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War in Courtroom over Paxil Drug TV Ads
Latest News Update
on Paxil Ad Court case
Thu Aug 22 By Gina Keating
LOS ANGELES (Reuters) - Pharmaceutical giant GlaxoSmithKline is waging war in a
Los Angeles courtroom over whether it can advertise its popular anti-depressant
Paxil as "not habit forming" in a television campaign designed to attract
millions of new users.
A controversial ruling on Monday by U.S. District Judge Mariana Pfaelzer
ordering the British-based company to stop airing the ads for its top-selling
product stunned drug companies and cheered consumer advocates.
The case could have a huge impact on drug companies using television ads to get
their message directly to consumers. TV advertising of prescription drugs is a
relatively new practice in the United States and one that is banned in Europe.
A group of Paxil users sued Glaxo under the California business code, contending
that it deliberately played down the severity of withdrawal symptoms in the U.S.
ads, while warning overseas users about potentially severe reactions associated
with stopping treatment.
Pfaelzer's ruling granting a preliminary injunction against the ads until the
case is decided stirred up a storm of protest over whether a court or the Food
and Drug Administration ( news - web sites) should have the final say in how
drugs are advertised.
Also at issue is the meaning of the phrase "not habit forming" -- does it give
potential users the idea that use of the medication can be stopped at anytime
with no side effects?
The company vowed to appeal the ruling and the U.S. Department of Justice ( news
- web sites) has asked the judge to reconsider. "The U.S. Food and Drug
Administration and not the courts has the responsibility for reviewing and
regulating pharmaceutical ads," David Stout, Glaxo's president of U.S.
Pharmaceuticals, said in a statement.
Justice Department attorneys said Pfaezler should reverse her decision because
she overstepped her authority in second-guessing the FDA, which had approved the
drug's marketing campaign.
"Having 50 different (state) versions of labeling of advertisements for
nationally marketed prescription drug products is unworkable at best and
confusing, to say the least," Assistant Attorney General Robert McCallum Jr.
wrote in a motion filed with the court.
A NOT SO EASY ISSUE
But a former FDA attorney who testified for disgruntled Paxil users said the
case is not so clear cut. "The issue here is not labeling for prescription drugs
-- which the FDA has jurisdiction over -- this case involves advertising,"
former FDA lawyer Jay Geller said.
"The FDA doesn't have authority to pre-approve advertising, so companies can
submit their ads to the FDA or not submit their ads to FDA," he said.
Attorney Karen Barth, who represents about three dozen people from across the
United States who said they suffered debilitating withdrawal symptoms when they
stopped taking Paxil, argued that the case revolves around false advertising.
She said she has received inquiries from more than 5,000 former Paxil users who
complained of being unable to stop the drug.
Tina Nieves, a lawyer who frequently sues drug companies, says the case has
major implications for the drug industry.
"(The advertising) really influences their sales dramatically. Patients are
going into their doctors' offices and, before they have a diagnosis, they are
saying, I want that Paxil," she said. "This is a real threat to that practice."
TV drug ads were virtually unknown before 1997 because of FDA guidelines that
all direct-to-consumer ads include voluminous information about side effects,
according to the Pharmaceutical Research and Manufacturers of America.
The FDA's move to relax that rule increased TV ads by sevenfold between 1996 and
2000, according to a study by the Harvard School of Public Health released in
February.
In 2000, total drug promotion in direct-to-consumer ads topped $15 billion, the
Harvard researchers found.
A 1999 study found that the ads encouraged about 24.7 million consumers to talk
to their doctors about a medical condition they had never discussed before
seeing the ads, Pharmaceutical Research said.
Glaxo spokesman Michael Fleming said the Paxil ads "are critical." "They do a
lot of good in encouraging people who may have the symptoms to come in and seek
treatment," he said.
LABELING VARIES BY COUNTRY
Attorney Barth maintains that Glaxo has a double standard, saying the company
warned Paxil users in foreign countries that the drug had withdrawal symptoms
while advertising that it was not habit-forming in the United States.
She said labels for Paxil, which is known in Europe as Seroxat, sold in Italy,
Britain, the Netherlands and Spain warn of "withdrawal symptoms"--including
dizziness, nausea, anxiety, tremors and sweating--associated with stopping the
drug.
The company and the Justice Department say "withdrawal symptoms" and "addictive"
are two different things.
"In FDA's scientific view, habit-forming drugs cause drug-seeking behavior,
often with the user escalating the dose for psychological or physical
gratification," Assistant Attorney General McCallum's brief said. The
"discontinuation syndrome," is addressed in Paxil ads, he added, "but it is not
habit forming."
The lawsuit asks that Glaxo be forced to stop advertising Paxil as non-habit
forming and to surrender any profits made on the drug. Paxil sales in 2001
reached $2.7 billion.
http://www.baumhedlundlaw.com/media/ssri/paxil/Injunction/press_release_injunction2.htm
Judge orders pharmaceutical giant, GlaxoSmithKline, to pull TV
commercials that claim the antidepressant drug Paxil is non habit-forming
August 19, 2002
Baum, Hedlund, Aristei, Guilford & Schiavo
12100 Wilshire Blvd., Suite 950
Los Angeles, CA 90025
Web: www.baumhedlundlaw.com
Los Angeles, August 19, 2002 - - A U.S. Federal Court in Los Angeles has ordered
GlaxoSmithKline (GSK) to pull all of its television commercials that claim Paxil
is "non habit-forming." The ruling was requested by representatives of a
nationwide class action claiming that the antidepressant drug, Paxil, causes
severe withdrawal reactions which are inconsistent with the "non-habit forming"
language in GSK's advertising material. Prior to the hearing, GSK also
stipulated with class counsel that it would stop distributing promotional
brochures stating that Paxil "may cause mild, usually temporary side effects in
some individuals" and "Paxil has been studied both in short-term and long-term
use and is not associated with dependence or addiction."
The injunction order states: "... the Plaintiffs are likely to succeed on their
argument that the ads were misleading and created inaccurate expectations about
the ease of withdrawal from the drug." In reaching her decision, Judge Mariana
Pfaelzer noted: "Indeed, the Paxil labeling in other countries warns of
withdrawal reactions following discontinuation of Paxil." Later in the ten-page
opinion, she states: "In the absence of a preliminary injunction in favor of the
Plaintiffs, members of the plaintiff class will be subject to a significant
threat of irreparable injury. . . . The Court finds that the public interest in
health and safety would be furthered by an issuance of the preliminary
injunction order." In response to GSK's vehement arguments against pulling the
commercials, Judge Pfaelzer observed that "such a removal can only help patients
make a more informed decision by forcing them to discuss the possibility of
withdrawal symptoms and addictive qualities with their physicians." The Court
stated that the ads have the potential to "create confusion in the
patient-doctor relationship if a physician's diagnosis is at odds with what the
patient has been led to believe based on the ads."
The injunction request was supported by five expert opinions, including two
renowned psychiatrists, British psychopharmacologist, Dr. David Healy, author of
The Antidepressant Era and Dr. Joseph Glenmullen, a Harvard psychiatrist and
author of the bestseller Prozac Backlash: Overcoming the Dangers Of Prozac,
Zoloft, Paxil, and Other Antidepressants with Safe, Effective Alternatives. Both
claimed that GSK's "non-habit forming" ads are false and misleading and their
continued airing will create imminent and irreparable harm to public health.
According to Dr. Healy, "between 5,000 to 7,000 people start on Paxil daily. Of
these, approximately 70% are in North America (between 3,000 to 5,000 people).
Of these patients, at least one third will have difficulties with withdrawal
symptoms. That is, at least 1,000 to 2,000 Americans per day enter the risk
pool. Of these 1,000 to 2,000, at least 10% will have severe problems either in
terms of the duration of withdrawal or in terms of the severity of the medical
complications. Accordingly, approximately 200 Americans per day are entering the
risk pool for serious problems as a result of the Paxil, and this rate of flow
of patients is being increased due to the direct-to-consumer advertising stating
that Paxil is not addictive, non-dependence producing and non habit-forming."
Dr. Glenmullen stated: "In response to the mounting reports of Paxil withdrawal,
[GSK] acknowledged in the December 14, 2001 revision that withdrawal can be
severe enough to require restarting the drug. Yet, even after acknowledging the
severe withdrawal and dependence, [GSK] continues to entice the public in
direct-to-consumer advertising that Paxil is not habit forming or associated
with dependence."
Dr. Stuart Shipko, a Los Angeles area clinician, also submitted a declaration
describing his first-hand clinical experience with patients suffering from Paxil
dependency and withdrawal problems and voiced his concerns over
GlaxoSmithKline's deceptive advertising. Dr. Shipko argued that "[w]hat the
average person is asking is 'Can I stop Paxil whenever I want?' This is what
'habit-forming,' a non-medical term, means to the average person. When patients
find out that they cannot stop Paxil when they want to . . . it is my clinical
experience that they feel deceived, trapped and violated."
In addition, Rutger's English Professor, William Lutz, author of Doublespeak:
From Revenue Enhancement to Terminal Living: How Government, Business,
Advertisers, and Others Use Language to Deceive You; The Cambridge Thesaurus of
American English and Webster's New World Thesaurus who explained the plain
meaning of the term "non-habit forming." According to Professor Lutz, the
television viewing audience understands "habit-forming" to mean what ordinary
dictionaries define it to mean and that "if something is 'non-habit forming,' it
means that one can 'take it or leave it.'" However, Lutz stated, "as even
defendant admits, one cannot just 'leave [Paxil].'"
A number of class members submitted declarations detailing their personal horror
stories concerning Paxil and voicing their outrage at GSK's television
commercials that state that Paxil is non habit-forming. One complained: "I am
outraged that [GSK] can still advertise Paxil as 'non habit-forming' when it
causes such debilitating withdrawal side-effects . . . If I had been given
truthful information from my doctor or [GSK], I would never have taken Paxil."
According to attorney Karen Barth of Baum, Hedlund, Aristei, Guilford & Schiavo:
"In a very well reasoned opinion, Judge Pfaelzer has admirably chosen to protect
the interests of the public health. It is incredible that GSK has placed
television commercials on our nation's airwaves that state 'Paxil is non-habit
forming' in the face of thousands of adverse reaction reports describing the
devastating withdrawal reactions Paxil users have experienced and continue to
experience when they try to stop taking Paxil. Even after the FDA ordered GSK to
add Paxil's withdrawal reactions to the Paxil warning label in December 2001,
GSK persisted in advertising the anti-depressant as 'non-habit forming.'
Fortunately, Judge Pfaelzer saw through the double speak."
Since "Direct to Consumer" or "DTC" ads for prescription drugs were legalized in
1999, there has been an ever increasing surge of drug ads targeted at consumers.
A recent Food & Drug Administration (FDA) survey indicates that "DTC" ads are
extremely effective and that a high percentage of physicians, in fact, respond
to patient demands by prescribing the medications that are requested.
Notwithstanding having stipulated to no longer distribute printed advertising
material claiming that "Paxil ... is not associated with dependence or
addiction," GSK has advised the Court that it intends to appeal the order to
pull the television ads stating that Paxil is "non-habit forming."
The injunction was granted by U.S. District Court Judge Mariana Pfaelzer in the
Central District of California, Los Angeles. The hearing on the preliminary
injunction took place on August 12, 2002. Judge Pfaelzer's opinion was issued on
Friday, August 16, 2002. The attorneys handling the Paxil class action
litigation are Karen Barth of the Los Angeles firm Baum, Hedlund, Aristei,
Guilford & Schiavo; Kevin Yourman of the Los Angeles firm Weiss & Yourman; and
Donald Farber, of San Rafael, California.
To receive the Order and/or excerpts from declarations submitted in support of
the preliminary injunction call Liz Huelsman, per information at top of release.
Could there be better evidence against the notion that the
Justice Department is no longer about Justice, and that the FDA is no longer
about protecting the interests of consumers, but rather those of the drug
industry?
They clearly state that pulling the ads would be "catastrophic to the drug
industry", but what do they have to say about the "catastrophic injuries" to the
consumers? What of the children who consumed their poison, now dead?
Please pray for this judge, that she will continue to see reason, and pray for
her safety.
- Dawn Rider
REUTERS
August 23, 2002
Glaxo Can Continue
Running Paxil TV Ads for Now
http://www.reuters.com/news_article.jhtml?type=healthnews&StoryID=1367069
LOS ANGELES (Reuters) - GlaxoSmithKline Plc has won a three-week reprieve
from a federal judge's order to pull its television ads for the popular
antidepressant Paxil, a company spokesman said on Friday.
A group of Paxil users sued the British-based company in federal court in Los
Angeles, claiming Glaxo deliberately played down the severity of withdrawal
symptoms associated with abruptly stopping the drug. The Paxil plaintiffs
claimed the TV ads, which describe the drug as "not habit forming," are harmful
and misleading and not consistent with Paxil ads in foreign countries that
advise users of "withdrawal symptoms."
GlaxoSmithKline denied that stopping the drug causes cravings -- only
"discontinuation syndrome" -- and pointed out that the ads for Paxil, its
top-selling product, passed muster with the Food and Drug Administration.
Earlier this week, US District Judge Mariana Pfaelzer granted a temporary
injunction against the ads until the case is decided, but she delayed the start
date of the order until at least Sept. 12. Pfaelzer made the decision after
conferring by telephone late Thursday with parties to the lawsuit and attorneys
for the US Department of Justice, who represent the FDA.
The Justice Department attorneys contend that the FDA has ultimate authority
over how prescription drugs are marketed in the United States and that
Pfaelzer's order, if allowed to stand, could have "catastrophic" effects on the
drug industry.
Pfaelzer told the attorneys that she would consider only information about how
the FDA approved the Paxil ads, said attorney Karen Barth, who represents the
plaintiffs.
"She said she would be willing to consider factual evidence about what they did
with regard to the content of the ads," Barth said.
Barth added that the judge told Glaxo and justice department attorneys to take
their arguments about whether she had authority to pull the ads to the 9th
Circuit Court of Appeals. Both Glaxo and the Justice Department have asked the
judge to reconsider her preliminary injunction against the ads. Barth criticized
the FDA for backing Glaxo in the case, saying it was inappropriate for a federal
regulator to side with a company against consumers.
Pfaelzer allowed the Justice Department two weeks to research and submit briefs,
and the plaintiffs one week to respond. "They will have that commercial on
longer and the harm will be continuing," Barth said.
Glaxo has called its TV ads "critical" to Paxil sales and a spokesman touted the
ads as educational to depression sufferers who may not otherwise recognize the
symptoms of the disease.
"We feel Paxil is safe and effective and it is a medication that has
successfully treated millions of patients around the world," Glaxo spokesman
Michael Fleming said. "We are pleased the judge has asked for more information
from the FDA and is willing to listen to the FDA." Paxil had sales of $2.7
billion in 2001.
