AstraZeneca became a truly multinational company when British-owned Zeneca Group merged with the Swedish company Astra AB in 1999. It is the world’s seventh-largest maker of pharmaceuticals, after giants like Pfizer, Merck, and others. The headquarters for AstraZeneca are in London, but the company operates out of more than 100 countries around the world and has acquired numerous smaller companies from a number of nations.
Some of AstraZeneca’s most successful products have been drugs like Prilosec and Nexium, Crestor, Onglyza, Farxiga, and more. In spite of the huge successes and billions of dollars in revenue, this huge pharmaceutical company has had major setbacks. From controversies regarding unethical marketing practices to harmful and dangerous drugs, AstraZeneca has had is fair share of problems and has had to pay up in many lawsuits.
AstraZeneca – Background
Based in London, AstraZeneca is a huge, multinational and international maker of pharmaceuticals. It employs over 50,000 people around the world and takes in billions of dollars in revenue each year. Today’s AstraZeneca formed in 1999 when Astra AB merged with Zeneca Group. The main areas of research and development for the company are oncology, respiratory illnesses, autoimmune disorders and inflammation, cardiovascular health, metabolic diseases, like type 2 diabetes, neuroscience, vaccines, and infections.
Type 2 diabetes has been a major area of focus for the company, especially since it bought the diabetes division of Bristol-Myers Squibb in 2014. Prior to that acquisition, AstraZeneca had partnered with Bristol-Myers Squibb to develop several type 2 diabetes drugs. Some of the most popular drugs made by AstraZeneca are Prilosec and Nexium, which treat acid reflux, Crestor for lowering cholesterol, Iressa and Zoladex for treating cancer, Seroquel, an antipsychotic, and Farxiga and Onglyza for lowering blood sugar in people with type 2 diabetes.
History of the Company
Astra AB began in Sweden in 1913, but was not profitable until the 1920s, reaching a pinnacle of success in the 1950s. Astra’s major breakthrough was the invention of lidocaine in 1948. This local anesthetic is important in medicine and helped launch the company to international success. Astra focused on pharmaceuticals in the 1980s and 1990s, developing and patenting several new drugs.
Zeneca Group, in comparison, was a relatively new company when it merged with Astra in 1999. It formed in 1993 when Imperial Chemical Industries fractured into several smaller companies. Imperial began in London in the 1920s and began making pharmaceuticals in the 1940s. Zeneca joined up with Astra at a time when many of the patents on its best selling drugs were about to expire. At the time that Zeneca acquired Astra the new company was the fourth-largest pharmaceutical company in the world.
AstraZeneca may be one of the largest maker of drugs in the world, but has also been a source of scandals and unethical practices. One of the most notorious scandals occurred in the early 2000s with the drug Seroquel. It is an antipsychotic indicated for the treatment of bipolar disorder and schizophrenia. A 2002 study found that the results of children taking Seroquel for bipolar disorder were inconclusive.
AstraZeneca published that study in spite of the head researcher’s finding that the results were inconclusive and claimed that Seroquel was more effective in treating bipolar in children than other medications. This led to widespread use of the drug and other similar antipsychotics in children. It quickly became the go-to drug for this use, even though it was not officially approved for use in children.
Later it was found that Seroquel could cause harmful effects in children and that AstraZeneca had covered up this evidence. Company emails prove that the company knew about the effects and were actively burying them. The researcher from the 2002 study was also later found to have taken consulting fees from AstraZeneca, seen as kickbacks. Ultimately AstraZeneca had to pay millions of dollars in fines for marketing Seroquel for off-label uses.
Crestor is a statin that is indicated for lowering blood cholesterol in people with high levels and at risk for heart attacks and strokes. It has been a big seller for AstraZeneca, but not without controversies. While the company claims that the drug can lower cholesterol levels by as much as 52 percent, some of the potential side effects and complications are serious enough that the FDA has considered pulling it from the market.
One major issue with Crestor has been liver damage. It has been found to increase the amount of certain liver enzymes in people who take it, more so with larger doses. In rare cases the medication has caused liver damage after a few months of treatment, and even hepatitis. Although the FDA decided against pulling Crestor, the agency does recommend that patients have liver tests before using it.
Another rare, but very serious possible complication is a condition called rhabdomyolysis. This occurs when muscle tissue breaks down and enters the bloodstream. It can cause pain, kidney damage, weight gain, seizures, and ultimately death if not treated. There is evidence that AstraZeneca knew about this very serious risk before getting Crestor approved.
Prilosec and Nexium
AstraZeneca’s popular heartburn and acid reflux medications have been well tolerated by many patients but have also been found to potentially cause magnesium deficiencies, heart attacks, bone fractures, and a specific type of gastrointestinal infection called Clostridium difficile-associated diarrhea. Although the FDA has issued warnings about all of these possible complications, the medications have remained on the market. Many experts have called for them to be removed, but the FDA has not taken that step.
AstraZeneca has also faced problems over one of its type 2 diabetes drugs, called Onglyza (saxagliptin). Created as a partnership between the company and Bristol Myers Squibb, saxagliptin has been proven to lower blood sugar in patients with type 2 diabetes, but also to increase the risk of developing pancreatitis, having heart disease, and experiencing a life-threatening condition called lactic acidosis.
Saxagliptin belongs to a class of drugs called DPP-4 inhibitors. They have been found to increase the risk of pancreatitis and pancreatic cancer. Some patients on these medications have developed acute pancreatitis, which can be deadly if not recognized and treated immediately. People taking the drug have also been found in autopsies to have developed pre-cancerous cells in the pancreas. Research and reports have also found that Onglyza can increase the risk of congestive heart failure and a condition called lactic acidosis. As with pancreatitis, lactic acidosis can be fatal if not treated right away.
Farxiga is another of AstraZeneca’s and Bristol-Myers Squibb’s type 2 diabetes drugs, designed to lower blood sugar levels. Farxiga belongs to a class of drugs called SGLT2 inhibitors and was only approved by the FDA in 2014. As a newer drug it has already been found to increase the risk of developing certain serious health conditions including bladder cancer and diabetic ketoacidosis.
Clinical trials with Farxiga demonstrated that patients taking it have an increased risk of developing bladder cancer. In 2015 the FDA warned that Farxiga and other SGLT2 inhibitors cold cause ketoacidosis, a serious condition that causes fat to break down and dangerous levels of ketones to build up in the bloodstream. This condition can be fatal if not treated right away. The FDA has required that more clinical trials be conducted to clarify the risks associated with the drug.
AstraZeneca has faced lawsuits over Crestor, for the risk of rhabdomyolysis and liver damage, especially since the company may have known about the risks and sought approval and marketed the drug anyway. Lawsuits have also focused on Onglyza, particularly by those people who lost a loved one to heart failure after taking the drug. Lawsuits over Farxiga are likely to be filed over cases of ketoacidosis and bladder cancer. As a new drug, there may be more problems that come to light and trigger lawsuits in the future.