According to the GlaxoSmithKline website, in 2001, the companies Glaxo Wellcome from the United States and SmithKline Beecham from England merged to form GlaxoSmithKline. Both of these companies had long histories dating back to the 1800s. The Glaxo Wellcome Company formed in 1995 as a result of the merger of Jason Nathan and Company and Burroughs Wellcome and Company. Both of these companies had been formed in the late 1800s. The SmithKline Beecham Company was founded by John K. Smith in 1830 with the opening of a drugstore. He added a partner, Mahlon Kline in 1865, and together, they bought numerous other companies, forming a large conglomerate.
GlaxoSmithKline employs more than 100,000 people worldwide, is headquartered in Brentford, England, and has sales in the tens of billions of dollars. GlaxoSmithKline markets products in well over 100 countries worldwide. It is an active partner with the World Health Organization in seeking to treat lymphatic filariasis, a condition that consists of an infestation of intestinal parasitic worms.
The company is divided into three major components that include:
The pharmaceutical component, which concentrates on treating diseases like cancer, HIV, and heart disease
The vaccine component, concentrating on polio, hepatitis, and typhoid – one of the largest vaccine businesses in the world
The consumer healthcare component, which concentrates on several different issues, such as skin problems, oral care, etc.
Medications Produced by GlaxoSmithKline
GlaxoSmithKline produces nearly 200 medications and markets them in numerous countries around the world. A complete list of all of their products and which products are available in specific countries can be found on the GlaxoSmithKline website. A partial list of some of the medications that GlaxoSmithKline manufactures follows:
Adartrel and Requip (ropinirole hydrochloride) are dopamine agonist medications that are used primarily for the treatment of Parkinson’s disease and for individuals with restless legs syndrome.
Advair (salmeterol, fluticasone propionate) is a medication that is used for respiratory disorders, particularly for the management of chronic obstructive pulmonary disorder (COPD) and asthma.
Amoxil (amoxicillin) and Augmentin (amoxicillin/clavulanate potassium) are antibiotic medications that are useful in treating a number of potential infections.
Avandia (rosiglitazone maleate) is a drug useful in the treatment of diabetes, particularly type II diabetes.
Avodart (dutasteride) is a medication that can be used to treat benign prostatic hyperplasia (an enlarged prostate gland) and may have some utility in addressing male pattern baldness or other forms of hair loss.
Bactroban (mupirocin) is an antibiotic that is typically administered topically to treat infections of the skin.
Becotide (beclomethasone dipropionate) is a steroid medication with a number of uses, including the treatment of asthma.
Benlysta (belimumab) is approved for the treatment of systemic lupus erythematosus.
Calpol (paracetamol) is better known as acetaminophen a popular over-the-counter analgesic medication.
Coreg (carvedilol) and Coreg CR (carvedilol phosphate) are used to treat congestive heart failure.
Dyazide (hydrochlorothiazide/triamterene) is used in the treatment of hypertension and edema (tissue swelling).
Flixonase/Flixotide (fluticasone propionate) is a corticosteroid that is used to treat asthma, allergies, Crohn’s disease, and ulcerative colitis, among other conditions.
Horizant (gabapentin enacarbil) is an anticonvulsant and pain-relieving drug that has a number of uses.
Lamictal (lamotrigine) is an anti-convulsive medication (for treating seizures) that is also used in the treatment of mood disorders, particularly bipolar disorder.
Levitra (vardenafil HCl) is used to treat erectile dysfunction.
Nimbex (cisatracurium besilate) is a muscle relaxant that is often used for anesthesia.
Paxil/Seroxat (paroxetine) is a selective serotonin reuptake inhibitor, or antidepressant medication – one of the bestselling antidepressant medications in the world.
Tykerb/Tyverb (lapatinib) is used in the treatment of breast cancer and other tumors.
Ultiva (remifentanil) is a short-acting opiate or narcotic drug that is most often used as a preanesthetic drug.
Wellbutrin (bupropion hydrochloride) is an antidepressant medication that also has a number of other uses. Wellbutrin is commonly used as an adjunctive medication to other antidepressants.
Zofran (ondansetron) is a serotonin receptor agonist that is used to treat nausea, especially for individuals undergoing chemotherapy.
As with any large corporation, GlaxoSmithKline has been involved in numerous legal battles. Some of their major legal battles and complications are outlined below.
In 1991, the Glaxo Wellcome Company got approval by the Food and Drug Administration (FDA) for their drug Zofran as a treatment for nausea in cancer patients. The drug is a serotonin receptor antagonist that blocks the effects of serotonin in areas of the brain that are associated with vomiting and nausea. The drug was also prescribed to pregnant women in an effort to treat the nausea associated with morning sickness, and this has been associated with a list of birth defects as well as the potential for causing serotonin syndrome (a potentially fatal condition as a result of an overabundance of serotonin) and erratic heartbeat. Evidence suggested that GlaxoSmithKline knew that pregnant women taking the drug would be at increased risk for having birth defects in their children as early as 1992. There have been numerous lawsuits filed against GlaxoSmithKline claiming that the company had knowledge of this potential and failed to warn the public about these risks.
In 1990, SmithKline Beecham introduced Paxil. The drug became a success for the company, bringing in billions of dollars between the 1990s and mid-2000s. Paxil became associated with several health-related issues, including suicidality (especially in adolescents and children), birth defects in fetuses when used by pregnant women, and others. The risks for pregnant women have actually been upgraded to indicate that there is research evidence indicating that use of Paxil in pregnant women can increase the risk of birth defects in their children; the FDA upgraded this from Class C evidence to Class D evidence to acknowledge that there is actual research suggesting this association exists.There have been numerous lawsuits filed against GlaxoSmithKline as a result of these findings as a result of allegations by people who claim their children suffered birth defects because they took Paxil while pregnant, and they were not informed of the risks even though GlaxoSmithKline was aware of them.
Avandia was approved by the FDA in 1999 for the treatment of type II diabetes. SmithKline Beecham marketed the drug aggressively because some of the other popular drugs in the same class that had been used to treat type II diabetes, thiazolidinediones, had been recalled due to evidence that they increased the risk for liver damage. By the mid-2000s, Avandia was one of the world’s bestselling diabetes medications.GlaxoSmithKline claimed that the drug only had very mild side effects; however, the drug was linked to thousands of cases of stroke and heart attack. There been more than 50,000 lawsuits against GlaxoSmithKline regarding this issue with approximately $460 million paid out. The FDA has suggested that even more heart attacks may be linked to the drug’s use and now requires a black box warning on packages of Avandia regarding its potential to cause heart failure.
A very controversial study relating to GlaxoSmithKline was published in the Journal of the American Academy of Child and Adolescent Psychiatry, now commonly referred to as Study 329. The study was a clinical trial sponsored by GlaxoSmithKline that investigated the effectiveness of Paxil for treating depression in children and adolescents. The results of the study claimed that Paxil is safe and effective for use in this demographic. The study influenced a marketing campaign by GlaxoSmithKline that increased its prescriptions of Paxil to more than 2 million young people during that year; however, the study was heavily criticized and GlaxoSmithKline released its data to the British Medical Journal researchers after having to make a huge settlement in 2012 on another issue (see below). The researches at the British Medical Journal found that the claims of the study were not true and use of the drug actually increases the risk of harm to adolescents and children (specifically issues with suicidality).
In 2012, GlaxoSmithKline was forced to make a $3 billion settlement regarding its illegal marketing practices. The Food and Drug Administration (FDA) had not approved some of the uses for drugs like Wellbutrin, Paxil, and Advair that GlaxoSmithKline was attempting to claim the medications had been approved to treat. For example, even though Paxil was only approved for use in adults, GlaxoSmithKline marketed the drug as being safe and effective for treating depression in teenagers and young children. The drug Wellbutrin does have FDA approval for the treatment of depression; however, GlaxoSmithKline was also marketing it for weight loss, to treat ADHD, to treat sexual dysfunction, and even as a withdrawal management medication.GlaxoSmithKline has been cited on numerous occasions for not informing the public of risks associated with using many of its products. The company was also found guilty of providing physicians with special favors in exchange for encouragement from physicians for these off-label uses and to get them to downplay known risks of certain drugs. In addition to the financial sentiment, GlaxoSmithKline agreed to be monitored by the federal government until 2018.
There are a number of other pending legal actions against GlaxoSmithKline as would be expected with any pharmaceutical company.
GlaxoSmithKline is a large conglomerate of companies that operates worldwide and distributes a number of different medications that treat a variety of conditions and diseases. GlaxoSmithKline has been the target of a number of lawsuits and investigations regarding its marketing practices for many of its drugs and continues to be monitored by the federal government as a result of past violations. There have been repeated accusations regarding GlaxoSmithKline’s unfair and unethical approaches to marketing its drugs for off-label uses.