Schumer Chucks the FDA?

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The Article

Who needs the Food and Drug Administration? New York Democrat Sen. Chuck Schumer and personal injury lawyers certainly don’t—at least to the extent the agency gets in the way of their political grandstanding and a multi-million dollar payday, respectively.

This column recently reported on the sad tale of the chemical bisphenol A (BPA)—that is, how junk science-fueled anti-chemical activists successfully rigged the scientific review process at the federal National Toxicology Program in order to cast doubt on the safety of BPA, which in turn led to decisions by Wal-Mart and other retailers 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 was 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 group.”

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 in order 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 under.

But just what does Michaels do now?

He runs something called the Project on Scientific Knowledge and Public Policy (SKAPP) 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 (SBI) plaintiff lawyers for legitimate services and expenses incurred in connection with the multi-billion dollar SBI 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 permit 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 Sen. 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, Sen. Charles, Schumer (N.Y.) 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,” Sen. Schumer said.

The bill’s introduction must be considered as 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 so far:

Activists manipulated long-standing scientific standards in order 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 would no doubt 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 Sen. Schumer’s bill will be—would a Democrat-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.

Steven Milloy
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