In Massive Bill, Someone Buried a Clause to Benefit Drug Maker
by Jonathan Weisman, Washington Post, November 28, 2002;
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It amounted to only two paragraphs at the end of a 475-page
bill to create the Department of Homeland Security. But the
brief provision -- designed to shield vaccine makers such as
Eli Lilly and Co. from lawsuits seeking billions of dollars
for families of autistic children -- has generated a whirlwind
of controversy and a mystery as to its origin.
The paragraphs appeared just days before the House was to vote
on the legislation. House Republicans rammed the bill through
during Congress's "lame duck session" and sent it to the
Senate, where Democrats, demoralized by the Nov. 5 election
results, could not to stop it.
And so, with little debate, Congress granted broad legal
protection to the makers of Thimerosal, a preservative in
childhood vaccines that has been circumstantially linked to
rising rates of autism and pediatric developmental problems.
It seemed a lobbying coup for Lilly and its allies. Yet,
strange to say in Washington, no one seems to want to take
Pharmaceutical lobbyists, Eli Lilly representatives and
lawmakers with the most knowledge of the Thimerosal issue have
denied any role in the provision's last-minute appearance.
Now, White House budget director Mitchell E. Daniels Jr., a
former Lilly executive, is the latest person to formally deny
a part. He did so in a sharply worded response to an
accusatory letter by Rep. Henry A. Waxman (D-Calif.).
Daniels said the provision was not approved or developed by
the White House Office of Management and Budget, adding:
"I also want to make clear that I personally had no
involvement whatsoever with these provisions. I spoke to no
one about these provisions, either inside the administration
or outside the administration. . . . I did not have any
communications with anyone from Eli Lilly regarding the issue.
Indeed, I had not even heard of Thimerosal until I received
your letter, which is not surprising because Eli Lilly stopped
making Thimerosal a decade before I began working there and
the lawsuits appear to have been filed after I left."
Since the provision's appearance, some Democrats and trial
lawyers have charged that it represented a timely payback for
the pharmaceutical industry's financial support in the midterm
elections. "President Bush and conservative Republicans are
going to give the pharmaceutical companies whatever they ask
for," said Michael Williams, an Oregon lawyer who represents
several families of autistic children and believes billions of
dollars could be at stake.
Under the provision, a raft of Thimerosal lawsuits will be
redirected from state courts to the federal Vaccine Injury
Compensation Program, which caps damages and sharply limits
who can file suits against vaccine makers. Proponents say the
provision merely closes a loophole, which had been exploited
by trial lawyers claiming that Thimerosal was a vaccine
"contaminant" not subject to existing legal regulations. If
action was not taken, advocates say, the lawsuits could have
driven vaccine makers out of business.
The provision was drafted more than a year ago by Sen. Bill
Frist (R-Tenn.) as part of a broader bill to revise the
vaccine program. That bill, which Frist had hoped to begin
action on next year, includes measures favoring plaintiffs as
well as manufacturers. It would raise the cap on damages,
extend the statute of limitations for filing suit and allow
the parents of autistic children to sue on their behalf.
An aide to retiring House Majority Leader Richard K. Armey
(R-Tex.) said Armey's staff put the Thimerosal provision in
with no prodding from the pharmaceutical industry or the White
But several corporate lobbyists said that is not credible.
Whoever was responsible had to have detailed knowledge of the
legal issues, had to know Frist had drafted the larger bill,
and had to understand exactly which provision applied to
Thimerosal because the brand name does not appear in the text.
Two sources said an official at the Department of Health and
Human Services gave the final approval, a statement that HHS
spokesman Bill Pierce adamantly denied.
What is clear is that as recently as two months ago, lobbyists
for Lilly and other drug makers were on Capitol Hill trying to
get the entire Frist vaccine bill inserted into the homeland
security legislation. But, the lobbyists said, they were as
surprised as anyone when the two-paragraph item was included.
One senior Republican Senate aide said a member of Frist's
staff received a call just days before the House passed the
homeland security bill, saying he had heard a rumor that the
Thimerosal provision was included. The Frist aide said the
lobbyist was confusing that provision with another measure to
protect makers of smallpox vaccines. The next day, the aide
said, Frist's staff found the Thimerosal provision in the bill
as they scanned it in the Senate cloakroom.
"We don't know how it became part of the House bill," said Rob
Smith, a Lilly spokesman. "We didn't know it was part of the
bill, and it was a surprise to us."
The provision could be the lobbying coup of the 107th
Congress. A series of ongoing academic studies should be able
to conclude within the next three years whether Thimerosal, a
mercury-based additive, can be scientifically linked to an
upswing in autism, Williams said. Absent the two-paragraph
provision, such a conclusion could open the legal floodgates.
Yet corporate lobbyists who might be expected to crow about
saving their clients potentially billions of dollars have
stayed mum. That may be in part because the deed was done
rather clumsily, one lobbyist said. The provision was not even
hidden. Instead, it was simply tacked on at the end of the
bill. That has brought down a wave of unwanted publicity on
vaccine makers, especially Lilly, the inventor of Thimerosal.
"They didn't even make an effort to be clever about it," the