Here is something that drives me nuts: watching the media and courts trash
companies for selling a “dangerous” product when there is no scientific evidence
to back up their allegations. I
suppose the most egregious example is the decimation of Dow Corning due to the silicone
breast implant debacle that began in the mid 1980’s and lasted through the
1990’s. Now we have the “pink
slime” fiasco, which is ongoing.
You may recall that in 1984 Dow Corning lost a suit on the
basis that silicone breast implants caused immunological problems for the
recipient. The initial $1.7 million
award of damages was just the beginning—lawsuits poured in and money poured out. In December of 1990, the “Face to Face”
TV show hosted by Connie Chung aired a special on “the dangers of silicone
breast implants.” In 1991 Ralph
Nader’s Public Citizen Health Research Group sent out warnings that silicone
breast implants caused cancer.
By December 1991, 137 individual lawsuits had been filed against Dow
Corning. By December 1993, the
number was 12,359 . By December
1994, it was 19,092.
So in May 1995, a beleaguered Dow Corning filed for bankruptcy
protection, and in November 1998 it applied for bankruptcy reorganization, which
included $3.2 billion in previously agreed-to settlements. The bankruptcy was settled in 1999, but
it took several more years for the litigation over the settlement to wind down. Dow finally managed to extricate itself
from the bankruptcy courts in 2004.
What makes this story so outrageous is that the scientific
community knew by 1991 that there was no scientific basis for the claims. And throughout the remainder of the 1990’s,
report after report showed no relationship between silicone implants and systemic
disease. Too bad for Dow, though.
The damage to the company had already been done. “Sorry guys! We just wrecked your company. Oops! Oh, and by the way, you don’t get your money back.”
But amazingly, Dow Corning survived, and it continues today
as a multinational corporation that provides over 7,000 products and services,
most of which are based on silicon:
semi-conductors, solar panels, cookware, sound absorbents, etc., etc.
But it seems that Dow Corning will never be put out of its
misery completely insofar as breast implants are concerned: a court in Korea
just ruled against Dow in a class action suit that is apparently based on
implants that have burst. Of
course, these claims are different in that they don’t seem to involve
allegations that the implants cause disease. I don’t know
what the company’s position is regarding the stability of the implants they
sell, but this seems like an aesthetic issue rather than a health issue to me.
And I just have to hit one of my own hot-buttons: science
illiteracy in a nation absolutely dependent on high technology and related
industries. Scary. But since I’ve already talked about
pseudo-science in my blog about the alleged link between vaccines and autism, I’ll
leave it there.
But there is a more recent public “scandal” that has resulted
in another company’s near-bankruptcy: pink slime.
Here is the deal: meat processors
routinely remove fatty areas from beef carcasses, and these trimmings often
include some residual meat. Basically, you can do three things with these
trimmings: throw them out, feed
them to animals, or feed them to humans.
The slaughter business, like all industries associated with feed and
food production, has become incredibly competitive—with very low profit
margins. And when you are
slaughtering thousands of animals, an improvement to the process can make the
difference between having a profitable or an unprofitable day, even if that improvement
only amounts to an increased profit of pennies per carcass.
Now, I don’t know how many of you have actually butchered an
animal—maybe you think meat comes from the supermarket, where it was
spontaneously produced on the spot.
But, having done it myself many many times, and having visited
slaughterhouses, I can tell you that it is a gross, messy, nasty, unappetizing,
and rather sad business. I
mean, no normal person could possibly believe that seeing beautiful animals
converted into hunks of meat is a pretty sight.
And no matter who does the butchering, the process is rife with
possibilities for contamination. In
particular, E. coli contamination from excrement. That’s right—if you’ve ever seen a cow, then you know it is
smeared with feces. And when you
butcher that animal, it is inevitable that some of the E. coli in the feces will come in contact with the resulting
meat. Think about it—when a knife
goes in to start a slit in the hide, bacteria may be dragged in along with the
blade. It is just unavoidable. And there are some strains of E. coli that are particularly nasty and
potentially lethal to humans—the bad actor being the famous strain called
0157:H7. Most of the news articles
reporting contaminated beef products, as well as vegetables and fruits, involve
this one bug.
So the world has expended a lot of resources in trying to
kill E. coli 0157:H7. The process we are concerned
with, which has been around since 1990, consists of taking meat trimmings,
warming them up to between 107F to 109F, and spinning them in a centrifuge,
which separates the fat from the meat. This meat is flash frozen at 15F for 90 seconds and then
exposed to extreme pressure that forms it into blocks or tubes. Apparently the combination of low
temperature and high pressure ruptures cell walls, thus killing the bacteria.
By the mid 1990’s, the public was becoming increasingly concerned
about E. coli, and so American
inventor Eldon Roth, founder of a company called Beef Products Incorporated
(BPI), started experimenting. To
date he has at least 68 patents that cover various ways of sterilizing
meat. The patents that are
critical to this story seem to have issued in 2002, claiming a sterilization method
that involves the injection of gaseous ammonia (NH3) into meat. Upon contact with water in the
meat, NH3 forms ammonium hydroxide, a very “basic” compound (the
opposite of acidic) that kills the bacteria. The USDA’s Food Safety and Inspection Service approved
this disinfection procedure in 2001.
The final product is apparently 94% to 97% meat. Its formal name is “lean finely
textured beef,” or LFTB. I should
also point out that LFTB is also produced with citric acid as a replacement for
ammonia gas (sold by Cargill). Tyson
Foods also sells LFTB, apparently buying it from other producers.
In early March 2012, LFTB was found in 70% of the ground
beef sold in the U.S. According
to USDA restrictions, ground beef that is more than 15% LFTB must be labeled as
containing LFTB, but if it contains less than 15%, you can’t tell just by
looking at the package that there is any at all. LFTB cannot be
sold directly to consumers—it is mixed in with ground beef at, for example,
grocery stores.
In 2007 there was such high confidence in LFTB disinfected with
ammonia gas that the USDA exempted it from routine testing.
So, up until December 30, 2009, the public knew nothing
about LFTB and had happily consumed millions of pounds of the stuff. Then the New York Times published an
article* that disparaged Eldon Roth (he wasn’t a “scientist”) and questioned the
safety of the product. It reported that some of the LFTB produced
by Beef Products Inc. had higher levels of bacterial contamination than the
USDA allowed and mentioned that people had objected to the smell of ammonia in LFTB,
apparently before it was mixed with ground beef. The article also stated that two 27,000-pound batches of
LFTB had been recalled: “The meat
was caught
before reaching lunch-rooms [sic] trays.” Snatched from the mouths of babes!
Oops. Then on January 12,
2010, the New York Times published a correction stating that the two “recalled”
batches mentioned above had actually been discovered by Beef Products Inc.
before being shipped. The NY Times also admitted that “[n]o meat
produced by Beef Products Inc. has been linked to any illnesses or outbreaks.” I bet the editors were sorry about having
to make that confession. No story
there.
The 2009 article also mentioned that LFTB was also known as
“pink slime,” a name apparently coined in 2002 by an employee within the
USDA. Although “pink slime” was
used as a pejorative, it really didn’t catch on with the public until March
2012, when ABC News used the term to hype a series of stories about LFTB.
What exactly the public’s concern was/is with LFTB, I can’t
really fathom. LFTB is 97% beef—so
what’s the beef? It’s ALL
beef! Was it because people actually
had to think about what can go into hamburger (“trimmings”)? Did they really believe that hamburger
was just ground-up sirloin? Was it
concern about the safety of the ammonia gas used to sterilize the final
product? (There was some
ridiculous media coverage involving a cook pouring a bottle of ammonia cleaner
onto “trimmings” and then putting the whole mess into a washing machine to make
“pink slime.” As if ammonia is
something unusual—it is a natural product in our bodies, a part of every
protein molecule.) Was it because the
labels on their meat failed to state that two different forms of hamburger had
been mixed together? Was it
because of LFTB’s industrial production? (What’s wrong with that—how do they think it ought to be
produced?)
Although the media tried very hard to make the case that
LFTB was “contaminated,” that never really stuck, except in the minds of some
particularly squeamish consumers.
The ammonia process works.
It is clean. It is harmless
to humans. It remains USDA
approved to this day.
In addition, ammonium hydroxide is used as a direct food
ingredient in almost every processed food you buy in the grocery store—baked
goods, cheeses, chocolates, and pastries.
Ammonia in other formulations—ammonium sulfate, ammonium alginate—is
used in condiments, relishes, soy protein, snack foods, jams, jellies, and
beverages. There are hundreds of
food products listed by the World Health Organization that use ammonium
hydroxide, including dairy products, fruits, vegetables, cereals, eggs, fish,
and BEER (and how many times have you seen a beer-drinker take a good long swig
and say, “Gross, this smells like ammonia”?)
In any event, all of the negative publicity resulted in BPI
closing down three of its four plants. Safeway, SUPERVALU, and Food Lion stopped selling LFTB
hamburger. McDonald’s, Burger
King, and Taco Bell announced they would discontinue using BPI’s LFTB in their
products. Wendy’s reported they
never used LFTB in the first place.
Five Guys stated that they don’t use “ammoniated procedures.” (I guess they don’t sell products made
by animals, since all animals use “ammoniated procedures.”) Further, various
school systems announced they would stop serving LFTB hamburger. I guess outlawing beef is next.
And so it went through 2012, one absurd news report after
another, and a public apparently unable to comprehend where their food comes
from.
Anyway, BPI may just have the last word. On September 13, 2012, BPI filed a $1.2
billion lawsuit against ABC News and three reporters—Diane Sawyer, Jim Avila,
and David Kerley. BPI claimed damages
as a result of ABC’s reports on “pink slime.” This will be an interesting case to watch.
In looking at the Dow Corning case as well as the BPI case,
it seems to me what they have in common is a sometimes-ignorant press featuring
sensationalized stories, an impressionable public, and a generalized antipathy
towards industry.
This combination, which is so lethal to industry, may slowly
be rectified by the development of laws that offer some protection from
scientific fraud.
A good place to begin is with “expert” witnesses. Clearly Dow suffered from expert
witnesses testifying that in their “expert” opinion, silicon implants caused
health problems. The problem is that
not all experts are expert.
In recognition of this problem, the Supreme Court developed guidelines, called the
“Daubert standard,” for the admissibility of expert witness testimony in federal
courts. This allows judges to keep
out evidence that they deem unqualified.
The Daubert standard was articulated by the Supreme Court as a result of
three cases heard by the Court the 1990’s, and by the year 2000, it was
codified in the Federal Rules of Evidence. After some tinkering with the wording, Rule 702 (Testimony
of Experts) now reads as follows
A witness who is qualified as an expert by
knowledge, skill, experience, training, or education may testify in the form of
an opinion or otherwise if:
(a) The
expert’s scientific, technical, or other specialized knowledge will help the
trier of fact to understand the evidence or to determine a fact in issue;
(b) The
testimony is based on sufficient facts or data;
(c) The
testimony is the product of reliable principles and methods; and
(d) The
expert has reliably applied the principles and methods to the facts of the
case.
Isn’t it amazing that it took until the year 2000 for these rules to
be adopted? I mean, they just
represent good scientific procedure.
But even at that, the Daubert standard is followed only in the federal
courts and in something over half of the state courts. Florida has passed a bill adopting the
Daubert standard that is awaiting signature by the Governor. Canada has used the Daubert standard in
at least two cases, and in the United Kingdom a recommendation has been made to
formulate a test that “builds” on the Daubert standard.
In all fairness, the courts were not entirely without guidance with
regard to the admissibility of expert testimony prior to Daubert. The standard previously in use was
called the Frye test, and the critical difference between the two was that Frye
permitted only testimony that was “generally accepted by experts.” That was okay, but it did not allow for
new scientific findings that had not yet been widely accepted. So Daubert substitutes a “reliability”
test based on scientific principles and methods for the Frye “general
acceptance” test. This means that,
under Daubert, if expert testimony is deemed reliable, the judge can allow it
to come in, even if it is so new that it is not yet generally accepted by the
majority of experts in the field.
The Daubert standard is often criticized for requiring that judges be
scientifically literate. I don’t
know why this is a problem—I expect that judges SHOULD be more scientifically literate
than jury members. They are judges,
after all. Another criticism is
that Daubert may set an evidentiary standard that is too high for many
plaintiffs to reach—well, duh, that is the general idea, to get rid of spurious
“evidence.” As an indication that
the new standard is working, a 2002 RAND study found that the percentage of
proposed scientific testimony that was excluded by the courts actually ROSE
after Daubert. I presume that is
because junk science got rejected.
That can’t be a bad thing.
I don’t know whether the Daubert standard will get used in BPI’s
suit against ABC, as that case seems to primarily revolve around the issue of
libel. That is, I don’t know whether
experts will testify in that case as to the safety of ammoniated LFTB since that
does not seem to be the primary issue.
But ABC may call experts to prove that what it said about LFTB was true,
and BPI may call experts to prove that it wasn’t. And in that case, the Daubert standard will apply.
In any event, if the Daubert standard had been part of the Federal
Rules of Evidence a little earlier, Dow Corning might still be happily making silicone
breast implants since much of the so-called “expert” testimony introduced by
the plaintiffs in those cases would almost certainly have been thrown out.
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