GlaxoSmithKline (GSK) is one of the world's largest drug companies. Its Type 2 diabetes drug Avandia, its antidepressant Paxil and its anti-nausea drug Zofran can cause serious side effects that often result in lawsuits.
GlaxoSmithKline specializes in cutting-edge vaccines and popular health products like AquaFresh toothpaste and Breathe Right strips. Its global headquarters is in Brentford, England, and its U.S. headquarters is in North Carolina.
GSK is known for its global initiative to make medicines affordable in developing countries and a recent partnership with Pfizer, another pharmaceutical company, to create ViiV, a company dedicated to fighting AIDS and helping communities affected by HIV. GSK has offices in more than 100 countries. The company reached sales of $37.9 billion in 2014 and employs nearly 100,000 people worldwide.
The company’s noble goal of “enabling people to do more, feel better and live longer” has been tarnished in recent years, however, as several of its products have come under fire. GSK’s Avandia used to be the world’s best-selling diabetes pill and brought in $3 billion in annual sales. But after studies linked the drug to an increased risk of heart attack, Avandia sales were suspended in Europe and temporarily restricted in the United States. The consequences were drastic, with sales dropping to around $1 billion in 2010.
In another scandal, GSK paid fines of $3 billion in a historic federal case over illegal marking and withholding of data in 2012. That case also involved Avandia, as well as two antidepressants, Paxil and Wellbutrin, and its asthma drug, Advair. The company is also facing litigation over some of its products that have caused debilitating side effects, including birth defects, suicidal thoughts and heart attacks.
History of GlaxoSmithKline
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.
Glaxo Wellcome was created in 1995 when Jason Nathan and Company, started in 1873, merged with Burroughs Wellcome and Company, started by Henry Wellcome and Silas Burroughs in 1880.
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.
Meanwhile, Thomas Beecham began his Beecham’s Pills business in England in 1842. One of Beecham’s first products, a laxative made from aloe, ginger and soap, became very successful. Later, scientists from the company’s 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.
|Fast facts about GlaxoSmithKline|
|Established: 2000||Founders: John Smith, Mahlon Kline and others|
|Headquarters: Brentford, England||Size: More than 97,000 employees worldwide|
|2014 Sales: $37.9 billion|
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.
GSK partners with the World Health Organization (WHO), seeking to fight lymphatic filariasis (intestinal worms). In 2002, the company donated 100 million albendazole tablets to treat the condition.
It also established one of the largest vaccine businesses in the world, distributing more than 1.1 billion doses of its vaccines to 173 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.
|Products sold by GlaxoSmithKline|
|Health care items|
Scandals Involving GlaxoSmithKline
GSK continues to create and market new products. However, some of the new products have been the center of litigation after questions arose over consumer safety and the company’s marketing practices.
$750 Million Contaminated Product Settlement
In 2010, GSK was held responsible for selling contaminated products like baby oil in a whistle-blower lawsuit that began in 2004 and ended six years later with a $750 million settlement.
The case involved 20 drugs that were contaminated in a Puerto Rico plant. Paxil, Avandia and the ointment Bactroban were some of the drugs that were contaminated. The facility manufactured products worth $5.5 billion annually but closed in 2009 after attempts to fix the plant following a U.S. Food and Drug Administration (FDA) investigation failed.
$3 Billion Illegal Marketing Settlement
GSK was involved in another scandal that ended in July 2012 with a $3 billion settlement – the largest health care fraud settlement in U.S. history. The case included charges of off-label marketing (promoting uses of a drug that the FDA has not approved) of antidepressants Paxil and Wellbutrin and an asthma medication, Advair.
Paxil was marketed to children and teens even though it was only approved for use in adults. Wellbutrin was marketed as a drug to help with weight loss, sexual dysfunction, drug addiction and ADHD even though it was only approved for depression.
GSK also failed to report that its diabetes drug, Avandia, could put people at risk for heart attacks. GSK’s sales department was also censured in the case after reports showed they were responsible for bribing doctors to sell their products through entertainment, vacations, concerts and payments to go on tours. The company admitted to both bribing doctors and encouraging off-label marketing.
In addition to paying the fine, GSK agreed to be monitored by the government until 2018 to ensure it complies with marketing rules. The settlement was the conclusion of an investigation involving the FDA, the Federal Bureau of Investigation and the Department of Health and Human Services.
Controversial Paxil Study
The Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP) published one of the most controversial psychiatry studies of all time in 2001. The industry-sponsored clinical trial, later referred to as Study 329, found Paxil was effective in treating depression in adolescents.
The study was instrumental in a 2002 GSK marketing campaign that helped lead to more than 2 million prescriptions to youth that year. But many experts and scholars strongly criticized the study.
GSK released its data to researchers at the BMJ as part of an initiative to be more transparent after the multi-billion dollar settlement in 2012. The researchers determined the effectiveness claims made by Study 329 were false, and the drug showed an increased rate of harm to children and adolescents.
GSK Products May Cause Birth Defects & Heart Attacks
A number of products developed and marketed by GSK have been linked to serious side effects like birth defects, heart attacks and strokes. The company currently faces hundreds of lawsuits filed by people claiming they were wrongfully hurt by the drugs.
Before the merger, SmithKline Beecham participated in the antidepressant boom of the 1990s, introducing Paxil (paroxetine) in 1992. The drug sold well, becoming the fifth-most prescribed antidepressant in the United States by 2007. From the late-1990s to the mid-2000s, Paxil brought in $11.6 billion.
Unfortunately, Paxil comes with serious side effects, like a risk of suicidal thoughts in children and birth defects if taken during pregnancy. The packaging for the drug includes a black box, the FDA’s most serious warning, that it can cause increased suicidal thoughts and behavior in children and young adults.
The birth defects associated with the drug are so severe that the pregnancy risk category was changed from C to the more hazardous designation D in 2005. Class D indicates that there is evidence of human fetal risk based on trials. An estimated 5,000 people have filed lawsuits against GSK after claiming Paxil led to birth defects or suicide.
Glaxo Wellcome also introduced a product that worked by affecting serotonin in the 90s. The FDA approved Zofran (ondansetron) in 1991 to prevent or treat nausea and vomiting in cancer patients. Zofran is a 5-HT3 receptor antagonist that blocks serotonin in the parts of the brain that control nausea and vomiting.
But doctors prescribed Zofran to pregnant women to treat morning sickness, and studies later revealed that it could be associated with birth defects. A 2014 Zofran study of 900,000 danish women indicated the drug caused a 30 percent increase in birth defects. It can also cause life-threatening side effects like Serotonin Syndrome (too much serotonin in the body) and QT Syndrome (erratic heartbeat).
Families of children harmed by Zofran accused GlaxoSmithKline of knowing of the risk of birth defects as early as 1992. They filed lawsuits claiming the company failed to warn of possible risks and promoted the drug for use in pregnant women illegally. More than 30 Zofran lawsuits have been filed in the U.S.
In 1999, the FDA approved SmithKline Beecham’s Avandia (rosiglitazone) to treat Type 2 diabetes. The drug is part of a classification known as thiazolidinediones, which includes Rezulin and Actos. Because the first of the thiazolidinediones, Rezulin, was found to cause liver damage and was recalled in 2000, Avandia was eagerly accepted by patients with Type 2 diabetes. By 2006, it was the world’s best-selling diabetes drug, bringing in $3 billion in sales.
As Avandia sales soared, trials and hearings on Avandia began to cast doubt on the drug’s safety. GSK claimed clinical studies of the drug revealed it caused only mild side effects. The FDA held hearings to measure the drug’s risks in 2007 and then severely restricted sales of Avandia in 2010 after the drug was linked to thousands of heart attacks, strokes and heart failures.
The FDA removed the restrictions near the end of 2013, but more than 50,000 people filed Avandia lawsuits against the company. GSK eventually paid more than $460 million to resolve claims.
The FDA estimates Avandia caused as many as 100,000 heart attacks. Studies confirmed the drug increases the risk of heart attack as much 43 percent. Because of this, the drug includes a black-box warning that it can cause congestive heart failure or myocardial infarction. GSK expects more cases to be filed and has set aside $6.4 billion for litigation and settlement costs.
Future of GlaxoSmithKline
GSK is looking to improve global access to its medicines, and develop 30 medicines over the next three years. The company is researching medicines and vaccines to treat HIV/AIDS, malaria and tuberculosis –all priority diseases noted by the WHO.
In an attempt to distance itself from the negative press following the $3 billion drug scandal, GSK began a voluntary initiative to make data from clinical trials open to the public. It hopes that by providing transparency, it can regain the public’s trust. Also, with open access, other research groups can contribute to studies and find quicker and more effective results.