Junk Science: Schumer Chucks the FDA?

Who needs the Food and Drug Administration?

New York Democratic Sen. Chuck Schumer and personal injury lawyers certainly
don’t — at least to the extent that the agency gets in the way of their
political grandstanding and a multimillion-dollar payday, respectively.

This column recently reported
on the sad tale of the chemical bisphenol A — that is, how junk
science-fueled anti-chemical activists successfully rigged the scientific review
process at the federal National Toxicology Program to cast doubt on the safety
of BPA, which led to decisions by Wal-Mart and others to stop selling plastic
baby bottles made with the chemical.

The saga has continued since that April 24 column. On April 27, the
Washington Post reported in an ominous front-page, above-the-fold article that
Congress is getting involved in the BPA controversy because, "Despite more than
100 published studies by government scientists and university laboratories that
have raised health concerns about a chemical compound that is central to the
multibillion-dollar plastics industry, the Food and Drug Administration has
deemed it safe largely because of two studies, both funded by an industry trade

While this 100-to-2 seems like daunting weight-of-the-evidence against BPA,
the fact is that the two industry studies were carefully conducted according to
FDA-dictated protocols and oversight.

In contrast, the alleged "100 published studies" supposedly raising concerns
about BPA are of such dubious scientific validity that the National Toxicology
Program had to all but eliminate traditional standards of science to shoehorn them in
as any kind of evidence against BPA’s long track record of safety.

Even with the threshold-of-credibility meter set to zero, the "100 published
studies" have no detectable pulse. Nevertheless, Post reporter Lyndsey Layton
glossed over these inconveniences, seemingly in a hurry to quote one David
Michaels, credited as a "federal regulator in the Clinton administration."

Michaels likened BPA makers to the tobacco industry because, he claimed, when
businesses raise questions about the science underlying regulatory action it is
merely a tactic to delay regulation. Apparently, the only decent thing for an
industry wrongfully besieged by activists and the government to do is to knuckle

But just what does Michaels do now?

He runs something called the Project on Scientific Knowledge and Public
Policy at the George Washington University. While its university affiliation and
academic name would seem to lend it a modicum of credibility, in fact, SKAPP’s
origins are much more revealing.

As I first reported in the Wall Street Journal in October 2003, SKAPP was
launched by something called the Common Benefit Trust — an expense account
originally established for the purpose of compensating silicone breast implant,
or SBI, plaintiff lawyers for legitimate services and expenses incurred in
connection with the multibillion-dollar litigation.

Oddly enough, some of that money was diverted to form SKAPP, whose mission
was to work to overturn the 1993 U.S. Supreme Court decision in Daubert v.
Merrell Dow Pharmaceuticals — the landmark decision that permits judges to set
up scientific review panels in federal litigation to keep junk science out of
the courtroom.

One Daubert panel played a pivotal role in stopping SBI litigation in federal
courts. As a proxy for personal injury lawyers, SKAPP hasn’t been able to land a
glove on Daubert so far, but a new opportunity may be at hand.

Enter Schumer and the trial lawyers. Under cover of all the recent alarmist
press on BPA and with support of Capitol Hill lobbying by anti-BPA activists and
researchers, including the University of Missouri’s Fred vom Saal, Schumer
introduced a bill on April 29 to ban BPA in baby and children’s products.

"There have been enough warning signs about the dangers of this chemical that
we cannot sit idly by and continue to allow vulnerable children and infants to
be exposed," Schumer said. The bill’s introduction must be considered a slap in
the face to the FDA, which had issued a statement the day before reaffirming the BPA’s safety.

"Based on our ongoing review, we believe there is a large body of evidence
that indicates that FDA-regulated products containing BPA currently on the
market are safe and that exposure levels to BPA from food contact materials,
including for infants and children, are below those that may cause health
effects," the FDA stated in its media release.

Then on April 30, personal injury lawyers got into the act, filing a billion-dollar class-action lawsuit against five baby
bottle manufacturers for their use of BPA in plastic baby bottles and toddler
training cups. It’s all quite breathtaking.

Let’s sit back and take stock of what has happened: Activists manipulated
long-standing scientific standards to enable a government agency ally to cast
dubious but impossible-to-disprove aspersions about BPA.

Sympathetic and/or too-dumb-to-know-better mainstream media ran with the
story, providing cover to activist-friendly politicians who introduced
legislation to ban BPA and personal injury lawyers who no doubt would be happy
to settle their meritless billion-dollar suit for a quick few million.

Meanwhile, the considered judgment of the government agency charged with
regulating BPA is cavalierly tossed aside as if it didn’t matter. Though I don’t
know what the fate of Schumer’s bill will be — would a Democratic-controlled
Congress really undermine the credibility of the FDA? — it looks like the
class-action lawsuit filed in federal court may be on a collision course with
the Daubert decision.

It may be at that point when we learn whether SKAPP has accomplished its
mission of re-admitting junk science into federal courts.