By SHERYL GAY STOLBERG
New York Times November 29, 2002
Man Behind The Vaccine
Dec. 12, 2002
Company that Potentially Contributed to the Rise in
Autism, Make Money Treating the Kids They Harmed?
Treatment, What Medications are Available
in lawyers' cross hairs again
may be linked to autism
knows for sure why autism is spreading among young
children, but that hasn't stopped some trial lawyers from
targeting a prime suspect in their eyes:
Indianapolis drugmaker faces at least 45 lawsuits over its
role in developing and selling for more than 40 years a
mercury-based preservative used in childhood vaccines and
now suspected of causing autism.
first case won't come to trial before next year, the
lawsuits pose a potential costly threat to Lilly and a
handful of vaccine makers also named as defendants.
In an era
when product-liability suits against big companies can
result in jury awards in the millions or even billions of
dollars, few cases can compare in jury-awakening pathos to
toddlers stricken with autism. A puzzling neurological
condition, autism can trigger profound mental problems in
a healthy child within months and wreak havoc with
alarm was sounded in 1999 that mercury-based preservatives
in vaccines might be linked to autism, trial lawyers have
met regularly to plan their legal assaults on behalf of
autistic children and their parents.
think the damages are catastrophic. One case certainly
could be worth millions," said Michael J. Miller,
senior partner for Miller & Associates, an Alexandria,
Va., law firm that's filed three lawsuits against vaccine
makers and Lilly.
more than 60 lawsuits have been filed against vaccine
makers, including such big firms as Aventis,
GlaxoSmithKline, Merck, and Johnson & Johnson. The
litigation has the potential to sign on thousands of
plaintiffs, said attorney C. Andrew Waters, whose Dallas
firm Waters & Kraus has taken a leading role in autism
cases with more than 50 filed.
thinks juries will sympathize with plaintiffs who can show
that drugmakers knowingly sold vaccines containing mercury
in doses much higher than allowed under federal
guidelines. "It just boggles the mind (how) you
inject someone, much less an 8-pound baby, with one of the
most toxic substances known to man."
a notoriously toxic metal that accumulates in the body and
can cause severe brain damage.
caught up in the autism litigation could hardly come at a
worse time for Lilly.
faces the loss of more than $2 billion a year in revenue
from Prozac, its former best-selling drug that lost patent
protection last year. And it's spending millions of
dollars and redeployed hundreds of workers to respond to
tougher Food and Drug Administration scrutiny that has
delayed approvals of at least three key upcoming drugs and
forced an overhaul of manufacturing quality-control
itself in the autism cases, Lilly has turned to the same
Kansas City law firm, Shook, Hardy & Bacon, it has
used in Prozac wrongful-death lawsuits nationally and in a
flurry of drug-tampering cases in Missouri.
lawyers will fight the charge that thimerosal, the
scientific name for the mercury-based preservative, can
cause autism, said Lilly spokeswoman Joan S. Todd.
causal link has been established between thimerosal and
adverse reactions in vaccines," she said. She
criticized trial lawyers in the autism cases for
"putting up these Web sites and trying to drum up
scientists developed thimerosal (pronounced
thigh-MARE-uh-sol) in the late 1920s and early 1930s and
began selling it as a preservative in vaccines in the
1940s. Marketed for some uses under the brand name
Merthiolate, thimerosal also has been used as a skin
disinfectant and a preservative in blood, cosmetics and
stopped selling thimerosal in 1991 "because it was
not a significant source of revenue," Todd said.
Lilly hasn't sold childhood vaccines since the 1970s.
lawyers believe Lilly still is liable for damages arising
from thimerosal, despite not having sold any for the past
can't design a product that's lethal and then just step
away from it. They made an enormous amount of money on it
over the years," Miller said.
whose firm took the first depositions in the autism cases
and may bring the first case to trial early next year,
said Lilly also is open to fraud and conspiracy charges,
based on evidence he dug up from the 1930s.
charges that Lilly "flim-flammed scientists" for
years with a 1931 study that concluded thimerosal wasn't
harmful to humans.
published in the American Journal of Hygiene, reported
that Merthiolate has "a very low order of toxicity .
. . for man."
further, Waters found out the study's toxicity data came
from experimental use of thimerosal by doctors from Lilly
and Indianapolis City Hospital on meningitis patients
during a severe outbreak in 1929-30.
study on severely ill people ended up being "quoted
in Lilly brochures into the 1980s," Waters said.
"It very clearly demonstrates an effort to do an
unethical study and then paint the results in a certain
way that help them sell this product."
ignored or covered up later evidence that thimerosal,
which contains 50 percent mercury by weight, can be
dangerous to humans, Waters said.
Todd said the drug firm knows of "two doctors
mentioning using this (thimerosal on an experimental
basis) in a study in 1929. They were not our
other trial lawyers concede that the lawsuits they've
filed outpace the state of science on the key question of
whether thimerosal causes autism.
uncertain. It is controversial. It's conceivable we won't
be able to establish that to the satisfaction of a judge
or a jury," Waters said.
He said his
firm is carefully picking clients to include only children
who suffered autism soon after getting injected with
mercury-containing vaccines. The firm also looks for
clients who have medical records showing high mercury
levels in the child's body.
remain far from convinced thimerosal can cause brain
evidence is inadequate to accept or reject a causal
relationship between thimerosal exposures from childhood
vaccines and the neurodevelopmental disorders of autism,
ADHD and speech or language delay," concluded the
Immunization Safety Review Committee of the National
Academy of Sciences last year.
precaution, the committee recommended the use of
thimerosal-free vaccines. It also called for further study
of the issue.
Society of America, the nation's largest autism group for
patients and their families, is following the lawsuits but
hasn't publicly supported them because the science is
unclear that thimerosal causes autism, said Lee Grossman,
the society's president.
there is a connection . . . why are there millions of
children being vaccinated that have not gotten
autism?" he asked.
just don't know why there's this huge explosion of
children being diagnosed (with autism). Vaccines may be
part of the issue, but that doesn't seem to explain the
tremendous growth in numbers we're seeing. The evidence is
affects 500,000 to 1.5 million Americans and has grown at
an annual rate of 10 percent to 17 percent since the late
1980s. That span coincides with the addition of new
government-required childhood vaccinations that increased
the levels of mercury that children were exposed to,
according to lawsuits.
where vaccinations are now required against up to eight
diseases before a child may start school, the number of
autistic children registered in schools has grown from 116
in 1989 to 3,789 last year.
have an epidemic on our hands," said Rep. Dan Burton,
R-Ind., in a hearing he held on the issue in April as
chairman of the Committee on Government Reform.
publicly suggested thimerosal might be to blame.
congressman said his own grandson Christian became
autistic shortly after getting a round of childhood
vaccinations in his second year of life.
after receiving his mandated vaccinations, he became a
different child," Burton said at the hearing.
longer spoke. He would not look anyone in the eye. He
cried endlessly, banging his head. He began running around
flapping his hands. We now know he was suffering from an
adverse reaction to his vaccines. We also know that he may
have received more mercury in his vaccines than is
considered safe by federal standards."
when the FDA and other government agencies warned of
potential harm from thimerosal in vaccines, manufacturers
have begun supplying doctors with thimerosal-free
vaccines, which are now widely used.
the long use of mercury-containing vaccines left a legacy
that could be costly and tragic, said Dr. James J.
Bradstreet, director of research at the International
Autism Research Center in Palm Bay, Fla., in a report to
must deal with the reality that our vaccine policy exposed
a generation of newborns to a neurotoxin --
Waters & Kraus, LLP
March 17, 2002
Claire M. Bothwell
Waters & Kraus, LLP
200 Oceangate, Suite 520
Long Beach, California 90802
Tel: (562) 436-8833
Fax: (562) 590-7296
Dallas-based law firm of Waters & Kraus announced
today that it has received documents as a result of the
discovery process in the case of ounter v. Eli Lilly &
Company, et al, currently pending in Brazoria County,
Texas that come from the archives of Eli Lilly &
Company. The documents clearly demonstrate that
Lilly's thimerosal product, the mercury-based vaccine
preservative implicated in a number of recent law suits as
causing neurological injury to infants, was known as early
as April 1930 to be dangerous.
apparent eagerness to promote and market the product, in
September, 1930, Eli Lilly secretly sponsored a
"human toxicity" study on patients already known
to be dying of meningococcal meningitis. Senior partner
Andrew Waters stated that, "Lilly then cited this
study repeatedly for decades as proof that thimerosal was
of low toxicity and harmless to humans. They never
revealed to the scientific community or the public the
highly questionable nature of the original research."
Eli Lilly made every effort to corrupt the medical and
scientific literature, the process of arranging to publish
the results of its questionable secret study, other
researchers have provided Lilly with numerous articles
since the 1930's indicating concerns about thimerosal and
its potential hazard to humans who might be exposed or
injected with the substance. The evidence clearly
demonstrates that Eli Lilly was advised repeatedly that
their conclusions of low toxicity were not warranted and
that they failed to pass the information on to appropriate
federal and public health authorities. The following
time line illustrates some, but by no means all, of the
documentary evidence on this point from Lilly's internal
1947 - Article received by
Lilly: "No eruptions or reactions have been observed
or reported to merthiolate internally, but it may be
dangerous to inject a serum containing merthiolate into a
patient sensitive to merthiolate."
1948 - Article received by
Lilly: "Merthiolate is such a commonly used
preservative for biologicals, plasma, cartilage, etc.,
that it would seem important to
determine whether harm would result following
its subcutaneous or intravenous injection in skin
1950 - New York Academy of
Science article, "Mercurials as Antiseptics:"It
(merthiolate) is toxic when injected parenterally and
therefore cannot be used in chemotherapy."
1963 - Article received by
Lilly: "There is another point of practical
significance: does the parenteral injection of
merthiolate-containing fluids cause disturbances in
merthiolate-sensitive patients?" "It
is known that persons that are contact sensitive to a drug
may tolerate the same medications internally, but it seems
advisable to use a preservative other than merthiolate for
injections in merthiolate-sensitive people."
8/17/67 - Medical/Science
department requests that the claim "non-toxic"
on thimerosal labels be deleted in next printing run.
8/29/67 - Draft label changed
to "non-irritating to body tissues," non-toxic
1972 - British Medical Journal
reports case of skin burns resulting from the chemical
interaction of thimerosal and aluminum.
"Mercury is known to act as a catalyst and to cause
aluminum to oxidize rapidly, with the production of
heat."The manufacturers who supply us with thimerosal
have been informed." [Thimerosal is being used
in vaccines which also contain aluminum].
1972 - Article received
by Lilly: Merthiolate in vaccines caused six deaths?
"The symptoms and clinical course of the six patients
suggest subacute mercury poisoning."
4/27/76 - Lilly responds to Rexall
Drug Company's efforts to place the following
warning on Merthiolate product:
prolonged use or application to large areas may cause
mercury poisoning." Lilly objects to this
proposed warning, stating: "We object to the
connection of our trademark with the unjustified alarm and
concern on the part of the user which the statement is
likely to cause? We are not aware of any instance of
'mercury poisoning' after decades of marketing this
product. This is because the mercury in the product
is organically bound ethylmercury as a completely
non-toxic nature, not methylmercury."
FDA's advance notice of
proposed rule making regarding thimerosal:
"At the cellular level, thimerosal has been found to
be more toxic for human epithelial cells in vitro than
mercuric chloride, mercuric nitrate, and merbromim (mercurichrom).
"It was found to be 35.3 times more toxic for
embryonic chick heart tissue than for staphylococcus
areus."1950 study showed that thimerosal was no
better than water in protecting mice from potential fatal
"The Panel concludes that thimerosal is not safe for
OTC topical use because of its potential for cell damage
if applied to broken skin and its allergy potential.
It is not effective as a topical antimicrobial because its
bacteriastatic action can be reversed."
4/7/83 - Additional language added to
some Lilly labels: "As with any drug, if you are
pregnant or nursing a baby, seek the advice of a health
professional before using this product."
1991 - Lilly ceases manufacture/sale
of thimerosal. Licensing agreements demonstrate
continued profits from the product until at least 2010.
12/8/99 Lilly MSDS
"Primary Physical &
Reproduction Effects: Nervous System and Reproduction
"Effects of exposure include
"Mercury poisoning may
"Exposure in children may
cause mild to severe mentalretardation... ."
to mercury is a medical condition aggravated
CERCLA Hazardous substance? toxic
& Kraus is litigating a growing number of individual
cases across the country involving infants that sustained
serious neurological injuries from the thimerosal
contained in their pediatric vaccines. Waters & Kraus
is leading the following coalition of firms in bringing
these cases to trial:
3405 Piedmont Road, Suite 225
Atlanta, Georgia 30305-1764
|DORAN & MURPHY, LLP
1234 Delaware Avenue
Buffalo, New York 14209
|Dogan & Wilkinson
726 Delmas Avenue
Pascagoula, Mississippi 39567
|O'CONNELL & O'SULLIVAN
217 N. McLean Blvd., Suite 2C
Elgin, Illinois 60123
|Hendrickson & Long
214 Capital Street
P.O. Box 11070
Charleston, W. VA 25339
40925 County Center Drive, Suite 210
Temecula, California 92591
|WISE & JULIAN, PC
3555 College Avenue
Alton, Illinois 62002
|MARTZELL & BICKFORD
338 Lafayette Street
New Orleans, Louisiana 70130
|NANCE, CACCIATORE AND HAMILTON
525 North Harbor Blvd.
Melbourne, Florida 32935
|FERRARO & ASSOCIATES, P.A.
First Union Financial Center
200 South Biscayne Boulevard, Suite 3800
Miami, Florida 33131
|Cantor, Arkema and Edmonds,
First National Bank Building
823 East Main Street
P.O. Box 561
Richmond, VA 23218-0561
|Thomasson, Gilbert, Cook &
715 North Clark
P.O. Box 1180
Cape Girardeau, Missouri 63702-1180
|WALLACE & GRAHAM
525 N. Main Street
Salisbury, North Carolina 28144
|THE HENDLER LAW FIRM, P.C.
816 Congress Avenue, Suite 1100
Austin, Texas 78701
wins shield from autism suits
may be temporary; lawmakers and White House must revisit
issue next year.
November 20, 2002
WASHINGTON -- Eli Lilly and Co. won what
may be a short-lived victory Tuesday.
The Senate narrowly upheld language in a
homeland security bill that could help shield the company
from damages in pending and future lawsuits for selling a
mercury-based preservative put in childhood vaccines.
But in order to get enough votes to ensure
final passage of the bill, Republican congressional
leaders and the White House had to agree to revisit the
issue in January.
Lawmakers opposed to the provision said
the parties had agreed the liability protection would at
least not extend to the 45 lawsuits already filed against
Lilly by parents who allege their children suffered
autism, a neurological disorder, from a mercury-based
preservative used in many childhood vaccines until about
three years ago. Lilly developed and sold the
preservative, called thimerosal, for more than 40 years.
A White House spokesman said he could not
comment on the specifics of the agreement but did say the
White House would work with the next Congress "to
address these issues and some members' concerns."
The protection was one of several items
slipped into the bill that didn't become widely known
until after the House approved the measure last week.
Sen. Evan Bayh, D-Ind., said he thought
the vaccine protections "had merit" but was
bothered by the help for companies that reincorporated
"I just thought on balance, this was
not the right thing to do," Bayh said.
Sen. Richard Lugar, R-Ind., said he
supported the provisions because making substantial
changes would have delayed passage of the bill. He said he
has no opinion on the merit of the liability protection.
Defenders of the provision said it's
needed to make sure fear of lawsuits doesn't cause
pharmaceutical companies to stop making vaccines,
particularly those needed to fight bioterrorism.
No one, however, was claiming ownership of
Lilly -- which is a major GOP campaign
donor, has a large lobbying presence in Washington, and
connections to the White House that include CEO Sidney
Taurel's appointment to the White House Homeland Security
Advisory Council -- said it did not ask for the change.
Senators pointed to House Republicans, who
pointed to the White House, which denied proposing it.
Rep. Henry Waxman, D-Calif., called on
White House Budget Director Mitch Daniels -- a former
Lilly executive -- to explain how the language got in the
Daniels' spokeswoman said his office
"had absolutely no involvement" on the issue.
Lilly spokesman Ed Sagebiel said the
company was pleased with the language approved Tuesday.
"We think this legislation will help
protect manufacturers from lawsuits that are either
without merit or scientific evidence," he said.
Call Maureen Groppe at 1-202-906-8118.
Pat Oliphant, Universal Press
The Answer To Washington's Hottest Whodunit
Filed December 4, 2002
1158 26th Street, P.O. Box 428
Santa Monica, CA 90403
email: [email protected]
Quick, somebody call Sherlock Holmes. Or at least the
Hardy Boys. Or maybe even newly-designated Homeland
Security Secretary Tom Ridge. There's a Washington mystery
that needs solving.
Everyone in D.C., it seems, is utterly baffled as to
how an ugly little provision shielding pharmaceutical
behemoth Eli Lilly from billions in lawsuits filed by the
parents of autistic children made its way, in the 12th
hour, into, of all things, the 475-page Homeland Security
"It's a mystery to us," shrugged Eli Lilly
spokesman Rob Smith.
It's a mystery to us, too, echoed spokesmen for the
White House, the Department of Health and Human Services,
Bill Frist, who had originally penned the Lilly-friendly
provision for a different bill.
The haphazard lawmaking also proved baffling for
pharmaceutical industry lobbyists, and for White House
budget director Mitch Daniels, a former Lilly executive,
who made a very public show of disavowing any knowledge of
the amendment's mystifying genesis. Gosh, maybe the little
provision just flew down from heaven. Or was immaculately
conceived. Or maybe Osama bin Laden snuck over and planted
the little public policy bomb himself.
The outrageous rider stuck onto the end of the Homeland
Security bill provides security for Lilly from suits filed
by the families of autistic children who believe that
their kids' condition is linked to Thimerosal, a
mercury-based preservative made by Lilly that used to be a
common ingredient in childhood vaccines.
But in a town where knowledge is power, and where there
is no shortage of people willing to take credit for even
the most minute accomplishment, there has been a sudden
outbreak of people playing dumb. Official Washington is
observing a code of omerta that makes the Sopranos look
like the loose-lipped gals on "The View." In
other words: nobody's seen nothin'.
Here are the clues we have to work with: over the
Veteran’s Day weekend, GOP negotiators from the House
and Senate hunkered down to finalize the details of the
elephantine security bill. At some point -- no one is
willing to say when -- someone -- no one is willing to say
who -- inserted the Lilly provision -- though no one is
willing to say why.
It's vital that we solve the mystery -- even if you
believe that the custom-made legislation is justified. We
need to find out because this kind of behind-closed-doors
monkey business is an affront to our democracy -- the very
democracy this bill was theoretically designed to protect.
Perhaps it should have been called "The Homeland and
Lilly Protection Act."
"The ability," Rep. Dennis Kucinich, D-Ohio,
told me "of a special interest group to secretly
insert provisions into law for its own narrow benefit and
to the detriment of the public interest raises fundamental
questions about the integrity of our government."
Kucinich has vowed to lead a challenge to congressional
rules that permit our representatives to do the bidding of
their deep-pocket donors away from the prying eyes of the
public. At the most crucial part of the bill-drafting
process -- when the language of the law is being finalized
-- Washington’s corporate alchemists work their black
magic to turn legislative gold into self-preserving lead.
"It's a defect in the system," explains
Kucinich. "When a bill goes into a conference
committee, it gets yanked out of the sunlight and into the
shadows. The conference process is a closed one, so you
can go into a conference committee and basically add
anything or take out anything you want and no one really
knows. It transforms the legislature into a secret
So this fight is about a lot more than pushing for the
repeal of the Lilly provision, something Sens. Debbie
Stabenow, D-Mich., and John McCain, R-Ariz., have promised
to do when the 108th Congress convenes in January. It's
about putting an end to the gaming of the system that is
turning the legislative process into a prize-a-minute
carnival for big contributors. “Inserting such favors
for special interests in a bill is a directive that can
only come from some very high places,” Stabenow told me.
Intriguingly, Stabenow, McCain, and Kucinich may have
found an unlikely ally in their battle -- one with a very
personal stake in the issue. It turns out that Rep. Dan
Burton, R-Ind., the chairman of the Government Reform and
Oversight Committee, has a grandson who first began
showing symptoms of autism within days of receiving
vaccinations containing Thimerosal. "He became
radically different," says Burton, "banging his
head against the wall, running around flapping his arms.
Twenty years ago we had one in 10,000 children that they
thought was autistic. Now, it's more than one out of
This is clearly not a left-right issue. Any politician
who has waxed lyrical about "accountability" and
"transparency" -- that includes you, Mr.
President -- owes it to the public to demand that Congress
get to the bottom of just whose directive it was to insert
into the homeland security bill a provision that has
absolutely nothing to do with homeland security. And to
find out whether the $1.6 million that Lilly contributed
in the last election cycle -- 79 percent of which went to
Republicans -- had anything to do with the inclusion of
this designer provision. And, come to think of it, whether
these donations had anything to do with the Bush
administration asking a federal claims court to block
public access to documents unearthed in over a thousand
For anyone remotely familiar with the ways of
Washington -- and Sherlock Holmes -- the answer should be
We're used to having pounds of fatty pork stirred into
almost every recipe Congress dishes up. But the abuse of a
bill about homeland security is especially distasteful.
Washington's greedy corporate masters may finally have
overreached. Their continued influence constitutes a clear
and present danger to our security and if the president is
serious about protecting the homeland, he should speak up.
US Senate Votes to
Keep Vaccine Language in Homeland Security Bill
By Julie Rovner
WASHINGTON, DC (Reuters Health) Nov 19 - The US Senate
on Tuesday turned back efforts to strike provisions from
the homeland security bill that Democrats said benefited
special interests, including one that would apparently
block lawsuits against the drugmaker Eli Lilly for a
preservative it used to include in its vaccines.
The 52-47 vote to defeat the amendment to remove the
contentious provisions came only after House and Senate
Republican leaders promised to revisit the vaccine
provision and two other provisions immediately after
Congress returns in January.
Maine Republican Senators Olympia Snowe and Susan
Collins flatly refused to vote down the amendment -- which
would have struck a half dozen different sections of the
bill -- until they received that assurance not only from
their own leaders, but also from House Speaker Dennis
Hastert, R-Ill., who was finally reached by phone while
traveling in Turkey.
The House last week completed its work and tentatively
adjourned for the year. House leaders had said that if the
Senate changed the Homeland Security Bill, House members
would not be able to return to consider the changes until
December. The bill is designed to create a Department of
A spokesman for Snowe said his boss was assured that
when Congress considers an omnibus spending bill in early
January, the vaccine language will be changed to clarify
that it would not block lawsuits already filed against
Lilly charging that the mercury-based preservative
Thimerosal caused autism in some children.
"I was deeply concerned about the egregious,
eleventh-hour addition of special interest provisions to
the Homeland Security legislation, and spoke against
inclusion of these provisions during a meeting of Senators
before the vote, because I didn't believe we could afford
to let them stand," said Snowe.
Added Collins, "I am pleased that my Senate
colleagues and I were able to ensure that a bill creating
the department will reach the President's desk this year
[and] at the same time, that three troubling provisions
hastily added to the bill without the benefit of debate or
committee review will be corrected as soon as
The language in question redefines "vaccine"
to include any ingredient listed on the label approved by
the US Food and Drug Administration, thus apparently
requiring families of children allegedly injured by
Thimerosal to submit claims through the Vaccine Injury
Compensation Trust Fund.
But aides to Senate Finance Committee Chairman Max
Baucus, D-Mont., said the language in the bill would
actually preclude families from collecting compensation
from that fund, because it does not change the Internal
Revenue Code to allow the fund to pay for such injuries.
"It appears that the effect of the provision is to
preclude court lawsuits over vaccine ingredients or
components, but it also precludes compensation from the
Fund, because the bill does not change the disbursement
purposes for the Fund," the aides wrote in a memo.
By SHERYL GAY STOLBERG
November 29, 2002
Nov. 28 — Lobbyists for Eli Lilly & Company, the
pharmaceutical giant, did not have much luck when they
made the rounds on Capitol Hill earlier this year, seeking
protection from lawsuits over a preservative in vaccines.
Senator Bill Frist, Republican of Tennessee, tucked a
provision into a bill that went nowhere. When lawmakers
rebuffed a request to slip language into domestic security
legislation, a Lilly spokesman said, the company gave up.
Now, in a Washington whodunit worthy of Agatha
Christie, the provision has been resurrected and become
law, as part of the domestic security legislation signed
on Monday by President Bush. Yet in a city where
politicians have perfected the art of claiming credit for
deeds large and small, not a single member of Congress —
or the Bush administration — will admit to being the
author of the Lilly rider.
"It's turning into one of Washington's most
interesting parlor games," said Dave Lemmon,
spokesman for Senator Debbie Stabenow, Democrat of
Michigan, who has promised to introduce legislation to
repeal the provision. "There's a lot of guessing, a
lot of speculation as to who did this."
The provision forces lawsuits over the preservative,
developed by Eli Lilly and called thimerosal, into a
special "vaccine court." It may result in the
dismissal of thousands of cases filed by parents who
contend that mercury in thimerosal has poisoned their
children, causing autism and other neurological ailments.
Among them are Joseph and Theresa Counter of Plano, Tex.,
devoted Republicans whose party allegiance has run smack
into family ties.
The Counters' 6-year-old son, Joseph Alexander, was
normal and healthy until he was 2, they say. Then he took
an unexplained downward slide. Today, the boy struggles
with words. He cannot zip his pants, snap buttons or tie
his shoes. His parents say tests eventually showed that he
had mercury poisoning, which they attribute to vaccines.
They sued last year.
"I know that our legislative system can be very,
very messy at times," said Mr. Counter, a political
consultant, who with his wife has spent many thousands of
dollars on medical care and therapy for their son.
"But for them to attempt this, in the dead of night?
It disgusts me. This morning, I am ashamed to be a
With lawmakers now scattered across the country,
Washington is rife with speculation about who is
responsible for aiding Lilly, a major Republican donor.
During the 2002 election cycle, the company gave more
money to political candidates, $1.6 million, than any
other pharmaceutical company, with 79 percent of it going
to Republicans, according to the Center for Responsive
Politics, a nonprofit research group that monitors
Critics of the provision, mainly Democrats and trial
lawyers, are quick to point out that the White House has
close ties to Lilly. The first president Bush sat on the
Lilly board in the late 1970's. The White House budget
director, Mitchell E. Daniels Jr., is a former Lilly
executive. The company's chairman and chief executive,
Sidney Taurel, was appointed in June by President Bush to
serve on a presidential council that will advise Mr. Bush
on domestic security.
The White House, however, has said that it did not ask
Congress for the provision. Rob Smith, a spokesman for
Lilly, said that the company's lobbyists "made
absolutely no contact with Mitch or anyone in his office
about this," and that Mr. Taurel "did not at any
time ask" for any favors.
"It's a mystery to us how it got in there,"
Mr. Smith said of the provision.
Senator Frist has said it is a mystery to him as well.
As the Senate's only doctor, he sought to include the
provision in legislation that would promote the
availability of vaccines. But the vaccine bill is stalled;
Senator Edward M. Kennedy, the Massachusetts Democrat who
is chairman of the Senate health committee, opposes it.
Mr. Frist's spokesman said he did not seek to have the
provision included in the domestic security bill.
On Capitol Hill, Congressional aides-turned-detectives
have traced the emergence of the provision to the Veterans
Day weekend. Flush from their party's victories on
Election Day, and with a mandate from President Bush to
pass a domestic security bill, Republican negotiators in
the House and Senate holed up for three days in the
Capitol to hammer out the details, said Richard Diamond,
spokesman for the retiring House majority leader,
Representative Dick Armey of Texas.
One aide said the language mysteriously appeared in the
House version of the bill in entirely different type than
the rest of the measure, as though someone had clipped it
out of Mr. Frist's legislation and simply pasted it in.
Mr. Diamond said all the negotiators supported the move,
but would not say who was responsible.
"If you want to give somebody credit for it,"
he said, "Mr. Armey takes ultimate credit. It's his
bill. We are happy to wrap ourselves around it, but Mr.
Armey is not a doctor, like Senator Frist. He's the source
of the language."
Whether thimerosal is truly harmful is the subject of
intense scientific controversy. Earlier this year, the
National Academy of Sciences issued a report saying there
was no scientific evidence either to prove or disprove a
link between thimerosal and brain disorders like autism.
But the academy did find that such a link was
"biologically plausible," and so it urged
pharmaceutical companies to eliminate thimerosal, which
has already been removed from many vaccines, as quickly as
The Lilly rider closes a loophole in a 1986 law that
requires victims to file claims with the vaccine court,
which awards payments from a taxpayer-financed
compensation fund, before going to civil court. But the
law covered only vaccines themselves, not their
ingredients, which meant people like the Counters could
sue ingredient manufacturers like Lilly directly.
While Washington debates the origins of the provision,
families are fuming. Some say the government fund will do
them no good, because they have missed the statute of
limitations — three years from the date symptoms first
appear — for filing claims. Scott and Laura Bono of
Durham, N.C., say that while their son Jackson, now 13,
showed symptoms similar to autism six or seven years ago,
it was not until August 2000 that they learned he had
mercury poisoning. They filed suit just the other day.
Aware of the controversy, lawmakers in both parties
have pledged to alter the thimerosal rider, but are
arguing about how to do so. While many Democrats want it
repealed, Republicans have suggested that they may simply
alter the language to apply to future cases only.
"I'll believe it when I see it," said Mr.
Waters, the Counters' lawyer.
In the meantime, Mr. Smith, the Lilly spokesman, said
his company would soon go to court to seek dismissal of
That news made Theresa Counter cry.
"It just makes me sick," she said. "I
cannot tell you how devastating it is to think that we
might have to start all over."
Behind The Vaccine Mystery
WASHINGTON, Dec. 12, 2002
Armey, R-Texas, says he's behind a provision in the
homeland security bill that protects Eli Lilly and Co. (CBS/AP)
"It's a matter of national
security. We need their vaccines if the country is
attacked with germ weapons."
House Majority Leader Dick Armey
(CBS) It's been a mystery in Washington for
weeks. Just before President Bush signed the homeland
security bill into law an unknown member of Congress
inserted a provision into the legislation that blocks
lawsuits against the maker of a controversial vaccine
preservative called "thimerosal," used in
vaccines that are given to children.
Drug giant Eli Lilly and Company makes thimerosal. It's
the mercury in the preservative that many parents say
causes autism in thousands of children – like Mary Kate
Asked if she thinks her daughter is a victim of
thimerosal, Mary Kate's mother, Kathy Kilpatrick, says,
"I think autism is mercury poisoning."
But nobody in Congress would admit to adding the
provision, reports CBS News Correspondent Jim Acosta
– until now.
House Majority Leader Dick Armey tells CBS News
he did it to keep vaccine-makers from going out of
business under the weight of mounting lawsuits.
"I did it and I'm proud of it," says Armey,
"It's a matter of national security," Armey
says. "We need their vaccines if the country is
attacked with germ weapons."
Rep. Dan Burton, R-Ind., isn't buying it. The
grandfather of an autistic child, Burton says Armey
slipped the provision in at the last minute, too late for
"And I said, 'Who told you to put it in?'" He
said, 'No, they asked me to do it at the White
Critics say the Bush family and the administration have
too many ties to Eli Lilly. There's President Bush's
father, who sat on the company's board in the 1970's;
White House budget director Mitch Daniels, once an Eli
Lilly executive; and Eli Lilly CEO Sidney Taurel, who
serves on the president's homeland security advisory
Officials at the drug giant insist they did nothing
wrong. "No one, not our CEO, not myself, not anyone
who works with me asked the White House to insert this
legislation," said Eli Lilly spokeswoman Debra
But Kathy Kilpatrick and her husband Michael argue that
the thimerosal provision is not designed to protect the
nation, but rather to protect Eli Lilly.
Asked what he'd say to a congressman who came forward
and admitted he was responsible for inserting the
provision, Michael Kilpatrick says, "I would ask him
if he knew he was protecting mercury being shot into our
Kathy Kilpatrick asks, "Why would anyone want to
save Eli Lilly on our children's backs?"
Because Armey is retiring at the end of the year, some
say the outgoing majority leader is the perfect fall guy
to take the heat and shield the White House from
It's a claim both the White house and Armey deny.
Lilly's Pipeline of
S&P says the giant
drugmaker's heavy investment in R&D should yield
several blockbuster products and accelerate earnings
By Herman Saftlas
DECEMBER 9, 2002
When a blockbuster drug and major
profit generator like Prozac
goes off-patent, it usually signals anxious times ahead
for company management and investors. But Eli Lilly (LLY
), which changed the shape of the antidepressant market
with that breakthrough prescription compound, has
strategically managed the 2001 loss of patent protection
on its former $2.5 billion (annual sales) cash cow through
heavy investments in research and development. Lilly's
efforts should soon begin to pay off in the form of
lucrative new products and accelerated earnings-per-share
Lilly, whose new-product filings
last year have already distinguished it from the Big
Pharma pack, should lead its peers in terms of new drug
launches and earnings growth over the 2003-07 period,
thanks to the planned introduction of eight blockbuster
products over the next two years. These new drugs could
eventually add over $4 billion to Lilly's annual sales by
2007, of which 28% could be brought down to the bottom
line (equal to over $1.00 a share).
SURPRISES. The shares have been highly
volatile during 2002, largely because of investor concerns
over Food & Drug Administration-cited quality-control
manufacturing problems at several plants. However, we at
S&P believe these issues will be cleared up in 2003.
Lilly carries S&P's highest investment ranking of 5
In a surprise move on Nov. 27, one
that came months ahead of expectations, the FDA approved
two important new Lilly drugs: Strattera
(atomoxetine HCl) for attention-deficit/hyperactivity
disorder (ADHD) in children, adolescents, and adults;
and Forteo, a treatment for severe osteoporosis. These
approvals relieved investor concerns that no new Lilly
drugs would be approved until all of its manufacturing
problems were resolved. Both Strattera and Forteo will be
produced at facilities free of manufacturing issues.
Strattera has a unique competitive
advantage over rival ADHD drugs: It's the first
FDA-approved ADHD drug not classified as a stimulant under
the Controlled Substances Act. That will enable Lilly to
more effectively market the drug with samples and
direct-to-consumer advertising, while parents and users
will have the option of phone-in refills. These features
are not allowed for controlled substances.
DIFFERENCES. ADHD, which affects some 3%-5%
of school-age children and 4% of adults, remains a very
underprescribed market -- only about 37% of impacted
children and less than 5% of adults are treated. Lilly
hopes to significantly expand that market. We see
Strattera sales of about $250 million in 2003, expanding
to close to $1 billion by 2006.
Forteo also has a significant edge
over competing osteoporosis therapies. Unlike conventional
treatments that work to reduce bone loss, Forteo is an
anabolic agent that increases skeletal mass, lowers
fracture risks, and stimulates the body's own bone-making
process. The drug's label will have a "black
box" warning because of some incidence of
osteosarcoma (bone cancer) in laboratory animals. However,
no incidence of osteosarcoma was seen in humans taking
Forteo. With premium pricing -- an annual cost per patient
of over $6,000 -- we expect Forteo sales to exceed $500
million by mid-decade.
The next big FDA approval for Lilly
should be Cialis -- another drug that will not be produced
at facilities associated with quality-control issues. A
novel treatment for erectile dysfunction, it was developed
in conjunction with ICOS Corp. Studies have shown Cialis
to work faster and last longer than Pfizer's popular
Viagra. Recently approved in Europe, Cialis should achieve
peak sales in the $2 billion range.
A NEW APPROACH.
Another potential $2 billion product is antidepressant
Cymbalta, a serotonin norepinephrine reuptake inhibitor (SNRI)
that differs from conventional selective serotonin
reuptake inhibitors (SSRI) such as Prozac, Zoloft, and
Paxil. Believed to be more potent than the SSRIs, Cymbalta
treats both mood and the painful physical symptoms
associated with depression. Lilly is also studying
Cymbalta for the treatment of stress incontinence.
Produced at Lilly's Indianapolis plant, FDA approval
hinges on resolution of manufacturing problems.
Unlike most of its peers, none of
Lilly's principal drug products face any generic threat
over the next five years. Even though the patent expires
at the end of 2003 on the growth hormone Humatrope, no
generic challenge is expected since that product is a
biologic and, to date, no generic biologics have yet been
Lilly's most important single drug,
Zyprexa, a treatment for schizophrenia and bipolar
disorder, accounts for about 31% of the U.S. antipsychotic
prescription market. Although the number of prescriptions
written over the near term may flatten somewhat due to the
entry of Bristol-Myers' rival Abilify, we still see
Zyprexa sales growing at a percentage rate in the low
teens in 2003. One edge Zyprexa has over Abilify is that
it can be prescribed for a broader range of conditions.
Sales should also be helped by its proven record of
efficacy, expansion into new markets, and anticipated FDA
clearance of a new injectible formulation.
POTENTIAL. Other key growth drugs include
Humalog human insulin for type 1 diabetes, Actos for type
2 diabetes, Gemzar anticancer therapy, Evista for
osteoporosis, and Xigris for sepsis. Despite recent
sluggishness, Xigris should achieve blockbuster status
over coming years, helped by regulatory approvals in
Europe and new studies demonstrating its effectiveness in
treating severe sepsis.
After four consecutive quarters of
declining earnings due to generic erosion in the Prozac
line that started in August, 2001, Lilly posted modestly
higher EPS in the third quarter of 2002, excluding
nonrecurring items. It had expected a stronger
performance, but results have been hurt by those
manufacturing quality-control issues, which were first
cited by the FDA in 2001. With negative Prozac comparisons
penalizing results for the first seven months of the year,
total revenues for 2002 are expected to dip about 3%, to
$11.1 billion, and diluted EPS will probably slip 1% to
$2.55, from 2001's $2.58 (before nonrecurring items in
Expenses associated with rectifying
manufacturing problems and the heavy cost launching of new
products are likely to restrict earnings growth to about
6%, to $2.70 a share, in 2003. However, sales growth
should accelerate over the 2003-06 period, driven by
rising contributions from a steady stream of new products.
Coupled with rapidly growing equity income and cost
efficiencies, pretax margins are expected to expand from
32% in 2002 to 36% in 2005. We project compound annual EPS
growth of over 20% over the 2003-2007 period.
NUMBERS. Examining Lilly's 2001 results on an
Core Earnings basis, its use of stock-option grants as
a form of employee compensation is roughly comparable with
the overall drug-industry average on a
percentage-of-earnings basis. Had Lilly expensed all
options, EPS in 2001 would have been reduced by 7.3%, vs.
an average decline of 7.5% for the overall Big Pharma
sector. Expensing pension costs would have reduced EPS by
an additional 7.8%, somewhat lower than the industry
average hit of 8.8%.
We believe Lilly's premium multiple
to the overall Big Pharma sector (24 times estimated 2003
EPS, based on a recent share price, vs. the group average
of 20%) is justified in light of its extended
patent-protected portfolio and unmatched pipeline
potential. Our 12-month target for the stock is $78, or
about 18% above the recent price, and is derived by
applying the present multiple to our 2004 estimate of
$3.25. Judged by the price-earnings ratio and three-year
projected growth-rate basis, Lilly recently traded at a
20% discount to the industry average. And finally, LLY was
selling at a 25% discount to its intrinsic value based on
our discounted-cash-flow model.
Company that Potentially Contributed to the Rise in
Autism, Make Money Treating the Kids They Harmed?
version (* pdf format, 7MB, 64 pages)
Publication No. 97-4023
Printed 1997. Booklet. 60p.
Medications are Available
No medication can correct the brain structures or
impaired nerve connections that seem to underlie autism.
Scientists have found, however, that drugs developed to
treat other disorders with similar symptoms are sometimes
effective in treating the symptoms and behaviors that make
it hard for people with autism to function at home,
school, or work. It is important to note that none of the
medications described in this section has been approved
for autism by the Food and Drug Administration (FDA). The
FDA is the Federal agency that authorizes the use of drugs
for specific disorders.
Medications used to treat anxiety and depression are
being explored as a way to relieve certain symptoms of
autism. These drugs include fluoxetine
(Prozac™), fluvoxamine (Luvox™),
sertraline (Zoloft™), and clomipramine (Anafranil™).
Some scientists believe that autism and these disorders
may share a problem in the functioning of the
neurotransmitter serotonin, which these medications
One study found that about 60
percent of patients with autism who used fluoxetine became
less distraught and aggressive. They became calmer and
better able to handle changes in their routine or
environment. However, fenfluramine, another
medication that affects serotonin levels, has not proven
to be helpful.
People with an anxiety disorder called
obsessive-compulsive disorder (OCD), like people with
autism, are plagued by repetitive actions they can't
control. Based on the premise that the two disorders may
be related, one NIMH research study found that
clomipramine, a medication used to treat OCD, does appear
to be effective in reducing obsessive, repetitive behavior
in some people with autism. Children with autism who were
given the medication also seemed less withdrawn, angry,
and anxious. But more research needs to be done to see if
the findings of this study can be repeated.
Some children with autism experience hyperactivity, the
frenzied activity that is seen in people with attention
deficit hyperactivity disorder (ADHD). Since stimulant
drugs like Ritalin™ are helpful in treating many people
with ADHD, doctors have tried them to reduce the
hyperactivity sometimes seen in autism. The drugs seem to
be most effective when given to higher-functioning
children with autism who do not have seizures or other
Because many children with autism have sensory
disturbances and often seem impervious to pain, scientists
are also looking for medications that increase or decrease
the transmission of physical sensations. Endorphins are
natural painkillers produced by the body. But in certain
people with autism, the endorphins seem to go too far in
suppressing feeling. Scientists are exploring substances
that block the effects of endorphins, to see if they can
bring the sense of touch to a more normal range. Such
drugs may be helpful to children who experience too little
sensation. And once they can sense pain, such children
could be less likely to bite themselves, bang their heads,
or hurt themselves in other ways.
Chlorpromazine, theoridazine, and haloperidol have also
been used. Although these powerful drugs are typically
used to treat adults with severe psychiatric disorders,
they are sometimes given to people with autism to
temporarily reduce agitation, aggression, and repetitive
behaviors. However, since major tranquilizers are powerful
medications that can produce serious and sometimes
permanent side effects, they should be prescribed and used
with extreme caution.
Vitamin B6, taken with magnesium, is also being
explored as a way to stimulate brain activity. Because
vitamin B6 plays an important role in creating enzymes
needed by the brain, some experts predict that large doses
might foster greater brain activity in people with autism.
However, clinical studies of the vitamin have been
inconclusive and further study is needed.
Like drugs, vitamins change the balance of chemicals in
the body and may cause unwanted side effects. For this
reason, large doses of vitamins should only be given under
the supervision of a doctor. This is true of all vitamins
For more information see:
Autism Medication Reference
Information taken from Appendix E of Autistic
Spectrum Disorders: Finding a Diagnosis and Getting Help by
Mitzi Waltz, copyright 2002 by O'Reilly & Associates,
Approves Non-Stimulant ADHD Drug-- Strattera (Atomoxetine)
BETHESDA, MD -- December 2, 2002
-- The Food and Drug Administration has approved --
Strattera, (atomoxetine) -- the first new drug in three
decades for treatment of symptoms of attention deficit
hyperactivity disorder, or ADHD, which includes
inattention, hyperactivity and impulsiveness. Strattera
has a different mechanism of action from the
stimulant-like drugs that have been used to treat ADHD.
Because Strattera does not appear to have a potential for
abuse, it will not be classified as a controlled
substance, although it will be a prescription drug.
According to the American
Psychiatric Association, about three to seven percent of
children have attention deficit hyperactivity disorder. It
is estimated that about four percent of adults have ADHD.
People with ADHD may make careless mistakes, fidget,
interrupt others, talk excessively and have problems
paying attention. Symptoms must be persistent, that is, be
present for at least six months, and must be more severe
than is typically observed in individuals at a comparable
level of development before a diagnosis can be made with
certainty, according to the Diagnostic and Statistical
Manual (DSM-IV), the diagnostic manual for psychiatric
disorders, published by the American Psychiatric
Association. Although the disorder is not as well defined
in adults, symptoms in adults may include a lack of
organization, daydreaming, irritability, and lack of
Strattera was studied in children,
adolescents and adults. The drug's safety and
effectiveness were established in six double-blind
placebo-controlled studies in patients who met specific
diagnostic criteria under DSM-IV. The clinical studies
demonstrated that Strattera significantly improves
patient's symptoms compared to placebo.
Side effects of the drug include
decreased appetite, upset stomach, nausea or vomiting and
tiredness. In addition to these adverse effects, some of
the most common side effects in adults were problems
sleeping, dry mouth, dizziness, and sexual side effects.
The drug will be marketed by Eli
Lilly and Company, Indianapolis, Ind.