Landmark consumer rights trials
— Amental disorder characterized by sadness,
International Coalition for Drug Awareness, a look at some other
difficulty in concentration, and sometimes inactivity. Prozac
controversial cases involving Prozac.
was developed as a treatment for depression.
— An orally administered antidepressant drug. Prozac
is one of the brand names under which fluoxetine is sold.
—A New York times review of the book Prozac Backlash
— Alternating moods of abnormal highs and
lows. Currently, more frequently called bipolar disorder. One of
the illnesses diagnosed in Joseph Wesbecker.
—Abrief article from Time magazine on the
— A drug manufactured by Eli Lilly and used to treat
arthritis. Ten years before the Wesbecker case, Eli Lilly pleaded
guilty to failing to report adverse reactions to the drug, evidence
Massachusetts News, an article about another suspected case of
that the judge does not admit in the Wesbecker trial.
murder induced by psychiatric drugs. Contains an overview of
—Aperson who brings a legal action, such as a lawsuit.
In Fentress v. Eli Lilly, the plaintiffs were a group of workers
from the printing plant attacked by Joseph Wesbecker .
— From the Louisville Courier-Journal, an article on
When we purchase a product or use a service, we have the
—The brand name of fluoxetine manufactured by Eli
Judge Potter's retirement, with his reflections on the Lilly case.
right to expect that what we buy is safe. And yet defective
products and harmful services are commonÑindeed, most
s c h i z o a ffective disorder
— Amood disorder characterized
Survivors Support Group," which, as the name indicates, is an
of the cases in the courts today arise out of just such
particularly by personality loss or social withdrawal, or both.
organization that takes a dim view of Prozac and related
occurrences. And sometimes lawsuits over products and
One of the illnesses diagnosed in Joseph Wesbecker.
services result in cases that grip the public in a major way.
U.S. Food and Drug Administration
— An agency of the Public
These cases may attract attention because of the huge
Health Service of the U.S. Department of Health and Human
— From ABC News, an article on the possible link between
numbers of people involved, the novel areas of modern life
Services. Founded in 1927, one of its main duties in to ensure
they reflect, or simply the large amounts of money
involved. LANDMARK CONSUMER RIGHTS TRIALS
Things to Think About
useful article on psychiatric drugs, including Prozac.
examines some of these unforgettable cases.
* Do you think that any drug can be perfectly safe? What if a
drug helped millions of people but carried a tiny risk of harming
Appleton, William S. Prozac and the New Antidepressants.
a very few? Would you be in favor of approving such a drug?
PROZAC ON TRIAL
Consider the well-known and long-used drug aspirin. What can
Breggin, Peter. Talking Back to Prozac.
St. Martin's Press, 1995.
you learn about its potential risk if used with children? Do you
Cornwell, John. The Power to Harm: Mind, Medicine, and
FENTRESS v. ELI LILLY
think that its risk of side effects makes it too harmful for over-
Murder on Trial.
Viking. Penguin, 1998. A book specifically on
The Prozac Controversy
* How well do you think the plaintiffs' attorneys made their case
Fieve, Ronald. Prozac: Questions and Answers for Patients,
In the early 1950s, many medical professionals in
that Prozac was to blame for Joseph Wesbecker' s deadly actions?
Family and Physicians.
the United States were alarmed by what they
Do you think that his previous history showed him to be the type
Glenmullen, Joseph. Prozac Backlash: Overcoming the Dangers
perceived as a growing incidence of mental illness.
of person that might become violent no matter what medication
of Prozac, Zoloft, Paxil, and Other Antidepressants with Safe,
Twice as many people were being committed to
.T ouchstone Books, 2001.
mental hospitals as were being sent there 50 years
*What do you know about the possible side effects of drugs that
Jonas, Jeffrey, et.al., Everything You Need To Know About
before. Consequently, scientists were excited by the
you or someone in your family might be taking? How can you
development of a new class of drugs used to treat
learn about these side effects? Does packaged information come
Kramer, Peter. Listening to Prozac.
mental illnessÑdrugs that promised to help mental
with the medications you or others take? What kinds of
*Should the CDER do its own studies or at least require the
chlorpromazine (sold under the brand name
studies be conducted by independent scientists with no
CONSUMER RIGHTS TRIALS
Thorazine) was approved by the U.S. Food and Drug
Administration (see Vocabulary). It seemed to have
a calming effect on patients, and within a decade 50
million people around the world were taking it.
pharmaceutical service, an article by two physicians that takes a
balanced, informed view of the Prozac controversy.
— From a
law professor, an article entitled "Prozac on Trial." with a
2001 Choices, Inc.All rights reserved.
Ever since, drug manufacturers have been seeking to improve
to ensure safety and the need to get potentially life-saving
antidepressant drugs, which could cause various side effects,
medications to the people who need them is a process that will
including tremors. One of the most promising new medications
probably never be perfect. The controversy continues.
was the antidepressant fluoxetine, which was introduced by Eli
— Regulatory authorities in Germany
Lilly in 1988 under the brand name Prozac. Early reports found
— One of two receptionists working on the
that it had fewer side effects and that it made patients feel much
r e p o r t t h a t t h e y b e l i e v e P r o z a c i s t o t a l l y
day of Wesbecker' s attack. One of the plaintiffs.
better than anything they had tried before. Prozac was accepted
unsuitable for the treatment of depression.
— Psychiatrist and key witness for the plaintiffs.
more quickly than any antidepressant before it.
He says that Prozac can be a killer when taken by someone like
But then reports started surfacing that some patients taking
antidepressant drug Prozac is put on the market.
Prozac were feeling suicidal and others were committing violent
— Former wife of Joseph
August 10, 1989
— Psychiatrist Lee Coleman
acts, including murder. Nevertheless, it was difficult to
testifies for the defense about his mental problems.
determine whether the drug, which had helped so many—
(see Important People) puts Joseph Wesbecker on
— Shooting victim and one of the plaintiffs.
indeed, which had been taken safely by 15 million people—was
— Psychiatrist who prescribed Prozac for Joseph
to blame. The trial of Fentress v. Eli Lilly, in which a group of
S e p t e m b e r 11, 1989
— Coleman finds that
people charged that Prozac had caused one of their former
Wesbecker has "deteriorated." He tells him to
— Juror in Fentress v. Eli Lilly
coworkers to go on a death-dealing rampage, brought the issue
— Head of the local printers' union.
into the courtroom. And given Prozac's popularity, the trial
— Attorney for Eli Lilly.
became one of the most important corporate cases of its day .
September 14, 1989
— Former employee Joseph
— Eli Lilly biochemist who discovered Prozac.
The Issue: When Is a Drug Safe?
Wesbecker, a Prozac user, returns to the Standard
A division of the U.S. Food and Drug Administration known as
Gravure printing plant in Louisville, Kentucky,
— One of the plaintiffs.
the Center for Drug Evaluation and Research (CDER) is
— One of the plaintiffs.
where he used to work, murders eight people,
charged with the task of assuring that safe and effective
— Defense witness and former Wesbecker
pharmaceutical drugs are available to the American people.
wounds twelve others, and then kills himself.
coworker who testifies for the defense that Wesbecker had
Drug manufacturers submit newly developed products to the
—A study done at Harvard University finds
been making violent threats for years.
CDER , which puts them through a rigorous analysis process
that Prozac may cause overwhelming thoughts of
— Psychiatrist who performs a "psychiatric
that includes a safety review. In deciding whether to approve
autopsy" on Joseph Wesbecker. Defense witness.
new drugs, the CDER does not conduct research itself; instead
— Defense witness who conducted studies of
it examines the results of studies done by the manufacturer. The
September 20, 1991
— The U.S. Food and Drug
CDER must ascertain that the new drug produces the benefits
Administration begins a hearing on the safety of
— One of the plaintiffs.
s supposed to without causing side effects that would
— Psychiatrist and author of the book Listening
December 12, 1994
— The Fentress v. Eli Lilly
Despite the government's best efforts, however, drugs can
— Doctor and attorney who testifies for the
trial concludes with 9 of the 12 jurors finding for
sometimes prove harmful after they are approved. Sometimes
it is not until a drug is used by millions that we discover that
— Friend of Joseph Wesbecker who testifies for
there are a few rare individuals who are harmed by it. In other
May 23, 1996
— Amid rumors that Lilly had
the defense about Wesbecker' s violent fantasies.
cases, critics blame insufficient testing by drug companies and
reached an agreement with some or all of the
inadequate review by the FDA. One of the most notorious cases
plaintiffs, the Kentucky Supreme Court, after
discrimination claim that Joseph Wesbecker filed against
of a dangerous drug was thalidomide, a medicine developed in
the late 1950s to treat insomnia and morning sickness in
studying the matter for four months, grants Judge
— Foreman at Standard Gravure who shrugged
pregnant women. It was soon learned that thalidomide could
Potter' s request to conduct a hearing to determine
off Wesbecker's threats of violence.
cause birth defects, and great numbers of deformed children
whether Lilly and the plaintiffs had misled the
Potter, John B.
—The judge in Fentress v. Eli Lilly.
were the result. Fortunately for Americans, the FDA did not
court about a pre-verdict agreement.
—Attorney for the plaintiffs.
approve the drug, which was being used in Europe, South
—Attorney for Eli Lilly.
S e p t e m b e r 6, 1996
— Judge Potter appoints
America, Australia, and elsewhere. Nevertheless, the
— Chief scientific officer for Eli Lilly
thalidomide scare underlined the need for vigilance in the drug
Kentucky Assistant Attorney General Ann M.
approval process. And yet just in recent years, many drugs have
Sheadel "to develop and present facts from which
— Personnel manager at Standard Gravure.
been recalled after being put on the market, having been granted
the Court can determine the true nature of the
Wernicke, Joachim (Joe)
— Head of the Eli Lilly team that
FDAapproval. Among them were Rezulin (for diabetes),
Seldane (an antihistamine), Ponidimin and Redux (for obesity),
— Former printing plant worker who
—Lilly admits that there had been a
returned to his place of work in September 1989, shot and
Nevertheless, the FDA has probably been under more
secret settlement with the plaintiffs in the
killed eight former coworkers, wounded twelve others, the then
criticism recently for its slowness in approving drugs that are
already helping people in other countries. Balancing the need
— Spokesman for Eli Lilly
—Attorney for the plaintiffs.
Associazione Italiana di Patologia Veterinaria ATTI III Congresso Nazionale ISSN 1825-2265 della Società Italiana di Patologia Tossicologica e Sperimentale del Gruppo di Patologia Clinica Veterinaria Pisa, 11-13 Maggio 2006 Associazione Italiana di Patologia Veterinaria – Italian Association of Veterinary Pathologists www.aipvet.it ALTERAZIONI MACROSCOPICHE E ISTO
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