Travis Huffman

Professor Shively
COMM 4700
5 November 2015
Johnson & Johnson/ GlaxoSmithKline Paxil Case Study
History:
GlaxoSmithKline (GSK) was created in 2001 in the merger of two established
companies, Glaxo Wellcome and SmithKline Beecham. These companies originated in
the United States and England, respectively, and their histories include a series of
mergers that began in the 1800s.
SmithKline Beecham began with John K. Smith opening a drugstore in
Philadelphia in 1830. He was joined by Mahlon Kline in 1865. Together Smith and Kline
acquired numerous companies, like a vaccines business and, most notably, French
Richards and Company, another well-respected drug wholesaler.
Thomas Beecham began his Beechams Pills business in England in 1842. One of
Beechams first products, a laxative made from aloe, ginger and soap, became very
successful. Later, scientists from the companys research laboratory discovered
amoxicillin and sold the antibiotic as Amoxil in 1972. Amoxil was widely accepted.
Beecham merged with Smith and Kline in 1989 to become SmithKline Beecham.
The merger of Glaxo Wellcome and SmithKline Beecham created
GlaxoSmithKline in 2001. Today the company is divided into three main segments:
pharmaceuticals (treating cancer, heart disease and HIV/AIDs), vaccines (treating
hepatitis, polio and typhoid), and consumer health care (treating oral and skin problems)
and has grown steadily, selling products in more than 170 countries.

More recently, GSK set itself apart by receiving approval for the first new lupus
treatment in 50 years and by providing laboratory equipment for the 2012 Olympics.

Past PR Efforts:
GlaxoSmithKline (GSK) has had numerous public relations cases and issues
surrounding their business, mainly dealing with the pharmaceuticals, and products
regulated under the Food and Drug Administration (FDA). On March 27, 2014 GlaxoSmithKline (GSK) Consumer Healthcare voluntarily recalled all alli weight loss
products from U.S. and Puerto Rico retailers as the company believed that some packages
of the product were tampered with and may contain product that is not authentic alli.
Safety is our first priority and we are asking retailers and pharmacies to remove all alli
from their shelves immediately, said Colin Mackenzie, President Consumer Healthcare
North America. We have posted a Consumer Alert on our website,www.myalli.com, and
issued a News Release with information and photographs to help consumers determine if
their alli is authentic.
GSK did not have much to say about their voluntary recall of alli weight loss pills.
They came out and stated that they were working on creating a better-sealed bottle to put
their drugs in to avoid tampering. GSK generally makes so much money off of their
products, that it doesnt hurt them too much when they have a problem with it. GSK
announced that they would be re-releasing alli with their new improved bottles. They are
very focused on profit, and not so much about consumer or media relations.

Biggest PR Challenge for GSK:

One of GSKs greatest public relations issues was concerning the drug Paxil.
Paxil is the commonly used name for the medication, Paroxetine, which is prescribed to
patients to treat depression and other psychological issues such as panic disorder,
obsessive compulsive disorder, social anxiety, generalized anxiety disorder, and
posttraumatic stress syndrome. Not only is this drug prescribed to treat psychological
disorders, it is also prescribed for premenstrual dysphoric disorder, chronic headaches,
tingling in the hands and feet caused by diabetes, and bipolar disorder.
Paxil is one of the most potent and selective of the SSRI (selective serotonin
reuptake inhibitor) type drugs. SSRIs work by denying your brain the action to reabsorb
already released serotonin. By preventing serotonin reabsorption, it helps people sustain
an optimistic mental equilibrium while alleviating negative feelings.
Paxil first hit the market in 1992 by the early found member of GSK, SmithKline
Beecham, a British pharmaceuticals company. The FDA approved Paxil for the American
market and by 2007 was the fifth-most prescribed antidepressant drug in America.
Paxil has many side effects and withdraw symptoms that GSK did not mention to
any physicians. They made an effort to not talk about withdraw symptoms and side
effects, because this would negatively affect their sales. This also means that physicians
are not properly educating their patients on the medication that is being prescribed. Some
of these side effects include drowsiness, sexual dysfunction, to severe suicidal thoughts
and birth defects. It was not until 2004 when the FDA required manufactures of all

antidepressant drugs to add a black box warning to their product labeling. A black box
warning is the most severe warning placed on prescription medication.
GSK did not disclose any of Paxils side effects or withdraw symptoms to
physicians, thus resulting in over 5,000 lawsuits. A lawsuit against GSK regarding Paxil
may be filed by anyone who discovers or suspects the drug has causes serious side effects
or who has a child who was born with birth defects from the result of a woman that used
Paxil while pregnant.
In October 2009, the first birth defect case against GSK went to trial and was
found that GSK negligently failed to warn doctors about Paxils risks and that the drug
was potentially causing fatal defects. This family was awarded $2.5 million, and by July
2010, GSK had settled nearly 800 Paxil birth defect cases at a cost of $1.14 billion. GSK
paid on average of $50,000 per case to conclude 3,200 claims that involved patients
becoming addicted to the medication. Plaintiffs claimed that they were not thoroughly
warned about the drugs withdrawal issues. This was a very big case, and issue because
GSK had advertised Paxil as a non-habit forming medication. The result of this was a
combined $390 million for suicides and attempted suicides that were linked to the Paxil
medication.
This all resulted in the largest health care fraud settlement in Americas history. In
2012 GlaxoSmithKline agreed to plead guilty to a three-part criminal indictment and pay
$3 billion in fines and civil penalties for the promotion of Paxil and Wellbutrin for
unapproved uses, including the treatment of children and adolescents, a tactic known as
off-label marketing, and for failing to report safety data about its diabetes drug,
Avandia, to the FDA.

GSK Response:
GSK denied all allegations that their products were faulty in any way. As well of
any notion of their paying kickback to doctors and according to federal prosecutors,
using every imaginable form of high-priced entertainment from Hawaiian vacations,
paying doctors millions of dollars to go on speaking tours, to tickets to Madonna
concerts. Prosecutors also alleged GSK helped publish a medical journal article that
misrepresented data from a clinical trial and exaggerated Paxils ability to treat
depression in children. This of which they did not admit any wrongdoing in the whole
case. They were finally enticed with a settlement of $3 billion, which was less than 15
percent of revenues for the drugs that they were being tried against. The whole time GSK
did not admit any wrongdoing to any of these allegations, thus ending in a settlement.
Analysis of Efforts:
GlaxoSmithKline did a horrific job as a company with these issues they had. The
company was completely dishonest with not only the people taking the drugs, but the
ones providing them and prescribing them, not caring about the wellbeing of its
customers. GSK did not take into consideration that information about consumer
concerns must be communicated to appropriate internal audiences so problems can be
corrected before they affect public opinion. GSK was making so much money from their
drugs that they did not care about the concerns, and wanted to sell as much as they could,
while they could. GSK also did not take into consideration that media influence is
cumulative and long term. GSK was ignoring the media the whole time the allegations
were going on. The company did not do a good job through the eyes of public relations in
any circumstance.

Conclusion:
In conclusion, I would not handle this issue in any similar way that GSK did. All that
GSK did was deny anything that the media asked them about or brought to their attention.
GSK did not ever admit to this day that they did any wrongdoing. As a company that
produces medication, you would think you would care about consumer opinion when
your products affect their way of life. If I was a consumer of Paxil and found out about
the GSK situation, I would not want to consume any other GSK products.

Source List
GlaxoSmithKline-Drug Manufacturer History & Products. (n.d.). Retrieved
November 5, 2015, from
http://www.drugwatch.com/manufacturer/glaxosmithkline/


Home | GSK. (n.d.). Retrieved November 5, 2015, from http://www.gsk.com/engb/


Paxil Antidepressant Recall & Pregnancy Side Effects. (n.d.). Retrieved
November 5, 2015, from http://www.drugwatch.com/paxil/