GlaxoSmithKline

GlaxoSmithKline (GSK) is a major pharmaceutical company with nearly 100,000 employees in over 150 countries. The company holds more than a third of emerging markets, showcasing 39 new medicines and 15 vaccines being developed in 2019.

GlaxoSmithKline was born from the merger of Glaxo Wellcome and SmithKline Beecham in 2001. GSK’s U.S. office is in North Carolina and its main headquarters is located in Brentford, England. The company has 89 manufacturing and research facilities in the U.K., U.S., Belgium and China.

In 2019, GlaxoSmithKline’s revenue for the final quarter of 2019 was $11.509 billion, positioning itself as the fifth-largest pharmaceutical corporation by revenue according to Becker’s Hospital Review. GSK has three main areas of production, including:

GSK’s list of accomplishments is long and far-reaching. Through partnerships with PULSE Volunteers, Save the Children, and the World Health Organization, GSK works to improve health care around the globe.

As a leader in vaccine manufacturing, GSK’s gave 701 million doses to 172 countries in 2019. The company works to improve the health of millions of children in Africa and other developing countries, investing billions in research and development.

The corporation and the WHO launched a campaign to treat a condition known as lymphatic filariasis, which is a parasitic roundworm in the intestines. GSK also manufactured a lupus treatment that has been the first to receive FDA-approval in 50 years.

Through GSK has a number of positive impacts in the medical community, the company has faced legal action for injuries to consumers.

Drugs + Devices

GSK manufactures everyday items like Sensodyne toothpaste and specialty treatments for HIV-infected individuals. Though GSK has an extensive product listing, two of its drugs have been thrust into the spotlight.

Zofran, an anti-nausea drug, and Paxil, an antidepressant, have injured thousands of consumers and their families. These drugs can cause birth defects and additional adverse reactions in children and adolescents.

Zofran

Zofran, also known as ondansetron, is a 5-HT3 receptor antagonist that acts on the brain’s serotonin levels. The anti-nausea drug was approved in 1991 to treat nausea and vomiting caused by chemotherapy, but many doctors prescribe it to treat a severe form of morning sickness known as hyperemesis gravidarum.

In 2014, a study published in the American Journal of Obstetrics and Gynecology found that Zofran caused an increased risk of birth defects. The study, which included 900,000 Danish women, showed a 30 percent higher risk associated with Zofran exposure.

Zofran has been linked to a number of birth defects, including:

• Congenital malformations
• Serotonin syndrome
• QT Syndrome or erratic heartbeat
• Facial/skull defects
• Club feet

GSK may have known about Zofran’s birth defect risk in 1992, but the company chose not to warn pregnant women. As a result of the company’s potential negligence, many babies were born with debilitating birth defects.

Paxil

Paxil, also known as paroxetine, is an antidepressant that was introduced to the market in 1992. In 2007, Paxil ranked as the fifth most prescribed in its class. Since its boom, Paxil has garnered more than $11 billion in sales.

In 2001, a controversial study on Paxil was published in the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP). The study, known as Study 329, provided data that showed Paxil could effectively treat depression in young adults. The study prompted the FDA to give GSK the green light to expand Paxil’s demographic and start marketing to American youth.

In 2002, GSK launched a marketing initiative that yielded a heavy increase in adolescent prescriptions. More than 2 million adolescents began using Paxil, though some scientists objected to the safety of its use.

Adhering to a transparent research and development platform, GSK’s Study 329 data was made public. A British Medical Journal review of the results not only led to doubts about the effectiveness of the drug, but it also found an increased risk for infants and young adults.

Paxil has been linked to birth defects, which prompted the FDA to alter the drug’s pregnancy category. In 2005, the agency elevated Paxil’s risk from category C to category D, which confirms “positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans,” according to the national Chemical Hazards Emergency Medical Management (CHEMM).

Babies exposed to Paxil in utero may be born with a number of birth defects, including:

• Cleft lip and cleft palate
• Clubfoot
• Developmental issues
• Reduced IQ
• Spina bifida
• Persistent Pulmonary Hypertension (PPHN)
• Hypoplastic Left/Right heart Syndrome (HLHS)
• Heart defects
• Brain and skull defects
• Intestinal/abdominal defects
• Miscarriage
• Premature birth

Paxil can also cause adverse reactions in children and adolescents. Paxil has been associated with an increased risk of suicidal thoughts and behaviors, a serious effect that prompted the FDA to add a Black Box warning to the drug’s labeling.

Legal Actions

GSK prides itself on “responsible business practices,” but the influential corporation has been held liable for failing to uphold consumer safety on more than one occasion. Legal teams linked GSK to healthcare fraud, illegitimate marketing, bribing prescribers, and non-disclosure of serious risk factors. Litigation ensued and the corporation chose to settle.

2010 Settlement

A whistleblower discovered that GSK had been selling 20 contaminated products manufactured in Puerto Rico. The list of corrupted products included baby oil, Bactroban cream, the antidepressant Paxil and the type 2 diabetes medication Avandia.

Though it began in 2004, the lawsuit lasted for six years. The FDA simultaneously investigated the company and the factory in Puerto Rico. In 2009, the company closed the manufacturing facility, which produced a number of items valued at $5.5 billion. GSK agreed to a $750 million settlement in 2010.

2012 Settlement

In 2012, GSK became enveloped in the largest health care fraud scandal to date. After an investigation by the FDA, the Federal Bureau of Investigation and the Department of Health and Human Services, it became clear the company marketed its drugs for unapproved uses and hid significant consumer safety data.

The corporation engaged in the off-label marketing of multiple drugs in its portfolio, including asthma drug Advair, type 2 diabetes drug Avandia, and antidepressants Paxil and Wellbutrin. Legal teams accused GSK of the following:

• Marketing Paxil, an antidepressant approved for adults, to children and adolescents
• Marketing Wellbutrin, an antidepressant approved for depression, to assist with sexual dysfunction, ADHD, substance abuse and weight loss
• Hiding data that showed Avandia, a type 2 diabetes drug, was linked to cardiac issues
• Bribing physicians to prescribe its drugs for unapproved uses with tickets, trips and tour invitations

GSK settled the case and paid out $3 billion. Until 2018, GSK’s marketing tactics were watched by government regulators. After the settlement, GSK hoped to repair its tarnished reputation with a commitment to transparency in all clinical trials.

Consumer Powerhouses

GSK is a multi-billion dollar operation. When safety fails to be a priority, it’s the consumer who gets hurt in the process.

Individuals injured by GSK’s drugs Paxil and Zofran have taken action against GSK for its marketing practices and withholding of data, which led to thousands of injuries and many deaths.

A group of 30 families has filed against the makers of Zofran to gain compensation that would allow them to provide medical care for babies born with birth defects. Paxil, also linked to birth defects, has caused a number of suicides, leading to 5,000 lawsuits against GSK.