German pharmaceutical company Boehringer Ingelheim has been in existence for nearly 150 years and it sells billions of dollars of pharmaceutical products every year. With nearly 50,000 employees around the world and more than 100 affiliate companies, Boehringer Ingelheim is one of the biggest drug makers in the world. Since the company was founded in 1885, the focus has been to research, develop, making, and selling innovative drugs with important therapeutic value.

Throughout its history, Boehringer Ingelheim has been responsible for creating and manufacturing several important drugs, including those that treat cancer, hepatitis, and type 2 diabetes. The company has also had some controversies, including drugs with serious side effects, poor quality control in manufacturing, and unethical clinical trials. Two of their most popular drugs, Tradjenta and Pradaxa, could cost the Boehringer Ingelheim millions in settlement funds.

Boehringer Ingelheim – Overview

Founded in Germany in 1885, Boehringer Ingelheim has been in the business of making drugs longer than almost any other pharmaceutical company. The company remains family-owned and is the largest such pharmaceutical maker in the world and among the top 20 largest of all pharmaceutical companies.

Boehringer Ingelheim researches, develops, manufactures, and sells a variety of medical products, both for humans and animals. The key areas of research focus for the company are medications for treating respiratory illnesses, cancer, metabolic disorders, and drugs related to the central nervous system and immunology. In 2015, Boehringer Ingelheim took in about 15 million Euros in revenue and spent approximately 20 percent of that revenue on the research and development of new drugs. The company has research centers in Germany, Italy, Austria, Japan, and the U.S.

Although Boehringer Ingelheim has had a largely good reputation for quality and ethical practices, there have been some missteps over the years. These include drugs that could be more harmful than the company originally communicated, unethical practices during clinical trials, and issues with poor quality control in manufacturing.

History of the Company

Today’s company was first founded in 1885 in Ingelheim, Germany by Albert Boehringer. With just a few employees making tartaric acid, the company grew over the decades to become one of the world’s most important maker of pharmaceuticals. Manufacturing has always been an important part of the business, even as the company branched out into research and development.

Boehringer Ingelheim didn’t become a worldwide company until the late 1940s when it started the first subsidiary outside of Germany. From there the company expanded throughout Europe and to other continents. Although it has remained a family company, Boehringer Ingelheim changed the organization in the 1990s to include managing directors not related to the family.

Tradjenta

Boehringer Ingelheim worked with Eli Lilly to develop Tradjenta, a drug to treat type 2 diabetes by lowering blood sugar levels. It is a relatively new type of drug in the class called DPP-4 inhibitors. These drugs have been proven to lower blood sugar, but since being approved by the U.S. Food and Drug Administration (FDA) in 2011, serious complications have been seen in some patients.

These include lactic acidosis, a buildup of lactic acid in the body that is dangerous and can be deadly, although it is treatable. Another issue is pancreatitis and pancreatic cancer. Tradjenta acts in the pancreas and several cases have been reported of patients developing acute and serious pancreatitis. Some of these patients have even been found to have developed pre-cancerous cells in the pancreas. More research is needed to clarify the risk of getting cancer while taking Tradjenta.

Pradaxa

The drug company has also had some serious issues with its blood thinner Pradaxa. Approved by the FDA in 2010, this is a newer type of blood thinner, one of several designed to be safer, more effective, and easier to use than warfarin and other older blood thinners. Boehringer Ingelheim has marketed Pradaxa as safer, and less prone to cause excessive bleeding, than warfarin, and yet this might not be true.

Studies from 2014 demonstrated that, in some patients, the risks of bleeding are even greater than with warfarin. This risk existed before Boehringer Ingelheim had developed an antidote, which could reverse the action of the drug and stop dangerous bleeding. Studies also found that Pradaxa carried a greater risk of heart attacks than warfarin. The FDA has issued warnings about these risks and some people have accused Boehringer Ingelheim of knowing about the risks and not communicating them.

Controversial Drug Trials

Dangerous drugs are not the only issues Boehringer Ingelheim has faced. A German magazine recently reported on unethical clinical trials the company may have conducted in the 1980s. Several drug companies took advantage of looser laws regarding medical trials in East Germany and conducted trials that now and in most countries would be both unethical and illegal.

Boehringer Ingelheim is being accused of being part of those trials, which included paying hospitals high amounts of money to test drugs on their patients. Many of these patients were never told about the trial and were not asked to give consent to be a part of them. Six hundred trials like this were conducted in East Germany, with more than 50,000 patients affected, many of whom died. Boehringer Ingelheim claims to only be aware of three such studies in which may have unknowingly participated.

Quality Control Issues

Boehringer Ingelheim has also faced issues over quality control. As both a researcher and manufacturer of pharmaceuticals, the company has to ensure that the drugs it makes are not contaminated or defective in any way. In 2013 the FDA issued a warning letter to the company, stating that the agency had observed several problems with quality control and manufacturing violations that needed to be corrected.

Once cited violation was that the company failed to fully investigate deviations from correct manufacturing of active pharmaceutical ingredients. In one specific example, the FDA stated that foreign particles had been found in one of these ingredients, but there was no adequate investigation into how the contamination happened, nor was there a correction.

Lawsuits

Lawsuits against companies that make newer diabetes drugs, including DPP-4 inhibitors like Tradjenta, are piling up and Boehringer Ingelheim may be the next to be forced to pay. Pradaxa has been a bigger source of lawsuits for the company, with thousands of cases settled in 2014. Although the company denied any wrongdoing, it did agree to pay $650 million to settle about 4,000 U.S. cases regarding Pradaxa. Boehringer Ingelheim is posed to grow even bigger, with new and innovative drugs, and yet it may have more setbacks in the form of lawsuits from patients who have been harmed by their products.