, it seems to me this is a problem; so how is it fixed?
1.10.2008 11:06am
Ralph Phelan (mail):
"if you can't think of anything besides genetic, environmental and dietary toxins, that leaves 90% to environmental and dietary toxins"

If you can't think of anything besides genetic, environmental and dietary toxins, you should STFU and leave the epidemiology to those not so overwhelmed with emotion that they have become incapable of thought.
1.10.2008 11:07am
frankcross (mail):
People confuse the meaning of the word "environmental." Doll &Peto long ago established that most cancers were environmental, in the sense of not genetic, but that very, very few were environmental in the sense of exposure to ambient toxics. For example, smoking cigarettes is classified as an environmental source of cancer for the smoker. And also, a great deal of the ambient exposure to carcinogens is natural, in the form of natural radiation.
1.10.2008 11:11am
Tony Tutins (mail):
Three factors to consider:
1. When bad things happen to those you love, the temptation to make someone pay is strong.
2. Some things routinely prescribed in the fifties to pregnant women were actually harmful to their kids, like DES.
3. Most of us are not aware of the true prevalence of allergies, etc. back in the fifties or earlier, for a number of reasons: we were too young to care; such information was accessible only to physicians; the cause of breathing difficulties was wrongly ascribed; etc. My eyes were opened when a fellow around 60 told me he had been diagnosed with ADD back in the 60s. I had thought ADHD was unknown before the 80s. Now we know more, and now the internet really facilitates the ability of interest groups to form and to share (mis)information.
1.10.2008 11:14am
Grover Gardner (mail):
"Not all that many years ago, we let the market take care of this sort of thing."

Hmmmm...

"if you can't get Bendectin, you take something that's been tested less"

Like what?

"if your obstetrician does an unnecessary C-section, your risk of dying in childbirth goes up"

The increased risk of death has a lot to do with the health problems a woman may have that lead to a c-section being necessary in the first place.

I agree with you about vaccinations (I think) and your notion that lawyers may not be the best people to determine public health policy. :-)
1.10.2008 11:19am
Allan (mail):
Alan,

The market is ill-equiped to take on the problem.

1. In a good market, everyone has equal information. That is not the case when the sellers are large conglomerates and the buyers are individuals with few resources.
2. Without good information, it is tough for individuals to make good choices.
3. Given the complexity of life, there are going to be tragedies. Because these tragedies are caused by society, one way or another, society should take care of them as a matter of course.

People should advance in society due to their abilities. They should not be punished for dumb luck, i.e., using defective products they had no idea were bad for them.
1.10.2008 11:23am
DSM:
I had written: "After reading it I believe that 'anti-vaccine nut' is not an unfair characterisation, at least to first-order."

GG replied: "I thoroughly disagree. I think there's an enormous difference between telling people not to vaccinate their children, and questioning the *safety* of some current vaccines."

True, there's a big difference between these two, but I don't think you need to actually tell people not to vaccinate to qualify as an anti-vaccine nut. In most of the other fringe viewpoints generally considered off-the-wall wacky, those involved often say they're merely "asking questions" -- the questions The Man doesn't want to you ask -- and I still think they're nuts. The question isn't even whether they're right or wrong-- it's whether their analysis is reasonable.

All of the usual signals of junky science alarmism are present here: big scary numbers (100,000,000) with no context; citations to nonexpert work for evidence that something is a concern ("The writers of this article make no claims of being authorities in the fields of genetics or immunology," -- wait for it -- ", but" [emphasis mine]); cui bono/cui prodest rhetorical questions; and so on.

That something winds up hitting all the crankery flags isn't by itself evidence that it's wrong, any more than all the stuff in my spam folder is always spam. But life is short.
1.10.2008 11:32am
neurodoc:
I do know far more kids who are allergic to peanuts these days and with this particular affliction it really does NOT seem to be a case of "said to be..." (with your implication that it's not true)
No question that allergies to peanuts are real. There are death to attest to that reality. But one shouldn't place to much reliance on "seems." It is a place to start from when talking about how common a condition is in the population (incidence and prevalence), but highly unreliable when talking about causation, as this "activist" mother does in her righteous, uninformed campaign.

(BTW, I myself have a very strong peanut-related allergy. When I am exposed even a little bit to former peanut farmers on the national or international stage, I am liable to experience something close to anaphylaxis.)
1.10.2008 11:32am
Randy R. (mail):
"Either we have litigation to have those responsible for the harm to pay or those who are harmed have no recourse. Not all that many years ago, we let the market take care of this sort of thing."

Yes, the market took care of it by saying you get nothing for your harm. I don't see how how that is better. If it WERE better, then would 'the market' say that getting nothing is better than trying your luck at litigation? Either way, this really makes no sense at all, except as an example of how people worship at the mantle of the supposed free market.

As for junk science, when I was in law school, it was pretty much defined as astrology, New Agers, doctors of 'Wholeology" or Joyologists, that sort of thing. It wasn't meant to exclude unproven scientific evidence. Just because you disagree with something doesn't make it junk.

Perhaps the confusion came when the creationists started all their litigation?
1.10.2008 11:33am
Ak:
"If 10% are genetic, then 90% are non-genetic, and if you can't think of anything besides genetic, environmental and dietary toxins, that leaves 90% to environmental and dietary toxins."

I'm guessing you never took biochemistry. 10% can be linked to a genetic susceptibility. The vast majority of the remainder are due to the fact that every human being generates malignant cells and repair/apoptosis systems miss a few every now and then. Whether or not those few cells end up being cancer depends on hundreds of things from the presence of growth factors to vascular supply and is essentially random, or at least unrelated to "external" factors.
1.10.2008 11:36am
neurodoc:
Dr. Marcia Angell, President of the AMA, published an editorial in JAMA about the problem.
Marcia Angell is not, has not been, and never will be President of the AMA. She is a pathologist who served under Arnold Relman when he was editor of the New England Journal of Medicine, and succeeded him in the prestigious and highly influential postion. This very smart woman did critique and dispose of the breast implant "junk science."
1.10.2008 11:38am
Ralph Phelan (mail):
Given the complexity of life, there are going to be tragedies. Because these tragedies are caused by society, one way or another, society should take care of them as a matter of course.


Wow.
I don't know where to begin.
Just ... wow.
1.10.2008 11:42am
bob (www):
While it makes for effective rhetoric, it is false to say that this case resulted in an effective treatment for morning sickness being denied to pregnant women. The two-drug cocktail in Bendectin is still available to anyone, simply by taking the OTC sleep aid unisom and vitamin B6. There are numerous references to this combination on the internet, some from prominent health institutions. The case increased Merrell Dow's costs and increased the price of Bendectin, but even before the price increase, Bendectin cost more than its two components purchased separately.
1.10.2008 11:44am
neurodoc:
Three Four factors to consider...
4. The scientifically soundest answers to "why", including "we don't know the cause," don't satisfy the need of many for THE answer. For them, those answers that more objective and better informed minds would reject out of hand as illogical/implausible/incredible are enthusiastically embraced. And if the answer implicates some identifiable party, especially the government, a corporation, a group of conspirators, etc., as responsible for the woe that has befallen them or their families, it may be still more welcome, since it gives them something to rail against other than a deity or a senseless universe.
1.10.2008 11:53am
rarango (mail):
Neorodoc: thanks for setting me straight on her position. A question for you: while Dr. Angell published a great editorial on the issue in JAMA, do you, wearing your MD hat, think she has really disposed of the issue at the level of the general public? I am guessing not.
1.10.2008 11:54am
Mary Katherine Day-Petrano (mail):
The Benedectin controversy is remarkably similar to the autism-mercury vaccines-caused-it controversy. In the latter, no doubt there has been a very angry parental backalsh for being arbitrarily blamed by the psychologists lobby for "refridgerator mothers" being blamed. Parents banding together to find the real cause of the autism.

In my opinion, it is difficult, if we are to believe mercury causes autism, to confine the mercury source to vaccines, rather than also looking at mercury emissions by coal-fired plants, mercury in fish pregnant mothers ingest, etc.

We now are discovering there are certain chromosome deletions and/or duplications on chromosomes 15, 16, and/or 22 that relate to autism, but the question still remains whether these chromosome deletions/duplications are additionally interacting with mercury poisoning, or somehow make a person more susceptible to mercury poisoning, all of it causing autism.

Of course it is only sensible for a person or parent of a person who has been affected to search for the source of the injury. And hopefully, as science and technology advance, we will begin to get better pharmaceuticals where the "cure" (harmful sideffects) are no longer worse than the original problem(s) for which it was prescribed.
1.10.2008 11:56am
KeithK (mail):
If the concern is liability based on flimsy evidence it seems to me that the appropriate solution is to raise the standard of proof required to prove causation. Use a "beyond a reasonable doubt" or "clear and convincing" standard for scientific evidence. This makes it less likely for a jury to make a bad verdict based on flimsy evidence (such as in the OP) and less likely that lawyers will bring such tenuous cases to court.
1.10.2008 11:56am
davidbernstein (mail):
"While it makes for effective rhetoric, it is false to say that this case resulted in an effective treatment for morning sickness being denied to pregnant women. The two-drug cocktail in Bendectin is still available to anyone, simply by taking the OTC sleep aid unisom and vitamin B6. There are numerous references to this combination on the internet, some from prominent health institutions. The case increased Merrell Dow's costs and increased the price of Bendectin, but even before the price increase, Bendectin cost more than its two components purchased separately."

It's true, and it's also true that it's legal to import the drug itself from Canada. But it's also true that doctors themselves rarely suggest doing either of these things, in part because of their own concerns re liability.
1.10.2008 12:05pm
DavidBernstein (mail):
Oh, and FWIW, the rate of hospitalizations for NVP (severe morning sickness) rose dramatically in the U.S. and Canada when Bendectin was taken off the market in both countries, then fell in Canada but not in the U.S. when Bendectin came back on the market in Canada but not the U.S. So the Unisom/B6 combo doesn't seem to be doing it.
1.10.2008 12:06pm
K Parker (mail):
Lior,
Peanut butter and other peanut-based foods are now a staple of the US diet, and children are exposed to them at a younger age. [emphasis added]
What previous time period are you using as a reference? AFAICT peanuts have been quite prevalent, at least in the US, for several generations now.

Aultimer,

I suspect it would be very hard to separate out populations for such a study.
1.10.2008 12:08pm
TruePath (aka logicnazi) (mail) (www):
Ak:

"Random" mutations have some microphysical cause. Maybe it's a stray cosmic ray or maybe it's some bizarre causal path from a statistically harmless environmental chemical or going running one day. These are still environmental in the strictest sense.

Of course I still think it is wrong because when the CDC or other biologist calls something a genetic cause they don't mean heritable cause. There could well be causes that result from non-genetic material passed down the cell line (not a noticeable amount perhaps but while we are being pedantic...)


Of course the real problem isn't that this may be a technically incorrect statement but that it misleadingly identifies environmental with preventable.
1.10.2008 12:15pm
TruePath (aka logicnazi) (mail) (www):
Ohh and IMO there should be a rule that protects companies if they release all of their safety studies (no cherry picking) in an easily accessible manner on a website listed on the product.

Of course most people without a background in science won't be able to make heads or tails of this but a jury made up of average citizens sure as hell shouldn't be able to determine that a company is liable because people like them couldn't be expected to understand the evidence they are evaluating.

Absent active attempts to mislead or other extenuating circumstances of course.
1.10.2008 12:18pm
lralston (mail):
"The Centers for Disease Control and Prevention put the number of deaths linked to food allergies at 12 in 2004, the most recent year for which data are available. However, its statisticians point out that such figures are drawn only from doctors’ notations on death certificates."
Doctors are now labeling the miscellany of developmental defects as autistic, food allergies are soon to follow?
1.10.2008 12:21pm
Tony Tutins (mail):

if we are to believe mercury causes autism, to confine the mercury source to vaccines, rather than also looking at mercury emissions by coal-fired plants, mercury in fish pregnant mothers ingest, etc.

Then isn't it rather silly to advocate replacement of incandescent bulbs with fragile compact fluorescents, which discharge mercury to the atmosphere immediately when broken?
1.10.2008 12:22pm
K Parker (mail):
Neurodoc,

Funny, I have the same peanut-farmer malady as you do, except in my case it induces severe nausea.

Mary Katherine,
And hopefully, as science and technology advance, we will begin to get better pharmaceuticals where the "cure" (harmful side effects) are no longer worse than the original problem(s) for which it was prescribed.
The situation you wish for is already very much the standard case.
1.10.2008 12:30pm
alkali (mail):
db writes:

According to the article, only 12 people in the United States were known to die of ANY food allergy last year.

This particular statistic is based on whether a doctor noted food allergy as a cause of death on the death certificate (rather than leaving it at "anaphylactic shock," or "cardiac arrest"). The correct figure is probably more like 100-200.

That is not a huge figure, but it is relatively large for deaths (1) where the deceased is neither a newborn nor above age 65 and (2) where the death is the result of something other than accident, violence, suicide or cancer.

None of which is to say that db's ultimate point isn't right; I just wanted to correct these statistics.
1.10.2008 12:31pm
neurodoc:
if we are to believe mercury causes autism, to confine the mercury source to vaccines, rather than also looking at mercury emissions by coal-fired plants, mercury in fish pregnant mothers ingest, etc.
The scientific evidence argues strongly against mercury as a cause of autism. But mercury (like lead) is unquestionably a neurotoxin; there has come to be more mercury (and lead), in our environment over the course of time; and it makes good sense for all of us, especially pre-menopausal women who may bear children, to limit our exposure to mercury (and lead).
1.10.2008 12:38pm
cathyf:
Doll &Peto long ago established that most cancers were environmental, in the sense of not genetic, but that very, very few were environmental in the sense of exposure to ambient toxics.
To take the specific example on offer, which is breast cancer, one of the causes in the 90%-not-genetic set is a mother's failure to breastfeed or breastfeeding for inadequate lengths of time a baby that she has given birth to. A perfect example of an "environmental" cause having nothing to do with exposure to ambient toxics. It's very on-topic as to the subject of "activist mothers" as well -- any evidence that suggests that a mother refusing to breastfeed her baby could have any negative physical consequences for either child or mother tends to start up huge battles in the "mommy wars".
1.10.2008 12:40pm
hattio1:
Lots of people here are blaming judges for letting in science that hasn't been proven. The fact is that Daubert was intended (generally) to lessen the burden of proof that someone has to meet to introduce scientific evidence. The judges aren't at fault. If you believe the system is broken (a view I don't ascribe to) then the fault is with the Daubert standard, not judges.
1.10.2008 12:47pm
Thoughtful (mail):
Neurodoc seems to be speaking in an area in which he has some expertise. My medical speciality is in another area. However, it is my understanding that, post-Edwards, the # of C-sections has dramatically increased in this country (more expensive, more risky to patient), while there has been no change in the incidence of cerebral palsy. Is there an explanation for this consistent with Edwards' claim (as I understand it) that OBs were 'causing' cerebral palsy by not delivering the babies early enough (via C-section)?

On another issue, the claim that x% of the cause of disease A is "genetic" implies that (1-x)% is environmental itself implies that we have full knowledge of all causes of disease A, which is almost never true. The large majority of diseases are, at one level or another, "idiopathic" in etiology. Granted, if by definition anything not genetic is environmental in cause, the percentages will eventually be complementary when all causes are known. But in that case, per the breast cancer example, there is no more reason to think that 90% are "environmental" than to think that eventually we'll find more than 10% are genetic. (And this doesn't even broach the issue of whether most diseases are monocausal or multicausal in etiology.)
1.10.2008 12:53pm
Thoughtful (mail):
DB: Were you attempting a double entendre in your title choice?
1.10.2008 12:54pm
neurodoc:
rarango, I don't know about the editorial in JAMA, but Angell, for many years the editor of the NEJM, did rebut the bogus breast implant "science," e.g., the implants cause rheumatologic disorders, in a book she wrote on the subject. (I think the book may have been a compilation of shorter pieces published previously in different places.)

Did she really dispose of the issue at the level of the general public? I expect you can answer that question as well or better than I. I doubt she has been much more successful in doing so than others have been in debunking other bogus medical causation claims and charlatanry. The effort is commendable and very worthwhile, though, since it does educate those who are educable.

BTW, while the notion that cerebral palsy is never attributable to birth trauma is nonsense (though very much less often than trial lawyers might have it, and then not always avoidable), the notion that myriad illnesses are attributable to breast implants is nonsense, as Angell maintains. (A well-qualified neurologist in Houston who specialized in peripheral nerve disorders sold himself as a plaintiff's expert in breast implant cases, did nerve biopsies in the women sent to him by attorneys, and found they all had evidence of peripheral neuropathies?! The NYT had a front page story on him, noting that he was chauffered about in a Rolls Royce, and it wasn't paid for by non-lawyer-referred patients.) The trial attorneys can claim all the credit for the bogus breast implant science, since they paid for it. (Public Citizen made money selling for almost $1K breast implant litigation packages to lawyers pursuing these cases.)
1.10.2008 12:55pm
Harry Eagar (mail):
To the list of dubious health scares, add mold.

I'm pretty sure mold co-existed with us when I was young, but I don't recall any buildings being closed down for mold poisoning.
1.10.2008 12:57pm
Waldensian (mail):
As I see it, the critical thing for people to keep in mind about junk science and nutcase "victim" activists is that their activities are very, very costly.

The case for autism being caused by mercury in vaccines, or by the MMR vaccine, is dead as a matter of science. Dead as a doornail. But the hangover of that junk science (propagated by "victim" parents, their lawyers, and brain-dead journalists) is still with us: People don't want to vaccinate their kids. That's a pretty costly reaction to a non-problem.

And who knows how many research dollars have been needlessly poured on top of the factually bankrupt "vaccine" theories to date, simply because the theories' proponents are vocal "victims" who can get the ear of a Dan Burton or whomever.
1.10.2008 1:01pm
neurodoc:
K Parker, glad to hear you suffer the same peanut-farmer malady as I do (misery loves company), but if it/he only causes you "severe nausea," then you have a much milder case of it than I do.

alkali, you are quite right about reasons for under-reporting of this and other conditions. (Just heard on the radio about a dramatic rise in the number of West Nile Fever cases in our state, but it seems that that may be largely a reflection of better data collection.) Also, death is a pretty extreme endpoint, and there may be more meaningful (though perhaps not to those affected by a death) than the number who die as the result of peanut allergies (e.g., number who require emergency medical attention).
1.10.2008 1:05pm
Aultimer:

"if you can't get Bendectin, you take something that's been tested less"

Like what?

You take (off-label) anti-emetics like Zofran and Compazine.
1.10.2008 1:20pm
rarango (mail):
Neurodoc: Thanks! Much appreciated.
1.10.2008 1:37pm
David Chesler (mail) (www):
What previous time period are you using as a reference? AFAICT peanuts have been quite prevalent, at least in the US, for several generations now.

What you said. I was born in 1962. For as far back in my childhood as I can remember, "my" sandwich was PB&J while my brother's was cream cheese and jelly. That's relatively way before I started school. I had a great aunt who used to save the mutant peanuts with three, or sometimes four, beans inside and give them to me. Like the foreign stamps relatives used to give me when I was older I didn't know what to do with them, so I'd keep the peanut around for a while and then eat it. That's also before school.

And I'll stand in the "this is hysteria" camp. The school nurses are acting as if any exposure would be life-threatening to any kid with an identified peanut allergy. Something that bad should be killing more than 12 or even 200 people per year. Many people, myself included, don't look for the kernel of truth in hysteria. In my kids' school someone has a strawberry allergy, so all students are forbidden to use strawberry-flavored sports drinks in gym.

That's why we entered this in the pumpkin-decorating contest. I had the kids slowly spread the notion that we were trying to make the scariest pumpkin in the world. As is often the case, my victims (they hysterical administrators and parents) didn't know I was making fun of them.

A friend of mine is allergic to shellfish. I think he itches and his eyes tear and his tongue swells. It made the decision to start keeping kosher a little easier. But he's not a fanatic about it. He'll eat at the same table; he might ask a waiter, or ask someone else to take a bite of something to see if it's got treif in it.
1.10.2008 1:38pm
john w. (mail):
Apologies if somebody mentioned this already, but there is fairly impressive evidence that the rise in allergiy problems (including, one would assume, food allergies) within the last 50 to 60 years is correlated with an excessive compulsion about hygiene in young children -- i.e. the kids who don't get enough exposure to germs in infancy supposedly are more apt to have allergy problems later.

It seems logical to me that the same personality trait in mothers that causes them to be hyper about cleanliness would also cause them to become 'activists.'
1.10.2008 1:40pm
frankcross (mail):
Great irony in this thread. Legitimate criticism of the use of junk science in litigation. Then claims are made about the awful consequences of this litigation. But these aren't even backed by junk science, just assertions.

Just as claims of medical causation require more rigorous scientific evidence, claims about the societal consequences of litigation require more rigorous economic evidence. Except for ideologues.
1.10.2008 1:42pm
MDJD2B (mail):

However, it is my understanding that, post-Edwards, the # of C-sections has dramatically increased in this country (more expensive, more risky to patient), while there has been no change in the incidence of cerebral palsy. Is there an explanation for this consistent with Edwards' claim (as I understand it) that OBs were 'causing' cerebral palsy by not delivering the babies early enough (via C-section)?


First, Edwards did not cause this problem all by himself.
There were lots of plaintiffs lawyers suing OB's besides him.

Second, the increase in C-Sections is multifactorial:


People want to have fewer children, so the danger of many C/S is not of as much concern

They want perfect children. this combined with fetal monitoring (a procedure with great sensitivity byut low specificity-- i.e., lots of flase positives) causes doctors and their patients to opt for surgery if there is any doubt.

C/S has become a lot safer.

The dangers of forceps delivery are better appreciated.

It is better appreciated that as an immediate or delayed effect, vaginal delivery can result in decreased sexual satisfaction for a woman and her partner, in urinary incontinence, and in fetal incontinence. Long labors and difficult vaginal deliveries are therefore avoided.

The dangers of vaginal breech delivery have become manifest, and these are rarely performed.

Some women do not want to experience the discomfort and what they perceive to be the indignity of labor.


There are other reasons, but you get the point. There are good reasons and bad for the rise in cesarean section rates. They are increasisng in other countries as well. In the meantime, fetal mortality has plummeted. It can't be proven that C-sections play a major part in this, but I think it is probable.

And, on another subject, no sensible obstetrician would prescribe the components of Bendectin separately, given what happened to Merrill-Dow!
1.10.2008 1:53pm
Milhouse (www):
The article calls her "food’s Erin Brockovich". That's probably exactly right - she's a fraud, just like Brockovich.
1.10.2008 1:57pm
Aultimer:

And I'll stand in the "this is hysteria" camp. [] In my kids' school someone has a strawberry allergy, so all students are forbidden to use strawberry-flavored sports drinks in gym.

Your skepticism seems to stop short of the "dehydration" hysteria started by Evian and Weight Watchers.

Why on earth does a kid need a sports drink in gym class? Can't junior survive it with a stop by the germ-y waterfountain before and after class?
1.10.2008 1:59pm
neurodoc:
MDJD2B, thanks for that great summary of reasons to do c-sections. I don't think you answered Thoughtful's (what medical specialty?) question, though, about why no drop in the reported incidence of cerebral palsy with increased number of c-sections, if c-sections are a cause of cerebral palsy. Do you have an answer for him (and me and others)?

I believe Thoughtful is correct that the number of c-sections has gone up over time and there has not been a corresponding drop in the incidence of cerebral palys. My partially informed guess is that this, like so much else, has more than one explanation. My first stab at it would be: only a small fraction of cases of "cerebral palsy" (a broad term that actually encompasses a variety of static brain problems) are attributable to hypoxic-ischemic encephalopathies which might be prevented by c-sections, so hard to see an effect even with a substantial increase in number of c-sections performed, not all of them on account of fetal distress. (Some of a low signal to noise problem.)

MDJD2B, you would agree, would you not, that while there may not be nearly as many cases of cerebral palsy due to birth-related trauma as P attorneys claim (and not as few as Ob-Gyns would have it), birth-related trauma, in particular intrapartum asphyxia (too little blood and oxygen to the brain during delivery), is beyond dispute a cause of cerebral palsy. You would also agree, would you not, that just as there as some attorneys who do not do their profession proud, so too are there some physicians who do not do theirs proud either, and again it is only a question of the respective numbers or %s. :)

(BTW, MDJD2B, what comes from a medical education followed by a legal one? Anything good?) :):)
1.10.2008 2:25pm
David M. Nieporent (www):
Serious question - IANAEpidemiologist - why aren't there studies comparing the allergic impact of home-farmed (organically and from heirloom/Amish source) milk, peanuts and strawberries to the impact of mass-market stuff?

Wouldn't they address the "additives/GM" boogey-persons pretty directly?
Your problem isn't that you're not an epidemiologist; your problem is that you're not a kook. If you were, you'd know that "studies" don't do anything to convince these people. The studies are all biased or flawed in ways that only parents and trial lawyers can detect, or part of the conspiracy.
1.10.2008 2:34pm
Elliot123 (mail):
I have to applaud anyone who advocates for a healthy diet of fresh fruits, vegetables, and unprocessed foods. That's just common sense; any doctor will endorse it. But, it's a bit puzzling why some of these folks have an overwhelming need to be victims. We know good food has all kinds of benefits, and they can be demonstarted by science. But, these people prefer to make unfounded claims and pretend to be targets of global conspiracies.
1.10.2008 2:35pm
David M. Nieporent (www):
As long as we're talking about junk science conspiracy theories, let's not forget Gulf War Syndrome.
1.10.2008 2:35pm
neurodoc:
Oh, MDJD2B, I may have overlooked your response about fetal monitors as being both very sensitive and non-specific, meaning a low predictive value, as part of the answer to Thoughtful's question. (Again, I think that part of the "low signal to noise" problem in teasing it all out.)
1.10.2008 2:36pm
titus32:
Great irony in this thread. Legitimate criticism of the use of junk science in litigation. Then claims are made about the awful consequences of this litigation. But these aren't even backed by junk science, just assertions.

This is wrong. A commenter noted the empirical evidence of the harm caused by the withheld drug from a comparison of Canada and the U.S. Anyway, perverse incentives created by failures in the tort system are indicative of bad consequences, even without empirical evidence--this could be called "economics" (of course empirical evidence makes a much stronger case).
1.10.2008 2:36pm
rarango (mail):
Frank Cross: I would assert the threat of litigation in this case (as well as the case of breast implants--both junk science) has two demonstrable effects: Driving Dow Chemical into bankruptcy thereby inflicting some harm to stock holders; putting some amount of Dow employees out of work; and resulted in taking a beneficial drug off the market that increased the discomfort, pain and suffering for those pregnant mothers possibly benefitting from the drug. I suppose it is possible to put some sort of dollar value on those things. Would such a cost-benefit model satisfy your requirement for proof?
1.10.2008 2:38pm
Elliot123 (mail):
And vaccines? Do people who have been vaccinated against smallpox and polio get smallpox and polio? How about in the same populations prior to vaccines? How does the number of cases compare?

Is this a conspiracy? If so, perhaps we can persuade the conspirators to target some other maladies. Are the people working on an AIDS vaccine conspirators, too?

I have avoided both polio and smallpox all my life. That's a great benefit compared to the risk prior to vaccines. I hope the drug companies made a fortune from those vaccines so they will be encouraged to keep up the good work. To date, I haven't seen many cures coming from the tort lawyers.
1.10.2008 2:47pm
neurodoc:
As long as we're talking about junk science conspiracy theories, let's not forget Gulf War Syndrome.
Largely BS, no doubt; entirely BS, I don't know.

Reputable people do believe that we are seeing a higher incidence of amyotrophic lateral sclerosis (ALS, or Lou Gehrig's disease) in PGWI veterans, for whatever reason.

[David M. Nieporent, care to see anything about the libertarian position on the role of government, e.g., FDA, in these things as a sponsor of research, regulator, etc.? And do you think the libertarian candidate leans in the direction of dubious science and policy on matters like vaccines, genetically modified foods, and dietary supplements? BTW, do you know if he gives credence to global warming as a theory? What should we make of the "creationism" business, cause for concern about fitness for office?]
1.10.2008 2:48pm
alkali (mail):
Anyway, perverse incentives created by failures in the tort system are indicative of bad consequences, even without empirical evidence--this could be called "economics" (of course empirical evidence makes a much stronger case).

Making predictions based on incentive structures and testing the predictions against empirical evidence is called "economics." Making predictions based on incentive structures and insisting your predictions must be right is something else.
1.10.2008 2:48pm
Tony Tutins (mail):

I'm pretty sure mold co-existed with us when I was young, but I don't recall any buildings being closed down for mold poisoning.

I'm going to blame energy conservation for this, too. Just as replacing incandescent bulbs with fragile compact fluorescents is sure to put more toxic mercury in your living environment, so has the hermetic sealing of the home promoted mold growth by decreasing or even eliminating ventilation. The standard used to be a certain amount of air change per hour, but I don't think anyone pays attention to that any more.
1.10.2008 2:55pm
pete (mail) (www):
But i think we all agree on the harm caused by dihydrogen monoxide (or Hydric acid) which multinational corporations, the federal government, and the AMA force on us despite the fact that it has been linked to literally millions of deaths, is a major component of acid rain, and is often found in tumors.

Won't somebody please think of the children?
1.10.2008 2:59pm
MDJD2B (mail):

I don't think you answered Thoughtful's (what medical specialty?) question, though, about why no drop in the reported incidence of cerebral palsy with increased number of c-sections, if c-sections are a cause of cerebral palsy. Do you have an answer for him (and me and others)?


Neurodoc,

There is a joint statement issued by the professional OB/GYN and Pediatric associations suggisting that birth injury results in 5-8% of cerebral palsy. The figure you gave was 12-25%.

So the obvious answer is that if the vast majority of CP is not caused by birth injury, then reduction of birth injury will not reduce the incidence of CP.

Erb's palsy is undoubtedly caused by traumatic delivery, and costs a lot in malpractice settlements. I don't know what changes there have been in the incidence of Erb's.
1.10.2008 3:00pm
Alan Gunn (mail):
frankcross said,


Great irony in this thread. Legitimate criticism of the use of junk science in litigation. Then claims are made about the awful consequences of this litigation. But these aren't even backed by junk science, just assertions.

Just as claims of medical causation require more rigorous scientific evidence, claims about the societal consequences of litigation require more rigorous economic evidence. Except for ideologues.

What particular claims do you doubt? That a C-section is generally riskier to the mother's health than a vaginal delivery? That Bendectin has been studied extensively and found safe? That not getting kids vaccinated increases the incidence of the diseases that the vaccines prevent? Or are you demanding citations to medical journals as a sort of all-purpose response to claims that litigation can cause harm?

Those who doubt that markets can provide safety ought to look at their cars some time. Things like anti-lock brakes, intermittent wipers, general improvements in reliability of mechanical components, even seat belts and air-bags are all good things provided by markets. Where is an example of the product-liability system leading to a major safety improvement? Markets are, essentially, mechanisms for getting people what they want. And one of the things that people want is (some level of) safety. So we should brush that aside in favor of juries as a decision-making mechanism? I wouldn't dream of letting a jury decide anything that affected me personally, given the choice. Would you?
1.10.2008 3:09pm
frankcross (mail):
Actually, there's a good example in medical malpractice. Lawsuits over anesthesia practices forced a change that significantly reduced death rates. Markets are good for safety. So may be litigation.

But your own C-section claim is instructive. I want to see empirical evidence that lawsuits changed C-section rates. MDJD2B showed that this might not be the case. As is your argument that litigation "can cause harm." True, also many products "can cause harm." The issue is overall net effects.

I'm sure there are some negative examples from litigation. And there are negative consequences from some drugs and consumer products. But if you want statistical evidence of a net harm from Bendectin, you should want statistical evidence of a net harm from litigation. Not anecdotal examples
1.10.2008 3:33pm
David Chesler (mail) (www):
Aultimer: I don't drink because I'm dehydrated, I drink because I'm thirsty. It's probably the same for the kids, or their classmates who actually have sports drinks with them.
Lousy germ-exposing parent that I am, my kids prefer drinks to water.
I see your point, if it's that one doesn't have to "hydrate" after 30 minutes of kickball; my point was they're overdoing the fear of anything strawberry.

As for germ exposure, there is a used-to-be-common that you have to eat a peck (or pound) of dirt during your lifetime. My mother says I got it out of the way early. I guess my kids are well on the way to completing their quota too. (Anybody know the expression, or what it means?)

I grew up downwind of the refineries where Meadowlands Stadium is now. Some seasonal allergy got me sent to an allergist, who used allergen therapy, which stuffed up my nose from the time I was 4 until I was about 8, so I speak very nasally (OTOH if I hold my nose food tastes the same) but I don't think it did any good. We moved to cleaner air, I stoped getting the shots, and I grew up and I became less congested. I just had a battery of skin-prick allergy tests, and I'm not allergic to most of the allergens they told me I was allergic to then. (Field testing tells me I am allergic to larder beetles, with whom we compete for the dirt, and I react to Virginia Creeper the way most people react to Poison Ivy.) They still won't test me for penicillin allergy. I licked some baby penicillin-like medicine once and nothing happened.
1.10.2008 3:42pm
rarango (mail):
Frank Cross: I understand your point, and its a valid one; but it is much easier from an epidemiological standpoint to demonstrate net harm from those that have used Benedectin and those that havent. You are basically dealing with a single variable.

The net harm from litigation (at least in the Benedectin and breast implant cases) is much more diffuse and much less easy to quantify. I am not aware of any multivariate techniques except possibly covariate structural modelling that could handle it easily.

And if one does a cost-benefit analysis, it would be necessary--as your anathesia example shows--to consider positive outcomes from litigation. Such a cost-benefit analysis would be, IMO, impossible.
1.10.2008 3:51pm
Dan Weber (www):
Like the foreign stamps relatives used to give me when I was older I didn't know what to do with them, so I'd keep the peanut around for a while and then eat it.
I finally found a fellow stamp-eater!

Philatelists beware! We are loud and we are proud!
1.10.2008 3:51pm
john w. (mail):
Those who doubt that markets can provide safety ought to look at their cars some time. Things like anti-lock brakes, intermittent wipers, general improvements in reliability of mechanical components, even seat belts and air-bags are all good things provided by markets.

Huh??? I'm not sure about anti-lock brakes or intermittant wipers, but seatbelts and airbags were forced down our throats by the Government, weren't they? I don't see where the 'market' had much of a choice.
1.10.2008 4:01pm
David Chesler (mail) (www):
i in ur albumz likkin ur filatileez

Dammit, Dan Weber, I rewrote that 3 times to eliminate ambiguities. Oh well.
1.10.2008 4:18pm
Milhouse (www):
The root of all this is a conviction that before "society got all complex" and they started putting things in our food that we couldn't pronounce, there was no cancer, allergies, asthma, autism, whatever. Therefore these ailments are obviously caused by what's changed, and if we return to the ways of our ancestors then we'll be spared them. Given the premise, the conclusion makes sense. Of course if you can't pronounce "riboflavin" and therefore refuse to eat any, you'll come down with all sorts of ailments, and probably won't live to get cancer.

There's also the "precautionary principle" that all these "chemicals" can't possibly be good for you. By eating them you're putting yourself at risk: either the corporations are right that they're harmless, in which case you break even, or they're wrong and you lose. So why take the chance? Why not eliminate all these things from your diet, and you'll be sure to be safe. But why assume that new ingredients can only be either harmless or harmful? Aren't they just as likely to be beneficial? How do you know that Purple #347 doesn't help prevent cancer? Perhaps childhood ingestion of offogthiotimolinbrilligum sulfide gives your future children protection against autism! Why is that less likely than that they cause some terrible disease?

Ultimately I think the cause is the theological idea that man is evil, and therefore so are his works, and therefore anything artificial is likely to be worse and more harmful than anything natural. Mother Nature tries to guide us and protect us, but we in our blindness reject her gifts and make problems for ourselves and for all her other children. Hence climate change must be man-made, and man-made climate change must be for the worse. Hence any species that becomes extinct must have done so through man's agency, and it must have been uniquely valuable and have carried the secret of a miraculous panacea that will now be forever lost to us, when ISTM it's just as likely to have carried some deadly poison or disease and we're better off without it.
1.10.2008 4:19pm
Kazinski:
The use of florescent bulbs reduces the amount of mercury released in the environment. Coal fired power plants are the largest source of mercury in the environment so:

Each bulb contains an average of 5 milligrams of mercury...
Approximately 0.0234 mg of mercury—plus carbon dioxide, sulfur dioxide and nitrogen oxide—releases into the air per 1 kwh of electricity that a coal-fired power plant generates. Over the 7500-hour average range of one CFL, then, a plant will emit 13.16 mg of mercury to sustain a 75-watt incandescent bulb but only 3.51 mg of mercury to sustain a 20-watt CFL (the lightning equivalent of a 75-watt traditional bulb). Even if the mercury contained in a CFL was directly released into the atmosphere, an incandescent would still contribute 4.65 more milligrams of mercury into the environment over its lifetime.


Only half the electricity in the country is from coal fired plants, but since most florescent bulbs end up entombed intact in landfills, it is likely that it understates the benefits of flourescents in reducing mercury polution.
1.10.2008 4:23pm
frankcross (mail):
rarango, it's very difficult. You would also have to consider what cannot be measured. An economist would say that the biggest effect of litigation is deterrence. A system that operated well would prevent hazardous risks from ever coming on the market. Of course, a bad system would deter good products. You might capture some of this from from international comparisons, though.

The US does have more product liability litigation than comparable nations, much more than some. You could do a comparative examination of the drugs and devices that litigation has stopped in the US but that continue to be sold in foreign nations.
1.10.2008 4:29pm
Alan Gunn (mail):
john w. wrote:

Huh??? I'm not sure about anti-lock brakes or intermittant wipers, but seatbelts and airbags were forced down our throats by the Government, weren't they? I don't see where the 'market' had much of a choice.

Well, Europe and Japan, both of which lack our product-liability system, had airbags long before we did; it has been claimed that fear of litigation (not unfounded) led to the delays here. I do not know whether these claims are true, but they are plausible--the best way to protect yourself against product-liability claims is to keep on doing what you and everyone else has been doing. Did the government invent either seatbelts or airbags? I bought a car with seatbelts (as an option) in 1963. For the most part, government auto regulation has pretty much concentrated on recalls, sometimes for "defects" that are less dangerous than the dangers of the added driving by people going to the dealer to comply with the recall. This is likely a good thing, as regulation has a tendency to freeze the status quo. You don't often see regulators insisting that new and better gadgets be developed.

On recalls and regulation, Mashaw's "The Search for Auto Safety" (by an author sympathetic to regulation) is a good source.
1.10.2008 4:32pm
Milhouse (www):
AIUI Edwards made his fortune by convincing juries that CP doesn't "just happen", it must have a cause, and medical negligence is the cause, and therefore that if a baby has CP it must be the doctor's fault. I'm not sure whether he went so far as to claim this even if there were no signs indicating a C/S might be advisable; that would be really outrageous. But it's also outrageous to suggest that just because there were signs, which the doctor ignored, therefore that must be the cause of the baby's CP, or even that it's likely to be the cause.
1.10.2008 4:34pm
happylee:
The post is a good example of "good" Bernstein, weighing the evidence while carefully reviewing the history of an event that exemplifies the problem. Nice. (Now all the good professor has to do is come around to the evils of flouridation, the HIV myth and usefulness of homeopathy.)

The comment by Milhouse closes the loop:


Ultimately I think the cause is the theological idea that man is evil, and therefore so are his works, and therefore anything artificial is likely to be worse and more harmful than anything natural.
1.10.2008 4:48pm
hattio1:

Where is an example of the product-liability system leading to a major safety improvement?

Ford Pinto anyone? I'm sure I can think of other examples, but that's the first one that pops to mind.
1.10.2008 5:07pm
bob (www):

Oh, and FWIW, the rate of hospitalizations for NVP (severe morning sickness) rose dramatically in the U.S. and Canada when Bendectin was taken off the market in both countries, then fell in Canada but not in the U.S. when Bendectin came back on the market in Canada but not the U.S. So the Unisom/B6 combo doesn't seem to be doing it.

It is quite likely that without a major pharmaceutical company pushing marketing the product, fewer women are taking it. That doesn't mean that the substitute doesn't work. It doesn't even necessarily mean that the wrong amount are taking it: In order for every woman who should take it to do so, a great many women who shouldn't take it would have to. Unisom (one of the components of Bendictin) is sold as a sleep aid. It causes drowsiness. Not everyone would or should go through their day sleepwalking to avoid morning sickness.

Whether or not the current delivery system for this drug combination are as efficient as they could be (is there any evidence that doctors fail to suggest this combination due to liability fear rather than normal conservative treatment practice?), I have a hard time seeing how the current situation justifies the characterization in your post that:

Bendectin, the only drug proved safe and effective in combating nausea and vomiting in pregnancy, remains unavailable in the U.S.

B6, by itself, has been proven safe and effective for treating morning sickness. Doxylamine has been proven safe and effective. The combination (whether in the single pill form of Bendectin or not) has been proven safe and effective. The substitution of other antihistamines appears safe and effective, though those combinations have not been subjected to the same scrutiny (see http://www.guideline.gov/guidelines/FTNGC-2454.html). Those seem like available alternatives to me.
1.10.2008 5:10pm
frankcross (mail):
Wikipedia is an uncertain source, but it reports:

In Europe, airbags were almost unheard of on family cars until the early 1990s.

Any evidence that they were adopted earlier in Europe?
1.10.2008 5:15pm
Alan Gunn (mail):
hattio1 said:

Where is an example of the product-liability system leading to a major safety improvement?


Ford Pinto anyone? I'm sure I can think of other examples, but that's the first one that pops to mind.

Actually, the Pinto was about average in safety for compact cars, on the basis of death rates per mile. (The AMC car was the worst.) The Pinto just happened to be the car that attracted well-publicized litigation. The car that will never catch fire when rear-ended at high speed has yet to be developed. The Pinto probably was more dangerous than other compacts when rear ended, but it was safer when hit from the side. And more cars are hit hard from the side than from behind.

The actual holding of the Pinto case on punitive damages was that Ford could be liable for punitive damages because it had once done a cost-benefit analysis. The analysis Ford did had nothing to do with the supposed defect that killed the victim in that case. And California law at the time told juries to do cost-benefit analyses in deciding whether a product was defective. Can this combination of rules--cost benefit is the test for defectiveness and a manufacturer who does one must pay punitive damages--be anything but crazy? So the Pinto case is a pretty poor poster child for products liability law.
1.10.2008 5:55pm
Alan Gunn (mail):
The Wikipedia article Frank Cross cites points out that Mercedes, which had had an airbag on a 1971 model, re-introduced it in 1980; Porsche followed soon after. It's true that Ford and GM sold a handful of cars with airbags in the US in the 1970s, but they didn't sell well and some people seem to have been killed by them, so they were dropped. I believe the Mercedes was the only car sold in the US in the mid-1980s with an airbag, but this is from memory, so I could be wrong.

This may not be all that relevant, as it remains controversial whether airbags save lives (though recent research does seem to show that seatbelts do). The problem is compensating behavior--cars with airbags are more likely to be involved in accidents than cars without them. Steven Landsburg (I think) once advocated putting a sharp dagger pointed at the driver's chest on steering wheels to encourage safe driving.
1.10.2008 6:08pm
happylee:
As to the Pinto, it was a very good car. I remember my pops buying one to tool around in. For a Detroitmobile it was almost euro in its handling, design and mileage.
1.10.2008 6:34pm
Thoughtful (mail):
I'm amazed that with all the doctors posting on this thread and all the discussion of allergies being more common now than a generation ago, no one has brought up Latex gloves. A generation ago, allergies to latex were rare. Now they are so common (I suffer from it myself) that many hospitals don't even give one a choice anymore, but have everyone wear non-latex protective gloves.

Alan Gunn: Landsburg didn't actually RECOMMEND the dagger on the steering column, he pointed out that a common consequence of making cares safer, often ignored by regulators but well known to both car makers and economists, is that as cars become safer, people drive less safely (faster, paying less attention, etc.), with the net result often being that improvements in car safety devices do not correlate all that well with a decrease in lives lost to driving accidents. Landsburg said that while this effect is immediately understood by economists, it is often dismissed by non-economists. As a THOUGHT experiment, he said, "What would be the effect of putting a dagger on the steering column?" If you respond, "I'd drive more slowly and avoid bumps" Landsburg has made his point. Because "marginally decreasing car safety makes your driving marginally more safe" is logically equivalent to saying "marginally increasing car safety makes your driving marginally less safe."
1.10.2008 6:39pm
Samantha (mail) (www):
Full disclosure: I'm a woman of childbearing age who has had increasingly unpleasant episodes of morning sickness.

I've seen a few comments here to the effect that women weren't really harmed by the demise of Bendectin. I was born in 1976. I was all of 7 years old when this product was taken off the market. Until about an hour ago I had no idea that something like Bendectin had ever existed or that a simple combination of B6 and doxylamine had been proven effective in treating morning sickness. In my experience the most advice a pregnant woman can expect from anyone these days on how to deal with morning sickness is to eat something before you get out or bed. Just between you and me that's not all that effective.

If anyone chose to look you would find at least a generation of women who suffered from this litigation because we were either small children or not even born yet when this all went down and had no way of learning that B6 and doxylamine would help relieve morning sickness. Who was going to tell us about it after the product had been taken off the market because of the litigation?
1.10.2008 8:03pm
Larry Fafarman (mail) (www):
Judges and juries should have the option of declaring scientific controversies to be "non-justiciable." In Vieth v. Jubelirer, 541 U.S. 267 (2004), the Supreme Court said,

Among the tests for determining the existence of a “nonjusticiable” or “political” question is a lack of judicially discoverable and manageable standards for resolving the question. Baker v. Carr, 369 U.S. 186, 217.

In Massachusetts et al. v. EPA, the courts appeared to treat the global warming controversy as non-justiciable. The arguments for non-justiciability are especially strong in "monkey trials" over the controversy of teaching evolution theory and the alternatives.

My blog has two articles on the justiciability of scientific controversies -- here and here.

As for thimerosal in vaccines, it is an antiseptic that can be eliminated if the vaccine is put in single-use containers instead of multi-use containers.
1.10.2008 8:20pm
Cousin Dave (mail):
nerodoc: I have to take issue with one statement, the one about mercury in our environment increasing. Where do people think mercury comes from, outer space? The amount of mercury in our environment is the same as it always has been. It is taken from the earth, and it eventually goes back to the earth. Of course, the real question is in what form it is returned, and what form it takes afterwards. Anyone of my age has handled pure mercury in their bare hands with no ill effects, because metallic mercury is almost impossible to absorb into the body. People who freak out about the mercury bubbles in their thermostats need to get a grip.

It's certain mercury salts and oxides that are toxic. (Also mercury vapor, but almost no one is exposed to any significant amount of mercury in its vapor state these days.) Does mercury deposited in a landfill react with the environment to form salts? Some of it probably does, and that is an area of concern. However, it does need to be balanced against the fact that some of the mercury came out of the earth in the form of salts in the first place, when it was mined. The question is whether the salts being formed in the landfill, or anywhere else in the environment where the mercury is deposited, are more toxic that the salts that were originally mined. Off hand, that's a question I don't know the answer to, and I don't know if that has been studied. (Probably somebody somewhere is thinking about it, but a quick Google search didn't turn up anything obvious.)
1.10.2008 8:53pm
SenatorX (mail):
I would be curious if any of you have read the Simpsonwood CDC conference report?

Some apparent excerpts from the meeting. You can find the whole pdf out there but you have to hunt for it an