GlaxoSmithKline Company Information
In 2001, Glaxo Welcome and SmithKline Beecham merged to form GlaxoSmithKline.
Today, the manufacturer is divided into three major segments; pharmaceuticals,
vaccines, and general health care. It has grown into one of the biggest
vaccine producers in the world and proudly distributes 1.1 billion vaccinations
to 173 countries. In recent years, one of its largest accomplishments
was getting approval to produce the first lupus treatment in five decades.
The company stands by its motto of “enabling people to do more, feel
better, and live longer.” However, as several of its products have
been facing criticism for bringing dangerous risks to human health, the
manufacturer has been under fire. Other marketing practice scandals have
rocked the company as well.
Product Recalls from GlaxoSmithKline Company
Over the years, GSK has experienced a number of product recalls. Some of
the latest involve Paxil, Alli, and its 2015 flu vaccine. On April 17,
2015, reports surfaced with information about a recall on the four-in-one
flu vaccine because its effectiveness was found to decline over time.
This meant many people who received the injection may not have been adequately
protected from the flu virus.
One year ago, Paxil, GSK’s popular prescription antidepressant, was
recalled as well. It was believed that its active ingredient was tainted.
However, GSK ignored the potential problems until the FDA publicly issued
a warning letter. Many questions were raised about the company’s
The company’s Alli weight loss pills were also recalled due to possible
tampering. Many Alli vials were found on store shelves without labels
and with fake tamper-resistant seals. Besides the bottles, pills were
found in different shapes and colors.
Lawsuits Facing GlaxoSmithKline
Many lawsuits have been filed against GSK. Two of the most serious cases
involve Paxil and Avandia. Paxil is used to treat depression, and Avandia
is meant to help people with type 2 diabetes. From the time of FDA approval,
Paxil has been shown to bring serious side effects. In 2004, the FDA noticed
a heightened risk of developing suicidal tendencies in children or teens
who took the medicine. One year later, further research revealed Paxil
could cause pregnant women to give birth to babies with severe defects.
Many consumers felt GSK did not adequately warn about these risks, so
numerous lawsuits were filed.
Avandia is meant to treat type 2 diabetes, but it brings side effects that
cause potentially fatal heart complications. The FDA uncovered Avandia
may have been responsible for over 100,000 heart attacks. Clinical trials
performed by the manufacturer showed taking this drug doubled the risks
of cardiovascular problems in patients. However, its black-box warning
label failed to include any mention of these side effects. In 2007, GSK
was forced by the FDA to make changes in its labeling and highlight the
possibilities of cardiovascular problems or death. Lawsuits against GSK’s
Avandia allege the company knew about the dangers of this drug and ignored
concerns of doctors. The manufacturer was responsible for warning the
public about the raised cardiac risks but did nothing. It placed profits
ahead of safety.
Verdicts Against GlaxoSmithKline Company
GSK agreed to pay $229 million to settle the initial lawsuits against its
drug Avandia. However, no admission of guilt was given. Along with this
settlement, it was reported that GSK set aside $6.4 billion in anticipation
for more lawsuits. Besides claims against negative side effects, the manufacturer
paid $3 billion and plead guilty to criminal charges for fraud. The verdict
was based on implications that GSK marketed products for unapproved uses
and failed to turn over safety data concerning Avandia. It was the largest
fraud settlement in U.S. history.
Other verdicts hitting GSK in the pocket involve its drug Paxil. During
one of the first court cases concerning this medicine, a GSK memo was
released stating the company planned to “bury” negative results
stemming from animal studies. In 1980, rat studies were performed and
showed a link between Paxil and birth defects. No warning was issued to
the public. By 1998, a large number of defects were reported. Clear GSK
negligence was demonstrated, and juries sided with innocent victims. By
2012, this pharmaceutical giant paid more than $1 billion to settle over
Other GlaxoSmithKline Company Scandals
As GSK has marketed new items, certain safety concerns have surfaced about
some of its products. In 2010, this company was found guilty of selling
contaminated products made in one of its Puerto Rican plants. Paxil, Avandia,
and certain baby oils were manufactured at this facility. Although it
was responsible for over $5 billion in sales, it was closed in 2009.
In July 2012, another scandal hit the company. It faced charges of promoting
drug uses not approved by the FDA. For example, GSK marketed Paxil to
adolescents, but it was only approved for adult use. Wellbutrin, a drug
approved to treat depression, was pushed as a prescription to overcome
weight gain, sexual dysfunction, and ADHD. It was also uncovered that
GSK bribed doctors to promote Avandia, a drug known to cause heart problems.
FDA Sanctions Against GlaxoSmithKline Company
After receiving numerous complaints of adverse side effects, the FDA announced
it would restrict the use of Avandia. Only individuals who cannot control
type 2 diabetes with other medications are allowed to use this drug. This
action was deemed the best and safest way to protect the public.
During the 2014 recall of Paxil, the FDA posted a warning letter blasting
a GSK plant in Ireland. An inspection uncovered the drug maker was releasing
products that contained contaminants from a waste tank. Besides obvious
unsanitary conditions, the FDA was concerned the flow of pharmaceutical
waste into its products did not raise red flags with the quality control of GSK.
Besides paying large settlements in civil cases for many of its drugs,
GlaxoSmithKline was forced into a five-year Corporate Integrity Agreement
with the Inspector General. GSK was required to make massive changes to
its business practices, including the way its sale force gets compensated.
Instead of being awarded for reaching sales quotas, salesmen are currently
paid on quality of service.